Embolisation of a Proximal Type I Endoleak Post-Nellix Aortic Aneurysm Repair Complicated by Reflux of Onyx into the Nellix Endograft Limb

Ameli-Renani, Seyed; Das, Raj; Weller, Alex; Chung, Raymond; Morgan, Robert

doi:10.1007/s00270-014-1044-5

Cited by 15 publications

(15 citation statements)

References 11 publications

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“…6,7 The results of this treatment were reportedly successful in the short-and midterm, but again long-term data are crucial to defining whether this treatment is effective in preventing aortic rupture. The importance of treating type I endoleaks after EVAS appears to be the same as after EVAR, with patients in the present series presenting with untreated type I endoleaks and aortic rupture.…”

Section: Discussionmentioning

confidence: 99%

“…One type Ia endoleak resolved spontaneously, and 4 were treated by transcatheter coil embolization and/or liquid embolic agents. 6,7 All of the type II endoleaks were small volume (between 0.1 and 0.3 mL), and 4 resolved spontaneously. The single persisting type II endoleak remained unchanged at latest follow-up, with no sac expansion or associated clinical sequelae.…”

Section: Endoleakmentioning

confidence: 99%

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Endovascular Aneurysm Sealing

et al. 2016

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Purpose: To report the early and 12-month results of a global registry of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic aneurysms (AAAs). Methods: The EVAS FORWARD Global Registry was a postmarket, multicenter, open-label, single-arm registry that enrolled 277 patients (mean age 75 years; 228 men) treated with the Nellix EVAS system for nonruptured AAAs at 18 sites over a 1-year period. The cohort had challenging aortic anatomy, with 17% having a proximal aortic neck length <10 mm, 8% a neck angulation >60°, and 20% an iliac diameter >25 mm. Baseline and follow-up computed tomography images were assessed by an independent core laboratory, and major adverse events were reviewed by an independent safety committee. Results: Three patients died within 30 days of the procedure (none device-related). There were 13 endoleaks recorded in this time frame: 8 type Ia, 1 type Ib, and 5 type II. Root cause analysis demonstrated that the majority of type Ia endoleaks were due to technical error (low device placement and underfilling of the endobags). Between 30 days and 1 year, there were 4 new type Ia endoleaks; all were treated. There was also 1 type III endoleak between a Nellix device and a distal extension limb. At 1 year, the persistent endoleak rate was 0.7% (1 type Ia and 1 type II). The Kaplan-Meier estimates of freedom from types I and II endoleak at 12-month follow-up were 96% and 98%, respectively. The estimate of freedom from open conversion (n=7) was 98% at 12 months and the rate of freedom from any reintervention was 92%. The need for secondary intervention was associated with aortic morphology; for patients meeting the requirements of the instructions for use (IFU), the freedom from reintervention at 12 months was 98% compared with 86% when the implant was outside the IFU (p=0.009). At 1 year, the estimates of freedom from aortic-related and all-cause mortality were 98% and 95%, respectively. Conclusion: The EVAS FORWARD Global Registry documents the 12-month outcome of EVAS in an unselected group of patients with challenging aortic morphology. The results at present appear acceptable with regard to perioperative outcomes and complications. The type II endoleak rate is low. The place of EVAS in the armamentarium of techniques to treat AAAs will be defined by durability data in the longer term.

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Section: Discussionmentioning

confidence: 99%

Section: Endoleakmentioning

confidence: 99%

Endovascular Aneurysm Sealing

et al. 2016

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“…6,7 Taking into account the likely underlying pathogenesis of type I endoleaks, namely, low stent-graft deployment, this approach seems questionable, since it fixes only the symptoms and not the pathology apparently responsible for it. In the abovementioned scenarios, we prefer the Nellix-in-Nellix application (NINA) to liquidate the endoleak.…”

Section: 3mentioning

confidence: 99%

Seduction and Its Impact on Instructions for Use

Zerwes

2016

J Endovasc Ther

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CommentaryIn the October 2016 issue of the JEVT, Thompson et al 1 report the early and midterm results of the EVAS FORWARD Global Registry. In this multicenter experience, 277 patients were treated with the Nellix Endovascular Aneurysm Sealing System (Endologix Inc, Irvine, CA, USA). The authors observed a persistent endoleak rate of 0.7% (1 type Ia and 1 type II) at 1 year, with freedom from types I and II endoleaks of 96.3% and 98.2%, respectively. Those results are particularly interesting as the registry contained an anatomically more challenging cohort compared to the GREAT and ENGAGE registries. 2,3What attracts even more attention, though, is a closer look at the percentages of patients treated beyond the instructions for use (IFU). In that regard, both the GREAT and the ENGAGE registries share similar numbers of patients (17% and 18%, respectively) treated beyond the IFU. In the EVAS FORWARD registry, however, close to 37% of patients were treated beyond the IFU, more than double the rates of GREAT and ENGAGE. This finding leads to an obvious question: Why is it that Nellix was implanted so many times beyond the IFU? Shouldn't one be extremely cautious with a new stent-graft that is still lacking long-term results? Even more so, given the fact that said stent-graft employs a quite different method of excluding the aneurysm?The answer appears to be seduction. The "sealing the entire aneurysm" idea of the Nellix system quite simply represents a very seductive concept that seems to lure vascular surgeons to go beyond the IFU. 4 Little to no neck? Angulated necks? Large necks? Large concomitant iliac artery aneurysms? All not a problem, the endobags will take care of it. Add the "one size fits all" component (after all, the only alternating variables are stent length and polymer amount with its associated pressure), and the sky seems the limit.This is precisely what happened in our service when we started using Nellix 3 years ago. 5 We thought we could treat anybody and any given anatomy. After well over 200 cases, we are now beyond the initial "honeymoon phase" of a new relationship and have dropped our rose-colored glasses. The reality is that just like with any other (new) stent-graft, preoperative planning and careful operative execution are key.At the beginning, too little attention was paid to proximal neck length, resulting in either landing too low, giving away precious proximal landing zone, or implanting Nellix in <10-mm proximal necks; we now take a very close look at the proximal neck. As suggested by Thompson and colleagues 1 after analyzing the type Ia endoleaks in the EVAS FORWARD registry, technical errors, such as low landing, seem to be responsible, an observation with which we agree. Hence, in order to avoid type Ia endoleak, it appears to be important to land as closely as possible to the renal arteries. We believe that this is likely to result in a different scenario of flow dynamics, potentially lowering the pressure burden exerted by the pulse wave onto the endobags. In necks <10 mm an...

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“…The incidence and significance of EL1a following Nellix EVAS is unknown with only a handful of cases reported [3][4][5]. Proximal perigraft endoleak is not uncommon following conventional EVAR occurring in up to 10 % of cases [6], and usually mandates early secondary intervention as the blood flow outside of the endograft lumen is associated with increased sac pressurisation (endotension) and a risk of rupture [7].…”

Section: Discussionmentioning

confidence: 96%

“…E Onyx injected into the interstices between the coils to provide complete occlusion of the endoleak cavity. F Completion angiography shows no residual endoleak published as a case report [3]. A smaller reflux of Onyx into the right Nellix limb was observed at completion of embolisation in another case (patient 4).…”

Section: Procedural Outcomementioning

confidence: 90%