Proof of Concept. Hemodynamic Response to Long-Term Partial Ventricular Support With the Synergy Pocket Micro-Pump

Bart Meyns, Stefan Klotz, Andre Simon, Walter Droogne, Filip Rega, Bartley Griffith, Robert Dowling, Mark J. Zucker, Daniel Burkhoff

Research output: Contribution to journalArticle

73 Citations (Scopus)

Abstract

Objectives: The purpose of this study was to test the hemodynamic effects of partial ventricular support in patients with advanced heart failure. Background: The use of current left ventricular assist devices (VADs) that provide full circulatory support is restricted to critically ill patients because of associated risks. Smaller, less-invasive devices could expand VAD use to a larger pool of less-sick patients but would pump less blood, providing only partial support. Methods: The Synergy Pocket Micro-pump device (CircuLite, Inc., Saddle Brook, New Jersey) pumps ∼3.0 l/min, is implanted (off pump) via a mini-thoracotomy, and is positioned in a right subclavicular subcutaneous pocket (like a pacemaker). The inflow cannula inserts into the left atrium; the outflow graft connects to the right subclavian artery. Results: A total of 17 patients (14 men), age 53 ± 9 years with ejection fraction 21 ± 6%, mean arterial pressure 73 ± 7 mm Hg, pulmonary capillary wedge pressure 29 ± 6 mm Hg, and cardiac index 1.9 ± 0.4 l/min/m2 received an implant. Duration of support ranged from 6 to 213 (median 81) days. In addition to demonstration of significant acute hemodynamic improvements in the first day of support, 9 patients underwent follow-up right heart catheterization at 10.6 ± 6 weeks. These patients showed significant increases in arterial pressure (67 ± 8 mm Hg vs. 80 ± 9 mm Hg, p = 0.01) and cardiac index (2.0 ± 0.4 l/min/m2 vs. 2.8 ± 0.6 l/min/m2, p = 0.01) with large reductions in pulmonary capillary wedge pressure (30 ± 5 mm Hg vs. 18 ± 5 mm Hg, p = 0.001). Conclusions: Partial support appears to interrupt the progressive hemodynamic deterioration typical of late-stage heart failure. If proven safe and durable, this device could be used in a relatively large population of patients with severe heart failure who are not sick enough to justify use of currently available full support VADs. (Safety and Performance Evaluation of CircuLite Synergy; NCT00878527).

Original languageEnglish (US)
Pages (from-to)79-86
Number of pages8
JournalJournal of the American College of Cardiology
Volume54
Issue number1
DOIs
StatePublished - Jun 30 2009

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Hemodynamics
Heart-Assist Devices
Pulmonary Wedge Pressure
Heart Failure
Equipment and Supplies
Arterial Pressure
Subclavian Artery
Thoracotomy
Cardiac Catheterization
Heart Atria
Critical Illness
Transplants
Safety
Population

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Meyns, Bart ; Klotz, Stefan ; Simon, Andre ; Droogne, Walter ; Rega, Filip ; Griffith, Bartley ; Dowling, Robert ; Zucker, Mark J. ; Burkhoff, Daniel. / Proof of Concept. Hemodynamic Response to Long-Term Partial Ventricular Support With the Synergy Pocket Micro-Pump. In: Journal of the American College of Cardiology. 2009 ; Vol. 54, No. 1. pp. 79-86.
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abstract = "Objectives: The purpose of this study was to test the hemodynamic effects of partial ventricular support in patients with advanced heart failure. Background: The use of current left ventricular assist devices (VADs) that provide full circulatory support is restricted to critically ill patients because of associated risks. Smaller, less-invasive devices could expand VAD use to a larger pool of less-sick patients but would pump less blood, providing only partial support. Methods: The Synergy Pocket Micro-pump device (CircuLite, Inc., Saddle Brook, New Jersey) pumps ∼3.0 l/min, is implanted (off pump) via a mini-thoracotomy, and is positioned in a right subclavicular subcutaneous pocket (like a pacemaker). The inflow cannula inserts into the left atrium; the outflow graft connects to the right subclavian artery. Results: A total of 17 patients (14 men), age 53 ± 9 years with ejection fraction 21 ± 6{\%}, mean arterial pressure 73 ± 7 mm Hg, pulmonary capillary wedge pressure 29 ± 6 mm Hg, and cardiac index 1.9 ± 0.4 l/min/m2 received an implant. Duration of support ranged from 6 to 213 (median 81) days. In addition to demonstration of significant acute hemodynamic improvements in the first day of support, 9 patients underwent follow-up right heart catheterization at 10.6 ± 6 weeks. These patients showed significant increases in arterial pressure (67 ± 8 mm Hg vs. 80 ± 9 mm Hg, p = 0.01) and cardiac index (2.0 ± 0.4 l/min/m2 vs. 2.8 ± 0.6 l/min/m2, p = 0.01) with large reductions in pulmonary capillary wedge pressure (30 ± 5 mm Hg vs. 18 ± 5 mm Hg, p = 0.001). Conclusions: Partial support appears to interrupt the progressive hemodynamic deterioration typical of late-stage heart failure. If proven safe and durable, this device could be used in a relatively large population of patients with severe heart failure who are not sick enough to justify use of currently available full support VADs. (Safety and Performance Evaluation of CircuLite Synergy; NCT00878527).",
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Proof of Concept. Hemodynamic Response to Long-Term Partial Ventricular Support With the Synergy Pocket Micro-Pump. / Meyns, Bart; Klotz, Stefan; Simon, Andre; Droogne, Walter; Rega, Filip; Griffith, Bartley; Dowling, Robert; Zucker, Mark J.; Burkhoff, Daniel.

