Long Term Outcomes of Open Versus Endovascular AAA Repair

描述（由申请方提供）：腹主动脉瘤破裂（AAA）是美国55岁以上男性的第十大死亡原因，AAA破裂的死亡率超过80%。直到最近，为了防止破裂，通常进行择期开放AAA修复术，死亡率为d5%。在过去的十年中，腹主动脉瘤腔内修复术作为开放修复术的微创替代方法被引入。美国FDA于1999年批准了腹主动脉瘤覆膜支架修复术，自那时以来，腔内修复术的使用稳步增长，取代了许多患者的开放手术。美国每年进行超过40，000例AAA修复，到2005年，在医疗保险人群中进行的所有择期AAA修复中，56%是血管内修复。 在短期头对头比较中，血管内AAA修复术的手术死亡率和发病率低于开放修复术。然而，最近的随机试验尚未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监测，并且更需要再次介入，尽管血管内技术仍在不断发展。为了了解各种干预措施的比较有效性，重要的是要将调查扩展到理想人群的小型随机对照试验之外，使用观察数据研究真实的世界环境中的干预措施。在AAA修复的情况下，从医疗保险计划中获得全面的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%）是在老年人群中进行的。医疗保险数据也非常适合包括长期随访和罕见并发症发生的研究。 本提案的具体目的是：1）在接受择期修复术的医疗保险患者的综合样本中研究腔内与开放式AAA修复术的长期结局; 2）确定技术变化（通过随时间引入新的腔内产品来衡量）是否影响了接受腔内修复术患者的围手术期和长期生存率;和3）严格定义、量化和测量开放性AAA修复术中剖腹手术相关并发症和腔内修复术中移植物相关并发症的影响。 公共卫生相关性：腹主动脉瘤破裂（AAA）是老年男性死亡的第十大原因，每年进行超过40，000次择期修复以防止这些死亡。1999年，引入了一种微创血管内技术作为开放手术修复的替代方法。在本研究中，我们将评价开放与腔内AAA修复术的长期比较有效性。

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.