New ischemic brain lesions on DW-MRI after CAS with double layer stent

Maria Antonella Ruffino, MD, EBIR, Claudio Rabbia, MD Vascular Radiology

Città della Salute e della Scienza – San Giovanni Battista Hospital

Torino, Italy

Disclosure

Speaker name:

Maria Antonella Ruffino

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

DAY 0: CAS 2x stroke rate of CEA - Catheterization of the arch - Plaque disruption - Suboptimal embolic protection - Suboptimal response to DAPT

DAY 1 – 30: CAS stroke rate still higher than CEA

Ann Surg. 2007 Oct;246(4):551-6

78% 60% ipsilateral

18% controlateral

Stroke 2009;40:841-846.

Delayed stroke could be related to the failure of the stent in complete scaffolding of the plaque

Higher risk of ipsilateral stroke or ispilateral stroke death in patients treated with an open cell stent (OR 2.13, 95% CI 1.07-3.76)

Dual layer design Closed cell stent platform Nitinol micromesh

Dual layer design Open cell stent platform Nitinol - PET micronet

- 16 protected CAS with Roadsaver stent on 16 consecutive patients - 11 protected CAS with CGuard stent on 11 consecutive patients - to determine the incidence of new ischemic lesions by means of DWI-MR

VASCULAR RADIOLOGY - TORINO

Incidenceofnewischemiclesionsa ercaro darterysten ngwiththeCGuard™duallayerdesigncaro dstent:aprospec vesinglecentrestudy

INTRODUCTIONCaro dArterySten ng(CAS)s llhasamajorrateofadverseneurologicaleventsincomparisontocaro dendoarterectomy(CEA)

at30-daysfollowupduetodistalcerebralemboliza oncausedbypoorplaquecoverage

bythestent.TheCGuardCaro dArteryStent(InspireMD,Israel)isani nolstentcoveredbypolyethyleneterphtalate(PET).Theporesize

ofthemeshis150to180μm.Thispropertyshouldpreventemboliza onbyplaqueandthrombuspar cleduring/a erCASthroughthestentnets.Theaimofthisstudyistodeterminetheincidenceofnewischemicipsilaterallesionsondiffusion-weightedmagne cresonance(DWI-ME)inthefirst11pa entstreatedinourcentrewiththisdevice.

11protectedCASwithCguardstentwereperformedin11pa ents.Pa entsdataarereportedinTable1andlesions

characteris csinTable2.DWI-MRwasperformed24-48hoursbefore

theprocedureandat24-48hoursand30daysa erCAS.Ischemiclesionloca on(ipsilateral,contralateral,andbilateral

hemisphere)andsizewererecorded.

METHODS RESULTS

CONCLUSIONS

ProtectedCASwithCGuardcaro darterystentseemstobesafeandeffec veintermsofreduc onofdelayedemboliceventsand

newipsilateralischemicbrainlesionsonDWI-MRintheearlyfollowupincomparisonto

conven onalcaro dstents.Despitetheseencouragingresults,moredataandstudiesonlargerpopula onareneededinordertoconfirmourpreliminaryfindings.

TABLES&FIGURES

Variable N=11

Age(years)Mean±SDMale

73.4±4.110(90.1)

Symptoma cSmokersFormersmokersDiabetesHypertensionHyperlipidaemiaPreviousTIAPreviousmyocardialinfarc onNIHSS012

3(27.3)3(27.3)2(18.2)3(27.3)9(81.8)7(63.6)3(27.3)5(45.5)4(36.4)5(45.5)2(18.2)

Table1.Pa entscharacteris cs

A

B

C

D

°VascularRadiologyUnit–Ci a’dellaSaluteedellaScienza–S.GiovanniBa staHospital–Torino,ItalyContactdetails:ma_ruffino@yahoo.it*RadiologyUnit–DepartmentofSurgicalScience–UniversityofTorino-AOUCi a’dellaSaluteedellaScienza–S.GiovanniBa staHospital–Torino,Italy

MariaAntonellaRuffino,MD,EBIR°;RiccardoFale ,MD*;andClaudioRabbiaMD°

Valuesaremean±devia onstandards,number(%)

Variable N=11

Loca onrightICAle ICA

8(72.7)2(18.2)

Primarystenosis 7(63.6)

PlaquemorphologyEcholucentEchogenicHeterogeneousPlaquesurfaceirregularityPlaqueulcera on

6(54.5)3(27.3)2(18.2)3(27.3)2(18.2)

Length,mm 14.3±4.2

Percentageofstenosis 83.5±4.1

ECApatency 11(100)

AnatomicvariableBovinearchAor carchtypeIAor carchtypeIIAor carchtypeIIIICAtortuosity(vesselkinking>60°)

2(18.2)6(54.5)1(9.1)2(18.2)1(9.1)

Table2.Lesionscharacteris cs

CASwastechnicallysuccessfulinallpa ents,withoutprocedure-relatedcomplica ons,withpatencyofexternal

caro dartery.DWIat24-48hoursshowednewacuteischemiclesionsin4/11pa ents

(36.4%)foratotalnumberof6lesions:5ipsilateraland1stand-alonecontrolateral.Themediannumberoflesionsperpa ent

was1(IQR0.5,TR1-2).Themedianvolumevaluewas0.04cm3(IQR=0.026-0-05,TR:0.011-0-068The30-daysDWI-MRshowedcompleteresolu onofalllesionswithoutnewischemiclesions.The30-daysMACCEratewas0%.

