Higher Risk Of Adverse Events Research Articles

Adverse events following transcatheter aortic valve implantation (TAVI) in patients with amyloidosis: observations from a global federated network

Abstract Background A high proportion of patients with aortic stenosis are affected by cardiac amyloidosis, but there is a paucity of data describing the effect of amyloidosis on the clinical course of patients who underwent transcatheter aortic valve implantation (TAVI). Purpose To assess the one-year risk of adverse events following TAVI in patients with amyloidosis. Methods Retrospective study using data from a large multinational electronic health record network (TriNetX). Patients aged 18 years or older who underwent TAVI between 2005 and 2022 were included in the analysis. The patients were categorised in two groups based on the presence of amyloidosis (ICD-10-cm code E85). Primary outcome was the one-year risk of the composite of emergency department (ED) admission, acute heart failure (HF), stroke, conduction system disease, pacemaker (PM) implantation, acute kidney injury, and all-cause death. Secondary outcomes were the risks for each component of the composite outcome. We used Cox regression analysis to calculate hazard ratio (HR) and 95% confidence interval (CI) after propensity score matching (PSM) 1:1. Results We identified 477 TAVI recipients with a diagnosis of amyloidosis (age 78.6±8.1 years, 31.4% females) and 43,379 TAVI patients without a diagnosis of amyloidosis (78.1±8.8, 40.2% females). Before PSM, patients affected by amyloidosis were more likely to be Black or African American and had a higher prevalence of cardiovascular risk factors compared to TAVI patients without amyloidosis. After PSM, patients with a diagnosis of amyloidosis showed a higher one-year risk of composite outcome (HR 1.28, 95%CI 1.10-1.49) compared to those who underwent TAVI without amyloidosis. Regarding secondary outcomes, amyloidosis patients had a higher risk of ED admission (HR 1.41, 95%CI 1.13-1.75), acute HF (HR 1.56, 1.23-1.99), stroke (HR 1.55, 1.04-2.32), conduction system disease (HR 1.27, 1.04-1.55), PM implantation (HR 1.55, 1.06-2.28), but not acute kidney injury (HR 1.11, 0.84-1.48) and all-cause death (HR 0.98, 0.66-1.45). Conclusion Among patients undergoing TAVI, those affected by amyloidosis are at higher risk of adverse events in the first year after TAVI. More studies are needed to define the exact role of amyloid fibrils in structural valve deterioration and to elucidate whether subtypes of amyloidosis have a different impact on patients’ outcomes following TAVI.Risk of composite outcome following TAVI

Machine-learning based calculator for personalized risk following ST-elevation myocardial infarction

Abstract Background Despite recent advancements in the management of patients with ST-elevation myocardial infarction (STEMI), a high risk for adverse events remains during the first year following the event. There are several risk scores which estimate the risk of major adverse cardiac events (MACE) following STEMI. However, the most established risk scores are not contemporary, their diagnostic accuracy ranges across populations, and they are far from being personalized. Purpose We aimed to develop a machine learning (ML)-based calculator to provide patients and physicians with a personalized prognostic tool based on modern-world data to determine outcomes for patients following STEMI. Our goal was to predict mortality within 1-year post-STEMI and contribute personalized recommendations to reduce the risk of events. Additionally, we aimed to have the calculator provide a personalized risk assessment for each independent variable. Methods We included patients from two large tertiary care centers in Israel and Italy. 2888 patients who suffered STEMI between the years of 2000 – 2020 were included in our training model. Our calculator leveraged CatBoost for supervised machine learning, utilizing gradient boosting on decision trees. The model was subsequently tested on 321 patients from the Israeli center and 132 patients from the Italian center. Results The calculator was able to accurately predict 1-year mortality (96.5% accuracy, ROC 0.97 in the Israeli center and 93.2% accuracy, ROC 0.89 in the Italian center). In the full cohort, left ventricular ejection fraction (LVEF) post-STEMI demonstrated the strongest contribution towards predicted outcome with a mean Shapley value (SHAP) of 0.978, with lower EFs correlating to higher likelihood of one-year mortality (figures 1 and 2). Other strong contributing factors were identified, including glomerular filtration rate (GFR), age, and Killip classification, with mean SHAPs of 0.580, 0.571, and 0.563, respectively. Importantly, the algorithm was designed to also output a personalized assessment of risk for each patient based on their individual variables. Conclusion ML-derived STEMI calculators can determine which risk factors and variables provide highest predictive value in determining outcomes in a personalized manner. They can be leveraged for high-accuracy prognostication and provide guidance for physicians and patients after STEMI.

Clinical characteristics and outcomes of patients with takotsubo syndrome and dynamic left ventricular outflow tract obstruction

Abstract Background Left ventricular outflow tract obstruction (LVOTO) is recognized as a serious complication of Takotsubo syndrome (TTS). However, its impact on patient prognosis remains insufficiently investigated. Purpose This study aimed to assess clinical characteristics and short- and long-term outcomes of patients with TTS complicated by LVOTO. Methods Patients with TTS were enrolled from the Takotsubo Italian Network (TIN). The primary outcome was the composite of acute heart failure, cardiogenic shock, and mortality during hospitalization. Secondary outcomes included the single components of the primary outcome and the occurrence of death or TTS recurrence during follow-up. Results Overall, 881 patients were included in the study [median age 72.0 (63.0–78.0) years; 91.3% female], with LVOTO detected in 59 patients (6.7%). Low diastolic blood pressure, ST-segment elevation, and moderate-to-severe mitral regurgitation were independently associated with occurrence of LVOTO. Propensity score weighting regression analysis revealed a significant higher risk of the primary outcome (OR, 2.99; 95% CI, 2.22–4.02), acute heart failure (OR, 2.19; 95% CI, 1.59–3.02), cardiogenic shock (OR, 4.56; 95% CI, 3.07–6.78), and in-hospital mortality (OR, 2.42; 95% CI, 1.13–5.21) in patients with TTS complicated by LVOTO. No significant association between LVOTO and long-term mortality or TTS recurrence was observed during follow-up. Conclusions In this real-world evidence study, LVOTO was detected in about 7% of TTS patients and was associated with a significantly higher risk of adverse events during hospitalization, including mortality. Early detection of LVOTO can aid in prognostic assessment and guide therapeutic management in patients with TTS.

Clinical phenotypes in relation to outcomes in heart failure patients with cardiac resynchronization therapy and defibrillators (CRT-D): an unsupervised cluster analysis

Abstract Background Patients with heart failure undergoing CRT are an heterogenous and complex population. Selecting patients before implantation is essential to obtain a favorable response to CRT-D. Data-driven cluster analysis may be an approach to identify different patients’ phenotypic categories. Purpose To identify different clusters of patients with CRT-D who share similar clinical phenotypes, and to evaluate the associations between clusters and clinical outcomes, using cluster analysis. Methods Three agglomerative hierarchical cluster analysis were performed in CRT-D patients seen between 2010 and 2019 in French hospitals. Associations between clusters and death at one year and death during whole follow-up (FU) were evaluated using Cox regression analyses. Results The study included 23,029 CRT-D patients with no prior history of VT/VF/cardiac arrest (mean age 67.7 ± 9.9 years; 78.8 % male), who were analyzed in relation to 3 ways, as follows: the first group was a 50% random sample of all patients (n = 11,514), the second group included patients dead at 1 year (n = 1,604) and the third group included those alive at 3 years FU (n = 14,228). A cluster analysis was performed on each group. Four clusters were identified in the first group: Cluster 1 identified young patients with dilated cardiomyopathy and low prevalence of coronary artery disease (CAD), cardiovascular (CV) risk factors and comorbidities (chronic kidney disease, lung and liver disease) (low-risk phenotype); Cluster 2 was composed of male patients with CAD but low burden of CV risk factors and comorbidities (CAD phenotype); Cluster 3 included CRT recipients with several CV risk factors but low prevalence of comorbidities (CV risk factors phenotype); Cluster 4 identified old patients with high prevalence of CAD, atrial fibrillation, CV risk factors and comorbidities (clinical complex phenotype). These phenotypes were maintained in the other two groups (dead at 1 year and alive at 3 years FU), with the highest consistency for low-risk and high-risk phenotypes(Cluster 1 and 4 respectively). Compared with Cluster 1, Clusters 2, 3 and 4 were independently associated with an increased risk of all-cause death at 1-year FU and during the whole FU (Cluster 2: HR 1.21, 95% CI 1.08 - 1.36; Cluster 3: HR 1.15, 95%CI 1.04 - 1.26; and Cluster 4: HR 1.79, 95%CI 1.65 - 1.96). There were high prevalences of CAD, atrial fibrillation, mitral regurgitation, and comorbidities (which are all predictors of CRT-nonresponse) not only in Cluster 4 at baseline, but also among patients who died at 1-year FU in all 4 clusters. Conclusion Cluster analysis identified four statistically driven groups of CRT recipients, with specific clinical phenotypes and associated with different risks for all-cause death. Identifying those patients at higher risk of adverse events might help in the selection of patients with heart failure undergoing CRT-D implantation, especially in relation to CRT-nonresponse.Risk of all-cause death in 4 clusters

