Surgical Weight Loss Centre, Mississauga, ON, Canada.
J Am Coll Surg. 2013 Nov;217(5):907-18. doi: 10.1016/j.jamcollsurg.2013.06.010. Epub 2013 Sep 10.
Laparoscopic adjustable gastric banding has several distinctive features, including band adjustability, easy reversibility, and lack of malabsorption, which contribute to its widespread use. The LAP-BAND AP System (LBAP; Allergan, Inc.), a redesigned and improved version of the original device, was approved by the US Food and Drug Administration in 2006. Because of limited information on LBAP, this study prospectively assesses the efficacy and safety of LBAP in real-world settings at clinical centers located in North America, Europe, and Australia.
This interim report of the ongoing 5-year prospective, observational, international, multicenter registry, Helping Evaluate Reduction in Obesity (HERO) Study (NCT00953173), describes clinical efficacy and safety of LBAP in real-world settings at 1 year.
One thousand one hundred and six patients were implanted with LBAP and 1-year data were available from 834 patients for efficacy analysis. At 1 year, the mean (SD) percentage of excess weight loss was 39.8% (22.3%), of weight loss was 16.9% (9.0%), and the mean (SD) body mass index decreased to 37.7 (7.0) kg/m(2) from 45.1 (6.9) kg/m(2) at baseline. Patients with type 2 diabetes mellitus or hypertension showed significant improvements at 1 year post LBAP (both p < 0.005). The most common device-related complications were port displacement (n = 20 [1.8%]), pouch dilation (n = 12 [1.1%]), band slippage (n = 7 [0.6%]), and band erosion (n = 5 [0.5%]). Eighteen (1.6%) patients had the device explanted.
At 1 year post LBAP, progressive weight loss was associated with improvement and/or resolution of comorbid conditions and was safe and well tolerated. Patient follow-up continues.
腹腔镜可调节胃束带术具有几个独特的特点，包括束带可调节、易于逆转以及缺乏吸收不良，这有助于其广泛应用。LAP-BAND AP 系统（LBAP；Allergan，Inc.）是原始设备的重新设计和改进版本，于 2006 年获得美国食品和药物管理局的批准。由于 LBAP 的信息有限，本研究前瞻性评估了北美、欧洲和澳大利亚的临床中心在真实环境下使用 LBAP 的疗效和安全性。
这是正在进行的为期 5 年的前瞻性、观察性、国际、多中心登记研究 Helping Evaluate Reduction in Obesity（HERO）研究（NCT00953173）的中期报告，描述了在真实环境下使用 LBAP 的临床疗效和安全性在 1 年时的数据。
1106 名患者植入了 LBAP，834 名患者可提供 1 年的数据进行疗效分析。在 1 年时，平均（标准差）超重减轻百分比为 39.8%（22.3%），体重减轻百分比为 16.9%（9.0%），平均（标准差）体重指数从基线时的 45.1（6.9）kg/m²下降到 37.7（7.0）kg/m²。患有 2 型糖尿病或高血压的患者在 LBAP 后 1 年显示出显著改善（均 p < 0.005）。最常见的设备相关并发症是端口移位（n = 20 [1.8%]）、囊袋扩张（n = 12 [1.1%]）、束带滑脱（n = 7 [0.6%]）和束带侵蚀（n = 5 [0.5%]）。18 名（1.6%）患者进行了设备取出。
在 LBAP 后 1 年，渐进性体重减轻与合并症的改善和/或解决相关，且安全且耐受良好。患者随访仍在继续。
