Long-Term Comparative Safety and Economic Outcomes of Sleeve Gastrectomy

摘要： 在过去的几年里，袖状胃切除术已迅速成为最常见的减肥 手术在美国，取代胃旁路手术。然而，令人震惊的是， 证明手术的长期效果人们越来越担心长期的安全性， 程序的持久性。袖状胃切除术现有的最佳证据来自小型随机试验 有几个局限性，包括：随访时间有限（例如3年）;缺乏统计学检验能力 重要的次要结果（例如，再次手术和翻修）;排除重要患者亚组 (e.g.,老年人，残疾人）;以及缺乏对经济结果的考虑（例如，保健用途和 支出）。由于袖状胃切除术的保险范围是交错进行的， 方法，有一个独特的机会，使用这些政策变化作为一个工具变量，在比较 袖状胃切除术与腹腔镜胃旁路术，金标准减肥手术。 我们有以下具体目标：目标1。比较袖状胃切除术与 胃旁路手术我们将使用两个互补的索赔数据集，包括一个大型的商业保险数据集。 人口从MarketScan和国家收费服务医疗保险的人口，以评估长期 袖状胃切除术与腹腔镜胃旁路手术相比的安全性， procedure.目标2.评价袖状胃切除术与传统胃切除术的长期医疗保健使用和费用。 胃旁路手术利用MarketScan和Medicare的数据，我们将评估医疗保健服务的使用情况。 （住院日、急诊科就诊和门诊就诊）和医疗保健支出 胃切除术（与胃旁路术）术后长达7年。目标3。为了评估异质性， 袖状胃切除术与胃旁路术的安全性、医疗保健使用和费用。我们将评估 重要患者亚组（包括老年人和残疾人）的安全性、医疗保健使用和支出 群体（例如，医疗保险受益人），那些基线健康状况不佳的人（例如，高度共病 负担和高基线支出），和选择的共病（例如，2型糖尿病患者） 并且对于具有不同特征的提供者（例如，外科医生具有更多与更少的体积）。更好的 了解袖状胃切除术（与胃旁路术相比）的长期结果将使患者能够 关于长期结果和是否需要额外手术的更明智的决定。这些数据也将 对于告知私人保险公司和医疗保险和医疗补助服务中心（CMS）是非常宝贵的，因为他们 重新评估他们对减肥手术的承保决定。

Abstract: In the past few years, sleeve gastrectomy has rapidly emerged as the most common weight loss procedure in the United States, displacing the gastric bypass procedure. However, there is shockingly little evidence of the procedure's long-term outcomes. There are growing concerns about the long-term safety and durability of the procedure. The best existing evidence on sleeve gastrectomy is from small randomized trials that have several limitations, including: limited follow up (e.g. 3 years); lack of statistical power to examine important secondary outcomes (e.g., reoperations and revisions); exclusion of important patient subgroups (e.g., older, disabled); and a lack of consideration of economic outcomes (e.g., health care use and expenditures). Because insurance coverage for sleeve gastrectomy proceeded in a staggered, regional approach, there is a unique opportunity to use these policy changes as an instrumental variable in comparing sleeve gastrectomy vs. laparoscopic gastric bypass, the gold-standard bariatric procedure. We have the following Specific Aims: Aim 1. To compare the long-term safety of sleeve gastrectomy vs. gastric bypass. We will use two complementary claims datasets, including a large, commercially insured population from MarketScan and the national fee-for-service Medicare population, to evaluate the long-term safety of the sleeve gastrectomy compared to laparoscopic gastric bypass surgery up to 7 years after their procedure. Aim 2. To evaluate long-term health care use and expenditures of sleeve gastrectomy vs. gastric bypass. Using data from MarketScan and Medicare, we will evaluate the use of health care services (hospital days, emergency department visits, and outpatient visits) and health care expenditures for sleeve gastrectomy (vs. gastric bypass) for up to 7 years after their procedure. Aim 3. To evaluate heterogeneity in safety, health care use, and expenditures for sleeve gastrectomy vs. gastric bypass. We will evaluate safety, health care use, and expenditures, for important patient subgroups, including older and disabled populations (e.g., Medicare beneficiaries), those with poor baseline health status (e.g., high comorbid disease burdens and high baseline expenditures), and select comorbid diseases (e.g., patients with type 2 diabetes) and for providers with different characteristics (e.g., surgeons with more vs. less volume). A better understanding of the long-term outcomes of sleeve gastrectomy (vs. gastric bypass) will allow patients to make more informed decisions regarding long-term outcomes and need for additional surgery. These data will also be invaluable for informing private insurers and the Center for Medicare and Medicaid Services (CMS) as they reassess their coverage decisions for bariatric surgery.