Left ventricular apical aneurysms and outcomes in hypertrophic cardiomyopathy

Abstract Background/Introduction The presence of left ventricular apical aneurysm (LVAA) has been shown to be associated with increased risk of adverse events in patients with hypertrophic cardiomyopathy (HCM). However, the between LVAA size and outcomes is uncertain. Purpose To explore associations between baseline LVAA diameter and progressive changes in LVAA size over time and poor outcomes in HCM patients. Methods Our HCM multimodality imaging database (transthoracic echocardiography (TTE) or cardiac magnetic resonance (CMR)) was retrospectively assessed for studies reporting LVAA, defined as one or more akinetic or dyskinetic apical segments. LVAA size (widest systolic diameter in millimetres in the transverse plane) was recorded at two time points: earliest identification and most recent imaging, with LVAA size progression (mm/year) calculated. Patients’ electronic records were reviewed for composite outcome including stroke, apical thrombus, death, and appropriate therapy from implantable cardioverter defibrillator (ICD). Continuous variables are presented as mean ± standard deviation (SD), categorical data numerically or as percentages. Comparisons between groups were made using Wilcoxon ranks sum and Fischer exact test for continuous and binary variables, respectively. Cox regression was used to assess independent associations with composite outcomes. A p value of <0.05 was considered statistically significant. Results A total of 106 patients were identified with LVAA and clinical follow-up (mean age 64.7±11.4 years, 70% male). Mean follow-up duration was 6.5±3.0 years. Baseline LVAA was confirmed by CMR and TTE in 70 and 30% of cases respectively. Mean LVAA size at baseline was 16.2±7.6 mm (range 6-56 mm). During multivariate Cox analysis, baseline LVAA size in mm was independently associated with the composite outcome (HR 1.04, 95% CIs 1.0 to 1.08, p=0.04). Mean duration between baseline and maximal LVAA size scan was 5.4±3.0 years. Median progression in LVAA size was 1.0 (IQR 0.6 to 1.8) mm per annum (range 0.0 to 8.1 mm). During multivariate analysis, LVAA progression rate in mm per year was independently associated with the composite outcome (HR 1.4 95% CIs 1.11 to 1.7, p=0.002). Conclusion(s) These data support the association between LVAA size and poor outcomes in HCM patients. We also demonstrate the progressive nature of LVAAs and indicate those more rapidly increasing in size are at highest risk of adverse events, with potential implications for management strategies.

Safety and efficacy of sertraline in depression among adults undergoing dialysis: A systematic review and meta-analysis

Background: Depression is prevalent among patients with end-stage renal disease (ESRD) undergoing dialysis, with significant implications for their quality of life and treatment compliance. Traditional treatments for depression, including various therapies and pharmacological interventions, have limitations due to their adverse effects. Sertraline, a selective serotonin re-uptake inhibitor (SSRI), offers a promising alternative, but its efficacy and safety in this population require thorough evaluation. Objective: This meta-analysis aims to assess the effectiveness and adverse effects of sertraline in treating depressive episodes in dialysis patients compared to placebo. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a comprehensive search of databases, including PubMed, Cochrane Library, and Science Direct, up to June 20, 2024. We included randomized controlled trials (RCTs) that compared sertraline with placebo in dialysis patients with depression. Two researchers independently performed data extraction and risk of bias assessment. Statistical analysis was conducted using ReviewManager 5.4.1, employing a random effects model. Results: Four RCTs involving 468 participants were included. Sertraline significantly reduced depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS) and Beck Depression Inventory-II (BDI-II) scores, at 6 and 12 weeks compared to placebo. Improvements in kidney disease-specific quality of life (KDQOL-36) scores were also noted. However, sertraline was associated with a higher risk of adverse events compared to placebo. Conclusions: Sertraline effectively reduces depressive symptoms and improves the quality of life in dialysis patients with ESRD. Despite the increased risk of adverse events, the overall benefits make sertraline a viable treatment option for this population. Larger, more comprehensive studies are needed to confirm these findings and optimize sertraline use in clinical practice.

Extracorporeal membrane oxygenation in critically ill patients with active hematologic and non-hematologic malignancy: a literature review

Combined progress in oncology and critical care medicine has led to new aspirations and discussions in advanced life support modalities in the intensive care unit. Over the last decade, extracorporeal membrane oxygenation, previously considered unsuitable for oncologic patients, has become increasingly popular, with more diverse applications. Nevertheless, mortality remains high in critically ill cancer patients, and eligibility for extracorporeal membrane oxygenation can be extremely challenging. This scenario is even more difficult due to the uncertain prognosis regarding the underlying malignancy, the increased rate of infections related to intensive care unit admission, and the high risk of adverse events during extracorporeal membrane oxygenation support. With advances in technology and better management involving extracorporeal membrane oxygenation, new data on clinical outcomes can be found. Therefore, this review article evaluates the indicators for extracorporeal membrane oxygenation in different types of oncology patients and the possible subgroups that could benefit from it. Furthermore, we highlight the prognosis, the risk factors for complications during this support, and the importance of decision-making based on a multidisciplinary team in the extracorporeal membrane oxygenation indication.

Implementing geriatric assessment for dose optimization of CDK4/6 inhibitors in older breast cancer patients.

Current evidence from both randomized trials and real-world studies suggests that older patients with advanced hormone receptor-positive/HER2-negative (HR+/HER2) breast cancer derive clinical benefit from the addition of CDK4/6 inhibitors to endocrine therapy. However, a higher risk for adverse events due to CDK4/6 inhibitors among older patients is evident, leading to a trend of initiating CDK4/6 inhibitors at lower dose in clinical practice, though without evidence. The aim of the IMPORTANT-trial, a pragmatic, multinational, open-label, partly decentralized randomized trial is to investigate whether lower starting dose of CDK4/6 inhibitors combined with endocrine therapy is comparable to full dose in older (≥70years old) patients with advanced HR+/HER2- breast cancer who are assessed as vulnerable or frail based on comprehensive geriatric assessment.Clinical Trial Registration: NCT06044623 (ClinicalTrials.gov); Registration date: 13 September 2023.

Efficacy of Bile Acid Sequestrants in the Treatment of Bile Acid Diarrhea: A Meta-Analysis of Randomized Controlled Trials.

Bile acid sequestrants (BASs) have often been used for bile acid diarrhea (BAD) but carry a high risk of adverse events. New generations of BASs show promising results; however, their efficacy remains unclear. This systematic review and meta-analysis was conducted using PubMed, Cochrane, and Embase to assess randomized controlled trials (RCTs) published up to November 2023 to retrieve studies that measured the parameters before and after the administration of BASs. The outcomes assessed were cessation or improvement in diarrhea, fecal consistency, abdominal cramping, frequency of diarrhea, and adverse events. Risk ratios (RRs) and mean differences with 95% confidence intervals (CIs) were pooled using a random-effects model. Statistical analyses were conducted using RStudio version 4.1.2. The protocol was prospectively registered with PROSPERO (CRD42023445444). Seven RCTs with a total of 311 patients were included, of which 168 (54%) were randomized to BASs. Among BAS-treated patients, 101 (60.1%) received colesevelam, 40 (23.8%) received chenodeoxycholate, 18 (10.7%) received cholestyramine, and 9 (5.3%) received colestid. BASs were associated with a significant improvement in the cessation of diarrhea (RR 3.27; 95% CI 2.08 to 5.15; P ≤ .05) and liquid stool to normal fecal consistency (RR 2.69; 95% CI 1.56 to 4.65; P ≤ .05), as well as an increase in abdominal cramps (RR 5.27; 95% CI 1.21 to 22.93; P ≤ .05). There were no differences in urgency, adverse events, or nausea between groups. These findings indicate that BASs are effective in the treatment of BAD, as indicated by the improvement or cessation of diarrhea episodes.

