Two-Year Outcomes of the Nellix EndoVascular Aneurysm Sealing System for Treatment of Abdominal Aortic Aneurysms

Abstract

Purpose: To analyze the 2-year outcomes of endovascular aneurysm sealing (EVAS) according to 2 versions of the instructions for use (IFU). Methods: A retrospective study was conducted involving 355 consecutive patients treated with the first-generation EVAS device from April 2013 to December 31, 2015, at 3 high-volume centers. Out of 355 patients treated with EVAS, 264 were elective asymptomatic infrarenal EVAS procedures suitable for analysis. In this cohort, 168 (63.3%) patients were treated within the IFU 2013 criteria; of these 48 (18.2%) were in compliance with the revised IFU 2016 version. Results: Overall technical success was 98.2% (165/168) in the IFU 2013 group and 97.9% (47/48) in the IFU 2016 subgroup (p=0.428). The 2-year freedom from reintervention estimates were 89.7% (IFU 2013) and 95.7% (IFU 2016), with significantly more reinterventions in the first 45 cases (p=0.005). The stenosis/occlusion estimates were 6.5% (IFU 2013) and 4.2% (IFU 2016; p=0.705). Nine (5.4%) endoleaks (8 type Ia and 1 type Ib) were observed within the IFU 2013 cohort; 3 (2.1%) were in the IFU 2016 subgroup (p=0.583). Migration ≥10 mm or ≥5 mm requiring intervention was reported in 12 (7.1%) patients in the IFU 2013 cohort but none within the IFU 2016 subgroup. Ten (6.0%) patients demonstrated aneurysm growth in the IFU 2013 cohort, of which 2 (4.2%) were in the IFU 2016 subgroup. Overall survival and freedom from aneurysm-related death estimates at 2 years were 90.9% and 97.6% in the IFU 2013 cohort (IFU 2016: 95.5% and 100.0%). The prevalence of complications seemed lower within IFU 2016 without significant differences. Conclusion: This study shows acceptable 2-year results of EVAS used within the IFU, without significant differences between the 2 IFU versions, though longer follow-up is indicated. The refined IFU significantly reduced the applicability of the technique.

Natural History, Diagnosis, and Management of Type II Endoleaks after Endovascular Aortic Repair: Review and Update

“…128,129 Thus, improvements in the technique and longer follow-up are necessary before it can be implemented on a large scale and its adoption with the sole purpose of reducing the rate of T2EL is not justified by current evidence. 130 Also, whether the best stent graft to prevent T2EL would combine the polymer sacs from Nellix with a conventional stent graft that uses self-expanding covered stents that generate radial force for adequate proximal sealing remains a topic to investigate.…”

<p>The Nellix endovascular aneurysm sealing system: current perspectives</p>

“…The full texts of the remaining 38 articles were obtained and assessed for eligibility. Fourteen studies met the inclusion criteria of our study and were included in qualitative and quantitative synthesis 8–21…”

“…The recruitment period in all but one study was 1 year or more 17. Four studies10,12,13,16 reported 1-year outcomes, while the remaining studies reported longer follow-up outcomes 8,9,11,14,15,18–21. The weighted mean follow-up was 11.6±5.4 months.…”

Endovascular Aortic Aneurysm Repair in Patients with Aortoiliac Occlusive Disease

“…The Nellix Endovascular sealing system (Endologix, Irvine, California) is an investigational device that has a femoral access diameter requirement of at least 7-mm and involves injecting a biostable polyethylene glycol polymer into "endobags," which allow exclusion of the aneurysm and prevention of type 2 endoleaks [51]. It has been successfully used in unilateral and bilateral common iliac artery occlusive disease ranging from 70% stenosis to complete occlusion [52].…”