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New AHRQ Study Finds Mixed Evidence on Use of Radiofrequency Catheter Ablation for Treating Atrial Fibrillation
Date:7/6/2009

ear that more research is needed to demonstrate its potential long-term benefits," said AHRQ Director Carolyn M. Clancy, M.D. "This report crystallizes the questions that researchers need to ask going forward."

Atrial fibrillation, the most common type of irregular heartbeat in adults, affects more than 2.2 million Americans, putting them at risk for heart failure, blood clots, or stroke. Patients with atria fibrillation are typically treated with medication first, but medicines only work for about half of patients for preventing recurrence of atrial fibrillation.

The report calls for more research on the effect of radiofrequency catheter ablation on quality of life. In particular, more research is needed for groups of patients for whom the research is especially lacking, such as women, the elderly, and patients who have other conditions such as heart failure or high blood pressure.

Earlier this year, HHS' Food and Drug Administration approved the first two ablation catheters indicated for use in treating atrial fibrillation, in the United States. However, physicians often use other catheters that have not been approved by the FDA for atrial fibrillation. The FDA also found that there is no conclusive evidence that people whose symptoms are reduced with ablation are less likely to have a stroke. Therefore, the FDA explicitly endorsed existing clinical guidelines that recommend that patients at risk for stroke continue to take preventive blood-thinning medications after radiofrequency catheter ablation.

As a condition of catheter approvals, the FDA mandated that the catheters' manufacturer must conduct two post approval studies (PAS) to collect long term safety data. The mandated studies apply only to FDA-approved catheters, and not to devices used off-label in clinical practice. The first PAS is a post approval registry, which will collect safety (adverse event) data and operator experience inform
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SOURCE Agency for Healthcare Research & Quality
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