Minimalist approach to left atrial appendage occlusion through three-dimensional intracardiac echocardiography: Procedural steps and single-center experience

Atrial fibrillation (AF), the most prevalent arrhythmia worldwide, is associated with an annual risk of ischemic stroke of up to 5%, with approximately 98% of thrombi originating from the left atrial appendage (LAA). Direct oral anticoagulants or vitamin K antagonists remain the gold standard for preventing systemic thromboembolism in patients with AF. LAA occlusion (LAAO) is an alternative stroke prevention technique for patients with AF who cannot tolerate long-term anticoagulation. Percutaneous LAAO typically employs a multimodal imaging approach with contrast fluoroscopy and transesophageal echocardiography (TEE) for visualization, device selection and deployment, and complication monitoring. TEE is also used for follow-up imaging. However, it necessitates general anesthesia or deep sedation and is associated with a high risk of adverse events. Three-dimensional intracardiac echocardiography (3D ICE) has been proposed as a viable alternative to TEE for LAAO procedures. In this review, we summarized the current evidence regarding ICE guidance in LAAO procedures. We also presented a case series of consecutive patients presenting at our center who underwent LAAO, which was performed by a single operator using a minimalist approach of moderate sedation, 3D ICE, and same-day discharge. We also presented a summary of the minimalist approach to LAAO using 3D ICE and detailed procedural steps of 3D ICE catheter manipulation for successful LAAO intervention.

Development and validation of a prediction model for people with mild chronic kidney disease in Japanese individuals

BackgroundChronic kidney disease (CKD) poses significant health risks due to its asymptomatic nature in early stages and its association with increased cardiovascular and kidney events. Early detection and management are critical for improving outcomes.ObjectiveThis study aimed to develop and validate a prediction model for hospitalization for ischemic heart disease (IHD) or cerebrovascular disease (CVD) and major kidney events in Japanese individuals with mild CKD using readily available health check and prescription data.MethodsA retrospective cohort study was conducted using data from approximately 850,000 individuals in the PREVENT Inc. database, collected between April 2013 and April 2023. Cox proportional hazard regression models were utilized to derive and validate risk scores for hospitalization for IHD/CVD and major kidney events, incorporating traditional risk factors and CKD-specific variables. Model performance was assessed using the concordance index (c-index) and 5-fold cross-validation.ResultsA total of 40,351 individuals were included. Key predictors included age, sex, diabetes, hypertension, and lipid levels for hospitalization for IHD/CVD and major kidney events. Age significantly increased the risk score for both hospitalization for IHD/CVD and major kidney events. The baseline 5-year survival rates are 0.99 for hospitalization for IHD/CVD and major kidney events are 0.99. The developed risk models demonstrated predictive ability, with mean c-indexes of 0.75 for hospitalization for IHD/CVD and 0.69 for major kidney events.ConclusionsThis prediction model offers a practical tool for early identification of Japanese individuals with mild CKD at risk for hospitalization for IHD/CVD and major kidney events, facilitating timely interventions to improve patient outcomes and reduce healthcare costs. The models stratified patients into risk categories, enabling identification of those at higher risk for adverse events. Further clinical validation is required.

Assessment of safety profile of ivabradine in real-world scenario using FDA adverse event reporting system database

ABSTRACT Background Ivabradine is primarily indicated for patients with sinus rhythm and a heart rate ≥ 75 beats/min, who have NYHA class II-IV chronic heart failure with systolic dysfunction. There is currently a lack of large-scale, real-world studies concerning its drug adverse reactions. Research design & methods This research assesses the side effects of ivabradine by analyzing reports of adverse events (AEs) from the FDA’s Adverse Event Reporting System (FAERS) database. To evaluate the importance of these AEs, four sequential analytic strategies were utilized. Results In total, 2,701 ivabradine-related AE reports were identified in the FAERS database. We identified 26 ivabradine-induced AEs, each with more than 20 reports, including some significant AEs not mentioned on the product label. The timing of AEs was also analyzed, with the majority of AEs occurring within the first month of ivabradine use. Gender-specific analysis indicates that female have a higher risk of AEs, such as off-label use, tachycardia, drug effectiveness for unapproved indications, and rash compared to male. Conclusion This study provides important information for maximizing the usage of ivabradine, increasing its efficacy, and reducing any possible negative effects. The actual clinical use of the medication will be greatly aided by this knowledge.

