New Devices and Techniques

J NeuroIntervent Surg: first published as 10.1136/neurintsurg-2019-015671.rep on 3 March 2020. Downloaded from http://jnis.bmj.com/ on December 15, 2024 by guest. Protected by
Case report

First-­in-­human, robotic-­assisted neuroendovascular

intervention
Vitor Mendes Pereira ‍ ‍,1 Nicole Mariantonia Cancelliere,2 Patrick Nicholson,1
Ivan Radovanovic,3 Kaitlyn E Drake,4 John-­Michael Sungur,4 Timo Krings,1
Aquilla Turk4,5
1
Division of Neuroradiology, Abstract Imaging also showed a tortuous pathway through
Department of Medical Imaging Robotic-­assisted technology has been used as a tool the vertebral arteries.
and Division of Neurosurgery,
Department of Surgery, to enhance open and minimally invasive surgeries
University Health Network as well as percutaneous coronary and peripheral Treatment
- Toronto Western Hospital, vascular interventions. It offers many potential benefits, Given the size and high-­risk location of the aneu-
Toronto, Ontario, Canada including increased procedural and technical accuracy
2
Joint Department of Medical rysm, definitive treatment was recommended.
as well as reduced radiation dose during fluoroscopic After a discussion of the relative risks and benefits
Imaging, Toronto Western
Hospital, Toronto, Ontario, procedures. It also offers the potential for truly “remote”of stent-­assisted neuroendovascular coiling versus
Canada procedures. Despite these benefits, robotic technology open surgical microclipping, the patient consented
3
Division of Neurosurgery, has not yet been used in the neuroendovascular to elective neuroendovascular intervention with
Department of Surgery, field, aside from diagnostic cerebral angiography.
University Health Network assistance from a robotic system. She was placed on
- Toronto Western Hospital, Here, we report the first robotic-­assisted, therapeutic, ticagrelor 180 mg/day and aspirin (ASA) 81 mg for
Toronto, Ontario, Canada neuroendovascular intervention performed in a human. 5 days prior to treatment.
4
Corindus, a Siemens This was a stent-­assisted coiling procedure to treat a The CorPath GRX Robotic System (Corindus, a
Healthineers Company, large basilar aneurysm. All intracranial steps, including
Waltham, Massachusetts, USA Siemens Healthineers Company, Waltham, Massa-
5 stent placement and coil deployment, were performed chusetts, USA) is currently cleared for percutaneous
Prisma Healthcare - Upstate,
Greenville, South Carolina, USA with assistance from the CorPath^© GRX coronary and peripheral vascular interventions
Robotic System (Corindus, a Siemens Healthineers (PCI and PVI) in the USA, European Union and

