Results from the study was presented at The Society of Thoracic Surgeons 53rd annual meeting last week.
Data came from 617 patients who underwent aortic valve replacements at a single center, London-based LivaNova said, and indicated a 99% rate of freedom from reoperation and 91.3% survival rate at 16 months. The company said the study is the largest single center experience with the Perceval valve to date.
“As one of the latest solutions in valve replacement surgery, the Perceval sutureless valve optimizes the overall surgical approach for surgeons. In the presented analysis, implantation with Perceval allowed surgeons to perform minimally invasive approaches with shorter procedure times, specifically reducing the cross-clamp and cardiopulmonary bypass time, which can lead to faster recovery times for patients,” Dr. Marco Solinas of Massa, Italy’s Monasterio Tuscany Foundation said in prepared remarks.
“These positive results reinforce findings from previous studies for Perceval1, the only truly sutureless valve designed for patients requiring surgical aortic valve replacement. With the foundation of advancing technology and transforming lives, LivaNova is committed to delivering advanced solutions for cardiac surgery and we look forward to continuing the expansion of Perceval’s clinical evidence base and its growing use in the international cardiac surgery community,” cardiac surgery medical affairs VP Dr. Brian Duncan said in a press release.
Last April, LivaNova said the 1st patient in the Persist-AVR trial of its Perceval sutureless aortic valve was implanted with the device at Nancy, France’s University of Lorraine.
The company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing the Perceval valve result in shorter intensive care unit stays, reduced ventilation time and less blood transfusions.
The Persist-AVR trial is slated to enroll over 1,200 patients with severe symptomatic aortic stenosis or steno-insufficiency in patients who are candidate for surgical replacement of their native aortic valves. In the trial, the company’s Perceval valve will be compared against standard sutured bioprosthesis in patients with aortic valve disease, the company said.