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SUPPLEMENTARY MATERIALTable S1. In-hospital parameters for patients undergoing TAVIParametersBase caseSourceHospital mortality7.19% REF _Ref514158795 \r \h \* MERGEFORMAT 1- REF _Ref514175645 \r \h \* MERGEFORMAT 4Renal dysfunction Acute2.46% REF _Ref514158795 \r \h \* MERGEFORMAT 1, REF _Ref514160668 \r \h \* MERGEFORMAT 3, REF _Ref514175645 \r \h \* MERGEFORMAT 4 Permanent0.25%Assumption (10% of acute renal dysfunction)Re-operation4.40% REF _Ref514175688 \r \h \* MERGEFORMAT 5Stroke2.24% REF _Ref514158795 \r \h \* MERGEFORMAT 1, REF _Ref514159592 \r \h \* MERGEFORMAT 2, REF _Ref514175645 \r \h \* MERGEFORMAT 4PMI18.90% REF _Ref514158795 \r \h \* MERGEFORMAT 1- REF _Ref514160668 \r \h \* MERGEFORMAT 3PVL risk mild37.00% REF _Ref514160668 \r \h \* MERGEFORMAT 3 moderate/severe18.65% REF _Ref514159592 \r \h \* MERGEFORMAT 2- REF _Ref514175645 \r \h \* MERGEFORMAT 4POVC (major)8.5% REF _Ref514158795 \r \h \* MERGEFORMAT 1- REF _Ref514175645 \r \h \* MERGEFORMAT 4Days in ICU (mean±SD)1.00±1.48median 1, IQR:0-2 REF _Ref514151924 \r \h \* MERGEFORMAT 6Days in Hospital (mean±SD)7.33±3.71median 7, IQR:5-10 REF _Ref514151924 \r \h \* MERGEFORMAT 6ICU: intensive care unit, IQR: interquantile range, PMI: pace-maker implantation, POVC: post-operative vascular complication, PVL: para-valvular leak, SD: standard deviationTable S2. List of included studies elaborated from Meco et al ( REF _Ref514152208 \r \h 7)SU-AVRTAVIYearInstitutionStudy periodNValveAge% malePredicted mortalityNValveAge% malePredicted mortalityBiancari et al. REF _Ref514248001 \r \h \* MERGEFORMAT 820156 European centers2007-2014144Perceval?79.4±5.438.9%EuroSCORE II 4.1±3.2144CoreValve, Sapien, Portico, Lotus79.0±6.037.5%EuroSCORE II 3.6±2.6D'Onofrio et al. REF _Ref514248006 \r \h \* MERGEFORMAT 920166 European centers/Italian Registry of TAVI2010-2014206Perceval?77.4±5.435.50%Logistic EuroSCORE 10.5±6.2206Sapien, Sapien XT77.7±7.935%Logistic EuroSCORE 12.4±9.1Kamperidis et al. REF _Ref514248025 \r \h \* MERGEFORMAT 102015Leiden University Medical Center, Netherlands2007-2013403F Enable?79±4.540%Logistic EuroSCORE 15.9±10.640Edwards, SAPIENXT,CoreValve79±5.940%Logistic EuroSCORE 15.5±8.4Miceli et al. REF _Ref514248012 \r \h \* MERGEFORMAT 112015Fondazione Monasterio, Italy2004-201337Perceval?79±4.530.1%Logistic EuroSCORE 16.1±1137Sapien78.8±7.440.5%Logistic EuroSCORE 15.7±8.5Muneretto et al. REF _Ref514248029 \r \h \* MERGEFORMAT 122014University of Brescia, Italy2010-2013204Perceval?79±430.02%Logistic EuroSCORE 16±11.7204Corevalve81±643.70%Logistic EuroSCORE 20.4±12.7Santarpino et al. REF _Ref514248034 \r \h \* MERGEFORMAT 132015Paracelsus Medical University, Germany2010-2014102Perceval?80±441.0%Logistic EuroSCORE 17±14Sapien, Sapien XT, CoreValve, Acurate TA79±743.0%Logistic EuroSCORE 18±11Table S3. Main results of Meco et al. REF _Ref514152208 \r \h \* MERGEFORMAT 7Post-operative outcomesSU-AVRTAVIEffectiveness measureEventsTotalEventsTotalOR (95% CI)Mortality24741447410.53 (0.32; 