Management of late main-body aortic endograft component uncoupling and type IIIa endoleak encountered with the Endologix Powerlink and AFX platforms

Skibba, Afshin A.; Evans, James R.; Greenfield, D. Tyler; Yoon, H. Richard; Katras, Tony; Ouriel, Kenneth; Rush, Daniel S.

doi:10.1016/j.jvs.2015.04.454

Cited by 49 publications

(32 citation statements)

References 24 publications

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“…Since the beginning of 2013 revised IFU, requirement of a minimum component overlap of at least 30 mm to 40 mm have been introduced, and these were carefully followed in the present study. Similarly, in the Skibba et al [6] series, no new type III endoleaks have been observed in patients treated with the revised IFU. Meticulous preoperative planning and proper selection of endograft components for a sufficient overlap are of utmost importance for endograft uncoupling and type III endoleak prevention.…”

Section: Discussionmentioning

confidence: 66%

“…From investigating 701 EVAR patients treated with the Endologix Powerlink or AFX endograft, Skibba et al [6] recently reported a type IIIa endoleak in 17 patients (2.4%). Welborn et al [7] reported a similar incidence (2.3%) in 108 patients treated with the AFX system.…”

Section: Discussionmentioning

confidence: 99%

“…Melas et al [5] and Welborn et al [7] reported no limb occlusion in a total of 129 patients. Skibba et al [6] by including 701 patients treated with the Endologix Powerlink and AFX platforms during a 8-year period, reported only 3 graft thrombosis that needed reintervention (0.4%). Moreover Carpenter et al [12] by reporting results from 3 Investigational Device Exemption studies found a 1.9% limb occlusion rate.…”

Section: Discussionmentioning

confidence: 99%

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Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Kouvelos

Nana

Bouris

et al. 2017

VSI

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PurposeThe newly designed unibody AFX endograft system for endovascular aortic aneurysm repair is the only graft with anatomical fixation to the aortic bifurcation in comparison to most other grafts that use the infrarenal neck as the main fixation point. The aim of this study was to assess the preliminary results of the AFX stent-graft system used with infrarenal aortic component and compare them with those obtained in patients treated with a well established endograft of the same material and pure infrarenal fixation as the Gore Excluder.Materials and MethodsA retrospective analysis of prospectively collected data from March 2014 to December 2014 identified 10 elective abdominal aortic aneurysm patients treated with the AFX endograft, in comparison to a matched group of 20 patients treated with the Excluder stent-graft. Endpoints included technical and clinical success, freedom from any secondary intervention, any type of endoleak and aneurysm related death.ResultsPrimary technical success was achieved in all patients and no 30-day device related complications or deaths were occurred. The two groups were similar in terms of radiation burden, contrast media, duration of the procedure, post implantation syndrome and in-hospital stay. During a median follow-up period of 23 months (range, 18–26 months) there were no differences in clinical success, freedom from reintervention and aneurysm related death. No type I endoleak was observed in either group. Five of the 6 type II endoleaks (1 in the AFX and 4 in the Excluder group) spontaneously resolved, while in only one patient (Excluder) the endoleak remained without however any change in aneurysm sac diameter (log rank=0.34).ConclusionThe initial experience with the AFX stent graft system is promising, with successful aneurysm exclusion and good short-term results. Further and larger studies are needed to fully evaluate the sort as well as the long-term results.

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Section: Discussionmentioning

confidence: 66%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Kouvelos

Nana

Bouris

et al. 2017

VSI

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“…7,8 However, the incidence of those experiencing modular migration without endoleak remained unclear. 9 Additionally, the true incidence of clinically significant type IIIa endoleaks may be much higher. In 2016, our group published a 7.2% modular separation event rate associated with implantation of the AFX aortic graft which led to the voluntary withdrawal of a portion of available grafts by Endologix.…”

Section: Discussionmentioning

confidence: 99%

Aggressive Surveillance Is Needed to Detect Endoleaks and Junctional Separation between Device Components after Zenith Fenestrated Aortic Reconstruction

Wang

Lemmon

Gupta

et al. 2019

Annals of Vascular Surgery

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Junctional separation and resulting type IIIa endoleak is a well-known problem after EVAR (endovascular aneurysm repair). This complication results in sac pressurization, enlargement, and eventual rupture. In this manuscript, we review the incidence of this late finding in our experience with the Cook Zenith Fenestrated endoprosthesis (ZFEN, Bloomington, IN) Methods: A retrospective review was performed of a prospectively maintained institutional ZFEN FEVAR (fenestrated EVAR) database capturing all ZFENs implanted at a large-volume, academic hospital system. Patients who experienced junctional separation between the fenestrated main body and distal bifurcated graft (with or without type IIIa endoleak) at any time after initial endoprosthesis implantation were subject to further evaluation of imaging and medical records to abstract clinical courses. Results: In 110 ZFENs implanted from October 2012 to December 2017 followed for a mean of 1.5 years, we observed a 4.5% and 2.7% incidence of clinically significant junctional separation and type IIIa endoleak, respectively. Junctional separation was directly related to concurrent type Ib endoleak in all five patients. Three patients presented with sac enlargement. One patient did not demonstrate any evidence of clinically significant endoleak and had a decreasing sac size during follow-up imaging. The mean time to diagnosis of modular separation in these patients was 40 months. Junctional separation was captured in surveillance in two patients and reintervened upon before manifestation of endoleak. However, the remaining three patients completed modular separation resulting in rupture and emergent intervention in two and an aortic-related mortality in the other. Conclusions: Junctional separation between the fenestrated main and distal bifurcated body with the potential for type IIIa endoleak is an established complication associated with the ZFEN platform. Therefore, we advocate for maximizing aortic overlap during the index procedure followed by aggressive surveillance and treatment of stent overlap loss captured on imaging.

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“…Fortunately, with newer generation devices, separation occurs less frequently. 31 Endograft limb kinking can occur in the setting of inferior translocation, with potential for graft occlusion or thrombosis. 32 Graft occlusions typically occur within the first year of placement, with posited risk factors for limb occlusion including small aortic bifurcations and tortuous, angulated iliac arteries 33,34 (►Fig.…”

Section: Structural Complicationsmentioning

confidence: 99%

Surveillance Imaging following Endovascular Aneurysm Repair: State of the Art

Kim

Litt

2020

Semin intervent Radiol

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Endovascular aneurysmal repair (EVAR) has become a prominent modality for the treatment of abdominal aortic aneurysm. Surveillance imaging is important for the detection of device-related complications, which include endoleak, structural abnormalities, and infection. Currently used modalities include ultrasound, X-ray, computed tomography, magnetic resonance imaging, and angiography. Understanding the advantages and drawbacks of each modality, as well available guidelines, can guide selection of the appropriate technique for individual patients. We review complications following EVAR and advances in surveillance imaging modalities.

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Management of late main-body aortic endograft component uncoupling and type IIIa endoleak encountered with the Endologix Powerlink and AFX platforms

Cited by 49 publications

References 24 publications

Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Aggressive Surveillance Is Needed to Detect Endoleaks and Junctional Separation between Device Components after Zenith Fenestrated Aortic Reconstruction

Surveillance Imaging following Endovascular Aneurysm Repair: State of the Art

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