Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair

Seline R. Goudeketting*, Kim van Noort, Jenske J.M. Vermeulen, Kenneth Ouriel, William D. Jordan, Jean M. Panneton, Cornelis H. Slump, Jean Paul P.M. de Vries

*Corresponding author for this work

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    Abstract

    Objective: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. Methods: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. Results: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. Conclusions: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.

    Original languageEnglish
    Pages (from-to)1726-1735
    Number of pages10
    JournalJournal of vascular surgery
    Volume69
    Issue number6
    Early online date19 Dec 2018
    DOIs
    Publication statusPublished - 1 Jun 2019

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    Endoleak
    Therapeutic Uses
    Aneurysm
    Tomography
    Blood Vessels
    Registries
    Thrombosis
    Arm
    Equipment and Supplies

    Keywords

    • Abdominal aortic aneurysm
    • Aneurysm neck
    • EndoAnchor implant
    • Endovascular aneurysm repair
    • Type IA endoleak

    Cite this

    Goudeketting, S. R., van Noort, K., Vermeulen, J. J. M., Ouriel, K., Jordan, W. D., Panneton, J. M., ... de Vries, J. P. P. M. (2019). Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair. Journal of vascular surgery, 69(6), 1726-1735. https://doi.org/10.1016/j.jvs.2018.09.035
    Goudeketting, Seline R. ; van Noort, Kim ; Vermeulen, Jenske J.M. ; Ouriel, Kenneth ; Jordan, William D. ; Panneton, Jean M. ; Slump, Cornelis H. ; de Vries, Jean Paul P.M. / Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair. In: Journal of vascular surgery. 2019 ; Vol. 69, No. 6. pp. 1726-1735.
    @article{2e3e5e9d16104d008676c562e4f483d0,
    title = "Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair",
    abstract = "Objective: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. Methods: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. Results: A total of 170 (29{\%}) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1{\%}) and 4 (2{\%}) EndoAnchor implants positioned above the fabric as well as 60 (18{\%}) and 103 (42{\%}) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4{\%}], 14 [5.2{\%}], and 20 [7.4{\%}] vs 97 [68.8{\%}], 18 [12.8{\%}], and 26 [18.4{\%}], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. Conclusions: In this subcohort of ANCHOR patients, almost 30{\%} of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.",
    keywords = "Abdominal aortic aneurysm, Aneurysm neck, EndoAnchor implant, Endovascular aneurysm repair, Type IA endoleak",
    author = "Goudeketting, {Seline R.} and {van Noort}, Kim and Vermeulen, {Jenske J.M.} and Kenneth Ouriel and Jordan, {William D.} and Panneton, {Jean M.} and Slump, {Cornelis H.} and {de Vries}, {Jean Paul P.M.}",
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    day = "1",
    doi = "10.1016/j.jvs.2018.09.035",
    language = "English",
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    Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair. / Goudeketting, Seline R.; van Noort, Kim; Vermeulen, Jenske J.M.; Ouriel, Kenneth; Jordan, William D.; Panneton, Jean M.; Slump, Cornelis H.; de Vries, Jean Paul P.M.

    In: Journal of vascular surgery, Vol. 69, No. 6, 01.06.2019, p. 1726-1735.

    Research output: Contribution to journalArticleAcademicpeer-review

    TY - JOUR

    T1 - Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair

    AU - Goudeketting, Seline R.

    AU - van Noort, Kim

    AU - Vermeulen, Jenske J.M.

    AU - Ouriel, Kenneth

    AU - Jordan, William D.

    AU - Panneton, Jean M.

    AU - Slump, Cornelis H.

    AU - de Vries, Jean Paul P.M.

    PY - 2019/6/1

    Y1 - 2019/6/1

    N2 - Objective: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. Methods: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. Results: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. Conclusions: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.

    AB - Objective: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. Methods: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. Results: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. Conclusions: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.

    KW - Abdominal aortic aneurysm

    KW - Aneurysm neck

    KW - EndoAnchor implant

    KW - Endovascular aneurysm repair

    KW - Type IA endoleak

    U2 - 10.1016/j.jvs.2018.09.035

    DO - 10.1016/j.jvs.2018.09.035

    M3 - Article

    C2 - 30578071

    AN - SCOPUS:85058633964

    VL - 69

    SP - 1726

    EP - 1735

    JO - Journal of vascular surgery

    JF - Journal of vascular surgery

    SN - 0741-5214

    IS - 6

    ER -