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

Abstract

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 metaanalysis 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.

Surgical or Transcatheter Aortic-Valve Replacement

“…Indeed, the rate of permanent pacemaker implantation was lower in the U.S. registry (16.4%, and 19.7% when the patients who had previously received pacemakers were excluded). 1 However, the rate in the SURTAVI trial is similar to that in our study from Geneva (23.9%), 2 a study from Israel (20.4%), 3 and a study from Germany (20.0%) 4 ( Table 1). We think that rates of permanent pacemaker implantation may be influenced by local practice.…”

“…1,2 Sutureless valves have been introduced into surgical use and appear to provide good hemodynamics but a greater need for new pacemakers and more paravalvular leaks than stented biologic valves, and data on the durability of sutureless valves are lacking. 3 In a randomized trial involving patients who were at high risk for standard surgery, we found that elements of the surgical technique did not influence outcomes. 4 Noble and colleagues emphasize the ongoing, considerable need for permanent pacemakers in patients who undergo TAVR.…”

“…3 As compared with the seven-field reference standard, one-field and two-field photography was shown to have acceptable specificity and sensitivity. 3 Finally, Lamoureux et al suggest that the personalized approach is unlikely to be adopted worldwide. However, we think that should not impede the implementation, whenever feasible, of the improved, data-driven, and cost-saving screening strategy we have described.…”

Early Structural Deterioration of a Sutureless Bioprosthetic Aortic Valve

“…This case raises the issue of the lack of much-needed data describing the long-term durability and hemodynamic performance of sutureless bioprosthetic valves, particularly in a lowrisk patient with excellent functional status. The SPV was only introduced in 2008 with a total of about 2,500 valves placed to date worldwide [19]. Therefore, the data on long-term durability are scarce to none.…”

“…Therefore, the data on long-term durability are scarce to none. Most of the studies reported shortterm results describing hemodynamic parameters and 30-day outcomes [5,6,16,19,20]. One multicenter study reported 5-year follow-up data and showed favorable hemodynamic parameters such as transaortic valve gradient as well as patient symptomatology [2].…”