title: Proof of concept: hemodynamic response to long-term partial ventricular support with the synergy pocket micro-pump.
abstract: OBJECTIVE
  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 approximately 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/m(2) 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/m(2) vs. 2.8 +/- 0.6 l/min/m(2), 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).
authors: University of Leuven, Leuven, Belgium.
authors: Bart
authors: B
authors: Meyns
authors: Stefan
authors: S
authors: Klotz
authors: Andre
authors: A
authors: Simon
authors: Walter
authors: W
authors: Droogne
authors: Filip
authors: F
authors: Rega
authors: Bartley
authors: B
authors: Griffith
authors: Robert
authors: R
authors: Dowling
authors: Mark J
authors: MJ
authors: Zucker
authors: Daniel
authors: D
authors: Burkhoff
mesh_terms: D000328:Adult; D005240:Feasibility Studies; D005260:Female; D006333:Heart Failure / Q000378:metabolism / Q000503:physiopathology / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects; D006439:Hemodynamics; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D006454:Hemoglobins