Medisch Spectrum Twente

'Breast Implant Illness' (BII) refers to non-specific constitutional, rheumatic, mental and cognitive symptoms experienced by women with silicone breast implants (SBIs). This potential late effect of SBIs challenges the safety of SBI-use in oncologic breast reconstruction (BR). Previous studies on BII mainly focused on women with cosmetic SBIs. It remains unclear whether symptoms reported in this population differ from those reported by breast cancer (BC) survivors with SBI-based BR. We conducted a cross-sectional survey in a Dutch cohort including 578 breast augmentation recipients and 2,884 BC survivors, of whom 1,039 had an SBI-based BR. Eighteen BII-related symptoms were assessed. Multivariable logistic regression was used to compare breast augmentation recipients with BC survivors with and without SBIs. Median follow-up time was 8.0 (IQR, 3.9) years. Overall, breast augmentation recipients had a higher risk of myalgia (Odds ratio (OR) 2.10, 95%CI [1.25-3.54]) and food intolerance (OR 1.77, 95%CI [1.01-3.09]) than BC survivors with SBIs, whereas the latter group did not report more BII-associated symptoms than BC survivors without SBIs. In a sensitivity analysis excluding BC patients treated with (neo)adjuvant systemic therapy, breast augmentation recipients reported more BII-related symptoms-headache, myalgia, hair loss, muscle weakness, sleep impairment, and morning stiffness (ORs 1.69-3.35; all p < 0.05) compared to BC survivors with SBIs. Breast augmentation recipients report more BII-related symptoms than BC survivors with or without SBIs. These findings do not support the hypothesis that BII is a distinct disease entity mediated by a generic SBI-related pathogenesis that exists across different populations.Trial registration: This study was preregistered at ClinicalTrials.gov on June 2 nd 2022 (NCT05400954).

Late-stage HIV diagnoses among heterosexuals remain a problem in Europe, yet little is known about its risk factors. We aimed to identify the trends and factors associated with late-stage HIV diagnosis among heterosexuals in the Netherlands. We used national HIV surveillance data and included individuals diagnosed between 2012 and 2022, with heterosexual contact as the suspected transmission route. We applied descriptive statistics and logistic regression analyses. Of 1637 HIV diagnoses among heterosexuals, 932 (57%) were late-stage disease. The proportion of late-stage diagnoses was stable during 2012-2022 (range 51-62%). Significant risk factors for late-stage diagnosis were male sex (adjusted odds ratio [AOR] = 1.72; 95% confidence interval [CI] = 1.40-2.13), older age (every 10-year increase: AOR = 1.48; 95% CI = 1.34-1.62), being born in Africa (AOR = 2.21; 95% CI = 1.70-2.88), and Asia (AOR = 2.93; 95% CI = 1.88-4.65). People born in eastern Europe approached significance (AOR = 1.70; 95% CI = 0.97-3.05). Most late-stage diagnoses occurred in hospitals. The proportion of late-stage HIV diagnoses remains high among heterosexuals in the Netherlands. Men; older people; and those born in Africa, Asia, and eastern Europe were associated with late-stage diagnosis.

About half of the patients with acute ischaemic stroke treated with endovascular thrombectomy (EVT) remains dependent or dies in the first 90days. Ghrelin is a naturally occurring hormone and mildly excitatory neurotransmitter that improved functional, histological, and cytological recovery in in vitro and in vivo ischaemia-reperfusion models. Acylated ghrelin (i.e. the bioactive form) has shown safety in a range of populations, including patients with cardiovascular or neurodegenerative disease. We hypothesise that treatment with acylated ghrelin improves early recovery and long-term functional outcome in patients with ischaemic stroke treated with EVT. We propose an investigator-initiated, phase 2, randomised, clinical trial with open-label treatment and blinded endpoint assessment in 80 patients with anterior circulation ischaemic stroke treated with EVT and a pre-EVT National Institutes of Health Stroke Scale (NIHSS) score ≥ 10. Patients will be randomised to intravenous acylated ghrelin, 600µg twice daily for 5days and started within 6h of symptom onset, in addition to standard care vs. standard care alone. The primary outcome is the NIHSS score on day 7 adjusted for pre-EVT NIHSS and other relevant baseline characteristics. Secondary outcomes include infarct size on MRI at day 3, adverse events, and functional recovery at 90days. The primary analysis will be a single comparison between the treatment groups of the primary outcome according to the intention-to-treat principle. The primary effect variable will be the adjusted beta for the difference in NIHSS score, estimated with multi-variable linear regression analysis. If administration of acylated ghrelin is found safe and potentially effective in patients with ischaemic stroke treated with EVT, this study can inform the sample size calculation for a subsequent randomised phase 3 trial to assess efficacy. The trial has been approved and registered on ClinicalTrials.gov (NCT05726240). The first patient has been included in November 2024.

