Guidance
3 Committee considerations
The evidence
3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 17 sources, which was discussed by the committee. The evidence included 3 randomised controlled trials, 4 single-arm observational studies (1 of which was a register), 3 systematic reviews, 3 comparative observational studies and 3 case reports, and is presented in table 2 of the interventional procedures overview. The committee also considered data from the NHS England Commissioning through Evaluation MitraClip registry. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: reduction in mitral regurgitation, improved quality of life, improved symptoms according to the New York Heart Association classification, reduced hospital admissions, and survival.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: cardiac tamponade, bleeding and embolisation.
3.4 Twenty commentaries from patients who had experience of this procedure were received, which were discussed by the committee.
Committee comments
3.5 The committee was informed that a trained company representative is present for each procedure.
3.6 The committee was informed that the device used in this procedure has evolved over time.
3.7 The committee was informed that the outcomes of the procedure differ between patients with degenerative mitral valve regurgitation and those with functional mitral valve regurgitation.
3.8 The committee was informed that the outcome of the procedure is better in patients with well-preserved left ventricular function.
3.9 The committee received a number of patient commentaries, most of which were positive about this procedure.
3.10 The committee noted that most of the evidence comes from 1 device (MitraClip).
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