LivaNova (NSDQ:LIVN) said today that its Perceval sutureless implant is safe and effective compared to standard aortic valve replacement, according to a clinical study.
The study, presented at the 100th annual meeting of the American Association of Thoracic Surgery (AATS), revealed that the Perceval sutureless surgical aortic valve demonstrated freedom from major adverse cerebral and cardiovascular events at a rate of 91.6% compared with 92% for the sutured aortic valve replacement (AVR) group, according to a news release.
Between March 2016 and September 2018, the Persist-AVR trial enrolled 910 patients with severe symptomatic AVR across 12 countries. Those patients were undergoing open-heart with and without coronary artery bypass grafting, including some receiving conventional or mini-sternotomy.
The rate of death after one year stood at 1% in both groups, while use of the Perceval implant shortened cardiopulmonary bypass procedure times for isolated AVR and AVR by 22% and 18%, respectively. Cross-clamp time for isolated AVR and AVR went down by 30% and 21%, respectively.
Using the New York Heart Association Functional Classification, the study determined that significant improvement of functional status after surgery and benefits persisted at one year.
The control arm of the study used various stented AVR models in five sizes, while the sutureless valve arm used four sizes of Perceval valves. LivaNova said the study found no difference with regard to paravalvular and central leak, while the rate of reintervention, stroke, endocarditis or other valve-related complications was low in both groups.
Implant rates recorded were statistically comparable and the sutureless valves showed a higher permanent pacemaker implantation (PPI) rate compared to sutured AVR, especially for the largest size valve.
Dr. Theodor Fischlein, director of the cardiac surgery dept. at Paracelsus Medical University Cardiovascular Center, Nuremberg Clinic, presented the data and said the findings confirm that Perceval can be considered “an important addition to any comprehensive valve program.”
LivaNova said that, having met its primary endpoint with up to 3 years of data from the study, it is discontinuing long-term follow-up for Persist-AVR. Instead, it plans to focus on study results analysis and its Perceval Plus next-generation valve.
“The Persist-AVR data demonstrate that the Perceval sutureless aortic valve replacement is as safe and effective as traditional sutured valves,” LivaNova VP of medical affairs Dr. Brian Duncan said in the news release. “We are pleased with the findings from this important study, which validate many critical benefits of Perceval. We continue to pursue innovation for our heart valve technologies and have introduced design enhancements with the next-generation Perceval Plus valve to mitigate PPI rates and further advance treatment of aortic valve stenosis.
“We are seeing very promising initial results, building on our strong body of evidence from clinical experience with Perceval, which now extends to more than 13 years.”