Late Clinical and Echocardiographic Results with the Magna Ease© Pericardial Aortic Bioprosthesis
Résumé
OBJECTIVES: The population of candidates to surgical aortic valve replacement (SAVR) is evolving. The Perimount Magna Ease© bioprosthesis has been introduced relatively recently in the practice. We aimed at evaluating its long-term results. METHODS: Single-center cohort of 1,016 consecutive SAVRs with the Magna Ease© valve (2008-2014), all-comers population. Prospective collection of in-hospital data, systematic clinical and echocardiographic follow-up. Evaluation of valve-related events: SVD, (structural valve deterioration, according to modified definition criteria), NSVD (nonstructural valve dysfunction), PPM (patient-prosthesis mismatch). RESULTS: Age at SAVR was 73.4 ± 9.5 years; calcified aortic stenosis was the indication to surgery in 59.6%. 974 patients entered the follow-up, 564 were alive at last follow; up (median duration: 9.8 years) (up to 13.4 years). NYHA class was I or II in 92.1%. Overall survival at 10 years was 56.8%±1.8. Freedom from SVD at 10 was 96.5%±0.8 (Kaplan-Meier), and 97.4%±0.6 (competing risks) (28 SVD events after 6.9 years ± 3.3). There were 15 reinterventions for SVD (redo-SAVR and TAVI); 10-year freedom from reintervention was 97.8% ± 0.6. Moderate and severe PPM occurred in 26.8% and 5.4%, respectively; without association with late mortality (p = 0.12 for moderate and p = 0.70 for severe PPM). Freedom from valve-related mortality was 97.8%±0.5 at 10 years. CONCLUSIONS: In this follow-up of the Magna Ease bioprosthesis for SAVR, data indicate good late outcomes (30-days outcomes are excluded). Continued follow-up is required to further support its use in patients with life expectancy greater than 10-12 years.