Sutureless valve shows promise in patients requiring surgical AVR

Aortic valve replacement using sutureless technology was linked to low mortality and high hemodynamic performance, according to data presented at the Society of Thoracic Surgeons 53rd Annual Meeting.

Researchers collected data on the safety and efficacy of the Perceval sutureless valve (LivaNova) designed for patients who required surgical AVR.

“As one of the latest solutions in valve replacement surgery, the Perceval sutureless valve optimizes the overall surgical approach for surgeons,” Marco Solinas, MD, cardiac surgeon from the G. Monasterio Tuscany Foundation in Massa, Italy, said in a press release. “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.”

Marco Solinas

Researchers enrolled 617 patients (mean age, 76 years; 63% women; mean logistic EuroSCORE, 12.3%) who underwent surgical AVR with the Perceval bioprosthesis between March 2011 and December 2015.

Procedures that were concomitant to the study were mitral valve surgery (n = 74), CABG (n = 42), tricuspid valve repair (n = 22), myectomy (n = 3) and ascending aorta replacement (n = 2).

The study resulted in 12 cases of in-hospital mortality (1.9%), and 475 patients (77%) underwent minimally invasive surgical AVR with an upper ministernotomy or right anterior minithoracotomy approach, according to the data.

Times for cardiopulmonary bypass and aortic cross-clamp were 81.7 ± 29.1 minutes and 50.5 ± 19.8 minutes for isolated surgical AVR, and 138.7 ± 51.5 minutes and 91.5 ± 29.5 minutes for combined procedures, the researchers wrote.

Freedom from reoperation was 99%, and patient survival was 91.3% at 16-month follow-up.

“These positive results reinforce findings from previous studies for Perceval, the only truly sutureless valve designed for patients requiring surgical [AVR],” Brian Duncan, MD, vice president of medical affairs, cardiac surgery business unit at LivaNova, said in the release. “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.” – by Dave Quaile

Reference:

Concistrè G, et al. Aortic valve replacement with sutureless Perceval bioprosthesis: single-center experience with 617 implants. Presented at: Society of Thoracic Surgeons 53rd Annual Meeting; Jan. 21-27, 2017; Houston.

Disclosure: Duncan is an employee of LivaNova. Solinas reports receiving proctor support from Edwards LifeSciences and LivaNova.