Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing.

Kim van Noort (Corresponding Author), Johannes Thomas Boersen, Sandra Zoethout, R.C.L. Schuurmann, Jan Heyligers, M.M.P.J. Reijnen, Clark Zeebregts, Cornelis H. Slump, J.P.P.M. de Vries

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)

Abstract

Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

Original languageEnglish
Pages (from-to)719-725
JournalJournal of Endovascular Therapy
Volume25
Issue number6
DOIs
Publication statusPublished - 25 Oct 2018

Fingerprint

Endoleak
Aneurysm
Abdominal Aortic Aneurysm
Neck
Regression Analysis
Growth
Stents
Tomography
Equipment and Supplies
Control Groups
Incidence

Keywords

  • UT-Hybrid-D

Cite this

van Noort, Kim ; Boersen, Johannes Thomas ; Zoethout, Sandra ; Schuurmann, R.C.L. ; Heyligers, Jan ; Reijnen, M.M.P.J. ; Zeebregts, Clark ; Slump, Cornelis H. ; de Vries, J.P.P.M. / Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing. In: Journal of Endovascular Therapy. 2018 ; Vol. 25, No. 6. pp. 719-725.
@article{8d7a8151860f4f34922fd7890b68797e,
title = "Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing.",
abstract = "Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8{\%}) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3{\%}) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3{\%}) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.",
keywords = "UT-Hybrid-D",
author = "{van Noort}, Kim and Boersen, {Johannes Thomas} and Sandra Zoethout and R.C.L. Schuurmann and Jan Heyligers and M.M.P.J. Reijnen and Clark Zeebregts and Slump, {Cornelis H.} and {de Vries}, J.P.P.M.",
note = "Sage deal",
year = "2018",
month = "10",
day = "25",
doi = "10.1177/1526602818808296",
language = "English",
volume = "25",
pages = "719--725",
journal = "Journal of Endovascular Therapy",
issn = "1526-6028",
publisher = "SAGE Publications",
number = "6",

}

Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing. / van Noort, Kim (Corresponding Author); Boersen, Johannes Thomas; Zoethout, Sandra; Schuurmann, R.C.L.; Heyligers, Jan; Reijnen, M.M.P.J.; Zeebregts, Clark; Slump, Cornelis H.; de Vries, J.P.P.M.

In: Journal of Endovascular Therapy, Vol. 25, No. 6, 25.10.2018, p. 719-725.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing.

AU - van Noort, Kim

AU - Boersen, Johannes Thomas

AU - Zoethout, Sandra

AU - Schuurmann, R.C.L.

AU - Heyligers, Jan

AU - Reijnen, M.M.P.J.

AU - Zeebregts, Clark

AU - Slump, Cornelis H.

AU - de Vries, J.P.P.M.

N1 - Sage deal

PY - 2018/10/25

Y1 - 2018/10/25

N2 - Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

AB - Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

KW - UT-Hybrid-D

U2 - 10.1177/1526602818808296

DO - 10.1177/1526602818808296

M3 - Article

VL - 25

SP - 719

EP - 725

JO - Journal of Endovascular Therapy

JF - Journal of Endovascular Therapy

SN - 1526-6028

IS - 6

ER -