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Transcatheter Aortic Valve ImplantationRisk assessment and Clinical OutcomeMalin Johansson1833245401510500DOCTORAL DISSERTATIONby due permission of the Faculty of Medicine, Lund University, Sweden.To be defended at Segerfalksalen, BMC, Lund. Wednesday April 29, 2015, at 09:00Faculty opponentProfessor Stefan Thelin, Uppsala University, SwedenOrganizationLUND UNIVERSITYDocument nameDOCTORAL DISSERTATIONDate of issue 2015-04-29Author MALIN JOHANSSONSponsoring organizationTitle and subtitle : Transcatheter Aortic Valve Implantation: Risk Assesment and Clinical OutcomeAbstract Background: Transcatheter aortic valve implantation (TAVI) has emerged as a treatment for patients with aortic stenosis (AS) and high surgical risk. To date, reports of short- and mid-term survival have been favourable. The aim of this thesis was to evaluate early safety, risk assessment and late survival following TAVI. Methods: In this work we studied clinical outcome, prediction of 30-day mortality and acute kidney injury and late renal dysfunction following TAVI. In paper I and IV, a comparisons to propensity score matched patients undergoing AVR were made.Results: The 30-day mortality following TAVI and AVR was 4.2% and 4.8% respectively (p=0.81); however, significant differences were seen in corresponding rates of survival (51.7±5.8% vs 72.3±4.3%; p<0.001) and in cumulative re-hospitalizations for congestive heart failure (CHF) (41.3±7.2% vs 23±4.3%; p=0.006) over a 4-year period. Postoperative AKI was diagnosed in 33% following TAVI and renal function remained impaired at 1 year of follow-up. The observed/expected mortality ratio was 0.16 for logistic EuroSCORE, 0.56 for STS score, and 0.52 for EuroSCORE II. The AUC was 0.69 (95% CI 0.54–0.84) for the logistic EuroSCORE, 0.60 (95% CI 0.38–0.82) for the STS score, and 0.66 (95% CI 0.46–0.86) for the EuroSCORE II. Conclusions: The results of this thesis confirm the merit of TAVI in high risk patients with AS, although late outcome with TAVI proved inferior to that of AVR in propensity score matched patients. In our view, the relationship between TAVI and AVR appears to be complementary rather than substitutive. Furthermore, more accurate risk assessment tools are needed. Key words: Aortic stenosis, transcatheter aortic valve implantation, outcome, acute kidney injuryClassification system and/or index terms (if any)Supplementary bibliographical informationLanguage EnglishISSN and key title 1652-8220, Doctoral Dissertation Series 2015:37978-91-7619-116-3Recipient’s notesNumber of pagesPriceSecurity classificationI, the undersigned, being the copyright owner of the abstract of the above-mentioned dissertation, herebygrant to all reference sources permission to publish and disseminate the abstract of the above-mentioned dissertation.Signature Date Transcatheter Aortic Valve ImplantationRisk assessment and Clinical OutcomeMalin Johansson1833245401510500Copyright Malin JohanssonLund University, Faculty of Medicine Doctoral Dissertation Series 2015:37ISBN 978-91-7619-116-3ISSN 1652-8220Printed in Sweden by Media-Tryck, Lund UniversityLund 2015 To Patrik, Klara, Bob and AliceContents TOC \o "1-3" \h \z \u List of Publications PAGEREF _Toc414537716 \h 8Popul?rvetenskaplig sammanfattning (Summary in Swedish) PAGEREF _Toc414537717 \h 10Slutsatser av delarbeten PAGEREF _Toc414537718 \h 11Abbreviations PAGEREF _Toc414537719 \h 12Introduction PAGEREF _Toc414537720 \h 13Aortic valve stenosis PAGEREF _Toc414537721 \h 13Pathophysiology PAGEREF _Toc414537722 \h 14Aortic valve replacement PAGEREF _Toc414537723 \h 14Transcatheter Aortic Valve Implantation PAGEREF _Toc414537724 \h 15Patient selection and risk assessment PAGEREF _Toc414537725 \h 16Prosthetic heart valves PAGEREF _Toc414537726 \h 17Operative Management PAGEREF _Toc414537727 \h 19Complications PAGEREF _Toc414537728 \h 22Postoperative pacemaker PAGEREF _Toc414537729 \h 22Paravalvular regurgitation PAGEREF _Toc414537730 \h 23Acute Kidney Injury PAGEREF _Toc414537731 \h 23VARC criteria PAGEREF _Toc414537732 \h 26Randomized trials PAGEREF _Toc414537733 \h 26Aims PAGEREF _Toc414537734 \h 28Paper I PAGEREF _Toc414537735 \h 28Paper II PAGEREF _Toc414537736 \h 28Paper III PAGEREF _Toc414537737 \h 28Paper IV PAGEREF _Toc414537738 \h 28Material and Methods PAGEREF _Toc414537739 \h 29Patients and study design PAGEREF _Toc414537740 \h 29Patients undergoing conventional Aortic Valve Replacement PAGEREF _Toc414537741 \h 32Statistical analysis PAGEREF _Toc414537742 \h 32Propensity-score matching PAGEREF _Toc414537743 \h 33Ethical aspects PAGEREF _Toc414537744 \h 32Results PAGEREF _Toc414537745 \h 35Paper I PAGEREF _Toc414537746 \h 35Operative Data PAGEREF _Toc414537747 \h 35Postoperative Complications PAGEREF _Toc414537748 \h 35Early and Late Outcome PAGEREF _Toc414537749 \h 36Paper II PAGEREF _Toc414537750 \h 41Paper III PAGEREF _Toc414537751 \h 46Operative data PAGEREF _Toc414537752 \h 4630-day mortality and causes of death PAGEREF _Toc414537753 \h 46Calibration analysis and observed versus expected 30-day mortality PAGEREF _Toc414537754 \h 46Discrimination analysis of 30-day mortality PAGEREF _Toc414537755 \h 47Paper IV PAGEREF _Toc414537756 \h 52Device success PAGEREF _Toc414537757 \h 52Early safety (at 30 days) PAGEREF _Toc414537758 \h 53Clinical efficacy and time-related valve safety PAGEREF _Toc414537759 \h 53Independent risk factors for mortality and for re-hospitalization due to congestive heart failure PAGEREF _Toc414537760 \h 53Discussion PAGEREF _Toc414537761 \h 60Comparison to AVR PAGEREF _Toc414537762 \h 60Renal function PAGEREF _Toc414537763 \h 61Prediction of 30-day mortality PAGEREF _Toc414537764 \h 63Limitations PAGEREF _Toc414537765 \h 64Conclusions PAGEREF _Toc414537766 \h 65Future perspectives PAGEREF _Toc414537767 \h 66Acknowledgments PAGEREF _Toc414537768 \h 67Financial support PAGEREF _Toc414537769 \h 68ReferenserList of PublicationsTransapical Versus Transfemoral Aortic Valve Implantation: A Comparison of Survival and SafetyMalin Johansson, Shahab Nozohoor, Per Ola Kimblad, Jan Harnek, G?ran K. Olivecrona and Johan Sj?gren. The Annals of Thoracic Surgery. 2011 Jan;91(1):57-63.Acute kidney Injury Assessed by Cystatin C After Transcatheter Aortic Valve Implantation and Late Renal Dysfunction Malin Johansson, Shahab Nozohoor, Henrik Bjursten, Per Ola Kimblad and Johan Sj?gren Journal of Cardiothoracic and Vascular Anesthesia, 2014 Vol 28,No4(August),:pp972–977Prediction of 30-day mortality after Transcatheter Aortic Valve Implantation: a comparison of logistic EuroSCORE, STS score, and EuroSCORE II Malin Johansson, Shahab Nozohoor, Igor Zindovic, Johan Nilsson, Per Ola Kimblad, and Johan, Sj?gren. The journal of Heart Valve Disease, 2014;24:567-574Transcatheter Aortic Valve Implantation: Late Survival and Re-hospitalization for heart failureMalin Johansson, Shahab Nozohoor, Henrik Bjursten, Matthias G?tberg, Per Ola Kimblad, Igor Zindovic and Johan Sj?gren. SubmittedPopul?rvetenskaplig sammanfattning (Summary in Swedish) Aortastenos (AS) ?r en hj?rtsjukdom, d?r backventilen (hj?rtklaffen) mellan hj?rtat och stora kroppspuls?dern, aorta, ?r f?rtr?ngd och f?rkalkad. AS ?r den vanligaste klaffsjukdomen i den industrialiserade delen av v?rlden och ?kar med stigande ?lder. F?rtr?ngningen i aortaklaffen g?r att hj?rtat har sv?rt att pumpa ut blod i kroppen, och patienten f?r symptom som yrsel, andf?ddhet, svimning, k?rlkramp och hj?rtsvikt. Sjukdomen minskar personens livskvalitet och risken ?r stor f?r att pl?tslig d?. Det finns ingen medicin mot AS utan den enda effektiva behandlingen ?r en hj?rtoperation. Operationen kallas aortic valve replacement (AVR) och inneb?r att br?stbenet s?gas upp, hj?rtat stannas och blodet pumpas runt i kroppen med hj?lp av en hj?rt-lungmaskin. Sedan klipps den f?rkalkade och sjuka klaffen ut och ers?tts med en konstgjord. Operationen ?r vanligt f?rekommande p? alla universitetsjukhus och resultaten ?r mycket goda. Men det finns en stor grupp av patienter, som p? grund av h?g ?lder och annan samtidig sjukdom (t.ex. tidigare hj?rtopererade, tidigare str?lbehandlade p? grund av cancer) anses vara f?r sjuka f?r att klara av att genomg? en hj?rtoperation. De ?r s? kallade h?griskpatienter och har tidigare nekats effektiv behandling. Senaste ?ren har en ny mindre invasiv metod utvecklats f?r att behandla h?griskpatienter med AS. Metoden kallas Transcatheter Aortic Valve Implantation (TAVI). Operationen inneb?r att en konstgjord hj?rtklaff f?rs in i kroppen, antingen genom ljumsken (kallas transfemoralt och f?rkortas TF) eller genom ett litet snitt mellan revbenen p? v?nster sida av br?stkorgen (transapikalt, TA). Den sjuka aortaklaffen tas inte bort utan trycks ist?llet ut mot aortav?ggen. Inget br?stben beh?ver s?gas upp, inget hj?rta stannas och ingen hj?rt-lungmaskin beh?vs. TAVI ?r en revolutionerande behandling som gett ett flertal patienter m?jlighet att f? f?rl?ngt liv med f?rb?ttrad livskvalitet. Tekniken sprider sig ?ver hela v?rlden och vi har i Lund som f?rsta center i Sverige, sedan 2008 erbjudit TAVI till dessa h?griskpatienter. B?de lokala resultat och fr?n st?rre internationella studier visar att TAVI fungerar utm?rkt som behandling mot AS och en internationell debatt p?g?r huruvida TAVI ?ven ska erbjudas till patienter som inte ?r fullt s? sjuka att de inte kan klara av vanlig hj?rtkirurgi. I dagsl?get ?r TAVI endast rekommenderat till h?griskpatienter med AS och det ?r viktigt att ett hj?rtteam som best?r av b?de thoraxkirurger och kardiologer beslutar om vilken behandling som l?mpar sig b?st f?r den enskilde patienten. Nackdelar med TAVI ?r bland annat att ett njurskadligt kontrastedel beh?vs, att endast biologiska klaffar med begr?nsad livsl?ngd kan anv?ndas och att det helt saknas l?ngtidsresultat. Eftersom patienter som genomg?r TAVI oftast ?r nekade vanlig hj?rtkirurgi p? grund av annan samtidig sjukdom s? skiljer sig denna patientgrupp fr?n patienter som genomg?r traditionell hj?rtkirurgi, vilket g?r det n?st intill om?jligt att j?mf?ra resultaten med varandra. N?gra enstaka studier finns d?r man slumpm?ssigt har j?mf?rt de tv? operationsmetoderna (randomiserade studier) och ytterligare s?dana studier p?g?r. Vi har i denna avhandling anv?nt en statistisk modell som kallas propensity score matchning i ett f?rs?ka att j?mf?ra patientgrupperna med varandra. Syftet med den h?r avhandlingen var att studera resultatet av TAVI; dvs ?verlevnad, komplikationer, hur njuren p?verkas, hur v?l olika riskmodeller st?mmer ?verens med resultatet samt att studera ?terinl?ggningar p? sjukhus p? grund av hj?rtsvikt och hj?rtinfarkt samt att kartl?gga riskfaktorer f?r detta. Avhandlingen syftar ?ven till att j?mf?ra resultatet av TAVI med standardbehandlingen av aortastenos, AVR.Slutsatser av avhandlingens delarbetenDelarbete I. Transapikal TAVI kan utf?ras s?kert f?r h?griskpatienter med AS och efter ett ?r var ?verlevnaden efter TAVI och AVR lika bra.Delarbete II. Det ?r stor risk att utveckla akut njursvikt (AKI) efter TAVI. F?r patienter med AKI ?terh?mtar sig inte njurarna fullt p? l?ngre sikt. Ett vanligt s?tt att m?ta njurfunktionen ?r genom ett blodprov, kreatinin. Ett annat blodprov, Cystatin C kan vara ett v?rdefullt till?gg. Delarbete III. Dagens modeller f?r att ber?kna patientens operationsrisk st?mmer inte ?verens med det verkliga resultatet efter TAVI. Vi tror att den nyare modellen EuroSCORE II kan vara v?rdefullt i den kliniska bed?mningen av patienter, men b?ttre riskmodeller f?r TAVI beh?vs. Delarbete IV. P? kort sikt har TAVI och AVR lika bra resultat med tanke p? s?kerhet och ?verlevnad. Men p? l?ngre sikt, upp till fyra ?r efter operationen s? ?r patienter som opererats med TAVI oftare inlagda p? sjukhus f?r hj?rtsvikt och hj?rtinfarkt. Patienter som redan innan operationen har allvarlig hj?rtsvikt med andf?ddhet och tr?tthet redan i vila, l?per st?rre risk f?r att bli ?terinlagd p? sjukhus f?r just hj?rtsviktsproblem. Vi tror att dessa patienter beh?ver noggrann uppf?ljning, information och medicinering f?r att undvika att f?rs?mras i sin hj?rtsvikt.AbbreviationsAKIAcute kidney injuryASAortic stenosisAVRAortic valve replacementBAVBalloon aortic valvuloplasty CABGCoronary artery bypass graftingCADCoronary artery diseaseCHFCongestive heart failureCPBCardiopulmonary bypasseGFREstimated Glomerular filtration rateLVLeft ventricleLVEFLeft ventricular ejection fractionMImyocardial infarctionPVRParavalvular regurgitationRIFLERisk Injury Failure Loss End-stageTAVITranscatheter Aortic valve implantationTATransapicalTFTransfemoralVARCValve academic research consortiumIntroduction With the introduction of transcatheter aortic valve implantation (TAVI), high-risk patients with severe aortic stenosis (AS) can now be offered a therapeutic option using a less invasive technique without the need for cardiopulmonary bypass (CPB) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DcmliaWVyPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE.DATA [1]. TAVI has led to improved outcomes in elderly patients with severe AS and significant comorbidity PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Kb2hhbnNzb248L0F1dGhvcj48UmVjTnVtPjM1PC9SZWNO
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ADDIN EN.CITE.DATA [2-4]. To date, TAVI has been performed in about 150,000 patients worldwide and requests for the procedure continue to rise ADDIN EN.CITE <EndNote><Cite><Author>Cribier</Author><Year>2014</Year><RecNum>93</RecNum><DisplayText>[5]</DisplayText><record><rec-number>93</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">93</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Cribier, A.</author><author>Durand, E.</author><author>Eltchaninoff, H.</author></authors></contributors><auth-address>Department of Cardiology, Hospital Charles Nicolle, University Hospital of Rouen, INSERM UMR 1096, Rouen, France.</auth-address><titles><title>Patient selection for TAVI in 2014: is it justified to treat low- or intermediate-risk patients? The cardiologist's view</title><secondary-title>EuroIntervention</secondary-title><alt-title>EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology</alt-title></titles><periodical><full-title>EuroIntervention</full-title></periodical><pages>U16-21</pages><volume>10 Suppl U</volume><dates><year>2014</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>1969-6213 (Electronic)
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ADDIN EN.CITE.DATA [6-8] . The prevalence increases with age, varying from 0.2 percent of patients aged between 50 to 60 years, up to 9.8 percent for patients aged between 80 to 90 years PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FdmVib3JuPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA [9]. Age-related degenerative calcifications are the most common cause of AS in adults, while congenital causes dominate in the younger age group and rheumatic AS has now become rare ADDIN EN.CITE <EndNote><Cite><Author>Carabello</Author><Year>2009</Year><RecNum>17</RecNum><DisplayText>[7]</DisplayText><record><rec-number>17</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">17</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Carabello, B. A.</author><author>Paulus, W. J.</author></authors></contributors><auth-address>Baylor College of Medicine, Department of Medicine and Veterans Affairs Medical Center, Houston, TX, USA.</auth-address><titles><title>Aortic stenosis</title><secondary-title>Lancet</secondary-title></titles><periodical><full-title>Lancet</full-title></periodical><pages>956-66</pages><volume>373</volume><number>9667</number><edition>2009/02/24</edition><keywords><keyword>Aging/*pathology</keyword><keyword>*Angioplasty, Transluminal, Percutaneous Coronary</keyword><keyword>*Aortic Valve Stenosis/etiology/physiopathology/therapy</keyword><keyword>Biological Markers</keyword><keyword>Calcinosis/*complications</keyword><keyword>Cardiac Output</keyword><keyword>Female</keyword><keyword>Heart Catheterization</keyword><keyword>*Heart Valve Prosthesis</keyword><keyword>Humans</keyword><keyword>Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use</keyword><keyword>Male</keyword><keyword>Physical Examination</keyword><keyword>Survival Analysis</keyword><keyword>Syncope/etiology</keyword></keywords><dates><year>2009</year><pub-dates><date>Mar 14</date></pub-dates></dates><isbn>1474-547X (Electronic)
1474-547X (Linking)</isbn><accession-num>19232707</accession-num><urls><related-urls><url>(09)60211-7 [pii]
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ADDIN EN.CITE.DATA [6]. Asymptomatic patients have a similar survival to the healthy population, but these patients need to be carefully educated about the importance both of follow-up visits including echocardiography, and of reporting symptoms as soon as they develop PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Kb2ludCBUYXNrIEZvcmNlIG9uIHRoZSBNYW5hZ2VtZW50
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Kb2ludCBUYXNrIEZvcmNlIG9uIHRoZSBNYW5hZ2VtZW50
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ADDIN EN.CITE.DATA [10]. For symptomatic patients with severe AS, the prognosis worsens significantly, and approximately 50% of these patients are reported dead within 3–5 years PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZWxsaWtrYTwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+
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ADDIN EN.CITE.DATA [6-8]. Although conventional AVR remains the standard treatment for AS, many patients are not suitable as surgical candidates due to the higher-than-acceptable perioperative risk of mortality. According to the European Heart Survey on Valvular Heart Disease, 31.8% of patients with severe symptomatic aortic stenosis did not undergo intervention, mainly because of comorbidities PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5JdW5nPC9BdXRob3I+PFllYXI+MjAwMzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [13].PathophysiologyThe most common cause of AS in adults is an age-related degenerative calcification of the aortic valve ADDIN EN.CITE <EndNote><Cite><Author>Carabello</Author><Year>2009</Year><RecNum>17</RecNum><DisplayText>[7]</DisplayText><record><rec-number>17</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">17</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Carabello, B. A.</author><author>Paulus, W. J.</author></authors></contributors><auth-address>Baylor College of Medicine, Department of Medicine and Veterans Affairs Medical Center, Houston, TX, USA.</auth-address><titles><title>Aortic stenosis</title><secondary-title>Lancet</secondary-title></titles><periodical><full-title>Lancet</full-title></periodical><pages>956-66</pages><volume>373</volume><number>9667</number><edition>2009/02/24</edition><keywords><keyword>Aging/*pathology</keyword><keyword>*Angioplasty, Transluminal, Percutaneous Coronary</keyword><keyword>*Aortic Valve Stenosis/etiology/physiopathology/therapy</keyword><keyword>Biological Markers</keyword><keyword>Calcinosis/*complications</keyword><keyword>Cardiac Output</keyword><keyword>Female</keyword><keyword>Heart Catheterization</keyword><keyword>*Heart Valve Prosthesis</keyword><keyword>Humans</keyword><keyword>Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use</keyword><keyword>Male</keyword><keyword>Physical Examination</keyword><keyword>Survival Analysis</keyword><keyword>Syncope/etiology</keyword></keywords><dates><year>2009</year><pub-dates><date>Mar 14</date></pub-dates></dates><isbn>1474-547X (Electronic)
