Intraoperative Completion Studies and their Associations with Carotid Endarterectomy Outcomes.

OBJECTIVE: This study aimed at assessing outcomes after carotid endarterectomy (CEA) in dependence of center policy with respect to imaging intraoperative completion study (ICS i ) usage. SUMMARY BACKGROUND DATA: Although randomized controlled studies are missing, a beneficial effect was shown for ICS i techniques (i.e., angiography and intraoperative duplex ultrasound) after CEA. METHODS: This secondary data analysis is based on the German statutory quality assurance database. Research was funded by Germany's Federal Joint Committee Innovation Fund (G-BA Innovationsfonds, 01VSF19016 ISAR-IQ). According to their ICS i policy, hospitals were categorized as routine ICSi (>90%), selective ICSi (10-90%), or sporadic ICSi (<10%) centers . Primary study outcome was in-hospital stroke or death. Multivariable regression analyses were performed. RESULTS: Between 2012 and 2016, a total of 119,800 patients underwent CEA. In-hospital stroke or death rates were lower in routine ICSicenters (1.7%) compared to selective (2.1%) and sporadic ICSicenters (2.0%). The multivariable regression analysis showed, that in routine ICSicenters , ICS i use was associated with lower rates of stroke or death (aOR 0.64; 95% CI 0.44-0.93). In selective ICSicenters , ICS i was not associated with the occurrence of either of the assessed outcomes. In sporadic ICSicenters , ICS i was associated with higher rates of stroke or death (aOR 1.91; 95% CI 1.26-2.91). CONCLUSIONS: Lowest in-hospital stroke or death rates are achieved in r outine ICSicenters . While ICS i is associated with a lower perioperative risk in r outine ICSicenters , it might act as a surrogate marker for worse outcomes due to intraoperative irregularities in sporadic ICSicenters . Routine use of ICS i is advisable.

Association between hospital ownership and patient selection, management, and outcomes after carotid endarterectomy or carotid artery stenting : - Secondary data analysis of the Bavarian statutory quality assurance database.

BACKGROUND: This study analyses the association between hospital ownership and patient selection, treatment, and outcome of carotid endarterectomy (CEA) or carotid artery stenting (CAS). METHODS: The analysis is based on the Bavarian subset of the nationwide German statutory quality assurance database. All patients receiving CEA or CAS for carotid artery stenosis between 2014 and 2018 were included. Hospitals were subdivided into four groups: university hospitals, public hospitals, hospitals owned by charitable organizations, and private hospitals. The primary outcome was any stroke or death until discharge from hospital. Research was funded by Germany's Federal Joint Committee Innovation Fund (01VSF19016 ISAR-IQ). RESULTS: In total, 22,446 patients were included. The majority of patients were treated in public hospitals (62%), followed by private hospitals (17%), university hospitals (16%), and hospitals under charitable ownership (6%). Two thirds of patients were male (68%), and the median age was 72 years. CAS was most often applied in university hospitals (25%) and most rarely used in private hospitals (9%). Compared to university hospitals, patients in private hospitals were more likely asymptomatic (65% vs. 49%). In asymptomatic patients, the risk of stroke or death was 1.3% in university hospitals, 1.5% in public hospitals, 1.0% in hospitals of charitable owners, and 1.2% in private hospitals. In symptomatic patients, these figures were 3.0%, 2.5%, 3.4%, and 1.2% respectively. Univariate analysis revealed no statistically significant differences between hospital groups. In the multivariable analysis, compared to university hospitals, the odds ratio of stroke or death in asymptomatic patients treated by CEA was significantly lower in charitable hospitals (OR 0.19 [95%-CI 0.07-0.56, p = 0.002]) and private hospitals (OR 0.47 [95%-CI 0.23-0.98, p = 0.043]). In symptomatic patients (elective treatment, CEA), patients treated in private or public hospitals showed a significantly lower odds ratio compared to university hospitals (0.36 [95%-CI 0.17-0.72, p = 0.004] and 0.65 [95%-CI 0.42-1.00, p = 0.048], respectively). CONCLUSIONS: Hospital ownership was related to patient selection and treatment, but not generally to outcomes. The lower risk of stroke or death in the subgroup of electively treated patients in private hospitals might be due to the right timing, the choice of treatment modality or actually to better structural and process quality.

Bony Stroke: Ischemic Stroke Caused by Mechanical Stress on Brain Supplying Arteries From Anatomical Bone or Cartilage Anomalies.

