Mechanisms Underlying Superior Clinical Outcomes of Transcatheter Aortic Valve Implantation with the Latest Balloon-Expandable Valve

Mechanisms Underlying Superior Clinical Outcomes of Transcatheter Aortic Valve Implantation with the Latest Balloon-Expandable Valve | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Mechanisms Underlying Superior Clinical Outcomes of Transcatheter Aortic Valve Implantation with the Latest Balloon-Expandable Valve Juri Iwata, Masanori Yamamoto, Ryo Arita, Tomonari Moriizumi, and 21 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7370210/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 14 You are reading this latest preprint version Abstract Transcatheter aortic valve implantation (TAVI) using SAPIEN 3 Ultra RESILIA (S3UR) offers improved hemodynamic performance than its former generation, SAPIEN 3 (S3). This study compared 1-year clinical outcomes after TAVI using S3UR and S3. Among 2,369 patients from the OCEAN-TAVI registry, a 1:1 propensity score-matched analysis identified 775 matched pairs. One-year post-TAVI, S3UR showed significantly lower all-cause mortality (10.3% vs. 13.4%, p=0.026), stroke (0.9% vs. 3.4%, p=0.001), and heart failure rehospitalization (1.4% vs. 2.7%, p<0.001) than S3. These differences were pronounced in patients receiving smaller valves (20–23 mm). S3UR demonstrated a larger effective orifice area, lower mean pressure gradient, and lower incidence of paravalvular leakage than S3 at discharge. At 1 year, S3UR showed significantly reduced paravalvular leakage and lower incidences of mean pressure gradient ≥20 mmHg than S3. We concluded that S3UR demonstrated superior hemodynamic performance to S3, exhibiting better prognosis, particularly in patients with smaller valves. Health sciences/Cardiology Health sciences/Diseases Health sciences/Medical research aortic valve stenosis transcatheter aortic valve implantation balloon-expandable valves Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction The excellent clinical outcomes of transcatheter aortic valve implantation (TAVI), especially with balloon-expandable (BE) transcatheter heart valves (THVs), are well established. 1 , 2 The SAPIEN 3 Ultra RESILIA (S3UR) is the fifth-generation valve in the SAPIEN series (Edwards Lifesciences, Irvine, CA, USA), the most commonly used BE-THV. Recent advancements in BE-THVs have led to significant clinical improvements, including reduced paravalvular leakage (PVL) and enhanced echocardiographic parameters of valve hemodynamics. 3 – 5 Additionally, surgical bioprosthetic valves incorporating RESILIA tissue have demonstrated similar favorable hemodynamic profiles on echocardiographic assessments. 6 S3UR, which exhibits more favorable post-procedural echocardiographic hemodynamics, was associated with improved 1-year clinical outcomes compared with the SAPIEN 3 (S3) or S3 Ultra. 4 However, whether these improvements in device performance translate to better clinical outcomes in more general populations remains to be broadly investigated. Herein, we assessed the 1-year clinical outcomes and hemodynamic performance of S3UR compared with those of S3, focusing on its impact on patients with small THVs and aortic annulus sizes, using data from a nationwide multicenter registry. Methods Study cohort The Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry is an ongoing nationwide prospective multicenter cohort study involving patients with aortic stenosis undergoing TAVI at 22 collaborating centers across Japan. Participating centers were mandated to enroll patients in the registry, adhere to the registry protocol, and provide patient information and clinical outcomes during follow-up. The study protocol was approved by the ethics committee of each center, and all patients provided written informed consent for participation. This study was conducted in compliance with the principles of the Declaration of Helsinki. Additionally, the study was registered with the University Hospital Medical Information Network Clinical Trial Registry and accepted by the International Committee of Medical Journal (UMINID:000020423). The present analysis included consecutive patients who underwent TAVI with S3UR between March 2023 and September 2023 and a historical cohort of patients who underwent TAVI with S3 between September 2021 and September 2023 at the participating institutes. Patients who underwent TAVI for degenerated surgical bioprostheses or THV were excluded. Data collection and endpoint definitions Baseline clinical, procedural, and follow-up data were prospectively recorded in a web-based database at each participating center. Regular follow-ups were scheduled pre-procedure, at discharge, and 1 month and 1 year post-TAVI. Comprehensive clinical follow-up data were collected from medical records at each center, documentation from referring physicians, and/or telephone interviews. The web-based database was systematically audited by data committee members for completeness and accuracy to ensure data integrity. In cases of incomplete or inaccurate data, all participating centers were required to respond to queries. Transthoracic echocardiography was performed before TAVI, at discharge, and annually thereafter. In accordance with the updated Valve Academic Research Consortium-3 (VARC-3) criteria, 7 prosthesis-patient mismatch (PPM) was assessed as the prosthesis effective orifice area (EOA) indexed to the body surface area and categorized as severe (≤ 0.65 cm 2 /m 2 in the population without obesity [body mass index 0.65 to 0.85 cm 2 /m 2 in the population without obesity; >0.55 to 0.70 cm 2/ m 2 in the population with obesity). All procedural complications were defined according to the VARC-3 criteria and relevant data were systematically collected. The clinical endpoints included all-cause mortality, stroke, and heart failure rehospitalization (HFH). Additionally, the incidence of aortic valve re-intervention was evaluated. Statistical analysis Categorical variables are reported as frequencies and percentages, with differences evaluated using the chi-square test or two-tailed Fisher’s exact test. Continuous variables are presented as means ± standard deviations or medians and interquartile ranges, with between-group comparisons performed using the two-sample t-test or the Mann–Whitney U test, as appropriate. For within-group comparisons, means and standard deviations were analyzed using a paired t-test. Time-to-event curves were depicted using the Kaplan–Meier method (censored at death or last valid contact in cases of those awaiting the next follow-up or consent withdrawal). A Cox proportional hazard model was used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for clinical endpoints. All p-values were two-sided, and a p-value < 0.05 was considered significant for all tests. Herein, we used propensity score matching to control for confounding factors due to baseline differences between patients undergoing TAVI with S3UR and S3. The propensity score was calculated using a multivariate logistic regression model based on the following 28 variables that could have affected study outcomes: age; sex; body mass index; Society of Thoracic Surgeons Predicted Risk of Mortality; clinical frailty scale score ≥ 4; New York Heart Association (NYHA) heart failure symptoms III or IV; hypertension; diabetes mellitus; peripheral artery disease; dialysis; chronic obstructive pulmonary disease; atrial fibrillation; hemoglobin level (g/dL); history of coronary artery disease; history of stroke; previous pacemaker implantation; echocardiographic variables such as aortic valve area (cm 2 ), aortic valve mean pressure gradient (mPG) (mmHg), left ventricular ejection fraction (≥ 50%: preserved; ≥40% to < 50%: mid-range; <40%: reduced), moderate or severe aortic regurgitation, moderate or severe mitral regurgitation, and moderate or severe tricuspid regurgitation; computed tomography variables such as annulus area (mm 2 ), annulus perimeter (mm); and procedural variables such as access site (transfemoral approach or non), pre-dilatation, post-dilatation, and valve size (20 mm, 23 mm, 26 mm, 29 mm). Herein, a 1:1 greedy nearest neighbor matching protocol with a caliper of 0.2 was used. Absolute standardized differences were estimated for all baseline variables, and absolute standardized differences < 0.10 were considered an indicator of good balance. The results for the overall matched cohort and cohorts comprising patients with small (20 and 23 mm) or large (26 and 29 mm) valve sizes were analyzed. In addition to valve size-based analyses, subgroup analyses were conducted based on annulus size, including small and large aortic annuli. Results Study population and baseline characteristics Among the 915 and 2945 patients who underwent TAVI with S3UR and S3, 887 and 1,482 met the inclusion criteria, respectively, and were included herein. A 1:1 propensity score matching resulted in 775 patients each in the S3UR and S3 groups (Fig. 1 ). The baseline characteristics of the unmatched and matched cohorts are presented in Table 1 . Before propensity score matching, the groups differed in several parameters, including clinical frailty scale scores and other comorbidities. In echocardiographic assessments, patients in the S3UR group exhibited a larger aortic valve area (0.69 ± 0.19 cm² vs. 0.67 ± 0.19 cm², p = 0.002), larger index aortic valve area (0.47 ± 0.13 cm²/m² vs. 0.45 ± 0.13 cm²/m², p < 0.001), and higher left ventricular ejection fraction (59.3 ± 12.3% vs. 57.6 ± 13.4%, p = 0.004) compared with those in the S3 group. After propensity score matching, patient characteristics of the S3UR and S3 groups were well balanced, with absolute standardized differences < 0.10 across all measured baseline characteristics. Table 1 Baseline characteristics of unmatched and matched cohorts Prematched cohort Matched cohort S3UR S3 S3UR S3 N = 887 N = 1482 p N = 775 N = 775 p ASD Age, years 83.8 ± 6.1 83.5 ± 6.3 0.177 83.6 ± 6.0 83.7 ± 6.4 0.485 0.085 Sex (male) 356 (40.1) 657 (44.3) 0.046 320 (41.3) 314 (40.5) 0.757 0.016 Body mass index, kg/m² 22.3 ± 3.9 22.2 ± 3.8 0.521 22.4 ± 3.9 22.4 ± 3.9 0.673 0.017 STS-PROM score, % 6.0 [4.0-9.1] 6.1 [3.8–9.5] 0.769 5.9 [4.0-8.9] 5.7 [3.7–9.4] 0.54 0 Clinical frailty scale ≥ 4 195 (22.0) 365 (24.6) < 0.001 175 (22.6) 188 (24.3) 0.516 0.041 NYHA III or IV 289 (32.6) 454 (30.6) 0.081 233 (30.1) 253 (32.6) 0.274 0.056 Hemoglobin, g/dL 11.5 [10.4–12.7] 11.4 [10.4–12.6] 0.572 11.5 [10.5–12.8] 11.5 [10.3–12.7] 0.385 0.055 Brain Natrium Peptide, pg/ml 194 [82–554] 312 [125–827] < 0.001 190 [80–534] 270 [110–705] 0.001 0.144 Concomitant diseases Hypertension 716 (80.7) 1183 (80.0) 0.687 626 (80.8) 648 (83.6) 0.144 0.025 Diabetes mellitus 296 (33.4) 456 (30.8) 0.101 251 (32.4) 238 (30.7) 0.477 0.036 Dyslipidemia 463 (52.2) 749 (50.7) 0.484 413 (53.3) 390 (50.4) 0.253 0.058 Chronic kidney disease (GFR < 60mL/min/1.73m²) 672 (75.8) 1141 (77.3) 0.407 582 (75.1) 586 (75.6) 0.814 0.012 Dialysis 181 (20.4) 411 (27.8) < 0.001 166 (21.4) 177 (22.8) 0.501 0.034 COPD 89 (10.0) 127 (8.6) 0.237 67 (8.6) 67 (8.6) 1 0 Atrial fibrillation 197 (22.2) 321 (21.8) 0.799 159 (20.5) 176 (22.7) 0.294 0.053 Coronary artery disease 293 (33.0) 545 (36.8) 0.065 262 (33.8) 263 (33.9) 0.957 0.003 Peripheral artery disease 142 (16.0) 261 (17.7) 0.298 119 (15.4) 121 (15.6) 0.888 0.007 Carotid stenosis 58 (6.5) 69 (4.7) 0.050 47 (6.1) 40 (5.2) 0.436 0.04 Previous history Smoking 246 (28.2) 462 (31.9) 0.064 213 (28.1) 242 (31.9) 0.104 0.083 History of PCI 158 (17.8) 333 (22.5) 0.006 143 (18.5) 167 (21.6) 0.124 0.078 History of CABG 32 (3.6) 56 (3.8) 0.831 28 (3.6) 22 (2.8) 0.388 0.044 History of myocardial infarction 47 (5.3) 119 (8.0) 0.011 43 (5.5) 55 (7.1) 0.21 0.064 History of stroke 91 (10.3) 194 (13.1) 0.022 85 (11.0) 90 (11.6) 0.561 0.02 Previous pacemaker 47 (5.3) 84 (5.7) 0.149 40 (5.2) 41 (5.3) 0.909 0.034 Echocardiographic data 1.148 0.968–1.360 0.113 Aortic valve area, cm² 0.69 ± 0.19 0.67 ± 0.19 0.002 0.69 ± 0.19 0.68 ± 0.19 0.292 0.035 Index aortic valve area, cm²/m² 0.47 ± 0.13 0.45 ± 0.13 < 0.001 0.47 ± 0.13 0.46 ± 0.13 0.406 0.028 Peak flow velocity, m/s 4.3 ± 0.65 4.3 ± 0.71 0.989 4.3 ± 0.65 4.3 ± 0.68 0.628 0.013 Aortic valve peak gradient, mmHg 74.9 ± 22.6 75.1 ± 25.2 0.922 74.4 ± 22.7 74.7 ± 23.7 0.693 0.012 Aortic valve mean gradient, mmHg 43.3 ± 14.4 43.5 ± 15.6 0.692 43.1 ± 14.4 43.4 ± 14.7 0.335 0.018 Left ventricular ejection fraction, % 59.3 ± 12.3 57.6 ± 13.4 0.004 59.4 ± 12.3 59.3 ± 12.3 0.594 0.011 Preserved (≥ 50%) 716 (80.7) 1121 (75.6) 0.005 623 (80.4) 630 (81.3) 0.865 0.016 Mid-range (≥ 40, < 50%) 86 (9.7) 166 (11.2) 77 (9.9) 71 (9.2) Reduced (< 40%) 85 (9.6%) 186 (12.6) 75 (9.7) 74 (9.5) Aortic regurgitation ≥ moderate 109 (12.3) 197 (13.3) 0.037 86 (11.1) 86 (11.1) 1 0 Mitral regurgitation ≥ moderate 93 (10.5) 305 (20.6) < 0.001 91 (11.7) 95 (12.3) 0.755 0.016 Tricuspid regurgitation ≥ moderate 58 (6.5) 164 (11.1) < 0.001 50 (6.5) 56 (7.2) 0.546 0.031 Computed Tomography Annulus Area, mm 2 424 ± 78 420 ± 74 0.426 423 ± 76 421 ± 77 0.572 0.026 Area < 430 mm 2 , % 523 (59.0) 886 (59.8) 0.006 456 (58.8) 488 (63.0) 0.096 Perimeter, mm 74.4 ± 6.8 74.0 ± 6.6 0.117 74.2 ± 6.6 73.3 ± 6.7 0.444 0.032 Data are depicted as means with standard deviations (± SD) or counts with percentages (%). S3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; STS-PROM, Society of Thoracic Surgeons-predicted risk of mortality; NYHA, New York Heart Association; GFR, Glomerular Filtration Rate; COPD, Chronic Obstructive Pulmonary Disease; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; ASD, absolute standardized difference. P-values are from Fisher's test (2 x 2 comparison), chi-squared test (n x 2 comparisons), or t-tests (continuous parameters). Table 2. Procedure, complications, and echocardiographic outcomes Prematched cohort Matched cohort Matched: small Matched: large S3UR S3 S3UR S3 S3UR S3 S3UR S3 N = 887 N = 1482 p N = 775 N = 775 p ASD N = 471 N = 477 p N = 304 N = 298 p Transfemoral 844 (95.2) 1420 (95.8) 0.447 739 (95.4) 741 (95.6) 0.807 0.012 491 (96.5) 488 (96.4) 0.986 302 (93.8) 306 (94.2) 0.845 Valve size 20 mm 70 (7.9) 73 (4.9) 0.003 53 (6.8) 56 (7.2) 0.977 0.012 53 (11.3) 56 (11.7) 0.814 23 mm 476 (53.7) 775 (52.3) 418 (53.9) 421 (54.3) 418 (88.7) 421 (88.3) 26 mm 276 (31.1) 540 (36.4) 250 (32.3) 243 (31.4) 250 (82.2) 243 (81.5) 0.825 29 mm 65 (7.3) 94 (6.3) 54 (7.0) 55 (7.1) 54 (17.8) 55 (18.5) Local anesthesia 651 (73.4) 1009 (68.1) 0.012 569 (73.4) 507 (65.4) < 0.001 0.174 345 (73.7) 303 (63.5) 0.001 224 (73.7) 204 (68.5) 0.157 Pre-dilatation 141 (15.9) 196 (13.3) 0.077 115 (14.8) 124 (16.0) 0.527 0.032 72 (15.3) 88 (18.4) 0.194 43 (14.1) 36 (12.1) 0.453 Post-dilatation 101 (11.4) 260 (17.6) < 0.001 94 (12.1) 111 (14.3) 0.202 0.065 68 (14.4) 74 (15.5) 0.642 26 (8.6) 37 (12.4) 0.122 Echocardiographic data Effective orifice area, cm² 1.87 ± 0.49 1.67 ± 0.47 < 0.001 1.88 ± 0.49 1.68 ± 0.45 < 0.001 1.73 ± 0.42 1.52 ± 0.37 < 0.001 2.12 ± 0.50 1.92 ± 0.45 < 0.001 Index effective orifice area, cm²/m² 1.27 ± 0.33 1.13 ± 0.30 < 0.001 1.27 ± 0.33 1.13 ± 0.29 < 0.001 1.23 ± 0.32 1.08 ± 0.27 < 0.001 1.34 ± 0.34 1.22 ± 0.30 < 0.001 Peak flow velocity, m/s 2.0 ± 0.45 2.3 ± 0.44 < 0.001 2.0 ± 0.45 2.3 ± 0.45 < 0.001 2.2 ± 0.44 2.4 ± 0.44 < 0.001 1.9 ± 0.38 2.1 ± 0.40 < 0.001 Mean pressure gradient, mmHg 9.0 ± 4.2 11.4 ± 4.6 < 0.001 9.0 ± 4.1 11.3 ± 4.5 < 0.001 10.2 ± 4.3 12.5 ± 4.6 < 0.001 7.3 ± 3.0 9.4 ± 3.8 < 0.001 Mean pressure gradient ≥ 20 mmHg 20 (2.3) 78 (5.3) < 0.001 16 (2.1) 39 (5.0) 0.002 16 (3.4) 33 (6.9) 0.034 0 (0) 6 (2.0) 0.017 Prosthesis-patient mismatch none 820 (92.4) 1199 (80.9) < 0.001 718 (92.6) 644 (83.1) < 0.001 428 (90.9) 376 (81.7) < 0.001 290 (96.3) 268 (91.8) 0.047 moderate 55 (6.2) 167 (11.3) 46 (5.9) 84 (10.8) 35 (7.4) 63 (13.7) 11 (3.7) 21 (7.2) severe 3 (0.3) 52 (3.5) 3 (0.4) 24 (3.1) 3 (0.6) 21 (4.6) 0 (0) 3 (1.0) Paravalvular leakage ≥ mild 126 (14.3) 308 (20.8) < 0.001 112 (14.5) 179 (23.1) < 0.001 73 (15.5) 108 (22.9) 0.014 39 (12.8) 71 (24.0) 0.002 Mitral regurgitation ≥ moderate 70 (7.9) 189 (12.8) < 0.001 61 (7.9) 66 (8.5) 0.754 35 (7.5) 42 (8.9) 0.574 26 (8.6) 24 (8.1) 0.976 Tricuspid regurgitation ≥ moderate 79 (9.0) 144 (9.7) 0.012 66 (8.5) 45 (5.8) 0.054 40 (8.5) 31 (6.6) 0.322 26 (8.6) 14 (4.9) 0.12 Ent days 6 [4–9] 6 [4–8] 0.4 6 [4–9] 6 [4–8] 0.702 5 [4–9] 6 [4–8] 0.382 6 [4–9] 6 [4–8] 0.636 In-hospital death 12 (1.4) 32 (2.2) 0.159 12 (1.5) 17 (2.2) 0.349 8 (1.7) 15 (3.1) 0.148 4 (1.3) 2 (0.7) 0.426 Open surgery 0 (0) 1 (0.1) 0.122 0 (0) 1 (0.1) 0.134 0 (0) 1 (0.2) 0.226 0 (0) 0 (0) NA Life-threatening and major bleeding 57 (6.4) 99 (6.7) 0.809 43 (5.5) 50 (6.5) 0.454 22 (4.7) 33 (6.9) 0.139 21 (6.9) 17 (5.7) 0.544 Disabling stroke 6 (0.7) 15 (1.0) 0.399 6 (0.8) 10 (1.3) 0.315 4 (0.8) 8 (1.7) 0.254 2 (0.7) 2 (0.7) 0.984 Major vascular complication 14 (1.6) 26 (1.8) 0.748 11 (1.4) 15 (1.9) 0.429 6 (1.3) 11 (2.3) 0.231 5 (1.6) 4 (1.3) 0.76 Tamponade 2 (0.2) 3 (0.2) 0.97 2 (0.3) 2 (0.3) 0.914 2 (0.4) 2 (0.5) 0.94 0 (0) 0 (0) NA New pacemaker implantation 45 (5.1) 77 (5.2) 0.22 40 (5.2) 44 (5.1) 0.157 20 (4.2) 26 (5.4) 0.205 20 (6.6) 14 (4.7) 0.33 Discharge NYHA III or IV 17 (2.0) 52 (4.0) 0.011 14 (1.8) 28 (3.6) < 0.001 11 (2.5) 20 (5.0) < 0.001 3 (1.0) 8 (3.0) 0.003 Data are depicted