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Preoperative transcatheter conduction system mapping to avoid conduction injury during complex congenital heart surgery
No full textComparative Performance of Machine Learning and Traditional Risk Scores in Predicting Adverse Events After Transcatheter Aortic Valve Replacement in Patients With Atrial Fibrillation
No full textPatients with atrial fibrillation (AF) following transcatheter aortic valve replacement (TAVR) remain at risk of ischemic stroke (IS) and bleeding. However, traditional risk scores provide modest predictions of IS and bleeding in these patients. We aimed to develop machine learning (ML) models that predict IS, major gastrointestinal bleeding (MGIB), all clinically relevant bleeding (CRB), and net adverse clinical events (NACE) using data from patients in the ENVISAGE-TAVI AF trial. Ten ML algorithms were trained per outcome using nested cross-validation; the best-performing model (highest F1 score) was validated on a 25% holdout set. Model performance was compared with logistic regression models using CHA₂DS₂-VA or HAS-BLED. Among 1,377 patients, 41 had an IS, 83 had MGIB, 375 had CRB, and 255 experienced NACE. The predictive abilities of a linear discriminant analysis algorithm for IS (F1 score = 0.08) and CHA₂DS₂-VA (F1 score = 0.09) were similarly low, but numerically better than HAS-BLED (F1 score = 0.05). Prediction of MGIB was similarly low for a logistic-lasso algorithm (F1 score = 0.11), CHA₂DS₂-VA (F1 score = 0.09), and HAS-BLED (F1 score = 0.12). For CRB, the predictive performance of a Naïve Bayes algorithm (F1 score = 0.39) was similar to CHA₂DS₂-VA (F1 score = 0.38) and HAS-BLED (F1 score = 0.41). The predictive ability of a logistic regression algorithm for NACE (F1 score = 0.33) was numerically better than CHA₂DS₂-VA (F1 score = 0.22) or HAS-BLED (F1 score = 0.27). In conclusion, ML offered similar predictive ability to established risk scores for thromboembolic and bleeding outcomes among TAVR patients with AF.</p
Introducing an integrated maternity care pathway for women with a history of small-for-gestational-age:Evaluation of its effect on care process and clinical outcomes
No full textIntroduction:This study focusses on the implementation of an integrated care pathway for women with SGA in their obstetric history that pursues value-based healthcare. This study aims to 1) Determine whether the integrated care pathway led to a reduction in the number of antenatal secondary care consultations, as an indicator of care efficacy, and 2) compare clinical outcomes for women with a history of SGA before and after implementation of the integrated care pathway. Methods:Retrospective cohort study including data from pregnant women with a history of SGA within integrated maternity care organisation Annature, 2017–2020. Intervention was an integrated care pathway (2018). Pre- and post-intervention periods were compared assessing prenatal secondary care consultations, place and mode of delivery, and perinatal outcomes. Results:The implementation of the care pathway for pregnant women with a history of SGA led to a reduction in mean number of prenatal secondary care consultations per pregnancy from 11 in 2017–5 in 2020, and fewer inductions of labour (78 (34.2%) vs 127 (26.8%), p = 0.045). Additionally, the number of births in primary care increased (35 (15.4%) vs 136 (28.8%), p < 0.001) with no significant adverse impact on neonatal outcomes in the post-intervention period compared to the pre-intervention period. Conclusion:The implementation of the care pathway for pregnant women with a history of SGA resulted in a reduction in prenatal secondary care consultations and fewer inductions of labour. Additionally, the number of births in primary care increased, with no significant adverse impact on neonatal outcomes in the post-intervention period compared to the pre-intervention period.</p
Intravascular ultrasound guidance for complex high-risk indicated procedures:The IVUS CHIP trial study design
No full textBackground:Intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI) has been associated with a reduction in clinical events. Whereas most evidence is generated in Asian-Pacific populations, its global adoption remains low. Methods:The IVUS complex high-risk indicated procedures (CHIP) trial is a multicenter, international, event-driven, randomized superiority trial comparing IVUS-guided PCI with angio-guided PCI during complex high-risk indicated procedures. The primary endpoint is target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target vessel revascularization. The IVUS CHIP trial utilizes an event-driven approach. The outcomes for the primary endpoint are first reported when at least 169 patients with a primary endpoint have been confirmed. A total of 2020 patients will be enrolled in 37 European sites. Conclusions:The aim of the IVUS CHIP trial is to assess the superiority of an IVUS-guided approach vs an angio-guided approach in patients undergoing complex high-risk indicated procedures in terms of the study primary endpoint of target vessel failure. Trial Registration:The IVUS CHIP trial is registered at ClinicalTrial.gov and assigned the identifier NCT04854070.</p
