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.

Patients with Acute Limb Ischemia Might Benefit from Endovascular Therapy-A 17-Year Retrospective Single-Center Series of 985 Patients.

Acute lower limb ischemia (ALI) is a common vascular emergency, requiring urgent revascularization by open or endovascular means. The aim of this retrospective study was to evaluate patient demographics, treatment and periprocedural variables affecting the outcome in ALI patients in a consecutive cohort in a tertiary referral center. Primary outcome events (POE) were 30-day (safety) and 180-day (efficacy) combined mortality and major amputation rates, respectively. Secondary outcomes were perioperative medical and surgical leg-related complications and the 5-year combined mortality and major amputation rate. Statistical analysis used descriptive and uni- and multivariable Cox regression analysis. In 985 patients (71 ± 9 years, 56% men) from 2004 to 2020, the 30-day and 180-day combined mortality and major amputation rates were 15% and 27%. Upon multivariable analysis, older age (30 d: aHR 1.17; 180 d: 1.27) and advanced Rutherford ischemia stage significantly worsened the safety and efficacy POE (30 d: TASC IIa aHR 3.29, TASC IIb aHR 3.93, TASC III aHR 7.79; 180 d: TASC IIa aHR 1.97, TASC IIb aHR 2.43, TASC III aHR 4.2), while endovascular treatment was associated with significant improved POE after 30 days (aHR 0.35) and 180 days (aHR 0.39), respectively. Looking at five consecutive patient quintiles, a significant increase in endovascular procedures especially in the last quintile could be observed (17.5% to 39.5%, p < 0.001). Simultaneously, the re-occlusion rate as well as the number of patients with any previous revascularization increased. In conclusion, despite a slightly increasing early re-occlusion rate, endovascular treatment might, if possible, be favorable in ALI treatment.

Editor's Choice - Temporal fluctuations of hospital incidence and mortality of ruptured abdominal aortic aneurysms in Germany: A secondary data analysis of German hospital episode statistics 2009 - 2018.

OBJECTIVE: Abdominal aortic aneurysm rupture (rAAA) is still associated with high mortality. Recent studies have shown higher incidences in autumn and winter, and worse outcomes after rAAA treatment on weekends in some countries. This study aimed to analyse seasonal, weekday, and daytime fluctuations of the hospital incidence, treatment modalities, and outcomes of rAAA, based on the most recent nationwide German real world data. METHODS: A secondary data analysis of diagnosis related group statistics (2009 - 2018), obtained from the German Federal Statistical Office, was conducted. Cases encoded by a diagnosis of rAAA in conjunction with procedural codes for endovascular aortic repair (EVAR) or open aortic repair were included. Patient and procedural characteristics, comorbidities, and outcomes were analysed for seasonal (spring, summer, autumn, and winter), weekday (Monday - Sunday) and daytime (0:00 - 8:00, 8:00 -16:00, 16:00 -20:00, and 20:00 - 24:00) fluctuations by descriptive statistics and multivariable regression analyses. RESULTS: Thirteen thousand and seventy patients (85% male, median age 75 years) were treated for rAAA. Endovascular aortic repair was associated with lower mortality (adjusted OR 0.40, 95% CI 0.37 - 0.44). While no significant seasonal fluctuations were found, on a weekday basis lower hospital incidences were found on Mondays (12%) and Sundays (11%) compared with other weekdays (15 - 16%). Similarly, EVAR rates were lower on Mondays and Sundays (25% and 24%, respectively) compared with other weekdays (30 - 33%). Multivariable analyses revealed higher mortality rates on Mondays and Sundays. On a daytime basis, lower EVAR rates and higher mortality rates were found during the 16:00 - 8:00 period. CONCLUSION: In German hospitals, incidences and EVAR rates to treat rAAA were lowest on Mondays and Sundays. The associated overall mortality rates were highest on the respective days. Further restructuring and centralisation of AAA treatment in Germany could potentially mitigate this weekday effect.

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.

Hospital incidence and mortality of patients treated for abdominal aortic aneurysms in Switzerland - a secondary analysis of Swiss DRG statistics data.

