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The treatment of intracranial aneurysms has undergone precipitous expansion since the first detachable
coils were used less than two decades ago. With rapidly expanding technology comes the need to keep all
involved parties informed. The objective of our review is to provide a comprehensive, succinct overview of
novel paradigms and devices used to treat intracranial aneurysms. We have divided these new
technologies into: (1) coils, (2) flow diverters, (3) adjunctive balloon devices, and (4) stents.
Keywords: Intracranial aneurysm, Treatment, Coil, Flow diversion, Balloon, Stent
Figure 1 Classes of HydroCoil: (A) HydroCoil Embolic System; (B.) HydroSoft coil; (C) HydroFrame coil; (D) HydroFill coil.
difference between the two coils in average total coil be able to receive the benefits of hydrogel based
length per aneurysm, packing density, and length of embolization, but without the greater difficulty of use
hospital stay. The authors believed the mechanism that was associated with the first generation hydro-
for improved outcomes with the HydroSoft was due coil. Furthermore, one hopes that this benefit will
to coil expansion at the neck of the aneurysm, leading result in better clinical outcomes. However, much
to a reduced neck remnant and decreased chance of more research and clinical experience is needed before
recurrence. Further supporting its role as a final coil, any such conclusions can be made.
in a canine bifurcation aneurysm model, researchers
HydroFill
packed nine aneurysms with HydroCoils and finished
Thye HydroFill (Microvention Terumo, Aliso Viejo,
each with a HydroSoft. The aneurysm necks were
CA, USA) is the newest of the three hydrocoils. The
able to be packed with the HydroSoft coil, despite
device is similar to its ancestors, HydroSoft and
an average neck size of 7 mm. Furthermore, the
HydroFrame, in its platinum overcoil and hydrogel.
HydroSoft induced neointima formation at the
However, the HydroFill has a hydrogel core under-
aneurysm neck.24
neath a platinum overcoil, and the hydrogel core
In a larger, retrospective study across three centers,
swells through the platinum coil, causing aneurysmal
authors explored perioperative safety of the Hydrosoft
obstruction and subsequent obliteration, seen in
coil and its purpose as the finishing coil.23 In 141
Fig. 1D.
aneurysms, 79 (56%) were completely embolized, 40
Killer et al.26 compared the new HydroFill
(28%) had residual neck, 21 (15%) had residual dome,
technology to the older HydroSoft and platinum
and in one case, the Hydrosoft coil could not be
coils in a rabbit model. Despite reduced post-
deployed. Procedural morbidity and mortality was
treatment angiographic occlusion in the HydroFill
2.1% and 1.4%, respectively, and no complications
group compared to the HydroSoft and platinum coil
were directly attributed to the Hydrosfot coils. The
groups, the HydroFill group showed increased
incidence of aneurysmal rupture, cerebral hemor-
volumetric filling, higher rates of stable occlusion at
rhage, ischemic event, vasospasm, and hydrocephalus
follow-up, and increased rates of neointima and
were comparable to the contemporary literature.
thrombus formation. In a small series of 14 ruptured
Perhaps the best evidence to date is a prospective and unruptured human aneurysms, Speirs et al.27
multi-institutional series of 127 aneurysms in 120 reported their clinical experience with the HydroFill.
patients treated with HydroSoft coils has demon- Immediate angiographic occlusion was seen in 100%
strated good results. Immediately after coiling, Park of the cases, packing density ranged from 13% to
et al.25 reported 69% aneurysm occlusion, 20% 135%, and immediate complication rates were 1/11
residual neck, and 12% residual sac. Six out of 127 (9%). Long-term follow-up showed complete occlu-
patients (4.7%) had complications, including bleeding sion in 12/14 (86%) aneurysms. Due in large part to
and thromboembolism. At 6 months, the overall its recent development, little data exist about the
recanalization rate was 3/105 aneurysms (3%), with HydroFill.