BACKGROUND: Bone or cartilage anomalies with affection of brain supplying arteries are a potential structural cause for ischemic stroke. In the following, we termed this entity bony stroke. Due to rarity of their description, there is no standardized workup and therapy for bony strokes. METHODS: Retrospectively, we extracted diagnostic and therapeutic workup of all patients considered to have had a bony stroke between January 2017 to March 2022 at our comprehensive care center. RESULTS: In total, 6 patients classified as a bony stroke were identified among 4200 acute patients with ischemic stroke treated during the study period. Each patient had recurrent ischemic strokes in the dependent vascular territory before diagnosis. Diagnosis was achieved by a combination of imaging devices, including sonography, computed tomography, and magnetic resonance imaging. In addition to conventional static imaging, the application of dynamic imaging modalities with the patients' head in rotation or reclination confirmed a vessel affection following head movements in 3 patients (50%). Treatment options were interdisciplinary assessed and included the following: conservative treatment (n=1), endovascular stenting (n=2) or occlusion (n=2), surgical removal of bone/ cartilage (n=2), and surgical bypass treatment (n=1). In follow-up (mean 11.7 months), no patient experienced further ischemia. CONCLUSIONS: As a differential diagnosis, bony strokes may be considered in patients with recurrent ischemic stroke of unknown cause in one dependent vascular territory. Interdisciplinary evaluation and treatment may eliminate risk of stroke recurrence.

Stronger influence of systemic than local hemodynamic-vascular factors on resting-state BOLD functional connectivity.

Correlated fluctuations in the blood oxygenation level dependent (BOLD) signal of resting-state functional MRI (i.e., BOLD-functional connectivity, BOLD-FC) reflect a spectrum of neuronal and non-neuronal processes. In particular, there are multiple hemodynamic-vascular influences on BOLD-FC on both systemic (e.g., perfusion delay) and local levels (e.g., neurovascular coupling). While the influence of individual factors has been studied extensively, combined and comparative studies of systemic and local hemodynamic-vascular factors on BOLD-FC are scarce, notably in humans. We employed a multi-modal MRI approach to investigate and compare distinct hemodynamic-vascular processes and their impact on homotopic BOLD-FC in healthy controls and patients with unilateral asymptomatic internal carotid artery stenosis (ICAS). Asymptomatic ICAS is a cerebrovascular disorder, in which neuronal functioning is largely preserved but hemodynamic-vascular processes are impaired, mostly on the side of stenosis. Investigated indicators for local hemodynamic-vascular processes comprise capillary transit time heterogeneity (CTH) and cerebral blood volume (CBV) from dynamic susceptibility contrast (DSC) MRI, and cerebral blood flow (CBF) from pseudo-continuous arterial spin labeling (pCASL). Indicators for systemic processes are time-to-peak (TTP) from DSC MRI and BOLD lags from functional MRI. For each of these parameters, their influence on BOLD-FC was estimated by a comprehensive linear mixed model. Equally across groups, we found that individual mean BOLD-FC, local (CTH, CBV, and CBF) and systemic (TTP and BOLD lag) hemodynamic-vascular factors together explain 40.7% of BOLD-FC variance, with 20% of BOLD-FC variance explained by hemodynamic-vascular factors, with an about two-times larger contribution of systemic versus local factors. We conclude that regional differences in blood supply, i.e., systemic perfusion delays, exert a stronger influence on BOLD-FC than impairments in local neurovascular coupling.

Resting-state BOLD functional connectivity depends on the heterogeneity of capillary transit times in the human brain A combined lesion and simulation study about the influence of blood flow response timing.

Functional connectivity (FC) derived from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging at rest (rs-fMRI), is commonly interpreted as indicator of neuronal connectivity. In a number of brain disorders, however, metabolic, vascular, and hemodynamic impairments can be expected to alter BOLD-FC independently from neuronal activity. By means of a neurovascular coupling (NVC) model of BOLD-FC, we recently demonstrated that aberrant timing of cerebral blood flow (CBF) responses may influence BOLD-FC. In the current work, we support and extend this finding by empirically linking BOLD-FC with capillary transit time heterogeneity (CTH), which we consider as an indicator of delayed and broadened CBF responses. We assessed 28 asymptomatic patients with unilateral high-grade internal carotid artery stenosis (ICAS) as a hemodynamic lesion model with largely preserved neurocognitive functioning and 27 age-matched healthy controls. For each participant, we obtained rs-fMRI, arterial spin labeling, and dynamic susceptibility contrast MRI to study the dependence of left-right homotopic BOLD-FC on local perfusion parameters. Additionally, we investigated the dependency of BOLD-FC on CBF response timing by detailed simulations. Homotopic BOLD-FC was negatively associated with increasing CTH differences between homotopic brain areas. This relation was more pronounced in asymptomatic ICAS patients even after controlling for baseline CBF and relative cerebral blood volume influences. These findings match simulation results that predict an influence of delayed and broadened CBF responses on BOLD-FC. Results demonstrate that increasing CTH differences between homotopic brain areas lead to BOLD-FC reductions. Simulations suggest that CTH increases correspond to broadened and delayed CBF responses to fluctuations in ongoing neuronal activity.

External Validity of Randomised Controlled Trials on Carotid Revascularisation: Trial Populations May Not Always Reflect Patients in Clinical Practice.

OBJECTIVE: The external validity of randomised controlled trials (RCTs) and their transferability to clinical practice is under investigated. This study aimed to analyse the exclusion criteria of recent carotid RCTs comparing carotid endarterectomy (CEA) and carotid artery stenting, and to assess the eligibility of consecutive clinical practice cohorts to those RCTs. METHODS: An analysis of the clinical and anatomical exclusion criteria of RCTs for asymptomatic (SPACE-2, ACST-2, CREST-1, and CREST-2) and symptomatic carotid stenosis (SPACE-1, CREST-1, ICSS, and EVA-3S) was performed. Two hundred consecutive asymptomatic and 200 consecutive symptomatic patients, treated by CEA, or transfemoral or transcarotid artery stenting at a tertiary referral university centre were assessed for their potential eligibility for each corresponding RCT. RCT patient data were pooled and differences from the clinical practice cohort analysed. Statistics were descriptive and comparative using Fisher's exact and t tests. RESULTS: The number of clinical and anatomical exclusion criteria differed widely between RCTs. Potential eligibility rates of the clinical practice cohort for RCTs with regard to asymptomatic carotid stenosis were 80.5% (ACST-2), 79.5% (SPACE-2), 47% (CREST-1), and 20% (CREST-2). For RCTs on symptomatic carotid stenosis the eligibility rates were 89% (ICSS), 86.5% (EVA-3S), 64% (SPACE-1), and 39% (CREST-1). Both clinical practice cohorts were older by about three years and patients were more often male vs. the RCTs. Furthermore, a history of smoking (asymptomatic patients), hypertension (symptomatic patients), and atrial fibrillation was diagnosed more often, whereas hypercholesterolaemia and coronary heart disease (asymptomatic patients) were less prevalent. More clinical practice patients were on antiplatelets, anticoagulants, and lipid lowering drugs. Symptomatic clinical practice patients presented more often with retinal ischaemia and less often with minor hemispheric strokes than patients in the RCTs. CONCLUSION: The external validity of contemporary carotid RCTs varies considerably. Patients in routine clinical practice differ from RCT populations with respect to age, comorbidities, and medication. These data are of interest for clinicians and guideline authors and may be relevant for the design of future comparative trials.

Decreasing Spatial Variability of Individual Watershed Areas by Revascularization Therapy in Patients With High-Grade Carotid Artery Stenosis.

BACKGROUND: Carotid artery stenosis can impair cerebral hemodynamics especially within watershed areas (WSAs) between vascular territories. WSAs can shift because of collateral flow, which may be an indicator for increased hemodynamic implications and hence higher risk for ischemic stroke. However, whether revascularization treatment can reverse the spatial displacement of individual WSAs (iWSAs) and impaired hemodynamics remains unknown. HYPOTHESIS: That iWSAs spatially normalize because of hemodynamic improvement resulting from revascularization treatment. STUDY TYPE: Prospective. POPULATION: Sixteen patients with unilateral, high-grade carotid artery stenosis confirmed by duplex ultrasonography and 17 healthy controls. FIELD STRENGTH/SEQUENCES: A 3 T-magnetization-prepared rapid acquisition gradient echo (MPRAGE), gradient-echo echo planar dynamic susceptibility contrast (DSC), and fluid-attenuated inversion recovery (FLAIR) sequences. Additionally, contrast-enhanced 3D gradient echo magnetic resonance angiography (MRA) and diffusion-tensor imaging (DTI) spin-echo echo planar imaging were performed. ASSESSMENT: iWSAs were delineated by a recently proposed procedure based on time-to-peak maps from DSC perfusion MRI, which were also used to evaluate perfusion delay. We spatially compared iWSAs and perfusion delay before and after treatment (endarterectomy or stenting). Additionally, the Circle of Willis collateralization status was evaluated, and basic cognitive testing was conducted. STATISTICAL TESTS: Statistical tests included two-sample t-tests and Chi-squared tests. A P value < 0.05 was considered to be statistically significant. RESULTS: After revascularization, patients showed a significant spatial shift of iWSAs and significantly reduced perfusion delay ipsilateral to the stenosis. Spatial shift of iWSA (P = 0.007) and cognitive improvement (P = 0.013) were more pronounced in patients with poor pre-existing collateralization. Controls demonstrated stable spatial extent of iWSAs (P = 0.437) and symmetric perfusion delays between hemispheres over time (P = 0.773). DATA CONCLUSION: These results demonstrate the normalization of iWSA and impaired hemodynamics after revascularization in patients with high-grade carotid artery stenosis. LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY: Stage 2.

Editor's Choice - Distribution of Care and Hospital Incidence of Carotid Endarterectomy and Carotid Artery Stenting: A Secondary Analysis of German Hospital Episode Data.

