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

Marcelo B. Bastos, Hannah McConkey, Oren Malkin, Corstiaan den Uil, Joost Daemen, Tiffany Patterson, Quinten Wolff, Isabella Kardys, Jan Schreuder, Mattie Lenzen, Felix Zijlstra, Simon Redwood, Nicolas M. Van Mieghem*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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.

Original languageEnglish
Pages (from-to)133-142
Number of pages10
JournalCardiovascular Revascularization Medicine
Volume42
DOIs
Publication statusPublished - Sep 2022

Bibliographical note

Funding Information:
The Erasmus Medical Center has received research grant support from PULSECATH BV .

Funding Information:
Dr Van Mieghem is advisor and received research grant support from PulseCath B.V. He received institutional research grant support from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi Sankyo.

Publisher Copyright:
© 2022 The Authors

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