Long Term Outcomes of Open Versus Endovascular AAA Repair

描述(由申请人提供)：腹主动脉瘤破裂(AAA)是美国55岁以上男性死亡的第十大原因，AAA破裂的死亡率超过80%。直到最近，为了防止破裂，选择性开放腹主动脉修补术的死亡率通常为5%。在过去的十年中，血管内AAA修复术作为开放修复术的一种侵入性较小的替代方案被引入。FDA于1999年批准在美国对AAA进行支架修复，自那时以来，血管内修复的使用一直在稳步增长，取代了许多患者的开放手术。在美国，每年进行的AAA修复超过40,000例，到2005年，在联邦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。在短期的头对头比较中，血管内AAA修补术的手术死亡率和发病率比开放修补术低。然而，最近的随机试验并没有证明血管内修复对死亡率有持续的好处。血管内修复还需要昂贵的后续监测，尽管血管内技术仍在不断发展，但对再次干预的需求更大。为了了解各种干预措施的相对有效性，重要的是将调查范围从理想人群的小型随机对照试验扩展到使用观测数据研究现实世界环境中的干预措施。在AAA修复的情况下，访问来自Medicare计划的全面数据是进行比较有效性研究的理想环境，因为绝大多数AAA修复(70%)是在这一老年人群中进行的。医疗保险数据也非常适合于包括长期随访和罕见并发症发生的研究。这项建议的具体目的是：1)在接受择期修复的联邦医疗保险患者中研究血管内修复与开放AAA修复的长期结果；2)确定以随着时间的推移推出新的血管内修复产品来衡量的技术变化是否对接受血管内修复的患者的围手术期和长期存活率产生影响；以及3)严格定义、量化和衡量开放AAA修复中的剖腹相关并发症以及血管内修复中的移植物相关并发症的影响。 公共卫生相关性：腹主动脉破裂(AAA)是导致老年男性死亡的第十大原因，每年进行超过40,000次选择性修复以防止这些死亡。1999年，一种侵入性较小的血管内技术被引入作为开放手术修复的替代方案。在这项研究中，我们将评估开放和血管内AAA修复术的长期比较效果。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: Ruptured aortic abdominal aneurysm (AAA) is the tenth leading cause of mortality in elderly men and over 40,000 elective repairs are performed annually in order to prevent these deaths. In 1999, a less invasive endovascular technique was introduced as an alternative to open surgical repair. In this study, we will evaluate the long term comparative effectiveness of open versus endovascular AAA repair.