Influence of the Revised Nellix Instructions for Use on Outcomes After Endovascular Aneurysm Sealing

Zerwes, Sebastian; Bruijnen, H.; Goßlau, Yvonne; Jakob, Rudolf; Hyhlik‐Dürr, A.

doi:10.1177/1526602818781353

Cited by 21 publications

(32 citation statements)

References 25 publications

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“…It is important to bear in mind that the number of patients treated within the revised IFU was small (18.4%) as the majority of infrarenal cases were undertaken before the IFU revision. This observation reflects that reported in another large series by Zerwes et al 18 Compliance with the original (2013) IFU did show significantly lower incidence of type IA endoleak, ARM, and ACM.…”

Section: Discussionsupporting

confidence: 90%

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Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

Stenson

Bruin

Loftus

et al. 2020

Journal of Vascular Surgery

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Background: Endovascular aneurysm sealing (EVAS) is a disruptive technology to treat abdominal aortic aneurysm (AAA). The use of sac filling rather than endograft fixation was designed to treat aortic aneurysms in a wide range of morphologic appearances and to reduce endoleaks. There are few data reporting outcomes beyond postoperative follow-up. This study reports outcomes up to 5 years for Nellix (Endologix, Irvine, Calif) EVAS. Methods: Data were prospectively collected for EVAS patients from the time of adoption of EVAS in 2013. All patients treated with the Nellix device are included in this study, and as such, it reports on infrarenal, ruptured, and iliac aneurysms as well as the Nellix-in-Nellix application. Juxtarenal and suprarenal aneurysms were treated using the EVAS system with parallel grafts into the visceral vessels and are included. Therapeutic failure, a composite outcome of migration, sac expansion >5 mm, type Ia and type Ib endoleak, and secondary aortic rupture, was the primary outcome along with all-cause mortality, aneurysm-related mortality, and reintervention rates. Results: There were 295 EVAS cases undertaken between March 2013 and July 2018. Indications for treatment were infrarenal (n ¼ 185), juxtarenal and suprarenal (n ¼ 73), ruptured (n ¼ 18), and iliac (n ¼ 13) aneurysms. There were 15 reinterventions using the Nellix-in-Nellix application. In some cases, EVAS was used to salvage failing endovascular or open aneurysm repairs. Median follow-up was 2.42 years (interquartile range, 1.07-3.57 years). Therapeutic failure was observed in 98 of the 295 cases (33.2%) overall and exceeded 50% in some subgroups. In 71 cases (24.1%), reintervention was performed, with reasons for no reintervention being mainly physiologic. Complications leading to therapeutic failure were most commonly seen beyond 2 years of follow-up. There were 15 secondary ruptures (5.36%), and 9 EVAS devices required explantation either electively or for aortic rupture. Conclusions: EVAS with the Nellix device has not met expectations, and early encouraging results have been eroded. The incidence of therapeutic failure has been high, occurring 2 years and beyond after implantation. The Nellix system has been voluntarily recalled by Endologix, and the CE mark has subsequently been suspended. The adoption of EVAS as a disruptive technology highlights the need for cautious adoption of novel technologies and the strict governance around such arrangements.

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Section: Discussionsupporting

confidence: 90%

“…There are few published data reporting outcomes with respect to the revised IFU; however, it is apparent that the morphologic applicability was significantly reduced. 18 This study reports the midterm outcomes of a large cohort of patients having undergone EVAS at a single large-volume aortic center.…”

mentioning

confidence: 99%

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

Stenson

Bruin

Loftus

et al. 2020

Journal of Vascular Surgery

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“…In the current study, preoperative aortic neck diameter, neck length, and diameter ratio were preoperative predictors of migration, any endoleak, and aneurysm growth after EVAS. Moreover, despite IFU refinement, more than a quarter of patients had complications over time, an observation similar to that recently reported by Zerwes et al 8 Previous studies 9,10 demonstrated caudal and lateral displacement of the EVAS endosystem, which might be due to the instability of intraluminal thrombus within the aneurysm sac. A larger ratio between the maximum AAA and lumen diameters might reflect the potential for this instability to adversely affect the endobags and stent frames, especially in patients with large sac thrombus volumes.…”

Section: Discussionsupporting

confidence: 83%

Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing

et al. 2018

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To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

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“…127 Indeed, anatomical constraints limit its applicability and outsideof-instructions for use greatly increases the risk of device failure. 128,129 Thus, improvements in the technique and longer follow-up are necessary before it can be implemented on a large scale and its adoption with the sole purpose of reducing the rate of T2EL is not justified by current evidence. 130 Also, whether the best stent graft to prevent T2EL would combine the polymer sacs from Nellix with a conventional stent graft that uses self-expanding covered stents that generate radial force for adequate proximal sealing remains a topic to investigate.…”

Section: Preventionmentioning

confidence: 99%

Natural History, Diagnosis, and Management of Type II Endoleaks after Endovascular Aortic Repair: Review and Update

D’Oria

Mastrorilli

Ziani

2020

Annals of Vascular Surgery

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Influence of the Revised Nellix Instructions for Use on Outcomes After Endovascular Aneurysm Sealing

Abstract: The IFU 2016 reduced the anatomic applicability to 34% from 75% for the original IFU 2013. The lack of significant intergroup differences in terms of survival and reinterventions suggests a limited effectiveness of the new IFU 2016.

Cited by 21 publications

References 25 publications

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing

Natural History, Diagnosis, and Management of Type II Endoleaks after Endovascular Aortic Repair: Review and Update

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