Severe symptomatic nickel allergy following stent graft implantation requiring excision and external iliac artery reconstruction.

Although nickel allergy is a common cause of contact dermatitis, systemic reactions to nitinol stents are rare. A 61-year-old woman had presented with a nonhealing toe wound. Angiography revealed an external iliac artery stenosis, which was treated with a nitinol stent graft. However, she developed severe truncal pruritus, and within 3 months, her external iliac stent graft had thrombosed. Allergy testing revealed nickel sensitivity. After medical therapy had failed, stent graft removal was performed, resulting in complete resolution of her symptoms. The present case demonstrates a rare allergic reaction to the nitinol in commercially available stent grafts. Pruritus and rash are rare reactions to stenting; however, a nitinol allergy should be considered for patients with no other identifiable primary source.

Learning curve and proficiency metrics for transcarotid artery revascularization.

BACKGROUND: When 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. METHODS: The 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. RESULTS: A 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. CONCLUSIONS: The 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.

Evaluating the optimal training paradigm for transcarotid artery revascularization based on worldwide experience.

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.

Trainee Experience in Simulation-Based Education of Open Vascular Surgery.

BACKGROUND: Simulation continues to be an important adjunct to vascular surgery training, yet the optimal implementation of simulation to complement conventional surgical training continues to evolve. This study aims to find areas for improvement in current simulation-based training of open vascular skills by characterizing the experience of vascular trainees attending a national simulation-based course. METHOD: This was a survey study conducted at the simulation course of the Annual UCLA/SVS Symposium: A Comprehensive Review and Update of What's New in Vascular and Endovascular Surgery, a national vascular surgery meeting. The survey consisted of 17 questions and was administered on paper or electronically via the Audience Response System, before the start of the course. The survey assessed the participants' experience in formal training, simulation training, and comfort with open surgical procedures. RESULTS: Between 2013 and 2018, the survey was completed by 150 participants of which 65% were vascular fellows. Only 48% of the participants had formal training in suturing and surgical instruments. Most participants had formal training in basic vascular techniques and advanced vascular operations. In 71%, simulation was incorporated into basic technique training and 60% in open surgical training. Simulation training was most commonly utilized in learning anastomotic techniques and open abdominal aortic aneurysm repair. Simulation skills were deemed translatable to the operating room by 59% of participants. Most participants were comfortable performing open vascular procedures. However, 68% of participants were uncomfortable performing an abdominal aortic aneurysm repair. CONCLUSIONS: There continues to be a significant portion of trainees who do not undergo a simulation-based education. Current simulation training is being targeted to meet trainee needs in open vascular surgery, specifically open aneurysm repair. Nonetheless, trainees continue to have doubts regarding applicability of simulation-based skills to the operating theater. Further studies investigating access to simulation education as well as its translatability are needed.

Clinical competence statement of the Society for Vascular Surgery on training and credentialing for transcarotid artery revascularization.

As the practice of medicine grows in complexity, the process of defining the expertise required for the competent execution of specific procedures has also become complex. The Society for Vascular Surgery therefore constituted a task force to provide informed recommendations on the knowledge, technical skills, resources, and infrastructure required to obtain and to maintain privileges for the safe and effective performance of transcarotid artery revascularization (TCAR). The TCAR procedure is being adopted rapidly, and it is therefore important that informed guidance be available expeditiously. Formal training in the pathophysiology and diagnosis of carotid occlusive disease and all management options is essential. Appropriate diagnostic, imaging, endovascular, surgical, and monitoring infrastructure is required, as are resources to maintain quality control. Credentialing and privileging require a combination of both open surgical and endovascular skills. As such, physicians must have hospital privileges to perform carotid endarterectomy. They should attend an appropriate program for education and simulated training in TCAR. In addition, physicians must have performed ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms plus ≥5 TCAR procedures as the primary operator (pathway 1); or they may have acquired ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms and a supplement of 5 TCAR procedures under proctored guidance if they have not performed sufficient TCAR procedures (pathway 2); or a team of two physicians can collaborate, combining the endovascular and surgical requirements plus at least 5 TCAR procedures under proctored guidance (pathway 3).

