title: Safety and efficacy of the MitraClip® system for severe mitral regurgitation: a systematic review.
abstract: BACKGROUND
  The MitraClip® system is a newer percutaneous device that has shown promising results but data on its safety and efficacy in low- and high-surgical risk populations continues to evolve. We performed a systematic review of the published studies reporting the safety and efficacy of MitraClip® implantation for treatment of moderate to severe and severe mitral regurgitation (MR).
  
  
  METHODS
  Reviewers independently searched for relevant articles in Medline and abstracted clinical information based on pre-defined criteria and end-points. Patients were classified as low- or high-surgical risk for conventional mitral valve (MV) surgery based on Society of Thoracic Surgeons score, EuroSCORE, or surgeon discretion. Primary safety outcome was 30-day mortality and primary efficacy outcomes were freedom from death, ≥3+ MR, and requirement for MV surgery during follow-up.
  
  
  RESULTS
  Immediate and long-term outcomes of 16 studies, including 2980 patients (age 73.7 ± 0.6 years; 63.3% males) receiving the MitraClip®, were analyzed. Acute procedural success rate was 91.4% with a procedural mortality of 0.1%. Mortality at 30 days and long-term (310 days) follow-up was 4.2 and 15.8%, respectively and was significantly higher in the high-risk group (P = 0.003 and 0.019, respectively). Incidence of major procedural adverse outcomes was relatively low with blood transfusion accounting for most events. At follow-up, the number of patients with ≥3+ MR reduced from 96.3% to 14.7% (P < 0.001), and those with NYHA class III/IV reduced from 83.2% to 23.4% (P < 0.001).
  
  
  CONCLUSIONS
  MitraClip® implantation for moderate to severe or severe MR appears to be safe with a very low procedural mortality. There is significant improvement in functional outcomes although long-term mortality is high, especially in high surgical risk patients.
authors: Division of Cardiology, University of Minnesota, Minneapolis, Minnesota.
authors: Kairav
authors: K
authors: Vakil
authors: Henri
authors: H
authors: Roukoz
authors: Mohammad
authors: M
authors: Sarraf
authors: Balaji
authors: B
authors: Krishnan
authors: Mark
authors: M
authors: Reisman
authors: Wayne C
authors: WC
authors: Levy
authors: Selcuk
authors: S
authors: Adabag
mesh_terms: D006328:Cardiac Catheterization / Q000379:methods*; D006350:Heart Valve Prosthesis; D006801:Humans; D008944:Mitral Valve Insufficiency / Q000175:diagnosis / Q000601:surgery*; D011474:Prosthesis Design; D012720:Severity of Illness Index
keywords: MitraClip; edge-to-edge mitral valve repair; mitral clip, mitral regurgitation