AIM OF THE STUDY: To analyse hospital incidence and in-hospital mortality of patients treated for abdominal aortic aneurysms in Switzerland. METHODS: Secondary data analysis of case-related hospital discharge data of the Swiss Federal Statistical Office for the years 2009-2018. Patients who were hospitalised and surgically treated for nonruptured abdominal aortic aneurysms or hospitalised and treated for ruptured abdominal aortic aneurysms were included in the analysis. Standardised annual incidences rates were calculated using the European standard population 2013. In-hospital all-cause mortality rates were calculated as raw values and standardised for age, sex, and the van Walraven comorbidity score. RESULTS: A total of 10,728 cases were included in this study, of which 87.1% were male. Overall, 22.7% of the patients presented with a ruptured abdominal aortic aneurysm; 46% of these cases were surgically treated whereas 54% received conservative therapy. The age-standardised cumulative hospital incidences for treatment of nonruptured abdominal aortic aneurysms were 2.6 (95% confidence interval 2.5-2.8) and 19.7 (19.2-20.1) per 100,000 for women and men, respectively; for ruptured aneurysms it was 0.4 (0.3-2.4) per 100,000 in women, and 2.7 (2.6-2.9) in men. The annual incidence rates were stable in the decade observed. The adjusted mortality rates for treatment of nonruptured aneurysms decreased from 5.5% (2.6-11.2%) in 2009 to 1.4% (0.5-3.6%) in 2018 in women, and from 2.4% (1.3-4.5%) in 2009 to 0.6% (0.2-1.5%) in 2018 in men. The adjusted mortality rates for treatment of ruptured abdominal aortic aneurysms remained high without relevant improvements for either sex over time: for women 32.4% (24.1-42.1%), for men 19.7% (16.8-22.8%). CONCLUSIONS: The hospital incidence rates for nonruptured and ruptured abdominal aortic aneurysms remained unchanged in the decade observed. Compared with Germany, there was no evidence for a decrease in the annual incidence rates for ruptured abdominal aortic aneurysms in Switzerland. Mortality rates in the elective setting were low and decreased in the last decade but remained high in patients treated for ruptured aneurysms. Efforts to reduce the incidence of ruptured abdominal aortic aneurysms are needed to reduce aneurysm-related mortality in Switzerland.

Utilization and Regional Differences of In-Patient Services for Peripheral Arterial Disease and Acute Limb Ischemia in Germany: Secondary Analysis of Nationwide DRG Data.

BACKGROUND: Peripheral arterial disease (PAD) and acute limb ischemia (ALI) pose an increasing strain on health care systems. The objective of this study was to describe the German health care landscape and to assess hospital utilization with respect to PAD and ALI. METHODS: Secondary data analysis of diagnosis-related group statistics data (2009-2018) provided by the German Federal Statistical Office. Inclusion of cases encoded by the International Classification of Diseases (ICD-10) codes for PAD and arterial embolism or thrombosis. Construction of line diagrams and choropleth maps to assess temporal trends and regional distributions. RESULTS: A total of 2,589,511 cases (median age 72 years, 63% male) were included, of which 2,110,925 underwent surgical or interventional therapy. Overall amputation rate was 17%, with the highest rates of minor (28%) and major amputations (15%) in patients with tissue loss. In-hospital mortality (overall 4.1%) increased in accordance to Fontaine stages and was the highest in patients suffering arterial embolism or thrombosis (10%). Between 2009 and 2018, the annual number of PAD cases with tissue loss (Fontaine stage IV) increased from 97,092 to 111,268, whereby associated hospital utilization decreased from 2.2 million to 2.0 million hospital days. Hospital incidence and hospital utilization showed a clustering with the highest numbers in eastern Germany, while major amputation rate and mortality were highest in northern parts of Germany. CONCLUSIONS: Increased use of endovascular techniques was observed, while hospital utilization to treat PAD with tissue loss has decreased. This is despite an increased hospital incidence. Addressing socioeconomic inequalities and a more homogeneous distribution of dedicated vascular units might be advantageous in reducing the burden of disease associated with PAD and ALI.

