Three-dimensional analysis of enlarging aneurysms after endovascular abdominal aortic aneurysm repair in the Gore Excluder Pivotal clinical trial.

OBJECTIVE: Recent reports have raised concern about the percentage of enlarging abdominal aortic aneurysms (AAAs) after endovascular repair with the Gore Excluder device. As part of the investigation into this issue, a morphologic analysis was performed on enlarging aneurysms in the Excluder Pivotal clinical trial.
METHODS: Computed tomographic scans were evaluated on all patients identified with enlarging aneurysms (5-mm increase by Core laboratory or site) and at least 4 years of follow-up in the Excluder Pivotal clinical trial. Three-dimensional reconstruction, a set of 24 standard morphologic measurements, and analysis of potential enlargement mechanisms were performed.
RESULTS: Of 112 trial patients with 4 years of follow-up, 38 AAAs (34%) were identified as enlarging. Data were obtained from 196 computed tomographic scans (the mean interval was 47 months from first to last scan). Of the 158 scans with a prior scan for comparison, 41% demonstrated growth relative to the initial scan by diameter criteria, but 79% demonstrated growth relative to the initial scan by 3-dimensional volume criteria (P < .0001 vs diameter; chi2 analysis). This difference was most evident at early time points: at 1 year, diameter criteria indicated that 8% of these AAAs were enlarging, but 56% were already enlarging by volume criteria. On average, enlargement was detected by volume 18 months before it was detected by diameter (P < .0001), and at a smaller diameter (55 +/- 1 mm vs 60 +/- 1 mm; P < .0001). Only 19% of scans (39% of patients) had apparent endoleaks. Scans with apparent endoleaks demonstrated a greater interval rate of growth as compared with those without apparent endoleak (3.6 +/- 0.8 mm vs 1.9 +/- 0.3 mm [P < .02] by diameter; 23 +/- 4 cm3 vs 11 +/- 1 cm3 [P < .001] by volume). Although the etiology of enlargement may be endotension or device permeability in up to 74% of patients, other potential causes of aneurysm enlargement included neck apposition length less than 15 mm (15 patients; 39%), large aortic diameter relative to device (18%), large iliac diameter (5%), and iliac apposition length less than 15 mm (20%). Multiple potential etiologies of enlargement were present in 53% of AAAs.
CONCLUSIONS: The etiology of aneurysm enlargement in the Excluder Pivotal trial is likely multifactorial, including endoleak, inadequate attachment site length, and endotension or device permeability. Even by conservative criteria, a substantial percentage of aneurysm growth with the original device is likely due to material permeability. Three-dimensional volume criteria detected aneurysm enlargement more frequently, at a smaller diameter, and on average 18 months sooner than standard diameter criteria, thus suggesting a role in further investigation of this issue.