12 9 15 Endovascular Syllabus

2015-12-09

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12/8/2015

Endovascular Treatment of Acute Ischemic
Stroke: Review of Recent Trials
Venu Vadlamudi, MD
NeuroInterventional Radiology
Vascular & Interventional Radiology
Association of Alexandria Radiologists, PC
INOVA Alexandria Hospital

No relevant disclosures

Objectives
• Review 2015 endovascular stroke trials and
impact on clinical practice
• Review updated AHA/ASA guidelines for
endovascular treatment of acute ischemic stroke

12/8/2015

2015 Endovascular Stroke
Trials

• MR CLEAN – Multicenter Randomized Clinical Trial of
Endovascular Treatment for Acute Ischemic Stroke in the
Netherlands
• ESCAPE – Endovascular Treatment for Small Core and Proximal
Occlusion Ischemic Stroke
• EXTEND-IA – Extending the Time for Thrombolysis in
Emergency Neurological Deficits - Intra-Arterial
• SWIFT PRIME – Solitaire With the Intention For Thrombectomy
as Primary Endovascular Treatment
• REVASCAT – Endovascular Revascularization With Solitaire
Device Versus Best Medical Therapy in Anterior Circulation
Stroke Within 8 Hours
• THRACE – Trial and Cost Effectiveness Evaluation of Intraarterial Thrombectomy in Acute Ischemic Stroke
• THERAPY – Assess the Penumbra System in the Treatment of
Acute Stroke

ASPECTS
• Alberta Stroke Program Early CT Score

Caudate
Putamen
Internal capsule
Insular cortex
M1: frontal operculum
M2: anterior temporal lobe
M3: posterior temporal lobe
M4: anterior frontal lobe
M5: middle/posterior frontal lobe
M6: parietal lobe

www.aspectsinstroke.com

12/8/2015

TICI Score

MR CLEAN (2015)
•
•
•
•
•
•

Netherlands
N = 500
Age ≥ 18
Pre-stroke mRS – no cutoff
ASPECTS > 5
Endovascular treatment w/in 6 hours
– Allowed GA

12/8/2015

MR CLEAN (2015)
• Primary outcome: mRS at 90 days
• Secondary outcomes:
– NIHSS at 24 hours and 1 week
– Barthel index at 90 days
– EuroQoL at 90 days

MR CLEAN (2015)
• 233 endovascular arm vs 267 medical arm
– IV TPA in most (87% in endovascular arm and
91% in medical arm)
– Median ASPECTS 9
– Median NIHSS 17
– Acute carotid stenting in 13% of cases
– Stent retriever in 97% of cases
• TICI 2b/3 in 58.7%

– 33% mRS 0-2 (c/w 19% in medical arm)
– No significant difference in hemorrhage (7.7% vs
6.4%) or death

MR CLEAN (2015)
• RCT clearly showed benefit of
endovascular treatment for LVO in AIS
• Domino effect on other
concurrent/subsequent endovascular
trials!

12/8/2015

ESCAPE (2015)
•
•
•
•
•
•
•

Canada and US
N = 500 (halted at 316)
Age ≥ 18
Pre-stroke mRS ≤ 1
ASPECTS > 5
Multiphase CTA (Menon et al. Radiology, 2015)
Endovascular treatment w/in 12 hours
– CT to groin 60 min; CT to recanalization 90 min
– Discouraged GA or CAS

ESCAPE (2015)
• 165 endovascular arm vs 150 medical arm
– IV TPA in most (73% in endovascular arm and
79% in medical arm)
– Median ASPECTS 9
– Median NIHSS 16
– Stent retriever in 86% of cases
• TICI 2b/3 in 72.4%

– 53% mRS 0-2 (c/w 29% in medical arm)
– No significant difference in hemorrhage (3.6%
vs 2.7%) or death

12/8/2015

ESCAPE (2015)
• Halted following MR CLEAN results and
showed similar clear benefit for
endovascular treatment for LVO