copyright.
Correspondence to Company, Waltham, MA, USA). This represents a major other select countries, and for neuroendovascular
Dr Vitor Mendes Pereira, Division milestone in the treatment of neurovascular disease and
of Neuroradiology, Department
intervention in the European Union, Australia and
opens the doors for the development of remote robotic New Zealand. It is not currently cleared for any
of Medical Imaging and Division
neuroendovascular procedures. use in Canada. Therefore, the robotic system was
of Neurosurgery, Department
of Surgery, University Health approved for off-­label use for this procedure under a
Network - Toronto Western Special Access application submitted by the treating
Hospital, Toronto, Canada; ​
vitormpbr@​hotmail.​com Background interventionalist to Health Canada. The general
Unruptured intracranial aneurysms larger than 7 mm set-­ up of the robotic system has been described
3
Received 27 November 2019
are at high risk of rupture with potentially devas- previously (figure 2). Briefly, arterial access and
Revised 21 January 2020
Accepted 29 January 2020 tating consequences.1 2 Craniotomy with surgical guiding catheter placement are performed manu-
microclipping or neuroendovascular coiling has ally. Next, the tableside, articulating robotic arm is
been the traditional choice of treatment; however, moved to bring the drive system and a single-­use
adoption of other interventions such as balloon-­ cassette into position for patient access. Interven-
assisted or stent-­assisted procedures continues to tional devices—catheters, guidewires, stent systems
grow. New technical measures that can improve and coiling systems—are loaded by a tableside assis-
the ease and safety of these interventions, such as tant into appropriate tracks of the cassette, which
robotic technologies, are therefore of interest. In serves as the sterile interface between the robotic
this report, we describe the first use of a robotic system and the patient. The interventionalist sits
system to assist in a therapeutic neuroendovascular behind a mobile, radiation-­ shielded workstation
intervention. and uses joysticks and touchscreen controls to
advance, retract, rotate and deploy the devices as
needed. Recent software and engineering modifi-
Case presentation cations specific to neuroendovascular procedures
In October 2019, a 64-­year-­old woman presented were described recently and included an ‘advanced
© Author(s) (or their with severe unexplained vertigo. She was a non-­ cassette’ and accessory kit designed to accept
employer(s)) 2020. Re-­use smoker and had no hypertension and no relevant and manage microcatheters, coil-­assist stents and
permitted under CC BY-­NC. No family history of intracranial aneurysms.
commercial re-­use. See rights coiling systems, and a software automation called
and permissions. Published the Active Device Fixation, which allows for more
by BMJ. Investigations precise control of the relative positions of the
To cite: Mendes Pereira V, CT angiography and MRI showed a wide-­necked, devices as they move.4
Cancelliere NM, Nicholson P, >10 mm saccular sidewall aneurysm originating off The treating physician and team spent more than
et al. J NeuroIntervent Surg the distal basilar artery (figure 1A). This was causing 30 hours familiarising themselves with the system
2020;12:338–340. no oedema in the surrounding brain parenchyma. using a variety of patient-­specific simulators. On
Mendes Pereira V, et al. J NeuroIntervent Surg 2020;12:338–340. doi:10.1136/​neurintsurg-​2019-​015671.​rep 1 of 4
 New Devices and Techniques

J NeuroIntervent Surg: first published as 10.1136/neurintsurg-2019-015671.rep on 3 March 2020. Downloaded from http://jnis.bmj.com/ on December 15, 2024 by guest. Protected by
were loaded into the robotic cassette, and the robotic arm was
brought into position for the procedure.
Using the robotic controls at the control console, the primary
interventionalist advanced the microwire into the P1 segment
of the right posterior cerebral artery, followed by the microca-
theter. The microwire was removed from the robotic cassette
and exchanged for a 4.5 mm × 21 mm Neuroform Atlas nitinol
self-­expanding microstent (Stryker Neurovascular), which was
advanced through the microcatheter to the distal basilar artery.
The microcatheter was then slowly retracted using millimetric
controls on the touchscreen panel of the control console to
enable stent deployment within the basilar artery, beginning
Figure 1 Digital subtraction angiography (DSA) images during the just proximal to the basilar bifurcation and extending across
robotic-­assisted neurointerventional procedure (anterior-­posterior view). the neck of the aneurysm.
(A) Preoperative imaging of a right vertebral injection showing the With the stent fully deployed, the stent delivery device was
sidewall basilar trunk aneurysm measuring 12 mm × 11 mm. (B) DSA removed from the robotic cassette and exchanged for the
per-­procedure imaging showing the Atlas stent deployed at the basilar microguidewire again, which was navigated, under robotic
artery below the bifurcation and across the aneurysm neck, and the first control, through the interstices of the stent wall into the
coil deployed inside the aneurysm. (C) Final DSA demonstrating the final aneurysmal lumen. The microcatheter was advanced over the
coil cast. (D) Final DSA showing the aneurysm occluded and a patent microwire, which was removed from the robotic cassette and
stent, with no perioperative complications. exchanged for the first embolic coil (Medtronic Neurovascular
Axium Prime, 10 mm × 20 cm). The coil was slowly advanced,
taking care not to allow the distal end of the coil to cross the
the day before the procedure, the complete interventional team stent back out into the lumen of the basilar artery. Once the first
performed two full procedure rehearsals to plan the steps and coil was fully deployed into the aneurysmal sac and detached
communication protocols while using a patient-­ specific flow from its delivery device, additional successive coils of progres-
model of the relevant neurovascular anatomy. The model was sively smaller sizes were exchanged into the robotic cassette
three-­dimensionally printed by Biomodex (Dassault Systemes, and similarly deployed into the aneurysmal lumen, all under
France), based on the patient’s 4D CT Angiogram (4DCTA) data. robotic control (figure 1B,C). The eighth coil encountered
The clinical procedure was performed under general anaes- resistance during deployment, and the resulting back-­pressure
thesia. Intravenous heparin bolus and maintenance doses were forced the microcatheter back out of the aneurysm. The

