Feasibility and Intermediate Results of Transcarotid Revascularization with a Prosthetic Conduit.

BACKGROUND: Transcarotid artery revascularization (TCAR) is a hybrid technique with excellent initial outcomes. The technical success and safety of TCAR is heavily dependent on an anatomically suitable common carotid artery (CCA). Many patients do not meet anatomic criteria and therefore are not eligible for this therapy. We sought to extend the eligibility of TCAR to patients with unfavorable CCA anatomy via the adoption of a prosthetic arterial conduit. METHODS: A single-center retrospective study of patients with critical carotid artery stenosis who underwent TCAR via a prosthetic conduit between June 2019 and October 2021 was performed. All patients in the study were considered high-risk for carotid endarterectomy based on anatomic features, such as restenosis post-carotid endarterectomy and neck radiation. Unfavorable CCA anatomy was defined as a clavicle to carotid bifurcation distance <5 cm, a CCA diameter <6 mm, and/or significant atherosclerotic disease at the intended arterial access site. The primary outcome of interest was technical success. Secondary outcomes included perioperative complications, intermediate and long-term patency, intermediate and long-term stroke and/or mortality and in-hospital length of stay. Follow-up ranged from 1 to 29 months. RESULTS: Eight patients underwent 10 TCAR procedures via a prosthetic conduit. A total of 2 procedures (20%) were performed on female patients and 8 procedures (75%) were performed on male patients. The mean age was 65 years old (standard deviation 11 years). Technical success was 100%. The 30-day ipsilateral stroke rate was 0%. The 30-day patency was 90%. There was no re-exploration for hemorrhage and 30 day mortality was 0%. CONCLUSIONS: TCAR is an excellent option for carotid artery revascularization. Unfavorable CCA anatomy has limited its applicability. TCAR via a prosthetic conduit has the potential to expand eligibility for this promising therapy.

Outcomes of Transcarotid Artery Revascularization Stratified by Institutional Designation: Academic Versus Community Hospitals.

BACKGROUND: The extent of practice setting's influence on transcarotid artery revascularization (TCAR) outcomes is not yet established. This study seeks to assess and compare TCAR outcomes in academic and community-based healthcare settings. METHODS: Retrospective review of prospectively maintained, systemwide TCAR databases from 2 institutions was performed between 2015 and 2022. Patients were stratified based on the setting of surgical intervention (i.e., academic or community-based hospitals). Relevant demographics, medical conditions, anatomic characteristics, intraoperative and postoperative courses, and adverse events were captured for multivariate analysis. RESULTS: We identified 973 patients who underwent TCAR, 570 (58.6%) were performed at academic and 403 (41.4%) at community-based hospitals. An academic facility was defined as a designated teaching hospital with 24/7 service-line coverage by a trainee-led surgical team. Baseline comorbidity between cohorts were similar but cases performed at academic institutions were associated with increased complexity, defined by high cervical stenosis (P < 0.001), prior dissection (P < 0.01), and prior neck radiation (P < 0.001). Intraoperatively, academic hospitals were associated with longer operative time (67 min vs. 58 min, P < 0.001), higher blood loss (55 mLs vs. 37 mLs, P < 0.001), and longer flow reversal time (9.5 min vs. 8.4 min, P < 0.05). Technical success rate was not statistically different. In the 30-day perioperative period, we observed no significant difference with respect to reintervention (1.5% vs. 1.5%, P ≥ 0.9) or ipsilateral stroke (2.7% vs. 2.0%, P = 0.51). Additionally, no difference in postoperative myocardial infarction (academic 0.7% vs. community 0.2%, P < 0.32), death (academic 1.9% vs. community 1.4%, P < 0.57), or length of stay (1 day vs. 1 day, P < 0.62) was seen between the cohorts. CONCLUSIONS: Cases performed at academic centers were characterized by more challenging anatomy, more frequent cardiovascular risk factors, and less efficient intraoperative variables, potentially attributable to case complexity and trainee involvement. However, there were no differences in perioperative outcomes and adverse events between the cohorts, suggesting TCAR can be safely performed regardless of practice setting.

Restenosis rates in patients with ipsilateral carotid endarterectomy and contralateral carotid artery stenting.

PURPOSE: We aimed to evaluate the long-term outcome of carotid endarterectomy (CEA) and carotid artery stenting (CAS) in patients who underwent both procedures on different sides. METHODS: In this single-center retrospective study (2001-2019), 117 patients (men, N = 78; median age at CEA, 64.4 [interquartile range {IQR}, 57.8-72.2] years; median age at CAS, 68.8 [IQR, 61.0-76.0] years) with ≥50% internal carotid artery stenosis who had CEA on one side and CAS on the other side were included. The risk of restenosis was estimated by treatment adjusted for patient and lesion characteristics. RESULTS: Neurological symptoms were significantly more common (41.9% vs 16.2%, P<0.001) and patients had a significantly shorter mean duration of smoking (30.2 [standard deviation {SD}, 22.2] years vs 31.8 [SD, 23.4] years, P<0.001), hypertension (10.1 [SD, 9.8] years vs 13.4 [SD, 9.1] years, P<0.001), hyperlipidemia (3.6 [SD, 6.6] years vs 5.0 [SD, 7.3] years, P = 0.001), and diabetes mellitus (3.9 [SD, 6.9] years vs 5.7 [SD, 8.9] years, P<0.001) before CEA compared to those before CAS. While the prevalence of heavily calcified stenoses on the operated side (25.6% vs 6.8%, P<0.001), the incidence of predominantly echogenic/echogenic plaques (53.0% vs 70.1%, P = 0.011) and suprabulbar lesions (1.7% vs 22.2%, P<0.001) on the stented side was significantly higher. Restenosis rates were 10.4% at 1 year, 22.3% at 5 years, and 33.7% at the end of the follow-up (at 11 years) for CEA, while these were 11.4%, 14.7%, and 17.2%, respectively, for CAS. Cox regression analysis revealed a significantly higher risk of restenosis (hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.05-3.10; P = 0.030) for CEA compared to that for CAS. After adjusting for relevant confounding factors (smoking, hypertension, diabetes mellitus, calcification severity, plaque echogenicity, and lesion location), the estimate effect size materially did not change, although it did not remain statistically significant (HR, 1.85; 95% CI, 0.95-3.60; P = 0.070). CONCLUSION: Intra-patient comparison of CEA and CAS in terms of restenosis tilts the balance toward CAS.

Choice of antithrombotic therapy for patients with atrial fibrillation undergoing carotid angioplasty and stenting: a nationwide population-based study.

Nonvalvular atrial fibrillation (NVAF) and carotid stenosis are important risk factors for stroke. Carotid angioplasty and stent placement (CAS) is recommended for patients with symptomatic high-grade carotid stenosis. The optimal medical management for patients with NVAF after CAS remains unclear. We aimed to clarify this issue using real-world data from the Taiwanese National Health Insurance Research Database (NHIRD). In total, 2116 consecutive NVAF patients who received CAS between January 1, 2010, and December 31, 2016, from NHIRD were divided into groups based on post-procedure medication as follows: only antiplatelet agent (OAP, n = 587); only anticoagulation agent (OAC, n = 477); dual antiplatelet agents (DAP, n = 49); and a combination of antiplatelet and anticoagulation agents (CAPAC, n = 304). Mortality, vascular events, and major bleeding episodes were compared after matching with the Charlson comorbidity index and CHA2DS2-VASc score. The CAPAC and the OAC groups had lower mortality rates than the OAP group (P = 0.0219), with no statistical differences in major bleeding, ischemic stroke, or vascular events. Conclusively, OAC therapy after CAS appears suitable for NVAF patients. CAPAC therapy might be considered as initial therapy or when there is concern about vascular events.

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

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

Differences in Perioperative Outcomes after Carotid Revascularization between White and Non-white Patients.

BACKGROUND: Racial disparities in carotid endarterectomy (CEA) and carotid artery stenting (CAS) continue to persist. We aimed to provide a large-scale analysis of racial disparities in perioperative outcomes of carotid revascularization in a nationally representative cohort of patients, with sub-analyses stratifying by procedure type and symptomatic status. METHODS: We studied all patients undergoing carotid revascularization between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Database. Univariate methods were used to compare patients' demographic and medical characteristics. Multivariable logistic regression analysis was used to compare adjusted perioperative outcomes between white patients (WP) and non-white patients (NWP). Sub-analysis was performed stratifying by method of revascularization and symptomatic status. RESULTS: A total of 31,356 carotid revascularizations were performed in 26,550 (84.7%) white patients and 4,806 (15.3%) non-white patients. On adjusted analysis, NWP had increased odds of stroke (OR:1.2, 95%CI:1.1-1.5, P = 0.0496), unplanned return to the OR (OR:1.4, 95%CI:1.1-1.6, P < 0.001) and restenosis (OR:2.6, 95%CI:1.7-3.9, P < 0.001). On sub-analysis, NWP undergoing CAS had increased odds of stroke/death (OR:2.2, 95%CI:1.1-4.3, P = 0.025), stroke (OR:2.9, 95%CI:1.3-6.0, P = 0.007), and stroke/TIA (OR:2.1, 95%CI:1.0-4.2, P = 0.025). NWP undergoing CEA had increased odds of unplanned return to the OR (OR:1.4, 95%CI:1.2-1.6, P < 0.001) and restenosis (OR:2.7, 95%CI:1.7-4.0, P < 0.001). CONCLUSION: NWP had higher rates of 30-day stroke, driven primarily by higher rates of perioperative stroke/death in NWP undergoing CAS. NWP undergoing CEA did not have higher rates of stroke/death after adjusted analysis, although they had higher rates of unplanned return to OR and restenosis. Upon stratification for symptomatic status, the stroke/death rate between NWP and WP was shown to be non-significant.

Contralateral Carotid Stenosis is a Predictor of Long-term Adverse Events in Carotid Endarterectomy.

Contralateral carotid stenosis (clCS) has been described as a perioperative predictor of mortality after carotid endarterectomy (CEA). However, its predictive value on long-term cardiovascular events remains controversial. The study aims to assess the potential role of clCS as a long-term predictor of major adverse cardiovascular events (MACE) in patients who underwent CEA. From January 2012 to July 2020, patients undergoing CEA under regional anesthesia for carotid stenosis in a tertiary care and referral center were eligible from a prospective database, and a post hoc analysis was performed. The primary outcome consisted in the occurrence of long-term MACE. Secondary outcomes included all-cause mortality, stroke, myocardial infarction, acute heart failure, and major adverse limb events. A total of 192 patients were enrolled. With a median 50 months follow-up, chronic kidney disease (CKD) (mean survival time (MST) 51.7 vs. 103.3, P < 0.010) and peripheral artery disease (PAD) (MST 75.1 vs. 90.3, P = 0.001) were associated with decreased survival time. After propensity score matching (PSM), CKD (MST 49.1 vs. 106.0, P = 0.001) and PAD (MST 75.7 vs. 94.0, P = 0.001) maintained this association. On multivariate Cox regression analysis, contralateral stenosis was associated with higher MACE (hazard ratio (HR) = 2.035; 95% CI: 1.113-3.722, P = 0.021 and all-cause mortality (HR = 2.564; 95% CI: 1.276-5,152 P = 0.008). After PSM, only all-cause mortality (HR 2.323; 95% CI: 0.993-5.431, P = 0.052) maintained a significant association with clCS. On multivariable analysis, clCS (aHR 2.367; 95% CI: 1.174-4.771, P = 0.016), age (aHR 1.039, 95% CI: 1.008-1.070), CKD (aHR 2.803; 95% CI: 1.409-5.575, P = 0.003) and PAD (aHR 3.225, 95% CI: 1.695-6.137, P < 0.001) were independently associated with increased all-cause mortality. Contrary to MACE, clCS is a strong predictor of long-term all-cause mortality after CEA. However, MACE risk may compromise CEA benefits by other competitive events. Therefore, further studies are needed to establish the role of clCS on postoperative events and on patients' specific assessments in order to determine the best medical treatment and easy access to surgical intervention.

Perioperative outcomes of carotid endarterectomy and transfemoral and transcervical carotid artery stenting in radiation-induced carotid lesions.

