Italian cardio device company Sorin Group has 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.
Background
Sorin’s Perceval sutureless biological surgical aortic valve possesses a unique self-anchoring frame that enables the surgeon to replace the native diseased valve without suturing it into place.
With implants now totalling over 8,000 patients in over 250 centres, in 34 countries in the world, it’s unsurprising to see a flurry of trials hitting the major congresses. One such, 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 at this year’s EACTS congress 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 device1.
“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.”
Health Economic Study
Professor Bart Meuris, University Hospitals of Leuven, Belgium, presented favorable health economic data for Perceval sutureless valve compared to traditional stented valves (Carpentier-Edwards Perimount) in a retrospective matched case-control study. Perceval reported lower use of resources, including significantly shorter intensive care unit and hospital stays, significantly shorter intubation time and reduced use of different blood products (packed cells, plasma and platelets).
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.
“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”.
Company comments
“Saving lives with cutting-edge technology is at the heart of everything we do. Because our latest innovations are developed with both optimal patient safety and greater economic value in mind, they are contributing to an overall reduction in healthcare spending,” said Michel Darnaud, President Cardiac Surgery Business Unit, Sorin Group.
Source: Sorin Group, SpA., Business Wire
published: October 14, 2014 in: Cardio, Clinical Studies/Trials, Congresses and Meetings, Sorin