Days at Home After Transcatheter Mitral Valve Repair Versus Medical Therapy Alone in Heart Failure

Background: Transcatheter edge-to-edge repair of the mitral valve (mTEER) reduced a hierarchical end point that included death and heart failure hospitalization in COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation Trial). However, the magnitude to which mTEER increases the number of days a patient spends at home (DAH) in the first few years after treatment, a patient-centered end point not captured routinely in clinical trials, has not been evaluated. We compared 1- and 2-year DAH among patients with functional mitral regurgitation and heart failure randomized to mTEER plus medical therapy versus medical therapy alone (control) by linking the COAPT trial to comprehensive health care claims data.

Methods and results: We linked data from COAPT trial participants to Medicare fee-for-service claims. DAH was calculated as the number of days alive and spent outside a hospital, skilled nursing facility, inpatient rehabilitation, long-term acute care hospital, emergency department, or observation stay after randomization. Treatment groups were compared using quantile regression to calculate the area under the curve of cumulative distribution functions. We linked 271 patients (mTEER 136/302, control 135/312) for a 2-year follow-up. Mean±SD DAH at 1 year was 312.0±95.6 in mTEER and 298.1±107.5 in controls with similar area under the curve (difference 13.9 days [-10.5 to 38.3], P=0.26). DAH at 2 years was 577.2±235.6 in mTEER and 518.2±253.0 in control with a higher area under the curve in mTEER (difference 59.0 days [0.07 to 117.9], P=0.0497).

Conclusions: In the COAPT trial linked to Medicare claims, patients randomized to mTEER spent a similar number of DAH at 1 year but more time at home at 2 years compared with medical therapy alone.