Abstract and Keywords - University of Manchester



Clinical InvestigationInadequacy of Existing Clinical Prediction Models for Predicting Mortality after Transcatheter Aortic Valve Implantation Glen P. Martin, MSc 1; Matthew Sperrin, PhD1; Peter F. Ludman, MA, MD, FRCP, FESC2; Mark A. de Belder, MA, MD, FRCP 3; Chris P. Gale, PhD, FRCP, FESC 4; William D. Toff, MD, FRCP, FESC 5,6; Neil E. Moat, MBBS, MS 7; Uday Trivedi, MBBS 8; Iain Buchan, MD, FFPH 1; Mamas A. Mamas, MA, DPhil, FRCP 1,91: Health e-Research Centre, University of Manchester, Manchester, United Kingdom2: Queen Elizabeth Hospital, Birmingham, United Kingdom3: James Cook University Hospital, Middlesbrough, United Kingdom4: MRC Bioinformatics Unit, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds5: Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, United Kingdom6: NIHR Leicester Cardiovascular Biomedical Research Unit, Leicester, United Kingdom 7: Royal Brompton and Harefield National Health Service (NHS) Foundation Trust, London, United Kingdom8: Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton,United Kingdom9: Keele Cardiovascular Research Group, Keele University, Stoke-on-Trent, UK, Royal Stoke Hospital, University Hospitals North Midlands, Stoke-on-Trent, United KingdomAbbreviated Title: CPMs predicting mortality after TAVIConflict of Interest: No conflicts of interest to declareCorresponding Author: Mamas A. MamasProfessor of Cardiology / Honorary Consultant CardiologistKeele Cardiovascular Research Group,University of KeeleStoke-on-Trent, United KingdomEmail: mamasmamas1@yahoo.co.ukAbstract and KeywordsBackgroundThe performance of emerging Transcatheter Aortic Valve Implantation (TAVI) clinical prediction models (CPMs) in national TAVI cohorts distinct from those where they have been derived is unknown. This study aimed to investigate the performance of the German Aortic Valve, FRANCE-2, OBSERVANT and American College of Cardiology (ACC) TAVI CPMs compared with the performance of historic cardiac CPMs such as the EuroSCORE and STS-PROM, in a large national TAVI registry. MethodsThe calibration and discrimination of each CPM were analysed in 6676 patients from the UK TAVI registry, as a whole cohort and across several subgroups. Strata included gender, diabetes status, access route and valve type. Furthermore, the amount of agreement in risk classification between each of the considered CPMs was analysed at an individual patient level. ResultsThe observed 30-day mortality rate was 5.4%. In the whole cohort, the majority of CPMs over-estimated the risk of 30-day mortality, although the mean ACC score (5.2%) approximately matched the observed mortality rate. The areas under ROC curve were between 0.57 for OBSERVANT and 0.64 for ACC. Risk classification agreement was low across all models, with Fleiss’s kappa values between 0.17 and 0.50.ConclusionsAlthough the FRANCE-2 and ACC models outperformed all other CPMs, the performance of current TAVI-CPMs was low when applied to an independent cohort of TAVI patients. Hence, TAVI specific CPMs need to be derived outside populations previously used for model derivation, either by adapting existing CPMs or developing new risk scores in large national registries.Keywords: Aortic Stenosis – Transcatheter Aortic Valve Implantation – Mortality Risk Prediction – Clinical Prediction ModelsIntroduction Despite surgical aortic valve replacement (SAVR) being the definitive treatment strategy for severe symptomatic Aortic Stenosis (AS), a significant proportion of patients are not offered surgery due to co-morbidities or frailty that contribute to high surgical risks and adverse outcomes in such patient groups ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1093/eurheartj/ehi471", "ISBN" : "0195-668X (Print)\\n0195-668X (Linking)", "ISSN" : "0195668X", "PMID" : "16141261", "abstract" : "AIMS: To analyse decision-making in elderly patients with severe, symptomatic aortic stenosis (AS). METHODS AND RESULTS: In the Euro Heart Survey on valvular heart disease, 216 patients aged > or =75 had severe AS (valve area < or =0.6 cm(2)/m(2) body surface area or mean gradient > or =50 mmHg) and angina or New York Heart Association class III or IV. Patient characteristics were analysed according to the decision to operate or not. A decision not to operate was taken in 72 patients (33%). In multivariable analysis, left ventricular (LV) ejection fraction [OR = 2.27, 95% CI (1.32-3.97) for ejection fraction 30-50, OR = 5.15, 95% CI (1.73-15.35) for ejection fraction < or =30 vs. >50%, P = 0.003] and age [OR = 1.84, 95% CI (1.18-2.89) for 80-85 years, OR=3.38, 95% CI (1.38-8.27) for > or =85 vs. 75-80 years, P = 0.008] were significantly associated with the decision not to operate; however, the Charlson comorbidity index was not [OR = 1.72, 95% CI (0.83-3.50), P = 0.14 for index > or =2 vs. <2]. Neurological dysfunction was the only comorbidity significantly linked with the decision not to operate. CONCLUSION: Surgery was denied in 33% of elderly patients with severe, symptomatic AS. Older age and LV dysfunction were the most striking characteristics of patients who were denied surgery, whereas comorbidity played a less important role.", "author" : [ { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cachier", "given" : "Agn\u00e8s", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Baron", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Messika-Zeitoun", "given" : "David", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Delahaye", "given" : "Fran\u00e7ois", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tornos", "given" : "Pilar", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gohlke-B\u00e4rwolf", "given" : "Christa", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Boersma", "given" : "Eric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ravaud", "given" : "Philippe", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vahanian", "given" : "Alec", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Heart Journal", "id" : "ITEM-1", "issued" : { "date-parts" : [ [ "2005" ] ] }, "page" : "2714-2720", "title" : "Decision-making in elderly patients with severe aortic stenosis: Why are so many denied surgery?", "type" : "article-journal", "volume" : "26" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(1)", "plainTextFormattedCitation" : "(1)", "previouslyFormattedCitation" : "(1)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(1). Transcatheter aortic valve implantation (TAVI) has emerged as an efficacious but less invasive treatment option in high and intermediate operative risk patients ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "abstract" : "Background Many patients with severe aortic stenosis and coexisting conditions are not candi- dates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. Methods We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. Results A total of 358 patients with aortic stenosis who were not considered to be suitable can- didates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan\u2013Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as com- pared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P = 0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. Conclusions In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. 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As such, treatment allocation between medical management, SAVR and TAVI depends on multiple factors, but key is the assessment of the patient’s procedural risk. Clinical prediction models (CPMs), which quantify the risks associated with the proposed treatment strategy at an individual patient level, can aid heart-teams in this clinical decision-making process and are vital for audit purposes between TAVI centres. Cardiac surgery CPMs for short-term mortality prediction, such as the European System for Cardiac Operative Risk Evaluation Score (EuroSCORE) ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1093/ejcts/ezs043", "ISSN" : "1010-7940", "PMID" : "22378855", "abstract" : "OBJECTIVES: To update the European System for Cardiac Operative Risk Evaluation (EuroSCORE) risk model. METHODS: A dedicated website collected prospective risk and outcome data on 22,381 consecutive patients undergoing major cardiac surgery in 154 hospitals in 43 countries over a 12-week period (May-July 2010). Completeness and accuracy were validated during data collection using mandatory field entry, error and range checks and after data collection using summary feedback confirmation by responsible officers and multiple logic checks. Information was obtained on existing EuroSCORE risk factors and additional factors proven to influence risk from research conducted since the original model. The primary outcome was mortality at the base hospital. Secondary outcomes were mortality at 30 and 90 days. The data set was divided into a developmental subset for logistic regression modelling and a validation subset for model testing. A logistic risk model (EuroSCORE II) was then constructed and tested. RESULTS: Compared with the original 1995 EuroSCORE database (in brackets), the mean age was up at 64.7 (62.5) with 31% females (28%). More patients had New York Heart Association class IV, extracardiac arteriopathy, renal and pulmonary dysfunction. Overall mortality was 3.9% (4.6%). When applied to the current data, the old risk models overpredicted mortality (actual: 3.9%; additive predicted: 5.8%; logistic predicted: 7.57%). EuroSCORE II was well calibrated on testing in the validation data subset of 5553 patients (actual mortality: 4.18%; predicted: 3.95%). Very good discrimination was maintained with an area under the receiver operating characteristic curve of 0.8095. CONCLUSIONS: Cardiac surgical mortality has significantly reduced in the last 15 years despite older and sicker patients. EuroSCORE II is better calibrated than the original model yet preserves powerful discrimination. 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That is most often accomplished through the use of risk models that account for preoperative patient factors that may impact outcomes. The Society of Thoracic Surgeons (STS) uses such risk models to create risk-adjusted performance reports for participants in the STS National Adult Cardiac Surgery Database (NCD). Although risk models were initially developed for coronary artery bypass surgery, similar models have now been developed for use with heart valve surgery, particularly as the proportion of such procedures has increased. The last published STS model for isolated valve surgery was based on data from 1994 to 1997 and did not include patients undergoing mitral valve repair. STS has developed new valve surgery models using contemporary data that include both valve repair as well as replacement. Expanding upon existing valve models, the new STS models include several nonfatal complications in addition to mortality. METHODS: Using STS data from 2002 to 2006, isolated valve surgery risk models were developed for operative mortality, permanent stroke, renal failure, prolonged ventilation (> 24 hours), deep sternal wound infection, reoperation for any reason, a major morbidity or mortality composite endpoint, prolonged postoperative length of stay, and short postoperative length of stay. The study population consisted of adult patients who underwent one of three types of valve surgery: isolated aortic valve replacement (n = 67,292), isolated mitral valve replacement (n = 21,229), or isolated mitral valve repair (n = 21,238). The population was divided into a 60% development sample and a 40% validation sample. After an initial empirical investigation, the three surgery groups were combined into a single logistic regression model with numerous interactions to allow the covariate effects to differ across these groups. Variables were selected based on a combination of automated stepwise selection and expert panel review. RESULTS: Unadjusted operative mortality (in-hospital regardless of timing, and 30-day regardless of venue) for all isolated valve procedures was 3.4%, and unadjusted in-hospital morbidity rates ranged from 0.3% for deep sternal wound infection to 11.8% for prolonged ventilation. The number of predictors in each model ranged from 10 covariates in the sternal infection model to 24 covariates in the composite mortality plu\u2026", "author" : [ { "dropping-particle" : "", "family" : "O'Brien", "given" : "Sean M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shahian", "given" : "David M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Filardo", "given" : "Giovanni", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ferraris", "given" : "Victor A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Haan", "given" : "Constance K", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rich", "given" : "Jeffrey B", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Normand", "given" : "Sharon-Lise T", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "DeLong", "given" : "Elizabeth R", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shewan", "given" : "Cynthia M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dokholyan", "given" : "Rachel S", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peterson", "given" : "Eric D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Edwards", "given" : "Fred H", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Anderson", "given" : "Richard P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The Annals of Thoracic Surgery", "id" : "ITEM-1", "issue" : "1", "issued" : { "date-parts" : [ [ "2009", "7" ] ] }, "note" : "Gives regression coefficients for the STS Score risk model for isolated valve surgery", "page" : "S23-S42", "publisher" : "The Society of Thoracic Surgeons", "title" : "The Society of Thoracic Surgeons 2008 Cardiac Surgery Risk Models: Part 2\u2014Isolated Valve Surgery", "type" : "article-journal", "volume" : "88" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(8)", "plainTextFormattedCitation" : "(8)", "previouslyFormattedCitation" : "(8)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(8), have been used to identify high-risk patients in randomised trials of TAVI ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "abstract" : "Background Many patients with severe aortic stenosis and coexisting conditions are not candi- dates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. Methods We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. Results A total of 358 patients with aortic stenosis who were not considered to be suitable can- didates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan\u2013Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as com- pared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P = 0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. Conclusions In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; number, NCT00530894.)", "author" : [ { "dropping-particle" : "", "family" : "Leon", "given" : "MB", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Smith", "given" : "CR", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mack", "given" : "Michael", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Miller", "given" : "D. Craig", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moses", "given" : "Jeffrey W.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Svensson", "given" : "Lars G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tuzcu", "given" : "E Murat", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Webb", "given" : "John G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fontana", "given" : "Gregory P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Makkar", "given" : "Raj R", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Brown", "given" : "David L.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Block", "given" : "Peter C.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Guyton", "given" : "Robert A.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pichard", "given" : "Augusto D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bavaria", "given" : "Joseph", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Herrmann", "given" : "Howard C", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Douglas", "given" : "Pamela S", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Petersen", "given" : "John", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Akin", "given" : "Jodi J", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Anderson", "given" : "William N", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Wang", "given" : "Duolao", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pocock", "given" : "Stuart", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The New England journal of medicine", "id" : "ITEM-1", "issue" : "17", "issued" : { "date-parts" : [ [ "2010" ] ] }, "note" : "The major PARTENER trial (cohort B)", "page" : "1597-1607", "title" : "Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery", "type" : "article-journal", "volume" : "363" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "author" : [ { "dropping-particle" : "", "family" : "Smith", "given" : "CR", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leon", "given" : "MB", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mack", "given" : "MJ", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Miller", "given" : "D. 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However, these surgical CPMs perform poorly in predicting risk after both SAVR and TAVI, as exemplified in the Placement of Aortic Transcatheter Valves (PARTNER) cohort A trial where there was large disagreement between the observed and STS-expected 30-day mortality ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "author" : [ { "dropping-particle" : "", "family" : "Smith", "given" : "CR", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leon", "given" : "MB", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mack", "given" : "MJ", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Miller", "given" : "D. 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Moreover, several cohort studies have shown the inaccuracy of the surgical CPMs in predicting mortality after TAVI ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.amjcard.2012.11.056", "ISSN" : "1879-1913", "PMID" : "23337835", "abstract" : "The original European System for Cardiac Operative Risk Evaluation (EuroSCORE) has been recently updated as EuroSCORE II to optimize its efficacy in cardiac surgery, but its performance has been poorly evaluated for predicting 30-day mortality in patients who undergo transcatheter aortic valve replacement (TAVR). Consecutive patients (n = 250) treated with TAVR were included in this analysis. Transapical access was used in 60 patients, while 190 procedures were performed using a transfemoral approach. Calibration (risk-adjusted mortality ratio) and discrimination (C-statistic and U-statistic) were calculated for the logistic EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons (STS) scores for predicting 30-day mortality. Observed mortality was 7.6% in the overall population (6.3% and 11.7% for the transfemoral and transapical cohorts, respectively). Predicted mortality was 22.6 \u00b1 12.8% by logistic EuroSCORE, 7.7 \u00b1 5.8% by EuroSCORE II, and 7.3 \u00b1 4.1% by STS score. The risk-adjusted mortality ratio was 0.34 (95% confidence interval [CI] 0.10 to 0.58) for logistic EuroSCORE, 0.99 (95% CI 0.29 to 1.69) for EuroSCORE II, and 1.05 (95% CI 0.30 to 1.79) for STS score. Moderate discrimination was observed with EuroSCORE II (C-index 0.66, 95% CI 0.52 to 0.79, p = 0.02) compared to the logistic EuroSCORE (C-index 0.63, 95% CI 0.51 to 0.76, p = 0.06) and STS (C-index 0.58, 95% CI 0.43 to 0.73, p = 0.23) score, without a significant difference among the 3 risk scores. Discrimination was slightly better in the transfemoral cohort compared to the transapical cohort with the 3 risk scores. In conclusion, EuroSCORE II and the STS score are better calibrated than the logistic EuroSCORE but have moderate discrimination for predicting 30-day mortality after TAVR.", "author" : [ { "dropping-particle" : "", "family" : "Durand", "given" : "Eric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Borz", "given" : "Bogdan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Godin", "given" : "Matthieu", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tron", "given" : "Christophe", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Litzler", "given" : "Pierre-Yves", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bessou", "given" : "Jean-Paul", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dacher", "given" : "Jean-Nicolas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bauer", "given" : "Fabrice", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cribier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-1", "issue" : "6", "issued" : { "date-parts" : [ [ "2013", "3", "15" ] ] }, "note" : "Compares risk scores in different access points for TAVI.", "page" : "891-7", "publisher" : "Elsevier Inc.", "title" : "Performance analysis of EuroSCORE II compared to the original logistic EuroSCORE and STS scores for predicting 30-day mortality after transcatheter aortic valve replacement.", "type" : "article-journal", "volume" : "111" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1016/j.ahj.2009.11.026", "ISSN" : "1097-6744", "PMID" : "20152233", "abstract" : "BACKGROUND: Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or \"inoperable\" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. OBJECTIVE: The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. METHODS: All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. RESULTS: Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% +/- 13.9% vs STS 6.7% +/- 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES > or =15%, 16% had an STS > or =10%, and 40% had an LES > or =20% or STS > or =10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. CONCLUSIONS: Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.", "author" : [ { "dropping-particle" : "", "family" : "Piazza", "given" : "Nicolo", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Wenaweser", "given" : "Peter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gameren", "given" : "Menno", "non-dropping-particle" : "van", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pilgrim", "given" : "Thomas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tsikas", "given" : "Apostolos", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Otten", "given" : "Amber", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Nuis", "given" : "Rutger", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Onuma", "given" : "Yoshinobu", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cheng", "given" : "Jin Ming", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kappetein", "given" : "A Pieter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Boersma", "given" : "Eric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Juni", "given" : "Peter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Jaegere", "given" : "Peter", "non-dropping-particle" : "de", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Windecker", "given" : "Stephan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Serruys", "given" : "Patrick W", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "American heart journal", "id" : "ITEM-2", "issue" : "2", "issued" : { "date-parts" : [ [ "2010", "2" ] ] }, "note" : "This article compares the logistic EuroScore (LES) with the Society of Thoacic Surgeons Predicted Risk of Mortality (STS). Both of these are commonly used to identify those that are at high-risk or &quot;inoperable&quot;patients for TAVI. The paper aimed to investigate the correlation between the two different scores. The paper highlights that STS is comprised of 41 variables which are divided into 8 categories demographics, risk factors, previous interventions, preoperative cardiac status, preoperative medications, hemodynamics and catheterization, operative, and valve surgery). 