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New Device Can Reverse Heart Failure, Study Finds
A new implantable device to control heart failure is showing promising results in the first trial to determine its safety and effectiveness in patients, according to lead researcher Dr. William Abraham of the Ohio State University Wexner Medical Center.
Results from the study were published in the Journal of the American College of Cardiology: Heart Failure.
“Heart failure is one of the fastest-growing forms of heart disease, and it’s one of the most common reasons people are hospitalized,” Abraham said. “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 and colleagues at seven U.S. centers assessed C-Pulse (Sunshine Heart Inc.), an extra-aortic counterpulsation system. 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. The device is 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. The patients were evaluated at 6 months and 1 year. At both time points, 16 of the patients (80%) showed significant improvements in NYHA functional class.
“At the 1-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,” Abraham said.
In addition, patients were able to walk an average 100 feet farther during standardized measures, and their average quality-of-life scores improved nearly 30 points. “Drug and device therapies that are currently available for heart failure improve that same quality-of-life score by only five or 10 points. So this is truly a significant improvement,” Abraham said.
The most common adverse effect during the trial was infection at the exit site, which was experienced by eight of the 20 participants (40%). 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 was due to the device remaining outside the bloodstream. Another important difference is that the C-Pulse device can be temporarily turned off and disconnected, allowing patients some conveniences that an LVAD doesn't permit, the authors said.
Source: MedicalXpress; October 7, 2014.