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

doi:10.1016/j.carrev.2022.03.013

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

Cardiovascular Research

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

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 language	English
Pages (from-to)	133-142
Number of pages	10
Journal	Cardiovascular Revascularization Medicine
Volume	42
Early online date	14 Mar 2022
DOIs	https://doi.org/10.1016/j.carrev.2022.03.013
Publication status	Published - Sept 2022

Keywords

Acute Coronary Syndrome
Dilated non ischemic cardiomyopathy
High-risk PCI
Ischemic cardiomyopathy
Mitral regurgitation
Pressure-volume
Ventricular assist device

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10.1016/j.carrev.2022.03.013

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Bastos, M. B., McConkey, H., Malkin, O., den Uil, C., Daemen, J., Patterson, T., Wolff, Q., Kardys, I., Schreuder, J., Lenzen, M., Zijlstra, F., Redwood, S., & Van Mieghem, N. M. (2022). Effect of next generation pulsatile mechanical circulatory support on cardiac mechanics - The PULSE trial. Cardiovascular Revascularization Medicine, 42, 133-142. https://doi.org/10.1016/j.carrev.2022.03.013

@article{8e4f16ae1bc94180b108310afef55e66,

title = "Effect of next generation pulsatile mechanical circulatory support on cardiac mechanics - The PULSE trial",

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.",

keywords = "Acute Coronary Syndrome, Dilated non ischemic cardiomyopathy, High-risk PCI, Ischemic cardiomyopathy, Mitral regurgitation, Pressure-volume, Ventricular assist device",

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

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: {\textcopyright} 2022 The Authors",

year = "2022",

month = sep,

doi = "10.1016/j.carrev.2022.03.013",

language = "English",

volume = "42",

pages = "133--142",

journal = "Cardiovascular Revascularization Medicine",

issn = "1553-8389",

publisher = "Elsevier Inc.",

}

Bastos, MB, McConkey, H, Malkin, O, den Uil, C, Daemen, J, Patterson, T, Wolff, Q, Kardys, I, Schreuder, J, Lenzen, M, Zijlstra, F, Redwood, S & Van Mieghem, NM 2022, 'Effect of next generation pulsatile mechanical circulatory support on cardiac mechanics - The PULSE trial', Cardiovascular Revascularization Medicine, vol. 42, pp. 133-142. https://doi.org/10.1016/j.carrev.2022.03.013

TY - JOUR

T1 - Effect of next generation pulsatile mechanical circulatory support on cardiac mechanics - The PULSE trial

AU - Bastos, Marcelo B.

AU - McConkey, Hannah

AU - Malkin, Oren

AU - den Uil, Corstiaan

AU - Daemen, Joost

AU - Patterson, Tiffany

AU - Wolff, Quinten

AU - Kardys, Isabella

AU - Schreuder, Jan

AU - Lenzen, Mattie

AU - Zijlstra, Felix

AU - Redwood, Simon

AU - Van Mieghem, Nicolas M.

N1 - 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

PY - 2022/9

Y1 - 2022/9

N2 - 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.

AB - 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.

KW - Acute Coronary Syndrome

KW - Dilated non ischemic cardiomyopathy

KW - High-risk PCI

KW - Ischemic cardiomyopathy

KW - Mitral regurgitation

KW - Pressure-volume

KW - Ventricular assist device

UR - http://www.scopus.com/inward/record.url?scp=85126888559&partnerID=8YFLogxK

U2 - 10.1016/j.carrev.2022.03.013

DO - 10.1016/j.carrev.2022.03.013

M3 - Article

AN - SCOPUS:85126888559

SN - 1553-8389

VL - 42

SP - 133

EP - 142

JO - Cardiovascular Revascularization Medicine

JF - Cardiovascular Revascularization Medicine

ER -

Effect of next generation pulsatile mechanical circulatory support on cardiac mechanics - The PULSE trial

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Keywords

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