Recent advances and controversial issues in the optimal management of asymptomatic carotid stenosis.

OBJECTIVE: The optimal management of patients with asymptomatic carotid stenosis (AsxCS) is enduringly controversial. We updated our 2021 Expert Review and Position Statement, focusing on recent advances in the diagnosis and management of patients with AsxCS. METHODS: A systematic review of the literature was performed up to August 1, 2023, using PubMed/PubMed Central, EMBASE and Scopus. The following keywords were used in various combinations: "asymptomatic carotid stenosis," "carotid endarterectomy" (CEA), "carotid artery stenting" (CAS), and "transcarotid artery revascularization" (TCAR). Areas covered included (i) improvements in best medical treatment (BMT) for patients with AsxCS and declining stroke risk, (ii) technological advances in surgical/endovascular skills/techniques and outcomes, (iii) risk factors, clinical/imaging characteristics and risk prediction models for the identification of high-risk AsxCS patient subgroups, and (iv) the association between cognitive dysfunction and AsxCS. RESULTS: BMT is essential for all patients with AsxCS, regardless of whether they will eventually be offered CEA, CAS, or TCAR. Specific patient subgroups at high risk for stroke despite BMT should be considered for a carotid revascularization procedure. These patients include those with severe (≥80%) AsxCS, transcranial Doppler-detected microemboli, plaque echolucency on Duplex ultrasound examination, silent infarcts on brain computed tomography or magnetic resonance angiography scans, decreased cerebrovascular reserve, increased size of juxtaluminal hypoechoic area, AsxCS progression, carotid plaque ulceration, and intraplaque hemorrhage. Treatment of patients with AsxCS should be individualized, taking into consideration individual patient preferences and needs, clinical and imaging characteristics, and cultural, ethnic, and social factors. Solid evidence supporting or refuting an association between AsxCS and cognitive dysfunction is lacking. CONCLUSIONS: The optimal management of patients with AsxCS should include BMT for all individuals and a prophylactic carotid revascularization procedure (CEA, CAS, or TCAR) for some asymptomatic patient subgroups, additionally taking into consideration individual patient needs and preference, clinical and imaging characteristics, social and cultural factors, and the available stroke risk prediction models. Future studies should investigate the association between AsxCS with cognitive function and the role of carotid revascularization procedures in the progression or reversal of cognitive dysfunction.

Comparative assessment of racial disparity in 30-day outcomes for Asian Americans undergoing carotid endarterectomy.

OBJECTIVE: Carotid endarterectomy (CEA) is an effective treatment for carotid stenosis. All previous studies on racial disparity of CEA outcomes omitted Asian Americans. This study aimed to address this gap by investigating racial disparities in 30-day outcomes following CEA among Asian Americans. METHODS: Asian American and Caucasian patients who underwent CEA were identified in the American College of Surgeons National Surgical Quality Improvement Program targeted database from 2011 to 2021. Patients with age less than 18 years old were excluded. Patients with symptomatic and asymptomatic carotid stenosis were examined separately. A 1:5 propensity-score matching was used to address preoperative differences. Thirty perioperative outcomes were assessed. RESULTS: There were 380 Asian Americans (2.27%) and 13,250 Caucasians (79.18%) with symptomatic carotid stenosis who underwent CEA. Also, 289 Asian Americans (1.40%) and 18,257 Caucasians (88.14%) with asymptomatic carotid stenosis had CEA. Asian Americans undergoing CEA presented with higher comorbid burdens and more severe symptomology. Also, asymptomatic Asian Americans were more likely to undergo surgeries for mild stenosis (<50%), which is not in line with practice guidelines. After 1:5 propensity-matching, all symptomatic Asian Americans were matched to 1550 Caucasian patients, and all asymptomatic Asian Americans were matched to 1445 Caucasians; preoperative differences were addressed. Asian Americans exhibited low overall 30-day mortality (symptomatic, 1.61%; asymptomatic, 0.35%) and stroke (symptomatic, 2.26%; asymptomatic, 0.69%). All perioperative outcomes were comparable to Caucasians, with the exception that Asian Americans experienced longer operation times. CONCLUSIONS: Evidence suggested that Asian Americans with asymptomatic stenosis were underrepresented in CEA. After propensity-score matching, Asian Americans demonstrated comparable 30-day outcomes to Caucasians. These suggest that, when afforded equal access to quality health care, CEA serves as an effective treatment for carotid stenosis among Asian Americans. Therefore, efforts may be aimed at addressing health care access, potentially in the screening for asymptomatic carotid stenosis in Asian Americans. This would ensure they have equitable benefits from CEA. Nevertheless, the exact preoperative differences and long-term CEA outcomes in Asian Americans should warrant further examination in future studies.

Carotid Artery Stenting versus Carotid Endarterectomy in Terms of Neuroprotection DW-MRI Detected and Neuropsychological Assessment Impairment.

