1. Impact of COAPT trial exclusion criteria in real-world patients undergoing transcatheter mitral valve repair.
- Author
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Iliadis, Christos, Metze, Clemens, Körber, Maria Isabel, Baldus, Stephan, and Pfister, Roman
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MITRAL valve , *VENTRICULAR ejection fraction , *CONGESTIVE heart failure , *SYSTOLIC blood pressure , *MITRAL valve insufficiency , *PULMONARY artery - Abstract
The generalizability of the COAPT trial results on the benefit of TMVR in patients with secondary mitral regurgitation is unclear. Functional and long-term clinical outcome were examined in 122 consecutive patients with secondary mitral regurgitation and reduced ejection fraction undergoing TMVR. "COAPT-like" patients were defined according to principal COAPT inclusion/exclusion criteria if all of the following was fulfilled: symptomatic mitral regurgitation grade 3+ or more according to American guidelines; left ventricular ejection fraction ≥ 20%, left ventricular end-systolic dimension ≤ 70 mm, estimated pulmonary artery systolic pressure ≤ 70 mmHg, mitral valve orifice area ≥ 4 cm2, no prior mitral valve procedure, no right sided congestive heart failure, no COPD requiring home oxygen therapy and NYHA class less than IVb. 51% of 122 patients (mean age 74 ± 10 years, 76% male) showed COAPT-like characteristics. COAPT-like patients showed a significantly lower hazard for the composite endpoint of mortality and heart failure hospitalization (HR 0.51, 95%CI 0.30–0.89, p =.017) during a mean follow-up of 16 ± 6 months, with an estimated 1-year event rate of 20% vs 43%, respectively. The improvement in functional outcomes 6 min walking distance (76 ± 136 m vs. 31 ± 90 m), Minnesota Living with Heart Failure Questionnaire (−6 ± 19 vs. −10 ± 23) and Short Form 36 physical component score (3.8 ± 10 vs. 5.5 ± 11) was similar in COAPT-like and the other patients. In this first real world cohort half of the patients undergoing TMVR showed COAPT-like characteristics and these patients showed a substantially better clinical outcome. The mid-term functional benefit was similar in COAPT-like and other patients. • Trials of TMVR in patients with secondary mitral regurgitation are controversial. • The COAPT trial showed a substantial benefit in a highly selected study population. • COAPT-like patients represent approximately half of TMVR patients in a real-world cohort. • Non COAPT-like patients had a substantially worse long-term clinical outcome. • Functional benefit was similar in COAPT-like and non COAPT-like patients. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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