Midterm Outcomes of the Nellix Endovascular Aneurysm Sealing System

Roberto Silingardi,Giovanni Coppi,Daniele Psacharopulo,Michelangelo Ferri,Antonio Lauricella,Emanuele Ferrero,Andrea Viazzo,Giuseppe Saitta

doi:10.1177/1526602816656355

Abstract

Purpose: To report midterm outcomes of the Nellix Endovascular Aneurysm Sealing (EVAS) System in the treatment of abdominal aortic aneurysm (AAA). Methods: Between September 2013 and July 2014, 64 AAA patients (mean age 76.6±6.8 years; 61 men) were treated with the EVAS system at 2 centers (only procedures performed at least 12 months prior to the analysis were included). Most patients were treated for a stable AAA, while 1 patient was treated for a ruptured aneurysm. Mean aneurysm diameter was 57.3±9.3 mm. The proximal neck measured a mean 21.5±3.3 mm in diameter and 27.0±12.1 mm long; the neck angle was 16.9°±19.3°. Eleven (17.2%) patients were treated outside the instructions for use (IFU). Results: Technical success was achieved in 63 (98.4%) of 64 patients; 1 type Ia endoleak was treated intraoperatively. One (1.6%) aneurysm-related death occurred at 4 months due to a secondary aortoenteric fistula. Overall, endoleaks occurred in 3 (4.7%) patients (2 type Ia, 1 type II). The estimated rates for 18-month overall survival, freedom from aneurysm-related death, and freedom from secondary interventions were 92.7%, 98.4%, and 95.0%, respectively. Patients treated outside the IFU had a significantly higher incidence of device-related complications (p=0.03). Conclusion: The use of the Nellix device in everyday clinical practice is safe and offers promising midterm results. The risk of secondary aortoenteric fistula requires further analysis. Longer follow-up is needed to assess the actual efficacy of the device, although the risk of migration with late endoleak seems low.

Highlights

Endovascular aneurysm sealing (EVAS) using the Nellix device (Endologix Inc, Irvine, CA, USA) has been recently introduced for the treatment of abdominal aortic aneurysm (AAA), with promising results.[1,2] The different concept of EVAS seems to expand the possibilities of endovascular treatment of aortic aneurysm disease and reduce the risk of type II endoleaks after treatment.[1]
As the real-world use of this new device is expanding rapidly, we report the midterm outcome of a group of patients with >12 months’ follow-up treated at 2 vascular centers
At the beginning of the EVAS experience at both centers, patients were considered for EVAS if their anatomy complied with the instructions for use (IFU) and they were older than average AAA patients

Summary

Introduction

Endovascular aneurysm sealing (EVAS) using the Nellix device (Endologix Inc, Irvine, CA, USA) has been recently introduced for the treatment of abdominal aortic aneurysm (AAA), with promising results.[1,2] The different concept of EVAS seems to expand the possibilities of endovascular treatment of aortic aneurysm disease and reduce the risk of type II endoleaks after treatment.[1] Two clinical trials and one investigational device exemption (IDE) pivotal trial have been published[1,2,3] to test the efficacy and safety of the Nellix device. As the real-world use of this new device is expanding rapidly, we report the midterm outcome of a group of patients with >12 months’ follow-up treated at 2 vascular centers

Methods

Results

Conclusion