Background: There is a considerable portion of patients with mitral regurgitation (MR) unsuitable for standard therapy as recommended by current guidelines. Transcatheter mitral valve implantation (TMVI) represents a novel therapeutic alternative for these patients. The CHOICE-MI registry is a global, retrospective study aiming to assess outcomes of MR patients evaluated for TMVI who are unsuitable for standard therapy.
Method: Clinical and functional outcomes of patients after TMVI were compared with those, who screen-failed TMVI and subsequently underwent bailout transcatheter edge-to-edge repair (TEER), high-risk surgery, or continued with medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1 year.
Results: Among 746 patients evaluated for TMVI (78.5 years [IQR 72.0–83.0], 45.7% female, EuroSCORE II 4.7% [IQR 2.7–9.7]), 229 (30.7%) were eligible. In contrast to TMVI-ineligible patients, patients in the TMVI group had higher estimated surgical risk, lower left ventricular (LV) and right ventricular function, more dilated ventricles and were more often treated for secondary MR. In two thirds of patients ineligible for TMVI, screen failure occurred due to small LV size, predicted risk of LV outflow tract obstruction or annular size outside the treatment range for TMVI. At 1 year, MR was eliminated (residual MR <1+) in 83.9% patients treated with TMVI, compared with 8.0% (TEER), 62.2% (surgery) and 3.7% (MT) in TMVI-ineligible patients (p < 0.001). NYHA functional Class I/II was most evident at 1 year in the TMVI group (82.6%) compared with surgery (73.3%), TEER (56.6%) and MT (34.0%) (p < 0.001). The primary endpoint occurred in 28.8% of the TEER group and in 39.2, 42.9, and 47.9% patients treated with TMVI, surgery or MT (p = 0.05), respectively.
Conclusion: In MR patients considered unsuitable for standard therapy, TMVI was associated with sustained MR elimination and functional improvement at 1 year. TEER and mitral valve surgery represent reasonable treatment alternatives when screen-failed from TMVI, even in patients at high risk and with suboptimal anatomy, while MT was associated with poor clinical and functional outcomes.
