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Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation.

Authors :: Obadia JF
Messika-Zeitoun D
Leurent G
Iung B
Bonnet G
Piriou N
Lefèvre T
Piot C
Rouleau F
Carrié D
Nejjari M
Ohlmann P
Leclercq F
Saint Etienne C
Teiger E
Leroux L
Karam N
Michel N
Gilard M
Donal E
Trochu JN
Cormier B
Armoiry X
Boutitie F
Maucort-Boulch D
Barnel C
Samson G
Guerin P
Vahanian A
Mewton N
Source :: The New England journal of medicine [N Engl J Med] 2018 Dec 13; Vol. 379 (24), pp. 2297-2306. Date of Electronic Publication: 2018 Aug 27.
Publication Year :: 2018
Abstract: Background: In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown.<br />Methods: We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm <superscript>2</superscript> or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, 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). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months.<br />Results: At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group 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). The rate of death from any cause 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). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56).<br />Conclusions: Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).