Seven-Year Valve Durability With Transcatheter or Surgical Aortic Valve Replacement

Importance: As transcatheter aortic valve replacement (TAVR) is considered for younger and lower-risk populations, the durability of bioprosthetic valves is increasingly important. Limited data exist on long-term (7 years and beyond) valve durability. Objective: To report 7-year valve durability outcomes for low-risk patients with symptomatic severe aortic stenosis treated with TAVR vs surgery. Design, Setting, and Participants: Between March 2016 and October 2017, a total of 1000 patients were enrolled at 71 centers in the US and Canada and randomized to undergo TAVR vs surgery. The patient population for the present analysis consisted of all patients who underwent valve implantation (495 with TAVR and 453 with surgery). The last 7-year follow-up occurred in March 2025. Interventions: Patients were randomized to balloon-expandable TAVR with the SAPIEN 3 valve or surgery with any commercially available valve. Main Outcomes and Measures: The main outcomes of this analysis were stage 2 or 3 bioprosthetic valve dysfunction (BVD) related to structural valve deterioration (SVD), thrombosis, or endocarditis; all-cause bioprosthetic valve failure (BVF); BVF related to SVD; and aortic valve reintervention at 7 years. Analyses are presented as cumulative incidence rates with death as a competing risk. Results: The mean (SD) age of the study population was 73.5 (6.0) years, and 657 participants (69.3%) were male. Of 671 patients who were still alive and enrolled in the study at 7-year follow-up, 537 (80.0%) were available for echocardiographic analysis. Cumulative incidence rates of stage 2 or 3 SVD-related BVD (7.3% vs 7.6%; hazard ratio [HR], 0.96; 95% CI, 0.59-1.57; P = .88), all-cause BVF (6.9% vs 7.5%; HR, 0.91; 95% CI, 0.55-1.49; P = .69), SVD-related BVF (3.9% vs 5.3%; HR, 0.72; 95% CI, 0.39-1.36; P = .31), and valve reintervention (6.0% vs 5.5%; HR, 1.09; 95% CI, 0.62-1.90; P = .77) were low and similar for TAVR and surgery, respectively. Stage 2 or 3 thrombosis-related BVD (subclinical and clinical) occurred more frequently with TAVR (5.2% vs 0.9%; HR, 5.52; 95% CI, 1.92-15.85; P < .001), although most events occurred within 3 years and few progressed to BVF. Rates of stage 2 or 3 endocarditis-related BVD were also low and similar (0.4% in the TAVR group vs 0.5% in the surgery group; HR, 0.85; 95% CI, 0.12-6.07; P = .87). The proportion of patients alive and free of all-cause BVF was 73.4% (331/451) with TAVR vs 74.8% (288/385) with surgery (P = .69). Conclusions and Relevance: In this ad hoc analysis of a randomized clinical trial among low-risk patients with symptomatic severe aortic stenosis randomized to TAVR or surgery, both TAVR and surgery demonstrated comparable and sustained valve durability, with low and similar rates of SVD, all-cause BVF, and reintervention through 7 years. These findings may inform discussions of valve replacement strategies. Trial Registration: ClinicalTrials.gov Identifier: NCT02675114.

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Journal
JAMA Cardiology
Published
2026-06-24
DOI
https://doi.org/10.1001/jamacardio.2026.2299
Primary Topic
Cardiac Valve Diseases and Treatments
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article
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article

Seven-Year Valve Durability With Transcatheter or Surgical Aortic Valve Replacement

A Salemi, K Hayashida, Sabah Skaf, Ezéquiel Guzzetti et al.
JAMA Cardiology
Cardiac Valve Diseases and Treatments
article

Seven-Year Valve Durability With Transcatheter or Surgical Aortic Valve Replacement

A Salemi, K Hayashida, Sabah Skaf, Ezéquiel Guzzetti, Mohammad Alkhouli, Ashish Pershad, A C Eisenhauer, Skipper Er, Webb Jg, Pedro Engel, Richard Richter, Bruce Bowers, Julien Ternacle, A Trento, K. Jones, Jonathan Beaudoin, S Kodali, Faraz Kerendi, Amélie Paquin, J.P. deVries, Iria Silva, Michael Rinaldi, Alexis Théron, Alberto Alperi, Gaetano Paone, James M. McCabe, Kevin Accola, Yiran Zhang, David L. Brown, Scott Goldman, Marcos Nores, Susheel K Kodali, Timothy Woods, S R Kapadia, DE Cohen, Mark Rothenberg, R K Makkar, Haïfa Mahjoub, Stephanie Mick, Jorge Castellanos, Edward Mcnulty, Mohammad El-Hajjar, William O’Neill, Tamim Nazif, Kevin Greason, Abdellaziz Dahou, Pierre Yves Turgeon, Joseph DeSimone, Carlos Giuliani, Vasilis Babaliaros, Eric Gnall, Robert Kipperman, Marvin Eng, Anthony Caffarelli, S Chris Malaisrie, Brett Grizzell, Nicole Cristell, Vinod H. Thourani, Philippe Généreux, Mark Russo, Dimitrios Apostolou, Robert Guyton, Jonathon A. Leipsic, Mathieu Bernier, Eric Sarin, Tamim M. Nazif, Todd Dewey, Philipp Blanke, Rebecca T. Hahn, Martin B. Leon, Paul Coady, Tsuyoshi Kaneko, Bassem Chehab, Isaac George, Brian Whisenant, Frank Zidar, Pinak Shah, Stephen Bailey, Kenith Fang, Philippe Pibarot, Robert Hagberg, Geoffrey Bergman, Basil Paulus, S. Chiu Wong, PARTNER 3 Investigators, Shahram Yazdani, Michael J. Mack, Mark Webster, Antonela Zanuttini, Marissa Gunnarsson, David Holmes, Raymond McKay, Mathew R. Williams, Wilson Y. Szeto, John Brown, Kendra Grubb
article en

