BACKGROUND: Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. METHODS: In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. RESULTS: Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. CONCLUSIONS: Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.
BACKGROUND: Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. METHODS: In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. RESULTS: Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. CONCLUSIONS: Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.
Authors: Catherine C Smith; Chao Zhang; Kimberly C Lin; Elisabeth A Lasater; Ying Zhang; Evan Massi; Lauren E Damon; Matthew Pendleton; Ali Bashir; Robert Sebra; Alexander Perl; Andrew Kasarskis; Rafe Shellooe; Garson Tsang; Heidi Carias; Ben Powell; Elizabeth A Burton; Bernice Matusow; Jiazhong Zhang; Wayne Spevak; Prabha N Ibrahim; Mai H Le; Henry H Hsu; Gaston Habets; Brian L West; Gideon Bollag; Neil P Shah Journal: Cancer Discov Date: 2015-04-06 Impact factor: 39.397
Authors: Francesco Onorati; Augusto D'Onofrio; Fausto Biancari; Stefano Salizzoni; Marisa De Feo; Marco Agrifoglio; Giovanni Mariscalco; Vincenzo Lucchetti; Antonio Messina; Francesco Musumeci; Giuseppe Santarpino; Giampiero Esposito; Francesco Santini; Paolo Magagna; Cesare Beghi; Marco Aiello; Ester Dalla Ratta; Carlo Savini; Giovanni Troise; Mauro Cassese; Theodor Fischlein; Mattia Glauber; Giancarlo Passerone; Giuseppe Punta; Tatu Juvonen; Ottavio Alfieri; Davide Gabbieri; Domenico Mangino; Andrea Agostinelli; Ugolino Livi; Omar Di Gregorio; Alessandro Minati; Mauro Rinaldi; Gino Gerosa; Giuseppe Faggian Journal: Interact Cardiovasc Thorac Surg Date: 2016-03-14
Authors: Suzanne V Arnold; Yang Lei; Matthew R Reynolds; Elizabeth A Magnuson; Rakesh M Suri; E Murat Tuzcu; John L Petersen; Pamela S Douglas; Lars G Svensson; Hemal Gada; Vinod H Thourani; Susheel K Kodali; Michael J Mack; Martin B Leon; David J Cohen Journal: Circ Cardiovasc Interv Date: 2014-10-21 Impact factor: 6.546
Authors: Hemal Gada; Ajay J Kirtane; Kaijun Wang; Yang Lei; Elizabeth Magnuson; Matthew R Reynolds; Mathew R Williams; Susheel Kodali; Torsten P Vahl; Suzanne V Arnold; Martin B Leon; Vinod Thourani; Wilson Y Szeto; David J Cohen Journal: Circ Cardiovasc Qual Outcomes Date: 2015-06-09
Authors: Adam B Greenbaum; William W O'Neill; Gaetano Paone; Mayra E Guerrero; Janet F Wyman; R Lebron Cooper; Robert J Lederman Journal: J Am Coll Cardiol Date: 2014-05-07 Impact factor: 24.094
Authors: Jayendrakumar S Patel; Amar Krishnaswamy; Lars G Svensson; E Murat Tuzcu; Stephanie Mick; Samir R Kapadia Journal: Curr Cardiol Rep Date: 2016-11 Impact factor: 2.931
Authors: Pamela S Douglas; Martin B Leon; Michael J Mack; Lars G Svensson; John G Webb; Rebecca T Hahn; Philippe Pibarot; Neil J Weissman; D Craig Miller; Samir Kapadia; Howard C Herrmann; Susheel K Kodali; Raj R Makkar; Vinod H Thourani; Stamatios Lerakis; Ashley M Lowry; Jeevanantham Rajeswaran; Matthew T Finn; Maria C Alu; Craig R Smith; Eugene H Blackstone Journal: JAMA Cardiol Date: 2017-11-01 Impact factor: 14.676