t.w., man 69 yo critical lica stenosis l haemisph...

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P Musialek @ i-MEET 2017

T.W., man 69 yo

critical LICA stenosis

L haemisph stroke 5mo

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T.W., man 69 yo



fundamental Qs:

LICA

(with haemorrh. transformation)

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T.W., man 69 yo



2 fundamental Qs:

whether ?(to intervene or not)

how ?

LICA .

.

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E.W., woman, 58 y, TWO recent ( 20d and 5d )

R haemisphericminor strokes despite OMT !





RICA




RICA

whether ?(to intervene or not)

how ?

.

.

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T.W., man 69 yo



LICA RICA

CREST

30 d


CREST

30 d


Who agreesthis indicates

no meaningful futurefor carotid stenting ?

CRESTCREST


CREST

30 d


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T.W., man 69 yo



LICA RICA

TCAR with CGuard: The perfect wayto protect brain!

Piotr Musialek, MD DPhilMariusz Trystula, MD PhD

Jagiellonian University Dept. of Cardiac & Vascular Diseasesand Dept. Vascular Surgery, John Paul II Hospital, Krakow, Poland

– are there any limitations?

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T.W., man 69 yo



LICA RICA

CAS (and CEA) are –and will remain–emboli-generating procedures


The Problem of Conventional Carotid Stents

Image courtesy Joan Rigla, MD PhD; Perceptual Imaging Lab, Univerity of Barcelona

Human carotid artery treated using a conventional stent; OCT


P. Musialek @ i-MEET 2017

Timing of neuro-embolic events after CAS

D. McCormick TCT 2012, modified

40-80%stroke timing with CAS in CAPTURE and CREST



40-80%*

post-procedural strokeswith CAS in CAPTURE

and CREST

*

CEA excludes the plaque.

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CEA excludes the plaque

In CAS, the stent shouldexclude the plaque too

.

.

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20

16

Mesh-covered carotid stents

CGuard EPS


CGuard EPS

Musialek P et al. EuroIntervention 2016;12:e658-70


30d data

CGuard™

TCT 2016 Featured Research

PARADIGM

P. Musialek, A. Mazurek et al. EuroIntervention 2016;12:e658-70 (PARADIGM design and 30-day outcome data)

P Musialek @ VEITH 2016

CGuard™ EPS human in situ OCT image courtesy Dr Joan Rigla, Perceptual Imaging Lab (University of Barcelona)

CGuard EPS

Musialek P et al. EuroIntervention 2016;12:e658-70

Wissgott C et al. J Endovasc Ther. 2017;24:130-137


Nitinol frame open-cell area ≈ 21 mm

MicroNet closed-cell area ≈ 0.3mm

carotid-dedicated design

√L A R G E S T

S M A L E S T

2

2 √ P Musialek @ i-MEET 2017

J. Schofer, P. Musialek et al. TCT 2014

Anti - Embolic Carotid Stent

K. Mathias 2013

Per-Protocol DW-MRI cerebral imagingat B/L, 24-48h after CAS, and at 30 days


The Power of DW-MRI…

24h after RICA-CAS (TCAR +CGuard)

a SINGLE lesion

0.054 mL

M. Urbanczyk, RP. Banys – Dept. Radiology JP2 Hospital, Krakow

Complete Resolution on 90d follow-up


. Intra-procedural cerebralembolization is minimized

Post-procedural proceduralcerebral embolization is

eliminated

.

J. Schofer, P. Musialek, et al. JACC Interv 20152015;8:1229-1234

CGuard™ CASE V I D E N C E

√

…

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T.W., man 69 yo



LICA RICA

enough?