1474-547X (Linking)</isbn><accession-num>19232707</accession-num><urls><related-urls><url>(09)60211-7 [pii]
10.1016/S0140-6736(09)60211-7</electronic-resource-num><language>eng</language></record></Cite></EndNote>[7]. As the disease progresses, the heart valve leaflets become thicker since calcium nodules form within the layers of the leaflets PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SYWphbWFubmFuPC9BdXRob3I+PFllYXI+MjAxMTwvWWVh
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Tm90ZT4A
ADDIN EN.CITE.DATA [7, 16]. This compensatory mechanism, together with the patient’s physical ability, may keep the patient asymptomatic for decades. Although cardiac muscle hypertrophy initially helps to preserve the left ventricular systolic performance, this compensational mechanism may however have detrimental consequences, since it decreases the myocardial elasticity and increases the diastolic pressure leading to impaired coronary blood flow. Therefore, any extra hemodynamic stress such as exercise or tachycardia can produce ischemia, even in the absence of coronary artery disease. Furthermore, late manifestations of the left ventricular hypertrophy include a smaller left ventricular chamber size, with decreased preload and worsened systolic dysfunction, with an insufficient stroke volume and cardiac output, and decreased LVEF. Finally, increased left ventricular pressure is transmitted backwards to the lungs, causing pulmonary congestion with pulmonary venous hypertension and reactive vasoconstriction PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LdXJ0ejwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [15, 17]. Aortic valve replacementSince its introduction in the 1960s, AVR has dramatically improved the outcome for patients with AS, and is considered the definitive therapy for severe and symptomatic AS, producing survival rates in AS patients similar to those of a healthy age- and gender-matched population PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbWVyaWNhbiBDb2xsZWdlIG9mPC9BdXRob3I+PFllYXI+
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ADDIN EN.CITE.DATA [6-8]. When aortic valve replacement is considered, the choice is between mechanical and bioprosthetic valves. Bioprosthetic options include stented valves, stentless valves, aortic homografts, and the Ross procedure (i.e. pulmonary autograft in the aortic position). For most patients, the choice is between a mechanical valve and a stented bioprosthesis. Mechanical valves require the patient to take lifelong oral anticoagulation (warfarin); this is not required with a bioprosthesis. However, mechanical valves have longer durability and therefore tend to benefit younger patients (i.e. <60 years). Bioprosthesis have reduced valve durability due to the risk of structural valve degeneration, and are therefore generally recommended for older patients (<65 years). According to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines, the choice of prosthesis type should depend on factors including anticoagulation contraindications, the risk of thrombosis, current tricuspid or mitral mechanical valves, and patient preferences PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbWVyaWNhbiBDb2xsZWdlIG9mPC9BdXRob3I+PFllYXI+
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ADDIN EN.CITE.DATA [6]. Moreover, rather than setting arbitrary age limits, the European Society of Cardiology/European Association for Cardiothoracic Surgery (ESC/EACTS) guidelines recommend that prosthesis should be individualized and discussed between the patient, cardiologists and surgeons, since patients aged of 60–65 years may have the choice of both options PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Kb2ludCBUYXNrIEZvcmNlIG9uIHRoZSBNYW5hZ2VtZW50
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Kb2ludCBUYXNrIEZvcmNlIG9uIHRoZSBNYW5hZ2VtZW50
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ADDIN EN.CITE.DATA [10].The 30-day mortality following isolated AVR is approximately 1–4% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HdW1tZXJ0PC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48
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ADDIN EN.CITE.DATA [13, 18, 19]. The operative mortality associated with AVR is dependent both on patient risk factors and the skill and experience of the surgical team. Risk factors for both perioperative mortality and impaired long-term survival include age, LV dysfunction, concomitant coronary artery disease (CAD), previous coronary artery bypass grafting (CABG), renal insufficiency, and chronic pulmonary disease. In addition, poor postoperative outcomes may result from prosthesis-related complications and suboptimal prosthetic valve hemodynamic performance PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bc2hpa2htaW5hPC9BdXRob3I+PFllYXI+MjAxMTwvWWVh
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ADDIN EN.CITE.DATA [20]. Postoperative complications such as stroke have an incidence of 1.5%, PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PJmFwb3M7QnJpZW48L0F1dGhvcj48WWVhcj4yMDA5PC9Z
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PJmFwb3M7QnJpZW48L0F1dGhvcj48WWVhcj4yMDA5PC9Z
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dGU+AG==
ADDIN EN.CITE.DATA [21] and mainly occur intraoperative or within the first 2 days of surgery PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MaWtvc2t5PC9BdXRob3I+PFllYXI+MjAwMzwvWWVhcj48
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ADDIN EN.CITE.DATA [22-24].Transcatheter Aortic Valve ImplantationCatheter-based treatment for patients with severe inoperable AS began in 1985 with the development of balloon aortic valvuloplasty (BAV). However, patients experienced only short term improvement, which led to the idea of a permanent catheter-based valve implantation therapy. Andersen and colleagues successfully implanted the first transcatheter aortic valve implantations in a pig model in 1992 ADDIN EN.CITE <EndNote><Cite><Author>Andersen</Author><Year>1992</Year><RecNum>115</RecNum><DisplayText>[25]</DisplayText><record><rec-number>115</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">115</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Andersen, H. R.</author><author>Knudsen, L. L.</author><author>Hasenkam, J. M.</author></authors></contributors><auth-address>Department of Cardiology, Skejby University Hospital, Aarhus, Denmark.</auth-address><titles><title>Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs</title><secondary-title>Eur Heart J</secondary-title><alt-title>European heart journal</alt-title></titles><periodical><full-title>Eur Heart J</full-title></periodical><pages>704-8</pages><volume>13</volume><number>5</number><keywords><keyword>Animals</keyword><keyword>*Aortic Valve/physiopathology</keyword><keyword>Aortic Valve Insufficiency/physiopathology/*therapy</keyword><keyword>Catheterization/*methods</keyword><keyword>Coronary Circulation/physiology</keyword><keyword>Denmark</keyword><keyword>*Disease Models, Animal</keyword><keyword>*Heart Valve Prosthesis</keyword><keyword>*Models, Cardiovascular</keyword><keyword>Prosthesis Design</keyword><keyword>Stents</keyword><keyword>Swine</keyword></keywords><dates><year>1992</year><pub-dates><date>May</date></pub-dates></dates><isbn>0195-668X (Print)
0195-668X (Linking)</isbn><accession-num>1618213</accession-num><urls><related-urls><url>;[25]. Eight years later, Bonhoeffer and colleagues performed the first human implantation of a catheter-based stented valve in a pediatric patient who had a degenerated right ventricle to pulmonary artery conduit ADDIN EN.CITE <EndNote><Cite><Author>Bonhoeffer</Author><Year>2000</Year><RecNum>116</RecNum><DisplayText>[26]</DisplayText><record><rec-number>116</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">116</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bonhoeffer, P.</author><author>Boudjemline, Y.</author><author>Saliba, Z.</author><author>Merckx, J.</author><author>Aggoun, Y.</author><author>Bonnet, D.</author><author>Acar, P.</author><author>Le Bidois, J.</author><author>Sidi, D.</author><author>Kachaner, J.</author></authors></contributors><auth-address>Service de Cardiologie Pediatrique, Hopital Necker, Enfants-Malades, Paris, France. philipp.bonhoeffer@nck.ap-hop-paris.fr</auth-address><titles><title>Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction</title><secondary-title>Lancet</secondary-title><alt-title>Lancet</alt-title></titles><periodical><full-title>Lancet</full-title></periodical><alt-periodical><full-title>Lancet</full-title></alt-periodical><pages>1403-5</pages><volume>356</volume><number>9239</number><keywords><keyword>Angiography</keyword><keyword>Child</keyword><keyword>Heart Septal Defects, Ventricular/complications/*surgery</keyword><keyword>Heart Valve Prosthesis Implantation/*methods</keyword><keyword>Heart Ventricles</keyword><keyword>Hemodynamics</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Pulmonary Artery</keyword><keyword>Pulmonary Atresia/*complications/ultrasonography</keyword><keyword>Pulmonary Valve</keyword><keyword>Stents</keyword></keywords><dates><year>2000</year><pub-dates><date>Oct 21</date></pub-dates></dates><isbn>0140-6736 (Print)
0140-6736 (Linking)</isbn><accession-num>11052583</accession-num><urls><related-urls><url>(00)02844-0</electronic-resource-num></record></Cite></EndNote>[26]. In April 2002, Cribier and colleagues performed the first in-human transcatheter aortic valve implantation PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DcmliaWVyPC9BdXRob3I+PFllYXI+MjAwMjwvWWVhcj48
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ADDIN EN.CITE.DATA [2]. To date, over 150,000 patients worldwide have been treated with TAVI and requests for the treatment continue to grow at the rate of about 40% annually ADDIN EN.CITE <EndNote><Cite><Author>Cribier</Author><Year>2014</Year><RecNum>93</RecNum><DisplayText>[5]</DisplayText><record><rec-number>93</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">93</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Cribier, A.</author><author>Durand, E.</author><author>Eltchaninoff, H.</author></authors></contributors><auth-address>Department of Cardiology, Hospital Charles Nicolle, University Hospital of Rouen, INSERM UMR 1096, Rouen, France.</auth-address><titles><title>Patient selection for TAVI in 2014: is it justified to treat low- or intermediate-risk patients? The cardiologist's view</title><secondary-title>EuroIntervention</secondary-title><alt-title>EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology</alt-title></titles><periodical><full-title>EuroIntervention</full-title></periodical><pages>U16-21</pages><volume>10 Suppl U</volume><dates><year>2014</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>1969-6213 (Electronic)
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ADDIN EN.CITE.DATA [10], and a Class IIa, B recommendation in high-risk patients with severe and symptomatic AS who may still be suitable for AVR, but in whom TAVI is favored by a cardiac team. The early- and mid-term results have been promising; however, due to the recent introduction of TAVI, and the aged and comorbid nature of the patient population, the long-term outcome following TAVI remains limited PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3VsZXRpPC9BdXRob3I+PFllYXI+MjAxNTwvWWVhcj48
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ADDIN EN.CITE.DATA [3, 4, 28, 29].Patient selection and risk assessmentThe criteria for the selection of suitable candidates for TAVI are under debate and various risk stratification models, initially developed for cardiac surgery, have been used to obtain an objective risk assessment. The two most established surgical risk scores for identifying patients at high risk for conventional cardiac surgery are the European System for Cardiac Operative Risk Evaluation (EuroSCORE), and the Society of Thoracic Surgeons (STS) predicted risk of mortality score PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYXNoZWY8L0F1dGhvcj48WWVhcj4xOTk5PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [10] and TAVI is suggested to patients denied surgery or at high surgical risk due to comorbidities evaluated at a multi-disciplinary meeting, i.e. the Heart Team, including a cardiologist, interventional cardiologist, and cardiothoracic surgeon. This approach allows risk factors such as patent grafts, malignancy, porcelain aorta, previous radiation therapy, liver cirrhosis, general frailty and the ability of postoperative mobilization to be taken into account. Recently, EuroSCORE II, the up-dated version of the logistic EuroSCORE, was developed in order to improve the predictive accuracy for mortality in modern cardiac surgery ADDIN EN.CITE <EndNote><Cite><Author>Nashef</Author><Year>2012</Year><RecNum>143</RecNum><DisplayText>[33]</DisplayText><record><rec-number>143</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">143</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nashef, S. A.</author><author>Roques, F.</author><author>Sharples, L. D.</author><author>Nilsson, J.</author><author>Smith, C.</author><author>Goldstone, A. R.</author><author>Lockowandt, U.</author></authors></contributors><auth-address>Papworth Hospital, Cambridge, UK. sam.nashef@papworth.nhs.uk</auth-address><titles><title>EuroSCORE II</title><secondary-title>Eur J Cardiothorac Surg</secondary-title><alt-title>European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery</alt-title></titles><periodical><full-title>Eur J Cardiothorac Surg</full-title></periodical><pages>734-44; discussion 744-5</pages><volume>41</volume><number>4</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Aged, 80 and over</keyword><keyword>Calibration</keyword><keyword>Cardiac Surgical Procedures/*adverse effects/methods/mortality</keyword><keyword>Databases, Factual</keyword><keyword>Evidence-Based Medicine/methods</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Prognosis</keyword><keyword>Risk Assessment/methods</keyword><keyword>Risk Factors</keyword><keyword>*Severity of Illness Index</keyword><keyword>Terminology as Topic</keyword><keyword>Young Adult</keyword></keywords><dates><year>2012</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>1873-734X (Electronic)
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ADDIN EN.CITE.DATA [34-39]. An accurate risk stratification system implemented clinically would help choose the correct therapy for each individual patient.Preoperative screening before TAVI includes transthoracic echocardiography (TTE), computed tomography (CT), coronary angiography, and if necessary, percutaneous coronary artery intervention (PCI), all performed at least 1 week before the TAVI procedure, to reduce the risk of nephrotoxicity. The size of the aortic annulus is measured by CT angiography. Accurate measurement of the aortic annulus and calcification assessment is crucial to determine the correct transcatheter valve size. CT studies have clearly shown the oval shape of the aortic annulus in most patients, further highlighting the complexity of aortic annulus measurement. In addition, CT angiography with 3D-imaging reconstruction also provides spatial and other important information for the evaluation of the aortic annulus ADDIN EN.CITE <EndNote><Cite><Author>Feuchtner</Author><Year>2013</Year><RecNum>190</RecNum><DisplayText>[40]</DisplayText><record><rec-number>190</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">190</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Feuchtner, G.</author></authors></contributors><auth-address>Department of Radiology, Innsbruck Medical University, 6020 Innsbruck, Austria.</auth-address><titles><title>Imaging of cardiac valves by computed tomography</title><secondary-title>Scientifica (Cairo)</secondary-title><alt-title>Scientifica</alt-title></titles><periodical><full-title>Scientifica (Cairo)</full-title><abbr-1>Scientifica</abbr-1></periodical><alt-periodical><full-title>Scientifica (Cairo)</full-title><abbr-1>Scientifica</abbr-1></alt-periodical><pages>270579</pages><volume>2013</volume><dates><year>2013</year></dates><isbn>2090-908X (Electronic)
