HEALTH TECHNOLOGY ASSESSMENT FOR MITRACLIP SYSTEM IN PATIENTS WITH MITRAL REGURGITATION

Abstract

Approximately 2% of the population have mitral regurgitation (MR) and many may be not tolerant for mitral valve surgery. The objective of this thesis was to investigate the comparative safety, effectiveness, and cost-effectiveness of percutaneous mitral valve repair using MitraClip System for patients with severe MR. Articles in MEDLINE, Embase, CNKI, and the Cochrane Library published from 1997 to February 2017 were searched for evidence of safety and effectiveness. A systematic review was conducted to address the uncertainty in the safety and effectiveness of MitraClip system in patients with MR. A cost-effectiveness analysis and cost-utility analysis in U.S. settings was conducted to address the uncertainty in health economic evaluation for the MitraClip system. One randomized trial and seven observational studies were included in the systematic review. The pooled data show that 30-day, one-year and two-year survival are similar in MitraClip arm and surgery arm. Residual MR occurs more frequently after MitraClip therapy than surgery, especially in younger patients, functional MR patients, and patients whose LVEF<50%. The risk of 30-day major adverse event from lower odds ratio appeared to be lower in older patients and patients whose LVEF≥50%.For economic evaluation, the base case incremental costs per LY and per QALY were $ 28,217.18 and $27,344.38 US dollars, respectively. Results were most sensitive to alternative assumptions regarding time horizon and long-term survival. Therefore, low quality of evidence due to lack of conclusive RCT data suggested that MitraClip system may provide improvements in MR, patients’ quality of life and survival advantage. It is cost-effective as threshold of $50,000 U.S. dollars per QALY gained for high surgical risk patients. Future RCT designed to reduce confounding and lessen participant attrition, which have adequate sample size, consistent reporting of outcomes, and adequate length of follow-up period will better evaluate the clinical benefits of the MitraClip System.