February 12, 2022Open Access

Clinical Comparison of a Novel Balloon-Expandable Versus a Self-Expanding Transcatheter Heart Valve for the Treatment of Patients with Severe Aortic Valve Stenosis: The EVAL Registry

Structured PICO

Does the Myval balloon-expandable THV reduce the rate of PPI and paravalvular leak compared to the ER self-expanding THV in patients with severe symptomatic AS undergoing TAVR?

Population

Patients with severe symptomatic aortic valve stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR)

Intervention

Myval balloon-expandable transcatheter heart valve (BE THV)

Comparator

ER self-expanding transcatheter heart valve (SE THV)

Outcome

Performance, rate of permanent pacemaker implantation (PPI), and ≥moderate paravalvular leak (PVL) within 30 days and 6 months after the procedure

In a registry of patients with severe symptomatic aortic stenosis, the Myval balloon-expandable valve showed comparable overall performance but lower rates of pacemaker implantation and paravalvular leak compared to the ER self-expanding valve.

Abstract

In patients with severe symptomatic AS undergoing TAVR, the novel Myval BE THV provided a comparable performance to the well-known ER SE THV, and it was associated with a lower rate of PPI and ≥moderate PVL within 30 days and 6 months after the procedure. Randomized, head-to-head comparison trials are needed to confirm our results.

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