TY - JOUR
T1 - Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair
AU - van Noort, Kim
AU - Vermeulen, Jenske J.M.
AU - Goudeketting, Seline R.
AU - Ouriel, Kenneth
AU - Jordan, William D.
AU - Panneton, Jean M.
AU - Slump, Cornelis H.
AU - de Vries, Jean Paul P.M.
N1 - Sage deal
PY - 2019/6/1
Y1 - 2019/6/1
N2 - Purpose: To investigate changes in penetration depths and angles of EndoAnchor implants with initially good penetration after therapeutic use in endovascular aneurysm repair.Materials and Methods: Patients were selected from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR; ClinicalTrials.gov identifier NCT01534819). Inclusion criteria were (1) EndoAnchor implantation to treat intraoperative or late type Ia endoleak and (2) at least 2 postoperative computed tomography angiography (CTA) scans. Exclusion criteria were the use of adjunct procedures. Based on these criteria, 54 patients (44 men) with 360 EndoAnchor implants were eligible for this analysis. Penetration depth of each EndoAnchor implant into the aortic wall was judged as (1) good (≥2-mm penetration), (2) borderline (<2 mm or when there was a gap between the endograft and the aortic wall), or (3) no penetration. The penetration depth and longitudinal angles of EndoAnchors with good penetration were investigated on the last available postprocedure CTA scan. Endoleaks were also analyzed.Results: EndoAnchor penetration on the first postprocedure CTA scan was good in 187 (51.9%), borderline in 69 (19.2%), and missing in 104 (28.9%). On the last CTA scan, 182 (97.4%) of the 187 initially well-positioned EndoAnchors remained good. Five (2.6%) EndoAnchors in 4 patients changed configuration over time (4 became borderline and 1 became nonpenetrating), all without any clinical sequelae. The median orthogonal angles of the EndoAnchor implants with good penetration on the first and last CTA scans were 92° [interquartile range (IQR) 85, 98] and 90° (IQR 84, 97), respectively (p=0.822); for longitudinal angles, medians of 85° (IQR 71, 96) and 84° (IQR 70, 96) were found (p=0.043). Of the 18 (33%) patients who had a type Ia endoleak on the first postprocedure CTA, 6 resolved over time. Median follow-up was 13 months, during which no new type Ia endoleak was found.Conclusion: Despite the small number of EndoAnchors analyzed, this study showed that the sustainability of EndoAnchor implants with initially good penetration is satisfactory at 1-year follow-up. The vast majority of EndoAnchor implants with good penetration initially remained in good position; <3% of implants became borderline or nonpenetrating, without any clinical consequence.
AB - Purpose: To investigate changes in penetration depths and angles of EndoAnchor implants with initially good penetration after therapeutic use in endovascular aneurysm repair.Materials and Methods: Patients were selected from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR; ClinicalTrials.gov identifier NCT01534819). Inclusion criteria were (1) EndoAnchor implantation to treat intraoperative or late type Ia endoleak and (2) at least 2 postoperative computed tomography angiography (CTA) scans. Exclusion criteria were the use of adjunct procedures. Based on these criteria, 54 patients (44 men) with 360 EndoAnchor implants were eligible for this analysis. Penetration depth of each EndoAnchor implant into the aortic wall was judged as (1) good (≥2-mm penetration), (2) borderline (<2 mm or when there was a gap between the endograft and the aortic wall), or (3) no penetration. The penetration depth and longitudinal angles of EndoAnchors with good penetration were investigated on the last available postprocedure CTA scan. Endoleaks were also analyzed.Results: EndoAnchor penetration on the first postprocedure CTA scan was good in 187 (51.9%), borderline in 69 (19.2%), and missing in 104 (28.9%). On the last CTA scan, 182 (97.4%) of the 187 initially well-positioned EndoAnchors remained good. Five (2.6%) EndoAnchors in 4 patients changed configuration over time (4 became borderline and 1 became nonpenetrating), all without any clinical sequelae. The median orthogonal angles of the EndoAnchor implants with good penetration on the first and last CTA scans were 92° [interquartile range (IQR) 85, 98] and 90° (IQR 84, 97), respectively (p=0.822); for longitudinal angles, medians of 85° (IQR 71, 96) and 84° (IQR 70, 96) were found (p=0.043). Of the 18 (33%) patients who had a type Ia endoleak on the first postprocedure CTA, 6 resolved over time. Median follow-up was 13 months, during which no new type Ia endoleak was found.Conclusion: Despite the small number of EndoAnchors analyzed, this study showed that the sustainability of EndoAnchor implants with initially good penetration is satisfactory at 1-year follow-up. The vast majority of EndoAnchor implants with good penetration initially remained in good position; <3% of implants became borderline or nonpenetrating, without any clinical consequence.
KW - UT-Hybrid-D
KW - Endograft
KW - Endoleak
KW - Endovascular aneurysm repair
KW - Fixation
KW - Stent-graft
KW - Abdominal aortic aneurysms
KW - 22/4 OA procedure
U2 - 10.1177/1526602819837753
DO - 10.1177/1526602819837753
M3 - Article
C2 - 30907259
AN - SCOPUS:85063618275
SN - 1526-6028
VL - 26
SP - 369
EP - 377
JO - Journal of Endovascular Therapy
JF - Journal of Endovascular Therapy
IS - 3
ER -