ANCHOR Registry Evaluates Aptus EndoAnchors to Address Type Ia Endoleak and Endograft Migration in EVAR

October 6, 2014—Findings from ANCHOR (Aneurysm Treatment Using the Heli-FX Aortic System Global Registry) were published by William D. Jordan Jr., MD, et al in the Journal of Vascular Surgery (2014;60:885–892).

The background of the study is that proximal attachment site complications continue to occur after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), specifically type Ia endoleak and endograft migration. The current study was undertaken to evaluate the potential benefit of treatment with EndoAnchors (Aptus Endosystems, Inc.), which were designed to enhance endograft proximal fixation and sealing.

As summarized in the Journal of Vascular Surgery, the investigators enrolled 319 patients at 43 sites in the United States and Europe during a 23-month period ending in December 2013. EndoAnchors were implanted in 242 patients (75.9%) at the time of an initial EVAR procedure (primary arm) and in 77 patients with an existing endograft and proximal aortic neck complications (revision arm). Technical success was defined as deployment of the desired number of EndoAnchors, adequate penetration of the vessel wall, and absence of EndoAnchor fracture. Procedural success was defined as technical success without a type Ia endoleak at completion angiography. Values are expressed as mean ± standard deviation and interquartile range.

The investigators reported that the 238 male (74.6%) and 81 female (25.4%) patients had a mean age of 74.1 ± 8.2 years. Aneurysms averaged 58 ± 13 (51–63) mm in diameter at the time of EndoAnchor implantation (core laboratory measurements). The proximal aortic neck averaged 16 ± 13 (7–23) mm in length (42.7% < 10 mm and 42.7% conical) and 27 ± 4 (25–30) mm in diameter; infrarenal neck angulation was 24° ± 15° (13°–34°). The number of EndoAnchors deployed was 5.8 ± 2.1 (4­–7).

Technical success was achieved in 303 patients (95%) and procedural success was achieved in 279 patients (87.5%), 217 of 240 (89.7%) in the primary arm and 62 of 77 (80.5%) in the revision arm. There were 29 residual type Ia endoleaks (9.1%) at the end of the procedure.

During mean follow-up of 9.3 ± 4.7 months, 301 patients (94.4%) were free from secondary procedures. Among the 18 secondary procedures, eight were performed for residual type Ia endoleaks, and the others were unrelated to EndoAnchors. There were no open surgical conversions, there were no aneurysm-related deaths, and no aneurysm ruptured during follow-up.

The ANCHOR registry investigators concluded that use of EndoAnchors to treat existing and acute type Ia endoleaks and endograft migration was successful in most cases and that prophylactic use of EndoAnchors in patients with hostile aortic neck anatomy appears promising; however, definitive conclusions must await longer-term follow-up data.

In August, Manish Mehta, MD, et al published findings from the pivotal study designed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors in the Journal of Vascular Surgery (2014;60:275–285).