Implications of the Centers for Medicare and Medicaid Services decision to expand indications for carotid artery stenting.

OBJECTIVE: On October 11, 2023, the Centers for Medicare and Medicaid Services (CMS) expanded the indications for carotid artery stenting (CAS) to include patients with ≥50% symptomatic or ≥70% asymptomatic carotid stenosis. The aim of this article was to investigate the implications of this decision. METHODS: The reasons behind the increased coverage for CAS are analyzed and discussed, as well as the various Societies supporting or opposing the expansion of indications for CAS. RESULTS: The benefits associated with expanding CAS indications include providing an additional therapeutic option to patients and enabling individualization of treatment according to patient-specific characteristics. The drawbacks of expanding CAS indications include a possible bias in decision-making and an increase in inappropriate CAS procedures. CONCLUSIONS: The purpose of the CMS recommendation to expand indications for CAS is to improve the available therapeutic options for patients. Hopefully this decision will not be misinterpreted and will be used to improve patient options and patient outcomes.

Natural history of internal carotid artery stenosis progression.

OBJECTIVE: The aim of this study was to investigate the natural history of internal carotid artery (ICA) stenosis progression. METHODS: This single-institution retrospective cohort study analyzed patients diagnosed with ICA stenosis of 50% or greater on duplex ultrasound from 2015 to 2022. Subjects were drawn from our institutional Intersocietal Accreditation Commission-accredited noninterventional vascular laboratory database. Primary outcomes were incidences of disease progression, and stroke or revascularization after index study. Progression was defined as an increase in stenosis classification category. Imaging, demographic, and clinical data was obtained from our institutional electronic medical record via a database mining query. Cases were analyzed at the patient and artery levels, with severity corresponding to the greatest degree of ICA stenosis on index and follow-up studies. RESULTS: Of 577 arteries in 467 patients, mean cohort age was 73.5 ± 8.9 years at the time of the index study, and 45.0% (n = 210) were female. Patients were followed with duplex ultrasound for a mean of 42.2 ± 22.7 months. Of 577 arteries, 65.5% (n = 378) at the index imaging study had moderate (50%-69%) stenosis, 23.7% (n = 137) had severe (70%-99%) stenosis, and 10.7% (n = 62) were occluded. These three groups had significant differences in age, hypertension, hyperlipidemia prevalence, and proportion on best medical therapy. Of the 467-patient cohort, 56.5% (n = 264) were on best medical therapy, defined as smoking cessation, treatment with an antiplatelet agent, statin, and antihypertensive and glycemic agents as indicated. Mean time to progression for affected arteries was 28.0 ± 20.5 months. Of those arteries with nonocclusive disease at diagnosis, 21.3% (n = 123) progressed in their level of stenosis. Older age, diabetes, and a history of vasculitis were associated with stenosis progression, whereas antiplatelet agent use trended towards decreased progression rates. Of the 467 patients, 5.6% (n = 26) developed symptoms; of those, 38.5% (n = 10) had ischemic strokes, 26.9% (n = 7) had hemispheric transient ischemic attacks, 11.5% (n = 3) had amaurosis fugax, and 23.1% (n = 6) had other symptoms. A history of head and neck cancer was positively associated with symptom development. Of 577 affected arteries, 16.6% (n = 96) underwent intervention; 81% (n = 78) of interventions were for asymptomatic disease and 19% (n = 18) were for symptomatic disease. No patient-level factors were associated with risk of intervention. CONCLUSIONS: A significant number of carotid stenosis patients experience progression of disease. Physicians should consider long-term surveillance on all patients with carotid disease, with increased attention paid to those with risk factors for progression, particularly those with diabetes and a history of vasculitis.

Association of stroke or death with severity of carotid lesion calcification in patients undergoing carotid artery stenting.

OBJECTIVE: Carotid artery stenting (CAS) for heavily calcified lesions is controversial due to concern for stent failure and increased perioperative stroke risk. However, the degree to which calcification affects outcomes is poorly understood, particularly in transcarotid artery revascularization (TCAR). With the precipitous increase in TCAR use and its expansion to standard surgical-risk patients, we aimed to determine the impact of lesion calcification on CAS outcomes to ensure its safe and appropriate use. METHODS: We identified patients in the Vascular Quality Initiative who underwent first-time transfemoral CAS (tfCAS) and TCAR between 2016 and 2021. Patients were stratified into groups based on degree of lesion calcification: no calcification, 1% to 50% calcification, 51% to 99% calcification, and 100% circumferential calcification or intraluminal protrusion. Outcomes included in-hospital and 1-year composite stroke/death, as well as individual stroke, death, and myocardial infarction outcomes. Logistic regression was used to evaluate associations between degree of calcification and these outcomes. RESULTS: Among 21,860 patients undergoing CAS, 28% patients had no calcification, 34% had 1% to 50% calcification, 35% had 51% to 99% calcification, and 3% had 100% circumferential calcification/protrusion. Patients with 51% to 99% and circumferential calcification/protrusion had higher odds of in-hospital stroke/death (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.02-1.6; P = .034; OR, 1.9; 95% CI, 1.1-2.9; P = .004, respectively) compared with those with no calcification. Circumferential calcification was also associated with increased risk for in-hospital myocardial infarction (OR, 3.5; 95% CI, 1.5-8.0; P = .003). In tfCAS patients, only circumferential calcification/protrusion was associated with higher in-hospital stroke/death odds (OR, 2.0; 95% CI, 1.2-3.4; P = .013), whereas for TCAR patients, 51% to 99% calcification was associated with increased odds of in-hospital stroke/death (OR, 1.5; 95% CI, 1.1-2.2; P = .025). At 1 year, circumferential calcification/protrusion was associated with higher odds of ipsilateral stroke/death (12.4% vs 6.6%; hazard ratio, 1.64; P = .002). CONCLUSIONS: Among patients undergoing CAS, there is an increased risk of in-hospital stroke/death for lesions with >50% calcification or circumferential/protruding plaques. Increasing severity of carotid lesion calcification is a significant risk factor for stroke/death in patients undergoing CAS, regardless of approach.

Carotid stenosis and cryptogenic stroke.

OBJECTIVES: Cryptogenic stroke represents a type of ischemic stroke with an unknown origin, presenting a significant challenge in both stroke management and prevention. According to the Trial of Org 10,172 in Acute Stroke Treatment criteria, a stroke is categorized as being caused by large artery atherosclerosis only when there is >50% luminal narrowing of the ipsilateral internal carotid artery. However, nonstenosing carotid artery plaques can be an underlying cause of ischemic stroke. Indeed, emerging evidence documents that some features of plaque vulnerability may act as an independent risk factor, regardless of the degree of stenosis, in precipitating cerebrovascular events. This review, drawing from an array of imaging-based studies, explores the predictive values of carotid imaging modalities in the detection of nonstenosing carotid plaque (<50%), that could be the cause of a cerebrovascular event when some features of vulnerability are present. METHODS: Google Scholar, Scopus, and PubMed were searched for articles on cryptogenic stroke and those reporting the association between cryptogenic stroke and imaging features of carotid plaque vulnerability. RESULTS: Despite extensive diagnostic evaluations, the etiology of a considerable proportion of strokes remains undetermined, contributing to the recurrence rate and persistent morbidity in affected individuals. Advances in imaging modalities, such as magnetic resonance imaging, computed tomography scans, and ultrasound examination, facilitate more accurate detection of nonstenosing carotid artery plaque and allow better stratification of stroke risk, leading to a more tailored treatment strategy. CONCLUSIONS: Early detection of nonstenosing carotid plaque with features of vulnerability through carotid imaging techniques impacts the clinical management of cryptogenic stroke, resulting in refined stroke subtype classification and improved patient management. Additional research is required to validate these findings and recommend the integration of these state-of-the-art imaging methodologies into standard diagnostic protocols to improve stroke management and prevention.

An analysis of the recommendations of the 2022 Society for Vascular Surgery clinical practice guidelines for patients with asymptomatic carotid stenosis.

OBJECTIVE: Patients with asymptomatic carotid artery stenosis currently account for the majority of carotid interventions performed in the United States; therefore, the following article will review the 2022 Society for Vascular Surgery (SVS) clinical practice guidelines perspective in treating patient with asymptomatic carotid stenosis. METHODS: A systemic review and meta-analysis were conducted by the evidence practice center of the Mayo Clinic using a specified population, intervention, comparison, outcome (PICO) framework. RESULTS: Based on published randomized trials and related supporting evidence, the following were noted: the SVS recommends that patients with asymptomatic ≥70% stenosis can be considered for carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), or transfemoral carotid artery stenting (TFCAS) for the reduction of long-term risk of stroke, provided the patient has a life expectancy of 3 to 5 years with risk of perioperative stroke and death not exceeding 3%. The type of carotid intervention should be based on the presence or absence of high-risk criteria for each specified intervention. Data from CREST, ACT, and the Vascular Quality Initiative suggest that certain properly selected asymptomatic patients can be treated with carotid stenting with equivalent outcome to CEA in the hands of experienced interventionalists. The institutions and operator performing carotid stenting must exhibit expertise sufficient to meet the established American Heart Association guidelines for treatment of patient with asymptomatic carotid stenosis (ie, combined stroke/death rate of less than 3%). CONCLUSIONS: SVS recommends that low surgical risk patients with asymptomatic carotid stenosis of ≥70% to be treated with CEA with best medical therapy over medical therapy alone for the long-term prevention of stroke/death (GRADE 1B). Carotid intervention should also be based on the presence or absence of high-risk criteria for each specified intervention (ie, CEA, TCAR, and TFCAS).

Real-world use of medical therapy in moderate asymptomatic carotid stenosis.

OBJECTIVE: Despite level 1 evidence demonstrating the benefit of carotid endarterectomy for the prevention of stroke in patients with severe asymptomatic carotid stenosis (ACS), there has been a trend toward recommending optimal medical therapy (OMT) alone. This recommendation has been promulgated based on the observation that modern advances in OMT reduce the overall stroke risk in the general population, but the success of this treatment strategy is dependent on patient and provider adherence. In current practice, patients with moderate ACS are nearly all treated with OMT alone. The objective of this study was to evaluate adherence to OMT in a cohort of patients with moderate ACS undergoing treatment with OMT alone. METHODS: Consecutive carotid duplex ultrasound examinations were reviewed for the years 2019 and 2020. Those with moderate (50%-69%) ACS based on Society for Vascular Surgery guidelines were included in the study. Patients were assessed for OMT at the time of the index duplex, the first follow-up visit, and at each subsequent follow-up visit until the end of the study. OMT was defined as abstinence from smoking, aspirin or other antiplatelet use, and statin or other lipid-lowering therapy. Patients were stratified based on their ability to achieve OMT, and each component was evaluated to identify shortfalls in therapy. RESULTS: A total of 323 duplex ultrasound examinations with moderate ACS in 255 patients were identified. Of the 255 patients, 143 (56.1%) were on OMT at the time of the first duplex; that number increased to 163 (63.9%) by the first follow-up visit and 175 (68.6%) by the completion of the study. There were 112 (43.9%) patients who were not on OMT at the time of the index duplex, 43 (38.4%) of whom achieved OMT over a median follow-up time of 2.7 years. By the end of follow-up, 86 (76.8%) were taking aspirin or another antiplatelet medication, 93 (83.0%) were on statin or other lipid-lowering therapy, and 74 (66.1%) were abstinent from smoking. Pre-duplex smoking was independently associated with failure to achieve OMT (hazard ratio: 0.452, P = .017). CONCLUSIONS: Among patients with moderate ACS who were not previously on OMT, the rate of OMT achievement is poor. Although advances in lipid management through statin therapy have been praised for their role in improving the effectiveness of OMT, smoking cessation represents an important target for improving uptake and as a result effectiveness of OMT.

The effect of controlled vs uncontrolled hypertension on outcomes of carotid revascularization procedures.

BACKGROUND: Hypertension (HTN) has been implicated as a strong predictive factor for poorer outcomes in patients undergoing various vascular procedures. However, limited research is available that examines the effect of uncontrolled HTN (uHTN) on outcomes after carotid revascularization. We aimed to determine which carotid revascularization procedure yields the best outcome in this patient population. METHODS: We studied patients undergoing carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), or transcarotid artery revascularization (TCAR) from April 2020 to June 2022 using data from the Vascular Quality Initiative. Patients were stratified into two groups: those with cHTN and those with uHTN. Patients with cHTN were those with HTN treated with medication and a blood pressure of <130/80 mm Hg. Patients with uHTN had a blood pressure of ≥130/80 mm Hg. Our primary outcomes were in-hospital stroke, death, myocardial infarction (MI), and 30-day mortality. Our secondary outcomes were postoperative hypotension or HTN, reperfusion syndrome, prolonged length of stay (LOS) (>1 day), stroke/death, and stroke/death/MI. We used logistic regression models for the multivariate analysis. RESULTS: A total of 34,653 CEA (uHTN, 11,347 [32.7%]), 8199 TFCAS (uHTN, 2307 [28.1%]), and 17,309 TCAR (uHTN, 4990 [28.8%]) patients were included in this study. There was no significant difference in age between patients with cHTN and patients with uHTN for each carotid revascularization procedure. However, compared with patients with cHTN, patients with uHTN had significantly more comorbidities. uHTN was associated with an increased risk of combined in-hospital stroke/death/MI after CEA (adjusted odds ratio [aOR], 1.56; 95% confidence interval [CI], 1.30-1.87; P < .001), TFCAS (aOR, 1.59; 95% CI, 1.21-2.08; P < .001), and TCAR (aOR, 1.39; 95% CI, 1.12-1.73; P = .003) compared with cHTN. Additionally, uHTN was associated with a prolonged LOS after all carotid revascularization methods. For the subanalysis of patients with uHTN, TFCAS was associated with an increased risk of stroke (aOR, 1.82; 95% CI, 1.39-2.37; P < .001), in-hospital death (aOR, 3.73; 95% CI, 2.25-6.19; P < .001), reperfusion syndrome (aOR, 6.24; 95% CI, 3.57-10.93; P < .001), and extended LOS (aOR, 1.87; 95% CI, 1.51-2.32; P < .001) compared with CEA. There was no statistically significant difference between the outcomes of TCAR compared with CEA. CONCLUSIONS: The results from this study show that patients with uHTN are at a higher risk of stroke and death postoperatively compared with patients with cHTN, highlighting the importance of treating HTN before undergoing elective carotid revascularization. Additionally, in patients with uHTN, TFCAS yields the worst outcomes, whereas CEA and TCAR proved to be safer interventions. Patients with uTHN with symptomatic carotid disease treated with CEA or TCAR have better outcomes compared with those treated with TFCAS.

Multi-center experience with intravascular lithotripsy for treatment of severe calcification during transcarotid artery revascularization for high-risk patients.

OBJECTIVE: Transcarotid artery revascularization (TCAR) offers a safe alternative to carotid endarterectomy (CEA), but severe calcification is currently considered a contraindication in carotid artery stenting. This study aims to describe the safety and effectiveness of TCAR with intravascular lithotripsy (IVL) in patients with traditionally prohibitive calcific disease. METHODS: All consecutive patients who underwent TCAR+IVL from 2018-2022 at nine institutions were identified. IVL was combined with pre-dilatation angioplasty to treat calcified vessels before stent deployment. The primary outcome was a new ipsilateral stroke within 30 days. Secondary outcomes included any new ipsilateral neurologic event (stroke/transient ischemic attack [TIA]) at 30 days, technical success, and <30% residual stenosis. RESULTS: Fifty-eight patients (62% male; mean age, 78 ± 6.6 years) underwent TCAR+IVL, with 22 (38%) for symptomatic disease. Fifty-seven patients (98%) met high-risk anatomical or physiologic criteria for CEA. Forty-seven patients had severely calcific lesions. Fourteen patients (30%) had isolated eccentric plaque, 20 patients (43%) had isolated circumferential plaque, and 13 (27%) had eccentric and circumferential calcification. Mean procedure and flow reversal times were 87 ± 27 minutes and 25 ± 14 minutes. The median number of lithotripsy pulses per case was 90 (range, 30-330), and mean contrast usage was 29 mL. No patients had electroencephalogram changes or new deficits observed intraoperatively. Technical success was achieved in 100% of cases, with 98% having <30% residual stenosis on completion angiography. One patient had an in-hospital post-procedural stroke (1.72%). Four patients total had any new ipsilateral neurologic event (stroke/TIA) within 30 days for an overall rate of 6.8%. One TIA and one stroke occurred during the index hospitalization, and two TIAs occurred after discharge. Preoperative mean stenosis in patients with any postoperative neurologic event was 93% (vs 86% in non-stroke/TIA patients; P = .32), and chronic renal insufficiency was higher in patients who had a new neurologic event (75% vs 17%; P = .005). No differences were observed in calcium, procedural, or patient characteristics between the two groups. The mean follow-up was 132 days (range, 19-520 days). Three stents developed recurrent stenosis (5%) on follow-up duplex; the remainder were patent without issue. There were no reported interventions for recurrent stenosis during the study period. CONCLUSIONS: IVL sufficiently remodels calcified carotid arteries to facilitate TCAR effectively in patients with traditionally prohibitive calcific disease. One patient (1.7%) suffered a stroke within 30 days, although four patients (6.8%) sustained any new neurological event (stroke/TIA). These results raise concerns about the risks of TCAR+IVL and whether it is an appropriate strategy for patients who could potentially undergo CEA.

Impact of head and neck radiation on long-term outcomes after carotid revascularization.

OBJECTIVE: Radiation-induced carotid artery stenosis (RICS) is a well-described phenomenon seen after head and neck cancer radiation. Previously published literature suggests that, compared with atherosclerotic disease, RICS may result in worse long-term outcomes and early restenosis. This study aims to evaluate the effect of radiation on long-term outcomes after various carotid revascularization techniques using a multi-center registry database. METHODS: Patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry for carotid artery intervention (carotid endarterectomy [CEA]; transfemoral carotid artery stenting [CAS]; transcarotid artery revascularization [TCAR]), who are 65 years or older were included in the study. VQI Vascular Implant Surveillance and Interventional Outcomes Network (VISION) Medicare-linked database was used to obtain long-term procedure-specific outcomes. Primary endpoints were 3-year death, stroke, and reintervention. We performed propensity matching between patients with prior radiation and those without. Kaplan-Meier analysis and a multivariate logistic regression model were used to analyze the outcome variables. RESULTS: A total of 56,472 patients had undergone carotid revascularization (CEA, n = 48,307; TCAR, n = 4593; CAS, n = 3572), 1244 patients with prior radiation and 54,925 patients without prior radiation. The prior radiation group was more likely to be male (71.9% vs 60.3%; P < .01), to receive a stent (47.5% vs 13.5%; P < .01), and to be on P2Y12 inhibitor (55.2% vs 38.3%; P < .01). Propensity matching was performed on 1223 patients (CEA, n = 655; TCAR, n = 292; CAS, n = 287). There were no significant differences in 30-day outcomes for death, stroke, or major adverse cardiovascular events for all three procedures. The prior radiation group had higher rates of cranial nerve injury (3.7% vs 1.8%; P = .04) and 90-day readmission (23.5% vs 18.3%; P = .01) after CEA. For long-term outcomes, prior radiation significantly increased mortality risk for CEA and CAS (hazard ratio [HR], 1.77; 95% confidence interval [CI], 1.38-2.27 and HR, 1.56; 95% CI, 1.02-2.36, respectively). The 3-year risk of stroke for CEA in radiated patients was also significantly higher (HR, 1.47; 95% CI, 1.03-2.09) compared with non-radiated patients. Prior radiation did not significantly affect death and stroke in patients undergoing TCAR. Prior radiation also did not impact the rates of short and long-term reintervention after CEA, CAS, or TCAR. CONCLUSIONS: Prior head and neck radiation significantly increases the risk for mortality and stroke for CEA and the risk for mortality after CAS. Long-term outcomes for TCAR are not significantly affected by prior radiation. TCAR may be the preferred treatment modality for patients with radiation-induced carotid stenosis.

Seven years of the transcarotid artery revascularization surveillance project, comparison to transfemoral stenting and endarterectomy.

OBJECTIVE: This study utilizes the latest data from the Vascular Quality Initiative (VQI), which now encompasses over 50,000 transcarotid artery revascularization (TCAR) procedures, to offer a sizeable dataset for comparing the effectiveness and safety of TCAR, transfemoral carotid artery stenting (tfCAS), and carotid endarterectomy (CEA). Given this substantial dataset, we are now able to compare outcomes overall and stratified by symptom status across revascularization techniques. METHODS: Utilizing VQI data from September 2016 to August 2023, we conducted a risk-adjusted analysis by applying inverse probability of treatment weighting to compare in-hospital outcomes between TCAR vs tfCAS, CEA vs tfCAS, and TCAR vs CEA. Our primary outcome measure was in-hospital stroke/death. Secondary outcomes included myocardial infarction and cranial nerve injury. RESULTS: A total of 50,068 patients underwent TCAR, 25,361 patients underwent tfCAS, and 122,737 patients underwent CEA. TCAR patients were older, more likely to have coronary artery disease, chronic kidney disease, and undergo coronary artery bypass grafting/percutaneous coronary intervention as well as prior contralateral CEA/CAS compared with both CEA and tfCAS. TfCAS had higher odds of stroke/death when compared with TCAR (2.9% vs 1.6%; adjusted odds ratio [aOR], 1.84; 95% confidence interval [CI], 1.65-2.06; P < .001) and CEA (2.9% vs 1.3%; aOR, 2.21; 95% CI, 2.01-2.43; P < .001). CEA had slightly lower odds of stroke/death compared with TCAR (1.3% vs 1.6%; aOR, 0.83; 95% CI, 0.76-0.91; P < .001). TfCAS had lower odds of cranial nerve injury compared with TCAR (0.0% vs 0.3%; aOR, 0.00; 95% CI, 0.00-0.00; P < .001) and CEA (0.0% vs 2.3%; aOR, 0.00; 95% CI, 0.0-0.0; P < .001) as well as lower odds of myocardial infarction compared with CEA (0.4% vs 0.6%; aOR, 0.67; 95% CI, 0.54-0.84; P < .001). CEA compared with TCAR had higher odds of myocardial infarction (0.6% vs 0.5%; aOR, 1.31; 95% CI, 1.13-1.54; P < .001) and cranial nerve injury (2.3% vs 0.3%; aOR, 9.42; 95% CI, 7.78-11.4; P < .001). CONCLUSIONS: Although tfCAS may be beneficial for select patients, the lower stroke/death rates associated with CEA and TCAR are preferred. When deciding between CEA and TCAR, it is important to weigh additional procedural factors and outcomes such as myocardial infarction and cranial nerve injury, particularly when stroke/death rates are similar. Additionally, evaluating subgroups that may benefit from one procedure over another is essential for informed decision-making and enhanced patient care in the treatment of carotid stenosis.

Outcomes of carotid revascularization stratified by procedure in patients with an estimated glomerular filtration rate of <30 and dialysis patients.

OBJECTIVE: Renal failure is a predictor of adverse outcomes in carotid revascularization. There has been debate regarding the benefit of revascularization in patients with severe chronic kidney disease or on dialysis. METHODS: Patients in the Vascular Quality Initiative undergoing transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (tfCAS), or CEA between 2016 and 2023 with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 or on dialysis were included. Patients were divided into cohorts based on procedure. Additional analyses were performed for patients on dialysis only and by symptomatology. Primary outcomes were perioperative stroke/death/myocardial infarction (MI) (SDM). Secondary outcomes included perioperative death, stroke, MI, cranial nerve injury, and stroke/death. Inverse probability of treatment weighting was performed based on treatment assignment to TCAR, tfCAS, and CEA patients and adjusted for demographics, comorbidities, and preoperative symptoms. The χ2 test and multivariable logistic regression analysis were used to evaluate the association of procedure with perioperative outcomes in the weighted cohort. Five-year survival was evaluated using Kaplan-Meier and weighted Cox regression. RESULTS: In the weighted cohort, 13,851 patients with an eGFR of <30 (2506 on dialysis) underwent TCAR (3639; 704 on dialysis), tfCAS (1975; 393 on dialysis), or CEA (8237; 1409 on dialysis) during the study period. Compared with TCAR, CEA had higher odds of SDM (2.8% vs 3.6%; adjusted odds ratio [aOR], 1.27; 95% confidence interval [CI], 1.00-1.61; P = .049), and MI (0.7% vs 1.5%; aOR, 2.00; 95% CI, 1.31-3.05; P = .001). Compared with TCAR, rates of SDM (2.8% vs 5.8%), stroke (1.2% vs 2.6%), and death (0.9% vs 2.4%) were all higher for tfCAS. In asymptomatic patients CEA patients had higher odds of MI (0.7% vs 1.3%; aOR, 1.85; 95% CI, 1.15-2.97; P = .011) and cranial nerve injury (0.3% vs 1.9%; aOR, 7.23; 95% CI, 3.28-15.9; P < .001). Like in the primary analysis, asymptomatic tfCAS patients demonstrated higher odds of death and stroke/death. Symptomatic CEA patients demonstrated no difference in stroke, death, or stroke/death. Although tfCAS patients demonstrated higher odds of death, stroke, MI, stroke/death, and SDM. In both groups, the 5-year survival was similar for TCAR and CEA (eGFR <30, 75.1% vs 74.2%; aHR, 1.06; P = .3) and lower for tfCAS (eGFR <30, 75.1% vs 70.4%; aHR, 1.44; P < .001). CONCLUSIONS: CEA and TCAR had similar odds of stroke and death and are both a reasonable choice in this population; however, TCAR may be better in patients with an increased risk of MI. Additionally, tfCAS patients were more likely to have worse outcomes after weighting for symptom status. Finally, although patients with a reduced eGFR have worse outcomes than their healthy peers, this analysis shows that the majority of patients survive long enough to benefit from the potential stroke risk reduction provided by all revascularization procedures.

Learning curve of transfemoral carotid artery stenting in the Vascular Quality Initiative registry.

OBJECTIVE: With the recent expansion of the Centers for Medicare and Medicaid Services coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. Because approximately 30% of perioperative strokes/deaths post-CAS occur after discharge, appropriate thresholds for in-hospital event rates have been suggested to be <4% for symptomatic and <2% for asymptomatic patients. This study evaluates the tfCAS learning curve using Vascular Quality Initiative (VQI) data. METHODS: We identified VQI patients who underwent tfCAS between 2005 and 2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. The primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/myocardial infarction (MI), 30-day mortality, in-hospital stroke/transient ischemic attack (stroke/TIA), and access site complications. The relationship between outcomes and procedure counts was analyzed using the Cochran-Armitage test and a generalized linear model with restricted cubic splines. Our results were then validated using a generalized estimating equations model to account for the variability between physicians. RESULTS: We analyzed 43,147 procedures by 2476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2%-1.7%), in-hospital stroke/death/MI (5.8%-1.7%), 30-day mortality (4.6%-2.8%), in-hospital stroke/TIA (5.0%-1.1%), and access site complications (4.1%-1.1%) as physician experience increased (all P values < .05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1%-1.6%), in-hospital stroke/death/MI (2.6%-1.6%), 30-day mortality (1.7%-0.4%), and in-hospital stroke/TIA (2.8%-1.6%) with increasing physician experience (all P values <.05). The in-hospital stroke/death rate remained above 2% until 13 procedures. CONCLUSIONS: In-hospital stroke/death and 30-day mortality rates after tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. Nevertheless, a substantially high rate of in-hospital stroke/death was found in physicians' first 25 procedures. With the recent Centers for Medicare and Medicaid Services coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased postoperative complications.

Survey-Based Assessment of the Quality of Reporting Guidelines of Carotid Artery Stenosis.

BACKGROUND: No evaluation of the quality of different carotid guidelines using validated scales has been performed to date. The present study aims to analyze 3 carotid stenosis guidelines, apprizing their quality and reporting using validated tools. METHODS: A survey-based assessment of the quality of the European Society for Vascular Surgery (ESVS) 2023, European Stroke Organisation (ESO) 2021, and the Society for Vascular Surgery (SVS) 2021 carotid stenosis guidelines, was performed by 43 vascular surgeons, cardiologists, neurologist or interventional radiologists using 2 validated appraisal tools for quality and reporting guidelines, the AGREE II instrument and the RIGHT statement. RESULTS: Using the AGREE II tool, the ESVS, SVS, and ESO guidelines had overall quality scores of 87.3%, 79.4%, and 82.9%, respectively (P = 0.001) The ESVS and ESO had better scores in the scope and purpose domain, and the SVS in the clarity of presentation domain. In the RIGHT statement, the ESVS, SVS, and ESO guidelines had overall quality scores of 84.0.7%, 74.3%, and 79.0%, respectively (P = 0.001). All 3 guidelines stood out for their methodology for search of evidence and formulating evidence-based recommendations. On the contrary, were negatively evaluated mostly in the cost and resource implications in formulating the recommendations. CONCLUSIONS: The 2023 ESVS carotid stenosis guideline was the best evaluated among the 3 guidelines, with scores over 5% higher than the other 2 guidelines. Efforts should be made by guideline writing committees to take the AGREE II and RIGHT statements into account in the development of future guidelines to produce high-quality recommendations.

