ANCHOR Analysis Evaluates Aptus EndoAnchors for EVAR by Indications for Use

December 3, 2014—In the Journal of Vascular of Surgery, Jean-Paul P.M. de Vries, MD, et al published findings from an analysis of the ANCHOR (Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry) study to evaluate the Heli-FX EndoAnchor system (Aptus Endosystems, Inc.) for endovascular aneurysm repair (EVAR) by indications for use (2014;60:1460–1467). The data were first presented in June at the 2014 Vascular Annual Meeting of the Society for Vascular Surgery in Boston, Massachusetts. 

The investigators noted that the proximal aortic neck remains one of the challenges of 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. The aim of this study was to assess their benefit analyzed by indication for use.

As reported in the Journal of Vascular Surgery, the investigators enrolled 319 patients during a 2-year period at 43 sites in the ANCHOR study. This prospective, multinational, real-world analysis of EndoAnchors comprised two groups of patients: those undergoing first-time EVAR (primary arm, n = 242) and those with proximal neck complications remote from the time of an initial endograft implantation (revision arm, n = 77). 

The primary arm was further subdivided into patients undergoing prophylactic EndoAnchor use for hostile proximal neck anatomy (178), those with a type Ia endoleaks evident during initial endograft deployment (60), and in conjunction with extender cuffs after unsatisfactory endograft deployment distally in the neck (4). 

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 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 on completion arteriography. A core laboratory analysis was performed on 249 baseline and 192 follow-up CT studies, 66 of which were available within the 1-year window.

The investigators reported that 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 on 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%).

The investigators concluded that 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, advised the investigators in the Journal of Vascular Surgery.