Carotid Artery Stenting Procedures Research Articles

Dual-layered micromesh stent technology for embolic prevention in carotid revascularization: technical experience and clinical outcomes from a high-volume interventional radiology center.

Carotid artery stenting (CAS) has become a cornerstone of carotid revascularization for stroke prevention. Despite the advantages of CAS, large-scale randomized trials involving prior (single-layer) generation of carotid stents demonstrated its higher risk of periprocedural cerebrovascular events compared to carotid endarterectomy (CEA). Dual-layer mesh-covered stents (DLSs) showed promising results in terms of 30-day embolic events. This study aims to evaluate 30-day clinical efficacy of DLS against a closed-cell single-layer stent, based on large-volume data. The study center is part of the Italian National Outcomes Evaluation Program (PNE). CAS procedures performed between November 2017 and September 2023 were retrospectively analyzed. Our primary endpoint was 30-day survival free of death, stroke, and myocardial infarction (MI). Periprocedural stroke rate, technical success and restenosis rate of CAS procedures performed with DLSs and first-generation stents (FGSs) were also evaluated. Over a total of 1101 CAS procedures (55 men; 745 males; mean age of 79±7.8 years), 80.2% were treated with DLS and 48.6% were symptomatic. The cumulative stroke-, MI- and death-free 30-day survival was 98.9%, Technical success was achieved in 98.9% of cases. The DLS group showed significantly lower 30-day death, stroke and death+stroke and periprocedural minor stroke rates compared to FGS group (P=0.04; P=0.04; P=0.003 and P=0.0002, respectively). The use of DLS in patients undergoing CAS in our large-volume center showed a high technical success rate and minimal cerebral embolic complications by 30 days. High volumes and an experienced interventional team may contribute to these favorable outcomes.

Mechanical marvels: robots in carotid artery stenting - a systematic review of effectiveness in neuroendovascular interventions

Aim: Carotid artery disease, or carotid stenosis, is a critical medical condition carrying the risk of stroke and fatality. The underlying pathology involves the accumulation of atheromatous plaques, leading to luminal constriction and disrupted blood flow. Endovascular interventions, such as carotid artery stenting (CAS), aim to restore vessel patency. Robotic assistance in CAS surgeries is rapidly evolving globally, offering precision and fatigue-free capabilities. Despite growing interest, a dedicated systematic review on robotic applications in CAS is notably absent. Methods: Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a comprehensive search strategy involving five databases. Data extraction encompassed study origin, patient demographics, procedural details, procedure times, complications, fluoroscopy, and radiation parameters. Results: Over 199 articles were identified from five databases. Seven studies meeting inclusion criteria were analyzed. The predominant robotic system, CorPath GRX, demonstrated advantages such as remote operation, precision, and compatibility with various catheter sizes. Magellan Robotic System, employed in one study, showcased remote-controlled capabilities. These studies involved a total of 44 patients undergoing carotid artery stenosis procedures with robotic assistance. Reported complications included access site conversion, Angio-Seal device failure, and residual stenosis. Mean operation time varied from 34 to 85 min. Conclusions: The integration of robotic assistance in carotid interventions, as demonstrated by the CorPath GRX and Magellan Robotic System, holds significant promise in improving the precision and safety of CAS procedures. However, the limited number of studies, the high risk of bias, and the need for further research and standardization highlight the evolving nature of this technology.

690 Residual In-stent Carotid Stenosis and Cigarette Smoking are Predictors of Restenosis After Stenting (CAS)

INTRODUCTION: Atherosclerosis of the internal carotid artery remains a significant contributor to stroke morbidity and mortality. While patient risk factors have been identified to be associated with carotid restenosis after carotid stenting (CAS), conflicting theroies exist on whether residual stenosis is an independent risk factor. METHODS: A single-center, prospectively maintained database was retrospectively reviewed for CAS procedures over a 12-year period. Patient demographic, procedural characteristics, radiographic and clinical details were noted. Comparison of baseline characteristics of patients with and without carotid restenosis were performed using chi-squared test for categorical variables and student t-test for continuous variables. Univariate and multivariate analyses were performed to determine risk factors associated with restenosis, defined as >70% on digital subtraction angiography. RESULTS: 1017 consecutive carotid artery stenting (CAS) procedures were performed in 905 patients over the 12-year period, with 738 CAS procedures in 632 patients included after exclusion criteria. Overall restenosis rate was 17%, with a 14% restenosis rate at 2 years-time. Multivariable analysis demonstrated former/current smoking status (OR=2.1 [95%CI 1.2-3.9]), moderate contralateral stenosis (OR 3.0 [95%CI 1.4-6.7]), severe contralateral stenosis (OR3.0 [1.4-6.3]), and residual stenosis (OR 454 [95% 85-2413]) were associated with restenosis. AUC for the multivariable model was 0.78. Cut-point degree for residual stenosis was ∼30%, where there was a 9% and 35% rate of restenosis in those less than, and greater than, 30% residual stenosis, respectively. CONCLUSIONS: We present the largest single-center data in the US to date on carotid artery stenosis treated with CAS, and factors associated with restenosis. Residual in-stent carotid stenosis and smoking history were independent predictors. Maximizing treatment of initial stenosis within stent for carefully selected patients and aggressive smoking cessation education are important steps in preventing future carotid restenosis.

