CEA: What is the current best patch if any? EAC: Quel est le meilleur patch (s il existe)? Alan Dardik, MD, PhD, FACS Yale University New Haven, USA

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Carotid latest news Carotide: données récentes CEA: What is the current best patch if any? EAC: Quel est le meilleur patch (s il existe)? Alan Dardik, MD, PhD, FACS Yale University New Haven, USA

Disclosure Speaker name: Alan Dardik... I have the following potential conflicts of interest to report: Consulting Employment in industry Shareholder in a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

Patches Les patchs Simple technique No contraindications Good for small arteries, shunt use, bifurcations Time consuming Potential prosthetic implant www.carotid.net

Patching after CEA is associated with Utiliser un patch après une EAC est associé à... reduced 30-day risk of ipsilateral stroke 1.6% vs. 4.8%, p=.001 reduced risk of stroke or death 2.5% vs. 6.1%, p=.007 reduced rates of return to surgery 1.1% vs. 3.1%, p=.01 reduced rates of arterial occlusion 0.5% vs. 3.6%, p=.0001 www.carotid.net Bond et al. Cochrane Database Syst Rev 2004; (2):CD000160. Bond et al. J Vasc Surg. 2004 Dec;40(6):1126-35.

The ideal patch Le patch idéal long term stability and durability low risk of restenosis compliance near that of the host artery comfortable handling characteristics easy harvest or ready to use anti-coagulant function resistance to infection and late degeneration

Autologous Vein Prosthetic Dacron PTFE Pericardial Future?? Tissue engineered Patch options Patchs: les options

Patch options - Autologous vein Patchs: les options - veine autologue Greater Saphenous vein Lesser saphenous vein Established grafts Biocompatible excellent long-term outcomes Excellent hemostasis Easy suturing Autologous Readily available Easy to use www.carotid.net

Patch options - Autologous vein Patchs: les options - veine autologue Everted cervical vein Facial or ext. jugular vein Established Biocompatible excellent long-term outcomes Excellent hemostasis Easy suturing double thickness sometimes hard

Patch options - Autologous vein Patchs: les options - veine autologue Cryopreserved homograft saphenous vein patch saphenous vein harvested during CAB (>3mm, from thigh) cryopreserved in 10% DMSO at -120 o C (up to 3 years) Excellent results reported by Plestis (1996) 1006 cases 1.2% strokes, 96% 10-year freedom from stroke 2% restenosis (>75%), 84% 10-year freedom from restenosis Plestis KA, Kantis G, Haygood K, Earl N, Howell JF. Carotid endarterectomy with homologous vein patch angioplasty: a review of 1006 cases. J Vasc Surg. 1996 Jul;24(1):109-19.

Patch options - Autologous artery Patchs: les options - artère autologue Superior Thyroid Artery Jenkins MP, Aly S, Sarin S, Adiseshiah M. Patch angioplasty following carotid endarterectomy using the ipsilateral superior thyroid artery. Eur J Vasc Endovasc Surg. 1997;14(1):60-2. advantages: excellent strength, reduced cost, excellent compliance match to host artery, available in field disadvantages: reduced patch size, focal arteriosclerosis, potential for distal ischemia Common Carotid Artery Endarterectomized Occluded Superfical Femoral Artery Bastounis EA, Maltezos CK, Balas PE. Carotid endarterectomy and patch angioplasty, utilizing a segment of autogenous endarterectomized superficial femoral artery. A case report. Int Angiol. 1995 Jun;14(2):209-13. advantages: eliminate potential for distal ischemia disadvantages:?? www.carotid.net

Polyester (Dacron) Patch options - Prosthetic Patchs: les options - prothèse Established, similar to other products grafts, umbilical tapes Many sizes available Biocompatible good tissue ingrowth Excellent hemostasis Easy suturing Fig. 188, Ouriel, Atlas of Vascular Surgery www.maquet.com http://aghneurosciences.org/programs/images/carotid10.gif

Patch options - Prosthetic Patchs: les options - prothèse PolyTetraFluoroEthylene (PTFE) carbon-fluoride resin, porous structure 20-30 µm fibril distance Established, similar to other products grafts Many sizes available Biocompatible good tissue ingrowth Excellent hemostasis Easy suturing www.carotid.net http://www.goremedical.com/acuseal/configurations#

Patch options - Prosthetic Patchs: les options - prothèse Bovine or Porcine pericardium Established, similar to other products anastomosis reinforcement Many sizes available Biocompatible good tissue ingrowth use in an infected field Excellent hemostasis Easy suturing Early duplex

Outcomes of patches Résultats des patchs Best established for CEA Extensive data for individual patch materials Some data comparing patch materials

Autologous vein patches Patchs veineux autologues First patch material only autologous available Many series with excellent results Essentially NO reports of patch infection or pseudoaneurysm