2090-908X (Linking)</isbn><accession-num>24490107</accession-num><urls><related-urls><url>;[40].Prosthetic heart valves Transcatheter prosthetic heart valves (THV) are only available as a bioprosthesis, and consist of a 3 leaflets of bovine or porcine pericardial tissue mounted in a stent. The insertion is via an antegrade (transapical) or retrograde (transfemoral TF, subclavian or direct aortic) access. The two valves with the most clinical experience and published data to date are the balloon expandable Edwards SAPIEN? (Edwards Lifesciences Inc., Irvine, CA) (initially Cribier-Edwards) and self-expandable Medtronic CoreValve? (Medtronic Inc., Minneapolis, USA), the latter only accessible via the retrograde approach. Developments in existing valves increasing the safety with TAVI, and minimizing of complications such as paravalvular regurgitation (PVR) and vascular complications due to wide introducer sheaths, have led to improvements and to the development of a second and third generation of valves such as the Edwards Sapien XT, Edwards Sapien 3, Medtronic CoreValve Evolut and Medtronic CoreValve Evolut-R. The repositionable Boston Scientific Lotus? valve (Boston Scientific Corp, Marlborough, MA, USA), has also been introduced, and is current the third largest transcatheter valve on the market due to the safety and minimal PVR attributes of the valve, demonstrated in the recently published Reprise II study ADDIN EN.CITE <EndNote><Cite><Author>Meredith</Author><Year>2012</Year><RecNum>92</RecNum><DisplayText>[41]</DisplayText><record><rec-number>92</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">92</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Meredith, I. T.</author><author>Hood, K. L.</author><author>Haratani, N.</author><author>Allocco, D. J.</author><author>Dawkins, K. D.</author></authors></contributors><auth-address>MonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia. ian.meredith@myheart.id.au</auth-address><titles><title>Boston Scientific Lotus valve</title><secondary-title>EuroIntervention</secondary-title><alt-title>EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology</alt-title></titles><periodical><full-title>EuroIntervention</full-title></periodical><pages>Q70-4</pages><volume>8 Suppl Q</volume><keywords><keyword>Aortic Valve Insufficiency/etiology/prevention & control</keyword><keyword>Aortic Valve Stenosis/physiopathology/*therapy</keyword><keyword>Cardiac Catheterization/adverse effects/*instrumentation</keyword><keyword>Evidence-Based Medicine</keyword><keyword>*Heart Valve Prosthesis</keyword><keyword>Heart Valve Prosthesis Implantation/adverse effects/*instrumentation/methods</keyword><keyword>Hemodynamics</keyword><keyword>Humans</keyword><keyword>Patient Selection</keyword><keyword>Prosthesis Design</keyword><keyword>Risk Assessment</keyword><keyword>Risk Factors</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2012</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>1969-6213 (Electronic)
1774-024X (Linking)</isbn><accession-num>22995115</accession-num><urls><related-urls><url>;[41]. Other valves are: the JenaValve? (JenaValve Technology GmbH, Munich, Germany), the Symetis Acurate? (Symetis, Lausanne, Switzerland) and the repositionable St. Jude Medical Portico (St. Jude Medical, Minneapolis, USA). Figure 1aBalloon expandable transcatheter heart valve. Reprinted with the permission of Edwards Lifesciences Inc.Figure 1bSelf–expandable transcatheter heart valve. Reprinted with the permission of Medtronic Inc.Operative Management All TAVI procedures are performed in a catheterization laboratory or hybrid operating room under surveillance using fluoroscopy and using the standard Seldinger technique PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TZWxkaW5nZXI8L0F1dGhvcj48WWVhcj4xOTUzPC9ZZWFy
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ADDIN EN.CITE.DATA [42-46]. A temporary pacemaker wire is inserted transvenously before the implantation. Figure 2aTransfemoral TAVI. Reprinted with the permission from Edwards Lifesciences Inc.Transfemoral approach The transfemoral (TF) approach is the first choice in the vast majority of centers performing TAVI procedures. An accurate evaluation with computed tomography of the iliofemoral anatomy is of major importance in determining the suitability for each individual patient. Although surgical cut-down was the technique used at the beginning of the TAVI experience, most centers are now using a fully percutaneous technique for this approach. The TF approach often makes it possible to avoid the use of general anesthesia.The TF procedure starts by inserting a pigtail catheter in the contralateral femoral artery, placed retrograde in the right coronary cusp, for the purposes of visualizing the aortic root ADDIN EN.CITE <EndNote><Cite><Author>Kasel</Author><Year>2014</Year><RecNum>184</RecNum><DisplayText>[47]</DisplayText><record><rec-number>184</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">184</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kasel, A. M.</author><author>Shivaraju, A.</author><author>Schneider, S.</author><author>Krapf, S.</author><author>Oertel, F.</author><author>Burgdorf, C.</author><author>Ott, I.</author><author>Sumer, C.</author><author>Kastrati, A.</author><author>von Scheidt, W.</author><author>Thilo, C.</author></authors></contributors><auth-address>Department of Cardiovascular Disease, Deutsches Herzzentrum Munchen, Lazarettstrasse 36, 80636 Munich, Germany. amkasel1@.</auth-address><titles><title>Standardized methodology for transfemoral transcatheter aortic valve replacement with the Edwards Sapien XT valve under fluoroscopy guidance</title><secondary-title>J Invasive Cardiol</secondary-title><alt-title>The Journal of invasive cardiology</alt-title></titles><periodical><full-title>J Invasive Cardiol</full-title><abbr-1>The Journal of invasive cardiology</abbr-1></periodical><alt-periodical><full-title>J Invasive Cardiol</full-title><abbr-1>The Journal of invasive cardiology</abbr-1></alt-periodical><pages>451-61</pages><volume>26</volume><number>9</number><dates><year>2014</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>1557-2501 (Electronic)
1042-3931 (Linking)</isbn><accession-num>25198489</accession-num><urls><related-urls><url>;[47]. Then a segment of the femoral vessel without calcification on the anterior wall is selected as the puncture site. After puncture and wire insertion, sutures for closure technique are put in place. Heparin is then administered. A sheath is then placed over an extra stiff wire. The native aortic valve is crossed, and the catheter is exchanged for a straight pigtail catheter. Thereafter a stiff wire is placed through the pigtail catheter and into the LV apex. This wire placement into the LV should be done carefully and under fluoroscopy, and care taken to avoid positioning it in the mitral apparatus. In a case of severe calcification, BAV can then be performed, although this is not always necessary. BAV is performed during a brief episode of rapid ventricular pacing. Thereafter, the valve is delivered through the introducer sheath, and positioned according to the particular recommendations relevant to the valve type. Aortic root injections are used to confirm the position of the valve and its three-dimensional orientation. Preferably, the valve should be perpendicular to the aortic annulus and longitudinal to the ascending aorta. The valve is deployed during direct fluoroscopic visualization within another brief period of rapid ventricular pacing. Clear communication is critical during this brief period of the procedure; and one person should dictate the timing of each step of the procedure in a standard clear format. Rapid ventricular pacing is not required with the repositionable Boston Scientific Lotus? (Boston Scientific Corp, Marlborough, MA, USA) prosthesis.After deployment, another angiographic root injection is performed to confirm the position of the valve, to rule out a paravalvular or central leak and to confirm the patency of the coronary arteries. Occasionally, the valve may require postdilatation with additional saline in the balloon in order to ensure full expansion of the valve. In case of severe regurgitation or suboptimal positioning, a second valve can be deployed into the first one. Once the result is deemed to be satisfactory, protamine is administered, the introducer sheath is removed and the puncture site is closed by using the previously placed sutures, and the contralateral arterial sheath is removed and closed after angiographic verification of vessel patency. For postoperative anticoagulation, 75 mg clopidogrel daily is administered for 1 month, together with a lifetime dose of 75 mg daily aspirin. Patients with atrial fibrillation or other indications for warfarin receive warfarin in monotherapy. Figure 2bTransapical TAVI. Reprinted with the permission from Edwards Lifesciences Inc.Transapical approach The transapical (TA) approach, first reported with the Cribier-Edwards valve system in 2006 ADDIN EN.CITE <EndNote><Cite><Author>Lichtenstein</Author><Year>2006</Year><RecNum>5</RecNum><DisplayText>[45]</DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">5</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lichtenstein, S. V.</author><author>Cheung, A.</author><author>Ye, J.</author><author>Thompson, C. R.</author><author>Carere, R. G.</author><author>Pasupati, S.</author><author>Webb, J. G.</author></authors></contributors><auth-address>Divisions of Cardiology and Cardiac Surgery, St Paul's Hospital, University of British Columbia, Vancouver, Canada.</auth-address><titles><title>Transapical transcatheter aortic valve implantation in humans: initial clinical experience</title><secondary-title>Circulation</secondary-title></titles><periodical><full-title>Circulation</full-title></periodical><pages>591-6</pages><volume>114</volume><number>6</number><edition>2006/08/02</edition><dates><year>2006</year><pub-dates><date>Aug 8</date></pub-dates></dates><isbn>1524-4539 (Electronic)
1524-4539 (Linking)</isbn><accession-num>16880325</accession-num><urls><related-urls><url> [pii]
10.1161/CIRCULATIONAHA.106.632927</electronic-resource-num><language>eng</language></record></Cite></EndNote>[45] is an alternative to the TF approach, and is mainly selected in patients in whom the TF approach has been rejected due to small, heavily calcified and tortuous femoral arteries. This approach requires general anesthesia. The apex is identified by transthoracic ultrasound. A small left lateral thoracotomy is made and a pericardiotomy is performed over the LV apex. Heparin is administrated. Double layers of pledged reinforced purse string sutures are placed at the LV apex. The apex is punctured with a standard access needle, and a soft access wire is inserted through the needle and followed by a 6F sheath delivered into the LV apex to maintain intraventricular access. Then, a stiff wire is inserted through the catheter and a 20–26F introducer sheath is delivered over the wire into the LV apex.The BAV and valve deployment is similar to the TF approach (see TF approach). Once the result is satisfactory, the introducer sheath is removed during a brief episode of rapid ventricular pacing and the purse string sutures are tied to secure hemostasis. Protamine is administered and a left pleural chest tube is inserted. Routine closure of the access site incision is performed. The postoperative routine is similar to that of the TF plicationsThe TAVI procedure has inherent risks for peri- and postoperative complications. The perioperative complications include: increased risk of vascular injury, apical laceration, hemorrhage, cardiac rupture of the aortic root or annulus, heart block requiring permanent pacemaker implantation, arrhythmia, myocardial ischemia or infarction, mitral valve apparatus injury and worsening of mitral regurgitation, embolization, coronary ostial obstruction and paravalvular or central regurgitation and death. Complications such as complete heart block and the occurrence of PVR are more frequent following TAVI than AVR PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HZW5lcmV1eDwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+
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ADDIN EN.CITE.DATA [48-50].Postoperative pacemakerPostoperative atrioventricular (AV) block requiring permanent pacemaker implantation is a well-described complication after both AVR and TAVI. However, postoperative permanent pacemaker implantation is more common after TAVI (0–44%) than after AVR (3–8%) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYWd1cjwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [41, 54-61], with the incidence varying within TAVI with the use of different valves, from that of 9–44% with the CoreValve?, approximately 28% with the Boston scientific Lotus ADDIN EN.CITE <EndNote><Cite><Author>Meredith</Author><Year>2012</Year><RecNum>91</RecNum><DisplayText>[41]</DisplayText><record><rec-number>91</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">91</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Meredith, I. T.</author><author>Hood, K. L.</author><author>Haratani, N.</author><author>Allocco, D. J.</author><author>Dawkins, K. D.</author></authors></contributors><auth-address>MonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia. ian.meredith@myheart.id.au</auth-address><titles><title>Boston Scientific Lotus valve</title><secondary-title>EuroIntervention</secondary-title><alt-title>EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology</alt-title></titles><periodical><full-title>EuroIntervention</full-title></periodical><pages>Q70-4</pages><volume>8 Suppl Q</volume><keywords><keyword>Aortic Valve Insufficiency/etiology/prevention & control</keyword><keyword>Aortic Valve Stenosis/physiopathology/*therapy</keyword><keyword>Cardiac Catheterization/adverse effects/*instrumentation</keyword><keyword>Evidence-Based Medicine</keyword><keyword>*Heart Valve Prosthesis</keyword><keyword>Heart Valve Prosthesis Implantation/adverse effects/*instrumentation/methods</keyword><keyword>Hemodynamics</keyword><keyword>Humans</keyword><keyword>Patient Selection</keyword><keyword>Prosthesis Design</keyword><keyword>Risk Assessment</keyword><keyword>Risk Factors</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2012</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>1969-6213 (Electronic)
1774-024X (Linking)</isbn><accession-num>22995115</accession-num><urls><related-urls><url>;[41] and 0–12% after implantation of the Edwards SAPIEN? valve (Edwards Lifesciences Inc., Irvine, CA, USA). Important structures of the conduction system are hard to visualize at a macroscopic level and the close location of the implantation site with the conduction system (membranous septum with atrioventricular bundle, left- and right-bundle branch), can cause a valve prosthesis to exert pressure on surrounding tissues and cause AV-block. The actual stent material is probably also of importance, since a nitinol (nickel/titanium) frame (i.e. the CoreValve) might apply greater pressure on the ventricular septum over time than the stainless steel or cobalt chromium frame (i.e. Edwards SAPIEN valve) ADDIN EN.CITE <EndNote><Cite><Author>Rodes-Cabau</Author><Year>2012</Year><RecNum>133</RecNum><DisplayText>[62]</DisplayText><record><rec-number>133</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">133</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rodes-Cabau, J.</author></authors></contributors><auth-address>Quebec Heart and Lung Institute, Laval University, 2725 Chemin Ste-Foy, G1V 4G5 Quebec City, QC, Canada. josep.rodes@criucpq.ulaval.ca</auth-address><titles><title>Transcatheter aortic valve implantation: current and future approaches</title><secondary-title>Nat Rev Cardiol</secondary-title><alt-title>Nature reviews. Cardiology</alt-title></titles><periodical><full-title>Nat Rev Cardiol</full-title><abbr-1>Nature reviews. Cardiology</abbr-1></periodical><alt-periodical><full-title>Nat Rev Cardiol</full-title><abbr-1>Nature reviews. Cardiology</abbr-1></alt-periodical><pages>15-29</pages><volume>9</volume><number>1</number><keywords><keyword>Aortic Valve Insufficiency/*surgery</keyword><keyword>Aortic Valve Stenosis/*surgery</keyword><keyword>*Cardiac Catheterization</keyword><keyword>Heart Valve Prosthesis Implantation/*methods/trends</keyword><keyword>Humans</keyword></keywords><dates><year>2012</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>1759-5010 (Electronic)
1759-5002 (Linking)</isbn><accession-num>22083020</accession-num><urls><related-urls><url>;[62]. Furthermore, a higher placement of the THV may decrease the need for a pacemaker but instead may increase the risk of another common and feared complication, paravalvular regurgitation ADDIN EN.CITE <EndNote><Cite><Author>Tarantini</Author><Year>2014</Year><RecNum>135</RecNum><DisplayText>[63]</DisplayText><record><rec-number>135</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">135</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Tarantini, G.</author><author>Mojoli, M.</author><author>Purita, P.</author><author>Napodano, M.</author><author>D'Onofrio, A.</author><author>Frigo, A.</author><author>Covolo, E.</author><author>Facchin, M.</author><author>Isabella, G.</author><author>Gerosa, G.</author><author>Iliceto, S.</author></authors></contributors><auth-address>Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy.</auth-address><titles><title>Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve</title><secondary-title>EuroIntervention</secondary-title><alt-title>EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology</alt-title></titles><periodical><full-title>EuroIntervention</full-title></periodical><dates><year>2014</year><pub-dates><date>Nov 19</date></pub-dates></dates><isbn>1969-6213 (Electronic)
1774-024X (Linking)</isbn><accession-num>25405801</accession-num><urls><related-urls><url>;[63]. According to Erkapic et al PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FcmthcGljPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48
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ADDIN EN.CITE.DATA [64], 63% of AV blocks requiring pacemaker implantation occurred immediately or within 24 hours after TAVI, 32% within 1 week, and 5% >7 days after TAVI PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FcmthcGljPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48
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ADDIN EN.CITE.DATA [64].Paravalvular regurgitationParavalvular regurgitation (PVR) is a well-described complication following TAVI, initially seen in up to 70% of patients following the procedure, and in approximately 15% of those have moderate or severe PVR ADDIN EN.CITE <EndNote><Cite><Author>Sinning</Author><Year>2013</Year><RecNum>193</RecNum><DisplayText>[65]</DisplayText><record><rec-number>193</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">193</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sinning, J. M.</author><author>Vasa-Nicotera, M.</author><author>Chin, D.</author><author>Hammerstingl, C.</author><author>Ghanem, A.</author><author>Bence, J.</author><author>Kovac, J.</author><author>Grube, E.</author><author>Nickenig, G.</author><author>Werner, N.</author></authors></contributors><auth-address>Medizinische Klinik und Poliklinik II, Universitatsklinikum Bonn, Bonn, Germany.</auth-address><titles><title>Evaluation and management of paravalvular aortic regurgitation after transcatheter aortic valve replacement</title><secondary-title>J Am Coll Cardiol</secondary-title><alt-title>Journal of the American College of Cardiology</alt-title></titles><periodical><full-title>J Am Coll Cardiol</full-title></periodical><pages>11-20</pages><volume>62</volume><number>1</number><keywords><keyword>Animals</keyword><keyword>Aortic Valve/pathology/surgery</keyword><keyword>Aortic Valve Insufficiency/*diagnosis/*surgery</keyword><keyword>Cardiac Catheterization/*methods</keyword><keyword>Disease Management</keyword><keyword>Heart Valve Prosthesis Implantation/*methods</keyword><keyword>Humans</keyword></keywords><dates><year>2013</year><pub-dates><date>Jul 2</date></pub-dates></dates><isbn>1558-3597 (Electronic)
