Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced the results of the Perceval CAVALIER Trial and of the Pooled European Multicenter Experience at the 28th Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Milan, Italy.
The CAVALIER multi-center European trial was 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 included from 25 selected European centers. The 30-day results, presented today at EACTS by Professor François Laborde, Institut Mutualiste Montsouris, Paris, France, demonstrated the safety of Perceval through excellent hemodynamic, low complication rates, and ease of implant with a reproducible technique in both sternotomy and the less invasive approach.
In a second study presented by Professor Malakh Shrestha, MHH, Hannover, Germany (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.
"Even in this elderly patient cohort with 40 percent of patients aged over 80 years old, early and late mortality were very low," said Shrestha. "The sutureless technique is a promising alternative to stented biological aortic valve replacement."
"The adoption of sutureless technology is growing day by day," stated Meuris. "This is a clear example of how innovation can improve patient outcomes and provide important savings to the hospital compared to traditional valves".
The mean total cost of the Perceval group patients compared with Perimount, net of valve costs, was reduced by 27 percent, i.e. a mean reduction of € 8,176 per case. These cost savings were mainly driven by reduced hospital stay costs and significantly lower procedural costs. In summary, patients with Perceval recovered faster than with Perimount, which led to increased hospital savings overall.