CLINICAL STUDIES

A 7-YEAR EXPERIENCE WITH BALLOON-MOUNTED

CORONARY STENTS FOR THE TREATMENT OF
SYMPTOMATIC VERTEBROBASILAR INTRACRANIAL
ATHEROMATOUS DISEASE
David Fiorella, M.D., Ph.D. OBJECTIVE: Balloon-mounted coronary stents (BMCS) have been adapted for use in
Departments of Neuroradiology the intracranial circulation for the treatment of symptomatic intracranial atheromatous
and Neurosurgery, disease (ICAD). We performed a retrospective analysis of our 7-year experience with these
The Cleveland Clinic Foundation,
Cleveland, Ohio
devices in an attempt to quantify the periprocedural risks and long-term outcomes in
patients with symptomatic ICAD of the vertebrobasilar (VB) system treated with BMCS.
Michael M. Chow, M.D. METHODS: A retrospective review of a prospectively maintained database was per-
Department of Neurosurgery, formed to determine the neurological and non-neurological periprocedural risks of
University of Alberta, BMCS treatment of ICAD. Patients were followed with serial transcranial Doppler (TCD)
Edmonton, Canada and, in some cases, angiographic imaging. The clinical status was determined based
on clinic visits and by telephone interviews when possible.
Michael Anderson, R.N. RESULTS: Over the 6-year period from March 1999 to May 2005, 44 patients (35 men,
Department of Neurosurgery, 9 women; average age, 64.8 yr) with 47 symptomatic atheromatous lesions of the VB sys-
The Cleveland Clinic Foundation,
Cleveland, Ohio
tem were treated with BMCS. In two patients, the BMSC could not be delivered across the
target lesion. Treatment of the remaining 45 lesions was technically successful (95.7%).
Henry Woo, M.D. The periprocedural neurological morbidity and mortality was 26.1% (10 clinically evident
Department of Neurosurgery,
strokes, 2 deaths). One additional patient experienced a periprocedural transient ischemic
The Cleveland Clinic Foundation, attack (TIA). Two patients died of non-neurological causes within 6 months (4.3%, myocar-
Cleveland, Ohio dial infarction and cholecystitis). The average stenosis measured 82.5%, declining to
10.0% stenosis after BMCS. TCD examinations showed a preprocedural velocity of 127.7
Peter A. Rasmussen, M.D. cm/second (n ⫽ 43; standard deviation, 63.7 cm/s), which declined to 54.0 cm/s imme-
Departments of Neuroradiology diately after the procedure (n ⫽ 42; standard deviation, 22.7 cm/s). In patients with serial
and Neurosurgery, TCD evaluations, velocities were typically constant over years of follow-up (six patients
The Cleveland Clinic Foundation,
with ⬎5 yr of follow-up; average velocity, 52.2 cm/s). Angiographic follow-up was avail-
Cleveland, Ohio
able for 11 patients. Three patients had stent occlusion (all symptomatic with TIAs), one
Thomas J. Masaryk, M.D.
patient had greater than 50% in-stent restenosis (ISR) (symptomatic with TIA) and seven
had no significant (⬍50%) stenosis. The overall ISR/occlusion rate was 12.5% (4 out of
Departments of Neuroradiology
and Neurosurgery, 32 lesions with angiographic and/or TCD follow-up ⬎ 6 mo). Of the 42 patients who
The Cleveland Clinic Foundation, successfully underwent BMCS, clinical follow-up was available for 33 (78.6%, average
Cleveland, Ohio follow-up period, 43.5 mo), three patients died before any follow-up could be performed,
and seven were lost to follow-up. Of the patients with follow-up, five had recurrent ver-
Reprint requests:
tebrobasilar ischemic symptoms (15%; four TIA, one stroke). Four out of five patients with
David Fiorella, M.D., Ph.D.,
Departments of Neuroradiology recurrent symptoms had ISR or occlusion verified on conventional angiography. At the time
and Neurosurgery, of the last follow-up examination, seven patients of 44 patients who underwent attempted
The Cleveland Clinic Foundation, treatment were dead (modified Rankin Scale [mRS] score, 6); four had an mRS score of
9500 Euclid Avenue, S80, 3 to 5, 16 had an mRS score of 1 or 2, and 10 had an mRS score of 0.
Cleveland, OH 44195.
Email: fioreld@ccf.org CONCLUSION: Percutaneous transluminal angioplasty and stenting using BMCS for
the treatment of symptomatic VB ICAD can be carried out with high rates of technical
Received, June 28, 2006. success and excellent immediate angiographic results. However, the procedure carries
Accepted, March 19, 2007. with it a very high rate of periprocedural morbidity and mortality. Greater than 50%
ISR or stent occlusion occurred in 12.5% of the patients and was associated with recur-
rent TIAs. In the absence of ISR/occlusion, patients who tolerated the initial procedure
did well neurologically and did not typically experience recurrent ischemic symptoms.
KEY WORDS: Angioplasty, Balloon-mounted coronary stent, Intracranial atheromatous disease, Stenting

Neurosurgery 61:236–243, 2007 DOI: 10.1227/01.NEU.0000255521.42579.31 www.neurosurgery-online.com

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BALLOON-MOUNTED CORONARY STENTS FOR SYMPTOMATIC VERTEBROBASILAR INTRACRANIAL ATHEROMATOUS DISEASE

