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Introduction: Both twin pregnancies and previous cesarean delivery are situations with increased risk of failed vaginal delivery. Cesarean delivery after a trial of labor is associated with an increased risk of postpartum hemorrhage Therefore, in twin pregnancies with a previous cesarean delivery, planned vaginal delivery could lead to an increased risk of postpartum hemorrhage due to an important rate of cesarean delivery after a trial of labor. Our objective was to evaluate the association between the planned mode of delivery and postpartum hemorrhage in women with twin pregnancies and a previous cesarean delivery., Methods: We conducted a secondary analysis of the JUMODA French population-based prospective cohort study of twin pregnancies (n = 8823). We included women with one previous cesarean and without contraindication to vaginal birth. The primary outcome was postpartum hemorrhage., Results: Among the 735 women included, 187 women (25.4%) had planned vaginal delivery and 548 (74.6%) had planned cesarean delivery. Among women with planned vaginal delivery, 125 (66.8%) had a successful vaginal delivery. The incidence of PPH was 8.2% in the planned cesarean group and 9.1% in the planned vaginal delivery group(p = 0.709). After adjustment for confounders, the planned mode of delivery was not associated with the risk of postpartum hemorrhage (adjusted relative risk 0.94, 95% CI 0.56-1.60). There were only 2 uterine ruptures, both in the planned cesarean delivery group., Conclusion: In women with a twin pregnancy and a previous cesarean delivery, there is no overall association between the planned mode of delivery and the risk of postpartum hemorrhage., Competing Interests: Declaration of competing interest Thomas Schmitz received consulting fees from Dilafor. The other authors have no conflict of interest to declare., (Copyright © 2024. Published by Elsevier Masson SAS.)

Background: The Mental Health Literacy Scale (MHLS) is a scale-based measure with 35 items that assesses various aspects of mental health literacy. The original English version was developed in Australia and has been translated into several languages. The present study aimed to translate and culturally adapt the questionnaire for its use in Germany and to determine the psychometric properties of the German version of the MHLS (MHLS-GER) in two different samples., Methods: After translation and cultural adaptation, the MHLS-GER was administered via an online survey in a general population sample and via a postal survey in patients with acute myocardial infarction (AMI). Exploratory factor analysis and confirmatory factor analysis were conducted to determine the dimensionality. Furthermore, internal consistency, known-groups-validity and measurement invariance were evaluated., Results: Data of 517 participants of the general population sample and 786 participants of the AMI sample were analyzed. In both samples a four-factor structure yielded good model fit indices. The four subscales of the MHLS-GER including 31 items comprise the topics 'knowledge' (11 items), 'information seeking' (4 items), 'stigmatization' (9 items) and 'social distance' (7 items). All four subscales showed good internal consistency (Cronbach's alpha: 0.80 to 0.90, average inter-item correlation: 0.30-0.59) and were mostly invariant across the two samples. Participants with previous experience with mental disorders (personal or professional context) showed higher scores on the four subscales., Conclusion: In contrast to the unidimensional structure of the original version, the MHLS-GER comprises four subscales. All subscales showed acceptable to good psychometric properties and can now be used to assess mental health literacy. Further validation studies to evaluate test-retest-reliability and responsiveness are required., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Antenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, its optimal dose remains unknown. A 50% dose reduction was proposed to decrease the potential dose-related long-term neurodevelopmental side effects, including psychological development, sleep, and emotional disorders. Because noninferiority of the half dose in terms of the need for exogenous surfactant was not shown in the primary analysis, its impact on survival without major neonatal morbidity needs to be investigated., Objective: This study aimed to investigate the impact of antenatal betamethasone dose reduction on survival of very preterm infants without severe neonatal morbidity, a factor known to have a strong correlation with long-term outcomes., Study Design: We performed a post hoc secondary analysis of a randomized, multicenter, double-blind, placebo-controlled, noninferiority trial, testing half (11.4 mg once; n=1620) vs full (11.4 mg twice, 24 hours apart; n=1624) antenatal betamethasone doses in women at risk of preterm delivery. To measure survival without severe neonatal morbidity at hospital discharge among neonates born before 32 weeks of gestation, we used the definition of the French national prospective study on preterm children, EPIPAGE 2, comprising 1 of the following morbidities: grade 3 to 4 intraventricular hemorrhage, cystic periventricular leukomalacia, necrotizing enterocolitis stage ≥2, retinopathy of prematurity requiring anti-vascular endothelial growth factor therapy or laser, and moderate-to-severe bronchopulmonary dysplasia., Results: After exclusion of women who withdrew consent or had pregnancy termination and of participants lost to follow-up (8 in the half-dose and 10 in the full-dose group), the rate of survival without severe neonatal morbidity among neonates born before 32 weeks of gestation was 300 of 451 (66.5%) and 304 of 462 (65.8%) in the half-dose and full-dose group, respectively (risk difference, +0.7%; 95% confidence interval, -5.6 to +7.1). There were no significant between-group differences in the cumulative number of neonatal morbidities. Results were similar when using 2 other internationally recognized definitions of severe neonatal morbidity and when considering the overall population recruited in the trial., Conclusion: In the BETADOSE trial, severe morbidity at discharge of newborns delivered before 32 weeks of gestation was found to be similar among those exposed to 11.4-mg and 22.8-mg antenatal betamethasone. Additional studies are needed to confirm these findings., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter edge-to-edge repair (TEER) has emerged to address symptomatic atrial functional mitral regurgitation (aFMR) in patients who are at high operative risk., Aims: No clinical data is available on the impact of residual mitral regurgitation (MR) following TEER in aFMR compared to ventricular functional MR (vFMR)., Methods: In the MITRA-PRO registry, 846 patients with FMR and MitraScore assessment for residual MR quantification were included (722 patients with vFMR and 124 patients with aFMR)., Results: Compared to vFMR similar procedural results in regard of residual MR following TEER were found in aFMR patients (MitraScore post TEER 2.5 ± 1.8 vs. 2.7 ± 1.9), while the amount of implanted TEER devices was increased in vFMR. 1-year survival was better in aFMR compared to vFMR regardless of relevant residual MR (MitraScore ≥ 4), while 1-year rehospitalization was comparable for both MR entities. Patients with aFMR and mild residual MR had a lower mortality rate (6.6% vs. 10.3%) and rehospitalization rate (29.1% vs. 46.2%) 1 year after mitral TEER. However, in contrast to vFMR a MitraScore ≥4 was no independent predictor of mortality in aFMR indicating a better tolerance toward residual MR., Conclusions: Residual MR is an independent predictor of 1-year mortality in vFMR patients, whereas in aFMR patients, a MitraScore of ≥4 is associated with higher mortality but is not an independent predictor in multivariate analysis. Therefore, minimizing MR through mitral TEER is crucial for survival in vFMR patients, while aFMR patients tolerate significant residual MR better 1 year after the procedure., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Maternal exposure to unfavourable social conditions is associated with a higher rate of perinatal complications, such as placental vascular pathologies. A higher risk of preterm birth (PTB) has also been reported, and variations across studies and settings suggest that different patterns may be involved in this association., Objective: To assess the association between maternal social deprivation and PTB (overall and by phenotype)., Methods: We analysed 9365 patients included in the PreCARE cohort study. Four dimensions (social isolation, insecure housing, no income from work and absence of standard health insurance) defined maternal social deprivation (exposure). They were considered separately and combined into a social deprivation index (SDI). The associations between social deprivation and PTB <37 weeks (primary outcome) were analysed with univariable and multivariable log-binomial models (adjusted for maternal age, parity, education level and birthplace). Then we used multinomial analysis to examine the association with preterm birth phenotypes (secondary outcome): spontaneous labour, preterm prelabour rupture of membranes (PPROM) and placental vascular pathologies., Results: In all, 66.3%, 17.8%, 8.9% and 7.0% of patients had an SDI of 0, 1, 2 and 3, respectively. Social isolation affected 4.5% of the patients, insecure housing 15.5%, no income from work 15.6% and no standard health insurance 22.4%. Preterm birth complicated 7.0% of pregnancies (39.8% spontaneous labour, 28.3% PPROM, 21.8% placental vascular pathologies and 10.1% other phenotypes). Neither the univariable nor multivariable analyses found any association between social deprivation and the risk of preterm birth overall (SDI 1 versus 0: aRR 1.02, 95% confidence interval [CI] 0.83, 1.26; 2 versus 0: aRR 1.05, 95% CI 0.80, 1.38; 3 versus 0: aRR 0.92, 95% CI 0.66, 1.29) or its different phenotypes., Conclusions: In the French PreCARE cohort, we observed no association between markers of social deprivation and the risk of preterm birth, regardless of phenotype., (© 2024 The Author(s). Paediatric and Perinatal Epidemiology published by John Wiley & Sons Ltd.)