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ADDIN EN.CITE.DATA [49, 65-70]. However, the results of the PARTNER cohort A Trial have suggested that even a minor degree of PVR following TAVI is associated with impaired survival PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb2RhbGk8L0F1dGhvcj48UmVjTnVtPjY3PC9SZWNOdW0+
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ADDIN EN.CITE.DATA [4, 49].PVR is characterized by a considerable diastolic runoff of blood back into the left LV, leading to volume overload. Patients with severe and symptomatic AS commonly have noncompliant and hypertrophic LV due to chronic pressure adaption, and are therefore unable to increase the end-diastolic volume. This results in rapidly increased left ventricular end-diastolic pressure with consecutive decrease in cardiac output leading to hemodynamic deterioration ADDIN EN.CITE <EndNote><Cite><Author>Gotzmann</Author><Year>2012</Year><RecNum>196</RecNum><DisplayText>[71]</DisplayText><record><rec-number>196</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">196</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gotzmann, M.</author><author>Lindstaedt, M.</author><author>Mugge, A.</author></authors></contributors><auth-address>Cardiology and Angiology, BG University-Hospital Bergmannsheil, Burkle-de-la-Camp-Platz 1, Bochum, Germany. michael_gotzmann@web.de</auth-address><titles><title>From pressure overload to volume overload: aortic regurgitation after transcatheter aortic valve implantation</title><secondary-title>Am Heart J</secondary-title><alt-title>American heart journal</alt-title></titles><periodical><full-title>Am Heart J</full-title></periodical><pages>903-11</pages><volume>163</volume><number>6</number><keywords><keyword>Aortic Valve Insufficiency/diagnosis/*etiology/*physiopathology</keyword><keyword>Aortic Valve Stenosis/physiopathology/*surgery</keyword><keyword>Catheterization</keyword><keyword>Coronary Angiography</keyword><keyword>Echocardiography, Transesophageal</keyword><keyword>Heart Valve Prosthesis</keyword><keyword>Heart Valve Prosthesis Implantation/*adverse effects/*methods</keyword><keyword>Humans</keyword><keyword>Prevalence</keyword><keyword>Ventricular Pressure</keyword></keywords><dates><year>2012</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1097-6744 (Electronic)
0002-8703 (Linking)</isbn><accession-num>22709742</accession-num><urls><related-urls><url>;[71]. To minimize the likelihood of postoperative PVR, an accurate preoperative measurement of the aortic annulus and a calcification assessment is of importance in determining the correct choice of valve and its size. Managing perioperative PVR includes perioperative angiographic root injection to confirm the position of the valve, and if needed, a postdilatation with additional saline in the balloon in order to ensure full expansion of the valve. In case of severe regurgitation or placement in a suboptimal position, a second valve can be deployed into the first with an additional postdilatation. An interventional closure of paravalvular leaks after TAVI has been described PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaW5uaW5nPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48
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ADDIN EN.CITE.DATA [72, 73], although not clinical routinely used.Acute Kidney InjuryAcute kidney injury (AKI) is considered a serious complication after cardiac surgery with cardiopulmonary bypass (CPB), and is associated with prolonged hospital stay and increased mortality PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbmRlcnNvbjwvQXV0aG9yPjxZZWFyPjE5OTk8L1llYXI+
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ADDIN EN.CITE.DATA [79, 80].TAVI has the benefit of avoiding the need for CPB; however, embolization of aortic debris, sequences of rapid pacing with hypoperfusion, the use of a nephrotoxic contrast agent, and a patient population with a greater incidence of preoperative chronic kidney disease are all potential risk factors for postoperative AKI. Previous studies have demonstrated that AKI following TAVI is common, with a reported incidence up to 57% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcmVnZ2VyPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48
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ADDIN EN.CITE.DATA [48, 82, 86]. However, the incidence of AKI following TAVI is variable, mainly due to the different definitions and classifications of AKI used over the years ADDIN EN.CITE <EndNote><Cite><Author>Palevsky</Author><Year>2006</Year><RecNum>161</RecNum><DisplayText>[87]</DisplayText><record><rec-number>161</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">161</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Palevsky, P. M.</author></authors></contributors><titles><title>Epidemiology of acute renal failure: the tip of the iceberg</title><secondary-title>Clin J Am Soc Nephrol</secondary-title><alt-title>Clinical journal of the American Society of Nephrology : CJASN</alt-title></titles><periodical><full-title>Clin J Am Soc Nephrol</full-title></periodical><pages>6-7</pages><volume>1</volume><number>1</number><keywords><keyword>Acute Kidney Injury/*epidemiology</keyword><keyword>Humans</keyword></keywords><dates><year>2006</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>1555-905X (Electronic)
1555-9041 (Linking)</isbn><accession-num>17699185</accession-num><urls><related-urls><url>;[87].Acute kidney injury classification The term AKI has replaced the earlier terms acute renal failure and acute renal dysfunction ADDIN EN.CITE <EndNote><Cite><Author>Mehta</Author><Year>2007</Year><RecNum>118</RecNum><DisplayText>[88]</DisplayText><record><rec-number>118</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">118</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mehta, R. L.</author><author>Kellum, J. A.</author><author>Shah, S. V.</author><author>Molitoris, B. A.</author><author>Ronco, C.</author><author>Warnock, D. G.</author><author>Levin, A.</author><author>Acute Kidney Injury, Network</author></authors></contributors><auth-address>Department of Medicine, University of California San Diego Medical Center 8342, 200 W, Arbor Drive, San Diego, CA 92103, USA. rmehta@ucsd.edu</auth-address><titles><title>Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury</title><secondary-title>Crit Care</secondary-title><alt-title>Critical care</alt-title></titles><periodical><full-title>Crit Care</full-title></periodical><pages>R31</pages><volume>11</volume><number>2</number><keywords><keyword>Acute Kidney Injury/classification/*diagnosis/*therapy</keyword><keyword>Adult</keyword><keyword>Child</keyword><keyword>Critical Care/standards</keyword><keyword>False Positive Reactions</keyword><keyword>Humans</keyword><keyword>Nephrology/standards</keyword><keyword>*Practice Guidelines as Topic</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2007</year></dates><isbn>1466-609X (Electronic)
1364-8535 (Linking)</isbn><accession-num>17331245</accession-num><urls><related-urls><url>;[88]. AKI is defined as a sudden decrease in kidney function, resulting in disturbance in electrolyte and acid-base balance, derangement of extracellular fluid volume, retention of nitrogenous waste products, and often decreased urine output ADDIN EN.CITE <EndNote><Cite><Author>Nissenson</Author><Year>1998</Year><RecNum>162</RecNum><DisplayText>[89]</DisplayText><record><rec-number>162</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">162</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nissenson, A. R.</author></authors></contributors><auth-address>Department of Medicine, UCLA School of Medicine, USA.</auth-address><titles><title>Acute renal failure: definition and pathogenesis</title><secondary-title>Kidney Int Suppl</secondary-title><alt-title>Kidney international. Supplement</alt-title></titles><periodical><full-title>Kidney Int Suppl</full-title><abbr-1>Kidney international. Supplement</abbr-1></periodical><alt-periodical><full-title>Kidney Int Suppl</full-title><abbr-1>Kidney international. Supplement</abbr-1></alt-periodical><pages>S7-10</pages><volume>66</volume><keywords><keyword>Acute Kidney Injury/*etiology/physiopathology/therapy</keyword><keyword>Animals</keyword><keyword>Capillary Permeability</keyword><keyword>Humans</keyword><keyword>Intensive Care</keyword><keyword>Kidney Glomerulus/blood supply/physiopathology</keyword><keyword>Kidney Tubules/injuries/physiopathology</keyword><keyword>Renal Circulation</keyword><keyword>Vasoconstriction</keyword></keywords><dates><year>1998</year><pub-dates><date>May</date></pub-dates></dates><isbn>0098-6577 (Print)
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ADDIN EN.CITE.DATA [90] and the Acute Kidney Injury Network (AKIN) ADDIN EN.CITE <EndNote><Cite><Author>Mehta</Author><Year>2007</Year><RecNum>118</RecNum><DisplayText>[88]</DisplayText><record><rec-number>118</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">118</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mehta, R. L.</author><author>Kellum, J. A.</author><author>Shah, S. V.</author><author>Molitoris, B. A.</author><author>Ronco, C.</author><author>Warnock, D. G.</author><author>Levin, A.</author><author>Acute Kidney Injury, Network</author></authors></contributors><auth-address>Department of Medicine, University of California San Diego Medical Center 8342, 200 W, Arbor Drive, San Diego, CA 92103, USA. rmehta@ucsd.edu</auth-address><titles><title>Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury</title><secondary-title>Crit Care</secondary-title><alt-title>Critical care</alt-title></titles><periodical><full-title>Crit Care</full-title></periodical><pages>R31</pages><volume>11</volume><number>2</number><keywords><keyword>Acute Kidney Injury/classification/*diagnosis/*therapy</keyword><keyword>Adult</keyword><keyword>Child</keyword><keyword>Critical Care/standards</keyword><keyword>False Positive Reactions</keyword><keyword>Humans</keyword><keyword>Nephrology/standards</keyword><keyword>*Practice Guidelines as Topic</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2007</year></dates><isbn>1466-609X (Electronic)
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ADDIN EN.CITE.DATA [92-96] AKINA modified version of RIFLE criteria, the Acute Kidney Injury Network (AKIN) classification of AKI was published in 2007 ADDIN EN.CITE <EndNote><Cite><Author>Mehta</Author><Year>2007</Year><RecNum>118</RecNum><DisplayText>[88]</DisplayText><record><rec-number>118</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">118</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mehta, R. L.</author><author>Kellum, J. A.</author><author>Shah, S. V.</author><author>Molitoris, B. A.</author><author>Ronco, C.</author><author>Warnock, D. G.</author><author>Levin, A.</author><author>Acute Kidney Injury, Network</author></authors></contributors><auth-address>Department of Medicine, University of California San Diego Medical Center 8342, 200 W, Arbor Drive, San Diego, CA 92103, USA. rmehta@ucsd.edu</auth-address><titles><title>Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury</title><secondary-title>Crit Care</secondary-title><alt-title>Critical care</alt-title></titles><periodical><full-title>Crit Care</full-title></periodical><pages>R31</pages><volume>11</volume><number>2</number><keywords><keyword>Acute Kidney Injury/classification/*diagnosis/*therapy</keyword><keyword>Adult</keyword><keyword>Child</keyword><keyword>Critical Care/standards</keyword><keyword>False Positive Reactions</keyword><keyword>Humans</keyword><keyword>Nephrology/standards</keyword><keyword>*Practice Guidelines as Topic</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2007</year></dates><isbn>1466-609X (Electronic)
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ADDIN EN.CITE.DATA [97, 98]. Cystatin C is an endogenous cysteine proteinase inhibitor with a low molecular weight (13kDa). Like creatinine, cystatin C is freely filtered at the glomerulus. However, cystatin C is constantly produced and nearly completely metabolized in proximal tubular cells without additional secretion or reabsorption, and without the influence of muscle mass or dietary protein intake. Thus, a reduction in GFR correlates well with a rise in cystatin C levels, and vice versa. Cystatin C levels may however be altered with older age, the use of corticosteroids, abnormal thyroid function, and elevated C-reactive protein PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbmlnaHQ8L0F1dGhvcj48WWVhcj4yMDA0PC9ZZWFyPjxS
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbmlnaHQ8L0F1dGhvcj48WWVhcj4yMDA0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [99]. The diagnostic value of cystatin C as an estimate of GFR has been shown to be superior to that of creatinine in discriminating between normal and impaired kidney function, and compared with creatinine, cystatin C may be a better estimator of GFR than creatinine in patients with lower creatinine levels, such as elderly patients, those with cirrhosis and those suffering from malnutrition PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ccm9uZGVuPC9BdXRob3I+PFJlY051bT40NDwvUmVjTnVt
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ADDIN EN.CITE.DATA [100-102]. VARC criteriaIn order to create consistency and facilitate comparisons with present and future TAVI studies, the Valve Academic Research Consortium (VARC) consensus manuscript was published in January 2011 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZW9uPC9BdXRob3I+PFJlY051bT40NjwvUmVjTnVtPjxE
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ADDIN EN.CITE.DATA [104], has been available since January 2013, which includes the composite endpoints, device success, early safety (at 30 days), clinical efficacy (after 30 days) and time-related valve safety, Table 1. Randomized trialsRandomized studies are the gold standard for clinical research, forming the basis for clinical guidelines and recommendations. However, patients with porcelain aorta, post-radiation therapy, malignancies and cirrhosis are often denied surgery and thus may be disqualified from inclusion in randomized studies comparing TAVI and AVR. To date, three randomized TAVI trials comparing TAVI and AVR have been published PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZGFtczwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [50, 105, 106]. They were preceded by a randomized trial comparing TAVI with medical treatment for inoperable patients with AS, the Cohort B of the Placement of Aortic Transcatheter Valves (PARTNER) trial PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZW9uPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [107]. This study involved 21 sites (17 in the United States), and compared TAVI (n=179) with medical treatment including BAV (n=179). By demonstrating superior survival for inoperable patients undergoing TAVI compared to medical treatment, it has led to the emerging acceptance and expansion of TAVI as a treatment for inoperable patients with aortic stenosis. Thereafter, the Cohort A of the Placement of Aortic Transcatheter Valves (PARTNER) trial was published, involving 25 centers, and 699 high risk patients with severe aortic stenosis were randomized to either TAVI (n=348) or AVR (n=351). Results up to five years of follow up did not identify any significant differences in all-cause mortality between patients undergoing TAVI and AVR PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb2RhbGk8L0F1dGhvcj48UmVjTnVtPjY3PC9SZWNOdW0+
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ADDIN EN.CITE.DATA [4, 49, 50].The STACCATO trial was conducted in 2 Danish centers PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OaWVsc2VuPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48
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ADDIN EN.CITE.DATA [106]. Patients included in this study presented with a lower surgical risk than those in the PARTNER trial, and all TAVI patients underwent the TA approach. Although 200 patients were planned for inclusion in the study, the STACCATO trial was prematurely terminated upon advice of the Data Safety Monitoring Board due to unexpectedly poor outcomes in the TAVI cohort (n=34), compared to the SAVR cohort (n=36). Authors of this trial concluded that current indications for TAVI should remain restricted to surgically inoperable patients only. In May 2014, the Core Valve trial by Adams was published PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZGFtczwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [105], a randomized study comparing high risk patients with AS undergoing TAVI (n=390) and AVR (n=357) at 45 centers in the United States. This study demonstrated that survival at 1 year following TAVI was superior compared to that after AVR. Aims Paper IThe aim of this study was to evaluate the complications occurring when using the TF and the TA techniques and to compare clinical outcome of TAVI to a propensity score matched group undergoing conventional AVR.Paper IIThe aim of this study was to evaluate AKI with cystatin C following TAVI and to assess the impact of postoperative AKI on outcome and late renal function.Paper IIIThe aim of this study was to evaluate whether the performance of the EuroSCORE II for predicting 30-day mortality following TAVI is superior to that of the currently used logistic EuroSCORE and STS score risk stratification models.Paper IVThe aim of this study was to evaluate late survival and composite clinical endpoints specified by the Valve Academic Research Consortium (VARC)-2, including re-hospitalization for congestive heart failure (CHF) following TAVI.Material and MethodsPatients and study designThe patients included in all four studies underwent TAVI at the Department of Cardiothoracic Surgery, Cardiothoracic Anesthesia and Intensive Care, Skane University Hospital, Lund University, Sweden. TAVI has been an alternative therapeutic option for inoperable or high risk patients at our Department since January 2008. The baseline risk of the patient population was estimated using the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ADDIN EN.CITE <EndNote><Cite><Author>Nashef</Author><Year>1999</Year><RecNum>73</RecNum><DisplayText>[30]</DisplayText><record><rec-number>73</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">73</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nashef, S. A.</author><author>Roques, F.</author><author>Michel, P.</author><author>Gauducheau, E.</author><author>Lemeshow, S.</author><author>Salamon, R.</author></authors></contributors><auth-address>Papworth Hospital, Cambridge, UK. sam.nashef@papworth-tr.anglox.nhs.uk</auth-address><titles><title>European system for cardiac operative risk evaluation (EuroSCORE)</title><secondary-title>Eur J Cardiothorac Surg</secondary-title></titles><periodical><full-title>Eur J Cardiothorac Surg</full-title></periodical><pages>9-13</pages><volume>16</volume><number>1</number><edition>1999/08/24</edition><keywords><keyword>Cardiac Surgical Procedures/*mortality</keyword><keyword>Europe/epidemiology</keyword><keyword>Evaluation Studies as Topic</keyword><keyword>Humans</keyword><keyword>Logistic Models</keyword><keyword>Quality of Health Care</keyword><keyword>ROC Curve</keyword><keyword>Regression Analysis</keyword><keyword>Risk Assessment/methods</keyword><keyword>Risk Factors</keyword><keyword>Survival Analysis</keyword></keywords><dates><year>1999</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1010-7940 (Print)
