Risk Factors For Adverse Events Research Articles

Abiraterone acetate and prednisone in metastatic castration-resistant prostate cancer: a real-world retrospective study in China.

This research work was aimed at evaluating the incidence and risk factors of adverse events (AEs) occurring in patients treated with abiraterone acetate (AA) and prednisone (PDN) outside clinical trials. These associations were assessed regarding the survival outcomes. The study included 191 patients aged ≥18 years of confirmed metastatic castration-resistant prostate cancer (mCRPC) between March 2017 and April 2022. AE incidences were descriptively summarized from the whole cohort. Baseline characteristics, safety (treatment-emergent AEs and severe AEs), and efficacy [progression-free survival (PFS)] were analyzed. Multi-variable Cox proportional hazards models were employed to assess the factors linked with PFS. Overall, the median PFS was 17.16 months (range, 0.5-57.58). Patient baseline prostate-specific antigen (PSA) ≧̸10 ng/ml (p = 0.000), multiple organ metastasis (p = 0.007), hypertension (p = 0.004), and coronary heart disease (p = 0.004) were associated with worse PFS; however, radiotherapy (p = 0.028) was linked to better PFS at univariate analysis in the overall cohort. Baseline multiple organ metastasis, hypertension, and radiotherapy remained statistically significant in multivariable models (p = 0.007, p= 0.005, and p = 0.011, respectively).Incidence of AEs showed increased bilirubin (BIL) (55/191 patients, 28.8%) followed by increased alanine aminotransferase/aspartate aminotransferase (ALT/AST) (48/191 patients, 25.09%). The most common grade 3 AEs were increased ALT (3/191, 1.57%) followed by elevated BIL, hypercholesterolemia, and hypokalemia. Anemia had shorter PFS. There were no unexpected AEs in any patient. AA is effective and tolerated in asymptomatic or slightly symptomatic mCRPC in "real-life" setting. The survival outcomes are influenced by multiple organ metastasis, hypertension, and radiotherapy.

Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India.

Various vaccines for protection against COVID-19 were provided emergency approval in late 2020 to early 2021. There is a scarcity of long-term safety data for many of these. The main aim of this study is to provide the one-year safety results of the ChAdOx1-nCoV-19/AZD1222 vaccine and determine the risk factors of adverse events of special interest (AESIs) and persistent AESIs. This was a prospective observational study conducted from February 2021 to April 2022 in a tertiary hospital in North India and its two associated centers. Health care workers, other frontline workers, and the elderly vaccinated with the ChAdOx1-nCoV-19 vaccine constituted the study population. Individuals were contacted telephonically at pre-decided intervals for one year and health issues of significant concern were recorded. Atypical adverse events developing after a booster dose of the COVID-19 vaccine were assessed. Regression analysis was conducted to determine risk factors of AESI occurrence and determinants of AESIs persisting for at least one month at the time of final telephonic contact. Of 1650 individuals enrolled, 1520 could be assessed at one-year post-vaccination. COVID-19 occurred in 44.1% of participants. Dengue occurred in 8% of participants. The majority of the AESIs belonged to the MedDRA® SOC of musculoskeletal disorders (3.7% of 1520). Arthropathy (knee joint involvement) was the most common individual AESI (1.7%). Endocrinal disorders such as thyroid abnormalities and metabolic disorders such as newly diagnosed diabetes developed in 0.4% and 0.3% of individuals, respectively. Regression analysis showed females, individuals with a pre-vaccination history of COVID-19, diabetes, hypothyroidism, and arthropathy had 1.78-, 1.55-, 1.82-, 2.47- and 3.9-times higher odds of AESI development. Females and individuals with hypothyroidism were at 1.66- and 2.23-times higher risk of persistent AESIs. Individuals receiving the vaccine after COVID-19 were at 2.85- and 1.94 times higher risk of persistent AESIs compared, respectively, to individuals with no history of COVID-19 and individuals developing COVID-19 after the vaccine. Among participants receiving a booster dose of the COVID-19 vaccine (n = 185), 9.7% developed atypical adverse events of which urticaria and new-onset arthropathy were common. Nearly half of the ChAdOx1-nCoV-19 vaccine recipients developed COVID-19 over one year. Vigilance is warranted for AESIs such as musculoskeletal disorders. Females, individuals with hypothyroidism, diabetes, and pre-vaccination history of COVID-19 are at higher risk of adverse events. Vaccines received after natural SARS-CoV-2 infection may increase the risk of persistence of adverse events. Sex and endocrinal differences and timing of the COVID-19 vaccine with respect to natural infection should be explored as determinants of AESIs in the future. Pathogenetic mechanisms of vaccine-related adverse events should be investigated along with comparisons with an unvaccinated arm to delineate the overall safety profile of COVID-19 vaccines.

