Determinants of Pre- and Post-Procedural Neurological Assessment, and Outcome of Carotid Endarterectomy or Stenting.

Background: The German-Austrian guideline on the treatment of carotid stenosis recommends specialist neurological assessment (NA) before and after carotid endarterectomy (CEA) or carotid artery stenting (CAS). This study analyzes the determinants of NA and the association of NA with the perioperative rate of stroke or death. Materials and Methods: This study is a pre-planned sub-study of the ISAR-IQ project, which analyzes data from the nationwide German statutory quality assurance carotid database. Patients were classified as asymptomatic (group A), elective symptomatic (group B), and others (group C: emergency (C1), simultaneous operation (C2), and other indications (C3)). The primary outcome event (POE) of this study was any in-hospital stroke or death. Adjusted odds ratios for pre- and post-NA and the POE were calculated using multivariable regression analyses. Results: We analyzed 228,133 patients (54% asymptomatic, 68% male, mean age 72 years) undergoing CEA or CAS between 2012 and 2018. Age and sex were not associated with the likelihood of pre-NA or post-NA. The multivariable regression analysis showed an inverse association between pre-NA and POE (adjusted odds ratio (aOR) 0.47; 95% CI 0.44-0.51, p < 0.001), and a direct association of post-NA and POE (aOR 4.39; 95% CI 4.04-4.78, p < 0.001). Conclusions: Pre- and postinterventional specialist NA is strongly associated with the risk of any in-hospital stroke or death after CEA or CAS in Germany. A relevant confounding by indication or reversed causation cannot be ruled out. Nevertheless, to improve the quality assurance of treatment, the NA recommended in the guideline should be carried out consistently.

Determinants of prehospital and in-hospital delay in patients with symptomatic carotid stenosis and their influence on the outcome after elective carotid endarterectomy.

BACKGROUND: This study analyses the determinants of prehospital (index event to admission) and in-hospital delay (admission to carotid endarterectomy (CEA)). In addition, the analysis addresses the association between prehospital or in-hospital delay and outcomes after CEA for symptomatic patients in German hospitals. MATERIALS AND METHODS: This retrospective analysis is based on the nationwide German statutory quality assurance database. 55 437 patients were included in the analysis. Prehospital delay was grouped as follows: 180-15, 14-8, 7-3, 2-0 days or 'in-hospital index event'. In-hospital delay was divided into: 0-1, 2-3 and >3 days. The primary outcome event (POE) was in-hospital stroke or death. Univariate and multivariable regression analyses were performed for statistical analysis. The slope of the linear regression line is given as the ß-value, and the rate parameter of the logistic regression is given as the adjusted OR (aOR). RESULTS: Prehospital delay was 0-2 days in 34.9%, 3-14 days in 29.5% and >14 days in 18.6%. Higher age (ß=-1.08, p<0.001) and a more severe index event (transitory ischaemic attack: ß=-4.41, p<0.001; stroke: ß=-6.05, p<0.001, Ref: amaurosis fugax) were determinants of shorter prehospital delay. Higher age (ß=0.28, p<0.001) and female sex (ß=0.09, p=0.014) were associated with a longer in-hospital delay. Index event after admission (aOR 1.23, 95% CI: 1.04 to 1.47) and an intermediate in-hospital delay of 2-3 days (aOR 1.15, 95% CI: 1.00 to 1.33) were associated with an increased POE risk. CONCLUSIONS: This study revealed that older age, higher American Society of Anesthesiology (ASA) stage, increasing severity of symptoms and ipsilateral moderate stenosis were associated with shorter prehospital delay. Non-specific symptoms were associated with a longer prehospital delay. Regarding in-hospital delay, older age, higher ASA stage, contralateral occlusion, preprocedural examination by a neurologist and admission on Fridays or Saturdays were associated with lagged treatment. A very short (<2 days) prehospital and intermediate in-hospital delay (2-3 days) were associated with increased risk of perioperative stroke or death.

Use of an embolic protection device during carotid artery stenting is associated with lower periprocedural risk.

OBJECTIVE: To investigate associations between individual embolic protection device (EPD) use and respective center policy with periprocedural outcomes after carotid artery stenting (CAS). METHODS: This analysis is based on the nationwide German statutory quality assurance database and was funded by Germany's Federal Joint Committee Innovation Fund (G-BA Innovationsfonds, 01VSF19016 ISAR-IQ). According to their policy towards EPD use, hospitals were categorized as routine EPD (>90%), selective EPD (10-90%), or sporadic EPD (<10%) centers. Primary study outcome was in-hospital stroke or death. Univariate and multivariate regression analyses were performed. RESULTS: Overall, 19 302 patients who had undergone CAS between 2013 and 2016 were included. The highest in-hospital stroke or death rate was found in sporadic EPD centers, followed by selective and routine EPD centers (3.1% vs 2.9% vs 1.8%; P<0.001). Across the whole cohort, EPD use was associated with a lower in-hospital stroke or death rate (OR=0.60; 95% CI 0.50 to 0.72). In the multivariate regression analysis, EPD use was independently associated with a lower in-hospital stroke rate (aOR=0.66; 95% CI 0.46 to 0.94). Regarding center policy, routine EPD centers showed a significantly lower in-hospital mortality compared with sporadic EPD centers (aOR=0.44; 95% CI 0.22 to 0.88). CONCLUSIONS: In a contemporary real-world cohort with low risk of selection bias, EPD use was associated with a lower in-hospital risk of stroke. A center policy of routine EPD use was associated with lower mortality. These data support routine use of EPD during CAS to enhance patient safety.

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.

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.