Risk Of Adverse Events Research Articles

Wait-times Benchmarks for risk-based prioritization in Transcatheter Aortic Valve Implantation: a simulation study.

Demand for transcatheter aortic valve implantation (TAVI) has increased in the last decade, resulting in prolonged wait-times and undesirable health outcomes in many health systems. Risk-based prioritization and wait-times benchmarks can improve equitable access to patients. We used simulation models to follow-up a synthetic population of 50,000 individuals from referral to completion of TAVI. Based on their risk of adverse events, patients could be classified as "low-", "medium-" and "high-risk", and shorter wait-times were assigned for the higher risk groups. We assessed the impacts of the size and wait-times for each risk group on waitlist mortality, hospitalization and urgent TAVIs. All scenarios had the same resource constraints, allowing us to explore the trade-offs between faster access for prioritized patients and deferred access for non-prioritized groups. Increasing the proportion of patients categorized as high-risk, and providing more rapid access to the higher-risk groups achieved the greatest reductions in mortality, hospitalizations and urgent TAVIs (relative reductions of up to 29%, 23% and 38%, respectively). However, this occurs at the expense of excessive wait-times in the non-prioritized low-risk group (up to 25 weeks). We propose wait-times of up to 3 weeks for high-risk patients and 7 weeks for medium-risk patients. Prioritizing higher-risk patients with faster access leads to better health outcomes, however this also results in unacceptably long wait-times for the non-prioritized groups in settings with limited capacity. Decision-makers must be aware of these implications when developing and implementing waitlist prioritization strategies.

Adherence to a Healthy Diet and Risk of Multiple Carotid Atherosclerosis Subtypes: Insights from the China MJ Health Check-Up Cohort.

Early-stage phenotypes of carotid atherosclerosis (CAS), such as increased carotid intima-media thickness (cIMT), and advanced-stage phenotypes, such as carotid plaque (CP), are at risk for adverse ischemic stroke events. There is limited evidence regarding the causal association between dietary patterns and the risk of CAS in Chinese adults. We therefore examined multiple dietary patterns associated with the risk of CAS and identified the optimal dietary pattern for preventing CAS. We analyzed data collected from the prospective MJ Health Check-up Study (2004-2020), including 13,989 participants 18-80 years of age without CAS. The dietary intake was measured using validated food frequency questionnaires, and dietary pattern scores were calculated for four a priori and four a posteriori dietary patterns. The Cox model was used to estimate the adjusted hazard ratios (HRs) relating various dietary pattern scores to the risk of CAS. During 43,903.4 person-years of follow-up, 3732 incidents of increased cIMT and 2861 incident CP events were documented. Overall, the seven dietary patterns, except for the high-protein diet, exhibited significant associations with the risk of increased cIMT and CP. Comparing the highest and lowest quartiles, the a posteriori high-fiber dietary pattern (HFIDP) score demonstrated the strongest inverse associations with the risk of increased cIMT (HR 0.65 [95% confidence interval (CI) 0.59-0.71]) and CP (HR 0.65 [95% CI 0.59-0.73]); conversely, another a posteriori high-fat dietary pattern (HFADP; i.e., incorporating high-fat and processed foods) demonstrated the strongest positive associations with the risk of increased cIMT (HR 1.96 [95% CI 1.75-2.20]) and CP (HR 1.83 [95% CI 1.61-2.08]) (all p for trend < 0.01). Multiple dietary patterns are significantly associated with the risk of early- and advanced-stage phenotypes of CAS. Notably, a high adherence to an HFIDP and low adherence to an HFADP may confer the greatest risk reduction for CAS.

Association of serum resolvin D1 with the risk of major adverse cardiovascular events in hemodialysis patients.