OBJECTIVE: Limited data are available to guide the choice of intervention for patients with radiation-induced carotid stenosis (RICS), either transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (TFCAS), or carotid endarterectomy (CEA). The purpose of the present study was to evaluate patients who had undergone these carotid artery interventions for RICS and the associated outcomes. METHODS: Patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) carotid artery stenting surveillance project registry and the SVS VQI CEA modules who had undergone carotid artery intervention (TCAR, TFCAS, or CEA) for RICS were included. Those aged >90 years and those with concomitant interventions (eg, coronary bypass) were excluded. A composite of death, myocardial infarction (MI), and stroke was the primary outcome. The secondary outcomes included death, MI, stroke, cranial nerve injury (CNI), and other local and systemic complications. Multivariable logistic regression controlling for presenting symptomatic status and comorbid medical conditions was conducted for the outcome variables, except for death, which was analyzed using Cox regression modeling. RESULTS: A total of 1927 patients with RICS had undergone CEA (n = 1172), TCAR (n = 253), or TFCAS (n = 502). The CEA group had a higher rate of diabetes (31% vs 25% for TCAR and 25% for TFCAS; P = .01), hypertension (85% vs 82% for TCAR and 79% for TFCAS; P < .01), and peripheral vascular disease (8% vs 4% for TCAR and 4% for TFCAS; P < .01). The TCAR and TFCAS groups had higher rates of coronary artery disease (21% for CEA vs 30% for TCAR and 29% for TFCAS; P < .01). The patients who had undergone TFCAS were more likely to have had symptomatic lesions (57% for TFCAS vs 47% for CEA and 41% for TCAR; P < .01) and prior stroke (55% for TFCAS vs 47% for CEA and 40% for TCAR; P < .001). The composite outcome occurred in 3.2% of TCAR patients, 11.2% of TFCAS patients, and 11.1% of CEA patients (P < .01) with an odds ratio of 0.27 for TCAR, 0.91 for TFCAS, and 1.00 for CEA. However, no differences in the individual outcomes were noted for any procedure. TCAR exhibited the lowest odds ratio for CNI (0.15) compared with TFCAS at 0.9, both relative to CEA (P = .03). CONCLUSIONS: RICS patients treated by TCAR in the SVS VQI had the lowest risk of the composite of stroke, death, and MI and CNI. Therefore, TCAR might be the preferred treatment modality. Further comparative studies are needed to evaluate the long-term outcomes in this population and to elucidate the relationship of these procedures to the individual outcomes of stroke, MI, and death.

Role of risk scoring systems in predicting life expectancy after carotid endarterectomy in asymptomatic patients.

OBJECTIVE: The aim of this study is to compare and to test the performance of all available risk scoring systems (RSSs) designed to predict long-term survival rate in asymptomatic candidate patients for carotid endarterectomy (CEA) for significant carotid artery stenosis. METHODS: Data on asymptomatic patients who underwent CEA in three high-volume centers were prospectively recorded. Through literature research using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations, six RSSs were identified for the intent of the study. Primary endpoints were 3- and 5-year survival rates after CEA. All items used as variables to compose multiple RSSs were applied to every patient in the study population. The 3- and 5-year mortality prediction rates for each score were assessed by sensitivity, specificity, and predictive negative and positive value calculation, as well as univariable Cox proportional hazard models with the Harrell C index. RESULTS: During the study period, 825 CEAs in 825 asymptomatic patients were analyzed. All items used in RSSs were available in the dataset, with some concerns regarding their definition and application among RSSs. The 3- and 5-year survival rates of the study cohort were 94.5% and 90.3%, respectively. Among the six RSSs analyzed, no RSS demonstrated optimal results in terms of mortality rate prediction accuracy, although some scores had good diagnostic and risk of death precision. CONCLUSIONS: RSSs, when used alone, fail to optimally detect postoperative life expectancy in asymptomatic CEA patient candidates. Further prospective controlled studies are needed to compose and validate RSSs with better calibration to predict outcomes.

A Systematic Review and Meta-analysis of Peri-Procedural Outcomes in Patients Undergoing Carotid Interventions Following Thrombolysis.

OBJECTIVE: To evaluate the safety of carotid artery stenting (CAS) and carotid endarterectomy (CEA) after thrombolytic therapy (TT). DATA SOURCES: Medline, Scopus, and Cochrane databases. REVIEW METHODS: Systematic review and meta-analysis of studies involving patients who underwent CEA/CAS after TT. RESULTS: In 25 studies (n = 147 810 patients), 2 557 underwent CEA (n = 2 076) or CAS (n = 481) following TT. After CEA, the pooled peri-procedural stroke/death rate was 5.2% (95% confidence interval [CI] 3.3 - 7.5) and intracranial haemorrhage (ICH) was 3.4% (95% CI 1.7 - 5.6). After CAS, the pooled peri-procedural stroke/death rate was 14.9% (95% CI 11.9 - 18.2) and ICH was 5.5% (95% CI 3.7 - 7.7). In case control studies comparing CEA outcomes in patients receiving TT vs. no TT, peri-procedural death/stroke was non-significantly higher after TT (4.3% vs. 1.5%; odds ratio [OR] 2.34, 95% CI 0.74 - 7.47), but ICH was significantly higher after TT (2.2% vs. 0.12%; OR 7.82, 95% CI 4.07 - 15.02), as was local haematoma formation (3.6% vs. 2.26%; OR 1.17, 95% CI 1.17 - 2.33). In case control studies comparing CAS outcomes in patients receiving TT vs. no TT, peri-procedural stroke/death was significantly higher after TT (5.2% vs. 1.5%; OR 8.49, 95% CI 2.12 - 33.95) as was ICH (5.4% vs. 0.7%; OR 7.48, 95% CI 4.69 - 11.92). Meta-regression analysis demonstrated an inverse association between the time interval from intravenous (IV) TT to undergoing CEA and the risk of peri-procedural stroke/death (p = .032). Peri-operative stroke/death was 13.0% when CEA was performed three days after TT and 10.6% when performed four days after TT, with the risk reducing to within the currently accepted 6% threshold after six-seven days had elapsed. CONCLUSION: Peri-procedural ICH and local haematoma were significantly more frequent in patients undergoing CEA after TT (vs. no TT), although there were no randomised comparisons. Peri-procedural hazards were also significantly higher for CAS after TT. The inverse relationship between timing to CEA and peri-procedural stroke/death mandates careful patient selection and suggests that it may be safer to defer CEA for six-seven days after TT.

The Predictive Role of a Novel Risk Index in Patients Undergoing Carotid Artery Stenting: Systemic Immune-Inflammation Index.

BACKGROUND: Inflammatory mechanisms play an important role in both atherosclerosis and stroke. There are several inflammatory peripheral blood count markers associated with carotid artery stenosis degree, symptomatic carotid artery lesions and carotid artery stent restenosis that reported in previous studies. However, the prognostic role of the blood cell counts and their ratios in predicting in-hospital and long-term outcomes in patients undergoing carotid artery stenting (CAS) has not been comprehensively investigated. Systemic immune-inflammation index (SII) proved its' efficiency in patients with solid tumors and its' role was rarely examined in cardiovascular disorders and stroke. The current study evaluated the effect of this novel risk index on in-hospital and long-term outcomes in a large patient population who underwent CAS. METHOD: A total of 732 patients with carotid artery stenosis who underwent CAS were enrolled to the study. SII was calculated using the following formula: neutrophil-to-lymphocyte ratio × total platelet count in the peripheral blood (per mm3) and the patients were stratified accordingly: T1, T2 and T3. In-hospital and 5-year outcomes were compared between the tertiles of SII. RESULTS: During the hospitalization, major stroke, ipsilateral stoke, myocardial infarction, death and major adverse cardiovascular events (MACE) rates were significantly higher in high SII level (T3) compared to SII levels (T1 and 2). In long-term outcomes, ipsilateral stroke, major stroke, transient ischemic attack, death, and MACE were significantly higher in the patients with higher SII level (T3). The 5-year Kaplan-Meier overall survival for T1, T2, and T3 were 97.5%, 96.7% and 86.0% respectively. In-hospital and 5-year regression analyses demonstrated that high SII was independently associated with MACE and mortality. CONCLUSION: SII was independently associated with in-hospital and long-term clinical outcomes in patients undergoing CAS. Immune and inflammation status, as assessed easily and quickly using SII, has a good discriminative value in these patients.

Early outcomes of routine delayed shunting in carotid endarterectomy for symptomatic patients.

BACKGROUND: The role of shunting during carotid endarterectomy (CEA) in symptomatic patients is unclear. The aim was to evaluate early outcomes of CEA with routine "delayed" shunt insertion, for patients with symptomatic carotid stenosis. METHODS: We conducted a single-center retrospective study of symptomatic patients undergoing CEA (2009-2020). All CEAs were performed under general anesthesia using a standardized technique, based on delayed routine shunt insertion after plaque removal. Primary endpoints were 30-days mortality and stroke. A logistic regression was performed to identify clinical and procedural factors associated with postoperative stroke. RESULTS: Two-hundred-sixty-three CEAs were performed for TIA (N.=178, 47%) or acute ischemic stroke (N.=85, 32%). Mean delay of surgery was 6±19 days, and early CEA (<48 hours) was performed in 98 cases (37%). Conventional CEA was performed in 171 patients (67%), eversion CEA in 83 (33%). Early (30-days) mortality was 0.3%. Stroke/death rate was 2.3%. Female sex (OR=5.14, 95% CI: 1.32-24.93; P=0.023), use of anticoagulants (OR=10.57, 95% CI: 2.67-51.86; P=0.001), preoperative stroke (OR=5.34, 95% CI: 1.62-69.21; P=0.006), and the presence of preoperative CT/MRI cerebral ischemic lesions (OR=5.96, 95% CI: 1.52-28.59; P=0.013) were associated with early neurological complications. Statin medication (OR=0.18, 95% CI: 0.04-0.71; P=0.019) and CEA timing <2 days (OR=0.14, 95% CI: 0.03-0.55; P=0.005) were protective from postoperative stroke. CEA outcomes were independent from time period (P=0.201) and operator's volume (P=0.768). A literature systematic review identified other four studies describing the CEA outcomes with routine shunting in symptomatic patients, with a large variability in the selection of patients, surgical technique, and description of the results. CONCLUSIONS: Routine delayed shunting after plaque removal seems to be a safe and effective technique, that contributed to maintain a low complication rate in neurologically symptomatic patients. Statin use and expedited timing were associated with improved outcomes using this technique.

Epidemiological Analysis of 37,424 Carotid Artery Stenosis Intervention Procedures During 11 Years in the Public Health System in Brazil: Stenting has Been More Common Than Endarterectomy.

BACKGROUND: Stroke is a leading cause of death worldwide, with carotid atherosclerosis accounting for 10-20% of cases. In Brazil, the Public Health System provides care for roughly two-thirds of the population. No studies, however, have analysed large-scale results of carotid bifurcation surgery in Brazil. METHODS: This study aimed to describe rates of carotid artery stenting (CAS) and carotid endarterectomy (CEA) performed between 2008 and 2019 in the country through web scraping of publicly available databases. RESULTS: Between 2008 and 2019, 37,424 carotid bifurcation revascularization procedures were performed, of which 22,578 were CAS (60.34%) and 14,846 (39.66%) were CEA. There were 620 in-hospital deaths (1.66%), 336 after CAS (1.48%) and 284 after CEA (1.92%) (P = 0.032). Governmental reimbursement was US$ 77,216,298.85 (79.31% of all reimbursement) for CAS procedures and US$ 20,143,009.63 (20.69%) for CEA procedures. The average cost per procedure for CAS (US$ 3,062.98) was higher than that for CEA (US$ 1,430.33) (P = 0.008). CONCLUSIONS: In Brazil, the frequency of CAS largely surpassed that of CEA. In-hospital mortality rates of CAS were significantly lower than those of CEA, although both had mortality rates within the acceptable rates as dictated by literature. The cost of CAS, however, was significantly higher. This is a pioneering analysis of carotid artery disease management in Brazil that provides, for the first time, preliminary insight into the fact that the low adoption of CEA in the country is in opposition to countries where utilization rates are higher for CEA than for CAS.

Cost-effectiveness of transcarotid artery revascularization versus carotid endarterectomy.

OBJECTIVE: Recent studies have demonstrated that transcarotid artery revascularization (TCAR) has comparable outcomes to the surgical gold standard, carotid endarterectomy (CEA). However, few studies have analyzed the cost of TCAR, and no study has evaluated its cost-effectiveness. The purpose of this study is to conduct a cost-effectiveness analysis comparing TCAR with CEA for carotid artery stenosis. METHODS: We built a Markov microsimulation using transition probabilities and utilities from existing literature for symptomatic patients undergoing TCAR or CEA. Costs were derived from literature then converted to 2019 dollars. The model included six health states with monthly cycle lengths: surgery, death, alive after surgery, alive after myocardial infarction, alive after stroke, and alive after stroke and death. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness. RESULTS: For symptomatic patients, CEA cost $7821 for 2.85 QALYs, whereas TCAR cost $19154 for 2.92 QALYs, leading to an ICER of $152,229 per QALY gained in the TCAR arm. Sensitivity analysis demonstrated that our model was most sensitive to probability of restenosis, costs of TCAR, and costs of CEA. Probabilistic sensitivity analysis demonstrated TCAR would be considered cost-effective in 49% of iterations. CONCLUSIONS: This study found that, although 5-year costs for TCAR were greater than CEA, TCAR afforded greater QALYs than CEA. TCAR became cost-effective at 6 years of follow-up.

Transcarotid artery revascularization versus carotid endarterectomy and transfemoral stenting in octogenarians.

OBJECTIVE: Transfemoral carotid artery stenting (TFCAS) has higher combined stroke and death rates in elderly patients with carotid artery stenosis compared with carotid endarterectomy (CEA). However, transcarotid artery revascularization (TCAR) may have similar outcomes to CEA. This study compared outcomes after TCARs relative to those after CEAs and TFCAS, focusing on elderly patients. METHODS: We included all patients with carotid artery stenosis and no prior endarterectomy or stenting who underwent either a CEA, TFCAS, or TCAR in the Vascular Quality Initiative from September 2016 (TCAR commercially available) to December 2019. We categorized patients into age decades: 60 to 69 years, 70 to 79 years, and 80 to 90 years. Outcomes included 30-day and 1-year composite rates of stroke or death. Cox proportional hazards models evaluated both outcomes after adjusting for patient demographics, clinical factors, symptomatology, hospital CEA volume, and clustering. RESULTS: We identified 33,115 patients who underwent either a CEA, TFCAS, or TCAR for carotid artery stenosis (35% in their 60s, 44% in their 70s, and 21% in their 80s), where one-half (50%) were symptomatic. The majority of patients had CEAs (80%), followed by TFCAS (11%) and TCARs (9.1%). The overall rate of 30-day stroke/death was 1.5% and of 1-year stroke/death was 4.4%. Octogenarians had the highest 30-day and 1-year stroke/death rates relative to their peers (2.3% and 6.3%, respectively). Among all patients, the adjusted hazards of TCARs relative to CEAs was similar for 30-day stroke/death (hazard ratio [HR] 1.10; 95% confidence interval [CI], 0.75-1.62) and slightly higher for 1-year stroke/death (HR, 1.34; 95% CI, 1.02-1.76). Among octogenarians, however, the adjusted hazards of TCARs relative to CEAs was similar for both 30-day stroke/death (HR, 1.12; 95% CI, 0.59-2.13) and 1-year stroke/death (HR, 1.28; 95% CI, 0.85-1.94). TFCAS relative to CEAs had higher hazards of both 30-day stroke/death (HR, 1.78; 95% CI, 1.10-2.89) and 1-year stroke/death (HR, 1.85; 95% CI, 1.35-2.54) in octogenarians. CONCLUSIONS: TCARs had similar outcomes relative to CEAs among octogenarians with respect to 30-day and 1-year rates of stroke/death. TCAR may serve as a promising less invasive treatment for carotid disease in older patients who are deemed high anatomic, surgical, or clinical risk for CEAs.

The novel collagen matrikine, endotrophin, is associated with mortality and cardiovascular events in patients with atherosclerosis.

BACKGROUND: Rupture of atherosclerotic plaques is the major cause of acute cardiovascular events. The biomarker PRO-C6 measuring Endotrophin, a matrikine of collagen type VI, may provide valuable information detecting subjects in need of intensified strategies for secondary prevention. OBJECTIVE: In this study, we evaluate endotrophin in human atherosclerotic plaques and circulating levels of PRO-C6 in patients with atherosclerosis, to determine the predictive potential of the biomarker. METHODS: Sections from the stenotic human carotid plaques were stained with the PRO-C6 antibody. PRO-C6 was measured in serum of patients enrolled in the Carotid Plaque Imagining Project (CPIP) (discovery cohort, n = 577) and the innovative medicines initiative surrogate markers for micro- and macrovascular hard end-points for innovative diabetes tools (IMI-SUMMIT, validation cohort, n = 1,378). Median follow-up was 43 months. Kaplan-Meier curves and log-rank tests were performed in the discovery cohort. Cox proportional hazard regression analysis (HR with 95% CI) was used in the discovery cohort and binary logistic regression (OR with 95% CI) in the validation cohort. RESULTS: PRO-C6 was localized in the core and shoulder of the atherosclerotic plaque. In the discovery cohort, PRO-C6 independently predicted future cardiovascular events (HR 1.089 [95% CI 1.019 -1.164], p = 0.01), cardiovascular death (HR 1.118 [95% CI 1.008 -1.241], p = 0.04) and all-cause death (HR 1.087 [95% CI 1.008 -1.172], p = 0.03). In the validation cohort, PRO-C6 predicted future cardiovascular events (OR 1.063 [95% CI 1.011 -1.117], p = 0.017). CONCLUSION: PRO-C6 is present in the atherosclerotic plaque and associated with future cardiovascular events, cardiovascular death and all-cause mortality in two large prospective cohorts.

Preoperative Dependent Functional Status Is Associated With Poor Outcomes After Carotid Endarterectomy and Carotid Stenting in Both Symptomatic and Asymptomatic Patients.

