LivaNova has announced new data from the Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR) clinical study and the Sorin Universal Registry on Aortic Valve Replacement (SURE-AVR).
Results from a PERSIST-AVR sub-analysis demonstrated better clinical outcomes for patients with aortic valve stenosis who received the Perceval sutureless surgical aortic valve via minimally invasive surgery than patients who received a stented valve through the same access. Data from a SURE-AVR sub-analysis further supported positive findings for Perceval using minimally invasive surgery or full sternotomy. The results were presented during a series of presentations at the 34th Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS 2020, 8–10 October, virtual).
“The new PERSIST-AVR data presented at EACTS highlight that the Perceval valve is a reliable and essential technology to be considered as part of any comprehensive valve program and an essential complement to transcatheter technology. Due to its innovative sutureless design, Perceval facilitates minimally invasive cardiac surgery and offers these patients significant benefits such as decreased procedure times, fewer complications and fewer re-hospitalizations,” said Brian Duncan, vice president of medical affairs at LivaNova. “New findings from SURE-AVR presented at EACTS further demonstrate important benefits from innovation in our next-generation Perceval Plus valve resulting in improved patient outcomes.”
The prospective, randomised, multicentre, international PERSIST-AVR study assessed the safety, efficacy and non-inferiority of the sutureless Perceval valve compared with standard stented bio-prostheses using conventional or mini-sternotomy. A total of 910 patients with severe symptomatic aortic valve stenosis were enrolled in 12 countries. A total of 578 patients underwent isolated aortic valve replacement (AVR).
PERSIST-AVR results presented during EACTS showed that patients who received Perceval during a mini-sternotomy in isolated AVR had a significantly lower incidence of:
- Major adverse cardiovascular and cerebrovascular events (MACCEs) – 5.2% of the Perceval group versus 10.8% of the stented valve group
- New onset of atrial fibrillation – 4.2% in the Perceval group versus 11.4% in the stented valve group
- Stroke – 1% in the Perceval group versus 5.4% in the stented valve group
Roberto Lorusso, full professor in the Cardiothoracic Surgery Department of the Maastricht University Medical Centre, Maastricht, The Netherlands, presented the new PERSIST-AVR data. “In this sub-cohort, Perceval significantly reduced MACCEs at one-year follow up, reduced re-hospitalisation days and demonstrated a 30% reduction in cross-clamping time, providing patients with a minimally invasive and less traumatic surgical solution compared to stented valves,” he said. “This data is encouraging as it provides further evidence that Perceval facilitates minimally invasive surgery and simplifies complex procedures when time matters.”
The ongoing, prospective, international SURE-AVR registry used real-world data to compare outcomes of patients who received Perceval using MICS or conventional full sternotomy. SURE-AVR is collecting data on outcomes from patients at 60 sites in 18 countries. One sub-analysis presented at EACTS was based on data from 980 isolated AVR patients at 52 international institutions. A total of 676 patients underwent MICS and 304 received a full sternotomy. Results showed that Perceval enables MICS, providing a rate of successful implantation similar to that of full sternotomy.
Marco Solinas, G Monasterio Foundation Heart Hospital, Massa, Italy, presented the SURE-AVR registry data at EACTS. “These real-life results from an international registry showed that implanting Perceval during minimally invasive surgery resulted in significantly shorter ICU stays than a complete sternotomy and that Perceval in isolated AVR is associated with early- and mid-term good clinical and haemodynamic results both in minimally invasive surgery and full sternotomy,” said Solinas. “Furthermore, Perceval in minimally invasive surgery results in comparable cross-clamping time to full-sternotomy, eliminating the main concern for broader MICS adoption and reinforcing the role of Perceval as a minimally invasive surgery enabler.”
Analysis of the SURE-AVR registry also provided initial real-world clinical performance data of the Perceval Plus valve. Perceval Plus is designed to enhance the Perceval platform by decreasing permanent pacemaker implantation (PPI) rates and improving durability, further advancing the treatment of aortic valve stenosis. Of patients enrolled in SURE-AVR between March 2011 and February 2020, 1,374 underwent AVR with the Perceval valve and 121 with the Perceval Plus valve.
Maximilian Scherner, Department of Cardiac and Thoracic Surgery, University Hospital Magdeburg, Magdeburg, Germany, presented data from SURE-AVR related to Perceval Plus during EACTS. “Perceval Plus further improved patient outcomes with reduced pacemaker implantation rates compared to Perceval, while both valves were associated with overall low morbidity and mortality,” he said. “Changes to the design did not impact the sealing at the annulus, and both Perceval and Perceval Plus demonstrated a low percentage of paravalvular regurgitation.”
LivaNova received CE Mark for Perceval in 2011 followed by US Food and Drug Administration (FDA) approval in 2016. The company received CE Mark for Perceval Plus in 2018.