Long-Term Comparative Effectiveness of the Lap Band

摘要： LAP Band的长期比较效果 病态肥胖症的外科手术呈指数级增长，现在是第二常见的腹部手术。 在美国运营。很大一部分增长是由使用的戏剧性增长推动的 腹腔镜可调节胃束带(LAP Band)。然而，人们越来越担心更长的时间 LAP BAND的术语安全性和有效性。 有新的证据表明，包括带状疱疹在内的晚期并发症的发生率很高(在某些病例中高达30%)。 侵蚀和滑移。此外，许多人担心，因为Lap Band在 在减肥和共病解决方面，与早期试验相比，在现实世界中是如此。最后， 无论是跨患者分组还是跨提供者，安全性和有效性是否存在异质性 特征，没有经过严格的评估。医疗保险和医疗保险中心最近的一项政策变化 医疗补助服务(CMS)，2006年全国减肥手术覆盖范围的决定，提供了独特的自然 评估LAP Band长期比较效果的实验。实践中的变化 在比较LAP Band与腹腔镜术时，可以作为一个辅助变量来减轻选择偏差 胃旁路手术，减肥的黄金标准。我们有以下三个具体目标：目标1 评估LAP带在医疗保险患者中的相对长期安全性。使用国家医疗保险 人群中，我们将评估LAP带与腹腔镜胃分流术的长期安全性 做手术。具体地说，我们将评估90天、1年和5年的再手术和住院率 初次手术的并发症。目的2.评估LAP的相对长期有效性 医疗保险患者中的带状病毒。使用国家医疗保险人口，我们将评估LAP的影响 与肥胖相关的并存疾病的医疗服务和相关医疗保险支付的范围。目标3. 评估LAP带在医疗保险患者中的安全性和有效性的异质性。因为 LAP Band可能对不同的组别或多或少有所裨益，我们会从以下方面评估其有效性 安全性和有效性，适用于不同年龄、基线健康状况和选择的并存疾病的患者。 我们将评估跨越不同提供商特征的LAP频段有效性的异质性 (例如，拥有更多经验或数量的医院和外科医生)。这项研究的结果将是 立即影响联邦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实际 世界各地LAP Band的安全性和有效性与其他程序相比将有助于其循证 承保决定。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LAP BAND的真正长期风险和好处。

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.