Outcome of Nellix-EVAS: single center mid-term results

Abstract

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. Technical success rate was 100% and there were no short-term vascular complications. One patient died from urosepsis 14 days after the procedure and was excluded from further analysis. A total of 6 out of 9 patients (67%) experienced device complications such as proximal graft kinking, limb separation or caudal migration. 5 also showed type Ia endoleak. Discussion: While no complication occurred short-term (up to 12 months), the Nellix system showed a high percentage of limb separation, caudal graft migration, and type Ia endoleak on mid-term follow-up, likely due to insufficient proximal anchoring of the device. Possible salvage treatments are discussed.

Progressive Device Failure at Long Term Follow Up of the Nellix EndoVascular Aneurysm Sealing (EVAS) System

“…Adherence to the original or the revised IFU did not appear to have an impact on propensity of device failure and these findings are corroborated by other centres. 16,17 At four years, 100% of Nellix patients are at risk of AAA growth associated with stent migration regardless of IFU adherence. 18 Alongside an enhanced surveillance programme, the authors suggest the following for management of failing Nellix EVAS:…”

A Meta-Analysis of Mid-Term Outcomes of Endovascular Aneurysm Sealing

“…After exclusion of articles whose titles had no relevance to the topic or that were subsequent publications from the same institution, the full texts of 22 articles were retrieved and assessed for eligibility. 4,11–31 One article was excluded as not having detailed outcome data. 19 Nine studies were excluded as a significant overlap with later studies from the same centers was evident.…”

“…Two studies (285 patients) compared the adherence of the patients treated within the 2013 and 2016 IFU. 11,12 Compliance with the 2013 IFU was observed in 58.2% (166/285) of the patients treated by EVAS, whereas compliance with the 2016 IFU was evident in only 23.9% (68/285) of the same cohort. The weighted mean maximum aneurysm diameter was 58.5mm.…”

Duodenal Obstruction in a Patient Previously Treated With EndoVascular Aneurysm Sealing System Repair

“…22 The standard endograft concept of EVAR, with proximal and distal fixation and sealing, is nonetheless associated with a non-negligible risk of endoleak occurrence, most commonly type I and II, with the consequent necessity of secondary re-interventions. 23,24 EVAS, specifically developed to avoid this kind of endoleak, 25 was introduced in 2013 with the aim of reducing the incidence of re-interventions observed after conventional endovascular AAA repair. 26 This system involves a paired balloonexpandable endograft supported by polymer-filled endobags to achieve anatomic fixation, as well as a paraprosthetic seal.…”