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Published online by Cambridge University Press: 31 December 2019
Controversy regarding the efficacy of transcatheter mitral valve repair with a clip (TMVRc) in reducing the mitral regurgitation is related to the lack of solid scientific evidence. Worldwide, refusal or conditional acceptance for implementation of TMVRc, reflect ongoing uncertainty. We sought to apply a systematic multicriteria framework to ensure a fair and reasonable decision regarding the use of TMVRc in Quebec.
The framework included the following domains: context, quality of evidence concerning safety, efficacy and effectiveness, unmet patient needs, expected volume of patients, and impact on the health system including costs. Each domain within the framework was examined by a review of the literature and through consultations with a scientific advisory committee, a TMVRc clinical expert committee, TMVRc clinical teams, industry representatives and the Institut national d'excellence en santé et en services sociaux (INESSS) clinical excellence committee.
The literature review indicated that uncertainty about the efficacy and effectiveness of TMVRc persists, particularly in the real world context, and this view was supported by scientific experts. The TMVRc clinical teams provided insight into the burden of mitral insufficiency on patients and the health system and their belief in the promise of TMVRc. They also highlighted the challenges of patient selection and organizational issues related to the introduction of TMVRc within their institutions. The advisory committee stressed the need for further evaluation prior to wide diffusion.
Using a multicriteria framework facilitated a more standardized and transparent approach to our literature review and consultations as well as to the development of the proposed recommendations. This was especially important in the context of an evaluation of a promising new approach to treat mitral valve disease with many important uncertainties. This multi-criteria approach will facilitate a more standardized process for deliberation on how new health technologies should be implemented into the Quebec health system.