Development and Usability Testing of a System to Detect Adverse Events and Medical Mistakes.

Many inpatient hospital visits result in adverse events, and a disproportionate number of adverse events are thought to occur among vulnerable populations. The personal and financial costs of these events are significant at the individual, care team, and system levels. Existing methods for identifying adverse events, such as the Institute for Healthcare Improvement Global Trigger Tool, typically involve retroactive chart review to identify risks or triggers and then detailed review to determine whether and what type of harm occurred. These methods are limited in scalability and ability to prospectively identify triggers to enable intervention before an adverse event occurs. The purpose of this study was to gather usability feedback on a prototype of an informatics intervention based on the IHI method. The prototype electronic Global Trigger Tool collects and presents risk factors for adverse events. Six health professionals identified as potential users in clinical, quality improvement, and research roles were interviewed. Interviewees universally described insufficiencies of current methods for tracking adverse events and offered important information on desired future user interface features. A key next step will be to refine and integrate an electronic Global Trigger Tool system into standards-compliant electronic health record systems as a patient safety module.

Adverse Events Following Immunization of mRNA and Inactivated Vaccines Against COVID-19 at Universitas Indonesia Hospital: A Cross-Sectional Study

Background: The coronavirus that causes severe acute respiratory syndrome (COVID-19) is coronavirus 2 (SARS-CoV- 2). This virus has caused a global pandemic. The adverse impact of this virus in the past two years has resulted in efforts to build herd immunity through vaccination. This study aimed to identify the side effects after getting the Pfizer and Sinovac vaccines at the Universitas Indonesia Hospital and the risk factors for Adverse Events Following Immunization (AEFI).Methods: This observational study used a descriptive, non-experimental method with a cross-sectional design. Google Forms was used to collect data.Results: The onset of AEFI symptoms ranged from 15 minutes to 24 hours. The common AEFI symptoms were pain at the injection site, fatigue, muscle aches, and joint pain. The AEFI severity was mostly at the mild level, and only a few participants took medication. Female participants, participants with comorbidities and allergies, previous medication histories within the last 6 months, and those with experience of COVID-19 had a higher risk for AEFI with a statistically significant effect (P <0.005).Conclusion: This study revealed that Pfizer and Sinovac COVID-19 vaccines were safe to administer as the AEFIs were mostly mild and automatically disappeared and decreased after 1 to 3 days.

Obesity is Not Associated with Adverse Perioperative or Poorer Clinical Outcomes following Thoracic and Fenestrated-Branched Endovascular Aortic Repair

Obesity is a risk factor for higher morbidity and mortality following open aortic repair but currently there is limited literature on its impact on clinical and procedural outcomes following thoracic endovascular aortic repair (TEVAR) and branched-fenestrated endovascular aortic repair (B-FEVAR). We conducted a retrospective case-control analysis of a prospectively collected nonrandomized database to evaluate the effects of obesity on procedural and clinical outcomes after B-FEVAR/TEVAR in treatment of pararenal/thoracoabdominal aortic aneurysm and dissection at the University hospital of Nantes (France) between January 2016 and December 2021. Patients were divided in 2 groups according to their body mass index (BMI) and the rate of technical success, complications (renal, pulmonary, cardiac, and neurological events), 30-day and long-term survival, freedom from target vessel instability and reintervention were compared. 195 patients were included (mean age 69.6 DS±11.2; n=135, 69.2% men; mean BMI: 26.6kg/m2 range 19-41) totalling n=72 (36.8%) TEVAR, n=107 (55.4%) FEVAR and n=14 (7.3%) BEVAR. Patients were divided in 2 groups [obese: BMI≥30kg/m2n=52 (26.7%); and nonobese, BMI<30kg/m2, n=143 (73.3%) that statistically differed only in terms of coronary artery disease (obese 42.3% vs. 26.6% nonobese, P=0.035) and diabetes (obese 25% vs. 12.6% nonobese, P=0.03). No statistical differences were noted in primary technical (94.2% vs. 94.4%, P=1.00) and clinical (92.3% vs. 95.1%, P=0.49) success. Overall morbidity (30.8% vs. 21.1%, P=0.16), visceral vessels instability (1.9% vs. 1.4% P=1.00), reintervention rate within 30days (9.6% vs. 5.6% P=0.33), 90days (7.7% vs. 9.8%, P=0.78) and during follow-up (9.8% vs. 20%, P=0.14) were comparable. No statistical difference were noted in 30-day mortality (3.8% vs. 4.9%, P=1.00) and the 2-year follow-up survival (86.8% vs. 78.4%, P=0.180) between the 2 groups. In this series, obesity was not associated to worst clinical outcomes or higher mortality rate following TEVAR/B-FEVAR. However, considering our small patient sample, a conclusive analysis on obesity as risk factors for adverse events after endovascular treatment is not possible. A larger sample from the collaboration of multiple centers will be required to obtain definitive conclusions.

