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Review
. 2022 Nov 22;80(21):2028-2049.
doi: 10.1016/j.jacc.2022.08.807.

Randomized Trials of Percutaneous Microaxial Flow Pump Devices: JACC State-of-the-Art Review

Mohit Pahuja  1 , Adam Johnson  2 , Ryan Kabir  3 , Sukhdeep Bhogal  4 , Jason P Wermers  5 , Nelson L Bernardo  6 , Itsik Ben-Dor  7 , Hayder Hashim  8 , Lowell F Satler  3 , Farooq H Sheikh  9 , Ron Waksman  10
Affiliations
Review

Randomized Trials of Percutaneous Microaxial Flow Pump Devices: JACC State-of-the-Art Review

Mohit Pahuja et al. J Am Coll Cardiol. .

Abstract

The use of mechanical circulatory support devices in cardiovascular practice has risen exponentially over the past decade. These devices are currently used for hemodynamic support in patients with cardiogenic shock, high-risk percutaneous coronary intervention, left ventricular unloading, protection of kidneys, and right ventricular failure. The Impella (Abiomed) percutaneous microaxial flow pump devices are rapidly gaining popularity. However, despite their increasing use, there are limited randomized clinical trials (RCTs) to support the benefits of the therapy and growing concern regarding complication rates. Vascular problems, including bleeding and acute limb ischemia, are associated with the devices, but published reports also highlight risks for cardiac perforations, mitral chordae rupture, and stroke. In this review, we summarize the history, mechanism of action, previously published RCT data, and upcoming RCTs on these devices.

Keywords: Impella; cardiogenic shock; high-risk percutaneous coronary intervention; mechanical circulatory support.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Hashim has served as a consultant for and received speaker fees from Abbott, Cardiovascular Systems, and Boston Scientific. Dr Waksman has served on the advisory boards for Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia; has served as a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia, Swiss Interventional Systems/SIS Medical, Transmural Systems, and Venous MedTech; has received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; has served on the Speakers Bureau for AstraZeneca; and is an investor in MedAlliance and Transmural Systems. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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