Log in to MyACC
M-TEER in COAPT-Ineligible Patients With Functional MR
Quick Takes
- Using data from the STS/TVT Registry, nearly one-half of patients who underwent M-TEER for functional MR between 2013 and 2020 would have been COAPT trial-ineligible.
- Compared to COAPT-eligible patients in the registry, trial-ineligible patients had lower rates of procedural technical success, more frequent in-hospital complications, and a higher risk of a composite endpoint of 1-year death or HF hospitalization, but a similar rate of clinically meaningful improvement in health status at 30 days.
Study Questions:
What are the outcomes of mitral valve transcatheter edge-to-edge repair (M-TEER) among patients with functional mitral regurgitation (FMR) who would have been excluded from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial?
Methods:
The Society of Thoracic Surgeons (STS)/Transcatheter Valve Therapy (TVT) Registry was used to identify patients who underwent an M-TEER procedure for FMR from January 2013–April 2020. Patients were characterized as “trial-ineligible” if any of the following were present: cardiogenic shock, inotropic support, left ventricular ejection fraction (LVEF) <20%, LV end-systolic dimension (LVESD) >7 cm, home oxygen use, or severe tricuspid regurgitation (TR). Trial-ineligible and trial-eligible groups were compared through 1 year using multivariable models. The primary endpoint was the composite of all-cause death or heart failure hospitalization (HFH) at 1 year. Secondary endpoints included technical procedural success (moderate or less residual MR without in-hospital death, reintervention, or open heart surgery), in-hospital procedural complications, and health status at 30 days assessed with the Kansas City Cardiomyopathy Questionnaire– overall summary score (KCCQ-OS).
Results:
Of 6,675 patients who underwent M-TEER for FMR, 3,721 (55.7%) were trial-eligible and 2,954 (44.3%) were trial-ineligible. Trial-ineligible patients had lower rates of technical procedural success (86.9% vs. 92.6%, p < 0.001) and more frequent in-hospital complications (11.8% vs. 5.7%, p < 0.001) compared with trial-eligible patients. A clinically meaningful improvement in health status at 30 days (KCCQ-OS score increase ≥5 points) was observed in 78.9% of trial-ineligible patients and 77.0% of trial-eligible patients. There was a higher risk of the composite endpoint of 1-year death or HFH in trial-ineligible patients (hazard ratio, 1.73; 95% confidence interval, 1.57-1.91; p < 0.001).
Conclusions:
Among patients in the STS/TVT Registry who underwent M-TEER for FMR, nearly one-half would have been ineligible for the COAPT trial. Health status improvement at 30 days was similar in COAPT-ineligible and COAPT-eligible patients, but trial-ineligible patients had higher 1-year rates of death or HFH.
Perspective:
Published in 2018, the COAPT trial (Stone GW, et al., N Engl J Med 2018;379:2307-18) documented lower rates of HFH and lower all-cause mortality at 24 months among symptomatic patients with HF and FMR who underwent M-TEER compared to those who were treated with medical therapy alone; since then, the use of M-TEER for FMR has increased substantially. Using data in the STS/TVT Registry, this study found that patients who would have been COAPT-ineligible (based on cardiogenic shock or inotropic support within 24 hours, LVEF <20%, LVESD >7 cm, home oxygen use, or severe TR) represented nearly one-half of those who underwent M-TEER for FMR; and had lower rates of procedural technical success, more frequent in-hospital complications, and a higher risk of a composite endpoint of 1-year death or HFH compared to COAPT-eligible patients, but a similar rate of clinically meaningful improvement in health status at 30 days based on KCCQ-OS. Notably, the use of guideline-directed medical therapy among patients in this trial was lower in both groups compared to the COAPT trial. Although these results could support the use of higher-risk M-TEER for FMR in some COAPT-ineligible patients, further research would be useful to help guide various management options for COAPT-ineligible patients.
Clinical Topics: Heart Failure and Cardiomyopathies, Valvular Heart Disease, Acute Heart Failure, Mitral Regurgitation
Keywords: Heart Failure, Mitral Valve Insufficiency, STS/ACC TVT Registry
< Back to Listings
