Evidence map›Paper›PMID 36866664›Full record

ArticleCirculation2023

Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study.

Eric A Secemsky, Yang Song, Tianyu Sun, Carmen Gacchina Johnson, Megan Gatski, Li Wang, Andrew Farb, Robert E Lee, Aurko Shaw, Jiaman Xu and 1 more

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Circulation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Device regulation and surveillance in vascular care: Challenges and opportunities.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2024
    Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Eric A SecemskyRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., Y.S., T.S., J.X., R.W.Y.).ORCID 0000-0003-3861-3163
Yang SongRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., Y.S., T.S., J.X., R.W.Y.).
Tianyu SunRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., Y.S., T.S., J.X., R.W.Y.).ORCID 0000-0002-3996-1381
Carmen Gacchina JohnsonCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (C.G.J., M.G., L.W., A.F., R.E.L., A.S.).
Megan GatskiCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (C.G.J., M.G., L.W., A.F., R.E.L., A.S.).
Li WangCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (C.G.J., M.G., L.W., A.F., R.E.L., A.S.).
Andrew FarbCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (C.G.J., M.G., L.W., A.F., R.E.L., A.S.).
Robert E LeeCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (C.G.J., M.G., L.W., A.F., R.E.L., A.S.).ORCID 0000-0002-3042-7721
Aurko ShawCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (C.G.J., M.G., L.W., A.F., R.E.L., A.S.).
Jiaman XuRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., Y.S., T.S., J.X., R.W.Y.).
Robert W YehRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., Y.S., T.S., J.X., R.W.Y.).ORCID 0000-0002-0564-4468
Center for Devices and Radiological Health · USDeaconess Hospital · USBeth Israel Deaconess Medical Center · US

Funding

Use of Registries, Claims and Health System Data to Enhance the Evaluation of Cardiovascular Therapies in Clinical TrialsR01HL136708 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Issa J. Dahabreh, Robert Yeh · 2017 to 2026
$6.9M
Shared Decision-Making to Improve the Health Status of Patients with Claudication: Developing and Implementing Strategies to Individualize Treatment DecisionsK23HL150290 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SECEMSKY, ERIC ALEXANDER · 2020 to 2024
$851k
NHLBI NIH HHS K23 HL150290NHLBI NIH HHS R01 HL136708
6 · The paper itself

Abstract

backgroundConcerns have been raised about the long-term performance of aortic stent grafts for the treatment of abdominal aortic aneurysms, in particular, unibody stent grafts (eg, Endologix AFX AAA stent grafts). Only limited data sets are available to evaluate the long-term risks related to these devices. The SAFE-AAA Study (Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries Study) was designed with the Food and Drug Administration to provide a longitudinal assessment of the safety of unibody aortic stent grafts among Medicare beneficiaries.

methodsThe SAFE-AAA Study was a prespecified, retrospective cohort study evaluating whether unibody aortic stent grafts are noninferior to non-unibody aortic stent grafts with respect to the composite primary outcome of aortic reintervention, rupture, and mortality. Procedures were evaluated from August 1, 2011, through December 31, 2017. The primary end point was evaluated through December 31, 2019. Inverse probability weighting was used to account for imbalances in observed characteristics. Sensitivity analyses were used to evaluate the effect of unmeasured confounding, including assessment of the falsification end points heart failure, stroke, and pneumonia. A prespecified subgroup included patients treated from February 22, 2016, through December 31, 2017, corresponding to the market release of the most contemporary unibody aortic stent grafts (Endologix AFX2 AAA stent graft).

resultsOf 87 163 patients who underwent aortic stent grafting at 2146 US hospitals, 11 903 (13.7%) received a unibody device. The average age of the total cohort was 77.0±6.7 years, 21.1% were female, 93.5% were White, 90.8% had hypertension, and 35.8% used tobacco. The primary end point occurred in 73.4% of unibody device-treated patients versus 65.0% of non-unibody device-treated patients (hazard ratio, 1.19 [95% CI, 1.15-1.22]; noninferior

conclusionsIn the SAFE-AAA Study, unibody aortic stent grafts failed to meet noninferiority compared with non-unibody aortic stent grafts with respect to aortic reintervention, rupture, and mortality. These data support the urgency of instituting a prospective longitudinal surveillance program for monitoring safety events related to aortic stent grafts.

Indexed as

Aortic Aneurysm, AbdominalBlood Vessel Prosthesis ImplantationEndovascular ProceduresAgedAged, 80 and overBlood Vessel ProsthesisFemaleHumansMaleMedicareProspective StudiesProsthesis DesignRetrospective StudiesStentsTreatment OutcomeUnited Statesaortic aneurysm, abdominalcomparative studyendovascular aneurysm repairtreatment outcome

Identifiers

PMID36866664
PMCPMC10133018
OpenAlexW4323036651

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.