A cardiothoracic surgeon in the Department of Surgery at The Ohio State University Medical Center has implanted a new device, designed as a treatment for moderate heart failure, into the first two patients in the United States to receive the therapy.

Dr. Benjamin C. Sun, associate professor of surgery and chief of the Division of Cardiothoracic Surgery, performed the implantation procedures April 15 and 16 at Ohio State’s Medical Center, as part of an FDA-approved, multicenter clinical trial of the safety and feasibilty of the therapy. The patients, a West Virginia man and a Central Ohio man, are the sixth and seventh patients worldwide to have the device implanted.

"Patients with moderate heart failure experience symptoms such as shortness of breath and fatigue during mild exercise," Sun says. "The concept of this therapy is to improve blood supply to the body and heart muscle, to avoid further progression of the condition."

The therapeutic device, called the C-Pulse, is a pliable, inflatable cuff that encircles a patient’s aorta, the main blood vessel that distributes blood throughout the body. The cuff inflates and deflates in time to the patient’s heartbeat, performing an action known as counterpulsation. When the cuff inflates, it pushes blood out of the aorta to the rest of the body and the coronary arteries. When it deflates, it opens up the aorta, which reduces aortic pressure and the heart’s work load. This allows the heart to pump more vigorously and efficiently, according to the web site of Sunshine Heart, Inc., of Tustin, Calif., which developed the C-Pulse.

Although implantation of the device requires an open chest procedure, it does not require heart-lung bypass and incisions to the heart and great vessels. Because the device is placed outside of the aorta, blood contact is avoided, which limits complications and reduces recovery time.

"This device holds promise for those who remain substantially symptomatic despite treatment with currently available drugs and devices," says Dr. William T. Abraham, professor and director of cardiovascular medicine and the national co-principal investigator for the clinical trial. "We are studying its effectiveness in improving how patients feel and their ability to perform activities of daily living."

OSU Medical Center is one of six centers participating in the clinical trial and is the only participant in Ohio. Dr. David S. Feldman, associate professor of clinical cardiovascular medicine, is the local principal investigator.

Heart failure is a chronic, progressive condition in which the heart is unable to pump enough blood through the heart to meet the body’s needs for blood and oxygen. According to the American Heart Association, 5.7 million Americans suffer from heart failure, and 670,000 new cases are diagnosed each year.