Occurrence and Classification of Proximal Type I Endoleaks After EndoVascular Aneurysm Sealing Using the Nellix™ Device

Abstract

Objective/Background: Plaque protrusion through stent struts represents one of the principal causes of cerebral embolisation during carotid artery stenting (CAS) and the stent healing period. The aim of this study was to evaluate the safety (technical success) and efficacy (clinical success) of the CGuard stent system e a new nitinol stent covered by a closed-cell polyethylene terephthalate mesh designed to prevent embolic events.Methods: Eighty-two consecutive patients who underwent CAS with CGuard from June 2015 were included in this study. The same surgeon performed all procedures. Primary endpoints included technical and clinical success. Clinical success was considered to be absence of death, major or minor stroke. The incidence of new ischaemic brain lesions was also evaluated by diffusion weighted magnetic resonance imaging (DW-MRI) in a subgroup of patients as a secondary endpoint.Results: In this study, 82 patients (73.8 6 8.5 years, 75% male, 19% symptomatic) underwent CAS procedures. Immediate technical success was 100%, with the stenosis diameter reduced from 81.4 6 4.9% to 11.0 6 3.5%. There was peri-operative technical and clinical success in 100% of symptomatic patients, and in 98.5% of asymptomatic patients, because of the occurrence of one acute stent thrombosis 4 hours post-CAS followed by a minor stroke. In the post-operative period (30 days), no new events were registered. The most recent 21 patients (24%) underwent DW-MRI in the peri-operative period: new ischaemic brain lesions were recorded in 23.8% of patients and the average lesion volume per patients was 0.039 6 0.025 cm 3 .Conclusions: The technical and clinical outcomes of this single centre study suggest that the CGuard may be a safe and effective device for endovascular treatment of symptomatic and asymptomatic subjects, independent of aortic arch anatomy. Further larger comparative studies are needed to confirm these benefits.

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

“…A retrospective 3D analysis of CT was performed to ensure all endoleaks were detected; the results were discussed with the research group, which enabled scoring of the endoleaks according to a new classification that is not yet in common practice. 26 In accordance with previous EVAS studies, type Ia was the predominant type of endoleak, while other types were extremely rare. This may be due to the fact that the endobags completely fill the aneurysm, reducing the risk of a type II endoleak, which is the most prevalent endoleak after EVAR.…”

Migration After Endovasclar Aneurysm Sealing in Conjunction With Chimney Grafts

“… a Number of new cases are reported in brackets and percentages in parentheses. b Endoleak was classified according to van den Ham et al 21 c One patient had a 1S1 endoleak at 30 days that progressed into a 1S3 at 6 months; this is counted as a 1S3 endoleak overall. d All in 1 patient. e One of the cases with stenosis occluded later and is classified as occlusion. f Both these cases had a prior complication (1 stenosis and 1 fracture) with the chimney stent-graft that progressed into occlusion. …”

“…The term "assisted technical success" was applied to cases in which unplanned endovascular or surgical procedures were required to successfully exclude the aneurysm during the index chEVAS procedure. 20 Endoleaks were defined according to the Society for Vascular Surgery reporting standards of vascular surgery, 19 and type Ia endoleaks were defined as specified by van den Ham et al 21 Type 1S1 endoleak is the appearance of contrast between the endobag and the wall of the proximal neck but not reaching the aneurysm sac itself. In a type 1S2 endoleak, the contrast reaches the aneurysm wall and extends into the aneurysm sac.…”

Status of Endovascular Aneurysm Sealing After 5 Years of Commercial Use

“…In a recent multicenter review of Nellix experience involving a large cohort of 1851 patients with a mean follow-up <1 year, a 3.1% incidence of post-EVAS type Ia endoleak was found, of which 1.5% occurred within 30 days. 19 The majority (84%) of these patients with a type Ia endoleak were treated outside the original IFU and 96% outside the refined IFU. Low stent positioning was the most likely cause of the endoleak in 44.6% and the combination of a hostile anatomy and low positioning in another 33.9%, again emphasizing the importance of both patient selection and procedural technique.…”