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.
Hayward
Christopher S
CS
Department of Cardiology, Heart Lung Transplant Unit, St. Vincent's Hospital, Darlinghurst, New South Wales, Australia. cshayward@stvincents.com.au
Peters
William S
WS
Merry
Alan F
AF
Ruygrok
Peter N
PN
Jansz
Paul
P
O'Driscoll
Gerry
G
Larbalestier
Robert I
RI
Smith
Julian A
JA
Ho
Betty
B
Legget
Malcolm E
ME
Milsom
F Paget
FP
D000368:Aged; D015908:Counterpulsation / Q000295:instrumentation*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008477:Mediastinal Diseases / Q000382:microbiology; D008875:Middle Aged; D010865:Pilot Projects; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome