Chronic extra-aortic balloon counterpulsation: First-in-human pilot study in end-stage heart failure
Hayward, C. S., Peters, W. S., Merry, A. F., Ruygrok, P. N., Jansz, P., O'Driscoll, G., et al. (2010). Chronic extra-aortic balloon counterpulsation: First-in-human pilot study in end-stage heart failure. Journal of Heart and Lung Transplantation, 29(12), 1427-1432. doi:10.1016/j.healun.2010.06.014
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.
peer-reviewed, counterpulsation, heart-assist devices, heart failure, aorta, histology, extra-aortic