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A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair
Published on: October 16, 2021
Early Outcomes Between the Two Latest Generation Mitral Valve Transcatheter Edge-to-Edge Repair Devices: OCEAN-Mitral
Yusuke Enta1, Masanori Yamamoto2,3,4, Hirofumi Hioki5
1Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.
The PASCAL device demonstrated comparable early clinical outcomes to the MitraClip system for treating primary mitral regurgitation. Both mitral valve transcatheter edge-to-edge repair (M-TEER) devices showed similar success rates, with PASCAL potentially offering a low single leaflet device attachment incidence.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- The PASCAL (Edwards Lifesciences) device for mitral valve transcatheter edge-to-edge repair (M-TEER) is a novel technology for primary mitral regurgitation (PMR).
- Comparing the latest-generation M-TEER systems, PASCAL and MitraClip (Abbott Vascular), is crucial for clinical decision-making.
Purpose of the Study:
- To compare the early clinical outcomes and procedural safety of the PASCAL M-TEER system against the MitraClip system in patients with PMR.
- To evaluate the efficacy of PASCAL in reducing mitral regurgitation (MR) severity.
Main Methods:
- A retrospective analysis of 150 patients treated with PASCAL from the Japanese OCEAN-Mitral registry.
- Comparison with a historical cohort of 679 patients treated with MitraClip for PMR.
- Propensity score (PS)-matching was employed to ensure balanced baseline characteristics between the PASCAL and MitraClip groups.
Main Results:
- The PASCAL group experienced one case of 30-day non-cardiac mortality and no deployment failures or additional surgeries.
- A single leaflet device attachment (SLDA) event occurred but was successfully retrieved, resulting in no final SLDA cases.
- Post-PS matching, both devices achieved comparable rates of MR grade ≤2+ (92.3% vs. 92.1%) and MR ≤1+ (71.6% vs. 65.8%) at 30 days.
- Device success (95.0% vs. 92.1%) and clinical success (93.5% vs. 87.8%) rates were similar between the PASCAL and MitraClip groups.
Conclusions:
- This study indicates no significant differences in early clinical outcomes between the latest-generation PASCAL and MitraClip devices for M-TEER in PMR.
- The PASCAL system's unique design may contribute to a low incidence of SLDA.
- PASCAL presents a viable alternative treatment option for patients with primary mitral regurgitation.
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