Resolvin D1 (RvD1) inhibits inflammation, reduces oxidative stress, and forecasts the risk of cardiovascular events, but relevant evidence in hemodialysis patients is lacking. This study intended to investigate the predictive value of RvD1 for major adverse cardiovascular events (MACE) risk in hemodialysis patients. Totally, 252 patients who underwent hemodialysis were included. Serum RvD1 was measured by enzyme-linked immunosorbent assay. Patients were followed up with a median of 12.1months. MACE was recorded during the follow-up period. RvD1 was inversely correlated with diabetes history (P = 0.002), cardiac troponin T (TnT) (P = 0.029), and high sensitivity C-reactive protein (hsCRP) (P < 0.001) in hemodialysis patients. 25 hemodialysis patients experienced MACE. RvD1 was reduced in hemodialysis patients with MACE versus those without MACE (P = 0.004). RvD1 exhibited a certain value in forecasting MACE risk, with an area under curve (AUC) of 0.675 [95% confidence interval CI: 0.565-0.786]. Increased RvD1 cut by median (P = 0.043) and cut by quartile (P = 0.042) were related to decreased accumulating MACE in hemodialysis patients. Moreover, RvD1 independently predicted declined MACE risk [odds ratio (OR) = 0.644, P = 0.045], but age (OR = 1.048, P = 0.039) and TnT (OR = 1.006, P = 0.005) independently predicted ascended MACE risk in hemodialysis patients. The combination of these independent factors displayed a good value for estimating MACE risk in hemodialysis patients with an AUC of 0.744 (95% CI: 0.640-0.849). Serum RvD1 is inversely correlated with diabetes history, TnT, and hsCRP in hemodialysis patients. More importantly, it could serve as a potential marker to predict MACE risk in these patients.

Stereotactic Radiosurgery for Residual, Recurrent, and Metastatic Hemangiopericytomas: A Single-Institution Retrospective Experience.

Hemangiopericytomas are infrequent vascular tumors originating from Zimmermann pericytes. The conventional treatment involves gross total resection, followed by adjuvant radiotherapy. Nevertheless, their tendency to infiltrate dural sinuses, high vascularity, and anatomic complexity pose challenges for radical resection, leading to a significant risk of recurrence. Stereotactic radiosurgery (SRS) has emerged as a promising adjuvant therapy to address these challenges. Our study provides the largest single-institutional retrospective, aiming to evaluate the effectiveness and safety of SRS as a treatment modality for residual, recurrent, and metastatic hemangiopericytomas. From 1998 to 2023, 27 patients with 101 tumors underwent CyberKnife SRS at Stanford University Medical Center. The median age was 51 years at the time of treatment. The median follow-up period from SRS was 103 months (range: 6-250). All patients underwent upfront surgical resection. The median tumor volume was 1.5 cc. The median single-fraction equivalent dose was 19 Gy. The SRS was administered at the 76% of the median isodose line (range: 64-89). Of the 101 treated tumors, 24 (23.8%) progressed with a median time to recurrence of 30 months. At 10 years, the rates of local tumor control (LTC), overall survival (OS), and progression-free survival (PFS) were 74.3%, 80.8%, and 67%, respectively. In patients with metastatic lesions, the LTC rates were significantly greater when compared with those with residual or recurrent tumors. There was no significant difference between patients with residual, recurrent, and metastatic hemangiopericytomas in OS and PFS. Notably, no cases of radiation-induced adverse events were detected. SRS leads to excellent LTC, PFS, and OS at 10 years with negligible risk for adverse events. Therefore, it is an effective and safe management modality for patients with residual, recurrent, and metastatic hemangiopericytomas.

Diagnosis and management of peripartum cardiomyopathy and recurrence risk

Peripartum cardiomyopathy (PPCM) is a rare, but serious condition, with a non-negligible risk of adverse events. Several risk factors for PPCM have been individuated over the years, including Afro-American ethnicity, preeclampsia, advanced maternal age, genetic predisposition, multiparity, twin pregnancy, obesity, smoking and diabetes. However, PPCM pathophysiology is still poorly understood, thus making it challenging to develop disease specific therapies. At present, Bromocriptine is the only targeted drug, but further evidence is needed to establish indication and timing of administration. Therefore, these patients are mainly treated following general heart failure guidelines. Even though in most patients left ventricular ejection fraction recovers during follow-up, cases of persistent left ventricular dysfunction are not uncommon. Moreover, all patients detain a certain risk of recurrence after subsequent pregnancies, which is difficult to estimate due to the dearth of long-term prospective data.In this manuscript, we aim to provide an updated review of current evidence about PPCM pathophysiology, diagnosis, treatment and recurrence risk. In addition, we discuss the gaps in knowledge that should be addressed by future research.