Background: The COVID-19 pandemic has affected various urban population groups in different ways. Earlier studies have shown that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disproportionally impacts nursing home residents by increasing morbidity and mortality following viral exposure. However, little is known about the epidemiology of this disease in detail. Therefore, the objective of this study is to analyze the development of the COVID-19 pandemic in 14 nursing homes across Berlin-Neukölln, Germany, during pandemic waves 1 to 5 (Feb 2020 - May 2022)., Methods: Reporting data to the Neukölln Department of Public Health on COVID-19 cases in connection with nursing homes were extracted from the SORMAS database. The case fatality rates (CFRs) and odds ratios (ORs) of demographic parameters, prevalent variants of concern (VOCs) and vaccine availability were calculated. In addition, the temporal course in waves 1-5 in Neukölln and the relevant government measures were examined., Results: Data collected from nursing homes providing age-dependent physical care revealed that 1.9 % of the total 108,600 cases registered in Berlin-Neukölln during the study period were related one of the 14 facilities. Compared to the general population in Neukölln, nursing homes exhibited a 20-fold increase in the CFR. Notably, nursing homes with higher bed capacities displayed a greater CFR than did smaller nursing homes. Similarly, elderly residents living in nursing homes faced a much greater mortality rate than did their counterparts living outside of medical settings (OR = 3.5). The original wild-type SARS-CoV-2 strain had the most severe direct impact, with a CFR of 16.7 %, compared to the alpha (CFR = 6.9 %), delta (CFR = 10.2 %) and omicron (CFR = 2.8 %) variants in nursing homes. Interestingly, the number of infections increased following vaccination campaigns, but this trend was accompanied by a decrease in the number of deaths from 2.6 to 1.1 per week. As a result, the CFR significantly decreased from 18.4 to 5.5, while still exceeding the mean CFR compared to that of the general population of Neukölln., Conclusions: Our findings reveal the changing patterns of outbreak frequency and severity across the five pandemic waves. They highlight the crucial role of rapid vaccination programs for residents, staff, visitors, and third-party services in safeguarding nursing homes. Additionally, improvements in containment and cluster strategies are essential in prevaccination scenarios to prevent future infection traps for elderly individuals in long-term care facilities. The presented data highlight the importance of tailored protection measures for one of the most vulnerable populations in our society., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated., Objectives: We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting., Methods: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment., Results: Enrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, P < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, P <0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375). Mortality was not associated with baseline TR grade or with center volume., Conclusions: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; NCT04483089)., Competing Interests: Funding Support and Author Disclosures The bRIGHT study is sponsored by Abbott Cardiovascular. Prof Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, Boehringer Ingelheim, and Daiichi-Sankyo; and has stock options with Innoventric. Prof von Bardeleben has received institutional research grants and speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Cardiovascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Nickenig has received research funding from the Deutsche Forschungsgemeinschaft (DFG), the Federal Ministry of Education and Research (BMBF), The European Union, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical; has received honoraria for lectures or Advisory Boards from Abbott, AGA Medical, AstraZeneca, Bayer, Berlin, Cardiovalve, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical; and has participated in clinical trials for Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Cardiovalve, Daiichi-Sankyo, Edwards Lifesciences Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical. Dr Estevez-Loureiro has been a consultant for Abbott Structural Heart, Edwards Lifesciences, Boston Scientific, and Venus Medtech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The latest generation ultrathin Supraflex Cruz (Sahajanand Medical Technologies Limited, Surat, India) sirolimus-eluting stent (SES) has shown early healing properties and represents an attractive percutaneous coronary intervention (PCI) device in a high bleeding risk (HBR) population. The aim of this Cruz HBR registry was to assess safety and efficacy of the Supraflex Cruz SES in a large cohort of all-comer patients, of whom about one third were patients at HBR., Methods: Patients undergoing PCI were enrolled in this prospective, multi-centre, open label registry and stratified into non-HBR and HBR groups. The primary endpoint was a device-oriented composite endpoint (DOCE), a composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization within 12 months after PCI. The predefined aims were to show non-inferiority of the non-HBR group to the Supraflex arm of the TALENT Trial, and of the HBR group to polymer-free biolimus-coated stent arm of LEADERS FREE Trial., Results: A total of 1203 patients were enrolled across 26 European centers, including a significant proportion (38.7%; N.=466) of HBR patients. A total of 1745 lesions were treated in 1203 patients and 2235 stents were implanted. The DOCE occurred within the total cohort in 5.8% of patients with a significant difference between HBR patients and non-HBR patients (8.1% vs. 4.4%; P<0.001). All-cause mortality at 12 months was significantly (P<0.0001) different among HBR (9.0%) and non-HBR patients (1.7%), respectively. At 12 months, the overall incidence of definite and probable stent thrombosis was 1.0%. Major bleeding occurred in 5.9% patients of the HBR group. These results met the non-inferiority criteria with respect to the TALENT trial for the non-HBR group (P<0.0001), and the LEADERS FREE trial for the HBR group (P<0.0001)., Conclusions: The Cruz HBR registry confirms that PCI with the Supraflex Cruz SES is associated with a favorable clinical outcome in an all-comer population, including complex patients with HBR.

Objective: To establish normal current values of various biochemical parameters during pregnancy in the northern area of Paris (France) in a subgroup from the PreCARE cohort and to study their changes according to the term of pregnancy, and to determine the influence of maternal precarity., Design: The PreCAREbio cohort of pregnant women was defined in the PreCARE study, a multicenter cohort study., Setting: Participants completed detailed questionnaires at enrolment and immediately postpartum. Data were collected prospectively. 26 biochemical parameters were longitudinally assessed., Population: All women registered to deliver or who delivered at one of the four participating university hospitals in Paris between October 2010 and November 2011 were eligible for study inclusion (n=10,419)., Methods: We studied 26 biochemical markers during pregnancy and the influence of maternal social deprivation., Main Outcome Measures: Baseline values for 26 biochemical markers and their changes according to the term of pregnancy, and the influence of maternal social deprivation on these biochemical markers., Results: 386 patients with 1733 blood samples recruited in one of the four centers in the PreCARE cohort were included. Baseline concentrations (median, 2.5th and 97.5th percentile) for each marker and did not differ at the different time points. Mean concentrations of each biochemical marker did not differ between socially deprived women and non-socially deprived women., Conclusions: We have established normal values for 26 biochemical parameters during pregnancy. We have also shown no difference in these values between socially deprived and non- socially deprived women., Competing Interests: Disclosure of interest T. Schmitz: consulting for Dilafor. The other authors have no declaration of interest., (Copyright © 2024. Published by Elsevier Masson SAS.)

Background: Transfemoral access is often used when large-bore guide catheters are required for percutaneous coronary intervention (PCI) of complex coronary lesions, especially when large-bore transradial access is contraindicated. Whether the risk of access site complications for these procedures may be reduced by ultrasound-guided puncture is unclear., Aims: We aimed to show the superiority of ultrasound-guided femoral puncture compared to fluoroscopy-guided access in large-bore complex PCI with regard to access site-related Bleeding Academic Research Consortium 2, 3 or 5 bleeding and/or vascular complications requiring intervention during hospitalisation., Methods: The ULTRACOLOR Trial is an international, multicentre, randomised controlled trial investigating whether ultrasound-guided large-bore femoral access reduces clinically relevant access site complications compared to fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions., Results: A total of 544 patients undergoing complex PCI mandating large-bore (≥7 Fr) transfemoral access were randomised at 10 European centres (median age 71; 76% male). Of these patients, 68% required PCI of a chronic total occlusion. The primary endpoint was met in 18.9% of PCI with fluoroscopy-guided access and 15.7% of PCI with ultrasound-guided access (p=0.32). First-pass puncture success was 92% for ultrasound-guided access versus 85% for fluoroscopy-guided access (p=0.02). The median time in the catheterisation laboratory was 102 minutes versus 105 minutes (p=0.43), and the major adverse cardiovascular event rate at 1 month was 4.1% for fluoroscopy-guided access and 2.6% for ultrasound-guided access (p=0.32)., Conclusions: As compared to fluoroscopy-guided access, the routine use of ultrasound-guided access for large-bore transfemoral complex PCI did not significantly reduce clinically relevant bleeding or vascular access site complications. A significantly higher first-pass puncture success rate was demonstrated for ultrasound-guided access., Clinicaltrials: gov identifier: NCT04837404.

Aims: Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors., Methods and Results: The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0-18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03-1.08, per year increase], heart failure (HR 1.73, CI: 1.24-2.41), vascular disease (HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63, CI: 1.15-2.33), abnormal liver function (HR 1.80, CI: 1.02-3.17), and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors., Conclusion: One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO., Clinical Trial Registration: The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Competing Interests: Financial Disclosure: Thomas Schmitz reports receiving consulting fees from Dilafor. He was the coordinator of the BETADOSE trial (NCT02897076). Loic Sentilhes received consulting fees from Dilafor and lecture fees from Bayer, GlaxoSmithKline, and Sigvaris, and lecture and consulting fees from Ferring Pharmaceuticals. Marie-Victoire Sénat did not report any potential conflicts of interest

Background: In this study, we investigated various acute myocardial infarction (AMI) symptoms and their associations with short-term (28 day) and long-term mortality., Methods: The analysis was based on 5900 patients, aged 25 to 84 years, with first-time AMI recorded by the population-based Myocardial Infarction Registry Augsburg between 2010 and 2017. Median follow-up time was 3.8 years (interquartile range: 1.1-6.3). As part of a face-to-face interview, the presence (yes/no) of 11 most common AMI symptoms at the acute event was assessed. Using multivariable-adjusted logistic regression and Cox regression models, the association between various symptoms and all-cause mortality was investigated. P values of the regression models were false discovery rate adjusted., Results: Pain in various body parts (chest pain, left and right shoulder/arm/hand, between shoulder blades), sweating, nausea/vomiting, dizziness and fear of death/feeling of annihilation were significantly associated with a decreased 28-day mortality after AMI. The pain symptoms and sweating were also significantly associated with a decreased long-term mortality. Shortness of breath was significantly associated with a higher long-term mortality., Conclusions: The absence of several symptoms, including typical chest discomfort (chest pain or retrosternal pressure/tightness), is associated with unfavourable outcomes after AMI. This finding has implications for patient management and public health measures designed to encourage appropriate and prompt medical consultation of patients with atypical AMI symptoms., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

In the naturally hypoxic in utero fetal environment of preterm infants, oxygen and oxygen-sensitive signaling pathways play an important role in brain development, with hypoxia-inducible factor-1α (HIF1α) being an important regulator. Early exposure to nonphysiological high oxygen concentrations by birth in room can induce HIF1α degradation and may affect neuronal and glial development. This involves the dysregulation of astroglial maturation and function, which in turn might contribute to oxygen-induced brain injury. In this study, we investigated the effects of early high oxygen exposure on astroglial maturation and, specifically, on astroglial stromal cell-derived factor 1 (SDF1) expression in vivo and in vitro. In our neonatal mouse model of hyperoxia preterm birth brain injury in vivo, high oxygen exposure affected astroglial development and cortical SDF1 expression. These results were further supported by reduced Sdf1 expression, impaired proliferation, decreased total cell number, and altered expression of astroglial markers in astrocytes in primary cultures grown under high oxygen conditions. Moreover, to mimic the naturally hypoxic in utero fetal environment, astroglial Sdf1 expression was increased after low oxygen exposure in vitro, which appears to be regulated by HIF1α activity. Additionally, the knockdown of Hif1α revealed HIF1α-dependent Sdf1 expression in vitro. Our results indicate HIF1α and oxygen-dependent chemokine expression in primary astrocytes and highlight the importance of oxygen conditions for brain development., (© 2024 The Authors. Developmental Neurobiology published by Wiley Periodicals LLC.)

Objectives: To summerize the results of the JUMODA study (JUmeaux MODe d'Accouchement) on the planned mode of delivery of twin pregnancy and the management of second twin delivery., Methods: JUMODA was a national observational prospective comparative study that took place between february 2014 and march 2015 in 176 french maternity units performing more than 1500 deliveries per year. Its main objectives were the comparison of neonatal and maternal morbidity according to the planned mode of delivery and the determination of the managements of second twin delivery associated with the best neonatal outcomes. To control for potential confounding factors and indication biases, statistical analyses comprized multivariate logistic regressions and matching on propensity scores., Results: The JUMODA study recruited 8823 women with twin delivery at or beyond 22 weeks of gestation. For twin pregnancies with a cephalic first twin at 32 weeks of gestation and beyond, severe neonatal morbidity was higher in the planned cesarean (150/2908 (5.2 %) than in the planned vaginal delivery group (199/8922 (2.2 %), aOR 1.56, 95 % CI 1.19-2.04). Increased neonatal morbidity in the planned cesarean delivery group was explained by higher severe morbidity in neonates born preterm (aOR 1.64, 95 % CI 1.13-2.39, for deliveries between 32 +0  and 34 +6  weeks of gestation, aOR 2.04, 95 % CI 1.22-3.41, for deliveries between 35 +0  SA and 36 +6  weeks of gestation) but not in neonates born at term (aOR 1.19, 95 % CI 0.58-2.44). In comparison with planned cesarean delivery, planned vaginal delivery was not associated with increased severe neonatal morbidity in case of breech presenting first twin after 32 weeks of gestation or with decreased survival witout severe neonatal morbidity in case of delivery before 32 weeks of gestation whatever the first twin presentation. In comparison with planned vaginal delivery, planned cesarean delivery was associated with increased severe maternal morbidity only in women aged 35 and higher. Delivery of non cephalic second twin was associated with similar severe neonatal morbidity rate than delivery of cephalic second twin. Finally, in case of cephalic second twin, internal version followed by total breech extraction was associated with less cesarean for the second twin but with higher severe neonatal morbidity in case of preterm birth in comparison with pushing efforts, ocytocin perfusion and artificial rupture of membranes., Conclusions: Planned vaginal delivery is the planned mode of delivery to encourage for the majority of pregnant women with twins, whatever first twin presentation and gestational age at delivery. No management of cephalic second twin appears better than an other, its choice will rest on obstetrician preferences., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Objective: To investigate whether specific immune response plasma proteins can predict an elevated risk of developing Long COVID symptoms or fatigue severity after SARS-CoV-2 infection., Methods: This study was based on 257 outpatients with test-confirmed SARS-CoV-2 infection between February 2020 and January 2021. At least 12 weeks after the acute infection, 92 plasma proteins were measured using the Olink Target 96 immune response panel (median time between acute infection and venous blood sampling was 38.8 [IQR: 24.0-48.0] weeks). The presence of Long COVID symptoms and fatigue severity was assessed 115.8 [92.5-118.6] weeks after the acute infection by a follow-up postal survey. Long COVID (yes/no) was defined as having one or more of the following symptoms: fatigue, shortness of breath, concentration or memory problems. The severity of fatigue was assessed using the Fatigue Assessment Scale (FAS). In multivariable-adjusted logistic and linear regression models the associations between each plasma protein (exposure) and Long COVID (yes/no) or severity of fatigue were investigated., Results: Nine plasma proteins were significantly associated with Long COVID before, but not after adjusting for multiple testing (FDR-adjustment): DFFA, TRIM5, TRIM21, HEXIM1, SRPK2, PRDX5, PIK3AP1, IFNLR1 and HCLS1. Moreover, a total of 10 proteins were significantly associated with severity of fatigue before FDR-adjustment: SRPK2, ITGA6, CLEC4G, HEXIM1, PPP1R9B, PLXNA4, PRDX5, DAPP1, STC1 and HCLS1. Only SRPK2 and ITGA6 remained significantly associated after FDR-adjustment., Conclusions: This study demonstrates that certain immune response plasma proteins might play an important role in the pathophysiology of Long COVID and severity of fatigue after SARS-CoV-2 infection., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Newborn infants face a rapid surge of oxygen and a more protracted rise of unconjugated bilirubin after birth. Bilirubin has a strong antioxidant capacity by scavenging free radicals, but it also exerts direct toxicity. This study investigates whether cultured rat alveolar epithelial cells type II (AEC II) react differently to bilirubin under different oxygen concentrations. The toxic threshold concentration of bilirubin was narrowed down by means of a cell viability test. Subsequent analyses of bilirubin effects under 5% oxygen and 80% oxygen compared to 21% oxygen, as well as pretreatment with bilirubin after 4 h and 24 h of incubation, were performed to determine the induction of apoptosis and the gene expression of associated transcripts of cell death, proliferation, and redox-sensitive transcription factors. Oxidative stress led to an increased rate of cell death and induced transcripts of redox-sensitive signaling pathways. At a non-cytotoxic concentration of 400 nm, bilirubin attenuated oxidative stress-induced responses and possibly mediated cellular antioxidant defense by influencing Nrf2/Hif1α- and NFκB-mediated signaling pathways. In conclusion, the study demonstrates that rat AEC II cells are protected from oxidative stress-induced impairment by low-dose bilirubin.

