Potential for an Atrial Fibrillation Sea Change

November 12, 2008 8:49 AM CT

Some of the reports out of the American Heart Association Scientific Sessions this week contain really heartening news, including one that hopefully is ushering in a sea change regarding approval of treatments for atrial fibrillation.

A problem I discuss occasionally is that, as of now, no devices are FDA-approved for atrial fibrillation treatment, even though they are approved for use on cardiac tissues and for other types of arrhythmias.

A major reason is that it’s not always easy to recruit for device clinical trials because the FDA requires that the device go head-to-head with medications. It’s easy to understand why it’s hard to recruit — as an afibber, when you have failed on a medication and have decided to have a life-saving procedure, signing up for a clinical trial means that you may end up being relegated to the control group and stuck on meds for a few more years. That just isn’t very appealing once you’ve decided you need or must have a procedure.

Thus a study reported at AHA this week is a major step forward. In this multicenter clinical trial consisting solely of those with symptomatic paroxysmal (intermittent) atrial fibrillation, those treated with catheter ablation using the NAVISTAR® THERMOCOOL® Catheter, from Biosense Webster, “were significantly more likely [62.7% vs. 17.2%] to be free of recurring AFib at nine months after initiation of treatment and experienced fewer serious adverse events after 90 days than those receiving AAD [anti-arrhythmic drug] therapy.

The results of this study enabled Biosense Webster to apply for FDA approval of this catheter for atrial fibrillation treatment and to receive fast-track priority review status. This is a first for a device to treat atrial fibrillation.

Catheter ablation is currently advised as “second-line treatment” for afib following failure with medication, but the discussion continues in medical circles as to whether catheter ablation should be “first-line treatment” since about half of those with afib aren’t successful on medication (called “drug refractory afib”). There is also some thinking that it’s better to aggressively treat afib sooner, not later.

So while no devices are approved for atrial fibrillation currently, they may still be used for treatment of afib at the discretion of individual doctors. The devices must still work as expected for doctors to feel safe in using them.

What I believe will change, if this catheter receives FDA approval, is that not only will it open the door for approval of other devices for treating atrial fibrillation, but it will also finally allow for more open discussion about treating afib, which is severely restricted today. I believe that this is one small step in the right direction. 

Read: Study Finds Catheter Ablation with the NAVISTAR® THERMOCOOL® Catheter Superior to Anti-Arrhythmic Drug Therapy for the Treatment of Symptomatic, Paroxysmal Atrial Fibrillation