Why the study?
The impact of the new MitraClip G4 transcatheter edge-to-edge repair system iteration on routine clinical practice and outcomes in secondary mitral regurgitation had not been assessed.
Does the MitraClip G4 system improve procedural and clinical outcomes compared to the G2 system in patients with secondary mitral regurgitation?
Does the MitraClip G4 system improve procedural and clinical outcomes compared to the G2 system in patients with secondary mitral regurgitation?
The MitraClip G4 system achieved comparable MR reduction and clinical outcomes to the G2 system while using fewer clips and resulting in lower transmitral gradients, despite treating more anatomically challenging valves.
G4 enables TEER for more challenging secondary MR anatomy with fewer clips and similar MR reduction; leaves open clinical outcome benefits.
BACKGROUND: The MitraClip G4 system is a new iteration of the transcatheter edge-to-edge repair system. We assessed the impact of the G4 system on routine practice and outcomes in secondary mitral regurgitation (2°MR). METHODS AND RESULTS: Consecutive patients with 2°MR treated with either the MitraClip G2 (n=89) or G4 (n=63) system between 2018 and 2021 were included. Baseline characteristics, procedures, and outcomes were compared. Inverse probability of treatment weighting and Cox regression were used to adjust for baseline differences. Baseline characteristics were similar, except for a lower surgical risk in the G4 group (Society of Thoracic Surgeons Predicted Risk of Mortality ≥8: 38.1% vs. 56.2%; P=0.03). In the G4 group, more patients had short (≤2 mm) coaptation length (83.7% vs. 54.0%; P<0.001) and fewer clips were used (17.5% vs. 36.0%; P=0.02). Acceptable MR reduction was observed in nearly all patients, with no difference between the G4 and G2 groups (100% vs. 97.8%, respectively; P=0.51). The G4 group had fewer patients with high transmitral gradients (>5mmHg; 3.3% vs. 13.6%; P=0.03). At 1 year, there was no significant difference between groups in the composite endpoint (death or heart failure rehospitalization) after baseline adjustment (10.5% vs. 20.2%; hazard ratio 0.39; 95% confidence interval 0.11-1.32; P=0.13). CONCLUSIONS: The G4 system achieved comparable device outcomes to the early-generation G2, despite treating more challenging 2°MR with fewer clips.
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Okuno et al. (2023) studied this question.
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