nellix

PURPOSE: The main objective of this work is to investigate hemodynamics phenomena occurring in EVAS (Endo Vascular Aneurysm Sealing), to understand if and how they could lead to type 1a endoleaks and following re-intervention. To this aim, methods based on computational fluid mechanics are implemented as a tool for checking the behavior of a specific EVAS configuration, starting from the post-operative conditions. Pressure and velocity fields are detailed and compared, for two configurations of the Nellix, one as attained after correct implantation and the other in pathological conditions, as a consequence of migration or dislocation of endobags...

OBJECTIVE: High rates of midterm failure of the Nellix EndoVascular Aneurysm Sealing (EVAS) System resulted in device withdrawal from the UK market. The study aim was to report long term Nellix EVAS outcomes and management of a failing device. METHODS: A retrospective review of EVAS procedures at a tertiary unit was performed. Device failure was defined as a triad of stent migration, stent separation, and secondary sac expansion, or any intervention for type 1 endoleak, device rupture, or explant...

BACKGROUND: Endovascular aneurysm sealing (EVAS) is an innovative alternative to conventional endovascular aneurysm repair (EVAR). EVAS relies on sac anchoring without proximal fixation to achieve sealing and should have allowed for the treatment of a broader range of anatomic features compared with standard EVAR. Despite the encouraging early reports, the mid- and long-term follow-up data have shown increased rates of failure. To address the issue, the manufacturer introduced revised instructions for use (IFU) in 2016...

Aims: We report the 6-year results of our use of the Nellix® endovascular aneurysm sealing system. Materials & methods: This is a retrospective review of patients we treated from 2013 to 2019. The outcomes described include technical success rate, mortality, all procedure-related complications, reinterventions, open surgical conversion and secondary sac rupture. Results & conclusions: A total of 68 patients were treated. Mortality was 2.9%. Secondary interventions were carried out for distal embolization (3), stent occlusion (1), pseudoaneurysm (1) and endoleak (5)...

PURPOSE: To evaluate the technical features and clinical results after open conversion for complications following endovascular aneurysm sealing (EVAS). MATERIALS AND METHODS: From July 2013 to February 2020, 44 patients (mean age 72±8 years; 36 men) underwent an open conversion due to EVAS complications in a single center. Data were collected on patient characteristics, reasons for conversion, characteristics and duration of the procedure, condition of the polymer, blood loss, time in the intensive care unit (ICU), and intra/postoperative complications...

The Nellix endovascular aneurysm sealing system (Endologix, Irvine, Calif) was presented as a novel concept in the treatment of abdominal aortic aneurysm. After numerous adverse events, the device was voluntarily withdrawn from the market by the manufacturer. This video describes the technical approach of a successful explantation of the Nellix endograft in a patient who underwent endovascular aneurysm sealing for abdominal aortic aneurysm.

OBJECTIVE: The aim of this study was to measure the incidence of post endovascular aneurysm sealing (EVAS) abdominal aortic aneurysm (AAA) growth, and its association with stent migration, in a cohort of patients with differing compliance to old and new Instructions For Use (IFU). METHODS: A retrospective single centre study was conducted to review the computed tomography (CT) and clinical data of elective, infrarenal EVAS cases, performed as a primary intervention, between December 2013 and March 2018...

INTRODUCTION: Over the years, endovascular aortic aneurysm repair (EVAR) has become the gold-standard of therapy for abdominal aortic aneurysm (AAA) repairs. This study aims to analyze the evolution of stent graft devices and discuss the future direction of technological development. MATERIALS AND METHODS: In this paper, we will review prior eras of graft development (1992 to 2019) that included physician-made devices (era one), industry-made devices (era two), branch devices (era three), and fenestrated devices (era four)...

OBJECTIVES: Endovascular aneurysm sealing (EVAS) was a widespread technology to treat abdominal aortic aneurysm (AAA). However, the particular morphology and structure of this Endoprosthesis predisposed to proximal sealing defects with a high rate of re-intervention or conversion to open surgery treatments. The purpose of this article is to report our experience on late open conversion of Nellix device, compared to previous reported experience. MATERIALS AND METHODS: Between September 2013 and February 2020, 8 late open surgical conversions for endoleak were performed in our center: four of these were for EVAR...

