title: Chronic extra-aortic balloon counterpulsation: first-in-human pilot study in end-stage heart failure.
abstract: 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.
authors.affiliation: Department of Cardiology, Heart Lung Transplant Unit, St. Vincent's Hospital, Darlinghurst, New South Wales, Australia. cshayward@stvincents.com.au
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Hayward
authors.forename: William S
authors.initials: WS
authors.lastname: Peters
authors.forename: Alan F
authors.initials: AF
authors.lastname: Merry
authors.forename: Peter N
authors.initials: PN
authors.lastname: Ruygrok
authors.forename: Paul
authors.initials: P
authors.lastname: Jansz
authors.forename: Gerry
authors.initials: G
authors.lastname: O'Driscoll
authors.forename: Robert I
authors.initials: RI
authors.lastname: Larbalestier
authors.forename: Julian A
authors.initials: JA
authors.lastname: Smith
authors.forename: Betty
authors.initials: B
authors.lastname: Ho
authors.forename: Malcolm E
authors.initials: ME
authors.lastname: Legget
authors.forename: F Paget
authors.initials: FP
authors.lastname: Milsom
mesh_terms: 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