January 29, 2019 — LivaNova PLC announced the publication of three separate studies highlighting the performance of its sutureless aortic valve, Perceval.
The results from the Perceval Aortic Heart Valve Study in North America, performed under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), were published in the Journal of Thoracic and Cardiovascular Surgery1. The study confirmed 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.
The primary endpoints of this study included safety (mortality and morbidity) and effectiveness (clinical status, hemodynamic performance and quality of life) at one year and highlighted positive outcomes for Perceval, including:
- Substantial functional improvement, with 97.6 percent of patients in New York Heart Association (NYHA) class I/II after surgery;
- Significant improvement in quality of life metrics; and
- Overall low hospital mortality (1.3 percent) and rate of ≥ moderate paravalvular leak (1.3 percent).
In addition, two separate articles were recently published and serve as further proof of the favorable economic profile of the Perceval valve.
The second article2 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 the higher risk of complexity for the cases in the Perceval group. “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. “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 article3 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, 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 percent of which were Perceval patients) or transcatheter aortic valves. A simulation estimated the long-term consequences following patient discharge from 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 (QALYs) greater than those treated with a transcatheter aortic valve.
Lifetime cost savings were reported across the board in all geographies under analysis. “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.”
For more information: www.livanova.com
1. Suri et al, “Prospective US Investigational Device Exemption Trial of a Sutureless Aortic Bioprosthesis: One-Year Outcomes”, JTCVS 2018 – Article in press, DOI: https://doi.org/10.1016/j.jtcvs.2018.08.121
2. Villa et al, “Sutureless aortic valve replacement in high risk patients neutralizes expected worse hospital outcome: A clinical and economic analysis”, Cardiology Journal 2018 – Epub ahead of print+, DOI: 10.5603/CJ.a2018.0098 https://journals.viamedica.pl/cardiology_journal/article/view/CJ.a2018.0098
3. Povero et al, “Cost-utility of surgical sutureless bioprostheses vs TAVI in aortic valve replacement for patients at intermediate and high surgical risk”, ClinicoEconomics and Outcomes Research 2018:10 733–745, DOI https://doi.org/10.2147/CEOR.S185743