as means with standard deviations (± SD) or counts with percentages (%). S3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; NYHA, New York Heart Association; ASD, absolute standardized difference. P-values are from Fisher's test (2 x 2 comparison), chi-squared test (n x 2 comparisons), or t-tests (continuous parameters). Table 3. One-year outcomes Overall Small size Large size Matched cohort S3UR S3 S3UR S3 S3UR S3 p p p Left ventricular ejection fraction, % 63.4 ± 8.1 63.2 ± 9.3 0.429 65.2 ± 6.6 64.9 ± 7.8 0.782 60.8 ± 9.4 60.6 ± 10.8 0.285 Effective orifice area, cm² 1.70 ± 0.45 1.56 ± 0.44 < 0.001 1.53 ± 0.39 1.41 ± 0.35 < 0.001 1.97 ± 0.42 1.80 ± 0.47 < 0.001 Index effective orifice area, cm²/m² 1.15 ± 0.32 1.06 ± 0.30 < 0.001 1.09 ± 0.33 1.00 ± 0.27 < 0.001 1.24 ± 0.29 1.13 ± 0.32 < 0.001 Peak flow velocity, m/s 2.3 ± 0.48 2.4 ± 0.48 < 0.001 2.4 ± 0.48 2.5 ± 0.47 < 0.001 2.0 ± 0.40 2.2 ± 0.41 < 0.001 Mean pressure gradient, mmHg 11.1 ± 5.5 12.5 ± 5.5 < 0.001 12.5 ± 5.9 14.0 ± 5.7 < 0.001 8.8 ± 3.8 10.1 ± 4.2 < 0.001 Mean pressure gradient ≥ 20 mmHg 25 (3.2) 52 (6.7) 0.006 22 (6.6) 47 (14.2) 0.007 3 (1.4) 5 (2.2) 0.237 Prosthesis-patient mismatch none 439 (85.9) 403 (75.5) < 0.001 261 (82.1) 229 (70.5) 0.003 178 (92.2) 174 (83.3) 0.006 moderate 59 (11.5) 101 (18.9) 44 (13.8) 73 (22.5) 15 (7.8) 28 (13.4) severe 13 (2.5) 30 (5.6) 13 (4.1) 23 (7.1) 0 (0) 7 (3.3) Paravalvular leakage ≥ mild 142 (27.1) 184 (33.9) 0.032 99 (30.7) 123 (37.2) 0.199 43 (21.3) 61 (28.6) 0.093 Increased paravalvular leakage 143 (27.3) 174 (32.2) 0.086 95 (29.5) 121 (36.7) 0.052 48 (23.9) 53 (25.1) 0.77 Mitral regurgitation ≥ moderate 41 (7.8) 42 (7.7) 0.711 26 (7.9) 29 (8.8) 0.925 15 (7.5) 13 (6.1) 0.314 Tricuspid regurgitation ≥ moderate 51 (9.6) 52 (9.6) 0.711 27 (8.3) 34 (10.2) 0.679 24 (11.9) 18 (8.5) 0.241 NYHA III or IV 5 (1.0) 14 (2.7) 0.04 4 (1.3) 8 (2.5) 0.248 1 (0.5) 6 (2.9) 0.061 Brain Natrium Peptide, pg/ml 93 [46–189] 111 [52–253] 0.04 94 [46–187] 118 [57–264] 0.018 93 [47–211] 101 [48–237] 0.706 Data are depicted as means with standard deviations (± SD) or counts with percentages (%). S3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; NYHA, New York Heart Association. P-values are from Fisher's test (2 x 2 comparison), chi-squared test (n x 2 comparisons), or t-tests (continuous parameters). Table 4. One-year clinical outcomes Overall Small size Large size Matched cohort S3UR S3 HR 95% CI p S3UR S3 HR 95% CI p S3UR S3 HR 95% CI p All-cause mortality 77 (10.3) 100 (13.4) 0.79 0.602–1.036 0.089 44 (9.7) 68 (14.7) 0.686 0.483–0.975 0.036 33 (9.8) 32 (11.2) 0.984 0.638–1.516 0.94 Stroke 7 (0.9) 25 (3.4) 0.385 0.186–0.798 0.01 4 (0.9) 19 (4.2) 0.359 0.152–0.851 0.02 3 (1.0) 6 (2.3) 0.473 0.119–1.872 0.286 Heart failure rehospitalization 10 (1.4) 19 (2.7) 0.466 0.228–0.952 0.036 6 (1.4) 13 (3.0) 0.366 0.144–0.932 0.035 4 (1.4) 6 (2.2) 0.686 0.221–2.128 0.514 Cumulative even rate (%). S3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; HR, Hazard ratio; CI, Confidence interval. P-values, HR, and 95% CI from the COX proportional hazard model. Procedural characteristics, complications, and echocardiographic outcomes The procedures, complications, and echocardiographic outcomes of the pre-matched and matched cohorts are shown in Table 2. After matching, no significant differences were observed in the incidence of procedural complications, including in-hospital death or conversion to open surgery, between the S3UR and S3 groups (all p > 0.05). Post-procedural echocardiography revealed a larger EOA (1.88 ± 0.49 cm 2 vs. 1.68 ± 0.45 cm 2 ; p < 0.001), larger index EOA (1.27 ± 0.33 cm 2 /m 2 vs. 1.13 ± 0.29 cm 2 /m 2 ; p < 0.001), lower peak flow velocity (2.0 ± 0.45 m/s vs. 2.3 ± 0.45 m/s, p < 0.001), and lower mPG (9.0 ± 4.1 mmHg vs. 11.3 ± 4.5 mmHg, p < 0.001; mPG ≥ 20 mmHg: 20 [2.3%] vs. 78 [5.3%], p < 0.001) in the S3UR group compared with the S3 group (Fig. 2 ). Patients in the S3UR group had a lower incidence of PPM (moderate: 46 [5.9%] vs. 84 [10.8%], severe: 3 [0.4%] vs. 24 [3.1%]; p < 0.001) and a lower incidence of PVL (none: 384 [49.8%] vs. 270 [35.2%], trivial: 275 [35.7%] vs. 319 [41.5%], mild: 107 [13.9%] vs. 169 [22.0%], moderate: 5 [0.6%] vs. 10 [1.3%], severe: 0% vs. 0%, p < 0.001) than those in the S3 group. The prevalence of NYHA heart failure symptoms III or IV was significantly lower in the S3UR group than in the S3 group (11 [2.5%] vs. 20 [5.0%], p < 0.001). These results were similar for both small and large valve sizes. Follow-up echocardiographic and other clinical data at 1 year, available for 1,097 of the 1,291 living patients (85.0%), are summarized in Table 3. At the 1-year follow-up, patients in the S3UR group showed significantly better echocardiographic parameters than those in the S3 group (EOA: 1.70 ± 0.45 cm 2 vs. 1.56 ± 0.44 cm 2 , p < 0.001; index EOA: 1.15 ± 0.32 cm 2 /m 2 vs. 1.06 ± 0.30 cm 2 /m 2 , p < 0.001; peak flow velocity: 2.3 ± 0.48 m/sec, vs 2.4 ± 0.48 m/sec, p < 0.001; mPG: 11.1 ± 5.5 mmHg vs. 12.5 ± 5.5 mmHg, p < 0.001) (Fig. 2 ). These results were similar for small and large valves in both groups. Additionally, the PVL grade differed between the S3UR and S3 groups (S3UR vs. S3; none: 252 [48.0%] vs. 191 [35.2%], trivial: 131 [25.0%] vs. 168 [30.9%], mild: 126 [24.0%] vs. 160 [29.5%], moderate: 14 [2.7%] vs. 18 [3.3%], severe: 2 [0.4%] vs. 6 [1.1%], p < 0.001). The proportion of patients whose PVL grade increased by one or more points 1 year after TAVI than at discharge was comparable between the S3UR and S3 groups (143 [27.3%] vs. 174 [32.2%], p = 0.086). When the data were assessed according to valve sizes, the PVL grade was comparable between the S3UR and S3 groups for larger valves, while the S3UR group demonstrated a significantly lower PVL grade than the S3 group for smaller valves. The number of patients with mPG ≥ 20 mmHg was significantly lower in the S3UR group than in the S3 group for smaller valves; however, no significant differences between the groups were observed for larger valves (small valve sizes: 22 [6.6%] vs. 47 [14.2%], p = 0.007; large valve sizes: 43 [21.3%] vs. 61 [28.6%], p = 0.093). One-year Clinical outcomes The average follow-up duration for living patients was 469 ± 260 days. Kaplan–Meier curves depicting the clinical outcomes according to the groups are shown in Fig. 3 and Table 4. Throughout the study period, 1-year mortality occurred in 10.3% and 13.4% of patients in the S3UR and S3 groups (p = 0.026), respectively, which tended to be lower in the S3UR group than in the S3 (HR 0.790; 95% CI 0.602–1.036; p = 0.089). Additionally, the incidence of stroke and HFH at 1 year was significantly lower in the S3UR group than in the S3 group, respectively (stroke; 0.9 vs. 3.4%, p = 0.001, HR 0.385; 95% CI 0.186–0.798; p = 0.01) (HFH; 1.4% vs. 2.7%, p < 0.001, HR 0.665; 95% CI 0.228–0.952; p = 0.036). None of the patients underwent aortic valve reintervention during the follow-up period. In the analyses according to the valve size, 1-year mortality was significantly lower in the S3UR group than in the S3 group for smaller valve sizes (9.7% vs. 14.7%, p = 0.011, HR 0.686; 95% CI 0.483–0.975; p = 0.036) but not for larger valve sizes (10.8% vs. 11.2%, p = 0.734, HR 0.984; 95% CI 0.638–1.516; p = 0.940). Additionally, the incidence of stroke and HFH was significantly lower in the S3UR group than in the S3 group respectively for smaller valve sizes (stroke; 0.9% vs. 4.2%, p = 0.003, HR 0.359; 95% CI 0.152–0.851; p = 0.02, HFH; 1.4% vs. 3.0%, p < 0.001, HR 0.366; 95% CI 0.144–0.932; p = 0.035) but not for larger valve sizes (stroke; 1.0% vs. 2.3%, p = 0.191, HR 0.473; 95% CI 0.119–1.872; p = 0.286, HFH; 1.4% vs. 2.2%, p = 0.191, HR 0.686; 95% CI 0.221–2.128; p = 0.514). We also compared the all-cause mortality in the S3UR and S3 groups according to the annulus size: <430 mm² and ≥ 430 mm²; however, no significant difference in all-cause mortality between the groups was observed (< 430 mm²: HR 0.775; 95% CI 0.546-1.100; p = 0.154, ≥ 430 mm²: HR 0.815; 95% CI 0.529–1.257; p = 0.354) (Fig. 4 ). Discussion The salient findings of the present study are as follows. 1) S3UR, the latest generation BE-THV, demonstrated better hemodynamic parameters in echocardiography than S3, both at discharge and 1 year after TAVI. 2) Overall, mortality, stroke, and HFH were significantly lower in the S3UR group than in the S3 group during the 1-year follow-up. These differences were more prominent in patients with smaller valve sizes, whereas the outcomes were comparable in those with larger valve sizes. 3) At discharge, the rate of PVL was significantly lower in the S3UR group than in the S3 group; however, it increased over 1 year regardless of the valve size. Previous studies have reported that S3UR valves demonstrate better hemodynamic performance in echocardiography than the former generations of BE-THVs. 4 , 5 , 8 In the era of expanding indications for TAVI for younger and lower-risk patients, clarifying the developmental processes of appropriate treatment strategies is crucial to maximize the advantages of THVs. This study showed that the better early-phase echocardiographic parameters of S3UR—including a larger indexed EOA and lower mPG for S3UR—compared with those of S3, were maintained even 1 year after TAVI. These findings were consistent for both small and large valves. Notably, the lower incidence of mPG ≥ 20 mmHg at 1 year after TAVI in the S3UR group was statistically significant for smaller valves but not for larger ones. Regarding PVL after TAVI, the current study demonstrated that S3UR exhibited a lower PVL rate than S3 at discharge. Furthermore, our registry previously reported that S3UR was associated with lesser PVL than the latest self-expandable THVs, suggesting one of the pivotal advantages of the S3UR. 9 These combined results suggest a potential association between S3UR and improved prognosis, highlighting the remarkable observation that modest changes in hemodynamic parameters and PVL can translate into better clinical outcomes. Furthermore, recent data from the large-scale Transcatheter Valve Therapy Registry indicated improved 1-year outcomes for S3UR compared with earlier-generation BE-THVs. 4 Therein, the authors attributed the survival benefit primarily to the reduced incidence of mild PVL, in addition to improved hemodynamics. Some previous studies reported that patients with mild PVL had a significantly increased risk of mortality at 1 or more years after TAVI compared with those with no or trace PVL. 10 – 12 These results confirmed that minimizing PVL severity to less than mild is clinically important. However, PVL progression occurred in approximately 30% of patients in this cohort. Although the S3UR showed a lower incidence of PVL at discharge, this advantage appeared to be attenuated by 1 year. These trends were recognized in the previous Transcatheter Valve Therapy Registry data. 4 In this regard, this study showed that the S3UR group had significantly lower PVL than the S3 group 1 year after TAVI for smaller valves but not for larger ones. The mechanism of worsening PVL in patients undergoing TAVI with S3UR and S3 valves remains unclear. We speculate that one of the underlying mechanisms for this phenomenon may be related to the recoil of BE-THVs, which could lead to a gradual reduction in the radial force. Given that PVL increased over time and that more than mild PVL was associated with poorer prognosis of patients receiving BE-THVs, further long-term follow-up investigations are needed to elucidate future treatment strategies using S3UR. Another contributing factor to the better clinical outcomes in the S3UR group may be the significantly lower incidence of PPM in this group. Although the clinical impact of moderate PPM remains inconclusive, 13 severe PPM is considered to be significantly associated with adverse prognosis, especially in patients with a small anatomy. 14 Patients with smaller annulus sizes and those who underwent TAVI with smaller valves, which are often used in those with a smaller body size, are well-known risk factors for PPM after TAVI. 15 , 16 Despite these anatomical characteristics, the incidence of PPM in this cohort was relatively low, even among patients with smaller valve sizes. Moreover, data from patients who underwent surgical aortic valve replacement revealed better post-procedural hemodynamics with the RESILIA tissue bioprosthesis than with the previous one. 17 , 18 The 20 mm and 23 mm S3UR valves incorporate a specific design in which each of the three leaflets is individually sewn at the commissural positions to allow for a larger EOA. Although better hemodynamics were observed for the 26 mm and 29 mm S3UR valves, the modifications in the 20 mm and 23 mm S3UR valves may contribute to better hemodynamics compared with previous models, especially for small valve sizes. Herein, an important new finding was that S3UR showed superior prognoses compared with S3 for smaller valve sizes but not for larger valve sizes. The multiple design improvements for 20 mm and 23 mm S3UR valves may have contributed to the enlargement of the indexed EOA, resulting in a lower incidence of severe PPM at discharge, fewer cases of mPG ≥ 20 mmHg, and lower PVL at 1 year after TAVI, potentially leading to improved prognosis. This study highlights that the prognostic advantages of newer-generation BE-THVs extend to a broader population, supporting their broader applicability across diverse clinical settings. These findings provide meaningful insights into the ongoing debate regarding THV selection in patients with smaller anatomies. Limitations Due to the use of observational, unblinded, and non-randomized registry data, this study has several limitations. First, as an observational cohort study, our findings may have been influenced by unmeasured variables and should be interpreted with caution. Although we used propensity score matching, the potential for bias due to confounding factors could not be eliminated. Herein, echocardiographic data were systematically collected and evaluated using the VARC-3 criteria; however, no independent core laboratories were included in this registry. Moreover, data from multi-detector computed tomography after TAVI were not available; thus, the phenomenon of decreasing EOA and increasing PVL could not be investigated in detail. Furthermore, this study did not collect data from patients who underwent S3UR and S3 at the same time. Therefore, a learning curve may exist, and it is possible that the performance of S3, which was used earlier, may have been poorer. However, we used a database with a large number of cases and performed PSM, successfully matching patient backgrounds. Finally, while our cohort reflects the general population that undergoes TAVI in Japan, with a mean age of 85 years, these results may not be generalizable to younger populations with longer life expectancies and greater exercise capacity. However, the registry used herein had high-quality follow-up data, with more than 80% of patients undergoing 1-year echocardiography, enabling us to demonstrate reasonable results. Conclusion The S3UR valve demonstrated superior hemodynamic performance compared with the S3 valve 1 year after TAVI, exhibiting lower rates of all-cause mortality and composite adverse outcomes, particularly in patients with smaller valve sizes. Similar findings have previously been reported in Western populations, and the consistency of these results in an Asian cohort, despite notable differences in body size and ethnicity, corroborates the generalizability of the benefits associated with newer-generation BE-THVs. Abbreviations TAVI, transcatheter aortic valve implantation BE, balloon-expandable THV, transcatheter heart valve S3UR, SAPIEN 3 Ultra RESILIA PVL, paravalvular leakage S3, SAPIEN 3 VARC-3, Valve Academic Research Consortium-3 PPM, prosthesis-patient mismatch EOA, effective orifice area HFH, Heart failure rehospitalization HR, hazard ratios CI, confidence intervals NYHA, New York Heart Association mPG, mean pressure gradient Declarations Funding The OCEAN-TAVI registry was supported by Edwards Life Sciences, Medtronic, Boston Scientific, Abbott, and Daiichi Sankyo, Japan. Disclosures H. Tsuruta and M. Izumo are screening proctors for Edwards Lifesciences. H. Shimizu is a clinical proctor for Edwards Lifesciences. F. Yashima and H. Nishina are clinical proctors for Medtronic. M. Asami and Y. Ohno are clinical proctors for Medtronic and Abbott. T. Shimura is a clinical proctor for Abbott. K. Ishizu is a proctor for intracardiac echocardiography for Johnson and Johnson. M. Yamamoto, S. Shirai, Y. Watanabe, T. Naganuma, H. Ueno, and K. Hayashida are clinical proctors for Edwards Lifesciences, Abbott, and Medtronic. The other authors have no conflicts of interest to declare. Acknowledgments The authors thank the investigators and institutions that participated in the OCEAN-TAVI registry. Author contributions J.I. conceptualized the study, developed the research question, performed the main data analysis, prepared the table, interpreted the data, and wrote the paper. M.Y. assisted with the development of the research question and methodology. T.O. contributed to the revision of methodology and assisted in the statistical modeling. H.H. and K.I. were also involved in the critical review of the project proposal, methodology and in the approval of the project proposal on behalf of the OCEAN-TAVI registry. K.H. was involved in conceptualization, supervision, resources, and funding acquisition. All authors reviewed the manuscript drafts, critically revised the manuscript, and approved the final manuscript. Data availability The datasets generated and analyzed during the current study are not publicly available because OCEAEN-TAVI registry database is not for open access, but are available from the corresponding author on reasonable request. References Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019; 380 :1695–1705. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016; 374 :1609–1620. Cannata S, Gandolfo C, Ribichini FL, van Mieghem N, Buccheri S, et al. One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry. EuroIntervention. 2023; 18 :1418–1427. Kini AS, Tang GHL, Yaryura R, Petrossian G, Roberts DK, et al. 1-Year real-world outcomes of TAVR with the fifth-generation balloon-expandable valve in the United States. JACC Cardiovasc Interv. 2025; 18 :785–797. Yamamoto M, Yashima F, Shirai S, Tada N, Naganuma T, et al. Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry. EuroIntervention. 2024; 20 :579–590. Bavaria JE, Griffith B, Heimansohn DA, Rozanski J, Johnston DR, et al. Five-year outcomes of the COMMENCE Trial investigating aortic valve replacement With RESILIA tissue. Ann Thorac Surg. 2023; 115 :1429–1436. VARC-3 WRITING COMMITTEE, Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021; 42 :1825–1857. Stinis CT, Abbas AE, Teirstein P, Makkar RR, Chung CJ, et al. Real-world outcomes for the fifth-generation balloon expandable transcatheter heart valve in the United States. JACC Cardiovasc Interv. 2024; 17 :1032–1044. Hioki H, Yamamoto M, Shirai S, Ohno Y, Yashima F, et al. Valve performance between latest-generation balloon-expandable and self-expandable transcatheter heart valves in a small aortic annulus. JACC Cardiovasc Interv. 2024; 17 :2612–2622. Yokoyama H, Sugiyama Y, Miyashita H, Jalanko M, Ochiai T, et al. Impact of mild paravalvular regurgitation on long-term clinical outcomes after transcatheter aortic valve implantation. Am J Cardiol. 2023; 191 :14–22. Hayashida K, Lefevre T, Chevalier B, Hovasse T, Romano M, et al. Impact of post-procedural aortic regurgitation on mortality after transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2012; 5 :1247–1256. Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med. 2020; 382 :799–809. Dismorr M, Glaser N, Franco-Cereceda A, Sartipy U. Effect of prosthesis-patient mismatch on long-term clinical outcomes after bioprosthetic aortic valve replacement. J Am Coll Cardiol. 2023; 81 :964–975. Ishizu K, Kitano K, Yamamoto K, Hayashi M, Shirai S, et al. Update on prosthesis-patient mismatch following transcatheter aortic valve replacement in Asian patients. JACC Asia. 2024; 4 :793–806. Okuno T, Izumo M, Takahiko K, Kuwata S, Koga M, et al. Extremely small 20-mm versus standard-size balloon-expandable transcatheter heart valves: propensity-matched analysis from the OCEAN-TAVI Registry. JACC Asia. 2025; 5 :245-254. Yashima F, Yamamoto M, Tanaka M, Yanagisawa R, Arai T, et al. Transcatheter aortic valve implantation in patients with an extremely small native aortic annulus: the OCEAN-TAVI registry. Int J Cardiol. 2017; 240 :126–131. Shala M, Niclauss L. Early results of the Resilia Inspiris aortic valve in the old age patients - a retrospective comparison with the Carpentier Edwards Magna Ease. J Cardiovasc Thorac Res. 2020; 12 :222–226. Bernard J, Georges G, Hecht S, Pibarot P, Clavel MA, et al. Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease. Interdiscip Cardiovasc Thorac Surg. 2023; 37 :ivad117. Additional Declarations No competing interests reported. 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Hayashida","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+klEQVRIiWNgGAWjYBACCQkwdYCH4QCQ8wHIZGMnRYvkDJAWZiK1gJE0D4hNSIvk7OZnEj/+3JHhO3468bbNr23yfMwMjB8+5uDWIi1zzEyyt+0Zj+SZ3M3WuX23DduYGZglZ27DrUVOIsFMgrfhMI/Bgdxt0rk9txmBWtiYefFqSf8m+ecPUMv5t9ukLXtu2xPUIi2RYybNwwbUcgNoC8OP24kEtUjOyCm2lm07zCN54+1my96G28ltzIzNeP0icSN94803fw7b853P3Xjjx5/btvPbmw9++IhHCxCwSMCZjG1gsgGveiBg/oBg/yGkeBSMglEwCkYiAAA6zFU2Bv3pdgAAAABJRU5ErkJggg==","orcid":"","institution":"Keio University School of Medicine","correspondingAuthor":true,"prefix":"","firstName":"Kentaro","middleName":"","lastName":"Hayashida","suffix":""}],"badges":[],"createdAt":"2025-08-14 06:08:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7370210/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7370210/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":90316246,"identity":"885c1b61-5013-4bd6-94d4-14b2862af3d2","added_by":"auto","created_at":"2025-09-01 10:20:27","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":130438,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eStudy flow chart.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOCEAN-TAVI, Optimized transcatheter vAlvular iNtervention – Transcatheter Aortic Valve Implantation; TAV, transcatheter aortic valve; SAV, surgical aortic valve; TA, transapical; DA, direct aorta.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7370210/v1/f56769cfb6691f1f88d4caeb.png"},{"id":90316247,"identity":"b419befa-79c1-414c-9623-affcb41fa4bf","added_by":"auto","created_at":"2025-09-01 10:20:28","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":172293,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eEchocardiographic data at discharge and 1 year after transcatheter aortic valve implantation comparing the S3UR and S3 valves.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eS3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7370210/v1/8a321634d4efddee0cf7978a.png"},{"id":90315333,"identity":"70bd8a44-3277-493e-bcc3-8d1056c88427","added_by":"auto","created_at":"2025-09-01 10:12:27","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":356565,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eKaplan–Meier curves comparing 1-year clinical outcomes for S3UR and S3 valves.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(A-C): All-cause mortality. (A) Overall, (B) Small valves, (C) Large valves.\u003c/p\u003e\n\u003cp\u003e(D-F): Stroke. (D) Overall, (E) Small valves, (F) Large valves.\u003c/p\u003e\n\u003cp\u003e(G-I); Heart failure rehospitalization. (G) Overall, (H) Small valves, (I) Large valves.\u003c/p\u003e\n\u003cp\u003eS3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; HR, hazard ratio; CI, confidence interval.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7370210/v1/1f73838e90d31f5ac6e43a86.png"},{"id":90315328,"identity":"a2435735-bd42-4698-8931-6d6b923f09ea","added_by":"auto","created_at":"2025-09-01 10:12:27","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":76886,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eKaplan–Meier curves comparing 1-year clinical outcomes for annulus areas \u0026lt;430 mm² and ≥430 mm².\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(A) Area \u0026lt;430 mm² (B) Area ≥430 mm².\u003c/p\u003e\n\u003cp\u003eHR, hazard ratio; CI, confidence interval.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7370210/v1/daeca61324698d84d9bcd911.png"},{"id":90318734,"identity":"572f7006-80fb-4804-87e1-b284572db277","added_by":"auto","created_at":"2025-09-01 10:36:29","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2446151,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7370210/v1/61b59270-e136-41b3-b6e0-1c33ed9fb939.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eMechanisms Underlying Superior Clinical Outcomes of Transcatheter Aortic Valve Implantation with the Latest Balloon-Expandable Valve\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe excellent clinical outcomes of transcatheter aortic valve implantation (TAVI), especially with balloon-expandable (BE) transcatheter heart valves (THVs), are well established.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e The SAPIEN 3 Ultra RESILIA (S3UR) is the fifth-generation valve in the SAPIEN series (Edwards Lifesciences, Irvine, CA, USA), the most commonly used BE-THV. Recent advancements in BE-THVs have led to significant clinical improvements, including reduced paravalvular leakage (PVL) and enhanced echocardiographic parameters of valve hemodynamics.\u003csup\u003e\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e Additionally, surgical bioprosthetic valves incorporating RESILIA tissue have demonstrated similar favorable hemodynamic profiles on echocardiographic assessments.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e S3UR, which exhibits more favorable post-procedural echocardiographic hemodynamics, was associated with improved 1-year clinical outcomes compared with the SAPIEN 3 (S3) or S3 Ultra.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e However, whether these improvements in device performance translate to better clinical outcomes in more general populations remains to be broadly investigated. Herein, we assessed the 1-year clinical outcomes and hemodynamic performance of S3UR compared with those of S3, focusing on its impact on patients with small THVs and aortic annulus sizes, using data from a nationwide multicenter registry.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy cohort\u003c/h2\u003e\u003cp\u003eThe Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry is an ongoing nationwide prospective multicenter cohort study involving patients with aortic stenosis undergoing TAVI at 22 collaborating centers across Japan. Participating centers were mandated to enroll patients in the registry, adhere to the registry protocol, and provide patient information and clinical outcomes during follow-up. The study protocol was approved by the ethics committee of each center, and all patients provided written informed consent for participation. This study was conducted in compliance with the principles of the Declaration of Helsinki. Additionally, the study was registered with the University Hospital Medical Information Network Clinical Trial Registry and accepted by the International Committee of Medical Journal (UMINID:000020423).\u003c/p\u003e\u003cp\u003eThe present analysis included consecutive patients who underwent TAVI with S3UR between March 2023 and September 2023 and a historical cohort of patients who underwent TAVI with S3 between September 2021 and September 2023 at the participating institutes. Patients who underwent TAVI for degenerated surgical bioprostheses or THV were excluded.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eData collection and endpoint definitions\u003c/h3\u003e\n\u003cp\u003eBaseline clinical, procedural, and follow-up data were prospectively recorded in a web-based database at each participating center. Regular follow-ups were scheduled pre-procedure, at discharge, and 1 month and 1 year post-TAVI. Comprehensive clinical follow-up data were collected from medical records at each center, documentation from referring physicians, and/or telephone interviews. The web-based database was systematically audited by data committee members for completeness and accuracy to ensure data integrity. In cases of incomplete or inaccurate data, all participating centers were required to respond to queries.\u003c/p\u003e\u003cp\u003eTransthoracic echocardiography was performed before TAVI, at discharge, and annually thereafter. In accordance with the updated Valve Academic Research Consortium-3 (VARC-3) criteria,\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e prosthesis-patient mismatch (PPM) was assessed as the prosthesis effective orifice area (EOA) indexed to the body surface area and categorized as severe (\u0026le;\u0026thinsp;0.65 cm\u003csup\u003e2\u003c/sup\u003e/m\u003csup\u003e2\u003c/sup\u003e in the population without obesity [body mass index\u0026thinsp;\u0026lt;\u0026thinsp;30 kg/m\u003csup\u003e2\u003c/sup\u003e]; \u0026le;0.55 cm\u003csup\u003e2\u003c/sup\u003e/m\u003csup\u003e2\u003c/sup\u003e in the population with obesity [body mass index\u0026thinsp;\u0026ge;\u0026thinsp;30 kg/m\u003csup\u003e2\u003c/sup\u003e]) or moderate (\u0026gt;\u0026thinsp;0.65 to 0.85 cm\u003csup\u003e2\u003c/sup\u003e/m\u003csup\u003e2\u003c/sup\u003e in the population without obesity; \u0026gt;0.55 to 0.70 cm\u003csup\u003e2/\u003c/sup\u003em\u003csup\u003e2\u003c/sup\u003e in the population with obesity). All procedural complications were defined according to the VARC-3 criteria and relevant data were systematically collected. The clinical endpoints included all-cause mortality, stroke, and heart failure rehospitalization (HFH). Additionally, the incidence of aortic valve re-intervention was evaluated.\u003c/p\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003eStatistical analysis\u003c/h2\u003e\u003cp\u003eCategorical variables are reported as frequencies and percentages, with differences evaluated using the chi-square test or two-tailed Fisher\u0026rsquo;s exact test. Continuous variables are presented as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviations or medians and interquartile ranges, with between-group comparisons performed using the two-sample t-test or the Mann\u0026ndash;Whitney U test, as appropriate. For within-group comparisons, means and standard deviations were analyzed using a paired t-test. Time-to-event curves were depicted using the Kaplan\u0026ndash;Meier method (censored at death or last valid contact in cases of those awaiting the next follow-up or consent withdrawal). A Cox proportional hazard model was used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for clinical endpoints. All p-values were two-sided, and a p-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered significant for all tests.\u003c/p\u003e\u003cp\u003eHerein, we used propensity score matching to control for confounding factors due to baseline differences between patients undergoing TAVI with S3UR and S3. The propensity score was calculated using a multivariate logistic regression model based on the following 28 variables that could have affected study outcomes: age; sex; body mass index; Society of Thoracic Surgeons Predicted Risk of Mortality; clinical frailty scale score\u0026thinsp;\u0026ge;\u0026thinsp;4; New York Heart Association (NYHA) heart failure symptoms III or IV; hypertension; diabetes mellitus; peripheral artery disease; dialysis; chronic obstructive pulmonary disease; atrial fibrillation; hemoglobin level (g/dL); history of coronary artery disease; history of stroke; previous pacemaker implantation; echocardiographic variables such as aortic valve area (cm\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e), aortic valve mean pressure gradient (mPG) (mmHg), left ventricular ejection fraction (\u0026ge;\u0026thinsp;50%: preserved; \u0026ge;40% to \u0026lt;\u0026thinsp;50%: mid-range; \u0026lt;40%: reduced), moderate or severe aortic regurgitation, moderate or severe mitral regurgitation, and moderate or severe tricuspid regurgitation; computed tomography variables such as annulus area (mm\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e), annulus perimeter (mm); and procedural variables such as access site (transfemoral approach or non), pre-dilatation, post-dilatation, and valve size (20 mm, 23 mm, 26 mm, 29 mm). Herein, a 1:1 greedy nearest neighbor matching protocol with a caliper of 0.2 was used. Absolute standardized differences were estimated for all baseline variables, and absolute standardized differences\u0026thinsp;\u0026lt;\u0026thinsp;0.10 were considered an indicator of good balance. The results for the overall matched cohort and cohorts comprising patients with small (20 and 23 mm) or large (26 and 29 mm) valve sizes were analyzed. In addition to valve size-based analyses, subgroup analyses were conducted based on annulus size, including small and large aortic annuli.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003eStudy population and baseline characteristics\u003c/h2\u003e\u003cp\u003eAmong the 915 and 2945 patients who underwent TAVI with S3UR and S3, 887 and 1,482 met the inclusion criteria, respectively, and were included herein. A 1:1 propensity score matching resulted in 775 patients each in the S3UR and S3 groups (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The baseline characteristics of the unmatched and matched cohorts are presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Before propensity score matching, the groups differed in several parameters, including clinical frailty scale scores and other comorbidities. In echocardiographic assessments, patients in the S3UR group exhibited a larger aortic valve area (0.69\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19 cm\u0026sup2; vs. 0.67\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19 cm\u0026sup2;, p\u0026thinsp;=\u0026thinsp;0.002), larger index aortic valve area (0.47\u0026thinsp;\u0026plusmn;\u0026thinsp;0.13 cm\u0026sup2;/m\u0026sup2; vs. 0.45\u0026thinsp;\u0026plusmn;\u0026thinsp;0.13 cm\u0026sup2;/m\u0026sup2;, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), and higher left ventricular ejection fraction (59.3\u0026thinsp;\u0026plusmn;\u0026thinsp;12.3% vs. 57.6\u0026thinsp;\u0026plusmn;\u0026thinsp;13.4%, p\u0026thinsp;=\u0026thinsp;0.004) compared with those in the S3 group. After propensity score matching, patient characteristics of the S3UR and S3 groups were well balanced, with absolute standardized differences\u0026thinsp;\u0026lt;\u0026thinsp;0.10 across all measured baseline characteristics.