168 high surgical risk patients with a CoreValve system implanted between 2005 and 2009. The primary end point of this study was mortality within 30 days of the procedure. \nFor the analysis, LES and STS performance was assessed in relation to the discrimination and calibration. Discrimination (ability to correctly classify dead or alive patients) was assessed through the c-index whereas calibration was assessed by comparing the observed and expected mortalities. In order to explore the relationship between LES and STS, a scatter plot was made from which the pearsons correlation coefficient indicated the strength and direction of any association. \u00a0 It was found that LES gave higher estimates of mortality than STS; with a 0.56 pearson correlation for the correlation between STS and LES. It was also concluded that STS performed better than LES, but both has less than optimal discriminatory power and calibration. \n\u201cThe large discrepancy between LES- and STS-predicted risks of mortality might invite a reappraisal as to whether some patients implanted with the CoreValve device were indeed high-risk surgical patients. One caveat, and a general shortcoming of all surgical risk algorithms, is the omission of several measurable and unmeasurable risk factors known to influence patient selection and mortality\u201d.", "page" : "323-9", "publisher" : "Mosby, Inc.", "title" : "Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system--a Bern-Rotterdam Study.", "type" : "article-journal", "volume" : "159" }, "uris" : [ "" ] }, { "id" : "ITEM-3", "itemData" : { "DOI" : "10.1016/j.carrev.2011.04.005", "ISSN" : "1878-0938", "PMID" : "21741324", "abstract" : "BACKGROUND: The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI. METHODS: The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 \u00b1 8.1 years, and 394 (54.8%) were female. RESULTS: The mean STS score was 11.5 \u00b1 6.1, and the mean logistic EuroSCORE was 39.7 \u00b1 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 \u00b1 6.2 vs.10.0 \u00b1 5.8 and 43.4 \u00b1 23.1 vs. 37.5 \u00b1 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE. CONCLUSION: In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options.", "author" : [ { "dropping-particle" : "", "family" : "Ben-Dor", "given" : "Itsik", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gaglia", "given" : "Michael A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbash", "given" : "Israel M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Maluenda", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hauville", "given" : "Camille", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gonzalez", "given" : "Manuel A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sardi", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laynez-Carnicero", "given" : "Ana", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Torguson", "given" : "Rebecca", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Okubagzi", "given" : "Petros", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Xue", "given" : "Zhenyi", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Goldstein", "given" : "Steven A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Suddath", "given" : "William O", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kent", "given" : "Kenneth M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Lindsay", "given" : "Joseph", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Satler", "given" : "Lowell F", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pichard", "given" : "Augusto D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Waksman", "given" : "Ron", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Cardiovascular revascularization medicine : including molecular interventions", "id" : "ITEM-3", "issue" : "6", "issued" : { "date-parts" : [ [ "2011" ] ] }, "note" : "As stated in the introduction \u201cTo be included in a current randomized TAVI trial and/or registry (PARTNER trial), a patient candidate must have a Society of Thoracic Surgeons (STS) risk score of &gt;10 or a logistic EuroSCORE of &gt;20\u201d. It is vital, therefore, that such risk prediction models are accurately and consistently predicting the risk factor for each patient. This study aimed to identify the correlation between STS and the logistic EuroScore in relation to TAVI. This was achieved by analysing 718 high risk patients with severe aortic stenosis who were candidates for TAVI clinical trials. It was found that in those high-risk patients, STS was superior to the logistic EuroScore in predicting mortality. \n\n\n\n\nThis article also investigated the relationship between logistic EuroScore (LES) with the Society of Thoacic Surgeons Predicted Risk of Mortality (STS). The ability to predict 30 day mortality in three patient groups (medical management or balloon aortic valvuloplasty (BAV), surgical aortic valve replacement (AVR); TAVI) was assessed.\u00a0 718 high-risk patients were considered", "page" : "345-9", "publisher" : "Elsevier B.V.", "title" : "Comparison between Society of Thoracic Surgeons score and logistic EuroSCORE for predicting mortality in patients referred for transcatheter aortic valve implantation.", "type" : "article-journal", "volume" : "12" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(9\u201311)", "plainTextFormattedCitation" : "(9\u201311)", "previouslyFormattedCitation" : "(9\u201311)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(9–11). Consequently, TAVI specific CPMs are beginning to emerge from large cohorts of TAVI patients ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.amjcard.2014.03.014", "ISSN" : "1879-1913", "PMID" : "24837264", "abstract" : "Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate <45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction <40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system.", "author" : [ { "dropping-particle" : "", "family" : "Capodanno", "given" : "Davide", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbanti", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tamburino", "given" : "Corrado", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "D'Errigo", "given" : "Paola", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ranucci", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santoro", "given" : "Gennaro", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santini", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Onorati", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grossi", "given" : "Claudio", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Covello", "given" : "Remo Daniel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Capranzano", "given" : "Piera", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rosato", "given" : "Stefano", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Seccareccia", "given" : "Fulvia", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-1", "issue" : "11", "issued" : { "date-parts" : [ [ "2014", "6", "1" ] ] }, "page" : "1851-8", "publisher" : "Elsevier Inc.", "title" : "A simple risk tool (the OBSERVANT score) for prediction of 30-day mortality after transcatheter aortic valve replacement.", "type" : "article-journal", "volume" : "113" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1093/ejcts/ezt114", "ISSN" : "1010-7940", "PMID" : "23477927", "abstract" : "OBJECTIVES: The aim of the study was to establish a scoring system to predict mortality in aortic valve procedures in adults [German Aortic Valve Score (German AV Score)] based upon the comprehensive data pool mandatory by law in Germany. METHODS: In 2008, 11 794 cases were documented who had either open aortic valve surgery or transcatheter aortic valve implantation (TAVI). In-hospital mortality was chosen as a binary outcome measure. Potential risk factors were identified on the basis of published scoring systems and clinical knowledge. First, each of these risk factors was tested in an univariate manner by Fisher's exact test for significant influence on mortality. Then, a multiple logistic regression model with backward and forward selection was used. Calibration was ascertained by the Hosmer-Lemeshow method. In order to define the quality of discrimination, the area under the receiver operating characteristic (ROC) curve was calculated. RESULTS: In 11 147 of 11 794 cases (94.5%), a complete data set was available. In-hospital mortality was 3.7% for all patients, 3.4% in the surgical group (95% confidence interval 3.0-3.7%, n = 10 574) and 10.6% in the TAVI group (95% confidence interval 8.2-13.5%, n = 573). Based on multiple logistic regression, 15 risk factors with an influence on mortality were identified. Among them, age, body mass index and left ventricular function were categorized in three (body mass index, left ventricular dysfunction) or 6 subgroups (age). The Hosmer-Lemeshow method corroborated a valid concordance of predicted and observed mortality in 10 different risk groups. The area under the ROC curve with a value of 0.808 affirmed the quality of discrimination of the established scoring model. CONCLUSIONS: It is well known that a predictive model works best in the setting where it was developed; therefore, the German AV Score fits well to the patient population in Germany. It was designed for fair and reliable outcome evaluation. It allows comparison of predicted and observed mortality for conventional aortic valve surgery and transcatheter aortic valve implantation in low-, moderate- and high-risk groups. Thus, it enables primarily a risk-adjusted benchmark of outcome and fosters the efforts for continuous improvement of quality in aortic valve procedures.", "author" : [ { "dropping-particle" : "", "family" : "Kotting", "given" : "J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schiller", "given" : "Wolfgang", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Beckmann", "given" : "Andreas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schafer", "given" : "E.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dobler", "given" : "K.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hamm", "given" : "Christian", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Veit", "given" : "Christof", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Welz", "given" : "Armin", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Journal of Cardio-Thoracic Surgery", "id" : "ITEM-2", "issue" : "5", "issued" : { "date-parts" : [ [ "2013", "5", "1" ] ] }, "page" : "971-977", "title" : "German Aortic Valve Score: a new scoring system for prediction of mortality related to aortic valve procedures in adults", "type" : "article-journal", "volume" : "43" }, "uris" : [ "" ] }, { "id" : "ITEM-3", "itemData" : { "DOI" : "10.1136/heartjnl-2013-305314", "ISSN" : "1468-201X", "PMID" : "24740804", "abstract" : "OBJECTIVE: Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. METHODS: A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. RESULTS: TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age \u226590 years, body mass index <30 Kg/m(2), New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, \u22652 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. CONCLUSIONS: Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.", "author" : [ { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laou\u00e9nan", "given" : "C\u00e9dric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Himbert", "given" : "Dominique", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Chevreul", "given" : "Karine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Donzeau-Gouge", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fajadet", "given" : "Jean", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leprince", "given" : "Pascal", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leguerrier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Li\u00e8vre", "given" : "Michel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Prat", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Teiger", "given" : "Emmanuel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laskar", "given" : "Marc", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vahanian", "given" : "Alec", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gilard", "given" : "Martine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Heart (British Cardiac Society)", "id" : "ITEM-3", "issue" : "13", "issued" : { "date-parts" : [ [ "2014", "7" ] ] }, "note" : "This article uses data from the \u201cFrench Aortic National CoreValve and Edwards\u201d registry in order to investigate predictive factors for early mortality after TAVI. In addition, it was aimed to develop a scoring system to predict mortality after TAVI.\u00a0 \n3933 patients who underwent TAVI in 33 French centres. The patients were classified as high risk for surgery. The primary endpoint was all cause mortality 30 days after procedure. \nStatistical analyses included the use of univariate and multivariate logistic regression to build the scoring system. Discrimination and calibration of the model were assessed using the c-index and comparing Obc/Exp respectively. \nWhen investigating the early mortality the results did report those with different ages, centres, procedure type. No difference in mortality was found in centres, volume activity, time and experience of using TAVI. Age was associate with a significant increase in early mortality. Low BMI was also linked with early mortality. \nEight patient related and one procedural related variables were identified as predictive factors of early mortality; which then was used to develop a scoring system. However, the results showed that discrimination was lacking. \nIn summary the study found nine predictive factors of early mortality after TAVI. In addition a scoring system was developed which provided reasonable but certainly room for improvement.", "page" : "1016-23", "title" : "Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.", "type" : "article-journal", "volume" : "100" }, "uris" : [ "" ] }, { "id" : "ITEM-4", "itemData" : { "DOI" : "10.1001/jamacardio.2015.0326", "ISSN" : "2380-6583", "author" : [ { "dropping-particle" : "", "family" : "Edwards", "given" : "Fred H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cohen", "given" : "David J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "O\u2019Brien", "given" : "Sean M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peterson", "given" : "Eric D.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mack", "given" : "Michael J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shahian", "given" : "David M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grover", "given" : "Frederick L.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tuzcu", "given" : "E. Murat", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Thourani", "given" : "Vinod H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Carroll", "given" : "John", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Brennan", "given" : "J. Matthew", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Brindis", "given" : "Ralph G.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rumsfeld", "given" : "John", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Holmes", "given" : "David R.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "JAMA Cardiology", "id" : "ITEM-4", "issue" : "1", "issued" : { "date-parts" : [ [ "2016", "4", "1" ] ] }, "page" : "46", "title" : "Development and Validation of a Risk Prediction Model for In-Hospital Mortality After Transcatheter Aortic Valve Replacement", "type" : "article-journal", "volume" : "1" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(12\u201315)", "plainTextFormattedCitation" : "(12\u201315)", "previouslyFormattedCitation" : "(12\u201315)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(12–15). In particular, the German Aortic Valve Score (German AV) was developed using patients who underwent either surgical replacement or TAVI ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1093/ejcts/ezt114", "ISSN" : "1010-7940", "PMID" : "23477927", "abstract" : "OBJECTIVES: The aim of the study was to establish a scoring system to predict mortality in aortic valve procedures in adults [German Aortic Valve Score (German AV Score)] based upon the comprehensive data pool mandatory by law in Germany. METHODS: In 2008, 11 794 cases were documented who had either open aortic valve surgery or transcatheter aortic valve implantation (TAVI). In-hospital mortality was chosen as a binary outcome measure. Potential risk factors were identified on the basis of published scoring systems and clinical knowledge. First, each of these risk factors was tested in an univariate manner by Fisher's exact test for significant influence on mortality. Then, a multiple logistic regression model with backward and forward selection was used. Calibration was ascertained by the Hosmer-Lemeshow method. In order to define the quality of discrimination, the area under the receiver operating characteristic (ROC) curve was calculated. RESULTS: In 11 147 of 11 794 cases (94.5%), a complete data set was available. In-hospital mortality was 3.7% for all patients, 3.4% in the surgical group (95% confidence interval 3.0-3.7%, n = 10 574) and 10.6% in the TAVI group (95% confidence interval 8.2-13.5%, n = 573). Based on multiple logistic regression, 15 risk factors with an influence on mortality were identified. Among them, age, body mass index and left ventricular function were categorized in three (body mass index, left ventricular dysfunction) or 6 subgroups (age). The Hosmer-Lemeshow method corroborated a valid concordance of predicted and observed mortality in 10 different risk groups. The area under the ROC curve with a value of 0.808 affirmed the quality of discrimination of the established scoring model. CONCLUSIONS: It is well known that a predictive model works best in the setting where it was developed; therefore, the German AV Score fits well to the patient population in Germany. It was designed for fair and reliable outcome evaluation. It allows comparison of predicted and observed mortality for conventional aortic valve surgery and transcatheter aortic valve implantation in low-, moderate- and high-risk groups. Thus, it enables primarily a risk-adjusted benchmark of outcome and fosters the efforts for continuous improvement of quality in aortic valve procedures.", "author" : [ { "dropping-particle" : "", "family" : "Kotting", "given" : "J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schiller", "given" : "Wolfgang", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Beckmann", "given" : "Andreas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schafer", "given" : "E.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dobler", "given" : "K.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hamm", "given" : "Christian", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Veit", "given" : "Christof", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Welz", "given" : "Armin", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Journal of Cardio-Thoracic Surgery", "id" : "ITEM-1", "issue" : "5", "issued" : { "date-parts" : [ [ "2013", "5", "1" ] ] }, "page" : "971-977", "title" : "German Aortic Valve Score: a new scoring system for prediction of mortality related to aortic valve procedures in adults", "type" : "article-journal", "volume" : "43" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(13)", "plainTextFormattedCitation" : "(13)", "previouslyFormattedCitation" : "(13)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(13), while TAVI-specific CPMs have been derived in the France TAVI registry (FRANCE-2 model) ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1136/heartjnl-2013-305314", "ISSN" : "1468-201X", "PMID" : "24740804", "abstract" : "OBJECTIVE: Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. METHODS: A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. RESULTS: TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age \u226590 years, body mass index <30 Kg/m(2), New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, \u22652 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. CONCLUSIONS: Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.", "author" : [ { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laou\u00e9nan", "given" : "C\u00e9dric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Himbert", "given" : "Dominique", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Chevreul", "given" : "Karine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Donzeau-Gouge", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fajadet", "given" : "Jean", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leprince", "given" : "Pascal", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leguerrier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Li\u00e8vre", "given" : "Michel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Prat", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Teiger", "given" : "Emmanuel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laskar", "given" : "Marc", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vahanian", "given" : "Alec", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gilard", "given" : "Martine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Heart (British Cardiac Society)", "id" : "ITEM-1", "issue" : "13", "issued" : { "date-parts" : [ [ "2014", "7" ] ] }, "note" : "This article uses data from the \u201cFrench Aortic National CoreValve and Edwards\u201d registry in order to investigate predictive factors for early mortality after TAVI. In addition, it was aimed to develop a scoring system to predict mortality after TAVI.\u00a0 \n3933 patients who underwent TAVI in 33 French centres. The patients were classified as high risk for surgery. The primary endpoint was all cause mortality 30 days after procedure. \nStatistical analyses included the use of univariate and multivariate logistic regression to build the scoring system. Discrimination and calibration of the model were assessed using the c-index and comparing Obc/Exp respectively. \nWhen investigating the early mortality the results did report those with different ages, centres, procedure type. No difference in mortality was found in centres, volume activity, time and experience of using TAVI. Age was associate with a significant increase in early mortality. Low BMI was also linked with early mortality. \nEight patient related and one procedural related variables were identified as predictive factors of early mortality; which then was used to develop a scoring system. However, the results showed that discrimination was lacking. \nIn summary the study found nine predictive factors of early mortality after TAVI. In addition a scoring system was developed which provided reasonable but certainly room for improvement.", "page" : "1016-23", "title" : "Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.", "type" : "article-journal", "volume" : "100" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(14)", "plainTextFormattedCitation" : "(14)", "previouslyFormattedCitation" : "(14)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(14), the Italian TAVI registry (OBSERVANT model) ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.amjcard.2014.03.014", "ISSN" : "1879-1913", "PMID" : "24837264", "abstract" : "Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate <45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction <40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system.", "author" : [ { "dropping-particle" : "", "family" : "Capodanno", "given" : "Davide", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbanti", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tamburino", "given" : "Corrado", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "D'Errigo", "given" : "Paola", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ranucci", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santoro", "given" : "Gennaro", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santini", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Onorati", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grossi", "given" : "Claudio", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Covello", "given" : "Remo Daniel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Capranzano", "given" : "Piera", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rosato", "given" : "Stefano", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Seccareccia", "given" : "Fulvia", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-1", "issue" : "11", "issued" : { "date-parts" : [ [ "2014", "6", "1" ] ] }, "page" : "1851-8", "publisher" : "Elsevier Inc.", "title" : "A simple risk tool (the OBSERVANT score) for prediction of 30-day mortality after transcatheter aortic valve replacement.", "type" : "article-journal", "volume" : "113" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(12)", "plainTextFormattedCitation" : "(12)", "previouslyFormattedCitation" : "(12)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(12) and the Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapy registry (ACC model) ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1001/jamacardio.2015.0326", "ISSN" : "2380-6583", "author" : [ { "dropping-particle" : "", "family" : "Edwards", "given" : "Fred H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cohen", "given" : "David J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "O\u2019Brien", "given" : "Sean M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peterson", "given" : "Eric D.