Optimizing Treatment of Significant Carotid Artery Stenosis in Times of Logistic Restraints as a Result of COVID-19 Pandemic.

BACKGROUND: COVID-19 confronted medical care with many challenges. During the pandemic, several resources were limited resulting in renouncing or postponing medical care like carotid endarterectomy (CEA) for patients with significant carotid artery stenosis. Although according to international guidelines CEA is the first choice, carotid artery stenting (CAS) could potentially be a reasonable alternative especially during logistical restraints. PURPOSE: To evaluate outcomes of CAS versus CEA before, during and after the COVID-19 pandemic. Our hypothesis was that a CAS first approach yielded comparable outcomes compared to a CEA first approach. METHODS: Retrospective analysis of consecutive patients with significant carotid artery stenosis treated with CEA or CAS between September 2018 and March 2023. Each consecutive period of 1.5 year marked a new (treatment) period: pre-COVID (CEA first strategy), during COVID (CAS first strategy) and post-COVID (patient-tailored approach). Primary outcome was the composite endpoint of stroke, transient ischemic attack or death within 30 days. Secondary outcome consisted of the rate of technical success, cerebral hyperperfusion syndrome, myocardial infarction or other cardiac complications needing intervention, bleeding of the surgical site needing intervention, nerve palsy, unintended IC admission, pseudoaneurysm, restenosis, or occlusion. RESULTS: A total of 318 patients were included. Out of 137 patients treated with CEA, 55, 36 and 46 were treated pre-COVID, during COVID and post-COVID, respectively. Out of 181 CAS procedures, 38, 59 and 84, respectively, were performed in each time period. Primary outcome occurred in 5.5%, 0% and 2.2% in the CEA group and 0%, 1.7% and 3.6% in the CAS group (P = 0.27; P = 1.00; P = 1.00, respectively). Overall technical success was 100% for CEA and 99.4% for CAS (P = 1.00). Rate of restenosis was the only secondary outcome measure which was significantly better after CAS compared to CEA in the pre- and post-COVID period (CEA vs. CAS, 12.7% vs. 7.9%, and 23.9% vs. 4.8% with a P-value of 0.03 and 0.03, respectively). Hospital presentation to treatment interval did not differ significantly during the pandemic. CONCLUSIONS: Outcomes were comparable between CAS versus CEA in patients with significant carotid artery stenosis before, during and after the COVID-19 pandemic. CAS showed better results in terms of other complications (i.e., restenosis rate) in the pre- and post-COVID period compared to CEA. Our results may support a CAS first approach when no relevant contra-indications exist without exposing the patient to complications associated with an open surgical approach. Discussion in a multidisciplinary team is advised.

Ocular Ischemic Syndrome and the Role of Carotid Artery Revascularization.

BACKGROUND: Ocular ischemic syndrome (OIS) is a rare presentation of atherosclerotic carotid artery stenosis that can result in permanent visual loss. This severely disabling syndrome remains under diagnosed and undertreated due to lack of awareness; especially since it requires expedited multidisciplinary care. The relevance of early diagnosis and treatment is increasing due to an increasing prevalence of cerebrovascular disease. METHODS: The long-term visual and cerebrovascular outcomes following intervention for nonarteritic OIS, remain poorly described and were the objective of this concise review. We conducted a PubMed search to include all English language publications (cohort studies and case reports) between 2002 and 2023. RESULTS: A total of 33 studies (479 patients) report the outcomes of treatment of OIS with carotid endarterectomy (CEA, 304 patients, 19 studies), and carotid artery stenting (CAS, 175 patients, 14 studies). Visual outcomes were improved or did not worsen in 447 patients (93.3%). No periprocedural stroke was reported. Worsening visual symptoms were rare (35 patients, 7.3%); they occurred in the immediate postoperative period secondary to ocular hypoperfusion (3 patients) and in the late postoperative period due to progression of systemic atherosclerotic disease. Symptomatic recurrence due to recurrent stenosis after CEA was reported in 1 patient (0.21%); this was managed successfully with CAS. None of these studies report the results of transcarotid artery revascularization, the long-term operative outcome or stroke rate. CONCLUSIONS: OIS remains to be an underdiagnosed condition. Early diagnosis and prompt treatment are crucial in reversal or stabilization of OIS symptoms. An expedited multidisciplinary approach between vascular surgery and ophthalmology services is necessary to facilitate timely treatment and optimize outcome. If diagnosed early, both CEA and CAS have been associated with visual improvement and prevention of progressive visual loss.

Predictors of Occlusion after Carotid Stenting.

BACKGROUND: Carotid artery stent (CAS) occlusion is a rare complication not well studied. We used a national dataset to assess real world CAS experience to determine the rate of stent occlusion. The purpose of this study was to 1) Identify risk factors associated with CAS occlusion on long-term follow-up (LTFU) and 2) Determine the adjusted odds of death/transient ischemic attack (TIA)/stroke (cerebrovascular accident (CVA)) in patients with occlusion. METHODS: The national Vascular Quality Initiative CAS dataset (2016-2021) comprised the sample. The primary endpoint was occlusion on LTFU (9-21 months postoperatively as defined by the Vascular Quality Initiative LTFU dataset) with secondary endpoint examining a composite of death/TIA/CVA. Descriptive analyses used chi-square and Wilcoxon tests for categorical and continuous variables respectively. Adjustment variables were selected a priori based on clinical expertise and univariate analyses. Multivariable logistic regression was used to model the odds of occlusion and the odds of death/TIA/CVA. Generalized estimating equations accounted for center level variation. RESULTS: During the study period, 109 occlusions occurred in 12,143 cases (0.9%). On univariate analyses, symptomatic indication, prior stroke, prior neck radiation, lesion calcification (>50%), stenosis (>80%), distal embolic protection device (compared to flow reversal), balloon size, >1 stent and current smoking at time of LTFU were predictive for occlusion. Age ≥ 65, coronary artery disease (CAD), elective status, preoperative statin, preoperative and discharge P2Y12 inhibitor, use of any protection device intraoperatively and protamine were protective. On multivariable analyses, age ≥ 65, CAD, elective status and P2Y12 inhibitor on discharge were protective for occlusion, while patients with prior radiation and those taking P2Y12 inhibitor on LTFU were at increased odds. The adjusted odds of death/TIA/CVA in patients with occlusion on LTFU were 6.05; 95% confidence interval: 3.61-10.11, P < 0.0001. CONCLUSIONS: This study provides an in-depth analysis of predictors for CAS occlusion on LTFU. On univariate analyses, variables related to disease severity (urgency, degree of stenosis, nature of lesion) and intraoperative details (balloon diameter, >1 stent) were predictive for occlusion. These variables were not statistically significant after risk adjustment. On multivariable analyses, prior neck radiation was strongly predictive of occlusion. Elective status, patient age ≥ 65, CAD, and P2Y12 inhibitor upon discharge (but not on LTFU) were protective for occlusion. Additionally, patients who developed occlusion had high odds for death/TIA/CVA. These findings provide important data to guide clinical decision-making for carotid disease management, particularly identifying high-risk features for CAS occlusion. Closer postoperative follow-up and aggressive risk factor modification in these patients may be merited.

The Effects of Clopidogrel Duration on Carotid Artery In-Stent Restenosis.

BACKGROUND: There are limited data supporting a specific duration for dual antiplatelet therapy in carotid artery stenting (CAS), and most clinical evidence is derived from studies involving coronary interventions. As a result, the appropriate duration of dual antiplatelet therapy after CAS is yet to be determined. We aimed to elucidate whether the duration of dual antiplatelet therapy played a role in the rate of carotid in-stent restenosis. METHODS: A retrospective analysis of all patients who underwent CAS at our institution over a 20-year period (1996-2016) was performed (n = 279). Patients who did not complete their follow-up duplex studies or were not discharged on clopidogrel were excluded from the study. Patients were separated into short-term (<6 weeks, n = 159) and long-term (>6 weeks, n = 112) clopidogrel users based on duration of therapy. We defined clinically significant in-stent restenosis as >50% restenosis (peak systolic velocity = 224 cm/s) in symptomatic patients and >80% restenosis (peak systolic velocity = 325 cm/s) in asymptomatic patients status-post prior CAS based on published velocity criteria. Rates of in-stent restenosis at 1-year, 2-year, and 5-year intervals were analyzed between the 2 groups using chi-squared analysis. RESULTS: Demographic information was largely similar between the 2 groups; however, short-term clopidogrel users were more likely to have a history of atrial fibrillation (9.43% vs. 1.68%, P = 0.008) and were less likely to have a history of coronary artery bypass graft (16.35% vs. 29.41%, P = 0.009), diabetes (33.34% vs. 49.58%, P = 0.006), and coronary artery disease (50.31% vs. 63.03%, P = 0.035). All patients were on long-term aspirin therapy. There was no significant difference between overall rates of in-stent restenosis between the short-term and long-term clopidogrel users (5.03% vs. 9.24%, P = 0.168) within 5 years of the index procedure. Similar results were observed when these groups were evaluated at 1-year (5.61% vs. 3%, P = 0.321), 2-year (2.02% vs. 6.59%, P = 0.072), and 5-year (2.24% vs. 3.57%, P = 0.635) follow-up. CONCLUSIONS: No statistically significant difference was observed in the rate of in-stent restenosis after CAS between short-term and long-term clopidogrel therapy. Patients in whom there is no other indication for longer duration clopidogrel therapy may be considered for shorter duration course of dual antiplatelet therapy following CAS.

Complications of Carotid Interventions for Symptomatic Lesions after Systemic Thrombolysis.

BACKGROUND: Series detailing complications after carotid endarterectomy (CEA) and transfemoral carotid stenting (tfCAS) for patients presenting with neurologic symptoms that are treated with systemic thrombolysis (ST) are sparse. We sought to determine if treatment with ST was associated with a higher rate of post-carotid intervention complications. METHODS: A multispecialty, institutional, prospectively maintained database was queried for symptomatic patients treated with CEA or tfCAS from 2007 to 2019. The primary outcomes of interest were bleeding complications (access/wound complications, hematuria, intracranial hemorrhage) or need for reintervention, stroke, and death. We compared rates of these outcomes between patients who were and were not treated with ST. To adjust for preoperative patient factors and confounding variables, propensity scores for assignment to ST and non-ST were calculated. RESULTS: There were 1,139 patients included (949 [82%] CEA and 190 [17%] tfCAS. All treated lesions were symptomatic (550 [48%] stroke, 603 [52%] transient ischemic attack). Fifty-six patients (5%) were treated with ST. Fifteen of 56 patients also underwent catheter-based intervention for stroke. ST was administered 0 to 1 day preoperatively in 21 (38%) patients, 2 to 6 days preoperatively in 27 (48%) patients, and greater than 6 days preoperatively in 8 (14%) patients. ST patients were more likely to present with stroke (93% vs. 45%; P < 0.001) and have higher preoperative Rankin scores. Unadjusted rate of bleeding/return to operating room was 3% for ST group and 3% for non-ST group (P = 0.60). Unadjusted rate of stroke was 4% for ST group and 3% for the non-ST group (P = 0.91), while perioperative mortality was 5% for ST group and 1% for non-ST group (P = 0.009). After adjusting for patient factors, preoperative antiplatelet/anticoagulation, and operative factors, ST was not associated with an increased odds of perioperative bleeding/return to the operating room (odds ratio 0.37; 95% confidence interval: 0.02-1.63; P = 0.309) or stroke (odds ratio 0.62; 95% confidence interval: 0.16-2.40; P = 0.493). CONCLUSIONS: ST does not convey a higher risk of complications after CEA or tfCAS. After controlling for other factors, patients that received ST had similar rates of local complications and stroke when compared to non-ST patients. Early carotid intervention is safe in patients that have received ST, and delays should be avoided in symptomatic patients given the high risk of recurrent stroke.

