Why the study?
Does transcatheter mitral-valve edge-to-edge repair reduce hospitalization for heart failure in patients with heart failure and moderate to severe mitral regurgitation?
Does transcatheter mitral-valve edge-to-edge repair reduce hospitalization for heart failure in patients with heart failure and moderate to severe mitral regurgitation?
This letter raises methodological concerns about the RESHAPE-HF2 trial, specifically regarding the inclusion of patients with potentially only mild mitral regurgitation and suboptimal baseline medical therapy.
To the Editor: In the RESHAPE-HF2 trial, Anker et al. (Nov. 14 issue) conclude that transcatheter mitral-valve edge-to-edge repair leads to a lower rate of hospitalization for heart failure. 1 However, there are several problems with how this conclusion was reached. First, the median effective regurgitant orifice area at baseline in the trial was 0.23 cm 2 , and 23% of the patients had an effective regurgitant orifice area of less than 0.20 cm 2 , a value that suggests mild mitral regurgitation, which is inconsistent with the inclusion criteria in the RESHAPE-HF2 trial (3+ or 4+ mitral regurgitation). Second, there was suboptimal baseline use . . .
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