Symptomatic intracranial atheromatous disease (ICAD) has was also assigned a modified Rankin Scale (mRS) score at the time of
an aggressive natural history with as many as 25% of the pa- the most recent follow-up evaluation.
tients experiencing new infarcts within 2 years despite the
“best” medical therapy (3). For these reasons, endovascular RESULTS
treatment options have been explored as a means of preventing
future strokes in this population. Patients
Balloon-mounted coronary stents (BMCS) have been adapted Over the 6-year period from March 1999 to May 2005, 44
for use in the cerebrovasculature to treat symptomatic ICAD. patients (35 men, 9 women; average age, 64.8 yr) with 47 symp-
We report the results of a retrospective analysis of our 7-year tomatic atheromatous lesions of the VB system underwent
experience using BMCS to treat symptomatic ICAD of the ver- endovascular procedures with the intention of performing per-
tebrobasilar (VB) system. cutaneous transluminal angioplasty and stenting (PTAS) using
BMCS. Forty-two of the 44 patients had failed medical therapy
METHODS with antiplatelet agents, anticoagulation, or both; 26 patients
had failed anticoagulation therapy with Coumadin (Bristol-
We conducted a retrospective analysis of a prospectively main- Myers Squibb, Princeton, NJ) or heparin; and 36 patients had
tained database encompassing procedures performed on patients with failed antiplatelet therapy.
symptomatic VB ICAD between 1999 and 2005. All patients treated
had either failed a trial of medical therapy (including antiplatelet Periprocedural Results
agents, heparin, or warfarin) or had presented with ischemic symp-
Angioplasty and stenting was successfully performed on 45
toms while on medical therapy for other vascular disease.
of the 47 lesions addressed, resulting in a 95.7% technical suc-
Interventional Procedures cess rate. In one patient, treatment was attempted but aborted
Prior to every procedure, written informed consent was obtained
owing to difficulty navigating the BMSC across the target
from the patient or his/her family for the intracranial angioplasty and lesion. This patient underwent angioplasty alone. In a second
stenting procedure using the available BMCS “off-label” within the patient, an intracranial flow limiting dissection precluded stent
cerebrovasculature. All intracranial angioplasty and stenting proce- placement during the attempted navigation of the BMCS to
dures were performed under general anesthesia. An evolving approach the targeted lesion.
toward anticoagulation and platelet inhibition was evident during the The periprocedural neurological morbidity and mortality
study period. Dual antiplatelet therapy was instituted for at least 3 rate was 26.1% (nine procedural clinically evident strokes, one
days before the procedures. This strategy was used for all patients postprocedural stroke, and two procedural deaths). The symp-
undergoing operation during the final 2 years of data collection. tomatic procedural strokes were documented by imaging
Previously, patients receiving warfarin were either continued on this
within the pons (n ⫽ 3), thalamus (n ⫽ 2), occipital lobe (n ⫽ 1),
therapy during the treatment or were converted to heparin for the
periprocedural period and then placed back on warfarin after treatment
medulla (n ⫽ 1), cervical cord (n ⫽ 1), and cerebellar hemi-
was accomplished. For patients not treated in the context of warfarin spheres (n ⫽ 1). The patient with postprocedural stroke pre-
therapy, heparin was administered to achieve an activated coagulation sented 12 days after the stenting procedure with hemorrhagic
time of between 250 and 300 seconds. Abciximab was not routinely conversion of a preexisting posterior inferior cerebellar territory
administered. Stents used included Velocity (Cordis, Miami, FL), Duet infarction and a new left superior cerebellar infarction. The two
(Guidant, Indianapolis, IN), Tetra (Guidant) and Vision (Guidant). Only periprocedural deaths were attributable to an occlusive basilar
one patient required predilation with an angioplasty balloon. All other dissection and a catastrophic subarachnoid hemorrhage,
patients were treated primarily with the BMCS without pre- or postdi- respectively. One additional patient experienced a periproce-
lation. The sheath was removed immediately after the procedure and dural transient ischemic attack (TIA). Two patients died of non-
hemostasis was achieved with either an Angioseal (St. Jude Medical, St.
neurological causes within 6 months of the procedure (4.3%,
Paul, MN) or Perclose (Abbott Labs, Chicago, IL). Heparin was not
reversed after the procedure. Patients were maintained on dual
myocardial infarction and cholecystitis/sepsis). The neurolog-
antiplatelet medications for 6 weeks with aspirin therapy maintained ical complications were evenly distributed over the course of
indefinitely thereafter. the series and among the various types of stents used.
Clinical follow-up was performed by the neurointerventionists The average stenosis measured 82.5% before treatment
involved with the primary procedure at 3, 6, and 12 months, and yearly (n ⫽ 45 lesions with films available for review), declining to
thereafter. In patients with incomplete clinical data, follow-up was per- 10.1% (n ⫽ 43 lesions) stenosis after successful BMCS place-
formed by phone interview when possible. Transcranial Doppler (TCD) ment (Fig. 1). Of the 47 lesions treated, 40 were more than 70%
velocities were obtained before treatment, immediately after treatment, stenotic and five were between 50 and 69% stenotic; procedural
at 3, 6, and 12 months, and yearly thereafter. Conventional angiography films were unavailable for review in 2 cases.
was performed in patients with recurrent neurological symptoms or
TCD evidence of restenosis. TCD and Conventional Angiographic Imaging
Periprocedural outcome measures included death, permanent neu-
rological morbidity, and all neurological morbidity (including death, TCD examination showed an average preprocedural velocity
permanent, and temporary neurological morbidity). At the time of fol- of 128.3 cm/s (n ⫽ 43; standard deviation, 63.0 cm/s), which
low-up, any recurrent or new neurological symptoms referable to the declined to 53.0 cm/s immediately after the procedure (n ⫽ 42;
vascular distribution of the treated lesion were recorded. Each patient standard deviation, 22.6 cm/s). Although preprocedural TCD

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FIORELLA ET AL.

