Results Of Carotid Endarterectomy Research Articles

Early carotid endarterectomy performed 2 to 5 days after the onset of neurologic symptoms leads to comparable results to carotid endarterectomy performed at later time points

BackgroundTiming of carotid endarterectomy (CEA) after onset of neurologic symptoms remains controversial. We assessed the association of CEA timing with postoperative outcomes. MethodsThe Vascular Study Group of New England (VSGNE) database (2003-2014) was queried to identify CEA performed for symptomatic carotid stenosis during the same hospitalization. Cases were divided into four groups based on the time from onset of neurologic symptoms to CEA: group I, <2 days; group II, 2 to 5 days; group III, ≥6 days; and group IV, same-day CEA. The χ2 test and t-test were used to compare demographics, medical history, modified Rankin scores, and outcomes (30-day postoperative death, stroke, myocardial infarction, and aggregate events [stroke/myocardial infarction]). Multivariable logistic regression was used to compare the association of time to surgery with outcomes while adjusting for confounding variables. Kaplan-Meier and Cox proportional hazards regression analyses were performed at 1 year to evaluate survival and stroke rates between the groups. ResultsThere were 989 of 14,864 VSGNE CEA cases that fit the inclusion criteria. The frequency of cases was highest in group II (36.6%), followed by groups I (31.9%), III (18.9%), and IV (12.4%). Age, gender, and comorbidity compositions were similar between groups, although group III had the highest rates of diabetes mellitus, coronary artery disease, coronary artery bypass graft procedures, congestive heart failure, and American Society of Anesthesiologists class 4 and the highest modified Rankin score (P < .05). Stroke rates were highest in group I (7.3%; P = .016), whereas group III had the highest rate of discharges to nursing facilities (37.2%; P < .001); other adverse outcomes were comparable among groups. CEAs in group I had significantly increased adjusted odds of stroke; adverse outcomes of CEAs in groups II and III were comparable to those in group IV. ConclusionsOur results suggest that CEAs performed 2 to 5 days after a neurologic event have similar outcomes to CEAs performed ≥6 days later. Early CEA should be considered an area for quality improvement among these patients.

Factors affecting operative time and outcome of carotid endarterectomy in the Vascular Quality Initiative

ObjectivePrior studies have suggested a relationship between operative (Op) time and outcome after major vascular procedures. This study analyzed factors associated with Op time and outcome after carotid endarterectomy (CEA) in the Vascular Quality Initiative (VQI) registry. MethodsElective, primary CEAs without high anatomic risk or concomitant procedures from 2012 to 2015 in the VQI were analyzed (N = 26,327, performed by 1188 surgeons from 249 centers). Multivariable analysis was used to identify patient, procedure, and surgeon factors associated with Op time and major adverse events (MAEs), categorized as either technical (ipsilateral stroke, cranial nerve injury, reoperation) or cardiac (myocardial infarction, congestive heart failure, dysrhythmia requiring treatment, surgical site infection, and death). ResultsThe mean CEA Op time in the VQI was 114 minutes, with the mean Op time for individual surgeons ranging from 37 to 305 minutes. Procedural factors and the surgeon's volume were responsible for much of the variation in overall Op time (patient factors that reflected demographics and comorbidities each added 5.9 to 6.8 minutes; procedural factors, such as patch angioplasty and completion duplex ultrasound, each added 5.5 to 16.4 minutes; the lowest quartile of the surgeon's annual case volume added 24 minutes). Chi-pie analysis demonstrated that patient factors accounted for 17% of variability in Op time; procedural factors, 44%; and the surgeon's annual volume, 39%. Increasing Op time was highly associated with increased rates of MAEs (P < .001 for cardiac, technical, and death rates). Based on hierarchical multiple logistic regression, cardiac complications were independently associated with increased Op time (comparing surgeons in highest quartile of Op time with those in the lowest: odds ratio, 2.16 for cardiac MAE; 95% confidence interval, 1.59-2.95; P < .001) but not with the surgeon's annual volume. Technical complications were independently associated with a surgeon's low volume (comparing surgeons with the highest annual case volume by quartile against the lowest: odds ratio, 1.25 for technical MAE; 95% confidence interval, 1.06-1.48; P < .001) but not with Op time. ConclusionsOp time for elective, primary CEAs varies substantially across surgeons in the VQI. Increased Op time is associated with a surgeon's lower annual CEA volume in addition to patient variables and techniques employed. Cardiac complications after CEA are associated with longer Op time, whereas technical complications are associated with a surgeon's low annual volume.

