Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck

Kim van Noort (Corresponding Author), S.P. Overeem, Ruben van Veen, Jan Heyligers, M.M.P.J. Reijnen, R.C.L. Schuurmann, Cornelis H. Slump, Rogier Kropman, J.P.P.M. de Vries

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Abstract

Purpose: To investigate the initial proximal position and seal of the Nellix EndoVascular Aneurysm Sealing (EVAS) system in the aortic neck using a novel methodology. Methods: Forty-six consecutive patients who underwent elective EVAS for an abdominal aortic aneurysm were retrospectively selected and dichotomized into an early (n=23) and a late (n=23) group. The aortic neck morphology and aortic neck surface (ANS) were determined on preoperative computed tomography (CT) scans; the endograft position and nonapposition surface (NAS) were determined on the 1-month CT scans. The position of the proximal endobag boundary was measured by 2 experienced observers to analyze the interobserver variability for the EVAS NAS measurements. The shortest distance from the lowest renal artery to the endobag (shortest fabric distance) and the shortest distance from the endobag to the end of the infrarenal neck (shortest sealing distance) were determined. The intraclass correlation coefficients (ICCs) are presented with the 95% confidence interval (CI). Continuous data are presented as the median and interquartile range (IQR: Q3 – Q1). Results: There were no differences between the early and late EVAS groups regarding aortic neck morphology except for the neck calcification circumference [41° (IQR 33°) vs 87° (IQR 60°), respectively; p=0.043]. Perfect agreement was observed for the NAS (ICC 0.897, 95% CI 0.780 to 0.956). The NAS as a percentage of the preoperative ANS was 47% (IQR 43) vs 49% (IQR 49) for the early vs late groups, respectively (p=0.214). The shortest fabric distances were 5 mm (IQR 5) and 4 mm (IQR 7) for the early and late groups, respectively (p=0.604); the shortest sealing distances were 9 mm (IQR 13) and 16 mm (IQR 17), respectively (p=0.066). Conclusion: Accurate positioning of the Nellix EVAS system in the aortic neck may be challenging. Despite considerable experience with the system, still around half of the potential seal in the aortic neck was missed in the current series, without improvement over time. This should be considered during preoperative planning and may be a cause of a higher than expected complication rate. Detailed post-EVAS nonapposition surface can be determined with the described novel methodology that takes into account the sometimes irregularly shaped top of the sealing endobags.
Original languageEnglish
Pages (from-to)428-434
JournalJournal of Endovascular Therapy
Volume25
Issue number4
Early online date22 May 2018
DOIs
Publication statusPublished - 1 Aug 2018

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Aneurysm
Tomography
Confidence Intervals
Observer Variation
Abdominal Aortic Aneurysm
Renal Artery
Neck

Keywords

  • UT-Hybrid-D

Cite this

van Noort, Kim ; Overeem, S.P. ; van Veen, Ruben ; Heyligers, Jan ; Reijnen, M.M.P.J. ; Schuurmann, R.C.L. ; Slump, Cornelis H. ; Kropman, Rogier ; de Vries, J.P.P.M. / Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck. In: Journal of Endovascular Therapy. 2018 ; Vol. 25, No. 4. pp. 428-434.
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title = "Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck",
abstract = "Purpose: To investigate the initial proximal position and seal of the Nellix EndoVascular Aneurysm Sealing (EVAS) system in the aortic neck using a novel methodology. Methods: Forty-six consecutive patients who underwent elective EVAS for an abdominal aortic aneurysm were retrospectively selected and dichotomized into an early (n=23) and a late (n=23) group. The aortic neck morphology and aortic neck surface (ANS) were determined on preoperative computed tomography (CT) scans; the endograft position and nonapposition surface (NAS) were determined on the 1-month CT scans. The position of the proximal endobag boundary was measured by 2 experienced observers to analyze the interobserver variability for the EVAS NAS measurements. The shortest distance from the lowest renal artery to the endobag (shortest fabric distance) and the shortest distance from the endobag to the end of the infrarenal neck (shortest sealing distance) were determined. The intraclass correlation coefficients (ICCs) are presented with the 95{\%} confidence interval (CI). Continuous data are presented as the median and interquartile range (IQR: Q3 – Q1). Results: There were no differences between the early and late EVAS groups regarding aortic neck morphology except for the neck calcification circumference [41° (IQR 33°) vs 87° (IQR 60°), respectively; p=0.043]. Perfect agreement was observed for the NAS (ICC 0.897, 95{\%} CI 0.780 to 0.956). The NAS as a percentage of the preoperative ANS was 47{\%} (IQR 43) vs 49{\%} (IQR 49) for the early vs late groups, respectively (p=0.214). The shortest fabric distances were 5 mm (IQR 5) and 4 mm (IQR 7) for the early and late groups, respectively (p=0.604); the shortest sealing distances were 9 mm (IQR 13) and 16 mm (IQR 17), respectively (p=0.066). Conclusion: Accurate positioning of the Nellix EVAS system in the aortic neck may be challenging. Despite considerable experience with the system, still around half of the potential seal in the aortic neck was missed in the current series, without improvement over time. This should be considered during preoperative planning and may be a cause of a higher than expected complication rate. Detailed post-EVAS nonapposition surface can be determined with the described novel methodology that takes into account the sometimes irregularly shaped top of the sealing endobags.",
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Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck. / van Noort, Kim (Corresponding Author); Overeem, S.P.; van Veen, Ruben; Heyligers, Jan; Reijnen, M.M.P.J.; Schuurmann, R.C.L.; Slump, Cornelis H.; Kropman, Rogier; de Vries, J.P.P.M.