1 year or longer. In patients without recurrent symptoms, serial

A B TCD values remained stable throughout the duration of the
follow-up period (Fig. 2).
Angiographic follow-up (range, 1–54 mo; average, 20.5 mo)
was available for 11 patients and was performed for either
recurrent symptoms, elevated TCD velocities, or in the context
of angiography being performed for a different procedure (e.g.,
carotid stenting). Three patients had stent occlusion (all symp-
tomatic with TIAs), one patient had greater than 50% in-stent
restenosis (ISR) symptomatic with TIA (Fig. 3), and seven had
no significant ISR. One of the patients without ISR on angio-
graphic follow up developed a new focus of high-grade steno-
sis several centimeters proximal to the stented basilar artery
(within the right vertebral artery), which was identified when
C D they presented with a new posterior circulation stroke. A sec-
ond patient undergoing angiography for increased TCD veloc-
ities demonstrated asymptomatic progression of a vertebral
artery stenosis proximal to the stented lesion (at the verte-
brobasilar junction). Thirty-two lesions were studied with TCD
or conventional angiography for at least 6 months, yielding an
overall ISR/occlusion rate of 12.5%.
Nine patients in the current series had both TCD and angio-
graphic follow-up. Correlation was excellent in seven of the
nine patients with TCD correctly predicting the presence or
FIGURE 1. A 57-year-old man with hypertension, diabetes, hyperlipi- absence of ISR. In one patient, ISR was suspected on the basis
demia, and coronary artery disease was admitted for recurrent episodes of of elevated TCD velocity (130 cm/s). However, conventional
dizziness and diplopia. Noninvasive workup demonstrated a high-grade angiography demonstrated no significant ISR. Of note, this
stenosis of the distal V4 segment of the left vertebral artery. These episodes patient also demonstrated relatively high immediate posttreat-
continued despite the institution of dual antiplatelet and heparin therapy. ment baseline velocities (97 cm/s). The subsequent measure-
A, conventional angiography performed from a left vertebral catheter posi- ment performed 2 years later was essentially equivalent to the
tion demonstrating a high-grade (85%) stenosis of the distal left vertebral immediate postprocedural measurement (102 cm/s). In another
artery (black arrow). The right vertebral artery terminated as the posterior patient, TCD indicated markedly increased velocities within
inferior cerebellar artery. Single-stage, primary angioplasty and stenting
the stented vessel, whereas correlative conventional angiogra-
were performed with a Vision 3 mm ⫻ 8 mm balloon mounted coronary
phy demonstrated stent occlusion.
stent. B, after angioplasty and stenting, control angiography performed
from the left vertebral artery demonstrated no residual stenosis (0%) in the
Clinical Follow-up
region of the treated lesion (black arrow). Immediately after the procedure,
the ischemic events stopped and the patient was discharged on aspirin and Of the 42 patients who successfully underwent BMCS, clini-
clopidogrel. The patient did well for 1 month but then re-presented with cal follow-up was available for 33 (78.6%, average follow-up
intractable emesis and vertigo. C, conventional angiography performed
from the left vertebral artery demonstrated occlusion of the stent. D,
angiography performed from a catheter positioned within the left internal
carotid artery demonstrated a small posterior communicating artery, which
provided collateral flow to the basilar apex with retrograde reflux into the
basilar trunk. Magnetic resonance imaging with diffusion demonstrated
evidence of acute infarction. The symptoms resolved over 48 hours.

velocities were typically substantially elevated (⬎100 cm/s) in

the region of the target lesion, the initial TCD velocities were
less than 70 cm/s in eight patients. In these eight patients, the
lesions were highly stenotic (average, 92.2%; standard devia-
tion, 6.0%). In four of these patients, the velocities actually
increased immediately after the procedure. In the other four
patients, the immediate postprocedural velocities either stayed
the same (n ⫽ 1) or decreased only minimally (⬍5 cm/s, n ⫽ 3).
FIGURE 2. Bar graph showing serial transcranial Doppler (TCD) measure-
Thirty patients had one or more TCD follow-up examination
ments in asymptomatic patients after successful VB angioplasty and stenting.
through at least 6 months, and 25 underwent serial TCDs for

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BALLOON-MOUNTED CORONARY STENTS FOR SYMPTOMATIC VERTEBROBASILAR INTRACRANIAL ATHEROMATOUS DISEASE