copyright.
administered to maintain an activated clotting time of approx- microcatheter was repositioned robotically, but when the coil
imately 300 s throughout the procedure. At bedside, a special- was advanced again it met with additional resistance, causing
ised robotic technologist managed the loading and exchange the robotic cassette to register an error. The coil was removed
of devices within the robotic system, and two neurointerven- and the cassette replaced with a new cassette. Six additional,
tionalists remained with the patient for safety purposes. The smaller coils were placed without incident, with the smallest
primary neurointerventionalist (VMP) operated the robot coil being 2.5 mm × 6 cm. Final angiogram confirmed a well-­
from the mobile workstation, which was situated at the distal packed aneurysm and a stent within the lumen of the basilar
end of the angiography room from the patient. artery, completely crossing the aneurysmal neck (figure 1D).
For the manual portion of the procedure, a 6F, 0.088-­inch To close the procedure, all devices were removed from the
inner diameter, 90 cm femoral sheath (Neuron MAX 088; patient and femoral haemostasis was achieved by 8F Angio-­
Penumbra, Alameda, California, USA) was placed and advanced Seal closure device (Terumo Medical, Phoenix, Arizona). She
to the right subclavian artery. An intermediate catheter (Sofia was brought to the post anesthesia (PACU) for recovery. Proce-
6F; Microvention, Irvine, California, USA) was then advanced dure time was 2 hours and 9 min.
up the V4 segment of the right vertebral artery. In preparation
for the robotic portion of the procedure, a 1.7F microcath- Outcome and follow-up
eter (Excelsior SL-10; Stryker Neurovascular, Fremont, USA) The patient experienced no complications and was discharged
and 0.014-­inch microwire (Synchro; Stryker Neurovascular) on the day following the procedure. Follow-­ up MRI/MR
Angiogram (MRA) performed 2 weeks later showed complete
obliteration of the aneurysm. At the time of this report, the
patient is doing well and has returned to normal activities.

Discussion
In this report we describe the first clinical use of robotic assis-
tance for neuroendovascular intervention. While originally
designed to manipulate the larger-­gauge devices used for PCI
and PVI, the robotic system has undergone a number of engi-
neering and software modifications to facilitate the use of
Figure 2 CorPath GRX Robotic System. (A) Robotic arm with smaller microcatheters and microwires, and longer working
advanced cassette. (B) The set-­up of the procedure. The primary lengths, necessary for intracranial access and intervention.
neurointerventionalist was located in the corner of the angiography Robotic technology is used for procedural assistance in an
room in a radiation-­shielded workstation. At bedside, the team consisted increasing number of surgical and interventional specialties.
of the specialised robotic technologist and two neurointerventionalists In neurosurgery, robotic assistance has been used for epilepsy
who load the devices and control the perfused lines and hubs. evaluation,5 subcortical surgery6 and spine surgery.7 We
2 of 4 Mendes Pereira V, et al. J NeuroIntervent Surg 2020;12:338–340. doi:10.1136/​neurintsurg-​2019-​015671.​rep
 New Devices and Techniques

