Society for Vascular Surgery clinical practice guidelines for management of extracranial cerebrovascular disease.

Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for the treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were reported. Since the 2011 guidelines, several studies and a few systematic reviews comparing CEA and CAS have been reported, and the role of medical management has been reemphasized. In the present publication, we have updated and expanded on the 2011 guidelines with specific emphasis on five areas: (1) is CEA recommended over maximal medical therapy for low-risk patients; (2) is CEA recommended over transfemoral CAS for low surgical risk patients with symptomatic carotid artery stenosis of >50%; (3) the timing of carotid intervention for patients presenting with acute stroke; (4) screening for carotid artery stenosis in asymptomatic patients; and (5) the optimal sequence of intervention for patients with combined carotid and coronary artery disease. A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (grades of recommendation assessment, development, and evaluation) approach, as was used for other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low-risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin scale score, 0-2), carotid revascularization is considered appropriate for symptomatic patients with >50% stenosis and should be performed as soon as the patient is neurologically stable after 48 hours but definitely <14 days after symptom onset. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients with an increased risk of carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. For patients with symptomatic carotid stenosis of 50% to 99%, who require both CEA and coronary artery bypass grafting, we suggest CEA before, or concomitant with, coronary artery bypass grafting to potentially reduce the risk of stroke and stroke/death. The sequencing of the intervention depends on the clinical presentation and institutional experience.

A systematic review supporting the Society for Vascular Surgery Guidelines on the management of carotid artery disease.

BACKGROUND: To support the development of guidelines on the management of carotid disease, a writing committee from the Society for Vascular Surgery has commissioned this systematic review. METHODS: We searched multiple data bases for studies addressing five questions: medical management vs carotid revascularization (CEA) in asymptomatic patients, CEA vs carotid artery stenting (CAS) in symptomatic low surgical risk patients, the optimal timing of revascularization after acute stroke, screening high-risk patients for carotid disease, and the optimal sequence of interventions in patients with combined coronary and carotid disease. Studies were selected and appraised by pairs of independent reviewers. Meta-analyses were performed when feasible. RESULTS: Medical management compared with carotid interventions in asymptomatic patients was associated with better early outcome during the first 30 days. However, CEA was associated with significantly lower long-term rate of stroke/death at 5 years. In symptomatic low-risk surgical patients, CEA was associated with a lower risk of stroke, but a significant increase in myocardial infarction compared with CAS during the first 30 days. When the long-term outcome of transfemoral CAS vs CEA in symptomatic patients were examined using preplanned pooled analysis of individual patient data from four randomized trials, the risk of death or stroke within 120 days of the index procedure was 5.5% for CEA and 8.7% for CAS, which lends support that, over the long term, CEA has a superior outcome compared with transfemoral CAS. When managing acute stroke, the comparison of CEA during the first 48 hours to that between day 2 and day 14 did not reveal a statistically significant difference on outcomes during the first 30 days. Registry data show good results with CEA performed in the first week, but not within the first 48 hours. A single risk factor, aside from peripheral artery disease, was associated with low carotid screening yield. Multiple risk factors greatly increase the yield of screening. Evidence on the timing of interventions in patients with combined carotid and coronary disease was sparse and imprecise. Patients without carotid symptoms, who had the carotid intervention first, compared with a combined carotid intervention and coronary artery bypass grafting, had better outcomes. CONCLUSIONS: This updated evidence summary supports the Society for Vascular Surgery clinical practice guidelines for commonly raised clinical scenarios. CEA was superior to medical therapy in the long-term prevention of stroke/death over medical therapy. CEA was also superior to transfemoral CAS in minimizing long-term stroke/death for symptomatic low risk surgical patients. CEA should optimally be performed between 2 and 14 days from the onset of acute stroke. Having multiple risk factors increases the value of carotid screening.

Perioperative outcomes for carotid revascularization on asymptomatic dialysis-dependent patients meet Society for Vascular Society guidelines.