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mack", "given" : "Michael J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shahian", "given" : "David M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grover", "given" : "Frederick L.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tuzcu", "given" : "E. Murat", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Thourani", "given" : "Vinod H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Carroll", "given" : "John", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Brennan", "given" : "J. Matthew", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Brindis", "given" : "Ralph G.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rumsfeld", "given" : "John", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Holmes", "given" : "David R.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "JAMA Cardiology", "id" : "ITEM-1", "issue" : "1", "issued" : { "date-parts" : [ [ "2016", "4", "1" ] ] }, "page" : "46", "title" : "Development and Validation of a Risk Prediction Model for In-Hospital Mortality After Transcatheter Aortic Valve Replacement", "type" : "article-journal", "volume" : "1" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(15)", "plainTextFormattedCitation" : "(15)", "previouslyFormattedCitation" : "(15)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(15). However, the performance of the aforementioned TAVI-CPMs in large cohorts of patients outside of their derivation cohorts is unknown. Hence, it is unclear if they can be reliably used in other national settings.Therefore, the aim of this study was to investigate the performance and agreement of the German AV, FRANCE-2, OBSERVANT and ACC TAVI-CPMs for predicting 30-day mortality outside their development cohorts, to examine if the performance was sufficient for them to be used for this purpose. The study compared the TAVI-CPM performance against surgical CPMs, namely the Logistic EuroSCORE (LES), EuroSCORE II (ESII) and STS score.MethodsUK TAVI RegistryProspectively collected data on every TAVI procedure in the United Kingdom from January 2007 to December 2014 were obtained through the UK TAVI registry ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1136/heartjnl-2012-302534", "ISBN" : "1355-6037", "ISSN" : "1355-6037", "PMID" : "22879533", "abstract" : "This registry was set up to create a comprehensive record of all TAVI procedures performed in the United Kingdom since the introduction of the technique in 2007, to help drive quality improvement and provide data for research. Funding is independent of industry. All hospitals in the UK provide data for every consecutive patient where TAVI was attempted. The dataset includes variables defining patient demographic features, indications, procedural details and outcomes up to the time of hospital discharge. There are variables for follow up at 1 and 3 years assessing symptoms and life status. An updated dataset will be collected from 2013. Mortality is tracked centrally. Data entry is performed by clinical staff and data clerks. No external validation. The data are available for research by application to the UK TAVI Steering Group using a data sharing agreement which can be obtained at NICOR (ucl.ac.uk/nicor/).", "author" : [ { "dropping-particle" : "", "family" : "Ludman", "given" : "Peter F.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Heart", "id" : "ITEM-1", "issue" : "24", "issued" : { "date-parts" : [ [ "2012", "12", "15" ] ] }, "page" : "1787-1789", "title" : "The UK transcatheter aortic valve implantation registry; one of the suite of registries hosted by the National Institute for Cardiovascular Outcomes Research (NICOR)", "type" : "article-journal", "volume" : "98" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(16)", "plainTextFormattedCitation" : "(16)", "previouslyFormattedCitation" : "(16)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(16). By the end of 2014, 34 UK centres were performing TAVI procedures with multi-disciplinary teams of cardiologists, surgeons and other health-care professionals at each centre deciding on patients’ suitability for TAVI ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1136/heartjnl-2012-302534", "ISBN" : "1355-6037", "ISSN" : "1355-6037", "PMID" : "22879533", "abstract" : "This registry was set up to create a comprehensive record of all TAVI procedures performed in the United Kingdom since the introduction of the technique in 2007, to help drive quality improvement and provide data for research. Funding is independent of industry. All hospitals in the UK provide data for every consecutive patient where TAVI was attempted. The dataset includes variables defining patient demographic features, indications, procedural details and outcomes up to the time of hospital discharge. There are variables for follow up at 1 and 3 years assessing symptoms and life status. An updated dataset will be collected from 2013. Mortality is tracked centrally. Data entry is performed by clinical staff and data clerks. No external validation. The data are available for research by application to the UK TAVI Steering Group using a data sharing agreement which can be obtained at NICOR (ucl.ac.uk/nicor/).", "author" : [ { "dropping-particle" : "", "family" : "Ludman", "given" : "Peter F.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Heart", "id" : "ITEM-1", "issue" : "24", "issued" : { "date-parts" : [ [ "2012", "12", "15" ] ] }, "page" : "1787-1789", "title" : "The UK transcatheter aortic valve implantation registry; one of the suite of registries hosted by the National Institute for Cardiovascular Outcomes Research (NICOR)", "type" : "article-journal", "volume" : "98" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(16)", "plainTextFormattedCitation" : "(16)", "previouslyFormattedCitation" : "(16)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(16). The web-based registry comprises 95 variables detailing patient demographics, risk factors for intervention, procedural details and adverse outcomes up to the time of hospital discharge. All-cause mortality tracking was obtained from the Office for National Statistics (ONS) providing the life-status of English and Welsh patients (two countries of the UK). Mortality tracking was unavailable for patients in Northern Ireland and Scotland and as such, these patients were removed from the analysis. Statistical AnalysisMultiple imputation was used for missing values, with ten datasets imputed ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "ISBN" : "0471655740", "abstract" : "Demonstrates how nonresponse in sample surveys and censuses can be handled by replacing each missing value with two or more multiple imputations. Clearly illustrates the advantages of modern computing to such handle surveys, and demonstrates the benefit of this statistical technique for researchers who must analyze them. Also presents the background for Bayesian and frequentist theory. After establishing that only standard complete-data methods are needed to analyze a multiply-imputed set, the text evaluates procedures in general circumstances, outlining specific procedures for creating imputations in both the ignorable and nonignorable cases. Examples and exercises reinforce ideas, and the interplay of Bayesian and frequentist ideas presents a unified picture of modern statistics.", "author" : [ { "dropping-particle" : "", "family" : "Rubin", "given" : "Donald B.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "id" : "ITEM-1", "issued" : { "date-parts" : [ [ "1987" ] ] }, "publisher" : "John Wiley & Sons", "title" : "Multiple Imputation for Nonresponse in Surveys", "type" : "book" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(17)", "plainTextFormattedCitation" : "(17)", "previouslyFormattedCitation" : "(17)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(17). Missing life-status was not imputed and this analysis excluded any patient who had such a missing endpoint. To avoid underestimation of covariate-outcome associations, 30-day mortality indication was used in the imputation models for missing covariates ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1136/bmj.b2393", "ISSN" : "0959-8138", "PMID" : "19564179", "author" : [ { "dropping-particle" : "", "family" : "Sterne", "given" : "Jonathan A C", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "White", "given" : "Ian R", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Carlin", "given" : "John B", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Spratt", "given" : "Michael", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Royston", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kenward", "given" : "Michael G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Wood", "given" : "Angela M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Carpenter", "given" : "James R", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "BMJ", "id" : "ITEM-1", "issue" : "1", "issued" : { "date-parts" : [ [ "2009", "9", "1" ] ] }, "page" : "b2393-b2393", "title" : "Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls", "type" : "article-journal", "volume" : "338" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(18)", "plainTextFormattedCitation" : "(18)", "previouslyFormattedCitation" : "(18)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(18). Further details of the imputation procedure are given in the supplementary material. The risk of 30-day mortality implied by each CPM was retrospectively calculated for each patient based on the published regression coefficients ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/S0195-668X(02)00799-6", "ISSN" : "0195668X", "author" : [ { "dropping-particle" : "", "family" : "Roques", "given" : "F.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Heart Journal", "id" : "ITEM-1", "issue" : "9", "issued" : { "date-parts" : [ [ "2003", "5", "1" ] ] }, "page" : "882", "title" : "The logistic EuroSCORE", "type" : "article-journal", "volume" : "24" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1093/ejcts/ezs043", "ISSN" : "1010-7940", "PMID" : "22378855", "abstract" : "OBJECTIVES: To update the European System for Cardiac Operative Risk Evaluation (EuroSCORE) risk model. METHODS: A dedicated website collected prospective risk and outcome data on 22,381 consecutive patients undergoing major cardiac surgery in 154 hospitals in 43 countries over a 12-week period (May-July 2010). Completeness and accuracy were validated during data collection using mandatory field entry, error and range checks and after data collection using summary feedback confirmation by responsible officers and multiple logic checks. Information was obtained on existing EuroSCORE risk factors and additional factors proven to influence risk from research conducted since the original model. The primary outcome was mortality at the base hospital. Secondary outcomes were mortality at 30 and 90 days. The data set was divided into a developmental subset for logistic regression modelling and a validation subset for model testing. A logistic risk model (EuroSCORE II) was then constructed and tested. RESULTS: Compared with the original 1995 EuroSCORE database (in brackets), the mean age was up at 64.7 (62.5) with 31% females (28%). More patients had New York Heart Association class IV, extracardiac arteriopathy, renal and pulmonary dysfunction. Overall mortality was 3.9% (4.6%). When applied to the current data, the old risk models overpredicted mortality (actual: 3.9%; additive predicted: 5.8%; logistic predicted: 7.57%). EuroSCORE II was well calibrated on testing in the validation data subset of 5553 patients (actual mortality: 4.18%; predicted: 3.95%). Very good discrimination was maintained with an area under the receiver operating characteristic curve of 0.8095. CONCLUSIONS: Cardiac surgical mortality has significantly reduced in the last 15 years despite older and sicker patients. EuroSCORE II is better calibrated than the original model yet preserves powerful discrimination. It is proposed for the future assessment of cardiac surgical risk.", "author" : [ { "dropping-particle" : "", "family" : "Nashef", "given" : "Samer A M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Roques", "given" : "Fran\u00e7ois", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sharples", "given" : "Linda D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Nilsson", "given" : "Johan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Smith", "given" : "Christopher", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Goldstone", "given" : "Antony R", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Lockowandt", "given" : "Ulf", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Journal of Cardio-Thoracic Surgery", "id" : "ITEM-2", "issue" : "4", "issued" : { "date-parts" : [ [ "2012", "4", "1" ] ] }, "note" : "Gives the regression coefficients for the EuroScore II.\n\n\nA good article giving details of all the risk factors considered in the ES2 model.", "page" : "734-745", "title" : "EuroSCORE II", "type" : "article-journal", "volume" : "41" }, "uris" : [ "" ] }, { "id" : "ITEM-3", "itemData" : { "DOI" : "10.1016/j.athoracsur.2009.05.056", "ISSN" : "00034975", "PMID" : "19559823", "abstract" : "BACKGROUND: Adjustment for case-mix is essential when using observational data to compare surgical techniques or providers. That is most often accomplished through the use of risk models that account for preoperative patient factors that may impact outcomes. The Society of Thoracic Surgeons (STS) uses such risk models to create risk-adjusted performance reports for participants in the STS National Adult Cardiac Surgery Database (NCD). Although risk models were initially developed for coronary artery bypass surgery, similar models have now been developed for use with heart valve surgery, particularly as the proportion of such procedures has increased. The last published STS model for isolated valve surgery was based on data from 1994 to 1997 and did not include patients undergoing mitral valve repair. STS has developed new valve surgery models using contemporary data that include both valve repair as well as replacement. Expanding upon existing valve models, the new STS models include several nonfatal complications in addition to mortality. METHODS: Using STS data from 2002 to 2006, isolated valve surgery risk models were developed for operative mortality, permanent stroke, renal failure, prolonged ventilation (> 24 hours), deep sternal wound infection, reoperation for any reason, a major morbidity or mortality composite endpoint, prolonged postoperative length of stay, and short postoperative length of stay. The study population consisted of adult patients who underwent one of three types of valve surgery: isolated aortic valve replacement (n = 67,292), isolated mitral valve replacement (n = 21,229), or isolated mitral valve repair (n = 21,238). The population was divided into a 60% development sample and a 40% validation sample. After an initial empirical investigation, the three surgery groups were combined into a single logistic regression model with numerous interactions to allow the covariate effects to differ across these groups. Variables were selected based on a combination of automated stepwise selection and expert panel review. RESULTS: Unadjusted operative mortality (in-hospital regardless of timing, and 30-day regardless of venue) for all isolated valve procedures was 3.4%, and unadjusted in-hospital morbidity rates ranged from 0.3% for deep sternal wound infection to 11.8% for prolonged ventilation. The number of predictors in each model ranged from 10 covariates in the sternal infection model to 24 covariates in the composite mortality plu\u2026", "author" : [ { "dropping-particle" : "", "family" : "O'Brien", "given" : "Sean M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shahian", "given" : "David M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Filardo", "given" : "Giovanni", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ferraris", "given" : "Victor A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Haan", "given" : "Constance K", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rich", "given" : "Jeffrey B", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Normand", "given" : "Sharon-Lise T", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "DeLong", "given" : "Elizabeth R", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shewan", "given" : "Cynthia M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dokholyan", "given" : "Rachel S", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peterson", "given" : "Eric D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Edwards", "given" : "Fred H", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Anderson", "given" : "Richard P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The Annals of Thoracic Surgery", "id" : "ITEM-3", "issue" : "1", "issued" : { "date-parts" : [ [ "2009", "7" ] ] }, "note" : "Gives regression coefficients for the STS Score risk model for isolated valve surgery", "page" : "S23-S42", "publisher" : "The Society of Thoracic Surgeons", "title" : "The Society of Thoracic Surgeons 2008 Cardiac Surgery Risk Models: Part 2\u2014Isolated Valve Surgery", "type" : "article-journal", "volume" : "88" }, "uris" : [ "" ] }, { "id" : "ITEM-4", "itemData" : { "DOI" : "10.1093/ejcts/ezt114", "ISSN" : "1010-7940", "PMID" : "23477927", "abstract" : "OBJECTIVES: The aim of the study was to establish a scoring system to predict mortality in aortic valve procedures in adults [German Aortic Valve Score (German AV Score)] based upon the comprehensive data pool mandatory by law in Germany. METHODS: In 2008, 11 794 cases were documented who had either open aortic valve surgery or transcatheter aortic valve implantation (TAVI). In-hospital mortality was chosen as a binary outcome measure. Potential risk factors were identified on the basis of published scoring systems and clinical knowledge. First, each of these risk factors was tested in an univariate manner by Fisher's exact test for significant influence on mortality. Then, a multiple logistic regression model with backward and forward selection was used. Calibration was ascertained by the Hosmer-Lemeshow method. In order to define the quality of discrimination, the area under the receiver operating characteristic (ROC) curve was calculated. RESULTS: In 11 147 of 11 794 cases (94.5%), a complete data set was available. In-hospital mortality was 3.7% for all patients, 3.4% in the surgical group (95% confidence interval 3.0-3.7%, n = 10 574) and 10.6% in the TAVI group (95% confidence interval 8.2-13.5%, n = 573). Based on multiple logistic regression, 15 risk factors with an influence on mortality were identified. Among them, age, body mass index and left ventricular function were categorized in three (body mass index, left ventricular dysfunction) or 6 subgroups (age). The Hosmer-Lemeshow method corroborated a valid concordance of predicted and observed mortality in 10 different risk groups. The area under the ROC curve with a value of 0.808 affirmed the quality of discrimination of the established scoring model. CONCLUSIONS: It is well known that a predictive model works best in the setting where it was developed; therefore, the German AV Score fits well to the patient population in Germany. It was designed for fair and reliable outcome evaluation. It allows comparison of predicted and observed mortality for conventional aortic valve surgery and transcatheter aortic valve implantation in low-, moderate- and high-risk groups. Thus, it enables primarily a risk-adjusted benchmark of outcome and fosters the efforts for continuous improvement of quality in aortic valve procedures.", "author" : [ { "dropping-particle" : "", "family" : "Kotting", "given" : "J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schiller", "given" : "Wolfgang", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Beckmann", "given" : "Andreas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schafer", "given" : "E.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dobler", "given" : "K.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hamm", "given" : "Christian", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Veit", "given" : "Christof", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Welz", "given" : "Armin", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Journal of Cardio-Thoracic Surgery", "id" : "ITEM-4", "issue" : "5", "issued" : { "date-parts" : [ [ "2013", "5", "1" ] ] }, "page" : "971-977", "title" : "German Aortic Valve Score: a new scoring system for prediction of mortality related to aortic valve procedures in adults", "type" : "article-journal", "volume" : "43" }, "uris" : [ "" ] }, { "id" : "ITEM-5", "itemData" : { "DOI" : "10.1136/heartjnl-2013-305314", "ISSN" : "1468-201X", "PMID" : "24740804", "abstract" : "OBJECTIVE: Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. METHODS: A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. RESULTS: TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age \u226590 years, body mass index <30 Kg/m(2), New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, \u22652 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. CONCLUSIONS: Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.", "author" : [ { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laou\u00e9nan", "given" : "C\u00e9dric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Himbert", "given" : "Dominique", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Chevreul", "given" : "Karine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Donzeau-Gouge", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fajadet", "given" : "Jean", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leprince", "given" : "Pascal", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leguerrier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Li\u00e8vre", "given" : "Michel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Prat", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Teiger", "given" : "Emmanuel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laskar", "given" : "Marc", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vahanian", "given" : "Alec", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gilard", "given" : "Martine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Heart (British Cardiac Society)", "id" : "ITEM-5", "issue" : "13", "issued" : { "date-parts" : [ [ "2014", "7" ] ] }, "note" : "This article uses data from the \u201cFrench Aortic National CoreValve and Edwards\u201d registry in order to investigate predictive factors for early mortality after TAVI. In addition, it was aimed to develop a scoring system to predict mortality after TAVI.