A

BFigure1.Cguard,Caro dArteryStent,InspireMD(israel)A:viewoftheself-expandableni noldoublelayerdevice.B:par cularofthedoublelayer

Volumeanalysisofacuteischemiclesionswasperformedonaseparateworksta on(VolumeCalculator,Osirix,Pixmeo).standarddevia on.Thenumber,volumeandloca onofnew

ischemiclesionsonDW-MRIatfollowupweresimilarlyassessedandrecordedCon nuousvariablesweretestedfor

normalitywiththeKolmogorov-Smirnov/LillieforstestandtheShapiro-WilksWtest.Whennormalitywasunanimouslyacceptedthedatawerepresentedasmean±Whennormalitywasinsteadrejected(lesionvolume)thedatawerepresentedasmedianaccompaniedbytheInterquar leRangeIQR(25-thand75-thpercen le)andthetotal

range(TR).Lesionvolumeswerecomparedwiththenon-parametricMann-Whitneytest

fortwoindependentdistribu ons.Sta s calsignificancewassetatp<0.05.Thesta s calprocedureswererunon

StatPlus:macPro(AnalystSo Inc.Walnut,CA,USA).

Incidenceofnewischemiclesionsa ercaro darterysten ngwiththeCGuard™duallayerdesigncaro dstent:aprospec vesinglecentrestudy

INTRODUCTIONCaro dArterySten ng(CAS)s llhasamajorrateofadverseneurologicaleventsincomparisontocaro dendoarterectomy(CEA)

at30-daysfollowupduetodistalcerebralemboliza oncausedbypoorplaquecoverage

bythestent.TheCGuardCaro dArteryStent(InspireMD,Israel)isani nolstentcoveredbypolyethyleneterphtalate(PET).Theporesize

ofthemeshis150to180μm.Thispropertyshouldpreventemboliza onbyplaqueandthrombuspar cleduring/a erCASthroughthestentnets.Theaimofthisstudyistodeterminetheincidenceofnewischemicipsilaterallesionsondiffusion-weightedmagne cresonance(DWI-ME)inthefirst11pa entstreatedinourcentrewiththisdevice.

11protectedCASwithCguardstentwereperformedin11pa ents.Pa entsdataarereportedinTable1andlesions

characteris csinTable2.DWI-MRwasperformed24-48hoursbefore

theprocedureandat24-48hoursand30daysa erCAS.Ischemiclesionloca on(ipsilateral,contralateral,andbilateralhemisphere)andsizewererecorded.

METHODS RESULTS

CONCLUSIONS

ProtectedCASwithCGuardcaro darterystentseemstobesafeandeffec veintermsofreduc onofdelayedemboliceventsand

newipsilateralischemicbrainlesionsonDWI-MRintheearlyfollowupincomparisonto

conven onalcaro dstents.Despitetheseencouragingresults,moredataandstudiesonlargerpopula onareneededinordertoconfirmourpreliminaryfindings.

TABLES&FIGURES

Variable N=11

Age(years)Mean±SDMale

73.4±4.110(90.1)

Symptoma cSmokersFormersmokersDiabetesHypertensionHyperlipidaemiaPreviousTIAPreviousmyocardialinfarc onNIHSS012

3(27.3)3(27.3)2(18.2)3(27.3)9(81.8)7(63.6)3(27.3)5(45.5)4(36.4)5(45.5)2(18.2)

Table1.Pa entscharacteris cs

A

B

C

D

°VascularRadiologyUnit–Ci a’dellaSaluteedellaScienza–S.GiovanniBa staHospital–Torino,ItalyContactdetails:ma_ruffino@yahoo.it*RadiologyUnit–DepartmentofSurgicalScience–UniversityofTorino-AOUCi a’dellaSaluteedellaScienza–S.GiovanniBa staHospital–Torino,Italy

MariaAntonellaRuffino,MD,EBIR°;RiccardoFale ,MD*;andClaudioRabbiaMD°

Valuesaremean±devia onstandards,number(%)

Variable N=11

Loca onrightICAle ICA

8(72.7)2(18.2)

Primarystenosis 7(63.6)

PlaquemorphologyEcholucentEchogenicHeterogeneousPlaquesurfaceirregularityPlaqueulcera on

6(54.5)3(27.3)2(18.2)3(27.3)2(18.2)

Length,mm 14.3±4.2

Percentageofstenosis 83.5±4.1

ECApatency 11(100)

AnatomicvariableBovinearchAor carchtypeIAor carchtypeIIAor carchtypeIIIICAtortuosity(vesselkinking>60°)

2(18.2)6(54.5)1(9.1)2(18.2)1(9.1)

Table2.Lesionscharacteris cs

CASwastechnicallysuccessfulinallpa ents,withoutprocedure-relatedcomplica ons,withpatencyofexternal

caro dartery.DWIat24-48hoursshowednewacuteischemiclesionsin4/11pa ents

(36.4%)foratotalnumberof6lesions:5ipsilateraland1stand-alonecontrolateral.Themediannumberoflesionsperpa ent

was1(IQR0.5,TR1-2).Themedianvolumevaluewas0.04cm3(IQR=0.026-0-05,TR:0.011-0-068The30-daysDWI-MRshowedcompleteresolu onofalllesionswithoutnewischemiclesions.The30-daysMACCEratewas0%.

A

BFigure1.Cguard,Caro dArteryStent,InspireMD(israel)A:viewoftheself-expandableni noldoublelayerdevice.B:par cularofthedoublelayer

Volumeanalysisofacuteischemiclesionswasperformedonaseparateworksta on(VolumeCalculator,Osirix,Pixmeo).standarddevia on.Thenumber,volumeandloca onofnew

ischemiclesionsonDW-MRIatfollowupweresimilarlyassessedandrecordedCon nuousvariablesweretestedfor

normalitywiththeKolmogorov-Smirnov/LillieforstestandtheShapiro-WilksWtest.

Whennormalitywasunanimouslyacceptedthedatawerepresentedasmean±Whennormalitywasinsteadrejected(lesion

volume)thedatawerepresentedasmedianaccompaniedbytheInterquar leRangeIQR(25-thand75-thpercen le)andthetotal

range(TR).Lesionvolumeswerecomparedwiththenon-parametricMann-Whitneytest

fortwoindependentdistribu ons.Sta s calsignificancewassetatp<0.05.Thesta s calprocedureswererunon

StatPlus:macPro(AnalystSo Inc.Walnut,CA,USA).

Patients and lesion characteristics

ROADSAVER STENT CGUARD STENT

Patients were scheduled to undergo clinical, duplex ultrasound and DWI-MR evaluations of their status at baseline, 24 h and at 30 days after the stenting

- All patients received 100 mg acetylsalicylic acid and a loading dose of 375 mg clopidogrel, if they were not

already on dual antiplatelet therapy for other reasons - After the procedure, a daily dose of 100 mg acetylsalicylic acid and 75 mg clopidogrel was administered for one

month, after which only acetylsalicylic acid

ROADSAVER STENT CGUARD STENT

INCIDENCE, NUMBER, SITE AND VOLUME OF NEW ISCHEMIC BRAIN LESIONS AT 24 HOURS DWI-MR

INCIDENCE OF NEW LESIONS

* the statistics presumably includes also the procedures with no lesions: in this case, our median volume would drop to reduced volume, i.e.for Roadsaver stent procedure to 0.03 cm3 with TR=0-0.389 cm3 ° study reports volumes as normal variables, i.e. as mean± standard deviation, even if the latter is twice as much as the former leading to virtual negative volumes

LESIONS VOLUME

INCIDENCE OF NEW ISCHEMIC BRAIN LESION @1 mo.: 0% DWI-MR at the 1-month FU examination showed complete recovery of all lesions and no evidence of new acute ischemic lesions

At 30-days ultrasound examination, ECA was patent in all cases Stents were patent without in-stent restenosis.

Clinical evaluation at 30 days excluded any major cerebrovascular event (MACCE rate 0%)

• Protected CAS with available double layer stents is safe, with 30 day MACCE of 0% and patency of ECA after the procedure and at 30 days

• The procedure has a lower incidence of new ischemic cerebral lesion in comparison to previous studies with conventional carotid stents

• All lesions had completely recovered by the 1 month follow up without evidence of

new ischemic lesions

• CAS procedure with micromesh Roadsaver Carotid Artery stent seem to be safe and effective in terms of reduction of delayed embolic events and new ipsilateral ischemic brain lesions on DWI-MR in comparison to conventional carotid stent

The results obtained with this device are consistent with those of CGuard stent, not only in our experience, but also when compared to CARENET study results

• If these data will be confirmed by larger studies and longer follow ups, they could lead to a rehearsal of carotid artery stenting

CONCLUSIONS

New ischemic brain lesions on DW-MRI after CAS with double layer stent

Maria Antonella Ruffino, MD, EBIR, Claudio Rabbia, MD Vascular Radiology

Città della Salute e della Scienza – San Giovanni Battista Hospital

Torino, Italy