Comparison of anesthesia methods for intra-arterial therapy of patients with acute ischemic stroke: an updated meta-analysis and systematic review

ObjectivesCurrently, there remains debate regarding the optimal anesthesia approach for patients undergoing intra-arterial therapy for acute ischemic stroke. Therefore, we conducted a comparative analysis to assess the effects of general anesthesia versus non general anesthesia on patient outcomes.MethodsThe research methodology entailed comprehensive searches of prominent databases such as the Cochrane Library, PubMed, Scopus, and Web of Science, covering the period from January 1, 2010, to March 1, 2024. Data synthesis employed techniques like risk ratio or standardized mean difference, along with 95% confidence intervals. The study protocol was prospectively registered with PROSPERO (CRD42024523079).ResultsA total of 27 trials and 12,875 patients were included in this study. The findings indicated that opting for non-general anesthesia significantly decreased the risk of in-hospital mortality (RR, 1.98; 95% CI: 1.50 to 2.61; p<0.00001; I2 = 20%), as well as mortality within three months post-procedure (RR, 1.24; 95% CI: 1.15 to 1.34; p<0.00001; I2 = 26%), while also leading to a shorter hospitalization duration (SMD, 0.24; 95% CI: 0.15 to 0.33; p<0.00001; I2 = 44%).ConclusionIschemic stroke patients who undergo intra-arterial treatment without general anesthesia have a lower risk of postoperative adverse events and less short-term neurological damage. In routine and non-emergency situations, non-general anesthetic options may be more suitable for intra-arterial treatment, offering greater benefits to patients. In addition to this, the neuroprotective effects of anesthetic drugs should be considered more preoperatively and postoperatively.

Placental Bioenergetics and Antioxidant Homeostasis in Maternal Obesity and Gestational Diabetes.

Maternal obesity has been associated with short- and long-term risks of pregnancy-perinatal adverse events, possibly due to alterations of placental mitochondrial bioenergetics. However, several detrimental mechanisms occurring in the placentas of women with obesity still need to be clarified. Here, we analyzed placental mitochondrial features and oxidative environment of 46 pregnancies in relation to pre-pregnancy BMI. Seventeen Caucasian normal-weight (NW) and twenty-nine women who were obese (OB) were enrolled. The protein expression of mitochondrial CypD and electron transfer chain complexes (C) I-V were measured, as well as ATP production and oxygen consumption rates (OCRs). The protein levels of the pro/anti-oxidant enzymes TXNIP, SOD2, and PON2 were also analyzed. Despite no differences in CypD expression, OCRs were significantly lower in OB vs. NW women. Accordingly, ATP synthase (CV) levels and ATP content were decreased in OB women, positively correlating with placental efficiency, suggesting a link between ATP deficiency and placental dysfunction. SOD2 expression negatively correlated with maternal BMI, indicating a possible impairment of antioxidant defenses with increasing BMI. These changes were worsened in 10 OB women presenting with gestational diabetes mellitus. Overall, these results suggest alterations of placental bioenergetics in pregnancies of women with obesity, possibly leading to placental dysfunction and altered fetal development and programming.

Development and validation of a predictive model for PACU hypotension in elderly patients undergoing sedated gastrointestinal endoscopy

