Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study

Gossetti, Bruno; Martinelli, Ombretta; Ferri, Michelangelo; Silingardi, Roberto; Verzini, Fabio; Angiletta, Domenico; Apostoulo, Dimitri; Bellandi, Guido; Berchiolli, Raffaella; Ficarelli, Roberta; Frigatti, Paolo; Galzerano, G; Garriboli, Luca; Giudice, Rocco; Grossi, Raimondo; Ippoliti, Arnaldo; Jannello, Antonio Maria; Barbera, Gaetano La; Lauricella, Antonio; Maioli, Fabiola; Mansour, Wassim; Marconi, Michele; Novali, Claudio; Parlani, Gianbattista; Pratesi, Giovanni; Pulli, Raffaele; Scrivere, Paola; Setacci, Carlo; Speziale, Francesco; Talarico, Francesco; Taurino, Maurizio; Viazzo, Andrea

doi:10.1016/j.jvs.2017.09.032

Cited by 39 publications

(47 citation statements)

References 15 publications

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“…The overall 8.9% mortality in this study is in accord with previous research (0.7%–9.5% 8 , 11 – 17 ) despite a longer follow-up. One patient died due to multiorgan failure after undergoing a conversion to open repair for an aortoenteric fistula, which is an interesting complication of EVAS.…”

Section: Discussionsupporting

confidence: 92%

“… 8 The EVAS device consists of dual balloon-expandable stent-grafts surrounded by endobags that are filled in situ with polymer to achieve seal and anatomical fixation. 9 , 10 Since its launch in 2013, the Nellix device has shown a high aneurysm exclusion rate and a low frequency of complications, 8 , 11 – 17 but concerns exist as regards migration and endoleak in the long term.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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Purpose: To analyze the 2-year outcomes of endovascular aneurysm sealing (EVAS) according to 2 versions of the instructions for use (IFU). Methods: A retrospective study was conducted involving 355 consecutive patients treated with the first-generation EVAS device from April 2013 to December 31, 2015, at 3 high-volume centers. Out of 355 patients treated with EVAS, 264 were elective asymptomatic infrarenal EVAS procedures suitable for analysis. In this cohort, 168 (63.3%) patients were treated within the IFU 2013 criteria; of these 48 (18.2%) were in compliance with the revised IFU 2016 version. Results: Overall technical success was 98.2% (165/168) in the IFU 2013 group and 97.9% (47/48) in the IFU 2016 subgroup (p=0.428). The 2-year freedom from reintervention estimates were 89.7% (IFU 2013) and 95.7% (IFU 2016), with significantly more reinterventions in the first 45 cases (p=0.005). The stenosis/occlusion estimates were 6.5% (IFU 2013) and 4.2% (IFU 2016; p=0.705). Nine (5.4%) endoleaks (8 type Ia and 1 type Ib) were observed within the IFU 2013 cohort; 3 (2.1%) were in the IFU 2016 subgroup (p=0.583). Migration ≥10 mm or ≥5 mm requiring intervention was reported in 12 (7.1%) patients in the IFU 2013 cohort but none within the IFU 2016 subgroup. Ten (6.0%) patients demonstrated aneurysm growth in the IFU 2013 cohort, of which 2 (4.2%) were in the IFU 2016 subgroup. Overall survival and freedom from aneurysm-related death estimates at 2 years were 90.9% and 97.6% in the IFU 2013 cohort (IFU 2016: 95.5% and 100.0%). The prevalence of complications seemed lower within IFU 2016 without significant differences. Conclusion: This study shows acceptable 2-year results of EVAS used within the IFU, without significant differences between the 2 IFU versions, though longer follow-up is indicated. The refined IFU significantly reduced the applicability of the technique.

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Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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“…9 Consistently with these data, the Italian IRENE retrospective observational study reported a freedom from aneurysm-related reintervention of 98.3% at 1 month and of 94.7% at 12 months of follow-up; the rates of early and late type IA endoleak were 0.3% and 1.4%, respectively and the reintervention incidence was 3.7%, that included 1.4% of surgical open conversions. 10 Although the low reported incidence of type 1A endoleak after Nellix EVAS, these endoleaks are one of the major concerns of EVAS because they are mostly high-pressure leaks and may lead to late rupture of aneurysms.…”

Section: Discussionmentioning

confidence: 99%

Nellix Endovascular Aortic Sealing Endoprosthesis Late Explantation for Concomitant Type I Endoleak and Stent Frames Proximal Caudal Migration

Martinelli

Fresilli

Irace

et al. 2019

Annals of Vascular Surgery

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Endovascular aneurysm sealing (EVAS) using the Nellix™ System was introduced in clinical practice with the aim of reducing the incidence of complications such as migration, endoleaks and reinterventions following conventional endovascular aneurysm repair (EVAR). Although, initial efficacy data on this device have been encouraging, EVAS has also demonstrated to undergo adverse events. Herein, we report a case of Nellix graft explant due to endobags shrinkage after bubbles air reabsorption leading to proximal type I A endoleak and stent migration. The focus of this article is on the importance of a more assiduous surveillance of this new device, in particular in those cases with air into the endobags immediately after the procedure; this surveillance should be aimed to timely identify complications which can otherwise lead to consequences that require open conversion.

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“…Early results appear to be promising but the ultimate role and value of this system are yet to be proven. 100,101 While a cut down is commonly required for the insertion of an endograft via the CFA, the feasibility of percutaneous EVAR has been reported with acceptable outcomes. 102 However, wound complication is a rare occurrence during EVAR.…”

Section: Infrarenal Abdominal Aortic Aneurysmmentioning

confidence: 99%

Endovascular Treatment of Various Aortic Pathologies: Review of the Latest Data and Technologies

2018

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The technologies and innovations applicable to endovascular treatment for complex aortic pathologies have progressed rapidly over the last two decades. Although the initial outcomes of an endovascular aortic repair have been excellent, as long-term data became available, complications including endoleaks, endograft migration, and endograft infection have become apparent and are of concern. Previously, the indication for endovascular therapy was restricted to descending thoracic aortic aneurysms and abdominal aortic aneurysms. However, its indication has expanded along with the improvement of techniques and devices, and currently, it has become possible to treat pararenal aortic aneurysms and Crawford type 4 thoracoabdominal aortic aneurysm (TAAA) using the off-the-shelf devices. Additionally, custom-made devices allow for the treatment of arch or more extensive TAAAs. Endovascular treatment is applied not only to aneurysms but also to acute/chronic dissections. However, long-term outcomes are still unclear. This article provides an overview of available devices and the results of endovascular treatment for various aortic pathologies.

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Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study

Cited by 39 publications

References 15 publications

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

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

Nellix Endovascular Aortic Sealing Endoprosthesis Late Explantation for Concomitant Type I Endoleak and Stent Frames Proximal Caudal Migration

Endovascular Treatment of Various Aortic Pathologies: Review of the Latest Data and Technologies

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