SVS Patient Safety Organization Launches TCAR Surveillance Project

 

September 15, 2016—The Society for Vascular Surgery (SVS) recently announced that 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 SVS Patient Safety Organization (PSO).

TCAR temporarily reverses 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 a stroke. 

According to SVS, initial publications suggest that TCAR may have a lower stroke rate than standard transfemoral carotid artery stenting (CAS), which is potentially because of the avoidance of 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 project will be directed by an SVS PSO Steering Committee, which will make periodic analyses of data collected in the VQI CAS and CEA Registries.

SVS noted that the TCAR Surveillance Project was evaluated by the US Food and Drug Administration (FDA) and was found to be scientifically valid and clinically relevant. Based on these findings, reimbursement for TCAR procedures performed by centers participating in the VQI TCAR Surveillance Project was approved by the Centers for Medicare and Medicaid Services (CMS) under the current National Coverage Determination on September 1, 2016.

The project requires that the TCAR 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 1-year follow-up be submitted to the VQI CAS Registry in order to qualify for Medicare coverage.

Larry Kraiss, MD, Chair of the PSO Governing Council, commented in the SVS announcement, “We are very pleased about this collaboration between the SVS PSO, CMS, and the FDA that has enabled this important study. 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.”

R. Clement Darling, MD, President-Elect of SVS, stated, “The SVS applauds the efforts of its PSO to continually explore new and innovative ways to improve patient care. We are excited to learn what this study will find, and encourage participation in the TCAR Surveillance Project.”

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. For further information about participating in the VQI CAS registry, please contact vqi@m2s.com or call (603) 298-5509.

In related news, Silk Road Medical, Inc. announced that the company’s Enroute transcarotid stent, used in conjunction with its Enroute transcarotid neuroprotection system (NPS) during the TCAR procedure, is eligible for CMS coverage under the National Coverage Determination and will be entered in the TCAR Surveillance Project. Silk Road Medical’s Enroute transcarotid stent and NPS are currently the only devices approved for the TCAR procedure by the FDA.

The company noted that TCAR is eligible for CMS coverage when patients are treated with any FDA-approved proximal embolic protection device and FDA-approved carotid artery stent system indicated for the transcarotid approach and entered into the new national TCAR Surveillance Project.

 

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