Intra-abdominal vagal blocking (VBLOC therapy): Clinical results with a new implantable medical device
Intra-abdominal vagal blocking (VBLOC therapy): Clinical results with a new implantable medical device
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DOI：
10.1016/j.surg.2008.03.015
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发表时间：
2008-06-01
期刊：
影响因子：
3.8
通讯作者：
Anvari, M.
中科院分区：
文献类型：
--
作者：
Camilleri, M.;Toouli, J.;Anvari, M.
背景一种新的医疗设备使用高频电子算法来创建间歇性迷走神经阻滞（VBLOC疗法）。目的是评估迷走神经阻滞对过度减肥（EWL）、安全性、饮食摄入和迷走神经功能的影响。在肥胖受试者（体重指数[BMI] 35-50 kg/m2）中进行了一项开放标签、3中心研究。在腹腔镜下将电极植入食管胃交界处附近的双侧迷走神经，以提供电阻滞。对患者进行为期6个月的体重、安全性、心电图、饮食摄入、饱腹感、饱腹感和血浆胰腺多肽（PP）对假喂养的反应随访。为了专门评估设备的影响，没有制定饮食或运动计划。31名患者（平均BMI，41.2 +/- 1.4 kg/m2）接受了该器械。植入后4周、12周和6个月的平均EWL分别为7.5%、11.6%和14.2%（均P <0.001）; 25%的患者在6个月时EKE丢失> 25%（最大值为36.8%）。无死亡或器械相关严重不良事件（AE）。在4周、12周和6个月时，卡路里摄入量下降>30%（均P
Background. A new medical device uses high-frequency electrical algorithms to create intermittent vagal blocking (VBLOC therapy). The aim is to assess the effects of vagal blocking on excess weight loss (EWL), safety, dietary intake, and vagal function.Methods. An open-label, 3-center study was conducted in obese subjects (body mass index [BMI] 35-50 kg/m(2)). Electrodes were implanted laparoscopically on both vagi near the esophagogastric junction to provide electrical block. Patients were followed for 6 months for body weight, safety, electrocardiogram, dietary intake, satiation, satiety, and plasma pancreatic polypeptide (PP) response to sham feeding. To specifically assess device effects alone, no diet or exercise programs were instituted.Results. Thirty-one patients (mean BMI, 41.2 +/- 1.4 kg/m(2)) received the device. Mean EWL at 4 and 12 weeks and 6 months after implant was 7.5%, 11.6%, and 14.2%, respectively (all P < .001); 25% of patients lost > 25% EKE at 6 months (maximum, 36.8%). There were no deaths or device-related serious adverse events (AEs). Calorie intake decreased by >30% at 4 and 12 weeks and 6 months (all P