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Introduction: Whole Exome Sequencing (WES) has emerged as an efficient tool in clinical cancer diagnostics to broaden the scope from panel-based diagnostics to screening of all genes and enabling robust determination of complex biomarkers in a single analysis., Methods: To assess concordance, six formalin-fixed paraffin-embedded (FFPE) tissue specimens and four commercial reference standards were analyzed by WES as matched tumor-normal DNA at 21 NGS centers in Germany, each employing local wet-lab and bioinformatics. Somatic and germline variants, copy-number alterations (CNAs), and complex biomarkers were investigated. Somatic variant calling was performed in 494 diagnostically relevant cancer genes. The raw data were collected and re-analyzed with a central bioinformatic pipeline to separate wet- and dry-lab variability., Results: The mean positive percentage agreement (PPA) of somatic variant calling was 76 % while the positive predictive value (PPV) was 89 % in relation to a consensus list of variants found by at least five centers. Variant filtering was identified as the main cause for divergent variant calls. Adjusting filter criteria and re-analysis increased the PPA to 88 % for all and 97 % for the clinically relevant variants. CNA calls were concordant for 82 % of genomic regions. Homologous recombination deficiency (HRD), tumor mutational burden (TMB), and microsatellite instability (MSI) status were concordant for 94 %, 93 %, and 93 % of calls, respectively. Variability of CNAs and complex biomarkers did not decrease considerably after harmonization of the bioinformatic processing and was hence attributed mainly to wet-lab differences., Conclusion: Continuous optimization of bioinformatic workflows and participating in round robin tests are recommended., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MMT reports speaker and travel Expenses from Twist. JS reports speaker honoraria from DLS, Molecular Health, AstraZeneca and Biocartis, outside the submitted work. UL reports speaker fees from AstraZeneca, GSK, Novartis, Menarini, advisory board from AstraZeneca and Novartis. DH reports speaker honorary AstraZeneca, adboard BMS, WD speaker honoraries BMS & Novartis. SMB reports speaker honoraria, advisory board fees and research grants from AstraZeneca, Daiichi, Menarini, Novartis, Roche, BMS, Pfizer, Bayer, MSD, Merck, Amgen, Molecular Health, Targos, DLS, Janssen, GSK, QuIP, outside the submitted work. SL reports research grant from BMS, advisory board/speaker invitation from AstraZeneca, Eli Lilly, Roche and Takeda outside of this work. NTG reports research support from Janssen-Cilag and Advisory Boards from Janssen-Cilag, AstraZeneca, Daiichi-Sankyo and BMS outside the submitted work. WW reports research grants from Roche, MSD, BMS and AstraZeneca. Advisory board, lectures and speaker bureau fees from Roche, MSD, BMS, AstraZeneca, Pfizer, Merck, Lilly, Boehringer, Novartis, Takeda, Bayer, Janssen, Amgen, Astellas, Illumina, Eisai, Siemens, Agilent, ADC, GSK und Molecular Health. SO received reimbursement for travel expenses and payment for conference presentations from Illumina Inc. and Oxford Nanopore Technologies. CS reports research funding from BMS Stiftung Immunonkologie and institutional grants from Illumina outside the submitted work. CPS reports an investigator-initiated grant from Illumnia outside of the submitted work. PS reports grants from Inctye, BMS, Gilead, Falk, speakers bureau/advisory board from MSD, BMS, AstraZeneca, Incyte, Astellas, Janssen, Eisai, Amgen, Boehringer Ingelheim. DK reports personal fees for speaker honoraria from AstraZeneca, and Pfizer, personal fees for Advisory Board from Bristol-Myers Squibb, outside the submitted work. NP reports speaker fees from Novartis, Bayer, Roche, AstraZeneca, Illumina, BMS, MSD, PGDX/Labcorp, advisory board from Novartis, Lilly, Roche, Janssen, travel expenses from Novartis, AstraZeneca, Illumina, BMS, MSD, PGDX/Labcorp, Research grants from Illumina. JB reports grants from German Cancer Aid and consulting from MSD, outside the submitted work. AS reports participation in Advisory Board/Speaker’s Bureau for Astra Zeneca, AGCT, Bayer, Bristol-Myers Squibb, Eli Lilly, Illumina, Janssen, MSD, Novartis, Pfizer, Roche, Seattle Genetics, Takeda, and Thermo Fisher, grants from Bayer, Bristol-Myers Squibb, and Chugai, outside the submitted work. All other authors report no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Based on a voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (DGTHG) in 1980, a well-defined but limited dataset of all cardiac and vascular surgery procedures performed in 77 German heart surgery departments is reported annually. For the year 2023, a total of 168,841 procedures were submitted to the registry. Of these operations, 100,606 are defined as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 28,996 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 2.8:1) was 97.6%; 97.7% for the 39,859 isolated heart valve procedures (23,727 transcatheter interventions included); and 99.2% for 19,699 pacemaker/implantable cardioverter defibrillator procedures. Concerning short and long-term mechanical circulatory support, a total of 2,982 extracorporeal life support/extracorporeal membrane oxygenation implantations and 772 ventricular assist device implantations (left/right ventricular assist device, BVAD, total artificial heart) were reported. In 2023, 324 isolated heart transplantations, 248 isolated lung transplantations, and 2 combined heart-lung transplantations were performed. This annually updated registry of the DGTHG represents nonrisk adjusted voluntary public reporting and encompasses acute data for nearly all heart surgical procedures in Germany. It constitutes trends in heart medicine and represents a basis for quality management (e.g., benchmark) for all participating institutions., Competing Interests: None declared., (Thieme. All rights reserved.)

Background:  The German Registry for Cardiac Operations and Interventions in Patients with Congenital Heart Disease is a voluntary registry initiated by the German Society for Thoracic and Cardiovascular Surgery and the German Society for Pediatric Cardiology and Congenital Heart Defects. Since 2012, the registry collects data for the assessment of treatment and outcomes of surgical and interventional procedures in patients with congenital heart disease (CHD) of all age groups., Methods:  This real-world, prospective all-comers registry collects clinical and procedural characteristics, adverse events (AEs), mortality, and medium-term outcomes (up to 90 days) of patients undergoing surgical and interventional. A unique pseudonymous personal identifier (PID) allows longitudinal data acquisition in case of further invasive treatment in any participating German heart center. Prior to evaluation, all data sets are monitored for data completeness and integrity. Evaluation includes risk stratification of interventional and surgical procedures and classification of AEs. Each year's data are summarized in annual reports containing detailed information on the entire cohort, all subgroups, and 15 index procedures. In addition, each participating center receives an institutional benchmark report for comparison with the national results. This paper presents a comprehensive summary of the annual report 2021., Results:  In 2021, a total of 5,439 patients were included by 22 participating centers. In total, 3,721 surgical, 3,413 interventional, and 34 hybrid procedures were performed during 6,122 hospital stays. 2,220 cases (36.3%) could be allocated to the 15 index procedures. The mean unadjusted in-hospital mortality ranged from 0.4% among interventional and 2% among surgical cases up to 6.2 % in cases with multiple procedures. In-hospital mortality among index procedures accounted for 2.3% in total cavopulmonary connection, 20.3% in Norwood procedures, and 0.4% following interventional closure of patent ductus arteriosus. For the remaining seven surgical and five interventional index procedures, no in-hospital deaths were recorded. The 10-year longitudinal evaluation of 1,795 patients after tetralogy of Fallot repair revealed repeat interventional or surgical procedures in 21% of the patients. Over the same period, 31.1% of 2,037 patients, following initial treatment of native coarctation, required at least one additional hospital admission, 39.4% after initial interventional, and 21.3% after initial surgical therapy., Conclusion:  The annual report 2021 of the German Registry for Cardiac Operations and Interventions in CHD shows continuously good results in accordance with previous data of the registry. Compared to international registries on CHD, it can be ascertained that in Germany invasive treatment of CHD is offered on a high medical level with excellent quality. The proven fact that patients with various malformations like tetralogy of Fallot and coarctation of the aorta require repeat procedures during follow-up confirms the urgent requirement for longitudinal assessment of all patients presenting with complex lesions., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS/DGTHG) in 1980, well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2022 are analyzed. Under the decreasing interference of the worldwide coronavirus disease 2019 pandemic, a total of 162,167 procedures were submitted to the registry. A total of 93,913 of these operations are summarized as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 27,994 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 3.2:1) was 97.5%. For the 38,492 isolated heart valve procedures (20,272 transcatheter interventions included) it was 96.9%, and for the registered pacemaker/implantable cardioverter-defibrillator procedures (19,531) 99.1%, respectively. Concerning short- and long-term circulatory support, a total of 2,737 extracorporeal life support/extracorporeal membrane oxygenation implantations, respectively 672 assist device implantations (L-/ R-/ BVAD, TAH) were registered. In 2022, 356 isolated heart transplantations, 228 isolated lung transplantations, and 5 combined heart-lung transplantations were performed. This annually updated registry of the GSTCVS/DGTHG represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, constitutes advancements in heart medicine, and represents a basis for quality management for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is up to date, appropriate, and nationwide patient treatment is always available., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: The annual report of the German Quality Assurance of Congenital Heart Disease displays a broad overview on outcome of interventional and surgical treatment with respect to patient's age and risk categorization. Particular features of the German all-comers registry are the inclusion of all interventional and surgical procedures, the possibility to record repeated treatments with distinct individual patient assignment, and to record various procedures within one case., Methods: International Pediatric and Congenital Cardiac Code terminology for diagnoses and procedures as well as classified adverse events, also recording of demographic data, key procedural performance indicators, and key quality indicators (mortality, adverse event rates). Surgical and interventional adverse events were classified according to the Society of Thoracic Surgeons and to the Congenital Heart Disease Adjustment for Risk Method of the congenital cardiac catheterization project on outcomes. Annual analysis of all cases and additional long-term evaluation of patients after repair of Fallot and primary treatment of native coarctation of the aorta were performed., Results: In 2020, 5,532 patients with 6,051 cases (hospital stays) with 6,986 procedures were treated in 23 German institutions. Cases dispense on 618 newborns (10.2%), 1,532 infants (25.3%), 3,077 children (50.9%), and 824 adults (13.6%). Freedom from adverse events was 94.5% in 2,795 interventional cases, 67.9% in 2,887 surgical cases, and 42.9% in 336 cases with multiple procedures (without considering the 33 hybrid interventions). In-hospital mortality was 0.5% in interventional, 1.6% in surgical, and 5.7% in cases with multiple treatments. Long-term observation of 1,632 patient after repair of Fallot depicts the impact of previous palliation in 18% of the patients on the rate of 20.8% redo cases. Differentiated analysis of 1,864 patients with native coarctation picture clear differences of patient, age, and procedure selection and outcome. The overall redo procedure rate in this patient population is high with 30.8%., Conclusion: Improvement in quality of care requires detailed analysis of risks, performance indicators, and outcomes. The high necessity of redo procedures in patients with complex congenital heart disease underlines the imperative need of long-term observations., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS) in 1980, well-defined data of all cardiac, thoracic and vascular surgery procedures performed in 78 German heart surgery departments during the year 2021 are analyzed. Under more than extraordinary conditions of the further ongoing worldwide coronavirus disease 2019 (COVID-19) pandemic, a total of 161,261 procedures were submitted to the registry. In total, 92,838 of these operations are summarized as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 27,947 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 3.2:1) was 97.3%. For the 36,714 isolated heart valve procedures (19,242 transcatheter interventions included) it was 96.7 and 99.0% for the registered pacemaker and International Classification of Diseases (ICD) procedures (19,490), respectively. Concerning short- and long-term circulatory support, a total of 3,404 ECLS/ECMO implantations and 750 assist device implantations (L-/ R-/ BVAD, TAH), respectively were registered. In 2021 329 isolated heart transplantations, 254 isolated lung transplantations, and one combined heart-lung transplantations were performed.This annually updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, constitutes advancements in heart medicine and represents a basis for quality management for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is up to date, appropriate, and nationwide patient treatment is guaranteed all the time., Competing Interests: None declared., (Thieme. All rights reserved.)

Purpose: We aimed to develop a modular Core Set based on the International Classification of Functioning, Disability and Health (ICF) for describing functioning in patients with substance use disorders (SUDs). To match the structure of the German health service system, the Core Set was split into modules for different service segments., Methods: We followed a consensus process including several preparatory studies. To identify candidate ICF categories, we performed an ICF linking of guideline-recommended assessments, patient focus groups and patient and expert surveys. Categories were prioritized for different service segments and compiled into preliminary modules. The Core Set was tested in 13 treatment sites. Health professionals rated each category's relevance, and contents of the Modular ICF-based Core Set for SUDs (MCSS) were compared to patient-reported treatment goals. An advisory board decided on revisions to the MCSS., Results: The MCSS consists of a basic module (25 categories) and five additional modules for these treatment segments: counselling (8), qualified withdrawal (6), orientation (7), rehabilitation (32), and social integration services (10)., Conclusions: The MCSS provides a framework for harmonizing communication, documentation and interface management in German SUD health services. The basic module, consisting of 25 categories, can be employed as a Brief ICF Core Set.Implications for rehabilitationThe MCSS can serve as a standard for describing functioning in patients with SUDs in Germany, as well as harmonize communication and reporting of treatment relevant information.In clinical practice, the MCSS can be used for the structured assessment of psychosocial problems and participation restrictions, goal setting, and outcome evaluation.Although the MCSS was developed in Germany, its proximity to the themes frequently identified in the literature regarding SUDs internationally suggests that it may be of use in other countries as well.The basic module may be employed as a Brief ICF Core Set.

Background: Based on a quality assurance initiative of the German Society for Thoracic and Cardiovascular Surgery (DGTHG) and the German Society for Pediatric Cardiology and Congenital Heart Defects (DGPK), a voluntary registry was founded for assessment of treatment and outcomes of patients with congenital heart disease in Germany. This evaluation by the German Registry for cardiac operations and interventions in patients with congenital heart disease reports the data and the outcome over a 6-year period in patients undergoing invasive treatment., Methods: This real-world database collects clinical characteristics, in-hospital complications, and medium-term outcome of patients who underwent cardiac surgical and interventional procedures within the prospective, all-comers registry. Patients were followed-up for up to 90 days., Results: In the period from 2013 to 2018, a total of 35,730 patients, 39,875 cases, respectively 46,700 procedures were included at up to 31 German institutions. The cases could be subcategorized according to the treatment intention into 21,027 (52.7%) isolated operations, 17,259 (43.3%) isolated interventions, and 1,589 (4.0%) with multiple procedures. Of these, 4,708 (11.8%) were performed in neonates, 10,047 (25.2%) in infants, 19,351 (48.5%) in children of 1 to 18 years, and 5,769 (14.5%) in adults. Also, 15,845 (33.9%) cases could be allocated to so-called index procedures which underwent a more detailed evaluation to enable meaningful comparability. The mean unadjusted in-hospital mortality of all cases in our registry ranged from 0.3% in patients with isolated interventions and 2.0% in patients with surgical procedures up to 9.1% in patients undergoing multiple procedures., Conclusion: This annually updated registry of both scientific societies represents voluntary public reporting by accumulating actual information for surgical and interventional procedures in patients with congenital heart disease (CHD) in Germany. It describes advancements in cardiac medicine and is a basis for internal and external quality assurance for all participating institutions. In addition, the registry demonstrates that in Germany, both interventional and surgical procedures for treatment of CHD are offered with high medical quality., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS) in 1980, well-defined data of all cardiac, thoracic and vascular surgery procedures performed in 78 German heart surgery departments during the year 2020 are analyzed. Under the more than extraordinary conditions of the ongoing worldwide coronavirus disease 2019 pandemic, a total of 161,817 procedures were submitted to the registry. A total of 92,809 of these operations are summarized as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 29,444 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 3.6:1) was 97.2%. For the 35,469 isolated heart valve procedures, (17,471 transcatheter interventions included), the survival rate was 96.7%. Concerning short- and long-term circulatory support, a total of 2,852 extracorporeal life support/extracorporeal membrane oxygenation implantations, respectively, 843 assist device implantations (left/right/biventricular assist device, total artificial device), were registered. In 2020, the number of isolated heart transplantations increased to 340, a rise of 2.1% compared with the previous year. The isolated lung transplantations amounted to 291, a decrease of 6.4%.This annually updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, constitutes advancements in heart medicine, and represents a basis for quality management for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is up to date, appropriate, and nationwide patient treatment is guaranteed all the time., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: The randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days., Objectives: The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial., Methods: Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites., Results: In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63)., Conclusions: In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150)., Competing Interests: Funding Support and Author Disclosures This study was supported by the German Heart Research Foundation, and Leipzig Heart Institute. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS) in 1980, well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2019 are analyzed. For this period, a total of 175,705 procedures were submitted to the registry, 100,446 summarized as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 34,224 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 3.8:1) was 97.3%. For the 36,650 isolated heart valve procedures (16,625 transcatheter interventions included), it was 96.4%. Concerning short- and long-term circulatory support, a total of 2,716 extracorporeal life support/extracorporeal membrane oxygenation implantations, resp. 953 assist device implantations (L-/ R-/ BVAD, TAH) were registered. In 2019, the number of isolated heart transplantations increased to 333, a rise of 6.7% compared to the previous year. The isolated lung transplantations amounted to 311, a decrease of 8.5%. This annually updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, constitutes advancements in heart medicine, and represents a basis for quality management for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is up to date, appropriate, and nationwide patient treatment is guaranteed all the time., Competing Interests: None declared., (Georg Thieme Verlag KG Stuttgart · New York.)