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.

[Relationship between regional settlement structure and hospital incidence, type of therapy and mortality of non-ruptured abdominal aortic aneurysms]. / Zusammenhang zwischen der regionalen Siedlungsstruktur und der Krankenhausinzidenz, Therapieform und Mortalität von nicht-rupturierten abdominalen Aortenaneurysmen. Sekundärdatenanalyse der deutschen DRG-Statistik von 2005­2014.

INTRODUCTION: In Germany, the regional settlement structure is heterogenous, ranging from densely populated cities with a tight network of vascular health care to large regions in which access to health care is limited in terms of space and time. Therefore, the aim of this secondary data analysis was to investigate the association between the settlement structure of the patient's home district (KT), and the hospital incidence, type of therapy, and mortality of non-ruptured abdominal aortic aneurysms (nrAAA). METHODS: The microdata of the DRG statistics of the Federal Statistical Office for the years 2005-2014 were evaluated. All patients with nrAAA (ICD-10 Code I71.4) who were admitted to a German hospital and treated by open surgery and endovascular repair were included. Classification of treatment was based on the German Operation and Procedure Code. Patients were grouped according to the settlement structure of their home district defined by the Federal Institute for Research on Building, Urban Affairs and Spatial Development (KT1 independent city, KT2 urban district, KT3 rural district, KT4 sparsely populated region). The age-, sex- and risk-adjusted association between the type of settlement structure and in-hospital mortality was analysed using a multivariable multi-level regression model. The Elixhauser co-morbidity score validated for administrative data was used for risk adjustment. RESULTS: Of 95,452 cases included, 88 % were men. Mean age was 72 years. There were 28,970 (30 %) patients in KT1, 37,759 (40 %) in KT2, 14,442 (15 %) in KT3 and 14,281 (15 %) in KT4. The hospital incidence was 12.4 per 100,000 inhabitants in KT1, 11.8 in KT2, 10.8 in KT3 and 11.2 in KT4 (p <0.001, falling trend). The proportion of EVAR treatment was 56 % in KT1, 54 % in KT2, 57 % KT3, and 59 % in KT4 (p <0.001, increasing trend). The raw hospital mortality of patients from KT1 to KT4 was 3.4 %, 3.4 %, 3.2 % and 3.6 %, respectively (p=0.553 for trend). The multivariable regression analysis revealed no statistically significant association between the KT and hospital mortality (KT1=reference, RR KT2=0.97 [95% CI 0.79-1.15], RR KT3=0.98 [0.81-1.14], RR KT4=0.98 [0.86-1.11]). CONCLUSIONS: The study shows that both the hospital incidence and the type of therapy (endovascular vs. open) differed between the settlement structural district types, but there is no urban-rural gap regarding in-hospital mortality of treated nrAAA.

Effect Modification of Sex and Age for the Hospital Volume-Outcome Relationship in Abdominal Aortic Aneurysm Treatment: Secondary Data Analysis of the Nationwide German Diagnosis Related Groups Statistics From 2005 to 2014.

Background Trials and registries associated female sex and high age with unfavorable outcomes in abdominal aortic aneurysm treatment. Many studies showed an inverse correlation between annual hospital volume and in-hospital mortality. The volume-outcome relationship has not been investigated separately for women and men or across the age range. The aim was to analyze whether sex and age are effect modifiers or confounders of the volume-outcome association. Methods and Results In a nationwide setting, all in-hospital cases from 2005 to 2014 with a diagnosis of intact abdominal aortic aneurysm and procedure codes for endovascular or open aortic repair were included. Primary outcome was in-hospital mortality. Using a multilevel multivariable regression model, hospital volume was modeled as a continuous variable. Separate analyses were performed for women and men and for predefined age groups. A total of 94 966 cases were included (12% women; median age, 72 years). Mortality was 4.9% in women and 3.0% in men (3.2% overall). Mortality increased with age. Although there was no significant volume-outcome association in women (P=0.57), there was in men (P=0.02). The strongest volume-outcome association was found in younger men. The younger female subpopulation was found to show a trend for an inverse volume-outcome relationship, whereas an opposite association was found for the women aged >79 years. Conclusions Women have a higher mortality risk after elective abdominal aortic aneurysm treatment. Sex and age are modifiers of the volume-outcome relationship. Unlike in male patients, in women there is no consistent effect of hospital volume on outcome.

