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Mitraclip Plus Medical Therapy Versus Medical Therapy Alone for Functional Mitral Regurgitation: A Meta-Analysis.

ABSTRACT: INTRODUCTION:The purpose of this meta-analysis is to compare the efficacy of MitraClip plus medical therapy versus medical therapy alone in patients with functional mitral regurgitation (FMR). FMR caused by left ventricular dysfunction is associated with poor prognosis. Whether MitraClip improves clinical outcomes in this patient population remains controversial. METHODS:We conducted an electronic database search of PubMed, CINAHL, Cochrane Central, Scopus, Google Scholar, and Web of Science databases for randomized control trials (RCTs) and observational studies with propensity score matching (PSM) that compared MitraClip plus medical therapy with medical therapy alone for patients with FMR and reported on subsequent mortality, heart failure re-hospitalization, and other outcomes of interest. Event rates were compared using a random-effects model with odds ratio as the effect size. RESULTS:Five studies (n = 1513; MitraClip = 796, medical therapy = 717) were included in the final analysis. MitraClip plus medical therapy compared to medical therapy alone was associated with a significant reduction in overall mortality (OR = 0.66, 95% CI = 0.44-0.99, P = 0.04) and heart failure (HF) re-hospitalization rates (OR = 0.57, 95% CI = 0.36-0.91, P = 0.02). There was reduced need for heart transplantation or mechanical support requirement (OR = 0.48, 95% CI = 0.25-0.91, P = 0.02) and unplanned mitral valve surgery (OR = 0.21, 95% CI = 0.07-0.61, P = 0.004) in the MitraClip group. No effect was observed on cardiac mortality (P = 0.42) between the two groups. CONCLUSIONS:MitraClip plus medical therapy improves overall mortality and reduces HF re-hospitalization rates compared to medical therapy alone in patients with FMR.

SUBMITTER: Goel S

PROVIDER: S-EPMC7237594 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveThe Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival.MethodsWe used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty.ResultsIn-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year.ConclusionsThe addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.

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Mitraclip Plus Medical Therapy Versus Medical Therapy Alone for Functional Mitral Regurgitation: A Meta-Analysis.

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