BackgroundHypotension, characterized by abnormally low blood pressure, is a frequently observed adverse event in sedated gastrointestinal endoscopy procedures. Although the examination time is typically short, hypotension during and after gastroscopy procedures is frequently overlooked or remains undetected. This study aimed to construct a risk nomogram for post-anesthesia care unit (PACU) hypotension in elderly patients undergoing sedated gastrointestinal endoscopy.MethodsThis study involved 2919 elderly patients who underwent sedated gastrointestinal endoscopy. A preoperative questionnaire was used to collect data on patient characteristics; intraoperative medication use and adverse events were also recorded. The primary objective of the study was to evaluate the risk of PACU hypotension in these patients. To achieve this, the least absolute shrinkage and selection operator (LASSO) regression analysis method was used to optimize variable selection, involving cyclic coordinate descent with tenfold cross-validation. Subsequently, multivariable logistic regression analysis was applied to build a predictive model using the selected predictors from the LASSO regression. A nomogram was visually developed based on these variables. To validate the model, a calibration plot, receiver operating characteristic (ROC) curve, and decision curve analysis (DCA) were used. Additionally, external validation was conducted to further assess the model’s performance.ResultsThe LASSO regression analysis identified predictors associated with an increased risk of adverse events during surgery: age, duration of preoperative water abstinence, intraoperative mean arterial pressure (MAP) <65 mmHg, decreased systolic blood pressure (SBP), and use of norepinephrine (NE). The constructed model based on these predictors demonstrated moderate predictive ability, with an area under the ROC curve of 0.710 in the training set and 0.778 in the validation set. The DCA indicated that the nomogram had clinical applicability when the risk threshold ranged between 20 and 82%, which was subsequently confirmed in the external validation with a range of 18–92%.ConclusionIncorporating factors such as age, duration of preoperative water abstinence, intraoperative MAP <65 mmHg, decreased SBP, and use of NE in the risk nomogram increased its usefulness for predicting PACU hypotension risk in elderly patient undergoing sedated gastrointestinal endoscopy.

Training and quality indicators in interventional endoscopic ultrasound.

Endoscopic ultrasound (EUS) has transformed the landscape of minimally invasive gastrointestinal procedures, necessitating specialized training for proficiency in interventional EUS (iEUS). This study evaluates the effectiveness of iEUS training, focusing on learning curves, success rates, and the associated risks in various procedures, aiming to recommend practices for standardizing training and ensuring competency. Key metrics such as procedure type, learning curve for proficiency, success rates, and risk of adverse events were analyzed to establish benchmarks for training programs. Proficiency in pancreatic fluid collection drainage was achieved after 20-30 procedures, with a 100% success rate and a complication rate ranging from 1.5 to 80%. Gallbladder drainage required 19 cases to reach an 86% success rate, with adverse events reported in 19% of cases. Choledocoduodenostomy mastery was observed after approximately 100 cases, with postintervention pancreatitis affecting 5.3-6.6% of all cases. Hepaticogastrostomy showed a 93% success rate after 33 cases, with a 24.8% adverse event rate. Hepaticoenterostomy reached 100% success beyond the 40th patient, with a 20% rate of postsurgical strictures. Pancreatic duct drainage achieved 89% technical and 87% clinical success after 27 cases, with 12-15% adverse events. Gastro-enteric anastomosis required 25 cases for proficiency and approximately 40 cases for mastery, with 5.5% immediate and 1% late adverse events. iEUS training outcomes vary significantly across different procedures, highlighting the importance of structured, procedure-specific training programs to achieve proficiency. These findings provide a foundation for developing universal competency benchmarks in iEUS, facilitating consistent and effective training worldwide.

Efficacy and outcomes of BCG Re-vaccination in COVID-19: a systematic review, meta-analysis, and meta-regression of randomized controlled trials

Introduction: The Bacillus Calmette-Guerin (BCG) vaccine has a beneficial “off-target” effect that offers heterologous protection against respiratory tract infections by inducing trained immunity. The need for producing antigen-specific COVID-19 vaccines leads to delays in vaccine administration. Current randomized controlled trials (RCTs) report conflicting data on BCG’s efficacy in COVID-19 infection. Methods: A comprehensive literature search was conducted using major bibliographic databases to identify RCTs evaluating the outcomes of BCG re-vaccination in COVID-19. For dichotomous outcomes, odds ratios (ORs) with 95% confidence intervals (CIs) were pooled using the DerSimonian-Laird random-effects model. Statistical significance was set at P&lt;0.05. Results: 13 RCTs with 13939 participants (7004 in the BCG re-vaccination group and 6935 in the placebo group) were included. BCG re-vaccination did not lead to a statistically significant difference in the incidence of COVID-19 infection [OR: 1.04; 95% CI: 0.91, 1.19; P=0.56], COVID-19-related hospitalizations [OR: 0.81; 95% CI: 0.38, 1.72; P=0.58), ICU admissions [OR: 0.43; 95% CI: 0.13, 1.46; P=0.18], or mortality [OR: 0.67; 95% CI 0.15, 3.04; P=0.60]. For safety outcomes, BCG re-vaccination led to a significant increase in the local injection site complications [OR: 99.79; 95% CI: 31.04, 320.80; P&lt;0.00001], however, the risk of serious adverse events was similar [OR: 1.19; 95% CI: 0.84, 1.67; P=0.33]. Conclusions: BCG re-vaccination does not decrease the incidence of COVID-19 infection, COVID-19-related hospitalizations, ICU admissions, COVID-19-related mortality, and serious adverse events, however, it leads to a rise in local injection site complications. Caution should be exercised when overstating BCG’s efficacy in COVID-19 prevention.