Regional variation in endovascular treatment rate and in-hospital mortality of abdominal aortic aneurysms in Germany.

Background: Abdominal aortic aneurysms (AAA) can be treated by either open surgery (OAR) or endovascular aortic repair (EVAR). The aim of this study was to analyze regional variations in application of (EVAR) and in-hospital mortality after intact AAA (iAAA) repair. Methods: Using data provided by the German Federal Statistical Office, a nationwide analysis for 2012 to 2014 was conducted. Patients with a diagnosis of iAAA (I71.4) and corresponding procedure codes for OAR (5-384.5/7) or EVAR (5-38a.1) were included. Odds ratios (ORs) for use of EVAR (proportion of EVAR among total EVAR + OAR cases) and mortality were calculated for all regions in Germany. ORs for EVAR use were adjusted for age, sex, and risk (Elixhauser score). ORs for mortality were additionally adjusted for type of procedure (OAR/EVAR). Results: Finally, 31,757 procedures for iAAA were included. Median age of all patients was 73 years (interquartile range 67-78 years) and 87.1 % were male. The mean proportion of EVAR procedures was 72.6 %; however, the application of EVAR for repair of iAAA varied widely depending on region. The lowest unadjusted regional rate of EVAR use was 48.8 %, while the highest was 92.5 %. After adjustment, the lowest regional OR for EVAR use (compared to the nationwide mean) was 0.23 (95 % confidence interval [0.15-0.36]), the highest 5.93 [1.79-19.65]. Overall in-hospital mortality was 2.9 % (OAR 6.2 %; EVAR 1.7 %). The adjusted regional OR for mortality ranged from 0.31 [0.07-1.42] to 4.98 [2.08-11.93]. Conclusions: This study reveals variations in use of EVAR and in-hospital mortality for iAAA treatment in Germany. This may imply that selection of treatment might not only be influenced by patient characteristics, but also by regional location. These results need to be taken into account when discussing centralization of AAA treatment in Germany.

Associations of Perioperative Variables With the 30-Day Risk of Stroke or Death in Carotid Endarterectomy for Symptomatic Carotid Stenosis.

Background and Purpose- This analysis was performed to assess the association between perioperative and clinical variables and the 30-day risk of stroke or death after carotid endarterectomy for symptomatic carotid stenosis. Methods- Individual patient-level data from the 5 largest randomized controlled carotid trials were pooled in the Carotid Stenosis Trialists' Collaboration database. A total of 4181 patients who received carotid endarterectomy for symptomatic stenosis per protocol were included. Determinants of outcome included carotid endarterectomy technique, type of anesthesia, intraoperative neurophysiological monitoring, shunting, antiplatelet medication, and clinical variables. Stroke or death within 30 days after carotid endarterectomy was the primary outcome. Adjusted risk ratios (aRRs) were estimated in multilevel multivariable analyses using a Poisson regression model. Results- Mean age was 69.5±9.2 years (70.7% men). The 30-day stroke or death rate was 4.3%. In the multivariable regression analysis, local anesthesia was associated with a lower primary outcome rate (versus general anesthesia; aRR, 0.70 [95% CI, 0.50-0.99]). Shunting (aRR, 1.43 [95% CI, 1.05-1.95]), a contralateral high-grade carotid stenosis or occlusion (aRR, 1.58 [95% CI, 1.02-2.47]), and a more severe neurological deficit (mRS, 3-5 versus 0-2: aRR, 2.51 [95% CI, 1.30-4.83]) were associated with higher primary outcome rates. None of the other characteristics were significantly associated with the perioperative stroke or death risk. Conclusions- The current results indicate lower perioperative stroke or death rates in patients operated upon under local anesthesia, whereas a more severe neurological deficit and a contralateral high-grade carotid stenosis or occlusion were identified as potential risk factors. Despite a possible selection bias and patients not having been randomized, these findings might be useful to guide surgeons and anesthetists when treating patients with symptomatic carotid disease.

