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DEVICE THERAPY

Reappraisal of the safety and effectiveness of Impella pumps

In the decade after the introduction of Impella heart pumps, their use has rapidly increased. However, to date, clinical trial data have not conclusively supported their superiority over other contemporary support devices, and observational experiences have identified signals of increased harm with Impella. Large, adequately powered clinical trials of Impella are eagerly awaited.

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Fig. 1: Impella platform FDA approvals and accelerating estimated use in the USA.

References

  1. Rathi, V. K., Kesselheim, A. S. & Ross, J. S. The US Food and Drug Administration 515 program initiative: addressing the evidence gap for widely used, high-risk cardiovascular devices? JAMA Cardiol. 1, 117–118 (2016).

    Article  Google Scholar 

  2. Abiomed. Investor Reports. Abiomed http://investors.abiomed.com (2019).

  3. Amin, A. P. et al. The evolving landscape of Impella® use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support. Circulation https://doi.org/10.1161/CIRCULATIONAHA.119.044007 (2019).

    Article  PubMed  Google Scholar 

  4. O’Neill, W. W. et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation 126, 1717–1727 (2012).

    Article  Google Scholar 

  5. Ouweneel, D. M. et al. Percutaneous mechanical circulatory support versus intra-aortic balloon pump for treating cardiogenic shock: meta-analysis. J. Am. Coll. Cardiol. 69, 358–360 (2017).

    Article  Google Scholar 

  6. Sukul, D. et al. The Comparative effectiveness and safety of Impella versus intra-aortic balloon pump in patients who underwent percutaneous coronary intervention: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Presented at Transcatheter Cardiovascular Therapeutics 2018 https://www.tctmd.com/slide/tct-81-comparative-effectiveness-and-safety-impella-versus-intra-aortic-balloon-pump-patients (2018).

  7. Dhruva, S. et al. Mortality and bleeding among patients with acute myocardial infarction complicated by cardiogenic shock undergoing percutaneous coronary intervention with Impella® versus intra-aortic balloon pump. Presented at the American Heart Association Scientific Sessions 2019 November 17, 2019. Philadelphia, PA (2019).

  8. Schrage, B. et al. Impella support for acute myocardial infarction complicated by cardiogenic shock. Circulation 139, 1249–1258 (2019).

    Article  Google Scholar 

  9. Khera, R. et al. Use of Mechanical circulatory support in percutaneous coronary intervention in the United States. Am. J. Cardiol. 117, 10–16 (2016).

    Article  Google Scholar 

  10. Rathi, V. K. et al. Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011. JAMA 314, 604–612 (2015).

    Article  CAS  Google Scholar 

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Correspondence to Mandeep R. Mehra.

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Competing interests

M.V. receives support from the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541), serves on advisory boards for Amgen, AstraZeneca, Baxter Healthcare, Bayer AG, Boehringer Ingelheim and Relypsa, and participates on clinical end point committees for studies sponsored by Novartis and the NIH. M.R.M. is a consultant for Abbott, Baim Institute for Clinical Research, Bayer AG, Fineheart, Janssen (a division of Johnson and Johnson), Leviticus, Medtronic, Mesoblast, NupulseCV, Portola and Triple Gene.

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Vaduganathan, M., Mehra, M.R. Reappraisal of the safety and effectiveness of Impella pumps. Nat Rev Cardiol 17, 203–204 (2020). https://doi.org/10.1038/s41569-020-0333-8

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