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Experimental Direct Measurement of Clot-Capturing Ability of Stent Retrievers-J.wneu.2018.09.106

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Experimental Direct Measurement of Clot-Capturing Ability of Stent Retrievers-J.wneu.2018.09.106

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Original Article

Experimental Direct Measurement of Clot-Capturing Ability of Stent Retrievers


Tomotaka Ohshima1, Reo Kawaguchi2, Yoshitaka Nagano3, Shigeru Miyachi1, Naoki Matsuo2, Masakazu Takayasu2

- BACKGROUND: Stent retrievers (SRs) can be used to INTRODUCTION


perform mechanical thrombectomy for the treatment of acute
major arterial occlusion. Recanalization is faster, and out-
comes are better with treatment involving these devices than
with internal treatment. Although several SRs are available,
F ast recanalization is essential for acute ischemic stroke
caused by major cerebral artery occlusion.1 Endovascular
approaches for acute ischemic stroke are continuously
evolving, and new stent retrievers (SRs) allow the immediate
restoration of cerebral blood flow. Recanalization is faster, and
their clot-capturing abilities are unclear. Therefore in the
present study, we numerically evaluated the clot-capturing success rates are higher with these devices than with previous
devices.2-4 However, the optimal selection and sequence of
abilities of SRs in an experimental vascular model.
stent devices, including the use of adjunctive techniques, are
- METHODS: A sham clot (urethane foam) was fixed with unclear.
sutures at the middle of a vascular model (polyvinyl chloride In the present experimental study, we aimed to evaluate the
tube). One end of the tube was connected to a measuring characteristics of currently available SRs and adjunctive techniques
instrument. From the other end, an SR was inserted and using an experimental vascular model, an equitable automatic
withdrawal machine, and a recording system.
deployed over the sham clot. The delivery wire of the stent
was then withdrawn at a constant velocity using an auto-
matic withdrawal machine. The maximum frictional force METHODS
before the stent left the clot was measured. Five stents
(Trevo ProVue [2 sizes], Revive, and Solitaire [2 sizes]) and Vascular Model and Sham Clot
three stent-deployment techniques (standard, push-and- A polyvinyl chloride tube (4 mm in diameter and 15 cm in length)
fluff, and wire-push techniques) were evaluated. was used as a vascular model. Urethane foam was used to create a
column-shaped sham clot (4 mm in diameter and 15 mm in
- RESULTS: The clot-capturing ability (maximum with- length). Konjac was initially used as a sham clot, according to a
drawing force [N: newton]) was greater for large-diameter previous report.5 It is a common Japanese jelly-like food that is
stents than for small-diameter stents (mean 0.39  0.11 vs. made from starch of taro. Although it appeared to be an accept-
0.56  0.18). For Trevo and Revive, the clot-capturing ability able material, it showed some changes with time. In addition, it
was highest with the push and fluff technique (mean 0.43  showed deterioration after repeated experiments. Therefore we
0.05). For Solitaire, the ability was the highest with the used a sham clot made of urethane foam. The results were similar
simple wire-push technique (mean 0.705  0.16). between fresh konjac and urethane clots. We confirmed that the
clot of urethane is similar numeric data to the clot of fresh konjac,
- CONCLUSIONS: We successfully numerically evaluated which could adjust hardness by its consistency. However, the
the clot-capturing abilities of SRs. The clot-capturing stability of urethane clots was greater than that of konjac, even
ability differed among SRs and among stent-deployment after repeated manipulations. This sham clot was fixed with 2
techniques. sutures at the middle of the vascular model. One end of the tube
was connected to a measuring instrument. From the other end of
the tube, an SR was inserted and deployed over the sham clot

Key words From the 1Neuroendovascular Therapy Center and 2Department of Neurosurgery, Aichi
- Acute ischemic stroke Medical University, Nagakute; and 3Department of Electronic Control and Robot Engineering,
- Endovascular treatment Aichi University of Technology, Nishihasama-cho, Gamagori, Aichi, Japan
- Experiment To whom correspondence should be addressed: Tomotaka Ohshima, M.D., Ph.D.
- Stent clot retriever [E-mail: [email protected]]
- Technique Citation: World Neurosurg. (2018).
https://doi.org/10.1016/j.wneu.2018.09.106
Abbreviations and Acronyms
Journal homepage: www.WORLDNEUROSURGERY.org
SR: Stent retriever
Available online: www.sciencedirect.com
1878-8750/$ - see front matter ª 2018 Elsevier Inc. All rights reserved.

