A new, implantable device to control heart failure is showing promising results in the first trial to determine safety and effectiveness in patients, a significant study shows.
"The optimal drug therapies we have today often are not enough to manage this disease for some patients, so we are always looking for new types of therapies," said lead researcher William Abraham from the Ohio State University Wexner Medical Centre in the US.
The researchers examined an extra-aortic counterpulsation system called C-Pulse, made by US-based Sunshine Heart Inc.
It is 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 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.
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," Abraham noted.
Additionally, patients were able to walk an average 100 feet farther during standardised measures and average quality of life scores improved nearly 30 points.
The findings appeared in the Journal of American College of Cardiology Heart Failure.
