MedCAC Calls For More Research On Catheter Ablation For Atrial Fibrillation

Article preview reprinted from "The Gray Sheet" - October 26, 2009

More evidence is needed to determine the benefits of using catheter ablation for treating atrial fibrillation, especially in the frail elderly population, according to the Medicare Evidence Development and Coverage Advisory Committee. Read more...

MedCAC Calls For More Research On Catheter Ablation For Atrial Fibrillation

Article preview reprinted from "The Gray Sheet" - October 26, 2009

More evidence is needed to determine the benefits of using catheter ablation for treating atrial fibrillation, especially in the frail elderly population, according to the Medicare Evidence Development and Coverage Advisory Committee.

The MedCAC panel met Oct. 21 at CMS headquarters in Baltimore to advise the agency on the adequacy of existing evidence.

The group would like to see whether clinical trial data that show symptoms are relieved and atrial fibrillation (AF) recurrence is reduced following catheter ablation in a general adult population can be extended to Medicare beneficiaries, particularly when the procedure is performed at smaller community hospitals.

MedCAC also advised CMS that more long-term research is needed to determine the impact of the procedures on stroke and survival rates.

Panelists suggested that CMS coverage with evidence development could help fill in some gaps.

Last year, CMS named AF ablation one of 20 potential topics for future national coverage reviews (The Gray Sheet' Aug. 4, 2008).

However, MedCAC chair Clifford Goodman, senior vice president at The Lewin Group, stressed that CMS has not opened a national coverage review of catheter ablation for AF and that coverage decisions are currently made at the local level.

AHRQ Review Finds Moderate Evidence Of Benefit

The day-long meeting included a summary of a technology assessment commissioned by the Agency for Healthcare Research and Quality, and conducted by the Tufts Medical Center Evidence-based Practice Center in Boston (The Gray Sheet' Dec. 8, 2008).

The review found a moderate level of evidence that ablation as a second-line treatment offers greater maintenance of sinus rhythm at one year than antiarrhythmic drug therapy does. It also found insufficient evidence on the risk of stroke or death and called for stronger study designs.

Speakers representing electrophysiologists and industry point out that the technology assessment did not incorporate the most recent research, such as the ongoing CABANA study comparing catheter ablation to AF treatment with antiarrhythmic drugs (The Gray Sheet' June 22, 2009).

Marshall Stanton, Medtronic vice president of cardiac rhythm disease management, clinical research and reimbursement, said investigators finished enrollment for the multi-site STOP-AF trial in May, but the results are not yet public (The Gray Sheet' July 20, 2009).

Johnson & Johnson/Biosense Webster's NaviStar ThermoCool and EZ Steer ThermoCool Navigational are the only cardiac ablation catheters approved by FDA to treat AF, although other devices are widely used off label.

- Monica Hogan

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