Le stenting carotidien par voie cervicale

Une technique simple ?

Pour les cas difficiles ?

JM CARDON

Hopital prive les franciscaines nimes

Criteres cliniques : AVC

Eva 3s Ipsi+contro 9,6% 527 2000/2005

SPACE IPSI 6,4% 1183 2001/2006

ICSS Ipsi+contro 7,4% 1713 2005/2010

CREST Ipsi+contro 4,1% 2522 2006/2011

RISQUE CLINIQUE CAS

RISQUE CEREBRAL CAS

criteres anatomiques

ICSS sub study124 CAS avec IRM pre/post Transfemoral+filtre distal

50% nouvelles lesions ischemiques

CASRISQUE ANATOMIQUE

1363 CAS 754 CEA

Nouvelle lesion IRM

37%

Nouvelle lesion IRM

10%

Metaanalyse KARSTRUP STROKE 2008 IRM PRE ET POST CAS /CEA

RISQUE CEREBRAL A LA NAVIGATIONQUEL TERRITOIRE ?

ZHU : j vasc surg 2011 Audit neuro + DWI pre /post : 30 CAS 1 minor stroke 131 nouvelles lesions

ischemiques IRM Ipsi : 83,1% Contro : 16,9% Territoire : c m : 91,6% ipsi et contro c p : 6,1% cerebelleuse: 2%

Grossetti : acta chir belg 201150 CAS: pas de predilatation ;filtre distalHR color flow mappingTCD intra op + 12 H post opDWI pre/post4 test psycometriquesAudit neuro

QUEL RISQUE A CAS ?

Minor stroke : 4% hits per op : 100% Hits post op : 10% Nouvelles lesions ischemiques : 44% Diminution capacites cognitives : 36%

Confidential

DW MRICLINICAL SIGNIFICANCE OF NEW WHITE LESIONS

Although the fundamental issues of the nature of the embolic particles, precise mechanisms of cerebral injury, and effective prevention remain debated and unclear, recent reports have provided substantial evidence of memory loss, cognitive decline, and dementia related to these so-called silent infarcts.

Gress DR. JACC 2012.

DW MRICLINICAL SIGNIFICANCE OF WHITE LESIONS

In population-based studies, a strong association has been found between MRI lesions and prevalent cognitive

dysfunction and dementia.

The more extensive the MRI lesions, the more severe is the observed cognitive impairment.

Sun X. JACC 2012;60:791–7.

En consequencependant cas

IL EXISTE UN RISQUE CLINIQUE ET ANATOMIQUE

LES HITS ( embol) ONT UNE CONSEQUENCE ANATOMIQUE:PETIRES LESIONS ISCHEMIQUES A L’IRM

MEME SI PAS D’AVC :DIMINUTION DES FONCTIONS COGNITIVES

Patients a risque pour la navigation

ANATOMIE DIFFICILE

en amont Arche bovine Crosse aortique type 3 Angulation CPG sur la crosse Tortuosites CP

La bifurcation naissance horizontale

En aval boucles et king king

Patient a risque pour la navigation:lesion emboligene

Crosse aortique : calcification debris atheromateux thrombus

Bifurcation carotidienneGros amas calcaireTrombusHemmoragie intraplaque

Lesions tandem

Patient a risque pour la navigation

age

Meta analyse Bonati :eur j vasc 2011 eva3s space icss : 3433 patientsTCMM a 120 jours : 8,9% age seul subgroup significatif: age<70 ans:5,8% age>70 ans:12%

Il existe donc un risque a la navigation

Navigation dans la crosse =risque AVC homo,contro et post

Navigation dans CP et dans CI= risque AVC homolateral

Franchissement de la lesion par le filtre est dangereux

Lesions intimales sur CI distales liees au filtre= HITS

Transfemoral CASLow risk of MI and CNI but increased peri-procedural stroke risk

CEA CAS P

CREST Peri-Procedural Stroke1 2.3% 4.1% 0.01

CREST Peri-Procedural Stroke, ≥ 75 years2 3.1% 6.9% 0.035

1N Engl J Med 2010;363:11-23. 2 Stroke. 2011;42:00-00.

Comment proteger?

