Advertisement

Late neck related adverse events are rare among patients with wide aortic neck undergoing endovascular aneurysm repair with the Ovation endograft

      Article highlights

      • This single-center retrospective cohort study found that patients undergoing EVAR with the Ovation endograft present low rates of neck dilatation and neck-related complications during follow-up, irrespective of baseline neck diameter. Fifty-nine patients with wide aortic necks presented similarly favorable mid-term outcomes as 222 patients with normal sized necks (type Ia endoleak 3.3% vs 0.7%, P-value=0.195). EVAR with the Ovation endograft results in low rates of late neck related complications in patients with wide aortic neck.

      Abstract

      Objective

      Patients with wide aortic necks undergoing Endovascular Aneurysm Repair (EVAR) have been shown to be at a higher risk for neck-related complications. We aim to examine outcomes of EVAR with an endograft exerting minimal outward pressure (Ovation-Endologix) in patients with a large baseline neck diameter.

      Methods

      We performed a retrospective single center study, including consecutive patients undergoing EVAR with the Ovation system from 05/2011 to 04/2021. Patients were divided in Groups 1 and 2 if the 20,23,26,29mm or the 34mm proximal diameter main body was used, respectively. According to the instructions for use of the device, for neck diameters 27-30mm the 34mm main body is required. Primary endpoint was rate of neck related complications during follow-up, (type Ia endoleak, migration >10mm and neck-related re-interventions) and rate of aortic neck dilatation (AND). AND was determined based on multiple aortic neck diameters that were recorded and compared between the 1-month computed tomography angiography (CTA) after EVAR and the last available follow-up CTA.Secondary endpoints were peri-procedural and follow-up outcomes such as endoleaks, reinterventions and overall mortality.

      Results

      In total 281 patients were included, 222 in Group 1 and 59 in Group 2. Patients in Group 2 presented significantly shorter neck length, higher neck angulation and more common reversed tapered configuration. Median follow-up was 36 months (Range:6-106). Early and late type Ia endoleak was observed in 4 and 2 patients in each group, respectively (P=0.063 and P=0.195, respectively). Distal migration was observed in 2 patients in Group 2 and AND was recorded in 2 patients in each group (P=0.195). Freedom from the primary endpoint was estimated at 98%, 94%, 94% at 12-, 36-, 60-months for Group 1 and at 98%, 95%, 86% for Group 2 (P-Value 0.266). Probability of survival was 95%, 86%, 75% at 12-, 36-, 60-months for Group 1 and 83%, 77%, 72% for Group 2 (P-Value 0.226).Multivariate regression analysis identified neither Group 1 vs Group 2 nor absolute value of aortic neck diameter as significant predictors of neck-related adverse events. Neck diameters did not display significant differences over time in any of the levels evaluated.

      Conclusions

      EVAR with the Ovation endograft results in low rates of late neck related complications which is also true for patients with wide baseline aortic necks.

      Key Words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Annals of Vascular Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      6. References

