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Percutaneous repair or medical treatment for secondary mitral regurgitation

New England Journal of Medicine Aug 31, 2018

Obadia JF, et al. - Researchers assessed whether or not percutaneous mitral-valve repair improves clinical outcomes in patients who have chronic heart failure with reduced left ventricular ejection fraction. Findings did not suggest a significant difference in the rate of death or unplanned hospitalization for heart failure at 1 year between patients who had percutaneous mitral-valve repair along with receiving medical therapy vs those who received medical therapy alone among patients with severe secondary mitral regurgitation.

Methods

  • Patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of > 20 mm2or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, were randomly assigned 1:1 to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients).
  • A composite of death from any cause or unplanned hospitalization for heart failure at 12 months was the primary efficacy outcome.

Results

  • In the intervention group, the rate of the primary outcome at 12 months was 54.6% (83 of 152 patients) and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53).
  • From any cause, the rate of death was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77).
  • In the intervention group the rate of unplanned hospitalization for heart failure, was 48.7% (74 of 152 patients) and in the control group it was 47.4% (72 of 152 patients) (hazard ratio, 1.13; 95% CI, 0.81 to 1.56).
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