October 13, 2016 — A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in comparison with carotid endarterectomy (CEA) is being launched by the Society for Vascular Surgery Patient Safety Organization (SVS PSO). Carotid artery stenting (CAS) and CEA are performed in patients with atherosclerotic narrowing of the carotid artery in order to reduce stroke risk.
In the TCAR procedure, a stent is inserted into the common carotid artery through a small neck incision (transcarotid), whereas typical carotid stents are inserted with a long catheter inserted in a groin artery (transfemoral) that must pass through the aorta to reach the carotid arterym, which is a potential source of stroke with the trans-femoral approach. During TCAR, stroke risk is also reduced by temporarily reversing blood flow direction in the carotid artery, so that any debris dislodged by the procedure will not travel to the brain where it could cause stroke. Initial publications suggest that TCAR may have a lower stroke rate than standard transfemoral CAS, potentially due to avoidance of a catheter manipulation in the aorta combined with carotid artery flow reversal.
The TCAR Surveillance Project is designed to obtain more data about real-world outcomes of TCAR in comparison with CEA as performed by centers participating in the Vascular Quality Initiative (VQI). The TCAR Surveillance Project will be directed by an SVS PSO Steering Committee that will make periodic analyses of data collected in the VQI CAS and CEA Registries.
The TCAR Surveillance Project was evaluated by the U.S. Food and Drug Administration (FDA) and found scientifically valid and clinically relevant. Based on this, reimbursement for TCAR procedures performed by centers participating in the VQI TCAR Surveillance Project was approved on Sept. 1, 2016, by the Centers for Medicare and Medicaid Services (CMS) under the current National Coverage Determination.
The project requires that the procedure be performed in high-surgical-risk patients (asymptomatic or symptomatic) using FDA-approved or FDA-cleared devices labeled for the transcarotid approach, and that data about the procedure and one-year follow-up be submitted to the VQI CAS Registry in order to qualify for Medicare coverage.
“We are very pleased about this collaboration between the SVS PSO, CMS and the FDA that has enabled this important study,” said Larry Kraiss, M.D., chair of the PSO Governing Council. “It is through initiatives like the TCAR Surveillance Project that we can accomplish the SVS PSO mission, by using real-world registry data to evaluate and improve the care of our patients with carotid artery disease.”
Sites interested in participating in the project can enroll in the VQI CAS Registry if they do not already participate and obtain the National Clinical Trial identifier required for billing.
“The SVS applauds the efforts of its PSO to continually explore new and innovative ways to improve patient care,” said R. Clement Darling, M.D., president-elect of the Society for Vascular Surgery. “We are excited to learn what this study will find, and encourage participation in the TCAR Surveillance Project.”
For more information: www.vascularqualityinitiative.org