J&J Heated Catheter Better Than Drugs for Irregular Heartbeats

Jan. 26 (Bloomberg) -- Johnson & Johnson’s Navistar ThermoCool catheter worked better than medicine to control irregular heartbeats in people who didn’t respond previously to at least one drug, a study found.

Sixty-six percent of patients who underwent the procedure known as catheter ablation, which used the J&J device, were free of recurring irregular beats compared with 16 percent of those treated with medicines, researchers said today in the Journal of the American Medical Association. The heated catheter burns away heart tissue to block the electrical pulses that cause the arrhythmic beats.

New Brunswick, New Jersey-based Johnson & Johnson won U.S. approval last year to sell the first devices, NaviStar ThermoCool and EZ Steer ThermoCool Nav, to ablate, or kill, the cells that trigger irregular heartbeats, or atrial fibrillation. The condition affects more than 2 million Americans and can cause blood clots and strokes, according to the American Heart Association. Today’s findings show that catheter ablation is the best alternative for people who tried drug therapy that didn’t stop their symptoms from returning, lead author David Wilber said.

“It argues for much earlier use of catheter ablation in treating patients who don’t respond to the initial attempts at drug therapy,” said Wilber, director of the Cardiovascular Institute at Loyola University Chicago’s Stritch School of Medicine, in a Jan. 25 telephone interview. “To continue to search for different drugs may not be helpful. They’ll have far better quality of life if they have catheter ablation instead.”

Competing Companies

J&J, the world’s largest health products company, is vying with Medtronic Inc., Boston Scientific Corp. and St. Jude Medical Inc. for the treatment of atrial fibrillation by burning, freezing, or otherwise destroying the malfunctioning heart cells that cause the condition.

Minneapolis-based Medtronic expects to bring its catheter to the U.S. market in the second half of this year if it wins Food and Drug Administration approval, said spokeswoman Catherine Peloquin. The device is approved outside the U.S.

St. Jude has FDA permission to begin enrollment in a medical trial of the safety and effectiveness of the company’s catheter ablation system for atrial fibrillation, Marisa Bluestone, a spokeswoman for St. Paul, Minnesota-based St. Jude, said today. Paul Donovan, a spokesman for Natick, Massachusetts- based Boston Scientific, said the company doesn’t have catheters indicated for treatment of atrial fibrillation in the U.S.

Electrical Signals

In atrial fibrillation, the electrical signals that regulate the heartbeat become irregular. Instead of beating regularly, the upper chambers of the heart quiver and don’t let all the blood pump out.

People with atrial fibrillation have fatigue, loss of the ability to tolerate exercise, chest discomfort and heart flutters, Wilber said. People diagnosed with the condition are generally given medicines that may affect other organs and have side effects that mimic the symptoms of the disease, he said.

The effectiveness of drugs to control the heart’s rhythm is “inconsistent” and the likelihood that arrhythmic beats will recur within 12 months is about 50 percent with most drugs, the study authors wrote.

The researchers studied 167 patients with irregular heartbeats who had failed treatment with at least one drug. Of those, 106 received catheter ablation, while 61 were given a different medicine than they had previously taken. The two most common drugs given in the study were the generic antiarrhythmic medicines flecainide and propafenone.

Quality of Life

Those who were given the ablation treatment had immediate improvements in their quality of life, while those who received drug therapy didn’t report any significant improvements, the researchers said.

The study also measured whether patients felt any symptoms of irregular heartbeats and found 70 percent of those treated by ablation remained free of symptoms compared with 19 percent of those who took the medicines.

J&J’s Biosense Webster Unit, which provided the catheters used, funded the study. Biosense Webster developed NaviStar ThermoCool. Wilber reported in the paper that he has received grants and consulting fees from Biosense Webster. The results of the study were part of the submission to the FDA for approval of the catheter in the U.S., said Marcia Yaross, vice president of clinical, regulatory and health economics at Diamond Bar, California-based Biosense Webster.

A larger study is under way to determine if atrial fibrillation patients who receive ablation live longer than those taking medicine. Wilber, who is a researcher on that study, said the results probably won’t be available for five or six years.

To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net.