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OBJECTIVE: The C-Pulse System (Sunshine Heart, Inc) is an implantable, non-blood contacting device designed to provide long-term counterpulsation therapy for advanced heart failure patients. Results from a recently completed 20 patient FDA-approved feasibility study demonstrated improvements in NYHA class and quality of life with a low incidence of adverse events. We describe our single center experience in a subgroup of patients undergoing implantation of the C-pulse system utilizing the first minimally invasive thoracotomy approach.
METHODS: Between July 2010 and March 2011, five patients underwent implantation of the C-Pulse device at a single institution under an FDA approved IDE prospective feasibility study. Safety endpoints included death, aortic injury, neurologic events, and major infection at 6 months. Quality of life was assessed using Minnesota Living with Heart Failure (MLWHF) and the Kansas City Cardiomyopathy Questionnaire (KCCQ). One patient underwent implantation using a hemisternotomy approach. Four patients underwent placement using a limited right parasternal thoracotomy incision, leaving the sternum intact.
RESULTS: Mean age was 53 years (range 34-71) and 80% were male. All patients were NYHA class III at baseline, with non-ischemic etiology in 80% (4/5). Two patients were inotrope dependent. Mean follow up was 351 days (range 64 - 498) with 1754 total patient days. There were no deaths. There were no neurologic events, aortic disruptions, or mediastinal infections. One patient was re-explored for mediastinal bleeding. One patient developed a driveline exit site infection prior to 6 months. One patient was transitioned to an LVAD at 64 days for worsening heart failure symptoms. Improvement in NYHA class was seen in 80% (4/5 patients). Significant improvements were seen at 6 months in MLWHF scores [baseline mean 50 (range 20-71) vs. mean 31 (range 5-49) at 6 months] and in KCCQ scores [baseline mean 56 (range 37-81) vs. mean 69 (range 52-92)].
CONCLUSIONS: The results of the C-pulse cardiac assist system study have demonstrated feasibility and preliminary safety and efficacy in patients with moderate to severe ambulatory heart failure. The system can be safely implanted utilizing a minimally invasive non-sternotomy approach. These findings warrant further study with a prospective, randomized control trial.