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 language | English (US) |
|---|---|
| Pages (from-to) | 79-86 |
| Number of pages | 8 |
| Journal | Journal of the American College of Cardiology |
| Volume | 54 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jun 30 2009 |
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All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine
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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 journal › Article
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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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 -