Review
The SILK flow diverter in the treatment of intracranial aneurysms

https://doi.org/10.1016/j.jocn.2013.07.006Get rights and content

Abstract

The SILK flow diverter (SFD; Balt Extrusion, Montmorency, France) is a flow diverting stent used in the endovascular treatment of intracranial aneurysms. It works on the principle of redirecting flow away from the aneurysm sac, leading to occlusion over time. We present a systematic review on the clinical outcomes and complications of the SFD. A literature search for English language articles were conducted on PubMed, Medline and EMBASE for articles on the treatment of intracranial aneurysms with the SILK flow diverter. The inclusion criteria were n > 10, use of SFD only, data on complications and aneurysm occlusion rate (AOR). Eight studies with 285 patients and 317 intracranial aneurysms were included. The mean age was 52.7 years and nearly 80% were women. In terms of angiographic distribution, 86.8% of aneurysms were located in the anterior circulation and 13.2% in the posterior circulation. As for the aneurysm size, 37.9% were classed as small, 44.4% as large and 17.7% as giant. Ischemic complications and parent artery occlusion each occurred in 10% of patients. Aneurysm rupture rate was 3.5%, while the cumulative mortality was 4.9%. The main outcome measure, 12 month AOR, was 81.8% with complete occlusion in 216 out of 264 aneurysms. Use of flow diverters for the treatment of intracranial aneurysm with complex morphologies has gained in popularity over the last few years. Our review suggests that SFD achieves comparable AOR to its contemporary, the Pipeline Embolization Device (ev3 Endovascular, Plymouth, MN, USA) but has a higher rate of higher rate of ischemic complications, aneurysm rupture and mortality.

Introduction

Endovascular treatment of intracranial aneurysms with complex morphology such as giant, wide-necked or fusiform aneurysms is challenging. Previously, the preferred option was stent assisted coiling, which is associated with a high recanalization rate. Introduction of flow diverter stents has provided a promising alternative option for the repair of such aneurysms [1], [2]. By reducing flow across the aneurysm neck, flow diverters lead to aneurysm thrombosis, and by promoting neo-intimal growth they cause parent vessel reconstruction [3], [4]. In 2007, the SILK flow-diverting stent (SFD; Balt Extrusion, Montmorency, France) became the first such flow diverter entering clinical use for intracranial circulation. The SILK is made of 48 braided Nitinol strands that offer a high-coverage mesh once expanded, and is available in different diameters (2–5 mm) and lengths (15–40 mm) [5]. The SFD kit includes a self-expanding stent and a reinforced catheter (Vasco 21; Balt Extrusion) for its delivery. A distinct advantage of this delivery system in contrast to other stents is that it allows resheathing and repositioning, even when up to 90% of it has been deployed [5].

While it has not yet received regulatory approval in the USA for monotherapy, it is widely used as a stand-alone treatment in Europe. Initial results with the SILK stent suggested a promising rate of aneurysm occlusion, morbidity and mortality [5], [6], [7], [8] but recent reports have highlighted a higher risk of thromboembolic complications and delayed aneurysm rupture, especially following treatment of giant aneurysms [9], [10]. To the best of our knowledge there is no comprehensive article exclusively on the clinical outcomes of SFD. We present a systematic review of the published literature to evaluate aneurysm occlusion rates, mortality and procedure-related complication rates for intracranial aneurysms treated with the SFD.

Section snippets

Search strategy

An English language literature search was performed on PubMed, Ovid Medline, Ovid EMBASE and Web of Science, from January 2005 to March 2013. A combination of the following keywords was used: “intracranial aneurysms”, “SILK flow diverter”, and “flow diverters”. The bibliographies of identified studies were searched for additional referenced studies, and this method was repeated until no further studies were found. The pre-specified inclusion criteria were n > 10 patients, SILK treatment without

Patient demographics

The search resulted in 109 articles of which a total of eight studies met the inclusion criteria. The patient demographics are listed in Table 1. We included 285 patients with 317 aneurysms. There were 224 female patients (78.6%, 95% confidence interval [CI]: 73.8–83.4%). The mean age was 52.7 years. One study failed to mention the mean age [11].

