Early and intermediate outcome after aortic valve replacement with a sutureless bioprosthesis: Results of a multicenter study.

Objective: The aim of this study was to evaluate the outcome of aortic valve replacement with the sutureless Perceval S aortic valve bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy). Methods: This is a retrospective analysis of 314 patients (mean age, 77.9 +/- 5.0 years, mean European System for Cardiac Operative Risk Evaluation II, 9.0% +/- 7.6%) who underwent aortic valve replacement with the Perceval S valve with (94 patients) or without (220 patients) concomitant coronary artery bypass surgery at 5 European centers. Results: The Perceval S valve was successfully implanted in all but 1 patient (99.7%). The mean aortic crossclamping time was 43 +/- 20 minutes (isolated procedure, 39 +/- 15 minutes; concomitant coronary surgery, 52 +/- 26 minutes). Severe paravalvular leak occurred in 2 patients (0.6%). In-hospital mortality was 3.2%(1.4% after isolated procedure and 7.4% after concomitant coronary surgery). In-hospital mortality was 2.8% and 4.0% among patients with a European System for Cardiac Operative Risk Evaluation II less than 10% and 10% or greater, respectively (P = .558). Octogenarians had slightly higher in-hospital mortality (5.2% vs 2.0%, P = .125; after isolated procedure: 2.7% vs 0.7%, P = .223; after concomitant coronary surgery: 9.5% vs 5.8%, P = .491) compared with younger patients. Full sternotomy did not increase the in-hospital mortality risk compared with ministernotomy or minithoracotomy access (1.3% vs 1.4%, when adjusted for baseline covariates: P = .921; odds ratio, 0.886; 95% confidence interval, 0.064-12.346). One-year survival was 90.5%. Freedom from valve-related mortality, stroke, endocarditis, and reoperation was 99.0%, 98.1%, 99.2%, and 98.3%, respectively. Conclusions: The sutureless Perceval S valve is associated with excellent early survival in high-risk patients, particularly among those undergoing an isolated procedure. Further studies are needed to prove the durability of this bioprosthesis.