Impacto de la natriuresis en el empeoramiento de la función renal durante un episodio de insuficiencia cardiaca aguda

Introduction and objectives: Worsening renal function (WRF) is a frequent complication in acute heart failure (AHF) with a controversial prognostic value. We aimed to study the usefulness of natriuresis to evaluate WRF.Methods: We conducted an observational, prospective, multicenter study of patients with AHF who underwent a furosemide stress test. The patients were classified according to whether WRF was present or absent and according to the median natriuretic response. The main endpoint was the combination of mortality, rehospitalization due to HF, and heart transplant at 6 months of follow-up.Results: One hundred and fifty-six patients were enrolled, and WRF occurred in 60 (38,5%). The patients were divided into 4 groups: a) 47 (30,1%) no WRF/low UNa (UNa ≤ 109 mEq/L); b) 49 (31,4%) no WRF/high UNa (UNa > 109 mEq/L); c) 31 (19,9%) WRF/low UNa and d) 29 (18,6%) WRF/high UNa. The parameters of the WRF/low UNa group showed higher clinical severity and worse diuretic and decongestive response. The development of WRF was associated with a higher risk of the combined event (HR, 1.88; 95%CI, 1.01-3.50; P = 0,046). When stratified by natriuretic response, WRF was associated with an increased risk of adverse events in patients with low natriuresis (HR, 2.28; 95%CI, 1.15-4.53; P = 0,019), but not in those with high natriuresis (HR, 1.18; 95%CI, 0.26-5.29; P = 0,826).Conclusions: Natriuresis could be a useful biomarker for interpreting and prognosticating WRF in AHF. WRF is associated with a higher risk of adverse events only in the context of low natriuresis.

Optimal Trough Concentration of Tacrolimus in Pediatric Patients With Primary Nephrotic Syndrome.

The trough concentration (C0) of tacrolimus in children with nephrotic syndrome (NS) has rarely been explored, so its target level was based on transplant research. This study aimed to determine the optimal tacrolimus C0 in NS children. Data from primary NS children treated with tacrolimus at Wuhan Children's Hospital in the last 10 years were retrospectively collected. According to the cutoff C0 analyzed by receiver-operator characteristics (ROC) analysis, patients were divided into very low- (< 4 ng/mL), low- (4-5 ng/mL), medium- (5-7 ng/mL), and high-concentration (7-10 ng/mL) groups. A total of 196 patients were enrolled for primary outcome analysis. Compared to medium-concentration group, only the very low-concentration group obtained significant inferior primary outcomes, including overall remission rate, relapse-free survival rate, and relapse rate at 6 months. For secondary outcomes, the very low-concentration group experienced more frequent treatment failure in 12 months, whereas the high-concentration group suffered a higher risk of adverse events than the medium-concentration group. For steroid-resistant NS, very low- and low-concentration groups required longer time to achieve remission compared to medium-concentration group. For steroid-sensitive NS, the very low-concentration group suffered a higher relapse frequency than medium-concentration group. Lastly, the dose of tacrolimus required for children with different CYP3A5 genotypes with or without Wuzhi capsules was analyzed. In conclusion, tacrolimus may be targeted to C0 of 4-7 ng/mL during the first 6 months in children with NS. For steroid-resistant NS, C0 of 5-7 ng/mL can achieve a rapid remission.

Feasibility of totally implantable venous access ports in the upper arm for patients with head and neck cancer in the modern era of chemotherapy.

With recent developments in chemotherapy, the prognosis of head and neck cancer patients has been prolonged, and it is expected that totally implantable venous access devices will be developed for use as feasible and safe chemotherapy routes. We investigated the feasibility of implanting totally implantable venous access ports in the upper arms of head and neck cancer patients in this modern era of chemotherapy. Relevant data of a cohort of 210 patients with head and neck cancer who had had totally implantable venous access devices implanted between January 2013 and December 2022 were investigated retrospectively. The totally implantable venous access ports were used for chemoradiotherapy, chemotherapy, radiotherapy, and palliative treatment. Adverse events related to totally implantable venous access devices were investigated and the associated variables subjected to statistical analysis. There were 22 (10.5%) adverse events, representing 0.201 adverse events per 1000 catheter days. Non-ultrasound-guided puncture (p = 0.015) and forearm implantation (p = 0.005) were associated with higher risk of adverse events according to univariate analysis. According to multiple logistic analysis, non-ultrasound-guided puncture was significantly associated with age and sex (OR = 2.89; 95% CI, 1.14, 7.36; p = 0.026). Peripherally implanted totally implantable venous access devices in the upper arm are feasible and safe for head and neck cancer patients. Ultrasound-guided implantation of totally implantable venous access ports into the upper arms of head and neck cancer patients may reduce the adverse event rate.