BACKGROUND: Carotid artery stenting (CAS) versus carotid endarterectomy (CEA) is well issue known, but the purpose of this study is to compare CAS versus CEA in terms of asymptomatic Diffusion-weighted magnetic resonance imaging (DW-MRI) demonstrated microembolic scattering of infarction and neuropsychological assessment impairment. METHODS: We performed a prospective, observational, cohort study on 211 consecutive carotid revascularizations at our institution. Patients were divided into 2 different cohorts: CEA was performed in n = 116 patients (Group A); CAS was performed in n = 95 (Group B). Adverse events were collected at 30 days and 6 months postoperative. Differences in terms of DW-MRI demonstrated microembolic scattering of infarction were analyzed and considered significative for P ≤ 0.05. Secondary objectives were: major and minor stroke, neuropsychological assessment impairment, death, myocardial infarction (MI). RESULTS: CEA was associated with a significative decreased rate of asymptomatic DW-MRI demonstrated microembolic scattering of infarction (13.8% vs. 51%; P = 0.0001) and of 6 months neuropsychological assessments impairment (0.8 vs. 7.4) (P = 0.04) in asymptomatic patients. There was no significant difference between 2 groups in terms of comorbidities. Stroke rates were similar at 30 days (1.7% CEA vs. 4.1% CAS) and 6 months (2.6% CEA vs. 5.3% CAS P = 0.32). There were no differences in terms of central neurological events, death, transient ischemic attack, MI between the groups. The composite end point of stroke/death/MI at 6 months postoperatively was 2.6% vs. 6.3% (P = 0.19). CONCLUSIONS: According to these results, CEA achieved better outcomes compared to patients treated by CAS with distal filter in terms of asymptomatic microembolic event and impairment National Institutes of Health Stroke Scale scale and neuropsychological assessments. Limitations of the study lead to limited conclusions only in the specific population and not generalized. Further, comparative randomized studies are warranted.

Comparison of Complications and Cost for Transfemoral Versus Transcarotid Stenting of Carotid Artery Stenosis.

BACKGROUND: Options for endovascular treatment of carotid artery disease have been developed to compliment with carotid endarterectomy, transfemoral carotid artery stenting (TFCAS) and a hybrid approach with transcarotid artery revascularization (TCAR). We sought to capture endpoints outside of stroke, myocardial infarction (MI), and death involved with each procedure at our institution as well as evaluate cost. METHODS: Carotid stent procedures performed from 2014 to 2020 at our institution underwent comparative analysis based upon access site and type of stent procedure performed, TFCAS versus TCAR. Procedural details and outcomes were captured prospectively and included in the National Cardiovascular Data Peripheral Vascular Intervention Registry (NCDR-PVI). Further retrospective review was performed to evaluate endpoints beyond stroke, MI, and death. Total in-hospital cost, including administrative, capital and utilities (fixed cost), and labor and supplies (variable cost) were also evaluated. RESULTS: One hundred thirty-seven patients were reviewed. Seventy-seven were treated with TFCAS and 60 with TCAR. The mean age was 74 years, predominantly male (68%) and Caucasian (90%). Patients undergoing TFCAS were more likely to be symptomatic compared to those receiving TCAR (81.8% vs. 50.0%, P = <0.001). There were no statistically significant differences in event rates, including mortality, recurrent cerebrovascular accident / transient ischemic attack, or bleeding. Complications not captured in the NCDR-PVI database were more frequent in the TCAR group (21.7% vs. 5.2%, P = 0.004) and included pneumothorax (n = 2), neck hematoma (n = 8), and common carotid artery stenosis or injury (n = 3). Rates of complications in the TFCAS group (n = 4) were lower and limited to groin hematoma (n = 2), central retinal artery occlusion causing vision loss and a case of postoperative dysphagia. Geographic miss of initial stent placement was identified in 15.0% of TCAR patients and 2.6% (P = 0.008) of TFCAS patients. Restenosis rates on duplex ultrasound were similar between the two groups (14.6% of patients) and were not associated with symptoms. The mean follow-up interval was similar for both groups of 31.8 months for TCAR and 30.7 months for TFCAS (P = 0.797). There was a statistically significant difference in total cost with TCAR being more expensive ($22,315 vs. $11,001) driven by direct costs that included devices, imaging, and extended length of stay in the TCAR group (P < 0.001). There was no significant difference between stroke free survival (91.1% vs. 88.6%, P = 0.69) and mortality (78.1% vs. 85.2%, P = 0.677) at 3 years follow-up between TCAR and TFCAS, respectively. CONCLUSIONS: Both TFCAS and TCAR provide similar 3-year stroke and mortality risk/benefit and are distinctly different procedures. Both should be evaluated independently with analysis of variables beyond stroke, death, and MI. TFCAS is more cost-effective than TCAR in this single institution study.

Propensity-Score Matched Analysis of Three Years Survival of Trans Carotid Artery Revascularization Versus Carotid Endarterectomy in the Vascular Quality Initiative Medicare-Linked Database.

OBJECTIVE: Carotid endarterectomy (CEA) remains the gold standard procedure for carotid revascularization. Transfemoral carotid artery stenting (TFCAS) was introduced as a minimally invasive alternative procedure in patients who are at high risk for surgery. However, TFCAS was associated with an increased risk of stroke and death compared to CEA. BACKGROUND: Transcarotid artery revascularization (TCAR) has outperformed TFCAS in several prior studies and has shown similar perioperative and 1-year outcomes compared with CEA. We aimed to compare the 1-year and 3-year outcomes of TCAR versus CEA in the Vascular Quality Initiative (VQI)-Medicare-Linked [Vascular Implant Surveillance and Interventional Outcomes Network (VISION)] database. METHODS: The VISION database was queried for all patients undergoing CEA and TCAR between September 2016 to December 2019. The primary outcome was 1-year and 3-year survival. One-to-one propensity-score matching (PSM) without replacement was used to produce 2 well-matched cohorts. Kaplan-Meier estimates, and Cox regression was used for analyses. Exploratory analyses compared stroke rates using claims-based algorithms for comparison. RESULTS: A total of 43,714 patients underwent CEA and 8089 patients underwent TCAR during the study period. Patients in the TCAR cohort were older and were more likely to have severe comorbidities. PSM produced two well-matched cohorts of 7351 pairs of TCAR and CEA. In the matched cohorts, there were no differences in 1-year death [hazard ratio (HR)=1.13; 95% CI, 0.99-1.30; P =0.065]. At 3-years, TCAR was associated with slight increased risk of death (HR=1.16; 95% CI, 1.04-1.30; P =0.008). When stratifying by initial symptomatic presentation, the increased 3-year death associated with TCAR persisted only in symptomatic patients (HR=1.33; 95% CI, 1.08-1.63; P =0.008). Exploratory analyses of postoperative stroke rates using administrative sources suggested that validated measures of claims-based stroke ascertainment are necessary. CONCLUSIONS: In this large multi-institutional PSM analysis with robust Medicare-linked follow-up for survival analysis, the rate of death at 1 year was similar in TCAR and CEA regardless of symptomatic status. The slight increase in the risk of 3-year death in symptomatic patients undergoing TCAR is likely confounded by more severe comorbidities despite matching. A randomized controlled trial comparing TCAR to CEA is necessary to further determine the role of TCAR in standard-risk patients requiring carotid revascularization.

Variation in Carotid Artery Stenosis Measurements Among Facilities Seeking Carotid Stenting Facility Accreditation.

BACKGROUND: Based on the inclusion criteria of clinical trials, the degree of cervical carotid artery stenosis is often used as an indication for stent placement in the setting of extracranial carotid atherosclerotic disease. However, the rigor and consistency with which stenosis is measured outside of clinical trials are unclear. In an agreement study using a cross-sectional sample, we compared the percent stenosis as measured by real-world physician operators to that measured by independent expert reviewers. METHODS: As part of the carotid stenting facility accreditation review, images were obtained from 68 cases of patients who underwent carotid stent placement. Data collected included demographics, stroke severity measures, and the documented degree of stenosis, termed operator-reported stenosis (ORS), by 34 operators from 14 clinical sites. The ORS was compared with reviewer-measured stenosis (RMS) as assessed by 5 clinicians experienced in treating carotid artery disease. RESULTS: The median ORS was 90.0% (interquartile range, 80.0%-90.0%) versus a median RMS of 61.1% (interquartile range, 49.8%-73.6%), with a median difference of 21.8% (interquartile range, 13.7%-34.4%), P<0.001. The median difference in ORS and RMS for asymptomatic versus symptomatic patients was not statistically different (24.6% versus 19.6%; P=0.406). The median difference between ORS and RMS for facilities granted initial accreditation was smaller compared with facilities whose accreditation was delayed (17.9% versus 25.5%, P=0.035). The intraclass correlation between ORS and RMS was 0.16, indicating poor agreement. If RMS measurements were used, 72% of symptomatic patients and 10% of asymptomatic patients in the population examined would meet the Centers for Medicare and Medicaid Services criteria for stent placement. CONCLUSIONS: Real-world operators tend to overestimate carotid artery stenosis compared with external expert reviewers. Measurements from facilities granted initial accreditation were closer to expert measurements than those from facilities whose accreditation was delayed. Since decisions regarding carotid revascularization are often based on percent stenosis, such measuring discrepancies likely lead to increased procedural utilization.

Contrast-Enhanced Ultrasound Combined With 2D Strain Imaging and Histopathological Multimodal Assessment of Carotid Plaque Vulnerability.

OBJECTIVE: The aim of this study was to explore the value of contrast-enhanced ultrasound (CEUS) combined with 2-D strain imaging in evaluating carotid plaque vulnerability and the correlations among CEUS perfusion parameters, strain parameters and histopathological findings in different plaque segments. METHODS: Patients with carotid artery stenosis who underwent carotid endarterectomy (CEA) at the First Affiliated Hospital of Xinjiang Medical University from September 2020 to June 2021 underwent preoperative carotid artery 2-D ultrasonography and CEUS. The plaques were divided into three segments: the proximal end of the shoulder, central cap and distal end of the shoulder. The peak intensity (PI) value and strain rate parameters of the regions of interest were analyzed. Plaques were divided into a stable group (8 cases) and an unstable group (19 cases). The microvascular density (MVD) and vascular endothelial growth factor (VEGF) expression of each patch in the unstable group were analyzed. RESULTS: The peak strain during the systolic period in each plaque segment in both groups showed the following pattern: proximal end shoulder > distal end shoulder > top (p < 0.05). The PI value for CEUS is also represented. In the unstable group, the PI values of each segment of the plaque were positively correlated with the MVD, near-center PI value and VEGF average optical density value. The average optical density of each segment was positively correlated with the MVD (p < 0.05). There were positive correlations between the PI values of the proximal and distal shoulder and the strain values (p < 0.05), and the MVD value of each segment, VEGF value and strain value were positively correlated (p < 0.05). CONCLUSION: PI and the pathological tissue components represented by CEUS were positively correlated with the mechanical parameters of the plaque along the long axis. There may be overlap between the high shear stress area of the plaque and the neovascular aggregation area, and the combination of the two has certain significance for assessing the vulnerability of the plaque.

Vascular Quality Initiative assessment of compliance with Society for Vascular Surgery clinical practice guidelines on the management of extracranial cerebrovascular disease.

OBJECTIVES: Compliance with Society for Vascular Surgery (SVS) clinical practice guidelines (CPGs) is associated with improved outcomes for the treatment of abdominal aortic aneurysm, but this has not been assessed for carotid artery disease. The Vascular Quality Initiative (VQI) registry was used to examine compliance with the SVS CPGs for the management of extracranial cerebrovascular disease and its impact on outcomes. METHODS: The 2021 SVS extracranial cerebrovascular disease CPGs were reviewed for evaluation by VQI data. Compliance rates by the center and provider were calculated, and the impact of compliance on outcomes was assessed using logistic regression with inverse probability-weighted risk adjustment for each CPG recommendation, allowing for clustering by the center. Our primary outcome was a composite end point of in-hospital stroke/death. As a secondary analysis, compliance with the 2021 SVS carotid implementation document recommendations and associated outcomes were also assessed. RESULTS: Of the 11 carotid CPG recommendations, 4 (36%) could be evaluated using VQI registry data. Median center-specific CPG compliance ranged from 38% to 95%, and median provider-specific compliance ranged from 36% to 100%. After adjustment, compliance with 2 of the recommendations was associated with lower rates of in-hospital stroke/death: first, the use of best medical therapy (antiplatelet and statin therapy) in low/standard surgical risk patients undergoing carotid endarterectomy for >70% asymptomatic stenosis (event rate in compliant vs noncompliant cases 0.59% vs 1.3%; adjusted odds ratio: 0.44, 95% confidence interval: 0.29-0.66); and second, carotid endarterectomy over transfemoral carotid artery stenting in low/standard surgical risk patients with >50% symptomatic stenosis (1.9% vs 3.4%; adjusted odds ratio: 0.55, 95% confidence interval: 0.43-0.71). Of the 132 implementation document recommendations, only 10 (7.6%) could be assessed using VQI data, with median center- and provider-specific compliance rates ranging from 67% to 100%. The impact of compliance on outcomes could only be assessed for 6 (4.5%) of these recommendations, and compliance with all 6 recommendations was associated with lower stroke/death. CONCLUSIONS: Few SVS recommendations could be assessed in the VQI because of incongruity between the recommendations and the VQI data variables collected. Although guideline compliance was extremely variable among VQI centers and providers, compliance with most of these recommendations was associated with improved outcomes after carotid revascularization. This finding confirms the value of guideline compliance, which should be encouraged for centers and providers. Optimization of VQI data to promote evaluation of guideline compliance and distribution of these findings to VQI centers and providers will help facilitate quality improvement efforts in the care of vascular patients.

Risk of Stroke, Death, and Myocardial Infarction Following Transcarotid Artery Revascularization vs Carotid Endarterectomy in Patients With Standard Surgical Risk.

Importance: Carotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known. Objective: To compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk. Design, Setting, and Participants: This retrospective propensity-matched cohort study was conducted from August 2016 to August 2019 with follow-up until August 31, 2020, using data from the multicenter Vascular Quality Initiative Carotid Artery Stent and Carotid Endarterectomy registries. Patients with standard surgical risk, defined as those lacking Medicare-defined high medical or surgical risk characteristics and undergoing transcarotid artery revascularization (n = 2962) or carotid endarterectomy (n = 35 063) for atherosclerotic carotid disease. In total, 760 patients were excluded for treatment of multiple lesions or in conjunction with other procedures. Exposures: Transcarotid artery revascularization vs carotid endarterectomy. Main Outcomes and Measures: The primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke. Results: After 1:3 matching, 2962 patients undergoing transcarotid artery revascularization (mean [SD] age, 70.4 [6.9] years; 1910 [64.5%] male) and 8886 undergoing endarterectomy (mean [SD] age, 70.0 [6.5] years; 5777 [65.0%] male) were identified. There was no statistically significant difference in the risk of the primary composite end point between the 2 cohorts (transcarotid 3.0% vs endarterectomy 2.6%; absolute difference, 0.40% [95% CI, -0.43% to 1.24%]; relative risk [RR], 1.14 [95% CI, 0.87 to 1.50]; P = .34). Transcarotid artery revascularization was associated with a higher risk of 1-year ipsilateral stroke (1.6% vs 1.1%; absolute difference, 0.52% [95% CI, 0.03 to 1.08]; RR, 1.49 [95% CI, 1.05 to 2.11%]; P = .02) but no difference in 1-year all-cause mortality (2.6% vs 2.5%; absolute difference, -0.13% [95% CI, -0.18% to 0.33%]; RR, 1.04 [95% CI, 0.78 to 1.39]; P = .67). Conclusions and Relevance: In this study, the risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke was similar in patients undergoing transcarotid artery revascularization compared with those undergoing endarterectomy for carotid stenosis.

Thirty-Day Perioperative Clinical Outcomes of Transcarotid Artery Revascularization vs Carotid Endarterectomy in a Single-Center Experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) has been proposed as a alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting in high-risk patients. Recently Centers for Medicare and Medicaid Services expanded coverage for TCAR to include standard surgical risk patients within the Society of Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project. Few single centers compared the clinical outcome of TCAR with CEA. This study compares 30-day perioperative clinical outcomes between TCAR and CEA. STUDY DESIGN: This is retrospective analysis of prospectively collected data from the TCAR Surveillance Project of TCAR patients enrolled in our institution and compared with CEAs done in the same time/with the same providers. The primary outcome was stroke and/or death. Secondary outcomes included stroke, death, MI, cranial nerve injury, bleeding, and others. Propensity matching was done to analyze outcomes. RESULTS: The study analyzed 501 patients (347 CEA, 154 TCAR). There were no significant differences in symptomatic status (43% for CEA vs 38% for TCAR, p = 0.303). TCAR had more patients with hypertension (p = 0.04), coronary artery disease (p = 0.028), and congestive heart failure (p = 0.039). The 30-day perioperative complication rates for CEA vs TCAR were as follows: stroke 1% vs 3% (p = 0.142), stroke/death 1% vs 3% (p = 0.185), MI 0.6% vs 0.7% (p = 1), death 0.6% vs 0% (p = 1), stroke/death/MI 2% vs 4% (p = 0.233), cranial nerve injury 4% vs 2% (p = 0.412), and major hematoma (requiring reintervention) 2% vs 3% (p = 1). After matching 154 CEA patients and 154 TCAR, 30-day perioperative complication rates were as follows: stroke 2% vs 3% (p = 0.723), stroke/death 3% vs 3% (p = 1), death 1.3% vs 0% (p = 0.498), MI 0.7% vs 0.7% (p = 1), and stroke/death/MI 3% vs 4% (p = 0.759). CONCLUSIONS: This study showed that using propensity match analysis, both CEA and TCAR have similar 30-day perioperative outcomes. Further long-term data are needed.

Operative and long-term outcomes of combined and staged carotid endarterectomy and coronary bypass.

OBJECTIVE: Optimal temporal surgical management of significant carotid stenosis and coronary artery disease remains unknown. Carotid endarterectomy (CEA) and coronary artery bypass (CABG) are performed concurrently (CCAB) or in a staged (CEA-CABG or CABG-CEA) approach. Using the Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network-Medicare-linked dataset, this study compared operative and long-term outcomes after CCAB and staged approaches. METHODS: The Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network dataset was used to identify CEAs from 2011 to 2018 with combined CABG or CABG within 45 days preceding or after CEA. Patients were stratified based on concurrent or staged approach. Primary outcomes were stroke, myocardial infarction (MI), all-cause mortality, stroke and death as composite (SD) and all as composite within 30 days from the last procedure as well as in the long term. Univariate analysis and risk-adjusted analysis using inverse propensity weighting were performed. Kaplan-Meier curves of stroke, MI, and death were created and compared. RESULTS: There were 1058 patients included: 643 CCAB and 415 staged (309 CEA-CABG and 106 CABG-CEA). Compared with staged patients, those undergoing CCAB had a higher preoperative rate of congestive heart failure (24.8% vs 18.4%; P = .01) and decreased renal function (14.9% vs 8.5%; P < .01), as well as fewer prior neurological events (23.5% vs 31.4%; P < .01). Patients undergoing CCAB had similar weighted rate of 30-day stroke (4.6% vs 4.1%; P = .72), death (7.0% vs 5.0%; P = .32), and composite outcomes (stroke and death, 9.8% vs 8.5%; P = .56; stroke, death, and MI, 14.7% vs 17.4%; P = .31), but a lower weighted rate of MI (5.5% vs 11.5%; P < .01) vs the staged cohort. Long-term adjusted risks of stroke (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.54-1.36; P = .51) and mortality (HR, 1.02; 95% CI, 0.76-1.36; P=.91) were similar between groups, but higher risk of MI long-term was seen in those staged (HR, 1.49; 95% CI, 1.07-2.08; P = .02). CONCLUSIONS: In patients undergoing CCAB or staged open revascularization for carotid stenosis and coronary artery disease, the staged approach had an increased risk of postoperative cardiac event, but the short- and long-term rates of stroke and mortality seem to be comparable. Adverse cardiovascular event risk is high between operations when staged and should be a consideration when selecting an approach. Although factors leading to staged sequencing performance need further clarity, CCAB seems to be safe and should be considered an equally reasonable option.

Assessment of Determinants of Value in Carotid Endarterectomy.

BACKGROUND: Over 150,000 carotid endarterectomies (CEA) are performed annually worldwide, accounting for $900 million in the United States alone. How cost/spending and quality are related is not well understood but remain essential components in maximizing value. We sought to identify determinants of variability in hospital 90-day episode value for CEA. METHODS: Medicare and private-payer admissions for CEA from January 2, 2014 to August 28, 2020 were linked to retrospective clinical registry data for hospitals in Michigan performing vascular surgery. Hospital-specific, risk-adjusted, 30-day composite complications (defined as reoperation, new neurologic deficit, myocardial infarction, additional procedure including CEA or carotid artery stenting, readmission, or mortality) and 30-day risk-adjusted, price-standardized total episode payments were used to categorize hospitals into low or high value by defining the intersection between complications and spending. RESULTS: A total of 6,595 patients across 39 hospitals were identified across both datasets. Patients at low-value hospitals had a higher rate of 30-day composite complications (17.9% vs. 10.1%, P < 0.001) driven by a significantly higher rate of reoperation (3.0% vs. 1.4%, P = 0.016), readmission (10.7% vs. 6.2%, P = 0.012), new neurologic deficit (4.6% vs. 2.3%, P = 0.017), and mortality (1.6% vs. 0.6%, P < 0.049). Mean total episode payments were $19,635 at low-value hospitals compared to $15,709 at high-value hospitals driven by index hospitalization ($10,800 vs. $9,587, P = 0.002), professional ($3,421 vs. $2,827, P < 0.001), readmission ($3,011 vs. $1,826, P < 0.001), and post-acute care payments ($2,335 vs. $1,486, P < 0.001). Findings were similar when only including patients who did not suffer a complication. CONCLUSIONS: There is tremendous variation in both quality and payments across hospitals included for CEA. Importantly, costs were higher at low-value hospitals independent of postoperative complication. There appears to be little to no relationship between total episode spending and surgical quality, suggesting that improvements in value may be possible by decreasing total episode cost without affecting surgical outcomes.

Cost-effectiveness of carotid artery stenting vs endarterectomy: A simulation.

OBJECTIVE: Clinical trials conducted before the introduction of modern medical management to prevent stroke demonstrated that carotid endarterectomy (CEA) and carotid artery stenting (CAS) prevent stroke following transient ischemic attack (TIA). We compared the cost-effectiveness of CEA, CAS, and modern medical management in two secular settings of medical management in individuals with incident TIA and type 2 diabetes. METHODS: Using simulation modeling, our base-case analyses were performed from the healthcare sector perspective over a 20-year time horizon with an annual 3% discount rate applied to both costs and quality-adjusted life years (QALYs). Outcomes depended on age, sex, biomarkers associated with cardiovascular risk, and treatment effects based on a validated model of type 2 diabetes. Our simulation population was drawn from the National Health and Nutrition Examination Survey (NHANES) 2014 cohort. Costs for modern medical management were based on average wholesale prices, and revascularization costs were derived from published literature. One-way and probabilistic sensitivity analyses were conducted. RESULTS: Compared to all other strategies, historical medical management plus CEA was either cost-saving or cost-effective at a threshold of $100,000 per QALY gained. Modern medical management was cost-effective compared to historical medical management without revascularization at a $100,000 acceptability threshold. However, both revascularization approaches (plus medical management) were cost-saving compared to modern medical management alone. CONCLUSION: Among individuals requiring carotid revascularization, carotid endarterectomy is the cost-effective strategy to treat individuals with type 2 diabetes following a TIA. For individuals for whom revascularization is contraindicated, modern medical therapy is cost-effective.

Cost-effectiveness of carotid endarterectomy in symptomatic patients.

BACKGROUND: Medical therapy for stroke prevention has improved significantly over the past 30 years. Recent analyses of medically treated cohorts have suggested that early rates of stroke may have reduced, and reports of the safety of carotid surgery have also shown improvements. Since the effectiveness of carotid surgery versus medical therapy was established in the 1990s, there is an urgent need to evaluate whether surgery remains cost-effective in the UK. METHODS: A decision model was developed to estimate the lifetime costs and utilities of modern medical therapy with and without carotid endarterectomy in patients with symptomatic stenosis from the perspective of the UK National Health Service. The base-case population consisted of adults aged 70 years with 70-99 per cent stenosis. Model data were obtained from clinical studies and wider literature. Univariate and probabilistic sensitivity analyses were carried out. RESULTS: In the base-case scenario, the 5-year absolute risk reduction with carotid endarterectomy was 5 per cent, and the incremental cost-effectiveness ratio was €12 021 (exchange rate £1 GBP = €1.1125 (Tuesday 1 January 2019)) per quality-adjusted life-year. Surgery was more cost-effective if performed rapidly after presentation. In patients with 50-69 per cent carotid stenosis, surgery appeared less clinically effective. However, there was considerable uncertainty. CONCLUSION: Surgery may not now be clinically effective and cost-effective in those with moderate carotid stenosis. However, these results are uncertain because of the limited data on modern medical therapy and an RCT may be justified.

Insurance status is associated with urgent carotid endarterectomy and worse postoperative outcomes.

