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Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Deeb, G. 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Van , Søndergaard, Lars , Olsen, Peter Skov , Crestanello, Juan A. , George, Isaac , Serruys, Patrick W. , Williams, Mathew , Adams, David , Investigators, SURTAVI Trial, Meyer, Karen, Roberts, Dana, Sorajja, Paul , Flavin, Thomas, Gössl, Mario , Mooney, Michael R , Pendleton, Kristin, Fry, Robert, Heine, Carl, Tran, Tin, Bremer, Karen, Pieter, Jan, Verbiest, Henk, Waller, Deborah, Ahmed, Arshad , Allaqaband, Suhail Q. , Werner, Paul , Bessette, Lynn, Klein, Jason, Brady, Kevin, Chung, Steven, Franz, Douglas, Pershad, Ashish , Porter, Charlotte, Craig, John, Elijovich, Lucas , Wolf, Bradley, Wright, Lance, Roberts, Brad, Henry, Carl, Laham, Roger J. , Burke, David, Chui, Angus Shing Fung , Liu, David M. , Nathan, Senthil, Pinto, Duane S. , Searls, D. Eric, Fisher, Susan, Lim, D. Scott , Ng, Ken, Bates, Michael, Grey, William, Rose, Geoffrey, Scherer, Markus, Martin, Jerry, Cheng, Wen, Kar, Saibal , Mody, Cyrus, Ramzy, Danny , Sohn, Jeanie, Hahn, Rebecca T , Contreras, Jose Gutierrez, Kummer, Benjamin R. , Miller, Eliza C. , Nazif, Tamim , Qureshi, Abid, Rostanski, Sara , Willey, Joshua , Yaghi, Shadi , Rosenbloom, Michael, Schell, Wendy, Huang, Hong , Ali, Omar, Henry, Scott, Bleiziffer, Sabine , Hengstenberg, Christian , Brenner, Susanne, Kasel, Albert Markus , Kreuzpointner, Robert , Poppert, Holger , Seifert, Christian, Voß, Bernhard , Cowhig, Dahlia, Newbold, Stephanie, Velazquez, Eric J. , Harrison, J. Kevin, Hughes, George Chad , Ali, Yasmin, Gokhale, Sankalp , Hendry, Robert, Hernandez, Christian, Klein, Michael, Kolls, Brad J. , Maldonado, Andres M. 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JAMA Cardiology | August 24, 2022 | Volume: 7 | Issue: 10 | Pages: 1000
Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.
Association of transcatheter edge-to-edge repair with improved survival in older patients with severe, symptomatic degenerative mitral regurgitation
Benfari, Giovanni , Sorajja, Paul , Pedrazzini, Giovanni , Taramasso, Maurizio , Gavazzoni, Mara , Biasco, Luigi , Essayagh, Benjamin , Grigioni, Francesco , Bae, Richard , Tribouilloy, Christophe , Bapat, Vinayak , Vancraynest, David, Curti, Moreno , Thapa, Prabin , Vancraeynest, David , Vanoverschelde, Jean-Louis , Michelena, Hector I , Bapat, Vinayak N , Klersy, Catherine , Curti, Moreno , Thapa, Prabin , Enriquez-Sarano, Maurice , Benfari, Giovanni , Essayagh, Benjamin , Sorajja, Paul , Vanoverschelde, Jean‐Louis , Michelena, Héctor I. , Klersy, Catherine , Enriquez‐Sarano, Maurice , Grigioni, Francesco
European Heart Journal | December 27, 2021 | Volume: 43 | Issue: 17 | Pages: 1626-1635
Abstract Background Randomized clinical trials demonstrated transcatheter edge-to-edge repair (TEER) efficacy in improving outcome vs. medical management for functional mitral regurgitation, but limited randomized data are available for the treatment of degenerative mitral regurgitation (DMR). We aimed to compare the outcome of older patients treated with TEER vs. unoperated DMR. Methods and results Registries including consecutive patients ≥65 years with symptomatic severe DMR treated with TEER (MitraSwiss and Minneapolis Heart Institute registries) or unoperated (MIDA registry) were analysed. Survival was compared overall and after matching for age, sex, EuroSCORE II, and ejection fraction. The study included 1187 patients (872 treated with TEER and 315 unoperated). During 24 ± 17 months of follow-up, 430 patients died, 18 ± 1% at 1 year and 50 ± 2% at 4 years. Patients undergoing TEER had similar age (82 ± 6 vs. 82 ± 7 years) and sex to unoperated patients, but higher surgical risk/comorbidity (EuroSCORE II 3.98 ± 4.28% vs. 2.77 ± 2.46%), more symptoms, and atrial fibrillation (P < 0.0001). Transcatheter edge-to-edge repair was associated with lower mortality accounting for age, sex, EuroSCORE II, New York Heart Association class, atrial fibrillation, and ejection fraction [hazard ratio (HR): 0.47, 95% confidence interval (CI): 0.37–0.58; P < 0.0001]. After propensity matching (247 pairs of patients), TEER consistently showed better survival compared with unoperated patients (49 ± 6% vs. 37 ± 3% at 4 years, P < 0.0001) even in comprehensive multivariable analysis (HR: 0.60, 95% CI: 0.40–0.91; P = 0.03). Procedural failure was infrequent but post-procedural mitral regurgitation, remaining moderate-to-severe in 66 (7.6%) patients, was associated with excess mortality vs. trivial residual regurgitation (30 ± 6% vs. 11 ± 1% at 1 year, P < 0.0001). Conclusion Amongst older patients with severe symptomatic DMR at high surgical risk, mitral TEER was associated with higher survival vs. unoperated patients. Successful control of mitral regurgitation was key to survival improvement with mitral TEER, which should be actively considered in patients deemed inoperable.