EXTEND-IA (2015)
•
•
•
•
•
•

Australia
N = 100 (halted at 70)
Age ≥ 18
Pre-stroke mRS ≤ 1
No minimum ASPECTS or NIHSS
RAPID software for CTP or MRI/P
assessment
• Endovascular treatment w/in 6 hours
– Allowed GA
– Discouraged CAS

12/8/2015

EXTEND-IA (2015)
• 35 endovascular arm vs 35 medical arm
– IV TPA in all
– Median ASPECTS 9
– Median NIHSS 17
– Stent retriever in 100% of cases (Solitaire)
• TICI 2b/3 in 86.2%

– 71% mRS 0-2 (c/w 29% in medical arm)
– No significant difference in hemorrhage (0%
vs 5.7%) or death

EXTEND-IA (2015)
• Halted following MR CLEAN results and
showed similar clear benefit for
endovascular treatment for LVO

12/8/2015

SWIFT PRIME (2015)
•
•
•
•
•
•
•

US and Europe
N = 477 (halted at 196)
Age 18-80
Pre-stroke mRS ≤ 1
ASPECTS ≥ 6
NIHSS 8-29
Endovascular treatment w/in 6 hours

SWIFT PRIME (2015)
• 98 endovascular arm vs 98 medical arm
–
–
–
–
–

IV TPA in all
Pre-stroke mRS 0
Median ASPECTS 9
Median NIHSS 17
Stent retriever in 100% of cases (Solitaire)
• TICI 2b/3 in 88%

– 60.2% mRS 0-2 (c/w 35.5% in medical arm)
– No significant difference in hemorrhage (0% vs
3.1%) or death

SWIFT PRIME (2015)
• Halted following MR CLEAN results and
showed similar clear benefit for
endovascular treatment for LVO

12/8/2015

ESO 2015
• European Stroke Organisation 2015
meeting (late April)
• Results of REVASCAT announced
• Preliminary results of THRACE and
THERAPY announced

REVASCAT (2015)
• Spain
• N = 690 (halted at 206)
• Age 18-80 (extended to 85 in mid 2014 if
ASPECTS 9-10)
• Pre-stroke mRS ≤ 1
• ASPECTS ≥ 7
• NIHSS ≥ 6
• Endovascular treatment w/in 8 hours

12/8/2015

REVASCAT (2015)
• 103 endovascular arm vs 103 medical arm
– IV TPA in most (68% in endovascular arm and
78% in medical arm)
– Pre-stroke mRS 0 in 83-86%
– Median ASPECTS 7-8
– Median NIHSS 17
– Stent retriever in 100% of cases (Solitaire)
• TICI 2b/3 in 65.7%

– 43.7% mRS 0-2 (c/w 28.2% in medical arm)
– No significant difference in hemorrhage (1.9% in
both) or death

REVASCAT (2015)
• Halted following MR CLEAN, ESCAPE,
EXTEND-IA and SWIFT-PRIME results
and showed similar clear benefit for
endovascular treatment for LVO

THRACE (2015)
•
•
•
•
•
•

France
N = 414
Age 18-80
Symptoms < 4 hours
NIHSS 10-25
All received IV TPA
– Assigned to endovascular arm if no/minor (< 5
points) NIHSS improvement
– Endovascular treatment to be completed by 6
hours

12/8/2015

THRACE (2015)
•
•
•
•
•

190 endovascular arm vs 195 IV TPA arm
Mean NIHSS 17
85% had M1 occlusion
54.2% mRS 0-2 (c/w 42.1% in IV TPA arm)
No reported significant difference in
hemorrhage or death

THERAPY (2015)
• N = 692 (halted at 108)
• Use of Penumbra aspiration thrombectomy
devices rather than stent retrievers
• Looked at clot length (≥ 8 mm)
• NIHSS ≥ 8
• Inclusion w/in 4.5 hours of onset
• Final results pending but preliminary results
indicate benefit in endovascular treatment vs
IV alone

12/8/2015

2015 Endovascular Stroke Trials

2015 AHA Guidelines

2015 AHA Guidelines
• Recommendations:
– Give IV TPA when able (up to 4.5 hrs per ECASS
III)
– Do no wait to look for improvement after IV TPA
– Pre-stroke mRS 0-1
– Baseline CT head – ASPECTS ≥ 6
– NIHSS ≥ 6
– Proceed with CTA or MRA to look for LVO
– Benefits of CTP/MRP not clear