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ADDIN EN.CITE.DATA [21] providing quantitative risk assessment, which was used together with clinical judgment in order to establish whether conventional AVR was associated with too high risks for these patients. The patients were allocated to TAVI if logistic EuroSCORE was ≥20% or deemed to be of excessive risk due to comorbidities at a multi-disciplinary meeting (cardiologist, interventional cardiologist, and cardiothoracic surgeon). This approach allowed risk factors such as malignancy, porcelain aorta, previous radiation therapy, liver cirrhosis, general frailty and the ability of postoperative mobilization to be taken into account. Preprocedural screening included transthoracic echocardiography, computed tomography (CT), and coronary angiography. Pre-, peri-, and postoperative variables were prospectively collected and entered into the department’s computerized cardiac surgical database for retrospective analysis. Survival data was obtained from the Swedish National Board of Health and Welfare, and the incidence and cause of hospitalization and the cause of death were obtained from patient records. Paper I was a retrospective study, in which 40 consecutive patients with severe symptomatic aortic stenosis underwent TAVI (41 procedures) with the 23-mm or 26-mm Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences Irvine, CA) between January 2008 and November 2009. Follow-up was performed in January 2010 and was 100% complete. The mean follow-up time was 10±8 months (median 7.5; interquartile range, 16). A comparison to propensity score matched patients undergoing AVR was made.Paper II was a prospective study, in which 68 consecutive patients with severe, symptomatic aortic stenosis underwent both transfemoral and transapical TAVI with the 23-mm or 26-mm Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences Inc., Irvine, CA) between September 2009 and September 2012. As two intraoperative deaths occurred, and two patients were converted to conventional AVR due to dislocation of the prosthesis in the left ventricle, the final study population consisted of 64 patients. Blood samples were collected on 4 occasions during the early part of the study to determine levels of s-creatinine and cystatin C: preoperatively (on admission to the ward, usually the day before the procedure), on arrival at the ICU, and on the first (D1) and third (D3) days postoperatively. Additionally, s-creatinine was collected at follow up 12 months postoperatively. The eGFR was calculated in two ways: The s-creatinine- based simplified Modification of Diet in Renal Disease formula ADDIN EN.CITE <EndNote><Cite><Author>Levey</Author><Year>2005</Year><RecNum>50</RecNum><DisplayText>[108]</DisplayText><record><rec-number>50</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">50</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Levey, A. S.</author><author>Eckardt, K. U.</author><author>Tsukamoto, Y.</author><author>Levin, A.</author><author>Coresh, J.</author><author>Rossert, J.</author><author>De Zeeuw, D.</author><author>Hostetter, T. H.</author><author>Lameire, N.</author><author>Eknoyan, G.</author></authors></contributors><auth-address>Tufts-New England Medical Center, Boston, Massachusetts 02111, USA. alevey@tufts-</auth-address><titles><title>Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO)</title><secondary-title>Kidney Int</secondary-title></titles><periodical><full-title>Kidney Int</full-title></periodical><pages>2089-100</pages><volume>67</volume><number>6</number><edition>2005/05/11</edition><keywords><keyword>Albuminuria/etiology</keyword><keyword>Chronic Disease</keyword><keyword>Glomerular Filtration Rate</keyword><keyword>Humans</keyword><keyword>Kidney Diseases/*classification/etiology</keyword><keyword>Proteinuria/etiology</keyword><keyword>Risk Factors</keyword></keywords><dates><year>2005</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>0085-2538 (Print)
0085-2538 (Linking)</isbn><accession-num>15882252</accession-num><urls><related-urls><url> [pii]
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ADDIN EN.CITE.DATA [109], eGFR (cystatinC).Renal function was assessed at a mean of 11.5±4 months postoperatively (median 12 months; interquartile range (IQR) 10 to 13 months) and was 87% complete. The collection of survival data was completed in October 2012, giving a mean follow-up of 17±12 months (median 17 months; IQR 6 to 29 months), and was 100% complete. AKI was defined according to the RIFLE classification.Paper III was a retrospective study, in which 123 patients with severe symptomatic aortic stenosis underwent TAVI with the 23 mm, 26 mm, or 29 mm Edwards SAPIEN? or SAPIEN XT? Transcatheter Heart Valve (Edwards Lifesciences Inc., Irvine, CA) between January 2008 and April 2013. The logistic EuroSCORE was calculated prospectively using an on-line calculator (), while the STS score (in case of no preoperative calculation) and the EuroSCORE II were calculated retrospectively using web-based systems ( WebRisk Calc261/de.aspx and , respectively). The follow up examination was performed in May 2013 and was 100% complete for the primary endpoint (30-day mortality). Intraprocedural device success was defined according to the Valve Academic Research Consortium (VARC-2) (24). The mean follow up was 1.7±1.5 years (median: 1.2 years; interquartile range: 0.4-2.9 years).Paper IV was a retrospective study, in which 166 consecutive patients with severe symptomatic aortic stenosis underwent TAVI with 168 procedures, between January 2008 and April 2014, using the Edwards SAPIEN?/Edward SAPIEN XT Transcatheter Heart Valve (Edwards Lifesciences Inc., Irvine, CA) or the Boston Scientific Lotus? (Boston Scientific Corp., Marlborough, MA). A total of 45% (n=76) underwent the TF access and 55% (n=92) underwent the TA access. Composite endpoints were defined according to the VARC-2 criteria PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LYXBwZXRlaW48L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFy
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ADDIN EN.CITE.DATA [104]. Rehospitalization for CHF, MI and the VARC-2 criteria were obtained from patient record. AKI was defined according to the AKIN classification. Follow-up analysis, conducted in May 2014, was 100% complete for survival and re-hospitalization, with means of 1.8±1.6 years (median, 1.3 years; interquartile range, 2.6 years) for TAVI and 4.6±3.0 years (median, 4.3 years; interquartile range, 4.9 years) for propensity score matched patients undergoing AVR.Table 1. Composite endpoints according to the VARC-2 criteriaDevice success Absence of procedural mortality ANDCorrect positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis–patient mismatcha and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitationa)Early safety (at 30 days) All-cause mortalityAll stroke (disabling and non-disabling)Life-threatening bleedingAcute kidney injury—Stage 2 or 3 (including renal replacement therapy)Coronary artery obstruction requiring interventionMajor vascular complicationValve-related dysfunction requiring repeat procedure (BAV, TAVI, or AVR)Clinical efficacy (after 30 days) All-cause mortalityAll stroke (disabling and non-disabling)Requiring hospitalizations for valve-related symptoms or worsening congestive heart failurebNYHA class III or IVValve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9–1.1 cm2c and/or DVI <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitationa)Time-related valve safety Structural valve deterioration Valve-related dysfunction AND/OR moderate or severe prosthetic valve regurgitation Requiring repeated procedure (TAVI or SAVR)Prosthetic valve endocarditisProsthetic valve thrombosisThrombo-embolic events (e.g. stroke)VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)BAV, balloon aortic valvuloplasty; TAVI, transcatheter aortic valve implantation; AVR, aortic valve replacement. aRefers to VARC definitions. bIncludes heart failure, angina, or syncope due to aortic valve disease requiring intervention or intensified medical management. cDepending on the body surface area.Patients undergoing conventional Aortic Valve ReplacementThe patients included in Paper I and Paper IV underwent conventional AVR with or without coronary artery bypass surgery at Department of Cardiothoracic Surgery, Cardiothoracic Anesthesia and Intensive Care, Skane University Hospital, Lund University, Sweden. Aortic valve replacement was performed through median sternotomy, using standard surgical techniques, with extracorporeal circulation. Pre-, peri-, and postoperative variables were prospectively collected and entered into the department’s computerized cardiac surgical database for retrospective analysis. Survival data was obtained from the Swedish National Board of Health and Welfare, and the incidence and cause of hospitalization and the cause of death were obtained from patient records. Between January 1999 and April 2009, 2,262 patients underwent conventional AVR with or without coronary artery bypass surgery at our department. Using this population, matching (relation 1:1) based on the propensity score was used to compare patients undergoing the different procedures in Paper I.Between September 1999 and September 2013, 2883 consecutive patients underwent conventional AVR with or without coronary artery bypass surgery (CABG) at our department. This population was used for matching based on the propensity score in Paper IV. Ethical aspectsThe studies were performed according to the principles of the Helsinki Declaration of Human Rights and were approved by The Ethics Committee for Clinical Research at Lund University, Sweden. Statistical analysisAll statistical analyses were performed and graphs plotted using the SPSS statistical software (SPSS Inc, Chicago, IL); version 17 in Paper I, version 20 in Paper II, version 21 in Paper III, and version 22 in Paper IV. Statistical significance was defined as p≤0.05. Data for continuous variables are presented as mean ± standard deviation. Categorical variables are presented as proportions with number of patients and percentage. Proportions were compared using the chi-squared or Fisher’s exact test (when frequencies were less than five), and continuous variables using Student’s t-test.Survival function was illustrated by Kaplan–Meier curves and log-rank test was used to compare statistical differences between groups.Calibration analysis (the degree to which the actual outcome is similar to the expected probability produced by the model) was examined by comparing average observed and predicted mortality. The Hosmer-Lemeshow test for goodness-of-fit was performed, where a p-value >0.05 indicates a well-calibrated model for the study population. Model calibration was also evaluated using the risk-adjusted mortality ratio. An observed/expected ratio >1.0 indicates that the model underestimates mortality, while an observed/expected ratio <1.0 indicates that the model overestimates mortality. Discrimination analysis was made to assess the prognostic value of a risk score model, using a receiver-operating characteristic curve (ROC) analysis and the C-index (area under the receiver-operating characteristic curve [AUC]) and its 95% confidence intervals. A C-index of 0.5 indicates no predictive ability, whereas a C-index of 1.0 represents perfect discrimination. U-statistics were used to investigate differences in C-index across different risk scores. The population was analyzed for specificity and sensitivity using established cut-off values: logistic EuroSCORE (>20%) and STS score (>10%). Furthermore, four different cut-off values for EuroSCORE II: >2.5%, >5%, >7.5%, and >10% were used for analysis of specificity and sensitivity. Linearized ratio (percentage per patient/year) for re-hospitalization for congestive heart failure and myocardial infarction were calculated in Paper IV.Multivariate Cox’s proportional hazard regression analysis was performed to determine independent predictors of late survival and re-hospitalization for congestive heart failure in Paper IV. The inclusion criterion for each outcome in the multivariate model was p<0.25 in the univariate analysis, and the limit for backward was p<0.05 for the exponential of the beta coefficient. Propensity-score matchingBecause treatment assignment in the thesis was not based on random allocation, propensity score adjustment PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EJmFwb3M7QWdvc3Rpbm88L0F1dGhvcj48WWVhcj4yMDA3
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ADDIN EN.CITE.DATA [110, 111] was used to reduce imbalances in covariates at baseline in Paper I and Paper IV. A logistic regression model was fitted (Hosmer-Lemeshow goodness-of-fit) where treatment (TAVI vs AVR) was the outcome, and baseline characteristics from the EuroSCORE model in addition to presence of coronary artery disease (defined as previous coronary artery bypass graft or PCI before the TAVI procedure) were the covariates in a bivariate analysis in Paper I. Propensity scores were generated for the AVR and TAVI patients using an SPSS macro (SPSS, Chicago, IL), and used to match patients from the two groups in a nearest neighbor fashion. In Paper I, the propensity score adjusted sample included 40 patients who underwent AVR and 40 who underwent TAVI (TA, n=30; TF, n=10). The covariate balance achieved by matching was assessed by checking that the variables included in the propensity score were no longer significant in the matched sample as well as calculating the absolute standardized differences in covariates between patients undergoing AVR and TAVI. An absolute standardized difference of less than 10 % for the measured covariate suggests appropriate balance between the patients undergoing the different treatment modalities. In Paper IV, the EuroSCORE model, the presence of coronary artery disease (defined as previous coronary artery bypass graft or PCI before the TAVI procedure), body mass index, aortic peak- and mean gradient, hemoglobin, eGFR were added to the covariates in a bivariate analysis. Further, a non-parsimonious propensity score matching was built. TAVI and AVR patients with the same probability score (caliper 0.2 match with 3-digit approximation) were matched. When matching pairs of TAVI and AVR with a caliper higher than 0.2, the propensity score analysis resulted in a 1:1 match but with less balanced groups and with greater differences in baseline characteristics. The propensity matching finally selected 125 propensity-matched patients.ResultsPaper IThe preoperative characteristics of patients undergoing TAVI and AVR are presented in Table I.1. The propensity score adjustment between TAVI and AVR with and without concomitant CABG is presented in Table I.2. Operative DataThe overall procedural success of TAVI was 92.5% (37 of 40). In the TA group, it was 93% (28 of 30), and in the TF group, it was 91% (10 of 11; 1 TF patient was converted to TA-TAVI). The TF procedure was converted owing to a rupture of the femoral artery after insertion of the introducer sheath. A Fluency Plus self-expanding covered graft (Bard Peripheral Vascular, Tempe, AZ) was inserted into the left femoral artery, covering the rupture. The patient was uneventfully discharged after 5 days and underwent TA-TAVI successfully 5 months later. Procedural failure occurred in 2 patients in the TA group: open surgery had to be performed in 1 patient owing to dislocation of the valve in the left ventricle; and one procedure was discontinued because of transient obstruction of the left main coronary artery during the initial balloon valvuloplasty. One patient (TA-TAVI) required valve-in-valve treatment (SAPIEN-in-SAPIEN) due to severe transprosthetic regurgitation. Postoperative ComplicationsPostoperative outcome is summarized in Table I.3. Major postoperative vascular complications occurred in 3 of 10 patients (30%) in the TF group. One patient underwent reoperation because of severe bleeding from the femoral access point caused by a dislocated wound closure device (Prostar XL, Abbott Vascular, Abbott Park, IL). The patient was taken to the operating room, an explorative laparotomy was performed, and the insertion point in the femoral artery was surgically closed. The second patient had a severe hemorrhage from the right femoral artery shortly after arrival in the intensive care unit and underwent emergent surgery with a repair of a ruptured branch of the femoral artery. Thereafter, an arterial embolectomy was successfully performed because of clinical signs of limb ischemia. The third patient had critical ischemia and was embolectomized at the same side as the femoral access in the lower limb on the 10th postoperative day. As the ischemia progressed slowly, the patient underwent a transtibial amputation, but died of multiple organ failure on the 35th postoperative day. Cerebrovascular events occurred in 3 patients (2 TF and 1 TA). The 2 TF patients were diagnosed with cerebrovascular ischemia due to embolism, and the TA patient