New Ischemic Cerebral Lesions in Postprocedural Magnetic Resonance Imaging in Carotid Artery Stenting Versus Carotid Endarterectomy: A Systematic Review and Meta-Analysis.

BACKGROUND: Recent randomized controlled trials (RCTs) have demonstrated similar outcomes in terms of ischemic stroke incidence after carotid endarterectomy (CEA) or carotid artery stenting (CAS) in asymptomatic carotid disease, while CEA seems to be the first option for symptomatic carotid disease. The aim of this meta-analysis is to assess the incidence of silent cerebral microembolization detected by magnetic resonance imaging (MRI) following these procedures. METHODS: A systematic search was conducted using PubMed, Scopus, and Cochrane databases, including comparative studies involving symptomatic or asymptomatic patients undergoing either CEA or CAS and reporting on new cerebral ischemic lesions in postoperative MRI. The primary outcome was the newly detected cerebral ischemic lesions. Pooled effect estimates for all outcomes were calculated using the random-effects model. Prespecified random effects metaregression and subgroup analysis were conducted to examine the impact of moderator variables on the presence of new cerebral ischemic lesions. RESULTS: 25 studies reporting on a total of 1827 CEA and 1500 CAS interventions fulfilled the eligibility criteria. The incidence of new cerebral ischemic lesions was significantly lower after CEA compared to CAS, regardless of the time of MRI assessment (first 24 hours; OR: 0.33, 95% CI: 0.17-0.64, P < 0.001), (the first 72 hours, OR: 0.25, 95% CI 0.18-0.36, P < 0.001), (generally within a week after the operation; OR: 0.24, 95% CI: 0.17-0.34, P < 0.001). Also, the rate of stroke (OR: 0.38, 95% CI: 0.23-0.63, P < 0.001) and the presence of contralateral new cerebral ischemic lesions (OR: 0.16, 95% CI 0.08-0.32, P < 0.001) were less frequent after CEA. Subgroup analysis based on the study design and the use of embolic protection device during CAS showed consistently lower rates of new lesions after CEA. CONCLUSIONS: CEA demonstrates significant lower rates of new silent cerebral microembolization, as detected by MRI in postoperative period compared with CAS.

The mid-term results of the Carotid Asymptomatic Stenosis (CARAS) observational study.

INTRODUCTION: Carotid endarterectomy (CEA) in patients with asymptomatic carotid stenosis (ACAS) remains a subject of debate. Current recommendations are based on randomized trials conducted over 20 years ago and improvements in medical therapies may have reduced the risk of cerebral ischemic events (CIE). This study presents a mid-term analysis of results from an ongoing prospective observational study of ACAS patients to assess their CIE risk in a real-world setting. METHODS: This is a prospective observational cohort study of patients with ACAS >60 % (NASCET criteria) identified in a single duplex ultrasonography (DUS) vascular laboratory (trial registered: NCT04825080). Patients were not considered for CEA due to their short life expectancy (<3 year) or absence of signs of plaque vulnerability (ulceration, ipoechogenic core). Patient enrollment started in January 2019 and ended in March 2020 with a targeted sample size of 300 patients.A 5-year follow-up was scheduled. Clinical characteristics, risk factors, and medical therapies were documented, and, when necessary, the best medical therapy (BMT), involving antiplatelet agents, blood pressure control, and statins, was recommended during clinical visits. The primary endpoint was to asses CIEs (including strokes, transient ischemic attacks, amaurosis-fugax) ipsilateral to ACAS along with plaque progression rate and patients survival. Follow-up involved annual clinical visit and carotid DUS examination, complemented by telephone interviews at six-month intervals. RESULTS: The study included 307 patients, with an average age of 80 ± 7 years, of whom 55 % were male. Contralateral stenosis exceeding 60 % was present in 61 (20 %) patients. Seventy-seven percent of patients were on BMT. At a mean follow-up of 41±9 months, 7 ispilateral strokes and 9 TIAs occurred, resulting in 14 CIEs (2 patients experienced both TIA and stroke). According to Kaplan-Meier analysis, the 4-year CIE rate was 6±2 %, with an annual CIE rate of 1.5 %. Fifty-eight (19 %) patients had a stenosis progression which was associated with a higher 4-year estimated CIE rate compared to patients with stable plaque (10.3 % vs 3.2 %, P=.01). Similarly, a contralateral carotid stenosis >60 % was associated with a higher 4-year estimated CIE rate: 11.7 % vs 2.9 %, P=.002. These factors were independently associated with high risk for CIE at the multivariate COX analysis: Hazard Ratio (HR): 3.2; 95 % Confidence Interval: 1.1-9.2 and HR: 3.6; 95 % CI: 1.2-10.5. CONCLUSION: The mid-term results of this prospective study suggest that the incidence of CIE in ACAS patients should not be underestimated, with plaque progression and contralateral stenosis serving as primary predictors of CIEs.