Risk factors for EUS-guided radiofrequency ablation adverse events in patients with pancreatic neoplasms: a large national French study (RAFPAN study)

EUS-guided radiofrequency ablation (EUS-RFA) has been described as a potentially curative option for solid and cystic pancreatic neoplasms. We aimed to assess the safety and efficacy of pancreatic EUS-RFA in a large study population. A retrospective study retrieving all consecutive patients who underwent pancreatic EUS-RFA during 2019 and 2020 in France was conducted. Indication, procedural characteristics, early and late adverse events (AEs), and clinical outcomes were recorded. Risk factors for AEs and factors related to complete tumor ablation were assessed on univariate and multivariate analyses. One hundred patients (54% men, 64.8 ± 17.6 years old) affected by 104 neoplasms were included. Sixty-four neoplasms were neuroendocrine neoplasms (NENs), 23 were metastases, and 10 were intraductal papillary mucinous neoplasms with mural nodules. No procedure-related mortality was observed, and 22 AEs were reported. Proximity of pancreatic neoplasms (≤1mm) to the main pancreatic duct was the only independent risk factor for AEs (odds ratio [OR), 4.10; 95% confidence interval [CI), 1.02-15.22; P= .04). Fifty-nine patients (60.2%) achieved a complete tumor response, 31 (31.6%) a partial response, and 9 (9.2%) achieved no response. On multivariate analysis, NENs (OR, 7.95; 95% CI, 1.66-51.79; P< .001) and neoplasm size<20mm (OR, 5.26; 95% CI, 2.17-14.29; P< .001) were independently related to complete tumor ablation. The results of this large study confirm an overall acceptable safety profile for pancreatic EUS-RFA. Close proximity (≤1mm) to the main pancreatic duct represents an independent risk factor for AEs. Good clinical outcomes in terms of tumor ablation were observed, especially for small NENs.

MP76-06 WATER VAPOR THERMAL THERAPY FOR BPH: IS LESS MORE?

You have accessJournal of UrologyCME1 Apr 2023MP76-06 WATER VAPOR THERMAL THERAPY FOR BPH: IS LESS MORE? Michelle C. Leach, Vi Nguyen, Clara Cerrato, Mimi V. Nguyen, and Seth K. Bechis Michelle C. LeachMichelle C. Leach More articles by this author , Vi NguyenVi Nguyen More articles by this author , Clara CerratoClara Cerrato More articles by this author , Mimi V. NguyenMimi V. Nguyen More articles by this author , and Seth K. BechisSeth K. Bechis More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003350.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Water vapor thermal therapy is an effective treatment for lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia (BPH) but can be associated with short term post-procedural irritative voiding symptoms. We sought to evaluate the effect of a minimal approach of water vapor thermal therapy (Rezum, Boston Scientific, Marlborough, MA, USA), defined as 1 vapor treatment per prostate lobe, on urinary symptoms and quality of life (QOL) compared to patients who received multiple treatments per lobe. METHODS: We performed a single-institution retrospective review of patients who underwent water vapor therapy for the treatment of symptomatic BPH from February 2017 to September 2022. Propensity score matching was utilized to generate patient cohorts based on the number of treatments per lobe (1 per lobe including median lobe if present vs ≥2 per lobe) matched for age, BMI, and pre-operative prostate volume (cc). Primary outcome of interest was post-operative complications and irritative symptoms. Secondary outcomes included differences in International Prostate Symptom Score (IPSS) and QOL sub score at baseline and at 1, 3, 6, and 12 months after the procedure. RESULTS: 146 patients were included in the PSM with 73 patients who received one vapor treatment per lobe and 73 patients receiving 2 or more treatments per lobe. DEMOGRAPHICS TABLE (Table 1a). On MVA, an increasing number of treatments (HR 1.3, p=0.039) and treatment of the median lobe (HR 4.7, p=0.008) were significant risk factors for adverse events after REZUM. On MVA looking at risk of post-op urinary retention, only increasing number of treatments (HR 1.6, p=0.005) was an independent risk factor while use of BPH medications, prostate volume, and median lobe treatment were not (p=0.3-0.72). Patient’s with minimal treatment had improved IPSS total and voiding sub-score at 1 month and non-inferior IPSS scores at 3-, 6-, and 12- month follow-up. CONCLUSIONS: Minimal Rezum treatment approach with a single water vapor injection per lobe is a safe and effective option for patients undergoing long-term treatment for BPH and is associated with improved postoperative complications and irritative voiding symptoms. Further studies are needed to investigate the effect of this minimal approach on longer-term outcomes. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1092 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michelle C. Leach More articles by this author Vi Nguyen More articles by this author Clara Cerrato More articles by this author Mimi V. Nguyen More articles by this author Seth K. Bechis More articles by this author Expand All Advertisement PDF downloadLoading ...

