CIRCULITE® SYNERGY® System for the Treatment of Intermacs ≥4 Heart Failure

Abstract

Purpose The CircuLite® Synergy® System, a micro-pump based assist device, has been optimized to improve performance in an EU clinical trial for chronic ambulatory heart failure patients. We report the results from the last 24 consecutive patients. Methods and Materials 24 non-inotrope dependent (INTERMACS ≥4; 20 males, 61±15yrs, EF 20±5%) patients were implanted in a minimally invasive off pump procedure. Blood is drawn through the inflow cannula from the left atrium to the micro-pump (placed in a right subclavicular pocket) and discharged through an outflow graft to the right subclavian artery. Results Mean duration of support is 7 months (range 5-713d). Follow up at 2 months showed improved mean PA pressure (38±12 vs 28.4±7), cardiac output (3.9±1 vs 4.9±1), pulmonary capillary wedge pressure (27.2±9 vs 17.3±6), peak VO2 (11.3±3 vs 12.9±3), 6 minute walk (299±143 vs 420±118) and Minnesota Living with Heart Failure Questionnaire (63.5±20.4 vs 49.2±24.3). Four devices have been explanted: 1 following full recovery of LV function; 1 following significant decrease in heart size causing suction events; 1 following reoccurring bleeding 72 days post-implant; 1 following epistaxis and anticoagulation changes that resulted in pump thrombosis. The most significant adverse event has been bleeding (4.5 events/patient year) with 3 perioperative deaths due to complications of bleeding, that has been addressed with additional training. No perioperative neurological or infection events were observed. Conclusions Synergy improves hemodynamics and functional status with low adverse event rates in chronic ambulatory heart failure patients (INTERMACS ≥4). The Synergy System has the potential for broad application in this population of patients not sick enough to justify the risks associated with more surgically invasive assist devices.