Key result
Perceval sutureless bioprosthesis shows ~89% valve failure-free survival at 4.5 years.
Why the study?
Although the safety and efficacy of sutureless surgical aortic valve devices such as the Perceval bioprosthesis are well established, data regarding their durability were lacking.
Does surgical aortic valve replacement with the Perceval sutureless bioprosthesis provide durable bioprosthetic valve failure-free survival in patients with severe aortic stenosis?
Observational (n=191)
No
Does surgical aortic valve replacement with the Perceval sutureless bioprosthesis provide durable bioprosthetic valve failure-free survival in patients with severe aortic stenosis?
While the Perceval sutureless bioprosthesis shows good short-term efficacy, mid-term durability (81.4% BVF-free survival at 6 years) and a 20.4% overall permanent pacemaker implantation rate present clinical concerns.
Background Based on the TAVI model, new generations of sutureless surgical devices, such as the Perceval bioprosthesis, have emerged as innovative alternatives for surgical aortic valve replacement. Purpose Although safety and efficacy of the sutereless devices are well established, data regarding their durability are lacking. Methods This monocentric study included consecutive patients who underwent aortic valve replacement with the Perceval sutureless bioprosthesis between Novembre 2013 and March 2022 for severe aortic stenosis. The primary endpoint was bioprosthetic valve failure (BVF) free survival at mean follow-up defined according to the 2021 Valve Academic Research Consortium-3 criteria. Secondary endpoints included aortic valve reintervention or structural valve deterioration (SVD) free-survival , incidence of permanent pacemaker implantation (PPI), stroke or transient ischemic attack (TIA), cardiac-related rehospitalization, and cardiac-related mortality at mean follow-up. Results A total of 191 patients were included, with a mean age of 75 years. Early mortality and PPI rate (≤ 30 days) was 3.7 % (n=7) and 13.6 % (n=26), respectively. With a mean follow-up of 4.5 years, BVF-free survival was 88.5% (95%CI= 82.2; 92.6), free from SVD was 95.7% (95%CI= 90.6; 98.1), and reintervention-free survival was 97.9% (95%CI= 93.5; 99.3) (figure) . At 6 years follow-up, it was 81.4%, 88.2% and 92% respectively. PPI was required in 20.4% of patients, with conduction abnormalities at cardiopulmonary bypass weaning (p=0.0003) and pre-existing conduction disorders (p=0.007) identified as independent predictors. Stroke/TIA-free survival, cardiac rehospitalization-free and freedom from cardiac-related death rates were 79.5%, 65.4% and 88.5% respectively. Conclusions The Perceval sutureless bioprosthesis demonstrates good short-term outcomes in terms of mortality and efficacy. However mid-term durability and high rate of conductive disorders requiring PPI may be a concern.
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Leclercq et al. (2026) conducted an observational in Severe aortic stenosis (n=191). Perceval sutureless bioprosthesis was evaluated on Bioprosthetic valve failure (BVF)-free survival at mean follow-up (VARC-3 criteria) (95% CI 82.2-92.6). The Perceval sutureless bioprosthesis achieved 88.5% (95% CI 82.2-92.6) bioprosthetic valve failure-free survival at a mean follow-up of 4.5 years, with a 20.4% pacemaker rate.
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