Seven-year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicentre analysis
Authors: Sabik Joseph F , Rao Vivek , Dagenais Francois , Moront Michael G , Reardon Michael J , Patel Himanshu J , Oh Jae K , Fukuhara Shinichi , Labrousse Louis , Günzinger Ralf , Baig Kamran , Ito Saki , Wu Tianhua , Klautz Robert J M ,   PERIGON Investigators, Pettersson Gosta , Koprivanac Marijan , Svensson Lars , Brown W Morris , Gammie James , Dawood Murtaza , Moront Michael G , Raikar Goya , Tahirkheli Naeem , Cannon Michael , Kress David , Ribakove Greg , Patel Himanshu J , Kerendi Faraz , Fullerton David , Baker Craig , Beaver Thomas , Ramlawi Basel , Reardon Michael J , Aldea Gabriel , Sundt Thoralf , Duff Steven , Steffen Robert J , Kshettry Vibhu , Borger Michael , Takeda Koji , Adams David H , Fischbein Michael , Hagberg Robert , Ruel Marc , Rao Vivek , Dagenais Francois , Cartier Raymond , Chu Michael , Kaufeld Tim , Shrestha Malakh , Alfieri Ottavio , Bensari Nawel , Holubec Tomas , Weber Alberto , Ouda Ahmed , Falk Volkmar , Schönhoff Florian , Carrel Thierry , Labrousse Louis , Klautz Robert J M , van Leeuwen Wouter J , Kappetein Ari Pieter , Walther Thomas , Moritz Anton , Baig Kamran , Bapat Vinayak , Kuhn Elmar , Wahlers Thorsten , Kiefer Philipp , Misfeld Martin , Günzinger Ralf , Lange Rudiger 
Published: November 2024

Abstract

OBJECTIVES
Safety, efficacy and durability are important considerations when selecting a bioprosthesis for aortic valve replacement (AVR). This study assessed 7-year clinical outcomes and haemodynamic performance of the Avalus bioprosthesis.

METHODS
Patients indicated for surgical AVR were enrolled in this prospective, nonrandomized trial, conducted across 39 sites globally. The primary end-point of this analysis was freedom from surgical explant or percutaneous valve-in-valve reintervention due to structural valve deterioration (SVD) at 7 years of follow-up, determined using Kaplan–Meier (KM) analysis. We also evaluated a composite end-point of SVD and/or severe haemodynamic dysfunction requiring reintervention. Survival, valve-related safety events and haemodynamic performance were assessed. Deaths and safety events were adjudicated by an independent clinical events committee.

RESULTS
A total of 1132 patients underwent surgical AVR. Mean age was 70 years; 854 patients (75%) were men. The mean STS risk of mortality was 2.0 ± 1.4%, and 659 patients (58%) had a New York Heart Association classification of I/II. One or more concomitant procedures were performed in 577 patients (51%). At 7 years, the Kaplan–Meier rate of freedom from SVD/severe haemodynamic dysfunction requiring reintervention was 1.2% (0.5–2.5%) with no cases adjudicated as SVD. The survival rate was 82.6% (79.5–85.0%). The KM event rate was 5.7% (4.3–7.7%) for reintervention, 6.3% (4.9–8.3%) for endocarditis and 0.4% (0.1–1.1%) for valve thrombosis. Mean aortic gradient, dimensionless velocity index and effective orifice area were 13.8 ± 5.9 mmHg, 0.42 ± 0.09 and 1.99 ± 0.53 cm2, respectively.

CONCLUSIONS
This analysis demonstrated excellent durability of the Avalus valve with good clinical outcomes and stable haemodynamic performance through 7 years of follow-up.