Midterm Outcomes of the Nellix Endovascular Aneurysm Sealing System

Silingardi, Roberto; Coppi, Giovanni; Ferrero, Emanuele; Lauricella, Antonio; Psacharopulo, Daniele; Saitta, Giuseppe; Viazzo, Andrea; Ferri, Michelangelo

doi:10.1177/1526602816656355

Cited by 22 publications

(37 citation statements)

References 15 publications

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“…Technical success was reported by 13 studies (1,233 patients) 8–15,17–21. The technical success rate ranged from 98% to 100%.…”

Section: Resultsmentioning

confidence: 99%

“…All 14 articles were single-arm observational studies and were published after 2011. 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.…”

Section: Resultsmentioning

confidence: 99%

“…The fluoroscopy time ranged from 8 to 33 minutes across 6 studies (717 patients) 8,9,11,13,16,17. The weighted mean was 17±12 minutes.…”

Section: Resultsmentioning

confidence: 99%

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

Choo

Hajibandeh

Antoniou

2019

MDER

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Background The Nellix endovascular aneurysm sealing (EVAS) system is a novel approach for the treatment of abdominal aortic aneurysm (AAA). We aimed to evaluate the efficacy of EVAS in the management of patients with AAA. Materials and methods We searched PubMed/MEDLINE, CINAHL, and bibliographic reference lists to identify studies reporting clinical outcomes in patients with asymptomatic, non-ruptured AAA treated with EVAS with the Nellix device. We pooled dichotomous outcome data using random-effects models. Results We identified 14 single-arm observational studies, reporting a total of 1,510 patients. The pooled estimate of technical success was 99% (95% CI =98–100; heterogeneity: P =0.869, I 2 =0%). Adjunctive procedures were carried out in 39% (95% CI =19–63; heterogeneity: P <0.0001, I 2 =88%). Two cases of aneurysm rupture were reported within 30 days of treatment (0.7%, 95% CI =0.3–1.6; heterogeneity: P =0.923, I 2 =0%) and another five cases of rupture occurred during follow-up (0.8%, 95% CI =0.4–1.6; heterogeneity: P =0.958, I 2 =0%). The pooled estimates of early (within 30 days) and late (during follow-up) type I endoleak were 2.8 % (95% CI =1.8–4.2; heterogeneity: P =0.254, I 2 =18%) and 1.9% (95% CI =1.3–2.8; heterogeneity: P =0.887, I 2 =0%), respectively. Sac enlargement was noted in 3.1% (95% CI =1.8–5.4; heterogeneity: P =0.419, I 2 =0%) and device migration in 2.1% (95% CI =0.8–5.3; heterogeneity: P =0.004, I 2 =65%). The early and late reintervention rates were 2.7% (95% CI =1.7–4.2; heterogeneity: P =0.183, I 2 =27%) and 3.5% (95% CI =2.3–5.5; heterogeneity: P =0.061, I 2 =42%), respectively. The pooled estimate of 30-day mortality was 1.5% (95% CI =0.9–2.6; heterogeneity: P =0.559, I 2 =0%) and the pooled estimate of aneurysm-related death during follow-up was 1.0% (95% CI =0.6–1.9; heterogeneity: P =0.872, I 2 =0%). Conclusion Reported outcomes of EVAS are acceptable. Type I endoleak, sac enlargement, device migration, and aneurysm rupture are recognized complications. High-level research is required to investigate potential advantages of EVAS over conventional treatments. ...

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“…Technical success was reported by 13 studies (1,233 patients) 8–15,17–21. The technical success rate ranged from 98% to 100%.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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

Choo

Hajibandeh

Antoniou

2019

MDER

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“…12 Endovascular aneurysm sealing (EVAS) is a welldescribed technique to treat aortic aneurysms using the Nellix EVAS system (Endologix Inc, Irvine, CA, USA). 13,14 Nellix consists of 2 balloon-expandable chromium-cobalt stents surrounded by polytetrafluoroethylene endobags that are filled with biocompatible polymer to seal proximally and distally and also occupy the aneurysm flow lumen. This mechanism vs the circumferential radial force of a conventional aortic stent-graft makes EVAS appropriate for treating paravisceral aneurysms.…”

Section: Introductionmentioning

confidence: 99%

Anatomical Applicability of Endovascular Aneurysm Sealing Techniques in a Consecutive Cohort of Fenestrated Endovascular Aneurysm Repairs

et al. 2017

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“…The 1-year estimates for freedom from secondary intervention and from any endoleak were 92% and 95%, respectively. Silingardi et al 4 concurrently reported the first midterm outcomes of 65 EVAS patients treated at 2 centers; their estimated 18-month freedom from secondary interventions was 95%.…”

Section: Introductionmentioning

confidence: 99%

Feasibility and Technical Aspects of Proximal Nellix-in-Nellix Extension for Late Caudal Endograft Migration

et al. 2016

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Purpose: To describe the feasibility and technical aspects of a proximal Nellix-in-Nellix extension to treat caudal stentgraft migration after endovascular aneurysm sealing (EVAS) in the in vitro and in vivo settings. Methods: In vitro studies were designed (1) to assess inner diameters of Nellix-in-Nellix extensions after postdilation with 12-mm balloons and (2) to test wall apposition in tubes with different diameters using a Nellix-in-Nellix stent-graft that extended out of the original Nellix stent-graft lumen by 10, 20, 30, and 40 mm. Simulated-use experiments were performed using silicone models in conjunction with a pulsatile flow pump. In the clinical setting, 5 patients (median age 74 years, range 73-83) presented at 2 centers with type Ia endoleak secondary to caudal Nellix stent-graft migration measuring a median 9 mm (range 7-15) on the left and 7 mm (range 0-11) on the right. Median polymer fill volume at the initial EVAS procedure was 42.5 mL (range 25-71). The median time to reintervention with a proximal Nellix extension was 15 months (range 13-32). Results: In vitro, the inner diameters of the Nellix-in-Nellix extensions were consistent after postdilation. Cases with 10 and 20 mm of exposed endobag resulted in a poor seal with endoleak, while cases with 30 and 40 mm of exposed endobag length exhibited angiographic seal. Fill line pressures of the second Nellix were higher than expected. In the 5 clinical cases, chimney grafts were required in each case to create an adequate proximal landing zone. The Nellix-in-Nellix procedure was successful in all patients. There were no procedure-related complications, and no endoleaks were observed during a median 12-month follow-up. Reinterventions were performed in 2 patients because of in-stent stenosis and chimney graft compression, respectively. Conclusion: Proximal Nellix-in-Nellix extension can be used to treat caudally migrated Nellix stent-grafts and to treat the consequent type Ia endoleak, but the technique differs from primary EVAS. The development of dedicated proximal extensions is desirable.

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Midterm Outcomes of the Nellix Endovascular Aneurysm Sealing System

Cited by 22 publications

References 15 publications

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

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

Anatomical Applicability of Endovascular Aneurysm Sealing Techniques in a Consecutive Cohort of Fenestrated Endovascular Aneurysm Repairs

Feasibility and Technical Aspects of Proximal Nellix-in-Nellix Extension for Late Caudal Endograft Migration

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