Around 50% of people who develop heart failure die within 5 years of diagnosis. But could a novel, implantable heart device change this? In a clinical trial, the C-Pulse - a cuff that wraps around the aorta and pumps blood from the heart around the body - has proved effective in reversing heart failure, even in some patients with severe cases.
The research team, led by Dr. William Abraham of The Ohio State University Wexner Medical Center, publish their findings in the Journal of the American College of Cardiology (JACC) Heart Failure.
Heart failure occurs when the heart is unable to pump enough blood and oxygen around the body to support other organs. Around 5.1 million people in the US have the condition.
There is no cure for heart failure, although there are medications to help manage symptoms. But Dr. Abraham notes such treatments are not always effective. "The optimal drug therapies we have today often aren't enough to manage this disease for some patients," he says, "so we are always looking for new types of therapies."
For their study, Dr. Abraham and his team implanted the C-Pulse device in 20 patients with either functional class III or ambulatory functional class IV heart failure, as defined by the New York Heart Association.
The device, developed by Sunshine Heart Inc., is an extra-aortic counterpulsation system. It consists of a cuff that is placed around the patient's aorta - the largest artery in the body - and is outside of the patient's bloodstream. The cuff is attached to a small balloon that inflates and deflates in sync with the patient's heartbeat. This pumps blood through the aorta and around the body.
According to the Sunshine Heart website, the device is designed to get more oxygen to the heart muscle, reduce the workload of the left ventricle in the heart, and increase blood flow from the heart.
A wire runs from the device through the abdomen to an external power pack called a "driver," which the patient wears. The driver can be battery powered or plugged in, and it can be disconnected temporarily to allow the patient to shower, for example, or carry out other short tasks where the pack may be inconvenient.
The C-Pulse can be implanted within 1 hour via a mini-thoracotomy (a small incision through the ribs) and a mini-sternotomy (a small incision through the sternum) or via a complete sternotomy.
C-Pulse 'effectively reversed heart failure' for some patients
The patients in the study were assessed 6 months and 1 year after device implantation. The team says that 16 of the 20 patients showed significant improvements in symptoms at both points in time.
Dr. Abraham says that three of the patients had mild or no symptoms of heart failure 1 year after implantation. "They went from class III or IV down to a functional class I, effectively reversing their heart failure," he adds.
The researchers also found that the patients were able to walk an average of 100 feet further, and the average quality of life score among patients improved by almost 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," Dr. Abraham explains. "So, this is truly a significant improvement."
One patient who has seen success from the C-Pulse device is Richard Jacob. He and Dr. Abraham discuss the device and its effectiveness in the video below:
The researchers note that because the device is outside of the patient's bloodstream, none of them were hospitalized for stroke, thrombosis, sepsis or bleeding, which they say can be common among patients using left ventricular assist devices.
They point out, however, that a common side effect - occurring among 8 of the 20 patients - was infection of the device exit site. In future trials, the team notes that this side effect should be reduced with stricter guidelines for management of the exit site and better wound care and antibiotic therapy.
Medical News Today recently reported on the development of a wearable, skin-like device that researchers say can monitor cardiovascular and skin health 24 hours a day.