Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy

Eur Heart J Acute Cardiovasc Care. 2021 Dec 6;10(9):999-1006. doi: 10.1093/ehjacc/zuab051.

Abstract

Aims: To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy.

Methods and results: A total of 406 patients have been included in this registry: 56.4% in the setting of CS, while 43.6% patients in the setting of HR-PCI. DRCs were defined as a composite endpoint of access-site bleeding, limb ischaemia, vascular complication requiring treatment, haemolysis, aortic injury, and left ventricular perforation. DRC incidence in the overall population was 25.6%, with significantly higher rate in the CS (37.1%) than in the HR-PCI (10.7%) group. The most frequent complication was haemolysis (11.8%), which occurred almost exclusively in CS population. Access-site bleeding was observed in 9.6% of the overall population, with no significant difference between the two groups. Limb ischaemia was observed in 8.3% of the overall population, with significantly higher rate in the CS group. CS and right ventricular dysfunction appear as the strongest independent predictors of DRC. One-year mortality in patients with DRC appears higher than in patients with no DRC. However, DRC was not confirmed as an independent predictor of 1-year mortality at multivariate analysis.

Conclusion: In the IMP-IT registry, the rate of DRC was 25.6%, with CS being the strongest independent predictor. DRC was not found as an independent predictor of 1-year mortality.

Keywords: Complications; Impella; Mechanical circulatory support.

Publication types

  • Multicenter Study

MeSH terms

  • Heart-Assist Devices* / adverse effects
  • Humans
  • Inosine Monophosphate
  • Percutaneous Coronary Intervention*
  • Registries
  • Retrospective Studies
  • Shock, Cardiogenic / epidemiology
  • Shock, Cardiogenic / etiology
  • Treatment Outcome

Substances

  • Inosine Monophosphate