Recovery from mild traumatic brain injury (mTBI) is believed to be mediated by the secondary injury response with oxidative stress (OS) playing a central role. Previous studies have largely examined isolated OS markers, yielding inconsistent results. This study adopts a more integrated approach by investigating various components of the reactive species interactome (RSI), a conceptual framework that captures the dynamic interplay of redox components, to better understand the role of OS in the recovery trajectory after mTBI. Twenty-two RSI components were measured in plasma obtained from 65 patients with mTBI in the acute phase (<24h) and subacute phase (four to six weeks) post-injury and 25 healthy controls (HC). Principal component analysis (PCA) was conducted to identify a subset of RSI markers capable of distinguishing between patients with mTBI and HC. Associations between RSI profiles and functional recovery at six months post-injury, as measured by the Glasgow Outcome Scale Extended, were assessed. Trends (uncorrected P<0.05) towards increases of hydrogen sulfide (H2S) and glutathione and decreases for zinc and peroxynitrite in patients with acute mTBI were observed. Across recovery groups, patients with complete recovery had significantly higher levels of acutely measured catalase (P=0.002, rrb=0.45) and lower levels of peroxynitrite (P=0.003, rrb=-0.43) than patients with incomplete recovery. Subject component scores obtained from the varimax rotated PCA component three (RC3) distinguished mTBI from HC and patients with complete functional recovery from patients with incomplete functional recovery. Strong positive loaders of RC3 included elevated levels of H2S, circulating ATP, and malondialdehyde, while loadings of calcium, zinc and peroxynitrite contributed negatively to this component. Our findings highlight a pattern of RSI component alterations associated with recovery following mTBI. These findings underscore the complexity of the redox response after mTBI and highlight potential therapeutic targets, including modulation of H2S, catalase activity and zinc homeostasis.

IntroductionInguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.Methods and analysisA national multicentre randomised controlled trial will be performed including 464 children aged 0–16 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.Ethics and disseminationThe protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.Trial registration numberClinicalTrials.gov PRS (ID NCT06451432).

BackgroundRobotic-assisted mitral valve surgery (RAMVS) has emerged as an alternative to conventional minimally invasive mitral valve surgery (MIMVS). However, previous studies have been limited by small sample sizes, heterogeneous techniques and reliance on unmatched or indirectly compared cohorts, resulting in inconclusive evidence. This meta-analysis focuses exclusively on propensity-matched studies to provide a more robust comparison of RAMVS and MIMVS.MethodsA comprehensive literature search was performed to identify propensity-matched studies comparing RAMVS and MIMVS. Pooled odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated using RevMan 8.13.0. Subgroup analyses, including mitral valve repair only, non-isolated mitral valve surgery and MIMVS via right minithoracotomy, were conducted to explore heterogeneity.ResultsEight studies comprising 3352 patients were included, with 1578 (47.1%) undergoing RAMVS. The RAMVS was associated with a shorter hospital stay (MD -1.8 days; 95% CI -3.0 to -0.5; p = 0.006) but significantly longer cardiopulmonary bypass time (MD 21.8 min; 95% CI 0.8-42.9; p = 0.04), and higher odds of conversion to sternotomy (OR 2.9; 95% CI 1.6-5.4; p = 0.0007) and re-exploration for bleeding (OR 1.86; 95% CI 1.1-3.2; p = 0.02). Intensive care unit stay, operative time and postoperative complications were comparable. All subgroup analyses consistently showed higher conversion rates with RAMVS.ConclusionThe RAMVS offers potential recovery benefits but at the cost of greater intraoperative complexity. Careful patient selection and technical expertise are essential to maximise outcomes.