October 16, 2014 — Sunshine Heart Inc. today announced the results of its feasibility study entitled “Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Severe Chronic Heart Failure,” published in the Journal of American College of Cardiology Heart Failure (JACC HF). The study showed that the use of the C-Pulse System in Class III and ambulatory Class IV heart failure (HF) patients is feasible while providing preliminary indications of safety and improvements in functional status and health-related quality of life (QOL).
William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center, said, “There are numerous challenges with the current treatment options of Class III and ambulatory Class IV heart failure patients. Surgical treatments available are often last resort, high-risk and invasive. The C-Pulse System addresses these challenges, is less invasive, has a lower risk profile and can be placed in patients too sick to be on optimal medical therapy alone, but not so sick that they require mechanical circulatory support or a heart transplant.”
The C-Pulse System feasibility study was a prospective, open-label, single-arm 20-patient study approved by the U.S. Food and Drug Administration (FDA) under an Investigational Device Exemption (IDE) and undertaken at seven centers in North America. Following baseline testing, eligible patients who had New York Heart Association (NYHA) Class III or ambulatory Class IV HF underwent implantation of the C-Pulse System between April 15, 2009 and June 20, 2011. No anti-coagulants were required with use of the C-Pulse System, reducing the risk of bleeding complications; and the location of the implanted cuff around the aorta mitigated the risk of intra-vascular clotting concerns.
At six months, C-Pulse produced statistically significant improvements in NYHA Class (3.1 to 1.9, p=0.0005), as well as in two validated QOL instruments including the Minnesota Living with Heart Failure questionnaire (63.6 to 40.2, p=0.0005) and the Kansas City Cardiomyopathy Questionnaire (43.6 to 65.6, p=0.0002). The 6 Minute Walk Distance improved at 6 months with statistically significant improvement at one year (289.7 to336.5, p=0.0425). There was no change in peak VO2 (14.5 to 13.1, p=0.2612). Importantly, over the 12 months following initial placement of the C-Pulse device, only 3 of the 20 implanted patients (15 percent) had 5 adjudicated heart failure related hospitalizations, none which occurred within 30 days of implant.
There were no 30-day operative deaths reported in the study. Additionally, there were no neurological events, no device related bleeding events, no stroke events and no myocardial infarctions through 12 months. At 12 months, there was one adjudicated device-related death. The device-related death was attributed to complications arising from a sternal wound infection in a patient who underwent repeated sternotomies and attempted sternectomy. Exit-site infections were also observed in eight patients which prompted the company to incorporate changes to mitigate this in the future.
Abraham added, “Although the study was not designed or powered to demonstrate efficacy, the magnitude of patient improvements using the C-Pulse System is clinically meaningful when compared to prior drug and device studies in heart failure. In addition, there were patients that were successfully weaned from the device, an early indication that C-Pulse may have reversed or prevented the progression of their disease,preventing the need for an LVAD or a heart transplant.”
For more information: www.sunshineheart.com