12 9 15 Endovascular Syllabus

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12/8/2015

1

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

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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 Intra-

arterial 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

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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

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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!

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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

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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

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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

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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

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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

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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

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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

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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

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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

1

0 |

Devices and

Techniques: Review

of stent retrievers,

suction, and

combination therapy

Joseph J Gemmete, MD, FACR, FSIR

Professor of Radiology and Neurosurgery

University of Michigan Hospitals

1 |

Outline

•Access issues

•Balloon guides / Sheaths

•Stent retrievers

•Solitare

•Trevo

•Suction thrombectomy

•ADAPT technique

•Solumbra

•Summary

2 |

Access Issues

•CTA done in emergency room

-aortic arch (type 1, 2, 3)

-carotid/ vertebral tortousity

-Ca2+/atherosclerotic plaque

•Access –common femoral, direct carotid, radial access

-puncture access site under U/S

Micropuncture kit

19G single wall with 0.035 glide / Amplatz

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

-radial limited 6F female/ ?7F male

-right radial (RVA, LCCA), left radial (LVA, RCCA)

12/8/2015

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3 |

Carotid/Vertebral Access

•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

4 |

5 |

Balloon Guides / Sheaths

•Balloon Guide - Cello 8F(.075in), Cello 6F,

FlowGate 8F (.084in), Merci 8F (>078in)

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

(.088in)

12/8/2015

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6 |

Preparation of Balloon Guide

•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

•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

7 |

Indication Overview

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

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.

8 |

Solitaire™FR Revascularization Device Overview

12/8/2015

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9 |

Procedural Overview

Procedure Components

1. Solitaire™FR revascularization device

2. Guide Catheter

(8F Balloon Guide Catheter

Recommended –1.90mm ID)

3. Microcatheter (Rebar®catheter 18/27)

4. Aspiration Syringe (60cc)

5. 014" Guidewire

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

10 |

Procedural Overview

Position the microcatheter

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.

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

11 |

Procedural Overview

Flush the introducer sheath

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 s ee IFU.

12/8/2015

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12 |

Procedural Overview

Introduce the Solitaire™ FR Device into the 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.

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

13 |

Procedural Overview

Deliver the Solitaire™ FR Device

Continue to advance the

Solitaire™FR until its distal

radiopaque markers reach the

end of the properly positioned

microcatheter.

WARNING: IF EXCESSIVE RESIST ANCE 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.

14 |

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.

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.

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

12/8/2015

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15 |

Procedural Overview

Prior to retrieval

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

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

16 |

Procedural Overview

Recovery

•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.

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

17 |

Procedural Overview

Recovery

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 s ee IFU.

12/8/2015

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18 |

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

19 |

Trevo® XP Pro Retriever

20 |

12/8/2015

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21 |

22 |

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

23 |Copyright © 2015 Penumbra, Inc. All rights reserved. 9097 Rev. B USA 05/15 23

12/8/2015

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24 |

ACE™Dimensions

ACE™64

ACE

Copyright © 2015 Penumbra, Inc. All rights reserved. 9097 Rev. B USA 05/15 24

25 |

MAX™Dimensions

Copyright © 2015 Penumbra, Inc. All rights reserved. 9097 Rev. B USA 05/15 25

26 |

•Baseline NIHSS = 18

•1 revascularization attempt

•TICI 3

•NIHSS at 24 hours = 0

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

Copyright © 2015 Penumbra, Inc. All rights reserved. 9097 Rev. B USA 05/15 26

ADAPT Technique

12/6/2015

1

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

2

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;35:1029-

1035

•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

3

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

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Brain Imaging

1. Interpretation of 200 CT and 50 CTA

2. Interpretation of 200 MRI and 50 MRA

3. Interpretation of 25 CT/MR perfusion

4. 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 single-

vessel vertebrobasilar injections)

OR

50 cerebral and 150 non cerebral

AND

b. 30 selective microcatheter procedures including 5

ICA/ECA

12/6/2015

5

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

6

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

7

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

1

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

2

Time is

Brain Imaging

Improving Patient Selection

MR CLEAN

REVASCAT

EXTEND-IA

SWIFT PRIME

ESCAPE

THRACE

THERAPY

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

3

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

4