Endovascular stenting of supra-aortic lesions using a transcarotid retrograde approach and flow reversal: A multicenter case series.

OBJECTIVE: Endovascular treatment has largely replaced open reconstruction of proximal brachiocephalic and left common carotid ostial arterial stenoses. The objective of this study was to report the technical feasibility and safety of a flow-based embolic protection system in stenting of single and tandem stenotic lesions of supra-aortic arch vessels. METHODS: All cases used flow-based neuroprotection by the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif). Case specifics, such as the stents used, the details of flow-based neuroprotection, the order in which lesions were treated, and the case-specific exceptions, are detailed in the body of the publication. The primary end point of this study was the occurrence of stroke or transient ischemic attack. RESULTS: Sixteen patients (12 women) with an average age of 68 years (range, 54-83 years) underwent endovascular stenting to treat single (11 patients) or tandem (5 patients) stenotic lesions of supra-aortic arch vessels. A total of 21 lesions were treated: 7 in the innominate artery, 1 in the right common carotid artery, 8 in the left common carotid artery, and 5 in the internal carotid artery (tandem cases). Eleven patients (69%) were symptomatic, and the stenoses of the five asymptomatic patients were identified during routine workup for comorbidities. Technical success was obtained in all cases. There were no strokes or transient ischemic attacks during the 30 days after the procedure. Minor complications included a minor wound dehiscence that healed secondarily without sequelae and a hematoma at the neck incision that resolved spontaneously without further intervention. CONCLUSIONS: The use of a transcarotid retrograde approach with flow-based neuroprotection is technically feasible for the endovascular stenting of single and tandem stenotic lesions of the supra-aortic arch vessels. These data further support the advantages of a transcarotid approach and flow-based neuroprotection to minimize the risk of intraoperative complications and embolic events during and after the procedure.

Duration of asymptomatic status and outcomes following carotid endarterectomy and carotid artery stenting in the Carotid Revascularization Endarterectomy vs Stenting Trial.

BACKGROUND: Most carotid revascularization studies define asymptomatic as symptom-free for more than 180 days; however, it is unknown if intervention carries similar risk among those currently asymptomatic but with previous symptoms (PS) vs those who were always asymptomatic (AA). METHODS: We compared the periprocedural and 4-year risks of PS vs AA patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) randomized to carotid endarterectomy (CEA) or carotid artery stenting (CAS)/angioplasty. Proportional hazards models adjusting for age, sex, and treatment were used to assess the risk of periprocedural stroke and/or death (S+D; any S+D during periprocedural period), stroke and death at 4 years (any S+D within the periprocedural period and ipsilateral stroke out to 4 years) and the primary end point at 4 years (any stroke, death, and myocardial infarction within the periprocedural period and ipsilateral stroke out to 4 years). Analysis was performed pooling the CEA-treated and CAS-treated patients, and separately for each treatment. RESULTS: Of 1181 asymptomatic patients randomized in CREST, 1104 (93%) were AA and 77 (7%) were PS. There was no difference in risk when comparing the AA and PS cohorts in the pooled CAS+CEA population for periprocedural S+D (2.0% vs 1.3%), S+D at 4 years (3.6% vs 3.2%), or the primary end point (5.2% vs 5.8%). There were also no differences among those assigned to CEA (periprocedural S+D, 1.5% vs 0%; S+D at 4 years, 2.7% vs 0%; or primary end point, 5.1% vs 2.4%) or CAS (periprocedural S+D, 2.5% vs 2.8%; S+D at 4 years, 4.4% vs 6.9%; or primary end point, 5.3% vs 9.8%) when analyzed separately. CONCLUSIONS: In CREST, only a small minority of asymptomatic patients had previous ipsilateral symptoms. The outcomes of periprocedural S+D, periprocedural S+D, and ipsilateral stroke up to 4 years, and the primary end point did not differ for AA patients compared with PS patients.

Direct Cervical Carotid Angioplasty with Flow Reversal: A Single-Center Report from the Roadster Trial.

BACKGROUND: Carotid stent and/or angioplasty (CAS) via the transfemoral route with distal protection carries twice the risk of stroke and/or death when compared with carotid endarterectomy (CEA) in multiple randomized trials. Potential causes for this include disadvantaged aortic arch anatomy and the need to traverse the lesion to place a distal protection device. This report describes the technique and our experience with direct CAS using flow reversal for embolic protection. METHODS: University of California at Los Angeles (UCLA) division of Vascular and Endovascular surgery was a participant in the multi-institutional Roadster Trial of high-risk patients. We are reporting on our experience with 8 patients who met high-risk criteria. Using a small supraclavicular cutdown, the Michi sheath from Silk Road Medical was inserted into the common carotid artery. This provides a working channel for internal CAS as well as a side port to reverse and divert blood flow to the femoral vein, for embolic protection. All patients qualified as medically high risk because of a combination of factors including advanced age, smoking history, hypertension, diabetes, coronary artery disease, or hostile neck anatomy. RESULTS: All 8 patients had 3 or more risk factors including age >75 years (6 of 8), smoking (6 of 8), hypertension (7 of 8), overt coronary artery disease (4 of 8), diabetes (2 of 8), and chronic obstructive pulmonary disease (1 of 8). All stenoses were in the 80-99% category, and all were asymptomatic. All patients tolerated temporary clamping with flow reversal with no electroencephalogram changes. There were no deaths, strokes, transient ischemic attacks, or myocardial infarctions. All patients were discharged on the first postoperative day. Follow-up ranged from 7 to 21 months. One patient developed in-stent restenosis (asymptomatic). CONCLUSIONS: Direct CAS with flow reversal appears to be a safe, less invasive alternative to CEA.

Recognition and Surgical Techniques for Management of Nonrecurrent Laryngeal Nerve during Carotid Endarterectomy.

The presence of a nonrecurrent laryngeal nerve (NRLN) during carotid endarterectomy (CEA) may significantly limit the exposure of the surgical field during this operation. Although its reported incidence is rare, NRLN typically overlies the carotid bifurcation and failure to recognize this anatomic variation increases the risk of NRLN injury. A retrospective chart review of all patients who underwent CEA for hemodynamically significant extracranial carotid stenosis between January 2005 and December 2014 was performed. All patients with NRLN encountered intraoperatively were identified. Clinical outcomes, surgical techniques, and complications were reviewed and reported. Four left-sided NRLN were identified and 4 were right sided. No cranial nerve deficits or injuries occurred after CEA in patients where NRLN was encountered. Two distinct surgical techniques were used to manage patients with NRLN and they are discussed in detail.

Carotid angiographic characteristics in the CREST trial were major contributors to periprocedural stroke and death differences between carotid artery stenting and carotid endarterectomy.

OBJECTIVE: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated a higher periprocedural stroke and death (S+D) rate among patients randomized to carotid artery stenting (CAS) than to carotid endarterectomy (CEA). Herein, we seek factors that affect the CAS-CEA treatment differences and potentially to identify a subgroup of patients for whom CAS and CEA have equivalent periprocedural S+D risk. METHODS: Patient and arterial characteristics were assessed as effect modifiers of the CAS-CEA treatment difference in 2502 patients by the addition of factor-by-treatment interaction terms to a logistic regression model. RESULTS: Lesion length and lesions that were contiguous or were sequential and noncontiguous extending remote from the bulb were identified as influencing the CAS-to-CEA S+D treatment difference. For those with longer lesion length (≥12.85 mm), the risk of CAS was higher than that of CEA (odds ratio [OR], 3.42; 95% confidence interval [CI], 1.19-9.78). Among patients with sequential or remote lesions extending beyond the bulb, the risk for S+D was higher for CAS relative to CEA (OR, 9.01; 95% CI, 1.20-67.8). For the 37% of patients with lesions that were both short and contiguous, the odds of S+D in those treated with CAS was nonsignificantly 28% lower than for CEA (OR, 0.72; 95% CI, 0.21-2.46). CONCLUSIONS: The higher S+D risk for those treated with CAS appears to be largely isolated to those with longer lesion length and/or those with sequential and remote lesions. In the absence of those lesion characteristics, CAS appears to be as safe as CEA with regard to periprocedural risk of S+D.

Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association.

The aim of this updated statement is to provide comprehensive and timely evidence-based recommendations on the prevention of stroke among individuals who have not previously experienced a stroke or transient ischemic attack. Evidence-based recommendations are included for the control of risk factors, interventional approaches to atherosclerotic disease of the cervicocephalic circulation, and antithrombotic treatments for preventing thrombotic and thromboembolic stroke. Further recommendations are provided for genetic and pharmacogenetic testing and for the prevention of stroke in a variety of other specific circumstances, including sickle cell disease and patent foramen ovale.

Agreement between site-reported and ultrasound core laboratory results for duplex ultrasound velocity measurements in the Carotid Revascularization Endarterectomy versus Stenting Trial.

OBJECTIVE: Patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) had duplex ultrasound (DU) scans prior to treatment and during follow-up to document the severity of carotid disease and the anatomic outcome of carotid endarterectomy (CEA) or carotid artery stenting (CAS). An ultrasound core laboratory (UCL) reviewed DU data from the clinical sites. This analysis was done to determine the agreement between site-reported and UCL-verified DU velocity measurements. METHODS: Clinical site DU worksheets, B-mode images, and Doppler velocity waveforms for the treated carotid arteries were reviewed at the UCL. The highest internal carotid artery peak systolic velocity (PSV) and associated Doppler angle were verified. If the angle was misaligned by >3 degrees, it was remeasured at the UCL and the PSV was recalculated. Agreement for PSV was defined as site-reported PSV within ± 5% of UCL-verified PSV. Transcription errors were corrected by the UCL but were not considered as disagreements. Follow-up analysis was limited to patients who received the assigned treatment. RESULTS: The UCL reviewed 1702 prior-to-treatment and 1743 12-month follow-up DU scans (873 CEA, 870 CAS) from 111 clinical sites. Site-reported and UCL-verified PSV agreed in 1124 (66%) of the prior-to-treatment scans and 1200 (69%) of the follow-up scans. In those cases with a disagreement, Doppler angle accounted for disagreement in 339 (59%) of the prior-to-treatment scans and 277 (51%) of the follow-up scans. Based on a threshold PSV for ≥ 70% stenosis of ≥ 230 cm/s on the prior-to-treatment scans and ≥ 300 cm/s on the follow-up scans, UCL review resulted in reclassification of stenosis severity in 75 (4.4%) of the prior-to-treatment scans and 13 (0.75%) of the follow-up scans. There is evidence that the proportion of reclassification at follow-up was greater for CAS (10 scans; 1.2%) than for CEA (three scans; 0.34%) (P = .057). CONCLUSIONS: There was a high rate of agreement between site-reported and UCL-verified DU results in CREST, and UCL review was associated with a low rate of stenosis reclassification. However, angle alignment errors were quite common and prompted recalculation of velocity in 20% of prior-to-treatment scans and 18% of follow-up scans. The use of a UCL provides a uniform process for DU interpretation and can identify sources of error and suggest technical improvements for future studies.

Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).

OBJECTIVE: Outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) did not differ between carotid artery stenting (CAS) and carotid endarterectomy (CEA) for the composite primary end point of stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke within 4 years. Rigorous credentialing and training of interventionists, including vascular surgeons, were required for the randomization phase of CREST. Because the lead-in phase of CREST had suggested higher perioperative risks after CAS performed by vascular surgeons, the purpose of this analysis was to examine differences in outcomes after randomization between CAS and CEA performed by vascular surgeons. METHODS: CREST is a prospective randomized controlled trial with blinded end point adjudication. Vascular surgeons performed 237 (21%) of the CAS procedures and 765 (65%) of the CEA procedures among 2320 patients who received their assigned treatment. Proportional hazards analyses were used to estimate the relative efficacy of CAS vs CEA for the composite primary end point and also for stroke and death. RESULTS: Among 2502 randomized patients, 1321 (53%) were symptomatic and 1181 (47%) were asymptomatic. For procedures performed exclusively by vascular surgeons, the primary end point did not differ between CAS and CEA at 4-year follow-up (6.2% vs 5.6%, respectively; hazard ratio [HR], 1.30; 95% confidence interval [CI], 0.70-2.41; P = .41) In this subgroup, the periprocedural stroke and death rates were higher after CAS than CEA for symptomatic patients (6.1% vs 1.3%; P = .01). Asymptomatic patients also had slightly higher stroke and death rates after CAS (2.6% vs 1.1%; P = .20), although this difference did not reach statistical significance. Conversely, cranial nerve injuries (0.0% vs 5.0%; P < .001) were less frequent after CAS than CEA. The MI rates were slightly lower after CAS (1.3% vs 2.6%; P = .24). In performing CAS, vascular surgeons had outcomes for the periprocedural primary end point comparable to the outcomes of all interventionists (HR, 0.99; 95% CI, 0.50-2.00) after adjusting for age, sex, and symptomatic status. Vascular surgeons also had similar results after CEA for the periprocedural primary end point compared with other surgeons (HR, 0.73; 95% CI, 0.42-1.27). CONCLUSIONS: When performed by surgeons, CAS and CEA have similar net outcomes, although the periprocedural risks vary (lower stroke with CEA and lower MI with CAS). These data suggest that appropriately trained vascular surgeons may safely offer both CEA and CAS for the prevention of stroke. The remarkably low stroke and death rates after CEA performed by vascular surgeons in CREST, particularly among symptomatic patients, represent the best outcomes ever reported after carotid interventions from a randomized controlled trial. ClinicalTrials.gov identifier: NCT0000473.

Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial.

BACKGROUND: In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion. METHODS: Patients with stenosis of the carotid artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732. FINDINGS: 2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had carotid artery stenting, 1105 who had carotid endarterectomy). In 2 years, 58 patients who underwent carotid artery stenting (Kaplan-Meier rate 6·0%) and 62 who had carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63-1·29; p=0·58). Female sex (1·79, 1·25-2·56), diabetes (2·31, 1·61-3·31), and dyslipidaemia (2·07, 1·01-4·26) were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after carotid endarterectomy (2·26, 1·34-3·77) but not after carotid artery stenting (0·77, 0·41-1·42). INTERPRETATION: Restenosis and occlusion were infrequent and rates were similar up to 2 years after carotid endarterectomy and carotid artery stenting. Subsets of patients could benefit from early and frequent monitoring after revascularisation. FUNDING: National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions.

Cost implications of more widespread carotid artery stenting consistent with the American College of Cardiology/American Heart Association guideline.

The recent American College of Cardiology/American Heart Association guideline recommended carotid artery stenting (CAS) as an alternative to carotid endarterectomy (CEA) for symptomatic patients. This and the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) form the basis for seeking more liberalized indications and reimbursement for CAS. For the years 2005-2007, >130,000 carotid interventions/year were performed, 88.6% of which were CEAs and 11.4% were CAS. For the same years, each CAS procedure had on average $12,000-$13,500 more expensive mean total hospital charges than each CEA. If the percentages of CAS and CEA had been equal (ie, 50% CAS and 50% CEA), this would translate into an additional $2,000,000,000 in charges for these 3 years. It seems unreasonable to approve enhanced reimbursement for CAS at this time, especially since the large incremental costs would go to support CAS procedures that are inferior in most symptomatic patients and possibly unnecessary in most asymptomatic patients.