two major and one minor recanalization. In conclusion with regards to hydrocoils, the
After a small number of preliminary studies, the prospective, randomized, international, multi-center
HydroSoft seems to perform better than traditional trial currently enrolling patients to evaluate hydrocoil
platinum coils with comparable rates of complica- efficacy and safety is called the hydrogel endovascular
tions to similar coils. Its use as a finishing coil gives aneurysm treatment (HEAT) Trial. The study’s goal
it a unique advantage when treating wide-necked is to test the effectiveness of hydrocoil embolization
aneurysms. system compared to the current standard bare
platinum coils. Two of the three hydrocoils men-
HydroFrame
tioned – hydrosoft and hydroframe – are being
The HydroFrame (Microvention Terumo, Aliso
evaluated in the study. There are over 29 centers
Viejo, CA, USA) is a framing hydrocoil used for
enrolling patients and the study is housed at
aneurysm embolization, shown in Fig. 1C. The
Northwestern University. The study began in 2011
delivery system is similar to a platinum coil with
and hopes to enroll approximately 600 patients.
simple coil detachment. Similar to other hydrocoils,
upon exposure to blood, the hydrogel core expands Versatile Range Fill Coils
and increases the diameter of the coil. The hope is to, Versatile range fill coils (Microvention, Tustin, CA,
by using a framing hydrocoil, place more hydrogel at USA) allow for a single coil to fill a range of
the neck. aneurysm diameters. Instead of stocking 18 different
By developing a less rigid, and less time-dependent coils for 3–20 mm aneurysms, VFC devices allow
framing coil that still includes the hydrogel technol- four coils to fulfill that 18 mm range: 3–6 mm, 6–
ogy, manufacturers believe that aneurysms will still 10 mm, 10–15 mm, and 15–20 mm.28 The coil is
Flow Diversion
Flow diversion represents a major paradigm shift
in the treatment of intracranial aneurysms. Flow
diverters alter flow dynamics within the aneurysm by
inducing thrombosis and occlusion within the aneur-
Figure 2 Alternate coils: (A) Versatile Range Fill Coils; (B) ysmal sac, while preserving physiologic flow in the
Penumbra 400. parent vessel.33,34 In a short period of time, the use of
flow diversion has increased rapidly, and in some
designed with complex loops, that provide stability, areas has drastically decreased the rates of coil and
and waves that allow for coil distribution and stent usage.33
increased packing density, as seen in Fig. 2A. Flow diversion arose from observations of flow
This technology has great tential to save costs and patterns in stented aneurysms, where flow was
minimize sizing difficulty, where several coils may be redirected away from the aneurysm and toward the
used to find the perfect fit. One of the primary parent artery. These tubular, braided metallic implants
criticisms of coil technology is the high inherent have shown the ability to completely occlude the
implant cost associated with its use.29,30 It is aneurysm in a high proportion of cases. Attention has
been refocused away from the aneurysm dome and
possible that the advent of coils such as the VFC,
which may treat a broader range of aneurysms with toward the neck as a point of intervention.35 The
a lower carrying cost, could provide a significant porosity (amount of metal coverage over the neck) and
advance in the efficiency and cost of aneurysm pore density (number of pores per area) are important
metrics when altering flow, with lower porosity and
treatment. We found no published data validating
higher pore density being the optimal conditions for
the use of VFC.