Treatment Results of Carotid Artery Stenting with an Open-Cell Stent: Analysis of 734 Consecutive Cases at a Single Center

In carotid artery stenting (CAS) for internal carotid artery stenosis (ICS), the stent is often selected according to the plaque properties and arterial tortuosity. In our institute, an open-cell stent is used as the first-line stent regardless of the characteristics of the lesion. This study was performed to examine the outcome of CAS with an open-cell stent as the real-world results. In total, 811 CAS procedures using open-cell stents were performed for ICS from April 2002 to December 2019. Of these patients, we excluded those with hyperacute conditions for which CAS was performed within 3 days of onset, those in whom acute mechanical thrombectomy was performed simultaneously with CAS, and those with stenosis due to arterial dissection. Thus, 734 patients were retrospectively analyzed. Perioperative and long-term outcomes and risk factors for perioperative infarction were investigated. The periprocedural stroke rate and mortality rate were 3.7% (27/734) and 0.4% (3/734), respectively. Low-echoic plaque was a significant risk factor for periprocedural stroke in both univariate (P < 0.03) and multivariate (odds ratio, 2.69; 95% confidence interval, 1.14-6.66; P = 0.02) analyses. Cerebral infarction and high-grade restenosis were observed in 15 (2.0%) and 17 (2.3%) patients during a median 50-month follow-up. CAS with open-cell stents showed good results in terms of both the postoperative stroke incidence and long-term severe restenosis rate. However, low-echoic plaque was a risk factor for perioperative stroke incidence, which should be considered when deciding on the indication for CAS with an open-cell stent.

Analysis of the therapeutic effect of aspiration thrombectomy for early carotid stent thrombosis

Objective: To investigate the clinical characteristics and the efficacy of thrombus aspiration in patients with early intrastent thrombosis (EST) following carotid artery stenting (CAS). Methods: This study is a retrospective case series, collecting clinical data of five patients who developed EST after CAS in the Department of Neurosurgery, Beijing Chaoyang Hospital, Capital Medical University from January 2021 to September 2023.All patients were male, with an age of (64.0±11.9) years (range:48 to 77 years), accounting for 2.0% (5/244) of CAS procedures during the same period.Among them, three patients did not receive standard dual antiplatelet therapy before the procedure, and one had an inadequate ADP inhibition rate (45.6%).Four patients received XACT carotid stents, while one received a Wallstent carotid stent.All five patients showed significant residual stenosis ranging from 43% to 55% after CAS.Emergency thrombus aspiration was performed in all cases, and data regarding perioperative conditions, vascular patency, and clinical outcomes were collected. Results: The interval between CAS and the occurrence of EST ranged from 3 hours to 14 days.The main clinical symptoms included sudden onset of consciousness disorders and contralateral limb weakness.None of the patients received preoperative intravenous thrombolysis, and thrombus aspiration was performed during the procedure to restore vascular patency.Four cases underwent balloon angioplasty during the procedure, and two cases utilized overlapping stents.Two patients experienced intraoperative embolization of thrombus to the C2 segment.In one case, the embolized thrombus was retrieved using an intracranial thrombectomy stent, while in another case, it was aspirated using a guiding catheter.Postoperatively, all patients had a thrombolysis in cerebral infarction grade of 3, and symptoms improved in four cases.One patient showed no improvement in symptoms, and MRI revealed extensive new infarction in the right frontal and insular regions, adjacent to the right lateral ventricle.Regular follow-up examinations after discharge did not reveal restenosis or embolism within the stent.The follow-up period ranged from 7.6 to 21.2 months, with modified Rankin scale scores of 0 to 1 point in four cases and 2 points in one case, indicating good recovery in all patients. Conclusions: Acute intrastent thrombosis is a rare complication after carotid artery stenting.The combined use of percutaneous thrombus aspiration and endovascular techniques, such as balloon angioplasty and stent overlapping, can rapidly restore vessel patency with favorable outcomes.However, further large-scale clinical studies are needed to confirm the effectiveness of these treatments for acute intrastent thrombosis.