Background: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established., Objectives: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study., Methods: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year., Results: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline)., Conclusions: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life., Competing Interests: Funding Support and Author Disclosures This work was supported by Edwards Lifesciences. Prof Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Schmitz has received speaker fees and proctor honorarium from Edwards Lifesciences and Abbott. Dr Geisler has received personal fees (lecture honoraria) and institutional research grants from Edwards Lifesciences. Dr Hausleiter is a consultant and receives speaker fees and institutional research support from Edwards Lifesciences. Prof Eitel has received research grants from Abbott Vascular and speaker fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Lubos has received grants from Abbott and personal fees from Abbott, Abiomed, AstraZeneca, Bayer, Edwards Lifesciences, New Valve Technology, and Novartis. Dr von Bardeleben is a principal investigator for Abbott, DZHK, Edwards Lifesciences, JensCare, Medtronic, NeoChord, and the University of Göttingen IIT; and serves as an advisor, proctor, or speaker for Abbott, Edwards Lifesciences, JenaValve, JensCare, Medtronic, NeoChord, Philips, and Siemens. Dr Berti has received honoraria from and is a consultant for Proctor & Gamble, Abbott, and Boston Scientific. Dr De Marco has received honoraria and consultation fees from Edwards Lifesciences. Dr Linke has received grants from Novartis and Edwards Lifesciences; personal fees from Abbott, Abiomed, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, Sanofi Genzyme, and Pfizer; and other fees from Picardia, Filterlex, and Transverse Medical outside the submitted work. Dr Hengstenberg has received institutional research grants from Edwards Lifesciences, Boston Scientific, Abbott, and Medtronic; and serves as a proctor for Edwards Lifesciences and Boston Scientific. Dr Baldus has received a research grant from Abbott; and lecture fees from Abbott and Edwards Lifesciences. Dr Spargias has received honoraria or consultation fees from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Denti is a consultant for InnovHeart, Approxima, Picardia, and HRV; and receives speaker fees from Edwards Lifesciences and Abbott. Prof Nickenig has received research funding from the Deutsche Forschungsgemeinschaft, the German Federal Ministry of Education and Research, the EU, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical; and has received honoraria for lectures or advisory boards from Abbott, AGA Medical, AstraZeneca, Bayer, Berlin, Cardiovalve, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical. Prof Möllmann has receives speaker/proctor fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Prof Rottbauer is a consultant for and receives speaker honoraria from Edwards Lifesciences. Dr Praz received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, Medira, and Siemens Healthineers. Dr Butter has received lecture fees from Edwards Lifesciences and Abbott; and educational grants from Boston Scientific. Dr Van Mieghem has received research grants from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi-Sankyo, AstraZeneca, and Teleflex; and scientific advisory fees from Anteris, JenaValve, Abbott Vascular, Boston Scientific, Medtronic, Amgen, Daiichi-Sankyo, Siemens, Pie Medical, and Teleflex. Dr Sherif is a consultant for and receives speaker honoraria from Edwards Lifesciences. Dr Swaans is a proctor/lecturer for Abbott Vascular, Boston Scientific, Bioventrix, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, Medtronic, and Philips Healthcare. Dr Witkowski is an advisory board member and has received honoraria from Abbott and Edwards Lifesciences. Dr Buch participates in the Abbott structural heart advisory group; and has received honoraria from Abbott. Prof Seidler has received honoraria for lectures, advisory boards, or travel grants from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Corvia, Cytokinetics, Edwards Lifesciences, Medtronic, Myocardia, Novartis, Pfizer, and Teleflex. Dr Eißmann has received honoraria or consultation fees from Edwards Lifesciences and Abbott Vascular. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott for which he receives no direct compensation. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and a speaker for Abbott. Dr Rassaf has received research funding from the Deutsche Forschungsgemeinschaft and Abbott; and receives honoraria for lectures or advisory boards from AstraZeneca, Bayer, Berlin Chemie, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Novartis, and Pfizer. Dr Luedike received research grants and honoraria for consulting and lectures from Edwards Lifesciences, Novartis, and Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

NAUSEA AND VOMITING IN PREGNANCY. Nausea and vomiting during pregnancy are common symptoms experienced by pregnant women. In more severe cases, known as hyperemesis gravidarum, these symptoms can become a pathological condition that can lead to significant complications in both the short and long term. Short-term complications include hydro-electrolyte imbalances, pregnancy termination, and growth retardation. Long-term complications may include anxiety disorders, depression, and post-traumatic stress disorder. Mild cases can often be alleviated through lifestyle and dietary adjustments or non-pharmacological treatments like ginger, acupuncture, or acupressure. However, moderate to severe cases require specific psychological support, anti-emetic treatments, and sometimes hospitalization with intravenous treatment and parenteral rehydration. Managing these cases is complex and challenging because it does not guarantee the complete disappearance of symptoms, which can pose difficulties for caregivers., Competing Interests: P. Deruelle déclare être membre du board scientifique de Norgine SAS et avoir effectué des conférences pour Exeltis. L. Sentilhes a exercé une activité de consultant et a réalisé des communications orales pour Ferring. T. Schmitz déclare avoir reçu des honoraires de consultation de Dilafor AB. Les autres auteurs déclarent n’avoir aucun lien d’intérêts.

The "A Randomized Trial of Induction Versus Expectant Management" trial (ARRIVE trial) published in 2018 suggested that induction of labor can be considered a "reasonable option" for low-risk nulliparous women at ≥39 weeks of gestation. The study results led some professional societies to endorse the option for elective induction of labor at 39 weeks of gestation in low-risk nulliparas, and this has begun to change obstetrical practice. The ARRIVE trial provided valuable information supporting the benefits of induction of labor; however, the trial is insufficient to serve as the primary justification for widespread elective induction of labor at 39 weeks of gestation in low-risk nulliparas because of concerns about external validity. Thus, the French ARRIVE trial was designed to test the hypothesis in a different setting that elective induction of labor at 39 weeks of gestation in low-risk nulliparas leads to a lower cesarean delivery rate than expectant management. This ongoing trial has been criticized as "pseudoscientific" and telling "women where, when, and how to give birth." We reject these allegations and extensively examine the ethical framework that should govern clinical and research interventions, including elective induction of labor at 39 weeks of gestation in low-risk nulliparas. This study aimed to discuss the ethical issues that emerge from randomized trials of elective induction of labor at 39 weeks of gestation in low-risk nulliparas and the ethics of the clinical practice itself. The analysis of existing evidence shows the importance of further research on induction of labor at 39 weeks of gestation in low-risk women. Certain aspects of research ethics in this area, particularly the consent of pregnant women in a context where autonomy remains fragile, call for vigilance. In addition, we emphasize that childbirth is not only a medical object but also a social phenomenon that cannot be regarded only from the perspective of a health risk to be managed by clinical research. Further research on this issue is needed to allow pregnant women to make informed decisions, and the results should be integrated with social issues. The perspective of women is required in constructing, evaluating, and implementing medical interventions in childbirth, such as induction of labor at 39 weeks of gestation., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Introduction: So far, health literacy (HL) and its related factors in patients with acute myocardial infarction received little attention. Thus, the objective of this study was to investigate the associations between the different dimensions of HL and disease-specific health-related quality of life (HRQOL), and factors that may affect these relations in patients after acute myocardial infarction (AMI)., Methods: All survivors of AMI between June 2020 and September 2021, from the Myocardial Infarction Registry Augsburg (n=882) received a postal questionnaire on HL [Health Literacy Questionnaire (HLQ)], HRQOL (MacNew Heart Disease HRQOL questionnaire) and depression (Patient Health Questionnaire). From the 592 respondents, 546 could be included in the analysis. Multivariable linear regression models were performed to investigate the associations between the nine subscales of the HLQ and the total score and three subscales of the MacNew questionnaire. A mediation analysis was performed to estimate direct and indirect effects of HL on HRQOL taking into account the mediating effect of depression., Results: In the sample of 546 patients (72.5% male, mean age 68.5 ± 12.2 years), patients with poor education showed significantly lower HLQ scores. Significant associations between the subscales of the HLQ and the MacNew were found, which remained significant after adjustment for sociodemographic variables with few exceptions. More than 50% of the association between HL and HRQOL was mediated by depression in seven HLQ subscales and a complete mediating effect was found for the HLQ subscales 'Actively managing my health' and 'Appraisal of health information'., Discussion: Depression mediates the associations between HL and disease-specific HRQOL in patients with myocardial infarction., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Kirchberger, Fischer, Raake, Linseisen, Meisinger and Schmitz.)

Background: The objective of this study was to investigate the differences in presenting symptoms between patients with and without diabetes being diagnosed with an acute myocardial infarction (AMI)., Methods: A total of 5,900 patients with a first-time AMI were included into the analysis. All patients aged between 25 and 84 years were recorded by the population-based Myocardial Infarction Registry in Augsburg, Germany, between 2010 and 2017. The presence (yes/no) of 12 AMI typical symptoms during the acute event was assessed within the scope of a face-to-face interview. Multivariable adjusted logistic regression models were calculated to analyze the associations between presenting symptoms and diabetes mellitus in AMI patients., Results: Patients with diabetes had significantly less frequent typical pain symptoms, including typical chest pain. Also, other symptoms like sweating, vomiting/nausea, dizziness/vertigo and fear of death/feeling of annihilation occurred significantly more likely in non-diabetic patients. The only exception was the symptom of shortness of breath, which was found significantly more often in patients with diabetes. In multivariable-adjusted regression models, however, the observed effects were attenuated. In patients younger than 55 years, the associations between diabetes and various symptoms were mainly missing., Conclusions: Type 2 diabetes mellitus is a risk factor not only for the development of AMI, but is also associated with an adverse outcome after AMI. Atypical clinical presentation additionally complicates the diagnostic process. It is therefore essential for physicians to be aware of the more often atypical symptoms that diabetic AMI patients report., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Schmitz, Wein, Raake, Heier, Peters, Linseisen and Meisinger.)

