High-risk PCI under support of a pulsatile left ventricular assist device - First German experience with the iVAC2L system

Int J Cardiol. 2019 Dec 15:297:30-35. doi: 10.1016/j.ijcard.2019.10.020. Epub 2019 Oct 12.

Abstract

Background: During high-risk percutaneous coronary intervention (PCI) complications may occur, leading to unstable hemodynamic conditions. Circulatory support devices might help to intercept these conditions by supporting cardiac output. We investigated in a prospective trial the performance of the pulsatile iVAC2L system in the setting of high-risk PCI.

Methods: Circulatory support by the iVAC2L device was attempted in 20 consecutive patients (three females, mean age 72 ± 9 years, LVEF 44 ± 12%) undergoing high-risk PCI. Aortic pressure data were collected after device placement and immediately after PCI.

Results: Successful device placement was achieved in 17 (85%) patients; kinking of iliac artery and device length limited correct device placement in the remaining three patients. PCI success was 100%. With ongoing support (overall support time 122 ± 32min) systolic, diastolic and mean blood pressure increased significantly and kept the higher level until device removal. Critical events occurred in three patients (massive vasospasm, coronary perforation, no-flow in LCA after wire placement), but the iVAC2L device helped to maintain stable hemodynamic conditions with no need for cardiopulmonary resuscitation. Serial controls of hemolysis related parameters in a subgroup of ten patients revealed no significant device related hemolysis after the performance of the iVAC2l system.

Conclusions: High-risk PCI under hemodynamic support by the iVAC2L device is feasible and safe. Aortic pressure increases with ongoing support. The device helps to stabilize hemodynamic situations if complications occur.

Keywords: Circulatory support; High-risk PCI; Left ventricular assist device; iVAC2L.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Coronary Artery Disease / physiopathology
  • Coronary Artery Disease / surgery*
  • Female
  • Germany
  • Heart-Assist Devices*
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / instrumentation*
  • Prospective Studies
  • Risk Factors
  • Stroke Volume
  • Treatment Outcome