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Device works better than drugs for atrial fibrillation

Posted Mar 26 2009 3:39pm

New breakthrough reported for atrial fibrillation patients
A common irregular and often rapid heart rhythm is known as atrial fibrillation or A Fib. Roughly 2.2 million Americans are suffering from some form of heart rhythm disorder. In atrial fibrillation, the heart's two small upper chambers (the atria) vibrate irregularly instead of beating effectively. Blood is also not pumped fully out of them, so it may clot more readily. A patient can suffer a stroke if a fragment of clotted blood in the atria leaves the heart and lodges in an artery in the brain. Doctors have known for years about the link between atrial fibrillation and strokes.

The regular heart rhythm is set by a "pacemaker" in the atrium, the SA node. This specialized group of heart cells discharges in a regular orderly fashion millions of times over a person's lifetime. In atrial fibrillation, the SA node discharges electrical impulses in an irregular fashion, resulting in irregular, disorganized, chaotic, and very rapid atrial contractions. Approximately 15 percent of strokes happen in people with atrial fibrillation.

As we age the likelihood of developing atrial fibrillation increases. Today three to five percent of people over 65 have atrial fibrillation and it is even more common in the age group of 80 years. In younger people atrial fibrillation can crop up without any underlying heart disease at all. Some of the causes of atrial fibrillation are overactive thyroid, alcohol use, or pulmonary embolism - a blood clot in lungs and pneumonia. Atrial fibrillation can occur in several different patterns such as intermittent (paroxysmal), persistent and permanent.

People with atrial fibrillation can use medical therapy to regulate the heart rhythm, drugs such as sotalol, amiodarone, or digoxin. These drugs have some disadvantages, such as lack of efficacy, side effects, or narrow therapeutic window, requiring frequent monitoring of doses.

Researchers have long sought a way for patients to avoid having to use these drugs, by destroying some of the aberrant cells in the SA node. A device known as a catheter ablation tool has been used for this purpose, but is not FDA approved.

the NaviStar ThermoColl Catheter from J&J’s Biosense Webster unit
is being used to treat atrial flutter in the United States but there
are no ablation catheters approved for marketing by the U.S. FDA for
the cure of atrial fibrillation.

Though doctors have been using such a device to control atrial fibrillation in patients, there had never been a study demonstrating how such technology performed compared to conventional drug therapy for atrial fib.

In a new study Johnson & Johnson’s catheter ablation device outclassed drug therapy for atrial fibrillation. The study, which was a randomized controlled study conducted on 167 people, patients received either catheter ablation treatment or drug therapy. The ablation group showed a 75 percent drop in atrial fibrillation recurrence, compared with 21 percent for patients who received anti-arrhythmic drugs.

Researchers reported at the annual meeting of the American Heart Association in New Orleans that after nine months' followup, patients undergoing the catheter ablation therapy would have fewer serious side effects than those who were receiving medication treatment.

An FDA advisory panel is planned to meet November 20 to possibly approve J&J's application for an atrial fibrillation indication for the catheter device.

Did you know?

Atrial fibrillation sometimes occurs after cardiothoracic (open heart) surgery, but frequently resolves in a few days. The symptoms of this disorder include weakness, lack of energy or shortness of breath with effort, and chest pain.

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