Sutureless aortic prosthesis linked to positive 1-year hemodynamic, clinical, functional outcomes

A sutureless aortic prosthesis for use in standard-risk surgical patients was associated with positive outcomes at 1 year, according to results presented at AATS Week.

Patients aged at least 18 years requiring surgical aortic valve replacement were included in the prospective, nonrandomized, multicenter, investigational device exemption trial of the safety and efficacy of the prosthesis (Perceval, LivaNova).

Patients were eligible if they had aortic valve stenosis or steno-insufficiency and were not contraindicated for AVR with a biological prosthesis.

“In terms of safety ... we compared it to the risk of mortality as defined by the Society of Thoracic Surgeons,” Rakesh M. Suri, MD, DPhil, chief of staff and chair of thoracic and cardiovascular surgery at Cleveland Clinic Abu Dhabi, told Cardiology Today. “There was one-third of the risk associated with the implantation valve as compared to what would be expected across America, as gauged by the STS risk calculator.”

Rakesh M. Suri

The primary endpoints were safety, defined as morbidity and mortality, and effectiveness, defined as clinical status and hemodynamic performance improvement, at 1 year. Participants were evaluated via independent echocardiographic core laboratory and quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 days, 3 to 6 months and 12 months.

Of the 356 patients who qualified for the study, there were 300 who underwent a valve attempt (mean age, 77 years; 54% men); the others did not meet all inclusion criteria. Implantation succeeded in 289 patients and failed in 11 (success rate, 96.3%).

Suri said rates of cardiac death were 0.7% at 30 days, 2.1% at 6 months and 2.8% at 1 year, whereas rates of all-cause death were 1% at 30 days, 3.5% at 6 months and 4.8% at 1 year.

At 1 year, 2.1% of patients had their device explanted, 1% had stroke, 2.4% had any thromboembolism, 2.1% had primary paravalvular leak, 2.1% had endocarditis, 5.2% had renal failure and 13.1% had major bleeding.

There was an improvement of at least one NYHA class in 81.2% of patients and mean improvement in KCCQ summary score of 22.5 points between baseline and 1 year (P < .01), he said.

Additionally, there was an improvement in left ventricular mass index (P < .01) at 1 year, Suri said.

“[We confirmed] that the gradients were stable, meaning the effectiveness of reduction of valve blockage following [AVR] was comparable over the year and the size of the orifice as measured by aortic valve area was also similar and, if anything, slightly increased over the first 12 months,” Suri told Cardiology Today.

PAGE BREAK

According to Suri, full sternotomy was performed in 72% of patients and a minimally invasive approach was performed in 27%. In a population of 20 patients with a bicuspid aortic valve, 17 were successfully implanted and had favorable outcomes.

“When you think about a younger, lower-risk patient with the need to undergo [surgical AVR], they typically desire a minimally invasive approach and that’s one of the ways that this new valve really has the potential to make an impact,” Suri said. – by Dave Quaile

Reference:

Suri R, et al. LB4. Presented at: AATS Week 2017; April 29-May 3, 2017; Boston.

Disclosure: Suri reports no relevant financial disclosures.