\u00a0 \n3933 patients who underwent TAVI in 33 French centres. The patients were classified as high risk for surgery. The primary endpoint was all cause mortality 30 days after procedure. \nStatistical analyses included the use of univariate and multivariate logistic regression to build the scoring system. Discrimination and calibration of the model were assessed using the c-index and comparing Obc/Exp respectively. \nWhen investigating the early mortality the results did report those with different ages, centres, procedure type. No difference in mortality was found in centres, volume activity, time and experience of using TAVI. Age was associate with a significant increase in early mortality. Low BMI was also linked with early mortality. \nEight patient related and one procedural related variables were identified as predictive factors of early mortality; which then was used to develop a scoring system. However, the results showed that discrimination was lacking. \nIn summary the study found nine predictive factors of early mortality after TAVI. In addition a scoring system was developed which provided reasonable but certainly room for improvement.", "page" : "1016-23", "title" : "Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.", "type" : "article-journal", "volume" : "100" }, "uris" : [ "" ] }, { "id" : "ITEM-6", "itemData" : { "DOI" : "10.1016/j.amjcard.2014.03.014", "ISSN" : "1879-1913", "PMID" : "24837264", "abstract" : "Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate <45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction <40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system.", "author" : [ { "dropping-particle" : "", "family" : "Capodanno", "given" : "Davide", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbanti", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tamburino", "given" : "Corrado", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "D'Errigo", "given" : "Paola", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ranucci", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santoro", "given" : "Gennaro", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santini", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Onorati", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grossi", "given" : "Claudio", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Covello", "given" : "Remo Daniel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Capranzano", "given" : "Piera", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rosato", "given" : "Stefano", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Seccareccia", "given" : "Fulvia", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-6", "issue" : "11", "issued" : { "date-parts" : [ [ "2014", "6", "1" ] ] }, "page" : "1851-8", "publisher" : "Elsevier Inc.", "title" : "A simple risk tool (the OBSERVANT score) for prediction of 30-day mortality after transcatheter aortic valve replacement.", "type" : "article-journal", "volume" : "113" }, "uris" : [ "" ] }, { "id" : "ITEM-7", "itemData" : { "DOI" : "10.1001/jamacardio.2015.0326", "ISSN" : "2380-6583", "author" : [ { "dropping-particle" : "", "family" : "Edwards", "given" : "Fred H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cohen", "given" : "David J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "O\u2019Brien", "given" : "Sean M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peterson", "given" : "Eric D.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mack", "given" : "Michael J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shahian", "given" : "David M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grover", "given" : "Frederick L.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tuzcu", "given" : "E. 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This analysis used clinical reasoning to make assumptions regarding translation between variable definitions in the published CPMs and those in the UK TAVI dataset. Any CPM risk-prediction variable that was not recorded in the UK TAVI registry was assumed risk factor absent for all patients. The full translation between each CPM and the TAVI registry variables is given in the Supplementary Material (Supplementary Table 1 – Supplementary Table 7) along with the statistical code used to calculate the scores.The performance of each CPM was assessed in terms of calibration and discrimination. Calibration is the agreement between the expected and observed event rates across the full risk range; discrimination is the ability of the CPM to distinguish between those who will experience an event and those who will not. Discrimination of the risk models was analysed using the area under the receiver operating characteristic (ROC) curve, with values between 0.5 and 1 where higher values indicate better discrimination. To examine the calibration of each CPM, a logistic regression model was fitted with the event indicator as the outcome and the linear predictor from the CPM as the only covariate ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "author" : [ { "dropping-particle" : "", "family" : "Cox", "given" : "DR", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Biometrika", "id" : "ITEM-1", "issue" : "3", "issued" : { "date-parts" : [ [ "1958" ] ] }, "page" : "562-565", "title" : "Two further applications of a model for binary regression", "type" : "article-journal", "volume" : "45" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(19)", "plainTextFormattedCitation" : "(19)", "previouslyFormattedCitation" : "(19)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(19). Perfect calibration would occur when the corresponding intercept and slope are zero and one respectively, with the intercept estimated assuming a slope of unity. 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CPM performance was analysed in the whole cohort and within several subgroups. The following subgroups were considered: age (≤ or > 75), sex, diabetes status, access route (Transfemoral vs. non-Transfemoral), valve type (SAPIENTM vs. CoreValveTM), previous coronary artery bypass graft (CABG) status, LV function (LVEF< 50% or LVEF ≥ 50%) and procedure urgency (elective vs. non-elective).Patient-level risk agreement between CPMs was analysed in the surgical models and the TAVI models separately to facilitate fair comparisons. It was decided, a priori, to derive cut-off values for each CPM that defined three risk levels (low-, medium- and high-risk), with approximately equal patient numbers in each. The proportions of patients for whom risk classification agreed between multiple CPMs was then calculated. 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The Health e-Research Centre, funded by the Medical Research Council [MR/K006665/1] and the North Staffordshire Heart Committee supported this work. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.ResultsThe UK TAVI registry included all 7431 patients who underwent a TAVI procedure between January 2007 and December 2014. All patients from Northern Ireland (n=400) and the majority of Scottish patients (n=193) were excluded from the analysis due to absence of ONS mortality tracking. Out of the remaining 6838 patients, a further 162 were removed due to missing life status, leaving 6676 patients studied in this analysis. The observed survival rates were 94.6%, 83.3% and 64.4% at 30-days, one-year and three-year follow-up, respectively. Table 1 presents summary statistics for baseline characteristics of the patients in the UK TAVI registry. Performance AnalysisFrom January 2007 to December 2014, there were 360 deaths within 30-days of the TAVI procedure (5.4%). The expected 30-day mortalities in the whole cohort were 21.9%, 8.1%, 5.1%, 7.4%, 9.2, 7.1% and 5.2% from the LES, ESII, STS, German AV, FRANCE-2, OBSERVANT and ACC CPMs, respectively (Table 2). The ACC score and STS model were the closest to the observed mortality in terms of absolute and relative differences, while the LES overestimated risk by a factor of four (Table 2). After a decrease from 2007 to 2008, the observed 30-day mortality per year remained approximately constant, with further decreases in 2013 and 2014 (Figure 1). In contrast, the profile of the majority of CPMs remained approximately constant throughout (Figure 1). The inflated observed 30-day mortality in the first two years likely reflects the UK learning curve and advances in TAVI technology, while the CPMs do not account for such factors. The observed and expected 30-day mortality rates over each subgroup are given in Supplementary Table 8. Table 3 shows the performance of each CPM in the whole cohort. While the calibration intercepts of the ACC and STS models were significantly close to zero (i.e. the observed and expected mortalities agreed), the 95% confidence intervals for the calibration slopes did not span one, indicating model miscalibration. Poor discrimination was observed, with area under the ROC curves between 0.57 and 0.64 for the whole cohort; the FRANCE-2 TAVI score and the ACC TAVI score had the highest AUC values of 0.62 and 0.64, respectively. Overall performance, as measure by the Brier score, was similar for the majority of models with values of 0.05; a Brier score of 0.09 for the LES was the highest (worst) amongst the models. Quantitatively similar results were obtained from a sensitivity analysis that excluded patients who underwent TAVI in 2007 or 2008 (n=337) where the observed mortality was elevated over that in subsequent years (Supplementary Table 9). The performances of all the CPMs in each subgroup are given in the supplementary material (Supplementary Table 10). The expected mortality from the ACC TAVI model was significantly close to the observed mortality across all strata, but satisfactory calibration (calibration intercept and slope close to zero and one, respectively) was only observed for this CPM in female and diabetic subgroups. All other models were miscalibrated across strata. The area under the ROC curve was below 0.7 for all CPMs across the subgroups, with the majority close to 0.6; the ACC and FRANCE-2 CPMs had the highest discrimination across subgroups.Agreement AnalysisThe chosen cut-off values that gave approximately equal numbers of patients in low-, medium- and high-risk categories are given in Table 4. Based on these cut-off values, the proportions of patients classified in each risk level who were similarly classified across the other CPMs were calculated (Figure 2 for the surgical based CPMs and Figure 3 for the TAVI based CPMs). A low level of agreement at an individual patient level was observed; for example, only 31.8% of the 1951 patients grouped as high-risk group by FRANCE-2 >10% were also grouped as high-risk by the OBSERVANT and ACC models (Figure 3). Quantifying agreement between the CPMs using Fleiss’s Kappa (κ), highlighted that agreement between all the surgical scores was moderate (κ=0.37), while that between all the TAVI models was poor (κ=0.20). The pairwise Fleiss’s Kappa values are given in Table 4, which shows that there was moderate agreement between the FRANCE-2 and ACC TAVI models (κ=0.33). Risk stratifications were re-defined to give a population ratio of approximately 1:3:1 for low-, medium- and high-risk. Here, the results indicated marginally improved levels of agreement, but these were still moderate. Specifically, the Fleiss’s Kappa across the surgical scores was 0.40 and that between the TAVI models was 0.20, with pairwise Fleiss’s Kappa values given in Supplementary Table 11. DiscussionClinical prediction models form the cornerstone of risk stratification for patients undergoing invasive procedures, helping to guide both treatment allocation and the consent process. However, their performance needs to be tested in large datasets independent to those in which the models were developed before they can be used in external populations ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1136/bmj.b605", "ISSN" : "0959-8138", "PMID" : "19477892", "author" : [ { "dropping-particle" : "", "family" : "Altman", "given" : "Douglas G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vergouwe", "given" : "Yvonne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Royston", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moons", "given" : "Karel G M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "BMJ", "id" : "ITEM-1", "issue" : "may28 1", "issued" : { "date-parts" : [ [ "2009", "5", "28" ] ] }, "page" : "b605-b605", "title" : "Prognosis and prognostic research: validating a prognostic model", "type" : "article-journal", "volume" : "338" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1136/bmj.i3140", "ISSN" : "1756-1833", "PMID" : "27334381", "author" : [ { "dropping-particle" : "", "family" : "Riley", "given" : "Richard D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ensor", "given" : "Joie", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Snell", "given" : "Kym I E", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Debray", "given" : "Thomas P A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Altman", "given" : "Doug G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moons", "given" : "Karel G M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Collins", "given" : "Gary S", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "BMJ", "id" : "ITEM-2", "issued" : { "date-parts" : [ [ "2016", "6", "22" ] ] }, "page" : "i3140", "title" : "External validation of clinical prediction models using big datasets from e-health records or IPD meta-analysis: opportunities and challenges", "type" : "article-journal", "volume" : "353" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(26,27)", "plainTextFormattedCitation" : "(26,27)", "previouslyFormattedCitation" : "(26,27)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(26,27). Our analysis of the UK TAVI registry has systematically demonstrated that outside their development cohorts, the German AV, FRANCE-2, OBSERVANT and ACC TAVI CPMs are miscalibrated and have low discrimination at predicting 30-day mortality. These results support previous work in this area ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.ijcard.2016.04.038", "ISBN" : "0167-5273", "ISSN" : "01675273", "PMID" : "27128536", "abstract" : "Background Accurate risk stratification is pivotal for appropriate selection of patients with severe symptomatic aortic stenosis for either surgical or transcatheter aortic valve replacement (TAVR). We sought to determine whether recent risk prediction models developed specifically in TAVR patients enhance prognostication in comparison with previous surgical scores used in clinical practice (EuroScore I, EuroScore II, STS). Methods The Israeli TAVR Registry Risk Model Accuracy Assessment (IRRMA) study utilized a multicenter prospective TAVR database (n = 1327) to perform a quantitative comparison between previous risk scores developed in either surgical or TAVR populations, with the present registry serving as an independent external validation set. Results In the IRRMA population, 4 variables (NYHA functional class IV, chronic obstructive pulmonary disease, systolic pulmonary artery pressure ??? 60 mm Hg, vascular access other than by the femoral route) identified by cross-validation and leave-one-out analyses provided the most discriminative model (C-statistic = 0.63) for predicting 30-day mortality. Previous scores developed in surgical (EuroScores I and II, STS), TAVR (France-2, OBSERVANT), or mixed (German AV score) populations were applied to the IRRMA cohort. Resultant C-statistics ranged between 0.52-0.71 (for the German AV and France-2 scores, respectively) and did not differ significantly (p = 0.07 for the comparison between the lowest and highest C-statistics). The observed C-statistic for 5 of these 6 scores was lower than originally reported when applied to the IRRMA population. Conclusion Available TAVR risk scores showed limited accuracy when applied to an independent validation set and did not enhance prognostication in comparison to previous surgical scores.", "author" : [ { "dropping-particle" : "", "family" : "Halkin", "given" : "Amir", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Steinvil", "given" : "Arie", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Witberg", "given" : "Guy", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barsheshet", "given" : "Alon", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barkagan", "given" : "Michael", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Assali", "given" : "Abid", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Segev", "given" : "Amit", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fefer", "given" : "Paul", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Guetta", "given" : "Victor", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbash", "given" : "Israel M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kornowski", "given" : "Ran", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Finkelstein", "given" : "Ariel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "International Journal of Cardiology", "id" : "ITEM-1", "issued" : { "date-parts" : [ [ "2016", "7" ] ] }, "page" : "227-231", "publisher" : "Elsevier Ireland Ltd", "title" : "Mortality prediction following transcatheter aortic valve replacement: A quantitative comparison of risk scores derived from populations treated with either surgical or percutaneous aortic valve replacement. The Israeli TAVR Registry Risk Model Accuracy A", "type" : "article-journal", "volume" : "215" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(28)", "plainTextFormattedCitation" : "(28)", "previouslyFormattedCitation" : "(28)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(28). In the current study, the FRANCE-2 and ACC models had the highest discrimination out of all those considered, with these comparing favourably to the internal validation results reported when these models were derived ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1136/heartjnl-2013-305314", "ISSN" : "1468-201X", "PMID" : "24740804", "abstract" : "OBJECTIVE: Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. METHODS: A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. RESULTS: TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age \u226590 years, body mass index <30 Kg/m(2), New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, \u22652 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. CONCLUSIONS: Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.", "author" : [ { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laou\u00e9nan", "given" : "C\u00e9dric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Himbert", "given" : "Dominique", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Chevreul", "given" : "Karine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Donzeau-Gouge", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fajadet", "given" : "Jean", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leprince", "given" : "Pascal", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leguerrier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Li\u00e8vre", "given" : "Michel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Prat", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Teiger", "given" : "Emmanuel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laskar", "given" : "Marc", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vahanian", "given" : "Alec", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gilard", "given" : "Martine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Heart (British Cardiac Society)", "id" : "ITEM-1", "issue" : "13", "issued" : { "date-parts" : [ [ "2014", "7" ] ] }, "note" : "This article uses data from the \u201cFrench Aortic National CoreValve and Edwards\u201d registry in order to investigate predictive factors for early mortality after TAVI. In addition, it was aimed to develop a scoring system to predict mortality after TAVI.\u00a0 \n3933 patients who underwent TAVI in 33 French centres. The patients were classified as high risk for surgery. The primary endpoint was all cause mortality 30 days after procedure. \nStatistical analyses included the use of univariate and multivariate logistic regression to build the scoring system. Discrimination and calibration of the model were assessed using the c-index and comparing Obc/Exp respectively. \nWhen investigating the early mortality the results did report those with different ages, centres, procedure type. No difference in mortality was found in centres, volume activity, time and experience of using TAVI. Age was associate with a significant increase in early mortality. Low BMI was also linked with early mortality. \nEight patient related and one procedural related variables were identified as predictive factors of early mortality; which then was used to develop a scoring system. However, the results showed that discrimination was lacking. \nIn summary the study found nine predictive factors of early mortality after TAVI. In addition a scoring system was developed which provided reasonable but certainly room for improvement.", "page" : "1016-23", "title" : "Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.", "type" : "article-journal", "volume" : "100" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1001/jamacardio.2015.0326", "ISSN" : "2380-6583", "author" : [ { "dropping-particle" : "", "family" : "Edwards", "given" : "Fred H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cohen", "given" : "David J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "O\u2019Brien", "given" : "Sean M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peterson", "given" : "Eric D.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mack", "given" : "Michael J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shahian", "given" : "David M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grover", "given" : "Frederick L.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tuzcu", "given" : "E. 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Additionally, although the ACC model was miscalibrated, the expected mortality was significantly close to the observed mortality across all subgroups considered in this analysis. However, of note is that the ACC model was predominately developed to predict in-hospital mortality, which potentially contributes to the agreement between the observed and expected event rates for this model. The performance of any CPM is expected to drop when they are applied in populations external to the development set since patient mix and procedure techniques can vary between populations ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/S0895-4356(01)00341-9", "ISBN" : "0895-4356 (Print)", "ISSN" : "08954356", "PMID" : "11470385", "abstract" : "The performance of a predictive model is overestimated when simply determined on the sample of subjects that was used to construct the model. Several internal validation methods are available that aim to provide a more accurate estimate of model performance in new subjects. We evaluated several variants of split-sample, cross-validation and bootstrapping methods with a logistic regression model that included eight predictors for 30-day mortality after an acute myocardial infarction. Random samples with a size between n = 572 and n = 9165 were drawn from a large data set (GUSTO-I; n = 40,830; 2851 deaths) to reflect modeling in data sets with between 5 and 80 events per variable. Independent performance was determined on the remaining subjects. Performance measures included discriminative ability, calibration and overall accuracy. We found that split-sample analyses gave overly pessimistic estimates of performance, with large variability. Cross-validation on 10% of the sample had low bias and low variability, but was not suitable for all performance measures. Internal validity could best be estimated with bootstrapping, which provided stable estimates with low bias. We conclude that split-sample validation is inefficient, and recommend bootstrapping for estimation of internal validity of a predictive logistic regression model. \u00a9 2001 Elsevier Science Inc. All rights reserved.", "author" : [ { "dropping-particle" : "", "family" : "Steyerberg", "given" : "Ewout W.