1-Year Outcomes after Transcatheter Mitral Valve Implantation: Results from the Global CHOICE-MI Registry

Background: Transcatheter mitral valve implantation (TMVI) is a novel treatment alternative for patients with mitral regurgitation (MR), who are suboptimal candidates for mitral valve surgery or transcatheter edge-to-edge repair. However, extensive data on outcomes of patients treated with TMVI is scarce.

Method: The global CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry (CHOICE-MI) included 767 patients from 26 centers, who underwent evaluation for TMVI eligibility. The present study included all patients with severe MR treated with TMVI. Clinical, echocardiographic and computed tomography baseline parameters were assessed for all patients. Outcomes included procedural characteristics, clinical, echocardiographic and functional outcome per MVARC criteria. The primary composite outcome was all-cause mortality or heart failure (HF) hospitalization after 1 year. Median follow-up time was 1.94 (1.53, 2.11) years.

Results: A total of 229 patients with MR (76 years [71.0, 81.0], 36.7% female, STS PROM 5.7% [3.2, 8.6]) underwent TMVI with 10 different dedicated devices (89.2% transapical, 10.8% transseptal). MR etiology was primary (28.8%), secondary (58.4%), or mixed (12.8%). Moderate or severe mitral annulus calcification (MAC) was present in 27 patients (13.0%). Median baseline ejection fraction was 40.0% (IQR: 35.0–54.0). Technical success was 95.2% with low procedural mortality (N = 4, 1.8%). Access site complications, reintervention for bleeding and conversion to surgery occurred in 9.6, 7.5, and 2.8%, respectively. Thirty-day mortality rate was 9.6%. The primary composite endpoint of all-cause mortality or HF hospitalization occurred in 39.2% of patients, without differences between primary MR (44.1%) and secondary MR (39.1%) and mixed primary/secondary MR (20.0%) (p = 0.68). Residual MR after TMVI was ≤1+ in 95.1% at discharge and 95.2% after 1 year (each p < 0.001, for the comparison to MR at baseline). After 1 year, 82.7% of followed-up patients had NYHA functional Class I or II (p < 0.001, for the comparison to NYHA functional Class at baseline).

Conclusion: In this global multicenter registry, TMVI was associated with high technical success and low procedural mortality regardless of MR etiology. Durable elimination of MR was achieved in the majority of treated patients. This finding was accompanied by significant functional improvement among surviving patients after 1 year.

Publication History

Article published online:
03 February 2022