Surgical simulation has come to the forefront to enhance the training of residents. The aim of our scoping review is to analyze the available simulation-based carotid revascularization techniques, including carotid endarterectomy (CEA) and carotid artery stenting (CAS) and suggest critical steps for evaluating competency in a standardized fashion. A scoping review of all reports on simulation-based carotid revascularization techniques including CEA and CAS was performed in PubMed/MEDLINE, Scopus, Embase, Cochrane, Science Citation Index Expanded, Emerging Sources Citation Index, and Epistemonikos databases. Data were collected according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. The English language literature was searched from January 1, 2000 to January 9, 2022. The outcomes evaluated included measures of assessment of operator performance. Five CEA and 11 CAS manuscripts were included in this review. The methods of assessments employed by these studies to judge performance were comparable. The 5 CEA studies sought to validate and demonstrate improved performance with training or distinguish surgeons by their experience level, either through assessing operative performance or end-product results. The 11 CAS studies used 1 of 2 types of commercial simulators and focused on determining the efficacy of simulators as teaching tools. By examining the steps of the procedure associated with preventable perioperative complications, it provides a reasonable framework for determining which elements of the procedure should be emphasized most. Furthermore, using potential errors as a basis for assessment of competency could reliably distinguish operators based on level of experience. Competency-based simulation training is becoming more relevant as our surgical training paradigm shifts with the increased scrutiny within training programs of work-hour regulations and the need to develop a curriculum to assess our trainees' ability to perform specific operations competently during their stipulated training period. Our review has given us an insight into the current efforts in this space regarding 2 specific procedures that are key for all vascular surgeons to master. Although many competency-based modules are available, there is a lack of standardization in the grading/rating system of what surgeons consider vital steps of each procedure to assess these simulation-based modules. Therefore, the next steps of curriculum development should be based on standardization efforts for the different protocols available.

ObjectivesTranscarotid artery revascularization (TCAR) is a carotid stenting technique that utilizes reversal of cerebral arterial flow to confer cerebral protection. Although carotid endarterectomy (CEA) remains the standard for treatment of symptomatic and asymptomatic carotid stenosis, the search for the optimal minimally invasive option for the high-risk surgical patient continues. The goal of the current study is to evaluate the 1-year safety and efficacy of TCAR in a prospective clinical trial. MethodsROADSTER 2 is a prospective, open-label, single-arm, multicenter, post-approval registry for patients undergoing TCAR. All patients were considered high risk for CEA and underwent independent neurological assessments preoperatively, postoperatively, and had long-term clinical follow-up. The primary end point was incidence of ipsilateral stroke after treatment with the ENROUTE Transcarotid Stent System. Secondary end points included individual/composite rates of stroke, death, and perioperative myocardial infarction. ResultsBetween June 2016 and November 2018, 155 patients at 21 centers in the United States and one in the European Union were enrolled and represented a subset of the overall trial. Asymptomatic (n = 119; 77%) and symptomatic patients (n = 36; 23%) with high-risk anatomic (ie, high lesion, restenosis, radiation injury; 43%), physiologic (32%), or combined factors (25%) were enrolled. No patient suffered a perioperative myocardial infarction or stroke. Over the year, no patient had an ipsilateral stroke, but four patients died (2.6%), all from non-neurological causes. Additionally, a technical success rate of 98.7% with a low cranial nerve deficit rate of 1.3% was achieved. ConclusionsIn patients with high risk factors, TCAR yields high technical success with a low stroke and death rate at 1 year. Further comparative studies with CEA are warranted.

