Skip to main content
SpringerLink
Log in

Prevalence of bleeding events in real-world Japanese registry for Percutaneous Ventricular Assist Device

  • Original Article
  • Artificial Heart (Clinical)
  • Published:
Journal of Artificial Organs Aims and scope Submit manuscript

Abstract

Purpose

Bleeding complication is a critical risk factor for outcomes of acute heart failure patients requiring mechanical circulatory support (MCS), including percutaneous catheter-type heart pumps (Impella). The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) is an ongoing, large-scale, real-world registry to characterize Japanese patients requiring Impella. Here we analyzed bleeding complication profiles in patients who received Impella.

Methods

All consecutive Japanese patients who received Impella from October 2017 to January 2020 were enrolled. The 30-day survival and bleeding complications were analyzed.

Results

A total of 1344 patients were included: 653 patients received Impella alone, 685 patients received a combination of veno-arterial extracorporeal membrane oxygenation and Impella (ECPELLA), and 6 patients had failed Impella delivery. Overall 30-day survival was 67.0%, with Impella alone at 81.9% and ECPELLA at 52.7%. Overall bleeding/hematoma adverse events with a relation or not-excluded relation to Impella was 6.92%. Among them, the rates of hematoma and bleeding from medical device access sites were 1.41% and 4.09%, respectively. There was no difference between etiologies for these events.

Conclusion

This study represents the first 3-year survival and the safety profile focused on bleeding adverse events from the J-PVAD registry. The results show that the real-world frequency of bleeding adverse events for patients who received Impella was an expected range from previous reports, and future real-world studies should aim to expand this data set to improve outcomes and adverse events.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

Data availability

The deidentified participant data will not be shared.

References

  1. Besser MW. Post-operative of bleeding, haemolysis and coagulation in mechanical circulatory support patients. Ann Transl Med [Internet]. 2020 [cited 2022 Oct 26];8:832. Available from: /pmc/articles/PMC7396228/

  2. Kapur NK, Whitehead EH, Thayer KL, Pahuja M. The science of safety: complications associated with the use of mechanical circulatory support in cardiogenic shock and best practices to maximize safety. F1000Res [Internet]. 2020 [cited 2022 Oct 26];9:794. Available from: https://f1000research.com/articles/9-794/v1

  3. Lemor A, Dabbagh MF, Cohen D, Villablanca P, Tehrani B, Alaswad K, et al. Rates and impact of vascular complications in mechanical circulatory support. Catheter Cardiovasc Interv [Internet]. 2022 [cited 2022 Oct 26];99:1702–11. Available from: https://onlinelibrary.wiley.com/doi/full/10.1002/ccd.30150

  4. Petricevic M, Milicic D, Boban M, Mihaljevic MZ, Baricevic Z, Kolic K, et al. Bleeding and thrombotic events in patients undergoing mechanical circulatory support: a review of literature. Thorac Cardiovasc Surg [Internet]. 2015 [cited 2022 Oct 26];63:636–46. Available from: http://www.thieme-connect.com/products/ejournals/html/10.1055/s-0035-1546296

  5. Succar L, Sulaica EM, Donahue KR, Wanat MA. Management of anticoagulation with Impella® percutaneous ventricular assist devices and review of new literature. J Thromb Thrombolysis [Internet]. 2019 [cited 2022 Oct 26];48:284–91. Available from: https://link.springer.com/article/10.1007/s11239-019-01837-6

  6. Ahmad S, Ahsan MJ, Ikram S, Lateef N, Khan BA, Tabassum S, et al. Impella versus Extracorporeal Membranous Oxygenation (ECMO) for cardiogenic shock: a systematic review and meta-analysis. Curr Probl Cardiol. 2023;48:101427.

    Article  PubMed  Google Scholar 

  7. Meani P, Lorusso R, Pappalardo F. ECPella: concept, physiology and clinical applications. J Cardiothorac Vasc Anesth. 2022;36:557–66.

    Article  CAS  PubMed  Google Scholar 

  8. Toda K, Ako J, Hirayama A, Kinugawa K, Kobayashi Y, Ono M, 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 [Internet]. 2022 [cited 2022 Aug 10]. Available from: https://pubmed.ncbi.nlm.nih.gov/35467195/

  9. Ikeda Y, Ako J, Toda K, Hirayama A, Kinugawa K, Kobayashi Y, et al. Short-term outcomes of Impella support in Japanese patients with cardiogenic shock due to acute myocardial infarction – Japanese registry for percutaneous ventricular assist device (J-PVAD). Circ J. 2023;87:588–97.

    Article  PubMed  Google Scholar 

  10. Nakamura M, Imamura T, Hori M, Yokoyama S, Doi T, Fukahara K, et al. Prognostic implication of risk scoring systems in patients with cardiogenic shock supported by ECMO and Impella. J Artif Organs [Internet]. 2021 [cited 2023 Oct 3];24:372–6. Available from: https://link.springer.com/article/10.1007/s10047-020-01232-6

  11. Nakamura M, Imamura T, Ueno H, Hori M, Ushijima R, Kinugawa K. Impact of the whole activated clotting time during Impella support on short-term prognosis. J Artif Organs [Internet]. 2022 [cited 2023 Oct 3];25:9–15. Available from: https://pubmed.ncbi.nlm.nih.gov/33987744/

  12. Iannaccone M, Venuti G, di Simone E, De Filippo O, Bertaina M, Colangelo S, et al. Comparison of ECMO vs ECpella in patients with non-post-pericardiotomy cardiogenic shock: an updated meta-analysis. Cardiovasc Revasc Med. 2022;40:134–41.

