Carotid Revascularization Research Articles

Socioeconomic status as a predictor of post-operative mortality and outcomes in carotid artery stenting vs. carotid endarterectomy.

The association between low socioeconomic status (SES) and worse surgical outcomes has become an emerging area of interest. Literature has demonstrated that carotid artery stenting (CAS) poses greater risk of postoperative complications, particularly stroke, than carotid endarterectomy (CEA). This study aims to compare the impact of low SES on patients undergoing CAS vs. CEA. The National Inpatient Sample (NIS) was queried for patients undergoing CAS and CEA from 2010 to 2015. Patients were stratified by highest and lowest median income quartiles by zip code and compared through demographics, hospital characteristics, and comorbidities defined by the Charlson Comorbidity Index (CCI). Primary outcome was in-hospital mortality. Secondary outcomes included acute kidney injury (AKI), post-operative stroke, sepsis, and bleeding requiring reoperation.Multivariable logistic regression was used to determine the effect of SES on outcomes. Five thousand four hundred twenty-five patients underwent CAS (Low SES: 3,516 (64.8%); High SES: 1,909 (35.2%) and 38,399 patients underwent CEA (Low SES: 22,852 (59.5%); High SES: 15,547 (40.5%). Low SES was a significant independent predictor of mortality [OR = 2.07 (1.25-3.53); p = 0.005] for CEA patients, but not for CAS patients [OR = 1.21 (CI 0.51-2.30); p = 0.68]. Stroke was strongly associated with low SES, CEA patients (Low SES = 1.5% vs. High SES = 1.2%; p = 0.03), while bleeding was with high SES, CAS patients (Low SES = 5.3% vs. High SES = 7.1%; p = 0.01). CCI was a strong predictor of mortality for both procedures [CAS: OR1.45 (1.17-1.80); p < 0.001. CEA: OR1.60 (1.45-1.77); p < 0.001]. Advanced age was a predictor of mortality post-CEA [OR = 1.03 (1.01-1.06); p = 0.01]. While not statistically significant, advanced age and increased mortality trended towards a positive association in CAS [OR = 1.05 (1.00-1.10); p = 0.05]. Low SES is a significant independent predictor of post-operative mortality in patients who underwent CEA, but not CAS. CEA is also associated with higher incidence of stroke in low SES patients. Findings demonstrate the impact of SES on outcomes for patients undergoing carotid revascularization procedures. Prospective studies are warranted to further evaluate this disparity.

Carotid endarterectomy compared with carotid artery stenting for extracranial carotid artery stenosis: a retrospective single-centre study

Aim: One of the main risk factors for an ischemic stroke is significant carotid artery stenosis, and extracranial severe carotid artery stenosis accounts for 20% of ischemic strokes. Prior to the development of carotid artery stenting (CAS), the only effective and reliable treatment for carotid artery stenosis was carotid endarterectomy (CEA). This study compares the results of CAS and CEA in patients with significant carotid artery stenosis. Methods: Between 2018 and 2022, hospital records of all patients who underwent carotid artery revascularization at the institution were retrospectively analyzed. Patients were divided into two groups depending on whether CEA or CAS was performed for carotid revascularization. Propensity score matching was performed to reduce bias by equating the baseline clinical characteristics of the groups. To compare 30-day, 1-year, and long-term outcomes, rates of transient ischemic attack (TIA), myocardial infarction, stroke, all-cause mortality, and composite endpoints were analyzed. Results: After PSM, 76 patients each in the CEA and CAS groups were compared. The mean age was 69.80 years ± 11.35 years and 121 (80%) were male. The patients were followed up for a mean of 33 months ± 6 months. The incidence of TIA in the perioperative period [9 (12%) vs. 4 (5%); P &lt; 0.05], TIA and composite endpoint at 1-year period [11 (15%) vs. 2 (3%); P &lt; 0.05 and 27 (36%) vs. 16 (21%); P &lt; 0.05, respectively] were significantly higher in the CAS group than in the CEA group. No difference was observed between the groups in the long-term. Conclusions: There was no noticeable difference between the CEA and CAS groups in the examination of cases with severe carotid artery stenosis in terms of 1-month, and 1-year results (apart from TIA and composite endpoints), or long-term outcomes. Extracranial carotid artery stenosis can be treated safely and effectively also by CAS.

Impact of acute silent ischemic lesions on clinical outcomes of carotid revascularization.

Previous literature has established an association between acute silent ischemic lesions (ASILs) and elevated susceptibility to future adverse clinical outcomes. The present study endeavors to scrutinize the prognostic significance of preprocedural ASILs, as detected through diffusion-weighted imaging and apparent diffusion coefficient metrics, in relation to subsequent adverse events-namely, stroke, myocardial infarction, and all-cause death-following carotid revascularization in a cohort of patients with symptomatic carotid stenosis. Subjects were extracted from a comprehensive retrospective dataset involving symptomatic carotid stenosis cases that underwent carotid revascularization at a tertiary healthcare institution in China, spanning January 2019 to March 2022. Of the 2663 initially screened patients (symptomatic carotid stenosis=1600; asymptomatic carotid stenosis=1063), a total of 1172 individuals with symptomatic carotid stenosis were retained for subsequent analysis. Stratification was implemented based on the presence or absence of ASILs. The primary endpoint constituted a composite measure of in-hospital stroke, myocardial infarction, or all-cause death. Both carotid endarterectomy (CEA) and carotid artery stenting (CAS) treatment modalities were individually subjected to propensity score-matched analyses. Among the 584 subjects who underwent CEA, 91 ASIL-positive and 91 ASIL-negative (NASIL) cases were propensity score-matched. Notably, the ASIL cohort demonstrated a statistically significant augmentation in the risk of primary outcomes relative to the NASIL group [10.99 vs. 1.10%; absolute risk difference, 9.89% (95% CI: 3.12-16.66%); RR, 10.00 (95% CI: 1.31-76.52); P =0.01]. Similarly, within the 588 CAS-treated patients, 107 ASIL-positive and 107 NASIL cases were matched, revealing a correspondingly elevated risk of primary outcomes in the ASIL group [9.35 vs. 1.87%; absolute risk difference, 7.48% (95% CI: 1.39-13.56%); RR, 5.00 (95% CI: 1.12-22.28); P =0.02]. ASILs portend an elevated risk for grave adverse events postcarotid revascularization, irrespective of the specific revascularization technique employed-be it CEA or CAS. Thus, ASILs may serve as a potent biomarker for procedural risk stratification in the context of carotid revascularization.

Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study.

In patients at urgent need for cardiac surgery coexisting with increased-stroke-risk carotid stenosis, any staged intervention increases the risk of complications from the primarily unaddressed pathology. In this challenging cohort, we assessed safety and feasibility of endovascular carotid revascularization under open-chest extracorporeal circulation (ECC) combined with cardiac surgery (hybrid-room true simultaneous treatment). Per-protocol (PP), after general anesthesia induction, chest-opening and ECC stand-by installation, carotid stenting (CAS) was performed (femoral/radial or direct carotid access) with ad-hoc/on-hand switch to ECC cardiac surgery. Over 78 months, 60 patients (70.7±6.9years, 85% male, all American Society of Anesthesiology grade IV) were enrolled. All were at increased carotid-related stroke risk (ipsilateral recent stroke/transient ischemick attack, asymptomatic cerebral infarct, increased-risk lesion morphology, bilateral severe stenosis). Majority of study procedures involved CAS+coronary bypass surgery or CAS+valve replacement±coronary bypass. 45 (75%) patients were PP- and 15 (25%) not-PP (NPP-) managed (context therapy). CAS was 100% neuroprotected (transient flow reversal-64.4%, filters-35.6%) and employed micronet-covered plaque-sequestrating stents with routine post-dilatation optimization/embedding. 4 deaths (6.7%) and 7 strokes (11.7%) occurred by 30-days. Despite CAS+surgery performed on aspirin and unfractionated heparin-only (delayed clopidogrel-loading), no thrombosis occurred in the stented arteries, and 30-days stent patency was 100%. NPP-management significantly increased the risk of death/ipsilateral stroke (OR 38.5; P<0.001) and death/any stroke (OR 12.3; P=0.002) by 30-days. In cardiac unstable patients at increased carotid-related stroke risk who require urgent cardiac surgery, simultaneous cardiac surgery and CAS with micronet-covered stent lesion sequestration is feasible and safe and shows efficacy in minimizing stroke risk. Larger-scale, multicentric evaluation is warranted. (SIMGUARD NCT04973579).

Prevalence and adverse outcomes of pre-operative frailty in patients undergoing carotid artery revascularization: a meta-analysis

IntroductionFrailty can lead to a decrease in the patient's resistance to interference such as injury and disease, and cause a series of complications. An increasing number of studies have found that pre-operative frailty exacerbates the occurrence of adverse events after carotid artery revascularization, but an integrated quantitative analysis is currently lacking. Therefore, we conducted a meta-analysis to evaluate the impact of pre-operative frailty on patients undergoing carotid artery revascularization.MethodAccording to the PRISMA guidelines, we systematically searched for relevant studies on Medline, Embase, Ovid, CINAHL, Web Of Science, and Cochrane Library from establishment until June 2023. Summarize the risk of adverse outcome events through OR and 95% CI.ResultsA total of 16 cohort studies were included, including 1692338 patients. Among patients who underwent carotid artery revascularization surgery, the prevalence of pre-operative frailty was 36% (95% CI = 0.18–0.53, P &amp;lt; 0.001). Compared with non frail individuals, frail individuals have an increased risk of mortality (OR = 2.35, 95% CI = 1.40–3.92, P = 0.001, I2 = 94%), stroke (OR = 1.33, 95% CI = 1.10–1.61, P = 0.003, I2 = 71%), myocardial infarction (OR = 1.86, 95% CI = 1.51–2.30, P &amp;lt; 0.001, I2 = 61%), and non-home discharge (OR = 2.39, 95% CI = 1.85–3.09, P &amp;lt; 0.001, I2 = 63%).ConclusionThe results of this article show that patients undergoing carotid artery revascularization have a higher prevalence of pre-operative frailty, which can lead to an increased risk of postoperative death, stroke, myocardial infarction, and non-home discharge. Strengthening the assessment and management of frailty is of great significance for patient prognosis.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=416234, identifier: CRD42023416234.

Duplex ultrasound and cross-sectional imaging in carotid artery occlusion diagnosis

ObjectiveInvestigations into imaging modalities in the diagnosis of extracranial carotid artery occlusion (CAO) have raised questions about the inter-modality comparability of duplex ultrasound (DUS) and cross-sectional imaging (CSI). This study examines the relationship between DUS and CSI diagnoses of extracranial CAO. MethodsThis single-institution retrospective analysis studied patients with CAO diagnosed by DUS from 2010 to 2021. Patients were identified in our office-based accredited vascular laboratory database. Imaging and clinical data was obtained via our institutional electronic medical record. Primary outcome was discrepancy between DUS and CSI modalities. Secondary outcomes included incidence of stroke and intervention subsequent to CAO diagnosis. ResultsOf our 140-patient cohort, 95 patients (67.9%) had DUS follow-up (mean, 42.7 ± 31.3 months). At index duplex, 68.0% of individuals (n = 51) were asymptomatic. Seventy-five patients (53.6%) had CSI of the carotids after DUS CAO diagnosis; 18 (24%) underwent magnetic resonance imaging and 57 (76%) underwent computed tomography. Indications for CSI included follow-up of DUS findings of carotid stenosis/occlusion (44%), stroke/transient ischemic attack (16%), other symptoms (12%), preoperative evaluation (2.7%), unrelated pathology follow-up (9.3%), and outside institution imaging with unavailable indications (16%). When comparing patients with CSI and those without, there were no differences with regard to symptoms at diagnosis, prior neck interventions, or hypertension. There was a significant difference between cross-sectionally imaged and non-imaged patients in anti-hypertensive medications (72% vs 53.8%; P = .04). Despite initial DUS diagnoses of carotid occlusion, 10 patients (13.3%) ultimately had CSI indicating patent carotids. Four of these 10 patients had stenoses of ∼99% (with 1 string sign), four of 70% to 99%, one of 50% to 69%, and one of less than 50% on CSI. The majority of patients (70%) had CSI within 1 month of the index ultrasound. There were no significant relationships between imaging discrepancies and body mass index, heart failure, upper body edema, carotid artery calcification, and neck hardware. Eight individuals (10.7%) underwent ipsilateral revascularization; 62.5% (n = 5) were carotid endarterectomy procedures, and the remaining three procedures were a transcervical carotid revascularization, subclavian to internal carotid artery bypass, and transfemoral carotid artery stenting. Eight patients (10.7%) underwent contralateral revascularization, with the same distribution of procedures as those ipsilateral to occlusions. Two of the 10 patients with discrepancies underwent carotid endarterectomy, and one underwent carotid stenting. ConclusionsIn our experience, duplex diagnosis of CAO is associated with a greater than 10% discordance when compared with CSI. These patients may benefit from closer surveillance as well as confirmatory computed tomography or magnetic resonance angiography. Further work is needed to determine the optimal diagnostic modality for CAO.

Simultaneous single-stage urgent cardiac surgery and endovascular carotid revascularization under open-chest cardiopulmonary bypass in extremely high-risk, unstable patients

Abstract Background Patients with symptomatic/severe carotid disease (recent carotid related TIA/stroke and/or high-risk plaque) and unstable, surgery-requiring cardiac disease (multivessel coronary artery disease-CAD and/or severe valvular heart disease-VHD) constitute a major decision-making and logistics challenge. Intervention limited to cardiac-only or carotid-only pathology may significantly increase the risk of serious/fatal complications arising primarily from "the other" (untreated) condition. Purpose To assess safety and feasibility of simultaneous, neuroprotected carotid artery stenting (CAS) under open-chest extracorporeal circulation (ECC) standby combined with urgent cardiac surgery in extreme risk patients with non-ST elevation myocardial infarction –(NSTEMI)/unstable angina (UA) and/or severe VHD (NYHA III) coexisting with symptomatic (recent stroke/TIA) carotid stenosis or high-risk lesion. Methods CAS and cardiac surgery were performed (multidisciplinary neurovascular team decision) in a hybrid room, during same anaesthetic setting (absence of delay). After chest opening and ECC stand-by connection, neuroprotected CAS was performed using transfemoral or direct carotid route with an immediate switch to ECC as required. Cardiac surgery followed immediately. Patients were on acetylsalicylic acid pre-procedurally. CAS heparinization was ACT-guided and was followed by ECC large-dose heparinization (protamine reversal). Clopidogrel (300 mg) was given within 12h, if surgical drainage was decreasing. Analysis was intention to treat (ITT). Results Over 60 months, 44 patients (age 71.2y, 81.8% male) meeting inclusion criteria were enrolled (ITT group), all in American Society of Anesthesiologists grade IV. Of those, 43 underwent treatment (1 death in transportation), 35 (79.5%) were treated per-protocol. Of the remaining 8 patients 5 with severe pulmonary disease/severe obesity/severely impaired ejection fraction/seriously impaired mobility were not cleared for surgery by anaesthesia ("too-sick for surgery"), in 3 cases hybrid room was not immediately available. 100% CAS were neuroprotected and all involved plaque sequestration with micronet-covered stent. CAS procedures (n=42, one lesion severity not confirmed) were 100% technically successful. Iv. inotropics were administered routinely, need for immediate switch to ECC occurred in 4 patients. The valve procedures in this study were due to severe aortic stenosis. For further details see Table. Patients "too-sick for surgery" (11.4%) underwent total endovascular treatment. On 30-day Carotid Doppler-Duplex ultrasound no in-stent restenosis/thrombosis occurred. Conclusions This study shows that truly simultaneous CAS+cardiac surgery in extremely high-risk, heamodynamically unstable patients is feasible and safe. Stent patency at 30 days and low 30-day death/MI/stroke rate (5.7% as per protocol) suggest efficacy of this novel strategy.

Abstract 17178: Rates of Micro Embolic Signals at Different Stages of Carotid Artery Revascularization

Background: The American Heart Association currently estimates that over 160,000 people die every year due to new or recurrent strokes, many from carotid artery stenosis. This association has led to increased use of carotid revascularization procedures such as carotid endarterectomy (CEA) and carotid artery stenting (CAS). In this study we aim to describe the different rates of micro embolic signals (MES) at different stages of carotid artery revascularization. Methods: Before elective carotid revascularization 57 patients (mean age 72±8 years; 15 males, 21 females) underwent 3-T MRI. After localization of the carotid bifurcation using phase contrast imaging, Time-of-Flight, 3D T1 weighting, transverse T1 and T2 weightings and proton density sequences were acquired. The different plaque components: lipid core, intraplaque hemorrhage, calcification and the characterization of the fibrous cap were assessed. While 34 patients underwent CEA, 20 patients had CAS. CES was divided into 9 stages: 1- Pre-procedure, 2- Dissection, 3- IC clamp, 4- Shunt placement, 5- Shunt open, 6- Endarterectomy, 7- Clamped, 8- IC opened, 9- Post-procedure. Similarly, CAS was divided into 9 stages: 1- Pre-procedure, 2- Arch-carotid angiography, 3- Wire insertion, 4- Filter deployment, 5- Pre-dilation, 6- Stent deployment, 7- Post-dilation, 8- Final angiography, 9- Post-procedure. Patients were monitored continuously with transcranial doppler (TCD) to detect pre-procedural, intra-procedural and post-procedural MES rates. Results: MES was detected in 20 (87%) patients undergoing CAS compared to 18 (53%) patients undergoing CES during the IC Clamp/Wire Insertion stage (p=0.004). Greater mean micro embolic signals were also found in symptomatic patients undergoing CAS than in asymptomatic patients during arch-carotid angiography (10.8 vs 2.4, p= 0.022), post-dilation (3.1 vs 1.1, p=0.047), and post-procedure (4.8 vs 1.3, p=0.044). Conclusion: MES is increased during the wire insertion stage of CAS in addition to post-dilation and post-procedure stages. Also, the finding of increased MES during arch-carotid angiography suggests that less invasive alternatives to diagnostic angiography should be considered in symptomatic patients.

Abstract 17231: Importance of Intra Plaque Hemorrhage During Carotid Artery Revascularization

Introduction: The American Heart Association currently estimates that every 3 minutes a person dies from a stroke. Carotid artery stenosis, a major risk factor for new and recurrent strokes, can be treated with carotid artery revascularization. Vascular emboli released during this procedure are non-invasively detected by transcranial doppler (TCD) ultrasound as micro embolic signals (MES). In this study we aim to show the relationship between carotid plaque characteristics and MES rates that were detected by TCD-monitoring throughout the stages of the carotid artery revascularization procedures. Methods: Before elective carotid revascularization 30 patients (mean age 72±8 years; 16 males, 14 females) underwent 3-T MRI. After localization of the carotid bifurcation using phase contrast imaging, Time-of-Flight, 3D T1 weighting, transverse T1 and T2 weightings and proton density sequences were acquired. The different plaque components: lipid core, intraplaque hemorrhage, calcification and the characterization of the fibrous cap were assessed. While 20 patients underwent carotid endarterectomy (CEA), 10 patients had carotid artery stenting (CAS). CES was divided into 9 stages: 1- Pre-procedure, 2- Dissection, 3- IC clamp, 4- Shunt placement, 5- Shunt open, 6- Endarterectomy, 7- Clamped, 8- IC opened, 9- Post-procedure. Similarly, CAS was divided into 9 stages: 1- Pre-procedure, 2- Arch-carotid angiography, 3- Wire insertion, 4- Filter deployment, 5- Pre-dilation, 6- Stent deployment, 7- Post-dilation, 8- Final angiography, 9- Post-procedure. Patients were monitored continuously with TCD to detect pre-procedural, intra-procedural and post-procedural MES rates. Results: Intraplaque hemorrhage was observed in 18 patients (60%). Patients with intra plaque hemorrhage had more MES during carotid artery dissection/arch-carotid angiography (p=0.028) and IC clamping/wire insertion (p=0.009) compared to patients without intra plaque hemorrhage in the pre-procedural stage. Conclusions: Carotid plaques with intra plaque hemorrhage is associated with higher MES during carotid artery revascularization procedures.

Abstract 17381: Relationship Between Amaurosis Fugax and Intraplaque Hemorrhage in Patient With Carotid Plaques

Introduction: The term amaurosis fugax is often used interchangeably to describe transient visual loss. However, it is employed widely in medicine to refer to any cause of transient monocular visual loss. Amaurosis fugax is associated with an imminent stroke and it could be linked to vascular thromboembolic events arising from the internal carotid arterial system. The aims of the study are to determine the plaque characteristics of patients who underwent carotid artery revascularization and the relationship of plaque characteristics with amaurosis fugax. Methods: Before elective carotid revascularization 44 patients (mean age 72±8 years; 25 males, 19 females) underwent 3-T MRI. After localization of the carotid bifurcation using phase contrast imaging, Time-of-Flight, 3D T1 weighting, transverse T1 and T2 weightings and proton density sequences were acquired. The different plaque components: lipid rich core, intraplaque hemorrhage, calcification and the characterization of the fibrous cap were assessed. Results: Carotid plaque samples had the following characteristics: Intraplaque hemorrhage (59%), surface defects (38.6%), stable fibrous cap (27.3%), lipid rich necrotic core (18%), and calcifications (11.4%). Amaurosis fugax history was identified in 7 patients (15.9%). Plaque samples from all 7 patients who had experienced amaurosis fugax revealed intraplaque hemorrhage. MRI revealed intraplaque hemorrhage in 19 (51%) patients without history of amaurosis fugax (p=0.016). The rest of the plaque characteristics did not show any statistically significant relationship with history of amaurosis fugax. Conclusions: This study demonstrated that intraplaque hemorrhage may be correlated to amaurosis fugax.

