Perceval Sutureless Aortic Valve Implantation: Midterm Outcomes

Abstract

Background: Because our center participated in the first-in-human trial with Perceval (LivaNova, Sallugia, Italy) in 2007, this series represents the longest available clinical follow-up (11 years) with sutureless technology in aortic valve replacement.

Methods: We collected all clinical and echocardiographic follow-up in 468 consecutive patients who received Perceval at our institution between 2007 and 2017. In 57% of cases, surgery was combined with coronary artery bypass grafting (39%), mitral valve surgery (17%), or other procedures (13%).

Results: Mean age was 79 years, mean EuroSCORE II was 5.1 ± 5.5 (range, 0.8-67) and mean Society of Thoracic Surgeons score was 5.8 ± 5.5. Mean cross-clamp times for isolated and combined procedures were 39 and 79 minutes, respectively. Observed all-cause 30-day mortality was 3.2%, with an early stroke rate of 1.8%. Pacemaker implantation rate was 7.9% overall, but only 3.9% in patients without preexisting conduction or rhythm disorders. All-cause mortality at 1 and 2 years was 8.8% ± 1.3% and 13.2% ± 1.6%, respectively. At the latest echocardiographic follow-up (mean, 3 years; range, 1-11 years), peak and mean gradients were 23 ± 10 mm Hg and 13 ± 6 mm Hg, respectively. During follow-up, we explanted 5 valves for endocarditis, and none for structural valve degeneration.

Conclusions: After more than 11 years of continued clinical use of the Perceval sutureless valve, we observe low mortality and stroke rates, with good hemodynamic behavior of the valve. None of our patients was reoperated for structural valve degeneration. Because of the key benefits of this rapid-deployment valve, it has an added value in surgical aortic valve replacement.