Impact of Provider Characteristics on Outcomes of Carotid Endarterectomy for Asymptomatic Carotid Stenosis in New York State

The purpose of this study is to explore the impact of surgeon characteristics (including annual volume, specialty, and years in practice) on outcomes of carotid endarterectomy (CEA) for asymptomatic carotid atherosclerosis in New York State. The New York Statewide Planning and Cooperation System database was utilized to identify patients undergoing CEA from 2004 to 2011. Provider characteristics were determined by linkage to the New York Office of Professions and National Provider Identification databases. Provider-level factors were characterized by defining 5 quintiles of equal size for each factor. Hierarchical logistic regression models were created to evaluate the impact of provider characteristics on outcome. In total, 36,495 patients underwent CEA for asymptomatic disease performed by vascular (75.7%), general (16.1%), cardiac (6%), and neuro (2.1%) surgeons. Outcomes of interest included in-hospital mortality (0.26%), stroke (0.45%), and the composite end point of mortality, stroke, or cardiac complication (2.2%). Unadjusted outcomes improved with increasing surgeon annual CEA volume. Mid-career surgeons had lower mortality and stroke rates than early or late-career surgeons. Odds of mortality were increased when surgery was performed by the lowest volume providers (quintile 1; 0-11 CEA/year) (odds ratio [OR] 2.62, 95% confidence interval [CI] 1.3-5.28) or a nonspecialty trained (general) surgeon (OR 1.64, 95% 1.01-2.67). After adjustment for all patient-level factors, provider volume remained an independent predictor of outcome, with significantly increased odds of mortality for volume quintile 1 (OR 2.57, 95% CI 1.27-5.23) and quintile 2 (12-22 CEA/year) (0.30%; OR 2.07, 95% CI 1-4.27) surgeons. Adverse events after CEA for asymptomatic disease are comparatively rare. However, surgeon characteristics impact outcome, with the best results offered by high-volume, mid-career, specialty-trained surgeons. Efforts to define the optimal treatment of asymptomatic carotid atherosclerosis must account for the impact of surgeon characteristics on patient outcomes.

IP125. Evaluation of High-Risk Criteria on Outcomes of Carotid Endarterectomy

IP125. Evaluation of High-Risk Criteria on Outcomes of Carotid Endarterectomy

Clinical Outcome of Carotid Artery Stenting According to Provider Specialty and Volume

Several studies have demonstrated better outcomes for carotid endarterectomy with high-volume hospitals and providers. However, only a few studies have reported on the impact of operator specialty/volume on the perioperative outcome of carotid artery stenting (CAS). This study will analyze the correlation of CAS outcomes and provider specialty and volume. Prospectively collected data of CAS procedures done at our institution during a 10-year period were analyzed. Major adverse events (MAEs; 30-day stroke, myocardial infarction, and death) were compared according to provider specialty (vascular surgeons [VSs], interventional cardiologists [ICs], interventional radiologists [IRs], interventional vascular medicine [IVM]), and volume (≥5 CAS/year vs. <5 CAS/year). Four hundred fourteen CAS procedures (44% for symptomatic indications) were analyzed. Demographics/clinical characteristics were somewhat similar between specialties. MAE rates were not significantly different between various specialties: 3.1% for IC, 6.3% for VS, 7.1% for IR, 6.7% for IVM (P=0.3121; 6.3% for VS and 3.8% for others combined, P=0.2469). When physicians with <5 CAS/year were excluded: the MAE rates were 3.1% for IC, 4.7% for VS, and 6.7% for IVM (P=0.5633). When VS alone were compared with others, and physicians with <5 CAS/year were excluded, the MAE rates were 4.7% for VS vs. 3.6% for non-VS (P=0.5958). The MAE rates for low-volume providers, regardless of their specialty, were 9.5% vs. 4% for high-volume providers (P=0.1002). Logistic regression analysis showed that the odds ratio of MAE was 0.4 (0.15-1.1, P=0.0674) for high-volume providers, while the odds ratio for VS was 1.3 (0.45-3.954, P=0.5969). Perioperative MAE rates for CAS were similar between various providers, regardless of specialties, particularly for vascular surgeons with similar volume to nonvascular surgeons. Low-volume providers had higher MAE rates.

