Brajesh K Lal1, Richard Cambria2, Wesley Moore3, Minerva Mayorga-Carlin4, William Shutze5, Christopher L Stout6, Heath Broussard7, H Edward Garrett8, Wayne Nelson9, Jessica M Titus10, Sumaira Macdonald11, Rachel Lake4, John D Sorkin12. 1. Department of Vascular Surgery, University of Maryland, Baltimore, Md. Electronic address: blal@som.umaryland.edu. 2. Division of Vascular Surgery, St Elizabeth's Medical Center, Boston, Mass. 3. Division of Vascular Surgery, University of California, Los Angeles, Los Angeles, Calif. 4. Department of Vascular Surgery, University of Maryland, Baltimore, Md. 5. Division of Vascular Surgery, Texas Vascular Associates, The Heart Hospital Plano, Plano, Tex. 6. Division of Vascular Surgery, Mercy Hospital, Springfield, Mo. 7. Division of Vascular Surgery, The Jackson Clinic PA, Jackson, Tenn. 8. Division of Vascular Surgery, University of Tennessee, Memphis, Tenn. 9. Division of Vascular Surgery, St Charles Medical Center, Bend, Ore. 10. Division of Vascular Surgery, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minn. 11. Silk Road Medical Inc, Sunnyvale, Calif. 12. Department of Medicine, University of Maryland, Baltimore, Md.
Abstract
BACKGROUND: Transcarotid artery revascularization (TCAR) is a new 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 using cadavers or synthetic models to that of 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, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, 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 the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training. RESULTS: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had 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% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians. CONCLUSIONS: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases.
BACKGROUND: Transcarotid artery revascularization (TCAR) is a new 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 using cadavers or synthetic models to that of 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, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, 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 the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training. RESULTS: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had 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% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians. CONCLUSIONS: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases.
Authors: Thomas G Brott; Robert W Hobson; George Howard; Gary S Roubin; Wayne M Clark; William Brooks; Ariane Mackey; Michael D Hill; Pierre P Leimgruber; Alice J Sheffet; Virginia J Howard; Wesley S Moore; Jenifer H Voeks; L Nelson Hopkins; Donald E Cutlip; David J Cohen; Jeffrey J Popma; Robert D Ferguson; Stanley N Cohen; Joseph L Blackshear; Frank L Silver; J P Mohr; Brajesh K Lal; James F Meschia Journal: N Engl J Med Date: 2010-05-26 Impact factor: 91.245
Authors: Jenifer H Voeks; George Howard; Gary S Roubin; Mahmoud B Malas; David J Cohen; W Charles Sternbergh; Herbert D Aronow; Mark K Eskandari; Alice J Sheffet; Brajesh K Lal; James F Meschia; Thomas G Brott Journal: Stroke Date: 2011-10-06 Impact factor: 7.914
Authors: Brajesh K Lal; William Jordan; Vikram S Kashyap; Christopher J Kwolek; Wesley S Moore; Dipankar Mukherjee; Marc L Schermerhorn Journal: J Vasc Surg Date: 2020-06-20 Impact factor: 4.268
Authors: H J Barnett; D W Taylor; M Eliasziw; A J Fox; G G Ferguson; R B Haynes; R N Rankin; G P Clagett; V C Hachinski; D L Sackett; K E Thorpe; H E Meldrum; J D Spence Journal: N Engl J Med Date: 1998-11-12 Impact factor: 91.245
Authors: Christopher J Kwolek; Michael R Jaff; J Ignacio Leal; L Nelson Hopkins; Rasesh M Shah; Todd M Hanover; Sumaira Macdonald; Richard P Cambria Journal: J Vasc Surg Date: 2015-11 Impact factor: 4.268