Key result
Transcatheter edge-to-edge mitral valve repair added to guideline-directed medical therapy reduced all hospitalizations for heart failure compared to medical therapy alone (61% vs. 83%, HR 0.49) at 5 years.
Why the study?
Does transcatheter edge-to-edge mitral valve repair (M-TEER) added to GDMT reduce hospitalizations for heart failure in patients with severe functional mitral regurgitation?
Does transcatheter edge-to-edge mitral valve repair (M-TEER) added to GDMT reduce hospitalizations for heart failure in patients with severe functional mitral regurgitation?
Hazard Ratio: 0.49 (95% CI 0.4–0.61)
Absolute Event Rate: 61% vs 83%
Despite the reported clinical benefits of M-TEER at 5 years in COAPT, this editorial argues that inadequate medical therapy and a lack of sustained echocardiographic improvements undermine the trial's conclusions.
Efficacy of Transcatheter Edge-to-Edge in Functional Mitral RegurgitationFunctional mitral regurgitation (FMR) is the result of tridimensional distortion in spatial configuration of the mitral valve (MV), whose constituent elements remain organically intact.It results from an imbalance between the forces of tension and coaptation in the opening and closing mechanism of the MV.As such, FMR is the effect but not the cause of the underlying disease.Guidelinedirected medical therapy (GDMT) or myocardial revascularization, as well as cardiac resynchronization when appropriate, are the only first-line treatments to be used in FMR.Transcatheter edgeto-edge mitral valve repair (M-TEER) has emerged as one of the latest cutting-edge breakthroughs for non-surgical cases with FMR.The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT ) trial is the only randomized controlled trial (RCT) supporting the use of M-TEER in FMR.The five-year results of the COAPT trial have been recently released [1] .In this RCT, 302 patients with severe FMR who underwent M-TEER in addition to GDMT were compared to 312 who received GDMT alone.The primary effectiveness endpoint was measured by all hospitalizations for heart failure (HF) rate, which was 61% vs. 83%, respectively (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.40-0.61).Additionally, death for any cause was 57.3% vs. 67.2%,respectively (HR, 0.72; 95% CI, 0.58 to 0.89), and death for any cause in combination with hospitalization for HF was 73.6% vs. 91.5%,respectively (HR, 0.53; 95% CI, 0.44 -0.64).In general terms, HF hospitalization and death for any cause rates improved in favor of M-TEER plus GDMT over GDMT alone at five years.However, these facts need to be carefully clarified.Firstly, the prevailing management attitudes today for FMR are based on the notion of "FMR elimination" which is inappropriate by scientific principles, since FMR is the effect but not the cause of the primary disease.
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Garcı́a-Villarreal et al. (2024) conducted an editorial in Severe functional mitral regurgitation (FMR) (n=614). Transcatheter edge-to-edge mitral valve repair (M-TEER) vs. Guideline-directed medical therapy (GDMT) alone was evaluated on All hospitalizations for heart failure (HF) rate (HR 0.49, 95% CI 0.40-0.61). Transcatheter edge-to-edge mitral valve repair added to guideline-directed medical therapy reduced all hospitalizations for heart failure compared to medical therapy alone (61% vs. 83%, HR 0.49) at 5 years.
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