Scientists have developed a new implantable device that can help in controlling and reversing heart failure.
According to lead researcher Dr. William Abraham of The Ohio State University Wexner Medical Center the new device has shown promising results in the first trial to determine safety and effectiveness in patients.
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 could be plugged in or battery-powered.
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 was due to the device remaining outside the bloodstream.
Another important difference was the C-Pulse device could be temporarily turned off and disconnected, allowing patients some conveniences that an LVAD doesn't permit.
The study is published in the Journal of American College of Cardiology Heart Failure.