Circulatory support in elderly chronic heart failure patients using the CircuLite® Synergy® system

OBJECTIVE: The Synergy (R) system, a miniature partial circulatory support device, is implanted with an off-pump, minimally invasive surgical approach. In our experience, implantation of this system is associated with fewer perioperative adverse events than current full support devices. This approach therefore offers the possibility of treating elderly chronic heart-failure patients who might not ordinarily be considered for long-term circulatory support. METHODS: A total of 54 patients (12 patients >= 70 years) were implanted with the Synergy system in an off-pump minithoracotomy procedure. Mean age (54 +/- 10 vs 73 +/- 3), body surface area (1.9 +/- 0.2 vs 1.7 +/- 0.1), blood urea nitrogen (BUN) (59 +/- 33 vs 91 +/- 38), estimated glomerular filtration rate (eGFR) (71 +/- 23 vs 50 +/- 38) and haemoglobin (12.6 +/- 1.9 vs 11.3 +/- 1.3) differed significantly between young and old. RESULTS: Older patients had longer mean durations of support (337 vs 188 days). On average, both groups showed similar improvements (changes from baseline) in haemodynamics (pulmonary capillary wedge pressure -9 +/- 16 vs -10 +/- 8 mmHg; CO +1.0 +/- 0.7 vs 0.9 +/- 1.0 l/min, periferical vascular resistance (PVR) -1.2 +/- 1.5 vs = 0.8 +/- 1.7 Wood) and 6 min walk (107 +/- 120 vs 130 +/- 121 m). Older patients showed less improvement in peak VO2 (0.5 +/- 2.9 vs 1.9 +/- 3.0 ml/kg/min). Major adverse events (old vs young) between groups included major bleeding (75 vs 38%), infection (25 vs 38%), renal dysfunction (0 vs 17%) and device-related stroke (8 vs 10%). Mortality rate was 20% for the young and 40% for the elderly. CONCLUSIONS: Older patients implanted with Synergy had smaller body sizes and worse renal function than younger patients. Both groups experienced similar haemodynamic benefits and functional improvements, though peak VO2 is less improved in the elderly. Risks of bleeding and renal dysfunction appear to be increased in the elderly, though still within acceptable ranges compared with other full support devices. Minimally invasive long-term circulatory support devices, like Synergy, offer a new treatment option to the elderly chronic heart-failure population.