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Three-year experience of catheter-based micro-axial left ventricular assist device, Impella, in Japanese patients: the first interim analysis of Japan registry for percutaneous ventricular assist device (J-PVAD)

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  • Artificial Heart (Clinical)
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Abstract

Catheter-based micro-axial ventricular assist device Impella® (Abiomed, Danvers, MA) has been used in Japanese patients with drug-refractory acute heart failure (AHF) since 2017. This is the first interim analysis of the ongoing Japan Registry for Percutaneous Ventricular Assist Device (J-PVAD) to investigate the safety and efficacy of Impella support. Between October 2017 and January 2020, 823 Japanese patients, who were treated with the Impella 2.5, CP, or 5.0 pump, were enrolled. The primary endpoints were safety profiles and cumulative 30-day survival. Among them, 44.8% of patients were acute myocardial infarction with cardiogenic shock. The Impella pumps were unable to implant in 4 patients. The Impella 2.5, CP, and 5.0 pumps were used in 72.4%, 6.2%, and 16.6%, respectively, and mean support duration was 8.1 ± 10.2 days. Combination use of Impella and venoarterial extracorporeal membrane oxygenation (VA-ECMO) was applied for 387 patients (47.3%). Pump stop occurred 22 patients (2.7%). Major adverse events included hemolysis (11.2%), hemorrhage/hematoma (6.1%), peripheral ischemia (1.6%), and stroke (1.6%). The overall 30-day survival was 62.2%. Survival of patients with single Impella support was significantly higher than patients with Impella combined with VA-ECMO support (81.1% vs 49.6%; p < 0.01), who had lower blood pressure, lower left ventricular ejection fraction, and higher degree of inotropic support. Results suggest that short-term outcome of Impella support for Japanese patients was favorable with acceptable safety profiles.

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Acknowledgements

A part of the current study was presented at 84th Annual Scientific Meeting of the Japanese Circulation Society, Late Breaking Session. IRB information: “Catheter-type ventricular assist device registry study”, Graduate School of Medicine/Faculty of Medicine, Osaka University Ethics Committee, Approval #17232

Funding

This study was partially funded by Japan Abiomed Post-Market Surveillance Program.

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Authors and Affiliations

  1. Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2, Yamada-Oka, Suita, Osaka, Japan

    Koichi Toda & Yoshiki Sawa

  2. Department of Cardiovascular Medicine, School of Medicine, Kitasato University, Kanagawa, Japan

    Junya Ako

  3. Department of Cardiology, Osaka Police Hospital, Osaka, Japan

    Atsushi Hirayama

  4. The Second Department of Internal Medicine, University of Toyama, Toyama, Japan

    Koichiro Kinugawa

  5. Department of Cardiovascular Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan

    Yoshio Kobayashi

  6. Department of Cardiac Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan

    Minoru Ono

  7. Department of Cardiovascular and Thoracic Surgery, Graduate School of Medicine, Ehime University, Ehime, Japan

    Takashi Nishimura

  8. Department of Cardiology, Kawaguchi Cardiovascular and Respiratory Hospital, Saitama, Japan

    Naoki Sato

  9. Division of Cardiology, National Center for Child Health and Development, Tokyo, Japan

    Takahiro Shindo

  10. Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan

    Morimasa Takayama

  11. Department of Pediatric Cardiology, Nagano Children’s Hospital, Nagano, Japan

    Satoshi Yasukochi

  12. Department of Cardiovascular Surgery, Kyushu University Graduate School of Medicine, Fukuoka, Japan

    Akira Shiose

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  1. Koichi Toda
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  2. Junya Ako
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  3. Atsushi Hirayama
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  6. Minoru Ono
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  8. Naoki Sato
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  9. Takahiro Shindo
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  10. Morimasa Takayama
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  11. Satoshi Yasukochi
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  12. Akira Shiose
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  13. Yoshiki Sawa
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J.-PVAD registry study investigators

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Correspondence to Yoshiki Sawa.

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Toda, K., Ako, J., Hirayama, A. et al. Three-year experience of catheter-based micro-axial left ventricular assist device, Impella, in Japanese patients: the first interim analysis of Japan registry for percutaneous ventricular assist device (J-PVAD). J Artif Organs 26, 17–23 (2023). https://doi.org/10.1007/s10047-022-01328-1

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  • DOI: https://doi.org/10.1007/s10047-022-01328-1

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