Influence of endograft oversizing on device migration, endoleak, aneurysm shrinkage, and aortic neck dilation: Results from the Zenith multicenter trial

Background: Generous endograft oversizing has been associated with propensity for aortic neck dilation and subsequent device migration in endografts without suprarenal fixation. Effects of variable oversizing of endografts with suprarenal fixation have been poorly studied. Methods: Three hundred fifty-one patients underwent endovascular AAA repair (EVAR) in a prospective multicenter trial using the Zenith AAA Endovascular Graft, a fully supported bifurcated 3-piece endograft with barb-enhanced suprarenal stent fixation. Blinded core-laboratory measurement of variables was prospectively recorded at predischarge and at 1, 6, 12, and 24 months after the procedure. Potential influence of endograft oversizing on subsequent aortic neck dilation (minor axis), aneurysm shrinkage (major axis), device migration, endoleak, rupture, open conversion, and death were retrospectively studied. Data are given as mean +/- SEM. Results: Risk of endograft migration (>5mm) at 12 months was 2.3% (6/261). However, patients with endograft versizing of >30% had a 14% (4/29) migration risk compared with those oversized less than or equal to30% (0.9%, 2/232), P < .002. There was zero device migration by the SVS definition (>10 mm or clinical event). Device oversizing >30% was associated with decreased AAA sac shrinkage (48% vs 77%) and with increased sac enlargement (9.5% vs 0.6%) at 24 months when compared with oversizing of less than or equal to30%, respectively (P = .001). Incidence rate of any endoleak at 12 and 24 months was 8.2% (21/256) and 7.1% (12/169), respectively. Oversizing of endografts by >30% was associated with an increased type 11 endoleak rate (11 vs 4.7%) that failed to reach statistical significance (P = .27). Aortic neck diameters increased significantly by 6 months (P < .001) but then stabilized through 24 months; the absolute changes at 1 (n = 298), 6 (n = 278), 12 (n = 264), and 24 months (n = 171) were 0.66 ± 0.10 mm (3.0%), 1.32 ± 0.11 mm (5.6%), 1.38 ± 0.12 nun (5.9%), and 1.44 ± 0.16 mm (6.1%), respectively. Linear regression analysis demonstrated no correlation between endograft oversizing and aortic neck dilation at 12 (P = .86) or 24 months (P = .64). Conclusions: Device migration and endoleaks were very infrequent after treatment with the Zenith AAA Endovascular Graft. However, endograft oversizing of >30% was associated with an similar to14-fold increase in device migration (>5 mm) at 12 months and with a similar to16-fold increased risk of AAA expansion at 24 months. Although further follow-up will be essential to assess whether these early associations continue, avoidance of excessive endograft oversizing is recommended.