0.88)Stroke12741277410.45 (0.23; 0.88)Aortic regurgitation217311337310.16 (0.11; 0.25)Renal failure35527375271.44 (0.46; 4.58)PMI69741707411.06 (0.54; 2.08)Blood transfusion88426264244.47 (2.77; 7.21)Vascular complications0490414900.06 (0.01; 0.25)mean±SETotalmean±SETotalMD (95% CI)ICU LOS1.84±0.325522.41±0.57552-0.51 (-1.42; 0.40)CI: confidence interval, ICU: intensive care units, LOS: length of stay, MD: mean difference, OR: odds ratio, PMI: pacemaker implantation, SE: standard error Table S4. Summary of effect estimate for each outcome resulting statistical significant in Meco et al. REF _Ref514152208 \r \h \* MERGEFORMAT 7Comparison (SU-AVR vs TAVI)Effect estimate (95% CI)Hospital mortalityRR=0.55 (0.34; 0.89)Re-operationRR=2.55 (1.09; 5.98)StrokeRR=0.46 (0.24; 0.89)PVL riskRR=0.16 (0.11; 0.25)POVC (major)RR=0.05 (0.01; 0.19)Days in hospitalMD=3.23 (1.68; 4.77)CI: confidence interval, MD: mean difference, POVC: post-operative vascular complication, PVL: para-valvular leak, RR: relative risk Table S5. Utility for NYHA class and utility decrement in case of re-hospitalization or lifetime dialysisBaseline utilityMeanNYHA distribution at discharge NYHA class I0.85557.1% NYHA class II0.77130.6% NYHA class III0.67311.2% NYHA class IV0.5321.1%Adverse eventsMean disutilitiesFrequency 1 re-hospitalization-0.024assumed 80% of hospitalization 2 re-hospitalizations-0.031assumed 15% of hospitalizations 3+ re-hospitalizations-0.055assumed 5% of hospitalizationLifetime dialysis-0.220NYHA: New York Heart AssociationTable S6. Clinical parameters investigated in the PsA (where not reported, SE was calculated as 5% of the mean)Clinical parametersDistributionMean (SE)RR In-hospital mortality (SU-AVR vs TAVI)normal0.55 (0.245)*RR re-operation for bleeding (SU-AVR vs TAVI)normal2.55 (0.434)*RR stroke (SU-AVR vs TAVI)normal0.46 (0.334)*RR PVLnormal0.16 (0.209)*Delta hospital stay (SU-AVR vs TAVI)normal3.23 (0.788)RR PO vascular complicationnormal0.05 (0.751)*Baseline agenormal81.773 (3.297)In-hospital mortality (TAVI)normal0.072 (0.017)Acute renal dysfunction rate (TAVI)normal0.025 (0.009)Permanent renal dysfunction rate (TAVI)normal0.002Re-operation for bleeding rate (TAVI)normal0.044Stroke rate (TAVI)normal0.022 (0.008)PMI rate (TAVI)normal0.189 (0.043)Mild PVL rate (TAVI)normal0.37Moderate to severe PVL rate (TAVI)normal0.187 (0.052)ICU stay (TAVI)normal1Hospital stay (TAVI)normal7.33POVCnormal0.085 (0.035)HR OS (PVL vs no PVL)normal0.747 (0.197)HR OS (dialysis vs no dialysis)normal0.696 (0.1)HR re-hospitalization (SU-AVR vs TAVI)normal-1.444 (0.13)% deaths due to re-operationnormal50%RBC units transfused (TAVI)normal0.86RBC units transfused (SU-AVR)normal1.215Utility related to NYHA statusnormal class Inormal0.855 (0.005) class IInormal0.771 (0.006) class IIInormal0.673 (0.006) class IVnormal0.532 (0.027)Disutility for re-hospitalizationsnormal 1 re-hospitalizationnormal-0.024 (0.007) 2 re-hospitalizationsnormal-0.031 (0.009) 3+ re-hospitalizationsnormal-0.055 (0.001)Disutility for dialysisnormal-0.22Reason for