Sponsored by Silk Road Medical
TCAR TEST Drive
Direct carotid stent/angioplasty with flow reversal (or transcarotid artery revascularization [TCAR]) is a new approach to carotid stenting. The potential for reducing risk of periprocedural complications associated with transfemoral carotid artery stenting was documented in the PROOF trial performed in Dusseldorf, Germany.1 This approach was brought to the United States in the form of an FDA investigational device exemption trial (ROADSTER). Following the successful outcome of the ROADSTER trial, the technology received FDA approval.2 Silk Road Medical, manufacturer of the ENROUTE® Transcarotid Neuroprotection System components for TCAR, considered it crucial for new users of the approach to receive adequate training prior to beginning clinical practice, and implemented the TEST DRIVE training program. This is now available for practicing surgeons as well as for individuals completing their vascular surgery training.
The TEST DRIVE training course, carried out in a facility near Chicago O’Hare airport, provides both didactic and “wet model” training. The course includes didactic lectures from respected surgeons who have had extensive experience with the procedure. Participants are encouraged to bring case material, including appropriate imaging for presentation, discussion, and case planning. Finally, training stations are set up to include instructions regarding the use of the ENROUTE® Transcarotid Stent delivery system (Silk Road Medical) and deployment of the stent. Angioscopy is included in the training, giving trainees the opportunity to visualize insertion of the micropuncture needle, guidewire passage, and insertion of the Uber-Flex™ arterial sheath (Silk Road Medical).
The company also has developed wet models that include a cutdown to expose a realistic carotid artery and jugular vein. The model has active fluid circulation to provide a realistic simulation of all procedural steps from needle puncture, guidewire placement, flow reversal with carotid clamping, and extracorporeal side arm connection to the femoral vein. Guidewire access to the lesion under fluoroscopic control and stent deployment completes the hands-on part of the program.
The TEST DRIVE program has been conducted 40 times to date, has been replicated off-site as a regional program, and trained over 1,000 practicing surgeons. Based on the success of the program and a need to meet an expanding clinical demand, a specific version of the program was developed in 2018 for vascular surgery residents and fellows. Leveraging the curriculum of the standard TEST DRIVE, specific modules were developed to meet trainees’ needs as they first enter practice. These modules included expanded information and tips on how to navigate value analysis committees, supply chain management, reimbursement, and how to utilize new technologies and industry partnerships in practice development. Fifty trainees completed the program last year, and an anticipated 80 more will matriculate through the program in 2019.
The success of this program is attested by the fact that 75% of participants in the ROADSTER 2 program were new operators. Having completed the TEST DRIVE program and subsequent proctoring of their initial three cases, these participants were able to provide results that were comparable to those seen in ROADSTER 1. Considering the ROADSTER trials were carried out in patients who were believed to be high surgical risk from either a medical or technical standpoint, the results were comparable to the best results of carotid endarterectomy in average-risk patients, as documented in clinical trials. Because the results of TCAR are far superior to results reported with the transfemoral approach to carotid stenting,3 TEST DRIVE training provides an excellent opportunity and service to the vascular community and their patients.
1. Alpaslan A, Wintermark M, Pintér L, et al. Transcarotid artery revascularization with flow reversal. J Endovasc Ther. 2017;24:265-270.
2. Kwolek CJ, Jaff MR, Leal JI, et al. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015;62:1227-1234.
3. Schermerhorn ML, Liang P, Dakour-Aridi H, et al. In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative [published online June 18, 2019]. J Vasc Surg.