Outcomes of aortic and mitral valve replacement with Dafodil™ pericardial bioprosthesis over 5-years: Dafodil™-1 trial.

ABSTRACT:

Objectives

The durability and performance of bioprosthetic valves are pivotal in managing valvular heart disease (VHD). This 5-year follow-up study evaluated the long-term clinical safety, haemodynamic performance, and quality-of-life (QoL) outcomes of the Dafodil™ pericardial bioprosthesis in patients undergoing aortic or mitral valve replacement (AVR/MVR).

Methods

In this prospective, multicenter, first-in-human trial conducted across 19 Indian centers, 136 patients with advanced VHD (67 AVR, 69 MVR) were enrolled. Key endpoints were evaluated over 5 years.

Results

The mean age of the patients in the AVR and MVR cohorts was 60.2 ± 8.3 years and 49.7 ± 14.4 years, respectively. A total of 124 patients (61 AVR, 63 MVR) completed the 5-year follow-up. In the AVR cohort

SUBMITTER: Hiremath CS 

PROVIDER: S-EPMC12828671 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature