Long Term Outcomes of Open Versus Endovascular AAA Repair

项目摘要：腹主动脉瘤破裂(AAA)是导致男性死亡的第十大原因。 美国55岁，腹主动脉破裂病死率超过80%。直到最近，为了防止破裂，可选的 开放性腹主动脉瘤修补术的死亡率为5%。在过去的十年里，血管内AAA 修复术是作为一种比开放修复术侵入性更小的选择而引入的。FDA批准AAA支架修复 美国于1999年批准了血管内修复，自那以来，血管内修复的使用一直在稳步增长 时间，取代了许多患者的开放手术。在美国，每年进行超过40,000次AAA维修 到2005年，在医疗保险人群中进行的所有选择性AAA修复中，56%是血管内修复。 血管内AAA修复术与开放手术相比，手术死亡率和发病率较低。 在短期的正面比较中修复。然而，最近的随机试验并没有证明 持续死亡率得益于血管内修复。血管内修复还需要昂贵的后续治疗 监测和再次干预的需要更大，尽管血管内技术继续 进化。为了了解各种干预措施的相对有效性，重要的是扩大 超越理想人群的小型随机对照试验研究现实世界中的干预措施 使用观测数据的设置。在AAA修复的情况下，访问来自Medicare的全面数据 该计划代表了进行比较有效性研究的理想环境，因为大多数 有70%的AAA修复术是在这一老年人群中进行的。医疗保险数据也非常适合于研究 这包括较长期的随访和罕见并发症的发生。 这项建议的具体目的是：1)研究血管内手术与开放手术的长期结果 在接受选择性修复的医疗保险患者中进行AAA修复的综合样本；2)确定 随着时间的推移，通过引入新的血管内产品来衡量技术的变化，是否 对接受血管内修复者的围手术期和长期生存的影响；以及3) 严格定义、量化和衡量开腹手术相关并发症的影响 血管内修复中的腹主动脉修复和移植物相关并发症。

Project Summary: Ruptured abdominal aortic aneurysm (AAA) is the 10th leading cause of death in men over age 55 in the US with mortality of ruptured AAA exceeding 80%. Up until recently, to prevent ruptures, elective Open AAA repair was typically performed with mortality of d5%. Within the last decade, endovascular AAA repair was introduced as a less invasive alternative to open repair. FDA approval for stentgraft repair of AAA in the United States was granted in 1999 and the use of endovascular repair has steadily grown since that time, replacing open surgery for many patients. Over 40,000 AAA repairs are performed annually in the United States and by 2005, 56% of all elective AAA repairs performed in the Medicare population were endovascular. Endovascular AAA repair has been shown to have a lower operative mortality and morbidity than open repair in short-term head to head comparisons. However, recent randomized trials have not demonstrated a sustained mortality benefit with endovascular repair. Endovascular repair also requires costly follow-up surveillance and there is a greater need for re-interventions, although endovascular technologies continue to evolve. In order to understand the comparative effectiveness of various interventions, it is important to extend inquiry beyond small randomized controlled trials of ideal populations to study interventions in real world settings using observational data. In the case of AAA repair, access to comprehensive data from the Medicare program represents an ideal setting in which to perform comparative effectiveness studies as the vast majority of AAA repairs (70%) are performed in this elderly population. Medicare data are also ideally suited to studies that include longer term follow-up and the occurrence of uncommon complications. The specific aims of this proposal are: 1) To study the long term outcomes of endovascular versus open AAA repair in a comprehensive sample of Medicare patients undergoing elective repair; 2) To determine whether changes in technology, as measured by the introduction of new endovascular products over time, has impacted both perioperative and long term survival of those undergoing endovascular repair; and 3) To rigorously define, quantify, and measure the impact of laparotomy related complications in the case of open AAA repair and graft-related complications in the case of endovascular repair.