Ten-year clinical and echocardiographic follow-up of third-generation biological prostheses in the aortic position.

Objectives: PERIMOUNT Magna Ease (Carpentier-Edwards; PME) prostheses have been widely implanted during the past decade for aortic valve replacement (AVR). Although promising results at midterm follow-up were reported, long-term outcome has yet to be confirmed. On this study we aimed to evaluate long-term results in terms of structural valve degeneration (SVD), major clinical outcomes, long-term hemodynamic valve performance, and left ventricular remodeling.

Methods: From 2010 to 2012, 689 consecutive patients underwent AVR with PME. Complete clinical 10-year follow-up was obtained. The degree of SVD was categorized on the basis of the latest guidelines. Echocardiographic data were analyzed at 1, 5, and 10 years. Competing risk analysis was performed for major events. Cumulative incidence of SVD, reoperation, and endocarditis were also assessed according to prosthetic sizes (19-21-23 mm vs 25-27-29 mm) and age (<65 vs 65-75 vs >75 years old).

Results: The overall cumulative incidence reported for SVD ≥2 and reoperation were 3.6% and 1.9% at 10 years, respectively. An early left ventricular reverse remodeling was noted after implantation and confirmed at follow-up. Patients younger than 65 years showed higher cumulative incidence of SVD ≥2 at 10 years compared with patients aged 65 to 75 and older than 75 years (9.7% vs 2.6% vs 2.7%; P = .013), as well as of redo AVR (7.8% vs 3.3% vs 0.4%; P = .002). There was no difference in terms of SVD and redo AVR for different prosthetic size categories (P > .05). The risk of endocarditis was similar among age and size groups.

Conclusions: PME provides very good durability at long-term and could be considered one of the high performing third-generation bioprostheses for AVR.