Medication Burden and Adverse Cardiovascular Events and Death in Patients Treated with Maintenance Hemodialysis

Key Points A higher medication burden was associated with a higher risk of adverse events in patients receiving maintenance hemodialysis.Medication burden can serve as a clinically relevant risk indicator for cardiovascular events and all-cause death in patients on maintenance hemodialysis. Background A high medication burden is associated with adverse outcomes. Although patients with ESKD have a substantial medication burden, the relationship between the number of medications in use and clinical outcomes in these patients remains unclear. Hence, this study aimed to investigate the prognostic implications of medication burden regarding adverse outcomes in patients with ESKD on maintenance hemodialysis. Methods We analyzed 29,690 patients receiving maintenance hemodialysis who participated in the Periodic Hemodialysis Quality Assessment conducted by the Health Insurance Review and Assessment Service. The exposure of interest was the number of routinely prescribed oral medications. The main outcome was a composite of nonfatal cardiovascular events (nonfatal myocardial infarction, coronary revascularization, nonfatal stroke, or hospitalization for heart failure) or all-cause death (major adverse cardiac and cerebrovascular events [MACCEs]). The secondary outcomes were the individual components of the primary outcome. Results During a follow-up period of 146,749 person-years (median, 6.0 years), MACCEs occurred in 17,573 patients (59.2%). Higher medication burden was associated with progressively higher incidence of MACCEs (84.7, 107.2, 130.2, and 168.9 events per 1000 person-years in Q1–Q4, respectively). In a multivariable Cox proportional hazard model, the adjusted hazard ratios (95% confidence intervals) for the second, third, and highest quartiles were 1.05 (1.00 to 1.10), 1.12 (1.07 to 1.17), and 1.27 (1.21 to 1.33), respectively, compared with the lowest quartile. In continuous modeling, each increase in the number of medication was associated with a 1.03-fold (95% confidence interval, 1.03 to 1.04) higher risk of the primary outcome. Conclusion A high medication burden was independently associated with higher risk of adverse cardiovascular outcomes and all-cause death in patients receiving maintenance hemodialysis. These findings suggest that a high medication burden could be a useful indicator of adverse clinical outcomes in patients undergoing hemodialysis.

Clozapine, relapse, and adverse events: a 10-year electronic cohort study in Canada.

Clozapine is the most effective medication for treatment-resistant psychoses, but the balance of benefits and risks is understudied in real-world settings. To examine the relative re-hospitalisation rates for mental health relapse and adverse events associated with clozapine and other antipsychotics in adult and child/youth cohorts. Data were obtained from the Canadian Institute of Health Information for adults (n = 45 616) and children/youth (n = 1476) initially hospitalised for mental health conditions in British Columbia, Manitoba and Saskatchewan from 2008 to 2018. Patient demographics and hospitalisations were linked with antipsychotic prescriptions dispensed following the initial visit. Recurrent events survival analysis for relapse and adverse events were created and compared between clozapine and other antipsychotics. In adults, clozapine was associated with a 14% lower relapse rate versus other drugs (adjusted hazard ratio: 0.86, 95% CI: 0.83-0.90) over the 10-year follow-up. In the first 21 months, the relapse rate was higher for clozapine but then reversed. Over 1000 person-months, clozapine-treated adults could be expected to have 38 relapse hospitalisations compared with 45 for other drugs. In children/youth, clozapine had a 38% lower relapse rate compared with other antipsychotic medications (adjusted hazard ratio: 0.62, 95% CI: 0.49-0.78) over the follow-up period. This equates to 29 hospitalisations for clozapine and 48 for other drugs over 1000 person-months. In adults, clozapine had a higher risk for adverse events (hazard ratio: 1.34, 95% CI: 1.18-1.54) over the entire follow-up compared with other antipsychotics. This equates to 1.77 and 1.30 hospitalisations over 1000 person-months for clozapine and other drugs, respectively. Clozapine was associated with lower relapse overall, but this was accompanied by higher adverse events for adults. For children/youth, clozapine was associated with lower relapse all throughout and had no difference in adverse events compared with other antipsychotics.

Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2.

