Clinical Issues Research Articles

Clinical Issues - August 2024.

Clinical Issues - August 2024.

Safety and Effectiveness of Coronary Sinus Reducer in the Therapy of Refractory Angina Pectoris-Mid-Term Results of the Real-Life Cohort.

Background: Despite continuous improvements in revascularization techniques, refractory angina without potential revascularization options remains a relevant clinical issue with significant impact on the patient's quality of life. Recently, a novel device, the Coronary Sinus Reducer (CSR), has been introduced into clinical practice as a therapeutic option for patients with disabling angina pectoris. In this single-center, observational study, we evaluated the mid-term (3-month) safety and efficacy of the CSR in a real-world cohort. Methods: The study population consisted of 55 patients with refractory angina without potential revascularization options, who were predominantly men (87.3%) with a high cardiovascular risk factor burden and advanced angina (baseline CCS angina class 3.15 ± 0.6). In terms of procedure safety, all patients underwent successful device deployment with only one periprocedural complication. Results: At the 3-month follow-up, we observed a statistically significant improvement in angina control measured CCS class and SAQ-7 total questionnaire along with increased abolition of physical limitation-6-MWT (233.3 ± 107.1 vs. 305.2 ± 126.8; p < 0.0001). Additionally, we observed significant improvement in terms of quality of life measurements SF-36, the EQ-5D-5L questionnaire, and the EQ-VAS. Conclusions: Our real-world data suggest that CSR implantation is a relatively safe procedure and appears to be particularly effective in relieving angina symptoms and improving quality of life in subjects with refractory angina.

Intelligent treatment system based on bioinformatics and neuro-immune-digestive tract diseases

There are currently many clinical issues plaguing digestive oncologists, including the impact of dietary habits on the occurrence of early gastrointestinal cancer, the association between irritable bowel syndrome, ulcerative colitis, and early gastrointestinal cancer, the expected changes in gastrointestinal cancer after IBS, IBD, and susceptibility gene mutations, and the mechanisms by which susceptibility gene mutations in gastrointestinal cancer lead to different diseases. Meanwhile, as a carcinogen, betel nut is also prone to cancer and emotional disorders, and there are also many doctor-patient conflicts in the current clinical treatment of digestive tract tumors. To address the aforementioned issues, the research team analyzed dietary habits data using SOM clustering algorithm and isolated forest algorithm. Based on bioinformatics, new therapies have been developed for the pathogenesis and immune pathways of various cancers in the digestive system. Using network pharmacology methods, explore the toxicological mechanism of betel nut and its mechanism in mediating emotional disorders. Molecular docking is used to elucidate drug prediction. Based on four AI algorithms, the occurrence of gastrointestinal cancer was predicted through dietary habits. Using computer vision technology to address the deficiencies in early clinical reporting of cancer. This article provides clinical doctors with new treatment tools.

Arrhythmogenic Mitral Valve Prolapse: Can We Risk Stratify and Prevent Sudden Cardiac Death?

Ventricular arrhythmias associated with mitral valve prolapse (MVP) and the capacity to cause sudden cardiac death (SCD), referred to as 'malignant MVP', are an increasingly recognised, albeit rare, phenomenon. SCD can occur without significant mitral regurgitation, implying an interaction between mechanical derangements affecting the mitral valve apparatus and left ventricle. Risk stratification of these arrhythmias is an important clinical and public health issue to provide precise and targeted management. Evaluation requires patient and family history, physical examination and electrophysiological and imaging-based modalities. We provide a review of arrhythmogenic MVP, exploring its epidemiology, demographics, clinical presentation, mechanisms linking MVP to SCD, markers of disease severity, testing modalities and management, and discuss the importance of risk stratification. Even with recently improved understanding, it remains challenging how best to weight the prognostic importance of clinical, imaging and electrophysiological data to determine a clear high-risk arrhythmogenic profile in which an ICD should be used for the primary prevention of SCD.

