Loyola University Medical Center is enrolling patients in a major clinical trial of treatments for a common heart rhythm disorder called atrial fibrillation (A-fib).
The study is comparing traditional drug therapy with a newer treatment called catheter ablation.
Standard drug therapy has been available for more than 30 years. It includes drugs to prevent the heart rate from going too fast and drugs to stop the abnormal heart rhythm. But medications don't always work, and they can cause side effects that significantly impair patients' quality of life. Moreover, medications do not halt the underlying progression of the disease.
In the newer ablation procedure, an electrophysiologist destroys areas of heart tissue that are responsible for the erratic electrical signals. A catheter (thin flexible tube) is guided through blood vessels to the heart. The tip of the catheter delivers radiofrequency energy that heats and destroys tissue.
Loyola is participating in an international, multi-center trial called CABANA (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial). The study will enroll 3,000 A-fib patients. Half will be randomly assigned to receive drug therapy and half will receive ablation.
A-fib patient Joel Stone is among the Loyola participants in CABANA who received catheter ablation. The procedure was performed by Dr. David Wilber, principal investigator for the Loyola site and director of the Cardiovascular Institute of Loyola University Chicago Stritch School of Medicine.
Stone spent one night in the hospital and was off work for three days. More than a year later, his A-fib symptoms have been eliminated, and he has been able to stop his A-fib medication and blood thinners. He has much more energy, has begun to exercise regularly and has lost 40 pounds.
"I'm 63, but I feel like I'm 25," he said.
More than 2 million Americans have atrial fibrillation, and there are about 160,000 new cases each year. The number is increasing, due in part to the aging population and the obesity epidemic.
A-fib is the most common form of irregular heartbeat. Electrical signals, which regulate the heartbeat, become erratic. Instead of beating regularly, the upper chambers of the heart quiver. Not all the blood gets pumped out, so clots can form. A-fib can lead to strokes and heart failure.
A-fib symptoms include heart palpitations, dizziness, chest pain, fatigue, shortness of breath, fainting and lightheadedness. "Many people are disabled," Wilber said.
"They have no energy. They can't work. They have a very poor quality of life."
Wilber was lead author of a 2010 study published in the Journal of the American Medical Association that found that catheter ablation worked dramatically better than medications in reducing A-fib episodes and improving quality of life. Patients who were enrolled in this earlier trial had already failed one or more drug treatments. By comparison, patients in CABANA need not have previously failed a drug; they begin treatment at an earlier stage of their disease.
The main outcome studied in the earlier trial was the percentage of patients who remained free of A-fit episodes or symptoms. CABANA is designed primarily to determine whether ablation patients live longer than patients treated by medications.
As a leading academic medical center, Loyola is able to offer cardiovascular patients opportunities to enroll in clinical trials of the latest treatments, technologies and medications for heart rhythm disorders and other cardiovascular conditions.
Loyola physicians perform about 500 ablations per year, making Loyola one of the highest-volume centers in the Midwest.
Source:
Loyola University Health System