Objective: Delirium has been characterized into its subtypes-hypoactive, hyperactive, mixed, or no motor subtype-along with the use of the Delirium Motor Symptom Scale (DMSS). The German version of this scale (DMSS-G), however, has not yet been validated. Method: We determined internal consistency, reliability, and validity of the DMSS-G in the surgical intensive care unit, using DSM-IV-TR criteria and the Delirium Rating Scale-Revised-98. Results: In total, 289 patients were included, and out of these, 122 were delirious. The DMSS-G showed excellent internal consistency (Cronbach's α = 0.92) and interrater reliability (Fleiss κ = 0.83). Additionally, the overall concurrent validity was substantial (Cramer's V = 0.69); within subtypes, hyperactive, hypoactive, or mixed, the concurrent validity remained at least substantial (Cohen's κ = 0.73-0.82) and the sensitivity ranged from 60% to 97%. In contrast, in those with no motor subtype, we found the concurrent validity (Cohen's κ = 0.31) and sensitivity to be low (22%). Overall, specificity for all individual subtypes was high (82% to 100%). The DMSS was very sensitive in both rating hyperactive and hypoactive motor symptoms of delirium. Conclusion: The DMSS-G is a highly reliable and valid instrument for detecting motor symptoms in delirium, which provides an accurate instrument to classify the motor subtypes of delirium.

Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2018 are analyzed. For this period, a total of 174,902 procedures were submitted to the registry, 98,707 summarized as heart surgery procedures in the classical meaning. The unadjusted in-hospital survival rate for 33,999 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 3.8:1) was 97.1% and for 34,915 isolated heart valve procedures, 14,396 transcatheter interventions included, it was 96.0%. Concerning short- and long-term circulatory supports, a total of 2,871 extracorporeal life support (ECLS)/extracorporeal membrane oxygenation (ECMO) implants, respectively, 942 assist device implantations (L-/R-/BVAD, TAH) were registered. In 2018, the number of isolated heart transplantations increased to 312, a growth of 23% compared with the previous year. The isolated lung transplantations reached 340, a rise of nearly 19%. This annual updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, constitutes advancements in heart medicine, and is a basis for quality management for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is appropriate and nationwide patient treatment is guaranteed all the time., Competing Interests: None., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Second-generation cryoballoon (CB2)-based pulmonary vein isolation (PVI) has demonstrated encouraging results in the treatment of atrial fibrillation (AF). This study sought to assess data on the safety, efficacy and clinical success of CB2-based PVI in patients with heart failure (HF) and reduced ejection fraction (HFrEF).Methods and Results:CB2-based PVI was performed in 551 consecutive patients in 3 highly experienced EP centers. Patients with HF and LVEF ≤40% were included (HFrEF group, n=50/551, 9.1%). Data were compared with propensity score-matched patients without HF and preserved left ventricular EF (LVEF) (n=50, control group). The median LVEF was HFrEF: 37% (35, 40) and control: 55% (55, 55), P<0.0001. Major periprocedural complications were registered in 4/50 (8%, HFrEF group) and 3/50 (6%, control group), P=0.695. The 12-month freedom from AF recurrence was 73.1% (95% confidence interval (CI): 61-88, HFrEF group) and 72.6% (95% CI: 61-87, control group), P=0.25. NYHA class decreased from 2.4±0.8 (baseline) to 1.7±0.8 at 12-month follow-up (P<0.0001). LVEF improved from a median of 37% (35, 40) prior to ablation to a median of 55% (40, 55), P<0.0001., Conclusions: CB2-based PVI in patients with HFrEF appeared to be safe, was associated with comparable periprocedural complications and showed promising clinical success rates equal to those for patients with preserved LVEF. NYHA class and LVEF significantly improved at 12-month follow-up.

Although the concept of subjective quality of life in the nursing home setting is seen as a promising approach to discovering opportunities for improvement from the resident's perspective, it appears problematic in classical surveys that self-reported quality ratings on the basis of satisfaction questions tend to turn out overly positive. The aim of this article is to analyze how people in residential care facilities interpret and process response stimuli received from a questionnaire on subjective quality of life. In this analysis, we aim to gain methodological insights into the way a survey instrument on subjective quality of life can adequately represent individual ratings, as well as expectations regarding different aspects of quality of life. To test the feasibility of the proposed approach, we employed a range of probing techniques from the cognitive interviewing approach. The result is a promising design principle for constructing survey instruments to measure subjective quality of life.

Objective: The importance of the proper identification of delirium, with its high incidence and adversities in the intensive care setting, has been widely recognized. One common screening instrument is the Intensive Care Delirium Screening Checklist (ICDSC); however, the symptom profile and key features of delirium dependent on the level of sedation have not yet been evaluated., Method: In this prospective cohort study, the ICDSC was evaluated versus the Diagnostic and Statistical Manual, 4th edition, text revision, diagnosis of delirium set as standard with respect to the symptom profile, and correct identification of delirium. The aim of this study was to identify key features of delirium in the intensive care setting dependent on the Richmond Agitation and Sedation Scale levels of sedation: drowsiness versus alert and calmness.ResultThe 88 delirious patients of 225 were older, had more severe disease, and prolonged hospitalization. Irrespective of the level of sedation, delirium was correctly classified by items related to inattention, disorientation, psychomotor alterations, inappropriate speech or mood, and symptom fluctuation. In the drowsy patients, inattention reached substantial sensitivity and specificity, whereas psychomotor alterations and sleep-wake cycle disturbances were sensitive lacked specificity. The positive prediction was substantial across items, whereas the negative prediction was only moderate. In the alert and calm patient, the sensitivities were substantial for psychomotor alterations, sleep-wake cycle disturbances, and symptom fluctuations; however, these fluctuations were not specific. The positive prediction was moderate and the negative prediction substantial. Between the nondelirious drowsy and alert, the symptom profile was similar; however, drowsiness was associated with alterations in consciousness.Significance of resultsIn the clinical routine, irrespective of the level of sedation, delirium was characterized by the ICDSC items for inattention, disorientation, psychomotor alterations, inappropriate speech or mood and symptom fluctuation. Further, drowsiness caused altered levels of consciousness.

Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2017 are analyzed. In 2017, a total of 179,337 procedures were submitted to the registry, and 101,728 were summarized as heart surgery procedures in the narrower sense. About 16.8% of these patients were at least 80 years old, resulting in an increase of 1.1% compared with the data of 2016. The 36,273 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 4.2:1) were associated with an unadjusted in-hospital survival rate of 97.3%. Concerning the 34,394 isolated heart valve procedures (including 12,965 transcatheter interventions), the unadjusted in-hospital survival rate was 96.0%.This annual updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, describes advancements in heart medicine, and is a basis for in- and external quality assurance for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is appropriate, and nationwide patient treatment is guaranteed at any time., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Translational surgical research can range from investigating clinically oriented basic pathophysiological research via the correlation of molecular findings with a patient's clinical outcome to conducting treatment response studies. Herein, the specialist's opinion as a 'surgeon scientist' plays a pivotal role, e.g. in planning experimental setups focusing on the clinically most relevant needs. SUMMARY AND KEY MESSAGES: This review provides a survey of genomic and proteomic technologies and gives an up-to-date overview of those studies applying these technologies exemplarily in colorectal cancer-based biomarker research. Although current results are promising, future validation studies within multicenter networks are required to promote the translation of 'omics' from bench to bedside. In this endeavor, departments of surgery and institutes of experimental surgery together should play a fundamental role. The program for 'clinician scientists' recently launched by the German Research Society (DFG) could be one tool to promote interdisciplinary networks and surgeons' impact on translational research., (© 2015 S. Karger AG, Basel.)

Background: A fundamental aim of social science and for practitioners is the improvement of the quality of life of inpatients residing in long term care homes. Health, as a vital part of quality of life, gains in subjective importance with rising age., Aim: This paper aims to analyse the aspects of «Intact mental abilities» and "Mobility" thorough in terms of the subjective quality of life of nursing home residents., Materials and Method: nine male and 33 female inpatients of eight independent nursing homes within Berlin and surrounding regions have been interviewed using narrative guidance questions. The interviewees were selected by the interviewer participating in their day to day life and through the means of direct conversations with the respective persons. The following analysis is based on Bohnsack's documentary method., Results: Findings suggest that it is important for the interviewees to retain their mental abilities up until old age to be capable of acting autonomously and independently controlling their own life. The respondents not only perceive the loss of their own cognitive abilities as problematic, but also that of their cohabitants, as such impedes social contacts. Another key component of well-being deems to be the ability "to walk", in other words, mobility is basis for retaining self-determination and facilitates to participate in activities within the nursing homes., Conclusion: Nursing home residents should receive tailored support in cognitive abilities. In addition, interested residents should receive enhanced information about the disease of dementia. The mobility should be largely preserved more close to everyday life movement offers available towards the residents.

