Seven-Year Valve Durability With Transcatheter or Surgical Aortic Valve Replacement
Julien Ternacle, Rebecca T. Hahn, Iria Silva, Alberto Alperi, Carlos Giuliani, Antonela Zanuttini, Alexis Théron, Abdellaziz Dahou, Nicole Cristell, Timothy Woods, Ezequiel Guzzetti, Pierre Yves Turgeon, Mathieu Bernier, Haïfa Mahjoub, Amélie Paquin, Sabah Skaf, Jonathan Beaudoin, Susheel K. Kodali, Mark Russo, Samir R. Kapadia, S. Chris Malaisrie, David J. Cohen, Jonathon Leipsic, Philipp Blanke, Mathew R. Williams, James M. McCabe, David L. Brown, Vasilis Babaliaros, Scott Goldman, Wilson Y. Szeto, Philippe Généreux, Ashish Pershad, Tamim M. Nazif, Yiran Zhang, Marissa Gunnarsson, John G. Webb, Raj R. Makkar, Vinod H. Thourani, Michael J. Mack, Martin B. Leon, Philippe Pibarot, , Mohammad El-Hajjar, Stephen Bailey, John Brown, Robert Kipperman, Mark Webster, Frank Zidar, Faraz Kerendi, Marvin Eng, Kenith Fang, Basil Paulus, Pinak Shah, Tsuyoshi Kaneko, Bassem Chehab, Brett Grizzell, Michael Rinaldi, Eric Skipper, Raj Makkar, Alfredo Trento, Andrew Eisenhauer, Susheel Kodali, Isaac George, Tamim Nazif, Geoffrey Bergman, S. Chiu Wong, Arash Salemi, Stephanie Mick, James DeVries, Joseph DeSimone, Vinod Thourani, Robert Guyton, Kendra Grubb, Vasilis Babaliaros, Kevin Accola, Raymond McKay, Robert Hagberg, William O'Neill, Gaetano Paone, Dimitrios Apostolou, Pedro Engel, Jorge Castellanos, Anthony Caffarelli, Shahram Yazdani, Eric Sarin, Brian Whisenant, Kent Jones, Marcos Nores, Mark Rothenberg, Edward McNulty, Richard Richter, Kentaro Hayashida, Paul Coady, Eric Gnall, Scott Goldman, David Holmes, Mohammad Alkhouli, Kevin Greason, Bruce Bowers, Todd Dewey, David Daniels, Conrad Vial, Noah Jones, Patrick Wells, Steve Xydas, Nirat Beohar, Willis Wu, Curtis Anderson, Omar Nass, Steven Martin, Mathew Williams, Mark Russo, Sergio Waxman, Bruce Haik, Justin Levisay, Hyde Russell, Chris Malaisrie, Charles Davidson, Stephen Ramee, Jose Tafur, Patrick Parrino, Mohammad Ghani, Mark Bodenhamer, Yasushi Sakata, Jeffrey Christy, Jeffery Goldstein, Salem Badr, Ethan Korngold, Jeffrey Swanson, Logan Vincent, Joseph Montarello, Fareed Collado, Adnan Chhatriwalla, Evelio Rodriguez, Andrew Morse, Paul Mahoney, Joseph Newton, Clinton Kemp, John Webb, Michael Fischebin, Alan Yeung, Michael Ingram, Pei-Hsiu Huang, Ken Kozuma, Dean Kereiakes, Geoffrey Answini, Samir Kapadia, Shinya Unai, Michael Mack, Molly Szerlip, Christian Spies, Benjamin Plank, Jeffrey Lau, Richard Smalling, Tom Nguyen, Brad Oldemeyer, Mark Guadagnoli, Vijay Iyer, Gary Grosner, James Davies, Richard Shemin, William Suh, Thomas Beaver, David Anderson, Phillip Horwitz, Gregory Helmer, Ranjit John, Joseph Bavaria, Nimesh Desai, Howard Herrmann, Gorav Ailawadi, Kenan Yount, John Kern, James McCabe, Christine Chung, Gabriel Aldea, Giorgio Gimelli, Lucian Lozonschi, Satoru Osaki, Alan Zajarias, Hersh Maniar, Amr Abbas, Richard Schwartz, Paul Tolerico, Mark BurlingameImportance
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: