Risk Factors For Adverse Events Research Articles

Risk Factors for Adverse Events of Nanoliposomal Irinotecan Plus 5-Fluorouracil and L-leucovorin.

The regimen with nanoliposomal irinotecan plus 5-fluorouracil and L-leucovorin (nal-IRI/FL) is used for metastatic pancreatic cancer. A clinical study has indicated that the uridine diphosphate-glucuronosyltransferase (UGT) 1A1 polymorphism is associated with neutropenia during nal-IRI/FL treatment; however, no studies have reported risk factors for the occurrence of adverse events in the clinical setting. This study aimed to explore the risk factors for adverse events of nal-IRI/FL. This study included patients with metastatic pancreatic cancer who started nal-IRI/FL treatment. Patient information, including laboratory data before nal-IRI/FL initiation and adverse events during nal-IRI/FL treatment, was retrospectively obtained from medical records. This study consisted of 36 patients, including 16, 16, and 4 with UGT1A1*6 or *28 wild-type (-/-), heterozygous (+/-), and homozygous (+/+), respectively. Patients with UGT1A1*6 or *28 (+/+) exhibited significantly lower nadir counts of white blood cells (p=0.033) and neutrophils (p=0.043). Multiple regression analyses revealed that the decreased white blood cell count was significantly associated with the genotype of UGT1A1*6 or *28 (+/+) (p=0.009), high aspartate aminotransferase (AST) value before the therapy (p=0.019), and pancreatic head cancer (p=0.030). Also, the decreased neutrophil count was significantly related to the genotype of UGT1A1*6 or *28 (+/+) (p=0.017). Patients with UGT1A1*6 or *28 (+/+) should be especially concerned about neutropenia and leukopenia during nal-IRI/FL treatment. Additionally, high AST value and pancreatic head cancer may be risk factors for leukopenia during nal-IRI/FL treatment.

A Comprehensive Prospective Analysis of Surgical Outcomes and Adverse Events in Spinal Procedures Among Octogenarians: A Detailed Analysis From a German Tertiary Center.

Prospective case series. Drawing from prospective data, this study delves into the frequency and nature of adverse events (AEs) following spinal surgery specifically in octogenarians, shedding light on the challenges and implications of treating this specific cohort as well as on risk factors for their occurrence. Octogenarians who received spinal surgery and were discharged between January 2019 and December 2022 were proactively included in our study. An AE was characterized as any incident transpiring within the initial 30days after surgery that led to an unfavorable outcome. From January 2020 to December 2022, 184 octogenarian patients (average age: 83.1 ± 2.8years) underwent spinal surgeries. Of these, 81.5% were elective and 18.5% were emergencies, with 69.0% addressing degenerative pathologies. Using the Charlson Comorbidity Index, the mean score was 8.1 ± 2.2, highlighting cardiac diseases as predominant. Surgical details show 71.2% had decompression, with 28.8% receiving instrumentation. AEs included wound infections 3.1% for degenerative, 13.3% for tumor and dural leaks. The overall incidence of dural leaks was found to be 2.7% (5/184 cases), and each case underwent surgical revision. Pulmonary embolism resulted in two fatalities post-trauma. Wound infections (26.7%) were prevalent in infected spine cases. Significant AE risk factors were comorbidities, extended surgery durations, and instrumentation procedures. In octogenarian spinal surgeries, AEs occurred in 15.8% of cases, influenced by comorbidities and surgical complexities. The 2.2% mortality rate wasn't linked to surgeries. Accurate documentation remains crucial for assessing outcomes in this age group.

A real-world study of different doses of rivaroxaban in patients with nonvalvular atrial fibrillation.

To explore the anticoagulant effect and safety of utilizing different doses of rivaroxaban for the treatment of patients with atrial fibrillation (AF) in the real world. A retrospective case-control analysis was performed by applying the hospital database, and 3595 patients with non-valvular atrial fibrillation (NVAF) who were hospitalized and taking rivaroxaban at Wuhan Asia Heart Hospital and Wuhan Asia General Hospital from March 2018 to December 2021 were included in the study, and were divided into the rivaroxaban 10 mg and 15 mg groups according to the daily prescribed dose, of which 443 cases were in the 10 mg group and 3152 cases were in the 15 mg group. The patients were followed up regularly, and the incidence of thrombotic events, bleeding events and all-cause deaths were recorded and compared between the 2 groups, and logistic regression was applied to analyze the influencing factors for the occurrence of adverse events. Comparison of the incidence of thrombosis, bleeding and all-cause death between the 2 groups of patients showed that the 10 mg group was higher than the 15 mg group, but the difference was not statistically significant (χ2 = 0.36, 3.26, 1.99, all P > .05); the incidence of total adverse events between the 2 groups of patients was higher in the 10 mg group than in the 15 mg group, with a statistically significant difference (χ2 = 4.53, P = .033); multifactorial logistic regression results showed that age [OR (95% CI) = 1.02 (1.00-1.04)], diabetes mellitus [OR (95% CI) = 1.69 (1.09-2.62)], D-dimer level [OR (95% CI) = 1.06 (1.00-1.11)] and persistent AF [OR (95% CI) = 1.54 (1.03-2.31)] were risk factors for adverse events (P < .05). In the real world, Asian clinicians recommend rivaroxaban 10 mg once daily for NVAF patients for a variety of reasons; however, this dose is not superior or even inferior to the 15 mg group in terms of effectiveness and safety. Advanced age, elevated D-dimer levels, history of diabetes mellitus, and persistent AF are risk factors for adverse events, and the optimal dosage of rivaroxaban or optimal anticoagulation strategy for Asian patients with nonvalvular AF requires further study.

The impact of renal tubulointerstitial dysfunction on the early and long-term prognosis in chronic heart failure patients with preserved left ventricular ejection fraction

Aim. To study the dependence of the early-term (1 year) and long-term (5 years) prognosis in patients with chronic heart failure (CHF) of ischemic origin with preserved left ventricular ejection fraction (LVEF) depending on renal tubulointerstitial functional disorders. Materials and methods. The study involved 88 patients (men – 46.6 % (n = 41); women – 53.4 % (n = 47)) with CHF of ischemic origin, stage II A–B, stage II–IV according to NYHA, 67 % (n = 59) with sinus rhythm, and 33 % (n = 29) with atrial fibrillation. Patients with sinus rhythm and atrial fibrillation were matched in age (p = 0.483), height (p = 0.345), weight (p = 0.317), body surface area (p = 0.153). NGAL levels were analyzed using an ELISA kit (E-EL-H0096, Elabscience, USA). NAG levels were analyzed using an ELISA kit (SEA 069 Hu, Cloud-Clone Corp., USA). KIM-1 levels were analyzed using an ELISA kit (SEA 785 Hu, Cloud-Clone Corp., USA). Kaplan–Meier curves and Cox proportional hazards regression analysis were performed. Results. No significant difference was found in the frequency of the cumulative endpoint during the first-year follow-up from the initial level of two markers of tubulointerstitial injury – KIM-1 (Log-Rank Test: p = 0.57529) and NAG (Log-Rank Test: p = 0.86001). According to the results of analysis of the Cox proportional hazards, only a tendency to increase in the risk factors of adverse events were observed in case of elevated KIM-1 (HR = 1.66; p = 0.5795) and NAG levels (HR = 1.1712; p = 0.8626) in this CHF patients’ cohort. Kaplan–Meier analysis revealed a probable (Log-Rank Test; p = 0.00141) increase in the frequency of the cumulative endpoint during the first year of follow-up in CHF patients with preserved LVEF due to increased serum NGAL level more than 168 ng/ml. According to the univariate model, an elevated serum NGAL level is associated with an increase in the relative risk by 4.2 times (95 % CI 1.78–16.89; p = 0.014). A reduced sodium level less than 142.5 mmol/l was associated with an increase in number of adverse cardiovascular events during the first-year follow- ups by 22 % (HR = 1.22, p = 0.029). After 5 years of follow-up, a decrease in sodium level less than 142.3 mmol/l is also characterized by a probable difference of the cumulative Kaplan–Meier’s curves (Cox–Mantel F-Test, p = 0.00287). According to the univariate model of Cox proportional hazards, the relative risk of adverse cardiovascular events in patients with CHF during the 5-year follow-up has a tendency to increase by 1.04 times (95 % CI 0.85–1.27; p = 0.72). Serum NGAL, a marker of renal tubulo-interstitial injury, doesn’t lose its properties as a powerful marker of an unfavorable long-term prognosis in patients with CHF with preserved LVEF (HR = 5.96; 95 % CI 1.17–30.50; p = 0.032). Conclusions. The most powerful factors of the early (1-year) prognosis of adverse cardiovascular events in CHF patients with preserved left ventricular ejection fraction are the marker of tubulointerstitial injury, serum NGAL over 168 ng/ml, as well as the marker of tubulointerstitial dysfunction – the serum sodium level less than 142.5 mmol/l. The electrolyte imbalance, decreased sodium level less than 142.3 mmol/l, remains a powerful marker of an unfavorable long-term 5-year prognosis in CHF patients with preserved left ventricular ejection fraction, meanwhile serum NGAL, a marker of renal tubulointerstitial injury, besides doesn’t lose its prognostic value (HR = 5.96; 95 % CI 1.17–30.50; p = 0.032), but also is independent from the parameters of the age (p = 0.409) and gender (p = 0.397) in such patients.

Uncovering risk factors for adverse events and infections in rheumatoid arthritis and rheumatoid arthritis with interstitial lung disease under treatment with biologics or targeted synthetic DMARDs: insights from the KOBIO Registry.

This study aimed to identify the risk factors associated with overall adverse events (AEs) and infections in patients with rheumatoid arthritis (RA) and comorbid interstitial lung disease (ILD), receiving biologic or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), using data from the Korean College of Rheumatology Biologics registry. We analysed data from a cohort of 2,266 adult patients with RA who received b/tsDMARDs, including 169 patients with comorbid ILD. We identified the risk factors for overall AEs and infections in both the all RA group and the subgroup of patients with RA-ILD and investigated the impact of infections on mortality in patients with RA-ILD. Among all patients with RA, 45.7% withdrew b/tsDMARDs, whereas among those with RA-ILD, a higher proportion of 57.4% withdrew their treatment regimen. The main reason for withdrawing b/tsDMARDs in the RA-ILD group was AEs, with infections accounting for the largest proportion of reported AEs. In multivariable analysis of the risk factors for overall AEs and infections in the RA-ILD group, older age was identified as a risk factor for overall AEs (odds ratio [OR], 3.01; p=0.014), and only a current smoking status was identified as a risk factor for infections (OR, 2.11; p=0.035). Patients with RA-ILD exhibited a higher rate of b/tsDMARDs withdrawal due to overall AEs and infections than those with RA without ILD. In the RA-ILD group, older age was identified as a risk factor for overall AEs, whereas a current smoking status was identified as a risk factor for infections.

Prediction of in-hospital complications in takotsubo syndrome: prospective cohort study

BACKGROUND: Until recently, takotsubo syndrome (TS) was considered a fairly benign disease in both early and late periods. However, in recent years, in-hospital complications in the acute period of TS are common and can be life-threatening.&#x0D; AIM: Based on clinical and laboratory-instrumental data, this study aimed to build models for predicting the risk of developing in-hospital complications in patients with TS during the acute period.&#x0D; MATERIALS AND METHODS: This prospective cohort study included 60 patients with TS, with an average age of 65.5±13.4 years. In the acute period (7–14 days), standard clinical and laboratory examination, peripheral arterial tonometry using the «EndoPAT 2000» apparatus, and psychological testing using validated questionnaires (hospital anxiety and depression scale and Beck depression scale) were performed.&#x0D; RESULTS: The integrated model for predicting the risk of acute heart failure (AHF) development (pulmonary edema and cardiogenic shock) identified admission LVEF as the leading prognostic parameter. With LVEF ≤40.5%, the probability of AHF in patients with TS in the acute period was 62.5%, and in patients with TS and QTc interval 487 ms, the risk reached 100%. The sensitivity and specificity of the developed model were 72.7% and 97.4%, respectively. The integrated model for predicting the development of cardiovascular complications (CVCs) revealed that the number of leukocytes in the peripheral blood was the leading risk factor for adverse events in patients with TS in the acute period. With a leukocyte count 11.1×109/L, the risk of CVCs in patients with TS increased to 89.9%, and if the erythrocyte count was 4.69×1012/L or ≤4.29×1012/L, it could reach 100%. The sensitivity and specificity of the resulting model were 92.6 and 97.0%, respectively.&#x0D; CONCLUSION: The models proposed in this study for predicting the likelihood of developing severe AHF and the overall risk of CVCs in the acute period of TS are personalized and easy to use, allowing for the selection of optimized treatment techniques.

Real-world NUDT15 genotyping and thiopurine treatment optimization in inflammatory bowel disease: a multicenter study

BackgroundThis study evaluated the effectiveness of NUDT15 codon 139 genotyping in optimizing thiopurine treatment for inflammatory bowel disease (IBD) in Japan, using real-world data, and aimed to establish genotype-based treatment strategies.MethodsA retrospective analysis of 4628 IBD patients who underwent NUDT15 codon 139 genotyping was conducted. This study assessed the purpose of the genotyping test and subsequent prescriptions following the obtained results. Outcomes were compared between the Genotyping group (thiopurine with genotyping test) and Non-genotyping group (thiopurine without genotyping test). Risk factors for adverse events (AEs) were analyzed by genotype and prior genotyping status.ResultsGenotyping test for medical purposes showed no significant difference in thiopurine induction rates between Arg/Arg and Arg/Cys genotypes, but nine Arg/Cys patients opted out of thiopurine treatment. In the Genotyping group, Arg/Arg patients received higher initial doses than the Non-genotyping group, while Arg/Cys patients received lower ones (median 25 mg/day). Fewer AEs occurred in the Genotyping group because of their lower incidence in Arg/Cys cases. Starting with < 25 mg/day of AZA reduced AEs in Arg/Cys patients, while Arg/Arg patients had better retention rates when maintaining ≥ 75 mg AZA. Nausea and liver injury correlated with thiopurine formulation but not dosage. pH-dependent mesalamine reduced leukopenia risk in mesalamine users.ConclusionsNUDT15 codon 139 genotyping effectively reduces thiopurine-induced AEs and improves treatment retention rates in IBD patients after genotype-based dose adjustments. This study provides data-driven treatment strategies based on genotype and identifies risk factors for specific AEs, contributing to a refined thiopurine treatment approach.

Individualized antiplatelet therapy for non-cardiogenic ischemic stroke

ObjectiveThis research aims to investigate the impact of individualized antiplatelet therapy guided by thromboelastography with platelet mapping (TEG-PM) on the clinical outcomes of patients with non-cardiogenic ischemic stroke. MethodsAmong a total of 1264 patients, 684 individuals diagnosed with non-cardiogenic ischemic stroke underwent TEG-PM testing. Based on the adjustment of antiplatelet medication, these patients were divided into individual and control groups. Within the individual group, in accordance with the TEG-PM test results, a Maximum amplitude (MA) value greater than 47mm was defined as high residual platelet reactivity (HRPR), while an MA value less than 31mm was defined as low residual platelet reactivity (LRPR). Patients with arachidonic acid (AA) less than 50% and adenosine diphosphate (ADP) less than 30% were classified as aspirin-resistant or clopidogrel-resistant. Treatment strategies for antiplatelet medication were subsequently adjusted accordingly, encompassing increment, decrement, or replacement of drugs. Meanwhile, the control group maintained their original medication regimen without alterations. ResultsThe individual group included 487 patients, while the control group had 197. In the individual group, approximately 175 patients (35.9%) were treated with increased medication dosages, 89 patients (18.3%) with reduced dosages, and 223 patients (45.8%) switched medications. The results showed that the incidence rate of ischemic events in the individual group was lower than that of the control group (5.54% vs. 12.6%, P = 0.001), but no significant difference was observed in bleeding events. Cox regression analysis revealed age (hazard ratio, 1.043; 95% CI, 1.01-1.078; P = 0.011) and coronary heart disease (hazard ratio, 1.902; 95% CI, 1.147-3.153; P = 0.013) as significant risk factors for adverse events. ConclusionIndividualized antiplatelet therapy based on TEG-PM results can reduce the risk of ischemic events in patients with non-cardiogenic ischemic stroke without increasing the risk of bleeding events or mortality. Advanced age and coronary heart disease were identified as risk factors affecting the outcomes of individualized antiplatelet therapy.

Sex Comparative Analysis of Branched and Fenestrated Endovascular Aortic Arch Repair Outcomes

Female sex is a risk factor for adverse events after endovascular aortic repair. Sex comparative early and mid term outcomes of fenestrated and branched endovascular aortic arch repair (f/b-Arch) are presented. Single centre retrospective sex comparative analysis of consecutive patients managed with f/b-Arch according to STROBE. Primary outcomes were sex comparative technical success, mortality, and cerebrovascular morbidity at 30 days. Kaplan-Meier estimates were used for follow up outcomes. Among 209 patients, 38.3% were women. Coronary artery disease (p < .001) and previous myocardial infarction (p = .001) were more common in women. Non- native proximal aortic landing was higher in women (women: 51.3%; men: 31.8%, p = .005) and aortic dissection rate was lower (28.8% vs. 48.1%, p = .005). Proximal landing to Ishimaru zones showed no difference (zone 0: p = .18; zone 1: p = .47; zone 2: p = .39). Graft configurations were equally distributed. In total, 416 supra-aortic trunks were bridged. Median number of revascularisations per patient was 2 (interquartile range 1, 3), with no difference between sexes (p = .54). Technical success (women: 97.5%; men: 96.7%, p = .80), 30 day mortality (women: 10%; men: 9.3%, p = .86), and cerebrovascular morbidity (women: 11.3%; men: 17.1%, p = .25) were similar. Women presented more access related complications (women: 32.5%; men: 16.3%, p = .006), without affecting access related re-interventions (p = .55). Survival (women: 81.1%, 95% confidence interval [CI] 76.3 - 85.9%; men: 79.8%, 95% CI 76.0 - 83.6%) and freedom from re-intervention (women: 56.6%, 95% CI 50.4 - 62.8%); men: 55.3%, 95% CI 50.1 - 60.5%) at 12 months were similar (log rank, p = .40 and p = .41, respectively). Both sexes presented similar outcomes after f/b-Arch. Appropriate patient selection may decrease the effect of sex in f/b-Arch outcomes.

Predicting Peri-Operative Cardiorespiratory Adverse Events in Children with Idiopathic Pulmonary Arterial Hypertension Undergoing Cardiac Catheterization Using Echocardiography: A Cohort Study.

General anesthesia in children with idiopathic pulmonary arterial hypertension (PAH) carries an increased risk of peri-operative cardiorespiratory complications though risk stratifying individual children pre-operatively remains difficult. We report the incidence and echocardiographic risk factors for adverse events in children with PAH undergoing general anesthesia for cardiac catheterization. Echocardiographic, hemodynamic, and adverse event data from consecutive PAH patients are reported. A multivariable predictive model was developed from echocardiographic variables identified by Bayesian univariable logistic regression. Model performance was reported by area under the curve for receiver operating characteristics (AUCroc) and precision/recall (AUCpr) and a pre-operative scoring system derived (0-100). Ninety-three children underwent 158 cardiac catheterizations with mean age 8.8 ± 4.6years. Adverse events (n = 42) occurred in 15 patients (16%) during 16 catheterizations (10%) including cardiopulmonary resuscitation (n = 5, 3%), electrocardiographic changes (n = 3, 2%), significant hypotension (n = 2, 1%), stridor (n = 1, 1%), and death (n = 2, 1%). A multivariable model (age, right ventricular dysfunction, and dilatation, pulmonary and tricuspid regurgitation severity, and maximal velocity) was highly predictive of adverse events (AUCroc 0.86, 95% CI 0.75 to 1.00; AUCpr 0.68, 95% CI 0.50 to 0.91; baseline AUCpr 0.10). Pre-operative risk scores were higher in those who had a subsequent adverse event (median 47, IQR 43 to 53) than in those who did not (median 23, IQR 15 to 33). Pre-operative echocardiography informs the risk of peri-operative adverse events and may therefore be useful both for consent and multi-disciplinary care planning.

Evaluation of effectiveness, hyperkalaemia, and hepatotoxicity of trimethoprim-sulphamethoxazole prophylaxis for Pneumocystis jirovecii pneumonia in paediatric patients: A single-centre retrospective study

BackgroundAmerican guidelines recommend trimethoprim-sulphamethoxazole (TMP-SMX) for preventing Pneumocystis jirovecii pneumonia (PJP) in paediatric patients at doses of 5–10 mg/kg/d of the TMP component, administered either daily, three times weekly, or twice weekly. However, limited studies describe the effectiveness and safety of these prophylactic regimens. Our study aimed to assess the clinical effectiveness and incidence of adverse events associated with each TMP-SMX regimen in paediatric patients, and to identify risk factors for adverse events. MethodsWe collected data regarding the onset of PJP, hyperkalaemia, and hepatotoxicity in patients aged 0–18 years who underwent prophylaxis with TMP-SMX from July 2018 to June 2023. ResultsA total of 215 paediatric patients met the inclusion criteria. No patients developed PJP. Hyperkalaemia occurred in 14.7%, patients receiving TMP-SMX daily, 15.4% receiving it three times weekly, and 15.5% receiving it twice weekly. Hepatotoxicity was most frequent in patients receiving TMP-SMX twice weekly (19%), followed by those receiving it three times weekly (7.7%), and daily (5.9%). Younger patients were significantly more prone to developing hyperkalaemia or hepatotoxicity. Patients aged <1 year had the highest incidences of hyperkalaemia (56.5%), and those aged 1–2 years had the highest incidence of hepatotoxicity (25%). ConclusionsNo patient developed PJP under various dosage prophylactic regimens of TMP-SMX. However, our findings suggest the need to monitor potassium levels and hepatic function in patients undergoing any of the three TMP-SMX regimens. In particular, patients aged <1 year old and 1–2 years old face a higher risk of hyperkalaemia and hepatotoxicity, respectively.

Safety of non-ionic contrast media in CT examinations for out-patients: retrospective multicenter analysis of 473,482 patients.

This study aimed to explore the incidence of and potential risk factors for adverse drug reactions (ADRs) after non-ionic iodinated contrast media (NICM) administration for CT exams in out-patient settings in China. A total of 473,482 out-patients who underwent intravenous NICM between January 1st, 2017, and Dec 31st, 2021, were retrospectively enrolled from three institutions. The occurrence of ADRs and clinical information were recorded. Chi-square test, Poisson regression, and logistic regression analyses were used to evaluate potential ADR risk factors and correlation with demographics, season, and NICM type. Among the 473,482 patients (mean age 55.22 ± 14.85; 253,499 male) who received intravenous NICM, the overall ADR incidence was 0.110% (522 of 473,482), with 0.099% acute-related drug reactions (469 of 473,482) and 0.0004% serious ADRs (two of 473,482). Iopromide was associated with a higher risk of acute ADRs. Late ADRs were more frequently observed with iodixanol 320. Multi-level logistic regression of patients with acute ADRs and a control group (matched 1:1 for age, gender, NICM, prescriber department, and institution) showed that summer (adjusted OR = 1.579; p = 0.035) and autumn (adjusted OR = 1.925; p < 0.001) were risk factors of acute ADRs. However, underlying disease and scanned body area were not related to a higher ADR incidence. The use of NICM for out-patients is in general safe with a low ADR incidence. The type of contrast medium (iopromide) and the seasons (summer and autumn) were associated with a higher risk of acute ADRs. Late ADRs were more often observed with iodixanol. In comparison to in-patients, out-patients may be exposed to higher risk due to a lack of extensive risk screening, less nursing care, and higher throughput pressure. Safety data about NICM from a large population may complement guidelines and avoid ambiguity. • The incidence and risk factors for adverse events after using non-ionic iodinated contrast media are complex in out-patients. • Non-ionic iodinated contrast media are safe for out-patients and the overall incidence of adverse drug reactions was 0.110%. • There is a higher risk of acute adverse drug reactions in summer and autumn.

Biomedical Applications of Wavelet Transform Algorithm on Deep Learning Ultrasonic Image Optimization as a Prognosis Model for Acute Myocarditis

We aimed to investigate the biomedical methods of wavelet transform algorithm on ultrasonic image denoising algorithm and the risk factors for the adverse prognostic events of patients with myocarditis and analyse its correlation with free triiodothyronine (FT3) level. A retrospective study was performed to include 68 patients diagnosed with acute myocarditis (AM). The included patients were enrolled into adverse event (AE) group (n = 7) and non-adverse event (NAE) group (n = 61). The clinical data, laboratory examination indicators, echocardiographic parameters, and thyroid functions between the patients in the two groups at admission were compared. Besides, wavelet transform (WT) algorithm was employed to process ultrasonic images containing noises. Univariate and multivariate analysis were performed using Logistic regression model. It was demonstrated that peak signal-to-noise ratio (PSNR) and structural similarity (SSIM) (35.279, 0.847) of wavelet transform algorithm were higher than those of denoising convolutional neural network (DnCNN) algorithm (30.673, 0.582) and Red-Net algorithm (28.489, 0.638). In the AE group, the QRS interval was longer ([102 (93, 135) ms] versus [86 (79, 102) ms]), the proportion of prolonged QRS period was higher (28.57%, 9.83%), and the creatine kinase isoenzyme, a marker of myocardial injury, was higher [32.87 (13.64, 78.62) U/L] versus 12.02 (9.89, 27.65) U/L], and the level of FT3 was lower [1.87 (1.23, 2.36) pg/mL versus 2.83 (1.83, 3.45) pg/mL] compared to the NAE group. The left ventricular ejection fraction (LVEF) in the adverse event group was lower than that in the non-adverse event group [45.78 (36.18, 54.32) % versus 63.72 (54.82, 64.68)]. Multivariate Logistic regression analysis showed that the risk factors for adverse events in patients with acute myocarditis included QRS interval &gt; 120 ms (OR = 1.021), creatine kinase isoenzyme &gt; 24 U/L (OR = 1.024), FT3 (OR = 0.067), and LVEF &lt; 50% (OR = 0.973). This work confirmed that the wavelet transform algorithm can optimize the image quality of echocardiography, improve the clarity, and provide a feasible idea for improving the prognosis of patients with acute myocarditis.

Usability of the 4Ms Worksheet in the Emergency Department for Older Patients: A Qualitative Study.

Older adults often have multiple comorbidities; therefore, they are at high risk for adverse events after discharge. The 4Ms framework-what matters, medications, mentation, mobility-has been used in acute and ambulatory care settings to identify risk factors for adverse events in older adults, although it has not been used in the emergency department (ED). We aimed to determine whether 1)use of the 4Ms worksheet would help emergency clinicians understand older adult patients' goals of care and 2)use of the worksheet was feasible in the ED. We conducted a qualitative, descriptive study among patients aged ≥60years and emergency clinicians from January-June 2022. Patients were asked to fill out a 4Ms worksheet; following this, semi-structured interviews were conducted with patients and clinicians separately. We analysed data to create codes, which were divided into categories and sub-categories. A total of 20 older patients and 19 emergency clinicians were interviewed. We identified two categories based on our aims: understanding patient goals of care (sub-categories: clinician/ patient concordance; understanding underlying goals of care; underlying goals of care discrepancy) and use of 4Ms Worksheet (sub-categories: worksheet to discussion discrepancy; challenges using worksheet; challenge completing worksheet before discharge). Rates of concordance between patient and clinician on main concern/goal of care and underlying goals of care were 82.4% and 15.4%, respectively. We found that most patients and emergency clinicians agreed on the main goal of care, although clinicians often failed to elicit patients' underlying goal(s) of care. Additionally, many patients preferred to have the interviewer fill out the worksheet for them. There was often discrepancy between what was written and what was discussed with the interviewer. More research is needed to determine the best way to integrate the 4Ms framework within emergency care.

A decade of experience in over 300 surgically treated spine patients with long-term oral anticoagulation: a propensity scorematched cohort study.

The aim of this study was to investigate the risks and outcomes of patients with long-term oral anticoagulation (OAC) undergoing spine surgery. All patients on long-term OAC who underwent spine surgery between 01/2005 and 06/2015 were included. Data were prospectively collected within our in-house Spine Surgery registry and retrospectively supplemented with patient chart and administrative database information. A 1:1 propensity score-matched group of patients without OAC from the same time interval served as control. Primary outcomes were post-operative bleeding, wound complications and thromboembolic events up to 90days post-surgery. Secondary outcomes included intraoperative blood loss, length of hospital stay, death and 3-month post-operative patient-rated outcomes. In comparison with the control group, patients with OAC (n = 332) had a 3.4-fold (95%CI 1.3-9.0) higher risk for post-operative bleeding, whereas the risks for wound complications and thromboembolic events were comparable between groups. The higher bleeding risk was driven by a higher rate of extraspinal haematomas (3.3% vs. 0.6%; p = 0.001), while there was no difference in epidural haematomas and haematoma evacuations. Risk factors for adverse events among patients with OAC were mechanical heart valves, posterior neck surgery, blood loss > 1000mL, age, female sex, BMI > 30kg/m2 and post-operative PTT levels. At 3-month follow-up, most patients reported favourable outcomes with no difference between groups. Although OAC patients have a higher risk for complications after spine surgery, the risk for major events is low and patients benefit similarly from surgery.

Factors associated with increased length of stay and risk of complications in 336 patients submitted to spine surgery. The role of a validated capture system (SAVES v2) as a first-line tool to properly face the problem

PurposeIn this study, we analyzed the use of a validated capture system (Spinal Adverse Events Severity system, SAVES V2) as a first non-technical skill to properly face the relevant problem of surgical complications (SCs) and adverse events (AEs) in spinal surgery.MethodsWe retrospectively collected AEs occurring in a tertiary referral center for spine surgery from January 2017 to January 2018 and classified them according to SAVES V2 system. We compared this collection of AEs with a prospective collection performed without any classification system. Univariate and multivariate logistic regression models were used to determined odds ratio (ORs) for selected potential risk factors of AEs and prolonged length of stay.ResultsOverall a higher number of AEs was retrospectively recorded using SAVES system compared to the prospective recording without the use of any capture system (97/336 vs 210/336, p < 0.001).The length of stay (LOS) increased in the group of complicated patients for all the procedures examined. In the non-oncological group, LOS was significantly higher for complicated patients compared to uncomplicated patients (F = 44.11, p = 0.0000). Similar results have been obtained in the oncological group of patients.In the multivariate regression model surgical time and postoperative AEs emerged as risk factors for prolonged LOS, while only the presence of previous surgeries was confirmed as risk factor for AEs.ConclusionConsidering that the rate of AEs and SCs in spinal surgery is still high despite the improvement of technical skills, we suggest the use of SAVES V2 capture system as a first-line tool to face the problem.

Complications of facial autologous fat grafting

Autologous fat grafting is a commonly performed procedure for facial volume augmentation and rejuvenation. While overall complication rates in the literature are low, adverse events related to fat grafting can range from minor to systemic and severe. It is crucial that the surgeon be aware of these potential complications, counsel patients appropriately, and take the necessary steps to mitigate these risks. Local graft site complications include contour irregularity, over- or under-volumization, prolonged edema and ecchymosis, fat necrosis, granuloma formation, and infection. Similar complications can also be seen at the donor sites, including contour irregularity, prolonged induration or erythema, infection, and skin pigmentation changes. Finally, the most severe complications, resulting from fat embolism due to intravascular injection, can result in vision loss or stroke. In this review, risk factors for adverse events, surgical techniques to mitigate risk, and potential treatment options for complications of autologous fat grafting are reviewed.

Relationship between parity and history of hypertension with MEOWS score in early onset severe preeclampsia patients

Introduction: Parity and a history of hypertension are some of the highest risk factors for severe preeclampsia, especially early onset. The severity of recurrent preeclampsia will increase compared to preeclampsia in the first pregnancy. Although there is a correlation between chronic hypertension and unfavorable pregnancy outcomes, several case-control studies have consistently shown that chronic hypertension is the most often acknowledged risk factor for adverse events affecting both the mother and the fetus. Women with the risk factors above can potentially fall into bad conditions, so close monitoring must be carried out. Modified Early Obstetric Warning System (MEOWS) is used for early detection, care, treatment, and referral of changes in obstetric patient parameters that are leading to worsening. Objective: Analyze the relationship between parity and history of hypertension with MEOWS scores in early-onset severe preeclampsia patients. Methods: A cross-sectional approach was used in this study by involving 63 patients. The population was early-onset severe preeclampsia patients treated at Dr. Soetomo Regional Public Hospital Surabaya Indonesia 2022; the sampling technique used was total sampling. This data was collected using secondary data from medical records and analyzed statistically using bivariate test, specifically the chi-square test using SPSS software. Results: The majority of patients were of reproductive age (73%), the gestational age was predominantly in the very preterm (28-&lt;32 weeks) category (49.2%), the most obstetric status was multigravida (77.8 ), and most patients had no history of hypertension (66.7%). The average MEOWS score in early-onset PEB patients was 8.11. Parity vs MEOWS score (p&gt;0.05), while the history of hypertension vs MEOWS score (p&lt;0.05). Conclusion: Parity and MEOWS score did not have a significant relationship, while the history of hypertension had a significant relationship with MEOWS score.

Usability of the 4Ms Worksheet in the Emergency Department for Older Patients: A Qualitative Study

Introduction: Older adults often have multiple comorbidities; therefore, they are at high risk for adverse events after discharge. The 4Ms framework—what matters, medications, mentation, mobility—has been used in acute and ambulatory care settings to identify risk factors for adverse events in older adults, although it has not been used in the emergency department (ED).Weaimed to determine whether 1) use of the 4Ms worksheet would help emergency clinicians understand older adult patients’ goals of care and 2) use of the worksheet was feasible in the ED. Methods: We conducted a qualitative, descriptive study among patients aged ≥60 years and emergency clinicians from January–June 2022. Patients were asked to fill out a 4Ms worksheet; following this, semi-structured interviews were conducted with patients and clinicians separately. We analysed data to create codes, which were divided into categories and sub-categories. Results: A total of 20 older patients and 19 emergency clinicians were interviewed. We identified two categories based on our aims: understanding patient goals of care (sub-categories: clinician/ patient concordance; understanding underlying goals of care; underlying goals of care discrepancy) and use of 4Ms Worksheet (sub-categories: worksheet to discussion discrepancy; challenges using worksheet; challenge completing worksheet before discharge). Rates of concordance between patient and clinician on main concern/goal of care and underlying goals of care were 82.4% and 15.4%, respectively. Conclusion: We found that most patients and emergency clinicians agreed on the main goal of care, although clinicians often failed to elicit patients’ underlying goal(s) of care. Additionally, many patients preferred to have the interviewer fill out the worksheet for them. There was often discrepancy between what was written and what was discussed with the interviewer. More research is needed to determine the best way to integrate the 4Ms framework within emergency care.

P694 Age is a strong of predictive risk factor for anti-TNF therapy related adverse events in IBD patients

Abstract Background Anti-TNFα is the first class of biologics approved for treatment of moderate-to-severely active Inflammatory Bowel Disease (IBD). More than two decades on, anti-TNFs remain one of the most commonly used biologics for both Ulcerative Colitis (UC) and Crohn’s Disease (CD), and often as first-line therapy. Although effective, they cause several adverse events (AEs), sometimes requiring withdrawal of therapy. We aimed to record AEs and understand factors that could predict risk of AEs. Methods All IBD patients exposed to anti-TNF therapy were identified from EMR at two centres of a large tertiary hospital between January 2009 and June 2022. All relevant demographic and clinical data were collected for those patients with well recorded AEs and follow-up. Data on cumulative AEs directly attributed to anti-TNFs that ranged from mild reactions to serious AEs (defined as those requiring review/withdrawal of anti-TNF), were collected. Adverse events (AEs) were recorded as per relevant systems involved e.g.- haematological, cardiac etc., including infections and malignancies as separate categories. All analysis (normalization, hypothesis testing, and visual reports were performed using R software package Version: R 4.2.1. Results A total of 844 IBD patients (Male =408) were included with an age range of 18-75yrs. Majority were Caucasian in ethnicity (514) and more patients with CD [605(71%)] were exposed to anti-TNF than UC. The age profiling analysis was performed across ethnic groups (Asian, Caucasian and Others). Age associated AE was reported across all the groups (data not shown). It must be mentioned that though not significant, Caucasian patients were more susceptible towards AE as compared to Asian. Conclusion · Patient age above 50yrs has a strong predictive risk factor for AEs related to anti-TNF therapy for IBD. · In our cohort, more than half of patients &amp;gt;50yrs reported at least one AE in UC, and the age was lower in CD. · Although Caucasians were more vulnerable to AEs, this was not statistically significant. · Clinicians should consider and discuss this risk before selecting patients for anti-TNF therapy. · With multiple biologic choices currently available, another class could be considered where possible, for the &amp;gt;50yr patient cohort.