Medium-term results and the impact of structural valve deterioration of Trifecta versus Perceval bioprostheses: analysis from the Perfecta study

Trifecta 与 Perceval 生物瓣膜的中期结果及结构性瓣膜退化的影响:来自 Perfecta 研究的分析

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Abstract

INTRODUCTION: Surgical aortic valve replacement remains the most effective treatment for severe aortic valve disease, thanks to the evolution and development of new-generation biological prostheses. AIM: The study aimed to compare the follow-up results of aortic valve replacement with implantation of the Perceval sutureless bioprosthesis and St. Jude Trifecta sutured bioprosthesis (the single-center Perfecta study), evaluating the following end-points: survival, event-free survival rates, and impact of structural valve deterioration (SVD) on freedom from reintervention. MATERIAL AND METHODS: Between December 2014 and June 2023, 280 patients underwent aortic valve replacement with Trifecta (n = 220; mean age: 75.2 ±6.5 years) and Perceval implantation (n = 60; mean age: 77.9 ±5.1 years); 274 survivors (Trifecta = 214, Perceval = 60) were followed. RESULTS: At 7 years for both bioprostheses, Trifecta vs.Perceval, survival (68 ±4.1% vs. 89 ±4.8%; p = 0.19), freedom from cardiac death (90 ±2.3% vs. 94 ±1.7%; p = 0.38), from endocarditis (96 ±1.4% vs. 94 ±3.0%; p = 0.99) and from reintervention (98 ±1.4% vs. 100%; p = 0.13) were similar. SVD was observed in 60 Trifecta implants - 53 of which were in the initial stages - and in one in Perceval implant. Freedom from overall SVD was 74 ±4.2% vs. 93 ±6.4% (p = 0.09). Moderate patient-prosthesis mismatch was more frequently observed in the Trifecta than the Perceval group (n = 38 [17.3%] vs. n = 5 [8.2%]; p = 0.004). Independent predictors of SVD, both in the initial stages and overall, were Trifecta implantation (HRs 20.5;22.4) and moderate PPM (HRs 2.5;2.3). NYHA class (I-II 79.6% and 98.3% vs. 46.3% and 40%) significantly improved compared to preoperatively in both groups (p < 0.001). CONCLUSIONS: Both bioprostheses appear to confer equally satisfactory late outcomes. Although the Trifecta prosthesis carries a higher risk of SVD, this risk does not seem to be significantly associated with worse clinical conditions or need for reoperation. The Perceval prosthesis can be considered a viable option in the context of the latest-generation bioprostheses.

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