had a traumatically incurred subarachnoid hemorrhage after falling in the ward. Four patients (3 TA and 1 TF) had renal failure (in this study defined as increased creatinine to >200 mmol/L or anuria). Two of the 3 TA patients with renal failure required hemodialysis. New-onset postoperative atrial fibrillation occurred in 3 patients, all in the TA group. No patient required pacemaker implantation for postoperative atrioventricular block. Early and Late OutcomeThere was no intraoperative mortality. The overall 30-day mortality was 5.0% (2 of 40). The in-hospital mortality was 10.0% (4 of 40): TA group 6.7% (2 of 30) versus TF group 20% (2 of 10). In the TA group, 1 patient died of traumatic subarachnoid hemorrhage 8 days postoperatively due to accidentally falling in the ward while on warfarin treatment. The second patient died of multiorgan failure 17 days postoperatively. In the TF group, 1 patient died of intestinal carcinoma with liver metastases 31 days postoperatively. One patient died of multiorgan failure related to critical ischemia in the lower limb 35 days postoperatively. Autopsies demonstrated functional valve prosthesis in all 4 patients. Late survival after TAVI was 77% both at 6 months and 1 year. One patient in the TF group died of heart failure with pulmonary edema 96 days postoperatively. Four patients in the TA group died during follow-up, 3 of myocardial infarction at 133, 153, and 481 days, and 1 died of heart failure 123 days postoperatively. The results after propensity score adjustment are given in Table I.2. Propensity score adjusted Kaplan-Meier survival estimates for the TF and TA treatment groups are compared with those for conventional AVR in Figure I.1, demonstrating that conventional AVR was not associated with a higher survival rate than the TAVI procedure (TA, p= 0.73; TF, p= 0.59). Table I.1. Preoperative characteristics of the patients undergoing transcatheter aortic valve implantation (TAVI) and aortic valve replacement (AVR)TFTAAVRVariablen = 10%n = 30%n=40%p-valueFemale 550155022550.91Hypertension330165314350.23Redo surgery previous CABG previous AVR404005117310250.45Diabetes mellitus1109304100.074Chronic obstructive pulmonary disease110124012300.20Neurological dysfunction1104134100.90Renal failure110133330.53Preoperative dialysis11013000.18Recent myocardial infarction1104134100.90Pulmonary hypertension00413130.12Peripheral vascular disease550144717430.89Atrial fibrillation22012409230.29NYHA IV 1101137250.002LVEF 30-50 11082710250.54LVEF <302203105130.71PCI prior to TAVI5501137NA0.48Cancer110310NA1.00Porcelain aorta00827NA0.17Other severe comorbidity6602170NA0.70MeanSDMeanSDMeanSDAge (years)8368068150.36Standard EuroSCORE (points)1121031130.88Logistic EuroSCORE (%)25.61523.51722.7160.73Creatinine 117611045099290.50BMI (kg/m?)28527 42650.50Aortic gradient (mmHg) peak mean895438248045241587NA230.490.17LVOT (mm)222222NA0.54Values given are number and percentage of patients, or mean ± SD. NA = data not available or applicable; NYHA = New York Heart Association Classification; LVEF = left ventricular ejection fraction; PCI = percutaneous coronary intervention; BMI = body mass index; LVOT = Left ventricle outflow tractTable I.2. Propensity-score adjustment between transcatheter aortic valve implantation (TAVI) with coronary artery disease and aortic valve replacement (AVR) with or without concomitant coronary artery bypass graft surgery at baselineTAVI AVRVariablen = 40%n = 40%p-valueAbSD (%)Female gender205022550.65-10Redo surgery102510251.0±0COPD1332.512300.815.4Neurological dysfunction512.54101.07.9Renal failure2512.51.013.1Recent myocardial infarction512.54101.07.9Pulmonary hypertension41012.50.3631Peripheral vascular disease1947.517430.659.1LVEF 30-50 922.510250.79-5.9LVEF <30512.5512.51.0±0Coronary artery disease2562.52357.50.65-10.2MeanSDMeanSDAge (years)8168150.73-5.6Standard EuroSCORE1131130.8-4.8Logistic EuroSCORE (%)241723160.716.8Propensity Score0.190.210.160.170.50Values given are number and percentage of patients, or mean ± SD. AbSD = Absolute standardized difference; COPD = Chronic obstructive pulmonary disease; LVEF = left ventricular ejection fractionTable I.3. Intra- and postoperative data for transcatheter aortic valve implantation patientsTF ApproachTA ApproachVariablen = 10%n = 30%p-valueProsthesis size 23 mm 26 mm46406013164555Hemodialysis0026.71.00Prolonged ventilator time11013.30.44New onset postop. AF003100.56Levosimendan infusion0013.3Norepinephrine >48 h22013.30.15Dobutamine >48 h22013.30.15MeanSDMeanSDContrast medium, mL288472091000.03Creatinine peak, μmol/L1791431521070.52Urine output 12 hours, mL130045012005500.63Ventilator time, hours16208100.25Perioperative bank blood (units)ICU bank blood (units)1.60.82.11.10.90.61.41.10.250.23Length of Stay ICU, hours, median (IQR) Total, days, median (IQR)341326 (19-23)11 (7-23)40761 (5-23)3 (3-6)0.750.11TnT peak, μg/L0.20.20.50.30.01CK-MB peak, μg/L7.73.220.17.8<0.001Hemoglobin, g/L Preoperatively At ICU discharge118112161312911014120.0380.65Values given are number and percentage of patients, mean ± SD, or median and interquartile range (IQR). Prolonged ventilator time = ventilator >48 h postoperatively; AF = atrial fibrillation; CK-MB = Creatine kinase-myocardial band; ICU = intensive care unit; TA = transapical; TF = transfemoral; TnT = Troponin T.28575-30480 Patients at risk AVR 40 32 30 27 26 26 26 25 TA 30 22 15 12 9 6 4 0 TF 10 6 6 6 6 3 3 100 Patients at risk AVR 40 32 30 27 26 26 26 25 TA 30 22 15 12 9 6 4 0 TF 10 6 6 6 6 3 3 1Figure I.parison between 2-years survival estimates for patients who underwent aortic valve replacement. AVR (straight line), transapical transcatheter aortic valve implantation (TA, broken thin line), and transfemoral transcatheter aortic valve implantation (TF, broken thick line) in propensity-matched groups. TAVI = transcatheter aortic valve implantation.Paper IIIncidence and risk factors of acute kidney injuryThe procedural success rate was 94% (64/68). Acute kidney injury was diagnosed in 25 patients (39%) with eGFR (cystatinC) and in 21 patients (33%) with eGFR (s-creatinine). One patient in the AKI+ group required postoperative hemodialysis. By univariate analysis, the AKI+ patients underwent TAVI with the TA approach significantly more often (p=0.001), received more peri-and postoperative red bloodcell (RBC) transfusions (p=0.009), and had a longer ICU stay (p=0.05). Other patient characteristics and laboratory parameters did not differ significantly between the AKI+ and AKI– groups (Table II.1). The mean preoperative eGFR (s-creatinine) was 67±24 mL/min/1.73m? compared to 45±21 mL/min/1.73 m? with eGFR (cystatinC) (p<0.001). In univariate analysis, preoperative renal impairment (CKD stage 3 or 4, eGFR < 60 mL/min/1.73 m?), did not significantly increase the risk of postoperative AKI (s-creatinine p=0.7 and cystatin C p=0.9). Late renal function.The mean eGFR based on s-creatinine and cystatinC for the AKI+ and AKI- groups at the different points are given in Table II.2. The mean differences in eGFR(s-creatinine) between preoperative values and the values at arrival in the ICU, on postoperative D1, postoperative D3, and 12 months following TAVI are presented in Figure II.1. In the AKI+ group, the mean eGFR was 57± 21 mL/min/1.73m? after 12 months compared to 67±23 mL/min/1.73m? preoperatively, p=0.071. The mean eGFR in the AKI+ group at 12 months follow up was improved significantly in comparison to the mean eGFR at D3 (57±21 vs 43±21 mL/min/1.73m?, p=0.023). In the AKI- group, the mean eGFR was 60±21 mL/min/1.73m? at 12-month follow up compared to 67±24 mL/min/1.73m? preoperatively, p=0.057. The mean eGFR in the AKI- group at 12 months follow up was reduced compared to D3 (60±21 vs 73±27 mL/min/1.73m?, p=0.001). There was no significant difference in mean eGFR between the AKI+ group and the AKI- group at12-month follow up (57±21 mL/min/ 1.73 m? vs 60±21 mL/min/1.73m?, p=0.49). SurvivalThe eGFR for patients with postoperative AKI and those without AKI surviving to 1 year, and patients with and without AKI who did not survive within the first year are presented in Figure II.2. Overall survival, including 2 intraoperative deaths (n=66), was 95.4± 2.6% at 30 days, 90.7±3.6% at 90 days, and 77.1±5.7% at 12 months. Causes of death are presented in Table II.2. The 30-day mortality was 4.8% for the AKI+ group and 0% for the AKI- group (p=0.33). The 90-day mortality was 14.3% for the AKI+ group and 2.3% for the AKI- group (p=0.099). For the AKI+ group, survival was 90.2±6.6% at 30 days, 85.2± 7.9% at 90 days, and 73.7± 10.2% at 12 months. For the AKI- group, survival was 97.6± 2.4% at 30 days, 97.6± 2.4% at 90 days, and 82.6±6.6% at 12 months, (logrank p=0.16), Figure II.3.2151380128905p=0.0400p=0.041599785226695p=0.5400p=0.542670810349885p<0.00100p<0.0013354359832485p=0.4900p=0.49 Figure II.1Time course of mean estimated glomerular filtration rate creatinine (eGFR, mL/min/1.73m?) over 12 months for patients with acute kidney injury (AKI) and without AKI (no AKI) following TAVI. eGFR <60-30 mL/min/1.73m? indicates chronic kidney disease stage 3 and eGFR<29 mL/min/1.73m? indicates chronic kidney disease stage 4. Bars show mean, 95% CI. Table II.1. Pre- peri- and postoperative characteristics, according to the occurrence of postoperative acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI)Clinical characteristicsAll (n=64)AKI+ (n=21)AKI? (n=43)pAge (years)80 ± 879 ± 7 80 ± 90.7Female 36 (56)10 (48)26 (61)0.3Previous surgery CABGAVR20 (31)19 (30)2 (3)6 (29)6 (29)014 (33)13 (30)2 (5)0.80.91.0Previous PCI26 (41)7 (33)19 (44)0.4Diabetes mellitus15 (23)5 (24)10 (23)1.0chronic obstructive pulmonary disease10 (16)4 (19)6 (14)0.7Hypertension31 (48)12 (57)19 (44)0.3Preoperative dialysis000Chronic kidney diseaseCreatinine (eGFR<60mL/min per 1.73m?)Cystatin C (eGFR<60mL/min per 1.73m?)25 (39)49 (77)9 (43)19/25 (76) 16 (37)30/39 (77) 0.70.9Pulmonary hypertension7 (11)2 (10)5 (12)1.0Peripheral vascular disease36 (56)14 (67)22 (51)0.2Atrial fibrillation18 (28)5 (24)13 (30)0.7NYHA IV 15 (23)5 (24)10 (23)1.0Malignancy3 (4.7)03 (7)0.5Porcelain aorta6 (9)2 (10)4 (9)1.0Other severe comorbidities61 (95)21 (100)40 (93)0.2BMI (kg/m?)27 ± 626 ± 827 ± 50.31Standard EuroSCORE (points)9.2 ± 3.58.7 ± 3.59.4 ± 3.50.42Logistic EuroSCORE (%)22 ± 1219 ± 1023 ± 130.20LVEF 30–50%LVEF <30%14 (22)6 (9)5 (24)2 (10)9 (21)4 (9)0.81.0AV peak gradient (mmHg)AV mean gradient (mmHg)79 ± 1948 ± 1284 ± 2249 ± 1577 ± 1648 ± 110.160.80Transapical TAVITransfemoral TAVI47 (73)17 (27)21(100)026 (61)17 (40)0.0010.001Amount of contrast agent (mL)130 ± 38139 ± 42126 ± 360.2Need of inotropic support? > 48 h1 (2)1 (5)0 0.3RBC transfusion14 (22)9 (43)5 (12)0.009Number of RBC transfusions0.6 ± 1.31.1 ± 1.70.3 ± 0.90.06CVI2 (3)2 (10)00.10Major bleeding2(3)1 (5)1 (2)1.0Time in ICU (h)39 ± 4963 ± 7928 ± 130.051Values given are numbers and percentages of patients, or mean ± SD. Abbreviations: AV, aortic valve; AVR, AVR, aortic valve replacement; BMI, body mass index; CABG, coronary artery bypass grafting; CVI, cerebrovascular insult; ; eGFR, estimated glomerular filtration rate; ICU, intensive care unit; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association classification; PCI, percutaneous coronary intervention; RBC, red blood cells. ?: including levosimendan (Simdax? Orion Pharma, Finland), dobutamine (Dobutrex? Hameln, Germany)Table II.2. Pre- and postoperative renal function, according to the RIFLE criteria; eGFR(creatinine) and eGFR(cystatin-C) following TAVI and cause of death in relation to acute kidney injury.eGFR(creatinine)eGFR(cystatin C)AKI+(n=21)AKI?(n=43)p-valueAKI+(n=25)AKI?(n=39)p-valuePreoperative On arrival in the ICUD1D3At 12 months Cause of deathMalignant diseaseCardiac failure/AMITraumatic CVI with MOFThromboembolic CVIRenal and cardiac failurePneumonia/meningitis with MOF67±2373±2262±2543±2157±21AKI+12111167±2477±2678±2973±2760±21AKI?1310021.00.540.04<0.0010.4948±2356±2545±2827±17NA 43±1954±1852±2042±18NA 0.410.680.22<0.001Values given are mean ± SD. Abbreviations: AKI, acute kidney injury; CVI, cerebrovascular insult; D1, day 1 postoperatively; D3, day 3 postoperatively; eGFR, estimated glomerular filtration rate (mL/min/1.73 m?); ICU, intensive care unit; MOF, multiorgan failure; NA, not available.Figure II.2eGFR for patients with acute kidney injury (AKI) and without (no AKI) surviving to 1 year and patients with and without AKI who did not survive.Figure II.3Kaplan-Meier survival curves for patients with acute kidney injury (AKI) and without (no AKI) following TAVI.Paper IIIOperative dataThe baseline preoperative characteristics of the study population are listed in Table III.1. During the relevant study period, 123 patients underwent TAVI, with a transapical access for valve implantation being used in 85 patients (69%) and a transfemoral access in 38 (31%). Transapical patients had significantly more peripheral vascular disease (64.7% versus 44.9%; p = 0.04) and a higher EuroSCORE II (8.8 ± 9.9 versus 5.6 ± 4.3; p = 0.01) compared to transfemoral patients. Percutaneous coronary intervention for significant coronary stenosis was performed preoperatively in 43 patients (35%). The distribution of valve sizes implanted for the Edwards SAPIEN Transcatheter Heart Valve or SAPIEN XT in the study population was 23 mm (n = 46), 26 mm (n = 63), and 29 mm (n = 14). Intraprocedural device success according to the VARC-2 criteria was 95.9% (118/123). 30-day mortality and causes of deathAll-cause mortality within 30 days was 4.1% (5/123). There was one death (2.6%) in the transfemoral group, and four deaths (4.7%) in the transapical group. The cause of death for the patient in the transfemoral group was intraprocedural dissection of the left anterior descending artery leading to conversion to a salvage procedure with coronary artery bypass grafting (CABG) while on extracorporeal circulation. The patient succumbed to low cardiac output syndrome in the intensive care unit later the same day. Causes of death in the transapical group were intraprocedural heart failure and circulatory collapse (n = 1), traumatic subarachnoid hemorrhage eight days postoperatively due to an accidental fall in the ward while receiving warfarin treatment (n = 1), and multiorgan failure on the 17th (n = 1) and 24th (n = 1) postoperative days. The individual risk scores for each risk stratification system in the diseased patients are listed in Table III.2. Calibration analysis and observed versus expected 30-day mortalityThe predicted 30-day mortality was 25.0 ± 15.7% by logistic EuroSCORE, 7.3 ± 6.9% by the STS score, and 7.8 ± 8.7% by EuroSCORE II. A majority of the patients (58.5%; 72/123) had a logistic EuroSCORE >20%, and 17.1% (21/123) had a STS score >10%. The H-L test demonstrated a poor calibration for logistic EuroSCORE, both for the overall study population (p <0.0001) as well as for the transapical group (p = 0.0003), but an acceptable calibration for the transfemoral group (p = 0.23). The H-L test for the STS score and EuroSCORE II showed an acceptable calibration for the overall study population as well as for the transapical and transfemoral groups. The riskadjusted mortality ratio indicated that all three evaluated risk score models were inadequately calibrated (Table III.3). All three risk score models overestimated 30-day mortality, both in the study population, as well as for the transapical and transfemoral groups. The logistic EuroSCORE overestimated mortality to a high extent in both the transapical group and the transfemoral group. In the transapical group, the STS score demonstrated the best calibration of the three risk models (observed/expected ratio 0.65). In the transfemoral group, the EuroSCORE II presented the best observed/expected ratio (0.62) of the three risk models.Discrimination analysis of 30-day mortalityThe discrimination analysis for the overall population, as well as for the transapical and transfemoral groups, is presented in Table III.4. The logistic EuroSCORE demonstrated the largest area under curve (AUC) for the overall study population (AUC 0.69; 95% CI 0.54-0.84) as well as for the transfemoral group (AUC 0.84; 95% CI 0.72-0.96), while the EuroSCORE II demonstrated the largest AUC (0.70) in the transapical group. The receiver operating curves of the logistic EuroSCORE, the STS score, and the EuroSCORE II are illustrated in Figure III.1. There was no significant difference in AUC between the three risk scores models: logistic EuroSCORE versus STS score (p=0.54); logistic EuroSCORE versus EuroSCORE II (p=0.79); STS score versus EuroSCORE II (p=0.67). The sensitivity and specificity for different cut-off values in each risk score model are listed in Table III.5.Table III.1. Preoperative patient characteristicsVariableOverall (n=123)TA (n=85)TF (n=38)p-valueAge (years) ?80.5 ± 7.580.2 ± 7.681.4 ± 7.30.400Female gender58 (47.2)36 (42.4)22 (57.9)0.11BMI (kg/m?)