re-hospitalization?dirichletNYHA status?,?dirichletNumber of re-hospitalization?dirichletICU: intensive care unit, NYHA: New York Heart Association, OS: overall survival, PMI: pace-maker implantation, POVC: post-operative vascular complication, PVL: para-valvular leak, RBC: red blood cell, RR: relative risk, SE: standard error. * SE of log(RR); ? Both for TAVI and SU-AVR arms; ? baseline, 6 months, 1 year, 2 years, 3 years and 4 yearsTable S7. Economic parameters investigated in the PsA expressed as mean (SE), where not reported SE was calculated as 5% of the mean (all values are sampled from normal distribution)US ($)Germany (€)France (€)Italy (€)UK (?)Australia (AUD)Cost OR (TAVI)6,641.92 (145.84)4,522.77 (141.45)3,363.70 (56.73)5,401.22 (336.87)5,586.81 (350.70)1,204.80Cost OR (SU-AVR)7,818.74 (171.68)5,324.11 (145.29)7,120.36 (453.15)6,358.20 (396.55)6,576.68 (412.83)6,917.00Cost diagnostic (TAVI)4,831.324,339.22 (324.86)4,633.464,927.701,706.912,731.98 (71.95)Cost diagnostic (SU-AVR)2,199.031,975.04 (195.97)2,108.972,242.89776.921,243.49 (32.75)Cost device (TAVI)32,000.0011,000.0014,500.0022,932.00Cost device (SU-AVR)12,220.466,000.006,000.008,977.00Cost re-operation (TAVI)6,544.974,526.833,519.835,318.935,107.671,634.47Cost re-operation (SU-AVR)7,207.585,193.187,260.406,125.625,796.477,101.56Cost in-hospital RRT978.1076.26152.74284.81159.81160.46Daily cost of ICU1,303.451,196.461,578.411,469.90 (286.68)1,360.004,877.46Daily cost in ward779.98469.88443.15484.20 (63.97)280.00789.80Cost in-hospital PMI5,974.254,507.153,242.593,265.732,886.004,692.00Cost in-hospital stroke16,732.36 (535.48)4,854.255,860.676,867.10 (304.96)3,479.0011,126.72RBC unit cost295.94105.53108.45153.00127.70231.26Dialysis annual cost67,497.3560,732.30 (4,033.25)53,047.5042,815.7823,713.95111,618.17Cost of re-hosp for stroke47,896.34 (1,216.49)23,385.3411,457.1413,967.4619,063.1841,008.49Cost of re-hosp for PMI48,211.798,945.02 (346.53)11,938.5612,133.5910,256.0714,208.18Cost of re-hosp for other27,249.0811,921.679,905.6511,399.587,168.9818,046.01ICU: intensive care unit, OR: operating room, PMI: pacemaker implantation, RBC: red blood cell, RRT: renal replacement therapy, SE: standard error. Table S8. Clinical parameters investigated in the DsA, where not reported range was calculated as ±25% of the mean value used in the based caseClinical parametersRangelog(RR) In-hospital mortality (SU-AVR vs TAVI)0.34 ─ 0.89log(RR) re-operation for bleeding (SU-AVR vs TAVI)1.09 ─ 5.98log(RR) stroke (SU-AVR vs TAVI)0.24 ─ 0.89log(RR) PVL0.11 ─ 0.25Delta hospital stay (SU-AVR vs TAVI)1.68 ─ 4.77log(RR) POVC0.01 ─ 0.19Baseline age80.9 ─ 83In-hospital mortality (TAVI)0.039 ─ 0.135Acute renal dysfunction rate (TAVI)0.011 ─ 0.03Permanent renal dysfunction rate (TAVI)Re-operation for bleeding rate (TAVI)Stroke rate (TAVI)0.011 ─ 0.028PMI rate (TAVI)0.121 ─ 0.237Mild PVL rate (TAVI)Moderate to severe PVL rate (TAVI)0.102 ─ 0.236ICU stay (TAVI)Hospital stay (TAVI)PO vascular complication0.019 ─ 0.174HR OS (PVL vs no PVL)0.358 ─ 1.131HR OS (dialysis vs no