Sorin announces enrolment completion for the Perceval IDE US study


Sorin has completed US enrolment of the Perceval Investigation Device Exemption (IDE) trial. The trial enrolment was completed on schedule with the implantation of 300 patients.

The IDE study is designed as a prospective, non-randomised, multicentre clinical trial. The purpose of this study is to demonstrate the safety and effectiveness of the Perceval valve when used to replace diseased or dysfunctional aortic valves or aortic valve prostheses. The patients enrolled in the US IDE study were all adult patients suffering from aortic valve stenosis or steno-insufficiency, indicated for native or prosthetic aortic valve replacement and available for postoperative follow-up beyond one year. In total, 18 US centres took part in the study with the first patient enrolled in June 2013. The US principal investigator of the study is Rakesh Suri of the Mayo Clinic. The objectives of the trial are to establish safety and clinical efficacy of the Perceval valve in comparison to historical controls.

For the patients who remain candidates for traditional surgical aortic valve replacement, Sorin says the Perceval valve offers the potential benefit of shortening the time spent supported by the heart-lung machine. All this is performed without the need for sutures around the valve, thereby offering the possibility of shorter operative times, decreased complication rates, and use of minimally invasive approaches.

Results from a similar study conducted in Europe were presented at the 29th EACTS congress in Milan. The Perceval CAVALIER trial included results from a pooled European multicentre experience. The trial was designed to evaluate the safety and effectiveness of the Perceval valve in a large population requiring aortic valve replacement with or without concomitant coronary bypass grafting. A total of 658 patients were implanted at 25 European centres. The 30-day results, presented by François Laborde, IMM, Paris, France, demonstrated the safety of Perceval with excellent haemodynamics, a low complication rate, and ease of implant with a reproducible technique in both traditional sternotomy and the less invasive approach.

In a second study presented by Malakh Shrestha (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 of follow-up. No valve migration, structural valve degeneration or valve thrombosis was observed in the largest patient cohort 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%) suggested favourable safety and efficacy profile of the Perceval valve. An additional benefit was the very low endocarditis rate of 0.3%.

The EACTS 2014 congress also highlighted the economic impact of Sorin’s solutions with Bart Meuris, University Hospitals of Leuven, Belgium, who presented favourable health economic data for Perceval sutureless valves compared to traditional stented valves (Perimount, Edwards Lifescience). The mean total cost of the Perceval patients group compared with Perimount, net of valve costs, showed a reduction of 27%, ie. a mean reduction of €8,176 (US$9,635) per case. These cost savings were mainly driven by reduced hospital stay costs and significantly lower procedural costs. In summary, patients implanted with Perceval recovered faster than with Perimount, which led to increased hospital savings overall.

In line with the European findings, a recently published article (Hector I Michelena et al., An Alternative for Surgical Management of Calcific Aortic Valve Stenosis: Sutureless Valve Implants. J Card Surg 2014; XX:1–4) reported the first successful experiences with Perceval in the USA, highlighting how the absence of major surgical complications, identifiable reductions in bypass/cross-clamp times, and complete absence of paravalvular leak are potentially appealing features of this device for severe calcific aortic valve stenosis.