Post-Ischemic Stroke Cardiovascular Risk Prevention and Management.

Cardiac death is the second most common cause of death among patients with acute ischemic stroke (IS), following neurological death resulting directly from acute IS. Risk prediction models and screening tools including electrocardiograms can assess the risk of adverse cardiovascular events after IS. Prolonged heart rate monitoring and early anticoagulation therapy benefit patients with a higher risk of adverse events, especially stroke patients with atrial fibrillation. IS and cardiovascular diseases have similar risk factors which, if optimally managed, may reduce the incidence of recurrent stroke and other major cardiovascular adverse events. Comprehensive risk management emphasizes a healthy lifestyle and medication therapy, especially lipid-lowering, glucose-lowering, and blood pressure-lowering drugs. Although antiplatelet and anticoagulation therapy are preferred to prevent cardiovascular events after IS, a balance between preventing recurrent stroke and secondary bleeding should be maintained. Optimization of early rehabilitation care comprises continuous care across environments thus improving the prognosis of stroke survivors.

Implementation of a Patient Decision Aid for Atrial Fibrillation Ablation Improves Patient Procedural Knowledge but Does Not Impact Perceived Involvement With the Shared Decision-Making Process.

Shared decision-making (SDM) is a method for a patient and physician to cooperatively consider a diagnostic or therapeutic option, ultimately empowering the patient to make an informed decision. Atrial fibrillation (AF) ablation is a procedure that would benefit from SDM given the risk of serious adverse events, the high rate of arrhythmia recurrence, and alternative treatment options. Implementing a patient decision aid (PDA) may help facilitate AF ablation SDM by succinctly conveying important information to patients. Patients scheduled for initial AF catheter ablation were randomized to a virtual SDM visit utilizing a PDA, which covered procedural risks and benefits, or a virtual control visit with a tool outlining periprocedural processes. Preoperatively, patients completed a questionnaire assessing procedural risk and benefit knowledge, as well as perceived involvement with the decision-making process. Unpaired t-tests were used to compare groups. The SDM group scored significantly better overall on knowledge-based questions compared to the control group (69% correct [n=34] vs 53% [n=32]; P=0.00013). In particular, the SDM group was significantly more likely to answer questions correctly about stroke risk (P=0.01), anticoagulation (P=0.01), and potential need for additional procedures (P=0.03 and P=0.03). Perceived involvement in the decision-making process was overall not improved with PDA use (4.7 vs 4.6 out of 5; P=0.72). The addition of a PDA for AF ablation significantly improved procedural knowledge but did not impact patients' perceived involvement in the decision-making process compared to traditional preprocedural discussion alone.

Effect of salt substitute and antihypertensive medications among high cardiovascular risk patients: A sub-study of Salt Substitute and Stroke Study (SSaSS).

The relationship between the differential protective effect of salt substitute between hypertensive and normotensive individuals and the use of cardiovascular medications remains unclear. This study involved 4211 individuals with a history of stroke or hypertension who participated in the Salt Substitute and Stroke Study (SSaSS) from 120 villages in Shanxi Province. The aim of this study was to investigate the differences in major adverse cardiovascular events and blood pressure changes between the salt substitute and the regular salt group in the subgroups of participants taking different antihypertensive medications. Mixed models were employed and adjusted for the cluster effect (village) and potential confounding variables. During the average follow-up period of 4.66 years, a significantly protective effect of salt substitute on reducing the risk of cardiovascular events was observed in the participants who taking antihypertensive medications (rate ratio: 0.81, 95% CI: 0.68 to 0.95. p=0.011), whereas no significant effect in participants not taking antihypertensive medications (rate ratio: 0.91, 95% CI: 0.62 to 1.32, p=0.612). Significant effects to lower systolic blood pressure of the salt substitutes were observed in the participants who took different antihypertensive medications. This study emphasized that the use of salt substitutes might enhance the efficacy of anti-hypertensive medications in lowering blood pressure and reducing the risk of adverse cardiovascular events.

