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Background: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited., Objectives: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study., Methods: The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S., Centers: Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints., Results: An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR., Conclusions: The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance., Competing Interests: Funding Support and Author Disclosures Medtronic funded the Low Risk study. Dr Zahr has received grant support/research support from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria from Edwards Lifesciences and Medtronic. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, LivaNova, and AtriCure. Dr Reardon has received grants from Medtronic (paid to institution) during the conduct of the study; and has received consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. Dr Deeb has received grants from Medtronic (paid to institution) during the conduct of the trial; and has received personal fees from Medtronic outside the submitted work. Dr Yakubov has received grants from Boston Scientific and Medtronic (paid to institution); and has received personal fees from Medtronic during the conduct of the study. Dr Song has received grant support/research contracts from Medtronic; and has received consultant fees from Medtronic. Dr Kleiman has received clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the study. Dr Chetcuti serves on the Advisory Board for Medtronic; and serves as a consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Gada has received personal fees from Medtronic, Abbott, Becton Dickinson, and Boston Scientific outside the submitted work. Dr Mumtaz has received grants and personal fees from Medtronic, Edwards Lifesciences, AtriCure, Japanese Organization for Medical Device Development, and Z Medical outside the submitted work. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Kauten serves as a consultant for Boston Scientific and Medtronic. Dr Huang is an employee and shareholder of Medtronic. Dr Forrest has received grant support/research contracts from Edwards Lifesciences and Medtronic; and has received 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 © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare outcomes in patients with bicuspid versus tricuspid anatomy undergoing transcatheter aortic valve replacement (TAVR)., Background: TAVR has shown excellent safety and efficacy in patients with tricuspid aortic valve stenosis, but limited data are available on the use of self-expanding valves in patients with bicuspid valves., Methods: The Society of Thoracic Surgeons/American College of Cardiology TVT Registry was used to analyze patients who underwent TAVR with the Evolut R or Evolut PRO valves. Clinical and echocardiographic outcomes were analyzed through 1-year follow-up., Results: Between July 2015 and September 2018 a total of 932 patients with bicuspid aortic valve stenosis underwent elective TAVR with the self-expanding Evolut R or Evolut PRO valve. These patients were compared with a group of 26,154 patients with tricuspid aortic stenosis who underwent TAVR during that same time period. At baseline, patients with bicuspid valves were younger, had fewer cardiac comorbidities, and had lower Society of Thoracic Surgeons Predicted Risk of Mortality scores (5.3 ± 4.2% vs. 6.9 ± 4.8%; p < 0.001). To account for these differences, propensity matching was performed, which resulted in 929 matched pairs. Within these match groups, the rates of all-cause mortality at 30 days (2.6% vs. 1.7%; p = 0.18) and 1 year (10.4% vs. 12.1%; p = 0.63), as well the rate of stroke at 30 days (3.4% vs. 2.7%; p = 0.41) and 1 year (3.9% vs. 4.4%; p = 0.93), were comparable., Conclusions: All-cause mortality, stroke, and valve hemodynamics did not differ at 30 days or 1 year between patient groups. In patients at increased surgical risk, TAVR for bicuspid aortic valve stenosis indicates acceptable safety outcomes with low complications rates., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)