Aortic & peripheral vascular disease
Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices
Authors' conclusion
The findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA.
Study context
- Population
- Patients receiving EVAR devices, Veterans Affairs Corporate Data Warehouse electronic health record (EHR) data, 2011–2021
- Participants
- 13,941 patients
- Exposure
- AFX EVAR devices vs non-AFX EVAR devices
- AFX-Sn = 718
- AFX-Dn = 404
- AFX2n = 682
- Non-AFXn = 12,137reference
- Outcome
- Rates of type III endoleaks and all-cause mortality, AFX vs non-AFX devices
- Follow-up
- 5 years
Methodological detailsdoubly robust causal modeling, Cox proportional hazards regression, Type III endoleaks identified from free-text clinical notes by natural language processing
- Doubly robust causal modeling
- Cox proportional hazards regression
- Type III endoleaks identified from free-text clinical notes by natural language processing
Main finding
As reported in the abstract
AFX2
- Type III endoleak
- 11.6% (95% CI, 8.1%-15.1%)
- All-cause mortality
- 19.0% (95% CI, 16.0%-22.0%)
Non-AFX
- Type III endoleak
- 5.7% (95% CI, 2.2%-9.2%)
- All-cause mortality
- 18.0% (95% CI, 15.0%-21.0%)
Type III endoleak
AFX211.6% (95% CI, 8.1%-15.1%)
Non-AFX5.7% (95% CI, 2.2%-9.2%)
All-cause mortality
AFX219.0% (95% CI, 16.0%-22.0%)
Non-AFX18.0% (95% CI, 15.0%-21.0%)
AFX2 vs Non-AFXAbsolute risk difference (95% CI)
Type III endoleaks
5.9%(2.3%–9.4%)
All-cause mortality
1.0%(−2.1% to 4.1%)
Observational data: associations, not effects.
Further findings
- UDI availability in EHR · partial unique device identifiers (UDIs) only for non-AFX — Non-AFX
- 0.1%
UDI availability in EHR
- UDIs not recorded in the EHR for any patient with an AFX device
Original publication
Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices. JAMA Intern Med. Published 1 October 2023. doi:10.
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