period, 43.5 mo), two patients died before follow-up could be At the time of the most recent follow-up examination, seven
performed, and seven were lost to follow-up. Of the patients patients were dead (mRS score, 6), four had an mRS score of 3
with follow-up, five had recurrent symptoms (15%; four TIA, to 5, 16 had an mRS score of 1 or 2, and 10 had an mRS score
one stroke). Four of the five patients with recurrent symptoms of 0. Of the seven patients who died, two died as a result of
(all with TIAs) had ISR or stent occlusion verified on conven- complications during or immediately after the procedure, two
tional angiography (Figs. 1 and 3). The patient presenting with died less than 6 months after the procedure of unrelated causes
ipsilateral stroke 16 months after the procedure demonstrated (myocardial infarction and acute cholecystitis), and three died
no ISR but had developed a high grade right vertebral stenosis of undetermined causes. Excluding the procedural deaths, the
several centimeters proximal to the stented basilar artery lesion. average time of death was 32.4 months (range, 1–77 mo). All
four patients who had mRS scores of 3 to 5 were disabled as a
A B result of their presenting infarcts; none had experienced proce-
dural complications and three of the four were without new
ischemic events after stenting. The one patient who sustained
a new stroke months after the stenting procedure did not
change in mRS score after the event.
Of the 10 patients who experienced nonfatal, clinically evi-
dent periprocedural infarcts, six were in good or excellent neu-
rological condition (mRS score 2, n ⫽ 3; mRS score 1, n ⫽ 2;
mRS score 0, n ⫽ 1; follow-up period, 27–59 mo; average fol-
low-up duration, 40.8 mo), two were deceased, and two were
lost to clinical follow-up.

DISCUSSION
Open surgical or endovascular strategies for the treatment of
C D patients with symptomatic ICAD must satisfy two criteria: rea-
sonable safety and long-term efficacy. Ultimately, the peripro-
cedural morbidity and mortality in combination with the post-
procedural stroke rate must compare favorably with the
natural history of the disease process in the context of the
“best” medical therapy.
The results of the recent Warfarin-Aspirin Symptomatic
Intracranial Disease (WASID) study indicate that patients with

FIGURE 3. A 72-year-old woman with multiple posterior circulation

strokes, hyperlipidemia, diabetes, and coronary artery disease presented
with crescendo TIAs (10–12 per day) while on aspirin and warfarin.
Conventional angiography performed from a catheter position within the
right vertebral artery in the transfacial (A) and lateral (B) projections
demonstrated an irregular long segment stenosis of the midbasilar artery
E F and a more proximal stenosis of the V4 segment of the right vertebral
artery. The right vertebral artery was dominant, and the left vertebral
artery was diminutive with a high-grade origin stenosis and multiple
tandem intracranial stenoses. Angioplasty and stenting were performed
via a transradial approach with a 2.5 ⫻ 12 mm Multilink Vision
(Guidant) placed within the basilar artery and a 2.5 ⫻ 8 mm Multilink
Vision placed within the distal V4 segment of the right vertebral artery.
Poststenting angiography in the transfacial (C) and lateral (D) projec-
tions demonstrated significant improvement of the basilar and vertebral
stenoses. Immediately after the procedure, the TIAs resolved. The prepro-
cedural basilar velocity was 152 cm/s, declining to 102 cm/s after the pro-
cedure. The patient did well neurologically after the procedure but then
experienced a recurrence of her TIAs. TCD demonstrated increased veloc-
ity within the basilar artery (191 cm/s). Conventional angiography in the
transfacial (E) and lateral (F) projections demonstrated severe basilar in-
stent restenosis (95%, black arrow) and less severe restenosis within the
proximal right vertebral stent (black arrow).

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FIORELLA ET AL.