Human resource management training of supervisors for improving health and well-being of employees.

BACKGROUND: Many workers suffer from work-related stress and are at increased risk of work-related cardiovascular, musculoskeletal, or mental disorders. In the European Union the prevalence of work-related stress was estimated at about 22%. There is consensus that stress, absenteeism, and well-being of employees can be influenced by leadership behaviour. Existing reviews predominantly included cross-sectional and non-experimental studies, which have limited informative value in deducing causal relationships between leadership interventions and health outcomes. OBJECTIVES: To assess the effect of four types of human resource management (HRM) training for supervisors on employees' psychomental stress, absenteeism, and well-being. We included training aimed at improving supervisor-employee interaction, either off-the-job or on-the-job training, and training aimed at improving supervisors' capability of designing the work environment, either off-the-job or on-the-job training. SEARCH METHODS: In May 2019 we searched CENTRAL, MEDLINE, four other databases, and most relevant trials registers (ICTRP, TroPHI, ClinicalTrials.gov). We did not impose any language restrictions on the searches. SELECTION CRITERIA: We included randomised controlled trials (RCT), cluster-randomised controlled trials (cRCT), and controlled before-after studies (CBA) with at least two intervention and control sites, which examined the effects of supervisor training on psychomental stress, absenteeism, and well-being of employees within natural settings of organisations by means of validated measures. DATA COLLECTION AND ANALYSIS: At least two authors independently screened abstracts and full texts, extracted data and assessed the risk of bias of included studies. We analysed study data from intervention and control groups with respect to different comparisons, outcomes, follow-up time, study designs, and intervention types. We pooled study results by use of standardised mean differences (SMD) with 95% confidence intervals when possible. We assessed the quality of evidence for each outcome using the GRADE approach. MAIN RESULTS: We included 25 studies of which 4 are awaiting assessment. The 21 studies that could be analysed were 1 RCT, 14 cRCTs and 6 CBAs with a total of at least 3479 employees in intervention and control groups. We judged 12 studies to have an unclear risk of bias and the remaining nine studies to have a high risk of bias. Sixteen studies focused on improving supervisor-employee interaction, whereas five studies aimed at improving the design of working environments by means of supervisor training.Training versus no interventionWe found very low-quality evidence that supervisor training does not reduce employees' stress levels (6 studies) or absenteeism (1 study) when compared to no intervention, regardless of intervention type or follow-up. We found inconsistent, very low-quality evidence that supervisor training aimed at employee interaction may (2 studies) or may not (7 studies) improve employees' well-being when compared to no intervention. Effects from two studies were not estimable due to missing data.Training versus placeboWe found moderate-quality evidence (2 studies) that supervisor training off the job aimed at employee interaction does not reduce employees' stress levels more than a placebo training at mid-term follow-up. We found low-quality evidence in one study that supervisor training on the job aimed at employee interaction does not reduce employees' absenteeism more than placebo training at long-term follow-up. Effects from one study were not estimable due to insufficient data.Training versus other trainingOne study compared the effects of supervisor training off the job aimed at employee interaction on employees' stress levels to training off the job aimed at working conditions at long-term follow-up but due to insufficient data, effects were not estimable. AUTHORS' CONCLUSIONS: Based on a small and heterogeneous sample of controlled intervention studies and in contrast to prevailing consensus that supervisor behaviour influences employees' health and well-being, we found inconsistent evidence that supervisor training may or may not improve employees' well-being when compared to no intervention. For all other types of interventions and outcomes, there was no evidence of a considerable effect. However, due to the very low- to moderate-quality of the evidence base, clear conclusions are currently unwarranted. Well-designed studies are needed to clarify effects of supervisor training on employees' stress, absenteeism, and well-being.

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.

