Endoluminal stent grafting of the thoracic aorta: Initial experience with the Gore Excluder

Purpose: The purpose of this study was to describe our experience with endoluminal graft repair of a variety of thoracic aorta pathologies with a commercially developed device currently under investigation. Our patient population included patients eligible for open surgical repair and those with prohibitive surgical risk. Methods: From February 2000 to February 2001, endovascular stent-graft repair of the thoracic aorta was performed in 46 patients (mean age, 70 years; 29 male and 17 female patients) with the Gore Excluder. Twenty-three patients (50%) had atherosclerotic aneurysms, 14 patients (30%) had dissections, three patients (7%) had aortobronchial fistulas, three patients (7%) had pseudoaneurysms, two patients (4%) had traumatic ruptures, and one patient (2%) had a ruptured aortic ulcer. Patient characteristics, procedural variables, outcome, and complications were recorded. All patients were followed with chest computed tomographic scans at 1, 3, 6, and 12 months. Follow-up period ranged from 1 month to 15 months, with a mean of 8.5 months. Results: All the procedures were technically successful. There were no conversions. Average duration of the procedure was 120 minutes. Average length of stay was 6 days, but most patients (64%) left the hospital within 4 days after endoluminal grafting. The overall morbidity rate was 23%. Two patients (4%) had endoleaks that necessitated a second procedure for successful repair. Two patients (4%) died in the immediate postoperative period. There were no cases of paraplegia. At follow-up examination, one patient had an endoleak found the day after the procedure and another patient had an endoleak 6 months after the procedure. Both cases were treated successfully with additional stent-grafts. There were no cases of migration. One patient died of a myocardial infarction 6 months after graft placement. In patients treated for aneurysm (n = 23), the aneurysm diameter ranged from 5.0 to 9.5 cm (mean, 6.8 cm). Residual sac measurements were obtained at 1, 6, and 12 months, with mean sac reductions of 0.59 cm, 0.77 cm, and 0.85 cm, respectively. In three cases, the sac remained unchanged, without evidence of endoleak. Conclusion: Thoracic endoluminal grafting with the Gore Excluder is a safe and feasible alternative to open graft repair and can be performed successfully with good results. Early data suggest an endoluminal approach to these disease entities may be favorable over classical resection and graft replacement.