Long-term clinical and hemodynamic outcomes of the Perceval aortic sutureless bioprosthesis
F Leclercq, S Maamar, S Souidene, P Rouviere, A Nigeolean, M C Brunet, A Agullo, G Cayla, T Gandet, R De MariaAbstract
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.