The results from the Perceval Aortic Heart Valve Study in North America found that Perceval achieves positive safety and efficacy outcomes whether or not an open or minimally invasive surgical approach is used. The multi-center, prospective, non-randomized, single-arm clinical trial included 300 patients from 18 U.S. centers and was performed under an FDA Investigational Device Exemption. The results were published in the Journal of Thoracic and Cardiovascular Surgery.
The study’s primary endpoints included safety (mortality and morbidity) and effectiveness (clinical status, hemodynamic performance, and quality of life) at one year. Outcomes included:
- Substantial functional improvement with 97.6% of patients in New York Heart Association (NYHA) class I/II after surgery.
- Significant improvement in quality-of-life metrics.
- Overall low hospital mortality (1.3%) and rate of ≥ moderate paravalvular leak (1.3%).
The second article compares costs associated with the Perceval sutureless valve to those of traditional sutured valves. In the study at the Poliambulanza Hospital in Brescia, Italy, Perceval was assigned to patients at higher surgical risk, while a cohort of patients at lower surgical risk was treated with traditional sutured valves. Daily per-patient costs were calculated and included preoperative tests, operating costs, disposables, drugs, blood components, and personnel costs. The results demonstrated that hospital costs excluding the prosthesis were similar in the two groups.
“Despite higher operative risks in the Perceval group, hospital mortality, morbidity and resource consumption did not differ,” said Giovanni Troise, M.D., head cardiac surgeon at Poliambulanza Hospital, in a prepared statement. “Operating times were shorter with the sutureless device. This improvement, coupled with the increasing adoption of minimally invasive approaches, should further favor the Perceval valve’s market acceptance.”
The third article assessed the incremental cost-utility of surgical sutureless aortic valves compared to transcatheter aortic valves for the treatment of intermediate- to high-risk patients in the U.S., Germany, France, Italy, the U.K., and Australia. The cost-utility study relied on a meta-analysis comparing efficacy and safety outcomes. The study analyzed more than 1,400 patients treated with either surgical sutureless valves (95% of whom were Perceval patients) or transcatheter aortic valves. A simulation estimated the long-term consequences following patient discharge from the hospital.
Due to lower in-hospital and overall mortality rates, the study showed that patients treated with Perceval are expected to live an average of 1.14 quality-adjusted life-years greater than those treated with a transcatheter aortic valve. Lifetime cost savings were reported across the board in all geographies under analysis, the company said.
“These relevant findings acknowledge the clinical and economic relevance of adding sutureless valves as an integral part of your structural heart program,” said Mattia Glauber, M.D., head cardiac surgeon at Istituto Clinico Sant’Ambrogio in Milan, Italy. “Our institution performs Perceval implantations on a routine basis via right anterior thoracotomy – the ultimate minimally invasive surgical procedure. This approach generates clear patient benefits, economic advantages, and represents an ideal complement to transcatheter aortic valves in the appropriate patient risk category.”