12/8/2015

2015 AHA Guidelines
• Recommendations:
– Groin puncture w/in 6 hrs
– Favor conscious sedation rather than GA when
possible
– Use stent retriever or other thrombectomy device
– Use balloon-guide catheter or large-bore distal
access catheter
– Aim for TICI 2b/3 reperfusion
– Salvage IA TPA can be used if needed

Take Home Points
• Endovascular thrombectomy for AIS
has become a standard of care
• Important considerations:
–
–
–
–

Pre-stroke mRS ≤ 1
Baseline CT head – ASPECTS ≥ 6
NIHSS ≥ 6
CTA or MRA with LVO and (ideally) good
collaterals
– Take for revascularization ASAP (< 6 hrs to groin
puncture)

Thank You!

12/8/2015

Devices and
Techniques: Review
of stent retrievers,
suction, and
combination therapy

Outline

Access Issues

• Access issues

• CTA done in emergency room
-aortic arch (type 1, 2, 3)

• Balloon guides / Sheaths

-carotid/ vertebral tortousity

• Stent retrievers

-Ca2+/atherosclerotic plaque

• Solitare

• Access – common femoral, direct carotid, radial access

• Trevo

-puncture access site under U/S

• Suction thrombectomy

Micropuncture kit

• ADAPT technique

Joseph J Gemmete, MD, FACR, FSIR
Professor of Radiology and Neurosurgery
University of Michigan Hospitals

19G single wall with 0.035 glide / Amplatz

• Solumbra

-8/9F sheath (24 cm / 13 cm) CFA/carotid access

• Summary

-radial limited 6F female/ ?7F male
-right radial (RVA, LCCA), left radial (LVA, RCCA)

0 |

1 |

2 |

12/8/2015

Balloon Guides / Sheaths

Carotid/Vertebral Access

• Balloon Guide - Cello 8F(.075in), Cello 6F,
FlowGate 8F (.084in), Merci 8F (>078in)

• Which Carotid Access Technique?
-Front loading telescopic technique
(Neuron Max, FlowGate, Cook shuttle
sheath)
-Back loading serial stiffening technique
(wire in external carotid then advanced
sheath or guide) (Cello 8F / 6F)
-Remote or Direct access

3 |

• Sheath -Cook shuttle sheath (.087in), Neuron Max
(.088in)
4 |

5 |

12/8/2015

Solitaire™ FR Revascularization Device Overview

Preparation of Balloon Guide

Indication Overview
The indication for the Solitaire™ FR revascularization device is as follows:

• Inspect balloon guide
• Attach RHV or Tuohy Borst with Side port to the BGC
• Flush lumen of BGC with heparinised saline
• Insert dilator/catheter through the lumen and flush with HS

The Solitaire™ FR Revascularization Device is intended to restore blood flow
by removing thrombus from a large intracranial vessel in patients
experiencing ischemic stroke within 8 hours of symptom onset. Patients who
are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who
fail IV t-PA therapy are candidates for treatment.

• FlowGate - Attach the flow valve, Cello no value
• Attach a 20 ml syringe with 50:50 contrast : saline using a
negative prep
• Inflate the balloon with a 50:50 contrast : saline for flow arrest
during stent retrieval
• During aspiration attached a three way with two 60 ml syringes so
can apply negative aspiration

6 |

7 |

8 |

12/8/2015

Procedural Overview

Procedure Components

Position the microcatheter

Flush the introducer sheath

1. Solitaire™ FR revascularization device
2. Guide Catheter
(8F Balloon Guide Catheter
Recommended – 1.90mm ID)
3. Microcatheter

(Rebar®

Advance the microcatheter
distal to the thrombus position
so that when the Solitaire™ FR
revascularization device is fully
deployed, it will extend beyond
both ends of the thrombus.

catheter 18/27)

4. Aspiration Syringe (60cc)
5. 014" Guidewire

Insert the introducer sheath partially into the RHV, tighten the RHV and verify that
fluid exits the proximal end of the sheath.

Solitaire™ FR revascularization device procedural steps taken from IFU. For complete instructions for use please see IFU.

9 |

Solitaire™ FR revascularization device procedural steps taken from IFU. For complete instructions for use please see IFU.

10 |

11 |

12/8/2015

Procedural Overview

Introduce the Solitaire™ FR Device into the microcatheter

Deliver the Solitaire™ FR Device

Procedural Overview
Positioning and Deployment
To deploy the Solitaire™ FR
revascularization device, fix the
push wire to maintain position of
the device and carefully
withdraw the microcatheter in
the proximal direction.

Continue to advance the
Solitaire™ FR until its distal
radiopaque markers reach the
end of the properly positioned
microcatheter.

Loosen the RHV. Advance the introducer sheath into the microcatheter hub until
firmly seated. Tighten the RHV and advance the Solitaire™ FR revascularization
device into the microcatheter. Once the flexible portion of the push wire has entered
the micro catheter shaft, remove the sheath.

To ensure full deployment, the
microcatheter must be proximal
to the proximal radiopaque
marker on the Solitaire™ FR
revascularization device. The
usable length of the deployed
Solitaire™ device should extend
beyond each side of the
thrombus.

WARNING: IF EXCESSIVE RESISTANCE IS ENCOUNTERED DURING THE DELIVERY OF THE SOLITAIRE™ FR REVASCULARIZATION
DEVICE, DISCONTINUE THE DELIVERY AND IDENTIFY THE CAUSE OF THE RESISTANCE. ADVANCEMENT OF THE SOLITAIRE™ FR
REVASCULARIZATON DEVICE AGAINST RESISTANCE MAY RESULT IN DEVICE DAMAGE AND/OR PATIENT INJURY.

Solitaire™ FR revascularization device procedural steps taken from IFU. For complete instructions for use please see IFU.

12 |

13 |

14 |

12/8/2015

Procedural Overview

Prior to retrieval

Recovery

Reposition the micro catheter
to cover the proximal zone
(proximal 3-4mm) of the
Solitaire™ FR revascularization
device. Lock the RHV onto the
Solitaire™ FR device pushwire.
Wait for 5 minutes to let stent
incorporate into thrombus

•

Prior to retrieval, inflate the balloon in the balloon guide catheter, if a balloon
guide catheter has been selected.

•

Do not perform more than three (3) recovery attempts in the same vessel.

•

Do not use each Solitaire™ FR revascularization device for more than two (2)
thrombus recoveries.
Retrieve the Solitaire™ FR revascularization device and the micro catheter as a unit
into the guiding catheter under constant aspiration. Continue to aspirate on the
guiding catheter until there is good flow reversal.
Remove the Solitaire™ FR revascularization device out of the distal end of the micro
catheter in order not to damage the device. If additional flow restoration attempts are
desired with the same device clean the device with saline solution. Do not use
solvents or autoclave.

Solitaire™ FR revascularization device procedural steps taken from IFU. For complete instructions for use please see IFU.

15 |

16 |

17 |

12/8/2015

Trevo® XP Pro Retriever

Trevo® XP Pro Retriever
 Sizes
– 6 mm x 25 mm - Excelsior XT-27 microcatheter
– 4 mm x 20 mm - Trevo Pro 18
– 3 mm x 20 mm – Trevo Pro 14, Trevo Pro 18

18 |

19 |

20 |

12/8/2015

ADAPT / Solumbra
• ADAPT

-place large bore suction catheter at the face
of the thrombus, then turn on pump
• Solumbra
-place 8 Fr guide catheter into the cervical
ICA, then 5 MAX /ACE catheter into M1
segment, advance a microcatheter distal to
the thrombus, deploy the stent retriever within
the thrombus and then remove the
microcatheter, under local aspiration remove
the 5 MAX/ACE catheter with the stent
retriever as a unit into the guide catheter
21 |

22 |

23 |

USA 05/15

12/8/2015

ACE™ Dimensions

ADAPT Technique

MAX™ Dimensions

ACE™ 64

ACE
With the courtesy of Dr. Murcia, San Sebastian, Spain

•
•
•
•
24 |

USA 05/15

25 |

USA 05/15

26 |

USA 05/15

12/6/2015

Training Standards, Credentials,
and Education for Intra-arterial
Catheter-directed Treatment of
Acute
Ischemic Stroke
David Sacks, MD
The Reading Health System
Dec 2015

Disclosures
• No conflicts of interest
• Intracranial drugs are off label

IA Stroke Issues
• Benefits of IA stroke care
• Risk/benefit very dependent on pt
selection, physician skills, infrastructure
• Hospital desire to keep stroke pts
• Need for IA manpower (24x7)
• Hirsch et al JNIS 2009

• Interest in IA from several specialties
• Problems with current training

12/6/2015

Training paradigms
• ABR certified
– Exclusive, what is the training provided?

• Fellowship
– Exclusive, what is the training?

• Case experience
– Must check outcomes
– Do outcomes meet benchmarks?
– What benchmarks

• What should you know, do you know, and can
you do?

Positions on IA stroke training
• SNIS
– Investigational, difficult, need ESN fellowship,
transport pt to regional center
• Meyers et al. J NeuroInterv Surg 2009
• Heck JNIS 2011

• SIR
– Not investigational, difficult, can train committed
and skilled interventionist, treat patient locally
• Connors et al. JVIR 2009
• Sacks and Connors commentary JVIR 2009
• Sacks JNIS 2011

Evidence
•
•
•
•

Not Class 1: RCT, case series, registries
Local anecdotes
INSTOR results
Case series by IR, IC
• Belisle et al. JVIR 2009;20:327-333
• Fjetland et al. Cardiovasc Interv Radiol 2012;35:10291035
• Burkart et al. JVIR 2013;24:1267-1272
• Sanak et al. JVIR 2013;24:1273-1279
• Htyte et al. Cath Cardiovasc Interv 2015;85:1043-1050
• Goktekin et al. Eurointervention 2014;10:876

12/6/2015

SIR IA Stroke Training
JVIR Dec 2009
•
•
•
•
•
•

Cognitive and Clinical
Imaging
Technical
Stroke specific experience
Facility
Exam

Cognitive
1. Understanding of and certification in assessing the
NIHSS
2. 6 months ACGME formal neuroscience training
including neuroanatomy, neuropathology,
neurovascular imaging, hemodynamics
3. Stroke specific training in clinical presentation of
stroke and associated vascular territories
4. Training in stroke specific exams for stroke mimics
and conversion reactions
5. Ability to evaluate imaging criteria for appropriate
patients for acute stroke treatment

Cognitive
6. Ability to differentiate acute ischemic lesions as
compared to chronic lesions and/or tumors, etc.
7. Ability to differentiate TIA from acute infarct
8. Ability to recognize etiology of TIA and acute stroke,
including stenosis and embolus
9. Knowledge of cerebrovascular hemodynamics as it
relates to perfusion imaging, and clinical presentation
10. Knowledge of pharmacological agents used for acute
stroke therapy
11. Understanding peri-procedural and post-procedural
hemodynamics and implications for appropriate patient
care

12/6/2015

Brain Imaging
1.
2.
3.
4.

Interpretation of 200 CT and 50 CTA
Interpretation of 200 MRI and 50 MRA
Interpretation of 25 CT/MR perfusion
Interpretation of 200 cerebral arteriograms

What about a Team Approach
•
•
•
•

Clinical is done by neurologist
Imaging is done by dx radiologist
Patient selection is done by neurologist
Procedure is done by interventionist
– No need for neuro skills (IR, IC)
– No need for imaging skills (IC)

Is this model good enough???
If so, discard the SIR training and INR fellowship

Technical
1. Hands on equipment experience
2. Arteriography performance
a. 100 cerebral (bilateral carotid and at least singlevessel vertebrobasilar injections)
OR
50 cerebral and 150 non cerebral
AND
b. 30 selective microcatheter procedures including 5
ICA/ECA

12/6/2015

IA Stroke Specific
• 5 proctored
– in person

OR
– electronically/telephonically
• What does this mean?

Facility
1. Primary stroke center or equivalent
2. Quality assurance program specifically assessing
stroke patients, acute stroke treatments, and
clinical outcomes
3. Facility support for submission of all cases to a
national stroke registry for interventional stroke
therapy
•
•
•

Commitment of facility
Education
National QA

Are these Standards
Restrictive?
YES
– This is not like hepatic embo for an exanguinating
trauma patient
– Stroke pts may improve spontaneously or may be
harmed by attempted revasc
– You need to know how to select and treat patients
– Dirty Harry

NO
The standards define your competence

12/6/2015

Problems with this Training
Model
1. Is it all really necessary? Obsolete?
What about the team approach?
2. There are few cerebral angios to do.
3. Who will proctor, how?
4. Local hospitals want it, want me to do
it, and if not me, who?
5. Where can I learn?
6. Who offers a test?

QA
• Locally
– 90 day clinical outcomes
– Times from sx onset to ER, CT/MRI, IR,
treatment
– Multisociety QA benchmarks

• Nationally
– INSTOR registry
– Need to revise training?

Multisociety QA
Sacks et al. JVIR 2013;24:151-163

•
•
•
•
•
•
•
•

Door to puncture < 2 hrs (75%)
Puncture to start of revasc < 45 mins (50%)
Recanalization (60%)
SICH < 12%
90 day good outcomes > 30%
Cases submitted to registry (100%)
Submitted for publication
May be adopted for accreditation

12/6/2015

IA Stroke Courses
• SIR Vancouver 1 day add on to meeting
• SIR ? Stand alone meeting
– Course prep prior to meeting

• CIRSE annual meeting
• ICCA Prague 2016
(www.iccaonline.org)

What do I really Think?
1. IR can do an excellent job treating strokes
2. Training needs are between the SIR
standards and the “Team” approach
3. The facility is every bit as critical as the
interventional physician
4. Not every hospital should offer IA
Offering this care badly but locally is worse than a transfer

5. Hospitals will do what they want, and they
may want you
6. QA QA QA QA QA QA

12/2/2015

An Algorithm for Treating
the Acute Stroke Patient:
Door to Lab Protocol
Martin G Radvany, MD, FSIR
Chief, Endovascular Surgical Neuroradiology
York Hospital, York PA

Disclosures
• Stryker – Medical Advisory Board

“Time
is
Brain”
The typical patient loses 1.9
million neurons each minute in
which stroke is untreated.
Saver, Stroke 2006

12/2/2015

Improving Patient Selection

Time is
Brain

MR CLEAN
REVASCAT
EXTEND-IA
SWIFT PRIME
ESCAPE
THRACE
THERAPY

Imaging

Indications for IA Stroke Therapy
(Class I; Level of Evidence A). (New recommendation):
a. Prestroke mRS score 0 to 1
b. Acute ischemic stroke receiving intravenous r-tPA within 4.5 hours
of onset according to guidelines from professional medical
societies
c. Causative occlusion of the internal carotid artery or proximal MCA
(M1)
d. Age ≥18 years
e. NIHSS score of ≥6
f. ASPECTS of ≥6
g. Treatment can be initiated (groin puncture) within 6 hours of
symptom onset
2015 AHA/ASA Stroke Guideline

Stroke Patient Flow

12/2/2015

Optimizing Door to Lab Time
• Pre-Hospital Assessment
– NIHSS
– LAMS (L.A. Motor Scale)
– RACE (Rapid Arterial oCclusion Evaluation)

• Stroke Protocol
– Alert ED/Stroke/Interventional Teams
– EMS vs POV

• Rapid Assessment with Imaging
– Point of care Renal Function Testing

• Prompt Treatment for patients with LVO

Facilitate patient care and movement
• Have designated transport monitoring
equipment ready
• Have a designated health care provider
accompany patient from the time they
enter hospital
– They get TPA in ED
– They go for intervention

Thank you!
Martin Radvany
mradvany@wellspan.org

12/2/2015

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