Late clinical and echocardiographic results with the Magna Ease© pericardial aortic bioprosthesis.

Abstract

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. This article describes a single-centre cohort of 1016 consecutive SAVRs with the Magna Ease© valve (2008-2014), consisting of an all-comers population. We performed a prospective collection of in-hospital data, systematic clinical and echocardiographic follow-up. Valve-related events were as follows: structural valve deterioration (SVD; according to modified definition criteria), nonstructural valve dysfunction, patient-prosthesis mismatch (PPM). Age at SAVR was 73.4 ± 9.5 years; calcified aortic stenosis was the indication to surgery in 59.6%. A total of 974 patients entered the follow-up; 564 were alive at the last follow-up (median duration: 9.8 years) (up to 13.4 years). New York Heart Association 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 ± 3.3 years). There were 15 reinterventions for SVD (redo-SAVR and Transcatheter Aortic Valve Implantation (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. In this follow-up of the Magna Ease bioprosthesis for SAVR, data indicate good late outcomes (30-day outcomes are excluded). Continued follow-up is required to further support its use in patients with life expectancy >10-12 years.