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

Abstract

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 , 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.