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. 2021 Aug 20;10(16):3710.
doi: 10.3390/jcm10163710.

Adverse Events of Percutaneous Microaxial Left Ventricular Assist Devices-A Retrospective, Single-Centre Cohort Study

Anna S Zaiser  1 , Gregor Fahrni  2 , Alexa Hollinger  1   3 , Demian T Knobel  1 , Yann Bovey  1 , Núria M Zellweger  1 , Andreas Buser  4 , David Santer  5 , Hans Pargger  1 , Caroline E Gebhard  1   3 , Martin Siegemund  1   3
Affiliations

Adverse Events of Percutaneous Microaxial Left Ventricular Assist Devices-A Retrospective, Single-Centre Cohort Study

Anna S Zaiser et al. J Clin Med. .

Abstract

Worldwide, the left ventricular assist device Impella® (Abiomed, Danvers, MA, USA) is increasingly implanted in patients with acute cardiogenic shock or undergoing high-risk cardiac interventions. Despite its long history of use, few studies have assessed its safety and possible complications associated with its use. All patients treated with a left-sided Impella® device at the University Hospital of Basel from 1 January 2011 to 31 December 2019 were enrolled. The primary endpoint was the composite rate of mortality and adverse events (bleeding, acute kidney injury, and limb ischemia). Out of 281 included patients, at least one adverse event was present in 262 patients (93%). Rates of in-hospital, 90-day, and one-year mortality were 48%, 47%, and 50%, respectively. BARC type 3 bleeding (62%) and hemolysis (41.6%) were the most common complications. AKI was observed in 50% of all patients. Renal replacement therapy was required in 97 (35%) of all patients. Limb ischemia occurred in 13% of cases. Bleeding and hemolysis are common Impella®-associated complications. Additionally, we found a high rate of AKI. A careful selection of patients receiving microaxial LV support and defining the indication for its use are essential measures to be taken for the benefits to outweigh potential complications.

Keywords: Impella®; acute heart failure; cardiogenic shock; mechanical circulatory support.

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Conflict of interest statement

D.S. received speaker honoraria and educational grants from Abott and Medtronic as well as speaker honoraria from Abiomed and Nycomed.

Figures

Figure 1
Figure 1
Frequency of adverse events. Numbers are percentages. For hemolysis, 71 out of 281 values were missing. It was assumed that these patients did not suffer from hemolysis.
Figure 2
Figure 2
Kaplan–Meyer survival analysis.
See this image and copyright information in PMC

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