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.