Early Outcomes Between the Two Latest Generation Mitral Valve Transcatheter Edge-to-Edge Repair Devices: OCEAN-Mitral Registry.

BACKGROUND

The PASCAL (PASCAL Precision, Edwards Lifesciences) device for mitral valve transcatheter edge-to-edge repair (M-TEER) was recently introduced in Japan for treating primary mitral regurgitation (PMR). This multicenter study aimed to compare the clinical outcomes of the latest-generation M-TEER systems: PASCAL and MitraClip (Generation 4, Abbott Vascular).

METHODS

Data from 150 consecutive patients with significant PMR who underwent M-TEER with the PASCAL were extracted from the Japanese OCEAN-Mitral registry. The early procedural safety and clinical outcomes of PASCAL were compared with those of a historical cohort of 679 patients treated with MitraClip for PMR. Propensity score (PS)-matching analysis was performed to minimize differences in baseline characteristics.

RESULTS

Among the PASCAL cohort, one case of 30-day non-cardiac mortality occurred, with no deployment failures or need for additional surgery. A single leaflet device attachment (SLDA) case occurred after releasing one of the two PASCAL lockline sutures; however, successful retrieval of the device resulted in no final SLDA cases. After PS-matching, the rates of MR grade ≤ 2+ were comparable between the groups at 30-day (92.3% vs. 92.1%, p = 0.89). Similarly, rates of MR ≤ 1+ showed no significant differences at 30-day (71.6% vs. 65.8%, p = 0.18). Both the device and clinical success rates were similar between the groups (95.0% vs. 92.1%, p = 0.33; 93.5% vs. 87.8%, p = 0.10, respectively).

CONCLUSIONS

This study revealed no significant differences in the early clinical outcomes after M-TEER between the latest-generation devices. The PASCAL system, with its distinctive structure, may be associated with a low incidence of SLDA and may represent a potential alternative option for the treatment of PMR.

CLINICAL TRIALS: OCEAN-Mitral registry (UMIN-ID: UMIN000023653).