Background: Different ST-segment elevation myocardial infarction (STEMI) localizations go along with dissimilarities in the size of the affected myocardium, the causing coronary vessel occlusion, and the right ventricular participation. Therefore, this study aims to clarify if there is any difference in long-term survival between anterior- and non-anterior-wall STEMI., Methods: This study included 2,195 incident STEMI cases that occurred between 2009 and 2017, recorded by the population-based Augsburg Myocardial Infarction Registry, Germany. The study population comprised 1.570 men and 625 women aged 25-84 years at acute myocardial infarction. The patients were observed from the day of their first acute event with an average follow-up period of 4.3 years, (standard deviation: 3.0). Survival analyses and multivariable Cox regression analyses were performed to examine the association between infarction localizations and long-term all-cause mortality., Results: Of the 2,195 patients, 1,118 had an anterior (AWS)- and 1,077 a non-anterior-wall-STEMI (NAWS). No significant associations of the STEMI localization with long-term mortality were found. When comparing AWS with NAWS, a hazard ratio of 0.91 [95% confidence interval: 0.75-1.10] could be calculated after multivariable adjustment. In contrast to NAWS, AWS was associated with a greater <28 day mortality, less current or former smoking and higher creatine kinase-myocardial band levels (CK-MB) and went along with a higher frequency of impaired left ventricular ejection fraction (<30%)., Conclusions: Despite pathophysiological differences between AWS and NAWS, and identified differences in multiple clinical characteristics, no significant differences in long-term mortality between both groups were observed., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Bauke, Schmitz, Harmel, Raake, Heier, Linseisen, Peters and Meisinger.)

Background: High throughput technologies provide new opportunities to further investigate the pathophysiology of ischemic strokes. The present cross-sectional study aimed to evaluate potential associations between the etiologic subtypes of ischemic stroke and blood-based proteins., Methods: We investigated the associations between ischemic stroke subtypes and a panel of circulating inflammation biomarkers in 364 patients included in the Stroke Cohort Augsburg (SCHANA). Stroke etiologies were categorized according to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification. Serum concentrations of 52 biomarkers were measured using the Bio-Plex Pro™ Human Cytokine Screening Panel, ICAM-1 set and VCAM-1 set, plus the Pro™ Human TH17 cytokine sCD40L set and IL31 set (all Bio-Rad, USA). Multivariable linear regression models were used to examine associations. Point estimates were calculated as the mean difference in σ -standardized cytokine levels on the log 2 -scale., Results: Stromal-cell-derived-factor 1 alpha (SDF-1a) showed significantly higher serum levels in cardioembolic compared with large vessel atherosclerotic stroke (β = 0.48; 95% CI 0.22; 0.75; P adj  = 0.036). Significantly lower levels of interleukin-6 (IL-6) (β = -0.53; 95% CI -0.84; -0.23; P adj  = 0.036) and macrophage migration inhibitory factor (MIF) (β = -0.52; 95% CI -0.84; -0.21; P adj  = 0.043) were found in the small vessel versus large vessel stroke subtype., Conclusions: Immune dysregulations observed in different stroke subtypes might help uncover pathophysiological mechanisms of the disease. Further studies are needed to validate identified biomarkers in diverse study populations before they can potentially be used in clinical practice to further improve stroke management and patient outcomes., (© 2023 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.)

Background: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coronary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months., Aims: We aimed to report the final study outcomes at 5 years., Methods: Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (composite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascularisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components)., Results: From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no differences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups., Conclusions: In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.

of recommendationsCorticosteroids should be administered to women at a gestational age between 24 +0 and 33 +6  weeks, when preterm birth is anticipated in the next seven days, as these have been consistently shown to reduce neonatal mortality and morbidity. (Strong-quality evidence; strong recommendation). In selected cases, extension of this period up to 34 +6  weeks may be considered (Expert opinion). Optimal benefits are found in infants delivered within 7 days of corticosteroid administration. Even a single-dose administration should be given to women with imminent preterm birth, as this is likely to improve neurodevelopmental outcome (Moderate-quality evidence; conditional recommendation).Either betamethasone (12 mg administered intramuscularly twice, 24-hours apart) or dexamethasone (6 mg administered intramuscularly in four doses, 12-hours apart, or 12 mg administered intramuscularly twice, 24-hours apart), may be used (Moderate-quality evidence; Strong recommendation). Administration of two "all" doses is named a "course of corticosteroids".Administration between 22 +0 and 23 +6  weeks should be considered when preterm birth is anticipated in the next seven days and active newborn life-support is indicated, taking into account parental wishes. Clear survival benefit has been observed in these cases, but the impact on short-term neurological and respiratory function, as well as long-term neurodevelopmental outcome is still unclear (Low/moderate-quality evidence; Weak recommendation).Administration between 34 + 0 and 34 + 6 weeks should only be offered to a few selected cases (Expert opinion). Administration between 35 +0 and 36 +6  weeks should be restricted to prospective randomized trials. Current evidence suggests that although corticosteroids reduce the incidence of transient tachypnea of the newborn, they do not affect the incidence of respiratory distress syndrome, and they increase neonatal hypoglycemia. Long-term safety data are lacking (Moderate quality evidence; Conditional recommendation).Administration in pregnancies beyond 37 +0  weeks is not indicated, even for scheduled cesarean delivery, as current evidence does not suggest benefit and the long-term effects remain unknown (Low-quality evidence; Conditional recommendation).Administration should be given in twin pregnancies, with the same indication and doses as for singletons. However, existing evidence suggests that it should be reserved for pregnancies at high-risk of delivering within a 7-day interval (Low-quality evidence; Conditional recommendation). Maternal diabetes mellitus is not a contraindication to the use of antenatal corticosteroids (Moderate quality evidence; Strong recommendation).A single repeat course of corticosteroids can be considered in pregnancies at less than 34 +0  weeks gestation, if the previous course was completed more than seven days earlier, and there is a renewed risk of imminent delivery (Low-quality evidence; Conditional recommendation).