OBJECTIVE: The current Society for Vascular Surgery practice guidelines recommend carotid revascularization for asymptomatic disease in patients with at least a 3-year life expectancy and stenosis >60% when the expected perioperative stroke and death rate is <3%. Based on this recommendation, it was previously determined that asymptomatic patients who require dialysis would not meet the perioperative stroke and death thresholds nor the long-term survival benchmarks to justify carotid surgery. To determine whether carotid surgery for patients requiring dialysis is appropriate, the present study compared the perioperative outcomes after carotid revascularization for dialysis-dependent patients relative to nondialysis patients in a contemporary, national cohort. METHODS: The targeted vascular module from the American College of Surgeons National Surgical Quality Improvement Program was queried to identify patients who undergone carotid endarterectomy or carotid artery stenting for asymptomatic carotid disease from 2011 to 2018. The cohort was categorized as requiring or not requiring dialysis. The primary 30-day outcomes included mortality and the composite of stroke/death and stroke/death/myocardial infarction (MI). Univariate analyses were performed using the Fisher exact test and Wilcoxon rank sum test. Multivariable analyses were used to assess the independent associations of the estimated glomerular filtration rate and dialysis dependence with the stroke/death rate. RESULTS: A total of 17,579 patients met the inclusion criteria. Of these patients, 226 (1.3%) required dialysis at revascularization. No difference was found in the degree of severe stenosis (80%-99%) demonstrated by 69% of the dialysis cohort and 72% of the nondialysis cohort (P = .9). Of the dialysis and nondialysis cohorts, 5% and 3.6% underwent carotid artery stenting (P = .3). The dialysis-dependent patients were younger (68 vs 71 years; P < .001) and were more likely to have insulin-dependent diabetes (47% vs 12%; P < .001), congestive heart failure (8.4% vs 1.4%; P < .001), and severe chronic obstructive pulmonary disease (15% vs 10%; P = .03). In the dialysis and nondialysis cohort, 2 (0.9%) and 88 (0.5%) patients died (P = .3); 4 (1.8%) and 247 (1.4%) experienced strokes (P = .6); and 3 (1.3%) and 185 (1.1%) patients experienced MI (P = .5), respectively. The composite outcomes of stroke/death and stroke/death/MI was 2.2% (n = 5) and 1.8% (n = 319; P = .6) and 3.5% (n = 8) and 2.8% (n = 479; P = .4) in the dialysis and nondialysis cohorts, respectively. After multivariable analysis, neither the estimated glomerular filtration rate (adjusted odds ratio, 1.0; 95% confidence interval, 1.00-1.01; P = .26) nor dialysis dependence (adjusted odds ratio, 0.21; 95% confidence interval, 0.03-1.57; P = .13) was independently associated with the composite outcome of stroke/death. CONCLUSIONS: The 30-day carotid revascularization outcomes for asymptomatic disease in dialysis-dependent patients met the Society for Vascular Surgery guidelines in this national cohort and might be better than previously surmised. Hence, vascular surgeons could consider carotid revascularization for select dialysis-dependent patients with the appropriate expected longevity and perioperative risk.

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.

Carotid endarterectomy for symptomatic carotid stenosis.

