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Background: Persistent non-plateauing adverse event rates in patients who underwent percutaneous coronary intervention (PCI) remain a challenge. A bioadaptor is a novel implant that addresses this issue by restoring the haemodynamic modulation of the artery, allowing cyclic pulsatility, vasomotion, and adaptative remodelling, by unlocking and providing dynamic support to the artery. We aimed to assess outcomes with the device versus a contemporary drug-eluting stent (DES) in a representative PCI population., Methods: INFINITY-SWEDEHEART is a single-blind, non-inferiority, registry-based, randomised controlled study conducted in 20 hospitals in Sweden. Patients aged 18-85 years, with chronic or acute coronary syndrome ischaemic heart disease, with an indication for PCI, with up to three de novo lesions suitable for implantation with one single device per lesion, and successful pre-dilatation were identified via the Swedish Coronary Angiography and Angioplasty Registry and eligible for enrolment. Participants were randomly assigned (1:1), using block randomisation with random variation in block size and stratified by site, to either the DynamX bioadaptor (Elixir Medical, Milpitas, CA, USA) or a zotarolimus-eluting DES (Resolute Onyx and Onyx Trustar, Medtronic, Minneapolis, MN, USA). The primary endpoint was the device-oriented clinical endpoint of target lesion failure at 12 months (a composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation), assessed in the intention-to-treat (ITT) population (ie, all patients randomly assigned to treatment, regardless of treatment received) who had either experienced an event up to 12 months or completed the trial up to 12 months. Non-inferiority was established if the upper limit of the two-sided 95% CI for the absolute risk difference was less than 4·2%. Powered secondary endpoints were landmark analyses from 6 months onwards for target lesion failure, target vessel failure (composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target vessel revascularisation), and target lesion failure for patients with acute coronary syndrome assessed in the ITT population). This study is registered with ClinicalTrials.gov, NCT04562805, and follow-up to 5 years is ongoing., Findings: Between Sept 30, 2020, and July 11, 2023, 2399 patients were randomly assigned to receive the bioadaptor (n=1201) or DES (n=1198; ITT population). Median age was 69·5 years (IQR 61·2-75·6), 575 (24·0%) of 2399 patients were female, and 1824 (76·0%) were male (data on race and ethnicity were not collected), and 1838 (76·6%) patients presented with acute coronary syndrome. The primary endpoint of 12-month target lesion failure occurred in 28 (2·4%) of 1189 assessable patients in the bioadaptor group versus 33 (2·8%) of 1192 assessable patients in the DES group, with a risk difference of -0·41% (95% CI -1·94 to 1·11; p non-inferiority <0·0001). In the prespecified landmark analysis from 6 months to 12 months, the Kaplan-Meier estimates of target lesion failure were 0·3% (with events in three of 1170 patients) in the bioadaptor group versus 1·7% (with events in 16 of 1176 patients) in the DES group (hazard ratio 0·19 [95% CI 0·06 to 0·65]; p=0·0079), of target vessel failure were 0·8% (events in eight of 1167) versus 2·5% (events in 23 of 1174; 0·35 [0·16 to 0·79]; p=0·011), and of target lesion failure in patients with acute coronary syndrome were 0·3% (events in two of 906) versus 1·8% (events in 12 of 895; 0·17 [0·04 to 0·74]; p=0·018). The rate of definite or probable device thrombosis, which was recorded as a safety outcome, was low and did not differ between groups (eight [0·7%] of 1201 in the bioadaptor group vs six [0·5%] of 1198 in the DES group; difference in event rates of 0·16% [95% CI -0·50 to 0·83])., Interpretation: Among patients with coronary artery disease, including those with acute coronary syndrome, treatment with the bioadaptor was non-inferior to contemporary DES, showing potential to mitigate non-plateauing device-related events and improving outcomes in patients undergoing PCI. The additional planned follow-up will help to reinforce the clinical significance of the 1-year findings., Funding: Elixir Medical., Competing Interests: Declaration of interests DE reports honoraria for advisory board or speaker fees from Amgen, AstraZeneca, Chiesi, Sanofi, Novo Nordisk, InfraredX/Nipro, and Kaminari Medical. PG reports consulting fees from Chiesi Pharma, lecture fess from Bayer Pharma, and advisory board participation for AstraZeneca. OW reports travel expenses from Abbott Medical. FB reports institutional research grants from Abbott and Boston Scientific; speaker fees from Pfizer, Abbott, Boston Scientific, and Amarin; and advisory board participation for Amarin. CH reports lecturer fees and honoraria for advisory boards from Amarin, AstraZeneca, Boehringer Ingelheim, Novo Nordisk, and Coala. PCS reports institutional grants from Abbott Vascular and SMT, consulting fees from Abbott Vascular and Microport, honoraria from SMT and Elixir, support for attending meetings from Elixir, participation in boards of the Legacy and the Proctor trials, and is a minority shareholder of the European Cardiovascular Research Center (known as CERC). CE and AA are employees of, and hold stock or stock options in, Elixir Medical. SJ and authors affiliated with the Uppsala Clinical Research Center (CH, HR, and JO) report receiving research grants for designing, conducting, and analysing the trial as an Academic Research Organization from Elixir Medical. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI)., Methods: The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients., Summary: The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population., Competing Interests: Conflict of interest Dr. Erlinge reports consulting/speaker fees from AstraZeneca, Bayer, Novartis, Amgen, Ciesi, InfraredX, NovoNordisk, and Sanofi. Dr. James reports institutional research grants/support from AstraZeneca, Novartis, Novo Nordisk, Janssen, and Amgen, participates in the DSMB/ advisory board New Amsterdam (Cardialysis) and valve proctoring fees from Medtronic. Dr. Fröbert reports consulting fees from GSK and participates at DSMB/ Advisory board of the Ischemia CTO study and the NOTION-3-TAVI study. Dr Böhm reports institutional research grants from Abbott and Boston Scientific, speaker fees from Pfizer, Abbott, Boston Scientific and Amarin, and advisory board participation for Amarin. Dr. Oldgren reports institutional research grants/support from Amgen, AstraZeneca, Bayer, Novartis, and Roche Diagnostics. Dr Claes Held reports consulting/speaker fees from AstraZeneca, Boehringer Ingelheim, Bayer, Novo Nordisk, Amarin, and Coala Life and institutional research grants from Pfizer. Candace Elek and Motasim Sirhan are employees of and hold stock/ stock options of Elixir Medical. The other authors have no conflict of interest to declare., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

The importance of Early Childhood (EC) educators' wellbeing has been brought into sharp focus during the COVID-19 pandemic, as educators have navigated numerous additional stressors while providing education and care services for some children and ongoing support for many others learning at home. This study aimed to explore the impact of the pandemic on EC educators' wellbeing and educator-child relationships, as growing evidence shows the influence of these factors on children's developmental outcomes. In July 2020, members of a Research Network of EC Professionals-who previously identified educator wellbeing as a priority issue-were invited to participate in an online survey. The survey included two published, validated scales: the Early Childhood Professional Wellbeing scale (ECPW) and the Student-Teacher Relationship Scale (modified). Survey items about educators' experiences during the pandemic were also included. Two hundred and thirty-two EC educators from across Australia completed the survey, mostly from Victoria where lockdowns were most severe. Linear regression analysis demonstrated stronger professional wellbeing was associated with less conflict in educator-child relationships and lower risk of staff turnover. This was more likely to be experienced by senior or more experienced staff. Although a negative impact of COVID-19 was reported, ECPW scores were relatively high, and organizational structures supporting professional wellbeing were most strongly associated with lower risk of turnover ( r  = 0.63, p  < 0.001). Findings highlight that supporting EC educators' wellbeing is essential for workforce retention, and for promoting quality educator-child relationships which are central to young children's learning and development., Competing Interests: Conflict of interestThe authors declare that there is no conflict of interest., (© The Author(s) 2021.)

A case-control study on different groups of isolated congenital limb deficiency was performed using a population-based and validated Hungarian data set of 537 cases. All groups showed a significantly lower birth weight. The adjusted odds ratio indicated a significantly lower mean birth weight in infants with terminal transverse deficiencies and a significantly higher rate of preterm birth in those with amniogenic defects (part of the early amnion rupture sequence). The different analyses showed that the lower birth weight in the terminal transverse group was caused mainly by intrauterine growth retardation. Lack of limb parts appears to be of secondary importance, especially in the upper limb.

Of 15 live births in one Hungarian village in 1989-90, 11 (73%) were affected by congenital abnormalities and 6 were twins. Of the 11, 4 had Down syndrome. Likely causes of such clusters (known teratogenic factors, familial inheritance, consanguinity) were excluded. A case-control study and environmental investigations pointed the finger of suspicion at the excessive use of trichlorfon at local fish farms. The content of this chemical was very high in fish (100 mg/kg) and several pregnant women, including all mothers of babies with Down syndrome, had consumed contaminated fish in the critical period for the congenital abnormalities observed.

Authors report on the genetic epidemiologic investigation of one of the sentinel anomalies made on purpose to define the birth prevalence of the different types of it, to calculate the mutation rate of autosomal dominant forms as well as to recognize the clinical features of Hungarian cases. 58% of all cases registered in the Hungarian Congenital Abnormality Registry in 1975-1984 proved to be atypical. The birth prevalence of autosomal dominant forms was 1.33/100.000 total birth. 71% of dominant forms was sporadic since 29% was familial. Thus the mutation rate was estimated 4.7 x 10(-6) +/- 1.22 x 10(-6).

The genetic consequences of radioactive fall-out deposition from the Chernobyl (USSR) accident in Hungary was evaluated as a part of the ongoing programme on the population-based Hungarian Surveillance of Germinal Mutations. The surveillance is based on three groups of indicator conditions: 15 sentinel anomalies (indicators of germinal dominant gene mutations), Down's syndrome (an indicator of germinal numerical and structural chromosomal mutations) and unidentified multiple congenital abnormalities (indicators of germinal dominant gene and chromosomal mutations). Cases with these indicator conditions were selected from the material of the Hungarian Congenital Abnormality Registry. After the diagnostic accuracies were checked, familial and sporadic cases were separated. Only the latter group was evaluated for evidence of new mutations. The analysis did not reveal any measurable germinal mutagenic effects of the Chernobyl accident. Furthermore, there were no significant differences in the rates of these three groups of indicator conditions between regions with higher and lower increased background radiation.

Authors report on the genetic epidemiologic investigation of the upper limb--cardiovascular (Holt-Oram) syndrome. The source of cases was the material of the Hungarian Congenital Malformation Registry. Birth prevalence was 0.95/100,000 total births. 85% of all cases proved to be consequences of new mutations, hence the mutation rate was 4.07 x 10(-6) +/- 3.12 x 10(-6).