Sammy Elmariah1, Igor F Palacios, Thomas McAndrew, Irene Hueter, Ignacio Inglessis, Joshua N Baker, Susheel Kodali, Martin B Leon, Lars Svensson, Philippe Pibarot, Pamela S Douglas, William F Fearon, Ajay J Kirtane, Hersh S Maniar, Jonathan J Passeri. 1. From the Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston (S.E., I.F.P., I.I., J.N.B., J.J.P.); Harvard Clinical Research Institute, Boston, MA (S.E.); Columbia University Medical Center/New York-Presbyterian Hospital and The Cardiovascular Research Foundation (T.M., I.H., S.K., M.B.L., A.J.K.); Department of Cardiovascular Medicine, Cleveland Clinic, OH (L.S.); Québec Heart and Lung Institute, Laval University, Québec, Canada (P.P.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (P.S.D.); Division of Cardiovascular Medicine, Stanford University School of Medicine, CA (W.F.F.); and Division of Cardiothoracic Surgery, Washington University, St. Louis, MO (H.S.M.).
Abstract
BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively) in high-risk patients with symptomatic, severe aortic stenosis. The aim of this study was to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function. METHODS AND RESULTS: The PARTNER trial randomized high-risk patients with severe aortic stenosis to TAVR or SAVR. Patients were stratified by the presence of LV ejection fraction (LVEF) <50%. All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique. In patients with LV dysfunction, mean LVEF increased from 35.7±8.5% to 48.6±11.3% (P<0.0001) 1 year after TAVR and from 38.0±8.0% to 50.1±10.8% after SAVR (P<0.0001). Higher baseline LVEF (odds ratio, 0.90 [95% confidence interval, 0.86, 0.95]; P<0.0001) and previous permanent pacemaker (odds ratio, 0.34 [95% confidence interval, 0.15, 0.81]) were independently associated with reduced likelihood of ≥10% absolute LVEF improvement by 30 days; higher mean aortic valve gradient was associated with increased odds of LVEF improvement (odds ratio, 1.04 per 1 mm Hg [95% confidence interval, 1.01, 1.08]). Failure to improve LVEF by 30 days was associated with adverse 1-year outcomes after TAVR but not SAVR. CONCLUSIONS: In high-risk patients with severe aortic stenosis and LV dysfunction, mortality rates and LV functional recovery were comparable between valve replacement techniques. TAVR is a feasible alternative for patients with symptomatic severe aortic stenosis and LV dysfunction who are at high risk for SAVR. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
RCT Entities:
BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively) in high-risk patients with symptomatic, severe aortic stenosis. The aim of this study was to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function. METHODS AND RESULTS: The PARTNER trial randomized high-risk patients with severe aortic stenosis to TAVR or SAVR. Patients were stratified by the presence of LV ejection fraction (LVEF) <50%. All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique. In patients with LV dysfunction, mean LVEF increased from 35.7±8.5% to 48.6±11.3% (P<0.0001) 1 year after TAVR and from 38.0±8.0% to 50.1±10.8% after SAVR (P<0.0001). Higher baseline LVEF (odds ratio, 0.90 [95% confidence interval, 0.86, 0.95]; P<0.0001) and previous permanent pacemaker (odds ratio, 0.34 [95% confidence interval, 0.15, 0.81]) were independently associated with reduced likelihood of ≥10% absolute LVEF improvement by 30 days; higher mean aortic valve gradient was associated with increased odds of LVEF improvement (odds ratio, 1.04 per 1 mm Hg [95% confidence interval, 1.01, 1.08]). Failure to improve LVEF by 30 days was associated with adverse 1-year outcomes after TAVR but not SAVR. CONCLUSIONS: In high-risk patients with severe aortic stenosis and LV dysfunction, mortality rates and LV functional recovery were comparable between valve replacement techniques. TAVR is a feasible alternative for patients with symptomatic severe aortic stenosis and LV dysfunction who are at high risk for SAVR. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
Authors: Frédéric Maes; Stamatios Lerakis; Henrique Barbosa Ribeiro; Martine Gilard; João L Cavalcante; Raj Makkar; Howard C Herrmann; Stephan Windecker; Maurice Enriquez-Sarano; Asim N Cheema; Luis Nombela-Franco; Ignacio Amat-Santos; Antonio J Muñoz-García; Bruno Garcia Del Blanco; Alan Zajarias; John C Lisko; Salim Hayek; Vasilis Babaliaros; Florent Le Ven; Thomas G Gleason; Tarun Chakravarty; Wilson Szeto; Marie-Annick Clavel; Alberto de Agustin; Vicenç Serra; John T Schindler; Abdellaziz Dahou; Mohammed Salah-Annabi; Emilie Pelletier-Beaumont; Melanie Côté; Rishi Puri; Philippe Pibarot; Josep Rodés-Cabau Journal: JAMA Cardiol Date: 2019-01-01 Impact factor: 14.676
Authors: Sammy Elmariah; Laurie A Farrell; Deborah Furman; Brian R Lindman; Xu Shi; Jordan E Morningstar; Eugene P Rhee; Robert E Gerszten Journal: JAMA Cardiol Date: 2018-03-01 Impact factor: 14.676
Authors: Suzanne J Baron; Suzanne V Arnold; Howard C Herrmann; David R Holmes; Wilson Y Szeto; Keith B Allen; Adnan K Chhatriwalla; Sreekaanth Vemulapali; Sean O'Brien; Dadi Dai; David J Cohen Journal: J Am Coll Cardiol Date: 2016-05-24 Impact factor: 24.094