high-grade intracranial stenosis presenting with stroke are at a stenotic lesions. The distal passage of these stiff exchange
high risk (approximately 25% over 2 yr) for subsequent stroke microwires into the posterior cerebral arteries can substantially
despite the “best” medical therapy (3, 8). These patients repre- deform these small intracranial vessels, producing vasospasm
sent the group with the greatest potential to benefit from revas- and exposing these delicate vessels to a potential risk of dissec-
cularization procedures. tion and perforation. Once delivered across the stenosis, the
We constructed a prospectively maintained database of stents are deployed via the inflation of a high-pressure angio-
symptomatic VB stenoses to allow us to evaluate the safety, plasty balloon, inducing significant vascular trauma with the
efficacy, and durability of PTAS using BMCS. The database was risks of plaque rupture and distal embolization in addition to
limited to VB stenoses for several reasons. First, all operators at the potential for vessel rupture. To achieve good stent apposi-
our institution followed a uniform approach to the treatment of tion over the entire length of the vessel and to free the stent of
these lesions, namely single-stage, primary PTAS with BMCS. the angioplasty balloon, an aggressive angioplasty was
Secondly, the literature predating the WASID study indicated required with dilation of the lesion to a diameter approaching
that the natural history of symptomatic lesions of the VB sys- that of the normal parent vessel. Underinflation of the angio-
tem was particularly malignant in comparison with other intra- plasty balloon increases the odds of an incomplete stent release
and extracranial stenoses (13, 14). Finally, strokes occurring in from the balloon with the risk of dragging the stent back
this distribution are frequently fatal or neurologically devastat- through the lesion during the attempted removal of the angio-
ing (15). The latter two factors support aggressive therapy in plasty catheter. At the same time, gross undersizing of the stent
selected patients, e.g., those with high-grade symptomatic risks poor apposition of the stent to the distal and proximal
stenosis refractory to medical therapy. parent vessel, creating an environment for turbulent flow and
the generation of thromboemboli.
Treatment of Symptomatic Vertebrobasilar ICAD
with BMCS: A Viable Treatment Option? Efficacy in Stroke Prevention
After successful PTAS, few patients (15%) experienced recur-
Periprocedural Morbidity rent symptoms and only one patient (3%) experienced a stroke
In the current series, we observed a high (26.1%) rate of within the ipsilateral vascular territory. Four of the five patients
major periprocedural morbidity and mortality relative to the with recurrent symptoms had ISR or stent occlusion, and all
natural history of the disease. Essentially, the patients treated four patients with ISR/occlusion presented with recurrent
with primary, single-stage angioplasty and stenting with the symptoms. These results indicate that patients with successful
balloon-mounted coronary stents used in this series were and durable revascularization have very low rates of recurrent
exposed to an “up front” periprocedural risk that equaled or events; none of the patients without either ISR/occlusion or a
exceeded that of the natural history of the disease treated with new focus of VB stenosis experienced recurrent ischemic symp-
medical therapy over a 2-year period. The periprocedural risks toms, whereas all patients with these problems did.
observed in the current study are similar to those reported in Although ISR/occlusion resulted in recurrent neurological
other smaller studies (9, 10, 17, 18). In this setting, even if the symptoms and sometimes necessitated retreatment (Fig. 3), this
risk of subsequent ipsilateral territory stroke was completely phenomenon was not a major contributor to permanent mor-
eradicated by the procedure, the viability of the procedure as a bidity in this population. The present data clearly indicate that
treatment option is still doubtful. Particularly considering that periprocedural morbidity, not delayed ISR/occlusion, is the
these patients are frequently older and have significant comor- major downfall of BMCS as an effective strategy for the treat-
bidities that may reduce their lifespan and thus limit the dura- ment of symptomatic ICAD. Correspondingly, better and safer
tion of time they have to benefit from a cerebral revasculariza- devices or improved techniques designed to reduce periproce-
tion procedure. In addition, the cost of the procedure represents dural morbidity will be required before intracranial angioplasty
an important consideration if the efficacy is marginal. and stenting can represent a viable treatment option for these
The morbidity associated with PTAS using BMCS is related patients. The recent enthusiasm surrounding the potential
not only to the disease process, but also to the physical charac- adaptation of drug-eluting coronary stents for use in the cere-
teristics of the available coronary devices adapted for intracra- brovasculature, represents a solution which fails to address the
nial use. Although the devices went through several iterations primary problem of periprocedural morbidity (1).
over the course of the study, the BMCS remained relatively
inflexible and difficult to navigate through the tortuous cere- Outcomes of Patients with Periprocedural Stroke
brovasculature. To support the navigation of these stents, Most patients who experienced periprocedural strokes (six
aggressive guide catheter access was necessary within the par- out of eight with follow-up) improved significantly after their
ent vessel leading to the target lesion. Distal parent vessel event, went on to good or excellent clinical outcomes, and were
catheterization with stiff, large bore, guiding catheters and free of future events. This represents an interesting caveat of the
sheaths frequently resulted in parent vessel trauma leading to current study, as one could hypothesize that the periprocedural
spasm and sometimes dissection. Distal access with stiff events encountered during therapy may be less significant if
exchange length microwires was also required to support the patients subsequently make substantial recoveries and are
delivery of these inflexible stents to and across the intracranial without recurrent stroke thereafter. Unfortunately, the pub-

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BALLOON-MOUNTED CORONARY STENTS FOR SYMPTOMATIC VERTEBROBASILAR INTRACRANIAL ATHEROMATOUS DISEASE

