Long Term Outcomes of Open Versus Endovascular AAA Repair

开放性 AAA 修复与血管内修复 AAA 的长期结果

• 批准号: 8020566
• 负责人: Bruce E. Landon
• 金额: $ 73.35万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-15 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8020566
• 关键词: Abdominal Aortic Aneurysm; Age; Blood Vessels; Cause of Death; Cessation of life; Clinical Trials; Collaborations; Data; Devices; Elderly; Elderly man; Employee Strikes; General Population; Grant; Head; Health Services Research; Hernia; Home Nursing Care; Intervention; Intervention Studies; Intestinal Obstruction; Laparotomy; Living Costs; Longitudinal Studies; Measures; Medicare; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Patients; Perioperative; Population; Positioning Attribute; Quality of life; Randomized Controlled Trials; Rehabilitation Nursing; Reporting; Research; Rupture; Ruptured Abdominal Aortic Aneurysm; Sampling; Scoring Method; Statistical Methods; Techniques; Technology; Time; United States; United States Centers for Medicare and Medicaid Services; Work; base; cohort; comparative effectiveness; follow-up; head-to-head comparison; member; men; mortality; older patient; prevent; programs; randomized trial; repaired

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.

描述（由申请人提供）：腹部主动脉瘤破裂（AAA）是美国55岁以上男性的第10大死亡原因，死亡率为AAA超过80％。直到最近，为了防止破裂，选择性开放的AAA修复通常以D5％的死亡率进行。在过去的十年中，引入了血管内AAA修复，作为开放修复的一种侵入性替代品。 FDA批准在1999年批准了美国AAA的支架维修，并且自那时以来，使用血管内修复的使用稳步增长，取代了许多患者的开放手术。每年在美国进行40,000多种AAA维修，到2005年，在Medicare人群中进行的所有选修AAA维修中，有56％是内血管内的。 血管内AAA修复已显示出比在短期头部进行比较的开放式修复的手术死亡率和发病率低。但是，最近的随机试验并未证明血管内修复具有持续的死亡率。血管内修复还需要昂贵的后续监测，尽管血管内技术继续发展，但还需要重新干预。为了了解各种干预措施的比较有效性，将查询范围扩展到理想人群的小型随机对照试验中，以使用观察数据在现实世界中进行干预措施。在AAA维修的情况下，从Medicare计划中获取综合数据代表了一个理想的环境，可以进行比较有效性研究，因为在这一老年人群中，绝大多数AAA修复（70％）进行了。 Medicare数据也非常适合于包括长期随访和不常见并发症发生的研究。 该提案的具体目的是：1）研究正在进行选修课的医疗保险患者中，研究血管内的长期结局与开放AAA修复； 2）确定通过随着时间的推移引入新的血管内产品来衡量技术的变化是否影响了那些接受血管内修复者的围手术期和长期生存； 3）在开放AAA修复和与移植物相关的并发症的情况下，严格定义，量化和测量与剖腹手术相关并发症的影响。 公共卫生相关性：腹部腹动脉瘤（AAA）破裂是老年男性死亡的第十个主要原因，每年进行40,000多次选修课，以防止这些死亡。在1999年，引入了一种侵入性的内血管内技术，作为开放手术修复的替代方法。在这项研究中，我们将评估开放性和血管内AAA修复的长期比较有效性。