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Goodney P, Mao J, Columbo J, Suckow B, Schermerhorn M, Malas M, Brooke B, Hoel A, Scali S, Arya S, Spangler E, Alabi O, Beck A, Gladders B, Moore K, Zheng X, Eldrup-Jorgensen J, Sedrakyan A, Society for Vascular Surgery's Patient Safety Organization. Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study. BMJ (Clinical research ed.). 2022 Oct 25; 379:e071452.
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.