Carotid Artery Diseases, Carotid Atherosclerosis, Stroke
Conditions
Brief summary
Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.
Detailed description
Surgical and endovascular treatment have been shown as effective treatment modalities in symptomatic and asymptomatic patients at high risk of stroke on medical therapy with significant carotid artery stenosis. Eversion carotid endarterectomy (eCEA) has proven effective as a surgical treatment modality. In highly selected instances carotid bypass may be indicated as a bailout procedure or primarily as a preoperatively planned maneuver. Usually, the decision for substitution of carotid bifurcation with a synthetic graft is made due to an extensive, severe atherosclerotic process on the distal part of the extracranial internal carotid artery, the presence of uncontrollable atherosclerotic plaque after endarterectomy, and in cases when an exceptionally thin artery wall remains after endarterectomy. Several techniques have been described for substituting carotid bifurcation with a synthetic graft. The most common technique involves complete resection and excision of the carotid bifurcation and reconstruction with graft interposition between the undiseased segment of the common carotid artery (CCA) proximally and the internal carotid artery (ICA) distally by creating proximal and distal end-to-end anastomoses. This technique requires ligation and exclusion of the external carotid (ECA) and the superior thyroid artery from circulation. The less common techniques that preserve flow through the external carotid artery are performed as a primary option for treatment without previous endarterectomy and are seldom applied. Currently, there are no recommendations regarding the administration of carotid bypass, nor comparisons of these techniques. In this study, the investigators are comparing a technique with graft interposition between endarterectomized CCA (creation of side-to-end anastomosis) and the distal segment of the ICA (end-to-end anastomosis) after failure of eCEA to provide technical success with the described common interposition by end-to-end anastomoses proximally and distally. Therefore, the role of flow preservation through the ECA could be defined.
Interventions
PROCEDURECarotid graft interposition
In patients with extensive atherosclerotic carotid disease, when endarterectomy isn't feasible, replacement of the carotid artery with a graft is needed. Graft interposition can be performed either by end-to-end proximal and distal anastomoses in the undiseased common and internal carotid artery with ligation of the external carotid artery, or by side-to-end proximal anastomosis on the origin of the internal carotid artery and end-to-end distal anastomosis on the internal carotid artery with flow preservation in the external carotid artery.
Sponsors
Institute for Cardiovascular Diseases Dedinje
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* symptomatic carotid stenosis (\> 50%) * unilateral asymptomatic carotid stenosis (\> 60%) * bilateral asymptomatic carotid stenosis (\> 60%)
Exclusion criteria
* carotid restenosis * major surgery in previous 6 months * previous brain trauma or surgery * malignant disease * epilepsy * carotid artery aneurysm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| periprocedural stroke and death | 30 days | onset of new neurological deficit or death during perioperative period |
| myocardial infarction | 30 days | development of new acute coronary events during perioperative period |
| stroke ipsilateral to the procedure | through study completion, an average of 2 years | development of new neurological events that are pathophysiological atributable to the operated side |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| restenosis rate | through study completion, an average of 2 years | restenosis after graft placement diagnosed by color Doppler sonographic examination or by multiplanar detection computerized tomography angiography |
| graft patency | through study completion, an average of 2 years | primary and primary assisted |
| patient survival | through study completion, an average of 2 years | defining cause of death |
Countries
Serbia
Contacts
Primary ContactSlobodan Pesic, MD
Backup ContactJovan Petrovic, MD
Outcome results
None listed