Chronic extra-aortic balloon counterpulsation: first-in-human pilot study in end-stage heart failure.

Background: Some patients continue to have significant heart failure symptoms despite optimal medical therapy.

Methods: We describe a first-in-human experience with an implantable non-blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years.

Results: All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60%) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway.

Conclusions: Although feasibility of this device is suggested by this pilot study, safety and efficacy will need to be examined in a larger cohort with longer follow-up.