Italian cardiovascular technology company Sorin Group tells us about the presentation of data at this year’s AATS meeting, demonstrating improved clinical outcomes after use of the next-generation Perceval sutureless aortic valves in European patients with severe aortic stenosis.
The Perceval sutureless biological valve represents one of the latest innovations in heart valve technology from a long line of products designed and manufactured by Sorin Group. Sorin’s sutureless biological aortic valve, which it calls Perceval. features a unique self-anchoring frame that enables the surgeon to replace the native diseased valve without suturing it into place. Implanted in over 10,000 patients in over 300 centers, in 34 countries across the world, the Perceval valve is currently under review by the U.S. FDA.
The new study findings were presented in three oral presentations at the 95th Annual American Association of Thoracic Surgery (AATS) Meeting held from April 25 to April 29, in Seattle, USA.
Study 1: The first set of findings compared rates of short and mid-term survival among 991 patients with severe aortic stenosis and an intermediate/high risk profileSTS Score 4-8%) following treatment with conventional surgery (sAVR), sutureless valve replacement (with Perceval) and Transcatheter Aortic Valve Replacement (TAVR). Conventional or sutureless valve replacement demonstrated significantly greater survival than the TAVR group.
“These results demonstrate that for intermediate-high risk patients, Perceval valve is associated with lower rates of mortality and postoperative complications compared to TAVR,” said Professor Claudio Muneretto, M.D.,Ph.D., Director of the Department of Cardiac Surgery at the University of Brescia Medical School in Brescia, Italy.
Study 2: “The rise of new technologies for aortic valve stenosis: a propensity-score analysis from two multicenter registries comparing sutureless and trans-catheter aortic valve replacement” presented by Dr. Augusto D’Onofrio showed that Perceval valves had better device success and a lower rate of mild paravalvular leakage (PVL) when compared to TAVR in patients with severe symptomatic aortic stenosis,
Study 3: “First Large Cohort with a Sutureless Aortic Valve: The 1 Year Follow-Up of 628 Consecutive Patients from an International Multicenter Prospective Trial” (CAVALIER) presented by Prof. Theodor Fischlein, Nürnberg, confirmed the safety and effectiveness of the Perceval Sutureless aortic valve at 1 year in a prospective, non-randomized, multi-center study.
The results showed that, despite the fairly old population (40% octogenarians) with an intermediate patient risk profile (STS Score 7.2%), the overall clinical outcomes at 1 year suggest a low rate of cardiac mortality, stroke, major paravalvular leak, valve explants, and no incidents of valve migration, valve thrombosis, or structural valve deterioration. The patient clinical status improved and remained stable throughout follow up.
“We’re committed to bringing advanced state-of-the-art treatment options to patients with critical unmet cardiovascular needs, and study results continue to reinforce the clinical evidence of Perceval valves,” said Michel Darnaud, President, Cardiac Surgery Business Unit. “Perceval valves have shown to enhance physician and patient experience during surgery, through reduced cross clamp time and shorter required stays in the ICU, and are also associated with improved short and mid-term outcomes over TAVR for aortic stenosis patients who are considering alternatives to conventional surgery. A recent study, reporting the widest and longest follow-up study of sutureless valves published to date, also demonstrates that Perceval is safe and efficacious up to five years, showing promising results also versus standard AVR.1”
Source: Business Wire