BACKGROUND: Stroke is the third leading cause of death and the most common cause of long-term disability. Severe narrowing (stenosis) of the carotid artery is an important cause of stroke. Surgical treatment (carotid endarterectomy) may reduce the risk of stroke, but carries a risk of operative complications. This is an update of a Cochrane Review, originally published in 1999, and most recently updated in 2017. OBJECTIVES: To determine the balance of benefit versus risk of endarterectomy plus best medical management compared with best medical management alone, in people with a recent symptomatic carotid stenosis (i.e. transient ischaemic attack (TIA) or non-disabling stroke). SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Web of Science Core Collection, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) portal to October 2019. We also reviewed the reference lists of all relevant studies and abstract books from research proceedings. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing carotid artery surgery plus best medical treatment with best medical treatment alone.  DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted the data. We assessed the results and the quality of the evidence of the primary and secondary outcomes by the GRADE method, which classifies the quality of evidence as high, moderate, low, or very low. MAIN RESULTS: We included three trials involving 6343 participants. The trials differed in the methods of measuring carotid stenosis and in the definition of stroke. Using the primary electronic data files, we pooled and analysed individual patient data on 6092 participants (35,000 patient-years of follow-up), after reassessing the carotid angiograms and outcomes from all three trials, and redefining outcome events where necessary, to achieve comparability. Surgery increased the five-year risk of any stroke or operative death in participants with less than 30% stenosis (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.99 to 1.56; 2 studies, 1746 participants; high-quality evidence). Surgery decreased the five-year risk of any stroke or operative death in participants with 30% to 49% stenosis (RR 0.97, 95% CI 0.79 to 1.19; 2 studies, 1429 participants; high-quality evidence), was of benefit in participants with 50% to 69% stenosis (RR 0.77, 95% CI 0.63 to 0.94; 3 studies, 1549 participants; moderate-quality evidence), and was highly beneficial in participants with 70% to 99% stenosis without near-occlusion (RR 0.53, 95% CI 0.42 to 0.67; 3 studies, 1095 participants; moderate-quality evidence). However, surgery decreased the five-year risk of any stroke or operative death in participants with near-occlusions (RR 0.95, 95% CI 0.59 to 1.53; 2 studies, 271 participants; moderate-quality evidence). AUTHORS' CONCLUSIONS: Carotid endarterectomy reduced the risk of recurrent stroke for people with significant stenosis. Endarterectomy might be of some benefit for participants with 50% to 69% symptomatic stenosis (moderate-quality evidence) and highly beneficial for those with 70% to 99% stenosis (moderate-quality evidence).

A Composite Measure for Quality of Care in Patients with Symptomatic Carotid Stenosis Using Textbook Outcome.

OBJECTIVE: Composite measures may better objectify hospital performance than individual outcome measures (IOM). Textbook outcome (TO) is an outcome measure achieved for an individual patient when all undesirable outcomes are absent. The aim of this study was to assess TO as an additional outcome measure to evaluate quality of care in symptomatic patients treated by carotid endarterectomy (CEA). METHODS: All symptomatic patients treated by CEA in 2018, registered in the Dutch Audit for Carotid Interventions, were included. TO was defined as a composite of the absence of 30 day mortality, neurological events (any stroke or transient ischaemic attack [TIA]), cranial nerve deficit, haemorrhage, 30 day readmission, prolonged length of stay (LOS; > 5 days) and any other surgical complication. Multivariable logistic regression was used to identify covariables associated with achieving TO, which were used for casemix adjustment for hospital comparison. For each hospital, an observed vs. expected number of events ratio (O/E ratio) was calculated and plotted in a funnel plot with 95% control limits. RESULTS: In total, 70.7% of patients had a desired outcome within 30 days after CEA and therefore achieved TO. Prolonged LOS was the most common parameter (85%) and mortality the least common (1.1%) for not achieving TO. Covariates associated with achieving TO were younger age, the absence of pulmonary comorbidity, higher haemoglobin levels, and TIA as index event. In the case mix adjusted funnel plot, the O/E ratios between hospitals ranged between 0.63 and 1.27, with two hospitals revealing a statistically significantly lower rate of TO (with O/E ratios of 0.63 and 0.66). CONCLUSION: In the Netherlands, most patients treated by CEA achieve TO. Variation between hospitals in achieving TO might imply differences in performance. TO may be used as an additive to the pre-existing IOM, especially in surgical care with low baseline risk such as CEA.

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).

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.

Most patients experiencing 30-day postoperative stroke after carotid endarterectomy will initially experience disability.