        • Wanhainen A.
        • Verzini F.
        • Van Herzeele I.
        • Allaire E.
        • Bown M.
        • Cohnert T.
        • et al.
        Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms.
        Eur J VascEndovasc Surg. 2019; 57: 8-93
        • McFarland G.
        • Tran K.
        • Virgin-Downey W.
        • Sgroi M.D.
        • Chandra V.
        • Mell M.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: 385-393
        • Oliveira N.F.G.
        • Bastos Gonçalves F.M.
        • Van Rijn M.J.
        • de Ruiter Q.
        • Hoeks S.
        • de Vries J.P.M.
        • 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
        • Gargiulo M.
        • Gallitto E.
        • Wattez H.
        • Verzini F.
        • Massoni C.B.
        • Loschi D.
        • et al.
        Outcomes of endovascular aneurysm repair performed in abdominal aortic aneurysms with large infrarenal necks.
        J Vasc Surg. 2017; 66: 1065-1072
        • Kouvelos G.N.
        • Spanos K.
        • Nana P.
        • Koutsias S.
        • Rousas N.
        • Giannoukas A.
        • 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
        • Oliveira N.F.G.
        • Oliveira-Pinto J.
        • van Rijn M.J.
        • Baart S.
        • Raa S.T.
        • Hoeks S.E.
        • et al.
        Risk Factors, Dynamics, and Clinical Consequences of Aortic Neck Dilatation after Standard Endovascular Aneurysm Repair.
        Eur J VascEndovasc Surg. 2021; 62: 26-35
        • Kouvelos G.N.
        • Oikonomou K.
        • Antoniou G.A.
        • Verhoeven E.L.
        • Katsargyris A.
        A Systematic Review of Proximal Neck Dilatation After Endovascular Repair for Abdominal Aortic Aneurysm.
        J EndovascTher. 2017; 24: 59-67
        • Mazzaccaro D.
        • Mazzeo G.
        • Zuccon G.
        • Modafferi A.
        • Malacrida G.
        • Righini P.C.
        • et al.
        Factors affecting the occurrence of proximal endoleak after endovascular abdominal aortic repair for abdominal aneurysms.
        J IntMedRes. 2020; 48 (300060520971515)
        • de Donato G.
        • Pasqui E.
        • Panzano C.
        • Brancaccio B.
        • Grottola G.
        • Galzerano G.
        • et al.
        The Polymer-Based Technology in the Endovascular Treatment of Abdominal Aortic Aneurysms.
        Polymers (Basel). 2021; 13: 1196
        • de Donato G.
        • Setacci F.
        • Bresadola L.
        • Castelli P.
        • Chiesa R.
        • Mangialardi N.
        • et al.
        Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft.
        J Vasc Surg. 2016; 63: 8-15
        • Swerdlow N.J.
        • Lyden S.P.
        • Verhagen H.J.M.
        • Schermerhorn M.L.
        Five-year results of endovascular abdominal aortic aneurysm repair with the Ovation abdominal stent graft.
        J Vasc Surg. 2020; 71: 1528-1537
        • Carrafiello G.
        • Ierardi A.
        • Piffaretti G.
        • Rivolta N.
        • Floridi C.
        • Aswad A.
        • et al.
        Treatment of abdominal aortic aneurysm with a new type of polymer-filled low profile device.
        Int J Surg. 2013; (S24-9): 11
        • Ierardi A.M.
        • Tsetis D.
        • Ioannou C.
        • Laganà D.
        • Floridi C.
        • Petrillo M.
        • et al.
        Ultra-low profile polymer-filled stent graft for abdominal aortic aneurysm treatment: a two-year follow-up.
        Radiol Med. 2015; 120: 542-548
        • Kontopodis N.
        • Papadopoulos G.
        • Galanakis N.
        • Tsetis D.
        • Ioannou C.V.
        Improvement of patient eligibility with the use of new generation endografts for the treatment of abdominal aortic aneurysms. A comparison study among currently used endografts and literature review.
        Expert Rev Med Devices. 2017; 14: 245-250
        • Kontopodis N.
        • Galanakis N, Tzartzalou I, Tavlas E, Georgakarakos E, Dimopoulos I
        • et al.
        An update on the improvement of patient eligibility with the use of new generation endografts for the treatment of abdominal aortic aneurysms.
        Expert RevMedDevices. 2020; 17: 1231-1238
        • Georgakarakos E.
        • Ioannou C.V.
        • Georgiadis G.S.
        • Storck M.
        • Trellopoulos G.
        • Koutsias S.
        • et al.
        The ovation abdominal stent graft for the treatment of abdominal aortic aneurysms: current evidence and future perspectives.
        Expert Rev Med Device. 2016; 13: 253-262
        • Georgakarakos E.
        • Papatheodorou N.
        • Argyriou C.
        • Tasopoulou K.M.
        • Doukas D.
        • Georgiadis G.S.
        An update on the ovation abdominal stent graft for the treatment of abdominal aortic aneurysms: current evidence and future perspectives.
        Expert Rev Med Device. 2020; 17: 1249-1256
        • Ioannou C.V.
        Tsetis DK.Going Beyond Current AAA Neck Angulation Limitations of the Ovation Ultra-low Profile Polymer-filled Stent Graft.
        Eur J VascEndovasc Surg. 2016; 52: 172
        • Kontopodis N.
        • Ioannou C.V.
        Parallel Grafts to Treat Juxtarenal Aneurysms Using the Ovation Stent Graft System.
        Eur J VascEndovasc Surg. 2020; 60: 479
        • Georgakarakos E.
        • Trellopoulos G.
        • Georgiadis G.S.
        • Kontopodis N.
        • Ioannou C.V.
        The chimney technique with the Ovation abdominal stent graft system: an ideal platform for self-expandable renal stents?.
        Cardiovasc InterventRadiol. 2014; 37: 1393-1394
        • Chaikof E.L.
        • Dalman R.L.
        • Eskandari M.K.
        • Jackson B.M.
        • Lee W.A.
        • Mansour M.A.
        • et al.
        The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm.
        J VascSurg. 2018; 67: 2-77
        • Chaikof E.L.
        • Fillinger M.F.
        • Matsumura J.S.
        • Rutherford R.B.
        • White G.H.
        • Blankensteijn J.D.
        • et al.
        Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair.
        J Vasc Surg. 2002; 35: 1061-1066
        • Balm R.
        • Stokking R.
        • Kaatee R.
        • Blankensteijn J.D.
        • Eikelboom B.C.
        • van Leeuwen M.S.
        Computed tomographic angiographic imaging of abdominal aortic aneurysms: implications for transfemoral endovascular aneurysm management.
        J Vasc Surg. 1997; 26: 231-237
        • Kehagias E.
        • Kontopodis N.
        • Tsetis D.
        • Ioannou C.V.
        Bifurcated aortoiliac endograft limb occlusion during deployment and its bailout conversion using the external iliac artery to internal iliac artery endograft technique.
        Ann Vasc Surg. 2015; 29: 1029-1034
      1. Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg2002;35:1048–1060.

        • Antoniou G.A.
        • Alfahad A.
        • Antoniou S.A.
        • Badri H.
        Prognostic significance of large diameter proximal aortic neck in endovascular aneurysm repair.
        Vasa. 2020; 49: 215-224
        • Kouvelos G.N.
        • Antoniou G.
        • Spanos K.
        • Giannoukas A.
        • Matsagkas M.
        Endovascular aneurysm repair in patients with a wide proximal aortic neck: a systematic review and meta-analysis of comparative studies.
        J Cardiovasc Surg (Torino). 2019; 60: 167-174
        • Cao P.
        • Verzini F.
        • Parlani G.
        • Rango P.D.
        • Parente B.
        • Giordano G.
        • et al.
        Predictive factors and clinical consequences of proximal aortic neck dilatation in 230 patients undergoing abdominal aorta aneurysm repair with self-expandable stent-grafts.
        J VascSurg. 2003; 37: 1200-1205
        • Kontopodis N.
        • E,LioudakiS Tavlas
        • Daskalakis N.
        • Chronis C,Dimopoulos I.
        • et al.
        Rate of female patients treated for Abdominal Aortic Aneurysm may beextremely low in specific populations.
        Hellenic JVascEndovasc Surg. 2021; 3: 43-47