Long-term clinical outcomes of percutaneous coronary intervention for ostial left main coronary artery disease.

There are limited data regarding the long-term prognosis of percutaneous coronary intervention treatment for left main (LM) ostial stenosis. The present study sought to investigate the long-term clinical outcomes and risk factors for adverse events in LM ostial lesions following drug-eluting stent implantation (DES) in a large cohort of an LM registry database. Patients presenting with LM coronary disease from January 2004 to December 2016 at Fuwai Hospital were included. The primary endpoint was target vessel failure (TVF), a composite endpoint of cardiac death, target vessel myocardial infarction and target vessel revascularisation. Cox proportional hazards models were constructed to identify independent predictors. Among 4,625 LM patients, 627 (13.6%) patients were identified with LM ostial lesions. There were more female patients in the ostial group (31.3%), compared with the shaft (18.1%) and bifurcation groups (19.9%) (p<0.0001). Among patients with DES implantation, 3-year TVF occurred in 44 patients (7.5%) in the ostial group, which is comparable with the other two groups. Myocardial infarction (MI) was significantly lower in the ostial group (2.0%) compared with the bifurcation group (4.2%) (p=0.02), especially for MI events originating in the LM vessel (p=0.02). For patients with ostial LM disease who received percutaneous coronary intervention (PCI) treatment, procedural complications were an independent risk factor for long-term cardiac death or MI, while a more recent PCI proved to be a protective factor. PCI treatment for ostial LM lesions achieved favourable long-term outcomes, with a similar MI risk compared with the mid-shaft group but a significantly lower risk of MI compared with the distal group.

Effect of topical anticholinergic medication on clinical manifestations control among patients with vasomotor rhinitis versus allergic rhinitis: as comparative clinical trials

BackgroundThe use of a topical anticholinergic medication, ipratropium bromide, and its ability to inhibit methacholine and rhinitis-induced hypersecretion is emphasized. Ipratropium bromide appears to be both safe and effective in reducing this troublesome symptom. This study is designed to show the therapeutic effect of anticholinergic local treatment on nasal mucosa in patients with vasomotor rhinitis.ObjectiveTo assess the therapeutic effect of local anticholinergic treatment on nasal mucosa in patients with vasomotor rhinitis compared to non-vasomotor (allergic) patients and normal individuals, and if there any down regulation of the muscarinic receptors or not.Patients and methodsThis prospective intervention study was conducted in Otorhinolaryngology Department, Faculty of Medicine, Ain Shams University. This study was conducted on 60 cases. All patients were divided into 3 groups: study group (1) includes 20 patients diagnosed clinically non-allergic rhinitis suggestive to be vasomotor rhinitis. Study group (2) includes 20 patients diagnosed as allergic rhinitis. Study group (3) includes 20 patients performing surgery for non-vasomotor rhinitis non-allergic causes (as septoplasty or rhinoplasty).ResultsComparison between the pre- and post-SNOT questionnaire of symptoms among vasomotor group showed that there was a significant difference between the pre- and post-treatment SNOT questionnaire symptoms; nasal obstruction, runny nose, post-nasal drip, thick nasal discharge and Lack of good night sleep. Among allergic cases group, there was a significant difference between the pre- and post-treatment IHC (immunohistochemistry) findings considering Epithelium, Glands, arteries and veins. 20% of cases had grade 3 epithelium before treatment while after treatment, this was dropped to 0%. Comparison between the pre- and post-SNOT questionnaire of symptoms among allergic group showed that there was a significant difference between the pre- and post-treatment SNOT questionnaire symptoms; runny nose, post-nasal drip, and thick nasal discharge. Among non-vasomotor rhinitis non-allergic causes (as septoplasty or rhinoplasty) group, there was a significant difference between the pre- and post-treatment IHC findings considering epithelium, glands, and arteries; however, no significant difference between the pre- and post-IHC veins grade. Also, there was no significant difference between the pre- and post-treatment SNOT questionnaire symptoms.ConclusionTopical anticholinergics such as ipratropium bromide nasal spray are effective in treating rhinorrhea symptoms in allergic and non-allergic rhinitis. Further controlled studies with larger sample size and longer follow-up are needed to confirm our results and to identify risk factors of adverse events.