Effects of Exercise-Based Cardiac Rehabilitation on Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

Objective: This study aims to systematically analyze the impact of exercise-based cardiac rehabilitation on patients undergoing percutaneous coronary intervention (PCI). Methods: We searched for original studies on the effect of exercise-based cardiac rehabilitation on patients undergoing PCI published in domestic and foreign databases such as PubMed, Web of Science, Embase, Cochrane Library, China Knowledge Network (CNKI), and VIP until December 2023. Studies retrieved were screened, and meta-analysis was extracted. The quality of the literature was evaluated; meta-analysis was carried out by RevMan5.4 software (Cochrane Collaboration, Oxford, UK). Results: A total of 1073 sufferers undergoing PCI were included in 11 literatures. Meta-analysis displayed that cardiogenic mortality [risk ratio (RR) = 0.23, 95% confidence interval (CI) (0.08, 0.64)], coronary restenosis rate [RR = 0.59, 95% CI (0.41, 0.87)], revascularization rate [RR = 0.58, 95% CI (0.43, 0.79)], incidence of recurrent angina pectoris [RR = 0.41, 95% CI (0.27, 0.62)], and late lumen loss [RR = –0.60, 95% CI (–0.98, –0.23)] in the trial group, were lower than those in the control group (p &lt; 0.05). No significant difference was found in the recurrence rate of myocardial infarction between the test group and the control group [RR = 0.52, 95% CI (0.22, 1.25)]. Conclusion: Exercise-based cardiac rehabilitation therapy can effectively reduce the risk of major adverse cardio-cerebrovascular events, such as cardiogenic death and coronary restenosis after PCI; it reduces the late lumen loss of the stent coronary segment and has no obvious effect on the recurrence of myocardial infarction. However, this therapy tends to reduce the recurrence rate of myocardial infarction.

Asymptomatic Intracranial Artery Stenosis/Occlusion in Heterozygous Familial Hypercholesterolemia: Its Frequency and Implications for Cerebrovascular and Cardiovascular Events.

The atherogenic characteristics of heterozygous familial hypercholesterolemia (HeFH) increase the risk of premature atherosclerotic cardiovascular disease including not only coronary artery disease but ischemic stroke. Asymptomatic intracranial artery stenosis/occlusion (IASO) is a major cause of ischemic stroke, but it has not yet been fully characterized in patients with HeFH. This study analyzed 147 clinically diagnosed subjects with HeFH who underwent magnetic resonance imaging/magnetic resonance angiography imaging for evaluation of IASO (≥50% diameter stenosis). Major adverse cerebrovascular and cardiovascular events (cardiac death, ischemic stroke, and acute coronary syndrome) were compared in patients with HeFH with and without asymptomatic IASO. Asymptomatic IASO was observed in 13.6% of patients with HeFH. The untreated low-density lipoprotein cholesterol level (240±95 versus 244±75 mg/dL; P=0.67) did not differ between the 2 groups. Despite the use of lipid-lowering therapies (statin, P=0.71; high-intensity statin, P=0.81; ezetimibe, P=0.33; proprotein convertase subxilisin/kexin type 9 inhibitor, P=0.39; low-density lipoprotein apheresis, P=0.14), on-treatment low-density lipoprotein cholesterol level in patients with both HeFH and IASO was still suboptimally controlled (97±62 versus 105±50 mg/dL; P=0.17), accompanied by a higher triglyceride level (median, 109 versus 79 mg/dL; P=0.001). During the 12.4-year observational period (interquartile range, 6.2-24.6 years), asymptomatic IASO exhibited a 4.04-fold greater likelihood of experiencing a major adverse cardiovascular event (95% CI, 1.71-9.55; P=0.001) in patients with HeFH. This increased risk of a major adverse cardiovascular event was consistently observed in a multivariate Cox proportional hazards model adjusting clinical characteristics (hazard ratio, 4.32 [95% CI, 1.71-10.9]; P=0.002). A total of 13.6% of Japanese subjects with HeFH presented with asymptomatic IASO. Despite lipid-lowering therapies, patients with both HeFH and IASO more likely had elevated risk of cerebrovascular and cardiovascular events. Our findings highlight asymptomatic IASO as a phenotypic feature of HeFH-related atherosclerosis, which ultimately affects future outcomes.

Characteristics of depression treatment in men with testosterone deficiency

BACKGROUND: Treatment of depression in men with testosterone deficiency is particularly challenging because of the overlap between the symptoms of depression itself and those associated with testosterone deficiency, which requires the development of additional diagnostic and therapeutic approaches. AIM: To enhance the effectiveness of comprehensive treatment of depression in men with testosterone deficiency. MATERIALS AND METHODS: The study involved 140 male participants (aged 18–65 years) diagnosed with depressive episodes and recurrent depressive disorder according to the International Classification of Diseases, 10th revision. Patients were divided into the main group (testosterone levels below 12.1 nmol/l) and the control group (normal testosterone levels). The main group (n=90) was further divided into three therapeutic subgroups of 30 patients each: receiving sertraline monotherapy, testosterone monotherapy, and combined sertraline and testosterone treatment. The control group included men with depression and normal testosterone levels (n=50), who received sertraline only. RESULTS: Depression in men in the context of testosterone deficiency has distinct clinical features, both phenomenologically and syndromally. The severity of the depressive syndrome in men with testosterone deficiency is lower (17.0 [16.0; 18.75] points on the HDRS scale) than in patients with normal testosterone levels (19.0 [18.0; 22.0] points on the HDRS scale), and the depressive episode tends to occur later in life (47.0 [42.0; 55.0] years) compared to those with normal levels of testosterone (29.5 [24.25; 40.0] years) and is less likely to be recurrent than in those with normal testosterone levels (29.5 [24.25; 40.0] years). The study of the efficacy and safety of depression therapy in the context of testosterone deficiency shows that a combined approach to the treatment of depression in men with testosterone deficiency has both advantages (considering the specifics of patients by normalizing testosterone levels and erectile function) and disadvantages (relatively higher risk of adverse events) compared to sertraline monotherapy. CONCLUSION: The identified characteristics of the course and treatment of depression in the context of reduced testosterone levels allowed for the development of a more effective therapeutic and diagnostic algorithm.

Pulsed-field ablation: An alternative ablative method for gastric electrophysiological intervention.

Pulsed-field ablation (PFA) is an emerging ablative technology that has been used successfully to eliminate cardiac arrhythmias. As a non-thermal technique it has significant benefits over traditional radio-frequency ablation with improved target tissue specificity and reduced risk of adverse events during cardiac applications. We investigated whether PFA is safe for use in the stomach and whether it could modulate gastric slow waves. Female weaner pigs were fasted overnight before anesthesia was induced using tiletamine hydrochloride (50 mg mL-1) and zolazepam hydrochloride (50 mg mL-1) and maintained with propofol (Diprivan 2%, 0.2‑0.4 mg kg‑1 min‑1). Pulsed-field ablation was performed on their gastric serosa in vivo. Adjacent point lesions (n=2-4) were used to create a linear injury using bipolar pulsed-field ablation consisting of 40 pulses (10 Hz frequency, 0.1 ms pulse width, 1000 V amplitude). High-resolution electrical mapping defined baseline and post-ablation gastric slow-wave patterns. A validated five-point scale was used to evaluate tissue damage in hematoxylin and eosin stained images. Results indicated that PFA successfully induced complete conduction blocks in all cases, with lesions through the entire thickness of the gastric muscle layers. Consistent post-ablation slow-wave patterns emerged immediately following ablation and persisted over the study period. Pulsed-field ablation induces rapid conduction blocks as a tool to modulate slow-wave patterns, indicating it may be suitable as an alternative to radio-frequency ablation.

