title: Ambulatory extra-aortic counterpulsation in patients with moderate to severe chronic heart failure.
abstract: OBJECTIVE
  The study sought to assess feasibility, safety, and potential efficacy of a novel implantable extra-aortic counterpulsation system (C-Pulse) in functional class III and ambulatory functional class IV heart failure (HF) patients.
  
  
  BACKGROUND
  30% to 40% of HF patients suffer from poor functional status and quality of life (QoL) but are not in need of end-stage treatments. We undertook a multicenter single-arm study to assess the C-Pulse System in such patients.
  
  
  METHODS
  New York Heart Association (NYHA) functional class III or ambulatory functional class IV HF patients were eligible. Safety was assessed continuously through 12 months. Efficacy measurements included changes from baseline to 6 and 12 months in NYHA functional class, Minnesota Living with Heart Failure (MLWHF) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 6-min walk distance (6MWD), and exercise peak oxygen consumption (pVO2; 6 months only).
  
  
  RESULTS
  Twelve men and 8 women (56.7 ± 7 years, 34 to 71 years of age) with ischemic (n = 7) or nonischemic (n = 13) cardiomyopathy were implanted. There was no 30-day mortality and no neurological events or myocardial infarctions through 12 months. At 6 months, there were 3 deaths (1 device-related). One-year survival was 85%. At 6 months, C-Pulse produced improvements in NYHA functional class (3.1 ± 0.3 to 1.9 ± 0.7, p = 0.0005), MLWHF (63.6 ± 19.9 to 40.2 ± 23.2, p = 0.0005), and KCCQ scores (43.6 ± 21.1 to 65.6 ± 21.5, p = 0.0002), but not 6MWD (275.5 ± 64.0 to 296.4 ± 104.9, p = NS) or pVO2 (14.5 ± 3.6 to 13.1 ± 4.4, p = NS). Improvements continued at 12 months, with 6MWD change becoming statistically significant (336.5 ± 91.8, p = 0.0425).
  
  
  CONCLUSIONS
  Use of C-Pulse in this population is feasible, appears safe, and improves functional status and QoL. A prospective, multicenter, randomized controlled trial is underway. (C-Pulse IDE Feasability Study-A Heart Assist System; NCT00815880).
authors.affiliation: Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. Electronic address: William.Abraham@osumc.edu.
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.affiliation: St. Luke's Mid-America Heart Institute, Kansas City, Missouri.
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Aggarwal
authors.affiliation: Division of Cardiovascular Medicine, University of Louisville, Louisville, Kentucky.
authors.forename: Sumanth D
authors.initials: SD
authors.lastname: Prabhu
authors.affiliation: Division of Cardiothoracic Surgery, McGill University Health Center, Montreal, Quebec, Canada.
authors.forename: Renzo
authors.initials: R
authors.lastname: Cecere
authors.affiliation: University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Salpy V
authors.initials: SV
authors.lastname: Pamboukian
authors.affiliation: United Heart and Vascular Clinic, St. Paul, Minnesota.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Bank
authors.affiliation: Minneapolis Heart Institute, Minneapolis, Minnesota.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Sun
authors.affiliation: Division of Cardiothoracic Surgery, Pennsylvania State University, Hershey, Pennsylvania.
authors.forename: Walter E
authors.initials: WE
authors.lastname: Pae
authors.affiliation: Heart Failure and Transplant Unit, St. Vincent's Hospital, Sydney, Australia.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Hayward
authors.affiliation: Division of Cardiothoracic Surgery, Northwestern University, Chicago, Illinois.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: McCarthy
authors.affiliation: Auckland University, Auckland, New Zealand.
authors.forename: William S
authors.initials: WS
authors.lastname: Peters
authors.affiliation: Sunshine Heart Inc., Eden Prairie, Minnesota.
authors.forename: Patrick
authors.initials: P
authors.lastname: Verta
authors.affiliation: Thoracic and Cardiovascular Surgery Division, University of Louisville, Louisville, Kentucky.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
mesh_terms: D000328:Adult; D000368:Aged; D009202:Cardiomyopathies / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D015908:Counterpulsation / Q000379:methods*; D005080:Exercise Test; D017079:Exercise Tolerance; D005240:Feasibility Studies; D005260:Female; D006333:Heart Failure / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010101:Oxygen Consumption; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: C-Pulse; counterpulsation; extra-aortic; heart failure; multicenter