The next generation of fenestrated endografts: results of a clinical trial to support an expanded indication for aortic arch aneurysm treatment.

OBJECTIVES Short- and mid-term data regarding the use of precurved, fenestrated endografts have shown that these devices are both safe and effective in carefully selected patients. The first generation of the product was limited to patients with proximal landing zones (LZs) of >20 mm. The next generation of these endografts has been refined to enable the treatment of patients with shorter proximal seal zones (<20 mm), using smaller fenestrations and a greater diversity of skeletons. We reviewed the clinical studies involving the next-generation product and analysed the morphological characteristics of aortic arch aneurysms that were successfully treated. METHODS Next-generation endografts were used to treat 393 patients with aortic arch aneurysms at 35 medical institutions during 2010 and 2011. There were 371 (94%) patients with sealing zones <20 mm and 244 (62%) with sealing zones <15 mm. The proximal sealing length was 2-35 (14.2 ± 5.1) mm. RESULTS Technical success was achieved in 390 (99.2%) patients. Of the treated patient population, 6 patients died, 7 experienced strokes and 17 were subsequently identified to have Type I endoleaks. In cases with proximal LZs <15 mm, the aneurysm was more likely to develop an endoleak. The proximal sealing zones (11 ± 12 vs 9 ± 13 mm) were not significantly associated with the development of endoleaks, but the proximal aortic diameters were (34.0 ± 13.3 vs 36.6 ± 6.3 mm; P < 0.01), in the univariate analysis. In the discriminant analysis, the maximum length of the aneurysm was the only factor that was predictive of Type I endoleaks (73 ± 55 vs 97 ± 59 mm; P < 0.001). CONCLUSIONS The next generation of precurved, fenestrated endografts shows promise as devices for aortic arch aneurysms with a <15-mm proximal sealing zone. These devices have a significant advantage in cases where the LZ has a short neck. However, more refinement is necessary to prevent Type I endoleaks, so that these devices can be used with aortic vessels with large proximal diameters and large aneurysms.