Risk Factors on the Adverse Events of Sedation for Diagnostic Tests in Pediatric: A Retrospective Case–Control Analysis

Background: This report intended to identify the peri-sedation risk factors associated with the adverse events of sedation for diagnostic tests in pediatric. Methods: This retrospective case study was approved by the local ethics committee and informed consent was waived. To investigate the risk factors for adverse events, we reviewed the medical records of 1182 pediatric patients receiving sedation from July 2016 to Oct 2021.

Elective ascending aortic aneurysm repair outcomes in a nationwide US cohort

ObjectiveTo quantify contemporary outcomes following elective ascending aortic aneurysm repair, to determine risk factors for adverse events and to evaluate difference by institutional surgical volume.MethodsWe included all elective hospitalisations of...

The impact of frailty on in-hospital complications in elderly patients with acute coronary syndrome.

Acute coronary syndrome (ACS) is linked to a range of in-hospital complications, and age is recognized as risk factor for adverse events. Discrepancies between physiological and chronological age are explained by frailty. However, the relationship between frailty and in-hospital complications is not clear. Assessment of frailty in patients was carried out using the FRAIL scale. In-hospital complications assessed included, bleeding, infection, arrhythmia, acute kidney injury (AKI), delirium, stroke/transient ischemic attack (TIA), liver injury, hypoglycemia, length of stay in the cardiac care unit (CCU). Of the 174 patients, frailty was identified in 39.1% and pre-frailty in 29.9%. Frailty was associated with a higher incidence of all types of bleeding (frail vs. robust: 45.5% vs. 16.7%, P < 0.001) and infection (54.4% vs. 11.1%, P < 0.001), including pneumonia/lower respiratory tract infections (LRTI) and urinary tract infections (UTI). Incidence of antibiotic therapy (52.9% vs. 13.0%, P < 0.001), atrial fibrillation (AF) (47.1% vs. 9.3%, P < 0.001), AKI (57.3% vs. 20.4%, P < 0.001), delirium (52.9% vs. 3.7%, P < 0.001), liver injury, were higher in frail patients (17.6% vs. 0, P = 0.001), whilst their length of stay in the CCU was longer (4 days (2-6.5) vs. 2 days (2-3), P < 0.001). Infections, pneumonia/LRTI, antibiotic therapy during hospitalization, the incidence of AF and liver injury were more often in patients with pre-frailty compared to the robust group. After adjustment for potential confounders, frailty remained independently associated with an increased risk of infection (OR: 3.3 [1.6-7.0]), including pneumonia/LRTI (OR: 2.5 [1.1-5.8]) and UTI (OR: 4.8 [1.8-12.5]). Frail individuals had an increased requirement for antibiotic therapy (OR: 3.9 [1.9-8.1]), and greater risk of AF (OR: 3.5 [1.3-9.3]), AKI (OR: 2.6 [1.2-5.3]) delirium (OR: 11.7 [4.8-28.7]), as well as having to stay longer in the CCU (> 3 days) (OR: 3.7 [1.9-7.3]). Frailty was associated with an increased risk of numerous in-hospital complications in elderly patients who had been hospitalized with ACS.

Baseline hepatocyte ballooning is a risk factor for adverse events in patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease.