dialysis)0.408 ─ 0.919HR re-hospitalization (SU-AVR vs TAVI)-1.731 ─ -1.22% deaths due to re-operationRBC units transfused (TAVI)RBC units transfused (SU-AVR)Utility related to NYHA status class I0.845 ─ 0.864 class II0.761 ─ 0.784 class III0.665 ─ 0.69 class IV0.48 ─ 0.584Disutility for re-hospitalizations 1 re-hospitalization-0.038 ─ -0.01 2 re-hospitalizations-0.049 ─ -0.013 3+ re-hospitalizations-0.057 ─ -0.053Disutility for dialysisDiscount rate efficacy0 ─ 5%Discount rate cost0 ─ 5%Time horizon (years)5 ─ 30ICU: intensive care unit, NYHA: New York Heart Association, OS: overall survival, PMI: Pacemaker implantation, POVC: post-operative vascular complication, PVL: para-valvular leak, RBC: red blood cell, RR: relative risk. Table S9. Economic parameters investigated in the DsA, where not reported range was calculated as ±20% of the mean value used in the based caseUS ($)Germany (€)France (€)Italy (€)UK (?)Australia (AUD)Cost OR (TAVI)714 ─ 9,064Cost OR (SU-AVR)Cost diagnostic (TAVI)Cost diagnostic (SU-AVR)Cost device (TAVI)Cost device (SU-AVR)Cost re-operation (TAVI)Cost re-operation (SU-AVR)Cost in-hospital RRTDaily cost of ICU493 ─ 3,556Daily cost in ward301 ─ 984Cost in-hospital PMI1,709 ─ 4,761Cost in-hospital strokeRBC unit costDialysis annual cost57,038 ─ 72,848Cost of re-hosp for strokeCost of re-hosp for PMI9,258 ─ 12,713Cost of re-hosp for other5,387 ─ 10,333ICU: intensive care unit, OR: operating room, PMI: pacemaker implantation, RBC: red blood cell, RRT: renal replacement therapy. ReferencesUssia GP, Barbanti M, Petronio AS, et al. Transcatheter aortic valve implantation: 3-year outcomes af self-expanding CoreValve prosthesis. European Heart Journal (2012) 33, 969–976Barbanti M, Petronio AS, Ettori F, et al. 5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis. JACC Cardiovasc Interv. 2015 Jul;8(8):1084-1091Codner P, Orvin K, Assali A, et al. Long-Term Outcomes for Patients With Severe Symptomatic Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation. Am J Cardiol. 2015 Nov 1;116(9):1391-8Toggweiler S, Humphries KH, Lee M, et al. 5-Year Outcome After Transcatheter Aortic Valve Implantation. Journal of the American College of Cardiology Vol. 61, No. 4, 2013Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients. N Engl J Med 2011;364:2187-98Wendler O, Schymik G, Treede H, et al. SOURCE 3 Registry Design and 30-Day Results of the European ostapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve. Circulation. 2017;135:1123–1132Meco M, Miceli M, Montisci A, et al. 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Eur J Cardiothorac Surg 2016;49:960–5Muneretto C, Bisleri G, Moggi A, et al. Treating the patients in the "grey-zone" with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement. Interact CardioVasc Thorac Surg 2015;20:90–5Santarpino G, Pfeiffer S, Jessl J, et al. Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis. Am J Cardiol. 2015 Dec 1;116(11):1737-43. doi: 10.1016/j.amjcard.2015.08.043 ................
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