Pulsatile iVAC 2L circulatory support in high-risk percutaneous coronary intervention

Our aim was to test the feasibility and safety of the transfemoral PulseCath iVAC 2L (PulseCath, Amsterdam, The Netherlands).

Circulatory support devices are helpful adjunctive tools to perform high-risk percutaneous coronary interventions (PCI). The PulseCath iVAC 2L is a novel pulsatile circulatory support system capable of generating output of up to 2 L/min. We performed a prospective clinical pilot study enrolling 14 patients who underwent high-risk PCI under protection with the iVAC 2L. Median age was 74 (56-84) years. Implantation of the iVAC 2L was successful in 13 (93%) patients. Median device flow was 1.4 (1.1-2.0) L/min. Total support time was 67 (23-149) minutes. The use of iVAC 2L support was associated with a better mean arterial pressure and cardiac output during the procedure. Angiographic success was 100%. There was one major procedural complication related to the 19 Fr access sheath. There were no major adverse events at three-month follow-up.

Circulatory support with the iVAC 2L device is feasible and safe in patients undergoing high-risk PCI.