8-year outcomes of aortic valve replacement with the Carpentier-Edwards PERIMOUNT Magna Ease valve

Introduction: The Carpentier-Edwards PERIMOUNT Magna Ease valve is a third-generation bioprosthesis for aortic valve replacement (AVR). This is a postapproval study reporting on its 8‑year outcomes. Methods: Adults undergoing AVR with the Magna Ease valve between October 2007 and December 2012 were enrolled for this prospective, nonrandomized, single‑arm, multicenter study. Assessments occurred preoperatively, at hospital discharge, 6 months, 1 year, and annually thereafter up to 8 years. Outcomes included safety endpoints, hemodynamic performance, and New York Heart Association (NYHA) Functional Class. Results: Of the 258 study patients, 67.5% were in NYHA Class I or II, and 32.5% were in NYHA Class III or IV at baseline. Concomitant procedures were performed in 44.2%. Total follow-up was 1,597.6 patient-years, median follow‑up was 7 years (interquartile range: 5.5–8.0 years). Eight years following AVR, functional class remained improved from baseline with 93.9% in NYHA Class I/II and 6.1% in NYHA Class III; thirty-eight deaths had occurred, eight of which were valve related; freedom from all‑cause mortality was 80.7% (95% confidence intervals 74.9, 86.4); freedom from valve-related mortality was 95.8% (92.8, 98.8); freedom from reintervention, explant, major bleeding events, and structural valve deterioration were 89.8% (85.1, 94.6), 94.8% (91.7, 97.9), 85.1% (80.0, 90.1), and 90.1% (84.7, 95.4), respectively; effective orifice area was 1.5±0.5 cm 2 , mean gradient was 14.8±8.3 mmHg, and 88.6% of patients had no or trivial aortic regurgitation. Conclusions: This study demonstrated satisfactory safety and sustained hemodynamic and functional improvements at 8 years following AVR with the Magna Ease valve.