CREST-2: Identifying the Best Method of Stroke Prevention for Carotid Artery Stenosis: National Institute of Neurological Disorders and Stroke Organizational Update.

One of the great achievements of modern medicine is the successful prevention of stroke and other cardiovascular diseases. Although the incidence of stroke has substantially declined over the last 30 years, ≈200 000 preventable stroke deaths still occur annually in the United States. According to a recent study based on the Greater Cincinnati/Northern Kentucky Stroke Study, annually ≈41 000 strokes in the United States are attributed to extracranial internal carotid artery stenosis. Early revascularization for symptomatic carotid stenosis—that is, in patients with recent ipsilateral stroke or TIA—is well established as effective at preventing ipsilateral stroke. Carotid stenosis in the absence of symptoms is extremely common, but the best treatment is unclear. While 2 randomized trials showed a benefit of carotid endarterectomy (CEA) over antiplatelet therapy with aspirin, the number needed to treat approaches 200. Does aggressive risk factor control change that balance? Population screening for carotid stenosis followed by revascularization is considered to cause net harm. Are complication rates from endarterectomy and stenting now low enough to justify expanding their indications in asymptomatic patients? The National Institute of Neurological Disorders and Stroke (NINDS)–funded CREST-2 trial (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial) is an ambitious attempt to further refine the treatment of asymptomatic carotid stenosis. As one of the largest randomized stroke prevention trials, the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) was designed to compare the safety and efficacy of 2 stroke prevention procedures for carotid artery narrowing—CEA and carotid artery stenting (CAS)—in symptomatic and asymptomatic individuals. Starting in December 2000, this NINDS-funded trial enrolled >2500 patients at 117 sites in the United States and Canada. Because of slow enrollment, the trial took 9 years to complete. In 2010, the results of CREST indicated that the 2 revascularization procedures were equivalent for …

Carotid Endarterectomy in the Southern California Vascular Outcomes Improvement Collaborative

The objective of this study was to examine the variation in practice patterns and associated outcomes for carotid endarterectomy (CEA) within the Southern California Vascular Outcomes Improvement Collaborative (So Cal VOICe), a regional quality group of the Vascular Quality Initiative. All cases entered in the CEA registry by the So Cal VOICe were included in the study. From September 2010 through September 2015, 1,110 CEA cases were entered by 9 centers in the So Cal VOICe. Six hundred seventy-seven patients (61%) were male with mean age of 73 years. Nine hundred eighty-eight (89%) were hypertensive, 655 (59%) were prior or current smokers, 389 (35%) were diabetics, and 233 (21%) had coronary artery disease. Eight hundred twenty-one (74%) patients were asymptomatic (no history of ipsilateral neurologic event). The percentage of asymptomatic patients varied across the 9 centers from 57% to 91%. Preoperatively, 344 (31%) underwent cardiac stress test, center variation 13-75%, 500 (45%) underwent only duplex, center variation 11-72%. Intraoperatively, 600 (54%) underwent routine shunting, whereas 67 (6%) were shunted for an indication, and 444 (40%) were not shunted. Wound drainage was used in 422 (38%) cases, center variation 2-98%. Completion imaging by duplex and/or angiogram was performed in 766 (69%) cases, center variation 0-100%. Postoperatively, 11 (1%) patients had a new ipsilateral postoperative neurologic event, center variation 0-1.3%, 6 (0.5%) had a postoperative myocardial infarction, center variation 0-1.3%, and 8 (0.7%) required return to operating room for bleeding, center variation 0-1.3%. Despite wide variation in practice patterns surrounding CEA in the So Cal VOICe, postoperative complications were uniformly low. Further work will focus on identifying practices that can be modified to improve cost-effectiveness while maintaining excellent outcomes.

Outcomes of Carotid Endarterectomy with Primary Closure.