aneurysm occlusion.34 Flow diverters may also be
Penumbra 400 more beneficial than stents. A recent study utilizing
The Penumbra 400 (PC 400) (Penumbra, Alameda, virtual models found that flow diverters reduced
CA, USA) represents a new class of softer, thicker aneurysmal flow velocity to a much greater degree
coils compared to conventional coils, shown in than stents.36
Fig. 2B. Approved by the FDA in April 2011, the Concerns about flow diversion include potential
PC 400 provides between 178% and 400% more occlusion of perforating arteries or other important
volume per unit length than traditional coils.31 The branches. However, in vitro studies have documented
coil texture is soft, with three classes approved for that there is minimal reduction in collateral flow
use: standard, soft, and extra soft. These gradations when a flow diverter is placed across an aneurysmal
of softness are determined by the nitinol stretch neck and collateral branches.34,37–40 These results
resistance wire, and not by the diameter filament make intuitive sense because flow through collaterals
wire, as in conventional coils.31 is driven by a pressure gradient, despite being jailed
Mascitelli et al.14 retrospectively compared 16 by a porous medium. Moreover, further limitations
aneurysms embolized with the PC 400 compared to include inability to treat certain aneurysm geometries,
79 matched aneurysms treated with conventional coils. such as at a bifurcation, and need for dual anti-
Despite limited numbers, aneurysm embolization with platelet therapy immediately after and for months
the PC 400 achieved a higher packing density (36.8% following treatment.41
vs. 28.1%; P , 0.005) with fewer coils per aneurysm Two classes of flow diverters currently exist:
(3.9 vs. 6.1; P , 0.05).14 Favorable results were intravascular (within the parent vessel) and intrasac-
achieved with significantly less procedure time and a cular (within the aneurysmal sac). Instead of being
trend toward less total coil length. In a similar study, deployed in the parent vessel, an intrasaccular diverter
Milburn et al.31 retrospectively reported results of 40 is placed entirely within the aneurysm cavity, creating
aneurysms treated with standard coils compared to 18 the same flow-diverting mechanism as the intraluminal
treated only with PC 400 coils. Mean packing density flow diverters.35 The intravascular class includes three
was significantly higher and the number of coils was options: (1) pipeline embolization device (PED) (ev3,
significantly fewer for the PC 400 group with compar- Menlo Park, CA, USA; Covidien, Mansfield, MA,
able aneurysm occlusion rates. The authors concluded USA), (2) Surpass NeuroEndGraft System (Surpass,
that the PC 400 system may be more efficient and cost- Miramar, FL, USA; Stryker Neurovascular Fremont,
effective. Currently, a prospective, multi-institution CA, USA), and (3) SILK (Balt Extrusion, Montmorency,
This study supports a promising technique for the than the vascular plug, showing promise for accurate
treatment of complex MCA aneursyms, but results placement and aneurysm occlusion.
cannot be extrapolated to aneurysms in other locations. In humans, the LUNA AES for Treatment of
The WEB device is an exciting new technology. Intracranial Aneurysm–PMCF study is currently
The major benefit appears to be its suitability for enrolling patients. The trial is a prospective, multi-
treating wide-necked aneurysms. Sizing appears to be center, non-randomized, non-blinded PMCF study
the most important factor in achieving success, in with 12-month follow-up across 30 different sites with
order to create a tight seal along the aneurysm neck.65 the goal of enrolling 63 patients. In a recent oral
Previous authors recommend that the width of the abstract, an update on the trial yielded 15 patients,
device should be equal to or greater than the with 14 unruptured and 1 ruptured saccular aneur-
aneurysm width. Upsizing by 1 mm in some cases ysms.75 In 14/15 (93%) patients, 1 LUNA AES was
can be too great a jump in size, and 0.5 mm sizes are deployed per aneurysm. Immediate complete occlu-
expected.71 The WEB device also does not preclude sion was seen in 1/14 ((7%) patients, near-complete
the use of additional embolization materials. Both of occlusion was seen in 9/14 (64%) cases, and no
the largest studies include patients that had adjunc- occlusion seen in 4/14 (29%) patients.75 At 6 months,
tive coiling. A recent case report highlighted standard 2/4 (50%) patients had complete occlusion and the
balloon-assisted coiling to close a regrown MCA remaining 2/4 had neck remnants. The authors
aneurysm after WEB placement.69 In terms of concluded promising early results with more long-
embolic risk, preclinical animal studies have shown term follow-up pending.