Autologous vein patches Patchs veineux autologues Jacobowitz NYU 2001 159 vein patches vs. 90 Dacron patches Stroke: vein 1.3%, Dacron 1.1% (p=ns) Restenosis: vein 2.2%, Dacron 8.5% (p=ns) Jacobowitz GR, Kalish JA, Lee AM, Adelman MA, Riles TS, Landis R. Long-term follow-up of saphenous vein, internal jugular vein, and knitted Dacron patches for carotid artery endarterectomy. Ann Vasc Surg. 2001;15(3):281-7. O Hara Cleveland Clinic 2002 207 cases, randomized vein/synthetic patch Stroke: vein 3.0%, synthetic 2.1% (p=.99) Restenosis: vein 4.8%, synthetic 6.3% (p=.99) O'Hara PJ, Hertzer NR, Mascha EJ, Krajewski LP, Clair DG, Ouriel K. A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy. J Vasc Surg. 2002 ;35(2):324-32.

Dacron and PTFE patches Patchs en Dacron et PTFE Dacron first material to be off the shelf PTFE became very popular upon introduction But less so with suture hole bleeding Recent prosthetics with little disadvantage compared to vein Similar rates of restenosis and occlusion OR 1.01, 95% CI = 0.61-1.66 www.carotid.net Bond et al. Cochrane Database Syst Rev 2004; (2):CD000071.

Comparison of different patch materials Comparaison entre les différents matériaux de patch n stroke restenosis Study vein Dacron eptfe vein Dacron eptfe vein Dacron eptfe AbuRahma 1996 130-134 0.8% - 2.2% 2.9% - 2.2% Archie 2000 903 359 27 0.6% 6.4% 3.7% Jacobowitz 2001 159 90-2.0% 2.2% - 2.2% 8.5% - Grego 2003 80-80 1.3% - 6.4% 9.3% - 13.3% Naylor 2004 134 133-4.5% 7% - 1.6% 7.1% - AbuRahma 2008-100 100-3% 2% - 21% 11%?? Increased restenosis in Dacron patches??

Prosthetic patches Patchs prothétiques Infection, pseudoaneurysm Unusual (0.37%) but treatable Some suggest life-long surveillance needed in susceptible populations Suggests that Dacron and PTFE are not perfect

Bovine pericardial patches Patchs de péricarde bovin Excellent results from many series Off the shelf, durable, biocompatible Duplex immediately in operating room Use in infected fields reported No reports of BSE after carotid patches

Patch options Patchs: les options Autologous Vein Prosthetic Dacron PTFE Pericardial Future?? Tissue engineered History of patch blowout Associated with infection, bleeding, pseudoaneurysms interest! Not yet available

How do patches heal? Comment les patchs s intègrent-ils? Does the body s cells infiltrate into the patch? Does the body cover the patch with cells? Does the body accept or reject the patch?

Data? None! Données? Aucunes! No literature describing patch healing Unfortunate, since surveillance ultrasounds are often performed after patch surgery The carotid artery is not part of the standard sampling for an autopsy

Method of patch study Méthode d étude des patchs implant pericardial patch into a Wistar rat bovine porcine aorta subcutanous study explanted patch 1-7 days 30 days

The implanted pericardial patch Le patch péricardique implanté

Preimplantation Patch Patch pré-implantatoire Bovine Patch Porcine Patch

Cells infiltrate into the patch Les cellules s'infiltrent dans le patch

Histology of Pericardial Patches Histologie des patchs péricardiques Middle Outside Edge Day 7 Patch: H&E staining, 40x

No vascular cells in the arterial patches! Pas de cellules vasculaires dans les patchs artériels! (only a few macrophages) (seuls quelques macrophages)

Arterial patches have arterial stem cells Les patchs artériels présentent des cellules souches artérielles

Arterial patches have arterial stem cell mrna Les patchs artériels présentent de l ARNm de cellules souches Ephrin-B2 CD34

Arterial patches have arterial stem cell protein Les patchs artériels présentent des protéines de cellules souches

Pericardial patches are covered with arterial stem cells Les patchs péricardiques sont recouverts de cellules souches artérielles

Pericardial Patches endothelialize Les patchs péricardiques s endothélialisent CD34 DPAI Merge VEGFR2

Pericardial patches are healed by 30 days Les patchs péricardiques sont intégrés au bout de 30 jours

Pericardial Patches Patchs péricardiques Cells infiltrate into the patch Macrophages Arterial stem cells Endothelialization of the patch by 1 week Arterial stem cells in endothelial position Promotes normal healing,? resistance to infection? Complete neointima by 30 days Continued arterial stem cell presence

Why do I use pericardium? Pourquoi dois-je utiliser un patch péricardique? Established Nice CEA size available Off the shelf No reports of viruses Biocompatible good tissue ingrowth use in an infected field Excellent handling Excellent hemostasis Easy suturing & trimming Good for surgical residents Early duplex Turns into an artery

Thank you Merci Yale University