Transcatheter Mitral Valve Repair Device for the Treatment of Tricuspid or Tricuspid and Mitral Regurgitation: A Review of Clinical Effectiveness and Cost-Effectiveness

Key Message

This report included one single-arm study regarding the clinical effectiveness of the transcatheter mitral valve repair device (MitraClip) for the treatment of tricuspid regurgitation, and four single-arm studies regarding the effectiveness of the device for tricuspid or both tricuspid and mitral regurgitation. No evidence regarding the cost-effectiveness of the transcatheter mitral valve repair device for this indication was identified.

Overall, compared to pre-procedure, patients MitraClip for the treatment of tricuspid regurgitation or both tricuspid and mitral regurgitation had significantly improved tricuspid regurgitation grade, New York Heart Association functional class, edema, and ascites at follow-up. Across four studies that reported on procedural success, the percentage of patients with procedural success ranged from 92% to 97%. There was no statistically significant difference in quality of life between baseline and follow-up in the three studies that measured this outcome. Four of the studies showed statistically significant improvement in the six-minute walking distance at one month or six months, in patients who received tricuspid valve (TV) repair or both TV and mitral valve (MV) repair. One study observed a numerical (but not significant) improvement in the six-minute walking distance from baseline to one-year follow up.  For heart failure severity when comparing baseline and follow up, two studies found significant improvement; two studies found no statistically significant difference; and one study demonstrated a statistically significant improvement in patients who received TV-only repair but no significant difference in patients who received both TV and MV repair. The mortality incidence after the procedure was 4.7% to 7% across the included studies.

The findings summarized in this report have a high degree of uncertainty due to the limitations of the included studies (e.g., a total of 209 patients in single-arm studies, longest follow-up duration of one year).