The MitraClip System: A Systematic Review of Indications, Procedural Requirements, and Guidelines

Abstract

Background Transcatheter interventions (TIs) are new treatment options for patients with severe mitral valve regurgitation (MR) who cannot undergo open mitral valve surgery (oMVS). Despite the lack of scientific evidence demonstrating the benefit of these procedures, there has been a steady increase in their use. The aim of this study was to evaluate whether there are any indication criteria, process, and structural requirements, or scientific society and institutional guidelines for the use of the MitraClip System (Abbott Vascular-Structural Heart, Menlo Park, California, United States). Method A systematic literature search was conducted using the common medical and scientific databases. Of a total of 1,395 publications, 42 publications met the inclusion criteria and were included for the evaluation. Results Despite a general lack of high-quality evidence and of consensus recommendations from scientific societies or institutions, an assessment of indication criteria and process and structural requirements for the use of the MitraClip System, including noncontrolled studies, was possible. The majority of studies agree that an interdisciplinary heart team including a cardiothoracic surgeon, an interventional cardiologist, and an echocardiographic specialist should actively participate in clinical decision making, and in the procedure itself. Participation in a scientific-based registry is strongly recommended. Conclusions The MitraClip System is a promising procedure, but evidence-based indication criteria, structural, and process requirements for its use are lacking. Further results from prospective, randomized controlled trials are needed to determine patients, potential adverse events, device durability, and long-term follow-up. MitraClip should be used in only a small number of centers with procedure-specific, high-quality surgical and interventional experience, and training.

Percutaneous Treatment Options for Recurrent Mitral Valve Disease after Failed Mitral Valve Surgery

“…In order to prevent emergency treatments, pre-interventional imaging plays a crucial role, in particular in patients with a repaired mitral valve. The decision whether a MC procedure or a percutaneous implantation of a mitral prosthesis is feasible and will result in durable benefit largely depends on morphological criteria, including definition of MR etiology, visibility of mitral valve leaflets, assessment of the mitral valve area and anterior mitral leaflet length, mobility and calcification as well as left ventricular outflow tract anatomy and annuloplasty ring characteristics [18,33]. The decision on the procedure of choice was taken based on a patient by patient analysis, taking into account all available clinical and imaging data as described above.…”