BackgroundTranscarotid artery revascularization (TCAR) is a hybrid approach to carotid revascularization. Limited information is available on the differences in periprocedural complications and performance measures of TCAR for men compared with women and for older vs younger adults. MethodsThe patient, lesion, and physician characteristics were collected for all TCAR procedures performed by each physician worldwide in an international quality assurance database between March 3, 2009 and May 7, 2020. Clinical composite (ie, death, stroke, transient ischemic attack, myocardial infarction) and technical composite (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, device failure) adverse events within 24 hours of the procedure were recorded. Four performance measures were recorded: flow-reversal time, fluoroscopy time, contrast volume, and skin-to-skin time. Poisson regressions were used to assess the effects of age and sex on the incidence of clinical and technical composite adverse events. Linear regressions were used to compare the four performance measures. ResultsA total of 18,240 TCARs were performed by 1273 physicians; 34.9% of the patients were women and 37.5% were symptomatic. The overall incidence of clinical and technical composite adverse events was low. The adjusted clinical (1.62% [95% confidence interval (CI), 1.17%-2.23%] vs 1.35% [95% CI, 1.01%-1.79%]; P = .22) and technical (7.84% [95% CI, 6.85%-8.97%] vs 7.80% [95% CI, 6.94%-8.77%]; P = .93) composite adverse event rates did not vary for women vs men. The adjusted clinical (P = .65) and technical (P = .55) composite adverse event rates also did not vary by age. The adjusted skin-to-skin time was shorter for the women (76.6 minutes; 95% CI, 74.6-78.6) than for the men (77.7 minutes; 95% CI, 75.7-79.6; P = .002). Significant differences were found by age group for fluoroscopy time, flow-reversal time, and skin-to-skin time, although the magnitude of these differences was small (<1 minute for each). ConclusionsThe clinical and technical outcomes of TCAR are not affected by age or sex. We found clinically minor differences in the procedural performance measures when stratified by age and sex. In addition to being safe for younger individuals, TCAR could also be the preferred method for performing carotid stenting in women and older patients, in particular, older women.

BackgroundWhen introduced to a new procedure, physicians improve their performance and reduce their procedural adverse event rates rapidly during the initial cases and then improvement slows, signaling that proficiency has been achieved. Determining when they have acquired proficiency has important implications for procedural innovation, education, credentialing, and patient safety. We analyzed the worldwide experience with transcarotid artery revascularization (TCAR), a hybrid approach to carotid revascularization, to identify the (1) procedural performance measures associated with clinical and technical adverse events; (2) target levels of performance measures that minimize adverse event rates; and (3) number of TCAR cases needed to achieve the target levels for the performance measures. MethodsThe patient, lesion, and physician characteristics were collected for each TCAR procedure performed by each physician worldwide in an international quality assurance database. Four procedural performance measures were recorded for each procedure: flow-reversal time, fluoroscopy time, contrast volume, and total skin-to-skin time. 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, device failure), occurring within 24 hours were also recorded. Correlations between each performance measure and the clinical and technical adverse event rates were computed. The inflection points in the performance measures were identified at which no further improvements occurred in the adverse event rates. Finally, the minimum number of TCAR cases required to achieve the target performance measure levels was computed. ResultsA total of 18,240 procedures performed by 1273 physicians were analyzed. Of the 18,240 patients, 34.9% were women and 62.5% were asymptomatic. The flow-reversal time correlated with clinical adverse events adjusted for age, sex, and symptomatic status (R2 = 0.91; P < .0001) and adjusted technical adverse events (R2 = 0.86; P < .0001). The skin-to-skin time correlated with adjusted technical adverse events (R2 = 0.92; P < .0001). A reduction in flow-reversal times to <13.1 minutes and the skin-to-skin time to <81 minutes did not translate into further improvements in the adverse event rates. A minimum of 26 TCAR cases was required to achieve the target flow-reversal time, and a minimum of 15 cases was required to achieve the target skin-to-skin time. ConclusionsThe flow-reversal time and skin-to-skin time are appropriate performance measures for establishing the level of expertise of physicians as they acquire skills to perform TCAR. A target time of ≤13.1 minutes for flow-reversal and 81 minutes for skin-to-skin time minimized the adverse event rates. Familiarity with the steps involved in performing TCAR was achieved after ≥15 cases, and minimizing clinical adverse events occurred after ≥26 cases.

