Source: Press Release
Disclosures: Wazni reports he speaks and consults for Biosense Webster, Boston Scientific and Medtronic.
June 22, 2021
1 min read

Cryoballoon ablation catheter now indicated as first-line treatment for AF

Source: Press Release
Disclosures: Wazni reports he speaks and consults for Biosense Webster, Boston Scientific and Medtronic.
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The FDA granted a new indication to a cryoballoon ablation catheter that allows it to be used as a first-line treatment for atrial fibrillation, before antiarrhythmic drugs.

Until the new indication for the catheter (Arctic Front Advance, Medtronic), catheter ablation was approved only for use in patients with AF who had failed antiarrhythmic drug therapy.

FDA approval
Source: Adobe Stock

The decision to grant the new indication was based on the results of the STOP AF First trial, in which, as Healio previously reported, patients who underwent first-line pulmonary vein isolation with the cryoballoon ablation catheter had a greater rate of freedom from AF and procedures related to it at 12 months compared with patients who took antiarrhythmic drug therapy.

Oussama Wazni

“This is a great development because we are now able to offer patients early ablation with FDA backing,” Oussama Wazni, MD, section head of electrophysiology and pacing at Cleveland Clinic, told Healio. “Over the years, we have learned that the sooner we ablate the atrial fibrillation, the better the outcomes of the procedure. This will enable us to take care of patients more expeditiously and with better outcomes.”

The decision of when to perform catheter ablation, and whether to try medical therapy first, should be made by the doctor and patient in conjunction, Wazni told Healio.

All the benefits and the risks should be taken into consideration,” he said. “Now we have data to discuss early ablation with the patient with more confidence. We can say it is very clear that we should not waste too much time. If the patient is more comfortable with trying medications first, that’s fine too. But sometimes, if a patient keeps switching medications and waiting on ablation, it can be too late. The atrium may already be remodeled and covered in scar tissue, and ablation is usually not as successful then.”

Wazni said he expects some operators to extrapolate the cryoballoon ablation catheter results to radiofrequency ablation catheters, but noted most of the data on first-line ablation have been generated with the cryoballoon ablation catheter. “The strategy of early ablation should be backed up by the evidence regardless of the technology,” he said.

The new indication does not deemphasize the importance of managing risk factors, including overweight/obesity, diabetes, sleep apnea and hypertension, in patients with AF, he said.

For more information:

Oussama Wazni, MD, can be reached at