lished WASID data do not address the long-term outcomes of These authors reported a 6.6% rate of periprocedural stroke
those patients who experienced stroke during the course of the and an additional stroke rate of 7.3% between 30 days and
trial while on medical therapy. As such, no comparative analy- 1 year (16). With respect to the intracranial lesions treated, these
sis with a medically treated group is possible. authors reported a 14% (6 out of 43) overall (periprocedural
and postprocedure) rate of stroke at 1 year. Despite these prom-
Utility of TCD as a Follow-up Study ising initial results, the Neurolink stent is not commercially
In most cases, immediate postprocedural TCD examinations available. As such, we will limit our discussion of alternative
demonstrated a significant decline in flow velocities across the therapies to angioplasty alone and PTAS with the Gateway-
treated lesion. In very highly stenotic lesions (⬎90%), the pre- Wingspan system.
procedural velocities were occasionally normal or only mini- The initial intracranial angioplasty series reported relatively
mally elevated with the immediate postprocedural TCD exam- high levels of periprocedural morbidity and mortality. For
inations in some cases actually demonstrating flow velocity example, Gress et al. (5) reported a 28% stroke/death compli-
increases after the procedures. cation rate in a series of 25 patients with vertebrobasilar ICAD
In patients without recurrent symptoms, serial TCD values treated at the University of California, San Francisco. However,
typically remained stable over years of follow-up. In most these initial procedures were performed without “modern”
cases with conventional angiographic follow-up, correlation dual antiplatelet therapy, and treatment was often performed
with TCD was excellent. None of the patients demonstrated without any antiplatelet therapy. In addition, significant
ISR or occlusion in the setting of stable TCD values. advances in the angioplasty technique were described by
We currently use TCD as a noninvasive screening modal- Connors and Wojak (4). These techniques, which involved the
ity with which to follow patients after angioplasty and stent- use of an undersized angioplasty balloon and a very slow bal-
ing. Conventional angiography is reserved for patients with loon inflation rate (1 atm/min), considerably lowered the
a change in TCD velocities from posttreatment baseline or periprocedural complications associated with PTA. More recent
new symptoms. single institution series of intracranial angioplasty without
stenting confirm that this procedure can be performed with an
Alternative Therapeutic Options for Symptomatic ICAD acceptable risk profile. Marks et al. (11) presented a retrospec-
Given the limitations of BMCSs for the treatment of sympto- tive analysis of 36 patients with symptomatic ICAD who
matic ICAD, other therapeutic options should be considered for underwent PTA. These authors reported two procedural deaths
these patients. Several strategies, both surgical and endovascu- and one symptomatic reperfusion hemorrhage. Of the 34
lar, have been evaluated to date. patients with clinical follow-up (average, 52.9 mo), two experi-
The extracranial-intracranial bypass trial evaluated the effi- enced ipsilateral strokes. Overall, the patients treated in this
cacy of surgical bypass for the treatment of symptomatic series had an 84.7% ipsilateral stroke-free survival rate. More
carotid occlusive disease. This study included a subset of recently, Marks et al. combined this data with other investiga-
patients with symptomatic middle cerebral artery stenosis (n ⫽ tors and composed a multicenter retrospective experience that
109) or occlusion (n ⫽ 159). Of all of the patients in the extracra- included 120 patients with 124 treated lesions (12). These inves-
nial-intracranial bypass trial, patients with severe middle cere- tigators reported a 5.8% rate of stroke and death within 30 days
bral artery stenosis fared the worst after surgical bypass ther- of the procedure with an additional 5.2% of the patients expe-
apy (χ2 ⫽ 4.74) with an incidence of fatal and nonfatal stroke riencing a recurrent stroke during the long-term follow-up
(22 out of 50 patients, 40%) nearly double that of the medical period (average, 42.3 mo). When considered in the context of
therapy group (14 out of 59, 23.7%). On the basis of these data, the WASID study (3, 8), these data support angioplasty as a
surgical bypass is generally recognized as a suboptimal treat- viable alternative to medical therapy for selected patients with
ment strategy in this group of patients. Furthermore, bypass for symptomatic ICAD, particularly those with high-grade steno-
VB atheromatous disease, as addressed in the current series, is sis (⬎70%) presenting with stroke.
a more technically demanding and morbid procedure without The Gateway balloon-Wingspan stent system was intro-
evidence to support its efficacy (7). duced for humanitarian device exemption use in the United
In addition to BMCS deployment, various endovascular States in November of 2005. Correspondingly, very little data
strategies have been applied to the revascularization of patients are available regarding the safety profile and efficacy of the
with symptomatic ICAD. Until the recent introduction of the system. Wingspan is a flexible, self-expanding, microcatheter-
Gateway balloon-Wingspan self-expanding stent system delivered, microstent designed specifically to reduce the
(Boston Scientific, Natick, MA), these strategies were limited to periprocedural morbidity of intracranial PTAS. The flexible,
percutaneous transluminal angioplasty (PTA) alone and PTAS low profile, stent system is delivered across the lesion over a
using a balloon-mounted stent designed for use in the cere- floppy microwire after the lesion has been dilated with an
brovasculature (Neurolink, Guidant). intermediate pressure (approximately 6 atm) angioplasty
Neurolink was evaluated in the multicenter Stenting of technique with an undersized angioplasty balloon (80% of
Symptomatic Atherosclerotic Lesions in the Vertebral or the estimated normal vessel diameter). Henkes et al. (6) per-
Intracranial Arteries trial, during which the stent was used to formed this procedure on 15 patients with symptomatic ICAD
treat both intra- and extracranial vertebral artery stenoses. with only one transient periprocedural ischemic event and

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FIORELLA ET AL.