Abstract 11771: Validity of an Administrative Claims-Based Measure of Low-Value Carotid Revascularization

Introduction: Low value care is defined as care where harms or costs outweigh benefits. Researchers, payers, and policymakers commonly use administrative claims data to identify low-value care, but the validity of many claims-based algorithms has not been assessed. Research Question: What is the validity of a commonly-used claims-based algorithm to identify low-value carotid artery revascularization (CAR) procedures, compared to a reference standard of chart review? Methods: This was a retrospective cohort study of Medicare fee-for-service beneficiaries attributed to a large accountable care organization. We used administrative claims data linked to electronic health record data and identified all CAR procedures (endarterectomy or stenting) from 01/01/2020-12/31/2021. We excluded patients without claims history in the year prior to CAR. Using methods previously described by policymakers and researchers, we classified CAR as low-value by claims if patients did not have diagnosis codes for stroke, transient ischemic attack, or other neurologic symptoms such as vision changes or hemiplegia in the year prior to CAR. We then reviewed linked electronic health records to determine if cases were misclassified by the claims-based measure. Per recent guidelines, we classified CAR as low-value by chart review if it was performed in patients with less than 50% symptomatic stenosis or greater than 80% asymptomatic stenosis. Results: A total of 127 CAR cases (mean age 77 years; 63% men; 87% white) with complete electronic health record data were identified, and 48 (38%) were classified as low-value by the claims-based algorithm. Only 11 of the 48 cases classified as low-value by claims were confirmed to be low-value by chart review. The positive predictive value of the claims-based algorithm was 23%. Conclusions: A commonly-used claims-based measure to identify low-value CAR procedures had poor accuracy with a positive predictive value of 23%. Using administrative claims to identify low-value CAR procedures might overestimate the number of procedures considered to be low-value. This has implications for the current system of quality reporting, particularly when quality is tied to financial incentives.

Abstract 18999: Long-Term Risk of Stroke After Coronary Artery Bypass Surgery With Carotid Revascularization: A Randomized Controlled Trial

Introduction: In patients with carotid artery stenosis, combined coronary and carotid surgery has been widely used despite lack of evidence from randomized trials. Moreover, there are no data on long-term outcome following carotid revascularization versus best medical treatment. Hypothesis: May simultaneous coronary artery bypass grafting (CABG) and carotid endarterectomy (CEA) prevent the long-term risk of stroke? Methods: In the Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis (CABACS) trial, patients with coronary disease and high-grade carotid stenosis (NASCET &gt;=70%) were randomized to receive combined simultaneous CABG+CEA or CABG alone. Primary endpoint was the composite rate of non-fatal stroke or death within 30 days after surgery, with both treatments assumed to be equally safe and efficacious. Secondary endpoints included any stroke, stroke or vascular death and death of any cause, and follow-up was five years. While our previous report focused on primary outcome, here we evaluate the long-term results of the trial. Results: The trial was terminated prematurely after recruitment of 129 patients in 17 centers in Germany and the Czech Republic. The rate of stroke or death at 30 days was not significantly different following combined CABG+CEA and CABG alone (18.5% (95% confidence interval [95% CI]: 0.099-0.300) versus 9.7% (95% CI: 0.036-0.199), p=0.203). By 5 years, stroke or death rate was 40.6% (95% CI: 0.285-0.536) following CABG+CEA and 35.0% (95% CI: 0.231-0.484) following CABG alone (p=0.581). Strokes of any kind tended to occur more frequently after CABG+CEA (5 years: 29.4% vs. 18.8%, p=0.245), while death rate was similar in both treatment arms (25.4% vs 23.3% (p=0.837). Subgroup analysis revealed no significant effect of center on outcomes. Conclusions: Long-term risk of stroke or death was higher after combined CABG+CEA, mainly due to increased perioperative event rates. Because of minor power, further trials are warranted to confirm our results.

Abstract 16929: Defining Thresholds for Meaningful 30-day Health Status Changes Following Transfemoral Carotid Artery Stenting

Introduction: Carotid artery stenosis treatment trials have focused on clinical endpoints such as stroke, death, and MI, but evidence of carotid revascularization’s impact on health status is limited. This study aims to establish minimal clinically important differences (MCIDs) to assess clinical improvement or worsening from the perspectives of patients with carotid artery stenosis undergoing transfemoral carotid artery stenting (TF-CAS). Methods: We studied patients in the multicenter Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) registry who underwent TF-CAS between 2010 and 2014 and who completed either the EQ-5D-3L or SF-36, two generic health-related quality-of-life surveys. Distribution-based MCIDs were calculated as 0.5 standard deviations for 30-day changes in health status scores post-TF-CAS for the EQ-5D-3L index value and visual analog scale (VAS) subscales and the SF-36 mental and physical component summary (MCS and PCS) subscales. We then stratified this analysis by symptom status (presence or abscence of prior stroke or TIA). Results: The study included 3,930 patients (27.7% symptomatic) who completed the EQ-5D-3L and 3,018 (30.5% symptomatic) who completed the SF-36. The MCIDs for the overall cohorts were 0.09, 11.02, 4.73, and 5.39 for the EQ-5D-3L index value, EQ-5D-3L VAS, SF-36 MCS, and SF-36 PCS, respectively. All MCIDs are summarized in Table 1. The MCIDs for each subscale were similar between asymptomatic and symptomatic subpopulations. Conclusions: Distribution-based thresholds for improvement and worsening of health status in patients undergoing TF-CAS were established for commonly-used generic health status instruments. These reference values can be used in both symptomatic and asymptomatic disease and will be important for interpreting future trial results focusing on the benefit of TF-CAS from patients’ perspectives.

Abstract 116: Reversal of Acute Ocular Ischemic Syndrome Following Rescue Carotid Revascularization: A Case Report

Introduction Ocular ischemic syndrome (OIS) is a rare, vision‐threatening condition resulting from severe carotid artery disease secondary to severe atherosclerosis or arteritis. Common clinical features include acute/subacute to gradual vision loss, ocular pain, amaurosis fugax, photophobia and diplopia. We are presenting a case of acute ocular ischemic syndrome secondary to acute re‐occlusion of the right internal carotid artery (RICA) post Carotid Endarterectomy (CEA), that reversed with carotid revascularization. Methods Case Summary: 59‐year‐old male with history of T2DM, hyperlipidemia, tobacco use presented to an outside hospital with complaints of dizziness, blurry vision, left upper extremity weakness and multiple falls with head trauma. Exam revealed left lower quadrantanopia, mild left arm weakness and left hemineglect. Computed Tomography (CT) Head showed scattered right middle cerebral artery (MCA) territory infarcts. CT Angiography (CTA) revealed ulcerated plaque with a small focus of thrombus intraluminally in the RICA. Subsequently, the patient was initiated on heparin infusion and underwent CEA. On postoperative day (POD) 2, the patient experienced severe stabbing right eye pain with reduced visual acuity and worsening of left arm weakness. Imaging revealed complete occlusion of the right common carotid artery (RCCA). Perfusion imaging did not reveal a core or a penumbra. Given acute loss of vision likely secondary to ocular ischemic syndrome, decision was taken to proceed with rescue stenting. Using a transfemoral approach, an 8‐French balloon guide catheter was advanced into the proximal RCCA. A primary suction thrombectomy was performed under proximal flow arrest. After achieving a complete recanalization in one pass, we started the patient on cangrelor 30 mcg/kg intravenous bolus followed by 4 mcg/kg/min infusion. Post bolus, we placed a tandem closed‐cell carotid stent measuring 8x36mm &amp; 10x37mm. The patient reported immediate relief of ocular pain, vision and weakness following the procedure. He transitioned from cangrelor infusion to ticagrelor 90 mg twice daily and aspirin 81 mg daily. On post‐stenting day 7, the patient experienced acute onset headache, and imaging revealed re‐occlusion of the entire carotid artery sparing only the ophthalmic segment of the RICA which now filled retrograde via anterior communicating artery (AcoA) from the contralateral carotid artery. However, his visual acuity remained unchanged and reported no ocular pain. At one month follow‐up the patient remains symptom‐free. Results Discussion: Incidence of OIS is estimated to be 7.5 cases per million every year. Carotid artery atherosclerosis is the most common etiology. Majority of OIS (∼90%) present with gradual vision loss and approximately 40% present with ocular pain. Gradual vision loss is predominantly related to chronic ocular hypoperfusion and resultant iris neovascularization and glaucoma. In this case, patient suffered acute vision loss secondary to acute ICA occlusion following CEA. Emergent carotid revascularization resulted in restoration of vision and resolution of ocular pain. Conclusion Our main goal is to emphasize the importance of rescue stenting to address symptoms of aOIS. Immediately post‐stenting, there was remarkable improvement in ocular pain and visual acuity. Although, the carotid re‐occluded within seven days post‐stenting, we hypothesize that gradual re‐occlusion while on DAPT provided enough time recruit and preserve collaterals into the right ophthalmic artery via retrograde flow into the ophthalmic segment of RICA from the contralateral carotid artery via the AcoA which was subsequently confirmed on imaging.

Vascular surgery study of the CGuard MicroNet-covered stent in patients with indication to carotid revascularization: POLGUARD.

In a recent randomized study, MicroNet-covered stent (CGuard) significantly reduced procedural and post-procedural cerebral embolism in relation to a single-layer CREST study carotid stent, but real-life clinical practice data are limited. The aim is to prospectively assess clinical outcomes of CGuard as a routine revascularization tool for patients with indication to carotid revascularization. From April 2019 to November 2021, 204 elective patients (age 71.0±7.1years, 69.6% males, 21.7% symptomatic) were enrolled. Mean basal peak-systolic velocity was 251.41±91.85 cm/s with angiographic diameter stenosis 89.7±8.46%. About 34.4% lesions were severely calcified, 6.8% were angulated, and 4.4% showed significant access tortuosity. Access was femoral, with 100% protection device (filter) use. Two hundred and three lesions in 203 patients were treated (1 cross-over to surgery for lack of effective access, no cross-over to other devices); in most cases (66.9%) the stent was placed directly. For pre-dilated lesions, mean balloon diameter was 3.36±0.34mm. Mean nominal stent diameter was 7.64±0.5 mm; length was 37.19±4.5 mm. All stents were post-dilated (balloon diameter 5.2±0.25 mm). Residual stenosis was <30% in all (3.77±6.91%). By discharge, there were 2 minor strokes (0.9%) and one transient ischemic attack. By 30-days, one other minor stroke occurred in relation to de-novo atrial fibrillation. With no deaths or myocardial infarctions, 30-day total death/stroke/myocardial infarction rate was 1.48%. No in-stent thrombosis or patency loss occurred by 30-days. In-stent peak-systolic velocity was 55.49±22.73 cm/s. Thirty-day results from POLGUARD study indicate safety and a low complication rate of the MicroNet-covered carotid stent use in every-day vascular surgery practice of carotid revascularization. Long-term observation is underway.

The Effect of Ipsilateral Carotid Revascularization on Contralateral Carotid Duplex Parameters in Patients with Bilateral Carotid Stenosis

Duplex-derived velocity measurements are often used to determine the need for carotid revascularization. There is evidence that severe ipsilateral carotid stenosis can cause artificially elevated velocities in the contralateral carotid artery, which may decrease following ipsilateral revascularization. The objective of this study was to determine if contralateral carotid artery duplex velocities decrease following ipsilateral carotid endarterectomy or stenting procedures. This is a single institutional retrospective study of prospectively collected data on all patients who underwent carotid revascularization from 2013 to 2021. Patients with immediate preoperative and first postoperative Duplex scan within 4months of carotid revascularization at our vascular laboratory were included for analysis. Patients with contralateral occlusion were excluded. Duplex criteria used to define moderate (50-69%) and severe (>70%) stenosis were systolic velocity ≥125cm/sec and ≥230cm/sec, respectively. Between 2013 and 2021, 129 patients with bilateral carotid stenosis underwent either carotid endarterectomy (98) or a stenting procedure (31). The majority of patients (90%) underwent intervention for severe stenosis. Preoperatively, the contralateral artery was categorized as severe in 30.4% patients. After ipsilateral carotid revascularization, 86 patients (67.2%) saw a decrease in the contralateral artery peak systolic velocity (PSV), while the remaining remained stable or increased. Fifty-four patients had a change in designated stenosis severity in the contralateral artery. Between the carotid endarterectomy and stenting cohorts, there was no significant difference in the proportion of patients whose contralateral velocity decreased (69.4% vs. 61.3%, P=0.402). Patients with coronary artery disease and diabetes were significantly less likely to experience a decrease in the contralateral artery PSV after ipsilateral intervention (P=0.018 and P=0.033). In patients with bilateral carotid disease, ipsilateral revascularization can change the contralateral artery velocity and perceived disease severity. Most patients were noted to have a decrease in the contralateral artery PSV, although almost one-third either stayed stable or increased. On multivariable analysis, patients with coronary artery disease and diabetes were less likely to see a decrease in the contralateral artery PSV after intervention. Patients who are at risk for artificial elevation of the contralateral artery may warrant a re-evaluation of the contralateral artery after ipsilateral intervention. These patients are potentially better assessed with axial imaging, although further research is needed.

Outcomes following carotid revascularization for stroke stratified by Modified Rankin Scale and time of intervention

ObjectivesThe relationship between baseline Modified Rankin Scale (mRS) in patients with prior stroke and optimal timing of carotid revascularization is unclear. Therefore, we evaluated the timing of transfemoral carotid artery stenting (tfCAS), transcarotid artery revascularization (TCAR), and carotid endarterectomy (CEA) after prior stroke, stratified by preoperative mRS. MethodsWe identified patients with recent stroke who underwent tfCAS, TCAR, or CEA between 2012 and 2021. Patients were stratified by preoperative mRS (0-1, 2, 3-4, or 5) and days from symptom onset to intervention (time to intervention; ≤2 days, 3-14 days, 15-90 days, and 91-180 days). First, we performed univariate analyses comparing in-hospital outcomes between separate mRS or time-to-intervention cohorts for all carotid intervention methods. Afterward, multivariable logistic regression was used to adjust for demographics and comorbidities across groups, and outcomes between the various intervention methods were compared. Primary outcome was the in-hospital stroke/death rate. ResultsWe identified 4260 patients who underwent tfCAS, 3130 patients who underwent TCAR, and 20,012 patients who underwent CEA. Patients were most likely to have minimal disability (mRS, 0-1 [61%]) and least likely to have severe disability (mRS, 5 [1.5%]). Patients most often underwent revascularization in 3 to 14 days (45%). Across all intervention methods, increasing preoperative mRS was associated with higher procedural in-hospital stroke/death (all P < .03), whereas increasing time to intervention was associated with lower stroke/death rates (all P < .01). After adjustment for demographics and comorbidities, undergoing tfCAS was associated with higher stroke/death compared with undergoing CEA (adjusted odds ratio, 1.6; 95% confidence interval, 1.3-1.9; P < .01) or undergoing TCAR (adjusted odds ratio, 1.3; 95% confidence interval, 1.0-1.8; P = .03). ConclusionsIn patients with preoperative stroke, optimal timing for carotid revascularization varies with stroke severity. Increasing preoperative mRS was associated with higher procedural in-hospital stroke/death rates, whereas increasing time to-intervention was associated with lower stroke/death rates. Overall, patients undergoing CEA were associated with lower in-hospital stroke/deaths. To determine benefit for delayed intervention, these results should be weighed against the risk of recurrent stroke during the interval before intervention.

Effect of Perioperative Stroke on Survival After Carotid Intervention.

Perioperative stroke is the most dreaded complication of carotid artery interventions and can severely affect patients' quality of life. This study evaluated the impact of this event on mortality for patients undergoing interventional treatment of carotid artery stenosis with three different modalities. Patients undergoing carotid revascularization at participating Memorial Hermann Health System facilities were captured from 2003-2022. These patients were treated with either carotid endarterectomy (CEA), transfemoral carotid stenting (TF-CAS), or transcarotid artery revascularization (TCAR). Perioperative outcomes, including stroke and mortality, as well as follow-up survival data at 6-month intervals, were analyzed and stratified per treatment modality. Of the 1681 carotid revascularization patients identified, 992 underwent CEA (59.0%), 524 underwent TCAR (31.2%), and 165 underwent TF-CAS (9.8%). The incidence of stroke was 2.1% (CEA 2.1%, TCAR 1.7%, and TF-CAS 3.6%; P = .326). The perioperative (30-day) death rate was 2.1% (n = 36). The perioperative death rate was higher in patients who suffered from an intraoperative stroke than in those who did not (8.3% vs 1.9%, P = .007). Perioperative death was also different between CEA, TCAR, and TF-CAS for patients who had an intraoperative stroke (.0% vs 33.3% vs .0%, P = .05). TCAR patients were likely to be older (P < .001), have a higher body mass index (P < .001), and have diabetes mellitus (P < .001). Patients who suffered from an intraoperative stroke were more likely to have a symptomatic carotid lesion (58.3% vs 28.8%, P < .001). The TCAR group had a significantly lower survival at 6months and 12months when compared to the other two groups (64.9% vs 100% P = .007). Perioperative stroke during carotid interventions significantly impacts early patient survival with otherwise no apparent change in mid-term outcomes at 5years. This difference appears to be even more significant in patients undergoing TCAR, possibly due to their baseline higher-risk profile and lower functional reserve.