Although many studies have investigated the impact of chronic hepatitis B virus (HBV) infection and nonalcoholic fatty liver disease (NAFLD) on liver disease, few have investigated the relationship between nonalcoholic steatohepatitis (NASH) defined by liver pathology and the prognosis of chronic HBV infection. Most patients were followed up for a short time. This study aimed to further explore the impact of NAFLD and the pathological changes confirmed by liver pathology in patients with chronic HBV infection. To study the effect of NAFLD confirmed using liver pathology on the outcomes of long-term serious adverse events [cirrhosis, hepatocellular carcinoma (HCC), and death] in patients with chronic hepatitis B (CHB) virus infection. We enrolled patients with chronic hepatitis B virus (HBV) infection who underwent liver biopsy at the Third People's Hospital of Zhenjaing Affiliated Jiangsu University between January 2005 and September 2020. Baseline clinical and pathological data on liver pathology and clinical data at the end of follow-up were collected. Propensity score matching (PSM) was used to balance baseline parameters, Kaplan-Meier (K-M) survival analysis was used to evaluate the risk of clinical events, and Cox regression was used to analyze the risk factors of events. Overall, 456 patients with chronic HBV infection were included in the study, of whom 152 (33.3%) had histologically confirmed NAFLD. The median follow-up time of the entire cohort was 70.5 mo. Thirty-four patients developed cirrhosis, which was diagnosed using ultrasound during the follow-up period. K-M survival analysis showed that NAFLD was not significantly associated with the risk of cirrhosis (log-rank test, P > 0.05). Patients with CHB with fibrosis at baseline were more prone to cirrhosis (log-rank test, P = 0.046). After PSM, multivariate analysis showed that diabetes mellitus, ballooning deformation (BD), and platelet (PLT) were independent risk factors for cirrhosis diagnosed using ultrasound (P < 0.05). A total of 10 patients (2.2%) developed HCC, and six of these patients were in the combined NAFLD group. K-M survival analysis showed that the cumulative risk of HCC in the NAFLD group was significantly higher (log-rank test, P < 0.05). Hepatocyte ballooning, and severe liver fibrosis were also associated with an increased risk of HCC (log-rank test, all P < 0.05). Cox multivariate analysis revealed that hepatocyte ballooning, liver fibrosis, and diabetes mellitus were independent risk factors for HCC. There was no significant correlation between chronic HBV infection and the risk of cirrhosis in patients with NAFLD. Diabetes mellitus, BD, and PLT were independent risk factors for liver cirrhosis. Patients with chronic HBV infection and NASH have an increased risk of HCC. BD, liver fibrosis, and diabetes mellitus are independent risk factors for HCC.

Evaluation of Usage of a Fracture Risk Assessment by FRAX Tool in Adults With Type 2 Diabetes Mellitus.

Fragility fractures are increasingly recognized as a complication of type 2 diabetes mellitus (T2DM). The FRAX-Port® is a calculation tool that assesses the 10-year risk of either major and hip fracture, integrating several clinical risk factors, including T2DM. We aimed to evaluate the fracture risk in adults with T2DM and determine the rate of patients at high risk for fracture under anti-osteoporotic therapy. We developed a cross-sectional study, including a convenience sample of adults with T2DM, followed in our tertiary center between 2019 and 2022. Fracture risk was evaluated according to FRAX-Port®. One hundred adults were included, 54% male, with a mean age of 68.4±9.2 years. Respecting fracture risk factors, 17% had a previous fragility fracture, 12% had a history of hip fracture in their parents, 9% had active alcohol consumption, and 4% had active smoking. Additionally, 17% presented secondary osteoporosis, being the most frequent cause of systemic corticosteroid exposure (10%). Regarding diabetes-specific risk factors, 94% had a diabetes duration longer than five years; HbA1c greater than 7% in 70%; 42% had diabetic retinopathy, 33% had diabetic chronic kidney disease, 18% had peripheral neuropathy, and 7% had autonomic neuropathy; 83% were on insulin, 2% on canagliflozin and 1% on pioglitazone. According to the FRAX-Port®, the median probability of major fracture was 6.8% (IQR 6.9), and hip fracture was 2.4% (IQR 3.9). Fracture risk was high, intermediate, and low at 41%, 15%, and 44%, respectively. Lastly, 56% of participants should undergo bone densitometry and 45% had a formal recommendation to begin an anti-osteoporotic treatment. However, only 6% were under anti-osteoporotic therapy: bisphosphonates (5%) and denosumab (1%). More than a third of T2DM patients evaluated had a high fracture risk. We found that FRAX-Port® is an easy-to-apply tool, which helps in the decision to perform densitometry or to institute anti-osteoporotic therapy. Given the increasing prevalence of T2DM and the associated risk of falls, this study highlights the need to recognize the fracture risk in these patients, usually a forgotten complication during the screening of risk factors for adverse events in adults with T2DM.

