Early results of the Sorin(®) Perceval S sutureless valve: systematic review and meta-analysis.

BACKGROUND: Minimally invasive aortic valve replacement (MAVR) has demonstrated a benefit with respect to increased patient satisfaction due to minimised pain and earlier recovery. Sutureless valves may benefit MAVR and conventional aortic valve replacement (AVR) by reducing operative times and blood transfusion requirements. The Perceval valve (Sorin, Salluggia, Italy) is a self-expanding prosthesis made from bovine pericardium mounted in a nitinol stent, designed to simplify the implantation of an aortic valve. This meta-analysis evaluates the clinical, haemodynamic, and survival outcomes of the Perceval sutureless valve.

METHODS: An electronic search of 4 databases was performed from January 2000 to December 2016. Primary outcomes included mortality and stroke. Secondary outcomes included minimally invasive access, paravalvular leak, overall long-term survival, postoperative echocardiographic findings, and functional class improvement.

RESULTS: After the application of inclusion and exclusion criteria, 14 of 66 relevant articles were selected for assessment. Of these 14 studies, a total number of 2,505 patients were included. The current evidence on the Perceval valve for aortic valve disease is limited to observational studies only. Minimally invasive surgery was performed in 976 patients, of which 336 were via the right anterior thoracotomy approach. The Perceval M and L sutureless valves were the most frequently used, 782 and 770 respectively. The incidence of major adverse events included 30-day mortality (0 to 4.9%), cerebrovascular accident (0 to 3%), permanent pacemaker insertion (0 to 17%), moderate to severe paravalvular leak (0 to 8.6%), and re-operation (0 to 4.8%). Post-operative mean aortic valve gradient ranged from 9 to 15.9 mmHg and post-operative New York Heart Association (NYHA) Class I or II ranged from 82% to 96%. The 1-year survival ranged from 86% to 100%; and 5-year survival was 71.3% to 85.5% in two studies.

CONCLUSIONS: The Perceval valve is associated with excellent post-operative results in MAVR and in conventional AVR. Larger randomised controlled studies are required to evaluate the long-term efficacy of the prosthesis.