China clinical practice guideline for stage Ⅳ primary lung cancer (2024 edition)

Primary lung cancer (abbreviated as lung cancer) stands as the most prevalent malignant disease and the leading cause of cancer-related death in China, with an estimated 106.06×104 incident cases and 73.33×104 deaths in 2022. Due to the absence of effective early screening methods, most patients with lung cancer in China are in stage Ⅳ when diagnosed. Multi-disciplinary treatment based on systemic therapy is the treatment principle for patients with stage Ⅳ lung cancer. Chemotherapy remains the cornerstone, but its effectiveness is still unsatisfactory. In recent years, with the rapid development of molecular targeted therapy and immunotherapy, the treatment concept for stage Ⅳ lung cancer has been continually evolving, leading to significant improvements in patient treatment outcomes. To ensure timely updates on the global progress in the treatment of stage Ⅳ lung cancer and further improve the level of standardized diagnosis and treatment of stage Ⅳ lung cancer in China, Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and Chinese Association for Clinical Oncologists organized experts to compile "China clinical practice guideline for stage Ⅳ primary lung cancer (2024 edition)". This guideline systematically and comprehensively updates epidemiological data, TNM staging, new drugs, treatment regimens, and new indications approved by China National Medical Products Administration before June 30, 2024, etc. Based on the " Clinical practice guideline for stage Ⅳ primary lung cancer in China(2021 version)" and the " Clinical practice guideline for stage Ⅳ lung cancer in China (2023 edition)." This guideline incorporates recommendation levels for therapeutic drugs and treatment flowcharts for stage Ⅳ lung cancer. The guideline covers common clinical issues and corresponding guidance in the diagnosis and treatment process of stage Ⅳ lung cancer. The guideline aims to guide the clinical practice of stage Ⅳ lung cancer, comprehensively improve the standardized diagnosis and treatment level in China, prolong the survival time of patients with stage Ⅳ lung cancer, and improve patients' quality of life.

Postoperative pain management is basic support of comfortable treatment in alveolar surgery

As a new clinical concept, comfortable treatment is gaining increasingly acceptance. Pain is the fifth vital sign in humans and the primary concern for patients. It is also a clinical issue that must be faced in alveolar surgery. This article summarizes pain cognition, the impact of postoperative pain and clinical pain grading. It also discusses the significance of postoperative pain management. It also categorizes commonly used analgesic medications in clinical practice; and introduces the concepts and techniques of comfortable treatment and comfortable therapy. The author suggests that in order to achieve comfortable treatment in alveolar surgery, the first step is to relieve postoperative pain. Postoperative pain management should not only be treated as temporary analgesia but should be managed around the perioperative period as the key stage. Using preemptive analgesia before the onset of pain, combined with non-pharmacological methods, provides basic support and guarantee for patients to achieve the goal of comfortable treatment. The purpose of this article is to emphasize comprehensive control of postoperative pain in alveolar surgery, guiding and promoting the popularization and promotion of corresponding technologies with the concept of comfortable treatment. This aims to reduce the adverse impact of surgery on both physical and mental well-being, facilitating physiological recovery and enhancing patient compliance. To ensure that patients undergo diagnosis, treatment, and rehabilitation processes with ease, comfort, and satisfaction.

Exploring the effects of combining health qigong and dance on working memory in middle-aged and elderly women: A preliminary investigation

ObjectiveCognitive decline represents a critical clinical and public health issue that adversely affects the quality of life for older patients and their families. This concern was exacerbated by the reduced engagement in outdoor activities among seniors during the COVID-19 pandemic, presenting substantial challenges to aging societies. The objective of this study was to investigate the impact of health qigong combined with Tibetan dance on working memory in middle-aged and elderly women, and to determine its potential as a preventive strategy against cognitive disorders. MethodsA pilot study was conducted to compare the effects of a Health Qigong exercise intervention with those of everyday life and sports routines. The primary outcome measure was working memory assessed using a 2-Back working memory task research paradigm. Between July and September 2021, a total of 33 women were divided into four groups: two middle-aged groups (N = 18, with 8 women in the experimental group and 10 in the control group) and two elderly groups (N = 15, with 7 in the experimental group and 8 in the control group). Participants in the experimental groups underwent a 10-week intervention, consisting of three 60-min sessions per week. Each session included a warm-up, Health Qigong combined with Tibetan dance, and a cool-down. Throughout the study, all participants continued their daily routines. Response times and error rates were analyzed using a mixed-design repeated-measures analysis of variance. ResultsA simple effects analysis revealed that Health Qigong combined with Tibetan dance significantly enhanced 2-Back response time and error rate in the middle-aged group. In contrast, the 2-Back error rate significantly increased in the elderly control group that did not receive the intervention (p < 0.05). ConclusionHealth Qigong demonstrates beneficial effects on middle-aged and elderly women. Combining Health Qigong with dance may serve as a preventive measure against cognitive disorders. This pioneering study conducted during the COVID-19 pandemic, assesses the new possibility of Health Qigong and dance, with the objective to offer more diverse indoor exercise options for middle-aged and elderly women.