BACKGROUND: Both Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are the most common procedures to treat patients with symptomatic, and asymptomatic high-grade carotid stenosis. Poor preoperative functional status (FS) is increasingly being recognized as predictor for postoperative outcomes. The purpose of this study is to determine the impact of preoperative functional status on the outcomes of patients who undergo CEA or CAS. METHODS: Data was obtained from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from the years 2011-2018. All patients in the database who underwent CEA or CAS during this time period were identified. Patients were then further divided into 2 subgroups: FS-Independent and FS-dependent. Bivariate and multivariate analyses was performed for pre, intra and post-operative variables with functional status. Outcomes for treatment of symptomatic carotid disease were compared to those with asymptomatic disease among the cohort of functionally dependent patients. RESULTS: A total of 27,163 patients (61.2% Males, 38.8% Females) underwent CEA (n = 26,043) or CAS (n = 1,120) from 2011-2018. Overall, primary outcomes were as follows: mortality 0.77% (n = 210) and stroke 1.87% (n = 507).Risk adjusted multivariate analysis showed that FS-D patients undergoing CEA had higher mortality (AOR 3.06, CI 1.90-4.92, P < 0.001), longer operative times (AOR 1.36, CI 1.17-1.58, P< 0.001) higher incidence of unplanned reoperation (AOR 1.68, CI 1.19-2.37, P = 0.003), postoperative pneumonia (AOR 5.43, CI 1.62 - 18.11, P = 0.006) and ≥3 day LOS (AOR 3.05, CI 2.62-3.56, P < 0.001) as compared to FS-I patients. FS-D patients undergoing CAS had higher incidence of postoperative pneumonia (AOR 20.81, CI 1.66-261.54, P = 0.019) and higher incidence of LOS ≥3 days (AOR 2.18, CI 1.21-3.93, P < .01) as compared to FS-I patients. Survival analysis showed that the best 30-day survival was observed in FS-I patients undergoing CEA, followed by FS-I patients undergoing CAS, followed by FS-D patients undergoing CEA, followed by FS-D patients undergoing CAS. FS-D status increased mortality after CEA by 2.11%. When the outcomes of CAS and CEA were compared to each other for the cohort of FS-D patients, CAS was associated with higher incidence of stroke (AOR 3.46, CI 0.32-1.97, P= 0.046), shorter operative times (AOR 0.25, CI 0.12-0.52, P < 0.001) and higher incidence of pneumonia (AOR 11.29, CI 1.32-96.74, P = 0.027). Symptomatic patients undergoing CEA had higher LOS as compared to symptomatic patients undergoing CAS, and asymptomatic patients undergoing CEA or CAS. CONCLUSIONS: FS-D patients, undergoing CEA have higher mortality as compared to FS-I patients undergoing CAS. FS-D patients undergoing CAS have higher incidence of postoperative pneumonia and longer LOS as compared to FS-I patients. For the cohort of FS-D patients undergoing either CEA or CAS, CAS was associated with higher risk of stroke and reduced operative times. Risk benefit ratio for any carotid intervention should be carefully assessed before offering it to FS-D patients. Preoperative Dependent Functional Status Is Associated with Poor Outcomes After Carotid Endarterectomy and Carotid Stenting in Both Symptomatic and Asymptomatic Patients.

Predictive Factors of Perioperative Stroke-Related Mortality Following Vascular Surgery: A Retrospective Analysis.

OBJECTIVE: Vascular surgical procedures have one of the highest risks of perioperative stroke and stroke-related mortality, yet the independent risk factors contributing to this increased mortality have not been described. Perioperative strokes are thought to result from a combination of embolism and hypoperfusion mechanisms. The purpose of this study is to describe the independent predictors of perioperative stroke-related mortality in the vascular surgical population using the Pennsylvania Health Care Cost Containment Council (PHC4) database which collects cause of death data. METHODS: This retrospective, case-control study evaluated 4,128 patients aged 18-99 who underwent a vascular, non-carotid surgical procedure and subsequently suffered perioperative mortality. Common surgical comorbidities and risk factors for perioperative stroke, including carotid stenosis and atrial fibrillation, were evaluated in multivariate regression analysis. RESULTS: Patients with carotid stenosis were 2.6 (aOR, 95% CI 1.4-4.5) times more likely to suffer perioperative mortality from stroke than from other causes. Additionally, in-hospital stroke, history of stroke, admission from a healthcare facility, and cancer were all positive predictive factors, whereas atrial fibrillation, emergency admission, hypertension, and diabetes were associated with decreased risk of perioperative stroke-related mortality. CONCLUSIONS: Identification of vascular surgical population-specific predictors of stroke-related mortality can help to enhance preoperative risk-stratification tools and guide perioperative management of identified high-risk patients. Increased neurophysiologic monitoring in the perioperative period to prevent delays in diagnosis of perioperative stroke offers a strategy to reduce risk of perioperative stroke-related mortality in vascular surgical patients.

Could Gender Impact on Immediate and Long-term Carotid Artery Stenting Outcome? Insight from an Italian Single Center Experience.

BACKGROUND: Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. MATERIAL AND METHODS: a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex, clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. RESULTS: Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. CONCLUSIONS: Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures' benefit and outcome.