Author + information
- Received January 28, 2014
- Revision received April 14, 2014
- Accepted April 15, 2014
- Published online October 1, 2014.
- William T. Abraham, MD∗∗ (, )
- Sanjeev Aggarwal, MD†,
- Sumanth D. Prabhu, MD‡,
- Renzo Cecere, MD§,
- Salpy V. Pamboukian, MD, MSPH‖,
- Alan J. Bank, MD¶,
- Benjamin Sun, MD#,
- Walter E. Pae Jr., MD∗∗,
- Christopher S. Hayward, MD††,
- Patrick M. McCarthy, MD‡‡,
- William S. Peters, MBChB, MD§§,
- Patrick Verta, MS Stat, MD‖‖,
- Mark S. Slaughter, MD¶¶,
- C-Pulse Trial Study Group
- ∗Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio
- †St. Luke’s Mid-America Heart Institute, Kansas City, Missouri
- ‡Division of Cardiovascular Medicine, University of Louisville, Louisville, Kentucky
- §Division of Cardiothoracic Surgery, McGill University Health Center, Montreal, Quebec, Canada
- ‖University of Alabama at Birmingham, Birmingham, Alabama
- ¶United Heart and Vascular Clinic, St. Paul, Minnesota
- #Minneapolis Heart Institute, Minneapolis, Minnesota
- ∗∗Division of Cardiothoracic Surgery, Pennsylvania State University, Hershey, Pennsylvania
- ††Heart Failure and Transplant Unit, St. Vincent's Hospital, Sydney, Australia
- ‡‡Division of Cardiothoracic Surgery, Northwestern University, Chicago, Illinois
- §§Auckland University, Auckland, New Zealand
- ‖‖Sunshine Heart Inc., Eden Prairie, Minnesota
- ¶¶Thoracic and Cardiovascular Surgery Division, University of Louisville, Louisville, Kentucky
- ↵∗Reprint requests and correspondence:
Dr. William T. Abraham, Division of Cardiovascular Medicine, The Ohio State University, 473 West 12th Avenue, Room 110P, Columbus, Ohio, 43210-1252.
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)
This study was funded by Sunshine Heart, Inc., Eden Prairie, Minnesota. The study was designed by Drs. Abraham, McCarthy, Peters, Hayward; other advisors Drs. Aggarwal, Cecere, Bank, Slaughter, Sun; and the sponsor. Data were monitored, collected, and managed by an independent Clinical Research Organization contracted by the sponsor. Dr. Abraham was the principal investigator for the C-Pulse Pilot Study sponsored by Sunshine Heart. Dr. Abraham, McCarthy, Peters, Slaughter, Bank, Cecere, Aggarwal, and Sun received consulting fees from Sunshine Heart, Inc. Dr. Prabhu is a site investigator for Sunshine Heart and Aastrom; and serves on the Data Safety and Monitoring Board for Genzyme (Sanofi-Aventis) and the Clinical Advisory Board for Sulfagenix. Dr. Bank has received consulting fees from Sunshine Heart. Dr. Pae is an investigator for Thoratec, Heartware, and St. Jude Medical; has received consulting fees from Thoratec; and has served on the Data Safety and Monitoring Board for BioStable. Dr. Peters holds intellectual property, stock, or stock options in Sunshine Heart, Inc.; and has received consulting fees. Dr. Verta is an employee of Sunshine Heart, Inc. and holds stock options. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 28, 2014.
- Revision received April 14, 2014.
- Accepted April 15, 2014.
- American College of Cardiology Foundation