Integration of radiation oncology teaching in medical studies by German medical faculties due to the new licensing regulations: an overview and recommendations of the consortium academic radiation oncology of the German Society for Radiation Oncology (DEGRO)

The new Medical Licensing Regulations 2025 (Ärztliche Approbationsordnung, ÄApprO) will soon be passed by the Federal Council (Bundesrat) and will be implemented step by step by the individual faculties in the coming months. The further development of medical studies essentially involves an orientation from fact-based to competence-based learning and focuses on practical, longitudinal and interdisciplinary training. Radiation oncology and radiation therapy are important components of therapeutic oncology and are of great importance for public health, both clinically and epidemiologically, and therefore should be given appropriate attention in medical education. This report is based on a recent survey on the current state of radiation therapy teaching at university hospitals in Germany as well as the contents of the National Competence Based Learning Objectives Catalogue for Medicine 2.0 (Nationaler Kompetenzbasierter Lernzielkatalog Medizin 2.0, NKLM) and the closely related Subject Catalogue (Gegenstandskatalog, GK) of the Institute for Medical and Pharmaceutical Examination Questions (Institut für Medizinische und Pharmazeutische Prüfungsfragen, IMPP). The current recommendations of the German Society for Radiation Oncology (Deutsche Gesellschaft für Radioonkologie, DEGRO) regarding topics, scope and rationale for the establishment of radiation oncology teaching at the respective faculties are also included

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369

Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding: UK Medical Research Council and Health Technology Assessment Programme

Parental responses to children’s pain : Analysis of the parental responses to their child’s pain in the German general population

Hintergrund: Wenn Kinder Schmerzen haben, reagieren Eltern kognitiv-affektiv und verhaltensbezogen. Dysfunktionale Reaktionen wie elterliches Katastrophisieren können zur Chronifizierung kindlicher Schmerzen beitragen. Ziel der Arbeit: Ziele der Online-Studie sind (1) die erstmalige psychometrische Überprüfung existierender Fragebögen zu kognitiv-affektiven (Pain Catastrophizing Scale for Parents; PCS-P) und verhaltensbezogenen Reaktionen (Inventar zum schmerzbezogenen Elternverhalten; ISEV-E) an 105 schmerzfreien Eltern, (2) der Vergleich der Reaktionen mit existierenden (inter-)nationalen klinischen und schmerzfreien Samples sowie mit 80 Eltern mit selbstberichteten chronischen Schmerzen. Methode: Die teilnehmenden Eltern machten per Online-Fragebogen Angaben zu ihren elterlichen Reaktionen auf kindlichen Schmerz. Ergebnisse: Die Faktoren des ISEV-E konnten nicht bestätigt werden; die Faktorenstruktur des PCS-P war replizierbar. Das elterliche Katastrophisieren der schmerzfreien Eltern war geringer als in klinischen Samples. Unterschiede zwischen schmerzfreien Eltern und Eltern mit selbstberichteten chronischen Schmerzen aus der Allgemeinbevölkerung zeigten sich nicht. Diskussion: Die Ergebnisse bieten eine Basis zur Einordnung des elterlichen Katastrophisierens, um Risikogruppen mit starker Katastrophisierungsneigung frühzeitig zu identifizieren.Background: Parental reactions to their child’s pain can comprise cognitive-affective and behavioral responses. Dysfunctional responses like parental catastrophizing may lead to an aggravation of the child’s pain. Objectives: Aims of the online-based study were (1) to psychometrically evaluate existing questionnaires into cognitive-affective (Pain Catastrophizing Scale for Parents; PCS-P) and behavioral responses (Inventar zum schmerzbezogenen Elternverhalten; ISEV-E) within a sample of 105 healthy parents, and (2) to compare their responses to existing (inter)national clinical samples and to the reactions of 80 parents with self-reported chronic pain from the general population. Methods: The assessment of parental pain-related reactions was online-based. Results: While the factor structure of the ISEV-E could not be replicated, the three factors of the PCS-P could be replicated. Parental catastrophizing of the healthy parents was lower compared to clinical samples. Healthy parents did not differ from parents with chronic pain from the general population. Conclusion: The results offer a basis to grade parental catastrophizing, so that risk-groups can be identified

Prognosis of persistent mitral regurgitation in patients undergoing transcatheter aortic valve replacement

Objective The objective of this study was to assess imaging predictors of mitral regurgitation (MR) improvement and to evaluate the impact of MR regression on long-term outcome in patients undergoing transcatheter aortic valve replacement (TAVR). Background Concomitant MR is a frequent finding in patients with severe aortic stenosis but usually left untreated at the time of TAVR. Methods Mitral regurgitation was graded by transthoracic echocardiography before and after TAVR in 677 consecutive patients with severe aortic stenosis. 2-year mortality was related to the degree of baseline and discharge MR. Morphological echo analysis was performed to determine predictors of MR improvement. Results 15.2% of patients presented with baseline MR >= 3 +, which was associated with a significantly decreased 2-year survival (57.7% vs. 74.4%, P = 3 +. Baseline parameters including non-severe baseline MR, the extent of mitral annular calcification and large annular dimension (>= 32 mm) predicted the likelihood of an improvement to MR <= 2 +. A score based on these parameters selected groups with differing probability of MR <= 2 + post TAVR ranging from 10.5 to 94.4% (AUC 0.816; P < 0.001), and was predictive for 2-year mortality. Conclusion Unresolved severe MR is a critical determinant of long term mortality following TAVR. Persistence of severe MR following TAVR can be predicted using selected parameters derived from TTE-imaging. These data call for close follow up and additional mitral valve treatment in this subgroup. Graphic abstract Factors associated with MR persistence or regression after TAVR [GRAPHICS]

Feasibility and rationale of direct current cardioversion immediately after transcatheter percutaneous edge-to-edge mitral valve repair

Aims Atrial fibrillation (AF) is a frequent comorbidity among patients with severe mitral regurgitation (MR). Direct current (DC) cardioversion is one of the strategies for rhythm control. However, the safety and feasibility of immediate DC cardioversion after MitraClip are not elucidated. Methods and Results In this study, patients with symptomatic severe MR who underwent MitraClip were included. After fixing the MR, synchronized DC cardioversion was attempted for those with AF. A total of consecutive 60 patients, 36 subjects (60%), comorbid with AF. DC cardioversion was performed in 30 patients (mean age of 76.0 +/- 9.3 years), and the successful conversion was achieved in 15 patients (50%). There was no any adverse event related to the cardioversion. Subjects with sustained conversion to SR experienced significant improvement in 6MWT (failed: 285 +/- 110-308 +/- 135 m,P = .278; successful: 269 +/- 109 m-328 +/- 78,P = .047) and reduction in NT-proBNP level (failed: 4411 +/- 7401-3296 +/- 4299 ng/mL,P = .217; successful: 4094 +/- 2735-2353 +/- 2856 ng/mL,P = .026) at 1 month. Conclusions Direct current cardioversion seemed to be safe and feasible immediately after the transcatheter edge-to-edge mitral valve repairs. Subjects who maintain SR experienced better functional improvement