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.
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 failurepatients, 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.
Authors: Christoph T Starck; Jakob Becker; Roland Fuhrer; Simon Sündermann; Jan Wendelin Stark; Volkmar Falk Journal: Interact Cardiovasc Thorac Surg Date: 2013-09-22
Authors: Carlo R Bartoli; Paul A Spence; Thorsten Siess; Daniel H Raess; Steven C Koenig; Robert D Dowling Journal: J Thorac Cardiovasc Surg Date: 2013-12-09 Impact factor: 5.209
Authors: Guruprasad A Giridharan; Thomas J Lee; Mickey Ising; Michael A Sobieski; Steven C Koenig; Laman A Gray; Mark S Slaughter Journal: Artif Organs Date: 2012-08 Impact factor: 3.094