@article{c8233ec88a174aa68215ef97292c5560,
title = "Propensity-Matched Outcomes Comparing TAVR in Bicuspid vs Surgery in Tricuspid Aortic Valve Stenosis",
abstract = "Objective: To compare 1-year outcomes in patients at low surgical risk with bicuspid aortic valve stenosis (AS) following transcatheter aortic valve replacement (TAVR) and low-risk patients with tricuspid AS following surgical aortic valve replacement (SAVR). Background: The pivotal randomized, prospective, multicenter TAVR trials compared TAVR vs SAVR in patients with tricuspid AS. No such trials exist for bicuspid AS. Methods: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled 150 patients from 25 sites in the United States. A screening committee confirmed bicuspid anatomy and valve classification based on computed tomography using the Sievers classification. Annular measurements guided valve sizing. These patients were propensity-matched to the SAVR patients in the randomized Evolut Low Risk Trial using 1:1 5-to-1-digit Greedy method, resulting in 144 matched pairs. For both trials, an independent clinical events committee adjudicated all serious adverse events, and the same independent core laboratory assessed all echocardiograms. Results: The 1-year composite of death, disabling stroke, or aortic valve–related rehospitalization for bicuspid TAVR vs tricuspid SAVR was 6 (4.2%) vs 6 (4.2%) (P =.99). The effective orifice area (2.2 ± 0.7 cm2 vs 2.0 ± 0.6 cm2) was larger and the valve gradient was lower (8.7 ± 3.9 mm Hg vs 11.2 ± 4.7 mm Hg) in the TAVR group at 1 year (both P <.001). Moderate/severe aortic regurgitation was present in 1 TAVR and 2 SAVR patients (0.8% vs 1.6%; P >.99). Conclusions: In this select group of low-risk bicuspid patients, in the short-term follow-up, TAVR appears to have similar outcomes to those seen in comparable low-risk tricuspid patients undergoing SAVR.",
keywords = "aortic stenosis, bicuspid aortic valve, supra-annular, transcatheter aortic valve replacement",
author = "Deeb, {G. Michael} and Yakubov, {Steven J.} and Reardon, {Michael J.} and Basel Ramlawi and Chetcuti, {Stan J.} and Kleiman, {Neal S.} and Firas Zahr and Song, {Howard K.} and Hemal Gada and Mubashir Mumtaz and Saki Ito and Jian Huang and Forrest, {John K.}",
note = "Funding Information: This work was supported by Medtronic . Funding Information: Jane Moore, MS, ELS, an employee of Medtronic, plc, collaborated with the primary author on the development of this manuscript. G. Michael Deeb serves on an advisory board for Medtronic and has received institutional grant support from Boston Scientific, Edwards LifeSciences, and Medtronic and has received fees as a proctor for Medtronic-sponsored SMART Trial. Steven J. Yakubov has received institutional research grants from Boston Scientific and Medtronic. Michael J. Reardon has received fees to his institution from Medtronic for consulting and providing educational services. Basel Ramlawi reports grants, personal fees and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Stan J. Chetcuti serves as a proctor for and reports grant support from Medtronic. Neal S. Kleiman has received educational and research grants from Medtronic. Firas Zahr has received educational and research grants from Medtronic. Howard K. Song has received grant support/research contracts and consultant fees from Edwards Lifesciences and Medtronic. Hemal Gada serves as a consultant for Abbott, Bard, Edwards Lifesciences, and Medtronic. Mubashir Mumtaz serves as a consultant to Atricure, Edwards, Medtronic, Millipede, Japanese Organization for Medical Device Development, Abbott, and Terumo. Saki Ito has nothing to disclose. Jian Huang is an employee and shareholder of Medtronic, plc. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/speakers{\textquoteright} bureau fees from Edwards Lifesciences and Medtronic. This work was supported by Medtronic. For the Low Risk Bicuspid Study and the Evolut Low Risk Trial, the institutional review boards approved the study protocols and each patient provided written, informed consent. The trials were conducted in accordance with the International Conference on Harmonization, Good Clinical Practice Guidelines, and the Declaration of Helsinki. Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2023",
month = jan,
day = "1",
doi = "10.1016/j.jscai.2022.100525",
language = "English (US)",
volume = "2",
journal = "Journal of the Society for Cardiovascular Angiography and Interventions",
issn = "2772-9303",
publisher = "Elsevier BV",
number = "1",
}