Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

Objectives: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis.
Background: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%.
Methods: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs.
Results: All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm ² vs 2.3 ± 0.6 cm ² , P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001).
Conclusions: There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.
Competing Interests: Funding Support and Author Disclosures Dr Deeb serves on an advisory board for Medtronic; and has received institutional grant support from Boston Scientific, Edwards LifeSciences, and Medtronic; he receives no personal remunerations. Dr Reardon has received fees to his institution from Medtronic for consulting and providing educational services. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Chetcuti serves as a proctor for and reports grant support from Medtronic. Dr Kleiman has received educational and research grants from Medtronic. Dr Yakubov has received institutional research grants from Boston Scientific and Medtronic. Dr Mangi has received grant support/research contracts and consultant fees/honoraria/proctoring fees and Speakers Bureau fees from Thoratec Corporation, Edwards Lifesciences, and Medtronic. Dr Zahr has received educational and research grant from Medtronic. Dr Song has received grant support/research contracts and consultant fees from Medtronic. Dr Gada serves as a consultant for Abbott, Bard, Edwards Lifesciences, and Medtronic. Dr Mumtaz serves as a consultant to Atricure, Edwards Lifesciences, Medtronic, Millipede, Japanese Organization for Medical Device Development, Abbott, and Terumo. Dr Kirshner serves as a consultant and proctor for Medtronic. Dr Noel serves as a proctor and has received educational grants from Medtronic. Dr Byrne has received proctor fees and honoraria from Medtronic; and has received consultative fees and honoraria from Abbott. Dr Huang is an employee and shareholder of Medtronic plc. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)