J NeuroIntervent Surg: first published as 10.1136/neurintsurg-2019-015671.rep on 3 March 2020. Downloaded from http://jnis.bmj.com/ on December 15, 2024 by guest. Protected by
identified only one report of a robotic system used for cerebral Our patient had a high-­risk aneurysm with tortuous anatomy
angiography, in which Vuong and colleagues8 describe the use and a location close to the basilar tip, potentially complicating
of the Magellan Robotic Catheter System (Hansen Medical, stent placement. Although the neurointerventionalist in this
Mountain View, California, USA), but no intervention was case was highly experienced and could have managed this case
performed nor was the system adapted to microcatheter and manually, this scenario represented an excellent example of
microwire manipulation. the kinds of cases in which the robot’s smooth, precise move-
The CorPath robotic platform has been in use since 2012 for ments were advantageous for navigation, stent placement and
PCI and was subsequently cleared in the USA for PVI. Experi- coiling. We found the system easy to use, and also found that
ence with these indications has shown that the key benefits of preprocedural training and preparation, clear definition of
robotic assistance include increased procedural and technical roles, and structured communication protocols were essential
accuracy, as well as reduced radiation dose during fluoroscopic to the team’s comfort with this new technology.
procedures. It also offers the potential for truly ‘remote’
procedures.3 9–11 Learning points
The set-­up for a robotic intervention is different from a classic
neuroendovascular procedure. Instead of one operator team ►► Neuroendovascular intervention using robotic assistance is
beside the patient, there are two teams in the robotic interven- feasible.
tion, one at bedside and another at the remote console, both ►► Robotic assistance improves the precision of
of which have to work in tune and in close communication neuroendovascular procedures while reducing radiation
during all steps of the procedure. When preparing this proce- exposure to the interventionalist.
dure, two rehearsals with a patient-­specific model (EVIAS, ►► Robotic systems such as the one used here open up the
Biomodex, Paris, France) were performed, and in addition to possibility of remote intervention, such as for stroke
practising the procedure itself we also worked on the commu- treatment.
nication and commands to be used during the procedure. ►► Team training, communication and preparation are essential
In our view, assistive robotic technologies have the poten- in the successful adoption of this technology.
tial to expand the current boundaries of neurointervention;
however, no technology is without limitations. In particular, Twitter Vitor Mendes Pereira @VitorMendesPer1
some interventionalists may wonder about the loss of tactile
Acknowledgements JM provided professional medical writing assistance. The
feedback felt during manual procedures. Using the robotic
medical writer worked at the direction of the authors.
system, we found that our ability to detect obstacles and fric-
Funding The authors have not declared a specific grant for this research from any
tion visually, by watching for subtle changes in the shape and

copyright.
funding agency in the public, commercial or not-­for-­profit sectors.
motion of devices, was more than sufficient to compensate for
Competing interests VMP, NC, PN, IR, and TK have no conflicts to disclose. KED,
the altered sensory profile. The console offers better visuali-
JMS, and AT are employees of Corindus.
sation of the screen compared with the bedside (figure 3) and
Patient consent for publication Obtained.
the operator is seated comfortably, operating the robotic arm
through the joysticks and the touchscreen controls. Again, Provenance and peer review Not commissioned; externally peer reviewed.
successful adaptation to robotic assistance and realisation Open access This is an open access article distributed in accordance with the
of its full benefits will depend on training, focus and team Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-­commercially,
communication. The addition of force-­sensing and feedback and license their derivative works on different terms, provided the original work is
technology, along with additional automations for the naviga- properly cited, appropriate credit is given, any changes made indicated, and the use
tional system, are areas for future exploration. is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/.

ORCID iD
Vitor Mendes Pereira http://​orcid.​org/​0000-​0002-​6804-​3985

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