Propensity-Matched Outcomes Comparing TAVR in Bicuspid Vs Surgery in Tricuspid Aortic Valve Stenosis

Overview

Journal J Soc Cardiovasc Angiogr Interv

Specialty Cardiology & Vascular Diseases

Date 2024 Aug 12

PMID 39132531

Authors

G Michael Deeb

Steven J Yakubov

Michael J Reardon

Basel Ramlawi

Stan J Chetcuti

Neal S Kleiman

Firas Zahr

Howard K Song

Hemal Gada

Mubashir Mumtaz

Saki Ito

Jian Huang

John K Forrest

Affiliations

Soon will be listed here.

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%) ( = .99). The effective orifice area (2.2 ± 0.7 cm vs 2.0 ± 0.6 cm) 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 < .001). Moderate/severe aortic regurgitation was present in 1 TAVR and 2 SAVR patients (0.8% vs 1.6%; > .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.

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