Department of Cardiology, St. Marianna University Hospital.
Department of Pharmacology, St. Marianna University School of Medicine.
Circ J. 2024 Mar 25;88(4):531-538. doi: 10.1253/circj.CJ-23-0503. Epub 2023 Nov 25.
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).
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).
The G4 system achieved comparable device outcomes to the early-generation G2, despite treating more challenging 2°MR with fewer clips.
MitraClip G4 系统是经导管缘对缘修复系统的新一代产品。我们评估了 G4 系统对继发性二尖瓣反流(2°MR)常规治疗和结局的影响。
连续纳入 2018 年至 2021 年期间接受 MitraClip G2(n=89)或 G4(n=63)系统治疗的 2°MR 患者。比较基线特征、手术过程和结局。采用逆概率治疗加权和 Cox 回归校正基线差异。两组基线特征相似,G4 组手术风险较低(胸外科医师协会预测死亡率≥8%:38.1% vs. 56.2%;P=0.03)。G4 组较短(≤2mm)的瓣叶对合长度(83.7% vs. 54.0%;P<0.001)和更少的夹子使用(17.5% vs. 36.0%;P=0.02)。几乎所有患者的二尖瓣反流均得到了可接受的改善,两组间无差异(分别为 100% vs. 97.8%;P=0.51)。G4 组跨瓣压差较高(>5mmHg)的患者较少(3.3% vs. 13.6%;P=0.03)。在调整基线后,两组在复合终点(死亡或心力衰竭再住院)方面 1 年无显著差异(10.5% vs. 20.2%;危险比 0.39;95%置信区间 0.11-1.32;P=0.13)。
尽管 G4 系统治疗更具挑战性的 2°MR 时使用的夹子更少,但仍获得了与早期 G2 系统相当的器械治疗结局。