Non-Invasive Median Nerve Stimulation May Improve Rhythm Outcomes After AF Ablation: Study
USA: A sham-controlled pilot study published in Heart Rhythm has found that non-invasive median nerve stimulation, used as an adjunct to atrial fibrillation (AF) ablation, showed promise in improving rhythm outcomes. The findings suggest that neuromodulation may have a potential role in reducing AF recurrence following ablation, although larger studies are needed to confirm its efficacy and clinical utility.
AF ablation is an established treatment to restore and maintain sinus rhythm, but arrhythmia recurrence remains a challenge. Clinicians may add ablation lesions to improve durability, but these approaches can further damage myocardial tissue. Researchers led by Vivek Y. Reddy, MD, Helmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, and colleagues investigated whether autonomic modulation through cutaneous median nerve stimulation (MNS) could provide a non-ablative alternative.
The NEUROPULSE study was conducted across three centers as a randomized, double-blind, sham-controlled pilot trial. A total of 77 patients undergoing AF ablation were randomized to receive either active MNS or sham stimulation. The modified intention-to-treat analysis included 59 participants, comprising 31 patients in the MNS group and 28 in the sham group.
Participants began stimulation within 48 hours of ablation, with most procedures performed using pulsed field ablation. Treatment continued for six months, consisting of daily sessions during the first two weeks followed by three sessions per week. Each active treatment session involved three 20-minute stimulation sessions per week. Rhythm surveillance included twice-daily two-minute ECG recordings using the study device, along with 10-day patch monitoring at two and six months.
The median participant age was 67 years, 39% were women, 68% had paroxysmal AF, and 27% had undergone repeat ablation. During the post-blanking period from months two through six, 12 AF, atrial tachycardia, or atrial flutter (AF/AT/AFL) events were recorded in the MNS group compared with 243 in the sham group. After excluding one sham participant with an unusually high event burden, the corresponding numbers were 12 and 28, respectively.
Key findings:
- AF/AT/AFL recurred in 2 of 31 patients receiving MNS compared with 5 of 28 receiving sham stimulation.
- Six-month arrhythmia-free survival was 90.0% with MNS versus 80.8% with sham stimulation.
- Premature atrial contraction counts and patient-reported outcomes did not significantly differ between groups.
- No serious adverse events related to MNS or the stimulation device were reported.
The study was limited by its small, heterogeneous sample, six-month follow-up, differential early discontinuation, and unequal ECG monitoring, while one sham participant contributed an unusually high event burden.
The authors concluded that wearable MNS was associated with fewer post-blanking AF/AT/AFL events, but larger, adequately powered trials with continuous rhythm monitoring are needed to confirm its efficacy.
Reference:
Reddy, V. Y., Nair, D. G., Turagam, M. K., Rosso, R., Banai, A., Henriques, L., Strzeciwilk, M., Schwartz, N., Holand, T., Benari, A., Puzhevsky, D., Ziv, A., & Chorin, E. (2026). Non-Invasive Median Nerve Stimulation with a Wearable Stimulator to Reduce Atrial Arrhythmia Recurrence after Atrial Fibrillation Ablation: The NEUROPULSE Pilot. Heart Rhythm. https://doi.org/10.1016/j.hrthm.2026.09.013
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