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).

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Journal
Catheterization and Cardiovascular Interventions
Published
2026-06-17
DOI
https://doi.org/10.1002/ccd.70702
Primary Topic
Cardiac Valve Diseases and Treatments
Type
article
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0.00

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article

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

Mike Saji, Hiroshi Ueno, Masahiko Asami, Yohei Ohno et al.
Catheterization and Cardiovascular Interventions
Cardiac Valve Diseases and Treatments
article

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

Mike Saji, Hiroshi Ueno, Masahiko Asami, Yohei Ohno, Hirofumi Hioki, Masanori Yamamoto, Kentaro Hayashida, Hisao Otsuki, Toshiaki Otsuka, Yusuke Enta, Gaku Nakazawa, Makoto Amaki, Daisuke Hachinohe, Toru Naganuma, Shinichi Shirai, Shunsuke Kubo, S Mizuno, OCEAN‐Mitral investigators, Shinya Okazaki, Yuki Izumi, Kazuhisa Kodama, Hiroki Bota, Masaki Izumo, Yusuke Watanabe
article en

Abstract

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).

Catheterization and Cardiovascular Interventions
Toho University (JP), Tokai University (JP), St. Marianna University School of Medicine (JP), Keio University (JP), Kurashiki Central Hospital (JP), Sapporo Higashi Tokushukai Hospital (JP), New Tokyo Hospital (JP), Saiseikai Kumamoto Hospital (JP), Sapporo Science Center (JP), Katsushika Medical Center (JP), National Cerebral and Cardiovascular Center (JP), Toyohashi Heart Center (JP), Sakakibara Hospital (JP), Mitsui Memorial Hospital (JP), Tokyo Women's Medical University (JP), Toyama University Hospital (JP), Juntendo University Hospital (JP), Nagoya Heart Center (JP), Shonan Kamakura General Hospital (JP), Gifu Heart Center (JP), Kokura Memorial Hospital (JP), Sendai Kousei Hospital (JP), Nippon Medical School (JP), Teikyo University (JP), Kindai University (JP)
Edwards Lifesciences, Boston Scientific Japan
Life below water
Openalex Percentile: Top 8%
Cardiac Valve Diseases and Treatments
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