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ORIGINAL ARTICLE
TOMOTAKA OHSHIMA ET AL. CLOT-CAPTURING ABILITY OF SRS

of 120 mm. The deployed stent was automatically withdrawn at


a speed of 1.0 mm/second.

Measurement and Recording System


All trials were monitored and recorded using an overhanging
charge-coupled-device video camera (Dino-Lite Digital Microscope
AM-2001; AnMo Electronics Corporation, New Taipei City,
Taiwan) (Figure 3). The measurement values were simultaneously
recorded on the video (Figure 4). The maximum friction force
Figure 1. A schematic drawing of the vascular model and sham clot. The
clot is fixed to the tube. The tube itself is freely mobilized. The
before the stent left the clot was recorded.
withdrawal force is measured using a sensor.
Stent Receivers and Deployment Techniques
The following 5 SRs of 3 different brands were evaluated: Trevo
ProVue (2 sizes; Stryker, Kalamazoo, MI), Revive (1 size; Codman,
(Figure 1). We prepared a negative control that involved a polyvinyl
Raynham, MA), and Solitaire Platinum (2 sizes; Medtronic, Irvine,
chloride tube without the sham clot for each stent.
CA) (Table 1). These devices were evaluated with the following 3
different deployment techniques. All stent deployments were
Equitable Automatic Withdrawal Machine performed within a temperature-controlled tray at 37 C. Each
A machine with a linear actuator to pull the delivery wire at a experiment was performed thrice, and the mean value was used in
constant velocity was designed and tested (Figure 2). The linear further analysis.
actuator included a stepping motor, a ball screw to convert the
rotational motion of the motor into a linear motion, and a Standard Technique. This technique involved positioning the SR
linear guide. It was capable of linear movement over a distance across the clot and simply unsheathing it by retracting the delivery
microcatheter with the left hand while immobilizing the delivery
wire with the right hand.

Push and Fluff Technique. Haussen et al6 reported an innovative


technique that involved continued push of the delivery wire to

Figure 2. Photograph of the apparatus. The vascular model with the Figure 3. Photograph of the system. The black arrow indicates the sham
sham clot (black arrow) is connected to the sensor (black arrowhead). clot in the vascular model. The black arrowhead indicates the linear
The white asterisk indicates the overhanging camera for recording. actuator that will pull the wire at a constant velocity.

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ORIGINAL ARTICLE
TOMOTAKA OHSHIMA ET AL. CLOT-CAPTURING ABILITY OF SRS

Figure 4. Photograph of the recorded video. (A) The in the session. The latter value indicates the
value at the upper left indicates the current clot-capturing ability of the stent. (B) On the way of
withdrawing force (N: newtons), and the value at the stent withdrawal.
upper right indicates the maximum withdrawing force

maximize stent expansion during deployment. Both the novel approach that allows direct experimental numerical
microcatheter and delivery wire were intermittently pushed to evaluation and comparison of different SRs and deployment
optimize stent impression against the clot. techniques.
For the same brand, we found that the clot-capturing ability
Simple Wire-Push Technique. After the distal end of the SR was was greater with large-diameter stents (6 mm) than small-
opened and anchored, only the delivery wire was pushed until the diameter stents (4 mm). The difference in the ability between
tip of the microcatheter became stagnant. Next, the deflection of stent sizes was greater for Solitaire Platinum than Trevo ProVue.
the microcatheter was retrieved with the left hand and the delivery Although Revive showed the lowest clot-capturing ability with the
wire was pushed again with the right hand (Figure 5). standard deployment, its clot-capturing ability was similar to that
of Trevo ProVue (4  20) with the adjunctive techniques. Trevo
RESULTS ProVue and Revive showed the highest clot-capturing ability with
The results of this study are presented in Figures 6e8. All negative the push-and-fluff technique, whereas Solitaire showed the
controls without the clot showed values <0.01 N. The highest clot-capturing ability with the simple wire-push tech-
clot-capturing ability (maximum friction force) was greater for nique. These results indicate that a tubing stent is suitable for the
large-diameter stents than small-diameter stents (mean 0.39  0. push-and-fluff technique, whereas a rolled sheet stent is suitable
11 vs. 0.56  0.18). Among all stents, the clot-capturing ability was for the simple wire-push technique in these experimental
greater with the adjunctive techniques than the standard tech- conditions.
nique. For Trevo ProVue and Revive, the clot-capturing ability was For beginners, the simple wire-push technique is easier than the
greater with the push-and-fluff technique than other techniques push-and-fluff technique. The degree of stent expansion can be
(mean 0.43  0.05). On the other hand, for Solitaire Platinum, the recognized from the deflection of the microcatheter. However, the
clot-capturing ability was greater with the simple wire-push push-and-fluff technique is challenging, especially for beginners,
technique than other techniques (mean 0.705  0.16). We could
not find any statistical significance in the study. We concluded
that there was only a tendency in this study.
Table 1. Stent Retrievers Evaluated in This Study
DISCUSSION
Size: Nominal
In cases of acute major arterial occlusion, recanalization has been Stent Retriever Diameter 3 Length (mm)
shown to be faster and outcomes have been shown to be better with
the use of an SR for mechanical thrombectomy than with internal Trevo ProVue 4  20, 6  25
treatments.7,8 Some innovative adjunctive techniques, such as the (Stryker, Kalamazoo, Michigan, USA)
push-and-fluff technique,7 have recently been developed, and Revive 4.5  22
authors have reported success while using several devices of (Codman, Raynham, Massachusetts, USA)
different sizes. However, no single combination that achieves the
Solitaire Platinum 4  20, 6  40
highest recanalization rates, fastest procedure time, and best (Medtronic, Irvine, California, USA)
clinical outcomes has been identified. Therefore we devised a

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ORIGINAL ARTICLE
TOMOTAKA OHSHIMA ET AL. CLOT-CAPTURING ABILITY OF SRS

Figure 5. A schematic drawing of the simple wire-push until the microcatheter stops unsheathing (C). Next, the
technique. Red arrows indicate the direction of deflection of the microcatheter (black arrowheads) is
manipulation. After the distal end of the stent is opened retrieved with the left hand (D), and the delivery wire is
and anchored (A), only the delivery wire is pushed (B) pushed again by the right hand (E).

because the process is difficult to recognize. Pushing the catheter clot might not be retrieved, and this is especially relevant for hard
and wire may cause an additional force. When the combined force is clots.
excessive, the clot might migrate piece by piece or the parent vessel The present study has some limitations. This study was not
might be injured. On the other hand, when the force is limited, the performed in a real-world setting, and thus it is not clear whether

Figure 6. Result of the standard technique.

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ORIGINAL ARTICLE
TOMOTAKA OHSHIMA ET AL. CLOT-CAPTURING ABILITY OF SRS

Figure 7. Result of the push-and-fluff technique.

our findings can be generalized to the clinical setting. Other needed to confirm our initial findings and assess these
vascular models and sham clots should be assessed in the future. possibilities.
It is possible that the straight and consistent tube model favored
better results with the Solitaire stent than with the other stents. CONCLUSIONS
However, this stent might be more harmful in a real-world setting. Here, we successfully numerically evaluated the clot-capturing
Arai et al9 reported that postoperative histologic changes of the abilities of SRs. The clot-capturing ability differed among SRs
intimal layers of rabbit carotid arteries were more common with and stent-deployment techniques, and it was better with adjunc-
the Solitaire stent than the Trevo stent. Further studies are tive techniques than with the standard technique.

Figure 8. Result of the wire-push technique.

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ORIGINAL ARTICLE
TOMOTAKA OHSHIMA ET AL. CLOT-CAPTURING ABILITY OF SRS

5. Ohshima T, Goto S, Yamamoto T, Ishikawa K. caused by stent retriever thrombectomy devices.


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e6 www.SCIENCEDIRECT.com WORLD NEUROSURGERY, https://doi.org/10.1016/j.wneu.2018.09.106

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