    Article  PubMed  Google Scholar 

  13. Patel SM, Lipinski J, Al-Kindi SG, Patel T, Saric P, Li J, et al. Simultaneous venoarterial extracorporeal membrane oxygenation and percutaneous left ventricular decompression therapy with impella is associated with improved outcomes in refractory cardiogenic shock. ASAIO J [Internet]. 2019 [cited 2022 Nov 10];65:21–8. Available from: https://journals.lww.com/asaiojournal/Fulltext/2019/01000/Simultaneous_Venoarterial_Extracorporeal_Membrane.3.aspx

  14. Pappalardo F, Schulte C, Pieri M, Schrage B, Contri R, Soeffker G, et al. Concomitant implantation of Impella® on top of veno-arterial extracorporeal membrane oxygenation may improve survival of patients with cardiogenic shock. Eur J Heart Fail [Internet]. 2017 [cited 2022 Nov 10];19:404–12. Available from: https://onlinelibrary.wiley.com/doi/full/10.1002/ejhf.668

  15. Belohlavek J, Hunziker P, Donker DW. Left ventricular unloading and the role of ECpella. Eur Heart J Suppl [Internet]. 2021 [cited 2022 Nov 10];23:A27–34. Available from: https://academic.oup.com/eurheartjsupp/article/23/Supplement_A/A27/6199261

  16. Kalbhenn J, Schmidt R, Nakamura L, Schelling J, Rosenfelder S, Zieger B. Early diagnosis of acquired von Willebrand Syndrome (AVWS) is elementary for clinical practice in patients treated with ECMO therapy. J Atheroscler Thromb [Internet]. 2015 [cited 2023 Oct 4]. Available from: https://www.jstage.jst.go.jp/article/jat/22/3/22_27268/_article/-char/ja/

  17. Tauber H, Ott H, Streif W, Weigel G, Loacker L, Fritz J, Heinz A, Velik-Salchner C. Extracorporeal membrane oxygenation induces short-term loss of high-molecular-weight von Willebrand factor multimers. Anesth Analg [Internet]. 2015 [cited 2023 Oct 4]. Available from: https://journals.lww.com/anesthesia-analgesia/FullText/2015/04000/Extracorporeal_Membrane_Oxygenation_Induces.11.aspx

  18. Vetrovec GW, Kaki A, Dahle TG. A review of bleeding risk with Impella-supported high-risk percutaneous coronary intervention. Heart Int. 2020;14:92.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Nakamura M, Imamura T, Ueno H, Kinugawa K. Current indication and practical management of percutaneous left ventricular assist device support therapy in Japan. J Cardiol. 2020;75:228–32.

    Article  PubMed  Google Scholar 

  20. Iida M, Shimokawa T. Impella®, percutaneous left ventricular assist device for cardiogenic shock our experiences. J Coron Artery Dis. 2021;27:1–6.

    Article  Google Scholar 

  21. Smith AA, Gupta N. Subclavian Artery Trauma. StatPearls [Internet]. 2022 [cited 2023 Feb 7]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554471/

  22. Kim JH, Brophy DF, Shah KB. Continuous-flow left ventricular assist device–related gastrointestinal bleeding. Cardiol Clin [Internet]. 2018 [cited 2023 Feb 7];36:519–29. Available from: http://www.cardiology.theclinics.com/article/S073386511830849X/fulltext

  23. Thakkar S, Patel HP, Kumar A, Tan BE-X, Arora S, Patel S, et al. Outcomes of Impella compared with intra-aortic balloon pump in ST-elevation myocardial infarction complicated by cardiogenic shock. Am Heart J Plus Cardiol Res Pract. 2021;12:100067.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

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

    Takashi Nishimura

  2. Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan

    Koichi Toda & Yoshiki Sawa

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

    Junya Ako

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

    Atsushi Hirayama

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

    Koichiro Kinugawa

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

    Yoshio Kobayashi

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

    Minoru Ono

  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 Cardiovascular Surgery, Kyushu University Graduate School of Medicine, Fukuoka, Japan

    Akira Shiose

  11. Department of Cardiovascular Internal Medicine, Sakakibara Heart Institute, Tokyo, Japan

    Morimasa Takayama

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

    Satoshi Yasukochi

Authors
  1. Takashi Nishimura
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Koichi Toda
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Junya Ako
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Atsushi Hirayama
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Koichiro Kinugawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Yoshio Kobayashi
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Minoru Ono
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Naoki Sato
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Takahiro Shindo
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Akira Shiose
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Morimasa Takayama
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Satoshi Yasukochi
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Yoshiki Sawa
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

J.-PVAD investigators

Corresponding author

Correspondence to Takashi Nishimura.

Ethics declarations

Conflict of interest

This study was partially funded by the Japanese Abiomed Post-Market Surveillance Program. The authors declare no additional conflicts of interest.

IRB information

“Catheter-type ventricular assist device registry study”, Graduate School of Medicine/Faculty of Medicine, Osaka University Ethics Committee, Approval #17232.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 36 KB)

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Nishimura, T., Toda, K., Ako, J. et al. Prevalence of bleeding events in real-world Japanese registry for Percutaneous Ventricular Assist Device. J Artif Organs (2024). https://doi.org/10.1007/s10047-023-01429-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s10047-023-01429-5

Keywords

Search

Navigation