Objectives: The use of current left ventricular assist devices (VADs) that provide full support is restricted to critically ill patients because of associated risks. Smaller devices could expand VAD use to a larger pool of patients. The purpose of this study was to test the hemodynamic effects of partial ventricular support in patients with advanced heart failure.
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. The inflow cannula inserts into the left atrium; the outflow graft connects to the right subclavian artery.
Results: A total of 26 patients (20 men), age 55[34-69] years with ejection fraction 21.6%[10-32], mean arterial pressure 73.5 mm Hg[60-91], pulmonary capillary wedge pressure 27.2 6mm Hg [15-56], and cardiac index 1.9 l/min/m2 [1.3-2.6] received an implant. 84% of our patients are alive at 6 months after implantation. Duration of support ranged from 6 to 213 (median 81) days. 13 patients underwent follow-up right heart catheterization at three months after implant. Increase in cardiac index and reduction in pulmonary artery pressure is depicted in Figure. Adverse events with an incidence >10% included: pump pocket hematoma (6), bleeding requiring transfusion (3), pump pocket bleeding (3), hemolysis with pump thrombus (3) and renal failure (3).
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.
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