Multicenter Nellix EndoVascular Aneurysm Sealing system experience in aneurysm sac sealing

Böckler, Dittmar; Holden, Andrew; Thompson, Matt; Hayes, Paul D.; Krieviņš, Dainis; Vries, Jean‐Paul P.M. de; Reijnen, Michel M.P.J.

doi:10.1016/j.jvs.2015.03.031

Cited by 125 publications

(125 citation statements)

References 33 publications

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“…Böckler and colleagues, in a recent multicentre case series analysis, reported type 1a, type 1b and type II endoleaks in a small number of patients [3]. Authors in the same publication documented the need for aneurysm-related interventions in 15 patients (9%) but there was an absence of any aneurysm ruptures or open surgical conversions.…”

Section: Introductionmentioning

confidence: 99%

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Migration of the Nellix endoprosthesis

England

Torella

Fisher

et al. 2016

Journal of Vascular Surgery

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PURPOSE: To report the incidence and sequelae of migration of the Nellix® endoprothesis following endovascular aneurysm sealing (EVAS).METHOD: A review was performed of the follow-up imaging of all EVAS patients in a University Hospital endovascular programme who had a minimum follow-up of one year. Using the first post-operative and latest follow-up CT scans, the distances between the proximal and distal borders of the stent-grafts relative to reference vessels were measured using a previously validated technique. Device migration was based on previously established criteria and defined as any stent-graft movement of ≥ 4 mm related to a predefined reference vessel. Device movement in a caudal direction was given a positive value (+) whereas movement in a cranial direction was denoted by a negative sign (-).RESULTS: 18 patients (35 stent-grafts) were eligible for inclusion in this retrospective review.The mean (SD; range) pre-operative AAA diameter and aortic neck length were 57 (5; 50 to 67) mm and 30 (16; 6 to 62) mm, respectively. Proximal migration, according to study definitions, was identified in six stent-grafts (17%), all in a caudal direction. At one year the mean (SD; range) proximal migration distance was +6.6 (1.6; +4.7 to +9.2) mm. Migration occurred in a single stent-graft in four patients and bilaterally in one. Distally, there were no cases of migration.CONCLUSIONS: Proximal migration of the Nellix® endoprosthesis does occur and in our series was without any sequelae. Further investigations into the long-term positional stability of the Nellix® device are required together with a more thorough understanding of the aetiology and consequences of migration.

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Section: Introductionmentioning

confidence: 99%

“…The Nellix® endoprosthesis (Endologix Inc, Irvine, California, USA) has been used to treat numerous patients with abdominal aortic aneurysms (AAA) [1][2][3]. The use of a sac-anchoring endograft such as the Nellix® has brought a change in the approach to aneurysm exclusion.…”

Section: Introductionmentioning

confidence: 99%

Migration of the Nellix endoprosthesis

England

Torella

Fisher

et al. 2016

Journal of Vascular Surgery

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“…In recent years, a novel technique, the endovascular aneurysm sealing (EVAS) technique, has emerged in an attempt to circumvent the afore-mentioned long-term deficiencies of EVAR, in particular migration and endoleak [3]. Even though EVAS applies the same procedural principle for the treatment of abdominal aortic aneurysms as EVAR, e.g.…”

Section: Introductionmentioning

confidence: 99%

Nellix stent graft migration after endovascular aneurysm sealing

Antoniou

Bashaeb

Ibrahim

2016

Vasa

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“…Böckler et al 2 reported similar good results of EVAS in a multicenter experience, including some patients from SGVI. Mortality was zero out of 171 patients, technical success was 99%.…”

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confidence: 76%

Commentary on ‘Endovascular Aneurysm Sealing for Infrarenal Abdominal Aortic Aneurysms: 30 Day Outcomes of 105 Patients in a Single Centre’

Koelemay

2015

European Journal of Vascular and Endovascular Surgery

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In this issue of the European Journal of Vascular and Endovascular Surgery, Brownrigg et al. 1 present a detailed analysis of 30 day outcome in 105 patients with an abdominal aortic aneurysm (AAA) treated by endovascular aneurysm sealing (EVAS). EVAS is a novel treatment concept for patients with an infrarenal AAA, and is aimed at reducing type II endoleaks and at expanding the options for endovascular repair in that it has been claimed to have the potential to treat more patients with unfriendly anatomy than other devices for EVAR. In this non-consecutive series of predominantly elective patients with 69% having adverse neck anatomy, technical success was achieved in 97%, with four patients having a proximal type I endoleak, which was resolved by Onyx and coil embolization. Thirty day mortality was 1%, one patient suddenly died 18 days post-operatively at home. These excellent results are a reflection of the St George's Vascular Institute's (SGVI) wide experience with AAA repair.In their paper, the authors share technical difficulties and complications that were encountered during their learning curve with the device. Of interest, some 62 (59%) of the patients had adjunctive iliac stenting, which seems to be a high proportion, and may have been triggered by the author's early experience. Three of the first 20 patients were treated post-operatively with additional stents because of >50% stenosis caused by inadequate stent dilatation or kinking. The operative technique was adapted by doing liberal pre-emptive stenting in order to avoid early stent occlusion. Another technical modification was to keep the balloons inflated during polymer curing. Finally, important lessons were learned from the occurrence of two iatrogenic ruptures in patients with narrow and calcified common iliac arteries, which were eventually resolved by insertion of covered stents.The current paper is the first of a series on early outcomes of EVAS that can be expected in the near future. Böckler et al. 2 reported similar good results of EVAS in a multicenter experience, including some patients from SGVI. Mortality was zero out of 171 patients, technical success was 99%. There were five type Ia and four type 1b endoleaks, and 11 (6%) patients had a re-intervention within 30 days, four for device occlusion. The early results of the EVAS Forward Registry (NCT02018744) with 300 patients and the EVAS Forward-IDE (investigational device exemption) in the United States (NCT01726257) with 179 patients are hopefully to be published shortly. It is important to realize that there will be some overlap in patients between the registries and reports of individual centers, and that results will be advertised as being achieved in real world patients. Yet, the results are a representation of real world patients treated in centers of excellence. Is the EVAS system going to change the practice of endovascular aneurysm repair? Although type II endoleaks occur in less than 1% of patients after EVAS, it is known that these have limited clinical significance in the ...

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Multicenter Nellix EndoVascular Aneurysm Sealing system experience in aneurysm sac sealing

Cited by 125 publications

References 33 publications

Migration of the Nellix endoprosthesis

Migration of the Nellix endoprosthesis

Nellix stent graft migration after endovascular aneurysm sealing

Commentary on ‘Endovascular Aneurysm Sealing for Infrarenal Abdominal Aortic Aneurysms: 30 Day Outcomes of 105 Patients in a Single Centre’

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