Evangelisches Krankenhaus Alsterdorf

Abstract Background Heart failure (HF) is one of the leading public health issues worldwide. Current guidelines recommend HF treatment using different drug classes depending on ejection fraction (EF) and underlying cause of HF. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are a drug class with a class IA recommendation in the current ESC-guidelines for HF treatment independent of EF. The SGLT2i dapagliflozin is approved for treatment of HF across the entire spectrum of EF in Germany. However, real-world data are limited. Purpose The aim of EVOLUTION-HF DEallEF is to generate data on real-world dapagliflozin use in HF patients independently of EF in Germany under the multinational umbrella EVOLUTION-HF study protocol. Methods EVOLUTION-HF DEallEF is a non-interventional, prospective, longitudinal cohort study. It is planned to enrol a total of 1000 patients with chronic HF in Germany, including 40% patients with preserved (HFpEF; EF ≥ 50%), 20% with mildly reduced (HFmrEF; EF 41-49%), and 40% with reduced EF (HFrEF; EF ≤ 40%). Patients willing to participate, aged ≥18 years, who started dapagliflozin treatment 14 to 90 days prior to enrolment according to the local product label, are eligible for participation. Among reasons for exclusion is previous SGLT2i treatment (including dapagliflozin). Data on medical history, clinical symptoms, previous and concomitant medication and patient-reported outcomes (PROs) are collected. EVOLUTION-HF DEallEF has included its first patient in 04/2024 and is currently open for enrolment. Interim analyses (IA) were planned at predefined timepoints (after 250, 500 enrolled patients and enrolment completion). The three different EF cohorts (HFpEF, HFmrEF, HFrEF) are analysed separately and as a total population. Only descriptive statistical methods are used. Results This 1st IA (data cutoff: 02/12/2024) included 249 patients in the safety set (all patients received at least one dose of dapagliflozin, one patient refused data usage) and 244 patients who fulfilled all eligibility criteria in the full analysis set (FAS). Patients were enrolled in 31 study sites, mainly in office-based cardiologic practices. In the FAS, distribution of patients to HF cohorts was 51% with HFpEF (n=125), 30% with HFmrEF (n=73), and 19% with HFrEF (n=46). Conclusions Patients’ and disease characteristics observed at the time of the first IA are in range with previously published data indicating that a representative cohort of patients newly treated with dapagliflozin for HF are enrolled in EVOLUTION-HF DEallEF. Dysbalance in expected enrolment proportion per EF cohort is mainly caused by exclusion of patients with SGLT2i-pretreatment. The study aims to provide further insights into real-world dapagliflozin treatment for HF in Germany, focussing on clinical and patients’ perspective.

Status epilepticus (SE) is a critical neurological emergency, with its most severe form, refractory status epilepticus (RSE) and super-refractory status epilepticus (SRSE), posing significant treatment challenges and high mortality rates. Despite robust early-phase treatment evidence, effective management of RSE and SRSE remains less defined. This study aimed to assess the incidence of potential RSE and SRSE in Germany from 2019 to 2022, evaluate diagnostic and non-pharmacological interventions, and analyze associated healthcare costs. A cross-sectional retrospective analysis was conducted using data from the Institute for the Hospital Remuneration System (InEK). Cases were identified using ICD-10 code G41 and included patients who underwent mechanical ventilation for at least one hour. Data on demographics, diagnostic procedures, therapeutic interventions, discharge outcomes, and healthcare costs were extracted and analyzed. Between 2019 and 2022, 89,921 SE cases were identified, with 21,729 (24.2 %) progressing to potential RSE or SRSE. Male patients comprised 56 % of these cases. The majority of cases occurred in patients aged 65-74 years. The overall mortality or hospice transfer rate for potential RSE/SRSE cases was 33.7 %. Common diagnostic procedures included EEG (80 %) and CT scans (113 %), while non-pharmacological interventions such as hypothermia therapy were used in 10 % of cases, and plasmapheresis was employed in 1 %. Electroconvulsive therapy, vagus nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, ketogenic diet, resection of foreign tissue from the brain, and epilepsy surgery were not performed at all. 4 % of the patients who died in the hospital or were discharged to a hospice received interventions in a palliative care setting. The total estimated cost for potential RSE/SRSE cases in 2022 was approximately €44.24 million, highlighting the economic burden on the healthcare system. The study underscores the need for improved diagnostic and therapeutic strategies in managing RSE and SRSE. It also calls for exploration of non-pharmacological treatments to reduce the high mortality and economic costs associated with these conditions. Further research is essential to establish evidence-based protocols for RSE and SRSE management.

Zusammenfassung Hintergrund Epilepsie unterliegt – unter anderem – dem Rhythmus von Tag und Nacht und dem Zyklus der verschiedenen Schlafstadien. Ausprägung und Schweregrad einer Epilepsie werden mit beeinflusst von der Schlafqualität und -kontinuität des Patienten. Zielsetzung Es wird ein Überblick über die Interaktion von Schlaf und Epilepsie und über den daraus möglichen Nutzen für Diagnostik und Therapie gegeben. Methode Die Arbeit ist eine Übersichtsarbeit. Ergebnisse und Diskussion Verschiedene Arten epileptischer und nichtepileptischer Anfälle folgen einer spezifischen circadianen bzw. Wach-Schlaf-Rhythmik, was sich differenzialdiagnostisch nutzen lässt. Schlafentzug führt zu einer verstärkten Epilepsieaktivität, nicht zuletzt durch den vermehrten, aber instabilen Schlaf am Folgetag. Im NREM-Schlaf kommt es zu einer Häufung und zu einer größeren räumlichen Ausbreitung epilepsietypischer Potenziale (ETP) und darum zu einer erhöhten Wahrscheinlichkeit von Anfällen und Anfallsgeneralisierung. Der REM-Schlaf hingegen ist infolge von EEG(Elektroenzephalogramm)-Desynchronisation und -Amplitudenminderung sowie aufgrund einer REM(„rapid eye movement“)-spezifischen funktionellen Diskonnektion v. a. des Frontallappens anfallsprotektiv, dies sogar mehr als der Wachzustand. Gelingt es trotzdem, ETP oder Anfälle im REM-Schlaf zu erfassen, so lässt sich aufgrund der im REM geringen ETP-Propagationstendenz aus diesen Daten oft eine wertvolle lokalisatorische Aussage zur Seizure-Onset-Zone ableiten. Anfälle im Schlaf und auch im Wachen, aber selbst schon das Auftreten interiktualer ETP im Schlaf verschlechtern die Schlafkontinuität, -struktur und -qualität. Dies kann die Ursache für affektive und kognitiv-mnestische Störungen im täglichen Leben der Patienten sein. Schlaffragmentierung und -mangel haben aber auch prokonvulsive Potenz und können somit zu einer weiteren Anfallsverschlechterung führen, was ihrerseits die Schlafqualität weiter beeinträchtigt. Dieser Teufelskreis wird noch befeuert durch das Bestehen von komorbiden schlafmedizinischen Erkrankungen oder schlafstörenden Nebenwirkungen der Antianfallstherapien. Werden solche Zusammenhänge erkannt und behandelt, dann bestehen mit einer Ausrichtung an seinen individuellen chronobio- und somnologischen Bedingungen gute Aussichten, einen bisher therapierefraktären Patienten zu einem „Responder“ zu transformieren.

Introduction: Optimizing patient safety and quality improvement is increasingly important in surgery. Benchmarks and clinical quality registries are being developed to assess the best achievable results for several surgical procedures and reduce unwarranted variation between different centers. However, there is no clinical database from international centers for establishing standardized reference values of patients undergoing surgery for mesial temporal lobe epilepsy.Design: The Enhancing Safety in Epilepsy Surgery (EASINESS) study is a retrospectively conducted, multicenter, open registry. All patients undergoing mesial temporal lobe epilepsy surgery in participating centers between January 2015 and December 2019 are included in this study. The patient characteristics, preoperative diagnostic tools, surgical data, postoperative complications, and long-term seizure outcomes are recorded.Outcomes: The collected data will be used for establishing standardized reference values (“benchmarks”) for this type of surgical procedure. The primary endpoints include seizure outcomes according to the International League Against Epilepsy (ILAE) classification and defined postoperative complications.Discussion: The EASINESS will define robust and standardized outcome references after amygdalohippocampectomy for temporal lobe epilepsy. After the successful definition of benchmarks from an international cohort of renowned centers, these data will serve as reference values for the evaluation of novel surgical techniques and comparisons among centers for future clinical trials.Clinical trial registration: This study is indexed at clinicaltrials.gov (NT 04952298).

Children of parents with mental health problems (CPM) have an increased risk for impaired health-related quality of life (HRQoL). This study aims at investigating the age- and gender-specific course of HRQoL and at exploring predictors of HRQoL in CPM based on longitudinal data (baseline, 1-year and 2-year follow-up) of a German population-based sample. Longitudinal data from the German BELLA study was analyzed (n = 1429; aged 11 to 17years at baseline). The SCL-S-9 in combination with the cutoff for the General Severity Index (GSI) from the longer SCL-90-R served to identify CPM (n = 312). At first, we compared domain-specific HRQoL according to the KIDSCREEN-27 in CPM versus Non-CPM. Focusing on CPM, we used individual growth modeling to investigate the age and gender-specific course, and to explore effects of risk and (personal, familial and social) resource factors on self-reported HRQoL in CPM. Self-reported HRQoL was reduced in CPM compared to Non-CPM in all domains, but in social support & peers. However, a minimal important difference was only reached in girls for the domain autonomy & parent relation. Internalizing and externalizing mental health problems were associated with impaired HRQoL in CPM. Self-efficacy, social support and family climate were identified as significant resources, but parental mental health problems over time were not associated with any investigated domain of HRQoL in CPM. Adolescent female CPM may be especially at risk for reduced HRQoL. When developing support programs for CPM, self-efficacy, social support and family climate should be considered, HRQoL and mental health problems in CPM should be addressed.