Background: The efficacy of antenatal corticosteroids for neonatal preterm complications wanes beyond 7 days after treatment. The neurodevelopmental effects of longer treatment-to-birth intervals have not been adequately evaluated., Objective: This study aimed to assess the impact of antenatal corticosteroid timing on survival without moderate or severe neurologic disabilities at 5½ years., Study Design: This was a secondary analysis of the EPIPAGE-2 study, a national population-based cohort (France) that recruited neonates in 2011 and followed them up at 5½ years (results first reported in 2021). Participants were children born alive between 24+0 and 34+6 weeks, with a complete corticosteroid course, delivery >48 hours after the first injection, and neither limitation of care decided before birth nor severe congenital malformation. The study included 2613 children, 2427 of whom were alive at 5½ years; 71.9% (1739/2427) had a neurologic assessment at this age; 1537 had a clinical examination (complete for 1532), and 202 were assessed with a postal questionnaire. Exposure was defined as the interval between the first injection of the last antenatal corticosteroid course and delivery in days, studied in 2 categories (days 3-7 and after day 7), in 4 categories (days 3-7, 8-14, 15-21, and after day 21), and continuously in days. The main outcome was survival at 5½ years without moderate/severe neurologic disabilities, defined as moderate/severe cerebral palsy, or unilateral or bilateral blindness or deafness, or Full-Scale Intelligence Quotient 2 standard deviations below the mean. A multivariate analysis with a generalized estimated equation logistic regression model assessed the statistical association between the main outcomes and the interval from the first corticosteroid injection of the last course to birth. Multivariate analyses were adjusted for potential confounders, defined with a directed acyclic graph: gestational age in days, number of corticosteroid courses, multiple pregnancy, and cause of prematurity in 5 categories. Because neurologic follow-up was complete in only 63.2% of cases (1532/2427), the analyses used imputed data., Results: Among 2613 children, 186 died between birth and 5½ years. Overall survival was 96.6% (95% confidence interval, 95.9-97.0), and survival without moderate or severe neurologic disabilities was 86.0% (95% confidence interval, 84.7-87.0). Survival without moderate or severe neurologic disabilities was lower after day 7 (85.0%) than during the interval from day 3 to day 7 (87.0%) (adjusted odds ratio, 0.70; 95% confidence interval, 0.54-0.89)., Conclusion: The association of a >7-day interval between antenatal corticosteroid administration and birth with a lower rate of survival without moderate or severe neurologic disabilities among children aged 5½ years emphasizes the importance of better targeting women at risk of preterm delivery to optimize the timing and thus benefits of treatment., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To identify strategies for reducing neonatal and maternal morbidity associated with intrahepatic cholestasis pregnancy (ICP)., Material and Methods: The quality of evidence of the literature was assessed following the GRADE methodology with questions formulated in the PICO format (Patients, Intervention, Comparison, Outcome) and outcomes defined a priori and classified according to their importance. An extensive bibliographic search was performed on PubMed, Cochrane, EMBASE and Google Scholar databases. The quality of the evidence was assessed (high, moderate, low, very low) and a (i) strong or (ii) weak recommendations or (iii) no recommendation were formulated. The recommendations were reviewed in two rounds with external reviewers (Delphi survey) to select the consensus recommendations., Results: Of the 14 questions (from 12 PICO questions and one definition question outside the PICO format), there was agreement between the working group and the external reviewers on 14 (100%). The level of evidence of the literature was insufficient to provide a recommendation on two questions. ICP is defined by the occurrence of suggestive pruritus (palmoplantar, nocturnal) associated with a total bile acid level>10μmol/L or an alanine transaminase level above 2N after ruling out differential diagnoses. In the absence of suggestive symptoms of a differential diagnosis, it is recommended not to carry out additional biological or ultrasound tests. In women with CIP, ursodeoxycholic acid is recommended to reduce the intensity of maternal pruritus (Strong recommendation. Quality of the evidence moderate) and to decrease the level of total bile acids and alanine transaminases. (Strong recommendation. Quality of the evidence moderate). S-adenosyl-methionine, dexamethasone, guar gum or activated charcoal should not be used to reduce the intensity of maternal pruritus (Strong recommendation. Quality of evidence low), and there is insufficient data to recommend the use of antihistamines (No recommendation. Quality of evidence low). Rifampicin (Weak recommendation. Very low quality of evidence) or plasma exchange (Strong recommendation. Very low quality of evidence) should not be used to reduce maternal pruritus and perinatal morbidity. Serum monitoring of bile acids is recommended to reduce perinatal morbidity and mortality (stillbirth, prematurity) (Low recommendation. Quality of the evidence low). The level of evidence is insufficient to determine whether fetal heart rate or fetal ultrasound monitoring are useful to reduce perinatal morbidity (No recommendation). Birth is recommended when bile acid level is above 99μmol/L from 36 weeks gestation to reduce perinatal morbidity, in particular stillbirth. When bile acid level is above 99μmol/L is below 100μmol/L, women should be informed that induction of labor could be considered 37 and 39 weeks gestation to reduce perinatal morbidity. (Strong recommendation. Quality of evidence low). In postpartum, total bile acids and alanine transaminases level should be checked and normalized before prescribing estrogen-progestin contraception, ideally with a low estrogen dose (risk of recurrence of pruritus and cytolysis) (Low recommendation. Quality of evidence very low)., Conclusion: Although the quality of evidence regarding ICP gestational cholestasis remains low, there is a strong consensus in France, as shown by our Delphi study, on how to manage women with ICP. The reference first-line treatment is ursodeoxycholic acid., (Copyright © 2023 CNGOF. Published by Elsevier Masson SAS.. All rights reserved.)

Objective: To evaluate the mother-child separation rate in twin pregnancies delivered in maternity units offering an appropriate level of neonatal care., Methods: JUMODA is a French, prospective, population-based cohort study of twin deliveries, including 7998 women who gave birth in maternity units with appropriate levels of neonatal care based on thresholds for weeks of gestational age (wGA) and birth weight according to French guidelines: level I (≥36 wGA), IIA (≥34 wGA), IIB (≥32 wGA and ≥ 1500 g), and IIII (<32 wGA or < 1500 g). The primary outcome was mother-child separation, defined as the transfer of at least one twin or the mother to another hospital., Results: Mother-child separation occurred in 2.1% of pregnancies. This rate was significantly higher in level I (4.8%, 95% confidence interval [CI] 1.5-12.5) and IIA (3.4%, 95% CI 2.4-4.7) compared with level IIB (1.6%, 95% CI 1.1-2.3) and level III maternity units (2.1%, 95% CI 1.9-2.8). In level IIA units, the rate of mother-child separation was higher for babies born between 34 and 36 wGA (8.3%) than for those born at 36 wGA or beyond (1.7%). In level IIb, the rate of mother-child separation for babies born between 32 and 34 wGA (7.5%) was higher than for those born between 34 and 36 wGA (2.1%) and at 36 wGA or beyond (0.9%)., Conclusion: Mother-child separation rates were low but differed by level of care. By using specific thresholds for twins to define levels of care, rather than data from singleton births, one-fifth of mother-child separations could have been avoided., (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

The interplay between fatigue and depression and their association with health-related quality of life (HRQoL) after acute myocardial infarction (AMI) has received little attention during the COVID-19 pandemic. Therefore, this study evaluated the frequency of fatigue and depression in post-AMI patients during the COVID-19 pandemic and investigated the cross-sectional associations between fatigue, depression and HRQoL., Methods: The analysis was based on population-based Myocardial Infarction Registry Augsburg data. All survivors of AMI between 1 June 2020 and 15 September 2021 were included ( n = 882) and received a postal questionnaire containing questions about fatigue (Fatigue Assessment Scale), depression (Patient Health Questionnaire), and HRQoL (MacNew Heart Disease HRQoL questionnaire) on 17 November 2021. The questionnaire was returned by 592 patients (67.1%), and 574 participants could be included in the analysis. Multivariable linear regression models were performed to investigate the associations between fatigue and depression (both exposures) and HRQoL (outcome)., Results: Altogether, 273 (47.6%) participants met the criteria for the presence of fatigue, about 16% showed signs of moderate to severe depression. Both fatigue and depression were significantly associated with a decreased HRQoL (total score and emotional, social, and physical subscales; all p -values < 0.0001). In particular, a combined occurrence of fatigue and depression was associated with a significantly reduced HRQoL., Conclusions: It seems necessary to screen post-MI patients for the presence of fatigue and depression in clinical practice on a routine basis to provide them with adequate support and treatment and thus also to improve their HRQoL.

Background: Obesity is associated with chronic low-grade inflammation, which is underpinned by the presence of elevated levels of circulating proinflammatory cytokines in obese individuals. Due to the close relationship between adipose tissue and the immune system, it can be speculated that the accumulation of fat may influence the frequency and phenotype of lymphocyte populations. The aim of our study was to investigate whether body fat distribution is associated with B lymphocyte composition in peripheral blood. We examined the association between visceral (VAT) and total body fat (TBF) and the frequencies of B-cell subsets in 238 subjects over a period of up to one year using random intercept models. B lymphocyte subsets were determined by fluorescence-based flow cytometry., Results: Inverse associations were found between body fat measurements and plasma blasts, memory B cells, and IgM - IgD - cells. VAT, but not TBF, was positively associated with naive CD19 cells. In our analyses, both VAT and TBF showed positive associations with IgD only B cells., Conclusions: In conclusion, body fat accumulation seems to be associated with a lower proportion of antibody-secreting plasma blasts and memory cells and an increasing amount of partially anergic, naive CD19 cells., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objective: To compare the effectiveness of prophylactic carbetocin with prophylactic oxytocin for preventing severe postpartum hemorrhage (PPH) following vaginal delivery., Methods: This before and after cohort study took place between 2020 and 2021 in a university maternity hospital. In 2021, the protocol for PPH prevention immediately after vaginal delivery changed: intravenous oxytocin (5 IU) was replaced by intravenous carbetocin (100 μg). All patients with vaginal births were included, with two groups compared: patients who received prophylactic oxytocin in 2020 and those who received prophylactic carbetocin in 2021. The primary outcome was severe PPH, defined as one or more of the following: estimated blood loss ≥1500 mL, transfusion ≥4 units of red blood cells, Bakri balloon use, embolization, vascular ligation, hysterectomy, and maternal death., Results: Among 4832 women included, 2417 received oxytocin and 2415 received carbetocin. The rate of severe PPH was similar in both groups (0.5% vs. 0.6%, respectively; adjusted odds ratio, 0.8 [95% confidence interval, 0.4-1.8]). The rate of PPH ≥500 mL was lower in the carbetocin group (4% vs. 5.8%; P = 0.004)., Conclusion: Although prophylactic carbetocin was associated with a reduction in the rate of PPH ≥500 mL, carbetocin is no different to oxytocin in preventing severe PPH caused by atony after vaginal delivery., (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Objective: To investigate the associations between several anthropometric parameters and regulatory T cells (Tregs) and circulating cytokines in a population-based cohort., Methods: Between 2018 and 2021, a total of 238 participants were examined up to three times within the scope of the MEGA study in Augsburg, Germany. Tregs were analyzed using flow cytometry and the serum concentrations of 52 cytokines were determined. Anthropometric parameters were measured, using also bioelectrical impedance analysis: body mass index (BMI), relative total body fat, relative visceral adipose tissue (rVAT), waist circumference (WC), waist-to-hip ratio (WHR) and body fat distribution. Associations were analyzed using linear mixed models with random intercept (Tregs) and conventional linear regression models (cytokines)., Results: WC and WHR were inversely associated with the general Treg subset. Four parameters (BMI, rVAT, WC, and WHR) were inversely associated with the conventional Treg population. Three cytokines showed a particularly strong association with several anthropometric parameters: the cutaneous T-cell attracting chemokine was inversely associated with anthropometric parameters, while hepatocyte growth factor and interleukine-18 showed positive associations., Conclusions: Anthropometric measures are associated with Tregs and serum cytokine concentrations revealing new important interconnections between obesity and the adaptive immune system., (© 2023. The Author(s).)