OBJECTIVE: This is a description of the German healthcare landscape regarding carotid artery disease, assessment of hospital incidence time courses for carotid endarterectomy (CEA) and carotid artery stenting (CAS), and simulation of potential effects of minimum hospital caseload requirements for CEA and CAS. METHODS: The study is a secondary data analysis of diagnosis related group statistics data (2005-2016), provided by the German Federal Statistical Office. Cases encoded by German operation procedure codes for CEA or CAS and by International Classification of Diseases (ICD-10) codes for carotid artery disease were included. Hospitals were categorised into quartiles according to annual caseloads. Linear distances to the closest hospital fulfilling hypothetical caseload requirements were calculated. RESULTS: A total of 132 411 and 33 709 patients treated with CEA and CAS from 2012 to 2016 were included. CEA patients had lower rates of myocardial infarction (1.4% vs. 1.8%) and death (1.2% vs. 4.0%), and CAS patients were more often treated after emergency admission (38.1% vs. 27.1%). Age standardised annual hospital incidences were 67.2 per 100 000 inhabitants for CEA and 16.3 per 100 000 inhabitants for CAS. The incidence for CEA declined from 2005 to 2016, with CAS rising again until 2016 after having declined from 2010 to 2013. Regarding distance from home to hospital, centres offering CEA are distributed more homogeneously across Germany, compared with those performing CAS. Hypothetical introduction of minimum annual caseloads (> 20 for CEA; > 10 for CAS) imply that 75% of the population would reach their hospital after travelling 45 km for CEA and 70 km for CAS. CONCLUSION: Differences in spatial distribution mean that statutory minimum annual caseloads would have a greater impact on CAS accessibility than CEA in Germany. Presumably because of a decline in carotid artery disease and a transition towards individualised therapy for asymptomatic patients, hospital incidence for CEA has been declining.

The TAXINOMISIS Project: A multidisciplinary approach for the development of a new risk stratification model for patients with asymptomatic carotid artery stenosis.

INTRODUCTION: Asymptomatic carotid artery stenosis (ACAS) may cause future stroke and therefore patients with ACAS require best medical treatment. Patients at high risk for stroke may opt for additional revascularization (either surgery or stenting) but the future stroke risk should outweigh the risk for peri/post-operative stroke/death. Current risk stratification for patients with ACAS is largely based on outdated randomized-controlled trials that lack the integration of improved medical therapies and risk factor control. Furthermore, recent circulating and imaging biomarkers for stroke have never been included in a risk stratification model. The TAXINOMISIS Project aims to develop a new risk stratification model for cerebrovascular complications in patients with ACAS and this will be tested through a prospective observational multicentre clinical trial performed in six major European vascular surgery centres. METHODS AND ANALYSIS: The risk stratification model will compromise clinical, circulating, plaque and imaging biomarkers. The prospective multicentre observational study will include 300 patients with 50%-99% ACAS. The primary endpoint is the three-year incidence of cerebrovascular complications. Biomarkers will be retrieved from plasma samples, brain MRI, carotid MRA and duplex ultrasound. The TAXINOMISIS Project will serve as a platform for the development of new computer tools that assess plaque progression based on radiology images and a lab-on-chip with genetic variants that could predict medication response in individual patients. CONCLUSION: Results from the TAXINOMISIS study could potentially improve future risk stratification in patients with ACAS to assist personalized evidence-based treatment decision-making.

Prospective Comparison of Duplex Ultrasound and Angiography for Intra-operative Completion Studies after Carotid Endarterectomy.

OBJECTIVE: The application of intra-operative completion studies may have contributed to the ongoing improvement of peri-operative outcomes in carotid surgery. METHODS: This prospective study aimed to compare angiography and duplex ultrasound (IDUS) as intra-operative completion studies after carotid endarterectomy (CEA) with respect to differences in the rating of vessel wall defects and interobserver reliability. Patients undergoing CEA for symptomatic or asymptomatic carotid stenosis were included. After CEA, angiography and IDUS were performed. Intra-operatively obtained video footage was evaluated at a later date by three independent and blinded raters with different levels of clinical experience. Rating was done according to a four step rating scale, with higher grades representing more severe defects. Standard statistical methods (Pearson's chi square test; permutation test; Wilcoxon signed rank test; Kendall's coefficient of concordance, Wt) were applied. RESULTS: In total, 150 patients (mean ± standard deviation age 72 ± 7 years, 68.7% male, 33.3% symptomatic) were enrolled between March 2016 and September 2017. Significantly more defects requiring intra-operative revision (grades 3 and 4 on rating scale) were detected by IDUS, which, in part, remained undetected by angiography: 22 (14.7%) vs. 10 (6.7%) (p = .040). Defects were also judged to be more severe with IDUS than with angiography: median rating grade 1: 74 (49.3%) vs. 102 (68.0%); grade 2: 54 (36.0%) vs. 38 (25.3%); grade 3: 21 (14.0%) vs. 9 (6.0%); grade 4: 1 (0.7%) vs.1 (0.7%) (p < .001). Furthermore, Wt was significantly higher for IDUS compared with angiography (0.70 vs. 0.57; p = .003). CONCLUSION: IDUS revealed more defects after CEA than angiography. Despite both techniques only showing moderate interobserver reliability, IDUS is less dependent on the surgeon's subjectivity than angiography. Taking into account the absence of procedure associated risks (i.e., adverse effects of iodinated contrast media and Xray), IDUS could be considered as an alternative intra-operative morphological assessment tool in carotid surgery.

Early and Midterm Outcomes of Open and Endovascular Revascularization of Chronic Mesenteric Ischemia.

BACKGROUND: Revascularization strategies for chronic mesenteric ischemia (CMI) include open (OR) and endovascular (ER) modalities. The primary objective of this study was to analyze the safety and effectiveness of OR and ER and the impact of clinical and morphological variables on early and midterm outcomes in a consecutive series of CMI patients in a tertiary referral center. PATIENTS AND METHODS: From 2004 to 2017, all CMI patients treated with OR and ER were retrospectively identified. Patient records, preoperative imaging, as well as peri- and postoperative outcomes were analyzed. Univariable and multivariable analysis was performed to identify clinical or morphological variables affecting reintervention rates within 2 years. RESULTS: In total, 63 patients (33% male; mean age 71, range 60-76 years) were treated by ER (41 patients) or OR (22 patients) for CMI. Mean follow-up was 26 (10-71) months. 30-day mortality was 0.0% after ER and 4.5% after OR (p = 0.069); 30-day morbidity was 9.8% vs. 31.8%, respectively (p = 0.030). Length of stay was significantly longer after OR (14 vs. 4 days; p < 0.001). Freedom from reintervention rate after 2 years was 82% after OR and 73% after ER (p = 0.14). Overall survival did not differ after 2 years (OR 85% vs. ER 86%; p = 0.35). Multivariable analysis revealed that smoking was associated with higher risk of reintervention (hazard ratio, HR: 4.14; 95% confidence interval, CI 1.11-15.53; p = 0.03). Additionally, a nonsignificant trend of lower reintervention rates after OR was detected (HR 0.23 95% CI 0.05-1.08; p = 0.06). CONCLUSION: Due to a lower invasiveness, despite the higher reintervention rate, an "endovascular first" strategy is justified and recommended.

Lack of durability after transarterial ethylene-vinyl alcohol copolymer-embolization of type II endoleak following endovascular abdominal aortic aneurysm repair.

Background: Type II endoleak (T2EL) after endovascular aortic repair is associated with AAA sac enlargements in up to 25%, reduction of attachment zones and rarely with aortic rupture. Indications for therapy and efficacy of interventions of T2EL are not clearly established. Transarterial embolization with application of ethylene-vinyl alcohol copolymer has been described with varying outcomes. Aim of this study is to evaluate durability of OnyxTM embolization (OE) in T2EL in a consecutive series at a single tertiary vascular center. Patients and methods: Demographic data, technical success, pre- and postoperative aneurysm growth, morbidity, mortality and reintervention rates during hospital stay as well as in follow up were recorded in patients treated with OE for T2EL between 01/2015 and 12/2017. The primary endpoint was defined as persistence or reoccurrence of T2EL (durability of OE). Results: In total 15 patients (78 ± 6 years, 13 men) were treated with OE because of sac enlargement (average growth of 12 ± 8%, n = 12), persistent bleeding after AAA rupture (n = 2) or persistent T2EL with stable but large aneurysm diameter (n = 1). Mean length of stay was 8 ± 11 days. Technical success was 93.3% (n = 14). Inhospital-morbidity was 26.7%, in-hospital- and 1-year-mortality rate were 6.6% (n = 1) and 20.0% (n = 3). T2EL persisted in 20.0% (n = 3) despite of OE. Re-EL-II occurred after 40 (30-114) days in 33.3% (n = 5). Reintervention rate was 13.3% (n = 2, at day 48 and 319). Altogether clinical success with stable aneurysm diameter was achieved in 80.0% (n = 12), but durable elimination of EL was only achieved in 46.7% of patients (n = 7). Conclusions: OE is technically possible in more than 90% of patients but might be associated with severe complications. Durability of this treatment is low, since T2EL persist or reoccur in more than 50% of all patients. OE of T2EL should be reserved for few selected cases.

Last neurologic event is associated with risk of in-hospital stroke or death after carotid endarterectomy or carotid artery stenting: Secondary data analysis of the German statutory quality assurance database.