Placenta-derived mesenchymal stem cells promote diabetic wound healing via exosomal protein interaction networks.

There is a lack of effective treatment options for diabetic refractory wounds, which presents a critical clinical issue that needs to be addressed urgently. Our research has demonstrated that human placenta-derived mesenchymal stem cells (plaMSCs) facilitate the migration and proliferation of HaCat cells, thereby enhancing diabetic wound healing primarily via the exosomes derived from plaMSCs (plaMSCs-Ex). Using label-free proteomics, plaMSCs and their exosomes were analysed for proteome taxonomic content in order to explore the underlying effective components mechanism of plaMSCs-Ex in diabetic wound healing. Differentially expressed proteins enriched in plaMSCs-Ex were identified and underwent bioinformatics analysis including GO annotation, KEGG pathway enrichment, gene set enrichment analysis (GSEA) and protein-protein interaction analysis (PPI). Results showed that the proteins enriched in plaMSCs-Ex are significantly involved in extracellular matrix organisation, epithelium morphogenesis, cell growth, adhesion, proliferation and angiogenesis. PPI analysis filtered 2 wound healing-related clusters characterised by hub proteins such as POSTN, FN1, SPARC, TIMP1, SERPINE1, LRP1 and multiple collagens. In brief, the exosomal proteins derived from plaMSCs reveal diverse functions of regeneration and tissue remodelling based on proteomics analysis and potentially play a role in diabetic wound healing.

Guidelines for clinical application of tissue matching techniques for kidney transplantation in China

Tissue matching is one of the key factors affecting the success of kidney transplantation and long-term graft survival. At present, the development of tissue matching technology and its application in the laboratory of transplant centers in China is different. In order to promote the standardization of clinical diagnosis and treatment of kidney transplantation tissue matching, the Chinese Transplantation Branch of the Chinese Medical Association, the Kidney Transplantation Branch of the China Medical Care International Exchange Promotion Association, and the Transplantation Technology Branch of the Chinese Medical Biotechnology Association jointly initiated the guidelines for clinical application of tissue matching techniques for kidney transplantation in China. This guide grades the quality of evidence and the strength of recommendation for each clinical issue using the 2009 Oxford Centre for Evidence-Based Medicine Grading and Strength of Recommendation criteria. Aiming at 15 clinical problems related to the laboratory detection technology and clinical application of kidney transplantation tissue matching, a total of 21 recommendations were put forward in line with China's clinical diagnosis and treatment practice, aiming at promoting tissue matching before kidney transplantation, improving the long-term survival time of recipients and transplanted kidneys, and giving play to the application value of precision medicine in the field of kidney transplantation.

Level 1 autism spectrum disorder as a risk factor for suicide in a child: case report

Introduction: Suicidal behavior is one in which the individual has thoughts, plans, and actions with the intention of ending their own life. This is a global public health problem. Recently, autism spectrum disorders have begun to be considered risk factor for suicidal behavior in children and adolescents. Method: Case report. Case presentation: A 12-year-old boy who made a suicide attempt, was admitted to the emergency department at Centro Psíquico da Adolescência e Infância. After a period of irregular treatment, this child made a suicide attempt. As an inpatient, autism spectrum disorder with comorbid depressive disorder was diagnosed after longitudinal and systematic assessments of multidisciplinary team. Treatment was performed according to clinical issues. Discussion: This patient had a form of autism spectrum disorder on which core aspects were not so evident. In this child, there was an overlap between depressive symptoms and symptoms of autism spectrum disorder. Despite social isolation being present, this patient proved capable to disguising his condition using techniques of social and behavioral imitation and camouflage with the aim of adapting to social environment. Conclusion: This study emphasizes the importance of longitudinal evaluation and multidisciplinary assessment to differential diagnosis and appropriate treatment. It also opens a window for further investigations of a possible association between autism spectrum disorders and suicidal behavior in youth.

