Why the study?
The eligibility and potential benefit of TEER plus GDMT for moderate-severe or severe secondary MR had not been reported in a contemporary HF population.
What is the real-world eligibility for and potential clinical benefit of transcatheter edge-to-edge repair (TEER) in a contemporary cohort of adults with heart failure?
What is the real-world eligibility for and potential clinical benefit of transcatheter edge-to-edge repair (TEER) in a contemporary cohort of adults with heart failure?
In a large contemporary real-world heart failure cohort, only 4.8% of patients met FDA eligibility criteria for transcatheter edge-to-edge repair (primarily due to absence of moderate-severe or severe MR), though eligible patients represent a high-acuity group that may derive substantial clinical benefit with low estimated numbers needed to treat.
Low TEER eligibility in real-world HF; leaves open questions on COAPT trial generalizability and need for expanded criteria.
Background: The eligibility and potential benefit of transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy to treat moderate-severe or severe secondary mitral regurgitation (MR) has not been reported in a contemporary heart failure (HF) population. Methods: Eligibility for TEER based on Food and Drug Administration (FDA) labeling: (1) HF symptoms, (2) moderate-severe or severe MR, (3) left ventricular ejection fraction (LVEF) 20% to 50%, (4) left ventricular end-systolic dimension 7.0 cm, and (5) receiving GDMT (blocker + angiotensin-converting enzyme inhibitor/angiotensin receptor blocker). The proportion (%) of patients eligible for TEER. The hypothetical number needed to treat to prevent or postpone adverse outcomes was estimated using relative risk reductions from published hazard ratios in the registration trial and the observed event rates. Results: We identified 50,841 adults with HF and known LVEF. After applying FDA criteria, 2461 patients (4.8%) were considered eligible for transcatheter mitral valve replacement (FDA+), with the vast majority of patients excluded (FDA-) based on a lack of clinically significant MR (N = 47,279). FDA+ patients had higher natriuretic peptide levels and were more likely to have a prior HF hospitalization compared to FDA- patients. Although FDA+ patients had a more dilated left ventricle and lower LVEF, median (25th-75th) left ventricular end-systolic dimension (cm) was low at 4.4 (3.7-5.1) and only 30.8% had severely reduced LVEF. FDA+ patients were at higher risk of HF-related morbidity and mortality. The estimated number needed to treat to potentially prevent or postpone all-cause hospitalization was 4.4, 8.8 for HF hospitalization, and 5.3 for all-cause death at 24 months in FDA+ patients. Conclusions: There is a low prevalence of TEER eligibility based on FDA criteria primarily due to absence of moderate-severe or severe MR. FDA+ patients are a high acuity population and may potentially derive a robust clinical benefit from TEER based on pivotal studies. Additional research is necessary to validate the scope of eligibility and comparative effectiveness of TEER in real-world populations.
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Ambrosy et al. (2023) studied this question.
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