Aneurysm characteristics

We included a total of 317 aneurysms in this review, of which nearly 87% (n = 275, 95% CI: 83–90.5%) were found in the anterior circulation and the

Discussion

Our systematic review on SFD included a total of 285 patients with 317 aneurysms. The main outcome measure, 12 month AOR, was 81.8%. This is comparable to the AOR seen with the other flow diverter currently in clinical use, the Pipeline Embolization Device (PED; ev3 Endovascular, Plymouth, MN, USA). Our previous systematic review on PED showed a 6 month AOR of 79.7% [12], with progressive occlusion of the aneurysm to 81–84% by the end of 12 months [13], [14]. The AOR is conspicuously higher with

Conclusions

Flow diverters have added a new dimension to the treatment of intracranial aneurysms, ranging from the small, uncomplicated ones to the large, giant, wide-necked aneurysms. The current data suggest a distinctly higher AOR in comparison to other alternative endovascular treatment strategies. The SFD, despite offering >80% AOR, has a higher incidence of complications, particularly thromboembolic events and aneurysm rupture relative to PED. Randomized prospective trials are currently underway to

Conflicts of interest/disclosure

The authors declare that they have no financial or other conflicts of interest in relation to this research and its publication.

References (28)

  • S.B. Murthy

    Venkatasubba Rao CP, Bershad E, et al. Treatment of unruptured intracranial aneurysms with pipeline embolization device: a systematic review of literature

    J Clin Neurosci

    (2013)
  • G.K. Wong et al.

    Flow diverters for treatment of intracranial aneurysms: current status and ongoing clinical trials

    J Clin Neurosci

    (2011)
  • I. Szikora et al.

    Treatment of intracranial aneurysms by functional reconstruction of the parent artery: the Budapest experience with the pipeline embolization device

    AJNR

    (2010)
  • P. Lylyk et al.

    Curative endovascular reconstruction of cerebral aneurysms with the pipeline embolization device: the Buenos Aires experience

    Neurosurgery

    (2009)
  • G. Canton et al.

    Flow changes caused by the sequential placement of stents across the neck of sidewall cerebral aneurysms

    J Neurosurg

    (2005)
  • D. Lopes et al.

    Histological postmortem study of an internal carotid artery aneurysm treated with the Neuroform stent

    Neurosurgery

    (2005)
  • S. Maimon et al.

    Treatment of intra-cranial aneurysms with the SILK flow diverter: 2 years’ experience with 28 patients at a single center

    Acta Neurochir

    (2012)
  • O.I. Tahtinen et al.

    The silk flow-diverting stent in the endovascular treatment of complex intracranial aneurysms: technical aspects and midterm results in 24 consecutive patients

    Neurosurgery

    (2012)
  • J.J. Shankar et al.

    SILK flow diverter for treatment of intracranial aneurysms: initial experience and cost analysis

    J Neurointerv Surg

    (2013)
  • M. Velioglu et al.

    Early and midterm results of complex cerebral aneurysms treated with Silk stent

    Neuroradiology

    (2012)
  • B. Turowski et al.

    Early fatal hemorrhage after endovascular cerebral aneurysm treatment with a flow diverter (SILK-Stent): do we need to rethink our concepts?

    Neuroradiology

    (2011)
  • Largen E. Urgent field safety notice. Montmorency, France: BALT Extrusion; 2010. Available from:...
  • M. Leonardi et al.

    Treatment of intracranial aneurysms using flow-diverting silk stents (BALT): a single centre experience

    Interv Neuroradiol

    (2011)
  • S.C. Yu et al.

    Intracranial aneurysms: midterm outcome of pipeline embolization device–a prospective study in 143 patients with 178 aneurysms

    Radiology

    (2012)
  • Cited by (45)

    • The DERIVO Embolization Device in the Treatment of Intracranial Aneurysms: Short- and Midterm Results

      2016, World Neurosurgery
      Citation Excerpt :

      They suggested that the usage of FDs in the posterior system should be reserved for patients who could not be treated with other surgical techniques, such as deconstructive surgery, including parent artery occlusion with flow reversal.14 Murthy et al.33 reviewed 8 studies with 285 patients and 317 intracranial aneurysms. Ischemic complications and parent artery occlusion each occurred in 10% of the patients.

    • Relationships and redundancies of selected hemodynamic and structural parameters for characterizing virtual treatment of cerebral aneurysms with flow diverter devices

      2016, Journal of Biomechanics
      Citation Excerpt :

      Endovascular treatment utilizing flow diverting devices (FDD) has recently been introduced for cerebral aneurysms (Arrese et al., 2013; Berge et al., 2012; De Vries et al., 2013; Gory et al., 2014; Murthy et al., 2014; Puffer et al., 2014; Takemoto et al., 2014; Zhou et al., 2014).

    View all citing articles on Scopus
    View full text