Mar. 26, 2001 UCSF researchers have begun clinical trials on a new device to treat patients with heart failure -- a progressive cardiovascular disease affecting more than five million Americans.
Investigators at UCSF implanted the first such device in the United States in 1996 and continue to lead research and development of implantable technology to fix hearts in which the lower chambers, the ventricles, don't pump together, as they do in a healthy heart.
The pacemaker-like device, works to resynchronize the left and right ventricles. The result is that the heart's pumping ability is stronger, according to Leslie Saxon, MD, and Teresa De Marco, MD, UCSF associate professors of medicine and co-investigators on a nationwide, randomized study to evaluate the device.
Preliminary data indicate that this technology can not only resynchronize the heart, but also support slow heart beats, detect abnormal beats before they become a significant problem, help heart failure physicians manage medications, and even prevent sudden death, said Saxon, who will present findings at the American College of Cardiology meeting March 18-21, 2001 in Orlando, Florida.
In an outpatient procedure, the device is placed under the skin near the shoulder. Physicians insert three electricity-delivering wires into a vein near the collarbone. Two wires are guided to the right ventricle of the heart, just as in a pacemaker implantation. The third wire, the new innovation, goes to the left ventricle and helps the two ventricles beat together. Heart failure is different from a heart attack. It occurs in people who may have survived a heart attack or who have had other diseases (high blood pressure, diabetes, malfunctioning heart valves, alcoholism, viruses) that damage the heart muscle, said Saxon. "These devices relieve symptoms such as shortness of breath, fatigue and fluid retention, and positively affect the lives of advanced heart failure patients who, at this time, have few alternatives," said De Marco.
Deprived of oxygen, patients with failing hearts often feel light-headed or faint and ultimately find it difficult to walk even a short distance. Only half of patients with mild to moderate heart failure survive for five years and only half of patients with severe failure survive for one year, she said, adding that, after medications have failed, their only option is to wait for a transplant. Because heart transplantation is a limited therapeutic option (due to the absence of organs) and technology is advancing at such a rapid rate, the new devices, manufactured by Indianapolis, Indiana-based Guidant Corporation, have enormous potential for the heart failure patient, De Marco said.
The multi-center clinical trial to test devices will enroll up to 2,200 patients in at least 80 medical centers across the United States and is expected to take three or four years to complete. Participants will be assigned randomly to one of three treatment groups:
* Drug therapy
* Drug therapy plus a heart failure device intended to provide resynchronization therapy
* Drug therapy plus a heart failure device intended to provide resynchronization therapy and a back-up defibrillation for irregular or dangerously fast heart beats.
Local patients participating in the trial are receiving care at the UCSF Cardiomyopathy and Arrythmia Research and Education (CARE) Center - the first U.S. center to provide the integrated services of heart failure specialists, arrhythmia specialists, and allied health care professionals. Founded by Saxon and De Marco, the approach combines basic clinical research, medical device and surgical therapies, prevention, and treatment, and serves as a prototype and central hub for similar sites being developed across the U.S.
The CARE center recently received a $1,000,000 grant from the Guidant Foundation, to maintain a national database of heart failure and arrhythmia research outcomes from up to 20 centers across the United States. The grant will also support the Center's efforts to train future generations of physicians who will care for heart failure patients.
Patients interested in enrolling in the trial should contact Kim Prouty, RN, UCSF research coordinator for heart failure and arrhythmia at 415-476-9218.
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