Five-year results of the pilot trial of a sutureless valve.

Objective: A prospective trial was designed to evaluate the feasibility of the Perceval sutureless aortic valve. We report the 5-year clinical and hemodynamic outcome.

Methods: A total of 30 patients (mean age: 80.4 ± 3.8 years; mean logistic European System for Cardiac Operative Risk Evaluation [euroSCORE]: 13.2 ± 7.3) received the valve in 3 European centers, between April 2007 and February 2008. Cumulative follow-up was 92.67 patient-years, with a median of 4.2 years. Patients with a small annulus were selected because only sizes 21 and 23 mm (covering annuli diameters from 19 to 23 mm) were available at this early stage of the trial. In 37% of the patients, a 21-mm valve was used; 63% received a 23-mm valve; 14 patients had concomitant coronary artery bypass grafting. Clinical and hemodynamic follow-up evaluation were performed annually, including echocardiography.

Results: Procedural success was 100%. Cardiopulmonary bypass time and cross-clamp time in isolated aortic valve replacement were 46.4 ± 6.7 minutes and 29.3 ± 8.0 minutes, respectively. One patient died during the hospital stay. Postoperative complications included 1 patient with mediastinal bleeding, and 1 with atrioventricular block that led to pacemaker implantation. No stroke occurred in either the early or late period. At the last available follow-up, 22 patients were alive. The mean gradient was 9.3 mm Hg, with an effective orifice area of 1.7 cm(2) at 5 years. No dislodgement, structural valve deterioration, hemolysis, or valve thrombosis was reported.

Conclusions: This study reports the first and longest experience with a truly sutureless valve, evaluating implantation feasibility and valve safety. Results from up to 5 years of follow up confirmed the performance and safety of this device, even in a medium- to high-risk patient population with a small aortic annulus.