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eBaseline characteristics of unmatched and matched cohorts\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"8\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e\u003cp\u003ePrematched cohort\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e\u003cp\u003eMatched cohort\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;887\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;1482\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;775\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;775\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003eASD\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge, years\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e83.8\u0026thinsp;\u0026plusmn;\u0026thinsp;6.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e83.5\u0026thinsp;\u0026plusmn;\u0026thinsp;6.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.177\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e83.6\u0026thinsp;\u0026plusmn;\u0026thinsp;6.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e83.7\u0026thinsp;\u0026plusmn;\u0026thinsp;6.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.485\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.085\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex (male)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e356 (40.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e657 (44.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.046\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e320 (41.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e314 (40.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.757\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.016\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBody mass index, kg/m\u0026sup2;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e22.3\u0026thinsp;\u0026plusmn;\u0026thinsp;3.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e22.2\u0026thinsp;\u0026plusmn;\u0026thinsp;3.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.521\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e22.4\u0026thinsp;\u0026plusmn;\u0026thinsp;3.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e22.4\u0026thinsp;\u0026plusmn;\u0026thinsp;3.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.673\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.017\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSTS-PROM score, %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6.0 [4.0-9.1]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6.1 [3.8\u0026ndash;9.5]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.769\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e5.9 [4.0-8.9]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e5.7 [3.7\u0026ndash;9.4]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.54\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eClinical frailty scale\u0026thinsp;\u0026ge;\u0026thinsp;4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e195 (22.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e365 (24.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e175 (22.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e188 (24.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.516\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.041\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNYHA III or IV\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e289 (32.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e454 (30.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.081\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e233 (30.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e253 (32.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.274\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.056\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHemoglobin, g/dL\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11.5 [10.4\u0026ndash;12.7]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.4 [10.4\u0026ndash;12.6]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.572\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e11.5 [10.5\u0026ndash;12.8]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e11.5 [10.3\u0026ndash;12.7]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.385\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.055\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBrain Natrium Peptide, pg/ml\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e194 [82\u0026ndash;554]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e312 [125\u0026ndash;827]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e190 [80\u0026ndash;534]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e270 [110\u0026ndash;705]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.144\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eConcomitant diseases\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypertension\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e716 (80.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1183 (80.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.687\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e626 (80.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e648 (83.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.144\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.025\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDiabetes mellitus\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e296 (33.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e456 (30.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.101\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e251 (32.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e238 (30.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.477\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.036\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDyslipidemia\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e463 (52.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e749 (50.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.484\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e413 (53.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e390 (50.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.253\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.058\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eChronic kidney disease (GFR\u0026thinsp;\u0026lt;\u0026thinsp;60mL/min/1.73m\u0026sup2;)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e672 (75.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1141 (77.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.407\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e582 (75.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e586 (75.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.814\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.012\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDialysis\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e181 (20.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e411 (27.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e166 (21.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e177 (22.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.501\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.034\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCOPD\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e89 (10.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e127 (8.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.237\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e67 (8.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e67 (8.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAtrial fibrillation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e197 (22.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e321 (21.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.799\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e159 (20.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e176 (22.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.294\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.053\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCoronary artery disease\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e293 (33.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e545 (36.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.065\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e262 (33.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e263 (33.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.957\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.003\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePeripheral artery disease\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e142 (16.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e261 (17.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.298\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e119 (15.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e121 (15.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.888\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.007\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCarotid stenosis\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e58 (6.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e69 (4.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.050\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e47 (6.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e40 (5.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.436\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.04\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePrevious history\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSmoking\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e246 (28.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e462 (31.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.064\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e213 (28.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e242 (31.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.104\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.083\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of PCI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e158 (17.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e333 (22.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.006\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e143 (18.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e167 (21.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.124\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.078\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of CABG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e32 (3.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e56 (3.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.831\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e28 (3.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e22 (2.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.388\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.044\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of myocardial infarction\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e47 (5.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e119 (8.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.011\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e43 (5.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e55 (7.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.064\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of stroke\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e91 (10.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e194 (13.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e85 (11.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e90 (11.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.561\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.02\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrevious pacemaker\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e47 (5.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e84 (5.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.149\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e40 (5.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e41 (5.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.909\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.034\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eEchocardiographic data\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.148\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.968\u0026ndash;1.360\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.113\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAortic valve area, cm\u0026sup2;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.69\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.67\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.002\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.69\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.68\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.292\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.035\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIndex aortic valve area, cm\u0026sup2;/m\u0026sup2;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.47\u0026thinsp;\u0026plusmn;\u0026thinsp;0.13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.45\u0026thinsp;\u0026plusmn;\u0026thinsp;0.13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.47\u0026thinsp;\u0026plusmn;\u0026thinsp;0.13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.46\u0026thinsp;\u0026plusmn;\u0026thinsp;0.13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.406\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.028\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePeak flow velocity, m/s\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.65\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.71\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.989\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e4.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.65\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e4.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.68\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.628\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.013\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAortic valve peak gradient, mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e74.9\u0026thinsp;\u0026plusmn;\u0026thinsp;22.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e75.1\u0026thinsp;\u0026plusmn;\u0026thinsp;25.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.922\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e74.4\u0026thinsp;\u0026plusmn;\u0026thinsp;22.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e74.7\u0026thinsp;\u0026plusmn;\u0026thinsp;23.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.693\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.012\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAortic valve mean gradient, mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e43.3\u0026thinsp;\u0026plusmn;\u0026thinsp;14.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e43.5\u0026thinsp;\u0026plusmn;\u0026thinsp;15.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.692\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e43.1\u0026thinsp;\u0026plusmn;\u0026thinsp;14.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e43.4\u0026thinsp;\u0026plusmn;\u0026thinsp;14.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.335\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.018\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLeft ventricular ejection fraction, %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e59.3\u0026thinsp;\u0026plusmn;\u0026thinsp;12.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e57.6\u0026thinsp;\u0026plusmn;\u0026thinsp;13.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.004\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e59.4\u0026thinsp;\u0026plusmn;\u0026thinsp;12.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e59.3\u0026thinsp;\u0026plusmn;\u0026thinsp;12.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.594\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.011\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePreserved (\u0026ge;\u0026thinsp;50%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e716 (80.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1121 (75.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.005\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e623 (80.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e630 (81.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.865\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.016\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMid-range (\u0026ge;\u0026thinsp;40, \u0026lt;\u0026thinsp;50%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e86 (9.