Preliminary Dual-Center Experience with the Bolton Treovance Endograft.
Thind A., Sarma D., Allouni AK., Abdallah F., Murray D., Thind K., Darby C., Handa A., Sideso E., Patel R., Bratby M., Uberoi R.
PURPOSE: To present the performance and safety of the Treovance stent graft for endovascular aortic aneurysm repair in a "real-world" patient cohort. METHODS: Patients from 2 centers, deemed unfit for open repair, were electively treated with the Treovance endograft. Clinical preoperative, operative, and up to 1-year postoperative follow-up data of patients were retrospectively analyzed. RESULTS: This study included 46 patients with abdominal aortic aneurysm (44 male), mean age of 78 years ± 8 standard deviation (SD; range: 58-93 years). All met the manufacturer's recommended anatomical requirements: average maximum sac diameter 63 mm ± 10 SD (range: 52-86 mm), proximal neck length 29 mm ± 12 SD (range: 11-60 mm), and neck angulation 30° ± 21 SD (range: 0°-70°). Fourteen had moderate to severe iliac tortuosity. A primary technical success rate of 80% was achieved (100% assisted primary technical success rate): 7 patients required adjunctive procedures intraoperatively and 2 successful treatments for type I endoleaks, which occurred within 24 hours postoperatively. There was 100% survival at 1-year follow-up; however, 4 (8.7%) patients required reintervention: 1 for a type I endoleak, 2 for limb stenosis, and 1 for a type II endoleak with an enlarging sac. No other device-related complications were identified. Reintervention and complication rates in hostile versus nonhostile anatomies were not statistically significant ( P = .28 and P = .42, respectively). CONCLUSION: The Treovance stent graft has a comparable safety profile to other next-generation stent grafts during the first year after endovascular aneurysm repair, which provides a rationale for further interrogation of its outcomes through clinical trials.