Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis.

ABSTRACT:

Objectives

Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue.

Methods

This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory.

Results

Mean patient age was 65.3 ± 13.5 ye

SUBMITTER: Bartus K 

PROVIDER: S-EPMC7850021 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature