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Abstract：
OBJECTIVE: The goal of this study is to evaluate the complications and mortality associated with vagus nerve stimulation (VNS).
METHODS: We retrospectively reviewed medical records of patients who underwent VNS implantation for the treatment of drug-resistant epilepsy (DRE) between 2000 and 2023. The mean follow-up time was 10.6 years, ranging from three months to 22 years.
RESULTS: In total, 55 adult and pediatric patients received VNS therapy with 117 procedures performed over 23 years. The most common early complications were hoarseness and cough which were reported in eight adult patients (6.8%). Four children with intellectual disability (ID) had infection (3.4%), eight patients had lead breakage (6.8%), and two had device migration (1.7%). Four of all patients (7.3%) demonstrated late complications due to chronic nerve stimulation including vocal cord dysfunction, late-onset severe AV block, and obstructive sleep apnea (OSA). Three patients (5.5%) had VNS deactivated permanently due to complications and/or lack of efficacy. Two patients died from probable sudden unexpected death in epilepsy (SUDEP) with an incidence of 3.4/1000 person-years.
CONCLUSIONS: VNS therapy is safe over long-term follow-up but not without risks. Most post-operative complications are minor and transient for adults. Children with ID tend to have infection and device migration. Late-onset cardiac complications and OSA can develop in some patients during VNS therapy and should not be overlooked. The SUDEP rate may decrease with VNS therapy over time.
METHODS: We retrospectively reviewed medical records of patients who underwent VNS implantation for the treatment of drug-resistant epilepsy (DRE) between 2000 and 2023. The mean follow-up time was 10.6 years, ranging from three months to 22 years.
RESULTS: In total, 55 adult and pediatric patients received VNS therapy with 117 procedures performed over 23 years. The most common early complications were hoarseness and cough which were reported in eight adult patients (6.8%). Four children with intellectual disability (ID) had infection (3.4%), eight patients had lead breakage (6.8%), and two had device migration (1.7%). Four of all patients (7.3%) demonstrated late complications due to chronic nerve stimulation including vocal cord dysfunction, late-onset severe AV block, and obstructive sleep apnea (OSA). Three patients (5.5%) had VNS deactivated permanently due to complications and/or lack of efficacy. Two patients died from probable sudden unexpected death in epilepsy (SUDEP) with an incidence of 3.4/1000 person-years.
CONCLUSIONS: VNS therapy is safe over long-term follow-up but not without risks. Most post-operative complications are minor and transient for adults. Children with ID tend to have infection and device migration. Late-onset cardiac complications and OSA can develop in some patients during VNS therapy and should not be overlooked. The SUDEP rate may decrease with VNS therapy over time.
摘要：
目的：本研究的目的是评估与迷走神经刺激（VNS）相关的并发症和死亡率。
方法：我们回顾性回顾了2000年至2023年间接受VNS植入治疗耐药癫痫（DRE）患者的医疗记录。平均随访时间为10.6年,从三个月到22年不等。
结果：总计，55名成人和儿童患者接受了VNS治疗，在23年内进行了117次手术。最常见的早期并发症是声音嘶哑和咳嗽，据报道有8例成年患者（6.8％）。四名智力残疾(ID)儿童感染(3.4%)，八名病人有铅断裂(6.8%),和两个有设备迁移(1.7%)。所有患者中有4例（7.3％）由于慢性神经刺激而出现晚期并发症，包括声带功能障碍。迟发性重度房室传导阻滞,阻塞性睡眠呼吸暂停（OSA）。由于并发症和/或缺乏疗效，三名患者（5.5％）的VNS永久停用。两名患者死于癫痫（SUDEP）的突然意外死亡，发生率为3.4/1000人年。
结论：VNS治疗在长期随访中是安全的，但并非没有风险。对于成年人来说，大多数术后并发症是轻微和短暂的。具有ID的儿童倾向于感染和设备迁移。在VNS治疗期间，某些患者可能会出现迟发性心脏并发症和OSA，因此不容忽视。随着VNS治疗,SUDEP率可随时间降低。
方法：我们回顾性回顾了2000年至2023年间接受VNS植入治疗耐药癫痫（DRE）患者的医疗记录。平均随访时间为10.6年,从三个月到22年不等。
结果：总计，55名成人和儿童患者接受了VNS治疗，在23年内进行了117次手术。最常见的早期并发症是声音嘶哑和咳嗽，据报道有8例成年患者（6.8％）。四名智力残疾(ID)儿童感染(3.4%)，八名病人有铅断裂(6.8%),和两个有设备迁移(1.7%)。所有患者中有4例（7.3％）由于慢性神经刺激而出现晚期并发症，包括声带功能障碍。迟发性重度房室传导阻滞,阻塞性睡眠呼吸暂停（OSA）。由于并发症和/或缺乏疗效，三名患者（5.5％）的VNS永久停用。两名患者死于癫痫（SUDEP）的突然意外死亡，发生率为3.4/1000人年。
结论：VNS治疗在长期随访中是安全的，但并非没有风险。对于成年人来说，大多数术后并发症是轻微和短暂的。具有ID的儿童倾向于感染和设备迁移。在VNS治疗期间，某些患者可能会出现迟发性心脏并发症和OSA，因此不容忽视。随着VNS治疗,SUDEP率可随时间降低。
