Objective To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. Design Observational surveillance study. Setting 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). Participants 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. Main outcome measures Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. Results Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. Conclusions The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions. This study is based on data sources obtained with specific data use agreements from the Society for Vascular Surgery’s Patient Safety Organization (SVS-PSO) and the Centers for Medicare and Medicaid Services (CMS) (CMS DUA# 57451). Although the data use agreements prohibit sharing of individual level data, aggregate files, methods, coding algorithms, and analytic code used to generate the tables, figures, and results in this manuscript will be made available upon requests to the corresponding author. Individual patient level data files may be requested directly from the SVS-PSO and CMS. According to CMS requirements, reuse of the Vascular Quality Initiative-Medicare linked dataset is possible only through collaboration with the original requestor at Weill Cornell Medicine. Further details are publicly available at .

中文翻译：

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使用链接的注册索赔数据对血管内腹主动脉瘤修复后的设备进行长期监测：观察性监测研究

目的 使用关联的注册索赔数据评估现实世界实践中主动脉内移植物的长期结果（腹主动脉瘤的再干预和晚期破裂）。设计观察性监测研究。在与美国医疗保险索赔相关联的血管质量倡议登记处设置 282 个中心 (2003-18)。参与者 20 489 名患者接受了四种用于腹主动脉瘤腔内修复术 (EVAR) 的装置类型：40.6% (n=8310) 接受了 Excluder (Gore)，32.2% (n=6606) 接受了 Endurant (Medtronic)，16.0% ( n=3281) Zenith (Cook Medical)，11.2% (n=2292) AFX (Endologix)。鉴于 2014 年底对 AFX 的修改，接受 AFX 设备的患者分为两组：早期 AFX 组 (n=942) 和晚期 AFX 组 (n=1350)，并与接受其他设备的患者进行比较，使用倾向匹配的 Cox 模型。主要结果测量 EVAR 后腹主动脉瘤的再介入和破裂；所有患者 (100%) 通过登记或基于索赔的结果评估或两者进行了完整的随访。结果 中位年龄为 76 岁（四分位数间距 (IQR) 70-82 岁），80.0% (16 386/20 489) 的患者为男性，中位随访时间为 2.3 年（IQR 0.9-4.1 年）。与其他设备相比，接受早期 AFX 设备的患者的五年粗略再干预率显着更高：Excluder 为 14.9%（95% 置信区间为 13.7% 至 16.2%），Endurant 为 19.5%（18.1% 至 21.1%）， Zenith 为 16.7%（15.0% 至 18.6%），早期 AFX 为 27.0%（23.7% 至 30.6%）。在倾向匹配的 Cox 模型（风险比 1.61，95% 置信区间 1.29 至 2.02）和使用 >33% AFX 的外科医生水平工具变量的分析中，与其他设备相比，接受早期 AFX 设备的患者的再干预风险更高他们实践中使用的移植物（1.75、1.19 至 2.59）。早在 2013 年年中，链接的注册索赔监控数据就确定了早期 AFX 设备的重新干预风险增加，远早于 2017 年美国发布的第一个监管警告。结论链接的注册索赔监控数据确定了设备特定的风险在腹主动脉瘤 EVAR 后的长期再干预中。设备制造商和监管机构可以利用链接的数据源来积极监测心血管干预后现实世界实践中的长期结果。本研究基于通过血管外科学会患者安全组织 (SVS-PSO) 和医疗保险和医疗补助服务中心 (CMS) (CMS DUA# 57451) 的特定数据使用协议获得的数据源。尽管数据使用协议禁止共享个人级别的数据，但用于生成表格、图形和本手稿结果的聚合文件、方法、编码算法和分析代码将应相应作者的要求提供。可以直接从 SVS-PSO 和 CMS 请求单个患者级别的数据文件。根据CMS要求，只有通过与 Weill Cornell Medicine 的原始请求者合作，才能重用 Vascular Quality Initiative-Medicare 关联数据集。更多详细信息可在以下位置公开获得.