Adverse events after repair of tetralogy of Fallot: prediction models by machine learning of a retrospective cohort study in western China.

The incidence of clinical adverse events after tetralogy of Fallot (TOF) repair remains high. This study was performed to explore risk factors for adverse events and develop a prediction model through machine learning (ML) to forecast the incidence of clinical adverse events after TOF repair. A total of 281 participants who were treated with cardiopulmonary bypass (CPB) at our hospital from January 2002 to January 2022 were included in the study. Risk factors for adverse events were explored by composite and comprehensive analyses. Five artificial intelligence (AI) models were used for ML to build prediction models and screen out the model with the best performance in predicting adverse events. CPB time, differential pressure of the right ventricular outflow tract (RVOTDP or DP), and transannular patch repair were identified as the main risk factors for adverse events. The reference point for CPB time was 116.5 minutes and that for right ventricular (RV) outflow tract differential pressure was 70 mmHg. SPO2 was a protective factor, with a reference point of 88%. By integrating the results for the training and validation cohorts, we confirmed that, among all models, the logistic regression (LR) model and Gaussian Naive Bayes (GNB) model were stable, showing good discrimination, calibration and clinical practicability. The dynamic nomogram can be used as a predictive tool for clinical application. Differential pressure of the RV outflow tract, CPB time, and transannular patch repair are risk factors, and SPO2 is a protective factor for adverse events after complete TOF repair. In this study, models developed by ML were established to predict the incidence of adverse events.

Proton beam therapy in pediatric patients with central nervous system tumors: method features, clinical data analysis

Introduction. Central nervous system (CNS) tumors are the most common pediatric solid tumor, that need multimodality treatment approach including surgery, intensive chemotherapy (CT) and radiotherapy (RT). Due to toxicity, mostly late, RT has limited use in children, especially those under 3 years of age. The physical characteristics of proton beam therapy (PBT) minimize the risk and types of toxicity compared to photons, making it the preferred choice for pediatric use. Aim – to analyze the experience of PBT in patients under 18 years of age with various types of CNS malignancies, the assessment of risk factors for acute and late toxicity and its clinical manifestations. Materials and methods. A retrospective analysis of 63 courses of PBT performed in 58 patients with CNS malignancies for the period from 2018 to 2022 was carried out on Proton Center of the Sergey Beresin Medical Institute. The manifestations of local and systemic toxicity (predominantly acute) were analyzed, with an assessment of the influence of age, the volume of RT, the use of previous and concomitant CT on the severity of adverse events (AE). Results. In the study cohort, patients with embryonal CNS malignancies predominated (72.3 %). Median age was 5 years 2 months, median follow-up was 15 months. In 36 % of cases, a complete response was achieved by the start of PBT. Patients with craniospinal irradiation (CSI) prevailed (60 %). Among the manifestations of toxicity, AE grade I–II predominated. The most common AE were local reactions (dermatitis (84 %), focal alopecia (96 %)). Among systemic AE, hematological complications (84 %) were the most often occurred. A more pronounced toxicity profile was registered in the group with CSI, while concomitant CT, the patient’s age, previous CT did not significantly affect the severity of most of the assessed AE parameters (p &gt; 0.05). The analysis of late toxic effects was difficult due to the short follow-up period, the cumulative effect of other treatment modalities on the AE’s development. The reported complications included persistent focal alopecia (14 % of cases), endocrinopathies (7 %), neurological manifestations (6 %). One (2 %) child had a severe neurological deficit, secondary epilepsy with psychomotor regression, which can also be associated with the potentiating effect of previous CT and high-dose CT. Conclusion. The analysis of our data and literature review allows to conclude that PBT has relatively low toxicity profile, which is the determining factor for choosing this method of RT in pediatric patients. The main risk factor of AE’s was CSI. The acceptable acute toxicity of repeat PBT makes it possible to be used in pts with disease progression or relapse in case of absence of alternative therapeutic options.

Preoperative Assessment and Optimization of Cardiopulmonary Disease in Noncardiac Surgery.