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e166 (11.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e77 (9.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e71 (9.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eReduced (\u0026lt;\u0026thinsp;40%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e85 (9.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e186 (12.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e75 (9.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e74 (9.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAortic regurgitation\u0026thinsp;\u0026ge;\u0026thinsp;moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e109 (12.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e197 (13.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.037\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e86 (11.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e86 (11.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMitral regurgitation\u0026thinsp;\u0026ge;\u0026thinsp;moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e93 (10.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e305 (20.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e91 (11.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e95 (12.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.755\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.016\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTricuspid regurgitation\u0026thinsp;\u0026ge;\u0026thinsp;moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e58 (6.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e164 (11.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e50 (6.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e56 (7.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.546\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.031\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eComputed Tomography\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAnnulus Area, mm\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e424\u0026thinsp;\u0026plusmn;\u0026thinsp;78\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e420\u0026thinsp;\u0026plusmn;\u0026thinsp;74\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.426\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e423\u0026thinsp;\u0026plusmn;\u0026thinsp;76\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e421\u0026thinsp;\u0026plusmn;\u0026thinsp;77\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.572\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.026\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eArea\u0026thinsp;\u0026lt;\u0026thinsp;430 mm\u003csup\u003e2\u003c/sup\u003e, %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e523 (59.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e886 (59.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.006\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e456 (58.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e488 (63.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.096\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePerimeter, mm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e74.4\u0026thinsp;\u0026plusmn;\u0026thinsp;6.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e74.0\u0026thinsp;\u0026plusmn;\u0026thinsp;6.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.117\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e74.2\u0026thinsp;\u0026plusmn;\u0026thinsp;6.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e73.3\u0026thinsp;\u0026plusmn;\u0026thinsp;6.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.444\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.032\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e\u003cp\u003eData are depicted as means with standard deviations (\u0026plusmn;\u0026thinsp;SD) or counts with percentages (%). S3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; STS-PROM, Society of Thoracic Surgeons-predicted risk of mortality; NYHA, New York Heart Association; GFR, Glomerular Filtration Rate; COPD, Chronic Obstructive Pulmonary Disease; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; ASD, absolute standardized difference. P-values are from Fisher's test (2 x 2 comparison), chi-squared test (n x 2 comparisons), or t-tests (continuous parameters).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e\u003ccolgroup cols=\"14\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c14\" colnum=\"14\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"7\" nameend=\"c7\" namest=\"c1\"\u003e\u003cp\u003eTable\u0026nbsp;2. Procedure, complications, and echocardiographic outcomes\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e\u003cp\u003ePrematched cohort\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e\u003cp\u003eMatched cohort\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c11\" namest=\"c9\"\u003e\u003cp\u003eMatched: small\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c14\" namest=\"c12\"\u003e\u003cp\u003eMatched: large\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c9\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c10\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c12\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c13\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;887\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;1482\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;775\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;775\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003eASD\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;471\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;477\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;304\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;298\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTransfemoral\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e844 (95.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1420 (95.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.447\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e739 (95.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e741 (95.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.807\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.012\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e491 (96.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e488 (96.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.986\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e302 (93.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e306 (94.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.845\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eValve size\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e20 mm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e70 (7.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e73 (4.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.003\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e53 (6.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e56 (7.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.977\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.012\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e53 (11.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e56 (11.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.814\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e23 mm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e476 (53.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e775 (52.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e418 (53.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e421 (54.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e418 (88.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e421 (88.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e26 mm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e276 (31.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e540 (36.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e250 (32.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e243 (31.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e250 (82.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e243 (81.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.825\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e29 mm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e65 (7.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e94 (6.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e54 (7.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e55 (7.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e54 (17.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e55 (18.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLocal anesthesia\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e651 (73.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1009 (68.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.012\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e569 (73.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e507 (65.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.174\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e345 (73.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e303 (63.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e224 (73.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e204 (68.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.157\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePre-dilatation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e141 (15.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e196 (13.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.077\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e115 (14.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e124 (16.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.527\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.032\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e72 (15.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e88 (18.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.194\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e43 (14.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e36 (12.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.453\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePost-dilatation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e101 (11.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e260 (17.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e94 (12.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e111 (14.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.202\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.065\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e68 (14.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e74 (15.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.642\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e26 (8.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e37 (12.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.122\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eEchocardiographic data\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEffective orifice area, cm\u0026sup2;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.87\u0026thinsp;\u0026plusmn;\u0026thinsp;0.49\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1.67\u0026thinsp;\u0026plusmn;\u0026thinsp;0.47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.88\u0026thinsp;\u0026plusmn;\u0026thinsp;0.49\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.68\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e1.73\u0026thinsp;\u0026plusmn;\u0026thinsp;0.42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e1.52\u0026thinsp;\u0026plusmn;\u0026thinsp;0.37\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e2.12\u0026thinsp;\u0026plusmn;\u0026thinsp;0.50\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e1.92\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIndex effective orifice area, cm\u0026sup2;/m\u0026sup2;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.27\u0026thinsp;\u0026plusmn;\u0026thinsp;0.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1.13\u0026thinsp;\u0026plusmn;\u0026thinsp;0.30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.27\u0026thinsp;\u0026plusmn;\u0026thinsp;0.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.13\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e1.23\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e1.08\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e1.34\u0026thinsp;\u0026plusmn;\u0026thinsp;0.34\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e1.22\u0026thinsp;\u0026plusmn;\u0026thinsp;0.30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePeak flow velocity, m/s\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2.0\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2.0\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e2.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e2.2\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e2.4\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e1.9\u0026thinsp;\u0026plusmn;\u0026thinsp;0.38\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e2.1\u0026thinsp;\u0026plusmn;\u0026thinsp;0.40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean pressure gradient, mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e9.0\u0026thinsp;\u0026plusmn;\u0026thinsp;4.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e9.0\u0026thinsp;\u0026plusmn;\u0026thinsp;4.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e11.3\u0026thinsp;\u0026plusmn;\u0026thinsp;4.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e10.2\u0026thinsp;\u0026plusmn;\u0026thinsp;4.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e12.5\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e7.3\u0026thinsp;\u0026plusmn;\u0026thinsp;3.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e9.4\u0026thinsp;\u0026plusmn;\u0026thinsp;3.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean pressure gradient\u0026thinsp;\u0026ge;\u0026thinsp;20 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e20 (2.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e78 (5.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e16 (2.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e39 (5.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.002\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e16 (3.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e33 (6.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.034\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e6 (2.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.017\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProsthesis-patient mismatch\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003enone\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e820 (92.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1199 (80.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e718 (92.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e644 (83.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e428 (90.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e376 (81.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e290 (96.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e268 (91.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.047\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003emoderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e55 (6.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e167 (11.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e46 (5.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e84 (10.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e35 (7.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e63 (13.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e11 (3.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e21 (7.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003esevere\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (0.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e52 (3.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e3 (0.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24 (3.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e3 (0.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e21 (4.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e3 (1.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eParavalvular leakage\u0026thinsp;\u0026ge;\u0026thinsp;mild\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e126 (14.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e308 (20.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e112 (14.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e179 (23.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e73 (15.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e108 (22.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.014\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e39 (12.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e71 (24.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.002\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMitral regurgitation\u0026thinsp;\u0026ge;\u0026thinsp;moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e70 (7.