TREAT-AF Trial shows that patients can self-administer an ear-clip treatment to decrease afib
May 9, 2019
- Summary: TREAT-AF Trial shows atrial fibrillation patients can self-administer ear-clip treatment to decrease afib
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Results from the novel and unique TREAT-AF Clinical Trial were presented May 9, 2019, during the Late-Breaking Clinical Trials session at the Heart Rhythm Scientific Sessions in San Francisco, CA. The TRanscutaneous Electrical vAgus nerve sTimulation to suppress Atrial Fibrillation (TREAT-AF) clinical trial was presented by Dr. Stavros Stavrakis of the University of Oklahoma Health Sciences Center in Oklahoma City, OK.
Atrial fibrillation can be challenging to treat; this study may provide another potential treatment option for those with afib.
As background, the autonomic nervous system is known to play a key role in atrial fibrillation. Animal studies from this research group and others indicated that afib could be decreased through vagus nerve stimulation (VNS), an FDA-approved treatment for epilepsy that had not been used for afib.
The TREAT-AF study used “low level transcutaneous electrical stimulation (LLTS) of the auricular branch of the vagus nerve at the tragus of the ear.” In patients with paroxysmal AF, just one hour per day of this treatment over six months was found to significantly decrease afib burden.
After undergoing monitoring for two weeks to determine afib burden, patients were randomized to receive either active treatment where the clip was attached at the tragus of the ear or sham treatment where the clip was attached to the ear lobe. Once patients were trained, they administered the treatment themselves for one hour per day for six months.
At three months and six months, they were monitored to determine afib burden, had a short EKG to measure heart rate variability, and had blood drawn to measure inflammatory cytokines, an indicator of inflammation in the body.
There were 53 study participants — 26 in the active treatment group and 27 in the sham group. Participants in both groups were closely matched.
After six months, the afib burden in the treatment group was reduced by 85% compared to the sham group. While treatment decreased the number of episodes, it did not convert people out of afib once an episode was started. Additionally, the active treatment group had less inflammatory cytokines than the sham group.
Additional studies are needed in much larger groups of patients and at multiple centers to determine which patients benefit most from this treatment approach.