Carotid endarterectomy (CEA) reduces the risk of stroke in patients with internal carotid artery stenosis, although the optimal surgical technique is debated. The literature suggests that patch angioplasty reduces complication risk, although primary closure shortens cross-clamp time and eliminates complications associated with grafts. The objective of this study was to assess the complication rate after CEA with primary closure. Retrospective review of 240 consecutive patients between 2002 and 2010. Of these patients, 70% returned for follow-up visits for at least 2 or more years. Primary closure was used in all patients. The average cross-clamp time was 18 minutes. Complications in the immediate postoperative period within 30 days were as follows: stroke (n = 3; 1.1%), transient ischemic attack (TIA; n = 4; 1.5%), myocardial infarction (MI; n = 3; 1.1%), and death (n = 1; 0.4%). Short-term follow-up revealed eight patients who were found to have significant restenosis (>80%) by carotid duplex imaging. Two to ten year postoperative complication rates were as follows: stroke (n = 7; 4.2%), TIA (n = 7; 4.2%), amaurosis fugax (n = 1; 0.6%), MI (n = 8; 4.8%), and death (n = 28; 17%). Mortality was due to stroke or heart attack (n = 2; 1.2%), cancer (n = 7; 4.2%), and unknown causes (n = 19; 11%). This study presents our experience with complications after primary closure after CEA. In our experience, CEA is a safe and effective surgical means of preventing stroke in the short term. Well-designed prospective studies are needed to confirm specific patient characteristics in which primary closure and patch angioplasty are indicated.

A contemporary evaluation of carotid endarterectomy outcomes in patients with chronic kidney disease in the United States.

Objectives Chronic kidney disease (CKD) has been identified as a significant risk factor for poor post-surgical outcomes. This study was designed to provide a contemporary analysis of carotid endarterectomy (CEA) outcomes in patients with CKD, end-stage renal disease (ESRD), and normal renal function (NF). Methods The Nationwide Inpatient Sample data 2006-2012 was queried to select patients aging 40 years old and above who underwent CEA during two days after admission and had a diagnosis of ESRD on long-term hemodialysis, patients with non-dialysis-dependent CKD, or NF. Patients with acute renal failure were excluded. We subsequently compared procedure outcomes and hospital resource utilization in these patients. Results Totally 573,723 CEA procedures were estimated: 4801 (ESRD)' 32,988 (CKD)' and 535,934 (NF). Mean age was 71.0 years, 57.7% were males, and 73.7% were white. Overall hospital mortality was 0.20%: 0.69% (ESRD), 0.35% (CKD), and 0.19% (NF), p < 0.0005 between groups. The overall stroke rate was 1.6%: 1.8% (ESRD), 2.0% (CKD), and 1.6% (NF). Comparing NF to CKD there was a significant difference: p < 0.0001. For CKD patients, compared to NF patients, there was an increased risk in cardiac complications (odds ratio = 1.2; 95% CI 1.15-1.32), respiratory complications (odds ratio = 1.2; 95% CI 1.15-1.32), and stroke (odds ratio = 1.1; 95% CI 1.04-1.23). For ESRD patients compared to NF patients there was an increased risk in respiratory complications (odds ratio = 1.3; 95% CI 1.08-1.47) and sepsis (odds ratio = 4.4; 95% CI 3.23-5.94). Mean length of stay and cost were: 2.8 d and $13,903 (ESRD), 2.2 d and $12,057 (CKD), and 1.8 d and $10,130 (NF), all p < 0.0001. Conclusions Patients with ESRD undergoing CEA had an increased risk of respiratory and septic complications, but not a higher risk of stroke compared to patients with normal renal function. The greatest risks of postoperative stroke, respiratory, and cardiac complications were found in patients with CKD. A diagnosis of ESRD and CKD were both found to significantly increase hospital mortality, length of stay and cost. Where clinicians typically consider ESRD patients the highest risk for CEA, further consideration should be given to patients with CKD not yet on dialysis as they had the higher risk of cardiac complications and stroke compared to the others evaluated.

Abstract WP309: Effects of Comprehensive Stroke Care Capabilities on Outcome of Carotid Endarterectomy and Carotid Artery Stenting (from the J-ASPECT Study [2013 to 2015

Background: The effectiveness of comprehensive stroke center (CSC) capabilities on outcome of carotid endarterectomy (CEA) and carotid artery stenting (CAS) remains uncertain. We performed a nationwide study to examine whether CSC capabilities influenced in-hospital outcome of CEA and CAS. Methods: We analyzed 12,943 carotid artery stenosis patients treated with CEA or CAS in 350 certified training hospitals in Japan. Data between April 1, 2013 and May 31, 2015 was obtained from Japanese Diagnosis Procedure Combination Database. Among the institutions that responded, outcome was assessed by in-hospital mortality, ischemic stroke and myocardial infarction. CSC capabilities were evaluated from the 749 certified training institutions in Japan, which responded to a questionnaire survey regarding CSC capabilities that queried the availability of personnel, diagnostic techniques, specific expertise, infrastructure, and educational components recommended for CSCs. Total CSC scores of the participating hospitals were classified into quartiles (Q1: 0-15, Q2: 16-17, Q3: 18-19, Q4: 20-24). Results: The proportion of CEA and CAS were 5068 and 7875 (2013: 1685 and 2590, 2014: 1668 and 2564, 2015: 1715 and 2721). Between CEA and CAS, mortality rates were 0.24% and 0.75%, ischemic stroke were 8.41% and 7.56% and myocardial infarction were 0.76% and 0.17%. These outcomes had no differences among the years. There was tendency that mortality rates were lower with high total CSC scores in patients with CEA (Q1: 0.42%, Q2: 0.26%, Q3: 0.12%, Q4: 0%, P=0.16), but there were no differences with CAS (Q1: 1.0%, Q2: 0.74%, Q3: 0.63%, Q4: 0.83%, P=0.73). Ischemic stroke were significantly lower with high CSC scores in CEA (Q1: 9.76%, Q2: 10.77%, Q3: 9.14%, Q4: 6.59%, P&lt;0.05) and CAS (Q1: 9.86%, Q2: 8.76%, Q3: 7.14%, Q4: 6.98%, P&lt;0.05). Myocardial infarction had no correlation with CSC scores in CEA (Q1: 0.21%, Q2: 0.35%, Q3: 0%, Q4: 0.36%, P=0.37) and CAS (Q1: 0.3%, Q2: 0%, Q3: 0.31%, Q4: 0.16%, P=0.19). Conclusion: It is reported using the data of Nationwide Inpatient Sample that operator volume was an important predictor of postprocedural outcomes in CAS. We demonstrated that CSC capabilities were associated with reduced in-hospital ischemic stroke in patients with CEA and CAS.

Abstract WP146: Outcomes of Carotid Endarterectomy Following the CMS Reimbursement Guidelines

Background: In 2005, the Center for Medicare Services (CMS) approved the reimbursement for carotid artery stenting for high-risk carotid stenosis; leaving carotid endarterectomy (CEA) to be performed primarily for a low-risk population. In this study, we assess trends of outcomes associated with CEA over the period of CMS regulation. Methods: A cohort of patients with CEA was identified from the National Inpatient Sample database using the procedure codes (38.12) for the years 2001 through 2009. Patients under age 18, missing information on the death status, transfer between hospitals, and urgent or emergent admissions were eliminated. Trend analysis for the following outcomes (post procedure stroke, myocardial infarction ‘MI’, and death) was performed over the year included in the study. Two periods encompass the implementation of the guideline (first period: 2001 through 2004 and second period: 2006 through 2009) were compared. Results: Over 9 years, 152 051 CEA procedures were performed; 63375 performed during the first period and 70886 in the second period. The mean age (71.02 ± 9.2) and male preponderance (57.4%) were similar in both treatment periods (P &gt; 0.05). Ninety six percent of this population was asymptomatic by the time CEA was performed. Overall poor outcome risk of post-procedure stroke, MI and death was 1.97%; being lower in the second compared to the first period (2.05% versus 1.88%; P =0.02; unadjusted odds ratio “OR’ 0.91; 95% CI, 0.84, 0.98; and adjusted OR 0.88; 95% CI, 0.82, 0.96). The risk of post-procedure stroke was similar in both periods (0.94% versus 0.97%; P = 0.56); however, the risks of MI (0.91% versus 0.76%; P = 0.002) and death (0.46% versus 0.33%; P &lt; 0.0001) declined over time. Conclusion: Following the CMS reimbursement guideline, CEA is associated with lesser risks of poor outcomes (MI and death).

Analysis of early Versus Delayed Carotid Surgery after Acute Ischemic Stroke

Objective: Evaluate the 30-day outcomes of patients with an internal carotid artery (ICA) stenosis responsible for an acute brain infarct who underwent early (≤ 14 days) carotid endarterectomy (CEA) or delayed (15 days to 3 months) CEA. Methods: From July 2010 to June 2014, patients with a recent cerebral infarct who underwent CEA within 3 months after symptom onset were collected. This was a continuous, monocentric, and retrospective series. Two groups were identified : Group A with patients who underwent CEA in the first fourteen days after symptom onset and Group B with patients who underwent CEA from the fifteenth day to the third month after symptom onset. Death, stroke and major cardiac events were analyzed. Results: Seventy-one patients with ICA stenosis responsible for an acute brain infarct underwent CEA (73.2% men, with a median age of 71). Nineteen patients underwent early CEA and 52 underwent delayed CEA. The mean interval from initial examination to surgery was 9.5 days (range, 3-14 days) in Group A and was 42 days (range, 15-92 days) in Group B. After one month, and with a 98.6% follow-up, no postoperative complication occurred in Group A and 2 patients had post-operative stroke (3.8%) in Group B. Conclusion: This retrospective study confirms the satisfactory outcomes of early CEA after acute brain infarct. A strict clinical and radiological selection of patients allows to prevent early neurological complications. Keywords : carotid stenosis, early surgery, results, brain infarct.

Perioperative safety analysis of carotid endarterectomy in diabetic patients

Objective: To compare perioperative outcome of carotid endarterectomy (CEA) between diabetic and non-diabetic patients and discuss the safety of CEA in diabetic patients. Methods: A total of 572 patients with carotid stenosis who underwent CEA from Juanuary 2006 to September 2014 in Peking Union Medical Colloge Hospital were collected and analyzed retrospectively. The patients were distributed into diabetes mellitus (DM) group and non-DM group according to the comorbidities. Their baseline characteristics, intraoperative index and major complications in perioperative period were analyzed and compared. Results: Of 572 cases, 184 had DM (32.2%). Diabetic patients more frequently had a history of coronary artery disease (30.4% vs 18.6%), peripheral artery disease (39.7% vs 27.3%), and hyperlipemia (50.5% vs 36.6%) than non-diabetic patients (all P<0.05). The incidence of perioperative myocardial infarction (0.5% vs 0.8%), stroke (1.6% vs 1.8%) and death (0.5% vs 0.3%) did not differ between two groups (all P>0.05). Data of follow-up was available in 89.6% of patients, with a median duration of 42 months. The incidence of myocardial infarction (4.3% vs 3.4%), stroke (1.8% vs 1.7%), death (1.1% vs 0.9%), and restenosis (2.9% vs 3.1%) did not differ between two groups (all P>0.05). Conclusion: DM does not increase the risk of perioperative complications and impair the long-term outcomes after CEA if the patients are appropriately evaluated and treated in perioperative period.

An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol

BackgroundCarotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared to CEA remains in question.ObjectiveThe purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil.MethodsThis study will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centers affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedures will be determined by each surgeon’s individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures will be (1) any in-hospital stroke or death, and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded from the study. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the .05 level. This study was approved by the Committee of Ethics in Research at the University Hospital of Ribeirao Preto Medical School, and in all other participating institutions linked to National Research System and National Board of Health in Brazil (Process 15695/2011).ResultsThis study is currently in the recruitment phase, and the final patient is expected to be enrolled by the end of 2018. We hope to recruit approximately 800 patients to the study. Analyses will focus on primary end points for patients that are allocated to each treatment group. During the per-procedural period, the occurrence of the primary end point components (stroke, MI, or death) for CAS and CEA will be analyzed for symptomatic or asymptomatic subjects.ConclusionsThe analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of São Paulo, Brazil.Trial RegistrationClinicaltrials.gov NCT02538276; https://www.clinicaltrials.gov/ct2/show/NCT02538276 (Archived by WebCite at http://www.webcitation.org/6m7APnFLD)

Effects of preoperative statin use on perioperative outcomes of carotid endarterectomy.

ObjectivesSeveral studies have shown the beneficial role of statins in reducing the risk of major perioperative complications and death associated with noncardiac vascular surgery, but few have focused on their effects in the event of carotid endarterectomy (CEA). This study analyzes the effects of preoperative statin use on perioperative outcomes in patients undergoing CEA.Materials and MethodsData from all consecutive patients who underwent primary CEA for symptomatic and asymptomatic carotid disease between 2002 and 2014 at a single institution were prospectively stored in a vascular surgery registry, recording risk factors, medication, and indication for surgery. Endpoints of the study were perioperative (30‐day) stroke and death.ResultsOverall, 784 patients were on statins (825 CEAs, Group I), while 494 were not (545 CEAs, Group II). There were two perioperative strokes in Group I (0.24%) and four in Group II (0.73%; p = .22), and no deaths. The only nonfatal cardiac complication occurred in Group II (0.18%, p = .39). A neurologist assessed patients at 1, 6, and 12 months after CEA, and every 2 years thereafter. Follow‐up (range: 0.1–13 years; mean, 6.3 ± 3.7 years) was obtained for 1,239 patients (1,326 CEAs). Because 165 patients (166 CEAs) crossed over from Group II to Group I during the follow‐up time, long‐term data were stratified by postoperative statin treatment rather than by preoperative statin use. The 5‐ and 10‐year restenosis/occlusion and survival rates did not differ significantly between the two groups.ConclusionsTaking statins prior to CEA did not seem to affect the risk of major perioperative ischemic events and death, most likely due to the extremely low overall incidence of perioperative complications.

Comparative Outcomes of Carotid Endarterectomy (CEA) and Carotid Artery Stenting (CAS): Analysis of the ACS-NSQIP Targeted Vascular Database

Chen, Samuel L. MD; Kabutey, Nii-Kabu MD; Kuo, Isabella J. MD; Fujitani, Roy M. MD, FACS Author Information

Perioperative and Long-term Outcomes After Carotid Endarterectomy in Hemodialysis Patients.

Early landmark trials excluding dialysis patients showed carotid endarterectomy (CEA) decreased stroke risk compared with medical management. Dialysis dependence has been associated with poor outcomes after CEA in small studies, but, to our knowledge, there are no large studies evaluating outcomes of CEA in this patient group. To delineate perioperative and long-term outcomes after CEA in dialysis-dependent patients in a large national database. A retrospective review of all patients who underwent CEA in the US Renal Disease System-Medicare-matched database between January 1, 2006, and December 31, 2011, was performed in June 2015. The median follow-up time was 2.5 years. Logistic and Cox regression analyses were used to evaluate perioperative and long-term outcomes. The primary outcomes of interest were perioperative stroke, myocardial infarction and mortality, and long-term stroke and mortality. A total of 5142 patients were studied; 83% of whom were asymptomatic. The mean (SD) age was 68.9 (9.6) years for asymptomatic patients and 70.0 (9.1) years for symptomatic patients. The 30-day stroke rate, myocardial infarction, and mortality for the asymptomatic and symptomatic groups were 2.7% vs 5.2% (P = .001), 4.6% vs 5.0% (P = .69), and 2.6% vs 2.9% (P = .61), respectively. Predictors of perioperative stroke were symptomatic status (odds ratio [OR], 2.01; 95% CI, 1.18-3.42; P = .01), black race (OR, 2.30; 95% CI, 1.24-4.25; P = .008), and Hispanic ethnicity (OR, 2.28; 95% CI, 1.17-4.42; P = .02). Freedom from stroke and overall survival were lower in symptomatic compared with asymptomatic patients at 1, 2, 3, 4, and 5 years (in asymptomatic vs symptomatic patients, freedom from stroke rates were 92% vs 87% at 1 year, 88% vs 83% at 2 years, 84% vs 78% at 3 years, 80% vs 73% at 4 years, and 79% vs 69% at 5 years, respectively, and overall survival rates were 78% vs 73% at 1 year, 60% vs 57% at 2 years, 46% vs 42% at 3 years, 37% vs 32% at 4 years, and 33% vs 29% at 5 years; P < .05). Predictors of long-term stroke were preoperative symptoms (hazard ratio, 1.67; 95% CI, 1.24-2.24; P < .001), female sex (hazard ratio, 1.34; 95% CI, 1.03-1.73; P = .04), and inability to ambulate (hazard ratio, 1.81; 95% CI, 1.25-2.62; P = .002). Predictors of long-term mortality were increasing age (OR, 1.02; 95% CI, 1.01-1.03; P < .01), active smoking (OR, 1.22; 95% CI, 1.00-1.48; P = .045), history of congestive heart failure (OR, 1.25; 95% CI, 1.12-1.39; P < .001), and chronic obstructive pulmonary disease (OR, 1.26; 95% CI, 1.09-1.45; P = .002). To our knowledge, this is the largest study to date of dialysis patients who have undergone CEA. We have shown that the risks of CEA in asymptomatic patients is high and may outweigh the benefits. The risk of CEA in symptomatic patients is also high, and it should only be offered to a small carefully selected cohort of symptomatic patients.

