Sutureless Perceval Aortic Valve Replacement: Results of Two European Centers

Background The Perceval S bioprosthesis (Sorin Biomedica Cardio Srl, Sallugia, Italy) is a self-expanding valve designed to preserve aortic sinuses and sinotubular junction. We report the midterm results of a prospective, multicenter clinical study evaluating the safety and efficacy of this stented bioprosthesis in patients undergoing aortic valve replacement with or without concomitant procedures. Methods From January 2007 to September 2011, a total of 208 high-risk patients (mean European system for cardiac operative risk evaluation: 8.7 ± 5.3 years) received a Perceval bioprosthesis in 2 European centers. Median follow up was 10 ± 20 months and 100% complete, and the total accumulated follow-up was 156 patient-years. Ten patients have reached a 4-year follow-up. Valve function was assessed in all patients. Results Valve implantation resulted in significant improvement of patients' symptoms. Mean preoperative and postoperative gradients were 48.6 ± 18.6 mm Hg and 10.4 ± 4.3 mm Hg, respectively, and preoperative and postoperative mean effective orifice areas were 0.7 ± 0.2 and 1.4 ± 0.4 cm 2 . Survival at 12 months was 87.1%, success of implantation was 95%, and freedom from reoperation was 96%. In hospital mortality was 2.4%. During follow-up, 9 patients (4%) required reoperation for paravalvular regurgitation; 7 early and 2 late reoperations. Mean cross-clamp time (CCT) and extracorporeal circulation time (ECT) were, respectively, 33 ± 14 minutes and 54 ± 24 minutes, including 45 patients who underwent surgery through ministernotomy. Concomitant coronary bypass was done in 48 patients with mean CCT 43 ± 13 and ECT 68 ± 25 minutes. Conclusions Perceval sutureless is a safe bioprosthesis that can easily be implanted, including by a minimally invasive technique. It provides excellent hemodynamic with significant clinical improvement. Overall, these data confirm the safety and utility of the Perceval bioprosthesis aortic valve replacement for high-risk patients.