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Mitral Valve Clip for Treatment of Mitral Regurgitation: An Evidence-Based Analysis
Mohammed T Ansari1, Nadera Ahmadzai1, Kathryn Coyle2
1Ottawa Hospital Research Institute, Ottawa, Ontario.
Insights
Percutaneous mitral valve clip repair for chronic mitral regurgitation in high-risk patients has inconclusive evidence. More research is needed to determine its effectiveness, harms, and cost-effectiveness compared to surgery.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Health Economics
Background:
- Chronic mitral regurgitation affects 500,000 North American patients.
- Many patients are poor candidates for traditional mitral valve surgery.
Purpose of the Study:
- To investigate the comparative effectiveness, harms, and cost-effectiveness of percutaneous mitral valve repair using mitral valve clips.
- Focus on patients at prohibitive risk for surgery.
Main Methods:
- Searched MEDLINE, Embase, Cochrane Library, NHS EED, and Tufts CEA registry (1994-2014).
- Included systematic reviews, randomized trials, and economic studies.
- Assessed study validity using Cochrane risk of bias tool and Phillips checklist.
Main Results:
- Evidence on effectiveness and harms is inconclusive and of very low quality.
- Percutaneous mitral valve clip repair may offer a survival advantage in the first 1-2 years for some patients.
- Cost-effectiveness could not be established due to study limitations.
Conclusions:
- Evidence quality is very low due to risk of bias, indirectness, and imprecision.
- No meaningful conclusions can be drawn regarding mitral valve clips in prohibitive-risk patients.
Background:
Many of the 500,000 North American patients with chronic mitral regurgitation may be poor candidates for mitral valve surgery.
Objective:
The objective of this study was to investigate the comparative effectiveness, harms, and cost-effectiveness of percutaneous mitral valve repair using mitral valve clips in candidates at prohibitive risk for surgery.
Data Sources:
We searched articles in MEDLINE, Embase, and the Cochrane Library published from 1994 to February 2014 for evidence of effectiveness and harms; for economic literature we also searched NHS EED and Tufts CEA registry. Grey literature was also searched.
Review Methods:
Primary studies were sought from existing systematic reviews that had employed reliable search and screening methods. Newer studies were sought by searching the period subsequent to the last search date of the review. Two reviewers screened records and assessed study validity. We used the Cochrane risk of bias tool for randomized, generic assessment for non-randomized studies, and the Phillips checklist for economic studies.
Results:
Ten studies including 1 randomized trial were included. The majority of the direct comparative evidence compared the mitral valve clip repair with surgery in patients not particularly at prohibitive surgical risk. Irrespective of degenerative or functional chronic mitral regurgitation etiology, evidence of effectiveness and harms is inconclusive and of very low quality. Very-low-quality evidence indicates that percutaneous mitral valve clip repair may provide a survival advantage, at least during the first 1 to 2 years, particularly in medically managed chronic functional mitral regurgitation. Because of limitations in the design of studies, the cost-effectiveness of mitral valve clips in patients at prohibitive risk for surgery also could not be established.
Limitations:
Because of serious concerns of risk of bias, indirectness, and imprecision, evidence is of very low quality.
Conclusions:
No meaningful conclusions can be drawn about the comparative effectiveness, harms, and cost-effectiveness of mitral valve clips in the population with chronic mitral regurgitation who are at prohibitive risk for surgery.
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