Objective: The proximal aortic neck remains one of the challenges of endovascular aneurysm repair (EVAR), and the risk of type Ia endoleak and endograft migration is increased in patients with short, large-diameter, or highly angulated necks. EndoAnchors have been used as an adjunct to EVAR in such patients, and the aim of this study was to assess their benefit analyzed by indication for use.
Methods: During a 2-year period, 319 patients were enrolled at 43 sites in the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) study. This prospective, multinational, real-world analysis of EndoAnchors comprised two groups of patients, those undergoing first-time EVAR (primary arm, 242) and those with proximal neck complications remote from the time of an initial endograft implantation (revision arm, 77). The primary arm was further subdivided into patients undergoing prophylactic EndoAnchor use for hostile proximal neck anatomy (178), with a type Ia endoleak evident during initial endograft deployment (60), and in conjunction with extender cuffs after unsatisfactory endograft deployment distally in the neck (four). The revision arm was subdivided into patients presenting with a type Ia endoleak alone (45), endograft migration alone (11), and migration with endoleak (21). Technical success was site reported as satisfactory deployment of the desired number of EndoAnchors without fracture or loss of integrity. Procedural success was defined as technical success without type Ia endoleak at completion arteriography. Core laboratory analysis was performed on 249 baseline and 192 follow-up computed tomographic studies, 66 of which were available within the 1-year window.
Results: Technical and procedural success rates were highest in the prophylactically treated subset (172 of 178; 96.6%). Whereas the technical success of EndoAnchor deployment was also high in the other subsets, residual type Ia endoleaks were more frequent at completion angiography when the indication for EndoAnchor use was type Ia endoleak, both in the primary arm (17 of 60; 28%) and in the revision arm (9 of 45; 20%). During a median imaging follow-up of 7 months, 183 of 202 patients (90.1%) remained free of type Ia endoleaks. Primary prophylactic patients were free from type Ia endoleak in 110 of 114 cases (96.5%). The most challenging subset was revision patients treated for type Ia endoleak; type Ia endoleaks were evident during follow-up in 10 of 29 of the cases (34%). Sac regression >5 mm in patients with 1-year imaging was observed in 26 of 66 patients (39%) and was highest in the primary prophylaxis subset (20 of 43; 47%).
Conclusions: EndoAnchor implantation can be a useful adjunct to EVAR as prophylaxis against proximal attachment site complications in patients with hostile aortic neck anatomy, as treatment for early and late type Ia endoleaks, or, in conjunction with aortic extension cuffs, for endograft migration. Whereas the most challenging patients are those who present with type Ia endoleaks remote from initial EVAR, EndoAnchors are still effective in treating the majority of these cases.
Trial registration: ClinicalTrials.gov NCT01534819.
Copyright © 2014 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.