Observational studyBMJ (Clinical research ed.)2022
Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study.
Observational study in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 34 citations in OpenAlex.
- Global burden of aortic aneurysm from high body mass index and systolic blood pressure in older adults: 1990-2021 and projections to 2050.Archives of medical science : AMS · 2026Article
- Large endograft diameter is associated with poor outcomes following thoracic endovascular aortic aneurysm repair in Medicare beneficiaries.Journal of vascular surgery · 2025Article
- Accuracy of posthospitalization stroke detection following carotid revascularization in Medicare claims.Journal of vascular surgery · 2025Article
- Duplex Ultrasound-Only Surveillance after Endovascular Abdominal Aortic Aneurysm Repair is Associated with Favorable Long-Term Outcomes.Annals of vascular surgery · 2024Article
- Observational
- Device regulation and surveillance in vascular care: Challenges and opportunities.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2024Review
- Size thresholds for repair of abdominal aortic aneurysms warrant reconsideration.Journal of vascular surgery · 2024Article
- Postmarket Surveillance of Neuroendovascular Devices.Stroke (Hoboken, N.J.) · 2024Review
- Late post-EVAR abdominal aortic aneurysm rupture: a meta-analysis study.Archives of medical sciences. Atherosclerotic diseases · 2024Article
- Delayed migration due to shortening of the lower part of AFX endograft's main body in angled fusiform abdominal aortic aneurysm.Journal of vascular surgery cases and innovative techniques · 2023Article
- Endovascular Aneurysm Sac Embolization for Treatment of Ruptured Aneurysms in the Aortoiliac Segment Using N-Butyl-Cyanoacrylate.Life (Basel, Switzerland) · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 11 institutions in 1 country.
Funding
Abstract
objectiveTo evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data.
designObservational surveillance study.
setting282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18).
participants20 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 measuresReintervention 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.
resultsMedian 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.
conclusionsThe 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.