OBJECTIVE: Underinsured patients can experience worse preoperative medical optimization. We aimed to determine whether insurance status was associated with carotid endarterectomy (CEA) urgency and postoperative outcomes. METHODS: We analyzed the Society for Vascular Surgery Vascular Quality Initiative Carotid Endarterectomy dataset from January 2012 to January 2021. Univariable and multivariable methods were used to analyze the differences across the insurance types for the primary outcome variable: CEA urgency. The analyses were limited to patients aged <65 years to minimize age confounding across insurers. We also examined differences in preoperative medical optimization and symptomatic disease and postoperative outcomes. A secondary analysis was performed to examine the effect of CEA urgency on the postoperative outcomes. RESULTS: A total of 27,331 patients had undergone first-time CEA. Of these patients, 4600 (17%) had Medicare, 3440 (13%) had Medicaid, 17,917 (65%) had commercial insurance, and 1374 (5%) were uninsured. The Medicaid and uninsured patients had higher rates of urgent operation compared with Medicare (20.0% and 34.7% vs 14.4%; P < .001), with no differences in the commercial group vs the Medicare group. Additionally, Medicaid and uninsured patients had lower rates of aspirin, statin, and/or antiplatelet use (93.6% and 93.5% vs 95.8%; P < .001) and higher rates of symptomatic disease (42.1% and 57.6% vs 36.2%; P < .001) compared with Medicare patients. The rate of perioperative stroke/death was higher for the Medicaid and uninsured patients than for the Medicare patients (1.63% and 1.89% vs 1.02%; P = .017 and P = .01, respectively), with no differences in the commercial group. Multivariable analysis demonstrated that compared with Medicare, Medicaid and uninsured status were associated with increased odds of an urgent operation (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.1-1.5; and OR, 2.3; 95% CI, 2.0-2.7, respectively), symptomatic disease (OR, 1.2; 95% CI, 1.1-1.4; and OR, 2.2; 95% CI, 1.9-2.5, respectively), and perioperative stroke/death (OR, 1.6; 95% CI, 1.1-2.4; and OR, 1.8; 95% CI, 1.1-3.0, respectively) and a decreased odds of aspirin, statin, and/or antiplatelet use (OR, 0.71; 95% CI, 0.6-0.9; and OR, 0.76; 95% CI, 0.6-0.99, respectively). Additionally, the rates of perioperative stroke/death were higher for patients who had required urgent surgery compared with elective surgery (2.8% vs 1.0%; P < .001). Multivariable analysis demonstrated increased odds of perioperative stroke/death for patients who had required urgent surgery (OR, 2.4; 95% CI, 1.9-3.1). CONCLUSIONS: Medicaid and uninsured patients were more likely to require urgent CEA, in part because of poor preoperative medical optimization. Additionally, urgent operation was independently associated with worse postoperative outcomes. These results highlight the need for improved preoperative follow-up for underinsured populations.

Medical center reimbursement for vascular procedures has increased over time while professional reimbursement has declined.

OBJECTIVE: The United States healthcare system uses different methods for assigning medical center reimbursement (MCR) and professional reimbursement (PR) for clinical services. We hypothesized that PR has not increased proportionately to MCR for the same vascular services. METHODS: MCR and PR were compared for commonly performed inpatient and outpatient vascular procedures between 2012 and 2021. MCR was calculated using the Medicare inpatient prospective payment system and outpatient prospective payment system. MCR is based on the Centers for Medicare and Medicaid Services definition and criteria for comorbidities and the occurrence of complications; thus, changes in MCR were reported as a range based on the degree of comorbidities and complications using the Diagnosis Related Group. PR was calculated using the Medicare physician fee schedule, which assigns a numerical work relative value unit to each surgical service, with final compensation determined by an annually adjusted conversion factor to yield a final dollar amount. The expected reimbursement based on the observed inflation during the study period using the consumer price index was calculated and compared to the actual reimbursement. RESULTS: From 2012 to 2021, MCR for inpatient procedures increased 20% to 26% for carotid endarterectomy, 24% to 27% for femoral endarterectomy, 24% to 27% for femoropopliteal bypass with vein, 14% to 19% for thoracic endovascular aortic repair, and 15% for aortobifemoral bypass. During the same period, PR increased 3.3% for carotid endarterectomy but decreased for femoral endarterectomy (-5.0%), femoropopliteal bypass (-4.6%), thoracic endovascular aortic repair (-4.2%), and aortobifemoral bypass (-5.0%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 10% to 17% reduction but MCR outpaced inflation by 3.7% to 10%. For outpatient procedures, MCR increased 117% for tibial angioplasty, 24% for superficial femoral artery (SFA) stenting, 62% for tunneled dialysis catheter (TDC) insertion, and 24% for iliac stenting but decreased 0.43% for arteriovenous fistula (AVF) creation and 7.6% for radiofrequency ablation (RFA). PR increased 0.91% for SFA stenting but decreased for tibial angioplasty (-17%), AVF creation (-6.4%), TDC insertion (-7.1%), iliac stenting (-3.8%), and RFA (-22%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 13% to 32% reduction. In contrast, MCR outpaced inflation 7.5% to 88% for tibial angioplasty, SFA stenting, TDC insertion, and iliac stenting but experienced a reduction for AVF (-13%) and RFA (-19%). CONCLUSIONS: MCR for commonly performed vascular procedures has increased and outpaced inflation. In contrast, PR for these same services has decreased across all procedure types. This decrease in PR was exacerbated when adjusted for inflation. This inequity in the reimbursement methods between MCR and PR poses a threat to the viability of the physician workforce. Either changes to the reimbursement methods or a reallocation of reimbursement to physicians are imperative to sustain physician practices.

