A new, implantable device to control heart failure is showing promising results in the first trial to determine safety and effectiveness in patients. Results of the study are published in the Journal of American College of Cardiology Heart Failure.
Researchers at seven U.S. centers examined an extra-aortic counterpulsation system called C-Pulse, made by Sunshine Heart Inc. It's a cuff that wraps around the aorta and syncs with the patient's heartbeat, rapidly inflating and deflating a small balloon to help squeeze blood through the aorta to circulate throughout the body. It's powered through a wire that exits the abdomen and connects to an external driver worn by the patient. The driver can be plugged in or battery-powered.
In the pilot study, 20 patients with New York Heart Association (NYHA) functional class III or ambulatory functional class IV heart failure were implanted with the device. Patients were evaluated at six months and one year. At both times, 16 of the patients showed significant improvements in NYHA functional class.
At the one year mark, three of the patients had mild or no symptoms of heart failure. They went from class III or IV down to a functional class I, effectively reversing their heart failure. Additionally, patients were able to walk an average 100 feet farther during standardized measures and average quality of life scores improved nearly 30 points.
The most common adverse effect during the trial was infection of the exit site, experienced by 8 out of 20 participants. Researchers noted that stricter guidelines for exit site management, wound care and antibiotic therapy could reduce that risk in future studies.
There were no hospitalizations among the participants for stroke, thrombosis, sepsis or bleeding, which often occurs in patients using left ventricular assist devices (LVADs). The researchers said this is due to the device remaining outside the bloodstream. Another important difference is the C-Pulse device can be temporarily turned off and disconnected, allowing patients some conveniences that an LVAD doesn't permit.