Factors Affecting Operative Time and Outcome of Carotid Endarterectomy in the Vascular Quality Initiative

Factors Affecting Operative Time and Outcome of Carotid Endarterectomy in the Vascular Quality Initiative

Operative morbidity and mortality in octogenarians after carotid endarterectomy: a propensity score matching study.

Carotid endarterectomy remains the most effective surgical treatment for reducing the risk of stroke in patients with significant carotid stenosis. In fact, endovascular approach is associated with a higher incidence of perioperative and long-term minor stroke when compared to carotid endarterectomy although long-term functional outcome and risk of major stroke are similar. However, advanced age resulted to be associated with an increased risk of complications after carotid endarterectomy. Therefore, we decided to evaluate the outcome of carotid endarterectomy in octogenarians in our high-volume center. Data of all patients who underwent CEA between June 2009 and December 2014 were retrospectively recorded. Patients were categorized as aged <80 or ≥80 years. Propensity score matching based on baseline clinical variables was performed to correct for any bias. Primary outcome was the difference in combined stroke and death. Secondary outcomes included incidence of myocardial infarction, surgical reintervention, unplanned intensive care unit admission and length of hospital stay. A total of 2463 carotid endarterectomies were performed, including 439 patients aged ≥80 years. After propensity score adjustment all octogenarians were matched one-to-one to younger patients. No differences in combined stroke and death were found (1.10% in octogenarians vs. 0.46% in younger patients; P=0.45). Octogenarians had an increased length of hospital stay when compared to younger patients (3.1±0.7 vs. 3.4±1.3 days; P=0.0001). No differences in other secondary outcomes were found. Age ≥80 years does not entail an increased perioperative risk after carotid endarterectomy. Hence, surgical carotid revascularization in octogenarians can be regarded as a safe and viable alternative to best medical therapy alone when performed in high-volume centers.

The Role of the Model of End-Stage Liver Disease Score in Predicting Outcomes of Carotid Endarterectomy.

The Model of End-Stage Liver Disease (MELD) score has been traditionally utilized to prioritize for liver transplantation; however, recent literature has shown its value in predicting surgical outcomes for patients with hepatic dysfunction. The benefit of carotid endarterectomy in asymptomatic patients is dependent on low perioperative morbidity. Our objective was to use MELD score to predict outcomes in asymptomatic patients undergoing carotid endarterectomy. Patients undergoing carotid endarterectomy were identified in the National Surgical Quality Improvement Program data sets from 2005 to 2012. The Model of End-Stage Liver Disease score was calculated using serum bilirubin, creatinine, and the international normalized ratio (INR). Patients were grouped into low (<9), moderate (9-14), and high (15+) MELD classifications. The effect of the MELD score on postoperative morbidity and mortality was assessed by multivariable logistic and gamma regressions and propensity matching. There were 7966 patients with asymptomatic carotid endarterectomy identified. The majority 5556 (70%) had a low MELD score, 1952 (25%) had a moderate MELD score, and 458 (5%) had a high MELD score. High MELD score was independently predictive of postoperative death, increased length of stay, need for transfusion, pulmonary complications, and a statistical trend toward increased cardiac arrest/myocardial infarction. The Model of End-Stage Liver Disease score did not affect postoperative stroke, wound complications, or operative time. High MELD score places asymptomatic patients undergoing carotid endarterectomy at a higher risk of adverse outcomes in the 30 days following surgery. This provides further empirical evidence for risk stratification when considering treatment for these patients. Outcomes of medical management or carotid stenting should be investigated in high-risk patients.