Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system

Chang, Robert W.; Rothenberg, Kara A.; Harris, Jessica; Gologorsky, Rebecca C.; Hsu, Jeffrey H.; Rehring, Thomas F.; Hajarizadeh, Homayon; Nelken, Nicolas A.; Paxton, Elizabeth W.; Prentice, Heather A.

doi:10.1016/j.jvs.2020.06.048

Cited by 21 publications

(27 citation statements)

References 23 publications

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“…The equivalent 2-year rates for all Type III endoleaks, Type IIIa endoleaks and Type IIIb endoleaks from the present study were 0.4%, 0% and 0.4% respectively, with the 4-year rates for the same categories being 1.1%, 0.6% and 0.4%. Clearly, the incidence of Type III endoleak observed in the present study as compared to the observations from Chang et al (2021) are at least an order of magnitude different.…”

Section: Plos Onecontrasting

confidence: 89%

“…Clearly, there is a large discrepancy in the outcomes reported by Chang et al (2021) and the current study. Part of the explanation for the variation in incident rates is the low number of patients in the Chang et al ( 2021) study as well as other limitations addressed in the publication such as a lack of endoleak sub-classification, the possibility that endoleaks were mis-classified, the indication for surgery, anatomy and surgical technique.…”

Section: Plos Onecontrasting

confidence: 79%

“…Given that the early versions of AFX had a higher than anticipated Type III endoleaks rate and that Type III endoleaks occur relatively late after initial implantation, the question arises as to whether the changes to the AFX platform have sufficiently mitigated the failure mode in the currently available AFX2 endograft. In a recent publication, Chang et al (2021) [10] suggested that AFX2 had a continued intrinsic issue as they reported that the 2-year incidence of Type III endoleak was 14.1% in a cohort of 33 patients analyzed retrospectively with 14 followed out to 2 years. The equivalent 2-year rates for all Type III endoleaks, Type IIIa endoleaks and Type IIIb endoleaks from the present study were 0.4%, 0% and 0.4% respectively, with the 4-year rates for the same categories being 1.1%, 0.6% and 0.4%.…”

Section: Plos Onementioning

confidence: 99%

“…The published literature on the performance of the AFX2 endograft is limited [5][6][7][8][9], but a recent publication by Chang et al (2021) [10] which reported a single integrated healthcare system experience of AFX and AFX2, suggested that the AFX2 endograft was associated with a high rate of adverse clinical events during follow up. The present study was designed to evaluate the outcomes derived by the AFX2 endograft in a series of patients from multiple centers in the USA.…”

Section: Introductionmentioning

confidence: 99%

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Midterm outcomes of 455 patients receiving the AFX2 endovascular graft for the treatment of abdominal aortic aneurysm: A retrospective multi-center analysis

et al. 2021

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Since being introduced into clinical practice the AFX family of endografts has undergone labelling updates, design and manufacturing changes to address a Type III failure mode. The published literature on the performance of the current endograft–AFX2 –is limited to small series with limited follow up. The present study reports the largest series of patients implanted with AFX2 for the treatment of abdominal aortic aneurysms. The study was a retrospective, 5 center study of patients receiving an AFX2 endograft from January 2016 until Dec 2020. Electronic case report forms were provided to four of the centers, with one additional site providing relevant outcomes in an independent dataset. Relevant outcomes were reported via Kaplan-Meier analysis and included all-cause mortality, aneurysm-related mortality, post EVAR aortic rupture, open conversion, device related reinterventions and endoleaks. Among a cohort of 460 patients, 405 underwent elective repair of an AAA, 50 were treated for a ruptured AAA, and 5 were aorto-iliac occlusive disease cases. For the elective cohort (mean age 73.7y, 77% male, mean AAA diameter 5.4cm), the peri-operative mortality was 1.7%. Freedom from aneurysm-related mortality was 98.2% at 1,2,3 and 4 years post-operatively, there were no post-operative aortic ruptures, and 2 patients required open conversion. Freedom from Type Ia endoleaks was 99.4% at 1, 2, 3 and 4 years. Freedom from Type IIIa and Type IIIb endoleaks were 100% and 100% (year 1), 100% and 99.6% (year 2), 99.4% and 99.6% (year 3), 99.4% and 99.6% (year 4) respectively. Freedom from all device-related reintervention (including Type II endoleaks) at 4 y was 86.8%. The AFX2 endograft appears to perform to a satisfactory standard in terms of patient centric outcomes in mid-term follow up. The Type Ia and Type III endoleaks rates at 4y appear to be within acceptable limits. Further follow up studies are warranted.

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Section: Plos Onecontrasting

confidence: 89%

Section: Plos Onecontrasting

confidence: 79%

Section: Plos Onementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Midterm outcomes of 455 patients receiving the AFX2 endovascular graft for the treatment of abdominal aortic aneurysm: A retrospective multi-center analysis

et al. 2021

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“…3 Cheng et al demonstrated incidence of kinking for AFX-Strata was 2.8%, AFX-Duraply was 10.3%, and AFX2 was 0%. 4 This case report reviews an acute presentation of a patient with aortic EVAR stent-graft migration, kinking and occlusion leading to bilateral lower limb ischemia. Prompt surgical intervention with open repair with graft bypass demonstrated a favorable outcome.…”

mentioning

confidence: 99%

Acute occlusion of aortic endovascular aneurysm repair stent graft with bilateral limb ischemia

Choi

Salvatore

DiMuzio

et al. 2022

Journal of Vascular Surgery Cases, Innovations and Techniques

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Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices

Wang,

Ayakulangara Panickan,

Cai

et al. 2023

JAMA Intern Med

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ImportanceThe US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a “total product life cycle” approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues.ObjectiveTo assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system.Design, Setting, and ParticipantsThis retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse.ExposureImplantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021.Main Outcomes and MeasuresThe primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed.ResultsIn total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, −2.1% to 4.1%).Conclusions and RelevanceThe findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.

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Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system

Cited by 21 publications

References 23 publications

Midterm outcomes of 455 patients receiving the AFX2 endovascular graft for the treatment of abdominal aortic aneurysm: A retrospective multi-center analysis

Midterm outcomes of 455 patients receiving the AFX2 endovascular graft for the treatment of abdominal aortic aneurysm: A retrospective multi-center analysis

Acute occlusion of aortic endovascular aneurysm repair stent graft with bilateral limb ischemia

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices

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