New Data on LivaNova Perceval Sutureless Aortic Valve Show Consistent Outcomes, Lower Procedure Times Compared to Sutured Valves
PERSIST-AVR study results presented at
PERSIST-AVR is the first prospective, randomized, multi-center international trial comparing Perceval outcomes with those of standard sutured valves. The study comes after more than 300 peer-reviewed publications providing clinical results obtained with Perceval. From
Perceval was found to be noninferior to, or equally as safe and effective as, sutured AVR with respect to the primary endpoint demonstrating freedom from MACCE at 91.6% for the Perceval group and 92.0% for the sutured AVR group. Additionally, the rate of early death after one year was low (1% in both groups) considering the need for coronary artery bypass grafting in almost one-quarter of the patient cohort.
The study showed that the use of Perceval sutureless AVR resulted in significantly lower procedure times. Cardiopulmonary bypass procedure times for isolated AVR and AVR combined procedures were shortened by 22% and 18%, respectively. Cross-clamp time for isolated AVR and AVR combined procedures was reduced by 30% and 21%, respectively. Further, significant improvement of functional status after surgery (using the New York Heart Association Functional Classification) and benefits persisted at one year.
In the control arm of the study, various stented AVR models in five sizes were used based on surgeon preference. The sutureless valve arm used four sizes of Perceval valves. Importantly, no difference was found with regard to paravalvular and central leak, demonstrating that Perceval ensures sealing at the aortic annulus equivalent to sutured valves. The rate of reintervention, stroke, endocarditis or other valve-related complications was also low in both groups. Implant success rates were statistically comparable, validating that Perceval allows for a safe and reproducible implant procedure. PERSIST-AVR data showed a higher permanent pacemaker implantation (PPI) rate with sutureless valves compared to sutured AVR, especially for the largest size valve. PPI has been found to be substantially reduced with modified intraoperative approaches and an emphasis on proper valve sizing.1,2
“The PERSIST-AVR data demonstrate that the Perceval sutureless aortic valve replacement is as safe and effective as traditional sutured valves. We are pleased with the findings from this important study, which validate many critical benefits of Perceval,” said Dr.
Now with the primary endpoint achieved and with up to three years of data from the study, long-term follow-up will be discontinued for PERSIST-AVR and emphasis will be placed on the study results analysis and the Company’s next-generation valve, Perceval Plus.
To date, more than 50,000 patients worldwide have been treated with the Perceval valve. To learn more about Perceval, visit www.livanova.com.
For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding Perceval and findings from the PERSIST-AVR clinical study. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended
Yanagawaet al. A simple modification to lower incidence of heart block with sutureless valve implantation J Thorac Cardiovasc Surg. 2016;152:630-632.
- Vogt et al. Sutureless Aortic Valve and Pacemaker Rate: From Surgical Tricks to Clinical Outcomes. The Annals of thoracic surgery. 2019;108:99-105.
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