OBJECTIVE: Although modern rates of stroke after carotid endarterectomy (CEA) have been low, the functional outcomes of stroke after CEA are unclear. Our goal was to assess the degree of initial disability in patients without baseline stroke-related impairment who had undergone CEA and experienced an early postoperative stroke. METHODS: The National Surgical Quality Improvement Program CEA-targeted database was queried for CEA cases from 2011 to 2014. Patients who had experienced a postoperative stroke were included, and the modified Rankin scale (mRS) was used to assess the degree of initial disability from stroke (0, none; 1, no significant; 2, slight; 3, moderate; 4, moderately severe; 5, severe disability; 6, dead). The mRS score was categorized as not applicable (NA) in the absence of any stroke. Patients were excluded if they had had a preoperative mRS score >1. The 30-day outcomes among the cohorts with a postoperative mRS score of NA/0 to 1, 2 to 3, and 4 to 5 were compared. Multivariable analysis was used to determine the predictors of higher initial postoperative mRS scores. RESULTS: A total of 8797 patients with CEA and preoperative mRS scores of NA/0 to 1 were identified. Their mean age was 71 ± 8.8 years, and 61% were men. Most were asymptomatic (88%) and had been taking antiplatelet agents (90%) and statins (82%) preoperatively. At 30 days, the postoperative stroke rate was 1.1% and mortality was 0.6%. Of the patients with a postoperative stroke after CEA, 35.4% had had stable initial postoperative mRS scores of NA/0 to 1, and most had had increased initial postoperative disability with mRS scores of 2 to 3 (32.3%) or 4 to 5 (32.3%). The cohorts with greater initial postoperative mRS scores exhibited a longer length of stay (2.2 ± 3.3 vs 5.8 ± 3.9 vs 11.9 ± 18.8 days; P < .001) and greater rates of major adverse cardiac events (2.7% vs 100% vs 100%; P < .001). Multivariable analysis showed that the initial postoperative disability, determined by a greater mRS score, was independently associated with preoperative bleeding disorder/chronic anticoagulation (odds ratio, 1.79; 95% confidence interval, 1.04-3.11; P = .037) and operative time by hour (odds ratio, 1.38; 95% confidence interval, 1.11-1.7; P = .003). CONCLUSIONS: Although the rate of stroke after CEA has been low, almost two thirds of patients who experienced a stroke within 30 days postoperatively developed some degree of initial postoperative disability and one third developed initial moderately severe to severe disability. These findings provide an evidence base for improved informed consent and risk-benefit discussions with patients.

Long-Term Outcomes After Carotid Endarterectomy: The Experience of an Average-Volume Surgeon.

BACKGROUND: Long-term outcome data for patients undergoing carotid endarterectomy (CEA) are lacking. As most of the published literature on CEA outcomes has been from high-volume providers, we wanted to investigate the outcomes of an average-volume cerebrovascular neurosurgeon. METHODS: We reviewed a single neurosurgeon's experience with CEA focusing on long-term outcomes. Most procedures (99.0%) were performed with primary closure of the arteriotomy. RESULTS: We studied 192 CEAs performed between 1998 and 2017, 77% for symptomatic disease. Two patients (1%) experienced immediate postoperative stroke. During an average follow-up of 53 months (range, 0-205 months), 2 more patients (1%) experienced ipsilateral carotid circulation stroke, and 5 patients (2.6%) experienced ipsilateral transient ischemic attacks. Five patients (2.6%) experienced contralateral transient ischemic attacks, and 6 (3.1%) experienced contralateral stroke. There were also 3 cases of (1.6%) hemorrhagic stroke and 6 cases (3.1%) of vertebrobasilar circulation stroke. The rate of ipsilateral stroke-free survival was 98.4% at 5 years post-CEA, 97.9% at 10 years post-CEA, and 97.9% at 15 years post-CEA. The rate of ipsilateral restenosis-free survival was 97.9% at 5 years post-CEA, 96.8% at 10 years post-CEA, and 96.8% at 15 years post-CEA. Six patients (3.1%) experienced restenosis >70% during follow-up. Two of these patients underwent carotid artery stenting. Almost all patients (>95%) were maintained on an antiplatelet medication and statin. CONCLUSIONS: In the hands of an average-volume cerebrovascular neurosurgeon, CEA can provide durable protection from recurrent stroke in the ipsilateral carotid distribution that extends beyond 15 years. Thus, this procedure should be considered the gold standard against which other revascularization modalities should be evaluated.