Renal Transplant Outcomes in Plasma Cell Dyscrasias and AL Amyloidosis after Treatment with Daratumumab.

Background: The morbidity and mortality from AL amyloidosis has significantly improved with the development of novel treatments. Daratumumab is a highly effective treatment for AL amyloidosis, but end-stage kidney disease is a common complication of this condition. Kidney transplantation is the ideal form of renal replacement therapy but has historically been contraindicated in this group of patients. Methods: Given the improved survival and better treatments of both conditions, we argue that it is time to reconsider transplanting these patients. Results: We report our experience of transplanting four patients with AL amyloidosis who had achieved stable remission through treatment with daratumumab. Conclusions: We highlight the key challenges involved and discuss important clinical issues for patients receiving daratumumab, particularly the difficulties with interpreting the crossmatch in light of daratumumab and immunoglobulin therapy interference. We also discuss the complexities involved in balancing the risks of infection, relapse, rejection, and immunosuppression in such patients.

Amantadine for Traumatic Brain Injury-Supporting Evidence and Mode of Action.

Traumatic brain injury (TBI) is an important global clinical issue, requiring not only prevention but also effective treatment. Following TBI, diverse parallel and intertwined pathological mechanisms affecting biochemical, neurochemical, and inflammatory pathways can have a severe impact on the patient's quality of life. The current review summarizes the evidence for the utility of amantadine in TBI in connection to its mechanism of action. Amantadine, the drug combining multiple mechanisms of action, may offer both neuroprotective and neuroactivating effects in TBI patients. Indeed, the use of amantadine in TBI has been encouraged by several clinical practice guidelines/recommendations. Amantadine is also available as an infusion, which may be of particular benefit in unconscious patients with TBI due to immediate delivery to the central nervous system and the possibility of precise dosing. In other situations, orally administered amantadine may be used. There are several questions that remain to be addressed: can amantadine be effective in disorders of consciousness requiring long-term treatment and in combination with drugs approved for the treatment of TBI? Do the observed beneficial effects of amantadine extend to disorders of consciousness due to factors other than TBI? Well-controlled clinical studies are warranted to ultimately confirm its utility in the TBI and provide answers to these questions.

Everyday Clinical Ethics: Essential Skills and Educational Case Scenarios.

Bioethics conjures images of dramatic healthcare challenges, yet everyday clinical ethics issues unfold regularly. Without sufficient ethical awareness and a relevant working skillset, clinicians can feel ill-equipped to respond to the ethical dimensions of everyday care. Bioethicists were interviewed to identify the essential skills associated with everyday clinical ethics and to identify educational case scenarios to illustrate everyday clinical ethics. Individual, semi-structured interviews were conducted with a convenience sample of bioethicists. Bioethicists were asked: (1) What are the essential skills required for everyday clinical ethics? And (2) What are potential educational case scenarios to illustrate and teach everyday clinical ethics? Participant interviews were analyzed using qualitative content analysis. Twenty-five (25) bioethicists completed interviews (64% female; mean 14.76 years bioethics experience; 80% white). Five categories of general skills and three categories of ethics-specific skills essential for everyday clinical ethics were identified. General skills included: (1) Awareness of Core Values and Self-Reflective Capacity; (2) Perspective-Taking and Empathic Presence; (3) Communication and Relational Skills; (4) Cultural Humility and Respect; and (5) Organizational Understanding and Know-How. Ethics-specific skills included: (1) Ethical Awareness; (2) Ethical Knowledge and Literacy; and (3) Ethical Analysis and Interaction. Collectively, these skills comprise a Toolbox of Everyday Clinical Ethics Skills. Educational case scenarios were identified to promote everyday ethics. Bioethicists identified skills essential to everyday clinical ethics. Educational case scenarios were identified for the purpose of promoting proficiency in this domain. Future research could explore the impact of integrating educational case scenarios on clinicians' ethical competencies.

