Positive trial data on Perceval Valve in AVD-Sorin

Sorin Group has announced the results of the Perceval CAVALIER Trial and of the Pooled European Multicenter Experience designed to evaluate the safety and effectiveness of the Perceval valve in a large population requiring Aortic Valve Replacement (AVR) with or without concomitant coronary bypass grafting. There were 658 patients with Aortic Vavle Disease included from 25 selected European centers. The data demonstrated the safety of Perceval through low complication rates, and ease of implant with a reproducible technique in both sternotomy and the less invasive approach.

In a second study (The European multicentre experience with sutureless Perceval valve: Clinical and haemodynamic outcomes up to 5 years in over 700 patients), Perceval demonstrated excellent and stable results at up to five years follow-up. No valve migrations, structural valve degeneration or valve thromboses were observed in the largest patient cohorts ever implanted with sutureless valves. Low early-30-day mortality (1.9%), low major early paravalvular leak (1.4%) and low early stroke (1.6%) rates confirmed the safety of the sutureless valve.

Another noteworthy clinical benefit was the extremely low endocarditis rate (0.3%). This is particularly important for patient outcomes as infective endocarditis is a serious and frequently fatal condition, particularly when it occurs on a valve replacement device. Data were presented at the 28th Annual Meeting of the European Association for Cardio-Thoracic Surgery.