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e189 (12.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e61 (7.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e66 (8.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.754\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e35 (7.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e42 (8.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.574\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e26 (8.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e24 (8.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.976\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTricuspid regurgitation\u0026thinsp;\u0026ge;\u0026thinsp;moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e79 (9.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e144 (9.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.012\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e66 (8.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e45 (5.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.054\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e40 (8.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e31 (6.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.322\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e26 (8.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e14 (4.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.12\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEnt days\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 [4\u0026ndash;9]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6 [4\u0026ndash;8]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6 [4\u0026ndash;9]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e6 [4\u0026ndash;8]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.702\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e5 [4\u0026ndash;9]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e6 [4\u0026ndash;8]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.382\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e6 [4\u0026ndash;9]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e6 [4\u0026ndash;8]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.636\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIn-hospital death\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12 (1.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e32 (2.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.159\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e12 (1.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e17 (2.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.349\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e8 (1.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e15 (3.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.148\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e4 (1.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e2 (0.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.426\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOpen surgery\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1 (0.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.122\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1 (0.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.134\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e1 (0.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.226\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003eNA\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLife-threatening and major bleeding\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e57 (6.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e99 (6.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.809\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e43 (5.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e50 (6.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.454\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e22 (4.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e33 (6.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.139\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e21 (6.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e17 (5.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.544\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDisabling stroke\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (0.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e15 (1.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.399\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6 (0.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e10 (1.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.315\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e4 (0.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e8 (1.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.254\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e2 (0.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e2 (0.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.984\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMajor vascular complication\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (1.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e26 (1.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.748\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e11 (1.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e15 (1.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.429\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e6 (1.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e11 (2.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.231\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e5 (1.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e4 (1.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.76\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTamponade\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (0.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (0.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.97\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2 (0.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e2 (0.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.914\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e2 (0.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e2 (0.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.94\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003eNA\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNew pacemaker implantation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e45 (5.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e77 (5.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.22\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e40 (5.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e44 (5.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.157\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e20 (4.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e26 (5.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.205\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e20 (6.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e14 (4.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.33\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDischarge NYHA III or IV\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17 (2.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e52 (4.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.011\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e14 (1.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e28 (3.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e11 (2.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e20 (5.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e3 (1.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e8 (3.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.003\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"14\" nameend=\"c14\" namest=\"c1\"\u003e\u003cp\u003eData are depicted as means with standard deviations (\u0026plusmn;\u0026thinsp;SD) or counts with percentages (%). S3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; NYHA, New York Heart Association; ASD, absolute standardized difference. P-values are from Fisher's test (2 x 2 comparison), chi-squared test (n x 2 comparisons), or t-tests (continuous parameters).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Tabb\" border=\"1\"\u003e\u003ccolgroup cols=\"10\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTable\u0026nbsp;3. One-year outcomes\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e\u003cp\u003eOverall\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e\u003cp\u003eSmall size\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c10\" namest=\"c8\"\u003e\u003cp\u003eLarge size\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"9\" nameend=\"c10\" namest=\"c2\"\u003e\u003cp\u003eMatched cohort\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003eS3UR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c9\"\u003e\u003cp\u003eS3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLeft ventricular ejection fraction, %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e63.4\u0026thinsp;\u0026plusmn;\u0026thinsp;8.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e63.2\u0026thinsp;\u0026plusmn;\u0026thinsp;9.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.429\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e65.2\u0026thinsp;\u0026plusmn;\u0026thinsp;6.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e64.9\u0026thinsp;\u0026plusmn;\u0026thinsp;7.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.782\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e60.8\u0026thinsp;\u0026plusmn;\u0026thinsp;9.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e60.6\u0026thinsp;\u0026plusmn;\u0026thinsp;10.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.285\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEffective orifice area, cm\u0026sup2;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.70\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1.56\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.53\u0026thinsp;\u0026plusmn;\u0026thinsp;0.39\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.41\u0026thinsp;\u0026plusmn;\u0026thinsp;0.35\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e1.97\u0026thinsp;\u0026plusmn;\u0026thinsp;0.42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e1.80\u0026thinsp;\u0026plusmn;\u0026thinsp;0.47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIndex effective orifice area, cm\u0026sup2;/m\u0026sup2;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.15\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.09\u0026thinsp;\u0026plusmn;\u0026thinsp;0.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e1.24\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e1.13\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePeak flow velocity, m/s\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2.4\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2.4\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e2.5\u0026thinsp;\u0026plusmn;\u0026thinsp;0.47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e2.0\u0026thinsp;\u0026plusmn;\u0026thinsp;0.40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e2.2\u0026thinsp;\u0026plusmn;\u0026thinsp;0.41\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean pressure gradient, mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11.1\u0026thinsp;\u0026plusmn;\u0026thinsp;5.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e12.5\u0026thinsp;\u0026plusmn;\u0026thinsp;5.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e12.5\u0026thinsp;\u0026plusmn;\u0026thinsp;5.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e14.0\u0026thinsp;\u0026plusmn;\u0026thinsp;5.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e8.8\u0026thinsp;\u0026plusmn;\u0026thinsp;3.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e10.1\u0026thinsp;\u0026plusmn;\u0026thinsp;4.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean pressure gradient\u0026thinsp;\u0026ge;\u0026thinsp;20 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e25 (3.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e52 (6.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.006\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e22 (6.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e47 (14.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.007\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e3 (1.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e5 (2.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.237\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProsthesis-patient mismatch\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003enone\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e439 (85.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e403 (75.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e261 (82.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e229 (70.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.003\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e178 (92.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e174 (83.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.006\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003emoderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e59 (11.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e101 (18.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e44 (13.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e73 (22.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e15 (7.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e28 (13.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003esevere\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13 (2.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e30 (5.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e13 (4.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e23 (7.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e7 (3.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eParavalvular leakage\u0026thinsp;\u0026ge;\u0026thinsp;mild\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e142 (27.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e184 (33.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.032\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e99 (30.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e123 (37.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.199\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e43 (21.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e61 (28.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.093\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIncreased paravalvular leakage\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e143 (27.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e174 (32.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.086\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e95 (29.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e121 (36.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.052\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e48 (23.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e53 (25.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.77\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMitral regurgitation\u0026thinsp;\u0026ge;\u0026thinsp;moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e41 (7.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e42 (7.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.711\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e26 (7.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e29 (8.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.925\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e15 (7.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e13 (6.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.314\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTricuspid regurgitation\u0026thinsp;\u0026ge;\u0026thinsp;moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e51 (9.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e52 (9.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.711\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e27 (8.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e34 (10.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.679\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e24 (11.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e18 (8.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.241\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNYHA III or IV\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (1.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e14 (2.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.04\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e4 (1.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e8 (2.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.248\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e1 (0.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e6 (2.