Customer Healthcare Complaints in Brazil Are Seldom about Medical Errors.

This study reviewed different country studies and noted that complaints in Brazil are more concentrated in complaints about being attended to and receiving access to services, rather than about clinical quality and safety issues. This paper explores the possible explanations for these differences based on the institutional logics theory and which logics actors privilege, and how they may play out in the healthcare field. To accomplish this undertaking, this study makes use of the healthcare complaint categorization developed by Reader and colleagues, which has been used by various studies. Next, a set of studies about healthcare complaints in different countries was examined to analyze the issues most common in the complaints and compare this information with the Brazilian data. This study identified three explanations why complaints about medical errors seldom occur. One group of studies highlights the hardships of local health systems. Another focuses on patient behavior. Finally, the third kind focuses on the issue of power to determine health orientation. The studies about a lack of resources do not directly explain why fewer complaints about clinical quality occur, thus helping to stress the management issues. Patient behavior studies indicate that patients may be afraid to point out medical errors or may be unaware of the procedures of how to do so, suggesting that family logic is left out of the decisions in the field. The third group of work highlights the prominence of the medical professional logic, both in terms of regulation and medical exercise.

Plasma metabolomics reveals the shared and distinct metabolic disturbances associated with cardiovascular events in coronary artery disease

Risk prediction for subsequent cardiovascular events remains an unmet clinical issue in patients with coronary artery disease. We aimed to investigate prognostic metabolic biomarkers by considering both shared and distinct metabolic disturbance associated with the composite and individual cardiovascular events. Here, we conducted an untargeted metabolomics analysis for 333 incident cardiovascular events and 333 matched controls. The cardiovascular events were designated as cardiovascular death, myocardial infarction/stroke and heart failure. A total of 23 shared differential metabolites were associated with the composite of cardiovascular events. The majority were middle and long chain acylcarnitines. Distinct metabolic patterns for individual events were revealed, and glycerophospholipids alteration was specific to heart failure. Notably, the addition of metabolites to clinical markers significantly improved heart failure risk prediction. This study highlights the potential significance of plasma metabolites on tailed risk assessment of cardiovascular events, and strengthens the understanding of the heterogenic mechanisms across different events.

Let's not abandon programmed frozen embryo transfers yet: a countercurrent perspective

The countercurrent opinion given in this paper is that the optimal management of frozen embryo transfers (FET) is not a one-size-fits-all matter, but rather one that should be decided after considering all the various parameters and options. This choice should notably encompass patients’ individual characteristics – including variable risks of obstetric complications – and weigh out the respective advantages of each FET option in each case. While there may be real advantages for natural-cycle FET in many cases, these need to be balanced against both practical and clinical issues. Contrary to several prevailing, sometimes loudly expressed suggestions, there is not a one single effective approach when it comes to choosing a mode of scheduling FET.

Prescribing patterns and medications costs in patients on maintenance hemodialysis and peritoneal dialysis.

Polypharmacy is a significant clinical issue for patients on dialysis but has been incompletely studied. We investigated the prevalence and costs of polypharmacy in a population-based cohort of participants treated with hemodialysis (HD) or peritoneal dialysis (PD). We studied adults aged≥20 years in Alberta, Canada receiving maintenance HD or PD as of March 31, 2019. We characterized participants as users of 0-29 drug categories of interest and those aged≥65 as users/non-users of potentially inappropriate medications (PIM). We calculated the number of drug categories, daily pill burden, total annual cost, and annual cost per participant, and compared this to an age- and sex-matched cohort from the general Alberta population. Among 2248 participants (mean age 63 years; 39% female) on HD (n=1781) or PD (n=467), the median number of prescribed drug categories was 6 [interquartile range (IQR) 4, 8]; median daily pill burden was 8.0 (IQR 4.6, 12.6) pills/day, with 5% prescribed≥21.7 pills/day, and 16.5% prescribed≥15 pills/day. Twelve % were prescribed at least one drug that is contraindicated in kidney failure. The median annual per participant cost was ${\$}$3,831, totaling approximately ${\$}$11.6 million annually for all participants. When restricting to the 1063 participants aged≥65, the median number of PIM categories was 2 (IQR 1, 2), with a median PIM pill burden of 1.2 pills/day (IQR 0.5, 2.4). Compared to PD participants, HD participants had similar daily pill burden, higher use of PIM, and higher annual per participant cost. Pill burden and associated costs for participants on dialysis were more than 3-fold and 10-fold higher, respectively, compared to the matched participants from the general population. Participants on dialysis have markedly higher use of prescription medications and associated costs than the general population. Effective methods to de-prescribe in the dialysis population are needed.

Treatment of Anemia Associated with Chronic Kidney Disease: Plea for Considering Physiological Erythropoiesis.

Traditionally, the treatment of anemia associated with chronic kidney disease (CKD) involves prescribing erythropoiesis-stimulating agents (ESAs) or iron preparations. The effectiveness and safety of ESAs and iron have been established. However, several clinical issues, such as hyporesponsiveness to ESAs or defective iron utilization for erythropoiesis, have been demonstrated. Recently, a new class of therapeutics for renal anemia known as hypoxia-inducible factor (HIF)/proline hydroxylase (PH) inhibitors has been developed. Several studies have reported that HIF-PH inhibitors have unique characteristics compared with those of ESAs. In particular, the use of HIF-PH inhibitors may maintain target Hb concentration in patients treated with a high dose of ESAs without increasing the dose. Furthermore, several recent studies have demonstrated that patients with CKD with defective iron utilization for erythropoiesis had a high risk of cardiovascular events or premature death. HIF-PH inhibitors increase iron transport and absorption from the gastrointestinal tract; thus, they may ameliorate defective iron utilization for erythropoiesis in patients with CKD. Conversely, several clinical problems, such as aggravation of thrombotic and embolic complications, diabetic retinal disease, and cancer, have been noted at the time of HIF-PH inhibitor administration. Recently, several pooled analyses of phase III trials have reported the non-inferiority of HIF-PH inhibitors regarding these clinical concerns compared with ESAs. The advantages and issues of anemia treatment by ESAs, iron preparations, and HIF-PH inhibitors must be fully understood. Moreover, patients with anemia and CKD should be treated by providing a physiological erythropoiesis environment that is similar to that of healthy individuals.

What do Australian primary care clinicians need to provide long-acting reversible contraception and early medical abortion? A content analysis of a virtual community of practice

BackgroundUptake of long-acting reversible contraception (LARC) is lower in Australia compared with other high-income countries, and access to early medical abortion (EMA) is variable with only 11% of general practitioners...

Chinese expert consensus on off-label use of Tocilizumab in rheumatic diseases

The interleukin-6 (IL-6) pathway plays a crucial role in various rheumatic diseases. Tocilizumab, a biologic targeting IL-6 receptor, has been widely used in clinical practice, though it's officially approved in China for only three indications. To address clinical challenges associated with the off-label use of tocilizumab in treating rheumatic diseases, the Committee of Chinese Primary Health Care Foundation for Rheumatologists and Immunologists engaged multidisciplinary experts and highlight 12 related clinical issues. We aggregated the drug specifications, the guidelines for clinical management of rheumatic diseases and the evidence from clinical research. Recommendations were formed through voting with the consensus conference method incorporating the Oxford evidence-based medicine criteria to evaluate the strength of evidence and recommendations. We have formulated 10 recommendations for off-label use of tocilizumab related to giant cell arteritis, polymyalgia rheumatica, Takayasu arteritis, systemic sclerosis, adult-onset Still's disease, rheumatoid arthritis, and juvenile idiopathic arthritis. This consensus aims to provide references for the rational use of tocilizumab in clinical practice and enhance pharmacovigilance monitoring.