LivaNova has announced the presentation of data from multiple studies demonstrating the safety and the effectiveness of the Perceval sutureless valve for aortic valve replacement patients and the Memo 3D ReChord for mitral valve repair. The three data presentations on Perceval, which included a late-breaking clinical trial and a poster presentation on the Memo 3D ReChord, were unveiled at the American Association for Thoracic Surgery (AATS) Centennial meeting (29 April—3 May, Boston, USA).
Key data presented included the late-breaking clinical trial presentation, “Prospective US IDE trial of a new sutureless aortic bioprosthesis in standard risk surgical patients: one year haemodynamic, clinical and functional outcomes,” which found that Perceval was a safe and effective aortic valve replacement device in surgical patients. The prospective, single-arm clinical trial consisting of 300 patients demonstrated that following sutureless valve therapy support, patients experienced haemodynamic relief from aortic stenosis and improvement in quality of life. At one-year follow up, health-related quality of life score increased from 63.2±22 before surgery to 85.4±18.1 at follow up.
Rakesh Suri (Cleveland Clinic and Cleveland Clinic Abu Dhabi) says: “The results of this prospective clinical trial approved under a FDA investigational device exemption (IDE) confirmed the safety and efficacy outcomes previously reported in three European clinical trials and several independent publications both in isolated and combined procedure and in any surgical approach. From this prospective trial, the demonstrated haemodynamics and enhancements in patient quality of life support the practice and use of sutureless valves in patients with severe aortic valve stenosis.”
The second presentation, “Sutureless aortic valves vs. transcatheter aortic valve in patients with severe aortic stenosis and intermediate risk profile: a propensity match comparison in the real world,” analysed and compared the outcome of intermediate-risk aortic stenosis patients undergoing isolated sutureless and transcatheter aortic valve implantation (TAVI) implants. The study found that at 30-day follow up, patients treated with the sutureless valve had a significantly lower mortality rate. At mean follow up of 36 months, the overall survival and freedom from adverse events were significantly better among patients who underwent sutureless valve procedures. When compared to TAVI, the use of Perceval significantly improved patient outcomes for intermediate-risk patients with isolated aortic stenosis.
Adding to the growing Perceval evidence base, the data presentation, “Sutureless aortic valve replacement in high risk patients neutralises expected worse hospital outcome: a clinical economic analysis,” highlighted the clinical and economic impact of using the Perceval valve in high-risk patients compared to those who underwent sutured valve aortic valve replacement with lower preoperative risk. The analysis found that, despite the higher patient risk profile in the Perceval group, the use of the sutureless valve resulted in no change to hospital mortality and hospital resources consumption compared to sutured valves.
Finally, in addition to the Perceval sutureless valve data unveiled at AATS Week, Antonio Lio (Istituto Clinico S. Ambrogio, Milan, Italy) presented a poster on a multicentre study from European and Asian centres demonstrating the benefits of the Memo 3D ReChord annuloplasty ring. As a prosthetic ring featuring an innovative chordal guiding system, the Memo 3D ReChord is used to treat patients with degenerative mitral valve disease.
The study, “Early outcomes of mitral valve repair using a new prosthetic ring with a chordal guiding system: a multicentre study,” showed that the use of Memo 3D ReChord during mitral valve repair procedures allowed surgeons to implant more accurately. With a short learning curve, use of the device could potentially improve surgical safety and shorten operation times for patients.