the WEB had similar thrombotic potential compared Amidst the encouraging results, substantial uncer-
to conventional intra-saccular coils.62 Limitations tainties remain. First, only animal data exist with
include its initial design for straightforward posterior limited use in humans. The aneurysms created in each
circulation; the WEB can be difficult to maneuver animal study are likely more regular and easier to
through more tortuous anterior vascular anatomy.65 treat than complex human aneurysms, that may be
Second, the device may be less qualified to redirect flow irregular, wide-neck, or fusiform.73 Second, little is
in irregular or fusiform aneurysms, as the symmetric known about precise sizing and positioning of the
geometry can only treat a similarly shaped aneurysm. device given each aneurysms has a unique 3-dimen-
Lastly, large studies to establish safety do not exist. sional morphology. Third, if incomplete occlusion is
found, the interventionalist may have limited options
LUNA for re-treatment, as coil placement into the lumen of
The LUNA AES is a self-expandable, round-ovoid the LUNA will not be possible.73
implant and delivery system, seen in Fig. 4C. The
implant is made from a double layer of 72 Nitinol Adjunctive Balloon Devices
wire 25 m mesh (144 wires) secured at both proximal Historically, wide-necked aneurysms are difficult to
and distal ends and clearly marked with radiopaque treat with coil embolization alone as the sac and neck
markers.72 Available sizes include 4.5 mm (B)– are often shaped such that it is difficult to maintain
8.5 mm (G). The system includes a micro-catheter the coils in the saccular portion. Given the angioarch-
shaft with detachment controlled by operator activa- itecture of wide-necked aneurysms, there is a high
tion of delivery handle. risk of progressive coil compaction and coil deposi-
Two preclinical studies on the LUNA AES system tion into the parent vessel leading to complications
exist. Using a rabbit model, Kwon et al.73 embolized such as thromboembolism and aneurysm recurrence.7
12 aneurysms with the LUNA AES and performed Thus, in order to achieve adequate occlusion of wide-
digital subtraction angiography (DSA) pre and 5, 10, necked aneurysms, it is often not feasible to perform
and 30 minutes post-implantation. At 30 minutes coil embolization without an assist device.
and 1 month, 10/12 (83%) were completely occluded. Industry has developed numerous solutions to
At 3 months, 7/8 (88%) aneurysms remained com- address the problem of difficult coil placement when
pletely occluded.73 Also at 3 months, microscopic coiling aneurysms with a poor dome-to-neck ratio.
examination showed 8/8 (100%) aneurysms had tissue One solution, referred to as balloon remodeling or
completely covering the devise and neointima forma- balloon-assisted coil embolization (BACE), involves
tion across the aneurysm neck. In a separate study placing a temporary balloon across the neck of the
1 year later, Turk et al.74 compared the Luna AES to aneurysm while concomitantly inserting coils. BACE
a vascular plug vascular plug in seven canines. Each for treatment of wide-necked intracranial aneurysms
animal received one LUNA and one vascular plug was introduced in 1997 by Moret and colleagues.76
device and was evaluated angiographically after This technique allows more coils to be inserted into
placement. At 28 and 55 days, the LUNA device the aneurysm allowing the neurointerventionalist to
provided higher levels of occlusion and durability obtain maximum coil density within the sac and neck
Unlike older balloon designs, TransForm is Neuroform stents have undergone numerous improve-
manufactured with micro-fabrication slits to allow ments to allow for better stability and maneuverability
rapid inflation and vessel occlusion (Fig. 3). Once for optimal stent delivery.99 The five iterations are
inflated across the neck of the aneurysm, a separate known as Neuroform 1, 2, 2 Treo, 3, and 3 EZ.100 In
intrasaccular catheter may deploy permanent coils one of the largest patient series, Fiorella et al.96 treated
limited to the aneurysm itself by the balloon 284 patients with 302 aneurysms using the Neuroform
wall.84 stent over 42 months. Eighty patients (48.2%) had
Due to its recent emergence as an approved device, aneurysm thrombosis, 40 (24.1%) were unchanged, 46
at the time of this manuscript’s completion no peer- (27.7%) had recanalization. Twenty-five ischemic
reviewed publications of TransForm’s clinical results strokes (8.8%) and eight (2.8%) neurovascular deaths
exist. Remaining questions are whether the advan- were seen. The authors concluded that although
tages offered by this more maneuverable single-lumen Neuroform aids in treatment of wide-necked aneur-
device outweigh the versatility offered by its dual- ysms, complete occlusion was low and significant
lumen counterpart, the Scepter C/XC. It is concei- complications occurred.
