Abstract
<title>Abstract</title> <p>This study compared the efficacy and safety of ECG-sensing closed-loop vagus nerve stimulation (VNS) with conventional VNS in patients with drug-resistant epilepsy (DRE) and ictal heart rate increase ≥ 20%. We retrospectively analyzed 28 DRE patients who underwent VNS implantation between January 2013 and December 2024, divided into closed-loop (n = 14) and conventional (n = 14) groups. The primary endpoint was 12-month responder rate (≥ 50% seizure reduction). Secondary outcomes included early response, seizure-free rate, QOLIE-31, ESS, and adverse events. The closed-loop group showed a significantly higher 12-month response rate (85.71% vs. 57.14%, P = 0.021), better QOLIE-31 and ESS scores (both P < 0.01). Adverse event rates were similar (42.86% vs. 35.71%, P = 0.699) with no severe complications. ECG-sensing closed-loop VNS is more effective than conventional VNS for DRE with ictal heart rate changes, with comparable safety.</p>