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Harrell", "given" : "Frank E.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Borsboom", "given" : "Gerard J.J.M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eijkemans", "given" : "M.J.C", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vergouwe", "given" : "Yvonne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Habbema", "given" : "J.Dik F", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Journal of Clinical Epidemiology", "id" : "ITEM-1", "issue" : "8", "issued" : { "date-parts" : [ [ "2001", "8" ] ] }, "page" : "774-781", "title" : "Internal validation of predictive models", "type" : "article-journal", "volume" : "54" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1136/bmj.b605", "ISSN" : "0959-8138", "PMID" : "19477892", "author" : [ { "dropping-particle" : "", "family" : "Altman", "given" : "Douglas G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vergouwe", "given" : "Yvonne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Royston", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moons", "given" : "Karel G M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "BMJ", "id" : "ITEM-2", "issue" : "may28 1", "issued" : { "date-parts" : [ [ "2009", "5", "28" ] ] }, "page" : "b605-b605", "title" : "Prognosis and prognostic research: validating a prognostic model", "type" : "article-journal", "volume" : "338" }, "uris" : [ "" ] }, { "id" : "ITEM-3", "itemData" : { "DOI" : "10.1136/bmj.i3140", "ISSN" : "1756-1833", "PMID" : "27334381", "author" : [ { "dropping-particle" : "", "family" : "Riley", "given" : "Richard D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ensor", "given" : "Joie", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Snell", "given" : "Kym I E", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Debray", "given" : "Thomas P A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Altman", "given" : "Doug G", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moons", "given" : "Karel G M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Collins", "given" : "Gary S", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "BMJ", "id" : "ITEM-3", "issued" : { "date-parts" : [ [ "2016", "6", "22" ] ] }, "page" : "i3140", "title" : "External validation of clinical prediction models using big datasets from e-health records or IPD meta-analysis: opportunities and challenges", "type" : "article-journal", "volume" : "353" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(26,27,29)", "plainTextFormattedCitation" : "(26,27,29)", "previouslyFormattedCitation" : "(26,27,29)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(26,27,29). Consequently, the findings of the current study are, perhaps, unsurprising given that the TAVI-CPMs achieved only moderate performance in their respective development datasets ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.amjcard.2014.03.014", "ISSN" : "1879-1913", "PMID" : "24837264", "abstract" : "Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate <45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction <40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system.", "author" : [ { "dropping-particle" : "", "family" : "Capodanno", "given" : "Davide", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbanti", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tamburino", "given" : "Corrado", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "D'Errigo", "given" : "Paola", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ranucci", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santoro", "given" : "Gennaro", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santini", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Onorati", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grossi", "given" : "Claudio", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Covello", "given" : "Remo Daniel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Capranzano", "given" : "Piera", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rosato", "given" : "Stefano", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Seccareccia", "given" : "Fulvia", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-1", "issue" : "11", "issued" : { "date-parts" : [ [ "2014", "6", "1" ] ] }, "page" : "1851-8", "publisher" : "Elsevier Inc.", "title" : "A simple risk tool (the OBSERVANT score) for prediction of 30-day mortality after transcatheter aortic valve replacement.", "type" : "article-journal", "volume" : "113" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1136/heartjnl-2013-305314", "ISSN" : "1468-201X", "PMID" : "24740804", "abstract" : "OBJECTIVE: Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. METHODS: A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. RESULTS: TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age \u226590 years, body mass index <30 Kg/m(2), New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, \u22652 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. CONCLUSIONS: Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.", "author" : [ { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laou\u00e9nan", "given" : "C\u00e9dric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Himbert", "given" : "Dominique", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Chevreul", "given" : "Karine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Donzeau-Gouge", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fajadet", "given" : "Jean", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leprince", "given" : "Pascal", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leguerrier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Li\u00e8vre", "given" : "Michel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Prat", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Teiger", "given" : "Emmanuel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laskar", "given" : "Marc", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vahanian", "given" : "Alec", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gilard", "given" : "Martine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Heart (British Cardiac Society)", "id" : "ITEM-2", "issue" : "13", "issued" : { "date-parts" : [ [ "2014", "7" ] ] }, "note" : "This article uses data from the \u201cFrench Aortic National CoreValve and Edwards\u201d registry in order to investigate predictive factors for early mortality after TAVI. In addition, it was aimed to develop a scoring system to predict mortality after TAVI.\u00a0 \n3933 patients who underwent TAVI in 33 French centres. The patients were classified as high risk for surgery. The primary endpoint was all cause mortality 30 days after procedure. \nStatistical analyses included the use of univariate and multivariate logistic regression to build the scoring system. Discrimination and calibration of the model were assessed using the c-index and comparing Obc/Exp respectively. \nWhen investigating the early mortality the results did report those with different ages, centres, procedure type. No difference in mortality was found in centres, volume activity, time and experience of using TAVI. Age was associate with a significant increase in early mortality. Low BMI was also linked with early mortality. \nEight patient related and one procedural related variables were identified as predictive factors of early mortality; which then was used to develop a scoring system. However, the results showed that discrimination was lacking. \nIn summary the study found nine predictive factors of early mortality after TAVI. In addition a scoring system was developed which provided reasonable but certainly room for improvement.", "page" : "1016-23", "title" : "Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.", "type" : "article-journal", "volume" : "100" }, "uris" : [ "" ] }, { "id" : "ITEM-3", "itemData" : { "DOI" : "10.1001/jamacardio.2015.0326", "ISSN" : "2380-6583", "author" : [ { "dropping-particle" : "", "family" : "Edwards", "given" : "Fred H.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cohen", "given" : "David J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "O\u2019Brien", "given" : "Sean M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peterson", "given" : "Eric D.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mack", "given" : "Michael J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shahian", "given" : "David M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grover", "given" : "Frederick L.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tuzcu", "given" : "E. 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Current TAVI cohorts predominantly represent a particularly high-risk and homogenous group of patients, potentially contributing to the lack of a highly predictive TAVI-CPM. Future TAVI-CPMs need to be developed by utilising the contemporary large registries that are emerging, which will inevitably require greater harmonisation between variable and outcome definitions amongst national datasets. Moreover, many of the co-morbidities used in the development of CPMs are cardiovascular risk factors, with important non-cardiovascular co-morbidities not considered ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.amjcard.2015.04.047", "ISSN" : "1879-1913", "PMID" : "26037294", "abstract" : "Co-morbidities have typically been considered as prevalent cardiovascular risk factors and cardiovascular diseases rather than systematic measures of general co-morbidity burden in patients who underwent percutaneous coronary intervention (PCI). Charlson co-morbidity index (CCI) is a measure of co-morbidity burden providing a means of quantifying the prognostic impact of 22 co-morbid conditions on the basis of their number and prognostic impact. The study evaluated the impact of the CCI on cardiac mortality and major adverse cardiovascular events (MACE) after PCI through analysis of the Nobori-2 study. The prognostic impact of CCI was studied in 3,067 patients who underwent PCI in 4,479 lesions across 125 centers worldwide on 30-day and 1- and 5-year cardiac mortality and MACE. Data were adjusted for potential confounders using stepwise logistic regression; 2,280 of 3,067 patients (74.4%) had \u22651 co-morbid conditions. CCI (per unit increase) was independently associated with an increase in both cardiac death (odds ratio [OR] 1.47 95% confidence interval [CI] 1.20 to 1.80, p = 0.0002) and MACE (OR 1.29 95% CI 1.14 to 1.47, p \u22640.0011) at 30 days, with similar observations recorded at 1 and 5 years. CCI score \u22652 was independently associated with increased 30-day cardiac death (OR 4.25, 95% CI 1.24 to 14.56, p = 0.02) at 1 month, and this increased risk was also observed at 1 and 5 years. In conclusion, co-morbid burden, as measured using CCI, is an independent predictor of adverse outcomes in the short, medium, and long term. Co-morbidity should be considered in the decision-making process when counseling patients regarding the periprocedural risks associated with PCI, in conjunction with traditional risk factors.", "author" : [ { "dropping-particle" : "", "family" : "Mamas", "given" : "Mamas A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fath-Ordoubadi", "given" : "Farzin", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Danzi", "given" : "Gian B", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Spaepen", "given" : "Erik", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kwok", "given" : "Chun Shing", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Buchan", "given" : "Iain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peek", "given" : "Niels", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Belder", "given" : "Mark A", "non-dropping-particle" : "de", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ludman", "given" : "Peter F", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Paunovic", "given" : "Dragica", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Urban", "given" : "Philip", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-1", "issue" : "3", "issued" : { "date-parts" : [ [ "2015" ] ] }, "page" : "364-371", "publisher" : "Elsevier Inc.", "title" : "Prevalence and Impact of Co-morbidity Burden as Defined by the Charlson Co-morbidity Index on 30-Day and 1- and 5-Year Outcomes After Coronary Stent Implantation (from the Nobori-2 Study).", "type" : "article-journal", "volume" : "116" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(30)", "plainTextFormattedCitation" : "(30)", "previouslyFormattedCitation" : "(30)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(30). In particular, frailty is not reflected in many of the CPMs, despite being particularly prevalent in elderly patients with AS and previous work suggesting frailty to be associated with poor TAVI outcomes ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.4244/EIJY14M08_03", "ISSN" : "1969-6213", "PMID" : "25136880", "abstract" : "AIMS: Transcatheter aortic valve implantation (TAVI) represents a less invasive treatment option for elderly patients. Therefore, we aimed to determine the impact of frailty measured by the Katz Index of activities of daily living (ADL) on short- and long-term mortality after TAVI. METHODS AND RESULTS: Our study included 300 consecutive patients (mean age, 82\u00b15 years) who had undergone TAVI at our institution (158 transapical, 142 transfemoral procedures). At baseline, 144 patients were impaired in at least one ADL and therefore defined as frail (Katz Index <6). Regarding in-hospital outcome, all serious complications except for stage 3 acute kidney injury were equally distributed in both groups, but early mortality was significantly higher in frail persons (5.5% vs. 1.3%, p=0.04 for immediate procedural mortality; 17% vs. 5.8%, p=0.002 for 30-day mortality; and 23% vs. 6.4%, p<0.0001 for procedural mortality). The risk-score-based 30-day mortality estimates (29% vs. 24% for log. EuroSCORE I, 9.5% vs. 7.5% for EuroSCORE II, and 8.8% vs. 5.9% for STS score) reflected neither the observed 30-day mortality in both groups nor the threefold risk elevation in frail patients. In contrast, the Katz Index <6 was identified as a significant independent predictor of long-term all-cause mortality by multivariate analysis (HR 2.67 [95% CI: 1.7-4.3], p<0.0001). During follow-up (median observation period 537 days) 56% of frail vs. 24% of non-frail patients died. CONCLUSIONS: Frailty status measured by the Katz Index represents a powerful predictor of adverse early and late outcome after TAVI, whereas commonly used risk scores lack calibration and discrimination in a TAVI-specific patient cohort. Therefore, we propose the incorporation of this simple and reproducible measure into pre-TAVI risk assessment.", "author" : [ { "dropping-particle" : "", "family" : "Puls", "given" : "Miriam", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sobisiak", "given" : "Bettina", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bleckmann", "given" : "Annalen", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Jacobshagen", "given" : "Claudius", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Danner", "given" : "Bernhard C", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "H\u00fcnlich", "given" : "Mark", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bei\u00dfbarth", "given" : "Tim", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sch\u00f6ndube", "given" : "Friedrich", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hasenfu\u00df", "given" : "Gerd", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Seipelt", "given" : "Ralf", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schillinger", "given" : "Wolfgang", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology", "id" : "ITEM-1", "issue" : "5", "issued" : { "date-parts" : [ [ "2014", "9" ] ] }, "language" : "en", "page" : "609-19", "title" : "Impact of frailty on short and long term morbidity and mortality after transcatheter aortic valve implantation: risk assessment by Katz Index of activities of daily living.", "type" : "article-journal", "volume" : "10" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1093/eurheartj/ehs304", "ISBN" : "0195-668x", "ISSN" : "0195668X", "PMID" : "23008508", "abstract" : "Aims This study aimed to assess functional course in elderly patients undergoing transcatheter aortic valve implantation (TAVI) and to find predictors of functional decline. Methods and results In this prospective cohort, functional course was assessed in patients \u226570 years using basic activities of daily living (BADL) before and 6 months after TAVI. Baseline EuroSCORE, STS score, and a frailty index (based on assessment of cognition, mobility, nutrition, instrumental and basic activities of daily living) were evaluated to predict functional decline (deterioration in BADL) using logistic regression models. Functional decline was observed in 22 (20.8%) of 106 surviving patients. EuroSCORE (OR per 10% increase 1.18, 95% CI: 0.83-1.68, P = 0.35) and STS score (OR per 5% increase 1.64, 95% CI: 0.87-3.09, P = 0.13) weakly predicted functional decline. In contrast, the frailty index strongly predicted functional decline in univariable (OR per 1 point increase 1.57, 95% CI: 1.20-2.05, P = 0.001) and bivariable analyses (OR: 1.56, 95% CI: 1.20-2.04, P = 0.001 controlled for EuroSCORE; OR: 1.53, 95% CI: 1.17-2.02, P = 0.002 controlled for STS score). Overall predictive performance was best for the frailty index [Nagelkerke's R(2) (NR(2)) 0.135] and low for the EuroSCORE (NR(2) 0.015) and STS score (NR(2) 0.034). In univariable analyses, all components of the frailty index contributed to the prediction of functional decline. Conclusion Over a 6-month period, functional status worsened only in a minority of patients surviving TAVI. The frailty index, but not established risk scores, was predictive of functional decline. Refinement of this index might help to identify patients who potentially benefit from additional geriatric interventions after TAVI.", "author" : [ { "dropping-particle" : "", "family" : "Schoenenberger", "given" : "Andreas W.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Stortecky", "given" : "Stefan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Neumann", "given" : "Stephanie", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Moser", "given" : "Andr\u00e9", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "J\u00fcni", "given" : "Peter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Carrel", "given" : "Thierry", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Huber", "given" : "Christoph", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gandon", "given" : "Marianne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bischoff", "given" : "Seraina", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schoenenberger", "given" : "Christa Maria", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Stuck", "given" : "Andreas E.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Windecker", "given" : "Stephan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Wenaweser", "given" : "Peter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Heart Journal", "id" : "ITEM-2", "issue" : "9", "issued" : { "date-parts" : [ [ "2013" ] ] }, "page" : "684-692", "title" : "Predictors of functional decline in elderly patients undergoing transcatheter aortic valve implantation (TAVI)", "type" : "article-journal", "volume" : "34" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(31,32)", "plainTextFormattedCitation" : "(31,32)", "previouslyFormattedCitation" : "(31,32)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(31,32). A CPM that aims to predict long-term mortality following TAVI found that the inclusion of frailty in their model significantly increased the discrimination ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1007/s00392-014-0692-4", "ISBN" : "0039201406", "ISSN" : "1861-0692", "PMID" : "24643728", "abstract" : "AIMS: Transcatheter aortic valve implantation (TAVI) is an increasingly common procedure in elderly and multimorbid patients with aortic stenosis. We aimed at developing a pre-procedural risk evaluation scheme beyond current surgical risk scores.\n\nMETHODS: We developed a risk algorithm for 1-year mortality in two cohorts consisting of 845 patients undergoing routine TAVI procedures by commercially available devices, mean age 80.9 \u00b1 6.5, 51 % women. Clinical variables were determined at baseline. Multivariable Cox regression related clinical data to mortality (n = 207 deaths).\n\nRESULTS: To account for variability related to age and sex and by enrolment site we forced age, sex, and cohort into the score model. Body mass index, estimated glomerular filtration rate, hemoglobin, pulmonary hypertension, mean transvalvular gradient and left ventricular ejection fraction at baseline were most strongly associated with mortality and entered the risk prediction algorithm [C-statistic 0.66, 95 % confidence interval (CI) 0.61-0.70, calibration \u03c7 (2)-statistic = 6.51; P = 0.69]. Net reclassification improvement compared to existing surgical risk predication schemes was positive. The score showed reasonable model fit and calibration in external validation in 333 patients, N = 55 deaths (C-statistic 0.60, 95 % CI 0.52-0.68; calibration \u03c7 (2)-statistic = 16.2; P = 0.06). Additional measurement of B-type natriuretic peptide and troponin I did not improve the C-statistic. Frailty increased the C-statistic to 0.71, 95 % CI 0.65-0.76.\n\nCONCLUSIONS: We present a new risk evaluation tool derived and validated in routine TAVI cohorts that predicts 1-year mortality. Biomarkers only marginally improved risk prediction. Frailty increased the discriminatory ability of the score and needs to be considered. Risk algorithms specific for TAVI may help to guide decision-making when patients are evaluated for TAVI.", "author" : [ { "dropping-particle" : "", "family" : "Seiffert", "given" : "Moritz", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sinning", "given" : "Jan-Malte", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Meyer", "given" : "Alexander", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Wilde", "given" : "Sandra", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Conradi", "given" : "Lenard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vasa-Nicotera", "given" : "Mariuca", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ghanem", "given" : "Alexander", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kempfert", "given" : "J\u00f6rg", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hammerstingl", "given" : "Christoph", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ojeda", "given" : "Francisco M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kim", "given" : "Won-Keun", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Koschyk", "given" : "Dietmar H", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schirmer", "given" : "Johannes", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Baldus", "given" : "Stephan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grube", "given" : "Eberhard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "M\u00f6llmann", "given" : "Helge", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Reichenspurner", "given" : "Hermann", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Nickenig", "given" : "Georg", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Blankenberg", "given" : "Stefan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Diemert", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Treede", "given" : "Hendrik", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Walther", "given" : "Thomas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Werner", "given" : "Nikos", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schnabel", "given" : "Renate B", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Clinical research in cardiology : official journal of the German Cardiac Society", "id" : "ITEM-1", "issue" : "8", "issued" : { "date-parts" : [ [ "2014", "8" ] ] }, "page" : "631-40", "title" : "Development of a risk score for outcome after transcatheter aortic valve implantation.", "type" : "article-journal", "volume" : "103" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(33)", "plainTextFormattedCitation" : "(33)", "previouslyFormattedCitation" : "(33)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(33). Similarly, a previously published CPM that aims to predict mortality and/ or a decline in quality of life following TAVI included an indication of 6-min walk test distance ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1161/CIRCULATIONAHA.113.007477", "ISBN" : "0009-7322", "ISSN" : "15244539", "PMID" : "24958751", "abstract" : "BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a less invasive option for treatment of high-risk patients with severe aortic stenosis. We sought to identify patients at high risk for poor outcome after TAVR using a novel definition of outcome that integrates quality of life with mortality.