Abstract TP50: Ensuring Safe Post-Procedure Throughput for CEA and CAS Patients

Background: A new policy was implemented in November 2021 to reduce the length of post-anesthesia-care-unit (PACU) stay from 6 hours to 4 hours to reduce the nursing care burden and decrease the length of stay, yet how it affected patients’ events after PACU discharge needed close evaluation. Thus, the QI project aimed to retrospectively examine unexpected or safety events of patients who underwent carotid artery stenting or carotid endarterectomy procedures before versus after implementing the new policy. Objective: To compare and examine the rates of unexpected or safety events that occurred before (5/1/2021 - 10/31/2021; PRE) vs. after (2/1/2022 - 7/31/2022; POST) adoption of the new policy. Methods: A determination of IRB review was granted for the retrospective QI project. The unexpected or safety events included patient issues (rapid response calls, STAT calls to service, or bounce back to a higher level of care) and issues with VS or neuro assessment variability. For group comparison, Fisher’s Exact tests were used for dichotomous information, and the Mann-Whitney U tests were performed for continuous data. Results: A total of 145 patients were identified during the study period composing 75 (51.7%) PRE and 70 (48.3%) POST patients. The rates of VS or neuro assessment variability were similar in both groups (PRE: 1.3% vs. POST: 1.3%, p =1.000). Though we saw a lower rate of patient issues within 24 hours on the floor in POST (4.3%), the difference was not statistically significant (PRE: 8.0%, p =0.496). Conclusion: Inefficient patient throughput can impact currently strained hospital resources. Findings of the QI project confirmed that the new policy did not incur a higher rate of instability on the nursing unit. This data lends confidence to Vascular Surgery and Stroke programs as they seek to streamline patient care and manage hospital resources.

Mid-Term Results of an Italian Multicentric Experience with the RoadsaverTM Dual-Layer Carotid Stent System.

Carotid artery stenting (CAS) using first-generation single-layer stents is widely accepted as a good alternative to standard carotid endarterectomy (CEA) but it is associated with worse outcomes in terms of both plaque prolapse and cerebral embolization. To evaluate the perioperative and midterm outcomes of CAS using the new-generation RoadsaverTM dual-layer micromesh-covered carotid stent. Herein, we present the results of an observational, retrospective, multicentric study on non-consecutive patients who underwent the CAS procedure between January 2017 and December 2022 at three Italian, high-volume vascular surgery centers. The inclusion criteria were the patients' eligibility for the CAS procedure in accordance with the current Italian guidelines, and the implantation of a Roadsaver stent. Both symptomatic and asymptomatic patients were included in the study. The patients requiring reintervention for carotid restenosis following CEA were also included. Perioperative data regarding procedural success was defined as the successful implantation of the device in the desired position, less than 30% residual stenosis, and the absence of intraoperative neurological complications. The primary outcome was any adverse cerebrovascular event such as stroke or transient ischemic attack (TIA) during the procedure and/or after discharge. The secondary outcomes were the need for further intervention, and all-cause death following procedure. Three-hundred-fifty-three (353) patients were included in our study; the mean age was 74.3 years. A total of 5.9% of the patients were symptomatic on their operated side, while 7.3% had contralateral carotid occlusion. A cerebral embolic protection device (CPD) was employed in all patients. A total of 13.3% of the patients were operated on for restenosis after CEA Technical success was achieved in 96.9% of the cases with an intraoperative report of six TIAs (1.7%) and six ipsilateral strokes (1.7%). The mean hospital stay was 1.8 days. The thirty-day follow up showed one TIA and one more stroke. At the mean 35-month follow-up time, the primary outcome was present in six patients (1.7%), where four TIAs (1.1%) and two strokes (0.5%) were reported. Restenosis occurred in five patients (1.4%). Death for any cause was reported in 11 patients (3.1%). As most recent, high-quality studies show, the CAS procedure with second-generation devices such as the Roadsaver stent is safe and effective in preventing carotid-related cerebrovascular events in both symptomatic and asymptomatic patients. The intraoperative and postoperative cerebrovascular complication rate in high volume centers is very low, ensuring confidence in its employment for the CAS procedure along with a CPD as a valid alternative to CEA.

