PMID- 25301151
OWN - NLM
STAT- MEDLINE
DCOM- 20151102
LR  - 20151119
IS  - 2213-1787 (Electronic)
IS  - 2213-1779 (Linking)
VI  - 2
IP  - 5
DP  - 2014 Oct
TI  - Ambulatory extra-aortic counterpulsation in patients with moderate to severe 
      chronic heart failure.
PG  - 526-33
LID - S2213-1779(14)00272-8 [pii]
LID - 10.1016/j.jchf.2014.04.014 [doi]
AB  - OBJECTIVES: 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).
CI  - Copyright (c) 2014 American College of Cardiology Foundation. Published by Elsevier 
      Inc. All rights reserved.
FAU - Abraham, William T
AU  - Abraham WT
AD  - Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. 
      Electronic address: William.Abraham@osumc.edu.
FAU - Aggarwal, Sanjeev
AU  - Aggarwal S
AD  - St. Luke's Mid-America Heart Institute, Kansas City, Missouri.
FAU - Prabhu, Sumanth D
AU  - Prabhu SD
AD  - Division of Cardiovascular Medicine, University of Louisville, Louisville, 
      Kentucky.
FAU - Cecere, Renzo
AU  - Cecere R
AD  - Division of Cardiothoracic Surgery, McGill University Health Center, Montreal, 
      Quebec, Canada.
FAU - Pamboukian, Salpy V
AU  - Pamboukian SV
AD  - University of Alabama at Birmingham, Birmingham, Alabama.
FAU - Bank, Alan J
AU  - Bank AJ
AD  - United Heart and Vascular Clinic, St. Paul, Minnesota.
FAU - Sun, Benjamin
AU  - Sun B
AD  - Minneapolis Heart Institute, Minneapolis, Minnesota.
FAU - Pae, Walter E Jr
AU  - Pae WE Jr
AD  - Division of Cardiothoracic Surgery, Pennsylvania State University, Hershey, 
      Pennsylvania.
FAU - Hayward, Christopher S
AU  - Hayward CS
AD  - Heart Failure and Transplant Unit, St. Vincent's Hospital, Sydney, Australia.
FAU - McCarthy, Patrick M
AU  - McCarthy PM
AD  - Division of Cardiothoracic Surgery, Northwestern University, Chicago, Illinois.
FAU - Peters, William S
AU  - Peters WS
AD  - Auckland University, Auckland, New Zealand.
FAU - Verta, Patrick
AU  - Verta P
AD  - Sunshine Heart Inc., Eden Prairie, Minnesota.
FAU - Slaughter, Mark S
AU  - Slaughter MS
AD  - Thoracic and Cardiovascular Surgery Division, University of Louisville, 
      Louisville, Kentucky.
CN  - C-Pulse Trial Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00815880
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JACC Heart Fail
JT  - JACC. Heart failure
JID - 101598241
SB  - IM
CIN - JACC Heart Fail. 2014 Oct;2(5):534-5. PMID: 25301152
CIN - JACC Heart Fail. 2015 Apr;3(4):342-3. PMID: 25858794
CIN - JACC Heart Fail. 2015 Apr;3(4):343-4. PMID: 25858795
MH  - Adult
MH  - Aged
MH  - Cardiomyopathies/complications/physiopathology/*therapy
MH  - Counterpulsation/*methods
MH  - Exercise Test
MH  - Exercise Tolerance
MH  - Feasibility Studies
MH  - Female
MH  - Heart Failure/etiology/physiopathology/*therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Oxygen Consumption
MH  - Prospective Studies
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
OTO - NOTNLM
OT  - C-Pulse
OT  - counterpulsation
OT  - extra-aortic
OT  - heart failure
OT  - multicenter
EDAT- 2014/10/11 06:00
MHDA- 2015/11/03 06:00
CRDT- 2014/10/11 06:00
PHST- 2014/01/28 00:00 [received]
PHST- 2014/04/14 00:00 [revised]
PHST- 2014/04/15 00:00 [accepted]
PHST- 2014/10/11 06:00 [entrez]
PHST- 2014/10/11 06:00 [pubmed]
PHST- 2015/11/03 06:00 [medline]
AID - S2213-1779(14)00272-8 [pii]
AID - 10.1016/j.jchf.2014.04.014 [doi]
PST - ppublish
SO  - JACC Heart Fail. 2014 Oct;2(5):526-33. doi: 10.1016/j.jchf.2014.04.014.