no recurrent TIAs or strokes in the treated patients during 5. Gress DR, Smith WS, Dowd CF, Van Halbach V, Finley RJ, Higashida RT:
1 month of follow-up. These data were incorporated into a Angioplasty for intracranial symptomatic vertebrobasilar ischemia.
Neurosurgery 51:23–29, 2002.
larger European-Asian Wingspan stent trial that included
6. Henkes H, Milosavski E, Lowens S, Reinartz J, Liebig T, Kuhne D: Treatment
43 patients with medically refractory intracranial atheroma- of intracranial atherosclerotic stenoses with balloon dilatation and self-
tous disease. The Wingspan system was used to treat these expanding stent deployment (WingSpan). Neuroradiology 47:222–228, 2005.
patients with an overall rate of ipsilateral stroke and death of 7. Hopkins LN, Budny JL: Complications of intracranial bypass for verte-
7% (three out of 43 patients) over 6 months (2). brobasilar insufficiency. J Neurosurg 70:207–211, 1989.
8. Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg
Currently, PTAS alone and possibly PTAS with the Wing- VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG,
span system seem to represent viable therapeutic options for Romano JG, Cloft HJ; Warfarin Aspirin Symptomatic Intracranial Disease
patients with symptomatic ICAD. When more safety and effi- Trial Investigators: Predictors of ischemic stroke in the territory of a sympto-
cacy data are available for the Wingspan system, it is possible matic intracranial arterial stenosis. Circulation 113:555–563, 2006.
9. Kessler IM, Mounayer C, Piotin M, Spelle L, Vanzin JR, Moret J: The use of
that one or both of these strategies will prove potentially supe-
balloon-expandable stents in the management of intracranial arterial dis-
rior to medical therapy. Ultimately, this determination will eases: A 5-year single-center experience. AJNR Am J Neurorad 26:2342–2348,
require a multicenter randomized trial of intervention versus 2005.
medical therapy. 10. Levy EI, Horowitz MB, Koebbe CJ, Jungreis CC, Pride GL, Dutton K, Purdy
The current study has several important limitations. First, PD: Transluminal stent-assisted angiplasty of the intracranial vertebrobasilar
system for medically refractory, posterior circulation ischemia: Early results.
the total number of patients is still relatively small and the con- Neurosurgery 48:1215–1221, 2001.
clusions drawn from the current data set may not be univer- 11. Marks MP, Marcellus ML, Huy MD, Schraedley-Desmond PK, Steinberg GK,
sally applicable. Second, a significant number (23%) of patients Tong DC, Albers GW: Intracranial angioplasty without stenting for sympto-
were lost to follow-up, introducing some uncertainty into the matic atherosclerotic stenosis: long-term follow-up. AJNR Am J Neuroradiol
26:525–530, 2005.
estimates of procedural efficacy for the prevention of recurrent
12. Marks MP, Wojak JC, Al-Ali F, Jayaraman M, Marcellus ML, Connors JJ, Do
ischemic symptoms and stroke. Finally, the current series rep- HM: Angioplasty for symptomatic intracranial stenosis: clinical outcome.
resents a retrospective review of a prospectively maintained Stroke 37:1016–1020, 2006.
single-institution database, with the adjudication of complica- 13. Marzewski DJ, Furlan AJ, St Louis P, Little JR, Modic MT, Williams G:
tions based upon the impression of the operators and the avail- Intracranial internal carotid artery stenosis: longterm prognosis. Stroke
13:821–824, 1982.
able clinical documentation, which is subject to an inherent 14. Moufarrij NA, Little JR, Furlan AJ, Leatherman JR, Williams GW: Basilar and
level of bias. distal vertebral artery stenosis: Long-term follow-up. Stroke 17:938–942, 1986.
15. Pessin MS, Gorelick PB, Kwan ES, Caplan LR: Basilar artery stenosis: Middle
SUMMARY and distal segments. Neurology 37:1742–1746, 1987.
16. SSYLVIA Study Investigators: Stenting of Symptomatic Atherosclerotic
PTAS for the treatment of symptomatic VB ICAD can be car- Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): Study results.
Stroke 35:1388–1392, 2004.
ried out using BMCS with high rates of technical success and 17. Weber W, Mayer TE, Henkes H, Kis B, Hamann GF, Schulte-Altedorneburg G,
excellent immediate angiographic results. However, the proce- Brueckmann H, Kuehne D: Stent-angioplasty of intracranial vertebral and
dure carries with it a very high rate of periprocedural morbid- basilar artery stenoses in symptomatic patients. Eur J Rad 55:231–236, 2005.
ity and mortality (26.1%), which represents the primary limita- 18. Yu W, Smith WS, Singh V, Ko NU, Cullen SP, Dowd CF, Halbach VV,
Higashida RT: Long-term outcome of endovascular stenting for symptomatic
tion of this modality for the treatment of ICAD. Greater than
basilar artery stenosis. Neurology 64:1055–1057, 2005.
50% ISR or stent occlusion occurred in 12.5% of patients and
was associated with recurrent, but typically transient, ischemic
symptoms. In the absence of ISR/occlusion, almost all patients COMMENTS
who tolerated the initial procedure did well neurologically and
did not typically experience recurrent ischemic symptoms.
F iorella et al. describe their 7-year experience treating 44 patients
with symptomatic atheromatous lesions of the vertebrobasilar (VB)
system using balloon-mounted coronary stents (BMCS). As the authors
REFERENCES alluded, the periprocedural technical success rate was approximately
96% and has been reported previously; the periprocedural neurologi-
1. Abou-Chebl A, Bashir Q, Yadav JS: Drug-eluting stents for the treatment of
intracranial atherosclerosis: Initial experience and midterm angiographic fol- cal morbidity and mortality was approximately 26.1% with 10 clinical
low-up. Stroke 36:e165–e168, 2005. strokes and two deaths occurring as a result of the treatment. One
2. Bose A: Theory and new technology for improving interventional therapy for additional patient experienced a periprocedural transient ischemic
intracranial atherosclerotic disease: Full results from the Wingspan HDE attack. Using transcranial Doppler methodology, they demonstrated
safety study. Presented at the American Society of Neuroradiology Annual that the hemodynamic lesion had been reversed. Ten patients were lost
Meeting, Toronto, Canada, May 23, 2005. to follow-up and, obviously, we have no way of knowing what tran-
3. Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel spired in these individuals. At a minimum, the periprocedural neuro-
MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG,
logical morbidity and mortality was 26%.
Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial
Investigators: Comparison of warfarin and aspirin for symptomatic intracra-
What is extremely important in this analysis is that the data demon-
nial arterial stenosis. N Engl J Med 352:1305–1316, 2005. strates that the rate limiting factor for long-term success was the
4. Connors JJ 3rd, Wojak JC: Percutaneous transluminal angioplasty for intracra- periprocedural morbidity and was not related to either intrastent steno-
nial atherosclerotic lesions: evolution of technique and short-term results. sis or delayed occlusion. Considering the natural history of this disease
J Neurosurg 91:415–423, 1999. if left untreated, if the periprocedural risks can be lowered to an accept-

242 | VOLUME 61 | NUMBER 2 | AUGUST 2007 www.neurosurgery-online.com

BALLOON-MOUNTED CORONARY STENTS FOR SYMPTOMATIC VERTEBROBASILAR INTRACRANIAL ATHEROMATOUS DISEASE

able level, as has been demonstrated from some preliminary unpub-

lished data regarding the Wingspan stent (Boston Scientific, Natick,
MA), I am confident that this type of treatment will replace medical
T he authors have presented the largest series of angioplasty and
stenting in the intracranial VB territory. Nearly all patients (42 out
of 44) had failed medical therapy (antiplatelets, anticoagulation, or
therapy, which has been shown to be ineffective in reducing long-term both). With the presumed poor natural history in these patients, it
risk of stroke resulting from intracranial atherosclerotic disease. In was reasonable to explore the use of stenting as a treatment option.
addition, drug-eluting stents may also reduce the incidence of The authors are to be congratulated on their honest assessment of
intrastent restenosis and occlusion. this procedure. With a 26.1% procedural complication rate and the
I congratulate the authors for their careful analysis of their findings current knowledge of the natural history from the Warfarin-Aspirin
and their contribution to the fact that this treatment is effective in Symptomatic Intracranial Disease study publications, they rightly state
reducing the risk of long-term stroke for intracranial atherosclerotic that using the coronary stent systems for this disease is untenable (2, 3).
disease of the VB system if the periprocedural morbidity and mortal- However, although the numbers are small, there is some tantaliz-
ity can equally be reduced. ing data hidden in this study. If the rate of stroke after a successful
Robert H. Rosenwasser procedure is very low (reported at 3%, with the remainder of evalu-
Philadelphia, Pennsylvania able patients having transient ischemic attacks only), we should
examine the aspects of this procedure that contribute to longer-term
stroke reduction risk. Only short-term data has been presented for
F iorella et al. report 44 patients with 47 symptomatic atheromatous
lesions of the VB system that were treated with BMCS. The techni-
cal success rate was 95.7%, and the average angiographic stenosis of
the Wingspan stent, but even it shows a higher 7% ipsilateral stroke
rate at 6 months (1). However, with 23% of patients lost to follow up
82.5% declined to 10.1% after stent placement. On the other hand, a in this current study, there is the possibility that the long-term stroke
high rate of periprocedural morbidity and mortality (26.1%) was risk is as high or higher than that seen in the Wingspan and
encountered. Warfarin-Aspirin Symptomatic Intracranial Disease trials (1, 3). Also,
The authors thoroughly describe disadvantages and possible risks of case series of angioplasty alone have shown much lower rates of
BMCS placement and mention the Gateway balloon-Wingspan stent procedural complications. Perhaps strategies that utilize the success-
system as a potential optimal option for symptomatic intracranial ful aspects of each therapy will be necessary to lower the procedural
atheromatous disease. Although the number of patients in the current risk while maintaining a lower long-term risk of stroke compared to
series is not large and angiographic follow-up data is available for only medical therapy.
11 patients, this article clearly presents practical problems associated There is other information that would be important to explore. It
with BMCS placement for symptomatic atheromatous VB system dis- would be interesting to map out the rate of complications by year for
ease and contributes to the literature on endovascular treatment of VB this study. Certainly, there were technical advances in the wires, stents,
intracranial atheromatous disease. and balloons used, and the operator experience increased throughout
the course of the study. Possibly, the numbers are too small to achieve
Junichi Yamamoto meaningful results. Also, over the 7-year period, there were 44 patients;
L. Nelson Hopkins in a busy institution, this may indicate that the authors were selective
Buffalo, New York in choosing which patients to treat. Tortuosity, proximal vessel disease,
and the anatomic characteristics of the lesions themselves have a great

F iorella et al. provide us with another evaluation of intracranial stent-

ing, this time a retrospective review of BMCS used off-label for
symptomatic VB atheromatous disease. Over a 7-year period, 44
impact on the risk profile of this treatment. In order to implement this
therapy, selection both by medical and anatomic factors is likely neces-
sary. These and many other questions remain. As the authors state, we
patients were treated with a high degree of stent-deployment success; will ultimately need a randomized trial.
however, the periprocedural morbidity and mortality were significant
in 26.1% of the cases. Additionally, angiographic follow-up data were Gary Duckwiler
limited and only 11 patients were evaluated. Despite these low num- Los Angeles, California
bers, the findings were alarming with three occluded vessels and one
with greater than 50% stenosis. Fifteen percent of patients with clinical
1. Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul
follow up had recurrent VB symptoms; three patients died.
J, Yu SC, Forsting M, Lui M, Lim W, Sit SP: A novel, self-expanding, nitinol
It is difficult to draw any specific comparisons between these data
stent in medically refractory intracranial atherosclerotic stenoses: The
and the limited information available for the currently available self- Wingspan study. Stroke 38:1531–1537, 2007.
expanding stent devices. The Stenting of Symptomatic Atherosclerotic 2. Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel
Lesions in the Vertebral or Intracranial Arteries Trial resulted in the MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG,
product not being released commercially. Referring physicians and Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial
neuroendovascular therapists should look very carefully at these Investigators: Comparison of warfarin and aspirin for symptomatic intracra-
reports and, as the authors suggest, support the development of a nial arterial stenosis. N Engl J Med 352:1305–1316, 2005.
prospective randomized evaluation of medical therapy versus intracra- 3. Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS,
Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano
nial endovascular therapy.
JG, Cloft HJ; Warfarin-Aspirin Symptomatic Intracranial Diesase Trial
Sean D. Lavine Investigators: Predictors of ischemic stroke in the territory of a symptomatic
New York, New York intracranial arterial stenosis. Circulation 113:555–563, 2006.

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