University Hospital Augsburg

Die Akut- und Notfallversorgung ist dynamisch, komplex und stark nachgefragt, während die Anforderungen an die Qualität gleichzeitig steigen. Eine sektorenübergreifende Datenbasis fehlt bislang. Qualitätsmanagement und Leitlinienentwicklung in der Notfallmedizin basieren häufig auf fragmentierten Daten. Zugleich sind klinische Studien im Notfallsetting nur eingeschränkt realisierbar, weshalb notfallmedizinische Leitlinien häufig auf niedrigeren Evidenzstufen beruhen. Ohne populationsbasierte Register ist eine systematische Bewertung von Struktur‑, Prozess- und Ergebnisqualität entlang der Rettungskette nicht möglich. Notfallregister erfassen organisatorische und medizinische Routinedaten zu Notfallereignissen und können durch gesetzliche Verankerung die Grundgesamtheit abbilden. Die resultierenden registerbasierten Daten sind eine zentrale Grundlage für Qualitätsmanagement und Versorgungsforschung. Perspektivisch erlauben Echtzeitregister individualisiertes Feedback für die Beteiligten und fördern die kontinuierliche Weiterentwicklung. Notfallregister sind eine notwendige Infrastruktur für eine lernende Notfallversorgung. Sie bieten die Chance nachhaltiger struktureller und fallbezogener Qualitätsverbesserung.

Background Despite growing scientific evidence and health guidelines, the global health paradox persists, with rising lifestyle-related diseases and escalating healthcare costs exposing the inadequacy of current efforts. Objective Three multidisciplinary congresses were held to generate evidence-based conclusions aimed at addressing the global health paradox. Methods A total of 58 experts from 62 entities participated in the international research and knowledge-exchange panels. Experts reviewed the latest findings to develop practical strategies and identify key research and policy priorities, focusing on the Healthy Eating & Active Living (HEAL) approach. Results, conclusion, and relevance The expert consortium endorsed a 33 evidence-based consensual-statement policy roadmap for addressing global health challenges, emphasizing that the HEAL approach can significantly contribute to the “Prevention First” appeal and broad ethical, social, ecological, and economic advantages, and ultimately supporting policy change.

Zusammenfassung Das Feld der klinischen und molekularen Genetik bei an Epilepsie erkrankten Personen entwickelt sich rasant weiter. In dieser Übersichtsarbeit bietet das Expertenpanel „Epilepsie und Genetik“ der Deutschen Gesellschaft für Epileptologie (DGfE) einen aktualisierten Überblick über die neuen Entwicklungen, sowohl klinisch etabliert als auch derzeit nur im Forschungskontext durchgeführt. Diese bauen auf der vorherigen Version von 2023 der allgemeinen Empfehlungen auf und ergänzen diese mit speziellen Aspekten. Hervorgehoben werden dabei moderne Ansätze in der Interpretation von Varianten unklarer Signifikanz, das Vorgehen bei ungelösten Fällen anhand von neuartigen Sequenziertechnologien und Omics-Ansätzen, die zunehmende Rolle der prä- und postoperativen Sequenzierung im Rahmen der Epilepsiechirurgie und die Risikostratifizierung anhand von polygenen Scores. Aus diesen Aspekten ergeben sich teils unmittelbar klinisch anwendbare Konsequenzen für alle Teilbereiche der Epileptologie.