In: Journal of the American College of Cardiology, Vol. 54, No. 1, 30.06.2009, p. 79-86.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Proof of Concept. Hemodynamic Response to Long-Term Partial Ventricular Support With the Synergy Pocket Micro-Pump

AU - Meyns, Bart

AU - Klotz, Stefan

AU - Simon, Andre

AU - Droogne, Walter

AU - Rega, Filip

AU - Griffith, Bartley

AU - Dowling, Robert

AU - Zucker, Mark J.

AU - Burkhoff, Daniel

PY - 2009/6/30

Y1 - 2009/6/30

N2 - Objectives: The purpose of this study was to test the hemodynamic effects of partial ventricular support in patients with advanced heart failure. Background: The use of current left ventricular assist devices (VADs) that provide full circulatory support is restricted to critically ill patients because of associated risks. Smaller, less-invasive devices could expand VAD use to a larger pool of less-sick patients but would pump less blood, providing only partial support. Methods: The Synergy Pocket Micro-pump device (CircuLite, Inc., Saddle Brook, New Jersey) pumps ∼3.0 l/min, is implanted (off pump) via a mini-thoracotomy, and is positioned in a right subclavicular subcutaneous pocket (like a pacemaker). The inflow cannula inserts into the left atrium; the outflow graft connects to the right subclavian artery. Results: A total of 17 patients (14 men), age 53 ± 9 years with ejection fraction 21 ± 6%, mean arterial pressure 73 ± 7 mm Hg, pulmonary capillary wedge pressure 29 ± 6 mm Hg, and cardiac index 1.9 ± 0.4 l/min/m2 received an implant. Duration of support ranged from 6 to 213 (median 81) days. In addition to demonstration of significant acute hemodynamic improvements in the first day of support, 9 patients underwent follow-up right heart catheterization at 10.6 ± 6 weeks. These patients showed significant increases in arterial pressure (67 ± 8 mm Hg vs. 80 ± 9 mm Hg, p = 0.01) and cardiac index (2.0 ± 0.4 l/min/m2 vs. 2.8 ± 0.6 l/min/m2, p = 0.01) with large reductions in pulmonary capillary wedge pressure (30 ± 5 mm Hg vs. 18 ± 5 mm Hg, p = 0.001). Conclusions: Partial support appears to interrupt the progressive hemodynamic deterioration typical of late-stage heart failure. If proven safe and durable, this device could be used in a relatively large population of patients with severe heart failure who are not sick enough to justify use of currently available full support VADs. (Safety and Performance Evaluation of CircuLite Synergy; NCT00878527).

AB - Objectives: The purpose of this study was to test the hemodynamic effects of partial ventricular support in patients with advanced heart failure. Background: The use of current left ventricular assist devices (VADs) that provide full circulatory support is restricted to critically ill patients because of associated risks. Smaller, less-invasive devices could expand VAD use to a larger pool of less-sick patients but would pump less blood, providing only partial support. Methods: The Synergy Pocket Micro-pump device (CircuLite, Inc., Saddle Brook, New Jersey) pumps ∼3.0 l/min, is implanted (off pump) via a mini-thoracotomy, and is positioned in a right subclavicular subcutaneous pocket (like a pacemaker). The inflow cannula inserts into the left atrium; the outflow graft connects to the right subclavian artery. Results: A total of 17 patients (14 men), age 53 ± 9 years with ejection fraction 21 ± 6%, mean arterial pressure 73 ± 7 mm Hg, pulmonary capillary wedge pressure 29 ± 6 mm Hg, and cardiac index 1.9 ± 0.4 l/min/m2 received an implant. Duration of support ranged from 6 to 213 (median 81) days. In addition to demonstration of significant acute hemodynamic improvements in the first day of support, 9 patients underwent follow-up right heart catheterization at 10.6 ± 6 weeks. These patients showed significant increases in arterial pressure (67 ± 8 mm Hg vs. 80 ± 9 mm Hg, p = 0.01) and cardiac index (2.0 ± 0.4 l/min/m2 vs. 2.8 ± 0.6 l/min/m2, p = 0.01) with large reductions in pulmonary capillary wedge pressure (30 ± 5 mm Hg vs. 18 ± 5 mm Hg, p = 0.001). Conclusions: Partial support appears to interrupt the progressive hemodynamic deterioration typical of late-stage heart failure. If proven safe and durable, this device could be used in a relatively large population of patients with severe heart failure who are not sick enough to justify use of currently available full support VADs. (Safety and Performance Evaluation of CircuLite Synergy; NCT00878527).

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