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.061\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBrain Natrium Peptide, pg/ml\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e93 [46\u0026ndash;189]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e111 [52\u0026ndash;253]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.04\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e94 [46\u0026ndash;187]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e118 [57\u0026ndash;264]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.018\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e93 [47\u0026ndash;211]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e101 [48\u0026ndash;237]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.706\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"10\" nameend=\"c10\" namest=\"c1\"\u003e\u003cp\u003eData are depicted as means with standard deviations (\u0026plusmn;\u0026thinsp;SD) or counts with percentages (%). S3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; NYHA, New York Heart Association. P-values are from Fisher's test (2 x 2 comparison), chi-squared test (n x 2 comparisons), or t-tests (continuous parameters).\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Tabc\" border=\"1\"\u003e\u003ccolgroup cols=\"16\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c14\" colnum=\"14\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c15\" colnum=\"15\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c16\" colnum=\"16\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTable\u0026nbsp;4. One-year clinical outcomes\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"5\" nameend=\"c6\" namest=\"c2\"\u003e\u003cp\u003eOverall\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"5\" nameend=\"c11\" namest=\"c7\"\u003e\u003cp\u003eSmall size\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"5\" nameend=\"c16\" namest=\"c12\"\u003e\u003cp\u003eLarge size\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"15\" nameend=\"c16\" namest=\"c2\"\u003e\u003cp\u003eMatched cohort\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cb\u003eS3UR\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cb\u003eS3\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eHR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e95% CI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u003cb\u003eS3UR\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e\u003cb\u003eS3\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eHR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e95% CI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e\u003cb\u003eS3UR\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e\u003cb\u003eS3\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003eHR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c15\"\u003e\u003cp\u003e95% CI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c16\"\u003e\u003cp\u003ep\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAll-cause mortality\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e77 (10.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100 (13.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.79\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.602\u0026ndash;1.036\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.089\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e44 (9.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e68 (14.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e0.686\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.483\u0026ndash;0.975\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.036\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e33 (9.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e32 (11.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.984\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c15\"\u003e\u003cp\u003e0.638\u0026ndash;1.516\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c16\"\u003e\u003cp\u003e0.94\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eStroke\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7 (0.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e25 (3.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.385\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.186\u0026ndash;0.798\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.01\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e4 (0.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e19 (4.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e0.359\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.152\u0026ndash;0.851\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.02\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e3 (1.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e6 (2.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.473\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c15\"\u003e\u003cp\u003e0.119\u0026ndash;1.872\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c16\"\u003e\u003cp\u003e0.286\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHeart failure rehospitalization\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10 (1.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e19 (2.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.466\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.228\u0026ndash;0.952\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.036\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e6 (1.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e13 (3.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e0.366\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.144\u0026ndash;0.932\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u003cp\u003e0.035\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c12\"\u003e\u003cp\u003e4 (1.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c13\"\u003e\u003cp\u003e6 (2.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c14\"\u003e\u003cp\u003e0.686\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c15\"\u003e\u003cp\u003e0.221\u0026ndash;2.128\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c16\"\u003e\u003cp\u003e0.514\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"16\" nameend=\"c16\" namest=\"c1\"\u003e\u003cp\u003eCumulative even rate (%). S3UR, SAPIEN 3 Ultra RESILIA; S3, SAPIEN 3; HR, Hazard ratio; CI, Confidence interval. P-values, HR, and 95% CI from the COX proportional hazard model.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eProcedural characteristics, complications, and echocardiographic outcomes\u003c/h2\u003e\u003cp\u003eThe procedures, complications, and echocardiographic outcomes of the pre-matched and matched cohorts are shown in Table\u0026nbsp;2. After matching, no significant differences were observed in the incidence of procedural complications, including in-hospital death or conversion to open surgery, between the S3UR and S3 groups (all p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Post-procedural echocardiography revealed a larger EOA (1.88\u0026thinsp;\u0026plusmn;\u0026thinsp;0.49 cm\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e vs. 1.68\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45 cm\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), larger index EOA (1.27\u0026thinsp;\u0026plusmn;\u0026thinsp;0.33 cm\u003csup\u003e2\u003c/sup\u003e/m\u003csup\u003e2\u003c/sup\u003e vs. 1.13\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29 cm\u003csup\u003e2\u003c/sup\u003e/m\u003csup\u003e2\u003c/sup\u003e; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), lower peak flow velocity (2.0\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45 m/s vs. 2.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45 m/s, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), and lower mPG (9.0\u0026thinsp;\u0026plusmn;\u0026thinsp;4.1 mmHg vs. 11.3\u0026thinsp;\u0026plusmn;\u0026thinsp;4.5 mmHg, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001; mPG\u0026thinsp;\u0026ge;\u0026thinsp;20 mmHg: 20 [2.3%] vs. 78 [5.3%], p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) in the S3UR group compared with the S3 group (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Patients in the S3UR group had a lower incidence of PPM (moderate: 46 [5.9%] vs. 84 [10.8%], severe: 3 [0.4%] vs. 24 [3.1%]; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) and a lower incidence of PVL (none: 384 [49.8%] vs. 270 [35.2%], trivial: 275 [35.7%] vs. 319 [41.5%], mild: 107 [13.9%] vs. 169 [22.0%], moderate: 5 [0.6%] vs. 10 [1.3%], severe: 0% vs. 0%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) than those in the S3 group. The prevalence of NYHA heart failure symptoms III or IV was significantly lower in the S3UR group than in the S3 group (11 [2.5%] vs. 20 [5.0%], p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). These results were similar for both small and large valve sizes.\u003c/p\u003e\u003cp\u003eFollow-up echocardiographic and other clinical data at 1 year, available for 1,097 of the 1,291 living patients (85.0%), are summarized in Table\u0026nbsp;3. At the 1-year follow-up, patients in the S3UR group showed significantly better echocardiographic parameters than those in the S3 group (EOA: 1.70\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45 cm\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e vs. 1.56\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44 cm\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001; index EOA: 1.15\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32 cm\u003csup\u003e2\u003c/sup\u003e/m\u003csup\u003e2\u003c/sup\u003e vs. 1.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.30 cm\u003csup\u003e2\u003c/sup\u003e/m\u003csup\u003e2\u003c/sup\u003e, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001; peak flow velocity: 2.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48 m/sec, vs 2.4\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48 m/sec, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001; mPG: 11.1\u0026thinsp;\u0026plusmn;\u0026thinsp;5.5 mmHg vs. 12.5\u0026thinsp;\u0026plusmn;\u0026thinsp;5.5 mmHg, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e2\u003c/span\u003e). These results were similar for small and large valves in both groups. Additionally, the PVL grade differed between the S3UR and S3 groups (S3UR vs. S3; none: 252 [48.0%] vs. 191 [35.2%], trivial: 131 [25.0%] vs. 168 [30.9%], mild: 126 [24.0%] vs. 160 [29.5%], moderate: 14 [2.7%] vs. 18 [3.3%], severe: 2 [0.4%] vs. 6 [1.1%], p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The proportion of patients whose PVL grade increased by one or more points 1 year after TAVI than at discharge was comparable between the S3UR and S3 groups (143 [27.3%] vs. 174 [32.2%], p\u0026thinsp;=\u0026thinsp;0.086). When the data were assessed according to valve sizes, the PVL grade was comparable between the S3UR and S3 groups for larger valves, while the S3UR group demonstrated a significantly lower PVL grade than the S3 group for smaller valves. The number of patients with mPG\u0026thinsp;\u0026ge;\u0026thinsp;20 mmHg was significantly lower in the S3UR group than in the S3 group for smaller valves; however, no significant differences between the groups were observed for larger valves (small valve sizes: 22 [6.6%] vs. 47 [14.2%], p\u0026thinsp;=\u0026thinsp;0.007; large valve sizes: 43 [21.3%] vs. 61 [28.6%], p\u0026thinsp;=\u0026thinsp;0.093).\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eOne-year Clinical outcomes\u003c/h3\u003e\n\u003cp\u003eThe average follow-up duration for living patients was 469\u0026thinsp;\u0026plusmn;\u0026thinsp;260 days. Kaplan\u0026ndash;Meier curves depicting the clinical outcomes according to the groups are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig13\" class=\"InternalRef\"\u003e3\u003c/span\u003e and Table\u0026nbsp;4. Throughout the study period, 1-year mortality occurred in 10.3% and 13.4% of patients in the S3UR and S3 groups (p\u0026thinsp;=\u0026thinsp;0.026), respectively, which tended to be lower in the S3UR group than in the S3 (HR 0.790; 95% CI 0.602\u0026ndash;1.036; p\u0026thinsp;=\u0026thinsp;0.089). Additionally, the incidence of stroke and HFH at 1 year was significantly lower in the S3UR group than in the S3 group, respectively (stroke; 0.9 vs. 3.4%, p\u0026thinsp;=\u0026thinsp;0.001, HR 0.385; 95% CI 0.186\u0026ndash;0.798; p\u0026thinsp;=\u0026thinsp;0.01) (HFH; 1.4% vs. 2.7%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, HR 0.665; 95% CI 0.228\u0026ndash;0.952; p\u0026thinsp;=\u0026thinsp;0.036). None of the patients underwent aortic valve reintervention during the follow-up period. In the analyses according to the valve size, 1-year mortality was significantly lower in the S3UR group than in the S3 group for smaller valve sizes (9.7% vs. 14.7%, p\u0026thinsp;=\u0026thinsp;0.011, HR 0.686; 95% CI 0.483\u0026ndash;0.975; p\u0026thinsp;=\u0026thinsp;0.036) but not for larger valve sizes (10.8% vs. 11.2%, p\u0026thinsp;=\u0026thinsp;0.734, HR 0.984; 95% CI 0.638\u0026ndash;1.516; p\u0026thinsp;=\u0026thinsp;0.940). Additionally, the incidence of stroke and HFH was significantly lower in the S3UR group than in the S3 group respectively for smaller valve sizes (stroke; 0.9% vs. 4.2%, p\u0026thinsp;=\u0026thinsp;0.003, HR 0.359; 95% CI 0.152\u0026ndash;0.851; p\u0026thinsp;=\u0026thinsp;0.02, HFH; 1.4% vs. 3.0%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, HR 0.366; 95% CI 0.144\u0026ndash;0.932; p\u0026thinsp;=\u0026thinsp;0.035) but not for larger valve sizes (stroke; 1.0% vs. 2.3%, p\u0026thinsp;=\u0026thinsp;0.191, HR 0.473; 95% CI 0.119\u0026ndash;1.872; p\u0026thinsp;=\u0026thinsp;0.286, HFH; 1.4% vs. 2.2%, p\u0026thinsp;=\u0026thinsp;0.191, HR 0.686; 95% CI 0.221\u0026ndash;2.128; p\u0026thinsp;=\u0026thinsp;0.514).\u003c/p\u003e\u003cp\u003eWe also compared the all-cause mortality in the S3UR and S3 groups according to the annulus size: \u0026lt;430 mm\u0026sup2; and \u0026ge;\u0026thinsp;430 mm\u0026sup2;; however, no significant difference in all-cause mortality between the groups was observed (\u0026lt;\u0026thinsp;430 mm\u0026sup2;: HR 0.775; 95% CI 0.546-1.100; p\u0026thinsp;=\u0026thinsp;0.154, \u0026ge;\u0026thinsp;430 mm\u0026sup2;: HR 0.815; 95% CI 0.529\u0026ndash;1.257; p\u0026thinsp;=\u0026thinsp;0.354) (Fig.\u0026nbsp;\u003cspan refid=\"Fig15\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe salient findings of the present study are as follows. 1) S3UR, the latest generation BE-THV, demonstrated better hemodynamic parameters in echocardiography than S3, both at discharge and 1 year after TAVI. 2) Overall, mortality, stroke, and HFH were significantly lower in the S3UR group than in the S3 group during the 1-year follow-up. These differences were more prominent in patients with smaller valve sizes, whereas the outcomes were comparable in those with larger valve sizes. 3) At discharge, the rate of PVL was significantly lower in the S3UR group than in the S3 group; however, it increased over 1 year regardless of the valve size.\u003c/p\u003e\u003cp\u003ePrevious studies have reported that S3UR valves demonstrate better hemodynamic performance in echocardiography than the former generations of BE-THVs.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e,\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e In the era of expanding indications for TAVI for younger and lower-risk patients, clarifying the developmental processes of appropriate treatment strategies is crucial to maximize the advantages of THVs. This study showed that the better early-phase echocardiographic parameters of S3UR\u0026mdash;including a larger indexed EOA and lower mPG for S3UR\u0026mdash;compared with those of S3, were maintained even 1 year after TAVI. These findings were consistent for both small and large valves. Notably, the lower incidence of mPG\u0026thinsp;\u0026ge;\u0026thinsp;20 mmHg at 1 year after TAVI in the S3UR group was statistically significant for smaller valves but not for larger ones.\u003c/p\u003e\u003cp\u003eRegarding PVL after TAVI, the current study demonstrated that S3UR exhibited a lower PVL rate than S3 at discharge. Furthermore, our registry previously reported that S3UR was associated with lesser PVL than the latest self-expandable THVs, suggesting one of the pivotal advantages of the S3UR.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e These combined results suggest a potential association between S3UR and improved prognosis, highlighting the remarkable observation that modest changes in hemodynamic parameters and PVL can translate into better clinical outcomes. Furthermore, recent data from the large-scale Transcatheter Valve Therapy Registry indicated improved 1-year outcomes for S3UR compared with earlier-generation BE-THVs.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e Therein, the authors attributed the survival benefit primarily to the reduced incidence of mild PVL, in addition to improved hemodynamics. Some previous studies reported that patients with mild PVL had a significantly increased risk of mortality at 1 or more years after TAVI compared with those with no or trace PVL.