One-year clinical outcomes of the EXCLUDER Conformable device in patients with an angulated proximal neck (Japanese Multicenter Study; the EXCLUDER Conformable endoprosThesis foR angulatEd proxiMal nEck anatomy registry).

OBJECTIVE

TheGore EXCLUDER Conformable abdominal aortic aneurysm endoprosthesis with ACTIVE CONTROL System (EXCC; W. L. Gore & Associates) is designed to treat abdominal aortic aneurysms with a challenging proximal neck. This study was conducted to investigate the safety and efficacy of the EXCC device in patients with an angulated proximal neck at 23 Japanese institutions (Excluder Conformable endoprosThesis foR angulatEd proxiMal nEck anatomy [EXTREME registry]).

METHODS

A retrospective analysis was conducted on all endovascular aneurysm repairs (EVARs) using an EXCC device. The primary end point was freedom from late complications (composite outcomes of aneurysm-related death, reinterventions, and aneurysm sac enlargement of >5 mm after 30 postoperative days). Secondary end points included intraoperative major adverse events, intraoperative endoleaks, perioperative outcomes, postoperative endoleaks, and aneurysm size.

RESULTS

The EXTREME registry consisted of 215 patients, of whom 109 were included in the angulated neck group (angulation >60°) and 106 in the nonangulated group (angulation ≤60°) according to the proximal neck (infrarenal) angulation. Technical success rates were 93.5% and 94.3% (P = .81), the incidence of type Ia endoleak at final aortogram was 5.5% and 1.8% (P = .16), and the incidence of major adverse events was 1.8% and 0.9% (P = .54) in the angulated and nonangulated groups, respectively. On postoperative (in-hospital) computed tomography examination, the incidence of type Ia endoleak was higher in the angulated group (3.6%) than in the nonangulated group (0%; P = .12). The mean follow-up period was 404 ± 190 days. Freedom from reintervention rates were 98.9% and 96.6% in the angulated group and 99.0% and 95.7% in the nonangulated group at 6 and 12 postoperative months, respectively (log-rank P = .99). Freedom from late complications rates were 99.0% and 96.6% in the angulated group and 99.0% and 95.8% in the nonangulated group at 6 and 12 postoperative months, respectively (log-rank P = .63).

CONCLUSIONS

Our multicenter study demonstrated the safety and efficacy of the EXCC device in patients with an angulated proximal neck (angle >60°), with low rates of type Ia endoleak. Long-term follow-up is required to understand the true efficacy of the EXCC device in challenging neck anatomy.