\\n\\nMETHODS AND RESULTS: Among 2137 patients who underwent TAVR in the PARTNER (Placement of Aortic Transcatheter Valve) trial or its associated continued access registry, quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Scale (KCCQ-OS; range 0-100, where a higher score equates to a better quality of life) at baseline and at 1, 6, and 12 months after TAVR. A poor 6-month outcome (defined as death, KCCQ-OS score <45, or \u226510-point decrease in KCCQ-OS score compared with baseline) occurred in 704 patients (33%). Using a split-sample design, we developed a multivariable model to identify a parsimonious set of covariates to identify patients at high risk for poor outcome. The model demonstrated moderate discrimination (c-index=0.66) and good calibration with the observed data, performed similarly in the separate validation cohort (c-index=0.64), and identified 211 patients (10% of the population) with a \u226550% likelihood of a poor outcome after TAVR. A second model that explored predictors of poor outcome at 1 year identified 1102 patients (52%) with \u226550% likelihood and 178 (8%) with \u226570% likelihood of a poor 1-year outcome after TAVR.\\n\\nCONCLUSIONS: Using a large, multicenter cohort, we have developed and validated predictive models that can identify patients at high risk for a poor outcome after TAVR. Although model discrimination was moderate, these models may help guide treatment choices and offer patients realistic expectations of outcomes based on their presenting characteristics.\\n\\nCLINICAL TRIAL REGISTRATION URL: . 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Aortic Valve Implantation in the UK: Temporal Trends, Predictors of Outcome and 6 Year Follow Up: A Report from the UK TAVI Registry 2007 to 2012", "type" : "article-journal", "volume" : "131" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1002/ccd.22961", "ISSN" : "15221946", "PMID" : "21656647", "author" : [ { "dropping-particle" : "", "family" : "Gurvitch", "given" : "Ronen", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tay", "given" : "Edgar L.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Wijesinghe", "given" : "Namal", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ye", "given" : "J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Nietlispach", "given" : "Fabian", "non-dropping-particle" : "", 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: "10.1161/CIRCULATIONAHA.110.013425", "ISSN" : "0009-7322", "PMID" : "21911801", "abstract" : "BACKGROUND: Transapical aortic valve implantation has evolved to a reproducible therapeutic option for high-risk patients. The aim of the present study was to evaluate our learning experience over 4 years and to analyze outcome-related risk factors.\\n\\nMETHODS AND RESULTS: A total of 299 patients who received transapical aortic valve implantation between February 2006 and January 2010 with the Edwards SAPIEN transcatheter prosthesis were analyzed according to early experience (EE; patients 1 to 150) and recent experience (RE; patients 151 to 299). Patients consistently demonstrated high risk scores, and major perioperative parameters were comparable between the 2 groups. RE patients had a significantly higher logistic EuroSCORE (RE 33.2 \u00b1 17.2, EE 29.4 \u00b1 14; P=0.039) but a significantly lower STS (Society of Thoracic Surgeons) score (RE 11.4 \u00b1 7.5, EE 13.5 \u00b1 7.8; P=0.019). Use of contrast dye (EE 104 \u00b1 78 mL, RE 93 \u00b1 46 mL) and the need to perform a balloon redilation were significantly reduced in the RE group. Thirty-day mortality decreased from 11.3% to 6.0%, and 1-year mortality improved significantly from 30.7% (EE) to 21.5% in the RE patients (P=0.047). Multivariate logistic regression analysis revealed reduced vital capacity (<70%) and concomitant preoperative mitral regurgitation >1+ as the only independent predictors of 30-day mortality. Classic variables such as age, logistic EuroSCORE >30%, and STS score >15% failed to predict mortality.\\n\\nCONCLUSIONS: Recent results with transapical aortic valve implantation indicate a progressive improvement in outcomes despite an unchanged patient risk profile, which reflects a significant learning curve that includes a better understanding of optimal patient selection. Classic surgical risk factors fail to predict outcome, which indicates the need for new transapical aortic valve implantation-specific risk scores.", "author" : [ { "dropping-particle" : "", "family" : "Kempfert", "given" : "J\u00f6rg", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rastan", "given" : "Ardawan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Holzhey", "given" : "David", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Linke", "given" : "Axel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schuler", "given" : "Gerhard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Linden", "given" : "A.", "non-dropping-particle" : "van", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Blumenstein", "given" : "Johannes", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Mohr", "given" : "Friedrich Wilhelm", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Walther", "given" : "Thomas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Circulation", "id" : "ITEM-3", "issue" : "suppl 1", "issued" : { "date-parts" : [ [ "2011", "9", "13" ] ] }, "page" : "S124-S129", "title" : "Transapical Aortic Valve Implantation: Analysis of Risk Factors and Learning Experience in 299 Patients", "type" : "article-journal", "volume" : "124" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(35\u201337)", "plainTextFormattedCitation" : "(35\u201337)", "previouslyFormattedCitation" : "(35,36)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(35–37). Nevertheless, measures of operator volume or experience are not used in CPMs since accounting for such variables would be inappropriate, particularly when the purpose of a CPM might be to benchmark an individual operators / centres performance. Similarly, the addition of operator volume/ experience in a CPM would make it almost impossible for a physician to convey the predicted risk to a parison with Performance of the Surgical CPMsThe current study confirms previous work in showing that the performance of the LES, ESII and STS models are poor at predicting 30-day mortality post TAVI ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.amjcard.2012.11.056", "ISSN" : "1879-1913", "PMID" : "23337835", "abstract" : "The original European System for Cardiac Operative Risk Evaluation (EuroSCORE) has been recently updated as EuroSCORE II to optimize its efficacy in cardiac surgery, but its performance has been poorly evaluated for predicting 30-day mortality in patients who undergo transcatheter aortic valve replacement (TAVR). Consecutive patients (n = 250) treated with TAVR were included in this analysis. Transapical access was used in 60 patients, while 190 procedures were performed using a transfemoral approach. Calibration (risk-adjusted mortality ratio) and discrimination (C-statistic and U-statistic) were calculated for the logistic EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons (STS) scores for predicting 30-day mortality. Observed mortality was 7.6% in the overall population (6.3% and 11.7% for the transfemoral and transapical cohorts, respectively). Predicted mortality was 22.6 \u00b1 12.8% by logistic EuroSCORE, 7.7 \u00b1 5.8% by EuroSCORE II, and 7.3 \u00b1 4.1% by STS score. The risk-adjusted mortality ratio was 0.34 (95% confidence interval [CI] 0.10 to 0.58) for logistic EuroSCORE, 0.99 (95% CI 0.29 to 1.69) for EuroSCORE II, and 1.05 (95% CI 0.30 to 1.79) for STS score. Moderate discrimination was observed with EuroSCORE II (C-index 0.66, 95% CI 0.52 to 0.79, p = 0.02) compared to the logistic EuroSCORE (C-index 0.63, 95% CI 0.51 to 0.76, p = 0.06) and STS (C-index 0.58, 95% CI 0.43 to 0.73, p = 0.23) score, without a significant difference among the 3 risk scores. Discrimination was slightly better in the transfemoral cohort compared to the transapical cohort with the 3 risk scores. In conclusion, EuroSCORE II and the STS score are better calibrated than the logistic EuroSCORE but have moderate discrimination for predicting 30-day mortality after TAVR.", "author" : [ { "dropping-particle" : "", "family" : "Durand", "given" : "Eric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Borz", "given" : "Bogdan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Godin", "given" : "Matthieu", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tron", "given" : "Christophe", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Litzler", "given" : "Pierre-Yves", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bessou", "given" : "Jean-Paul", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dacher", "given" : "Jean-Nicolas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bauer", "given" : "Fabrice", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cribier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-1", "issue" : "6", "issued" : { "date-parts" : [ [ "2013", "3", "15" ] ] }, "note" : "Compares risk scores in different access points for TAVI.", "page" : "891-7", "publisher" : "Elsevier Inc.", "title" : "Performance analysis of EuroSCORE II compared to the original logistic EuroSCORE and STS scores for predicting 30-day mortality after transcatheter aortic valve replacement.", "type" : "article-journal", "volume" : "111" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1016/j.ahj.2009.11.026", "ISSN" : "1097-6744", "PMID" : "20152233", "abstract" : "BACKGROUND: Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or \"inoperable\" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. OBJECTIVE: The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. METHODS: All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. RESULTS: Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% +/- 13.9% vs STS 6.7% +/- 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES > or =15%, 16% had an STS > or =10%, and 40% had an LES > or =20% or STS > or =10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. CONCLUSIONS: Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.", "author" : [ { "dropping-particle" : "", "family" : "Piazza", "given" : "Nicolo", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Wenaweser", "given" : "Peter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gameren", "given" : "Menno", "non-dropping-particle" : "van", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pilgrim", "given" : "Thomas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tsikas", "given" : "Apostolos", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Otten", "given" : "Amber", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Nuis", "given" : "Rutger", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Onuma", "given" : "Yoshinobu", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cheng", "given" : "Jin Ming", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kappetein", "given" : "A Pieter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Boersma", "given" : "Eric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Juni", "given" : "Peter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Jaegere", "given" : "Peter", "non-dropping-particle" : "de", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Windecker", "given" : "Stephan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Serruys", "given" : "Patrick W", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "American heart journal", "id" : "ITEM-2", "issue" : "2", "issued" : { "date-parts" : [ [ "2010", "2" ] ] }, "note" : "This article compares the logistic EuroScore (LES) with the Society of Thoacic Surgeons Predicted Risk of Mortality (STS). Both of these are commonly used to identify those that are at high-risk or &quot;inoperable&quot;patients for TAVI. The paper aimed to investigate the correlation between the two different scores. The paper highlights that STS is comprised of 41 variables which are divided into 8 categories demographics, risk factors, previous interventions, preoperative cardiac status, preoperative medications, hemodynamics and catheterization, operative, and valve surgery). 168 high surgical risk patients with a CoreValve system implanted between 2005 and 2009. The primary end point of this study was mortality within 30 days of the procedure. \nFor the analysis, LES and STS performance was assessed in relation to the discrimination and calibration. Discrimination (ability to correctly classify dead or alive patients) was assessed through the c-index whereas calibration was assessed by comparing the observed and expected mortalities. In order to explore the relationship between LES and STS, a scatter plot was made from which the pearsons correlation coefficient indicated the strength and direction of any association. \u00a0 It was found that LES gave higher estimates of mortality than STS; with a 0.56 pearson correlation for the correlation between STS and LES. It was also concluded that STS performed better than LES, but both has less than optimal discriminatory power and calibration. \n\u201cThe large discrepancy between LES- and STS-predicted risks of mortality might invite a reappraisal as to whether some patients implanted with the CoreValve device were indeed high-risk surgical patients. One caveat, and a general shortcoming of all surgical risk algorithms, is the omission of several measurable and unmeasurable risk factors known to influence patient selection and mortality\u201d.", "page" : "323-9", "publisher" : "Mosby, Inc.", "title" : "Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system--a Bern-Rotterdam Study.", "type" : "article-journal", "volume" : "159" }, "uris" : [ "" ] }, { "id" : "ITEM-3", "itemData" : { "DOI" : "10.1016/j.carrev.2011.04.005", "ISSN" : "1878-0938", "PMID" : "21741324", "abstract" : "BACKGROUND: The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI. METHODS: The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 \u00b1 8.1 years, and 394 (54.8%) were female. RESULTS: The mean STS score was 11.5 \u00b1 6.1, and the mean logistic EuroSCORE was 39.7 \u00b1 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 \u00b1 6.2 vs.10.0 \u00b1 5.8 and 43.4 \u00b1 23.1 vs. 37.5 \u00b1 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE. CONCLUSION: In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options.", "author" : [ { "dropping-particle" : "", "family" : "Ben-Dor", "given" : "Itsik", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gaglia", "given" : "Michael A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbash", "given" : "Israel M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Maluenda", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hauville", "given" : "Camille", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gonzalez", "given" : "Manuel A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sardi", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laynez-Carnicero", "given" : "Ana", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Torguson", "given" : "Rebecca", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Okubagzi", "given" : "Petros", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Xue", "given" : "Zhenyi", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Goldstein", "given" : "Steven A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Suddath", "given" : "William O", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kent", "given" : "Kenneth M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Lindsay", "given" : "Joseph", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Satler", "given" : "Lowell F", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pichard", "given" : "Augusto D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Waksman", "given" : "Ron", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Cardiovascular revascularization medicine : including molecular interventions", "id" : "ITEM-3", "issue" : "6", "issued" : { "date-parts" : [ [ "2011" ] ] }, "note" : "As stated in the introduction \u201cTo be included in a current randomized TAVI trial and/or registry (PARTNER trial), a patient candidate must have a Society of Thoracic Surgeons (STS) risk score of &gt;10 or a logistic EuroSCORE of &gt;20\u201d. It is vital, therefore, that such risk prediction models are accurately and consistently predicting the risk factor for each patient. This study aimed to identify the correlation between STS and the logistic EuroScore in relation to TAVI. This was achieved by analysing 718 high risk patients with severe aortic stenosis who were candidates for TAVI clinical trials. It was found that in those high-risk patients, STS was superior to the logistic EuroScore in predicting mortality. \n\n\n\n\nThis article also investigated the relationship between logistic EuroScore (LES) with the Society of Thoacic Surgeons Predicted Risk of Mortality (STS). The ability to predict 30 day mortality in three patient groups (medical management or balloon aortic valvuloplasty (BAV), surgical aortic valve replacement (AVR); TAVI) was assessed.\u00a0 718 high-risk patients were considered", "page" : "345-9", "publisher" : "Elsevier B.V.", "title" : "Comparison between Society of Thoracic Surgeons score and logistic EuroSCORE for predicting mortality in patients referred for transcatheter aortic valve implantation.", "type" : "article-journal", "volume" : "12" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(9\u201311)", "plainTextFormattedCitation" : "(9\u201311)", "previouslyFormattedCitation" : "(9\u201311)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(9–11). Despite being poor, the STS model outperformed the other surgical models, with the STS expected 30-day mortality rate not significantly different from the observed 30-day mortality rate. This finding has been previously observed ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.amjcard.2012.11.056", "ISSN" : "1879-1913", "PMID" : "23337835", "abstract" : "The original European System for Cardiac Operative Risk Evaluation (EuroSCORE) has been recently updated as EuroSCORE II to optimize its efficacy in cardiac surgery, but its performance has been poorly evaluated for predicting 30-day mortality in patients who undergo transcatheter aortic valve replacement (TAVR). Consecutive patients (n = 250) treated with TAVR were included in this analysis. Transapical access was used in 60 patients, while 190 procedures were performed using a transfemoral approach. Calibration (risk-adjusted mortality ratio) and discrimination (C-statistic and U-statistic) were calculated for the logistic EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons (STS) scores for predicting 30-day mortality. Observed mortality was 7.6% in the overall population (6.3% and 11.7% for the transfemoral and transapical cohorts, respectively). Predicted mortality was 22.6 \u00b1 12.8% by logistic EuroSCORE, 7.7 \u00b1 5.8% by EuroSCORE II, and 7.3 \u00b1 4.1% by STS score. The risk-adjusted mortality ratio was 0.34 (95% confidence interval [CI] 0.10 to 0.58) for logistic EuroSCORE, 0.99 (95% CI 0.29 to 1.69) for EuroSCORE II, and 1.05 (95% CI 0.30 to 1.79) for STS score. Moderate discrimination was observed with EuroSCORE II (C-index 0.66, 95% CI 0.52 to 0.79, p = 0.02) compared to the logistic EuroSCORE (C-index 0.63, 95% CI 0.51 to 0.76, p = 0.06) and STS (C-index 0.58, 95% CI 0.43 to 0.73, p = 0.23) score, without a significant difference among the 3 risk scores. Discrimination was slightly better in the transfemoral cohort compared to the transapical cohort with the 3 risk scores. In conclusion, EuroSCORE II and the STS score are better calibrated than the logistic EuroSCORE but have moderate discrimination for predicting 30-day mortality after TAVR.", "author" : [ { "dropping-particle" : "", "family" : "Durand", "given" : "Eric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Borz", "given" : "Bogdan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Godin", "given" : "Matthieu", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tron", "given" : "Christophe", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Litzler", "given" : "Pierre-Yves", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bessou", "given" : "Jean-Paul", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dacher", "given" : "Jean-Nicolas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bauer", "given" : "Fabrice", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cribier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-1", "issue" : "6", "issued" : { "date-parts" : [ [ "2013", "3", "15" ] ] }, "note" : "Compares risk scores in different access points for TAVI.", "page" : "891-7", "publisher" : "Elsevier Inc.", "title" : "Performance analysis of EuroSCORE II compared to the original logistic EuroSCORE and STS scores for predicting 30-day mortality after transcatheter aortic valve replacement.", "type" : "article-journal", "volume" : "111" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1016/j.carrev.2011.04.005", "ISSN" : "1878-0938", "PMID" : "21741324", "abstract" : "BACKGROUND: The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI. METHODS: The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 \u00b1 8.1 years, and 394 (54.8%) were female. RESULTS: The mean STS score was 11.5 \u00b1 6.1, and the mean logistic EuroSCORE was 39.7 \u00b1 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 \u00b1 6.2 vs.10.0 \u00b1 5.8 and 43.4 \u00b1 23.1 vs. 37.5 \u00b1 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE. CONCLUSION: In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options.", "author" : [ { "dropping-particle" : "", "family" : "Ben-Dor", "given" : "Itsik", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gaglia", "given" : "Michael A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbash", "given" : "Israel M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Maluenda", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hauville", "given" : "Camille", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gonzalez", "given" : "Manuel A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sardi", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laynez-Carnicero", "given" : "Ana", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Torguson", "given" : "Rebecca", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Okubagzi", "given" : "Petros", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Xue", "given" : "Zhenyi", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Goldstein", "given" : "Steven A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Suddath", "given" : "William O", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kent", "given" : "Kenneth M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Lindsay", "given" : "Joseph", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Satler", "given" : "Lowell F", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pichard", "given" : "Augusto D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Waksman", "given" : "Ron", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Cardiovascular revascularization medicine : including molecular interventions", "id" : "ITEM-2", "issue" : "6", "issued" : { "date-parts" : [ [ "2011" ] ] }, "note" : "As stated in the introduction \u201cTo be included in a current randomized TAVI trial and/or registry (PARTNER trial), a patient candidate must have a Society of Thoracic Surgeons (STS) risk score of &gt;10 or a logistic EuroSCORE of &gt;20\u201d. It is vital, therefore, that such risk prediction models are accurately and consistently predicting the risk factor for each patient. This study aimed to identify the correlation between STS and the logistic EuroScore in relation to TAVI. This was achieved by analysing 718 high risk patients with severe aortic stenosis who were candidates for TAVI clinical trials. It was found that in those high-risk patients, STS was superior to the logistic EuroScore in predicting mortality. \n\n\n\n\nThis article also investigated the relationship between logistic EuroScore (LES) with the Society of Thoacic Surgeons Predicted Risk of Mortality (STS). The ability to predict 30 day mortality in three patient groups (medical management or balloon aortic valvuloplasty (BAV), surgical aortic valve replacement (AVR); TAVI) was assessed.