\u003csup\u003e\u003cspan additionalcitationids=\"CR11\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e These results confirmed that minimizing PVL severity to less than mild is clinically important. However, PVL progression occurred in approximately 30% of patients in this cohort. Although the S3UR showed a lower incidence of PVL at discharge, this advantage appeared to be attenuated by 1 year. These trends were recognized in the previous Transcatheter Valve Therapy Registry data.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e In this regard, this study showed that the S3UR group had significantly lower PVL than the S3 group 1 year after TAVI for smaller valves but not for larger ones. The mechanism of worsening PVL in patients undergoing TAVI with S3UR and S3 valves remains unclear. We speculate that one of the underlying mechanisms for this phenomenon may be related to the recoil of BE-THVs, which could lead to a gradual reduction in the radial force. Given that PVL increased over time and that more than mild PVL was associated with poorer prognosis of patients receiving BE-THVs, further long-term follow-up investigations are needed to elucidate future treatment strategies using S3UR.\u003c/p\u003e\u003cp\u003eAnother contributing factor to the better clinical outcomes in the S3UR group may be the significantly lower incidence of PPM in this group. Although the clinical impact of moderate PPM remains inconclusive,\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e severe PPM is considered to be significantly associated with adverse prognosis, especially in patients with a small anatomy.\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e Patients with smaller annulus sizes and those who underwent TAVI with smaller valves, which are often used in those with a smaller body size, are well-known risk factors for PPM after TAVI.\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e,\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e Despite these anatomical characteristics, the incidence of PPM in this cohort was relatively low, even among patients with smaller valve sizes. Moreover, data from patients who underwent surgical aortic valve replacement revealed better post-procedural hemodynamics with the RESILIA tissue bioprosthesis than with the previous one.\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e,\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e The 20 mm and 23 mm S3UR valves incorporate a specific design in which each of the three leaflets is individually sewn at the commissural positions to allow for a larger EOA. Although better hemodynamics were observed for the 26 mm and 29 mm S3UR valves, the modifications in the 20 mm and 23 mm S3UR valves may contribute to better hemodynamics compared with previous models, especially for small valve sizes. Herein, an important new finding was that S3UR showed superior prognoses compared with S3 for smaller valve sizes but not for larger valve sizes. The multiple design improvements for 20 mm and 23 mm S3UR valves may have contributed to the enlargement of the indexed EOA, resulting in a lower incidence of severe PPM at discharge, fewer cases of mPG\u0026thinsp;\u0026ge;\u0026thinsp;20 mmHg, and lower PVL at 1 year after TAVI, potentially leading to improved prognosis.\u003c/p\u003e\u003cp\u003eThis study highlights that the prognostic advantages of newer-generation BE-THVs extend to a broader population, supporting their broader applicability across diverse clinical settings. These findings provide meaningful insights into the ongoing debate regarding THV selection in patients with smaller anatomies.\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eLimitations\u003c/h2\u003e\u003cp\u003eDue to the use of observational, unblinded, and non-randomized registry data, this study has several limitations. First, as an observational cohort study, our findings may have been influenced by unmeasured variables and should be interpreted with caution. Although we used propensity score matching, the potential for bias due to confounding factors could not be eliminated. Herein, echocardiographic data were systematically collected and evaluated using the VARC-3 criteria; however, no independent core laboratories were included in this registry. Moreover, data from multi-detector computed tomography after TAVI were not available; thus, the phenomenon of decreasing EOA and increasing PVL could not be investigated in detail. Furthermore, this study did not collect data from patients who underwent S3UR and S3 at the same time. Therefore, a learning curve may exist, and it is possible that the performance of S3, which was used earlier, may have been poorer. However, we used a database with a large number of cases and performed PSM, successfully matching patient backgrounds. Finally, while our cohort reflects the general population that undergoes TAVI in Japan, with a mean age of 85 years, these results may not be generalizable to younger populations with longer life expectancies and greater exercise capacity. However, the registry used herein had high-quality follow-up data, with more than 80% of patients undergoing 1-year echocardiography, enabling us to demonstrate reasonable results.\u003c/p\u003e\u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe S3UR valve demonstrated superior hemodynamic performance compared with the S3 valve 1 year after TAVI, exhibiting lower rates of all-cause mortality and composite adverse outcomes, particularly in patients with smaller valve sizes. Similar findings have previously been reported in Western populations, and the consistency of these results in an Asian cohort, despite notable differences in body size and ethnicity, corroborates the generalizability of the benefits associated with newer-generation BE-THVs.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eTAVI,\u0026nbsp;transcatheter aortic valve\u0026nbsp;implantation\u003c/p\u003e\n\u003cp\u003eBE, balloon-expandable\u003c/p\u003e\n\u003cp\u003eTHV,\u0026nbsp;transcatheter heart valve\u003c/p\u003e\n\u003cp\u003eS3UR, SAPIEN\u0026nbsp;3 Ultra RESILIA\u003c/p\u003e\n\u003cp\u003ePVL,\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eparavalvular leakage\u003c/p\u003e\n\u003cp\u003eS3, SAPIEN 3\u003c/p\u003e\n\u003cp\u003eVARC-3,\u0026nbsp;Valve Academic Research Consortium-3\u003c/p\u003e\n\u003cp\u003ePPM,\u0026nbsp;prosthesis-patient mismatch\u003c/p\u003e\n\u003cp\u003eEOA,\u0026nbsp;effective orifice area\u003c/p\u003e\n\u003cp\u003eHFH, Heart failure rehospitalization\u003c/p\u003e\n\u003cp\u003eHR,\u0026nbsp;hazard ratios\u003c/p\u003e\n\u003cp\u003eCI,\u0026nbsp;confidence intervals\u003c/p\u003e\n\u003cp\u003eNYHA, New York Heart Association\u003c/p\u003e\n\u003cp\u003emPG, mean pressure gradient\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe OCEAN-TAVI registry was supported by Edwards Life Sciences, Medtronic, Boston Scientific, Abbott, and Daiichi Sankyo, Japan.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDisclosures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eH. Tsuruta and M. Izumo are screening proctors for Edwards Lifesciences. H. Shimizu is a clinical proctor for Edwards Lifesciences. F. Yashima and H. Nishina are clinical proctors for Medtronic. M. Asami and Y. Ohno are clinical proctors for Medtronic and Abbott. T. Shimura is a clinical proctor for Abbott. K. Ishizu is a proctor for intracardiac echocardiography for Johnson and Johnson. M. Yamamoto, S. Shirai, Y. Watanabe, T. Naganuma, H. Ueno, and K. Hayashida are clinical proctors for Edwards Lifesciences, Abbott, and Medtronic. The other authors have no conflicts of interest to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the investigators and institutions that participated in the OCEAN-TAVI registry.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJ.I. conceptualized the study, developed the research question, performed the main data analysis, prepared the table, interpreted the data, and wrote the paper. M.Y. assisted with the development of the research question and methodology. T.O. contributed to the revision of methodology and assisted in the statistical modeling. H.H. and K.I. were also involved in the critical review of the project proposal, methodology and in the approval of the project proposal on behalf of the OCEAN-TAVI registry. K.H. was involved in conceptualization, supervision, resources, and funding acquisition. All authors reviewed the manuscript drafts, critically revised the manuscript, and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analyzed during the current study are not publicly available because OCEAEN-TAVI registry database is not for open access, but are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. \u003cem\u003eN Engl J Med.\u003c/em\u003e 2019;\u003cstrong\u003e380\u003c/strong\u003e:1695\u0026ndash;1705.\u003c/li\u003e\n\u003cli\u003eLeon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, et al. 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Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry. \u003cem\u003eEuroIntervention. \u003c/em\u003e2024;\u003cstrong\u003e20\u003c/strong\u003e:579\u0026ndash;590.\u003c/li\u003e\n\u003cli\u003eBavaria JE, Griffith B, Heimansohn DA, Rozanski J, Johnston DR, et al. Five-year outcomes of the COMMENCE Trial investigating aortic valve replacement With RESILIA tissue. \u003cem\u003eAnn Thorac Surg.\u003c/em\u003e 2023;\u003cstrong\u003e115\u003c/strong\u003e:1429\u0026ndash;1436. \u003c/li\u003e\n\u003cli\u003eVARC-3 WRITING COMMITTEE, Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. \u003cem\u003eEur Heart J.\u003c/em\u003e 2021;\u003cstrong\u003e42\u003c/strong\u003e:1825\u0026ndash;1857.\u003c/li\u003e\n\u003cli\u003eStinis CT, Abbas AE, Teirstein P, Makkar RR, Chung CJ, et al. Real-world outcomes for the fifth-generation balloon expandable transcatheter heart valve in the United States. \u003cem\u003eJACC Cardiovasc Interv. \u003c/em\u003e2024;\u003cstrong\u003e17\u003c/strong\u003e:1032\u0026ndash;1044.\u003c/li\u003e\n\u003cli\u003eHioki H, Yamamoto M, Shirai S, Ohno Y, Yashima F, et al. Valve performance between latest-generation balloon-expandable and self-expandable transcatheter heart valves in a small aortic annulus.\u003cem\u003e JACC Cardiovasc Interv.\u003c/em\u003e 2024;\u003cstrong\u003e17\u003c/strong\u003e:2612\u0026ndash;2622.\u003c/li\u003e\n\u003cli\u003eYokoyama H, Sugiyama Y, Miyashita H, Jalanko M, Ochiai T, et al. Impact of mild paravalvular regurgitation on long-term clinical outcomes after transcatheter aortic valve implantation. \u003cem\u003eAm J Cardiol.\u003c/em\u003e 2023;\u003cstrong\u003e191\u003c/strong\u003e:14\u0026ndash;22. \u003c/li\u003e\n\u003cli\u003eHayashida K, Lefevre T, Chevalier B, Hovasse T, Romano M, et al. Impact of post-procedural aortic regurgitation on mortality after transcatheter aortic valve implantation. \u003cem\u003eJACC Cardiovasc Interv.\u003c/em\u003e 2012;\u003cstrong\u003e5\u003c/strong\u003e:1247\u0026ndash;1256. \u003c/li\u003e\n\u003cli\u003eMakkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. \u003cem\u003eN Engl J Med. \u003c/em\u003e2020;\u003cstrong\u003e382\u003c/strong\u003e:799\u0026ndash;809.\u003c/li\u003e\n\u003cli\u003eDismorr M, Glaser N, Franco-Cereceda A, Sartipy U. Effect of prosthesis-patient mismatch on long-term clinical outcomes after bioprosthetic aortic valve replacement. \u003cem\u003eJ Am Coll Cardiol.\u003c/em\u003e 2023;\u003cstrong\u003e81\u003c/strong\u003e:964\u0026ndash;975. \u003c/li\u003e\n\u003cli\u003eIshizu K, Kitano K, Yamamoto K, Hayashi M, Shirai S, et al. Update on prosthesis-patient mismatch following transcatheter aortic valve replacement in Asian patients. \u003cem\u003eJACC Asia.\u003c/em\u003e 2024;\u003cstrong\u003e4\u003c/strong\u003e:793\u0026ndash;806. \u003c/li\u003e\n\u003cli\u003eOkuno T, Izumo M, Takahiko K, Kuwata S, Koga M, et al. Extremely small 20-mm versus standard-size balloon-expandable transcatheter heart valves: propensity-matched analysis from the OCEAN-TAVI Registry. \u003cem\u003eJACC Asia.\u003c/em\u003e 2025;\u003cstrong\u003e5\u003c/strong\u003e:245-254. \u003c/li\u003e\n\u003cli\u003eYashima F, Yamamoto M, Tanaka M, Yanagisawa R, Arai T, et al. Transcatheter aortic valve implantation in patients with an extremely small native aortic annulus: the OCEAN-TAVI registry. \u003cem\u003eInt J Cardiol.\u003c/em\u003e 2017;\u003cstrong\u003e240\u003c/strong\u003e:126\u0026ndash;131.\u003c/li\u003e\n\u003cli\u003eShala M, Niclauss L. Early results of the Resilia Inspiris aortic valve in the old age patients - a retrospective comparison with the Carpentier Edwards Magna Ease. \u003cem\u003eJ Cardiovasc Thorac Res.\u003c/em\u003e 2020;\u003cstrong\u003e12\u003c/strong\u003e:222\u0026ndash;226. \u003c/li\u003e\n\u003cli\u003eBernard J, Georges G, Hecht S, Pibarot P, Clavel MA, et al. Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease. \u003cem\u003eInterdiscip Cardiovasc Thorac Surg.\u003c/em\u003e 2023;\u003cstrong\u003e37\u003c/strong\u003e:ivad117.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"npj-cardiovascular-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [npj Cardiovascular Health](https://www.nature.com/npjcardiohealth)","snPcode":"44325","submissionUrl":"https://submission.springernature.com/new-submission/44325/3","title":"npj Cardiovascular Health","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"NPJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"aortic valve stenosis, transcatheter aortic valve implantation, balloon-expandable valves","lastPublishedDoi":"10.21203/rs.3.rs-7370210/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7370210/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eTranscatheter aortic valve implantation (TAVI) using SAPIEN 3 Ultra RESILIA (S3UR) offers improved hemodynamic performance than its former generation, SAPIEN 3 (S3). This study compared 1-year clinical outcomes after TAVI using S3UR and S3. Among 2,369 patients from the OCEAN-TAVI registry, a 1:1 propensity score-matched analysis identified 775 matched pairs. One-year post-TAVI, S3UR showed significantly lower all-cause mortality (10.3% vs. 13.4%, p=0.026), stroke (0.9% vs. 3.4%, p=0.001), and heart failure rehospitalization (1.4% vs. 2.7%, p\u0026lt;0.001) than S3. These differences were pronounced in patients receiving smaller valves (20–23 mm). S3UR demonstrated a larger effective orifice area, lower mean pressure gradient, and lower incidence of paravalvular leakage than S3 at discharge. At 1 year, S3UR showed significantly reduced paravalvular leakage and lower incidences of mean pressure gradient ≥20 mmHg than S3. We concluded that S3UR demonstrated superior hemodynamic performance to S3, exhibiting better prognosis, particularly in patients with smaller valves.\u003c/p\u003e","manuscriptTitle":"Mechanisms Underlying Superior Clinical Outcomes of Transcatheter Aortic Valve Implantation with the Latest Balloon-Expandable Valve","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-01 10:12:23","doi":"10.21203/rs.3.rs-7370210/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-09-16T11:28:27+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-09-15T08:15:29+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-09-12T18:20:20+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-09-03T14:30:45+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"58051377379070876759970955007323505536","date":"2025-08-26T04:13:02+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-25T08:17:21+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"12872299597589522073185169663323389236","date":"2025-08-25T06:43:21+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"295307197979925902474352538438960012826","date":"2025-08-23T18:02:18+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"99596306863835950343359782869237327183","date":"2025-08-23T17:13:32+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"126359055238075903598964120946906836631","date":"2025-08-22T12:38:59+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-21T16:21:28+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-21T15:45:50+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-18T12:36:56+00:00","index":"","fulltext":""},{"type":"submitted","content":"npj Cardiovascular Health","date":"2025-08-14T05:57:59+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"npj-cardiovascular-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [npj Cardiovascular Health](https://www.nature.com/npjcardiohealth)","snPcode":"44325","submissionUrl":"https://submission.springernature.com/new-submission/44325/3","title":"npj Cardiovascular Health","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"NPJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"138b409a-fbae-43e6-8c7e-ec992c866563","owner":[],"postedDate":"September 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":53915054,"name":"Health sciences/Cardiology"},{"id":53915055,"name":"Health sciences/Diseases"},{"id":53915056,"name":"Health sciences/Medical research"}],"tags":[],"updatedAt":"2026-01-27T12:09:55+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-01 10:12:23","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7370210","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7370210","identity":"rs-7370210","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}