Utility of automated data-adaptive propensity score method for confounding by indication in comparative effectiveness study in real world Medicare and registry data.

BACKGROUND: Confounding by indication is a serious threat to comparative studies using real world data. We assessed the utility of automated data-adaptive analytic approach for confounding adjustment when both claims and clinical registry data are available. METHODS: We used a comparative study example of carotid artery stenting (CAS) vs. carotid endarterectomy (CEA) in 2005-2008 when CAS was only indicated for patients with high surgical risk. We included Medicare beneficiaries linked to the Society for Vascular Surgery's Vascular Registry >65 years old undergoing CAS/CEA. We compared hazard ratios (HRs) for death while adjusting for confounding by combining various 1) Propensity score (PS) modeling strategies (investigator-specified [IS-PS] vs. automated data-adaptive [ada-PS]); 2) data sources (claims-only, registry-only and claims-plus-registry); and 3) PS adjustment approaches (matching vs. quintiles-adjustment with/without trimming). An HR of 1.0 was used as a benchmark effect estimate based on CREST trial. RESULTS: The cohort included 1,999 CAS and 3,255 CEA patients (mean age 76). CAS patients were more likely symptomatic and at high surgical risk, and experienced higher mortality (crude HR = 1.82 for CAS vs. CEA). HRs from PS-quintile adjustment without trimming were 1.48 and 1.52 for claims-only IS-PS and ada-PS, 1.51 and 1.42 for registry-only IS-PS and ada-PS, and 1.34 and 1.23 for claims-plus-registry IS-PS and ada-PS, respectively. Estimates from other PS adjustment approaches showed similar patterns. CONCLUSIONS: In a comparative effectiveness study of CAS vs. CEA with strong confounding by indication, ada-PS performed better than IS-PS in general, but both claims and registry data were needed to adequately control for bias.

Transcarotid artery revascularization is associated with similar outcomes to carotid endarterectomy regardless of patient risk status.

BACKGROUND: Carotid artery stenting (CAS), including both transfemoral carotid artery stenting (TFCAS) and transcarotid artery revascularization (TCAR), reimbursement has been limited to high-risk patients by the Centers for Medicare & Medicaid Services (CMS) since 2005. We aimed to assess the association of CMS high-risk status with perioperative outcomes for carotid endarterectomy (CEA), TFCAS, and TCAR. METHODS: We performed a retrospective review of all Vascular Quality Initiative patients who underwent carotid revascularization between 2015 and 2020. Patients were stratified by whether they met CMS CAS criteria, and univariable and multivariable logistic regression analyses were performed to assess the association of procedure type (CEA, TFCAS, TCAR) with perioperative outcomes. RESULTS: Of 124,531 individuals who underwent carotid revascularization procedures, 91,687 (73.6%) underwent CEA, 17,247 (13.9%) underwent TFCAS, and 15,597 (12.5%) underwent TCAR. Among patients who met the CMS CAS criteria (ie, high-risk patients), the incidence of perioperative stroke was 2.7% for CEA, 3.4% for TFCAS, and 2.4% for TCAR (P < .001). Among standard-risk patients, the incidence of perioperative stroke was 1.7% for CEA, 2.7% for TFCAS, and 1.8% for TCAR (P < .001). After adjusting for baseline demographic and clinical characteristics, the odds of perioperative stroke were lower for TCAR versus CEA in high-risk patients (adjusted odds ratio [aOR], 0.82; 95% confidence interval [CI], 0.68-0.99) and similar in standard-risk patients (aOR, 1.05; 95% CI, 0.84, 1.31). In contrast, the adjusted odds of perioperative stroke were higher for TFCAS versus CEA in high-risk patients (aOR, 1.23; 95% CI, 1.03-1.46) and standard-risk patients (aOR, 1.60; 95% CI, 1.37-1.86). In both populations, TFCAS and TCAR patients had significantly lower odds of myocardial infarction than CEA patients (both P < .001). CONCLUSIONS: The perioperative risks associated with CEA, TFCAS, and TCAR in high-risk patients support the current CMS criteria, although the risks associated with each revascularization approach in standard-risk patients suggest that distinguishing TCAR from TFCAS may be warranted.

[Anesthetic and Perioperative Management in Carotis Endarterectomy (CEA) - Part 2: Neurological Assessment]. / Anästhesie und perioperatives Management der Karotis-Endarteriektomie (CEA).

The second part of "Anesthetic and Perioperative Management in Carotid Endarterectomy (CEA)" reviews the apparative/diagnostic and clinical techniques regarding neurological monitoring and perioperative complications. In particular, advantages and disadvantages concerning different methods of neurological assessment will be presented. Perioperative complications and their management will be discussed.