Patients with Prior Exposure to a Combination of Statins & Angiotensin-Converting Enzyme Inhibitors (ACE-Is)/Angiotensin Receptor Blockers (ARBs) Have Better Outcomes after Carotid Revascularization than Patients with Prior Exposure to Statins Alone: A MultiCenter Analysis

Statin use has been studied and confirmed to have a beneficial impact on perioperative carotid endarterectomy (CEA) and carotid artery stenting (CAS) outcomes. The benefits of Angiotensin-converting enzyme inhibitors (ACE-I) in hypertension, ischemic heart disease, heart failure, diabetes mellitus, and renal disease are well-known; however, the impact of continuing or withholding ACE-Is/angiotensin receptor blockers (ARBs) on CEA and CAS outcomes is not addressed well in the literature. This study aimed to evaluate the impact of preoperative statin use combined with ACE-Is/ARBs in patients undergoing CEA or CAS on mortality and morbidity using a multi-institutional database. Using the data of all patients who underwent carotid artery revascularization, including CEA, transcarotid artery revascularization, and transfemoral carotid artery stenting from 2016 to 2021 in the Vascular Quality Initiative data, we determined as our primary outcome 30-day mortality/stroke after carotid revascularization based on periop exposure to statins alone, or the combination of statins and ACE-Is/ARBs. Secondary outcomes were postop myocardial infarction and postop congestive heart failure. Poisson regression with robust variance was used to determine postop outcomes comparing the combination of statin and ACE-Is/ARBs group with statins alone group. A total of 131,285 patients were included in the study, with 59,860 (46%) patients receiving statin only, and 71,425 (54%) receiving both statin and ACE-Is/ARBs preoperatively. Both patient groups differed significantly in preop clinical and demographic characteristics. After adjusting for potential confounders, the statins plus ACE-I/ARB group had a 12% lower risk of postop mortality/stroke (Incident Rate Ratio comparing Statin/ACE group to Statins Only group [IRR] 0.88, 95% confidence interval 0.81-0.95, P=0.001), 18% lower risk of postop congestive heart failure (IRR 0.82, 95% CI 0.68-0.98, P=0.029), and similar risk of postop myocardial infarction (IRR 1.05 95% confidence interval 0.91-1.20, P=0.54) compared to the statin-only group. Statins combined with ACE-Is/ARBs perioperatively offer better protection compared to statins alone in patients undergoing carotid revascularization surgery. We recommend the continuation of ACE-Is/ARBs use in patients undergoing carotid revascularization, especially if they have concurrent hypertension. Further prospective studies are needed to evaluate the benefit of adding ACE-Is/ARBs.

Echogenicity of carotid atherosclerotic plaques as a predictor of adverse cardiovascular events in patients aged 40–64: prospective study

INTRODUCTION: Noninvasive assessment of carotid atherosclerotic plaque (CAP) morphology represents a promising direction, allowing to optimize not only cardiovascular event risk assessment, but also the selection of patients for carotid revascularization. Determination of CAP echogenicity by means of GSM-analysis can be used as part of multiparametric assessment of CAP instability and prediction of adverse cardiovascular events.OBJECTIVE: To assess the predictive value of echogenicity of carotid atherosclerotic plaques in relation to the development of adverse cardiovascular events in patients 40–64 years old.MATERIALS AND METHODS: The study included 191 patients with carotid atherosclerosis aged 40–64 years. All patients underwent duplex scanning of the arteries of the carotid basin with determination of the echogenicity of carotid ASBs. The combined end point (CEP) consisted of the following possible events: nonfatal myocardial infarction or unstable angina, nonfatal stroke, coronary revascularization or peripheral artery revascularization, and death from cardiovascular causes. Data on the onset of CVD were collected during follow-up visits and using medical information systems. Statistics: Data were analyzed using MedCalc software (version 20.216). Frequencies and percentages were used to describe nominal data, and medians and quartiles were used for quantitative data. The Kaplan-Meier survival analysis method was used to estimate the probability of events constituting the combined endpoint. Cox regression analysis was used to estimate the risk of the event and the influence of independent variables on the risk.RESULTS: By correlation analysis, carotid AP echogenicity (GSM) was inversely correlated with BMI (r=-0,355; p&lt;0,0001), waist circumference (r=-0.37; p&lt;0.0001), triglyceride levels (r=-0.163; p=0.027), uric acid (r=-0.188; p=0.028). The duration of the follow-up period was 15.1 (12.2; 22.9) months. Events constituting CEP occurred in 15 (7.85%) patients: nonfatal myocardial infarction in 2 (1.05%) patients, nonfatal stroke in 2 (1.05%) patients, myocardial revascularization in 6 (3.14%) patients, unstable angina in 5 (2.61%) patients. The presence of carotid AP with echogenicity ≤39 conventional units allowed predicting the development of events constituting CEP with sensitivity of 53.3% and specificity of 80.7%. Kaplan-Meier survivalanalysis revealed that cumulative survival of patients with carotid AP with echogenicity ≤39 conventional units was statistically significantly lower compared to patients with carotid ASB with echogenicity &gt;39 conventional units.DISCUSSION: It should be noted that in the presented study, decreased echogenicity of carotid AP was associated with the risk of adverse cardiovascular events only in the simple and sex- and age-adjusted models, but not in the full-adjusted model. It is likely that this may be due to the fact that the echogenicity of CAP is closely related to the cumulative burden of cardiovascular risk factors, which has been shown in earlier studies including. Probably, combined assessment of carotid atherosclerosis burden and morphological features of CAP may be the most promising approach to obtain additional prognostic information in patients with carotid atherosclerosis.CONCLUSION: Among patients with carotid atherosclerosis 40–64 years old, the presence of ACS with echogenicity ≤39 conventional units was associated with a 3.44 (95% CI 1.19–9.91) fold increase in the relative risk of events constituting the combined endpoint after adjusting for sex and age.