Multi-tyrosine kinase inhibitors in paediatric soft tissue sarcoma – A review
No full textNeoadjuvant systemic treatment for paediatric patients with soft tissue sarcomas (STS) consists of conventional chemotherapy, predominantly ifosfamide and doxorubicin, with a limited role for innovative therapies. Many multi-tyrosine kinase inhibitors (mTKIs) have been developed in the past decades for the treatment of various types of malignancies. Over a decade ago, the mTKI pazopanib was authorized by the EMA and FDA for the treatment of adults with STS. Paediatric development of innovative treatments often follows years after the first marketing authorisations in adults has been obtained. To date, a series of clinical trials have been conducted investigating the value of mTKIs in paediatric patients with STS. Nevertheless, the positioning of mTKIs in the treatment of paediatric STS remains unclear and selection of mTKIs for clinical trials is more often made on grounds of availability rather than on mechanism of action, efficacy data, or toxicity profile. In this manuscript, we provide an overview of studies evaluating mTKIs in paediatric, adolescent, and adult STS patients, aiming to assist in prioritization of future clinical trials in paediatric STS. We performed a systematic literature review with the purpose of collecting data on activity and safety. The results of 107 relevant clinical trials, including 23 trials conducted in the paediatric population and 84 trials in the adult population, were critically assessed and summarized (Appendix 1). Accelerating the development of innovative treatments in patients with such ultra-rare diseases will require innovative clinical trial designs, and international collaboration is necessary. Considering the age distribution of STS, collaboration between paediatric oncologists and medical oncologists should be considered.</p
Guiding treatment decisions in early breast cancer:A model-based comparison of the OncotypeDX and MammaPrint tests
No full textIntroduction: Genomic tests may improve chemotherapy allocation in early-stage breast cancer beyond traditional clinical factors. We compared the clinical usefulness of two multi-genomic tests, MammaPrint and OncotypeDX, in guiding adjuvant chemotherapy decisions. Methods: The MINDACT and TAILORx trials provided prospective validation for the MammaPrint and OncotypeDX tests, respectively. We generated two synthetic cohorts to evaluate both tests in both trial contexts. Chemotherapy was assumed to be indicated if it was expected to reduce the risk of an event by at least 5 %, defining events as 10-year distant metastases or breast cancer–related death. We compared treatment decision making informed by clinical risk information alone versus clinical information plus either the MammaPrint (dichotomous score: high/low risk) or OncotypeDX test (dichotomous and continuous scores). These strategies were evaluated using Net Benefit: a weighted difference of preventing events through treatment and the number of treatments given. Results: Treatment decision-making informed by clinical information alone would result in a positive balance between preventing events and treatments given in both synthetic cohorts (4.8 net benefit in MINDACT, 3.0 in TAILORx per 1000 patients). Incorporating OncotypeDX into risk assessment improved treatment allocation more than MammaPrint (+2.6 vs + 1.6 in MINDACT, +1.3 vs + 1.0 in TAILORx contexts), with substantial uncertainty. Using the dichotomized OncotypeDX score limited its clinical usefulness compared to using its underlying continuous score. Discussion: Both MammaPrint and OncotypeDX tests improve identifying candidates for chemotherapy among women with early breast cancer, with broadly equivalent clinical usefulness. The tests should be implemented into existing risk algorithms to maximize their clinical usefulness.</p
Practical strategies for environmentally sustainable practices in gynecologic oncology
No full textSustainability in health care is an increasingly urgent priority, and gynecologic oncology (as a resource-intensive surgical specialty) offers opportunities to reduce environmental impact without compromising patient care. This review provides actionable, evidence-based strategies that individual clinicians, departments, and institutions can readily implement into routine practice.Practical anesthetic strategies, such as total intravenous anesthesia, regional anesthesia, and low-flow techniques, substantially decrease greenhouse gas emissions. Transitioning from disposable to reusable surgical instruments, drapes, and gowns significantly curbs waste. Energy-efficient solutions in the operating room, including optimized heating, ventilation, air conditioning systems, as well as light emitting diode lighting, minimize unnecessary energy use.Optimizing diagnostic imaging through clinical justification and powering down equipment when feasible further decreases energy consumption. Pharmaceutical-related strategies, including accurate chemotherapy dosing, safe medication disposal through drug take-back programs, and environmentally conscious procurement, mitigate harmful emissions and pharmaceutical waste. Surgical techniques such as sentinel lymph node biopsy, rather than extensive lymphadenectomy, also support sustainability goals by reducing resource consumption and procedural waste.Digital innovations, notably telemedicine, demonstrate clear environmental advantages by minimizing patient travel, particularly for routine follow-up and the collection of patient-reported outcomes. Enhanced Recovery After Surgery protocols, promoting shorter hospital stays and digital preoperative assessments, represent additional avenues for improvement.Preventive interventions, such as human papillomavirus vaccination programs and early cancer screening, are vital long-term sustainability investments, reducing resource-intensive treatments associated with advanced disease. By highlighting practical examples from recent studies and clinical experience, this review aims to encourage widespread adoption of sustainable practices in gynecologic oncology, aligning clinical excellence with global environmental goals.</p
Trends in the economic burden of mental disorders over twelve years:the Netherlands mental health survey and incidence study
No full textObjective:Mental disorders impose a substantial economic burden, making updated cost estimates essential for informed policymaking. This study provides recent cost-ofillness estimates for mental disorders in the general population and examines trends over a 12-year period. Method: The Netherlands Mental Health Survey and Incidence Study (NEMESIS) is a cohort representative for the Dutch population in which common DSM-IV/DSM-5 mental disorders (mood disorders, anxiety disorders, substance use disorders and attention-deficit/hyperactivity disorder) were diagnosed using the Composite International Diagnostic Interview 3.0. In baseline data of NEMESIS-3 (2019-2022, N=6,194, age 47.9±16.4 years, 50.4% women) we estimated healthcare, productivity, travel costs associated with mental disorders through weighted regression models and compared these estimates with baseline data from NEMESIS-2 (2007-2009; N=6,506, age 44.3±12.5 years, 55.2% women), assuming identical unit prices.Results: Total annual per capita costs of any mental disorder were €5,630. Productivity costs comprised the largest share of total costs (61%-85%). In all conditions, except substance use disorder, both total annual costs and productivity costs were lower in 2019-2022 compared to 2007-2009. Healthcare costs were substantially lower for mood and substance use disorders in 2019- 2022, even though primary healthcare utilization was increased in 2019-2022. Discussion: Productivity costs are the primary cost driver of mental disorders. While primary care utilization has increased– possibly due to the introduction of general practice mental health professionals– healthcare resource use has decreased over time. This may indicate a shift in service provision toward primary care from specialized mental healthcare, potentially contributing to more cost-effective mental healthcare delivery.</p
Response to Letter to Editor From Yeap et al:“Endogenous Sex Steroid Hormones, Sex Hormone-Binding Globulin, and Risk of All-Cause and Cause-Specific Mortality: A Systematic Review and Dose-Response Meta-Analysis of Prospective Cohort Studies”
No full textTreatable traits in interstitial lung disease:opportunities and challenges
No full textDespite recent advances in disease-targeted pharmacotherapies for interstitial lung disease (ILD), disease progression occurs in a significant proportion of patients with consequent impact on health-related quality of life. Patients with ILD and their caregivers, clinicians, and researchers have expressed the need for more comprehensive care in ILD. The treatable traits approach is proposed as a person-centred framework for management of ILD, delivering the right treatment to the right patient at the right time, targeting distinct traits that affect health outcomes beyond the lung disease itself. These treatable traits can be subdivided into aetiological, pulmonary, extra-pulmonary, and behavioural and lifestyle domains, with multiple opportunities for treatment within each domain. In this review, we highlight opportunities to integrate the treatable traits approach into the existing ILD care throughout the patient journey, taking into account the changing treatment goals at different disease stages. We further highlight the next steps that are required to validate and further develop the treatable traits approach, with the ultimate aim to improve health outcomes for patients with ILD.</p