Health data space nodes for privacy-preserving linkage of medical data to support collaborative secondary analyses.

Introduction: The potential for secondary use of health data to improve healthcare is currently not fully exploited. Health data is largely kept in isolated data silos and key infrastructure to aggregate these silos into standardized bodies of knowledge is underdeveloped. We describe the development, implementation, and evaluation of a federated infrastructure to facilitate versatile secondary use of health data based on Health Data Space nodes. Materials and methods: Our proposed nodes are self-contained units that digest data through an extract-transform-load framework that pseudonymizes and links data with privacy-preserving record linkage and harmonizes into a common data model (OMOP CDM). To support collaborative analyses a multi-level feature store is also implemented. A feasibility experiment was conducted to test the infrastructures potential for machine learning operations and deployment of other apps (e.g., visualization). Nodes can be operated in a network at different levels of sharing according to the level of trust within the network. Results: In a proof-of-concept study, a privacy-preserving registry for heart failure patients has been implemented as a real-world showcase for Health Data Space nodes at the highest trust level, linking multiple data sources including (a) electronical medical records from hospitals, (b) patient data from a telemonitoring system, and (c) data from Austria's national register of deaths. The registry is deployed at the tirol kliniken, a hospital carrier in the Austrian state of Tyrol, and currently includes 5,004 patients, with over 2.9 million measurements, over 574,000 observations, more than 63,000 clinical free text notes, and in total over 5.2 million data points. Data curation and harmonization processes are executed semi-automatically at each individual node according to data sharing policies to ensure data sovereignty, scalability, and privacy. As a feasibility test, a natural language processing model for classification of clinical notes was deployed and tested. Discussion: The presented Health Data Space node infrastructure has proven to be practicable in a real-world implementation in a live and productive registry for heart failure. The present work was inspired by the European Health Data Space initiative and its spirit to interconnect health data silos for versatile secondary use of health data.

Penetrance, cancer incidence and survival in HFE haemochromatosis-A population-based cohort study.

BACKGROUND AND AIMS: Haemochromatosis is characterized by progressive iron overload affecting the liver and can cause cirrhosis and hepatocellular carcinoma. Most haemochromatosis patients are homozygous for p.C282Y in HFE, but only a minority of individuals with this genotype will develop the disease. The aim was to assess the penetrance of iron overload, fibrosis, hepatocellular carcinoma and life expectancy. METHODS: A total of 8839 individuals from the Austrian region of Tyrol were genotyped for the p.C282Y variant between 1997 and 2021. Demographic, laboratory parameters and causes of death were assessed from health records. Penetrance, survival, and cancer incidence were ascertained from diagnosed cases, insurance- and cancer registry data. Outcomes were compared with a propensity score-matched control population. RESULTS: Median age at diagnosis in 542 p.C282Y homozygous individuals was 47.8 years (64% male). At genotyping, the prevalence of iron overload was 55%. The cumulative penetrance of haemochromatosis defined as the presence of provisional iron overload was 24.2% in males and 10.5% in females aged 60 years or younger. Among p.C282Y homozygotes of the same ages, the cumulative proportion of individuals without fibrosis (FIB-4 score < 1.3) was 92.8% in males and 96.7% in females. Median life expectancy was reduced by 6.8 years in individuals homozygous for p.C282Y when compared with population-matched controls (p = .001). Hepatocellular carcinoma incidence was not significantly higher in p.C282Y homozygotes than in controls matched for age and sex. CONCLUSION: Reduced survival and the observed age-dependent increase in penetrance among p.C282Y homozygotes call for earlier diagnosis of haemochromatosis to prevent complications.

Transforming Clinical Information Systems: Empowering Healthcare through Telemedicine, Data Science, and Artificial Intelligence Applications.

OBJECTIVE: In this synopsis, the editors of the Clinical Information Systems (CIS) section of the IMIA Yearbook of Medical Informatics overview recent research and propose a selection of best papers published in 2022 in the CIS field. METHODS: The editors follow a systematic approach to gather relevant articles and select the best papers for the section. This year, they updated the query to incorporate the topic of telemedicine and removed search terms related to geographic information systems. The revised query resulted in a larger number of identified papers, necessitating the appointment of a third section editor to handle the increased workload. The editors narrowed the initial pool of articles to 15 candidate papers through a multi-stage selection process. At least seven independent reviews were collected for each candidate paper, and a selection meeting with the IMIA Yearbook editorial board led to the final selection of the best papers for the CIS section. RESULTS: The query was carried out in mid-January 2023 and retrieved a deduplicated result set of 5,206 articles from 1,500 journals. This year, 15 papers were nominated as candidates, and four were finally selected as the best papers in the CIS section.Including telemedicine in the query resulted in a substantial increase in the number of papers found. The analysis highlights the growing convergence between clinical information systems and telemedicine, with mobile health (mHealth) technologies and data science applications gaining prominence. The selected candidate papers emphasize the practical impact of research efforts, focusing on patient-centric outcomes and benefits, including intelligent mobile health monitoring systems and AI-assisted decision-making in healthcare. CONCLUSIONS: Looking ahead, the field of CIS is expected to continue evolving, driven by advances in telemedicine, mHealth technologies, data science, and AI integration, leading to more efficient, patient-oriented, and intelligent healthcare systems and overall improvement of global healthcare outcomes.

Moonlight surgery: no influence of moon phase or Friday 13th on outcomes of total knee arthroplasty.

OBJECTIVES: The purpose of the present study was to investigate associations between revision-free survival and functional scores of total knee arthroplasty (TKA) and moon phase on the day of surgery, as well as operations performed on a Friday 13th. PARTICIPANTS: The data of all patients that received TKA between 2003 and 2019 were extracted from the Tyrol arthroplasty registry. Patients that had undergone previous total or partial knee arthroplasty as well as patients that had missing pre- or post-operative WOMAC were excluded. Patients were allocated to one of the following four groups according to moon phase on the day of surgery: new, waxing, full and waning. Patients operated on a Friday 13th were also identified and compared to patients operated on any other days/dates. A total of 5923 patients met the inclusion criteria, with mean age of 69 ± 9 years, and comprising 62% women. RESULTS: There were no significant differences in revision-free survival among the four moon phase groups (p = 0.479), and no significant differences in preoperative and postoperative total WOMAC (p = 0.260, p = 0.122), There were no significant differences in revision-free survival patients operated on Friday 13th vs. other days/dates (p = 0.440). The preoperative total WOMAC was significantly worse for patients operated on a Friday 13th (p = 0.013), which was observed in the pain (p = 0.032) and function (p = 0.010) subscales. There were no significant differences in postoperative total WOMAC at 1 year follow-up (p = 0.122). CONCLUSIONS: Neither moon phase on the day of surgery nor Friday 13th were associated with revision-free survival or clinical scores of TKA. Patients operated on a Friday 13th had significantly worse preoperative total WOMAC but similar postoperative total WOMAC at 1-year follow-up. These findings could help reassure patients that TKA renders consistent outcomes regardless of the preoperative pain or function, and in spite of bad omens or moon phases.

Can virtual care reduce treatment burden in pediatric leukemia? A retrospective cost analysis.

We conducted a retrospective analysis to determine the potential reduction in treatment burden through the expansion of virtual care among children with leukemia (n = 152). Patients living in urban areas traveled median distances of 1555 km compared with 7536 km for patients living in rural areas (p < .05). For the latter group, a median reduction in travel distance of 3560 km (interquartile range [IQR], 2136-5787 km), travel time of 51 h (IQR, 26-78 h), and CO2 emissions of 623 kg (IQR, 374-1013 kg) was estimated, if every second visit was replaced by video consultations.

The Surviral Epidemiological Early Warning System Tyrol Dashboard - System, Functionality and Findings.

BACKGROUND: Dashboards provide a good retrospective view of the development of the disease. Yet, current COVID-related dashboards typically lack the capability to predict future trends. However, this is important for health policy makers and health care providers in order to adopt meaningful containment strategies. OBJECTIVES: The aim of this paper is to present the Surviral dashboard, which allows the effective monitoring of infectious disease dynamics. METHODS: The presented dashboard comprises a wide range of information, including retrospective and prognostic data based on an agent-based simulation framework. It served as the basis for informed decision-making and planning of disease control strategies within the federal state of Tyrol. RESULTS: By visualizing the information in an understandable format, the dashboard provided a comprehensive overview of the COVID-19 situation in Tyrol and allowed for the identification of trends and patterns. CONCLUSION: The presented dashboard is a valuable tool for managing pandemics such as COVID-19. It provides a convenient and efficient way to monitor the spread of a disease and identify potential areas for intervention.

Making a Virtue of Necessity - A Highly Structured Clinical Data Warehouse as the Source of Assured Truth in a Hospital.

Data-driven decision-making in health care is becoming increasingly important in daily clinical use. A data warehouse, storing all the clinically relevant information in a highly structured way, is a primary basis for achieving this goal. We are developing a clinical data warehouse where more than 20 years of clinical data can be persisted, and newly generated data from different sources can be integrated. A back room was created to store all hospital information system data in a PostgreSQL database. Due to the enormous number of diverse forms in the hospital information system, a broker service was developed that integrates the individual data sources into the data warehouse as soon as they are released for storage. The front room represents the interface from the infrastructure to the targeted analysis. Database query and visualization tools or business intelligence tools can display and analyze processed and interleaved data. In all areas of business and medicine, structured and quality-adjusted data is of major importance. With the help of a clinical data warehouse system, it is possible to perform patient-centered analyses and thus realize optimal therapy. Furthermore, it is possible to provide staff and management with dashboards for control purposes.

Telemedicine Research from Big Bang to 2022.

The Clinical Information Systems (CIS) section of the IMIA Yearbook of Medical Informatics systematically screens about 2,500 publications from more than 1,000 journals annually to find the best CIS publications. The editors of the CIS section have noticed a trend toward patient-centered care supported by AI and machine learning and increased research in cross-institutional data sharing, particularly in telemedicine. As a result, they adjusted their search query to include the MeSH term "telemedicine." As a preliminary step and to get a sense of the historical development of telemedicine research activity, they performed a bibliometric analysis of all previously published papers in PubMed indexed with the tag "Telemedicine" as MeSH Major Topic. They retrieved 29,289 publications from 1976 to 2022 and used their titles and abstracts to create a bibliometric network that visualizes the most relevant terms, their frequency and relationship to each other, and the chronological sequence of their publication. The development over time also shows a clear move toward patient-centeredness. Interestingly, the term "Covid," which has only recently come into use, takes on a central role in the network.

Towards a Verification Approach of a Smart Registry for Chronic Heart Failure Patients.

BACKGROUND: The daily increasing amount of health data from different sources like electronic medical records and telehealth systems go hand in hand with the ongoing development of novel digital and data-driven analytics. Unifying this in a privacy-preserving data aggregation infrastructure can enable services for clinical decision support in personalized patient therapy. OBJECTIVES: The goal of this work was to consider such an infrastructure, implemented in a smart registry for heart failure, as a comparative method for the analysis of health data. METHODS: We analyzed to what extent the dataset of a study on the telehealth program HerzMobil Tirol (HMT) can be reproduced with the data from the smart registry. RESULTS: A table with 96 variables for 251 patients of the HMT publication could theoretically be replicated from the smart registry for 248 patients with 80 variables. The smart registry contained the tables to reproduce a large part of the information, especially the core statements of the HMT publication. CONCLUSION: Our results show how such an infrastructure can enable efficient analysis of health data, and thus take a further step towards personalized health care.

Impact of Professional Background on Inter-Annotator Variability and Accuracy During Annotation of Clinical Notes.

BACKGROUND: The aging population's need for treatment of chronic diseases is exhibiting a marked increase in urgency, with heart failure being one of the most severe diseases in this regard. To improve outpatient care of these patients and reduce hospitalization rates, the telemedical disease management program HerzMobil was developed in the past. OBJECTIVE: This work aims to analyze the inter-annotator variability among two professional groups (healthcare and engineering) involved in this program's annotation process of free-text clinical notes using categories. METHODS: A dataset of 1,300 text snippets was annotated by 13 annotators with different backgrounds. Inter-annotator variability and accuracy were evaluated using the F1-score and analyzed for differences between categories, annotators, and their professional backgrounds. RESULTS: The results show a significant difference between note categories concerning inter-annotator variability (p<0.0001) and accuracy (p<0.0001). However, there was no statistically significant difference between the two annotator groups, neither concerning inter-annotator variability (p=0.15) nor accuracy (p=0.84). CONCLUSION: Professional background had no significant impact on the annotation of free-text HerzMobil notes.

Classification of Clinical Notes from a Heart Failure Telehealth Network.

Heart failure is a common chronic disease which is associated with high re-hospitalization and mortality rates. Within the telemedicine-assisted transitional care disease management program HerzMobil, monitoring data such as daily measured vital parameters and various other heart failure related data are collected in a structured way. Additionally, involved healthcare professionals communicate with one another via the system using free-text clinical notes. Since manual annotation of such notes is too time-consuming for routine care applications, an automated analysis process is needed. In the present study, we established a ground truth classification of 636 randomly selected clinical notes from HerzMobil based on annotations of 9 experts with different professional background (2 physicians, 4 nurses, and 3 engineers). We analyzed the influence of the professional background on the inter annotator reliability and compared the results with the accuracy of an automated classification algorithm. We found significant differences depending on the profession and on the category. These results indicate that different professional backgrounds should be considered when selecting annotators in such scenarios.

Total knee arthroplasty without patella resurfacing leads to worse results in patients with patellafemoral osteoarthritis Iwano Stages 3-4: a study based on arthroplasty registry data.

PURPOSE: To determine whether the preoperative degree of degeneration of the patellofemoral joint really affects the outcome of total knee arthroplasty (TKA) surgery without patella resurfacing and thus to establish a parameter that might serve as a guiding factor to decide whether or not to perform retropatellar resurfacing. It was hypothesized that patients with preoperative mild patellofemoral osteoarthritis (Iwano Stages 0-2) would significantly differ from patients with preoperative severe patellofemoral osteoarthritis (Iwano Stages 3-4) in terms of patient-reported outcome (Hypothesis 1) and revision rates/survival (Hypothesis 2) after TKA without patella resurfacing. METHODS: Application of a retrospective-comparative design on the basis of Arthroplasty Registry data that included patients with primary TKA without patella resurfacing. Patients were allocated to the following groups based on preoperative radiographic stage of patellofemoral joint degeneration: (a) mild patellofemoral osteoarthritis (Iwano Stage ≤ 2) and (b) severe patellofemoral osteoarthritis (Iwano Stages 3-4). The Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) score was assessed preoperative and 1 year postoperative (0: best, 100 worst). In addition, implant survival was calculated from the Arthroplasty Registry data. RESULTS: In 1209 primary TKA without patella resurfacing, postoperative WOMAC total and WOMAC subscores did not differ significantly between groups, but potentially suffered from type 2 error. Three-year survival was 97.4% and 92.5% in patients with preoperative mild and severe patellofemoral osteoarthritis, respectively (p = 0.002). Five-year survival was 95.8% vs. 91.4% (p = 0.033) and 10-year survival was 93.3% vs. 88.6% (p = 0.033), respectively. CONCLUSIONS: From the study findings, it is concluded that patients with preoperative severe patellofemoral osteoarthritis have significantly higher risks for reoperation than do those with preoperative mild patellofemoral osteoarthritis-when treated with TKA without patella resurfacing. Hence, it is recommended that patella resurfacing be applied in patients with severe Iwano Stage 3 or 4 patellofemoral osteoarthritis during TKA. LEVEL OF EVIDENCE: III, Retrospective comparative.

Teenage Pregnancies in Austria - an Epidemiological Study on Prevalence and Perinatal Outcome.

Introduction Even though teenage pregnancy rates have been declining in the last decades, their global prevalence is still high and shows country-specific discrepancies. Insufficient sexual education, poor availability of contraceptives and early marriage are some of the multifactorial causes for adolescent pregnancies. Very often teenage pregnancies are classified as high-risk pregnancies. Studies have found higher rates of peripartal complications, such as preterm birth, low birth weight or low fetal Apgar-Scores. The aim of this retrospective cohort study is to evaluate the prevalence of teenage pregnancies in Austria and to identify principal differences in maternal and neonatal outcome. Material and methods Data were collected from the Austrian Birth Registry between 01/2012 and 12/2020. A total of 751661 deliveries in Austria were documented. Obstetric, maternal and neonatal parameters were descriptively analyzed. Mothers were subclassified into two age groups: teenage mothers of 19 years and younger and adult mothers of 20 to 39 years of age. Results Newborns of teenage mothers were significantly smaller (49.98 ± 3.11 vs. 50.31 ± 3.16 cm, p < 0.001) and had a lower birth weight (3216 ± 564 vs. 3247 ± 576 g, p < 0.001) than newborns of adult mothers. The percentage of caesarean deliveries in the teenage group was significantly lower than in adult mothers (21.1 vs. 31.8%, p < 0.001). Newborns of teenage mothers had significantly higher rates of very low (< 4) and low (< 7) 5-minute Apgar scores (5-minute Apgar < 4: 0.75 vs. 0.54%, p = 0.004) (5-minute Apgar < 7: 1.77 vs. 1.37%, p = 0.001) and significantly lower arterial umbilical-cord pH (7.25 ± 0.08 vs. 7.26 ± 0.08, p < 0.001). Perinatal mortality was higher in the age group below 20 years (0.7 vs. 0.6%, p = 0.043). Conclusion The data of this study show significantly poorer outcomes in pregnancies of teenagers compared to adult women, even though the healthcare system in Austria is considered excellent. Future guideline recommendations should focus on important aspects of obstetric care in teenage mothers.

Evaluation of the New SingularityTM Air versus Ambu® Aura GainTM: A Randomized, Crossover Mannequin Study.

Background: This randomised crossover mannequin study aimed to compare the insertion time for the newly developed SingularityTM Air and the Ambu® AuraGainTM. The SingularityTM Air includes a bendable tube in order to allow optimal passform. Methods: Fifty anaesthetists with a minimum of 100 supraglottic airway device insertions were recruited and randomly assigned to start either with the SingularityTM Air or with the Ambu® AuraGainTM. Participants watched a tutorial video the day before the assessment and received a standardized introduction immediately before the assessment. The primary outcome was the time for successful insertion. Secondary parameters were the overall insertion success rate, the numbers of insertion attempts (maximum three), the glottic view through a flexible bronchoscope, and the success rate for gastric tube insertion. Results: Fifty participants were eventually recruited and randomly assigned to insert both devices according to the randomization. The insertion time was 24 s for SingularityTM Air as compared to 20 s for Ambu® AuraGainTM (p < 0.001). Overall insertion rate was 92% for the SingularityTM Air as compared to 100% for the Ambu® AuraGainTM (p could not be derived as one variable is a constant). The primary insertion success rate was better for the Ambu® AuraGainTM than for the SingularityTM Air (94% versus 68%; p: 0.002, respectively). Conclusion: The time for successful insertion and the insertion success rate for the newly developed SingularityTM Air is inferior to that for the Ambu® AuraGainTM.

External validation of the Tyrolean hip arthroplasty registry.

PURPOSE: Arthroplasty registries gained increasing importance to the re-certification of orthopaedic implants according to the European Union (EU) Medical Device Regulation (MDR) adopted in 2017. Until recently, several European countries only had regional arthroplasty registries. Whether regional registries deliver data quality comparable with national registries remained unclear. Therefore, the purpose of this study was to validate the Austrian Tyrolean Hip Arthroplasty Registry (THAR) and to evaluate if this regional registry showed adequate adherence, completeness and correctness when compared with well-established national registries. METHODS: A consecutive series of 1100 primary total hip arthroplasties were identified from our institution's medical database. Patients were interviewed by phone and completed questionnaires after a mean follow-up period of 8.05 years and were asked if they had had revision surgeries. The data were compared to the corresponding dataset from the THAR. RESULTS: Adherence was 97.91% for primary total hip arthroplasty. Clinical follow-up identified 10 missing cases, resulting in adherence of 81.48% for revisions. Completeness of patient-reported outcome measurements was 78.55% before surgery and 84.45% 1 year after surgery. Correctness was 99.7% for demographic data, 99.54% for implant specifications, and 99.35% for mode of fixation. CONCLUSION: The data of this study showed that regional arthroplasty registries can deliver data quality comparable with well-established national registries. The main reason for unrecorded revision cases and wrongly recoded implants was human error. Further digitalization with more automatic data submission may have the potential to reduce these failure rates in the future. Overall, the THAR represents a valid data source for re-certification of medical implants according to the EU's MDR.

Hairy Cell Leukemia Patients Have a Normal Life Expectancy-A 35-Year Single-Center Experience and Comparison with the General Population.

Classic hairy cell leukemia (HCL) is an uncommon hematologic malignancy characterized by an excellent prognosis since purine analogues (PA), such as cladribine (2-CdA), have been introduced in the 1990s. However, most data on long-term outcomes is gathered from patients treated with PA first-line or include limited information on previous treatment outcomes, i.e., Interferon-α (IFN-α). Survival curves from previous series did not reach a plateau, indicating that nearly all patients ultimately relapse. Yet, overall survival (OS) data were rarely corrected for life expectancy of the general population. We here report 83 consecutive HCL patients treated between 1983 and 2017 at the University Center in Innsbruck, Austria. Median follow-up was 170 months (1-498). IFN-α, the first-line treatment of choice before 1990, was administered to 24 patients, achieving an overall response rate (ORR) of 86% and an unconfirmed complete remission (CRu) in 23%. All these patients relapsed after a median progression-free survival (PFS) of 30 months (3-80), but either remained drug-sensitive upon re-exposure to IFN-α or were successfully salvaged with PA. All 42 patients exposed to first-line 2-CdA responded (ORR of 100%). Sixteen patients received two to four successive courses of PA with a continuous decrease in the response quality (CRu rate 85.7% 1st-line vs. 41.5% 3rd-line treatment). Median PFS was not reached in both treatment-naïve patients and those retreated at first relapse. Although pretreatment with IFN-α was associated with a shortened median PFS of 81 months (43-118) after PA therapy, this tendency of inferior PFS did not result in inferior OS. OS of all 83 patients was excellent and equivalent to that of age-, sex-, and diagnostic period-matched controls from the Tyrolean general population (standardized mortality ratio 0.8), regardless of their age at diagnosis or whether they were diagnosed until or after the year 2000. These results confirm that HCL patients may look forward to a normal lifespan when treated with PA irrespective of their pretreatment history.

Universal gestational diabetes screening and antepartum stillbirth rates in Austria-A population-based study.

INTRODUCTION: Occult or untreated gestational diabetes (GDM) is a well-known risk factor for adverse perinatal outcomes and may contribute to antepartum stillbirth. We assessed the impact of screening for GDM on the rate of antepartum stillbirths in non-anomalous pregnancies by conducting a population-based study in 974 889 women in Austria. MATERIAL AND METHODS: Our database was derived from the Austrian Birth Registry. Inclusion criteria were singleton live births and antepartum stillbirths ≥24+0 gestational weeks, excluding fetal congenital malformations, terminations of pregnancy and women with pre-existing type 1 or 2 diabetes. Main outcome measures were (a) overall stillbirth rates and (b) stillbirth rates in women at high risk of GDM (i.e., women with a body mass index ≥30 kg/m2 , history of previous intrauterine fetal death, GDM, previous macrosomic offspring) before (2008-2010, "phase I") and after (2011-2019, "phase II") the national implementation of universal GDM screening with a 75 g oral glucose tolerance test in Austrian pregnant women by 2011. RESULTS: In total, 940 373 pregnancies were included between 2008 and 2019, of which 2579 resulted in intrauterine fetal deaths at 33.51 ± 5.10 gestational weeks. After implementation of the GDM screening, a statistically significant reduction in antepartum stillbirth rates among non-anomalous singletons was observed only in women at high risk for GDM (4.10‰ [95% confidence interval (CI) 3.09-5.43] in phase I vs. 2.96‰ [95% CI 2.57-3.41] in phase II; p = 0.043) but not in the general population (2.76‰ [95% CI 2.55-2.99] in phase I vs. 2.74‰ [95% CI 2.62-2.86] in phase II; p = 0.845). The number needed to screen with the oral glucose tolerance test to subsequently prevent one case of (non-anomalous) intrauterine fetal death was 880 in the high-risk and 40 000 in the general population. CONCLUSIONS: The implementation of a universal GDM screening program in Austria in 2011 has not led to any significant reduction in antenatal stillbirths among non-anomalous singletons in the general population. More international data are needed to strengthen our findings.

The impact of dexamethasone as a perineural additive to ropivacaine for PECS II blockade in patients undergoing unilateral radical mastectomy - A prospective, randomized, controlled and double-blinded trial.

STUDY OBJECTIVE: Dexamethasone is commonly used as an adjuvant to local anesthetics to prolong duration of peripheral nerve blocks with minimal side-effects. The present study investigates the efficacy of dexamethasone added to ropivacaine 0.2% as compared to ropivacaine 0.2% alone for pectoral nerves block II (PECS II) in unilateral radical mastectomy. DESIGN: A prospective, randomized, controlled and double-blinded trial. SETTING: The study was performed at Innsbruck Medical University Hospital, Austria, between January 2019 and October 2020. PATIENTS: Sixty female patients with an American Society of Anesthesiologists Score I-II (18-90 years, BMI 18-35) scheduled for unilateral radical mastectomy without one-stage immediate autologous breast reconstruction were randomly assigned to receive PECS II block with ropivacaine 0.2% with or without dexamethasone 8 mg. INTERVENTIONS: Patients were randomly assigned to receive PECS II block with ropivacaine 0.2% with or without dexamethasone 8 mg. MEASUREMENTS: Primary outcome parameter was the cumulative opioid consumption during the first 72 postoperative hours. Secondary outcome parameters were the duration of analgesia and the course of the visual analogue scale (VAS) and the area under the curve VAS (AUC-VAS). MAIN RESULTS: There was no difference in cumulative opioid consumption after 72 h between the ropivacaine 0.2% plus dexamethasone group and the ropivacaine 0.2% plus placebo group (11.89 vs 11.90 morphine milligram equivalent, respectively; p 0.831). Duration of analgesia also did not differ significantly between the ropivacaine 0.2% plus dexamethasone group and the ropivacaine 0.2% plus placebo group (12.75 versus 8.75 h, respectively; p 0.680). There also was no difference in the course of VAS and AUC-VAS. CONCLUSIONS: Dexamethasone 8 mg when added to ropivacaine 0.2% for PECS II block in unilateral radical mastectomy was not found to reduce total opioid consumption over 72 postoperative hours or to prolong duration of analgesia as compared to pure ropivacaine 0.2%.

Prevalence of VOYAGER PAD trial exclusion criteria in unselected patients undergoing lower limb revascularization.

BACKGROUND: The VOYAGER PAD trial investigated data on dual pathway inhibition after lower limb revascularization for peripheral arterial disease (PAD). Multiple exclusion criteria were applied. However, neither data on the prevalence of exclusion criteria nor on the total number of patients screened for inclusion was discussed. METHODS: We performed a single-center prospective observational study in unselected PAD patients undergoing lower limb revascularization. Demographic and disease-specific data was collected. RESULTS: One hundred fifty patients were included with only 29 patients (19.3%) as potential candidates for the VOYAGER PAD study medication. Poorly controlled diabetes or severe uncontrolled hypertension (33.3%), major tissue loss (18.7%), acute limb ischaemia within prior 2 weeks (17.3%) and a history of intracranial hemorrhage, stroke or TIA (16%) were amongst the exclusion criteria most frequently met. Compared to VOYAGER PAD study patients, significant differences regarding sex (36.7% female vs. 25.8%), renal insufficiency (29.0% vs. 20.1%), previous myocardial infarction (16.7% vs. 11.1%) and known carotid artery disease (18.7% vs. 8.6%) revealed. Patients presented significantly more frequently with critical limb ischemia (56.7% vs. 30.4%) and a history of previous peripheral revascularization (72.0% vs. 35.9%). Fewer endovascular interventions (52% vs. 65.5%) and more surgeries (58% vs. 34.5%) were performed. CONCLUSIONS: In unselected patients undergoing revascularization for peripheral arterial disease, the majority presents with characteristics that, at present, preclude prescription of rivaroxaban in addition to aspirin. This patient cohort represents a population with higher rates of comorbidities and more complex vascular interventions, but might also benefit from dual pathway inhibition strategy.