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
N1 - Funding Information:
This study was supported by CircuLite, Inc., Saddle Brook, New Jersey. Dr. Burkhoff is an employee of CircuLite, Inc. Drs. Meyns, Griffith, Dowling, and Zucker are consultants to CircuLite, Inc.
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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U2 - 10.1016/j.jacc.2009.04.023
DO - 10.1016/j.jacc.2009.04.023
M3 - Article
C2 - 19555845
AN - SCOPUS:67449085092
VL - 54
SP - 79
EP - 86
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 1
ER -