Background: The impact of intracoronary imaging on outcomes, after provisional versus dual-stenting for bifurcation left main (LM) lesions, is unknown., Objectives: We investigated the effect of intracoronary imaging in the EBC MAIN trial (European Bifurcation Club LM Coronary Stent study)., Methods: Four hundred and sixty-seven patients were randomized to dual-stenting or a stepwise provisional strategy. Four hundred and fifty-five patients were included. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was undertaken at the operator's discretion. The primary endpoint was death, myocardial infarction or target vessel revascularization at 1-year., Results: Intracoronary imaging was undertaken in 179 patients (39%; IVUS = 151, OCT = 28). As a result of IVUS findings, operators reintervened in 42 procedures. The primary outcome did not differ with intracoronary imaging versus angiographic-guidance (17% vs. 16%; odds ratio [OR]: 0.92 (95% confidence interval [CI]: 0.51-1.63) p = 0.767), nor for reintervention based on IVUS versus none (14% vs. 16%; OR: 0.88 [95% CI: 0.32-2.43] p = 0.803), adjusted for syntax score, lesion calcification and ischemic symptoms. With angiographic-guidance, primary outcome events were more frequent with dual versus provisional stenting (21% vs. 10%; adjusted OR: 2.11 [95% CI: 1.04-4.30] p = 0.039). With intracoronary imaging, there were numerically fewer primary outcome events with dual versus provisional stenting (13% vs. 21%; adjusted OR: 0.56 [95% CI: 0.22-1.46] p = 0.220)., Conclusions: In EBC MAIN, the primary outcome did not differ with intracoronary imaging versus none. However, in patients with angiographic-guidance, outcomes were worse with a dual-stent than provisional strategy When intracoronary imaging was used, there was a trend toward better outcomes with the dual-stent than provisional strategy., (© 2023 Wiley Periodicals LLC.)

Importance: Bacterial vaginosis (BV) is a well-known risk factor for preterm birth. Molecular diagnosis of BV is now available. Its impact in the screening and treatment of BV during pregnancy on preterm births has not been evaluated to date., Objective: To evaluate the clinical and economic effects of point-of-care quantitative real-time polymerase chain reaction screen and treat for BV in low-risk pregnant women on preterm birth., Design, Setting, and Participants: The AuTop trial was a prospective, multicenter, parallel, individually randomized, open-label, superiority trial conducted in 19 French perinatal centers between March 9, 2015, and December 18, 2017. Low-risk pregnant women before 20 weeks' gestation without previous preterm births or late miscarriages were enrolled. Data were analyzed from October 2021 to November 2022., Interventions: Participants were randomized 1:1 to BV screen and treat using self-collected vaginal swabs (n = 3333) or usual care (n = 3338). BV was defined as Atopobium vaginae (Fannyhessea vaginae) load of 108 copies/mL or greater and/or Gardnerella vaginalis load of 109 copies/mL or greater, using point-of-care quantitative real-time polymerase chain reaction assays. The control group received usual care with no screening of BV., Main Outcomes and Measures: Overall rate of preterm birth before 37 weeks' gestation and total costs were calculated in both groups. Secondary outcomes were related to treatment success as well as maternal and neonate health. Post hoc subgroup analyses were conducted., Results: Among 6671 randomized women (mean [SD] age, 30.6 [5.0] years; mean [SD] gestational age, 15.5 [2.8] weeks), the intention-to-treat analysis of the primary clinical and economic outcomes showed no evidence of a reduction in the rate of preterm birth and total costs with the screen and treat strategy compared with usual care. The rate of preterm birth was 3.8% (127 of 3333) in the screen and treat group and 4.6% (153 of 3338) in the control group (risk ratio [RR], 0.83; 95% CI, 0.66-1.05; P = .12). On average, the cost of the intervention was €203.6 (US $218.0) per participant, and the total average cost was €3344.3 (US $3580.5) in the screen and treat group vs €3272.9 (US $3504.1) in the control group, with no significant differences being observed. In the subgroup of nulliparous women (n = 3438), screen and treat was significantly more effective than usual care (RR, 0.62; 95% CI, 0.45-0.84; P for interaction = .003), whereas no statistical difference was found in multiparous (RR, 1.30; 95% CI, 0.90-1.87)., Conclusion and Relevance: In this clinical trial of pregnant women at low risk of preterm birth, molecular screening and treatment for BV based on A vaginae (F vaginae) and/or G vaginalis quantification did not significantly reduce preterm birth rates. Post hoc analysis suggests a benefit of screen and treat in low-risk nulliparous women, warranting further evaluation in this group., Trial Registration: ClinicalTrials.gov Identifier: NCT02288832.

Clinical decision support systems (CDSSs) can strengthen the quality of integrated management of childhood illness (IMCI) in resource-constrained settings. Several IMCI-related CDSSs have been developed and implemented in recent years. Yet, despite having a shared starting point, the IMCI-related CDSSs are markedly varied due to the need for interpretation when translating narrative guidelines into decision logic combined with considerations of context and design choices. Between October 2019 and April 2021, we conducted a comparative analysis of 4 IMCI-related CDSSs. The extent of adaptations to IMCI varied, but common themes emerged. Scope was extended to cover a broader range of conditions. Content was added or modified to enhance precision, align with new evidence, and support rational resource use. Structure was modified to increase efficiency, improve usability, and prioritize care for severely ill children. The multistakeholder development processes involved syntheses of recommendations from existing guidelines and literature; creation and validation of clinical algorithms; and iterative development, implementation, and evaluation. The common themes surrounding adaptations of IMCI guidance highlight the complexities of digitalizing evidence-based recommendations and reinforce the rationale for leveraging standards for CDSS development, such as the World Health Organization's SMART Guidelines. Implementation through multistakeholder dialogue is critical to ensure CDSSs can effectively and equitably improve quality of care for children in resource-constrained settings., (© Beynon et al.)

Background: The aim of this study was to investigate the association between inflammatory plasma protein concentrations and long-term mortality in patients with ST-elevation myocardial infarction (STEMI)., Methods: For 343 STEMI patients recorded between 2009 and 2013 by the population-based Myocardial Infarction Registry Augsburg, 92 inflammatory plasma proteins were measured at the index event using the OLINK inflammation panel. In multivariable-adjusted Cox regression models, the association between each plasma protein and all-cause long-term mortality was investigated. Median follow-up time was 7.6 (IQR: 2.4) years. For plasma protein that showed a strong association with long-term mortality, a 5-year survival ROC analysis was performed., Results: One plasma protein, namely Fibroblast Growth Factor 23 (FGF-23), was particularly well associated with long-term mortality in the multivariable-adjusted Cox model with an FDR-adjusted p -value of <0.001 and a Hazard Ratio (HR) of 1.57 [95% CI: 1.29-1.91]. In the 5-years ROC analysis, an AUC of 0.6903 [95% CI: 0.594-0.781] was estimated for FGF-23. All other plasma protein didńt show strong associations, each marker with FDR-adjusted p -values >0.05 in the multivariable-adjusted Cox models., Conclusions: FGF-23 is independently associated with long-term mortality after STEMI and might play an important role in the response to myocardial injury. The results suggest FGF-23 to be a useful marker in the long-term treatment of STEMI patients and a potential target for drug development., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Schmitz, Wein, Heier, Peters, Meisinger and Linseisen.)