Residual In-Stent Carotid Stenosis and Cigarette Smoking are Independent Predictors of Carotid Restenosis After Carotid Artery Stenting—Results from 738 Carotid Artery Stenting Procedures at a Single Center

BACKGROUND AND OBJECTIVES: Carotid artery stenting (CAS) has become a viable alternative to carotid endarterectomy for the management of carotid stenosis. Our aim was to determine the rate of radiographic restenosis after CAS and clinical, radiographic, and procedural predictors of in-stent restenosis. METHODS: Our single-center, prospectively maintained database was retrospectively reviewed for CAS procedures performed in symptomatic and asymptomatic patients over 12 years (2010-2022). Baseline demographic data, procedural characteristics, and preprocedural and postprocedural radiographic and clinical details were noted. Baseline characteristics of patients with and without carotid restenosis were compared using the χ2 test for categorical variables and the Student t-test for continuous variables. Univariate and multivariate analyses were performed to determine risk factors associated with restenosis, defined as &gt;70% on digital subtraction angiography. RESULTS: A total of 1017 consecutive CAS procedures were performed in 905 patients during the 12-year period, with 738 in 632 patients included in our study. Our cohort's overall restenosis rate was 17%, with a 14% restenosis rate at 2 years. On multivariate regression analysis, former or current smoking status (odds ratio [OR] = 2.3, 95% CI 1.2-4.1), plaque irregularity (OR 0.55, 95% CI 0.33-0.91), moderate (50.1%-75%) contralateral stenosis (OR 3.2, 95% CI 1.4-7.2), severe (75.1%-99.9%) contralateral stenosis (OR 2.8, 95% CI 1.3-6.0), and residual (&gt;70%) in-stent stenosis after initial stenting (OR 433, 95% CI 80-2346) were significantly associated with carotid restenosis. Area under the curve for the multivariate regression model analysis was 0.78. Patients with &lt;28.6% initial (residual) in-stent stenosis (45/517 cases) had a 9% restenosis rate, whereas those with &gt;28.6% initial in-stent stenosis (77/221 cases) had a 35% restenosis rate. CONCLUSION: In this large, single-center study of carotid artery stenosis treated with CAS, residual in-stent carotid stenosis of approximately 30% and smoking status were independent predictors for restenosis. Maximizing treatment of initial stenosis and smoking cessation education are important steps in preventing future carotid restenosis.

Elective carotid stenting fulfills quality standards defined in guidelines.

According to evidence from randomized trials and current guidelines, elective carotid artery stenting (CAS) is still considered second-line therapy compared with carotid endarterectomy (CEA). However, the publication of randomized comparative trials for patients with symptomatic stenoses occurred well over 10 years ago. In view of problems regarding German quality assurance when differentiating elective from emergency interventions and low case numbers for CAS indications, it seemed reasonable to present neurologically controlled CAS results and to investigate whether elective CAS consistently fulfills the strict quality criteria and what differences exist with respect to emergency CAS interventions in acute ischemic stroke. Between 01/2012 and 07/2022, 141 elective CAS procedures were performed to treat patients with symptomatic (n = 123) and asymptomatic (n = 18) stenoses. Protection by a filter system was achieved in 134 of these elective procedures (95 %). During the same period, 158 patients underwent carotid stenting for acute stroke. Complication rates were determined using neurologically controlled data. CAS-related complications (stent thrombosis, stent-associated vascular damage, thromboembolism, and symptomatic hemorrhage) were extracted from emergency interventions, and clinical outcome (NIHSS progression) was determined during the inpatient stay. The rate of stroke and death determined during the inpatient stay for elective symptomatic patients was 0.8 %. Early treatment within the first 7 days after the index event, age > 70 years, and operator experience were not significant risk factors for the occurrence of complications. No complications were observed after CAS of asymptomatic stenoses. The procedure-related complication rate for emergency procedures was 7.8 %, which was significantly higher than after elective CAS, as expected (p < 0.006). Even with limited indications and limited case numbers, compliance with the strict quality criteria of the current S3 Guideline 2022 for elective CAS interventions is possible for both symptomatic and asymptomatic stenoses in an experienced center. Emergency CAS interventions have significantly higher complication rates under other conditions and must be considered separately with regard to quality assurance. · Elective carotid stenting fulfills the strict quality criteria of the current S3 guideline 2022.. · Emergency carotid stenting has significantly higher complication rates than elective procedures.. · Elective and emergency carotid stenting cannot be meaningfully compared.. · Keil F, Stahn S, Reitz SC et al. Elective carotid stenting fulfills quality standards defined in guidelines. Fortschr Röntgenstr 2024; 196: 471 - 481.

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

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

Abstract 133: Safe Guiding Catheter Navigation in Carotid Artery Stenting for Low‐positioned Common Carotid Lesions: “No‐touching” Technique

Introduction In carotid artery stenting (CAS), a guiding catheter (GC) placement to the appropriate position is the first step of the successful procedure. In normal settings, GC is navigated along with stable support of guidewire and inner‐catheter which are sent distally to external carotid artery. In cases of low‐positioned common carotid artery (CCA) lesions, however, safe GC placement without touching lesions is often difficult. Herein, we report the technique of safe GC navigation of “no‐touching” to the low‐position CCA plaque using Newton‐shaped stiff inner‐catheter. Methods We reviewed CAS procedures with low‐positioned CCA lesions using “no‐touching” technique: a balloon guiding catheter (BGC) was coaxially advanced in combination with 4‐French Newton‐shaped stiff inner‐catheter (Newton‐T®, Medikit, Tokyo, Japan). With its advantage of shape and stiffness buffering the kickback force with support of lesser curvature of aortic arch, BGCs were navigated to the appropriate position without touching to the plaques. Results The technique were applied in 5 cases (age: 73‐85 years old, 4 males, 4 left‐sided lesions) among the 37 consequent CAS cases. GC fixation by GooseNeck snare was used concurrently in 2 cases. BGCs were successfully navigated without touching plaques in all cases. CAS procedures were subsequently undergone and no complication was observed. Conclusion GC navigation using “no‐touching” technique with Newton‐T catheter was safe and useful in CAS procedures for low‐positioned CCA lesions.

Abstract 234: Antithrombotic use in Emergent Cervical Carotid Artery Stenting in Thrombectomy

Introduction Current literature suggests a benefit in functional outcomes and reperfusion rates when carotid artery stenting (CAS) and mechanical thrombectomy (MT) are performed emergently. However, rates of symptomatic intracranial hemorrhages have been inconclusive. Antithrombotic protocols used in CAS and MT tend to be heterogenous among physicians. There is no standardized data on antithrombotic therapy use during CAS and MT procedures with less associated rates of symptomatic hemorrhagic transformation. We aimed to compare the efficacy and safety of antithrombotic use in patients requiring CAS and MT. Additionally, we sought to analyze clinical and mortality outcomes in CAS and MT retrospectively at our institution. Methods We searched for patients who underwent emergency cervical ICA stent placement and intracranial thrombectomy with stent‐retriever and/or aspiration devices in our institution between 2019‐2023. Clinicoangiographic and antithrombotic data were analyzed. Good clinical outcomes were a &lt; 4 points of NIHSS at 24 hours, mRS (0‐3) at 90 days, and disposition to home or inpatient rehabilitation. Characteristics of hemorrhagic transformation (HT) according to the European Cooperative Acute Stroke Study (ECASS). Clinical, radiographic, and mortality outcomes were described. Results Twenty‐seven patients were treated. The mean age was 64 years, nine females: mean occlusion time 400 minutes, mean fluoro time 32 minutes. Fourteen patients received IV tissue‐type plasminogen (tPA) activator. The admission NIHSS score mean was 16. Stent placement was feasible in all cases. Thrombolysis in Cerebral Infarction score of 2B was achieved in 18 patients (66.7%); the rest had a TICI 3 score. Twelve patients had improved 4 NIHSS points between admission and 24 hours. Dual antiplatelet therapy with aspirin and clopidogrel was used in 15 patients before stenting. While six patients received aspirin and ticagrelor, and the rest received eptifibatide drip. Seven (26%) patients had symptomatic intracranial hemorrhages. Antithrombotic type of treatment had no significant association with bad outcomes (p‐value: 0.872), neither did IV tPA use (p‐value: 0.853). Fourteen patients had good clinical outcomes (mRS 0‐3) at discharge, while eight died. At 90 days follow‐up, the median mRS was 3. Conclusion Our analysis suggests no significant association between symptomatic hemorrhagic transformation with IV tPA or heterogenous antithrombotic use. Our retrospective study has several limitations, including sample size and heterogeneous pathology. Larger studies are needed to stratify symptomatic hemorrhages' high‐risk profile in CAS and MT.

Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials

ObjectiveSex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. MethodsWe analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. ResultsWe included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). ConclusionsProspective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

Medication error during nonoperating room anesthesia—a case report

Despite a lot has already been done in the field of safety improvement during anesthesia, medication errors still occur during everyday practice. Syringe or ampule swaps are usually the most frequent type of medication error. Recent studies prove that nearly 80% of these errors are preventable. In our case, 30 mg (3 ml) of dopamine (Dopamin Fresenius 10 mg/ml) was injected to the patient’s intravenous line instead of 3 mg (3 ml) midazolam (Midazolam Accord 1 mg/ml) during the preparation for the carotid artery stenting procedure in nonoperating room environment. The error was realized immediately after the application. Besides temporary fulminant hypertensive reaction, tachycardia, restlessness, skin rush, troponin leak, and temporary ST-segment depression, there were no permanent consequences to the patient's health. The team was able to perform the planned procedure 30 min after the event. This medication error of ampule swap, packages of which were stored in the medication cupboard one above the other, was caused by alignment of the latent vulnerable layers of the safety system (Swiss Cheese Model of System Error and Hot Cheese Model) plus the influence of the environmental factors and active failures done by the anesthesia staff. After this event, new safety measures were established by introducing color-coded ISO 26825:2020 syringe labeling, new anesthesia trolleys with color-coded medication compartments, and color-coded medication storage cupboards. Besides this safety committee was formed for the promotion of medication safety education programs.

Vulnerable carotid plaque characteristics on magnetic resonance vessel wall imaging: potential predictors for hemodynamic instability during carotid artery stenting.

This cross-sectional study sought to explore the possible risk factors assessed with magnetic resonance (MR) vessel wall imaging for hemodynamic instability (HI) during carotid artery stenting (CAS). Patients with carotid stenosis who were referred for CAS from January 2017 to December 2019 were recruited and underwent carotid MR vessel wall imaging. The vulnerable plaque features, including lipid-rich necrotic core (LRNC), intraplaque hemorrhage (IPH), fibrous cap rupture, and plaque morphology, were evaluated. The HI was defined as a drop of systolic blood pressure (SBP) of ≥30 mmHg or the lowest SBP measurement of <90 mmHg after stent implantation. The carotid plaque characteristics were compared between the HI and non-HI groups. The association between carotid plaque characteristics and HI was analyzed. A total of 56 participants (mean age 68.7±8.3 years; 44 males) were recruited. Patients in the HI group (n=26, 46%) had a significantly greater wall area [median 43.2 (IQR, 34.9-50.5) vs. 35.9 (IQR, 32.3-39.4) mm2; P=0.008], total vessel area (79.7±17.2 vs. 69.9±17.3 mm2; P=0.03), prevalence of IPH (62% vs. 30%; P=0.02), prevalence of vulnerable plaque (77% vs. 43%; P=0.01), and volume of LRNC [median 344.7 (IQR, 155.1-665.7) vs. 103.1 (IQR, 53.9-162.9) mm3; P=0.001] in carotid plaque compared to those in non-HI group (n=30, 54%). Carotid LRNC volume (OR =1.005, 95% CI: 1.001-1.009; P=0.01) and presence of vulnerable plaque (OR =4.038, 95% CI: 0.955-17.070; P=0.06) were significantly and marginally associated with HI, respectively. Carotid plaque burden and vulnerable plaque features, particularly a larger LRNC, might be effective predictors for HI during the CAS procedure.

Protamine Sulfate Following Carotid Artery Stenting: Does the Patient’s Gender Matter?

Protamine sulfate can be administrated to decrease the risk of bleeding after the carotid artery stenting (CAS) procedure. Although a few studies reported data regarding the efficacy and safety of protamine, the existing literature assessing its impact under more personalized patient circumstances is limited. Therefore, in this study, we aimed to identify the potential factors where the patients are more likely to benefit from protamine sulfate after CAS procedures. A retrospective review of Vascular Quality Initiative data between 2016 and 2022 to identify all patients who underwent CAS procedures was performed. The patients were divided into two groups based on the surgical approach: transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR). A multivariate model was conducted to identify the perioperative predictors of bleeding complications in each cohort. In addition, a propensity score matching was performed to compare the rates of thrombotic events between protamine vs no protamine groups in both cohorts. A total of 61,686 patients were identified; 36.6% were female. Approximately 53% of the patients underwent TCAR (protamine: 85.6%; no protamine: 14.4%), whereas TF-CAS was performed in 46.8% (protamine: 18.9%; no protamine: 81.1%). Protamine use was associated with a decreased risk of bleeding complications after TCAR (0.26 [0.2-0.3]; P < .001) but not TF-CAS (1.06 [0.8-1.3]; P = .6164). However, the protamine beneficial impact is more apparent among the female patients regardless of the surgical approach (Table). In addition, no significant increase was noted in the thrombotic complications in both TF-CAS (protamine vs no protamine: death, 7.9% vs 11.5%; myocardial infarction, 0.5% vs 0.9%; stroke/transient ischemic attack, 2.8% vs 2.9%; P > .05 for all, except death P < .001) and TCAR (protamine vs no protamine: death, 7.7% vs 7.3%; myocardial infarction, 0.4% vs 0.3%; stroke/transient ischemic attack, 2.4% vs 2.9%; P > .05 for all) groups. Protamine sulfate appears to be effective in reducing the bleeding complications in patients who undergo TCAR but not TF-CAS, without an increase in the thrombotic complications. However, this beneficial impact is more significant among female patients regardless of the CAS approach.TablePerioperative predictors of bleeding complications after TCAR and TF-CASaCovariatebNo protamineProtamineAdjusted odds ratio (95% CI)P valueAdjusted odds ratio (95% CI)P value(A) TCAR Sex (female)1.45 (1.2-1.9).00501.08 (0.9-1.3).4639 Race (Asian) (Ref: White)4.29 (1.4-13.1).01041.31 (0.6-3.0).5139 Symptomatic CHF1.67 (1.1-2.6).02451.21 (0.8-1.7).3206(B) TF-CAS Sex (female)1.76 (1.4 – 2.2)<.0011.14 (0.8 – 1.7).5277ACEI, Angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; CHF, congestive heart failure; CI, confidence interval; COPD, chronic obstructive pulmonary disease; TCAR, transcarotid artery revascularization; TF-CAS, transfemoral carotid artery stenting.aOnly the perioperative predictors that were statistically significant on the univariate and multivariate analysis are shown in this table.bOther covariates: age ≥65, Hispanic ethnicity, comorbidities (hypertension, diabetes, dialysis status, smoking, and COPD), perioperative medications (aspirin, antiplatelet, statin, β-blockers, ACEIs/ARBs), and type of anesthesia. Open table in a new tab

Young patients undergoing carotid stenting procedures have an increased rate of procedural failure at 1-year follow-up

ObjectiveThe outcomes of patients with premature cerebrovascular disease (age ≤55 years) who undergo carotid artery stenting are not well-defined. Our study objective was to analyze the outcomes of younger patients undergoing carotid stenting. MethodsThe Society for Vascular Surgery Vascular Quality Initiative was queried for transfemoral carotid artery stenting (TF-CAS) and transcarotid artery revascularization (TCAR) procedures between 2016 and 2020. Patients were stratified based on age ≤55 or >55 years. Primary endpoints were periprocedural stroke, death, myocardial infarction (MI), and composite outcomes. Secondary endpoints included procedural failure (defined as ipsilateral restenosis ≥80% or occlusion) and reintervention rates. ResultsOf the 35,802 patients who underwent either TF-CAS or TCAR, 2912 (6.1%) were ≤55 years. Younger patients were less likely than older patients to have coronary disease (30.5% vs 50.2%; P < .001), diabetes (31.5% vs 37.9%; P < .001), and hypertension (71.8% vs 89.8%; P < .001), but were more likely to be female (45% vs 35.4%; P < .001) and active smokers (50.9% vs 24.0%; P < .001) Younger patients were also more likely to have had a prior transient ischemic attack or stroke than older patients (70.7% vs 56.9%; P < .001). TF-CAS was more frequently performed in younger patients (79.7% vs 55.4%; P < .001). In the periprocedural period, younger patients were less likely to have a MI than older patients (0.3% vs 0.7%; P < .001), but there was no significant difference in the rates of periprocedural stroke (1.5% vs 2.0%; P = .173) and composite outcomes of stroke/death (2.6% vs 2.7%; P = .686) and stroke/death/MI (2.9% vs 3.2%; P = .353) between our two cohorts. The mean follow-up was 12 months regardless of age. During follow-up, younger patients were significantly more likely to experience significant (≥80%) restenosis or occlusion (4.7% vs 2.3%; P = .001) and to undergo reintervention (3.3% vs 1.7%; P < .001). However, there was no statistical difference in the frequency of late strokes between younger and older patients (3.8% vs 3.2%; P = .129). ConclusionsPatients with premature cerebrovascular disease undergoing carotid artery stenting are more likely to be African American, female, and active smokers than their older counterparts. Young patients are also more likely to present symptomatically. Although periprocedural outcomes are similar, younger patients have higher rates of procedural failure (significant restenosis or occlusion) and reintervention at 1-year follow-up. However, the clinical implication of late procedural failure is unknown, given that we found no significant difference in the rate of stroke at follow-up. Until further longitudinal studies are completed, clinicians should carefully consider the indications for carotid stenting in patients with premature cerebrovascular disease, and those who do undergo stenting may require close follow-up.