OBJECTIVE: We sought to analyze the association between last neurologic event and the risk of stroke or death among patients treated with carotid endarterectomy (CEA) or carotid artery stenting (CAS) under routine conditions in Germany. METHODS: Secondary data analysis was performed based on the German statutory quality assurance database for carotid procedures. A total of 144,347 patients treated by CEA and 14,794 patients treated by CAS were included in the analysis. Primary outcome was any in-hospital stroke or death. To analyze the association between the last neurologic event and outcome, multilevel multivariable regression analysis was performed. RESULTS: In patients treated by CEA, raw risk for any in-hospital stroke or death was 2.0% (2923/144,347), with a risk of 1.4% in asymptomatic and 3.0% in symptomatic patients. In patients treated by CAS, raw risk for any in-hospital stroke or death was 3.6% (538/14,794), with a risk of 1.7% in asymptomatic and 6.1% in symptomatic patients. Regression analysis revealed that increasing severity of last neurologic event was significantly associated with an increasing risk of any in-hospital stroke or death in patients treated by both CEA and CAS (P < .004). However, the risk of any stroke or death did not significantly differ between asymptomatic patients and patients with amaurosis fugax before CEA or CAS (P = .219 for CEA, P = .124 for CAS). CONCLUSIONS: Increasing severity of last neurologic event is associated with an increasing risk of any in-hospital stroke or death in patients treated by CEA and CAS. The risk of any stroke or death did not differ between asymptomatic patients and patients with amaurosis fugax.

Age but not sex is associated with higher risk of in-hospital stroke or death after carotid artery stenting in symptomatic and asymptomatic carotid stenosis.

OBJECTIVE: The aim of this study was to analyze the correlation of age and sex with the outcome after carotid artery stenting (CAS). We used the statutory nationwide quality assurance database in Germany, in which, among others, all endovascular procedures on the extracranial carotid artery are filed. METHODS: We performed a secondary data analysis of all CAS procedures (N = 13,086) between 2012 and 2014 in Germany. The primary outcome was defined as any in-hospital stroke or death; the secondary outcomes were defined as in-hospital stroke (alone) and in-hospital death (alone). Descriptive analyses as well as multilevel multivariable analyses were applied. RESULTS: About 70% of the patients were male, and the mean age of all patients was 69.7 ± 9.3 years. Carotid stenosis was symptomatic in 36% of all patients. The primary outcome occurred in 2.4% (n = 317) of patients (2.5% of women, 2.4% in men, 1.7% of asymptomatic patients, and 3.7% of symptomatic patients). Multivariable regression analysis indicated that age (linear effect per 10-year increase) was significantly correlated with a higher risk of in-hospital stroke or death after CAS (risk ratio [RR], 1.54; 95% confidence interval [CI], 1.35-1.75). The risks of stroke alone (RR, 1.47; 95% CI, 1.26-1.72) and death alone (RR, 1.62; 95% CI, 1.01-2.58) were also significantly associated with age in CAS patients. Sex did not significantly alter the age effect and was not associated with the primary outcome rate (RR, 0.99; 95% CI, 0.78-1.26). CONCLUSIONS: Age but not sex is correlated with a higher risk of in-hospital stroke or death in asymptomatic and symptomatic patients after CAS under routine conditions. The primary outcome rate was fueled to a comparable magnitude by both components of the composite outcome.

Different perioperative antiplatelet therapies for patients treated with carotid endarterectomy in routine practice.

OBJECTIVE: There is currently no clear consensus regarding the optimal perioperative antiplatelet therapy regimen for carotid surgery. Therefore, associations between different antiplatelet therapies and the risk of stroke or death and perioperative complications after carotid endarterectomy on a national level in Germany were analyzed. METHODS: Overall, 117,973 elective carotid endarterectomies for asymptomatic or symptomatic carotid artery stenosis between 2010 and 2014 were included. Data were extracted from the statutory nationwide quality assurance database. The primary outcome was any in-hospital stroke or death until discharge from the hospital. Secondary outcomes were any major stroke or death, death alone, stroke, myocardial infarction, local bleeding, and any local complications (cranial nerve palsy, severe bleeding, acute occlusion). Descriptive statistics and multilevel multivariable regression analyses were applied. Single-agent therapy with aspirin was used as reference. RESULTS: Patients were predominantly male (68%), with a mean age of 71 years. Carotid stenosis was symptomatic in 40%. Of all patients, 82.8% were treated perioperatively by monotherapy with aspirin alone, 2.7% received other platelet inhibitors, and 4.8% of the patients were operated on under dual antiplatelet therapy. The primary outcome occurred in 1.8% of all patients. Multilevel multivariable regression analysis revealed that the combined stroke and death rate of patients with no perioperative antiplatelet therapy was significantly higher (risk ratio [RR], 1.21; 95% confidence interval [CI], 1.04-1.42) compared with the group of patients receiving monotherapy. The same was true for the major stroke and death rate (RR, 1.23; 95% CI, 1.02-1.48). In contrast, dual antiplatelet therapy was associated with a lower risk of death alone (RR, 0.67; 95% CI, 0.51-0.88) but with a significantly higher rate of secondary bleeding requiring reoperation (RR, 2.16; 95% CI, 1.88-2.50). CONCLUSIONS: This study shows that the risk of stroke or death was significantly higher in patients without any perioperative antiplatelet therapy. In contrast, dual antiplatelet therapy vs aspirin monotherapy was associated with a lower risk only of perioperative death but with a higher risk of neck bleeding until discharge. Perioperative antiplatelet therapy was significantly associated with a decreased in-hospital stroke and death risk. Further studies are needed to evaluate the risk-benefit ratio of single vs dual antiplatelet therapy.