Prognostic value of cardiopulmonary exercise test in patients with acute myocardial infarction after percutaneous coronary intervention

To determine the independent risk factors of cardiopulmonary exercise test (CPET) parameters related to adverse prognostic events within 5 years in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI), and establish a prediction model for the occurrence of adverse events within 5 years to provide a reference for cardiac rehabilitation training. From August 2015 to December 2021, patients who underwent PCI for AMI and completed CPET within 1–2 weeks after surgery before discharge from the Department of Cardiovascular Medicine of Zhengzhou Central Hospital Affiliated to Zhengzhou University, Henan Provincial Hospital of Traditional Chinese Medicine, and Anyang District Hospital were selected as participants. Univariate and multivariate analyses were used to screen for independent risk factors associated with 5-year adverse events. Feature importance was interpreted using SHapley Additive exPlanations (SHAP), and a logistic regression model was established for prediction. A receiver operating characteristic (ROC) curve was constructed to evaluate the performance of the prediction model. Calibration was assessed by the Hosmer–Lemeshow test and the calibration curve. In total, 375 patients met the inclusion criteria. Based on whether adverse events occurred during the 5-year follow-up period, the patients were divided into two groups: the event group (n = 53) and the non-event group (n = 322). Peak oxygen uptake (peakVO2), carbon dioxide ventilation equivalent slope (VE/VCO2slop), and peak end-tidal carbon dioxide partial pressure (PETCO2) were three independent risk factors for re-acute myocardial infarction (re-AMI), heart failure (HF), and even death after PCI for AMI (P < 0.05). The SHAP plots demonstrated that the significant contributors to model performance were related to peakVO2, VE/VCO2slop, and PETCO2. The risk of adverse events was significantly reduced when the peakVO2 was ≥ 20 mL/kg/min and the VE/VCO2slop was < 33. The ROC curves of the three models were drawn, including the no-event and event groups, re-AMI group, and HF group, which performed well, with AUC of 0.894, 0.760, and 0.883, respectively. The Hosmer–Lemeshow test showed that the three models were a good fit (P > 0.05). The calibration curve of the three models was close to the ideal diagonal lines. CPET parameters can predict the prognosis of adverse events within 5 years after PCI in patients with AMI and provide a theoretical basis for cardiac rehabilitation training.

Clinical benefits of transarterial chemoembolization combined with tyrosine kinase and immune checkpoint inhibitors for unresectable hepatocellular carcinoma.

Combination therapy has emerged as the focus of research for unresectable hepatocellular carcinoma (HCC). In recent years, several studies have explored the clinical efficacy and safety of the combination therapies of transarterial chemoembolization (TACE) with tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs). To conduct an updated meta-analysis verifying the clinical benefits and adverse effects of the triple combination therapy for unresectable HCC. All eligible cohort, non-randomized controlled, and randomized controlled trial studies from the PubMed, Web of Science, Embase, Cochrane Library, and MedLine databases up to March 20, 2024 were screened for the present meta-analysis. The study endpoints included complete response (CR), objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs). Stata 16/18 software was used for this meta-analysis, and a P value of <0.05 was considered statistically significant. A total of 29 studies with 1754 patients were included. Among the patients who received the TACE therapy with TKIs and ICIs, the tumor response results revealed a pooled CR, ORR, and DCR of 14% [95%CI (0.11-0.18)], 61% [95%CI (0.55-0.66)], and 85% [95%CI (0.83-0.87)], respectively. In terms of the survival outcomes, the pooled median PFS and OS were 10.25 months [95%CI (9.31-11.18)] and 20.47 months [95%CI (18.98-21.97)], respectively. The pooled prevalence of all-grade AEs during the triple treatment was 90% [95%CI (0.84-0.94)] and that of grade ≥ 3 AEs was 32% [95%CI (0.24-0.42)]. The combination therapy of TACE, TKIs, and ICIs exhibits great clinical benefits for unresectable HCC in terms of tumor responses and survival outcomes without increasing the risk of severe AEs.

Pituitary Complications of Checkpoint Inhibitor Use.

Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy but are associated with a risk of endocrine immune-related adverse events (irAEs), including pituitary complications. Autoimmune hypophysitis, traditionally a rare diagnosis, has become a more frequently encountered clinical entity with the emergence of antitumor immunotherapy. This mini-review aims to consolidate current knowledge, encompassing the epidemiology, pathophysiology, clinical presentation, diagnosis, and management of pituitary complications of ICI use.