LivaNova PLC (NASDAQ:LIVN) has announced that new clinical data for its sutureless surgical aortic valve, Perceval ®, will be unveiled at this year’s American Association for Thoracic Surgery (AATS) meeting.
On May 4, Prof. Bart Meuris from Leuven University Hospital (BE) will present the data from his center’s 11-year clinical experience with Perceval, which represents the longest clinical follow-up for the valve that has been published. The results demonstrate the strong performance of the Perceval valve both in terms of durability and outcomes, which reaffirm its position as a trusted platform. Of particular significance in the findings is the absence of explants due to structural valve deterioration (SVD), as well as the low rate of paravalvular leak (PVL) reported.
The retrospective, observational, single-center study included 468 consecutive patients implanted with Perceval between 2007 and 2017:
- Patient mean age was 79, mean EuroSCORE II was 5.0 and STS score was 5.8.
- The majority of the cases treated were all-comers, including emergencies.
- 55% of cases were conducted as part of concomitant procedures, while a high rate of the isolated aortic valve replacement (AVR) cases was carried out through minimally invasive surgery.
This new clinical data folds into the extensive literary evidence already available surrounding the Perceval technology and its use in hospitals around the world.
“The Perceval sutureless valve offers a stable, time-saving and safe surgical result, both in isolated and in combined procedures,” said Prof. Meuris based on the results from his 11-year experience with Perceval. “We observed promising long-term durability given the current low incidence of SVD after 11 years of continued clinical use.”
“It is critical for a distinctive technology such as Perceval to have strong, real life data to back up its success,” said Alistair Simpson, LivaNova General Manager of Cardiac Surgery. “We are extremely proud of these impressive results at Leuven that further demonstrate the versatility of our valve in isolated and concomitant procedures. The fact that no explants were carried out as a result of SVD, and that PVL was very low is a testament to the quality of our innovative valve design and to our commitment of improving patient care.”
The presentation by Prof. Meuris, “Sutureless AVR Experience in a Single Centre: 11 Years of Use in 468 Patients,” will take place on May 4 at AATS 2019 in Toronto:
- Session Name: Minimal Surgery and Novel Approaches
- Session Time: 10 – 11:30 a.m.
- Session Location: MTCC, 206AC
- Presentation Time: 11 – 11:15 a.m.
To read the abstract from the presentation, visit the AATS website.