Comparison of device-specific adverse event profiles between Impella platforms

J Card Surg. 2020 Dec;35(12):3310-3316. doi: 10.1111/jocs.15038. Epub 2020 Sep 16.

Abstract

Background: The Impella (Abiomed) ventricular support system is a family of temporary mechanical circulatory support (MCS) devices used to treat patients with cardiogenic shock, acute cardiogenic decompensation, and for high-risk percutaneous or surgical revascularization. These devices include the percutaneously implanted 2.5/cardiac power (CP) and the surgically implanted 5.0/left direct (LD). Despite the beneficial effects and increased usage of these devices, data to assess adverse outcomes and guide clinician decision-making between the Impella CP and 5.0/LD are limited.

Methods: This is a retrospective analysis of 91 consecutive patients who required at least 24 h of Impella support, from January 1, 2015 to December 31, 2019. Groups were stratified based on either initial Impella CP or 5.0/LD placement. Clinical outcomes and in-hospital complications were compared.

Results: Impella CP was implanted in 66 patients (mean age: 61 ± 15 years, male 71.2%) and Impella 5.0/LD was implanted in 25 patients (mean age: 62 ± 9 years, male 84.0%). There was greater stability of device position (p = .033), less incidence of hemolysis (p < .001), and less frequent need for additional MCS (p = .001) in patients implanted with the Impella 5.0/LD compared with Impella CP in this study cohort. Patients with Impella 5.0/LD were more likely to survive from Impella and survive to discharge.

Conclusions: This study suggests that for patients who require temporary MCS for more than 24 h, the Impella 5.0/LD may have a more favorable device-specific adverse profile compared with the Impella CP.

Keywords: Impella device complications; Impella-associated hemolysis; cardiogenic shock.

MeSH terms

  • Aged
  • Heart-Assist Devices* / adverse effects
  • Hospital Mortality
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Shock, Cardiogenic / therapy
  • Treatment Outcome