CGuard™ embolic prevention system

Mesh Prevention

of embolization

”works”

only from the moment

the mesh stent is implanted



40-80%*

post-procedural strokeswith CAS (CAPTURE and

CREST data)

*

Procedural

Embolic ProtectionSystem

TransCarotid Artery Revascularization (TCAR)

Blood flow is reversed

Dynamic Flow Controller

& Integrated 200µ Filter

Hi / Low / Off

Blood flow is returned

to femoral vein

Working channel for

interventional devices

ENROUTE® Transcarotid

Stent System (57cm)

TransCarotid Artery Revascularization (TCAR)

Blood flow is reversed from

the common carotid artery

Dynamic Flow Controller

& Integrated 200µ Filter

Hi / Low / Off

Blood flow is returned

to femoral vein

Working channel for

interventional devices

ENROUTE® Transcarotid

Stent System (57cm)

TCAR = CLEAR ADVANTAGES1. avoiding arch2. avoiding access route-dependent embolization3. DYNAMIC flow reversal => ROBUST protection

√√√

TCAR=transcarotid CAS

efficient capture & removalof intra-procedural debris

.P Musialek @ i-MEET 2017

TCAR CGuard™

less embolic material during CASsustained anti-embolic after CAS

..Magnified image: C. Wissgott J Endovasc Ther. 2016



Prospective evaluation of All-comer perRcutaneous cArotiDrevascularization In symptomatic and increased-stroke-riskasymptomatic carotid artery stenosis using the CGuard™™

MicroNet – covered embolic prevention stent system:

The PARADIGM –> EXTEND study

PARADIGM-101 P. Musialek, A. Mazurek, M. Trystula et al. EuroIntervention 2016

n=221 (31 May 2017)Consecutive Patient

CGuard CAS


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T.W., man 69 yo



LICA

(with haemorrh. transformation)

TW, man 69 yocritical LICA stenosis post stroke


TW, man 69 yo 9 Dec 2015critical LICA stenosis

(stroke with haemorragic transformation 5mo before,now neuro-cleared for carotid revascularization )


TW, man 69 yo 9 Dec 2015critical LICA stenosis

(stroke with haemorragic transformation in Feb 2015,now neuro-cleared for carotid revascularization )

Hostile access

MoMa-FR intended

endoroutine accessabandoned

after 35 min attempts


TW, man 69 yo (Case #1) 12 Jan 2016critical LICA stenosis, post-stroke

First-in-Poland direct carotid access TCAR-FR CAS Under En Route (SilkRoad Medical) Flow Reversal

Surgical Team: M. Trystula, M. Kazubudzki, J. Krzywoń, A. Brzychczy; L. PinterEndo: P. Musialek & A. Mazurek

SurgicalAccess


TW, man 69 yo 12 Jan 2016critical LICA stenosis, post-stroke

movie movieP Musialek @ i-MEET 2017


lesion crossing, predil, CGuard stent implantation and postdilunder En Route (SilkRoad Medical) Flow Reversal



First-in-Poland direct carotid access CAS underEn Route (SilkRoad Medical) Flow Reversal

CGuard 7.0 x 30mm full endovascular reconstruction



First-in-Poland direct carotid access CAS underEn Route (SilkRoad Medical) Flow Reversal

CGuard 7.0x30mm full endovascular reconstruction



First-in-Poland direct carotid access CAS under En Route(SilkRoad Medical) Flow Reversal + CGuard™ MicroNet Stent

Z E R O new lesions

24h prior to CAS 48h after CAS

Brain Imaging: M. Urbanczyk, RP. Banys, Dept. Radiology, JP2 Hospital, Krakow P Musialek @ i-MEET 2017



Z E R O new lesions

Brain Imaging: M. Urbanczyk, RP. Banys, Dept. Radiology, JP2 Hospital, Krakow

First-in-Poland direct carotid access CAS under En Route(SilkRoad Medical) Flow Reversal + CGuard™ MicroNet Stent


TW, 69 y, h/o L haemispheric stroke with haemorragic transformation

Images: M. Urbanczyk & RP. Banys, Dept. of Radiology, John Paul II Hospital, Krakow

TTPTime-To-Peak

Flow

redis prolongued

yellowshows fast

Profound improvement of L hemiphericviable tissue perfusion


TCAR plus CGuard (Krakow, TCAR consecutive Case #1)


TTPTime-To-Peak

Flow

redis prolongued

yellowshows fast





En Route plus CGuard


TTPTime-To-Peak

Flow

redis prolongued

yellowshows fast







MTTMean Transit

Time

yellowgreen

is prolongued

blueshows fast







WE, woman, 58 y, 2x recent R haemispheric (minor) stroke

TCAR plus CGuard™ (Krakow, TCAR consecutive Case #2)

RICA


En Route (SilkRoad Medical) Dynamic Flow Reversal

movie





movie





movie

Debriscaptured

in the A-V shuntfilter

in this procedure




CGuard 7.0x30 mm full endovascular reconstruction

Final Result

plus NO new lesions on DW-MRI !




Z E R O new lesions


Brain Imaging: M. Urbanczyk, RP. Banys, Dept. Radiology, JP2 Hospital, Krakow




TTPTime-To-Peak

Flow

redis prolongued

yellowshows fast


Profound improvement in R hemiphericperfusion





PARADIGM - ExtendTCAR Substudy

Symptomatic – 73%; LICA – 64% (RICA – 36%)

Contralateral occlusion – 27%

PSV 2.4 – 4.7 (median 3.4) m/s

EDV 0.5 – 1.9 (median 1.1) m/s

Diabetes – 36%

Known CAD – 54% (h/o PCI or CABG = 67% CAD)

h/o RadioTx – 9%

All (100%) subjects – ipsilateral ischemic lesions

.

on baseline MRI

.

.

.

.

.

.


All TCAR & CGuard CAS study patients(ie, clinically ”asymptomatic” and clinically symptomatic)

had ipsilateral cerebral ischemic lesions on MRI prior to CAS

=> HIGH CEREBRAL RISK cohort !

Pt ZCKRK-PARADIGM TCAR + CGuard #5 (LICA 100%, target RICA 90%)

Pt AK KRK-PARADIGM TCAR + CGuard #3 RICA 78%, irregular lesion

< examples >



General anesthesia – 36%, regional/local – 64% 100% CGuard™ EPS 1 CGuard™ stent per lesion/artery

(sizes: 7.0x30, 7.0x40, 8.0x30, 8.0x40, 9.0x30mm)Direct stenting – 9%, predilated – 91%Postdil with Φ 4.5-6.0mm balloon up to 20atm to minimizeresidual stenosis consistent with the PARADIGM algorithm*Flow reversal time 6min 20s – 11min 30s (median 7min 50s)

Duplex at 30 days: PSV 0.36-1.02 m/s (median 0.6)EDV 0.15m/s (median 0.15m/s)

ECA patency – 100%

.Procedural data:

.

..

..

.

* P. Musialek, A. Mazurek, M. Trystula et al. EuroIntervention 2016 P Musialek @ i-MEET 2017


MRI Cerebral Imaging (incl. DW-MRI with ADC)3 time points: ≤24h before CAS

≤48h after CAS

@ 90 ± 10 days after CASSlice thickness 5mm636 slices total, median number per patient/time-point – 19

2 independent radiologists, per-agreement evaluationMedis QBrain 1.1

100% clinical, neurologic, and MRI follow-up

No death, no stroke, no MI up to 90 days

.MRI Protocol & Analysis:

.

.

.

.

.


Patient BK KRK-PARADIGM TCAR + CGuard #11(S, cresc TIAs, high embolism risk)

TCAR + CGuard: The ONLY Post–proceduralCerebral Lesions (n=2 pts)

(this and next slide)

24h prior to RICA-CAS 24h after RICA-CAS 90 days after RICA-CAS

A SINGLE lesion 0.054 mL TOTAL resolutionNO new lesions


Patient PW (S) KRK-PARADIGM TCAR + CGuard #4

24h prior to LICA-CAS

”CAS-L” No 1

”CAS-L” No 2

”CAS-L” No 3

24h after LICA-CAS 90 days afer LICA-CAS

TCAR + CGuard For Symptomatic and High-Embolism Risk ”Asymptomatic” Carotid Stenosis

*High-risk plaque features plus MRI evidence of ipsilateral ischemic lesionsin ALL study subjects

Uncomplicated procedure

No neuro complications by discharge and 90 days

Nearly eliminated peri-procedural embolism (MRI)

Totally eliminated post-procedural embolismduring stent healing and by 90 days (MRI)

.

.

.

.

*

- V. low incidence (!)- V. low number (!)- V. low volume (!)


TCAR CGuard™



. ..Magnified image: C. Wissgott J Endovasc Ther. 2016

c o m p l e m e n t a r y.


TCAR CGuard™




c o m p l e m e n t a r yextremely efficient together.

.