INTRODUCTION: Endovascular aneurysm sealing represents an alternative to advanced technology devices for compromised patients with abdominal aortic aneurysms. We report our results of 15 fragile patients with very low-quality infrarenal necks treated with endovascular aneurysm sealing. MATERIAL AND METHODS: All patients treated with Nellix device in our hospital between June 2015 and October 2016 were retrospectively reviewed. The primary endpoints are the following: overall survival and freedom from reintervention rates...

BACKGROUND: Postimplantation syndrome (PIS) is a systemic inflammatory response occurring in early phase after abdominal aortic aneurysm (AAA) endovascular repair (EVAR). PIS can also occur after endovascular aneurysm sealing (EVAS) with Nellix system which prevent new onset of mural thrombus inside. Aim was to compare the incidence of PIS after EVAS and EVAR in order to evaluate the possible role of the new-onset thrombus inside the aneurysmal sac. Secondary aims were to assess the effect of AFX (Endologix) endoskeleton compared with other commercially available exoskeleton PTFE stent grafts on inflammatory response and its relationship with the clinical outcomes...

Purpose: To investigate the physiological uptake of hybrid fluorine-18-fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) before and after an uncomplicated endovascular aneurysm sealing (EVAS) procedure as a possible tool to diagnose EVAS graft infection and differentiate from postimplantation syndrome. Materials and Methods: Eight consecutive male patients (median age 78 years) scheduled for elective EVAS were included in the prospective study ( ClinicalTrials.gov identifier NCT02349100)...

No abstract text is available yet for this article.

OBJECTIVE: Adverse outcomes observed late in the Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) investigational device exemption trial prompted refinement of the anatomic instructions for use (IFU). This study aimed to investigate the association of procedural factors during Nellix endograft deployment and patient outcomes. METHODS: We retrospectively reviewed 1-month imaging of 333 patients enrolled in the prospective, multicenter EVAS investigational device exemption trial between January 2014 and September 2016...

BACKGROUND: Endovascular aortic sealing (EVAS) using the Nellix system was a new approach to reduce the frequency of type II endoleaks after endovascular aortic repair. We analyzed the mid-term results, specifically looking at device migration, endoleaks and subsequent necessary secondary interventions. RESULTS: Ten patients underwent elective EVAS treatment during our study period. 7 patients were within the IFU while 3 patients had a proximal neck shorter than 10 mm...

No abstract text is available yet for this article.

A 66-year-old man arrived at our emergency department 3 years after an endovascular aneurysm sealing procedure performed at another center. Computed tomography angiography showed distal migration of a Nellix endoprosthesis (Endologix, Irvine, Calif) and a posterior contained rupture. The left kidney was excluded by an occluded iliac-left renal bypass, which was performed at the time of the Nellix implantation because of unintended coverage. A t-Branch (Cook Medical, Bloomington, Ind) was implanted in an emergency, but the delivery caused disruption of the Nellix limb, requiring relining...

BACKGROUND: Postimplantation syndrome (PIS) is a systemic inflammatory response occurring in an early phase after abdominal aortic aneurysm (AAA) endovascular aneurysm repair (EVAR). The pathophysiology underlying PIS is still not well understood. It is speculated that the type of the stent graft or the mural thrombus within the AAA may play a role in determining this inflammatory response. At present, there is no consensus about the influence of PIS on clinical outcomes during follow-up...

BACKGROUND: Endovascular aneurysm repair (EVAR) is the dominant treatment modality for abdominal aortic aneurysm (AAA). Periprocedural risks are low, and cardiovascular events are the principle determinants of long-term survival. Recently, the concept of endovascular aneurysm sealing (EVAS) has been introduced into clinical investigation. In previous cohort studies, EVAS has been associated with a lower all-cause mortality than expected despite device issues. We used a propensity weighted approach to investigate whether EVAS was associated with lower all-cause mortality after aneurysm repair...

OBJECTIVES: The implication of haemodynamics in the occurrence of complications after endovascular aneurysm repair (EVAR) has been raised in the literature. Different aortic stent graft configurations may lead to different haemodynamic properties. The current study deals with the post-operative haemodynamic variability between four stent graft systems with different structure, material, and type of fixation. METHODS: Computed tomography data of 32 patients were used, equally distributed among the four endograft groups, namely the AFX, Endurant, Excluder, and Nellix...