In: Journal of Endovascular Therapy, Vol. 25, No. 4, 01.08.2018, p. 428-434.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck

AU - van Noort, Kim

AU - Overeem, S.P.

AU - van Veen, Ruben

AU - Heyligers, Jan

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

AU - Schuurmann, R.C.L.

AU - Slump, Cornelis H.

AU - Kropman, Rogier

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

N1 - Sage deal

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Purpose: To investigate the initial proximal position and seal of the Nellix EndoVascular Aneurysm Sealing (EVAS) system in the aortic neck using a novel methodology. Methods: Forty-six consecutive patients who underwent elective EVAS for an abdominal aortic aneurysm were retrospectively selected and dichotomized into an early (n=23) and a late (n=23) group. The aortic neck morphology and aortic neck surface (ANS) were determined on preoperative computed tomography (CT) scans; the endograft position and nonapposition surface (NAS) were determined on the 1-month CT scans. The position of the proximal endobag boundary was measured by 2 experienced observers to analyze the interobserver variability for the EVAS NAS measurements. The shortest distance from the lowest renal artery to the endobag (shortest fabric distance) and the shortest distance from the endobag to the end of the infrarenal neck (shortest sealing distance) were determined. The intraclass correlation coefficients (ICCs) are presented with the 95% confidence interval (CI). Continuous data are presented as the median and interquartile range (IQR: Q3 – Q1). Results: There were no differences between the early and late EVAS groups regarding aortic neck morphology except for the neck calcification circumference [41° (IQR 33°) vs 87° (IQR 60°), respectively; p=0.043]. Perfect agreement was observed for the NAS (ICC 0.897, 95% CI 0.780 to 0.956). The NAS as a percentage of the preoperative ANS was 47% (IQR 43) vs 49% (IQR 49) for the early vs late groups, respectively (p=0.214). The shortest fabric distances were 5 mm (IQR 5) and 4 mm (IQR 7) for the early and late groups, respectively (p=0.604); the shortest sealing distances were 9 mm (IQR 13) and 16 mm (IQR 17), respectively (p=0.066). Conclusion: Accurate positioning of the Nellix EVAS system in the aortic neck may be challenging. Despite considerable experience with the system, still around half of the potential seal in the aortic neck was missed in the current series, without improvement over time. This should be considered during preoperative planning and may be a cause of a higher than expected complication rate. Detailed post-EVAS nonapposition surface can be determined with the described novel methodology that takes into account the sometimes irregularly shaped top of the sealing endobags.

AB - Purpose: To investigate the initial proximal position and seal of the Nellix EndoVascular Aneurysm Sealing (EVAS) system in the aortic neck using a novel methodology. Methods: Forty-six consecutive patients who underwent elective EVAS for an abdominal aortic aneurysm were retrospectively selected and dichotomized into an early (n=23) and a late (n=23) group. The aortic neck morphology and aortic neck surface (ANS) were determined on preoperative computed tomography (CT) scans; the endograft position and nonapposition surface (NAS) were determined on the 1-month CT scans. The position of the proximal endobag boundary was measured by 2 experienced observers to analyze the interobserver variability for the EVAS NAS measurements. The shortest distance from the lowest renal artery to the endobag (shortest fabric distance) and the shortest distance from the endobag to the end of the infrarenal neck (shortest sealing distance) were determined. The intraclass correlation coefficients (ICCs) are presented with the 95% confidence interval (CI). Continuous data are presented as the median and interquartile range (IQR: Q3 – Q1). Results: There were no differences between the early and late EVAS groups regarding aortic neck morphology except for the neck calcification circumference [41° (IQR 33°) vs 87° (IQR 60°), respectively; p=0.043]. Perfect agreement was observed for the NAS (ICC 0.897, 95% CI 0.780 to 0.956). The NAS as a percentage of the preoperative ANS was 47% (IQR 43) vs 49% (IQR 49) for the early vs late groups, respectively (p=0.214). The shortest fabric distances were 5 mm (IQR 5) and 4 mm (IQR 7) for the early and late groups, respectively (p=0.604); the shortest sealing distances were 9 mm (IQR 13) and 16 mm (IQR 17), respectively (p=0.066). Conclusion: Accurate positioning of the Nellix EVAS system in the aortic neck may be challenging. Despite considerable experience with the system, still around half of the potential seal in the aortic neck was missed in the current series, without improvement over time. This should be considered during preoperative planning and may be a cause of a higher than expected complication rate. Detailed post-EVAS nonapposition surface can be determined with the described novel methodology that takes into account the sometimes irregularly shaped top of the sealing endobags.

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DO - 10.1177/1526602818777494

M3 - Article

VL - 25

SP - 428

EP - 434

JO - Journal of Endovascular Therapy

JF - Journal of Endovascular Therapy

SN - 1526-6028

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ER -