vable that neither is outright superior but rather that The Enterprise stent (Cordis, Miami Lakes, FL,
each has its unique role in the treatment of lesions USA) was FDA approved in 2007 and is a newer
that are themselves heterogeneous. Regardless, objec- flexible nitinol stent also designed for endovascular
tive conclusions loom as the field of neurointerven- treatment of intracranial wide-necked aneurysms. The
tional surgery awaits data on the safety and efficacy Enterprise stent was approved for use in coil emboliza-
of one if its newest technologies. tion of aneurysms with wide neck (§4 mm) or poor
dome-to-neck ratios (,2). The stent also has a fixed
Stents closed-cell design. The specific design of the Enterprise
The advent of stent-assisted-coiling (SAC) with self- allows the stent to be partially deployed, recaptured,
expanding stents has allowed neurointerventionalists to and redeployed as needed. A long-term retrospective
treat wide-necked aneurysms formerly deemed untrea- follow-up study concluded the Enterprise stent as an
table. Self-expandable stents are versatile with several effective, safe, and durable treatment with coiling for
advantages compared to older treatments. Originating in intracranial aneurysms.95 Additionally, Mocco et al.98
the field of cardiology,85 the use of stents migrated to used the Enterprise for SAC in 141 patients with 142
neurosurgical intervention in the late 1990s, but not aneurysms and found a 76% rate of §90% occlusion
without trepidation.86,87 Coronary vasculature is sur- with a 6% temporary morbidity, 2.8% permanent
rounded by stiff myocardium, whereas intracranial morbidity, and 2% mortality (0.8% unruptured, 12%
vessels are free floating in CSF. Could the same ruptured).
technology be transferred to more delicate anatomy? Both the Neuroform and Enterprise stent systems
After the use of cerebrovascular SAC was reported overall have comparable safety profile, specifically,
in animals in 1994,88 Higashida et al., in 1995, became similar rates of in-stent stenosis and throm-
the first to describe the use of an intravascular stent to boembolic complications.95,96 Stent-assisted-coiling
support coil embolization in humans.89 These micro- of intracranial aneurysms with self-expanding stents
stents are flexible, self-expanding metal entities that has allowed an alternative neuro-endovascular
utilize a micro-catheter delivery system.90 They act as a option to those aneurysms previously regarded as
support mechanism under the aneurysm to prevent ‘uncoilable’.97
coil prolapse into the parent vessel. Advantages of Despite large gains, new stent-technologies are on
self-expandable stents include improved coil neck the horizon to address challenging aneurysms such as
coverage, increased packing density within the aneur- double-barrel stents, Pulsar vascular aneurysm neck
ysm,91 successful flow diversion,90 and rigid scaffolding reconstruction device (PVANRD) (Pulsar Vascular,
for orifice endothelialization.92 Additionally, grow- San Jose, CA, USA), and the similar Pulse-Rider
ing evidence suggests that these stents may have System (Pulsar Vascular), and the Barrell Stent.101–
flow-remodeling effects that lead to aneurysm 103
We describe each new stent below.
obliteration.93,94 There are currently two commonly
used stents: (1) Neuroform and (2) Enterprise stents. Double-barrel stents
Both technologies have comparable safety profile, Double-barrel stents is a technique of placing two
specifically, similar rates of in-stent stenosis and self-expandable stents (Neuroform or Enterprise)
thromboembolic complications.95–98 that are aligned in a side-by-side configuration across
In 2002, the Neuroform microstent (Boston the orifice of the aneurysm, depicted in Fig. 6A. They
Scientific, Natick, MA, USA) became the first self- function as bridge for optimal support at the base of
expanding stent designed specifically for intracranial the aneurysm to enable coil embolization.104,105
use.99 It is a nitinol stent with an open-cell design. Different configurations of the double-barrel stents
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