Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial.

OBJECTIVES: To describe hemodynamic effects of iVAC2L mechanical circulatory support (MCS). BACKGROUND: MCS is increasingly used in the context of high-risk percutaneous coronary intervention (PCI). The effect of the pulsatile iVAC2L MCS on left ventricular loading conditions and myocardial oxygen consumption (MVO2) is unknown. METHODS: This prospective single-arm two-center study included 29 patients who underwent high-risk PCI with iVAC2L MCS using simultaneous invasive pulmonary pressure monitoring and left ventricular pressure-volume analysis. Hemodynamic recordings were performed during steady state conditions with MCS off and on before and after PCI. Pressure-volume variations were analyzed to denote responders and non-responders. RESULTS: The mean age was 74 (IQR: 70-81) years and the mean SYNTAX score was 31 ± 8.3. Left ventricular unloading with iVAC2L MCS was demonstrated in 22 out of 27 patients with complete PV studies. Patients with moderate or severe mitral regurgitation or presenting with acute coronary syndrome (ACS) had higher filling pressures and volumes and were most responsive to iVAC2L unloading (9/10 patients with moderate or severe MR and 11/11 patients with ACS). Pulsatile MCS activation reduced MAP (-4%), SBP (-9%), ESP (-11%), ESV (-15%) and EDV (-4%) among responders but not among non-responders. Responders experienced significant reductions in afterload (Ea: -19%) with increases in stroke volume (+11%) and cardiac output (+11%). CONCLUSIONS: Pulsatile iVAC2L MCS in patients with advanced coronary artery disease at high to prohibitive operative risk resulted in LV unloading and reduced myocardial oxygen consumption particularly in patients with ACS or significant MR with higher filling pressures at baseline. CLINICAL TRIAL REGISTRATION: NCT03200990.

The PulseCath iVAC 2L left ventricular assist device: conversion to a percutaneous transfemoral approach.

AIMS: This technical report describes the essentials and practical implantation technique of the completely percutaneous PulseCath iVAC 2L left ventricular assist device. METHODS AND RESULTS: Percutaneously inserted mechanical left ventricular assist devices are used for circulatory support during cardiogenic shock or high-risk percutaneous coronary interventions. The PulseCath concept is a novel pulsatile design that consists of an extracorporeal membrane pump connected to a large-bore catheter which is inserted across the aortic valve retrogradely into the left ventricle. A genuine intra-aortic balloon pump (IABP) console drives the pulsatile pump. CONCLUSIONS: The percutaneous PulseCath iVAC 2L is driven by a genuine IABP console and provides more left ventricular support.