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.

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.

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.

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.

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.

Increasing Incidence of Thoracic Aortic Aneurysm Repair in Germany in the Endovascular Era: Secondary Data Analysis of the Nationwide German DRG Microdata.

OBJECTIVES: Nationwide population based data on epidemiology and surgical treatment of descending thoracic aortic (DTA) aneurysms are not available for Germany. The aim was to assess the in hospital incidence, and to report outcomes of patients who received surgical treatment. METHODS: Data were acquired by analysing the diagnosis related group (DRG) statistics of the German Federal Statistical Office. All inpatient cases of ruptured (rDTA aneurysm, ICD Code I71.1) or non-ruptured DTA aneurysm (nrDTA aneurysm; I71.2) who received thoracic endovascular (TEVAR; OPS procedure code 5-38a.7/70/8/80) or open aortic repair (OAR; OPS 5-384.3) between 2005 and 2014 were included. To adjust for sex, age, medical risk (Elixhauser comorbidity score), type of procedure, and type of admission, a multilevel multivariable regression model with robust error variance was applied. The primary outcome was in hospital mortality; secondary outcomes were organ complications. A volume outcome analysis was performed. RESULTS: A total of 48,098 cases of DTA aneurysm (5,848, 12.2% rDTA aneurysm) were identified. The average age was 69 ± 12 years. 65.2% were male. Frequent comorbidities were hypertension (74.9%), peripheral artery disease (including abdominal aortic aneurysm, 42.6%), other heart diseases (41.6%), coronary heart disease (26.2%), and renal failure (22.5%). Surgical treatment was received by 4969 patients (10.3%): 4057 TEVAR (81.6%) and 912 OAR (18.4%) procedures. Mortality for rDTA aneurysm was 42.9% (OAR) and 22.3% (TEVAR). It was 10.5% and 3.7% for DTA aneurysm, respectively. Rupture, increasing age, and higher comorbidity score were significantly associated with higher mortality (RR 6.66, 5.33-8.25; 1.28, 1.17-1.40; and 1.06, 1.05-1.08, respectively). Endovascular treatment was associated with lower mortality (RR 0.31, 0.23-0.41). Hospital volume was not significantly associated with in hospital mortality. CONCLUSIONS: Eighty per cent of patients treated surgically for a DTA aneurysm receive endovascular therapy, with low peri-operative mortality in non-ruptured cases. Elective endovascular repair should be considered for individuals at a high risk of rupture who are fit for surgery. Open repair, increased age, and a high comorbidity score are associated with higher mortality.

Editor's Choice - Hospital Incidence, Treatment, and In Hospital Mortality Following Open and Endovascular Surgery for Thoraco-abdominal Aortic Aneurysms in Germany from 2005 to 2014: Secondary Data Analysis of the Nationwide German DRG Microdata.

OBJECTIVE: Hospital incidence, treatment modality, and in hospital mortality after surgery are reported for thoraco-abdominal aortic aneurysms (TAAAs) treated by endovascular or open means in Germany from 2005 to 2014. METHODS: Data were extracted from diagnosis related group statistics from the German Federal Statistical Office. All inpatient cases with a diagnosis of ruptured and non-ruptured TAAA (ICD-10 I71.5 and I71.6) and procedure codes for fenestrated or branched endovascular aortic repair (f/bEVAR 5-38a.7x and 5-38a.8x), open aortic repair (OAR 5-384.4), or hybrid procedure (5-384.b/c, 5-38a.a/b/8/80) were included. To adjust for sex, age, medical risk (Elixhauser comorbidity score), type of procedure, and type of admission, a multilevel multivariable regression model with robust error variance was applied. The primary outcome was in hospital mortality; secondary outcomes were organ complications. The relationship between annual hospital volume and outcome was analysed. RESULTS: A total of 2607 cases (406 rTAAA, 2201 nrTAAA) were included. f/bEVAR was performed in 856 cases (32.8%), OAR in 1422 cases (54.5%), and hybrid repair in 354 cases (13.6%). Endovascular repair became more frequent over time (6% in 2005 vs. 76% in 2014 for nrTAAA). Hypertension (75.2%), peripheral artery disease (including abdominal aortic aneurysm, 49.5%), other heart diseases (44.6%), coronary heart disease (30.6%), and renal failure (28.7%) were the most frequently coded comorbidities. The number of hospitals treating TAAAs almost tripled within 9 years. The in hospital mortality was 46.1% for rTAAA and 15.9% for nrTAAA. f/bEVAR (RR 0.35, 0.24-0.51) and high hospital volume (p < .001) were significantly associated with decreased in hospital mortality. Aortic rupture, increasing age, and comorbidity were significantly associated with higher mortality (RR 3.17, 2.45-4.09; 1.52, 1.32-1.76, and 1.05, 1.04-1.06). CONCLUSIONS: Seventy-six percent of all TAAAs were treated endovascularly in 2014 with increasing frequency over a decade. In hospital mortality is lower with endovascular repair and in high volume centres. Aortic rupture, age, and severe comorbidities are associated with worse outcomes.

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.

Objective Performance Goals for Surgical Treatment of Critical Limb Ischemia.

BACKGROUND: Based on prospective vein bypass trials for lower leg ischemia, objective performance goals (OPG) were established by the Society for Vascular Surgery (SVS) and are used as a benchmark tool for open and endovascular treatments. This study aims to analyze OPG of all patients with critical limb ischemia (CLI) treated by open revascularization techniques at a tertiary care facility in routine practice. METHODS: From January 2005 to March 2013, 315 patients (mean age 72 years) with CLI were retrospectively included in this study. Inclusion criteria were patients with Fontaine stage III and IV, realized revascularization with open surgical procedures (bypass grafting or endarterectomy), or hybrid method (open + endovascular). Exclusion criteria were primary major amputations, patients with revascularization treatments of the index leg within the last 3 months, and missing aftercare. Primary end point was "amputation-free survival" (AFS), and secondary end point was "freedom from major adverse limb event + perioperative death (30 days)" (MALE + POD) according to the SVS. The technical end point was primary patency. Mean follow-up was 34 months. The following variables were studied: clinical stage (Fontaine), previous interventions, bypass material used, and site of the distal anastomosis. The statistical evaluation and preparation was carried out using the Kaplan-Meier estimator and the log-rank test. A multivariate analysis was performed using the Cox proportional hazards model. A P value ≤0.05 was considered to be statistically significant. RESULTS: A total of 128 patients (31%) fulfilling the adjusted SVS OPG criteria showed significantly better results for AFS, MALE + POD, and primary patency (P = 0.013, P = 0.015, P = 0.002, respectively). Regarding the AFS (1 year: 74%), multivariate analysis displayed significant worse results for patients with end-stage renal disease (hazard ratio [HR] 2.90, 95% confidence interval [CI] 1.83-4.60, P < 0.001) and Fontaine stage IV (HR 1.69, 95% CI 1.11-2.57, P = 0.015). Regarding MALE + POD (1 year: 64%), male patients (HR 0.64, 95% CI 0.46-0.90, P = 0.011) showed a significantly better outcome and patients without previous interventions of the index leg (HR 1.51, 95% CI 1.09-2.09, P = 0.013) showed a significantly worse outcome. CONCLUSIONS: In this study, we were able to show that it is possible to reach the efficacy of OPGs set by SVS in a surgically treated all-comers cohort of CLI patients. Nevertheless, patients who did not fulfill the SVS OPG criteria showed significantly worse results for AFS and MALE + POD.

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.

Editor's Choice - High Annual Hospital Volume is Associated with Decreased in Hospital Mortality and Complication Rates Following Treatment of Abdominal Aortic Aneurysms: Secondary Data Analysis of the Nationwide German DRG Statistics from 2005 to 2013.

OBJECTIVES: The aim of this study was to analyse the association between annual hospital procedural volume and post-operative outcomes following repair of abdominal aortic aneurysms (AAA) in Germany. METHODS: Data were extracted from nationwide Diagnosis Related Group (DRG) statistics provided by the German Federal Statistical Office. Cases with a diagnosis of AAA (ICD-10 GM I71.3, I71.4) and procedure codes for endovascular aortic repair (EVAR; OPS 5-38a.1*) or open aortic repair (OAR; OPS 5-38.45, 5-38.47) treated between 2005 and 2013 were included. Hospitals were empirically grouped to quartiles depending on the overall annual volume of AAA procedures. A multilevel multivariable regression model was applied to adjust for sex, medical risk, type of procedure, and type of admission. Primary outcome was in hospital mortality. Secondary outcomes were complications, use of blood products, and length of stay (LOS). The association between AAA volume and in hospital mortality was also estimated as a function of continuous volume. RESULTS: A total of 96,426 cases, of which 11,795 (12.6%) presented as ruptured (r)AAA, were treated in >700 hospitals (annual median: 501). The crude in hospital mortality was 3.3% after intact (i)AAA repair (OAR 5.3%; EVAR 1.7%). Volume was inversely associated with mortality after OAR and EVAR. Complication rates, LOS, and use of blood products were lower in high volume hospitals. After rAAA repair, crude mortality was 40.4% (OAR 43.2%; EVAR 27.4%). An inverse association between mortality and volume was shown for rAAA repair; the same accounts for the use of blood products. When considering volume as a continuous variate, an annual caseload of 75-100 elective cases was associated with the lowest mortality risk. CONCLUSIONS: In hospital mortality and complication rates following AAA repair are inversely associated with annual hospital volume. The use of blood products and the LOS are lower in high volume hospitals. A minimum annual case threshold for AAA procedures might improve post-operative results.

Spatial Analysis of Hospital Incidence and in Hospital Mortality of Abdominal Aortic Aneurysms in Germany: Secondary Data Analysis of Nationwide Hospital Episode (DRG) Data.

OBJECTIVE: This study aimed to analyze the spatial distribution and regional variation of the hospital incidence and in hospital mortality of abdominal aortic aneurysms (AAA) in Germany. METHODS: German DRG statistics (2011-2014) were analysed. Patients with ruptured AAA (rAAA, I71.3, treated or not) and patients with non-ruptured AAA (nrAAA, I71.4, treated by open or endovascular aneurysm repair) were included. Age, sex, and risk standardisation was done using standard statistical procedures. Regional variation was quantified using systematic component of variation. To analyse spatial auto-correlation and spatial pattern, global Moran's I and Getis-Ord Gi* were calculated. RESULTS: A total of 50,702 cases were included. Raw hospital incidence of AAA was 15.7 per 100,000 inhabitants (nrAAA 13.1; all rAAA 2.7; treated rAAA 1.6). The standardised hospital incidence of AAA ranged from 6.3 to 30.3 per 100,000. Systematic component of variation proportion was 96% in nrAAA and 55% in treated rAAA. Incidence rates of all AAA were significantly clustered with above average values in the northwestern parts of Germany and below average values in the south and eastern regions. Standardised mortality of nrAAA ranged from 1.7% to 4.3%, with that of treated rAAA ranging from 28% to 52%. Regional variation and spatial distribution of standardised mortality was not different from random. CONCLUSIONS: There was significant regional variation and clustering of the hospital incidence of AAA in Germany, with higher rates in the northwest and lower rates in the southeast. There was no significant variation in standardised (age/sex/risk) mortality between counties.

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.

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.

Impact of sex and age on carotid plaque instability in asymptomatic patients-results from the Munich Vascular Biobank.

BACKGROUND: It is still a controversial issue whether carotid endarterectomy (CEA) for asymptomatic carotid stenosis is superior to best medical treatment. The aim of this study was therefore to analyze the impact of sex and age on carotid plaque instability in asymptomatic patients undergoing CEA. PATIENTS AND METHODS: Atherosclerotic plaques from 465 asymptomatic patients with high-grade carotid artery stenosis (2004 - 2013) at the Munich Vascular Biobank were analyzed. Ascertainment of lesion stability/instability was performed on formalin-fixed paraffin-embedded tissue samples using hematoxylin-eosin and elastic van Gieson staining. Unstable plaques were considered lesions with a fibrous cap < 200 µm overlaying lipid-rich atheroma. RESULTS: The average age of the patients was 69.3 ± 8.2 years. Independent of age, asymptomatic men had in total more frequently unstable plaques in contrast to women (41 % versus 52%, p = 0.042). No differences were found in plaque instability between age-related quartiles (< 65, 65- 69, 70 - 74, > 74 years) for female sex (p = 0.422). In men, a continuous increase in plaque instability with age was observed, without achieving statistical significance (p = 0.125). The greatest differences between male and female sex were found in the last quartile (> 74 years), without achieving statistical significance (p = 0.053). The chance of unstable carotid plaques in men was significantly higher than in women (OR = 1.562, p = 0.040). The probability of age-associated quartiles related to the first quartile demonstrated significant increase in plaque instability in the group of 65- to 69-year-old patients (OR 1.867, p = 0.024) and for patients older than 74 years (OR 1.740, p = 0.040). CONCLUSIONS: Asymptomatic men had in total more frequently unstable plaques in contrast to women. Thus, male sex seems to be an additional risk factor for ischemic stroke.