J Vasc Surg. 2021 Sep 22:S0741-5214(21)02137-6. doi: 10.1016/j.jvs.2021.08.085. Online ahead of print.
BACKGROUND: Transcarotid artery revascularization (TCAR) is new a hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure, and compared the effectiveness of training physicians on cadavers or synthetic models to traditional in-person training on live cases.
METHODS: Physicians underwent one of three mandatory training programs: 1) in-person proctoring on live TCAR procedures, 2) supervised training on human cadavers, 3) supervised training on synthetic models. Training details and information on all subsequent independently performed TCAR procedures were recorded. Composite clinical adverse events (transient ischemic attack, stroke, myocardial infarction, or death) and composite technical adverse events (aborted procedure, conversion to surgery, bleeding, dissection, cranial-nerve injury, or device failure, occurring within 24 hours were recorded. Four procedural proficiency measures were recorded: procedure time, flow-reversal time, fluoroscopy time, and contrast volume. We compared adverse event rates between procedures performed by physicians after undergoing the three training modes, and tested whether proficiency measures achieved during TCAR after training on cadavers and synthetic models were non-inferior to proctored training.
RESULTS: From March 3rd, 2009 to May 7th, 2020, 1,160 physicians underwent proctored (19.1%), cadaver-based (27.4%) and synthetic model-based (53.5%) TCAR training and subsequently performed 17,283 TCAR procedures. Proctored physicians treated younger patients and more patients with asymptomatic carotid stenosis, and had more prior experience with transfemoral carotid stenting. The overall 24-hour composite clinical and technical adverse event rates adjusted for age, sex, and symptomatic status were 1.0% (95% CI [0.8, 1.3]) and 6.0% [5.4, 6.6] respectively, and did not differ significantly by training mode. Proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to proctored physicians.
CONCLUSIONS: We present key objective proficiency metrics for performing TCAR, and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieve clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures that are similar to those achieved by physicians trained by traditional proctoring on live cases.