Patient characteristics and in-hospital outcomes of emergency carotid endarterectomy and carotid stenting after stroke in evolution.

OBJECTIVE: The objective of this study was to describe characteristics and in-hospital outcomes of patients treated with carotid endarterectomy (CEA) and carotid artery stenting (CAS) for stroke in evolution (SIE) under routine conditions in Germany. METHODS: This secondary data analysis is based on the German statutory quality assurance database for carotid revascularization procedures. Patients with SIE who had undergone CEA or CAS were included. The primary outcome was any new stroke or all-cause death until hospital discharge. Descriptive statistics were calculated using statistical standard methods. To identify factors that are associated with the primary or secondary outcomes, a multilevel multivariable regression analysis was performed (exploratory approach). RESULTS: Between 2009 and 2014, a total of 5058 patients (mean age, 70 ± 11 years; 68% male) with SIE were treated with CEA (n = 3176) or percutaneous transluminal angioplasty/CAS (n = 1882). The primary outcome occurred in 9.0% and 11.7% after CEA and CAS, respectively. The multivariable regression analysis revealed that age (per 10-year increase: risk ratio [RR], 1.30; 95% confidence interval [CI], 1.12-1.50), American Society of Anesthesiologists (ASA) class (ASA class 4 and 5 vs ASA class 3: RR, 2.34; 95% CI, 1.65-3.32), ipsilateral degree of stenosis (occlusion vs severe stenosis: RR, 1.90; 95% CI, 1.29-2.79; low grade vs severe stenosis: RR, 3.06; 95% CI, 1.55-6.02), and neurologic deficit on admission (modified Rankin scale score of 3-5 vs 0-2: RR, 1.48; 95% CI, 1.04-2.10) are significantly associated with the risk of stroke or death after emergency CEA for SIE. In patients treated with CAS, only age (per 10-year increase: RR, 1.58; 95% CI, 1.37-1.82), ASA class (ASA class 1 and 2 vs ASA class 3: RR, 0.66; 95% CI, 0.46-0.95; ASA class 4 and class 5 vs ASA class 3: RR, 1.91; 95% CI, 1.31-2.78), and ipsilateral degree of stenosis (moderate vs severe stenosis: RR, 0.19; 95% CI, 0.04-0.77; occlusion vs severe stenosis: RR, 1.63; 95% CI, 1.18-2.25) were significantly associated with the primary outcome rate. CONCLUSIONS: Emergency carotid revascularization is associated with a combined stroke or death rate of about 10% under routine conditions in Germany. Lower age, lower ASA class, moderate to high-grade stenosis, and less severe neurologic deficit preceding CEA potentially serve as protective factors.

Increased variability of watershed areas in patients with high-grade carotid stenosis.

PURPOSE: Watershed areas (WSAs) of the brain are most susceptible to acute hypoperfusion due to their peripheral location between vascular territories. Additionally, chronic WSA-related vascular processes underlie cognitive decline especially in patients with cerebral hemodynamic compromise. Despite of high relevance for both clinical diagnostics and research, individual in vivo WSA definition is fairly limited to date. Thus, this study proposes a standardized segmentation approach to delineate individual WSAs by use of time-to-peak (TTP) maps and investigates spatial variability of individual WSAs. METHODS: We defined individual watershed masks based on relative TTP increases in 30 healthy elderly persons and 28 patients with unilateral, high-grade carotid stenosis, being at risk for watershed-related hemodynamic impairment. Determined WSA location was confirmed by an arterial transit time atlas and individual super-selective arterial spin labeling. We compared spatial variability of WSA probability maps between groups and assessed TTP differences between hemispheres in individual and group-average watershed locations. RESULTS: Patients showed significantly higher spatial variability of WSAs than healthy controls. Perfusion on the side of the stenosis was delayed within individual watershed masks as compared to a watershed template derived from controls, being independent from the grade of the stenosis and collateralization status of the circle of Willis. CONCLUSION: Results demonstrate feasibility of individual WSA delineation by TTP maps in healthy elderly and carotid stenosis patients. Data indicate necessity of individual segmentation approaches especially in patients with hemodynamic compromise to detect critical regions of impaired hemodynamics.

Intraoperative Completion Studies, Local Anesthesia, and Antiplatelet Medication Are Associated With Lower Risk in Carotid Endarterectomy.

