Safety and efficacy of the MitraClip® system for severe mitral regurgitation: A Systematic Review. Issue 1 (7th January 2014) - Vakil, Kairav
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). Conclusion: 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. © 2013 Wiley Periodicals, Inc.