?27.2 ± 6.327.0 ± 6.927.8 ±4.80.487Hypertension59 (48.0)39 (45.9)20 (52.6)0.49Diabetes mellitus32 (26.0)25 (29.4)7 (18.4)0.20PCI prior to TAVI43 (35.0)32 (37.6)11 (28.9)0.35Previous cardiac surgery 40 (32.5)32 (37.7)8 (21.1)0.07COPD26 (21.1)21 (24.7)5 (13.2)0.15Cerebrovascular disease9 (7.3)5 (5.9)4 (10.5)0.46Renal failure?22 (17.9)15 (12.2)7 (18.4)0.92Creatinine (?mol/L)104.0 ± 51.4100.7 ± 39.3111.5 ± 71.60.284Preoperative dialysis8 (6.5)4 (4.7)4 (10.5)0.25Recent MI (<90 days)13 (10.6)9 (10.6)4 (10.5)1.0Pulmonary hypertension (>55mmHg)16 (13.0)11 (12.9)5 (13.2)1.0Peripheral vascular disease72 (58.5)55 (64.7)17 (44.7)0.04Atrial fibrillation40 (32.5)30 (35.3)10 (26.3)0.33NYHA Class IV 24 (19.5)20 (23.5)4 (10.5)0.09LVEF 30-50% 33 (26.8)25 (29.4)8 (21.1)0.33LVEF 20-30%13 (10.6)8 (9.4)5 (13.2)0.54LVEF <20%1 (0.8)1 (1.2)0 (0)1.0Logistic EuroSCORE (%) ?25.0 ± 15.725.9 ± 17.223.1 ± 11.70.294EuroSCORE II ?7.8 ± 8.78.8 ± 9.95.6 ± 4.30.013STS score ?7.3 ± 6.97.3 ± 6.27.3 ± 8.30.977Aortic gradient, peak (mmHg) ?79.0 ± 22.378.3 ± 20.880.7 ± 25.50.604? Values are mean ± SD. Values in parenthesis are percentages. ? Creatinine clearance estimate <50mL/min/1.73m?. BMI: body mass index; COPD: chronic obstructive pulmonary disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NYHA = New York Heart Association Classification; PCI: percutaneous coronary intervention; TA: transapical; TF: transfemoralTable III.2. Risk scores for deceased patients (within 30 days post-procedure)Patient no. Mortality (days post-procedure)Valve implantation accessLogistic EuroSCORE (%)STS score (%)Euro-SCORE II (%)#10TA26.23.610.8#20TF33.34.93.8#38TA40.06.35.4#417TA38.212.426.3#524TA19.610.16.3TA= Transapical; TF = TransfemoralTable III.3. Risk ScoreObserved/Expected RatioH-LstatisticsH-Lp-valueLogistic EuroSCORE Overall0.1637.1<0.0001 Transapical0.1829.40.0003 Transfemoral0.2210.60.23STS score Overall0.568.50.39 Transapical0.657.40.50 Transfemoral0.328.50.39EuroSCORE II Overall0.525.90.66 Transapical0.536.20.63 Transfemoral0.627.20.52Calibration analysisH-L = Hosmer-Lemeshow testTable III.4. Discrimination analysisRisk ScoreAUC95% CILogistic EuroSCOREOverall0.69(0.54-0.84)Transapical0.66(0.49-0.82)Transfemoral0.84(0.72-0.96)STS scoreOverall0.60(0.38-0.82)Transapical0.63(0.37-0.88)Transfemoral0.46(0.30-0.62)EuroSCORE IIOverall0.66(0.46-0.86)Transapical0.70(0.52-0.88)Transfemoral0.38(0.22-0.54)AUC: area under the curve; CI=confidence intervalTable III.5. Cut-off values for logistic EuroSCORE, STS score, and EuroSCORE IICut-off valuen(%)Observed mortality (%)(95% CI)Predicted mortality (%)(95% CI)Sensitivity(%)Specificity(%)PPV (%)NPV (%)Log EuroSCORE >20%72 (59)5.6 (0.2-10.9)34.8 (31.7-37.8)80.042.45.698.0STS score >10%21 (17)9.5 (0.0-22.4)18.6 (14.4-22.9)40.083.99.597.1EuroSCORE II >2.5%100 (81)5.0 (0.7-9.3)9.2 (7.4-11.0)10019.55.0100EuroSCORE II >5%67 (54)6.0 (0.3-11.7)11.9 (9.5-14.3)80.046.66.098.2EuroSCORE II >7.5%38 (31)5.3 (0.0-12.5)16.5 (12.9-20.2)40.069.55.396.5EuroSCORE II >10%27 (22)7.4 (0.0-17.5)19.7 (15.1-24.3)40.078.87.496.9PPV: positive predictive value; NPV: negative predictive value Figure III.1Risk-score discrimination and 30-day mortality. Reciever operating characteristic (ROC) curves for the logistic EuroSCORE, the STS score, and the EuroSCORE IIPaper IVBaseline preoperative characteristics for unmatched and propensity score-matched TAVI and AVR groups are presented in Table IV.1. Despite attempted matching, baseline characteristics of the two treatment groups differed significantly. Patients in the TAVI group more often were older patients (p=0.007) of female gender (p=0.032) with pulmonary hypertension (p=0.033) and peripheral vascular disease (p=0.035) who had undergone CABG (p=0.005) and percutaneous coronary intervention (PCI) (p=0.025) procedures prior to TAVI. Concomitant CABG was performed in 59% (n=74) of the propensity score-matched AVR population.Device successComposite endpoints following TAVI and AVR are presented in Table IV.2. Device success was 94.0% (158/168) in the TAVI group. Intraprocedural mortality with TAVI was 1.8% (n=3). These patients succumbed due to; intraoperative dissection of the left anterior descending coronary artery leading to left ventricle rupture despite a salvage CABG procedure with ECC (n=1); intraoperative heart failure with circulatory collapse (n=1); intraoperative aortic root rupture during valve deployment leading to an unsuccessful salvage AVR procedure with ECC (n=1). There was no perioperative death in the AVR-group. Correct positioning of a single prosthetic valve in the TAVI group was achieved in 95.8% (161/168). Prosthetic valve migration occurred in two patients. Four patients in the TAVI group did not receive a prosthetic valve at the first attempt due to transient obstruction of the left main coronary artery during the initial balloon valvuloplasty (n=1), heavy calcification in the common femoral artery (n=1) (the patient successfully received a TA-TAVI five months later), and heavy calcification in the ascending aorta preventing transfemoral passage (n=1). One transfemoral Boston Scientific Lotus valve was placed in incorrect position and the respositioning mechanism failed, whereas the implantation was aborted (the patient underwent a successful TF Sapien 5 weeks later). In a single instance where severe perioperative transprosthetic regurgitation was evident by transesophageal echocardiography, valve-in-valve placement (SAPIEN-in-SAPIEN) was required. Perioperative transesophageal echocardiography demonstrated no moderate or severe trans- or paravalvular regurgitation, or mean gradient higher than 20 mmHg in the TAVI group. Early safety (at 30 days) In TAVI and AVR treatment groups, 30-day mortality rates were 4.2% and 4.8% (p=0.81) and all-cause stroke rates were 3.0% and 0.8% (p=0.24), respectively. Early safety at 30 days was 87% (146/168) in the TAVI group and 86% (108/125) in the AVR group (p=1.0) (Table IV.2). Postoperative permanent pacemaker implantation was required in 9.0% (n=15) and 5.6% (n=7) of TAVI- and AVR-treated patients, respectively (p=0.24).Clinical efficacy and time-related valve safetySurvival rates were 80.5±3.4% vs 89.6±2.7% at 1 year and 51.8±5.8% vs 72.3±4.3% at 4 years for TAVI and AVR groups, respectively (p=0.001) (Figure IV.1). Clinical efficacy rates were 78.2±3.5% vs 89.6±2.7% at 1 year and 34.9±5.2% vs 66.8±4.4% at 4 years for TAVI and AVR groups, respectively (p<0.001). Rates of freedom from all-cause stroke were 92.3±2.2% vs 99.2±0.8% at 1 year and 81.2±5.2% vs 95.6±2.2% at 4 years for TAVI and AVR groups, respectively (p=0.001). Prosthetic valve endocarditis was diagnosed in four patients (two per group): TAVI, 1.3%; AVR, 1.7% (p=1.0). Deaths in the TAVI group are listed by cause in Table IV.3.Re-hospitalization due to congestive heart failure and myocardial infarction Cumulative incidences of re-hospitalization for CHF were16.3±3.2% vs 6.8±2.3% at 1 year and 41.3±7.2% vs 23±4.3% at 4 years after TAVI and AVR, respectively (p=0.006) (Figure IV.2a). Corresponding linearized rates of re-hospitalization due to CHF were 24.5% (n=72) vs 15.0% (n=86) per patient/year. Cumulative incidences of re-hospitalization for MI were 3.5±1.8% vs 0.8±0.8% at 1 year and 17.1±5.5% vs 4.8±2.4% at 4 years after TAVI and AVR, respectively (p=0.003) (Figure IV.2b). Corresponding linearized rates of re-hospitalization for MI were 5.1% (n=15) vs 1.6% (n=9) per patient/year.Independent risk factors for mortality and for re-hospitalization due to congestive heart failureUni- and multivariate analyses of risk factors for mortality and re-hospitalization due to CHF are delineated in Table IV.4. Independent risk factors for mortality were diabetes mellitus (hazard ratio [HR]=2.0; 95% confidence interval [CI], 1.15-3.47; p=0.015) and estimated glomerular filtration rate (HR=0.98; 95% CI, 0.97-0.99; p=0.011). NYHA Functional Class IV preoperative status was identified as an independent risk factor for re-hospitalization due to CHF (HR=2.43; 95% CI, 1.19-4.95; p=0.015). Table IV.1 Unmatched MatchedVariableAVRn=2883n (%)TAVIn=166n (%)p-valueAVRn=125n (%)TAVIn=166n (%)p-valueFemaleNYHA Class IVDiabetes mellitusCOPDPulmonary hypertensionPeripheral vascular diseaseNeurological dysfunctionRecent MIPrevious cardiac surgery CABG AVRPCI prior to TAVI/AVRPreoperative dialysisCritical preoperative stateLVEF <50% <30%791 (27)157 (5)315 (11)246 (9)86 (3)244 (8)37 (1)300 (10)84 (3)98 (3)31 (1)44 (2)488 (17)153 (5)81 (49)35 (21)40 (24)29 (18)27 (16)86 (52)13 (7.8)17 (10)81 (49)4 (2.4)52 (32)11 (6.7)064 (39)5 (3.0)0.123<0.0010.0210.129<0.001<0.001<0.0010.044<0.001<0.001<0.0010.1740.0010.01646 (37)17 (14)20 (16)19 (15)10 (8)49 (39)10 (8)16 (13)40 (32)2 (1.6)24 (19)4 (3.2)3 (2.4)51 (41)9 (7.2)81 (49)35 (21)40 (24)29 (18)27 (16)86 (52)13 (7.8)17 (10)81 (49)4 (2.4)52 (32)11 (6.7)064 (39)5 (3.0)0.0320.0930.0800.5700.0330.0350.9860.5230.0050.0250.1820.1700.6680.104Mean ± SDp-valueMean ± SDp-valueAgeBody Mass IndexAortic gradient, mmHg Peak MeanHemoglobin, g/LeGFRLogistic EuroSCORE76±727±478±2545±14129±1373±2412±1180±927±578±2244±12125±1556±2523±15<0.0010.7030.7450.7450.002<0.001<0.00178±627±478±2544±14129±1861±2220±1480±927±578±2244±12125±1556±2523±150.0070.8830.9760.9740.0920.0910.083Propensity score adjustment (TAVI and AVR) with or without concomitant CABG at baseline.Values expressed as number and percentage of patients, mean ± SD. AVR = aortic valve replacement, TAVI = transcatheter aortic valve implantation, NYHA = New York Heart Association Functional Classification, COPD = chronic obstructive pulmonary disease, Pulmonary hypertension = >60mmHg, CABG = coronary artery bypass grafting, PCI = percutaneous coronary intervention, LVEF = left ventricular ejection fraction, eGFR = estimated glomerular filtration rate (calculated by abbreviated MDRD equation)Table IV.2. Composite endpoints following transcatheter aortic valve implantation (TAVI) and propensity score-matched aortic valve replacement (AVR) VariableTAVIn=168 (%)AVRn=125 (%)p-valueDevice success Early Safety (at 30 days) All-cause mortality All-cause stroke Life-threatening bleeding Acute kidney injury* – Stage 2 or 3 Coronary obstruction requiring intervention Major vascular complications Repeated procedure (valve-related dysfunction)158 (94.0%)146 (86.9%)7 (4.2%)5 (3.0%)10 (5.9%)7 (4.2%)1 (0.6%)8 (4.8%)0-108 (86.4%)6 (4.8%)1 (0.8%)8 (6.4%)7 (5.6%)000-1.0000.8120.2420.7250.5751.0000.021-Composite endpoints expressed as number and (%)*Defined by AKINTable IV.3. Cause of death in patients undergoing transcatheter aortic valve implantation (TAVI)Deaths (n=56) by causeTAVI(n=166) Postoperative dayProcedure relatedCardiovascular mortality Congestive heart failure Acute myocardial infarction Sudden death Stroke, ischemic Ruptured aortic UnknownNoncardiovascular mortality Malignancy Traumatic hemorrhage Pneumonia Sepsis Hepatic failure Gastrointestinal hemorrhage Renal failure Multi-organ failure310712110534311230, 0, 023, 86, 123, 130, 136, 263, 296, 493, 653, 105537, 133, 363, 481, 946, 1292, 1559152466, 689467218, 344, 460, 593, 849, 1108, 1332, 1465, 1599, 1718 151, 157, 341, 560, 16808, 44, 48177, 324, 941, 1102285, 1030, 1718128383915, 1270 25, 37, 489Table IV.4. Cox regression analysis: predictors of mortality and re-hospitalization for congestive heart failure following TAVI.Univariate analysisMultivariate analysisPredictors of mortalityHR(95% CI)p-valueHR(95% CI)p-valueAge, per 1-year increment1.030.99-1.070.166Female gender0.760.45-1.300.319Hypertension1.71.02-2.960.0411.590.93-2.720.088Diabetes mellitus2.11.19-3.610.0102.01.15-3.470.015LVEF<501.530.90-2.610.118NYHA Class IV1.450.81-2.600.212eGFR0.980.97-0.990.0070.980.97-0.990.011Renal replacement therapy0.870.27-2.800.873COPD1.040.56-1.940.898Aortic gradient, mean0.990.97-1.020.591Pulmonary hypertension1.951.04-3.630.036Previous CABG1.741.02-2.960.041Previous PCI0.830.48-1.450.510Predictors of re-hospitalization for congestive heart failureHR(95% CI)p-valueHR(95% CI)p-valueAge, per 1-year increment1.040.99-1.010.1111.050.99-1.120.079Female gender1.230.62-2.420.558Hypertension0.950.48-1.890.892Diabetes mellitus1.410.65-3.070.391LVEF<501.910.95-3.830.0692.010.98-4.120.055NYHA Class IV2.671.31-5.450.0072.431.19-4.950.015eGFR0.990.98-1.010.288Renal replacement therapy0.780.18-3.320.734COPD0.850.35-2.060.714Aortic gradient, mean1.010.98-1.040.628Pulmonary hypertension2.020.91-4.500.084Previous CABG0.950.48-1.880.892Previous PCI1.070.53-2.140.854HR = Hazard ratio, CI = Confidence interval, LVEF = left ventricular ejection fraction, NYHA = New York Heart Association Functional Classification, eGFR = estimated glomerular filtration rate (calculated by abbreviated MDRD equation), COPD = chronic obstructive pulmonary disease, Pulmonary hypertension = >60mmHg, CABG = coronary artery bypass grafting, PCI = percutaneous coronary intervention.Figure IV.1Comparison between survival for high risk patients undergoing transcatheter aortic valve implantation (TAVI) and propensity score matched patients undergoing aortic valve replacement (AVR).Figure IV.2aCumulative incidences of re-hospitalization for congestive heart failure in high-risk- patients undergoing transcatheter aortic valve implantation (TAVI) and propensity score matched patients undergoing aortic valve replacement (AVR).Figure IV.2bCumulative incidences of re-hospitalization for myocardial infarction in high-risk- patients undergoing transcatheter aortic valve implantation (TAVI) and propensity score matched patients undergoing aortic valve replacement (AVR).DiscussionThe results of the present thesis confirm the merits of TAVI as a therapeutic option in high-risk patients with AS PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Kb2hhbnNzb248L0F1dGhvcj48UmVjTnVtPjM1PC9SZWNO
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ADDIN EN.CITE.DATA [2]. Early safety was excellent, although the risk of postoperative AKI was considerable ADDIN EN.CITE <EndNote><Cite><Author>Johansson</Author><Year>2014</Year><RecNum>89</RecNum><DisplayText>[83]</DisplayText><record><rec-number>89</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">89</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Johansson, M.</author><author>Nozohoor, S.</author><author>Bjursten, H.</author><author>Kimblad, P. O.</author><author>Sjogren, J.</author></authors></contributors><auth-address>Department of Cardiothoracic Surgery, Anaesthesia, and Intensive Care, Skane University Hospital, Lund University, Lund, Sweden.
Department of Cardiothoracic Surgery, Anaesthesia, and Intensive Care, Skane University Hospital, Lund University, Lund, Sweden. Electronic address: shahab.nozohoor@med.lu.se.</auth-address><titles><title>Acute kidney injury assessed by cystatin C after transcatheter aortic valve implantation and late renal dysfunction</title><secondary-title>J Cardiothorac Vasc Anesth</secondary-title><alt-title>Journal of cardiothoracic and vascular anesthesia</alt-title></titles><periodical><full-title>J Cardiothorac Vasc Anesth</full-title><abbr-1>Journal of cardiothoracic and vascular anesthesia</abbr-1></periodical><alt-periodical><full-title>J Cardiothorac Vasc Anesth</full-title><abbr-1>Journal of cardiothoracic and vascular anesthesia</abbr-1></alt-periodical><pages>972-7</pages><volume>28</volume><number>4</number><dates><year>2014</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>1532-8422 (Electronic)
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ADDIN EN.CITE.DATA [112]. Comparison to AVRIn the present thesis an attempt to compare TAVI and AVR was made in Paper I and Paper IV. It is difficult to compare outcomes between TAVI and AVR owing to obvious differences in baseline characteristics, as patients determined for TAVI are considered high-risk and commonly denied conventional AVR. To minimize the wide discrepancy between the two different patient populations, we performed propensity score matching to try to balance baseline covariates. However, our matching was not perfect, either in Paper I or in Paper IV. In some previous studies using propensity score matching, the TAVI population was reduced as well in order to find a better 1:1 match, leaving the sickest TAVI patents outside the study PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYXBhZG9wb3Vsb3M8L0F1dGhvcj48WWVhcj4yMDE0PC9Z
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ADDIN EN.CITE.DATA [55, 113]. In Paper IV, we selected an AVR group smaller than the TAVI group for better matching. Despite this, there are significant differences in the two populations, and once again the TAVI patients carry more comorbidity and have a higher risk profile.In Paper I, a comparison between one year survival for patients undergoing TAVI and AVR was made, showing that survival with both the TF and TA approaches was similar to that after AVR (Figure I.1). When increasing the study population (Paper IV) the TAVI group showed inferior survival rates (Figure IV.1). This finding contrasts with two previously randomized studies and the meta-analysis by Takagi et al, in which TAVI was similar or superior to AVR in survival PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZGFtczwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [3, 115] and therefore poorer late outcomes may be expected compared to AVR PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LYXBhZGlhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48
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ADDIN EN.CITE.DATA [116, 117]. However, early safety (including all-cause mortality, all-cause stroke, life-threatening bleeding, AKI, coronary obstruction requiring intervention, major vascular complications and repeated procedure, all within 30 days) was surprisingly excellent for both TAVI and AVR groups, reflecting careful patient selection, good clinical performance and optimal postoperative care in this vulnerable patient cohort. The TAVI procedure has an integrated risk of procedural failure without parallel in AVR. In Paper IV, the device success was 94%, leaving 10 patients with an unsatisfying result, related to the 0% perioperative mortality in the AVR group. Our device success was comparable with that of previous studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BYmRlbC1XYWhhYjwvQXV0aG9yPjxZZWFyPjIwMTQ8L1ll
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ADDIN EN.CITE.DATA [118-120]. However, how to manage this result is of great importance, since exclusions from further analysis may have a significant impact on the overall outcomes and skew the results in favor of TAVI. In Paper IV, in the present thesis, we found that re-hospitalizations for CHF and MI were more frequent following TAVI than with AVR. Even if our comparison was not ideal, the purpose of intervention for elderly patients with AS and significant comorbidities should be symptom relief, and not only prolonged life-expectancy. One can assume that more frequent hospitalizations due to CHF and MI may affect the patients’ quality of life, although this was not evaluated in this thesis. However, some previous published studies have linked untreated significant coronary artery disease with poorer survival following TAVI PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZXdleTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [121, 122]. Likewise, a recent study by Thalji et al ADDIN EN.CITE <EndNote><Cite><Author>Thalji</Author><Year>2014</Year><RecNum>113</RecNum><DisplayText>[123]</DisplayText><record><rec-number>113</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">113</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Thalji, N. M.</author><author>Suri, R. M.</author><author>Daly, R. C.</author><author>Greason, K. L.</author><author>Dearani, J. A.</author><author>Stulak, J. M.</author><author>Joyce, L. D.</author><author>Burkhart, H. M.</author><author>Pochettino, A.</author><author>Li, Z.</author><author>Frye, R. L.</author><author>Schaff, H. V.</author></authors></contributors><auth-address>Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn. Electronic address: suri.rakesh@mayo.edu.
Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minn.
Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn.</auth-address><titles><title>The prognostic impact of concomitant coronary artery bypass grafting during aortic valve surgery: Implications for revascularization in the transcatheter era</title><secondary-title>J Thorac Cardiovasc Surg</secondary-title><alt-title>The Journal of thoracic and cardiovascular surgery</alt-title></titles><periodical><full-title>J Thorac Cardiovasc Surg</full-title></periodical><dates><year>2014</year><pub-dates><date>Sep 17</date></pub-dates></dates><isbn>1097-685X (Electronic)
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ADDIN EN.CITE.DATA [74-76]. TAVI has the benefit of avoiding CPB, however, embolization of aortic debris, sequences of rapid pacing with hypoperfusion, the use of a nephrotoxic contrast agent and patient population with preoperative chronic kidney disease to a higher extent are all potential risk factors for postoperative AKI. Data from Paper II in the present thesis indicates that AKI following TAVI is common, with approximately 30% to 40% developing AKI after TAVI. However, data from study IV in the present thesis demonstrates only 4.2% of AKI following TAVI. This obvious discrepancy in incidence of postoperative AKI can be explained by the different classifications of AKI (i.e. RIFLE and AKIN) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZWxsb21vPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZWxsb21vPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE.DATA [81], and similar with a Hartrumpf et al ADDIN EN.CITE <EndNote><Cite><Author>Hartrumpf</Author><Year>2015</Year><RecNum>153</RecNum><DisplayText>[124]</DisplayText><record><rec-number>153</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">153</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hartrumpf, M.</author><author>Erb, M.</author><author>Zytowski, M.</author><author>Kuehnel, R. U.</author><author>Aigner, S.</author><author>Butter, C.</author><author>Albes, J.</author></authors></contributors><auth-address>Department of Cardiovascular Surgery, Heart Center Brandenburg, Bernau bei Berlin, Germany.
Department of Cardiology, Heart Center Brandenburg, Bernau bei Berlin, Germany.</auth-address><titles><title>Radiation Exposure and Contrast Volume Differ between Transapical and Transfemoral Aortic Valve Implantation with the Edwards SAPIEN Aortic Valve</title><secondary-title>Thorac Cardiovasc Surg</secondary-title><alt-title>The Thoracic and cardiovascular surgeon</alt-title></titles><periodical><full-title>Thorac Cardiovasc Surg</full-title><abbr-1>The Thoracic and cardiovascular surgeon</abbr-1></periodical><alt-periodical><full-title>Thorac Cardiovasc Surg</full-title><abbr-1>The Thoracic and cardiovascular surgeon</abbr-1></alt-periodical><dates><year>2015</year><pub-dates><date>Feb 17</date></pub-dates></dates><isbn>1439-1902 (Electronic)
0171-6425 (Linking)</isbn><accession-num>25703634</accession-num><urls><related-urls><url>;[124], we did not observe a higher amount of contrast agent used in the TA approach in Paper I. However, another explanation may be the additional hypoperfusion for patients undergoing TA approach since an extra sequence of rapid pacing is needed during the introducer retraction. Furthermore, a recent study by Petronio et al, showed that general anesthesia generated a higher incidence of AKI stage 3 compared to local anesthesia ADDIN EN.CITE <EndNote><Cite><Author>Petronio</Author><Year>2015</Year><RecNum>215</RecNum><DisplayText>[125]</DisplayText><record><rec-number>215</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">215</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Petronio, A. S.</author><author>Giannini, C.</author><author>De Carlo, M.</author><author>Bedogni, F.</author><author>Colombo, A.</author><author>Tamburino, C.</author><author>Klugmann, S.</author><author>Poli, A.</author><author>Guarracino, F.</author><author>Barbanti, M.</author><author>Latib, A.</author><author>Brambilla, N.</author><author>Fiorina, C.</author><author>Bruschi, G.</author><author>Martina, P.</author><author>Ettori, F.</author></authors></contributors><auth-address>Cardiac Catheterization Laboratory, Cardiothoracic Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.</auth-address><titles><title>Anaesthetic management of transcatheter aortic valve implantation: results from the Italian CoreValve registry</title><secondary-title>EuroIntervention</secondary-title><alt-title>EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology</alt-title></titles><periodical><full-title>EuroIntervention</full-title></periodical><volume>10</volume><number>11</number><dates><year>2015</year><pub-dates><date>Mar 16</date></pub-dates></dates><isbn>1969-6213 (Electronic)
1774-024X (Linking)</isbn><accession-num>25772903</accession-num><urls><related-urls><url>;[125]. Interestingly, at 12 months follow up, the mean eGFR in the AKI+ group had recovered compared to the lowest postoperative eGFR. However, there was a trend towards impaired renal function compared to preoperative eGFR levels, for both AKI+ (p=0.071) and AKI-patients (p=0.057). Even if these differences were not statistically significant, it seems plausible that the result could have attained statistical significance had the number of patients been larger. The current findings may suggest that patients with or without AKI following TAVI demonstrate a deteriorating renal function over time. Causes of renal impairment are multifactorial with a plethora of etiologies of which several are chronic and progressive with the potential of affecting renal function during the postoperative period. Diabetes mellitus, hypertensive cardiovascular and peripheral vascular disease are common co-morbidities in this patient population, with established long-term negative effects on renal function. In Paper II in the present thesis, there was a significant difference in preoperative eGFR between creatinine and cystatin C. This may reflect a diminished muscle mass in aged patients with severe aortic stenosis and reduced functional capacity. One of the hemodynamic consequences of valve replacement due to AS is an afterload reduction leading to improved systodiastolic function, cardiac reverse remodeling and symptom relief. Postoperatively, patients often demonstrate a substantial improvement in their physical ability and exercise tolerance and may therefore rebuild muscle mass with an increase in creatinine that cannot be translated into a renal functional impairment over time. Prediction of 30-day mortalityThe ability to predict postoperative mortality in patients undergoing cardiac surgery and TAVI is necessary in order to individualize current treatment for AS. Since logistic EuroSCORE have lost its advantage in calibration over the years ADDIN EN.CITE <EndNote><Cite><Author>Hickey</Author><Year>2013</Year><RecNum>213</RecNum><DisplayText>[126]</DisplayText><record><rec-number>213</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">213</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hickey, G. L.</author><author>Grant, S. W.</author><author>Murphy, G. J.</author><author>Bhabra, M.</author><author>Pagano, D.</author><author>McAllister, K.</author><author>Buchan, I.</author><author>Bridgewater, B.</author></authors></contributors><auth-address>Northwest Institute for Bio-Health Informatics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.</auth-address><titles><title>Dynamic trends in cardiac surgery: why the logistic EuroSCORE is no longer suitable for contemporary cardiac surgery and implications for future risk models</title><secondary-title>Eur J Cardiothorac Surg</secondary-title><alt-title>European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery</alt-title></titles><periodical><full-title>Eur J Cardiothorac Surg</full-title></periodical><pages>1146-52</pages><volume>43</volume><number>6</number><keywords><keyword>Calibration</keyword><keyword>Cardiac Surgical Procedures/adverse effects/*methods/*trends</keyword><keyword>Europe</keyword><keyword>Humans</keyword><keyword>Logistic Models</keyword><keyword>*Models, Statistical</keyword><keyword>Prospective Studies</keyword><keyword>Reproducibility of Results</keyword><keyword>Risk</keyword><keyword>Risk Assessment</keyword></keywords><dates><year>2013</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1873-734X (Electronic)
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ADDIN EN.CITE.DATA [34-39].In Paper III in the present thesis, we found a good calibration for the EuroSCORE II and the STS score, but despite this the risk score models overestimated 30-day mortality by factors of 1.8 and 1.9, respectively. The logistic EuroSCORE was poorly calibrated in the overall population (H-L test, p<0.0001) and in the TA group (H-L test, p=0.0003), but had acceptable calibration in the TF group (H-L test, p= 0.23). The logistic EuroSCORE also overestimated 30-day mortality with a factor of 6.3, which was similar to the data reported previously by Goetzenich et al PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Hb2V0emVuaWNoPC9BdXRob3I+PFllYXI+MjAxMjwvWWVh
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Hb2V0emVuaWNoPC9BdXRob3I+PFllYXI+MjAxMjwvWWVh
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ADDIN EN.CITE.DATA [35]. The present data were similar to those in a previous report from Sedaghat and colleagues PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TZWRhZ2hhdDwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+
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ADDIN EN.CITE.DATA [37], who demonstrated a tendency to overestimate mortality for all three risk models. In contrast to recent studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EdXJhbmQ8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [34, 37, 39], the present study was unable to identify an improved discriminatory power for the EuroSCORE II compared to the logistic EuroSCORE. The EuroSCORE II presented good discriminative power in the TA group (AUC 0.70), and even though the logistic EuroSCORE demonstrated a very good discriminative power in the TF group (AUC 0.84) this may be questionable since we only had one event in the TF group.The present data indicated that a large number of patients undergoing TAVI were selected based on other criteria than those presented in the evaluated risk score models. As increasing numbers of patients with intermediate EuroSCORE/STS scores are being referred for TAVI, and all of the established risk score models are limited by an inadequate estimation of 30-day mortality, a well-calibrated and accurate risk stratification model is necessary. LimitationsThe limitations of the present thesis were the limited number of patients and the mainly retrospective and observational single-center design, such that the data acquired may not be generalized to other clinical settings or may influence the strength of the statistical inferences drawn. Even though propensity-score matching can be used to balance measured baseline covariates, patients selected for TAVI are more likely to have comorbidities such as porcelain aorta, malignancies and cirrhosis that may remain unadjusted for, compared to the AVR group. The causes of AKI (nephrotoxic, ischemic, or atheroembolic) could not be determined due to the absence of renal biopsies. Unfortunately, we have not studied the incidence and consequences of PVR following TAVI. Finally, the TAVI population included our early experience, which may have included learning curve effects. ConclusionsBased on the findings of the studies presented in this thesis, the following conclusions can be drawn: Paper I. TAVI can be safely performed in selected high-risk patients. After propensity score matching, survival with both the TA and TF approaches was similar to that after conventional AVR. However, owing to the lack of long-term data, the relationship between TAVI and AVR appears to be complementary rather than substitutive.Paper II. The risk of postoperative AKI is considerable following TAVI, and the acute postoperative renal impairment in these patients does not fully recover in the long term. There is a progressive renal impairment in both groups postoperatively. Cystatin C may be a valuable adjunct to the established biomarker creatinine for preoperative risk assessment and postoperative diagnosis of AKI. Paper III. EuroSCORE II predict 30-day mortality more accurately for the TAVI cohort compared to the more established logistic EuroSCORE and compares on par with the STS-score. In general, all three evaluated risk scores models demonstrated rather poor performance in predicting 30-day mortality after TAVI. In lack of a more TAVI-oriented risk stratification system, the EuroSCORE II may be a valuable adjunct in the clinical setting.Paper IV. Results of this study confirm the merit of TAVI as a therapeutic option in high risk patients with aortic stenosis, even though late survival with TAVI proved inferior to that of AVR in propensity-matched subjects. Early safety was excellent for both treatment groups, however, patients undergoing TAVI had a higher incidence of re-hospitalization for CHF an MI during follow up. In our, view, patients with severe CHF should be carefully monitored and aggressively treated to improve above outcome measures.Future perspectivesTAVI has revolutionized the treatment of inoperable patients with severe symptomatic AS PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LYXBhZGlhPC9BdXRob3I+PFllYXI+MjAxNTwvWWVhcj48
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ADDIN EN.CITE.DATA [130, 131], thus beneficial long-term data and more TAVI specific risk models for optimizing patient selection will be needed before expanding the indications for TAVI. There are ongoing randomized studies comparing TAVI and AVR in intermediate risk patients, i.e. the PARTNER II Trial (Placement of AoRTic TraNscathetER Valves), with completed inclusion calculated for December 2015 (n=6650) and the Medtronic CoreValve SURTAVI Trial (SURgical replacement and Transcatheter Aortic Valve Implantation) with complete inclusion (n=2500) calculated for August 2016, and with 5 years of follow-up thereafter. It will be interesting to see the clinical outcome from these two large randomized studies, since they may almost certainly be influential in the future management of AS. One of the main issues with TAVI is the occurrence and unfavorable consequences of PVR. Whether or not ongoing prosthesis development and more accurate preoperative calcification imaging will lead to a decreasing problem with PVR remains to be elucidated PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GZXVjaHRuZXI8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy
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ADDIN EN.CITE.DATA [40, 41].Finally, the TF TAVI-procedure performed on conscious patients without the need of general anesthesia may be a tremendous improvement for this elderly, vulnerable patient population, eliminating the risks for postoperative complications ADDIN EN.CITE <EndNote><Cite><Author>Petronio</Author><Year>2015</Year><RecNum>215</RecNum><DisplayText>[125]</DisplayText><record><rec-number>215</rec-number><foreign-keys><key app="EN" db-id="0wd9ax007ep5fyea2f85vdf6eaefa5ttf2rs">215</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Petronio, A. S.</author><author>Giannini, C.</author><author>De Carlo, M.</author><author>Bedogni, F.</author><author>Colombo, A.</author><author>Tamburino, C.</author><author>Klugmann, S.</author><author>Poli, A.</author><author>Guarracino, F.</author><author>Barbanti, M.</author><author>Latib, A.</author><author>Brambilla, N.</author><author>Fiorina, C.</author><author>Bruschi, G.</author><author>Martina, P.</author><author>Ettori, F.</author></authors></contributors><auth-address>Cardiac Catheterization Laboratory, Cardiothoracic Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.</auth-address><titles><title>Anaesthetic management of transcatheter aortic valve implantation: results from the Italian CoreValve registry</title><secondary-title>EuroIntervention</secondary-title><alt-title>EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology</alt-title></titles><periodical><full-title>EuroIntervention</full-title></periodical><volume>10</volume><number>11</number><dates><year>2015</year><pub-dates><date>Mar 16</date></pub-dates></dates><isbn>1969-6213 (Electronic)
1774-024X (Linking)</isbn><accession-num>25772903</accession-num><urls><related-urls><url>;[125].AcknowledgmentsI would like to thank all people that have helped and supported me during this work with the thesis. I would especially like to thank:All the patients in the studies for their participation.Associate Professor Johan Sj?gren, my main supervisor for introducing me into cardiothoracic surgery research with such an enthusiasm, dedication and positive energy; and for being an excellent role model throughout the years, in research, in surgery, and as a person.Dr Shahab Nozohoor, my co-supervisor for having inexhaustible energy when it comes to research, always available when needed, and for the tremendous patience you displayed while working with me. Thank you for taking the time to teach me how to think and write in a scientific way. Dr Per-Ola Kimblad, my co-supervisor and initially my clinical supervisor, who always works with dedication and perfection, making surgery look like art.Dr Igor Zindovic, my resident colleague for valuable help, interesting conversations and for having the best coffee at the Lund University Hospital, together with our resident colleague and Icelandic friend Dr Sigurdur Ragnarsson, whom I am grateful to know. Dr Henrik Bjursten for always taking the time to discuss TAVI, research and kidney function.Dr Johan Nilsson for sharing your knowledge in research methodology.Dr Matthias G?tberg, for your contagious passion for TAVI.All my elderly colleagues and primary call colleagues of today and over the past years for making it enjoyable to go to work every day.All nurses at Thiva and at ATH plan 7 & 8 for taking such good care of the TAVI patients and helping me with blood sampling.Jan Karlsson for helping me with computer problems over the yearsAll anesthesiology colleagues, nurses at OR and perfusionists at our department in Lund for creating such a professional and nice working atmosphere.Suvi and Anna, two fantastic persons and a part of my family. Thank you for outstanding and appreciated help with looking after my children. Mamma Inga-Greta och pappa Rolf f?r att ni alltid st?ttar och uppmuntrar, och f?r att ni givit mig och mina systrar en fantastisk uppv?xt, med enorm sammanh?llning och minnesv?rd tid tillsammans. Lillasyster Jennie f?r att du arbetar s? h?rt och m?lmedvetet, och kommer att n? dit du vill. Storasyster Anna-Karin och hennes underbara familj, Johan, Axel, Erik, och Olle f?r att ni alltid sprider gl?dje omkring er.Min lillasyster Lotta, f?r att du alltid lyssnar, f?rst?r, st?ttar och uppmuntrar. Tack f?r att du finns. Patrik, Klara, Bob och lilla Alice f?r att ni varje dag fyller mitt liv med k?rlek och p?minner mig om vad som ?r viktigast i livet ?Financial supportThe studies were supported by Sk?ne University Hospital Funds and donations, Lund; Skane county council?s research and development foundation; Olle Dahlb?cks Fund and Capio.References ADDIN EN.REFLIST 1.Cribier A, Eltchaninoff H, Tron C, et al. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol, 2004. 43(4): p. 698-703. 2.Johansson M, Nozohoor S, Kimblad PO, Harnek J, Olivecrona GK, and Sjogren J. Transapical versus transfemoral aortic valve implantation: a comparison of survival and safety. Ann Thorac Surg. 91(1): p. 57-63. 3.Kapadia SR, Leon MB, Makkar RR, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015. 4.Mack MJ, Leon MB, Smith CR, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015. 5.Cribier A, Durand E, and Eltchaninoff H. 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