1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses
G Michael Deeb, Stanley J Chetcuti, Michael J Reardon, Himanshu J Patel, P Michael Grossman, Theodore Schreiber, John K Forrest, Tanvir K Bajwa, Daniel P O'Hair, George Petrossian, Newell Robinson, Stanley Katz, Alan Hartman, Harold L Dauerman, Joseph Schmoker, Kamal Khabbaz, Daniel R Watson, Steven J Yakubov, Jae K Oh, Shuzhen Li, Neal S Kleiman, David H Adams, Jeffrey J Popma, G Michael Deeb, Stanley J Chetcuti, Michael J Reardon, Himanshu J Patel, P Michael Grossman, Theodore Schreiber, John K Forrest, Tanvir K Bajwa, Daniel P O'Hair, George Petrossian, Newell Robinson, Stanley Katz, Alan Hartman, Harold L Dauerman, Joseph Schmoker, Kamal Khabbaz, Daniel R Watson, Steven J Yakubov, Jae K Oh, Shuzhen Li, Neal S Kleiman, David H Adams, Jeffrey J Popma
Abstract
Objectives: This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF).
Background: Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk.
Methods: The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation.
Results: SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001).
Conclusions: Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.
Keywords: TAV in SAV; TAVR; prospective trial; surgical valve failure.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed