Le stenting carotidien par voie cervicale Une technique simple ? Pour les cas difficiles ? JM CARDON Hopital prive les franciscaines nimes

RISQUE CLINIQUE CAS Criteres cliniques : AVC Eva 3s Ipsi+contro 9,6% 527 2000/2005 SPACE IPSI 6,4% 1183 2001/2006 ICSS 7,4% 1713 2005/2010 CREST 4,1% 2522 2006/2011

RISQUE CEREBRAL CAS criteres anatomiques ICSS sub study 124 CAS avec IRM pre/post Transfemoral+filtre distal 50% nouvelles lesions ischemiques

CAS RISQUE ANATOMIQUE 1363 CAS 754 CEA Nouvelle lesion IRM 37% 10% Metaanalyse KARSTRUP STROKE 2008 IRM PRE ET POST CAS /CEA

RISQUE CEREBRAL A LA NAVIGATION QUEL 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%

QUEL RISQUE A CAS ? Grossetti : acta chir belg 2011 50 CAS: pas de predilatation ;filtre distal HR color flow mapping TCD intra op + 12 H post op DWI pre/post 4 test psycometriques Audit neuro

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

DW MRI Clinical 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 MRI Clinical 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 consequence pendant 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 carotidienne Gros amas calcaire Trombus Hemmoragie intraplaque Lesions tandem

Patient a risque pour la navigation age Meta analyse Bonati :eur j vasc 2011 eva3s space icss : 3433 patients TCMM 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 CAS Low risk of MI and CNI but increased peri-procedural stroke risk In the periprocedural period, the CAS arm in CREST had an excess of stroke (4.1% vs 2.3%, p=0.01), and there was an increased rates in both arms for patients greater than 75 years old. Therefore, although transfemoral CAS offers the advantage of a lower risk of MI anc CNI there is an increased risk of peri-procedural stroke risk as reflected in the CREST dats. 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 2010 Ballon occlusif,filtration distale,flow reverse Arrete les gros debris mais environ 100 000 microparticules pendant 1 CAS protegee Ballon occlusif↓↓ hits Distal filter↑↑hits embolisation controllee Flow reverse stop hits

Direct Carotid Revascularization CEA Direct Carotid Revascularization Transfemoral CAS Advantages Complete neuroprotection Direct access Durable Disadvantages More invasive, general anesthesia Myocardial infarction risk Cranial nerve injury Wound complications Potential Benefits Neuroprotection Minimally Invasive Decreased Stroke Risk Decreased MI Risk Decreased CNI Risk Local Anesthesia Fast Advantages Minimally invasive Local anesthesia Durable Disadvantages Access-related stroke Excess stroke risk Asymptomatic brain infarction Transcervical carotid revascularization is intended to reduce the respective complications of CEA and transfemoral CAS. Embolic risk is reduced by a) direct carotid access to avoid catheter manipulation in the arch and supra-aortic trunk, and b) stenting and angioplasty under high rate blood flow reversal to shunt debris of all sizes away from the brain. The use of local anesthesia and a supraclavicular mini-incision are intended to reduce the risk of MI, cranial nerve injury, and bleeding complications.

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 minimal comme CEA: risque cerebral minimal

DW MRI Prospective Studies Study Procedure Embolic Protection # subjects % w/ New DWI Lesions PROFI1 Transfemoral CAS Distal filter (Emboshield) 31 87% ICSS2 Distal filter (various) 51 73% Proximal occlusion (MO.MA) 45% DESERVE3 Proximal occlusion (MO.MA) 127 30% PROOF Transcervical CAS MICHI 57 19% CEA Clamp, backbleed 107 17% The incidence of new DWI lesions for transcervical CAS falls within the range of CEA. 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.

Le flow reverse avec abord carotidien Abord au cou sous AL Flow reverse home made Stenting sur guide 0,14

Pas de franchissement de la lesion sans protection Inconvenients 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

ECHOGRAPHIE PRÉOPÉRATOIRE: TECHNIQUE ECHOGRAPHIE PRÉOPÉRATOIRE:

TECHNIQUE INCISION:

DISSECTION VEINEUSE ET ARTÉRIELLE: TECHNIQUE DISSECTION VEINEUSE ET ARTÉRIELLE:

TECHNIQUE PONCTION VEINEUSE:

TECHNIQUE PONCTION VEINEUSE:

HÉPARINISATION SISTÉMIQUE: TECHNIQUE PONCTION ARTERIELLE: HÉPARINISATION SISTÉMIQUE:

TECHNIQUE CONNEXION:

FISTULE ARTERIO-VEINEUSE: TECHNIQUE FISTULE ARTERIO-VEINEUSE:

TECHNIQUE PASSAGE DE LA LÉSION:

TECHNIQUE LIBÉRATION DU STENT ET BALONEMENT:

CONFIRMATION ARTERIOGRAPHIQUE: TECHNIQUE CONFIRMATION ARTERIOGRAPHIQUE:

SUTURE DE L’ARTÉRIOTOMIE: TECHNIQUE SUTURE DE L’ARTÉRIOTOMIE:

FERMETURE DE L’INCISION: 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

Transcervical Carotid Revascularization With Flow Reversal In The Literature Study Number of Stents Death (30 days) Major Stroke Minor Stroke Patency Chang 2004 21 100% at 6M Lin 2005 31 2 100% at 6M Pippinos 2005 17 100% at 12M Matas 2007 62 98% at 6M Criado 2007 104 97% at 40M Faraglia 2008 48 1 Leal 2010 35 100% at 3M TOTAL 318 0.6% 1.6% A new alternative which aims to addresses the challenges of both CEA and transfemoral CAS is transcervical CAS with flow reversal. Results to date with this novel approach as reported in the literature have been very good, with a 0.6% major stroke rate at 30 days from the following series of single center experiences. J Vasc Surg 2004;40:92-7 Criado E. VEITH 2010.

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

PROOF First In Man Results Pinter L. JVS 2011;54:1317-23.

PROOF Procedural Results Parameter Value (n=44) Secondary Endpoints Establishment of Silk Road reverse flow circuit 42 (96%) Acute Device Success 40 (90.9%) Procedural Success 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

PROOF Safety 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 DW-MRI Substudy (n=31) Subjects with new DW-MRI lesion(s) 24-72 hours post 5 (16.1%) No strokes, death or myocardial infarction at 30 days Major Bleeding Event: Subject developed a GI bleed / diverticulitis 2 days post procedure 1One subject developed a GI bleed 2 days post procedure

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 ?

Summary Carotid Revascularization With MICHI Neuroprotection System 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 In summary…..

Atherosclerotic Aortic Lesions Can Increase the Risk of Cerebral Embolization during CAS In Patients With Complex Aortic Arch Anatomy N=59 Patients Undergoing CAS In patients with all three AA characteristics, mean number and volume of embolic brain lesions was significantly greater compared with other patients. Faggioli G. J Vasc Surg 2009;49:80-5.

Transcervical CAS Vs. 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.” Leal I. JVS 2012.

Gupka :j vasc surg 2011 TCD 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

CAS in CREST Experience & Learning Curve Gray WA. Circulation. 2012;125:2256-2264

CAS Procedural Evolution 2003 2010 Clair D. Cath Cardiovasc Int 77:420–429 (2011).

FAQ How do you manage intolerance? Intolerance can be managed. There are many options: Supplemental O2 Increase blood pressure Expeditiously complete procedure and restore antegrade flow Manage flow: intermittently switch to lo flow or stop flow 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).