title: 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).
  
  
  METHODS
  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.
authors.affiliation: Competence-Center Quality Assurance, Medical Service of Statutory, Healthcare Insurance, Tuebingen and Stuttgart, Germany.
authors.forename: Dorothee Hl
authors.initials: DH
authors.lastname: Bail
authors.affiliation: Competence-Center Quality Assurance, Medical Service of Statutory, Healthcare Insurance, Tuebingen and Stuttgart, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Doebler
mesh_terms: D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards; D004867:Equipment Design; D006801:Humans; D008943:Mitral Valve / Q000503:physiopathology*; D008944:Mitral Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010348:Patient Care Team; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome