ORIGINAL RESEARCH
INTERVENTIONAL
Balloon-Guide Catheters Are Needed for Effective Flow
Reversal during Mechanical Thrombectomy
X O. Nikoubashman, X D. Wischer, X H.M. Hennemann, X J. Sandmann, X T. Sichtermann, X F.S. Müschenich, X A. Reich, and
X M. Wiesmann
ABSTRACT
BACKGROUND AND PURPOSE: Blood flow management in the carotid artery during mechanical thrombectomy is crucial for safety and
effectiveness. There is an ongoing discussion about whether balloon-guide catheters or large-bore sheaths are needed for effective flow
management. We compared general flow characteristics of proximal aspiration through a large-bore sheath and a balloon-guide catheter
in a porcine in vivo model.
MATERIALS AND METHODS: We investigated blood flow in a porcine common carotid artery with and without aspiration (VacLok
syringe and Penumbra pump, Pump MAX) through an 8F-long sheath and an 8F balloon-guide catheter. Blood hemodynamics were
assessed via continuous duplex sonography.
RESULTS: Average vessel diameter and baseline blood flow were 4.4 ⫾ 0.2 mm and 244 ⫾ 20 mL/min, respectively. For the 8F sheath,
pump aspiration resulted in a significant flow reduction (225 ⫾ 25 mL/min, P ⬍ .001), but with a persisting antegrade stream. Manual
aspiration resulted in collapse of the vessel in 2 of 7 measurements and oscillatory flow with antegrade systolic and retrograde diastolic
components in the remaining 5 measurements. Net flow was antegrade (52 ⫾ 44 mL/min) in 3 and retrograde (⫺95 ⫾ 52 mL/min) in the
remaining 2 measurements. For balloon-guide catheters, balloon inflation always resulted in flow arrest. Additional pump or manual
aspiration resulted in significant flow reversal of ⫺1100 ⫾ 230 and ⫺468 ⫾ 46 mL/min, respectively (both, P ⬍ .001).
CONCLUSIONS: Only balloon-guide catheters allow reliable blood flow arrest and flow reversal in combination with aspiration via
syringes or high-flow pump systems. Aspiration through an 8F sheath results in either collapse of the vessel or oscillatory flow, which can
result in a net antegrade or retrograde stream.
ABBREVIATIONS: BGC ⫽ balloon-guide catheter; CCA ⫽ common carotid artery
E ndovascular mechanical thrombectomy has been established
as the standard treatment option for acute ischemic stroke
caused by large-vessel occlusion.1 Even though the basic principle
TIS) Registry data, that BGCs are associated with higher rates of
good clinical outcome (mRS ⱕ 2), successful revascularization, a
trend toward higher rates of complete first-pass revascularization,
of mechanical thrombectomy is established, actual procedures and a lower number of overall passes.7 Because these data are not
differ in many ways, ranging from the choice of stent retrievers to derived from randomized prospective trials, it is possible that the
the choice of access catheters.2-4 Recent clinical studies imply bet- superiority of BGCs simply reflects their being used by more ex-
ter procedural and clinical outcomes for patients who are treated
perienced interventionalists. Nonetheless, it is reasonable that
with balloon-guide catheters (BGCs) compared with other carot-
blood flow management in the carotid artery is crucial for safety
id-access catheters such as large-bore sheaths.5,6 Zaidat et al5
and effectiveness during mechanical thrombectomy.8 It has been
found, in their analysis of the Systematic Evaluation of Patients
Treated With Stroke Devices for Acute Ischemic Stroke (STRA- shown that thrombectomy maneuvers produce thousands of
small clot fragments that may occlude small arterioles and capil-
laries.4 The result can be small infarctions that can have a relevant
Received April 30, 2018; accepted after revision August 13.
clinical impact despite being invisible on MR imaging.9,10 Hence,
From the Departments of Diagnostic and Interventional Neuroradiology (O.N.,
D.W., H.M.H., J.S., T.S., F.S.M., M.W.) and Neurology (A.R.), RWTH Aachen University flow arrest is important regardless of the specific thrombectomy
Hospital, Aachen, Germany. technique (eg, classic stent-retriever thrombectomy, A Direct As-
Please address correspondence to Omid Nikoubashman, MD, Klinik für Neuroradi-
ologie, Universitätsklinikum Aachen, Pauwelsstr 30, 52074 Aachen, Germany;
piration First Pass Technique [ADAPT], Solumbra, or other
e-mail:
[email protected] techniques). Antegrade blood flow should be reversed during me-
http://dx.doi.org/10.3174/ajnr.A5829 chanical thrombectomy to prevent embolization of clot frag-
AJNR Am J Neuroradiol 39:2077– 81 Nov 2018 www.ajnr.org 2077
ments.8 This is usually attempted via blood aspiration through an
access catheter in the internal carotid artery . There is a variety of
access catheters, ranging from small (5F–7F) guiding catheters
to large-bore sheath catheters (8F) and BGCs, but there is no
consensus about which access catheter is most suitable.4,8,11-13
Mechanical thrombectomy is becoming more common, and
many interventionalists must decide which technique to choose.
Because empiric data are lacking and large randomized prospec-
tive studies are needed to resolve this issue from a clinical point of
view, we addressed this question with a simple technical ap-
proach. To reflect basic principles of flow management in real-life
settings, we quantified and compared flow characteristics and as-
piration volumes of proximal aspiration through a large-bore
sheath and a BGC with both manual and pump aspiration. Be-
cause it is practically impossible to quantify blood flow during
mechanical thrombectomy in the ICA, let alone in the cerebral
arteries, we decided to investigate flow characteristics in an in vivo
porcine model.
MATERIALS AND METHODS
All experiments were performed on 4 female Landrace swine
(weight, 50 – 60 kg) with peri- and intrainterventional manage-
ment as reported previously.14 The experiments were performed
in accordance with the German legislation governing animal
studies following the “Guide for the Care and Use of Laboratory
Animals” (https://grants.nih.gov/grants/olaw/Guide-for-the-
Care-and-use-of-laboratory-animals.pdf) and the “Directive
2010/63/EU on the Protection of Animals Used for Scientific Pur-
poses” (https://www.researchgate.net/publication/233428185_
DIRECTIVE_201063EU_on_the_protection_of_animals_used_
for_scientific_purposes). Official permission was granted from
the governmental animal care and use office, Landesamt für
Natur, Umwelt und Verbraucherschutz Nordrhein-Westfalen,
Recklinghausen, Germany.
We investigated flow in a porcine common carotid artery
(CCA) with and without aspiration through a large-bore sheath
and a BGC. We chose the CCA because its diameter is comparable
with that of the human ICA.15 We adapted flow in the CCA, which
has a physiologic blood flow that is twice as high the human ICA FIG 1. Schematic illustration of the porcine anatomy and the experi-
mental setup. The catheter (thick gray line) is placed in the common
blood flow, by injecting blood clots into the subsequent arteries. carotid artery, which has a diameter comparable with that of the
This procedure was repeated until a blood flow between 200 and human internal carotid artery. The flow in the CCA was reduced to
280 mL/min was achieved in the target vessel. We assessed blood comparable values by clogging the subsequent vessels. US indicates
sonography probe; ECA, external carotid artery; MA, maxillary artery;
flow via duplex sonography (LOGIQ S8; GE Healthcare, Milwau- AP, ascending pharyngeal artery; RM, rete mirabile; CW, circle of Wil-
kee, Wisconsin) by measuring vessel diameter and flow speed us- lis. Note that swine have a true bovine arch and that the internal
ing the built-in software and GraphClick software (Arizona Soft- carotid arteries arise from the rete mirabile, which is a spongiform
conglomerate of blood vessels that serves as a filter for clots.
ware, Neuchâtel, Switzerland).
Instead of testing all possible access catheters ranging from 5F assessed 7–10 cm distal to the sheath/BGC tips (Fig 1). We did not
guide catheters to large-bore sheaths, we chose 1 large-bore sheath measure immediately behind the catheter tips to avoid measuring
and 1 large-bore BGC to investigate flow characteristics in 2 set- blood flow in areas of turbulent flow. After quantifying the base-
ups that supposedly allow maximum flow control. We used an line blood flow in the CCA, we quantified blood flow with and
8F-long sheath, Shuttle Select (Cook, Bloomington, Indiana; without aspiration through the sheath and the inflated BGC. As-
outer diameter, 3 mm; inner diameter, 2.87 mm) and an 8F Flow- piration was performed manually with a 60-mL VacLok syringe
Gate II BGC (Concentric Medical, Mountain View, California; (Merit Medical Systems, South Jordan, Utah) and with a Penum-
outer diameter, 2.7 mm; inner diameter, 2.1 mm), which are cur- bra pump, Pump MAX (Penumbra, Alameda, California), which
rently the largest of the most commonly used proximal access is the most common aspiration pump, with the recommended
catheters. Sheaths and BGCs were introduced through a femoral vacuum pressure of ⫺25.5 Hg. All experiments were performed at
access and placed 5–7 cm behind the CCA origin. Blood flow was least 7 times, and all measurements were included in our final
2078 Nikoubashman Nov 2018 www.ajnr.org
FIG 3. Oscillatory blood flow with antegrade flow in systole and ret-
rograde flow in diastole after manual aspiration through the 8F
sheath.
FIG 2. A, Typical sonography blood flow profile in the common ca-
rotid artery in our model. B, Typical flow profile in the common ca-
rotid artery during pump aspiration through an 8F sheath. Note that
the profile is almost unchanged and flow remains antegrade. C, This
feature is likely because aspiration results in an additional pressure
gradient that mobilizes additional flow from the aortic arch into the
CCA along the catheter (C, light arrows), while antegrade flow in the
distal CCA is maintained (C, dark arrows).
analysis. Because our experiments resulted in considerable blood
loss, not all experiments were repeated in all swine. However,
every setup was performed in at least 2 swine to increase the vari-
ance. To restrict aspirated blood volume, we performed only 3
aspiration experiments with an inflated BGC as a proof of princi-
ple. Blood flow was assessed regularly between experiments to
anticipate unnoticed shifts of baseline values.
Statistical Analysis
Student t tests were used for comparison of flow volumes after
testing our data for normal distribution with a Shapiro-Wilk test. FIG 4. A, Balloon inflation results in flow arrest in the CCA. B, Manual
aspiration through an inflated BGC results in a constant and significant
P values of an ␣ level of ⱕ.05 were significant. All statistical anal- flow reversal.
yses were performed with SPSS 23 software (IBM, Armonk, New
York). aspirated through an inflated BGC compared with the 8F sheath,
regardless of pump or syringe aspiration (both, P ⬍ .001).
RESULTS
The average diameter of the CCA and baseline blood flow were DISCUSSION
4.4 ⫾ 0.2 mm and 244 ⫾ 20 mL/min, respectively (Fig 1). The 8F Ever since mechanical stroke treatment has been established as a
sheath resulted in an average reduction of vessel diameter and standard treatment technique, the focus of neurointerventional
cross-sectional area of 61% and 37%, respectively, and the sheath stroke research has shifted to finding the optimal treatment tech-
did not significantly reduce blood flow (236 ⫾ 25 mL/min, P ⫽ niques.1,2,4,16-18 Proximal aspiration in the ICA to achieve flow
.19). Pump aspiration resulted in a significant flow reduction with reversal has been established as a standard technique for mechan-
a net flow of 225 ⫾ 25 mL/min (P ⬍ .001) (Fig 2). However, flow ical thrombectomy. In an average patient and without application
always remained antegrade, and there was no flow arrest or rever- of a balloon-guide catheter, which restricts antegrade flow, the
sal. Manual aspiration through the 8F sheath resulted in collapse amount of aspirated blood in the ICA should surpass its normal
of the vessel in 2 of 7 measurements. In the remaining 5 measure- flow of 240 mL/min to achieve reliable flow reversal.19 There is an
ments, there was an oscillatory flow with antegrade flow in systole ongoing discussion of whether BGCs or large-bore sheaths are
and retrograde flow in diastole (Fig 3). Net flow was antegrade needed for effective flow management. Large-bore sheaths allow
(52 ⫾ 44 mL/min) in 3 of 5 measurements and retrograde (⫺95 ⫾ aspiration of high-flow volumes up to approximately 1000 mL/
52 mL/min) in the remaining 2 measurements. min.20 However, the handling of these sheaths is rather compli-
The noninflated 8F BGC in the CCA led to an average reduc- cated because their stiffness necessitates additional guiding
tion of vessel diameter and cross-sectional area of 61% and 37%, catheters for placement. BGCs allow reliable occlusion of the re-
respectively, and slightly reduced blood flow (from 244 ⫾ 20 to spective artery and consecutive reduction of antegrade flow.
228 ⫾ 22 mL/min, P ⫽ .02). Balloon inflation always resulted in However, rather difficult handling and their comparably small
arrest of antegrade flow (Fig 4). Additional pump aspiration and inner diameters, which restrict the choice of catheters/devices that
manual aspiration through an inflated BGC resulted in a constant can be introduced through the BGC, prevent many intervention-
and significant flow reversal with a flow of ⫺1100 ⫾ 230 and alists from using BGCs.
⫺468 ⫾ 46 mL/min, respectively (both, P ⬍ .001) (Fig 4). Net Our results show that the choice of carotid access catheter has
flow in the carotid artery was significantly lower when blood was in important impact on blood flow in the target vessel. We have
AJNR Am J Neuroradiol 39:2077– 81 Nov 2018 www.ajnr.org 2079
found that only BGCs allow reliable flow arrest in our in vivo Such an experiment would need transcranial Doppler measure-
porcine model. In a patient, this does not mean that balloon in- ments in patients during thrombectomy, which is impossible due
flation results in arrest of cerebral perfusion because collaterals to the artifacts caused by the microcatheter and stent retriever in
may maintain cerebral blood flow distal to the occlusion site. As place. As an approximation, we estimated the following: Physio-
long as the clot is located above the circle of Willis, flow from the logic blood flow in an internal carotid artery is approximately 240
posterior and anterior communicating arteries and the ophthal- mL/min. It has been shown that aspiration flow through an 8F
mic artery can sustain the full physiologic flow volume of the ICA BGC with pump and syringe aspiration can surpass 350 mL/min
and may cause embolization of clot fragments.21 Consequently, (pump) and 500 mL/min (syringe), which again should be suffi-
aspiration of blood through an inflated BGC is necessary for reli- cient to allow flow arrest despite collateral flow. Nonetheless,
able retrograde flow and control of peripheral embolization. As- there remains the possibility that collateral flow through the circle
piration through the BGC with the syringe and with the Penum- of Willis may be enough to maintain antegrade cerebral blood
bra pump resulted in constant retrograde flow. However, only the flow despite high-aspiration flow volumes.20 Also, due to the na-
syringe achieved high flow that surpassed the required antegrade ture of our study, we could not investigate whether flow reversal
flow rate of 240 mL/min for reliably reverting blood flow at the has an effect on clinical outcome, but our results may serve as a
level of the terminal segment of the internal carotid artery. There- foundation for future research that specifically addresses this
fore, we discourage using the Penumbra pump if flow reversal question. Also, even though the porcine cardiovascular system
during mechanical thrombectomy is intended. serves as an excellent model, it may be arguable whether our
Surprisingly, aspiration with large-bore sheaths did not neces- quantitative results can be translated to patients without restric-
sarily result in flow arrest or reversal, despite high-aspiration flow tions. Nonetheless, because it is impossible to conduct such an
volumes. Aspiration through an 8F sheath with a syringe or a experiment in patients the porcine model is the best approxima-
Penumbra pump results in flow volumes of ⬇800 and ⬇240 mL/ tion to real life.22 Last, flow volume measurements based on du-
min, respectively.20 By simply adding antegrade and retrograde plex sonography may not always reflect actual flow volumes and
flow, we would have expected a net backward flow of ⬎500 mL/ are a minor limitation of our study.23 However, even if flow vol-
min with the syringe and flow arrest with the Penumbra pump. umes are over- or underestimated, our results remain valid on a
However, aspiration through an 8F sheath did not result in reli- qualitative level because the direction of flow is unaffected by the
able flow reversal. At best, there was oscillatory flow with small net measuring method.
backward flow volumes, which would not suffice to reverse blood
flow above the circle of Willis. This behavior is likely because CONCLUSIONS
aspiration results in an additional pressure gradient that mobi- Only BGCs allow reliable flow reversal and should be used with
lizes additional flow from the aortic arch into the CCA along the syringes or high-flow pump systems. Aspiration through an 8F
catheter while antegrade flow in the ICA is maintained (Fig 2). In sheath in the ICA results in either collapse of the vessel or oscilla-
the worst-case scenario, aspiration resulted in vessel collapse, tory flow with antegrade flow in systole and retrograde flow in
which coincides with our clinical experience: During our inter- diastole, which can result in a net antegrade or retrograde flow.
ventions, we have found that when too much suction is applied,
blood cannot be aspirated until the suction is decreased either Disclosures: Martin Wiesmann—UNRELATED: Consultancy: Stryker Neurovascular;
Payment for Lectures Including Service on Speakers Bureaus: Bracco, Medtronic,
because the catheter tip has engaged the vessel wall or—as we Siemens, Stryker Neurovascular; Payment for Development of Educational Presen-
surmise—the vessel collapsed. Vessel collapse in perfused vessels tations: Abbott, ab medica, Acandis, Bayer HealthCare, Bracco, B. Braun, Codman
Neurovascular, Kaneka Pharma Europe, Medtronic, Dahlhausen Medizintechnik, Mi-
is mainly due to the Bernoulli effect, which causes the vessel walls
croVention, Penumbra, phenox, Philips Healthcare, Route 92, Siemens, Silk Road
to converge during aspiration of high flow volumes. This issue is Medical, St. Jude, Stryker Neurovascular.* *Money paid to the institution.
relevant in clinical practice because it is almost impossible to pre-
dict vessel collapse: Many factors such as flow volume, position of
the catheter, occlusion site, and the diameter of the vessel and its REFERENCES
rigidity have an impact on the applied forces that cause vessel 1. Goyal M, Menon BK, van Zwam WH, et al; HERMES collaborators.
collapse. Given that aspiration with large-bore sheaths did not Endovascular thrombectomy after large-vessel ischaemic stroke: a
meta-analysis of individual patient data from five randomised tri-
reliably result in flow arrest or reversal, we discourage using large- als. Lancet 2016;387:1723–31 CrossRef Medline
bore catheters or sheaths for flow arrest in the ICA, regardless of 2. Maus V, Behme D, Kabbasch C, et al. Maximizing first-pass com-
syringe or pump aspiration. Furthermore, we specifically discour- plete reperfusion with SAVE. Clin Neuroradiol 2018;28:327–38
age using smaller guiding catheters (5F–7F), which are very com- CrossRef Medline
3. Turk AS, Frei D, Fiorella D, et al. ADAPT FAST study: a direct aspi-
mon because of their easy handling and low cost but face the same
ration first pass technique for acute stroke thrombectomy. J Neu-
issue of insufficient aspiration like the larger sheath tested in our rointerv Surg 2014;6:260 – 64 CrossRef Medline
experiment. Notably, even under ideal conditions (perfect vacuum 4. Chueh JY, Puri AS, Wakhloo AK, et al. Risk of distal embolization
and no external resistors), aspiration flow through a 6F catheter with with stent retriever thrombectomy and ADAPT. J Neurointerv Surg
a stent retriever in its lumen does not reach 240 mL/min.17 2016;8197–202 CrossRef Medline
5. Zaidat O, Liebeskind D, Jahan R, et al. O-005 influence of balloon,
conventional, or distal catheters on angiographic and technical
Limitations outcomes in STRATIS. J Neurointerv Surg 2016;8(Suppl 1):A3.2– 4
A major limitation of our study is that it does not allow assessing CrossRef
whether cerebral blood flow above the circle of Willis is reversed. 6. Velasco A, Buerke B, Stracke CP, et al. Comparison of a balloon
2080 Nikoubashman Nov 2018 www.ajnr.org
guide catheter and a non-balloon guide catheter for mechanical 15. Mühlenbruch G, Nikoubashman O, Steffen B, et al. Endovascular
thrombectomy. Radiology 2016;280:169 –76 CrossRef Medline broad-neck aneurysm creation in a porcine model using a vascular
7. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Systematic plug. Cardiovasc Intervent Radiol 2013;36:239 – 44 CrossRef Medline
evaluation of patients treated with neurothrombectomy devices for 16. Wiesmann M, Brockmann MA, Heringer S, et al. Active push deploy-
acute ischemic stroke: primary results of the STRATIS Registry. ment technique improves stent/vessel-wall interaction in endovas-
Stroke 2017;48:2760 – 68 CrossRef Medline cular treatment of acute stroke with stent retrievers. J Neurointerv
8. Chueh JY, Kühn AL, Puri AS, et al. Reduction in distal emboli with Surg 2017;9:253–56 CrossRef Medline
proximal flow control during mechanical thrombectomy: a quan- 17. Nikoubashman O, Alt JP, Nikoubashman A, et al. Optimizing endo-
titative in vitro study. Stroke 2013;44:1396 – 401 CrossRef Medline vascular stroke treatment: removing the microcatheter before clot
9. Jouvent E, Poupon C, Gray F, et al. Intracortical infarcts in small retrieval with stent-retrievers increases aspiration flow. J Neuroin-
vessel disease: a combined 7-T postmortem MRI and neuropatho- terv Surg 2017;9:459 – 62 CrossRef Medline
logical case study in cerebral autosomal-dominant arteriopathy 18. Massari F, Henninger N, Lozano JD, et al. ARTS (Aspiration-Re-
with subcortical infarcts and leukoencephalopathy. Stroke 2011;42:
triever Technique for Stroke): initial clinical experience. Interv
e27–30 CrossRef Medline
Neuroradiol 2016;22:325–32 CrossRef Medline
10. Shih AY, Blinder P, Tsai PS, et al. The smallest stroke: occlusion of
19. Schöning M, Walter J, Scheel P. Estimation of cerebral blood flow
one penetrating vessel leads to infarction and a cognitive deficit.
through color duplex sonography of the carotid and vertebral ar-
Nat Neurosci 2013;16:55– 63 CrossRef Medline
teries in healthy adults. Stroke 1994;25:17–22 CrossRef Medline
11. Eesa M, Almekhlafi MA, Mitha AP, et al. Manual aspiration throm-
20. Nikoubashman O, Wischer D, Hennemann HM, et al. Under
bectomy through balloon-tipped guide catheter for rapid clot bur-
den reduction in endovascular therapy for ICA L/T occlusion. Neu- pressure: comparison of aspiration techniques for endovascular
roradiology 2012;54:1261– 65 CrossRef Medline mechanical thrombectomy. AJNR Am J Neuroradiol 2018;39:905– 09
12. Lally F, Soorani M, Woo T, et al. In vitro experiments of cerebral CrossRef Medline
blood flow during aspiration thrombectomy: potential effects on 21. Eckard DA, Purdy PD, Bonte FJ. Temporary balloon occlusion of the
cerebral perfusion pressure and collateral flow. J Neurointerv Surg carotid artery combined with brain blood flow imaging as a test to
2016;8:969 –72 CrossRef Medline predict tolerance prior to permanent carotid sacrifice. AJNR Am J
13. Madjidyar J, Hermes J, Freitag-Wolf S, et al. Stent-thrombus Neuroradiol 1992;13:1565– 69 Medline
interaction and the influence of aspiration on mechanical 22. Gralla J, Schroth G, Remonda L, et al. A dedicated animal model for
thrombectomy: evaluation of different stent retrievers in a circula- mechanical thrombectomy in acute stroke. AJNR Am J Neuroradiol
tion model. Neuroradiology 2015;57:791–97 CrossRef Medline 2006;27:1357– 61 Medline
14. Nikoubashman O, Pjontek R, Brockmann MA, et al. Retrieval of 23. Burns PN, Jaffe CC. Quantitative flow measurements with Doppler
migrated coils with stent retrievers: an animal study. AJNR Am J ultrasound: techniques, accuracy, and limitations. Radiol Clin
Neuroradiol 2015;36:1162– 66 CrossRef Medline North Am 1985;23:641–57 Medline
AJNR Am J Neuroradiol 39:2077– 81 Nov 2018 www.ajnr.org 2081