A cardiologist in the carotids
1Endovascular Care, Swedish Cardiovascular Research, Seattle, Washington 98104, USA. william.gray@swedish.org
Insights
Carotid stenting shows promise as an alternative to surgery for stroke prevention in high-risk patients. Challenges remain regarding reimbursement and specialized training for this emerging endovascular intervention.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Neurology
Background:
- Carotid endarterectomy has been the standard for stroke prevention in carotid bifurcation disease for 50 years.
- Carotid stenting has emerged as a viable surgical alternative over the past decade.
- Filter embolic protection devices enhance the safety of carotid stenting.
Purpose of the Study:
- To evaluate the efficacy of carotid stenting compared to endarterectomy in high-risk patients.
- To discuss the implications of FDA approval and future challenges for carotid stenting.
Main Methods:
- Randomized controlled trial (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy [SAPPHIRE]).
- Registry data (ACCULINK for Revascularization of Carotids in High Risk Patients [ARCHeR], Registry Study to evaluate the Neuroshield Bare-Wire Cerebral Protection System and X-Act Stent in patients at high risk for Carotid Endarterectomy [SECuRITY]).
Main Results:
- Carotid stenting compared favorably to endarterectomy in high-risk patients.
- High-risk conditions include cardiac, pulmonary, renal disease, prior neck surgery, radiation, or difficult anatomy.
Conclusions:
- FDA approval of carotid stenting is anticipated, offering a new therapeutic option.
- Challenges include restricted reimbursement, the need for a national coverage decision, and limited expertise requiring tailored training across specialties.
Abstract:
Carotid endarterectomy for stroke prevention has been the standard of care for 50 years in patients with extra-cranial carotid bifurcation disease. Over the past decade, carotid stenting has emerged as a viable alternative to surgery. Combined with filter embolic protection devices, both a randomized control trial (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy registry [SAPPHIRE]) as well as registry data (ACCULINK for Revascularization of Carotids in High Risk Patients registry [ARCHeR] and Registry Study to evaluate the Neuroshield Bare-Wire Cerebral Protection System and X-Act Stent in patients at high risk for Carotid Endarterectomy [SECuRITY]) have compared favorably to endarterectomy in patients at high risk for operative revascularization. Conditions associated with high operative risk included patients with significant cardiac, pulmonary, and renal disease; previous neck operation; previous radiation; and anatomically difficult surgical access. On the basis of these results, a carotid stent system approved by the Food and Drug Administration (FDA) is anticipated in 2004. Although this will be a welcome addition to endarterectomy in the armamentarium of therapeutic options for patients with carotid disease, several challenges lie ahead. Coverage and reimbursement for the carotid stenting has been severely restricted to include only those procedures performed as part of an FDA investigational device exemption trial protocol, and a national noncoverage decision will have to be reckoned with before broader coverage can be put into place (assuming FDA approval). In addition, the level of national expertise in carotid endovascular intervention is limited, and training will need to be tailored to the three specialties likely to perform the procedure: cardiology, radiology, and vascular surgery. Each of these specialties will have specific, and different, requirements for their training, further complicating the task of education.
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