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J Thorac Cardiovasc Surg 2008;135:237-239
© 2008 The American Association for Thoracic Surgery

Editorial

Percutaneous treatment of mitral regurgitation: So near, yet so far!

Cardiopulmonary Research Science and Technology Institute, Dallas, Tex.

Received for publication June 25, 2007; accepted for publication July 9, 2007.

^_* Address for reprints: Michael J. Mack, MD, 7777 Forest Lane, Suite A-323, Dallas, TX 75230. (Email: mmack@crsti.org).

The first 300 words of the full text of this article appear below.

Dr Mack

The percutaneous treatment of mitral regurgitation (MR) is now a clinical reality, with multiple innovative devices in proof of concept and feasibility trials and one device well into a pivotal study. More than 350 percutaneous mitral valve repair procedures have been performed with at least 6 different devices in the past 3 years. Whereas progress has been rapid and early clinical efficacy has been demonstrated in transcatheter aortic valve therapy, the demonstration of clinical benefit has been somewhat more elusive in percutaneous mitral valve therapy. This development scenario is the opposite of what was widely anticipated 5 years ago, as preclinical proof of concept studies were completed and the brave new world of clinical transcatheter valve therapy was about to commence. It seemed that that the larger clinical unmet need and greater safety margins for transcatheter mitral valve therapy would drive the clinical adoption of this technology much faster than aortic interventions. However, a number of issues have proven problematic in the road to clinical reality, including the inability to demonstrate effective proof of concept and clinical efficacy, and hurdles in regulatory trial design and patient selection.

Concepts are being used to treat MR caused by both intrinsic degenerative diseases and annular dilatation associated with functional MR (FMR) (Table 1). Percutaneous mitral valve approaches can be divided into those that address the leaflets, which are mainly but not totally being used for intrinsic disease, and those that use various concepts of annular remodeling in FMR. The Evalve Mitraclip (Evalve, Inc, Redwood City, Calif) device and the Edwards Mobius Stitch (Edwards Lifesciences, LLC, Irvine, Calif) device are based on the concept of the edge-to-edge leaflet approximation technique of Alfieri and colleagues.¹ Some 248 patients have been enrolled in the various Evalve trials, including 55 in the EVEREST . . . [Full Text of this Article]

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