Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue.

ABSTRACT:

Objective

Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE.

Methods

Adult patients requiring mitral valve replacement were enrolled in a prospective, single-arm trial at 17 sites in the United States and Canada. An independent clinical events committee adjudicated safety events using definitions from established guidelines, and hemodynamic performance was evaluated by an independent echocardiographic core laboratory.

Results

Eighty-two patients (median age 70 years) successfully underwent mitral valve replacement with the study valve. Five-year event-f

SUBMITTER: Heimansohn DA 

PROVIDER: S-EPMC10556809 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature