Propensity score-matched analysis of 1-year outcomes of transcarotid revascularization with dynamic flow reversal, carotid endarterectomy, and transfemoral carotid artery stenting.

OBJECTIVE: Initial studies showed no significant differences in perioperative stroke or death between transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) and lower stroke/death rates after TCAR compared with transfemoral carotid artery stenting (TFCAS). This study focuses on the 1-year outcomes of ipsilateral stroke or death after TCAR, CEA, and TFCAS. METHODS: All patients undergoing TCAR, TFCAS, and CEA between September 2016 and December 2019 were identified in the Vascular Quality Initiative (VQI) database. The latest follow-up was September 3, 2020. One-to-one propensity score-matched analysis was performed for patients with available 1-year follow-up data for TCAR vs CEA and for TCAR vs TFCAS. Kaplan-Meier survival and Cox proportional hazard regression analyses were used to evaluate 1-year ipsilateral stroke or death after the three procedures. RESULTS: A total of 41,548 patients underwent CEA, 5725 patients underwent TCAR, and 6064 patients underwent TFCAS during the study period and had recorded 1-year outcomes. The cohorts were well-matched in terms of baseline demographics and comorbidities. Among 4180 TCAR vs CEA matched pairs of patients, there were no significant differences in 30-day stroke, death, and stroke/death. However, TCAR was associated with a lower risk of 30-day stroke/death/myocardial infarction (2.30% vs 3.25%; relative risk, 0.71; 95% confidence interval [CI], 0.55-0.91; P = .008), driven by a lower risk of myocardial infarction (0.55% vs 1.12%; hazard ratio [HR], 0.49; 95% CI, 0.30-0.81; P = .004). At 1 year, no significant difference was observed in the risk of ipsilateral stroke or death (6.49% vs 5.68%; HR, 1.14; 95% CI, 0.95-1.37; P = .157). Among 4036 matched pairs in the TCAR vs TFCAS group, TCAR was also associated with lower risk of perioperative stroke or death compared with TFCAS (1.83% vs 2.55%; HR, 0.72; 95% CI, 0.54-0.96; P = .027). At 1 year, the risks of ipsilateral stroke or death of TCAR and TFCAS were comparable (6.07% vs 7.07%; HR, 0.85; 95% CI, 0.71-1.01; P = .07). Symptomatic status did not modify the association in TCAR vs CEA. However, asymptomatic patients had favorable outcomes with TCAR vs TFCAS at 1 year (HR, 0.78; 95% CI, 0.62-0.98; P = .033). CONCLUSIONS: In this propensity score-matched analysis, no significant differences in ipsilateral stroke/death-free survival were observed between TCAR and CEA or between TCAR and TFCAS. The advantages of TCAR compared with TFCAS seem to be mainly in the perioperative period, which makes it a suitable minimally invasive option for surgically high-risk patients with carotid artery stenosis. Larger studies, with longer follow-up and data on restenosis, are warranted to confirm the mid- and long-term benefits and durability of TCAR.

Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy.

BACKGROUND: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. METHODS: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. FINDINGS: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91-1·32; p=0·21). INTERPRETATION: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. FUNDING: UK Medical Research Council and Health Technology Assessment Programme.

Plaque Vulnerability Index Predicts Cardiovascular Events: A Histological Study of an Endarterectomy Cohort.

Background The balance between stabilizing and destabilizing atherosclerotic plaque components is used in experimental studies and in imaging studies to identify rupture prone plaques. However, we lack the evidence that this balance predicts future cardiovascular events. Here we explore whether a calculated histological ratio, referred to as vulnerability index (VI), can predict patients at higher risk to suffer from future cardiovascular events. Methods and Results Carotid plaques and clinical information from 194 patients were studied. Tissue sections were used for histological analysis to calculate the VI (CD68 [cluster of differentiation 68], alpha-actin, Oil red O, Movat pentachrome, and glycophorin A). Postoperative cardiovascular events were identified through the Swedish National Inpatient Health Register (2005-2013). During the follow-up (60 months) 45 postoperative cardiovascular events were registered. Patients with a plaque VI in the fourth quartile compared with the first to third quartiles had significantly higher risk to suffer from a future cardiovascular event (P=0.0002). The VI was an independent predictor and none of the 5 histological variables analyzed separately predicted events. In the 13 patients who underwent bilateral carotid endarterectomy, the VI of the right plaque correlated with the VI of the left plaque and vice versa (r=0.7, P=0.01). Conclusions Our findings demonstrate that subjects with a high plaque VI have an increased risk of future cardiovascular events, independently of symptoms and other known cardiovascular risk factors . This strongly supports that techniques which image such plaques can facilitate risk stratification for subjects in need of more intense treatment.

Carotid Endarterectomy Following Intravenous Thrombolysis in the UK.

OBJECTIVE: The aim of this study was to evaluate the effect of pre-operative intravenous thrombolytic therapy (ivTT) on short term outcomes after carotid endarterectomy (CEA) among patients who presented with ischaemic stroke. METHODS: A retrospective study using a large population based dataset from the National Vascular Registry in the United Kingdom (UK-NVR). The cohort included adult patients who underwent CEA for ischaemic stroke between 1 January 2014 and 31 December 2019. NVR records provided information on patient demographics, Rankin score, medication, time from onset of symptoms to surgery and whether the patient received ivTT prior to surgery. Logistic regression was used to evaluate the relationship between ivTT and rates of any stroke at 30 days after CEA and in hospital complication rates for neck haematoma. Secondary outcomes included in hospital cardiac and respiratory complications, and cranial nerve injury. RESULTS: Between 2014 and 2019, 9 030 patients presented with a stroke and underwent CEA, of whom 1 055 (11.7%) had received pre-operative ivTT. Those receiving ivTT were younger (mean 70.6 vs. 72.0 years, p < .001). The median (IQR) time from symptom to CEA was 10 days (6 - 17) for ivTT patients and 11 days (7 - 20) for CEA patients not receiving ivTT. Post-operative rates of 30 day stroke were similar between the no ivTT (2.1%) and ivTT (1.8%) cohorts (p = .48). In hospital neck haematomas were statistically significantly more common in CEA patients receiving ivTT (3.7%) vs. no ivTT (2.3%) (p = .006). There was no statistically significant association between 30 day stroke and neck haematoma complications when stratified for delays from symptom onset to CEA, but the overall cohort contained few adverse events for analysis during the very early time period. CONCLUSION: The use of ivTT before CEA in stroke patients was not associated with an increased risk of 30 day stroke, but there was an increase in the risk of neck haematoma.

Editor's Choice - Distribution of Care and Hospital Incidence of Carotid Endarterectomy and Carotid Artery Stenting: A Secondary Analysis of German Hospital Episode Data.

OBJECTIVE: This is a description of the German healthcare landscape regarding carotid artery disease, assessment of hospital incidence time courses for carotid endarterectomy (CEA) and carotid artery stenting (CAS), and simulation of potential effects of minimum hospital caseload requirements for CEA and CAS. METHODS: The study is a secondary data analysis of diagnosis related group statistics data (2005-2016), provided by the German Federal Statistical Office. Cases encoded by German operation procedure codes for CEA or CAS and by International Classification of Diseases (ICD-10) codes for carotid artery disease were included. Hospitals were categorised into quartiles according to annual caseloads. Linear distances to the closest hospital fulfilling hypothetical caseload requirements were calculated. RESULTS: A total of 132 411 and 33 709 patients treated with CEA and CAS from 2012 to 2016 were included. CEA patients had lower rates of myocardial infarction (1.4% vs. 1.8%) and death (1.2% vs. 4.0%), and CAS patients were more often treated after emergency admission (38.1% vs. 27.1%). Age standardised annual hospital incidences were 67.2 per 100 000 inhabitants for CEA and 16.3 per 100 000 inhabitants for CAS. The incidence for CEA declined from 2005 to 2016, with CAS rising again until 2016 after having declined from 2010 to 2013. Regarding distance from home to hospital, centres offering CEA are distributed more homogeneously across Germany, compared with those performing CAS. Hypothetical introduction of minimum annual caseloads (> 20 for CEA; > 10 for CAS) imply that 75% of the population would reach their hospital after travelling 45 km for CEA and 70 km for CAS. CONCLUSION: Differences in spatial distribution mean that statutory minimum annual caseloads would have a greater impact on CAS accessibility than CEA in Germany. Presumably because of a decline in carotid artery disease and a transition towards individualised therapy for asymptomatic patients, hospital incidence for CEA has been declining.

Editor's Choice - Risk of Stroke before Revascularisation in Patients with Symptomatic Carotid Stenosis: A Pooled Analysis of Randomised Controlled Trials.

OBJECTIVE: Current guidelines recommending rapid revascularisation of symptomatic carotid stenosis are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today. The risk of stroke and its predictors among patients with symptomatic carotid stenosis awaiting revascularisation in recent randomised controlled trials (RCTs) and in medical arms of earlier RCTs was assessed. METHODS: The pooled data of individual patients with symptomatic carotid stenosis randomised to stenting (CAS) or endarterectomy (CEA) in four recent RCTs, and of patients randomised to medical therapy in three earlier RCTs comparing CEA vs. medical therapy, were compared. The primary outcome event was any stroke occurring between randomisation and treatment by CAS or CEA, or within 120 days after randomisation. RESULTS: A total of 4 754 patients from recent trials and 1 227 from earlier trials were included. In recent trials, patients were randomised a median of 18 (IQR 7, 50) days after the qualifying event (QE). Twenty-three suffered a stroke while waiting for revascularisation (cumulative 120 day risk 1.97%, 95% confidence interval [CI] 0.75 - 3.17). Shorter time from QE until randomisation increased stroke risk after randomisation (χ2 = 6.58, p = .011). Sixty-one patients had a stroke within 120 days of randomisation in the medical arms of earlier trials (cumulative risk 5%, 95% CI 3.8 - 6.2). Stroke risk was lower in recent than earlier trials when adjusted for time between QE and randomisation, age, severity of QE, and degree of carotid stenosis (HR 0.47, 95% CI 0.25 - 0.88, p = .019). CONCLUSION: Patients with symptomatic carotid stenosis enrolled in recent large RCTs had a lower risk of stroke after randomisation than historical controls. The added benefit of carotid revascularisation to modern medical care needs to be revisited in future studies. Until then, adhering to current recommendations for early revascularisation of patients with symptomatic carotid stenosis considered to require invasive treatment is advisable.

Editor's Choice - Early and Late Outcomes after Transcarotid Revascularisation for Internal Carotid Artery Stenosis: A Systematic Review and Meta-Analysis.

OBJECTIVE: Transcarotid/transcervical revascularisation (TCAR) is an alternative to carotid endarterectomy (CEA) and transfemoral carotid stenting (tfCAS). This review aimed to evaluate pooled data on patients undergoing TCAR. DATA SOURCES: Medline, Embase, Scopus, and Cochrane Library databases were used. REVIEW METHODS: This systematic review was conducted under Systematic Reviews and Meta-Analysis guidelines. Eligible studies (published online up to September 2020) reported 30 day mortality and stroke/transient ischaemic attack (TIA) rates in patients undergoing TCAR. Data were pooled in a random effects model and weight of effect for each study was also reported. Quality of studies was evaluated according to Newcastle - Ottawa scale. RESULTS: Eighteen studies (three low, seven medium, and eight high quality) included 4 852 patients (4 867 TCAR procedures). The pooled 30 day mortality rate was 0.7% (n = 32) (95% confidence interval [CI] 0.5 - 1.0), 30 day stroke rate 1.4% (n = 62) (95% CI 1.0 - 1.7), and 30 day stroke/TIA rate 2.0% (n = 92) (95% CI 1.4 - 2.7). Pooled technical success was 97.6% (95% CI 95.9 - 98.8). The cranial nerve injury rate was 1.2% (95% CI 0.7 - 1.9) (n = 14; data from 10 studies) while the early myocardial infarction (MI) rate was 0.4% (95% CI 0.2 - 0.6) (n = 16; data from 17 studies). The haematoma/bleeding rate was 3.4% (95% CI 1.7 - 5.8) (n = 135; data from 10 studies), with one third of these cases needing drainage or intervention. Within a follow up of 3 - 40 months the restenosis rate was 4% (95% CI 0.1 - 13.1) (data from nine studies; n = 64/530 patients) and death/stroke rate 4.5% (95% CI 1.8 - 8.4) (data from five studies; n = 184/3 742 patients). Symptomatic patients had a higher risk of early stroke/TIA than asymptomatic patients (2.5% vs. 1.2%; odds ratio 1.99; 95% CI 1.01 - 3.92); p = .046; data from eight studies). CONCLUSION: TCAR is associated with promising early and late outcomes, with symptomatic patients having a higher risk of early cerebrovascular events. More prospective comparative studies are needed in order to verify TCAR as an established alternative treatment technique.

Impact of hospital safety-net status on clinical outcomes following carotid artery revascularization.

BACKGROUND: High hospital safety-net burden has been associated with inferior clinical outcomes. We aimed to characterize the association of safety-net burden with outcomes in a national cohort of patients undergoing carotid interventions. METHODS: The 2010-2017 Nationwide Readmissions Database was used to identify adults undergoing carotid endarterectomy and carotid artery stenting. Hospitals were classified as low (LBH), medium, or high safety-net burden (HBH) based on the proportion of uninsured or Medicaid patients. Multivariable models were developed to evaluate associations between HBH and outcomes. RESULTS: Of an estimated 540,558 hospitalizations for a carotid intervention, 28.5% were at HBH. Patients treated at HBH were more likely to be admitted non-electively (28.7% vs 20.2%, P < .001), have symptomatic presentation (11.0% vs 7.7%, P < .001), and undergo carotid artery stenting (18.7% vs 8.9%, P < .001). After adjustment, HBH remained associated with increased odds of postoperative stroke (AOR 1.19, P = .023, Ref = LBH), non-home discharge (AOR 1.10, P = .026), 30-day readmissions (AOR 1.14, P < .001), and 31-90-day readmissions (AOR 1.13, P < .001), but not in-hospital mortality (AOR 1.18, P = .27). HBH was linked to increased hospitalization costs (ß +$2,169, P = .016). CONCLUSION: HBH was associated with postoperative stroke, non-home discharge, readmissions, and increased hospitalization costs after carotid revascularization. Further studies are warranted to alleviate healthcare inequality and improve outcomes at safety-net hospitals.

Prospective validation of Canadian TIA Score and comparison with ABCD2 and ABCD2i for subsequent stroke risk after transient ischaemic attack: multicentre prospective cohort study.

OBJECTIVE: To validate the previously derived Canadian TIA Score to stratify subsequent stroke risk in a new cohort of emergency department patients with transient ischaemic attack. DESIGN: Prospective cohort study. SETTING: 13 Canadian emergency departments over five years. PARTICIPANTS: 7607 consecutively enrolled adult patients attending the emergency department with transient ischaemic attack or minor stroke. MAIN OUTCOME MEASURES: The primary outcome was subsequent stroke or carotid endarterectomy/carotid artery stenting within seven days. The secondary outcome was subsequent stroke within seven days (with or without carotid endarterectomy/carotid artery stenting). Telephone follow-up used the validated Questionnaire for Verifying Stroke Free Status at seven and 90 days. All outcomes were adjudicated by panels of three stroke experts, blinded to the index emergency department visit. RESULTS: Of the 7607 patients, 108 (1.4%) had a subsequent stroke within seven days, 83 (1.1%) had carotid endarterectomy/carotid artery stenting within seven days, and nine had both. The Canadian TIA Score stratified the risk of stroke, carotid endarterectomy/carotid artery stenting, or both within seven days as low (risk ≤0.5%; interval likelihood ratio 0.20, 95% confidence interval 0.09 to 0.44), medium (risk 2.3%; interval likelihood ratio 0.94, 0.85 to 1.04), and high (risk 5.9% interval likelihood ratio 2.56, 2.02 to 3.25) more accurately (area under the curve 0.70, 95% confidence interval 0.66 to 0.73) than did the ABCD2 (0.60, 0.55 to 0.64) or ABCD2i (0.64, 0.59 to 0.68). Results were similar for subsequent stroke regardless of carotid endarterectomy/carotid artery stenting within seven days. CONCLUSION: The Canadian TIA Score stratifies patients' seven day risk for stroke, with or without carotid endarterectomy/carotid artery stenting, and is now ready for clinical use. Incorporating this validated risk estimate into management plans should improve early decision making at the index emergency visit regarding benefits of hospital admission, timing of investigations, and prioritisation of specialist referral.

Safety and Efficacy of Early Carotid Endarterectomy in Patients with Symptomatic Carotid Artery Stenosis: A Meta-Analysis.

DESIGN: A systematic document retrieval of studies published in the past 10 years reporting periprocedural stroke/mortality/MI after carotid endarterectomy (CEA) related to the time between CEA and qualifying neurological symptoms. The application database has "PubMed, EMbase and Cochrane databases." RevMan5.3 software provided by the Cochrane collaboration was used for meta-analysis. RESULTS: A systematic literature search was conducted in databases. A total of 10 articles were included in this study. They were divided into early CEA and delayed CEA with operation within 48 h, 1 w, or 2 w after onset of neurological symptoms. Incidence of the postoperative stroke in patients undergoing delayed CEA (≥48 h) was significantly higher than patients with delayed CEA (<48 h) (OR = 2.14, 95% CI: 1.43-3.21, P = 0.0002). The postoperative mortality of patients after delayed CEA (≥48 h) was significantly higher than patients after early CEA (<48 h) (OR = 1.35, 95% CI: 1.06-1.71, P = 0.02). The risk of postoperative mortality of patients treated with delayed CEA (≥7 d) was significantly higher than patients after the early CEA group (<7 d) (OR = 1.69, 95% CI: 1.21-2.32, P = 0.001). CONCLUSION: Early CEA is safe and effective for a part of patients with symptomatic carotid stenosis, but a comprehensive preoperative evaluation of patients with carotid stenosis must be performed.

Carotid endarterectomy surgeon volumes in contemporary practice: A comparison to randomized trial inclusion criteria.

BACKGROUND: Clinical decisions regarding the utility of carotid revascularization are informed by randomized controlled trial (RCT) results. However, RCTs generally require participating surgeons to meet strict inclusion criteria with respect to procedure volume. The purpose of this study was to compare annual surgeon volume for carotid endarterectomy (CEA) in contemporary practice to RCT inclusion thresholds. METHODS: Surgeon volume thresholds were identified in 17 RCTs evaluating the efficacy of CEA (1986-present, n = 17). Contemporary annual surgeon volumes (2012-2017) were identified by aggregating data from the Medicare Provider Utilization Database and Healthcare Cost and Utilization Project Network (HCUP), and compared to RCT inclusion thresholds. Further comparisons were performed over time, and across specialties (i.e., vascular surgeon vs. other, based on board certification associated with provider NPI). RESULTS: Minimal surgeon volume in 17 RCTs ranged from 10 to 25 CEA annually when specific case volumes were required. From 2012 to 2017, CEA incidence in Medicare beneficiaries declined from 68,608 to 56,004 and became increasingly consolidated in fewer providers (7,331 vs. 6,626). However, in 2016 only 26.2% of surgeons performing CEA in Medicare beneficiaries would have met the least stringent volume requirement (10 CEA/year). Only 6.5% of surgeons performing CEA met the most stringent RCT volume threshold (25 cases/year) during the same time period. In 2017, 819 vascular surgeons (25.5% of those certified in the specialty) performed >10 CEA in Medicare beneficiaries. CONCLUSIONS: The majority of surgeons performing CEA do not meet the annual volume thresholds required for participation in the RCTs that have evaluated the efficacy of carotid revascularization. Given the established volume-outcome relationship in CEA, the disparity between surgeon experience in the context of RCTs versus contemporary practice is concerning. These findings have potential implications for informed decision-making, hospital privileging, and regionalization of care.

Comparative Effectiveness of Carotid Endarterectomy vs Initial Medical Therapy in Patients With Asymptomatic Carotid Stenosis.

Importance: Carotid endarterectomy (CEA) among asymptomatic patients involves a trade-off between a higher short-term perioperative risk in exchange for a lower long-term risk of stroke. The clinical benefit observed in randomized clinical trials (RCTs) may not extend to real-world practice. Objective: To examine whether early intervention (CEA) was superior to initial medical therapy in real-world practice in preventing fatal and nonfatal strokes among patients with asymptomatic carotid stenosis. Design, Setting, and Participants: This comparative effectiveness study was conducted from August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs. Data analyzed were those of veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009. Patients without a carotid imaging report, those with carotid stenosis of less than 50% or hemodynamically insignificant stenosis, and those with a history of stroke or transient ischemic attack in the 6 months before index imaging were excluded. A cohort of patients who received initial medical therapy and a cohort of similar patients who received CEA were constructed and followed up for 5 years. The target trial method was used to compute weighted Kaplan-Meier curves and estimate the risk of fatal and nonfatal strokes in each cohort in the pragmatic sample across 5 years of follow-up. This analysis was repeated after restricting the sample to patients who met RCT inclusion criteria. Cumulative incidence functions for fatal and nonfatal strokes were estimated, accounting for nonstroke deaths as competing risks in both the pragmatic and RCT-like samples. Exposures: Receipt of CEA vs initial medical therapy. Main Outcomes and Measures: Fatal and nonfatal strokes. Results: Of the total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received initial medical therapy within 1 year after the index carotid imaging. The observed rate of stroke or death (perioperative complications) within 30 days in the CEA cohort was 2.5% (95% CI, 2.0%-3.1%). The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%). In an analysis that incorporated the competing risk of death, the risk difference between the 2 cohorts was lower and not statistically significant (risk difference, -0.8%; 95% CI, -2.1% to 0.5%). Among patients who met RCT inclusion criteria, the 5-year risk of fatal and nonfatal strokes was 5.5% (95% CI, 4.5%-6.5%) among patients randomized to CEA and was 7.6% (95% CI, 5.7%-9.5%) among those randomized to initial medical therapy (risk difference, -2.1%; 95% CI, -4.4% to -0.2%). Accounting for competing risks resulted in a risk difference of -0.9% (95% CI, -2.9% to 0.7%) that was not statistically significant. Conclusions and Relevance: This study found that the absolute reduction in the risk of fatal and nonfatal strokes associated with early CEA was less than half the risk difference in trials from 20 years ago and was no longer statistically significant when the competing risk of nonstroke deaths was accounted for in the analysis. Given the nonnegligible perioperative 30-day risks and the improvements in stroke prevention, medical therapy may be an acceptable therapeutic strategy.

[Incidence of postoperative cognitive dysfunction after simultaneous carotid surgery and coronary artery bypass grafting in patients with asymptomatic cerebral atherosclerosis]. / Chastota razvitiia posleoperatsionnoi kognitivnoi disfunktsii posle simul'tannoi operatsii na koronarnykh i vnutrennikh sonnykh arteriiakh pri asimptomnom techenii tserebral'nogo ateroskleroza.

AIM: To evaluate the incidence of early postoperative cognitive dysfunction (POCD) after simultaneous carotid surgery and coronary artery bypass grafting (CABG) in patients with asymptomatic cerebral atherosclerosis. MATERIAL AND METHODS: Fifty-three patients with polyvascular disease and asymptomatic cerebral atherosclerosis undergoing simultaneous unilateral carotid endarterectomy (CEE) and CABG were recruited in the study. Core cognitive functions were assessed with the Mini Mental State Examination (MMSE) and Frontal Assessment Battery (FAB) at days 2-3 before the indexed surgery and at days 7-10 after it. All the patients were assigned to two groups based on the baseline MMSE score: one group with mild cognitive impairment (MCI) and another one without MCI. Neurodynamic measurements were performed using the Status-PF hardware-software complex (certificate #2001610233 of the Russian Agency for Patents and Trademarks), followed by the calculation of the integral indicator of the main cognitive domains according to the corresponding algorithms. Attention, memory and neurodynamics were evaluated in all participants. POCD was diagnosed with a decrease from the initial indicators of memory, attention and neurodynamics by 20% in 20% of the tests. RESULTS: Patients had complications in the early postoperative period, regardless of the presence of MCI. A decline among the core cognitive functions was observed in both groups of patients at days 7-10 after the surgery. Patients demonstrated an increase in the reaction time while performing neurodynamic test battery compared with the baseline values. Alterations in memory and attention were not significant. Significant changes in the integral indicator of cognitive status were determined in both groups of patients. It increased by 14% in patients without MCI (0.34±0.2 in the preoperative period vs. 0.39±0.3 in the postoperative period, p=0.04), and by 36% in patients with MCI (0.25±0.19 vs. 0.39±0.3, p=0.003). Regardless of the presence or absence of MCI, all patients had low cognitive status or even that below the average in the perioperative period. Despite the increase in the average values of cognitive status indicators in the postoperative period, 56% of patients (n=14) without MCI and 71% of patients with MCI (n=20) had early POCD. CONCLUSION: Patients with polyvascular disease, regardless of the presence of MCI, had low cognitive status or even that below the average, probably contributing to the elimination of the expected positive effects of CEE. The absence of MCI at baseline does not guarantee the preservation of cognitive status after surgery. Patients with polyvascular disease after myocardial and cerebral revascularization remain at high risk of exacerbating cognitive impairment, and, therefore, require an individual approach and a reasonable choice of the optimal surgical strategy.

Anatomic criteria in the selection of treatment modality for atherosclerotic carotid artery disease.

OBJECTIVE: Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. METHODS: A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. RESULTS: CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance <5 cm (n = 17), common carotid artery diameter <6 mm (n = 3), or significant plaque at the TCAR sheath access site (n = 20), yielding 368 arteries (85.0%) that were eligible for TCAR. CONCLUSIONS: A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.

Timeliness and outcomes of carotid endarterectomy for symptomatic carotid artery stenosis: a single centre audit.

BACKGROUND: For patients presenting with symptomatic internal carotid artery stenosis, carotid endarterectomy (CEA) surgery is recommended to be performed generally within a 48-hr to 14-day window. This study aimed to assess timeliness of delivery, and outcomes, of CEA surgery in a tertiary vascular centre. METHOD: Patients with symptomatic internal carotid artery stenosis who underwent CEA between 1 June 2014 and 31 June 2017 were identified and data were obtained from hospital records. The timeline of their journey from presentation to surgery was then mapped together with their outcomes. RESULTS: One hundred and seventy-two cases were included in the study. Overall, the median time from development of presenting symptoms to surgery was 9 days and 119 (69%) cases were operated on within 14 days. The median time from development of presenting symptoms to ultrasound imaging was 2 days and the median time from symptoms to vascular referral was also 2 days. There were no deaths, strokes or transient ischaemic attacks within 30 days of CEA. At 1 year, survival was 100% but 15 (8.7%) had experienced at least one transient ischaemic attack or stroke. In the 53 cases operated upon beyond 14 days the dominant cause of delay in 32 (60%) was accessing surgery after review by the vascular service. CONCLUSION: The aim of delivering CEA within 14 days of developing relevant symptoms was achieved in most cases with good outcomes. Nevertheless, points of delay in the patient journey that could be targeted for future quality improvement were identified.

Race and sex-based disparities associated with carotid endarterectomy in the Atherosclerosis Risk in Communities (ARIC) study.

BACKGROUND AND AIMS: The indications for carotid endarterectomy (CEA) are well established. The aim of the current study was to investigate sex and race-based disparities in the incidence of CEA after adjusting for carotid artery stenosis risk factors. METHODS: We conducted a prospective cohort analysis of 14,492 black and white participants in the Atherosclerosis Risk in Communities (ARIC) study without prevalent stroke at baseline (1987-1989). We used Kaplan-Meier curves and Cox proportional hazards models adjusting for sociodemographic, cardiovascular, and disease severity risk factors to quantify the associations of sex and race with incident CEA. RESULTS: CEA was performed in 330 of 14,492 ARIC participants during a median of 27 years of follow-up [incidence rate 1.00 (95% CI 0.90-1.12) per 1000 persons-years]. The crude incidence of CEA varied significantly by sex [female vs. male: HR 0.60 (95% CI 0.48-0.74)] and race [black vs. white: HR 0.65 (95% CI 0.49-0.86)]. Adjustment for sociodemographic and cardiovascular risk factors, carotid intima-media thickness, and symptomatic status attenuated the association of sex with CEA [females vs. males HR 0.96 (0.76-1.22)], but black participants had a lower risk of incident CEA after adjustment [HR 0.68 (95% CI 0.49-0.95)]. CONCLUSIONS: We found significant variation in the incidence of CEA procedures based on race that was independent of traditional risk factors and carotid IMT. Whether this disparity is a reflection of differences in disease presentation or access to care deserves investigation.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

The Efficacy of Carotid Surgery by Subgroups: The Concept of Stroke Prevention Potential.

OBJECTIVE: Considering carotid endarterectomy (CEA), reporting treatment delay, symptom status, and surgical complication rates separately gives an incomplete picture of efficacy; therefore, the aim was to combine these factors and develop a reporting standard that better describes the number of potentially prevented strokes. With a real life cohort and theoretical inclusion scenarios, the aim was to explore the stroke prevention potential of different carotid practices. METHODS: Landmark studies for symptomatic and asymptomatic patients were revisited. By using published estimates of treatment effect, a simplified calculator was designed to assess the five year stroke prevention rate per 1000 CEAs (stroke prevention potential [SPP], range 0-478), including the presence and recentness of symptoms, sex, increasing stenosis severity, and complication rates. Patients operated on for carotid stenosis at Helsinki University Hospital (HUH) between 2008 and 2016 were collected from a vascular registry (HUSVASC) and categorised according to the model. The local annual complication rate was re-evaluated and added to the model. The HUH patient cohort was incorporated into the SPP model, and changes over time analysed. Finally, theoretical changes in patient selection were compared in order to explore the theoretical impact of patient selection and shortening of the delay. RESULTS: Fifteen hundred and five symptomatic and 356 asymptomatic carotid stenoses were operated on with stroke plus death rates of 3.6% and 0.3%, respectively. The proportion of CEAs performed within two weeks of the index event increased over the follow up period, being 77% in 2016. The SPP increased from 123 in 2008 to 229 in 2016. Theoretically, 350 ischaemic strokes were prevented in the period 2008-16, with 1861 CEAs. CONCLUSIONS: National and international comparison of different CEA series is irrelevant if the inclusion criteria are not considered. A calculator that is easy to apply to large scale high quality registered data was developed and tested. SPP was found to increase over time, which is a probable sign of improved patient selection and an increased number of strokes prevented by the CEAs performed.

Value of Carotid Ultrasound in Cardiovascular Risk Stratification in Patients With Psoriatic Disease.

OBJECTIVE: This study aimed to assess whether subclinical atherosclerosis, as evaluated by carotid ultrasound, could predict incident cardiovascular events (CVEs) in patients with psoriatic disease (PsD) and determine whether incorporation of imaging data could improve CV risk prediction by the Framingham Risk Score (FRS). METHODS: In this cohort analysis, patients with PsD underwent ultrasound assessment of the carotid arteries at baseline. The extent of atherosclerosis was assessed using carotid intima-media thickness (CIMT) and total plaque area (TPA). Incident CVEs (new or recurrent) that occurred following the ultrasound assessment were identified. The association between measures of carotid atherosclerosis and the risk of developing an incident CVE was evaluated using Cox proportional hazards models, with adjustment for the FRS. RESULTS: In total, 559 patients with PsD were assessed, of whom 23 had incident CVEs ascertained. The calculated rate of developing a first CVE during the study period was 1.11 events per 100 patient-years (95% confidence interval [95% CI] 0.74-1.67). When analyzed separately in Cox proportional hazards models that were controlled for the FRS, the TPA (hazard ratio [HR] 3.74, 95% CI 1.55-8.85; P = 0.003), mean CIMT (HR 1.21, 95% CI 1.03-1.42; P = 0.02), maximal CIMT (HR 1.11, 95% CI 1.01-1.22; P = 0.03), and high TPA category (HR 3.25, 95% CI 1.18-8.95; P = 0.02) were each predictive of incident CVEs in patients with PsD. CONCLUSION: The burden of carotid atherosclerosis is associated with an increased risk of developing future CVEs. Combining vascular imaging data with information on traditional CV risk factors could improve the accuracy of CV risk stratification in patients with PsD.

State of the Union in Open Neurovascular Training.

BACKGROUND: The evolution of minimally invasive endovascular approaches and training paradigms has reduced open neurovascular case exposure for neurosurgical residents. There are no published estimates of open neurovascular case volumes during residency or Committee on Advanced Subspecialty Training (CAST) accredited fellowships. METHODS: Case volumes from residency programs submitting data for CAST accredited fellowship applications were collected and analyzed. The study period covered the academic years of 2013-2016. Case index volumes were calculated to provide an estimate of total volume of cases each trainee participated in a given year. The case index volume was defined as the total volume of cases per year divided by the total training complement. RESULTS: Over the study period, institutional data from 46 programs were available. Of those programs, 9 programs had CAST accredited open cerebrovascular fellowships. Across all 46 programs, the median number of vascular cases was 246 (interquartile range [IQR]: 148-340), whereas the median number of open vascular cases was 105 (IQR: 67-152). The median number of open aneurysm cases among programs with CAST cerebrovascular fellowships was 80 (IQR: 54-103) and among programs without CAST cerebrovascular fellowships was 34 (IQR: 24-63). The median open aneurysm case index volume for trainees at programs with and without CAST cerebrovascular fellowships was 23 (IQR: 14-29) and 19 (IQR: 11-24). CONCLUSIONS: Strong neurovascular training can be obtained through dedication and planning. Completion of a CAST accredited cerebrovascular fellowship will often more than double aneurysm case exposure of trainees.