INTRODUCTION
Stenosis and regurgitation are common conditions affecting the aortic
valve.[1] When severe and symptomatic, aortic valve replacement
(AVR) is the guideline-recommended treatment.[2, 3] Over the last
two decades, the proportion of AVR undertaken with bioprostheses has
increased, substituting for mechanical valve prostheses.[4]
The effectiveness and durability of the Carpentier-Edwards PERIMOUNT
valve (Edwards Lifesciences, Irvine, CA, USA), a stented bovine
pericardial bioprosthesis, have been well described.[5-8] The
Carpentier-Edwards PERIMOUNT Magna Ease aortic valve (model 3300TFX;
Edwards Lifesciences) is an evolution of the original PERIMOUNT valve.
The reduced profile was designed to facilitate supra-annular placement.
It also incorporates a scalloped sewing ring to improve conformity with
the native aortic leaflet attachment line. The Magna Ease valve was
approved by the United States (US) Food and Drug Administration (FDA) in
2009. In a single-center study, it demonstrated excellent mid-term
survival and good hemodynamics, but additional durability data are
required.[11] This study was conducted to satisfy conditional FDA
approval, evaluating the 8‑year safety and effectiveness of the Magna
Ease valve in patients undergoing AVR with or without concomitant
procedures.