BACKGROUND AND PURPOSE: In Germany, all surgical and endovascular procedures on the carotid bifurcation must be documented in a statutory nationwide quality assurance database. We aimed to analyze the association between procedural and perioperative variables and in-hospital stroke or death rates after carotid endarterectomy. METHODS: Between 2009 and 2014, overall 142 074 elective carotid endarterectomy procedures for asymptomatic or symptomatic carotid artery stenosis were documented in the database. The primary outcome of this secondary data analysis was in-hospital stroke or death. Major stroke or death, stroke, and death, each until discharge were secondary outcomes. Adjusted relative risks (RRs) were assessed by multivariable multilevel regression analyses. RESULTS: The primary outcome occurred in 1.8% of patients, with a rate of 1.4% in asymptomatic and 2.5% in symptomatic patients, respectively. In the multivariable analysis, lower risks of stroke or death were independently associated with local anesthesia (versus general anesthesia: RR, 0.85; 95% confidence interval [CI], 0.75-0.95), carotid endarterectomy with patch plasty compared with primary closure (RR, 0.71; 95% CI, 0.52-0.97), intraoperative completion studies by duplex ultrasound (RR, 0.74; 95% CI, 0.63-0.88) or angiography (RR, 0.80; 95% CI, 0.71-0.90), and perioperative antiplatelet medication (RR, 0.83; 95% CI, 0.71-0.97). No shunting and a short cross-clamp time were also associated with lower risks; however, these are suspected to be confounded. CONCLUSIONS: Local anesthesia, patch plasty compared with primary closure, intraoperative completion studies by duplex ultrasound or angiography, and perioperative antiplatelet medication were independently associated with lower in-hospital stroke or death rates after carotid endarterectomy.

A short time interval between the neurologic index event and carotid endarterectomy is not a risk factor for carotid surgery.

OBJECTIVE: Current guidelines recommend that carotid endarterectomy (CEA) be performed as early as possible after the neurologic index event in patients with 50% to 99% carotid artery stenosis. However, recent registry data showed that patients treated ≤48 hours had a significantly increased perioperative risk. Therefore, the aim of this single-center study was to determine the effect of the time interval between the neurologic index event and CEA on the periprocedural complication rate at our institution. METHODS: Prospectively collected data for 401 CEAs performed between 2004 and 2014 for symptomatic carotid stenosis were analyzed. Patients were divided into four groups according to the interval between the last neurologic event and surgery: group I, 0 to 2 days; group II, 3 to 7 days; group III, 8 to 14 days; and group IV, 15 to 180 days. The primary end point was the combined rate of in-hospital stroke or mortality. Data were analyzed by way of χ2 tests and multivariable regression analysis. RESULTS: The patients (68% men) had a median age of 70 years (interquartile range, 63-76 years). The index events included transient ischemic attack in 43.4%, amaurosis fugax in 25.4%, and an ipsilateral stroke in 31.2%. CEA was performed using the eversion technique in 61.1% of patients, and 50.1% were treated under locoregional anesthesia. The perioperative combined stroke and mortality rate was 2.5% (10 of 401), representing a perioperative mortality rate of 1.0% and stroke rate of 1.5%. Overall, myocardial infarction, cranial nerve injuries, and postoperative bleeding occurred in 0.7%, 2.2%, and 1.7%, respectively. We detected no significant differences for the combined stroke and mortality rate by time interval: 3% in group I, 3% in group II, 2% in group III, and 2% in group IV. Multivariable regression analysis showed no significant effect of the time interval on the primary end point. CONCLUSIONS: The combined mortality and stroke rate was 2.5% and did not differ significantly between the four different time interval groups. CEA was safe in our cohort, even when performed as soon as possible after the index event.

Short Time Interval Between Neurologic Event and Carotid Surgery Is Not Associated With an Increased Procedural Risk.

BACKGROUND AND PURPOSE: Guidelines recommend that carotid endarterectomy should be performed within 2 weeks in patients with a symptomatic carotid stenosis. Because a Swedish register study indicated that patients treated within the first days after a stroke or transient ischemic attack might have an increased perioperative stroke and mortality risk, this study aimed to find out whether these findings are also true under everyday conditions in Germany. METHODS: Secondary data analysis including 56 336 elective carotid endarterectomy procedures performed for symptomatic carotid stenosis under everyday conditions between 2009 and 2014. The patient cohort was divided into 4 groups according to time interval between index event and surgery (I: 0-2, II: 3-7, III: 8-14, and IV: 14-180 days). Primary outcome was any in-hospital stroke or death. For risk-adjusted analyses, a multilevel multivariable regression model was used. RESULTS: Mean patients' age was 71.1±9.6 years; 67.5% were men. Overall rate of any stroke or death was 2.5% (n=1434). Risk of any in-hospital stroke or death was 3.0% in group I, 2.5% in group II, 2.6% in group III, and 2.3% in group IV. Multivariable regression analysis revealed that the time interval was not significantly associated with the primary outcome. CONCLUSIONS: The time interval between the index event and carotid endarterectomy was not associated with the risk of any in-hospital stroke or death in patients with symptomatic carotid stenosis in Germany. In clinically stable patients, carotid endarterectomy might, therefore, be performed safely as soon as possible after the neurological index event.