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Pilot study of counterpulsation system successful in patients with HF
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A novel implantable extra-aortic counterpulsation system was safe and improved functional status and quality of life in patients with HF in a recent pilot study.
Researchers evaluated the feasibility, safety and potential efficacy of the counterpulsation system (C-Pulse System, Sunshine Heart Inc.), which includes a nonobligatory, non-blood contacting counterpulsation heart assist pump designed to be implanted in a minimally invasive manner without the need for cardiopulmonary bypass.
According to the study background, the system can be turned off or weaned if the patient experiences sustained cardiac recovery, there is a low risk for death or disability if the device fails, and anticoagulation is not required for patients using the device.
William T. Abraham
William T. Abraham, MD, and colleagues implanted the counterpulsation system in 20 patients (12 men; mean age, 56.7 years) with ischemic or nonischemic cardiomyopathy who had poor functional status and quality of life but did not require end-stage therapies.
They assessed safety at 12 months and the following efficacy measures at 6 and/or 12 months: change in NYHA functional class, Minnesota Living with Heart Failure score, Kansas City Cardiomyopathy Questionnaire score, 6-minute walk distance and exercise peak oxygen consumption.
Abraham, director of the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, and colleagues observed no 30-day mortality, neurological events or MI at 12 months. There were three deaths at 6 months, one of which was device-related, and the 1-year survival rate was 85%, the researchers wrote.
At 6 months, the counterpulsation system was associated with improvements from baseline in NYHA functional class (from 3.1 to 1.9; P=.0005), Minnesota Living with Heart Failure score (from 63.6 to 40.2; P=.0005) and Kansas City Cardiomyopathy Questionnaire score (from 43.6 to 65.6; P=.0002), according to the researchers. However, there was no improvement in 6-minute walk distance (from 275.5 m to 296.4 m; P=.2239) or exercise peak oxygen consumption (from 14.5 mL/kg/min to 13.1 mL/kg/min; P=.2612).
At 12 months, the NYHA and questionnaire scores continued to improve, and the difference in 6-minute walk distance became statistically significant (275.5 m at baseline vs. 336.5 m at 12 months; P=.0425), according to the researchers.
“The optimal drug therapies we have today often aren’t enough to manage this disease for some patients, so we are always looking for new types of therapies,” Abraham said in a press release.
The counterpulsation system is now being evaluated in a prospective, multicenter, randomized controlled trial, the researchers wrote.
Disclosure: The study was funded by Sunshine Heart. See the full study for a list of the researchers’ relevant financial disclosures.
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