Influence of stent design and use of protection devices on outcome of carotid artery stenting: a pooled analysis of individual patient data.

BACKGROUND AND PURPOSE: Carotid artery stenting is an alternative to endarterectomy for the treatment of symptomatic carotid stenosis but was associated with a higher risk of procedural stroke or death in randomized controlled trials (RCTs). Technical aspects of treatment may partly explain these results. The purpose of this analysis was to investigate the influence of technical aspects such as stent design or the use of protection devices, as well as clinical variables, on procedural risk. METHODS: We pooled data of 1557 individual patients receiving stent treatment in three large RCTs comparing stenting versus endarterectomy for symptomatic carotid stenosis. The primary outcome event was any procedural stroke or death occurring within 30 days after stenting. RESULTS: Procedural stroke or death occurred significantly more often with the use of open-cell stents (61/595 patients, 10.3%) than with closed-cell stents (58/962 patients, 6.0%; RR 1.76; 95% CI 1.23 to 2.52; P=0.002). Procedural stroke or death occurred in 76/950 patients (8.0%) treated with protection devices (predominantly distal filters) and in 43/607 (7.1%) treated without protection devices (RR 1.10; 95% CI 0.71 to 1.70; P=0.67). Clinical variables predicting the primary outcome event were age, severity of the qualifying event, history of prior stroke, and level of disability at baseline. The effect of stent design remained similar after adjustment for these variables. CONCLUSIONS: In symptomatic carotid stenosis, the use of stents with a closed-cell design is independently associated with a lower risk of procedural stroke or death compared with open-cell stents. Filter-type protection devices do not appear to reduce procedural risk.

Factors that Predict Failure to Meet Merit-Based Incentive Payment System Quality Measures for Asymptomatic Carotid Endarterectomy.

BACKGROUND: The Physician Quality Reporting System (PQRS) created by the Centers for Medicare and Medicaid Services financially penalizes providers who fail to meet expected quality of care measures. The purpose of this study is to evaluate the factors that predict failure to meet PQRS measures for carotid endarterectomy (CEA). METHODS: PQRS measure 260 (discharge by postoperative day 2 following CEA in asymptomatic patients) and 346 (rate of postoperative stroke or death following CEA in asymptomatic patients) were evaluated using hospital records from the state of Florida from 2008 to 2012. The impact of demographics, comorbidities, hospital factors, admission variables, and individual practitioner data upon timely discharge, and postoperative stroke and death. Odds ratios, 95% confidence intervals, and significance (P < 0.05) were determined through the development of a logistic regression model. Surgeons were identified by national provider identifier number, and practitioner data obtained from the American Medical Association Physician Masterfile. RESULTS: A total of 34,235 patient records and 701 providers were identified over the 5-year period. Significant negative predictors for PQRS measure 260 included weekend admission (odds ratio [OR], 2.9), Medicaid (OR, 2.4), surgeon historical postoperative stroke rate >2.0% (OR, 1.7), African-American race (OR, 2.0), and female gender (OR, 1.3). The presence of any of these factors was associated with a 13.5% rate of failure. The most significant negative predictor for PQRS measure 346 was surgeon postoperative stroke rate >2.0% (OR, 6.2 for stroke and OR, 29.0 for death). Surgeons in this underperforming group had worse outcomes compared to their peers despite having patients with fewer risk factors for poor outcomes. Surgeon specialty, board certification, and case volume do not impact either PQRS measures. CONCLUSIONS: Selected groups of patients and surgeons with a disproportionately high rate of postoperative stroke are at risk of failing to meet PQRS pay for performance quality measures. Awareness of these risk factors may help mitigate and minimize the risk of adversely impacting the value stream. Further evaluation of the causative factors that lead to surgeon underperformance could help to improve the quality of care.