Howard C Herrmann1, Vinod H Thourani2, Susheel K Kodali2, Raj R Makkar2, Wilson Y Szeto2, Saif Anwaruddin2, Nimesh Desai2, Scott Lim2, S Chris Malaisrie2, Dean J Kereiakes2, Steven Ramee2, Kevin L Greason2, Samir Kapadia2, Vasilis Babaliaros2, Rebecca T Hahn2, Philippe Pibarot2, Neil J Weissman2, Jonathon Leipsic2, Brian K Whisenant2, John G Webb2, Michael J Mack2, Martin B Leon2. 1. From Perelman School of Medicine at the University of Pennsylvania, Philadelphia (H.C.H., W.Y.S., S.A., N.D.); Emory University, Atlanta, GA (V.H.T., V.B.); Columbia University Medical Center, New York, NY (S.K.K., R.T.H., M.B.L.); Cedars-Sinai Medical Center, Los Angeles, CA (R.R.M.); University of Virginia, Charlottesville (S.L.); Northwestern University, Chicago, IL (S.C.M.); The Christ Hospital, Cincinnati, OH (D.J.K.); Ochsner Clinic, New Orleans, LA (S.R.); Mayo Clinic, Rochester, MN (K.L.G.); Cleveland Clinic, OH (S.K.); Department of Medicine, Laval University, Quebec, Canada (P.P.); Medstar Health Research Institute and Georgetown University, Washington, DC (N.J.W.); St. Paul's Hospital, Vancouver, BC, Canada (J.L., J.G.W.); Intermountain Medical Center, Salt Lake City, UT (B.K.W.); and Baylor Scott and White Health, Plano, TX (M.J.M.); and the PARTNER Trial Publication Office, New York, NY (H.C.H., V.H.T., S.K.K., R.R.M., D.J.K., S.K., V.B., R.T.H., P.P., N.J.W., J.L., J.G.W., M.J.M., M.B.L.). Howard.herrmann@uphs.upenn.edu. 2. From Perelman School of Medicine at the University of Pennsylvania, Philadelphia (H.C.H., W.Y.S., S.A., N.D.); Emory University, Atlanta, GA (V.H.T., V.B.); Columbia University Medical Center, New York, NY (S.K.K., R.T.H., M.B.L.); Cedars-Sinai Medical Center, Los Angeles, CA (R.R.M.); University of Virginia, Charlottesville (S.L.); Northwestern University, Chicago, IL (S.C.M.); The Christ Hospital, Cincinnati, OH (D.J.K.); Ochsner Clinic, New Orleans, LA (S.R.); Mayo Clinic, Rochester, MN (K.L.G.); Cleveland Clinic, OH (S.K.); Department of Medicine, Laval University, Quebec, Canada (P.P.); Medstar Health Research Institute and Georgetown University, Washington, DC (N.J.W.); St. Paul's Hospital, Vancouver, BC, Canada (J.L., J.G.W.); Intermountain Medical Center, Salt Lake City, UT (B.K.W.); and Baylor Scott and White Health, Plano, TX (M.J.M.); and the PARTNER Trial Publication Office, New York, NY (H.C.H., V.H.T., S.K.K., R.R.M., D.J.K., S.K., V.B., R.T.H., P.P., N.J.W., J.L., J.G.W., M.J.M., M.B.L.).
Abstract
BACKGROUND: In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. METHODS: Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. RESULTS: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. CONCLUSIONS: In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.
BACKGROUND: In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. METHODS: Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. RESULTS: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. CONCLUSIONS: In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.
Authors: Matteo Pagnesi; Luca Baldetti; Paolo Del Sole; Antonio Mangieri; Marco B Ancona; Damiano Regazzoli; Nicola Buzzatti; Francesco Giannini; Antonio Colombo; Azeem Latib Journal: Interv Cardiol Date: 2017-09
Authors: Sarah K L Moore; Katherine H Chau; Salma Chaudhary; Geoffrey Rubin; Joseph Bayne; Uma Mahesh R Avula; Daniel Y Wang; Carmine Sorbera; Jose Dizon; Angelo Biviano; Marc Waase; Vivek Iyer; Isaac George; Susheel K Kodali; Tamim M Nazif; Hasan Garan; Elaine Y Wan Journal: Pacing Clin Electrophysiol Date: 2019-03-18 Impact factor: 1.976
Authors: Costanza Pellegrini; Tobias Rheude; Lukas Mahr; Teresa Trenkwalder; N Patrick Mayr; Jonathan Michel; Heribert Schunkert; A Markus Kasel; Michael Joner; Christian Hengstenberg; Adnan Kastrati; Oliver Husser; Thorsten Kessler Journal: J Thorac Dis Date: 2019-05 Impact factor: 2.895