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.