In critically ill patients, endotracheal intubation (ETI) is lifesaving but carries a high risk of adverse events, notably hypoxemia. Preoxygenation is performed before introducing the tube to increase the safe apnea time. Oxygenation is monitored by pulse oximeter measurement of peripheral oxygen saturation (SpO2). However, SpO2 is unreliable at the high oxygenation levels produced by preoxygenation and, in the event of desaturation, may not decrease sufficiently early to allow preventive measures. The oxygen reserve index (ORI) is a dimensionless parameter that can also be measured continuously by a fingertip monitor and reflects oxygenation in the moderate hyperoxia range. The ORI ranges from 0 to 1 when arterial oxygen saturation (PaO2) varies between 100 to 200 mmHg, as occurs during preoxygenation. No trial has assessed the potential effects of ORI monitoring to guide preoxygenation for ETI in unstable patients. We designed a multicenter, two-arm, parallel-group, randomized, superiority, open trial in 950 critically ill adults requiring ETI. The intervention consists in monitoring ORI values and using an ORI target for preoxygenation of at least 0.6 for at least 1 minute. In the control group, preoxygenation is guided by SpO2 values recorded by a standard pulse oximeter, according to the standard of care, the goal being to obtain 100% SpO2 during preoxygenation, which lasts at least 3 minutes. The standard-of-care ETI technique is used in both arms. Baseline parameters, rapid-sequence induction medications, ETI devices, and physiological data are recorded. The primary outcome is the lowest SpO2 value from laryngoscopy to 2 minutes after successful ETI. Secondary outcomes include cognitive function on day 28. Assuming a 10% standard deviation for the lowest SpO2 value in the control group, no missing data, and crossover of 5% of patients, with the bilateral alpha risk set at 0.05, including 950 patients will provide 85% power for detecting a 2% between-group absolute difference in the lowest SpO2 value. Should ORI monitoring with a target of ≥0.6 be found to increase the lowest SpO2 value during ETI, then this trial may change current practice regarding preoxygenation for ETI. Trial registration: Registered on ClinicalTrials.gov (NCT05867875) on April 27, 2023.

Endoscopic Resection for Superficial Non-Ampullary Duodenal Epithelial Tumors.

An increasing number of superficial non-ampullary duodenal epithelial tumors (SNADETs) have been detected recently owing to the development of endoscopic imaging technology and increased awareness of this disease. Endoscopic resection is the first-line treatment for SNADETs, with methods including cold snare polypectomy (CSP), conventional endoscopic mucosal resection (cEMR), underwater EMR (uEMR), and endoscopic submucosal dissection (ESD). Here, we review the current status and recent advances in endoscopic resection for SNADETs. Endoscopic resection in the duodenum is more difficult and has a higher risk of adverse events than that in other organs owing to specific anatomical disadvantages. SNADETs ≤10 mm in size are candidates for CSP, cEMR, and uEMR. Among these lesions, suspected carcinoma lesions should not be treated using CSP because of their low curability. cEMR or uEMR is considered for lesions sized 10 to 20 mm, whereas piecemeal EMR or ESD is considered for tumors >20 mm in size. In particular, ESD or surgical resection should be considered for suspected carcinoma lesions >30 mm in size. The treatment plan should be selected on a case-to-case basis, considering the balance between the risk of adverse events and the necessity of en bloc resection.

Endoscopic submucosal dissection vs. endoscopic mucosal resection in the treatment of early Barrett's neoplasia: Systematic review and meta-analysis.

Endoscopic resection is the preferred approach to treat early Barrett's neoplasia, reducing the need for surgical interventions. However, the best choice between endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) remains unclear. The study aimed to compare the efficacy and safety of EMR vs. ESD for early Barrett's neoplasia. An electronic search was conducted in MEDLINE, Central Cochrane, EMBASE, and LILACS until November 2023. Studies comparing ESD vs. EMR in the treatment of patients with early Barrett's neoplasia were included. This study was performed according to the Preferred Report Items for Systematic Reviews and Meta-Analyses guidelines. The ROBIN-I tool was used to analyze the risk of bias and GRADE to measure the quality of the evidence. A total of 9352 patients from 15 observational studies were included. Patients undergoing ESD had significantly higher rates of en-bloc (odds ratio [OR] 25.96, 95% confidence interval [CI] 13.82, 48.74; I2 = 52%; P < 0.00001) and R0 (OR 5.10, 95% CI 3.29, 7.91; I2 = 73%; P < 0.00001) with a higher risk of adverse events, including bleeding, stricture formation, and perforation. In a subgroup analysis of patients who did not receive radiofrequency ablation, ESD had a lower recurrence rate than EMR (OR 0.22, 95% CI 0.05, 0.94; I2 = 88%; P = 0.04). Endoscopic submucosal dissection is more effective than EMR in treating early Barrett's neoplasia at the expense of higher adverse events rates.