S macdonald : j cardiovasc surg 2010Ballon occlusif,filtration distale,flow reverse Arrete les gros debris mais environ 100 000

microparticules pendant 1 CAS protegeeBallon occlusif↓↓ hitsDistal filter↑↑hits embolisation

controlleeFlow reverse stop hits

Confidential

Advantages

Minimally invasive

Local anesthesia

Durable

Disadvantages

Access-related stroke

Excess stroke risk

Asymptomatic brain infarction

Advantages

Complete neuroprotection

Direct access

Durable

Disadvantages

More invasive, general anesthesia

Myocardial infarction risk

Cranial nerve injury

Wound complications

CEA Transfemoral CAS

Potential Benefits

NeuroprotectionMinimally Invasive

Decreased Stroke RiskDecreased MI RiskDecreased CNI RiskLocal Anesthesia

Fast

Direct Carotid Revascularization

Flow reverse est la solution

Par abord femoral ne regle pas le probleme car l embolisation peut se produire lors de la montee du système dans la carotide primitive et lors de son retrait

Par abord trans cervical tous les problemes sont regles:

comme CAS: risque corronaire minimalcomme CEA: risque cerebral minimal

Study Procedure Embolic Protection

# subjects % w/ New DWI Lesions

PROFI1 Transfemoral CAS

Distal filter (Emboshield) 31 87%

ICSS2 Transfemoral CAS Distal filter (various) 51 73%

PROFI1 Transfemoral CAS

Proximal occlusion (MO.MA) 31 45%

DESERVE3 Transfemoral CAS

Proximal occlusion(MO.MA) 127 30%

PROOF Transcervical CAS MICHI 57 19%

ICSS2 CEA Clamp, backbleed 107 17%

1 J AM COLL CARDIOL. 2012 JAN 19 [EPUB AHEAD OF PRINT].2 LANCET NEUROL. 2010 APR;9(4):353-62.3 P RUBINO, 2011 EUROPCR.

DW MRIProspective Studies

Le flow reverse avec abord carotidien

Abord au cou sous AL

Flow reverse home made

Stenting sur guide 0,14

Avantages

Pas de navigation

Pas de franchissement de

la lesion sans protection

couts

Inconvenients

Hemodetournement cerebral

CI si calcification CP

Exposition des mains

2 techniques

Custom

Silk road

TECHNIQUE

ECHOGRAPHIE PRÉOPÉRATOIRE:

TECHNIQUE

INCISION:

TECHNIQUE

DISSECTION VEINEUSE ET ARTÉRIELLE:

TECHNIQUE

PONCTION VEINEUSE:

TECHNIQUE

PONCTION VEINEUSE:

TECHNIQUE

PONCTION ARTERIELLE:

HÉPARINISATION SISTÉMIQUE:

TECHNIQUE

CONNEXION:

TECHNIQUE

FISTULE ARTERIO-VEINEUSE:

TECHNIQUE

PASSAGE DE LA LÉSION:

TECHNIQUE

LIBÉRATION DU STENTET BALONEMENT:

TECHNIQUE

CONFIRMATION ARTERIOGRAPHIQUE:

TECHNIQUE

SUTURE DE L’ARTÉRIOTOMIE:

TECHNIQUE

FERMETURE DE L’INCISION:

resultats Criado : j vasc surg 2004 : 50 patients Chang : j vasc surg 2004 : 21 Matas : j vasc surg 2007 : 62 Alvarez : j vasc surg 2008 : 81 > 80 ans Fast cas registre : 65

Criado E. VEITH 2010.J Vasc Surg 2004;40:92-7

Study Number of Stents

Death(30 days)

Major Stroke

(30 days)

Minor Stroke

(30 days)

Patency

Chang 2004 21 0 0 0 100% at 6M

Lin 2005 31 0 0 2 100% at 6M

Pippinos 2005 17 0 0 0 100% at 12M

Matas 2007 62 0 2 0 98% at 6M

Criado 2007 104 0 0 2 97% at 40M

Faraglia 2008 48 0 0 1 100% at 6M

Leal 2010 35 0 0 0 100% at 3M

TOTAL 318 0 0.6% 1.6%

Transcervical Carotid RevascularizationWith Flow Reversal In The Literature

resultats

TCMM=0 a 5% IDM= 0% Intolerance : 7% Complication locale : 2% HITS : 6% Nouvelles lesions DWI :16,7%

Silk road 8F Transcervical Arterial Sheath 8F Venous Return Sheath

Large bore flow reversal circuit Flow controller with stop, HI and LO flow

PROOFFIRST IN MAN RESULTS

Pinter L. JVS 2011;54:1317-23.

44

Parameter Value (n=44)

Secondary Endpoints

Establishment of Silk Road reverse flow circuit 42 (96%)

Acute Device Success 40 (90.9%)

Procedural Success 40 (90.9%)

Tolerance to reverse flow (per protocol) 41 (93%)

Investigator-reported transient intolerance 4 (9%)

Procedural Data (median ± SD)

Time on reverse flow, min 19 ± 9

Time on Hi flow, min 11 ± 6

Post procedure residual stenosis, % 7.6 ± 9.8

Volume of contrast used, cc 18.2 ± 9.9

PROOFProcedural Results

Parameter Value (n=44)

Safety Endpoint

Subjects completing 30-day Follow Up 43 (97.7%)

Composite of any major stroke, myocardial infarction and death from the index procedure through the 30-day post procedural period

0 (0%)

Major Bleeding Event1 1 (2%)

Cranial Nerve Injury 0 (0%)

DW-MRI Substudy (n=31)

Subjects with new DW-MRI lesion(s) 24-72 hours post 5 (16.1%)

1One subject developed a GI bleed 2 days post procedure

PROOFSafety Results

Conclusion

Risque cerebral equivallent a CEA Rique corronarien equivallent a CAS

Cela va-t-il reconcilier chirurgien et CAS? Dans notre practique 10% des CAS mais

a barcelone 100% Silk road : la solution ?

The MICHI™ Neuroprotection System was shown to be a safe and feasible method for carotid revascularization

Low rate of MI and cranial nerve Injury is commensurate with transfemoral CAS and shows improvement over CEA

Low rate of stroke/death and new DWI lesions is commensurate with CEA and shows improvement over transfemoral CAS

Larger, multi-center experience is underway to confirm initial results

SummaryCarotid Revascularization With MICHI Neuroprotection System

Atherosclerotic Aortic Lesions

Faggioli G. J Vasc Surg 2009;49:80-5.

CAN INCREASE THE RISK OF CEREBRAL EMBOLIZATION DURING CAS IN PATIENTS WITH COMPLEX AORTIC ARCH ANATOMY

52

In patients with all three AA characteristics, mean number and volume of embolic brain lesions was significantly greater compared with other patients.

28.8%35.5%

57.6%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

Difficult Arch ComplicatedAortic Plaque

Tortuosity Index>150*

N=59 Patients Undergoing

CAS

ConfidentialLeal I. JVS 2012.

53

TRANSCERVICAL CASVS. TRANSFEMORAL CAS

“The low 12.9% incidence in the transcervical group is comparable to the best series of CEA and a great improvement over the results of CAS with distal filters.”

“The results of CAS are clearly influenced by the access route and cerebral protection methods…..The risk of embolic complications with transfemoral

carotid stenting is related to instrumentation of the arch and proximal supra-aortic trunks, crossing of the carotid lesion without protection, and use of distal

filter protection devices of questionable benefit.”

Gupka :j vasc surg 2011TCD 33 patients: mean hits ipsi : 14 CAS+DF : 320 5 CAS+FR : 185 14 CEA : 15 Periode hits pendant pour DF avant pour FR apres pour CEA

Confidential

CAS IN CREST

Gray WA. Circulation. 2012;125:2256-2264

EXPERIENCE & LEARNING CURVE

58

Confidential

Clair D. Cath Cardiovasc Int 77:420–429 (2011).

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

Stroke/death

2003 2010

CASPROCEDURAL EVOLUTION

Confidential

FAQHOW DO YOU MANAGE INTOLERANCE?

Intolerance can be managed. There are many options:

1. Supplemental O2

2. Increase blood pressure

3. Expeditiously complete procedure and restore antegrade flow

4. Manage flow: intermittently switch to lo flow or stop flow

5. Intermittently restore antegrade flow by unclamping

In the PROOF study, 5 of 65 (7.7%) patients experienced investigator-reported intolerance. All patients successfully received a stent and intolerance resolved without clinical sequelae. Intolerance was not associated with post-procedure DWI lesions.

One of the benefits of direct carotid revascularization is the ability to perform a very quick procedure and limit the duration of CCA clamping and flow reversal (in contrast to CEA).