Abstract

Importance: As transcatheter aortic valve replacement (TAVR) is considered for younger and lower-risk populations, the durability of bioprosthetic valves is increasingly important. Limited data exist on long-term (7 years and beyond) valve durability. Objective: To report 7-year valve durability outcomes for low-risk patients with symptomatic severe aortic stenosis treated with TAVR vs surgery. Design, Setting, and Participants: Between March 2016 and October 2017, a total of 1000 patients were enrolled at 71 centers in the US and Canada and randomized to undergo TAVR vs surgery. The patient population for the present analysis consisted of all patients who underwent valve implantation (495 with TAVR and 453 with surgery). The last 7-year follow-up occurred in March 2025. Interventions: Patients were randomized to balloon-expandable TAVR with the SAPIEN 3 valve or surgery with any commercially available valve. Main Outcomes and Measures: The main outcomes of this analysis were stage 2 or 3 bioprosthetic valve dysfunction (BVD) related to structural valve deterioration (SVD), thrombosis, or endocarditis; all-cause bioprosthetic valve failure (BVF); BVF related to SVD; and aortic valve reintervention at 7 years. Analyses are presented as cumulative incidence rates with death as a competing risk. Results: The mean (SD) age of the study population was 73.5 (6.0) years, and 657 participants (69.3%) were male. Of 671 patients who were still alive and enrolled in the study at 7-year follow-up, 537 (80.0%) were available for echocardiographic analysis. Cumulative incidence rates of stage 2 or 3 SVD-related BVD (7.3% vs 7.6%; hazard ratio [HR], 0.96; 95% CI, 0.59-1.57; P = .88), all-cause BVF (6.9% vs 7.5%; HR, 0.91; 95% CI, 0.55-1.49; P = .69), SVD-related BVF (3.9% vs 5.3%; HR, 0.72; 95% CI, 0.39-1.36; P = .31), and valve reintervention (6.0% vs 5.5%; HR, 1.09; 95% CI, 0.62-1.90; P = .77) were low and similar for TAVR and surgery, respectively. Stage 2 or 3 thrombosis-related BVD (subclinical and clinical) occurred more frequently with TAVR (5.2% vs 0.9%; HR, 5.52; 95% CI, 1.92-15.85; P < .001), although most events occurred within 3 years and few progressed to BVF. Rates of stage 2 or 3 endocarditis-related BVD were also low and similar (0.4% in the TAVR group vs 0.5% in the surgery group; HR, 0.85; 95% CI, 0.12-6.07; P = .87). The proportion of patients alive and free of all-cause BVF was 73.4% (331/451) with TAVR vs 74.8% (288/385) with surgery (P = .69). Conclusions and Relevance: In this ad hoc analysis of a randomized clinical trial among low-risk patients with symptomatic severe aortic stenosis randomized to TAVR or surgery, both TAVR and surgery demonstrated comparable and sustained valve durability, with low and similar rates of SVD, all-cause BVF, and reintervention through 7 years. These findings may inform discussions of valve replacement strategies. Trial Registration: ClinicalTrials.gov Identifier: NCT02675114.

JAMA Cardiology
Rutgers, The State University of New Jersey (US), Northwestern University (US), Cedars-Sinai Medical Center (US), Beth Israel Deaconess Medical Center (US), Cleveland Clinic (US), NewYork–Presbyterian Hospital (US), Emory University (US), New York Hospital Queens (US), St. Paul's Hospital (CA), Piedmont Atlanta Hospital (US), Johnson University (US), Lankenau Medical Center (US), Morristown Medical Center (US), Tunisia Private University (TN), Chandler–Gilbert Community College (US), NYU Langone Health (US), Assistance Publique Hôpitaux de Marseille (FR), Centre hospitalier universitaire de Québec (CA), St. Francis Hospital (US), Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CA), Hôpital Cardiologique du Haut-Lévêque (FR), Hospital Universitario Central de Asturias (ES), Institut universitaire de cardiologie et de pneumologie de Québec (CA), Cardiovascular Research Foundation (US), Geisinger Wyoming Valley Medical Center (US), GEO Partner (Switzerland) (CH), Edwards Lifesciences (United States) (US), Baylor Scott & White Health (US), Geisinger Health System (US), Columbia University (US), University of Pennsylvania (US)
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Cardiac Valve Diseases and Treatments
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