The morphological applicability of a novel endovascular aneurysm sealing (EVAS) system (Nellix) in patients with abdominal aortic aneurysms

摘要

Objective Endovascular aneurysm sealing (EVAS) using the Nellix system is a promising alternative to endovascular repair (EVR) and open surgery for abdominal aortic aneurysms (AAA). The aim of this study was to investigate the proportion of patients with AAA who are morphologically suitable for treatment with Nellix. Methods Patients presenting with AAA were investigated at two regionalised vascular units. Separate cohorts were identified, who had undergone infrarenal EVR, open aneurysm repair, fenestrated endovascular repair (FEVR) or non-operative management. Pre-operative morphology was quantified using three-dimensional computed tomography according to a validated protocol. Each aneurysm was assessed for compliance with the instructions for use (IFU) of Nellix Results 776 patients were identified with mean age 75 ± 9 years. 730/776 (94.1%) had undergone infrarenal EVR, 6/776 (0.8%) open repair, 27/776 (3.5%) FEVR and 13/776 (1.7%) had been managed non-operatively. 544/776 (70.1%) of all AAA were morphologically suitable for Nellix. 533/730 (73.0%) of patients who had undergone infrarenal EVR were compliant with Nellix IFU, compared with 497/730 (68.1%), 379/730 (51.9%) and 214/730 (29.3%) with the IFU for Medtronic Endurant (p =.04) or Cook Zenith (p <.01) and Gore C3 Excluder (p <.01) endografts respectively. Conclusions Nellix technology appears widely applicable to contemporary infrarenal AAA practice, and may provide an option for patients that are outside current EVR device instructions for use. However, formal outcomes study is still required, and will ultimately dictate the clinical relevance of this feasibility study. The major limitation to anatomic suitability for Nellix is currently the maximum patent lumen diameter of large AAA.