Introduction: The widespread availability of handheld point-of-care ultrasound systems (HHUS) has rapidly increased the number of preclinical emergency medicine ultrasound examinations in Germany. HHUS used by emergency physicians at the Southside Festival (SSF) in southern Germany was evaluated over several years according to its feasibility and ability to change patients’ disposition and treatment process. Methods: By questionnaire, the doctors performing the examination were asked about the indication, the body region examined, the ultrasound protocol used, if any, the duration of the examination, and any changes in the further procedure. In addition, the subjective assessment of the accessibility, the visualization under the existing lighting, and the ultrasound experience of the users were surveyed. Results: In three years, a total of 29 ultrasound examinations were assessed by the sonographers. The majority of examined regions were the abdomen (55.2%). 27.6% used the (e)FAST protocol; no protocol was used in 41.4%. Indications: 31.0% pain, 20.7% trauma, 27.6% examiner’s interest, 24.1% confirmation of suspected diagnosis, 3.4% as part of CPR. Duration: examination 41.4% <2 min, 41.4% 2-5 min. In 20.7%, the procedure was changed due to the examination. Accessibility and visualization were rated 2 (1 very good - 6 poor). Half of the users considered themselves experienced. Conclusion: Ultrasound examinations under medical service conditions at an MGE were feasible and accessible. The majority of examinations concerned the abdomen. US protocols were only used in half of the cases. The duration of the examination was usually less than 5 minutes, and the procedure was changed further by the examination in 20.6% of cases. Since there is supposed to be a large amount of extremities trauma in festival visitors, this percentage might be even higher when (in fracture and joint ultrasound) trained emergency physicians are in charge. Data collection will continue.

Quantitative coronary plaque measures differ in prognostic value between women and men. It remains unclear whether cardiovascular risk increases proportionally with plaque extent in both sexes. We aimed to compare cardiovascular risk trajectories across quantitative coronary plaque measures in women and men with stable chest pain. We analyzed data from the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) coronary computed tomography angiography arm, quantifying total coronary plaque volume and burden (plaque burden [PB]; % vessel volume), including calcified, noncalcified, and low-attenuation components. Associations with major adverse cardiovascular events (death, myocardial infarction, or unstable angina hospitalization) were assessed using sex-stratified spline Cox models over a median 26 months (interquartile range, 18-34). Among 4267 patients (mean age, 60.4±8.2; 2199 women), plaque was less frequent in women (55% versus 75%; P<0.001), with lower total plaque volume but similar total PB and incident major adverse cardiovascular events (2.3% versus 3.4%). Major adverse cardiovascular event risk became elevated at lower PB in women than in men: for total PB, hazard ratio crossed 1.0 at 20% in women versus 28% in men, reaching hazard ratio 1.5 at 32% in women versus 42% in men, respectively. Noncalcified PB showed a similar pattern, crossing hazard ratio 1.0 at 7% in women versus 9% in men; hazard ratio 1.5 at 13% in women versus 20% in men. Findings were similar after adjustment for atherosclerotic cardiovascular disease risk score. In women, major adverse cardiovascular events appeared to emerge at a lower PB, and to rise more sharply. Findings support sex-specific interpretation of coronary computed tomography angiography-derived plaque metrics for timely intervention in women. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01174550.

The impact of demographic change has far-reaching consequences for the entire healthcare system. One of the areas particularly affected is palliative and hospice care. To meet the demand for palliative and hospice care services, adequate capacity planning in inpatient and outpatient settings is essential. However, the available capacities per one million inhabitants in Germany vary significantly within the individual regions. For an improved assessment of care needs, we propose a simulation-based analysis, carried out both retrospectively for 2019 and prospectively for 2039 for the southern German region of Swabia, and calculate the required capacities of hospices and specialized outpatient palliative care. We focus on cancer patients, as this group represents the largest proportion of patients requiring palliative and hospice care. Driven by demographic change and the increasing incidence of cancer in older age groups, the number of patients requiring palliative care is expected to increase substantially. Accordingly, our results indicate a marked rise in the demand for hospice and specialized outpatient palliative care for cancer patients up to the year 2039. This projected trend underscores the growing care needs within this patient population in the coming decades. Our study introduces a simulation-based framework for estimating demand for hospice and specialized outpatient palliative care. By offering a quantitative, mathematical-statistical perspective, the approach complements existing qualitative research and supports informed decision making in palliative care planning.

Abstract Background: Current data support that metastatic hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer offers distinct treatment options targeting both the hormone receptor and the HER2-pathway. This might lead to increased treatment efficacy with the potential of omitting chemotherapy in these patients. The aim of the randomized multicenter phase III DETECT V trial was to analyze the efficacy of chemotherapy free and CDK4/6 inhibitor containing treatment strategies compared to current standard treatment. Methods: Between 09/2015 and 11/2022, 271 patients with HER2+ and HR+ MBC in the 1st-3rd line setting were randomized 1:1 to receive trastuzumab and pertuzumab combined with either endocrine therapy or chemotherapy followed by maintenance therapy with dual HER2 targeted and endocrine therapy. Chemotherapy and the endocrine agents could be chosen from a variety of available regimens according to physicians’ choice. In January 2019, the protocol was amended with the addition of the CDK4/6 inhibitor ribociclib to both treatment arms. The primary objective of DETECT V was to compare tolerability between the treatment arms, and secondary objectives comprised the comparison of overall survival (OS), progression-free survival (PFS) and safety, as well as the evaluation of the effect of adding ribociclib to both treatment arms. Here we report results of the final efficacy analyses as based on the modified ITT set of 262 patients (9 patients did not receive any study treatment and were excluded). Of these, 120 patients were recruited before the addition of ribociclib (59 and 61 patients in the chemotherapy-free and chemotherapy-containing treatment arm, respectively), and 142 patients were recruited after the addition of ribociclib (73 and 69 patients in the chemotherapy-free and chemotherapy-containing treatment arm, respectively). Results: Median patient age was 60 years, 202 (77.1%) of patients were in the first line setting and 137 (52.3%) patients had a metastasis-free interval (from primary diagnosis) exceeding 12 months. The overall comparison between all patients receiving chemotherapy-free and chemotherapy-containing treatment showed no significant difference with regard to OS and PFS (median OS not reached vs 46.1 months, HR 0.98, 95% CI 0.60 - 1.59, p = 0.93; median PFS 19.5 vs 23.0 months, HR 1.15, 95% CI 0.82 - 1.62, p = 0.42). However, both OS and PFS were significantly improved by the (non-randomized) addition of ribociclib (OS: median OS not reached vs 46.1 months, HR 0.43, 95% CI 0.26 - 0.72, p = 0.001; PFS: median PFS 29.7 vs 15.6 months, HR 0.48, 95% CI 0.34 - 0.67, p &amp;lt; 0.001). A separate analysis for the two treatment arms showed that the addition of ribociclib to chemotherapy-containing treatment significantly improved both OS (median OS not reached vs 38.7 months, HR 0.30, 95% CI 0.14 - 0.64, p = 0.002) and PFS (median PFS 33.1 vs 15.4 months, HR 0.35, 95% CI 0.21 - 0.59, p &amp;lt; 0.001), while the addition of ribociclib to chemotherapy-free treatment significantly improved PFS (median PFS 27.2 vs 15.6 months, HR 0.61, 95% CI 0.38 - 0.98, p = 0.040) but not OS (median OS not reached in both groups, HR 0.60, 95% CI 0.30 - 1.23, p = 0.163). An exploratory cross-cohort comparison revealed significantly improved outcome for patients receiving chemotherapy-free treatment plus ribociclib vs chemotherapy-containing treatment without ribociclib (OS: median OS not reached vs 38.7 months, HR 0.48, 95% CI 0.24 - 0.94, p = 0.033; PFS: median PFS 27.2 vs 15.4 months, HR 0.53, 95% CI 0.33 - 0.85, p = 0.008). Conclusion: Our results suggest that chemotherapy-free treatment for patients with HER2+ and HR+ MBC may be a valuable and effective treatment alternative, and may improve survival with the addition of ribociclib. Citation Format: W. Janni, T. Fehm, V. Müller, J. Blohmer, A. De Gregorio, T. Decker, A. Hartkopf, N. Ditsch, M. Schmidt, P. Wimberger, T. Engler, M. Banys-Paluchowski, P. A. Fasching, B. Rack, A. Schneeweiss, K. Pantel, T. W. Friedl, F. Schochter, J. Huober. Efficacy Analysis of the Randomized Phase III DETECT V trial: Treatment De-escalation by Omission of Chemotherapy and the Effect of Adding Ribociclib in HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr RF4-02.

