Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial.

ABSTRACT:

Background

The use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory-adjudicated data are scarce, however. Here we report final 7-year data on RDV use.

Methods

TRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory-adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention,

SUBMITTER: Malaisrie SC 

PROVIDER: S-EPMC10897657 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature