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Friday 3rd Speaker - Dr. Patrick T. Noonan

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Published by graphitiks, 2018-11-01 12:15:41

Friday 3rd Speaker - Dr. Patrick T. Noonan

Friday 3rd Speaker - Dr. Patrick T. Noonan

Acute Stroke and Cerebrovascular
Disease: Diagnosis and Treatment

2018 Update

Patrick T. Noonan, Jr., M.S., M.D.
Interventional Neuroradiologist
Doctors Hospital at Renaissance

Disclosures:

No conflicts of interest

Off-label use of devices will be discussed

The views expressed in this talk are those of the author and do not necessarily
reflect the official policy or position of the Food and Drug Administration, the
Department of Health and Human Services, or the United States Government.

5/17/2018 PT Noonan MD



Only to be redacted

Based on recent feedback received from the clinical stroke community related to the article by Powers
et al, “2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline
for Healthcare Professionals From the American Heart Association/American Stroke Association,”
which published ahead of print January 24, 2018, and appeared in the March 2018 issue of the journal
(Stroke. 2018;49:e46–e110. DOI: 10.1161/STR.0000000000000158), the American Heart
Association/American Stroke Association has reviewed the guideline and is preparing clarifications,
modifications, and/or updates to several sections in it. Currently, those sections, listed here, have been
deleted from the guideline while this clarifying work is in process:

Section 1.3 EMS Systems Recommendation 4
Section 1.4 Hospital Stroke Capabilities Recommendation 1
Section 1.6 Telemedicine Recommendation 3
Section 2.2 Brain Imaging Recommendation 11
Section 3.2 Blood Pressure Recommendation 3
Section 4.3 Blood Pressure Recommendation 2
Section 4.6 Dysphagia Recommendation 1
Section 6.0 All subsections (11)
We continue to support this corrected version of the guideline and its support for clinical decision-
making. After review, a revised guideline, with consideration given to the clarifications, modifications,
and/or updates of the sections noted above, will be posted over the coming weeks.

EMS Systems: original and revised versions

Hospital Stroke capabilities: Original ………… Redacted without replacement

Telemedicine: original and revised

Brain imaging: original and revised

Blood pressure, Part 1: original and revised

Recommendation 3.2.1 was proposed in 1994!

Blood pressure, Part 2: original and revised

Eliminated completely

Q: Should you continue to screen
for AFIB, carotid disease, etc.?

A: Yes

Unless you find a contraindication, give aspirin

Regarding decompressive
craniectomy

Mechanical Thrombectomy
aka
Endovascular Thrombectomy

Previously healthy late 60’s RH man with sudden onset of left sided weakness 90 minutes ago …

Advanced CT
diagnosis.
RMCA
occlusion
without core
infarct
Received IV
tPA
And …

Angiography: Proximal R MCA plugged by embolus and branches beyond embolus are missing

Select the Right MCA with a wire and catheter and then advance a
Stent Retriever

Deploy a retriever. Wait 5 minutes. Inflate balloon to reverse carotid flow and pull out the retriever.

Results: On second
pass, clot retrieved,
flow restored, and
weakness resolved
by 5 hours and 45
minutes after Sx.

Actual results with intervention: Probable results without intervention:
small CVA, full recovery large CVA, paralysis, possibly death

Biggest Change/Addition: endovascular treatment of late presenting LVO

DAWN DEFUSE III

DEFUSE III - Terminated early for efficacy by DMSB

n = 182: thrombectomy with user choice devices + medical therapy = 92, medical therapy alone = 90

Clinical Inclusion Criteria (selected):
1. Signs and symptoms c/w acute anterior circulation ischemic stroke
2. Age 18‐90 years
3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization
4. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of time last known well
5. mRS ≤ 2

Neuroimaging Inclusion Criteria (all volumes and ratios determined by RAPID software)
• ICA (with or without tandem MCA lesions) or MCA-M1 occlusion by MRA or CTA, AND
• Target Mismatch Profile on MRI or CTP (ischemic core volume <70 ml, mismatch ratio ≥1.8 and mismatch volume
≥15 ml)

Alternative neuroimaging criteria when perfusion imaging, MRA, or CTA is technically inadequate, :
A) If CTA (or MRA) is technically inadequate
• Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion; AND
• Target Mismatch Profile (ischemic core volume <70 ml, mismatch ratio ≥1.8 and mismatch volume ≥15 ml)
B) If MRP is technically inadequate
• ICA or MCA-M1 occlusion by MRA (or CTA, if MRA is technically inadequate) AND
• DWI lesion volume <25 ml
C) If CTP is technically inadequate
• Patient can be screened with MRI and enrolled if neuroimaging criteria are met.

DAWN

n= 206, thrombectomy + standard of care (Trevo) = 107, standard of care alone = 99

Clinical Inclusion Criteria (selected):
1. Clinical signs and symptoms c/w acute ischemic stroke, and
a. failed IV t-PA therapy (confirmed persistent occlusion 60 min after administration)
b. IV t-PA administration contraindicated
2. Age ≥18
3. Baseline NIHSS ≥10 (assessed within one hour prior to measuring core infarct volume)
4. Subject can be randomized between 6 to 24 hours after time last known well
5. < 1/3 MCA territory involved, as evidenced by CT or MRI

Neuroimaging Inclusion Criteria
1. Occlusion of the intracranial ICA and/or MCA-M1, as evidenced by MRA or CTA
2. Clinical Imaging Mismatch (CIM) defined as one of the following on RAPID MRDWI or CTP-rCBF maps:
a. 0-20 cc core infarct and NIHSS ≥ 10 (and age ≥ 80 years old)
b. 0-30 cc core infarct and NIHSS ≥ 10 (and age < 80 years old)
c. 31 cc to < 50 cc core infarct and NIHSS ≥ 20 (and age < 80 years old)

DAWN DEFUSEIII

Consequences: one stent retriever used in DAWN receives an expanded indication for use

59 y/o RH M last seen well at 22:00. Presents to ER at 10:00 next morning with L sided weakness





TICI 2b flow restoration. Left sided weakness diminished. Patient discharged to outpatient rehab 7 days later.

Why can’t a 60 y/o woman, last seen well at 22:00 and aphasic and R hemiplegic at 06:30, get thrombectomy?
ASPECTS < 6



Craniectomy offered, performed, and saved her life.

Next Day Post Craniectomy 1 Week Later

What about other devices?

No other stent retriever has an on-label indication for use beyond 8 hours

1 other stent retriever (Solitaire) also has a clinical benefit indication for use within 6 hours of symptom
onset in a patient who has also received IV tPA (when IV tPA given on-label (within 3 hours))

Clinical benefit indication for use only applies to device use in anterior circulation (ICA and M1)

Aspiration devices and other stent-retriever-like devices have not demonstrated clinical benefit

Many devices (Trevo, Solitaire, other stent retrievers, and aspiration devices) are approved as tools to
restore flow if use begins by 8 hours after symptom onset

70 yo man last seen well 12 hours before. When he awoke,
he had left sided weakness, unsteady gait, nausea, and
dizzyness. He fell hit his head on a bathtub, and vomited.





Ischemic stroke prevention:
Mitigate risk factors: you know the ones
Medicate: with the usual agents
Occasionally use devices:
WATCHMAN Left Atrial Appendage Closure Device
LARIAT Device (for closure of soft tissue structures)
AMPLATZER PFO Occluder



Symptomatic intracranial arteriosclerotic disease

Maximal medical therapy (including DAPT), risk factor mitigation, and lifestyle management

Medical treatment arm of SAMMPRIS Trial (terminated early for excessive risk in device treated arm)

Occasionally use devices:

Wingspan Stent and Gateway Balloon System

The device treatment arm of the SAMMPRIS Trial

HUD device, HDE marketing status (8000 case/year limit)

Limited indications:
For use in improving cerebral artery lumen diameter in patients 22 to 80 years old with recurrent (2 or
more) strokes despite a comprehensive regimen of medical therapy that are due to atherosclerotic
disease of intracranial vessels with 70-99% stenosis accessible to the system. The most recent stroke
must have occurred > 7 days prior to treatment with the Wingpsan Stent System AND Modified Rankin
Score (mRS) is 3 or less at the time of treatment.

CMS NCD: non-coverage outside of an IDE clinical trial



76 y/o RH woman with aphasia admitted after third CVA in past two months



PTA without stent

INITIAL POST 7 MONTHS

Serial follow-up MRA 11 MONTHS
No recurrence of Sx

Hemorrhagic stroke

ICH due to HTN, amyloid angiopathy, etc: may be amenable to minimally invasive transcranial procedures
Cerebral aneurysm:

Pre-2018 devices: Coils, flow diverter (Pipeline Embolization Device), HDE stents for coiling, surgical clips
New devices:

PulseRider Aneurysm Neck Reconstruction Device (HUD, HDE), Neuroform Atlas Stent (HUD, HDE), LVIS/LVIS Jr
Stent (PMA), Surpass Streamline Flow Diverter (PMA)
On the horizon: WEB (not approved for use in USA – for now), additional PMA devices
Brain Arteriovenous Malformation (BAVM): traditionally open miocrosurgery or XRT +/- pre-op endovascular embolization
Endovascular devices (PMA or 510k) with pre-op BAVM embolization indication: PVA, TruFill nBCA, and Onyx
No new endovascular devices approved for use in BAVM embolization in USA
Intracranial dural arteriovenous fistula (DAVF): common off-label treatment using TruFill nBCA and/or Onyx

PulseRider Surpass LVIS Jr

How safe is the device(s)?: Defined as rate of major ipsilateral stroke (∆ NIHSS ≥4) or death
Depends on device type and combination of device types, e.g., stent-coiling: 2.3% (mortality); PED: 5.6% (M&M)

Is it efficacious?
Depends on aneurysm location, aneurysm size, neck morphology (wide or not), device, and device combinations

What is complete occlusion? Raymond 1. Adequate occlusion? Raymond 1 and Raymond 2. Recurrence? Raymond 3.
What are complete occlusion rates and remnant aneurysm rates of endovascular devices?

PED (and maybe SURPASS) per published data: by 3 years 93.4%, remnant 6.6%
Stent/coiling per meta-analysis: 57.7% immediately (20.2%-89.2%), remnant after follow-up 12.7%
PulseRider (HUD/HDE) per published data: by 12 months 67%, remnant 10%
WEB (available in EU, not approved for sale in USA) per EU studies: by 12 months 53%, remnant 20.9%
Is dual antiplatelet therapy required?
The more metal in the parent or branch vessels, the more likely the answer is YES

Anatomic location and morphology of an aneurysm determines best treatment device and is considered in pre-approval
clinical trial: the IFU will frequently specify anatomic locations in which the device may be used based on an IDE clinical
trial.

Aneurysm size, neck width, dome to neck width ratio could also be specified

Devices are appropriate for certain locations and vessels of certain sizes based on design characteristics, e.g., open cell
stents may conform to curves better and achieve full wall apposition in curves compared to closed cell types

Device coverage of normal vessel wall and normal side wall branches: might occlude normal branches as in the case of
small pore devices such as flow divertors

Minimal vessel diameters for device implantation are specified in labeling (based on animal testing and IDE trial):

NeuroForm Atlas and LVIS Jr stents: 2.0 mm

Enterprise stent: 2.5 mm

PED and SURPASS (and FRED which is not approved in USA): 3.0 mm

PulseRider: 2.7 mm (inflow vessels)

Users forgetting these facts and/or not reading instructions needed a 08 May 2018 reminder:

Because bad things (death
and stroke) were happening
in the real world.


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