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“Large Diameter” Aortic Endografts are Associated With Aneurysm Sac Expansion

      Background

      The purpose of this study was to evaluate the association between aortic endograft diameter and long-term outcomes following endovascular aneurysm repair (EVAR) performed in accordance with manufacturer instructions for use (IFU).

      Methods

      A retrospective review of consecutive patients undergoing on-IFU EVAR (2000–2018) was performed to facilitate a comparative analysis of long-term patient outcomes based on device diameter. “Large diameter” devices were defined as >34 mm. The primary outcome of interest was freedom from sac expansion throughout long-term follow-up. Analyses included standard bivariate analyses, Kaplan–Meier with log-rank comparison, and Cox proportional hazards multivariate analysis.

      Results

      A total of 1,099 underwent on-IFU EVAR from 2000–2018. Follow-up data were available for 980 patients. Of these, 75 patients (7.6%) were treated with >34-mm devices. There were no significant differences in demographics or comorbidities between the 2 groups, although preoperative abdominal aortic aneurysm size was greater in patients undergoing implantation of >34-mm devices (58 ± 8.5 mm vs. 56 ± 17.4 mm; P = 0.05). Median follow-up was 10.3 years. Patients with grafts >34 mm had reduced freedom from sac expansion throughout follow-up (P = 0.038). There were no significant differences in reintervention rates, open conversion, or rupture when stratified by graft diameter. A multivariate Cox regression identified patient age, preoperative abdominal aortic aneurysm size, need for reintervention, and use of >34-mm endografts as independent factors associated with expansion.

      Conclusions

      The use of large diameter aortic endografts is associated with higher rates of sac expansion during long-term follow-up. Although there is undoubtedly a role for large diameter graft use in selected patients, it is important to recognize that these devices were typically approved post hoc without the same regulatory scrutiny of smaller endografts. These findings underscore the importance of ongoing surveillance for patients treated with >34-mm grafts, irrespective of compliance with manufacturer IFU.
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      References

        • Albuquerque Jr., F.C.
        • Tonnessen B.H.
        • Noll Jr., B.H.
        • et al.
        Paradigm shifts in the treatment of abdominal aortic aneurysm: trends in 721 patients between 1996 and 2008.
        J Vasc Surg. 2010; 51: 1348-1352
        • Antoniou G.A.
        • Alfahad A.
        • Antoniou S.A.
        • et al.
        Prognostic significance of large diameter proximal aortic neck in endovascular aneurysm repair.
        Vasa. 2020; 49: 215-224
        • AbuRahma A.F.
        • DerDerian T.
        • AbuRahma Z.T.
        • et al.
        Comparative study of clinical outcome of endovascular aortic aneurysms repair in large diameter aortic necks (>31 mm) versus smaller necks.
        J Vasc Surg. 2018; 68: 1345-1353.e1
        • Laczynski D.J.
        • Caputo F.J.
        Systematic review and meta-analysis of endovascular abdominal aortic repair in large diameter infrarenal necks.
        J Vasc Surg. 2021; 74: 309-315.e2
        • Oliveira N.F.G.
        • Bastos Gonçalves F.M.
        • Van Rijn M.J.
        • et al.
        Standard endovascular aneurysm repair in patients with wide infrarenal aneurysm necks is associated with increased risk of adverse events.
        J Vasc Surg. 2017; 65: 1608-1616
        • Kouvelos G.N.
        • Spanos K.
        • Nana P.
        • et al.
        Large diameter (≥29 mm) proximal aortic necks are associated with increased complication rates after endovascular repair for abdominal aortic aneurysm.
        Ann Vasc Surg. 2019; 60: 70-75
        • McFarland G.
        • Tran K.
        • Virgin-Downey W.
        • et al.
        Infrarenal endovascular aneurysm repair with large device (34- to 36-mm) diameters is associated with higher risk of proximal fixation failure.
        J Vasc Surg. 2019; 69 (ISSN 0741-5214): 385-393
        • Kaladji A.
        • Steintmetz E.
        • Goueffic Y.
        • et al.
        Long-term results of large stent grafts to treat abdominal aortic aneurysms.
        Ann Vasc Surg. 2015; 29: 1416-1425
        • Antoniou G.A.
        • Georgiadis G.S.
        • Antoniou S.A.
        • et al.
        A meta-analysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy.
        J Vasc Surg. 2013; 57: 527-538
        • Schanzer A.
        • Greenberg R.K.
        • Robinson W.P.
        • et al.
        Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair.
        Circulation. 2011; 123: 2848-2855
        • Zacharias N.
        • Warner C.J.
        • Taggert J.B.
        • et al.
        Anatomic characteristics of abdominal aortic aneurysms presenting with delayed rupture after endovascular aneurysm repair.
        J Vasc Surg. 2016; 64: 1629-1632
        • Dingemans S.A.
        • Jonker F.H.
        • Moll F.L.
        • et al.
        Aneurysm sac enlargement after endovascular abdominal aortic aneurysm repair.
        Ann Vasc Surg. 2016; 31: 229-238
      1. Gore excluder AAA endoprothesis instructions for use. W.L. Gore & associates.
        https://eifu.goremedical.com/
        Date: 2020
        Date accessed: April 19, 2022
      2. FDA summary of safety and effectiveness data (SSED).
      3. Zenith AAA Endovascular Graft Annual Clinical Update. Cook Medical, Bloomington, IN2019
        • Maitrias P.
        • Kaladji A.
        • Plissonnier D.
        • et al.
        Treatment of sac expansion after endovascular aneurysm repair with obliterating endoaneurysmorrhaphy and stent graft preservation.
        J Vasc Surg. 2016; 63: 902-905
        • Deery S.E.
        • Ergul E.A.
        • Schermerhorn M.L.
        • et al.
        Vascular study group of New England. Aneurysm sac expansion is independently associated with late mortality in patients treated with endovascular aneurysm repair.
        J Vasc Surg. 2018; 67: 157-164
        • Sartwell P.E.
        Retrospective studies: a review for the clinician.
        Ann Intern Med. 1974; 81: 381-386