Long-Term Comparative Effectiveness of the Lap Band

摘要： Lap Band的长期比较有效性 外科手术治疗病态肥胖呈指数增长，现在是第二大最常见的腹部手术。 在美国的业务。增长的很大一部分是由使用量的急剧增加推动的 腹腔镜可调节胃束带（Lap Band）。然而，人们越来越担心， 长期安全和有效性的圈带。 有新的证据表明晚期并发症的发生率很高（在某些病例系列中高达30%），包括带状疱疹。 侵蚀和滑动。此外，许多人担心，因为圈带没有那么有效， 与早期试验相比，在真实的世界中，最后， 患者亚组或提供者之间的安全性和有效性是否存在异质性 这些特征，并没有得到严格的评估。医疗保险中心最近的一项政策变化， 医疗补助服务（CMS），2006年全国范围内的减肥手术的决定，提供了一个独特的自然 评估Lap Band长期比较有效性的实验。实践中的变化 可用作工具变量，以减轻比较腹腔镜带与腹腔镜时的选择偏倚 胃分流术，黄金标准的减肥手术我们有以下三个具体目标：目标1。到 评估医疗保险患者使用Lap Band的相对长期安全性。使用国家医疗保险 人群中，我们将评价腹腔镜带与腹腔镜胃旁路术相比的长期安全性 手术具体而言，我们将评估90天、1年和5年的再手术率和住院率， 初次手术的并发症。目标二。评价腹腔镜手术的相对长期有效性 医疗保险患者中的乐队。使用全国医疗保险人口，我们将评估圈的影响 与肥胖相关的合并症的医疗保健服务和相关的医疗保险支付。目标3. 评价Lap Band在Medicare患者中的安全性和有效性的异质性。因为 腹腔镜带可能或多或少有益于不同的亚组，我们将评估其有效性，在 安全性和有效性，适用于不同年龄、基线健康状况和选定共病的患者。 我们将评估在不同的供应商特征的有效性的异质性圈带 (e.g.,医院和外科医生具有更多的经验或数量）。这项研究的结果将大多数 立即影响医疗保险和医疗补助服务中心（CMS）及其全国覆盖范围 减肥手术的决定。CMS积极重新评估减肥覆盖率和真实的准确估计- 与其他手术相比，腹腔镜带的全球安全性和有效性将有助于他们的循证医学 覆盖决定。患者将是这项研究的最终受益者，因为他们将获得更好的信息。 关于圈带的真正长期风险和益处。

Abstract: Long-term comparative effectiveness of the Lap Band Surgery for morbid obesity has grown exponentially and is now the 2nd most common abdominal operation in the United States. A large part of the growth has been driven by the dramatic increase in the use of laparoscopic adjustable gastric banding (Lap Band). However, there are growing concerns about the longer term safety and effectiveness of the Lap Band. There is emerging evidence of high rates (up to 30% in some case series) of late complications, including band erosion and slippage. Moreover, many are concerned because the Lap Band has not been as effective, in terms of weight loss and comorbid disease resolution, in the real world as compared to early trials. Finally, whether there is heterogeneity in safety and effectiveness, either across patient subgroups or provider characteristics, has not been rigorously assessed. A recent policy change by the Center for Medicare and Medicaid Services (CMS), the 2006 national coverage decision for bariatric surgery, provides a unique natural experiment for evaluating the long-term comparative effectiveness of the Lap Band. The change in practice can be used as an instrumental variable to mitigate selection bias in comparing the Lap Band vs. laparoscopic gastric bypass, the gold-standard weight loss procedure. We have the following three Specific Aims: Aim 1. To evaluate the comparative long-term safety of the Lap Band in Medicare patients. Using the national Medicare population, we will evaluate the long term safety of the Lap Band compared to laparoscopic gastric bypass surgery. Specifically, we will evaluate 90-day, 1-year, and 5-year reoperation and hospitalization rates for complications of the initial surgery. Aim 2. To evaluate the comparative long-term effectiveness of the Lap Band in Medicare patients. Using the national Medicare population, we will evaluate the impact of the Lap Band on healthcare services and related Medicare payments for obesity-related comorbid conditions. Aim 3. To evaluate heterogeneity in the safety and effectiveness of the Lap Band in Medicare patients. Because the Lap Band may be more or less beneficial for different subgroups, we will evaluate its effectiveness, in terms of safety and effectiveness, for patients with different age, baseline health status, and select comorbid diseases. We will evaluate heterogeneity in the effectiveness of the Lap Band across different provider characteristics (e.g., hospitals and surgeons with more vs. less experience or volume). Results from this study will most immediately impact the Center for Medicare and Medicaid Services (CMS) and their national coverage decision for bariatric surgery. CMS actively re-evaluates bariatric coverage and accurate estimates of real- world safety and effectiveness of Lap Band compared to other procedures will help their evidence-based coverage decisions. Patients will be the ultimate beneficiaries of this research as they will be better informed regarding the true long term risks and benefits of the Lap Band.