Background: A fundamental aim of social science and for practitioners is the improvement of the quality of life of inpatients residing in long-term care homes. This research aims to determine aspects of their privacy in the context of quality of life from the residents' perspective, which has long been neglected., Materials and Method: A total of 42 narrative interviews with nursing home residents were conducted and analyzed using the documentary method., Results: Four dimensions of privacy were identified. Intimate areas concern personal hygiene and toilet matters, non-intimate areas included mainly eating and the residents' private living area. Violations of privacy are associated with unpleasant feelings such as shame and disgust and are often subject to taboos. Respondents tended to be more open to talk about taboo subjects the less the topic referred to their own body., Conclusion: Privacy is perceived as a significant aspect of the respondents' quality of life. To be able to address inhibition thresholds and shameful topics, a good relationship between patient and personnel is required. This postulates that the caregivers are also aware of their own inhibition threshold and negative feelings.

Background: Infant regulatory problems, that is, excessive crying, feeding and/or sleeping difficulties, are precursors of adverse development. However, the aetiology of regulatory problems is still unclear. The aim of this study was to investigate pre-, peri- and post-natal neurophysiological and psychosocial predictors of single and multiple regulatory problems at 5 months of age., Methods: This prospective longitudinal study included all children born at neonatal risk in a geographically defined area in southern Germany. The data of n = 5093 singleton infants (83.6%) were analysed using crude and multivariate logistic regression analyses. As outcome measures we used single and multiple regulatory problems, that is, crying, feeding and/or sleeping difficulties at 5 months of age, which were assessed via a standardized interview with the parents by study paediatricians as part of a neurodevelopmental examination., Results: In total, 30.7% of the sample suffered from single or multiple regulatory problems at 5 months. Breastfeeding increased the odds of single sleeping problems 5.12-fold, but decreased the odds of single feeding problems [odds ratio (OR) 0.51; 95% confidence interval (CI) 0.35-0.74]. Very preterm birth was predictive of single feeding (OR 1.79; 95% CI 1.25-2.55) and multiple regulatory problems (OR 2.03; 95% CI 1.19-3.46), and foetal abnormalities increased the odds of single feeding and multiple regulatory problems from 1.53- to 1.64-fold. Family adversity and psychosocial stress factors were associated with single crying and multiple regulatory problems., Conclusions: Pre-, peri- and post-natal neurophysiological and psychosocial factors are predictive of single and multiple regulatory problems. The results may be useful in terms of early recognition of at risk groups for regulatory problems., (© 2011 Blackwell Publishing Ltd.)

Chronic cerebrospinal venous insufficiency (CCSVI) has been postulated as a cause for multiple sclerosis (MS). Venous pressure assessments have not been made. Intracranial venous pressure was assessed using ophthalmodynamometry in 29 MS patients and compared with 28 healthy controls and 19 cases with elevated intracranial pressure (ICP). MS and control subjects had normal venous pressures (mean 15.5 resp. 15.1 cmHg). Only cases with intracranial pressure pathology had elevated venous pressures (mean 28.8 cmHg). There is no evidence of an increased intracranial venous pressure in MS patients.

Objective: The goal was to compare health-related quality of life of 12- to 16-year-old adolescents born at an extremely low birth weight in regional cohorts from Ontario (Canada), Bavaria (Germany), and the Netherlands., Methods: Patients were extremely low birth weight survivors from Canada, Germany, and the Netherlands. Health-related quality of life was assessed with Health Utilities Index 3. Missing data were substituted by proxy reports. Differences in mean Health Utilities Index 3 scores were tested by using analysis of variance. Differences in the numbers of children with affected attributes were tested by using logistic regression analyses., Results: Survival rates were similar; response rates varied between 71% and 90%. Significant differences in health-related quality of life were found between the cohorts, with Dutch children scoring highest on Health Utilities Index 3 and German children scoring lowest, independent of birth weight, gestational age, and cerebral palsy. Differences in mean utility scores were mainly attributable to differences in the cognition health attribute. Most of the results were corroborated by logistic regression analyses., Conclusions: There were significant differences between the 3 cohorts in health-related quality of life, not related to differences in birth weight, gestational age, or cerebral palsy. Survival and response rates alone cannot explain these differences.