Background: Women with atrial fibrillation (AF) generally experience worse symptoms, poorer quality of life, and have a higher risk of stroke and death. There is limited availability of sex-related differences regarding left atrial appendage occlusion (LAAO)., Aims: The aim of this study was to evaluate the sex-related differences in patients undergoing LAAO in EWOLUTION., Methods: A total of 1025 patients scheduled for elective LAAO therapy employing the WATCHMAN Gen 2.5 prospectively consented for participation; 1005 patients received a successful implant and were followed for 2 years. As we detected sex-related differences in baseline data we performed a propensity score matching. The primary endpoint is a combined endpoint of survival free from mortality, major bleeding, ischemic stroke, transitory ischemic attack (TIA) and systemic embolization (SE) up to 2-year clinical follow-up. Secondary Endpoints were periprocedural data and overall 2-year survival., Results: Women were older but had less often vascular disease and hemorrhagic stroke. There was no sex-related significant difference after LAAO at 2 years in the combined endpoint of survival free from mortality, major bleeding, ischemic stroke, TIA, and SE (female vs. male: 79% vs.76%, p = 0.24) or in overall survival (female vs. male: 85% vs. 82%, p = 0.16). Procedural data showed a higher sealing rate after the implantation in women (complete sealing female 94% vs. male 90%, p = 0.033), significantly more pericardial effusions (female 1.2% vs. male 0.2%, p = 0.031) and a similar periprocedural risk profile., Conclusions: Females undergoing LAAO differ in various baseline variables, but after adjustment, we observed similar safety and efficacy of LAAO with no significant difference in long-term outcomes between women and men., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Introduction: Our objective was to study the strength of the association between meconium-stained amniotic fluid and severe morbidity among neonates of nulliparas with prolonged pregnancies., Material and Methods: This was a secondary analysis of the NOCETER randomized trial that took place between 2009 and 2012 in which 11 French maternity units included 1373 nulliparas at 41 +0  weeks of gestation onwards with a single live fetus in cephalic presentation. This analysis excluded patients with a cesarean delivery before labor and those with bloody amniotic fluid or of unreported consistency. The principal end point was a composite criterion of severe neonatal morbidity (neonatal death, 5-minute Apgar <7, convulsions in the first 24 h, meconium aspiration syndrome, mechanical ventilation ≥24 h, or neonatal intensive care unit admission for 5 days or more). The neonatal outcomes of pregnancies with thin or thick meconium-stained amniotic fluid were compared with those with normal amniotic fluid. The association between the consistency of the amniotic fluid and neonatal morbidity was tested by univariate and then multivariate analysis adjusted for gestational age at birth, duration of labor, and country of birth., Results: This study included 1274 patients: 803 (63%) in the group with normal amniotic fluid, 196 (15.4%) in the thin amniotic fluid group, and 275 (21.6%) in the thick amniotic fluid group. The neonates of patients with thick amniotic fluid had higher rates of neonatal morbidity than those of patients with normal amniotic fluid (7.3% vs. 2.2%; p < 0.001; adjusted relative risk [aRR] 3.3, 95% confidence interval [CI] 1.7-6.3), but those of patients with thin amniotic fluid did not (3.1% vs. 2.2%; p = 0.50; aRR 1.0, 95% CI, 0.4-2.7)., Conclusions: Among nulliparas at 41 +0  weeks onwards, only thick meconium-stained amniotic fluid is associated with a higher rate of severe neonatal morbidity., (© 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Background: Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality., Objectives: The authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) in a contemporary, real-world setting., Methods: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device) postapproval study is a prospective, single-arm, open-label, multicenter, postmarket registry conducted at 26 sites in Europe. Echocardiographic assessment was performed at a core laboratory., Results: Enrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days., Conclusions: Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population. (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device [bRIGHT]; NCT04483089)., Competing Interests: Funding Support and Author Disclosures This work was funded by Abbott Structural Heart. Dr Lurz has been a consultant to Abbott Structural Heart, Edwards Lifesciences, and ReCor. Dr Besler has received institutional (nonpersonal) lecture honoraria from Abbott. Dr Nickenig has received research funding from the Deutsche Forschungsgemeinschaft (DFG), the Federal Ministry of Education and Research (BMBF), The European Union, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical. Dr Möllmann has received honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Prof von Bardeleben has received institutional research grants and speaker honoraria from Abbott Vascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Schmeisser has received research funding and speaker honoraria from Abbott. Dr Estevez-Loureiro has been a consultant for Abbott Vascular, Edwards Lifesciences, Boston Scientific, and Venus Medtech. Dr Lubos has received lecture fees and research grants from Abbott Vascular and Edwards Lifesciences; has received honoraria for advisory board activities from New Valve Technology; and has received travel expenses from Cardiovalve, Abbott Vascular, and Edwards Lifesciences. Drs Heitkemper and Huang are employees of Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Stroke is a leading cause of mortality and disability worldwide and its occurrence is expected to increase in the future. Blood biomarkers have proven their usefulness in identification and monitoring of the disease. Stroke severity is a major factor for estimation of prognosis and risk of recurrent events, but knowledge on respective blood biomarkers is still scarce. Stroke pathophysiology comprises a multitude of ischemia-induced inflammatory and immune mediated responses. Therefore, the assessment of an immune-related panel in correlation with stroke severity seems promising., Methods: In the present cross-sectional evaluation, a set of 92 blood biomarkers of a standardized immune panel were gathered (median 4.6 days after admission) and related to stroke severity measures, assessed at hospital admission of acute stroke patients. Multivariable logistic regression models were used to determine associations between biomarkers and modified Rankin Scale (mRS), linear regression models were used for associations with National Institute of Health Stroke Scale., Results: 415 patients (mean age 69 years; 41% female) were included for biomarker analysis. C-type lectin domain family 4 member G (CLEC4G; OR = 2.89, 95% CI [1.49; 5.59], p adj  = 0.026, Cytoskeleton-associated protein 4 (CKAP4; OR = 2.38, 95% CI [1.43; 3.98], p adj  = 0.019), and Interleukin-6 (IL-6) (IL6; OR = 1.97, 95% CI [1.49; 2.62], p adj  < 0.001) were positively associated with stroke severity measured by mRS, while Lymphocyte antigen 75 (LY75; OR = 0.37, 95% CI [0.19; 0.73], p adj  = 0.049) and Integrin alpha-11 (ITGA11 OR = 0.24, 95% CI [0.14, 0.40] p adj  < 0.001) were inversely associated. When investigating the relationships with the NIHSS, IL-6 (β = 0.23, 95% CI [0.12, 0.33] p adj  = 0.001) and ITGA11 (β =  - 0.60, 95% CI [- 0.83, - 0.37] p adj  < 0.001) were significantly associated., Conclusions: Higher relative concentrations of plasma CLEC4G, CKAP4, and IL-6 were associated with higher stroke severity, whereas LY75 and ITGA11 showed an inverse association. Future research might show a possible use as therapeutic targets and application in individual risk assessments., (© 2023. The Author(s).)

Blood lipids play a major role in the manifestation of cardiovascular diseases. Recent research suggested that there are connections between cholesterol levels and immunological alterations. We investigated whether there is an association between serum cholesterol levels (total, HDL, and LDL) and immune cells (B cell and regulatory T cells [Tregs]). The analysis was based on data from 231 participants of the MEGA study in Augsburg, Germany, recruited between 2018 and 2021. Most participants were examined two different times within a period of 9 months. At every visit, fasting venous blood samples were taken. Immune cells were analyzed immediately afterward using flow cytometry. Using multivariable-adjusted linear regression models, the associations between blood cholesterol concentrations and the relative quantity of several B-cell and Treg subsets were analyzed. We found that particularly HDL cholesterol concentrations were significantly associated to some immune cell subpopulations: HDL cholesterol showed significant positive associations with the relative frequency of CD25++ Tregs (as proportion of all CD4+CD25++ T cells) and conventional Tregs (defined as the proportion of CD25+CD127- cells on all CD45RA-CD4+ T cells). Regarding B cells, HDL cholesterol values were inversely associated with the cell surface expression of IgD and with naïve B cells (CD27-IgD+ B cells). In conclusion, HDL cholesterol levels were associated with modifications in the composition of B-cell and Treg subsets demonstrating an important interconnection between lipid metabolism and immune system. Knowledge about this association might be crucial for a deeper and more comprehensive understanding of the pathophysiology of atherosclerosis., Competing Interests: Conflict of interest The authors declare that they have no conflicts of interest with the contents of this article., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Despite the known association of chronic cardiovascular diseases and more severe courses of COVID-19, little is known about individual risk perception of patients with a history of acute myocardial infarction (AMI) and resulting preventive behaviours. In May 2020, a postal survey was conducted, including 150 patients with previous AMI from the myocardial infarction registry Augsburg. The study objective was to assess COVID-19 knowledge, individual risk perception, worries, infection likelihood and preventive behaviours in this patient cohort. From the 100 respondents, 69.7% perceived themselves to be at high risk of developing a severe course of COVID-19. There was a significant positive correlation between dangerousness assessment and knowledge on COVID-19. Despite a majority (70%) of patients rating their susceptibility for an infection as moderate to very high, the individual likelihood of being infected was rated at only 3%. Almost 70% of patients with previous MI classified themselves at high risk for a severe course of COVID-19 infection. As seen in other risk groups as well, the availability of valuable information sources as well as the support in individual risk reduction strategies and psychological coping mechanisms are mandatory, especially since higher knowledge correlates with dangerousness assessment and might lead to better compliance with preventive behaviours.