Abstract Background: Most patients with breast cancer and axillary nodal involvement achieve a clinical and radiological response after primary systemic treatment (PST). In this case, a surgical axillary de-escalation should be offered to reduce surgical trauma and subsequent morbidity. Sentinel lymph node biopsy (SLNB) (with a dual tracer and/or removal of at least 3 sentinel lymph nodes) or targeted axillary dissection (TAD) can safely replace axillary lymphadenectomy. The more axillary lymph nodes removed, the higher the morbidity. Therefore, SLNB and TAD represent surgical de-escalation procedures with lower body impact and arm injury compared to full axillary lymphadenectomy. Retrospective studies observed no difference in oncological outcome between SLNB and TAD. Follow-up data from the current ongoing prospective registry AXSANA (EUBREAST 3) will provide unique real-world evidence on this topic. In the meantime, surgical axillary staging is characterized by a lack of standardization and a wide heterogeneity between countries, institutions, and guidelines. The choice of treatment is therefore determined by preferences of institutions and/or surgeons rather than benefits for the patients. Currently, there is no consensus on whether SLNB or TAD minimizes the number of lymph nodes removed. No randomized clinical trials have compared SLNB versus TAD in node positive breast cancer patients converting to node negative after PST. The aim of the current study (SLYMT-AXSANA, EUBREAST 3R) is to use a pragmatic design and conduct, to our knowledge, the first registry-based randomized controlled trial in this setting. We will compare the number of lymph nodes removed during SLNB versus TAD and related morbidity in patients with breast cancer who initially present with clinically node-positive status and convert to clinical node-negative after receiving PST. The number of additional nodes included, the failure of techniques, and the need for subsequent axillary lymphadenectomy according to the results of the frozen section during SLNB versus TAD will be assessed in order to better define both techniques. Methodology: Following similar inclusion and exclusion criteria of the AXSANA(EUBREAST 3) study (cT1-4, cN+, M0 breast cancer patients undergoing PST), eligible patients will be randomized to SLNB versus TAD, prior to PST. The biopsy of the metastatic lymph node/s and the marking of the positive lymph node(s) will be required, regardless of the arm of the study. Only patients achieving complete clinical and radiological axillary response will be included in the analysis. Data will be prospectively collected in RedCap. Patient-reported outcome measures (PROMS) will be collected at a predefined time. Sample size calculation: For 80% power to detect whether the number of removed lymph nodes differs between SLNB and TAD (type 1 error=5%), a sample size of 170 patients per group (340 in total) would be required if the number of lymph nodes removed after TAD is 15% lower than after SLNB (ratio=0.85), i.e., assuming 2.72 removed lymph nodes after TAD and 3.2 after SLNB (according to preliminary data from the AXSANA(EUBREAST-3) registry on 4,336 patients from 284 study sites and 26 countries). The calculation is based on a test for the ratio of two Poisson rates, and parameters mean=3.2 and variance=2.7 of the Poisson distribution for SLNB were calculated from the AXSANA (EUBREAST 3). Citation Format: M. Gasparri, S. Hartmann, M. Hauptmann, M. Banys-Paluchowski, N. Ditsch, R. Di Micco, O. Gentilini, T. Kuehn. Patients with breast cancer and axillary involvement undergoing Sentinel LYMph Node Biopsy versus Targeted AXillary Dissection after primary systemic treatment: which axillary staging saves more lymphnodes? A registry-based randomized controlled trial (SLYMT-AXSANA EUBREAST 3R) [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-08-22.