Background: The increased survival chances of extremely low-birthweight (ELBW) infants (weighing <1000 g at birth) has led to concern about their behavioural outcome in childhood. In reports from several countries with different assessments at various ages, investigators have noted a higher frequency of behavioural problems in such infants, but cross-cultural comparisons are lacking. Our aim was to compare behavioural problems in ELBW children of similar ages from four countries., Methods: We prospectively studied 408 ELBW children aged 8-10 years, whose parents completed the child behaviour checklist. The children came from the Netherlands, Germany, Canada, and USA. The checklist provides a total problem score consisting of eight narrow-band scales. Of these, two (aggressive and delinquent behaviour) give a broad-band externalising score, three (anxious, somatic, and withdrawn behaviour) give a broad-band internalising score, and three (social, thought, and attention problems) indicate difficulties fitting neither broad-band dimension. For each cohort we analysed scores in ELBW children and those in normal- birthweight controls (two cohorts) or national normative controls (two cohorts). Across countries, we assessed deviations of the ELBW children from normative or control groups., Findings: ELBW children had higher total problem scores than normative or control children, but this increase was only significant in European countries. Narrow-band scores were raised only for the social, thought, and attention difficulty scales, which were 0.5-1.2 SD higher in ELBW children than in others. Except for the increase in internalising scores recorded for one cohort, ELBW children did not differ from normative or control children on internalising or externalising scales., Interpretation: Despite cultural differences, types of behavioural problems seen in ELBW children were very similar in the four countries. This finding suggests that biological mechanisms contribute to behavioural problems of ELBW children.

The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire that can be completed in about 5 minutes by the parents and teachers of 4-16 year olds. The scores of the English version correlate well with those of the considerably longer Child Behavior Checklist (CBCL). The present study compares the German versions of the questionnaires. Both SDQ and CBCL were completed by the parents of 273 children drawn from psychiatric clinics (N = 163) and from a community sample (N = 110). The children from the community sample also filled in the SDQ self-report and the Youth Self Report (YSR). The children from the clinic sample received an ICD-10 diagnosis if applicable. Scores from the parent and self-rated SDQ and CBCL/YSR were highly correlated and equally able to distinguish between the community and clinic samples, with the SDQ showing significantly better results regarding the total scores. They were also equally able to distinguish between disorders within the clinic sample, the only significant difference being that the SDQ was better able to differentiate between children with and without hyperactivity-inattention. The study shows that like the English originals, the SDQ-Deu and the German CBCL are equally valid for most clinical and research purposes.

Anecdotal reports have suggested that sleeping problems are a frequent complaint from parents of preterm infants. This prospective epidemiological study examined the incidence and stability of sleeping problems of very preterm (< 32 weeks gestation at birth), preterm (32-36 weeks gestation) and fullterm infants, all admitted to special care baby units (SCBU) after birth, in comparison to healthy term infants over the first 5 years of life. Preterm infants were found to have fewer and shorter night-wakings at 5 months. No differences in sleeping behaviour compared with healthy term children were found at 20 and 56 months of age. Similar significant, and moderate, stability of nightwaking from one age to the next were found for exSCBU-graduates and healthy fullterm infants. Parental interventions such as staying with the child until sleep and taking the infant into bed af night were related to nightwaking problems and increased parental distress. It is concluded that prematurity, and thus neurological immaturity and special care experience are less important than caretaking behaviour in the development of sleeping problems in both preterm and fullterm infants.

The prevalence and persistence of sleeping problems was studied in a prospective investigation of a representative sample of 432 German children at the ages of 5, 20 and 56 months. 21.5% of children had night waking problems at 5 months, 21.8% at 20 months and 13.3% at 56 months. Falling asleep difficulties were diagnosed in 12.1% of 4-5 year olds. One in four of five year-olds slept regularly in the bed with the parents (co-sleeping). Children with night waking problems had a 2.2 to 2.5 fold increased risk to remain nightwakers from one assessment point to the next compared with non-wakers. 7 to 14% of parents were distressed by their children's sleeping behaviour. Parental behaviour often contributed to continued sleeping problems because the children were not supported in acquiring appropriate skills to settle to sleep unaided. A developmental model for the treatment of sleeping problems is discussed.

From 1978 to 1988 in the district of Annaberg (Saxony, state frontier to Czechoslovakia) investigations were accomplished to assess the state of health in people living there. The southern part of the district rises to a crest (Saxon Ore Mountain). It is influenced by air pollution from Northern Bohemia. The incidence of acute infections of the upper airways showed a remarkable dependence on the degree of air pollution in the age groups up to 18 years, especially in the group of infants. In the polluted area (high overload) the morbidity of infants was 7-fold in relation to the unpolluted area of the district. In the polluted area when temperature was lower than -5 degrees C the incidence of acute respiratory infections in infants closely correlated (r = 0.90) with the concentration of SO2 in ambient air. In the town Annaberg (urban air pollution) the frequency of absence of children from school caused by acute respiratory infections was elvated in relation to the rural parts of the district, but there were no differences among these rural parts. In the polluted area the severe stages of cardiorespiratory diseases were passed through with evident acceleration. In healthy adults living there the mean values for immunoglobulins of class A and class M tended to be elevated, and in school children the antibody titers against influenza A and B were increased.