\u00a0 718 high-risk patients were considered", "page" : "345-9", "publisher" : "Elsevier B.V.", "title" : "Comparison between Society of Thoracic Surgeons score and logistic EuroSCORE for predicting mortality in patients referred for transcatheter aortic valve implantation.", "type" : "article-journal", "volume" : "12" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(9,11)", "plainTextFormattedCitation" : "(9,11)", "previouslyFormattedCitation" : "(9,11)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(9,11) and is perhaps attributable to the fact the STS score has a specific model for isolated valve surgery ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.athoracsur.2009.05.056", "ISSN" : "00034975", "PMID" : "19559823", "abstract" : "BACKGROUND: Adjustment for case-mix is essential when using observational data to compare surgical techniques or providers. That is most often accomplished through the use of risk models that account for preoperative patient factors that may impact outcomes. The Society of Thoracic Surgeons (STS) uses such risk models to create risk-adjusted performance reports for participants in the STS National Adult Cardiac Surgery Database (NCD). Although risk models were initially developed for coronary artery bypass surgery, similar models have now been developed for use with heart valve surgery, particularly as the proportion of such procedures has increased. The last published STS model for isolated valve surgery was based on data from 1994 to 1997 and did not include patients undergoing mitral valve repair. STS has developed new valve surgery models using contemporary data that include both valve repair as well as replacement. Expanding upon existing valve models, the new STS models include several nonfatal complications in addition to mortality. METHODS: Using STS data from 2002 to 2006, isolated valve surgery risk models were developed for operative mortality, permanent stroke, renal failure, prolonged ventilation (> 24 hours), deep sternal wound infection, reoperation for any reason, a major morbidity or mortality composite endpoint, prolonged postoperative length of stay, and short postoperative length of stay. The study population consisted of adult patients who underwent one of three types of valve surgery: isolated aortic valve replacement (n = 67,292), isolated mitral valve replacement (n = 21,229), or isolated mitral valve repair (n = 21,238). The population was divided into a 60% development sample and a 40% validation sample. After an initial empirical investigation, the three surgery groups were combined into a single logistic regression model with numerous interactions to allow the covariate effects to differ across these groups. Variables were selected based on a combination of automated stepwise selection and expert panel review. RESULTS: Unadjusted operative mortality (in-hospital regardless of timing, and 30-day regardless of venue) for all isolated valve procedures was 3.4%, and unadjusted in-hospital morbidity rates ranged from 0.3% for deep sternal wound infection to 11.8% for prolonged ventilation. The number of predictors in each model ranged from 10 covariates in the sternal infection model to 24 covariates in the composite mortality plu\u2026", "author" : [ { "dropping-particle" : "", "family" : "O'Brien", "given" : "Sean M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shahian", "given" : "David M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Filardo", "given" : "Giovanni", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ferraris", "given" : "Victor A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Haan", "given" : "Constance K", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rich", "given" : "Jeffrey B", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Normand", "given" : "Sharon-Lise T", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "DeLong", "given" : "Elizabeth R", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Shewan", "given" : "Cynthia M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Dokholyan", "given" : "Rachel S", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Peterson", "given" : "Eric D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Edwards", "given" : "Fred H", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Anderson", "given" : "Richard P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The Annals of Thoracic Surgery", "id" : "ITEM-1", "issue" : "1", "issued" : { "date-parts" : [ [ "2009", "7" ] ] }, "note" : "Gives regression coefficients for the STS Score risk model for isolated valve surgery", "page" : "S23-S42", "publisher" : "The Society of Thoracic Surgeons", "title" : "The Society of Thoracic Surgeons 2008 Cardiac Surgery Risk Models: Part 2\u2014Isolated Valve Surgery", "type" : "article-journal", "volume" : "88" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(8)", "plainTextFormattedCitation" : "(8)", "previouslyFormattedCitation" : "(8)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(8). Of note, previous TAVI registries have reported mean STS values higher than that found in this study, perhaps due to the assumptions made in our study regarding the calculation of the STS model. For example, the FRANCE TAVI registry reported STS values of around 18%, while the Italian CoreValve registry reported values of 11% ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1093/eurheartj/ehq261", "ISSN" : "1522-9645", "PMID" : "20843959", "abstract" : "AIMS: Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN\u2122 or CoreValve\u2122 in high-surgical-risk patients with severe aortic stenosis.\n\nMETHODS AND RESULTS: The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE \u226520%, STS \u226510%, or contra-indication to AVR) were enrolled. Mean age was 82 \u00b1 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less.\n\nCONCLUSION: This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.", "author" : [ { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Prat", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gilard", "given" : "Martine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leguerrier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Blanchard", "given" : "Didier", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fournial", "given" : "G\u00e9rard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Donzeau-Gouge", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tribouilloy", "given" : "Christophe", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Debrux", "given" : "Jean-Louis", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pavie", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gueret", "given" : "Pascal", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European heart journal", "id" : "ITEM-1", "issue" : "2", "issued" : { "date-parts" : [ [ "2011", "1" ] ] }, "note" : "Evaluates the TAVI registry in FRANCE of patients considered at too high risk for conventional SAVR (multi-centre study). 244 patients were included who both had TA and TF approaches. \n\n\n\n\nThe mean age of the patients was 82 with 43% of them being female. \n\n\n\n\nThe one-month mortality was 12.7% (81% of them in the first week).", "page" : "191-7", "title" : "Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.", "type" : "article-journal", "volume" : "32" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1093/eurheartj/ehr491", "ISBN" : "0195-668X", "ISSN" : "0195-668X", "PMID" : "22240494", "abstract" : "AIMS: The paucity of evidences about the long-term durability of currently available transcatheter prostheses is one of the main issues of transcatheter aortic valve implantation (TAVI). We sought to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third generation CoreValve prosthesis (Medtronic Incorporation, MN, USA). METHODS AND RESULTS: From the Italian CoreValve registry, 181 who underwent TAVI from June 2007 to August 2008 and eligible for 3-year follow-up were analysed. All outcomes were defined according to the Valve Academic Research Consortium. All-cause mortality at 1, 2, and 3 years was 23.6, 30.3, and 34.8%, respectively. Cardiovascular death at 1, 2, and 3 years was 11.2, 12.1, and 13.5%, respectively. The actuarial survival free from a composite of death, major stroke, myocardial infarction, and life-threatening bleeding was 69.6% at 1 year, 63.5% at 2 years, and 59.7% at 3 years. Patients with renal insufficiency had a higher mortality at 3-year follow-up (49.0 vs. 29.2%, P = 0.007); moreover, patients experiencing post-procedural major or life-threatening bleeding had a higher rate of mortality already seen at 30 days (21.6 vs. 2.8%; P < 0.001) and this result was sustained at 3-year follow-up (62.2 vs. 27.7%; P < 0.001). Mean pressure gradients decreased from 52.2 \u00b1 18.1 mmHg (pre-TAVI) to 10.3 \u00b1 3.1 mmHg (1-year post-TAVI) (P < 0.001); aortic valve area increased from 0.6 \u00b1 0.2 cm(2) (pre-TAVI) to 1.8 \u00b1 0.4 cm(2) (1-year post-TAVI); these results remained stable over the 3 years of follow-up. Paravalvular leak was observed in the majority of patients. There were no cases of progression to moderate or severe regurgitation. No cases of structural valve deterioration were observed. CONCLUSION: This multicentre study demonstrates that TAVI with the 18-Fr CoreValve ReValving System is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic stenosis up to 3-year follow-up. Non-cardiac causes accounted for the majority of deaths at follow-up.", "author" : [ { "dropping-particle" : "", "family" : "Ussia", "given" : "G. P.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbanti", "given" : "M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Petronio", "given" : "A. S.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tarantini", "given" : "G.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ettori", "given" : "F.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Colombo", "given" : "A.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Violini", "given" : "R.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ramondo", "given" : "A.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santoro", "given" : "G.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Klugmann", "given" : "S.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bedogni", "given" : "F.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Maisano", "given" : "F.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Marzocchi", "given" : "A.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Poli", "given" : "A.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Carlo", "given" : "M.", "non-dropping-particle" : "De", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Napodano", "given" : "M.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fiorina", "given" : "C.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Marco", "given" : "F.", "non-dropping-particle" : "De", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Antoniucci", "given" : "D.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cillis", "given" : "E.", "non-dropping-particle" : "de", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Capodanno", "given" : "D.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tamburino", "given" : "C.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Heart Journal", "id" : "ITEM-2", "issue" : "8", "issued" : { "date-parts" : [ [ "2012" ] ] }, "page" : "969-976", "title" : "Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis", "type" : "article-journal", "volume" : "33" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(38,39)", "plainTextFormattedCitation" : "(38,39)", "previouslyFormattedCitation" : "(37,38)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(38,39). Nonetheless, comparing the surgical CPMs to the TAVI-CPMs highlights that the latter performed better than the former when internally validated ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.amjcard.2014.03.014", "ISSN" : "1879-1913", "PMID" : "24837264", "abstract" : "Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate <45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction <40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system.", "author" : [ { "dropping-particle" : "", "family" : "Capodanno", "given" : "Davide", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbanti", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tamburino", "given" : "Corrado", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "D'Errigo", "given" : "Paola", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Ranucci", "given" : "Marco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santoro", "given" : "Gennaro", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Santini", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Onorati", "given" : "Francesco", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Grossi", "given" : "Claudio", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Covello", "given" : "Remo Daniel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Capranzano", "given" : "Piera", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rosato", "given" : "Stefano", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Seccareccia", "given" : "Fulvia", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The American journal of cardiology", "id" : "ITEM-1", "issue" : "11", "issued" : { "date-parts" : [ [ "2014", "6", "1" ] ] }, "page" : "1851-8", "publisher" : "Elsevier Inc.", "title" : "A simple risk tool (the OBSERVANT score) for prediction of 30-day mortality after transcatheter aortic valve replacement.", "type" : "article-journal", "volume" : "113" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1136/heartjnl-2013-305314", "ISSN" : "1468-201X", "PMID" : "24740804", "abstract" : "OBJECTIVE: Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. METHODS: A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. RESULTS: TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age \u226590 years, body mass index <30 Kg/m(2), New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, \u22652 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. CONCLUSIONS: Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.", "author" : [ { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laou\u00e9nan", "given" : "C\u00e9dric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Himbert", "given" : "Dominique", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eltchaninoff", "given" : "H\u00e9l\u00e8ne", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Chevreul", "given" : "Karine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Donzeau-Gouge", "given" : "Patrick", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Fajadet", "given" : "Jean", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leprince", "given" : "Pascal", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Leguerrier", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Li\u00e8vre", "given" : "Michel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Prat", "given" : "Alain", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Teiger", "given" : "Emmanuel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laskar", "given" : "Marc", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Vahanian", "given" : "Alec", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gilard", "given" : "Martine", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Heart (British Cardiac Society)", "id" : "ITEM-2", "issue" : "13", "issued" : { "date-parts" : [ [ "2014", "7" ] ] }, "note" : "This article uses data from the \u201cFrench Aortic National CoreValve and Edwards\u201d registry in order to investigate predictive factors for early mortality after TAVI. In addition, it was aimed to develop a scoring system to predict mortality after TAVI.\u00a0 \n3933 patients who underwent TAVI in 33 French centres. The patients were classified as high risk for surgery. The primary endpoint was all cause mortality 30 days after procedure. \nStatistical analyses included the use of univariate and multivariate logistic regression to build the scoring system. Discrimination and calibration of the model were assessed using the c-index and comparing Obc/Exp respectively. \nWhen investigating the early mortality the results did report those with different ages, centres, procedure type. No difference in mortality was found in centres, volume activity, time and experience of using TAVI. Age was associate with a significant increase in early mortality. Low BMI was also linked with early mortality. \nEight patient related and one procedural related variables were identified as predictive factors of early mortality; which then was used to develop a scoring system. However, the results showed that discrimination was lacking. \nIn summary the study found nine predictive factors of early mortality after TAVI. In addition a scoring system was developed which provided reasonable but certainly room for improvement.", "page" : "1016-23", "title" : "Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.", "type" : "article-journal", "volume" : "100" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(12,14)", "plainTextFormattedCitation" : "(12,14)", "previouslyFormattedCitation" : "(12,14)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(12,14) and the current study shows that the FRANCE-2 and ACC models outperformed the surgical scores. Surgical CPMs are limited in their use in transcatheter procedures because they were derived from surgical populations. Not only are the procedural risks of TAVI different from those in SAVR, but there is a lack of grading between the severities of co-morbidities in the surgical CPMs. For example, chronic obstructive pulmonary disease (COPD) is a risk factor in LES, but there is no further distinction between the severity of COPD or even other severe lung disease. Since the heart-team considers such severities when deciding between SAVR and TAVI, grading of co-morbidities should be included in future TAVI-CPMs. Patient-level Agreement Analysis This study highlighted that the classification of patient risk varies between multiple CPMs, even when comparing surgical and TAVI based CPMs separately. A Pearson correlation coefficient of 0.56 has previously been reported between the LES and STS score ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.ahj.2009.11.026", "ISSN" : "1097-6744", "PMID" : "20152233", "abstract" : "BACKGROUND: Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or \"inoperable\" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. OBJECTIVE: The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. METHODS: All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. RESULTS: Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% +/- 13.9% vs STS 6.7% +/- 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES > or =15%, 16% had an STS > or =10%, and 40% had an LES > or =20% or STS > or =10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. CONCLUSIONS: Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.", "author" : [ { "dropping-particle" : "", "family" : "Piazza", "given" : "Nicolo", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Wenaweser", "given" : "Peter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gameren", "given" : "Menno", "non-dropping-particle" : "van", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pilgrim", "given" : "Thomas", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Tsikas", "given" : "Apostolos", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Otten", "given" : "Amber", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Nuis", "given" : "Rutger", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Onuma", "given" : "Yoshinobu", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cheng", "given" : "Jin Ming", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kappetein", "given" : "A Pieter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Boersma", "given" : "Eric", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Juni", "given" : "Peter", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Jaegere", "given" : "Peter", "non-dropping-particle" : "de", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Windecker", "given" : "Stephan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Serruys", "given" : "Patrick W", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "American heart journal", "id" : "ITEM-1", "issue" : "2", "issued" : { "date-parts" : [ [ "2010", "2" ] ] }, "note" : "This article compares the logistic EuroScore (LES) with the Society of Thoacic Surgeons Predicted Risk of Mortality (STS). Both of these are commonly used to identify those that are at high-risk or &quot;inoperable&quot;patients for TAVI. The paper aimed to investigate the correlation between the two different scores. The paper highlights that STS is comprised of 41 variables which are divided into 8 categories demographics, risk factors, previous interventions, preoperative cardiac status, preoperative medications, hemodynamics and catheterization, operative, and valve surgery). 