Raj R Makkar1, Vinod H Thourani1, Michael J Mack1, Susheel K Kodali1, Samir Kapadia1, John G Webb1, Sung-Han Yoon1, Alfredo Trento1, Lars G Svensson1, Howard C Herrmann1, Wilson Y Szeto1, D Craig Miller1, Lowell Satler1, David J Cohen1, Todd M Dewey1, Vasilis Babaliaros1, Mathew R Williams1, Dean J Kereiakes1, Alan Zajarias1, Kevin L Greason1, Brian K Whisenant1, Robert W Hodson1, David L Brown1, William F Fearon1, Mark J Russo1, Philippe Pibarot1, Rebecca T Hahn1, Wael A Jaber1, Erin Rogers1, Ke Xu1, Jaime Wheeler1, Maria C Alu1, Craig R Smith1, Martin B Leon1. 1. From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - both in Atlanta; Baylor Scott and White Healthcare, Plano (M.J.M., D.L.B.), and Medical City Dallas Hospital, Dallas (T.M.D.) - both in Texas; Columbia University Medical Center/New York-Presbyterian Hospital (S.K.K., R.T.H., M.C.A., C.R.S., M.B.L.) and NYU Langone Medical Center (M.R.W.) - both in New York; Cleveland Clinic, Cleveland (S.K., L.G.S., W.A.J.); St. Paul's Hospital, Vancouver, BC (J.G.W.), and Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Quebec, QC (P.P.) - both in Canada; University of Pennsylvania, Philadelphia (H.C.H., W.Y.S.); Medstar Washington Hospital Center, Washington, DC (L.S.); University of Missouri-Kansas City School of Medicine, Kansas City (D.J.C.); Christ Hospital, Cincinnati (D.J.K.); Barnes-Jewish Hospital, Washington University, St. Louis (A.Z.); Mayo Clinic, Rochester, MN (K.L.G.); Intermountain Medical Center, Salt Lake City (B.K.W.); Providence St. Vincent Medical Center, Portland, OR (R.W.H.); and Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ (M.J.R.).
Abstract
BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
RCT Entities:
BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
Authors: Molly Szerlip; Deborah Tabachnick; Mohanad Hamandi; LuAnn Caras; Allison T Lanfear; John J Squiers; Katherine Harrington; Srinivasa P Potluri; J Michael DiMaio; Jordan Wooley; Benjamin Pollock; Justin M Schaffer; William T Brinkman; David L Brown; Michael J Mack Journal: Proc (Bayl Univ Med Cent) Date: 2020-09-23
Authors: Gudrun Lamm; Matthias Hammerer; Uta C Hoppe; Martin Andreas; Rudolf Berger; Ronald K Binder; Nikolaos Bonaros; Georg Delle-Karth; Matthias Frick; Michael Grund; Bernhard Metzler; Thomas Neunteufl; Philipp Pichler; Albrecht Schmidt; Wilfried Wisser; Andreas Zierer; Rainald Seitelberger; Michael Grimm; Alexander Geppert Journal: Wien Klin Wochenschr Date: 2021-03-23 Impact factor: 1.704
Authors: Michael L Williams; Campbell D Flynn; Andrew A Mamo; David H Tian; Utz Kappert; Manuel Wilbring; Thierry Folliguet; Antonio Fiore; Antonio Miceli; Augusto D'Onofrio; Giorgia Cibin; Gino Gerosa; Mattia Glauber; Theodor Fischlein; Francesco Pollari Journal: Ann Cardiothorac Surg Date: 2020-07
Authors: Domenico Paparella; Giuseppe Santarpino; Marco Moscarelli; Pietro Guida; Adriano De Santis; Khalil Fattouch; Luigi Martinelli; Roberto Coppola; Elisa Mikus; Alberto Albertini; Mauro Del Giglio; Renato Gregorini; Giuseppe Speziale Journal: Interact Cardiovasc Thorac Surg Date: 2021-07-26
Authors: S L Hungerford; A I Adji; N K Bart; L Lin; N Song; A Jabbour; M F O'Rourke; C S Hayward; D W M Muller Journal: Int J Cardiol Hypertens Date: 2021-05-28
Authors: Horea Feier; Andrei Grigorescu; Lucian Falnita; Oana Rachita; Marian Gaspar; Constantin T Luca Journal: J Clin Med Date: 2021-05-11 Impact factor: 4.241