[Temporary percutaneous ventricular assist devices for cardiogenic shock and high-risk percutaneous coronary

Antonella Negro1, Valentina Pecoraro1, Maria Domenica Camerlingo1

  • 1Agenzia Sanitaria e Sociale Regionale - Regione Emilia-Romagna, Bologna.

Giornale Italiano Di Cardiologia (2006)
|February 14, 2020
PubMed

Insights

Percutaneous ventricular assist devices (pVADs) show similar efficacy and safety compared to intra-aortic balloon pumps (IABP) or medical therapy for cardiogenic shock (CS) complicating acute myocardial infarction (AMI) or high-risk PCI. However, pVAD use increases major bleeding risk.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Medical Devices

Background:

  • Cardiogenic shock (CS) is a severe complication of acute myocardial infarction (AMI), associated with high mortality.
  • Percutaneous ventricular assist devices (pVADs) are increasingly used for hemodynamic support in CS and high-risk percutaneous coronary intervention (PCI).
  • Available pVADs in Europe include Impella, HeartMate PHP, TandemHeart, and PulseCath iVAC2L.

Purpose of the Study:

  • To evaluate the efficacy and safety of pVADs in patients with refractory CS complicating AMI.
  • To assess the effectiveness of pVADs in patients undergoing high-risk PCI.
  • To compare pVADs with intra-aortic balloon pumps (IABP) and medical therapy.

Main Methods:

  • Systematic search of randomized controlled trials (RCTs) and controlled observational studies up to September 2018.
  • Inclusion of studies comparing pVADs with IABP or medical therapy in CS complicating AMI or high-risk PCI.
  • Meta-analysis of data where possible, using random effects models to calculate risk ratios (RR) and 95% confidence intervals (CI).

Main Results:

  • Meta-analysis of 5 studies (3 RCTs, 2 observational) in CS complicating AMI showed no significant difference in 30-day mortality between pVADs and controls (RR 1.05, 95% CI 0.84-1.31).
  • Patients treated with pVADs had a 2-fold higher risk of major bleeding compared to controls.
  • For high-risk PCI, 3 studies were included; meta-analysis was not possible due to limited data. One RCT and two non-randomized studies reported no difference in mortality between pVADs and IABP.

Conclusions:

  • pVADs demonstrate comparable efficacy to IABP and medical therapy for CS complicating AMI or high-risk PCI.
  • A significant increase in major bleeding risk is associated with pVAD use.
  • Further research is needed, particularly for high-risk PCI patients, to fully elucidate the role of pVADs.
Abstract

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