Elsevier

Journal of Vascular Surgery

Volume 42, Issue 3, September 2005, Pages 392-401
Journal of Vascular Surgery

Clinical research study
Mid- and long-term device migration after endovascular abdominal aortic aneurysm repair: A comparison of AneuRx and Zenith endografts

Presented at the Twenty-Ninth Annual Meeting of the Southern Association for Vascular Surgery, Marco Island, Florida, Jan 19-22, 2005.
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Background

Freedom from migration is key to the durability of endovascular aneurysm repair (EVAR). This study evaluates the mid- and long-term incidence of migration with two different endografts.

Methods

Between September 1997 and June 2004, 235 patients were scheduled for EVAR with an AneuRx (Medtronic/AVE Inc.) or Zenith (Cook) endograft. Patients with fusiform, infrarenal aneurysms and a minimum 12 months of follow-up were analyzed, for a final cohort of 130 patients. Migration was assessed on axial computed tomography (CT) (2.5 to 3 mm cuts) as the distance from the most caudal renal artery to the first slice containing endograft (AneuRx) or to the top of the bare suprarenal stent (Zenith). Aortic neck diameters were measured at the most caudal renal artery. The initial postoperative CT scan was the baseline. Migration was defined by caudal movement of the endograft at two thresholds, ≥5 mm and ≥10 mm, or any migration with a related clinical event.

Results

Life-table analysis demonstrated AneuRx freedom from migration (≥10 mm or clinical event) was 96.1%, 89.5%, 78.0%, and 72.0% at 1, 2, 3, and 4 years, respectively. Zenith freedom from migration was 100%, 97.6%, 97.6%, and 97.6% at 1, 2, 3, and 4 years, respectively (P = .01, log-rank test). The stricter 5-mm migration threshold found 67.4% of AneuRx and 90.1% of Zenith patients free from migration at 4 years of follow-up. Twelve out of 14 (85.7%) AneuRx patients (12/14) with migration (≥10 mm or clinical event) underwent 14 related secondary procedures (13 endovascular, 1 open conversion). The single Zenith patient with migration (≥10 mm) has not required adjuvant treatment. Mean follow-up was 39.0 ± 2.3 months (AneuRx) and 30.8 ± 1.9 months (Zenith, P = .01). Patients with and without migration did not differ in age, gender ratio, aneurysm diameter, and neck diameter. However, initial neck length was shorter in patients with migration (22.1 ± 2.1 mm vs 31.2 ± 1.2 mm, P = .02). A subset of patients (21.6%) experienced significant (defined as ≥3 mm) maximum aortic neck dilation. Of the AneuRx patients, ≥3 mm aortic neck dilation affected 30.8% of migrators vs 13.0% of nonmigrators (P = .20).

Conclusions

Endograft migration is a time-dependent phenomenon affected by both device choice and aortic neck length. A great majority of patients (85.7%) with migration of the AneuRx device ultimately required treatment. A minority of patients experienced aortic neck dilation that could be considered clinically significant. Careful surveillance for migration is an essential component of long-term follow-up after EVAR.

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Competition of interest: Dr Sternbergh and Dr Money have been paid consultants for Medtronic/AVE and Cook Endovascular. Medtronic/AVE and Cook have also provided research support to administer US Food and Drug Administration trials of their endografts.