| Literature DB >> 30834934 |
Adam A Dmytriw1,2, Mohamed M Salem2, Victor X D Yang1, Timo Krings1, Vitor M Pereira1, Justin M Moore2, Ajith J Thomas2.
Abstract
Flow modification has caused a paradigm shift in the management of intracranial aneurysms. Since the FDA approval of the Pipeline Embolization Device (Medtronic, Dublin, Ireland) in 2011, it has grown to become the modality of choice for a range of carefully selected lesions, previously not amenable to conventional endovascular techniques. While the vast majority of flow-diverting stents operate from within the parent artery (ie, endoluminal stents), providing a scaffold for endothelial cells growth at the aneurysmal neck while inducing intra-aneurysmal thrombosis, a smaller subset of endosaccular flow disruptors act from within the lesions themselves. To date, these devices have been used mostly in Europe, while only utilized on a trial basis in North America. To the best of our knowledge, there has been no dedicated review of these devices. We therefore sought to present a comprehensive review of currently available endosaccular flow disruptors along with high-resolution schematics, presented with up-to-date available literature discussing their technical indications, procedural safety, and reported outcomes. © Congress of Neurological Surgeons 2019.Entities:
Keywords: Aneurysm; Embolization; Endosaccular device; Endovascular; Flow disruption
Year: 2020 PMID: 30834934 PMCID: PMC7239377 DOI: 10.1093/neuros/nyz017
Source DB: PubMed Journal: Neurosurgery ISSN: 0148-396X Impact factor: 4.654
FIGURE 1.Woven EndoBridge (WEB; Microvention) device with A, deployed view, and B, overhead view showing lowest porosity in highest-flow areas. The device is delivered with the C, proprietary VIA catheter, which possesses internal coils for stability and a Polytetrafluoroethylene liner. The D, high-density braiding has conceived for both neck and dome sealing.
Main Features of Intrasaccular Flow-Disrupting Devices
| Device | Dimensions, mm | Structure | Coverage[ | Porosity, % | Pore size μm | Deployment | Resheathable | Comments |
|---|---|---|---|---|---|---|---|---|
| WEB | Diameter 3–11 Height 2–9 | Available in 2 configurations (SL, SLS), both with EV | 60 | Not reported | Not reported | Electrothermal detachment; delivered via a ≥0.17-inch microcatheter | Yes, completely | Proximal and distal radiopaque markers |
| Medina | Not reported | 3D coil with “petal” filamentsb | Not reported | Not reported | Not reported | Mechanical detachment | Yes, completely | Hybrid flow disruption device and detachable coil with filaments that have shape memory |
| Artisse (LUNA) | Not reported | Not reported | Not reported | Not reported | Not reported | Mechanical detachment | Not reported | Oval shape designed to treat small aneurysms |
| Contour | Not reported | Dual-layer radiopaque shape-memory mesh | Not reported | Not reported | Not reported | Electrolytical detachment | Yes, completely | Flat disc which after deployment, assumes a tulip-like configuration |
| Cerus Intrasaccular Stent | Not reported | Dual-layer radiopaque shape-memory mesh | Not reported | Not reported | Not reported | Electrolytical detachment | Yes, completely | Can be coiled through per operator preference |
EV, enhanced visualization; SL, single layer (standard; barrel shaped); SLS, single layer sphere; WEB, Woven EndoBridge.
At aneurysm outflow.
Available in framing and filling styles (filler softer and designed to fill internal space after framing device has been deployed to provide a suitable basket).
Outcomes From Key Trials of Intrasaccular Flow-Disrupting Devices
| Device | Study | Description | Patients, N | Aneurysms, N | Indication(s) | Occlusion rate, % | Morbidity, % | Mortality, % |
|---|---|---|---|---|---|---|---|---|
| WEB | Pierot et al[ | WEBCAST: prospective, multicenter, European trial of WEB DL | 51 | 51 | Predominantly unruptured, wide-neck (≥4 mm); bifurcation aneurysms, mean neck diameter 5.6 mm | 56.1a(6 mo) | 2.0 (1 mo) | 0 (1 mo) |
| Pierot et al[ | French observatory: prospective, multicenter, French GCP study of WEB-DL (30 patients/31 aneurysms) and WEB SL/SLS (32 patients with 32 aneurysms) | 62 | 63 | Predominantly unruptured, wide-neck (≥4 mm) bifurcation aneurysms | 51.7b (1 yr) | 3.2 (1 mo) | 0 (1 mo) | |
| Pierot et al[ | WEBCAST 2: prospective, multicenter, European Registry study of WEB SL/SLS and EV | 55 | 55 | Predominantly unruptured, wide-neck (≥4 mm) bifurcation aneurysms, mean neck diameter 4.6 mm | 54.0 | 1.8 (1 mo) | 0 (1 mo) | |
