美国达特茅斯-希区柯克医疗中心Philip Goodney团队研究了血管内腹主动脉瘤修复后，使用链接注册索赔数据对设备进行长期监测的结果。2022年10月25日出版的《英国医学杂志》发表了这项成果。

为了使用相关注册声明数据，在现实世界中评估主动脉腔内移植术的长期预后（再次介入和晚期腹主动脉瘤破裂），课题组进行了一项观察监测研究，将血管质量倡议登记处的282个中心与美国医疗保险索赔（2003-18年）关联起来。

20489名患者接受了用于血管内腹主动脉瘤修补（EVAR）的四种类型装置的治疗：40.6%（n=8310）接受了Excluder（Gore），32.2%（n=6606）接受了Endurant（Medtronic），16.0%（n=3281）接受了Zenith（Cook Medical），11.2%（n=2292）接受了AFX（Endologix）。在2014年末对AFX进行了修改后，接受AFX设备的患者被分为两组：早期AFX组（n=942）和晚期AFX（n=1350）组，并使用倾向匹配Cox模型与接受其他设备的患者进行比较。主要结局为EVAR术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全随访。

参与者的中位年龄为76岁，80.0%（16386/20489）为男性，中位随访2.3年。接受早期AFX设备的患者与其他设备相比，粗五年再住院率明显更高：其中Excluder组为14.9%，Endurant组为19.5%，Zenith组为16.7%，早期AFX组为 27.0%。在倾向匹配Cox模型中，接受早期AFX装置的患者再次接受治疗的风险高于其他装置（危险比为1.61），利用外科医生水平的工具变量对手术中使用的>33% AFX移植物进行分析后危险比为1.75。相关注册机构声称，在2013年年中，早在2017年美国首次发布监管警告之前，监控数据就发现了重新使用早期AFX设备的风险增加。

综上，相关注册机构声称，监测数据表明，腹主动脉瘤EVAR术后长期再介入存在设备特异性风险。设备制造商和监管者可以利用链接的数据源积极监测心血管干预后现实世界实践中的长期预后。

附：英文原文

Title: Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study

Author: Philip Goodney, Jialin Mao, Jesse Columbo, Bjoern Suckow, Marc Schermerhorn, Mahmoud Malas, Benjamin Brooke, Andrew Hoel, Salvatore Scali, Shipra Arya, Emily Spangler, Olamide Alabi, Adam Beck, Barbara Gladders, Kayla Moore, Xinyan Zheng, Jens Eldrup-Jorgensen, Art Sedrakyan

Issue&Volume: 2022/10/25

Abstract:

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 20489 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% (16386/20489) 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.

DOI: 10.1136/bmj-2022-071452

Source: https://www.bmj.com/content/379/bmj-2022-071452