BackgroundIn patients deemed high risk for carotid endarterectomy (CEA) who are indicated for treatment of carotid artery stenosis (CAS), transcarotid artery revascularization (TCAR) has been demonstrated as a safe and effective alternative to trans-femoral carotid artery stenting (TF-CAS). Compared to CEA, where approx. 12% of patients undergoing awake intervention do not tolerate internal carotid artery (ICA) clamping, only 1–2% of patients were observed to have intolerance to flow reversal during TCAR based on data from the ROADSTER1/2 trials. This study reviewed awake interventions from those trials to assess factors associated with intolerance to flow reversal and review how those cases were managed. MethodsThis is a retrospective review of prospectively collected data from Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial along with the subsequent post-approval (ROADSTER-2) trial. The subset of patients from both trials undergoing awake TCAR was analyzed to compare demographics, procedural details, and anatomic factors between patients who did and did not experience intolerance to reversal of flow to assess for predisposing factors. Patients were deemed intolerant to flow reversal at the discretion of the operator, often related to changes in completion of neurologic tasks, hemodynamic stability, or patient reported symptoms. ResultsA total of 103 patients from ROADSTER and 194 patients from ROADSTER-2 underwent TCAR under local/regional anesthesia. Of these, 8 patients had intolerance to flow reversal, though all cases were successfully completed. While intraoperative hemodynamic data was only available for 5 of the 8 intolerant patients, none experienced hypotension. 4 cases were completed under low flow reversal, 3 cases were successfully weaned from low to high flow over several minutes, and 1 case required general anesthesia. No significant association was found between intolerance to flow reversal and comorbidities including diabetes mellitus (DM), hypertension (HTN), hyperlipidemia (HLD), congestive heart failure (CHF), prior MI or angina, pre-op CAS-related symptoms, prior stroke, prior CAS or CEA, prior neck radiation, tandem stenosis, high cervical stenosis, or hostile neck. A trend towards significance was seen with chronic obstructive pulmonary disease (COPD) and contralateral carotid artery occlusion (P = 0.086 and 0.139, respectively). ConclusionsDespite intolerance to flow reversal, TCAR cases were successfully completed by adjusting reversal-of-flow rate and do not typically require conversion to GETA. While factors contributing to intolerance of flow reversal during TCAR remain poorly understood, this study identified a trend towards significance with an association of preexisting COPD and contralateral carotid artery occlusion. Given the low number of patients who experienced this issue, a larger sample size is required to better elucidate these trends.

Transcarotid artery revascularization (TCAR) is a novel and attractive alternative to carotid endarterectomy (CEA) or transfemoral carotid artery stenting for interventional treatment of carotid artery stenosis in high-risk patients. In a direct carotid approach, TCAR uses temporary reversal of cerebral arterial blood flow to offer neuroprotection from emboli during stent placement. At present, the optimal surgical management for high-risk patients is unknown. We aimed to evaluate the 1-year safety and efficacy of TCAR in a prospective clinical trial.

BackgroundTranscarotid 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. MethodsPhysicians 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. ResultsFrom 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. ConclusionsWe 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.

ObjectiveOver the years where stents have been used to treat carotid lesions, a great deal has been learned about which anatomic characteristics lead to adverse outcomes. This review summarizes the anatomic and morphologic characteristics of the carotid vasculature that can help guide patient selection and clinical decision-making. MethodsEach of the carotid artery anatomy and lesion characteristics that are relevant to carotid stenting is described in detail. These are accompanied with evidence-based outcomes and results. ResultsData on the prevalence of carotid artery lesions that are unsuitable for stenting are summarized and the implications of these data for practice are discussed, especially as they pertain to transcarotid artery revascularization. ConclusionsCarotid artery stenting can be a viable option for carotid revascularization, but the lesion must be acceptable and safe for stent placement. There should be thorough assessment to rule out the presence of severe tortuosity, long-segment disease, severe calcification (circumferential or exophytic), mobile plaque, swollen internal carotid artery sign, and carotid diameters outside the acceptable range. In carefully chosen lesions with the absence of the unfavorable characteristics described, transcarotid artery revascularization may offer improved periprocedural success and carotid artery stenting may attain better long-term durability.

ObjectiveTranscarotid artery revascularization (TCAR) seems to be a safe and effective alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). The TCAR system represents a paradigm shift in the management of carotid artery stenosis with potential for a significant decrease in periprocedural morbidity. However, as with CEA or TF-CAS, TCAR is associated with infrequent complications related to user technical error, most of which are preventable. Our goal is to describe these low-frequency events, and to provide guidelines for avoiding them. MethodsThe U.S. Food and Drug Administration (FDA) requires that all medical device manufacturers create a system for receiving, reviewing, and evaluating complaints (Code 21 of Federal Regulations 820.198). Silk Road Medical, Inc (Sunnyvale, Calif), has established a process by which all feedback, including complaints that may not meet FDA criteria, is captured and stored in a database for detailed analysis. More than 13,300 cases have been performed; submitted complaints were reviewed for incidents of serious injury and periprocedural complications, above and beyond the device-related events that must be reported to the FDA. ResultsA total of 13,334 patients have undergone TCAR worldwide between early 2011 and December 2019 using the SilkRoad device. Reported complications included 173 dissections (1.4% overall rate) of the common carotid artery at the access point, of which 22.5% were managed without intervention or with medical therapy alone and 24.3% were converted to CEA (considered failing safely). Errors in the location of stent deployment occurred in 16 cases (0.13%), with the most common site being the external carotid artery (75%). One wrong side carotid artery stent was placed in a patient with a high midline pattern of the bovine arch. Cranial nerve injury was reported in 11 cases (0.08%), only one of which persisted beyond 3 months. There have been three reported pneumothoraces and one reported chylothorax. Many of these errors can be recognized and prevented with careful attention to detail. ConclusionsIn high-risk patients requiring treatment for carotid artery stenosis, TCAR has been proven as an alternative to TF-CAS with an excellent safety profile. As with CEA or TF-CAS, this procedure has the potential for infrequent complications, often as a result of user technical error. Although significant, these events can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described.

Nearly half of all mild brain injury sufferers experience long-term cognitive impairment, so an important goal in rehabilitation is to address their multiple cognitive deficits to help them return to prior levels of functioning. Cognitive training, or the use of repeated mental exercises to enhance cognition, is one remediation method for brain injury. The primary purpose of this hypothesis-generating pilot study was to explore the statistical and clinical significance of cognitive changes and transfer of training to real-life functioning following 60 h of Brain Booster, a clinician-delivered cognitive training program, for six patients with mild traumatic brain injury (TBI) or non-traumatic acquired brain injury (ABI). The secondary purpose was to explore changes in functional connectivity and neural correlates of cognitive test gains following the training. We used a multiple case study design to document significant changes in cognitive test scores, overall IQ score, and symptom ratings; and we used magnetic resonance imaging (MRI) to explore trends in functional network connectivity and neural correlates of cognitive change. All cognitive test scores showed improvement with statistically significant changes on five of the seven measures (long-term memory, processing speed, reasoning, auditory processing, and overall IQ score). The mean change in IQ score was 20 points, from a mean of 108 to a mean of 128. Five themes emerged from the qualitative data analysis including improvements in cognition, mood, social identity, performance, and Instrumental Activities of Daily Living (IADLs). With MRI, we documented significant region-to-region changes in connectivity following cognitive training including those involving the cerebellum and cerebellar networks. We also found significant correlations between changes in IQ score and change in white matter integrity of bilateral corticospinal tracts (CST) and the left uncinate fasciculus. This study adds to the growing body of literature examining the effects of cognitive training for mild TBI and ABI, and to the collection of research on the benefits of cognitive training in general.Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02918994.