Long Term Outcomes of Open Versus Endovascular AAA Repair

腹主动脉瘤破裂（AAA）是男性死亡的第10大原因， 美国55岁，AAA破裂死亡率超过80%。直到最近，为了防止破裂， 开放式AAA修复术的死亡率通常为5%。在过去十年中，血管内AAA 修复术作为开放修复术的微创替代方法引入。FDA批准覆膜支架修复AAA 自1999年在美国获得批准以来，腔内修复术的使用稳步增长 时间，取代了许多患者的开放手术。美国每年进行超过40，000次AAA修复 到2005年，在医疗保险人群中进行的所有择期AAA修复术中，56%是血管内修复术。 血管内AAA修复术的手术死亡率和发病率均低于开放手术 在短期的头对头比较中修复。然而，最近的随机试验并没有证明 腔内修复术的持续死亡率获益。血管内修复术还需要昂贵的随访 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， 超越理想人群的小型随机对照试验，研究真实的世界中的干预措施 使用观测数据进行设置。在AAA修复的情况下，访问来自Medicare的全面数据 该计划代表了一个理想的设置，在其中进行比较有效性研究，因为绝大多数 的AAA修复术（70%）在该老年人群中进行。医疗保险数据也非常适合研究 包括长期随访和罕见并发症的发生。 本提案的具体目的是：1）研究血管内与开放手术的长期结局 在接受择期修复的Medicare患者的综合样本中进行AAA修复; 2）确定 技术的变化（通过新血管内产品的引入来衡量）是否 影响接受腔内修复术患者的围手术期和长期生存率;以及3） 严格定义、量化和测量开腹手术相关并发症的影响， 腔内修复术中的AAA修复术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.