Vascular Annual Meeting

SVS Carotid Vascular Registry: CAS Vs. CEA Outcomes Comparison

Anton N. Sidawy1, Robert M. Zwolak2, Rodney A. White3, Flora S. Siami4, Marc L. Schermerhorn5, Gregorio A. Sicard6, SVS Outcomes Committee.

1VA Medical Center, Washington, D.C. 2Dartmouth-Hitchcock Medical Center, Lebanon, N.H.;3Harbor-UCLA Medical Center, Torrance, Calif.;4New England Research Institutes, Inc, Watertown, Mass.;5Beth Israel Deaconess Medical Center, Boston, Mass.;6Washington University, St. Louis, Mo.

OBJECTIVES: The Outcomes Committee of Society for Vascular Surgery (SVS) developed the Vascular Registry (VR) on Carotid Procedures in response to the Centers for Medicare and Medicaid Services’ (CMS) National Coverage Decision on carotid artery stenting (CAS). Although CMS requires data submission only on CAS, SVS designed VR to collect similar data on carotid endarterectomy (CEA) to allow comparison of outcomes, with potential for expansion to other procedures.

METHODS: SVS-VR on-line, provider-reported data include pre-procedure demographics, medical history, and symptom status; diagnostic imaging; procedural information; complications; and follow-up. An independent data center maintains the database, which is HIPAA-compliant and auditable. CAS and CEA providers from 7 specialties contribute data.

RESULTS: Electronic data entry began July 11, 2005. Currently, 6403 procedures with discharge data have been entered by 287 providers at 56 centers on 2763 CAS patients (1450 with 30-day outcomes, 52.5%) and 3259 CEA patients (1368 with 30-day outcomes, 42%). Of the total cohort, 98% of CEA and 70.7% of CAS (p<0.001) were done for atherosclerotic disease; and 22.3% and 4.5% of CAS were done for restenosis and radiation-induced stenosis, respectively. 49.2% of CAS and 42.4% of CEA were performed for symptomatic disease, p<0.001. CAS patients had higher prevalence of pre-procedure stroke, amaurosis fugax, CAD, MI, CHF, COPD and cardiac arrhythmia. For CAS, death/stroke/MI at 30-days was 7.13% for symptomatic patients and 4.60% for asymptomatic patients. For CEA, death/stroke/MI at 30-days was 3.75% in symptomatic patients and 1.97% in asymptomatic patients. After risk-adjustment for age, history of stroke, diabetes and ASA grade (i.e., significant confounders in outcomes using backwards elimination), logistic regression analysis demonstrated better outcomes following CEA.

CONCLUSIONS: SVS-VR provides an excellent venue for collection of CAS data to meet CMS facility recertification requirements. With continued enrollment and follow-up, analysis of SVS-VR will supplement randomized trials by providing real-world comparisons of CAS and CEA with sufficient numbers to serve as an outcome assessment tool of important patient subsets and across the spectrum of peripheral vascular procedures.
AUTHOR DISCLOSURES: A.N. Sidawy, None; R.M. Zwolak, None; R.A. White, None; F.S. Siami, None; M.L. Schermerhorn, None; G.A. Sicard, None.

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