Patient Selection Criteria and Procedural Standardization for Carotid Artery Stenting-A Single Center Experience.

The gold standard for the treatment of carotid artery stenosis is the carotid endarterectomy (CEA). According to current guidelines, carotid artery stenting (CAS) is an alternative. Randomized control trials (RCTs) show significantly higher rates of peri-interventional strokes after CAS compared to CEA. However, these trials were usually characterized by a great heterogeneity in the CAS procedure. In this retrospective analysis from 2012 to 2020, 202 symptomatic and asymptomatic patients were treated with CAS. Patients were carefully pre-selected according to anatomical and clinical criteria. In all cases, the same steps and material were used. All interventions were performed by five experienced vascular surgeons. Primary endpoints of this study were perioperative death and stroke. Asymptomatic carotid stenosis was present in 77% of the patients and symptomatic in 23%. The mean age was 66 years. The average degree of stenosis was 81%. The CAS technical success rate was 100%. Periprocedural complications occurred in 1.5% of cases, including one major stroke (0.5%) and two minor strokes (1%). The results of this study indicate that through a strict patient selection based on anatomical and clinical criteria, CAS can be performed with very low complication rates. Furthermore, standardization of the materials and the procedure itself is crucial.

Percutaneous Superficial Temporal Artery Access Facilitating Carotid Artery Stenting Performed From Distal Radial Artery.

The purpose of the study is to describe carotid artery stenting (CAS) via distal transradial access (dTRA) facilitated by additional superficial temporal artery (STA) access, in a patient with complex aortic arch vessel anatomy. A 72-year-old woman with a prior history of complex cervical surgery and radiotherapy due to laryngeal malignancy, presented with a symptomatic 90% stenosis of the left internal carotid artery (ICA). Due to high cervical lesion, the patient was rejected from carotid endarterectomy. Angiography demonstrated 90% stenosis of the left ICA and a type III aortic arch. After failure of left common carotid artery (CCA) cannulation with appropriate catheter support via dTRA and transfemoral approaches, CAS was attempted a second time. After percutaneous ultrasound guided access to right dTRA and left STA, a 0.035 inch guidewire introduced to the left CCA from the contralateral dTRA was snared and externalized via left STA to improve wire support for guiding advancement. Thereafter, the left ICA lesion was successfully stented with a 7×30 mm self-expanding stent via right dTRA. All vessels involved were patent at 6-month follow-up. The STA may be a promising adjunctive access site to increase transradial catheter support for CAS or neurointerventional procedures in the anterior circulation. Transradial cerebrovascular interventions have been gaining popularity, however, unstable catheter access to distal cerebrovascular structures limits its widespread use. Guidewire externalization technique via additional STA access may improve transradial catheter stabilty and increase procedural success with possibly low access stie complication rate.

Karotid Arter Darlık Oranı ile Perioperatif Stent Komplikasyonları İlişkisi

Objective: This study aimed to examine complications that may occur after carotid artery stenting (CAS) and their relationships with carotid artery stenosis rate.&#x0D; Materials and Methods: Complications, such as cerebral hyperperfusion, stroke, death, stent thrombosis or occlusion and restenosis, were evaluated on the 30th day after CAS and at the end of the first year. &#x0D; Results: Of the 205 CAS procedures, complications developed in 12 patients. The complication rate for the first 30 days after the procedure was 4,87%, and at the end of the first year, it was 5,85%. Of the 12 patients with complications, 8 had carotid stenosis of ≥90%. Death occurred in 4 of 195 patients with carotid artery stenosis. The mortality rate within the first 30 days and during the 1-year follow-up period was 1,53% and 2,05%, respectively. Ischemic stroke occurred in 6 of 195 patients with carotid artery stenosis. After the first 30 days and one year follow-up, ischemic stroke had occurred in 3,07% of patients. Stent thrombosis and occlusion rate was 4,87% in 205 CAS procedures, and 7 of them occurred in the first 24 hours and another 3 occurred within the first 30 days. Restenosis rates were 0,48% and 0,97% at 6 months and the first year, respectively. &#x0D; Conclusion: The complications of CAS have been associated with the urgency of treatment (emergency), symptom presence (symptomatic patients) and high degree of stenosis (≥90%); whereas bilateral stenosis is not associated with complications. In addition, stent thrombosis and occlusion were observed as the most common CAS complication.