Heart rhythm · 2026
Non-Invasive Median Nerve Stimulation with a Wearable Stimulator to Reduce Atrial Arrhythmia Recurrence after Atrial Fibrillation Ablation: The NEUROPULSE Pilot.
СтатьяНазвание и аннотация: Перевод в очереди
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Reddy Vivek Y, Nair Devi G, Turagam Mohit K, Rosso Raphael, Banai Ariel, Henriques Louise, Strzeciwilk Magdalena, Schwartz Naama, Holand Tsahi, Benari Adi, Puzhevsky Daniela, Ziv Amos, Chorin Ehud
Аннотация
BACKGROUND: To improve atrial fibrillation (AF) ablation success, empiric lesions are often placed - with variable effectiveness - but at the expense of myocardial destruction. Autonomic modulation may provide a non-ablative adjunct that improves rhythm outcomes without excess myocardial injury.
OBJECTIVE: To evaluate cutaneous median nerve stimulation (MNS) after AF ablation.
METHODS: NEUROPULSE was a 3-center, randomized, double-blind, sham-controlled pilot study. Seventy-seven patients were randomized 1:1 to active MNS (3x20-min sessions/week) or sham; the modified intention-to-treat (mITT) population included 59 patients (31 MNS, 28 sham). Treatment began within 48 hours after ablation (largely pulsed field ablation) and continued for 6 months (daily for 2 weeks, then 3 times weekly). Surveillance included twice-daily 2-minute device ECGs and 10-day patches at 2 and 6 months.
RESULTS: Median age was 67 years (IQR, 56-74 years), 39% female, 68% paroxysmal AF, and 27% redo ablation. Blinding was maintained. During post-blanking follow-up (months 2-6), 12 AF/AT/AFL events occurred with MNS and 243 with sham (rate ratio [RR] 17.93; 95%CI 10.04-32.0; P<0.0001). Excluding 1 high-burden sham outlier, 12 vs 28 events occurred (RR 2.17; 95%CI 1.10-4.27; P=0.025). AF/AT/AFL recurred in 2 of 31 MNS and 5 of 28 sham patients; six-month arrhythmia-free survival was 90.0% vs 80.8% (hazard ratio 2.15; 95%CI 0.42-11.1; P=0.36), respectively. PAC counts and patient-reported outcomes did not differ. No MNS- or device-related serious adverse events occurred.
CONCLUSIONS: Wearable MNS after AF ablation was associated with fewer recurrent atrial arrhythmia events. This pilot study warrants confirmation in an adequately-powered trial.
OBJECTIVE: To evaluate cutaneous median nerve stimulation (MNS) after AF ablation.
METHODS: NEUROPULSE was a 3-center, randomized, double-blind, sham-controlled pilot study. Seventy-seven patients were randomized 1:1 to active MNS (3x20-min sessions/week) or sham; the modified intention-to-treat (mITT) population included 59 patients (31 MNS, 28 sham). Treatment began within 48 hours after ablation (largely pulsed field ablation) and continued for 6 months (daily for 2 weeks, then 3 times weekly). Surveillance included twice-daily 2-minute device ECGs and 10-day patches at 2 and 6 months.
RESULTS: Median age was 67 years (IQR, 56-74 years), 39% female, 68% paroxysmal AF, and 27% redo ablation. Blinding was maintained. During post-blanking follow-up (months 2-6), 12 AF/AT/AFL events occurred with MNS and 243 with sham (rate ratio [RR] 17.93; 95%CI 10.04-32.0; P<0.0001). Excluding 1 high-burden sham outlier, 12 vs 28 events occurred (RR 2.17; 95%CI 1.10-4.27; P=0.025). AF/AT/AFL recurred in 2 of 31 MNS and 5 of 28 sham patients; six-month arrhythmia-free survival was 90.0% vs 80.8% (hazard ratio 2.15; 95%CI 0.42-11.1; P=0.36), respectively. PAC counts and patient-reported outcomes did not differ. No MNS- or device-related serious adverse events occurred.
CONCLUSIONS: Wearable MNS after AF ablation was associated with fewer recurrent atrial arrhythmia events. This pilot study warrants confirmation in an adequately-powered trial.