Intermediate-term outcomes after aortic valve replacement with a novel RESILIA^TM tissue bioprosthesis.

ABSTRACT:

Background

The durability of bioprosthetic heart valves is limited by structural valve deterioration (SVD) due to long-term calcification. A novel bioprosthetic tissue (RESILIA^TM) has been developed which, in preclinical studies, has shown reduced calcification. The purpose of this study was to evaluate the intermediate-term clinical outcomes and hemodynamic performance of this tissue.

Methods

A prospective, single-arm, observational trial was conducted in patients who required surgical aortic valve replacement (AVR). Between July 2011 and February 2013, 133 patients were implanted at two sites in Poland. Hemodynamic performance and clinical outcomes were assessed annually through 4 years of follow-up. All safety events were adjudicated by an independent Clinical

SUBMITTER: Bartus K 

PROVIDER: S-EPMC6688015 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature