ANCHOR Global Registry Supports Aptus Endosystems' EndoAnchor in Urgent EVAR

November 5, 2014—VIVA Physicians, Inc. announced that Peter A. Schneider, MD, presented findings from a subanalysis of a series of patients treated by urgent endovascular aneurysm repair (EVAR) using EndoAnchors (Aptus Endosystems, Inc.) in the larger ANCHOR global registry. Dr. Schneider presented the ANCHOR subset data during the late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada. There is critical need in urgent EVAR for a bailout adjunct to treat proximal seal complications or address concerns in complex proximal neck anatomy, noted the announcement.

The ANCHOR registry was conducted at 32 centers and enrolled 39 patients who were classified as urgent over 18 months through July 2014, comprising the subset presented at VIVA 2014. Among these patients, 36 (92%) aneurysms were intact and three (8%) were ruptured.

Indications for EndoAnchor use in primary EVAR cases included prevention of late proximal neck complications in 23 patients (59%) and treatment of intraoperative type Ia endoleaks in eight (21%) patients. Indications for revisions included late type Ia endoleak treatment (four, 10%), type Ia endoleak with migration (three, 8%), or migration alone (one, 3%). Mean clinical follow-up was 14 ± 7 months.

Treated endografts included Endurant (Medtronic, Inc.; 16, 41%), Excluder (Gore & Associates; 12, 31%), Zenith (Cook Medical; six, 15%), and other devices (five, 13%). Proximal necks averaged 27 ± 3 mm in diameter and 17 ± 11 mm in length; 27% were ≤ 10 mm. Neck angulation averaged 35 ± 16°; 27% of necks were conical. The total EndoAnchor deployment time was 15 ± 8 minutes.

At completion angiography, 92% of patients (37) were free from type Ia endoleaks. No patient developed rupture after repair. In the three patients treated after AAA rupture, there has been no reported recurring hemorrhage. Additionally, there were no reinterventions or deaths due to proximal seal complications or EndoAnchors.

Aneurysm-related reinterventions occurred in two patients (5%): one endograft limb stenosis and one type II endoleak. There was one aneurysm-related death (2.6%) from renal failure after repair of a symptomatic unruptured AAA. Core laboratory analysis of postoperative CT imaging (3-months mean follow-up) confirmed absence of type Ia endoleaks in all 16 patients with contrast studies.

The excellent results in this cohort suggest EndoAnchors promise a useful adjunct in patients requiring urgent aneurysm repair, stated the VIVA Physicians summary of the presentation.