TCAR CGuard™




c o m p l e m e n t a r yextremely efficient together

each ’helps’ differently( and at different stage ! )

..

.


The Problem of Conventional Carotid Stents

Image courtesy Joan Rigla, MD PhD; Perceptual Imaging Lab, Univerity of Barcelona

Human carotid artery treated using a conventional stent; OCT


CGuard™ embolic prevention system

TCT 2016 Featured ResearchCGuard OCT Image - human, in situ

Courtesy Dr Joan Rigla, MD PhDPerceptual Imaging Lab, Univerity of Barcelona CGuard™ EPS


13 March 2017; 68y man, Leriche aortaminor L haemisph stroke 5 days before, current TIA

whatwould YOU

do ?

…if no TCAR available



P. Musialek, M. Trystula P Musialek @ i-MEET 2017


P. Musialek, M. Trystula

Local anaesthesia Trans-carotid MoMa with Flow Reversal + CGuard




Trans-carotid MoMa with Flow Reversal + CGuard


CGuard Full Carotid Bifurcation Reconstruction, Pt discharged home 14.03.2017


Self-tapering with the CGuard

SmartFit technology



TCAR CGuard™+


any limitations ?

TCAR CGuard™+


L i m i t a t i o n s

TCAR CGuard™+


L i m i t a t i o n sare very rare

TCAR CGuard™+


L i m i t a t i o n sare very rare

anatomiclimitations

to TCAR(access)

limitationsto (any)

stent

TCAR


• >5cm = Working distance from clavicle to bifurcation– Distal tip of ENROUTE Arterial Sheath– Proximal edge of ENROUTE Transcarotid

Stent

• >6mm = CCA reference diameter

• CCA free of significant disease for safe sheath insertion – Avoid scar tissue from previous CEA

(if applicable)

Patient head and neck in position to be used during surgery

NOT for TCAR


movie

NOT for TCAR, NOT for CGuard


Man, 48y, minor stroke 4 days

thr

thr

CEAuncomplicated

NOT for (any) stent


Man, 54y, post-stroke TIAs

CEAuncomplicated



Man, 63y, TIAs

Why?



Man, 63y, TIAs

CEA

short neck

low CCA division(not enough CCA for

TCAR sheath)

CCA disease

rock of calcium

.

.

.

.

TCAR CGuard™+


TCAR CGuard™

In conclusion,

It is NOT one ”or” the other

but

B O T HB O T HP Musialek @ i-MEET 2017

TCAR CGuard™


..Magnified image: C. Wissgott J Endovasc Ther. 2016


.

+


TCAR + CGuard: Study Team

M. Trystula Vascular SurgeryA. Mazurek CardiologyA. Borratynska NeurologyM. Urbanczyk RadiologyP. Banys RadiologyR. Musial AnesthesiologyI. Leal Vascular SurgeryL. Pinter Vascular SurgeryA. Lesniak-Sobelga Duplex ImagingK. Bederski Thoracic SurgeryM. Kazibudzki Vascular SurgeryA. Brzychczy Vascular SurgeryM. Brozda Duplex ImagingM. Misztal Interv. AngiologyP. Podolec CardiologyP. Musialek Angiology & Cardiology

Investigator-Initiated, Non-Industry Funded, Academic Study

Jagiellonian University Medical College& John Paul II Hospital, Krakow, Poland

TCT 2016 Featured ResearchP Musialek @ i-MEET 2017

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Another ( Rare but Important ) Problem of Conventional Carotid Stents:

Stent Design Allows Atherosclerotic Plaque In-Growth

Pt MK RICA

Precise 5.0x30mm (2005)

2014-2016 ”increasing restenosis”P Musialek @ i-MEET 2017

Atherosclerotic Plaque Growth Into The Open-Cell Stent Lumen

Treated with Neroprotected PTA Under IVUS – and CGuard™

PTA No flow

(movie)

Aspiration ’Half-open’Filter

RemovalP Musialek @ i-MEET 2017

Atherosclerotic Plaque Growth Into The Open-Cell Stent Lumen

Treated with Neroprotected PTA Under IVUS – and CGuard™

CGuard™ 8.0 x 40mm

(movie)


t.w., man 69 yo critical lica stenosis l haemisph...

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