Hospital Incidence and In-Hospital Mortality of Surgically and Interventionally Treated Aortic Dissections: Secondary Data Analysis of the Nationwide German Diagnosis-Related Group Statistics From 2006 to 2014.

Background Population-based data about the incidence and mortality of patients with aortic dissections ( ADs ) are sparse. Therefore, the hospital incidence and in-hospital mortality of patients undergoing open or endovascular surgery for type A ADs ( TAADs ) and type B ADs ( TBADs ) in Germany were analyzed on a nationwide basis between 2006 and 2014. Methods and Results A secondary data analysis of the nationwide diagnosis-related group statistics, compiled by the German Federal Statistical Office, was performed for patients who were surgically/interventionally treated for AD ( International Classification of Diseases, Tenth Revision, German Modification [ ICD -10- GM] codes I71.00-I71.07; n=20 533). By using specific procedure codes, a distinction between TAAD (n=14 911/72.6%) and TBAD (n=5622/27.4%) could be made. The standardized hospital incidence of surgically/interventionally treated AD was 2.7/100 000 per year, comprising 2.0/100 000 per year for TAAD and 0.7/100 000 per year for TBAD . The in-hospital mortality of TAAD was 19.5%; and of TBAD, 9.3%. Both the incidence and in-hospital mortality increased over the 9-year period. The share of endovascularly treated TBAD increased steadily during the same time interval. A multilevel multivariable analysis revealed that, for TAAD , age and comorbidity were significantly associated with a higher mortality risk. The latter was also true for TBAD . Sex was not significantly associated with mortality. A significant association between higher annual center volume and mortality was found for TAAD , but not for TBAD . Conclusions This is the first report on hospital incidence and mortality for surgically/interventionally treated AD on a nationwide basis. Overall, in Germany, hospital incidence and mortality of TAAD and TBAD increased over time. In addition, TAAD is performed more safely in high-volume centers.

Quality appraisal of systematic reviews, and meta-analysis of the hospital/surgeon-linked volume-outcome relationship of carotid revascularization procedures.

INTRODUCTION: Several systematic reviews and meta-analyses of primary studies have been published on the relationship between annual case load of carotid endarterectomy (CEA) and carotid artery stenting (CAS) performed at hospital level or by individual surgeons, and perioperative outcomes. Many studies on volume-outcome relationship have already been published and high-quality systematic reviews are crucial for further guideline development. EVIDENCE ACQUISITION: Systematic reviews and meta-analyses on the relationship between hospital or surgeon CEA/CAS volume and periprocedural outcomes were identified through a systematic literature search of Medline, Web of Science, and the Cochrane Database of Systematic Reviews. Methodological quality of the systematic reviews was appraised using the AMSTAR2 tool independently by two authors. Systematic reviews were aggregated in their volume-outcome findings. Quantitative data from primary studies included in the systematic reviews were synthesized. Additionally, volume definitions and the time point of outcome assessment used in primary studies were analyzed. EVIDENCE SYNTHESIS: In total, five systematic reviews published between 2000 and 2018 were identified, each comprising 11-25 primary studies. Methodological quality appraisal of these reviews revealed high quality for only the most recent review, low quality for three reviews, and critically low quality in one review. Aggregation of the systematic reviews revealed a significant inverse relationship between hospital/operator volume and the periprocedural risk of death or stroke following CEA. For CAS, high operator volume was associated with lower outcome rates. Regarding hospital volume, an inverse but non-significant relationship between CAS hospital volume and outcome rate was found. In our synthesis of primary studies from these systematic reviews an inverse CEA hospital and operator volume relationship was present for stroke or death and for CAS for hospital volume, respectively. A high heterogeneity regarding the definitions of volume categories, and of time points assessing outcomes was apparent. CONCLUSIONS: For CEA, high quality aggregated evidence revealed an inverse relationship between hospital/surgeon CEA volume and periprocedural rate of stroke or death. The same was true for operator linked CAS volume. Regarding hospital linked CAS volume, no unequivocal evidence was found. Additionally, heterogeneity was found regarding volume definition, and time of outcome assessment. Thus, future studies should aim to harmonize volume definitions and outcome time points.

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.