From the Russell H. Morgan Department of Radiology and Radiological Science (C.R.W., J.V., B.P.H., O.A., F.N., K.P., K.H., T.D., H.Z., D.L.K.), Department of Medicine (E.J.S.), Department of Surgery (K.E.S.), and Department of Psychiatry and Behavioral Sciences (T.H.M.), The Johns Hopkins University School of Medicine, Baltimore, MD 21287; Department of Health, Behavior, and Society (L.J.C.) and Department of Biostatistics (R.E.T.), The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; The Johns Hopkins University School of Medicine, Baltimore, MD (G.O.A., S.B.); Department of Radiology, Mount Sinai Hospital, New York, NY (A.M.F., R.S.P.); and Department of Radiology, Piedmont Healthcare, Atlanta, GA (A.A.).
Radiology. 2019 Jun;291(3):792-800. doi: 10.1148/radiol.2019182354. Epub 2019 Apr 2.
Background Bariatric embolization is a new endovascular procedure to treat patients with obesity. However, the safety and efficacy of bariatric embolization are unknown. Purpose To evaluate the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure. Materials and Methods For this prospective study (NCT0216512 on ), 20 participants (16 women) aged 27-68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 were enrolled at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300- to 500-µm embolic microspheres. Primary end points were 30-day adverse events and weight loss at up to 12 months. Secondary end points at up to 12 months included technical feasibility, health-related quality of life (Short Form-36 Health Survey ([SF-36]), impact of weight on quality of life (IWQOL-Lite), and hunger or appetite using a visual assessment scale. Analysis of outcomes was performed by using one-sample tests and other exploratory statistics. Results Bariatric embolization was performed successfully for all participants with no major adverse events. Eight participants had a total of 11 minor adverse events. Mean excess weight loss was 8.2% (95% confidence interval [CI]: 6.3%, 10%; < .001) at 1 month, 11.5% (95% CI: 8.7%, 14%; < .001) at 3 months, 12.8% (95% CI: 8.3%, 17%; < .001) at 6 months, and 11.5% (95% CI: 6.8%, 16%; < .001) at 12 months. From baseline to 12 months, mean SF-36 scores increased (mental component summary, from 46 ± 11 to 50 ± 10, = .44; physical component summary, from 46 ± 8.0 to 50 ± 9.3, = .15) and mean IWQOL-Lite scores increased from 57 ± 18 to 77 ± 18 ( < .001). Hunger or appetite decreased for 4 weeks after embolization and increased thereafter, without reaching pre-embolization levels. Conclusion Bariatric embolization is well tolerated in severely obese adults, inducing appetite suppression and weight loss for up to 12 months. Published under a CC BY-NC-ND 4.0 license.
背景 减重栓塞术是一种新的血管内治疗肥胖症的方法。然而，其安全性和疗效尚不清楚。目的 评估在术后长达 12 个月时，对严重肥胖成年人进行减重栓塞术的安全性和疗效。材料与方法 本前瞻性研究（NCT0216512 号）纳入了 2014 年 6 月至 2018 年 2 月在 2 家机构入组的 20 名参与者（16 名女性，年龄 27-68 岁，平均 44 岁 ± 11 岁），平均 BMI 为 45 ± 4.1。采用 300-500μm 栓塞微球进行胃底经动脉栓塞术。主要终点为 30 天不良事件和术后长达 12 个月时的体重减轻。次要终点包括在长达 12 个月时的技术可行性、健康相关生活质量（36 项简短健康调查问卷 [SF-36]）、体重对生活质量的影响（IWQOL-Lite）和饥饿或食欲（采用视觉评估量表）。通过单样本 t 检验和其他探索性统计分析评估结局。结果 所有参与者均成功进行了减重栓塞术，无重大不良事件。8 名参与者共发生 11 次小不良事件。术后 1 个月、3 个月、6 个月和 12 个月时的平均超重减轻率分别为 8.2%（95%置信区间：6.3%，10%； <.001）、11.5%（95%置信区间：8.7%，14%； <.001）、12.8%（95%置信区间：8.3%，17%； <.001）和 11.5%（95%置信区间：6.8%，16%； <.001）。基线至 12 个月时，SF-36 评分升高（精神成分量表，从 46 ± 11 增至 50 ± 10， =.44；生理成分量表，从 46 ± 8.0 增至 50 ± 9.3， =.15），IWQOL-Lite 评分从 57 ± 18 增至 77 ± 18（ <.001）。栓塞后 4 周内食欲下降，此后食欲增加，但未恢复到栓塞前水平。结论 减重栓塞术在严重肥胖成年人中耐受良好，可诱导长达 12 个月的食欲抑制和体重减轻。在知识共享署名-非商业性使用-禁止演绎 4.0 国际许可协议下发布。