| Papagiannaki et al[ | Retrospective, multicenter, French cohort study of WEB DL | 83 | 85 | Predominantly unruptured, wide-neck (>4 mm) aneurysms, mean neck diameter 5.6 mm | 56.9 (mean follow-up, 5.3 mo)c | 1.3 | 0 | |
| Clajus et al[ | Retrospective, single-center cohort study of WEB DL (49 devices), WEB SL (44 devices), and WEB SLS (17 devices) | 108 | 114d | Predominantly wide-neck (dome:neck <2 or neck ≥4 mm), anterior aneurysms, 47 patients with SAH | 57.8 (mean follow-up, 13.4 mo)e | 5.3f | 8.5f | |
| Mine et al[ | Retrospective, multicenter cohort study of WEB DL | 48 | 49 | Predominantly unruptured, wide-neck, mostly MCA bifurcation aneurysms, mean neck diameter 4.9 mm | 74.3g (12 mo)72i (mean follow-up, 39 mo) | 6.2h | 0 | |
| Caroff et al[ | Retrospective, multicenter, European cohort study of WEB SL | 90 | 98 | Predominantly wide-neck, bifurcation aneurysms, 66% unruptured, mean neck 5.2 mm, including 11 patients requiring planned or unplanned additional treatment | 65j (average follow-up, 3.3 mo) | 2.2k (average follow-up, 3.8 mo) | 1.1k (average follow-up, 3.8 mo) | |
| Lawson et al[ | Retrospective, multicenter, UK registry safety study | 109 | 109 | Predominantly unruptured, wide-neck, saccular aneurysms, 45% bifurcation, mean neck diameter 6.18 mm | – | 0 | 0 | |
| Popielski et al[ | Retrospective, 2-center, European cohort study of WEB SL and WEB SLS | 101 | 102 | Predominantly wide-neck and fundus width between 3 and 10 mm MCA and anterior communicating aneurysm (AComA) aneurysms, 63.7% unruptured, median neck diameter 4.6 mm | 80.7% (3 mo)l77.6% (12 mo)m | 4 | 1 | |
| van Rooij et al[ | Retrospective, single-center European cohort | 100 | 100 | Predominantly wide-neck (66% ≥4 mm) AComA (44%) and posterior communicating aneurysm (22%) aneurysms, all ruptured | 96% (at 3 mo)n | 3 | 1 | |
| van Rooij et al[ | Retrospective, single-center European cohort | 40 | 46 | Predominantly ruptured (54%) very small AcomA and MCA aneurysms (height/dome ratio ≤0.5) | 72% (at 3 mo)o | 4 | 1 | |
| Medina | Sourour et al[ | Retrospective, single-center cohort study | 12 | 13 | Predominantly unruptured, wide-neck (dome:neck <2 or neck diameter ≥4 mm) aneurysms | 83p (mean follow-up, 5.2 mo) | 0? | 0? |
| Aguilar Perez et al[ | Retrospective, single-center cohort study | 15 | 16 | Predominantly unruptured aneurysms with a fundus diameter ≥5 mm | 81q (mean follow-up, 1.7 mo) | 0? | 0? | |
| Bhogal et. al[ | Retrospective, single-center cohort study | 13 | 14 | Predominantly unruptured spherical or ovoid aneurysms >5 mm | 71r (mean follow-up, 3.2 mo) | 23 | 0 | |
| Artisse (LUNA) | Piotin et al[ | Prospective, multicenter European cohort | 63 | 64 | Predominantly unruptured bifurcation or terminal aneurysms, mean neck diameter 3.8 mm | 78.0%s (12 mo)79.2%t (36 mo) | 0 (12 mo)1.6 (36 mo) | 1.6 |
EV, enhanced visualization; MCA, middle cerebral artery; SAH, subarachnoid hemorrhage; SL, single layer (standard; barrel shaped); SLS, single layer sphere; WEB, Woven EndoBridge; WEBCAST, WEB Clinical Assessment of Intrasaccular Aneurysm Therapy.
aForty-one patients (29.3% had neck remnants).
bFifty-eight patients (27.6% had neck remnants).
cSixty-five aneurysms (35.4% had neck remnants).
dOne hundred ten devices successfully deployed.
eNinety aneurysms (17.8% neck remnants).
fNinety-four patients.
gThirty-five aneurysms (including 2 retreated).
hForty-eight patients.
iTwenty-five aneurysms (including 2 retreated).
jSixty-nine patients.
kFifty-two patients.
lSeventy-eight patients.
mForty-nine patients.
nSeventy-four patients (23% had neck remnants).
oThirty-nine aneurysms (23% had neck remnants).
pThirteen aneurysms.
qEleven aneurysms (45% had neck remnants).
rFourteen aneurysms (45% had neck remnants).
sFifty-nine patients.
tFifty-three patients.
FIGURE 2.The Medina (Medtronic) device forms A, a mesh scaffold of nitinol-platinum petals at the aneurysm neck by B, self-orienting along the axis of the core wire, whereas Artisse (Medtronic) deploys as a semi-fixed construct which may be C, flared or D, spheroid in nature.
FIGURE 3.A–C, Contour acts as both a neck and intrasaccular flow disruptor, the former of which is designed to promote neointimal growth without an intraluminal stabilizing component, and which D, aligns to the equatorial plane of the aneurysm.
FIGURE 4.Cerus Intrasaccular Stent A–C, is designed to treat a wider range of aneurysm morphologies, requiring only neck sizing without a proprietary cathether. With a smaller intrasaccular profile, it permits D, adjunctive same-session coiling.