More than 50 million surgical procedures are carried out every year in the United States with the estimated risk of major adverse cardiac events perioperatively between 1.4 and 3.9%. Given that the majority of surgeries are elective, this allows ample opportunity to identify patients at higher risk of perioperative adverse events and optimize them for surgery. Preexisting cardiopulmonary disease is a major risk factor for adverse events perioperatively and can lead to significant morbidity and mortality. It can predispose patients to perioperative myocardial ischemia and infarction, perioperative pulmonary complications, and perioperative stroke among other complications. This article details an approach to preoperative interview and examination, indications for preoperative testing, and strategies for optimization in patients with underlying cardiopulmonary disease. It also includes guidelines on optimal timing of elective surgery in certain clinical scenarios that can escalate perioperative risk. Through the use of thorough preoperative assessment, targeted preoperative testing, and multidisciplinary optimization of preexisting disease, perioperative risk can be decreased significantly and perioperative outcomes improved.

Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events. (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture? Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death. Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention. Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant. Level III, therapeutic study.

Impact of frozen elephant trunk on the outcomes of thoracoabdominal aortic repair with normothermic iliac perfusion.

Frozen elephant trunk technique (FET) has been proven to provide an excellent landing zone for second-stage thoracoabdominal (TA) aortic repair. The aim of this study was to evaluate the impact of FET in TA aortic repair with normothermic iliac perfusion. From January 2008 to December 2019, 144 patients undergoing TA repair with normothermic iliac perfusion were enrolled in this study. Early and mid-term outcomes of patients with previous FET implantation (group A, n = 62) were compared with patients without previous FET implantation (group B, n = 82). The logistic regression analysis was performed to investigate the risk factors for adverse events, which were defined as early death, permanent stroke, permanent paraplegia, or permanent renal failure necessitating dialysis. The proximal aortic clamp time and operating time was 14.26 ± 5.57 min and 357.40 ± 94.51 respectively in group A, which were both significantly shorter than that in group B (18.67 ± 5.24 min and 18.67 ± 5.24 min). The incidence of adverse event was significantly lower in group A than that in group B (9.7% vs. 25.6%, P = 0.027). There was no significant difference between two groups with regard to other complications or late outcomes. In addition, age >50 years, a Ccr < 90 ml/min/1.73 m2 and the operating time were identified as significant risk factors through logistic regression analysis for adverse events of TA repair. The FET technique simplifies the operative technique of proximal anastomosis, decreases the operating time and improves the early outcomes in TA repair, whereas does not provide a significant benefit with regard to late outcomes. Long-term follow-up and studies with larger sample sizes are necessary for further confirmation.

Adverse events during endovascular treatment of ruptured aneurysms: A prospective nationwide study on subarachnoid hemorrhage in Sweden

IntroductionA range of adverse events (AEs) may occur in patients with subarachnoid hemorrhage (SAH). Endovascular treatment is commonly used to prevent aneurysm re-rupture. Research questionThe aim of this study was to identify AEs related to endovascular treatment, analyze risk factors for AEs and how AEs affect patient outcome. Material and methodsPatients with aneurysmal SAH admitted to all neurosurgical centers in Sweden during a 3.5-year period (2014–2018) were prospectively registered. AEs related to endovascular aneurysm treatment were thromboembolic events, aneurysm re-rupture, vessel dissection and puncture site hematoma. Potential risk factors for the AEs were analyzed using multivariate logistic regression. Functional outcome was assessed at one year using the extended Glasgow outcome scale. ResultsIn total, 1037 patients were treated for ruptured aneurysms. Of which, 715 patients were treated with endovascular occlusion. There were 115 AEs reported in 113 patients (16%). Thromboembolic events were noted in 78 patients (11%). Aneurysm re-rupture occurred in 28 (4%), vessel dissection in 4 (0.6%) and puncture site hematoma in 5 (0.7%). Blister type aneurysm, aneurysm smaller than 5 mm and endovascular techniques other than coiling were risk factors for treatment-related AEs. At follow-up, 230 (32%) of the patients had unfavorable outcome. Patients suffering intraprocedural aneurysm re-rupture were more likely to have unfavorable outcome (OR 6.9, 95% CI 2.3–20.9). Discussion and conclusionAdverse events related to endovascular occlusion of a ruptured aneurysm were seen in 16% of patients. Aneurysm re-rupture during endovascular treatment was associated with increased risk of unfavorable functional outcome.