Structured 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 cm2, 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.
Keywords
Aortic valve replacement; aortic stenosis; bioprosthetic valve;
bioprosthesis