168 high surgical risk patients with a CoreValve system implanted between 2005 and 2009. The primary end point of this study was mortality within 30 days of the procedure. \nFor the analysis, LES and STS performance was assessed in relation to the discrimination and calibration. Discrimination (ability to correctly classify dead or alive patients) was assessed through the c-index whereas calibration was assessed by comparing the observed and expected mortalities. In order to explore the relationship between LES and STS, a scatter plot was made from which the pearsons correlation coefficient indicated the strength and direction of any association. \u00a0 It was found that LES gave higher estimates of mortality than STS; with a 0.56 pearson correlation for the correlation between STS and LES. It was also concluded that STS performed better than LES, but both has less than optimal discriminatory power and calibration. \n\u201cThe large discrepancy between LES- and STS-predicted risks of mortality might invite a reappraisal as to whether some patients implanted with the CoreValve device were indeed high-risk surgical patients. One caveat, and a general shortcoming of all surgical risk algorithms, is the omission of several measurable and unmeasurable risk factors known to influence patient selection and mortality\u201d.", "page" : "323-9", "publisher" : "Mosby, Inc.", "title" : "Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system--a Bern-Rotterdam Study.", "type" : "article-journal", "volume" : "159" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(10)", "plainTextFormattedCitation" : "(10)", "previouslyFormattedCitation" : "(10)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(10), with similar correlation between these scores reported in other studies ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1016/j.carrev.2011.04.005", "ISSN" : "1878-0938", "PMID" : "21741324", "abstract" : "BACKGROUND: The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI. METHODS: The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 \u00b1 8.1 years, and 394 (54.8%) were female. RESULTS: The mean STS score was 11.5 \u00b1 6.1, and the mean logistic EuroSCORE was 39.7 \u00b1 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 \u00b1 6.2 vs.10.0 \u00b1 5.8 and 43.4 \u00b1 23.1 vs. 37.5 \u00b1 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE. CONCLUSION: In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options.", "author" : [ { "dropping-particle" : "", "family" : "Ben-Dor", "given" : "Itsik", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gaglia", "given" : "Michael A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Barbash", "given" : "Israel M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Maluenda", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hauville", "given" : "Camille", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Gonzalez", "given" : "Manuel A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sardi", "given" : "Gabriel", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Laynez-Carnicero", "given" : "Ana", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Torguson", "given" : "Rebecca", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Okubagzi", "given" : "Petros", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Xue", "given" : "Zhenyi", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Goldstein", "given" : "Steven A", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Suddath", "given" : "William O", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Kent", "given" : "Kenneth M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Lindsay", "given" : "Joseph", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Satler", "given" : "Lowell F", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pichard", "given" : "Augusto D", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Waksman", "given" : "Ron", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Cardiovascular revascularization medicine : including molecular interventions", "id" : "ITEM-1", "issue" : "6", "issued" : { "date-parts" : [ [ "2011" ] ] }, "note" : "As stated in the introduction \u201cTo be included in a current randomized TAVI trial and/or registry (PARTNER trial), a patient candidate must have a Society of Thoracic Surgeons (STS) risk score of &gt;10 or a logistic EuroSCORE of &gt;20\u201d. It is vital, therefore, that such risk prediction models are accurately and consistently predicting the risk factor for each patient. This study aimed to identify the correlation between STS and the logistic EuroScore in relation to TAVI. This was achieved by analysing 718 high risk patients with severe aortic stenosis who were candidates for TAVI clinical trials. It was found that in those high-risk patients, STS was superior to the logistic EuroScore in predicting mortality. \n\n\n\n\nThis article also investigated the relationship between logistic EuroScore (LES) with the Society of Thoacic Surgeons Predicted Risk of Mortality (STS). The ability to predict 30 day mortality in three patient groups (medical management or balloon aortic valvuloplasty (BAV), surgical aortic valve replacement (AVR); TAVI) was assessed.\u00a0 718 high-risk patients were considered", "page" : "345-9", "publisher" : "Elsevier B.V.", "title" : "Comparison between Society of Thoracic Surgeons score and logistic EuroSCORE for predicting mortality in patients referred for transcatheter aortic valve implantation.", "type" : "article-journal", "volume" : "12" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(11)", "plainTextFormattedCitation" : "(11)", "previouslyFormattedCitation" : "(11)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(11). Such an analysis does not necessarily indicate the level of agreement between two risk models, since the correlation is only assessing the linear relationship between them ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "author" : [ { "dropping-particle" : "", "family" : "Altman", "given" : "DG", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bland", "given" : "JM", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "The statistician", "id" : "ITEM-1", "issue" : "3", "issued" : { "date-parts" : [ [ "1983" ] ] }, "note" : "This paper provides a more statistical reasonaing behind the ideas given in Bland and Altmans paper &quot;Statistical methods for assessing agreemtne between two methods of clinical measurement&quot;. \n\n\n\n\n\n\n\n\nIn particular the paper looks at methods when comparing two methods in which the &quot;true value&quot; cannot be given from either method. The situation in which compares a new method with a precise one is a calibration problem and this is not discussed.", "page" : "307-317", "title" : "Measurement in medicine: the analysis of method comparison studies", "type" : "article-journal", "volume" : "32" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(40)", "plainTextFormattedCitation" : "(40)", "previouslyFormattedCitation" : "(39)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(40). Although the current study found higher agreement between the surgical models than between the TAVI models, this was driven by the ESII being an updated version of the LES. The lack of agreement between the scores further highlights previous published recommendations that risk assessment should be based on heart-team discussion in combination with multiple CPMs ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1093/eurheartj/ehs109", "ISSN" : "0195-668X", "PMID" : "22922415", "author" : [ { "dropping-particle" : "", "family" : "Vahanian", "given" : "Alec", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Alfieri", "given" : "Ottavio", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Andreotti", "given" : "Felicita", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Antunes", "given" : "Manuel J", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Baron-Esquivias", "given" : "G.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Baumgartner", "given" : "Helmut", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Borger", "given" : "Michael Andrew", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Carrel", "given" : "Thierry P", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bonis", "given" : "Michele", "non-dropping-particle" : "De", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Evangelista", "given" : "Arturo", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Falk", "given" : "Volkmar", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Lancellotti", "given" : "Patrizio", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Pierard", "given" : "Luc", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Price", "given" : "Susanna", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schafers", "given" : "H.-J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schuler", "given" : "Gerhard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Stepinska", "given" : "Janina", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Swedberg", "given" : "Karl", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Takkenberg", "given" : "Johanna", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Oppell", "given" : "Ulrich Otto", "non-dropping-particle" : "Von", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Windecker", "given" : "Stephan", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Zamorano", "given" : "Jose Luis", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Zembala", "given" : "Marian", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bax", "given" : "J. 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T.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Walther", "given" : "T.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Heart Journal", "id" : "ITEM-1", "issue" : "19", "issued" : { "date-parts" : [ [ "2012", "10", "1" ] ] }, "page" : "2451-2496", "title" : "Guidelines on the management of valvular heart disease (version 2012): The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)", "type" : "article-journal", "volume" : "33" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(4)", "plainTextFormattedCitation" : "(4)", "previouslyFormattedCitation" : "(4)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(4).LimitationsA limitation of the current work is that assumptions were required when linking the definitions of model variables with the TAVI dataset, as described in the Supplementary Material. For example, the lowest LV function category in the ESII model is LVEF<20% whereas that in the UK TAVI dataset is LVEF<30%, with this analysis assuming these definitions to be equivalent. Such assumptions are an artefact of different recording practices between national registries. Accordingly, some of the surgical CPMs could not be calculated exactly as they were published, which could induce bias into the calculated predicted risks. This study used surrogate variables to mitigate this wherever possible and all assumptions were made to reflect the TAVI procedure as accurately as possible. As noted above, the calculated STS score in this study is lower than previously reported values from other TAVI registries. Lack of variables including mitral valve, hypertension and severity of pulmonary disease could have contributed to this, but our findings compare favourably to previous work. Similarly, the assumption of risk factor absent for variables that were included in CPMs but not recorded in the UK TAVI registry (e.g. mitral valve replacement or infective endocarditis) may induce bias, but any such bias is likely to be negligible given the variables where this assumption was needed. Implications for Future WorkBased on this work, the development of further TAVI-CPMs is recommended in populations of interest. 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Rather than developing new scores from scratch, model updating techniques could be applied to the current TAVI-CPMs to adapt them to new national cohorts ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.1002/sim.1844", "ISSN" : "0277-6715", "PMID" : "15287085", "abstract" : "A logistic regression model may be used to provide predictions of outcome for individual patients at another centre than where the model was developed. When empirical data are available from this centre, the validity of predictions can be assessed by comparing observed outcomes and predicted probabilities. Subsequently, the model may be updated to improve predictions for future patients. As an example, we analysed 30-day mortality after acute myocardial infarction in a large data set (GUSTO-I, n = 40 830). We validated and updated a previously published model from another study (TIMI-II, n = 3339) in validation samples ranging from small (200 patients, 14 deaths) to large (10,000 patients, 700 deaths). Updated models were tested on independent patients. Updating methods included re-calibration (re-estimation of the intercept or slope of the linear predictor) and more structural model revisions (re-estimation of some or all regression coefficients, model extension with more predictors). We applied heuristic shrinkage approaches in the model revision methods, such that regression coefficients were shrunken towards their re-calibrated values. Parsimonious updating methods were found preferable to more extensive model revisions, which should only be attempted with relatively large validation samples in combination with shrinkage.", "author" : [ { "dropping-particle" : "", "family" : "Steyerberg", "given" : "Ewout W", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Borsboom", "given" : "Gerard J J M", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Houwelingen", "given" : "Hans C", "non-dropping-particle" : "van", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Eijkemans", "given" : "Marinus J C", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Habbema", "given" : "J Dik F", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "Statistics in Medicine", "id" : "ITEM-1", "issue" : "16", "issued" : { "date-parts" : [ [ "2004", "8", "30" ] ] }, "page" : "2567-2586", "title" : "Validation and updating of predictive logistic regression models: a study on sample size and shrinkage", "type" : "article-journal", "volume" : "23" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(41)", "plainTextFormattedCitation" : "(41)", "previouslyFormattedCitation" : "(40)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(41). For instance, re-fitting the current models to the population of interest and/or the addition of new risk factors, such as frailty, could improve prediction ADDIN CSL_CITATION { "citationItems" : [ { "id" : "ITEM-1", "itemData" : { "DOI" : "10.4244/EIJY14M08_03", "ISSN" : "1969-6213", "PMID" : "25136880", "abstract" : "AIMS: Transcatheter aortic valve implantation (TAVI) represents a less invasive treatment option for elderly patients. Therefore, we aimed to determine the impact of frailty measured by the Katz Index of activities of daily living (ADL) on short- and long-term mortality after TAVI. METHODS AND RESULTS: Our study included 300 consecutive patients (mean age, 82\u00b15 years) who had undergone TAVI at our institution (158 transapical, 142 transfemoral procedures). At baseline, 144 patients were impaired in at least one ADL and therefore defined as frail (Katz Index <6). Regarding in-hospital outcome, all serious complications except for stage 3 acute kidney injury were equally distributed in both groups, but early mortality was significantly higher in frail persons (5.5% vs. 1.3%, p=0.04 for immediate procedural mortality; 17% vs. 5.8%, p=0.002 for 30-day mortality; and 23% vs. 6.4%, p<0.0001 for procedural mortality). The risk-score-based 30-day mortality estimates (29% vs. 24% for log. EuroSCORE I, 9.5% vs. 7.5% for EuroSCORE II, and 8.8% vs. 5.9% for STS score) reflected neither the observed 30-day mortality in both groups nor the threefold risk elevation in frail patients. In contrast, the Katz Index <6 was identified as a significant independent predictor of long-term all-cause mortality by multivariate analysis (HR 2.67 [95% CI: 1.7-4.3], p<0.0001). During follow-up (median observation period 537 days) 56% of frail vs. 24% of non-frail patients died. CONCLUSIONS: Frailty status measured by the Katz Index represents a powerful predictor of adverse early and late outcome after TAVI, whereas commonly used risk scores lack calibration and discrimination in a TAVI-specific patient cohort. Therefore, we propose the incorporation of this simple and reproducible measure into pre-TAVI risk assessment.", "author" : [ { "dropping-particle" : "", "family" : "Puls", "given" : "Miriam", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sobisiak", "given" : "Bettina", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bleckmann", "given" : "Annalen", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Jacobshagen", "given" : "Claudius", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Danner", "given" : "Bernhard C", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "H\u00fcnlich", "given" : "Mark", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Bei\u00dfbarth", "given" : "Tim", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Sch\u00f6ndube", "given" : "Friedrich", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Hasenfu\u00df", "given" : "Gerd", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Seipelt", "given" : "Ralf", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Schillinger", "given" : "Wolfgang", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology", "id" : "ITEM-1", "issue" : "5", "issued" : { "date-parts" : [ [ "2014", "9" ] ] }, "language" : "en", "page" : "609-19", "title" : "Impact of frailty on short and long term morbidity and mortality after transcatheter aortic valve implantation: risk assessment by Katz Index of activities of daily living.", "type" : "article-journal", "volume" : "10" }, "uris" : [ "" ] }, { "id" : "ITEM-2", "itemData" : { "DOI" : "10.1093/eurheartj/ehv756", "ISSN" : "0195-668X", "PMID" : "26819226", "author" : [ { "dropping-particle" : "", "family" : "Puri", "given" : "Rishi", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Iung", "given" : "Bernard", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Cohen", "given" : "David J.", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" }, { "dropping-particle" : "", "family" : "Rod\u00e9s-Cabau", "given" : "Josep", "non-dropping-particle" : "", "parse-names" : false, "suffix" : "" } ], "container-title" : "European Heart Journal", "id" : "ITEM-2", "issued" : { "date-parts" : [ [ "2016" ] ] }, "page" : "ehv756", "title" : "TAVI or No TAVI: identifying patients unlikely to benefit from transcatheter aortic valve implantation", "type" : "article-journal" }, "uris" : [ "" ] } ], "mendeley" : { "formattedCitation" : "(31,42)", "plainTextFormattedCitation" : "(31,42)", "previouslyFormattedCitation" : "(31,41)" }, "properties" : { "noteIndex" : 0 }, "schema" : "" }(31,42). Further work in this area is recommended. Secondly, developing TAVI models that predict both short- and long-term outcomes would be particularly valuable, especially if they included a measure of futility. ConclusionsThe FRANCE-2 and ACC TAVI models had the highest performance across all CPMs considered. However, all the CPMs had low calibration and discrimination, reducing their suitability for risk stratification outside their development cohorts. Future iterations of existing TAVI models may benefit from including non-cardiovascular co-morbidities such as frailty. The derivation of new TAVI-CPMs in contemporary large registries is recommended, but it remains to be determined if this is best achieved by updating/ revising existing TAVI scores, by developing new CPMs in specific cohorts, or a combination of the two.AcknowledgementsWe would like to acknowledge the National Institute for Cardiovascular Outcomes Research (NICOR) for provided the UK TAVI registry extract for this study.ReferencesADDIN Mendeley Bibliography CSL_BIBLIOGRAPHY 1. Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, et al. Decision-making in elderly patients with severe aortic stenosis: Why are so many denied surgery? Eur Heart J. 2005;26:2714–20. 2. Leon M, Smith C, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597–607.3. Smith C, Leon M, Mack M, Miller DC, Moses JW, Svensson LG, et al. 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Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012;33(8):969–76. 40. Altman D, Bland J. Measurement in medicine: the analysis of method comparison studies. Stat. 1983;32(3):307–17.41. Steyerberg EW, Borsboom GJJM, van Houwelingen HC, Eijkemans MJC, Habbema JDF. Validation and updating of predictive logistic regression models: a study on sample size and shrinkage. Stat Med. 2004;23(16):2567–86.42. Puri R, Iung B, Cohen DJ, Rodés-Cabau J. TAVI or No TAVI: identifying patients unlikely to benefit from transcatheter aortic valve implantation. Eur Heart J. 2016;ehv756.Figure LegendsFigure 1. Temporal changes in observed and expected mortality over each of the CPMs. Figure 2. The proportion of patients that agree in risk allocation over the surgical based CPMs. Each bar represents a risk stratification by one of the surgical CPMs, with the segments of that bar showing the proportion of patients that were also grouped in that risk strata by none, one or both of the other surgical CPMs.Figure 3. The proportion of patients that agree in risk allocation over the TAVI based CPMs. Each bar represents a risk stratification by one of the TAVI-CPMs, with the segments of that bar showing the proportion of patients that were also grouped in that risk strata by none, one or both of the other TAVI-CPMsTablesTable 1. Summary statistics, before multiple imputations of the missing data, of baseline and procedural characteristics in the UK TAVI dataset.VariableSummary (% of n = 6676)Missing (% of n = 6676)Age, mean [range]81.3 [29-101]0 (0%)Females, n (%)3085 (46.2%)22 (0.3%)Weight (Kg), mean [range]74.0 [32.0-190.0]131 (2.0%)Height (m), mean [range]1.6 [1.1-2.4]159 (2.4%)NYHA42 (0.6%) Class I, n (%)185 (2.8%) Class II, n (%)1116 (16.7%) Class III, n (%)4186 (62.7%) Class IV, n (%)1147 (17.2%)Creatinine, ?mol/L, mean [range]114.3 [29.0-1044.0]73 (1.1%)Creatinine greater than 200 ?mol/L, n (%)379 (5.7%)73 (1.1%)LVEF59 (0.88%) ≥ 50%, n (%)4074 (61.0%) 30 ? 49%, n (%)1929 (28.9%) < 30%, n (%)614 (9.2%)Extracardiac Arteriopathy, n (%)1572 (23.5%)88 (1.3%)Diabetes35 (0.52%) Dietary control, n (%)290 (4.3%) Oral medicine, n (%)884 (13.2%) Insulin, n (%)363 (5.4%)Dialysis, n (%)127 (1.9%)66 (0.99%)MI33 (0.49%) within 90 days of TAVI, n (%)153 (2.3%) within 30 days of TAVI, n (%)65 (0.97%) within 24 hours of TAVI, n (%)6 (0.09%)Procedure Urgency7 (0.10%) Elective, n (%)5853 (87.7%) Urgent, n (%)772 (11.6%) Emergency, n (%)35 (0.52%) Salvage, n (%)9 (0.13%)Valve Type31 (0.46%) Edwards SAPIEN Valve, n (%)3684 (55.2%) Medtronic CoreValve, n (%)2735 (41.0%)Access Route13 (0.19%) TF Access, n (%)4965 (74.4%) Transapical Access, n (%)1064 (15.9%)Chronic Lung Disease, n (%)1879 (28.1%)94 (1.4%)Cerebrovascular Disease, n (%)1139 (17.1%)35 (0.52%)Previous cardiac surgery, n (%)2087 (31.3%)35 (0.52%)Critical preoperative state, n (%)110 (1.6%)81 (1.2%)PA systolic > 60mmHg785 (11.8)1860 (27.9)LMS> 50% or Triple vessel disease, n (%)887 (13.3%)74 (1.1%)LMS: Left Main Stem Disease, LVEF: Left Ventricular Ejection Fraction, MI: Myocardial Infarction,NYHA: New York Heart Association Functional Classification, PA: Pulmonary Artery, TF: Transfemoral Access RouteTable 2. Absolute and relative differences of the expected to observed 30-day mortalities. Risk ModelExpected 30-day Mortality (%)Absolute Difference to observed mortality*Relative Difference to observed mortality ? (%)LES21.916.5405.6ESII8.12.7150.0STS5.10.394.4German AV7.42.0137.0FRANCE-29.23.8170.4OBSERVANT7.11.7131.5ACC TAVI5.20.296.3*: calculated as the absolute value of expected minus observed. ?: calculated as (expected/observed)×100.Table 3. Calibration, discrimination and Brier score for 30-day mortality in the whole cohort. Risk ModelCalibration Intercept (95% CI) *Calibration Slope (95% CI)AUC (95% CI)Brier ScoreLES-1.75 (-1.86, -1.64)0.35 (0.23, 0.48)0.57 (0.54, 0.61)0.093ESII-0.47 (-0.59, -0.36)0.40 (0.28, 0.53)0.59 (0.55, 0.62)0.054STS0.07 (-0.04, 0.18)0.56 (0.42, 0.71)0.60 (0.57, 0.63)0.051German AV-0.36 (-0.47, -0.25)0.44 (0.32, 0.57)0.59 (0.56, 0.62)0.053FRANCE-2-0.60 (-0.71, -0.49)0.69 (0.53, 0.86)0.62 (0.59, 0.65)0.053OBSERVANT-0.31 (-0.42, -0.20)0.39 (0.25, 0.53)0.57 (0.54, 0.60)0.052ACC TAVI0.04 (-0.07, 0.15)0.67 (0.52, 0.82)0.64 (0.60, 0.67)0.051*The reported calibration intercept is that estimated assuming a slope of one; satisfactory calibration would occur if the 95% confidence intervals for the calibration intercept and slope span zero and one respectively.Table 4. Cut-off values and the pairwise kappa values for the surgical and TAVI based CPMs.CPMLow Risk*High Risk*Fleiss’s kappa ?Surgical BasedLESESIISTSGerman AVLES≤ 14%>24%n/a0.500.290.34ESII≤ 4%>8%0.50n/a0.340.27STS≤ 3%>5%0.290.34n/a0.47German AV?≤ 4%>8%0.340.270.47n/aTAVI BasedGerman AVFRANCE-2OBSERVANTACCGerman AV?≤ 4%>8%n/a0.170.130.26FRANCE-2≤ 6%>10%0.17n/a0.140.33OBSERVANT≤ 4.5%>9%0.130.14n/a0.18ACC≤ 3%>5%0.260.330.18n/a*: All cut-off values were chosen to give approximately equal numbers of patients in low-, medium- and high-risk categories. Patients with predicted risks between the low- and high-risk cut-off values were classified as medium risk. ?:Values give the pairwise agreement between the two indicated CPMs. ?: The German AV model was derived in a cohort with both surgical and TAVI patients, thus is considered in both groups of models. ................
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