Risk Factors For Adverse Events Research Articles

Preoperative Risk Factors for Adverse Events in Adults Undergoing Bowel Resection for Inflammatory Bowel Disease: 15-Year Assessment of the American College of Surgeons National Surgical Quality Improvement Program.

Older adults with inflammatory bowel disease (IBD) are at higher risk for postoperative complications as compared to their younger counterparts; however, factors contributing to this are unknown. We assessed risk factors associated with adverse IBD-related surgical outcomes, evaluated trends in emergency surgery, and explored differential risks by age. Using the American College of Surgeons National Surgical Quality Improvement Program database, we identified adults ≥18 years of age who underwent an IBD-related intestinal resection from 2005 to 2019. Our primary outcome included a 30-day composite of mortality, readmission, reoperation, and/or major postoperative complication. Overall, 49,746 intestinal resections were performed with 9,390 (18.8%) occurring among older adults with IBD. Nearly 37% of older adults experienced an adverse outcome as compared to 28.1% among younger adults with IBD ( P < 0.01). Among all adults with IBD, the presence of preoperative sepsis (adjusted odds ratio [aOR], 2.08; 95% confidence interval [CI] 1.94-2.24), malnutrition (aOR, 1.22; 95% CI 1.14-1.31), dependent functional status (aOR, 6.92; 95% CI 4.36-11.57), and requiring emergency surgery (aOR, 1.50; 95% CI 1.38-1.64) increased the odds of an adverse postoperative outcome, with similar results observed when stratifying by age. Furthermore, 8.8% of surgeries among older adults were emergent, with no change observed over time ( P = 0.16). Preoperative factors contributing to the risk of an adverse surgical outcome are similar between younger and older individuals with IBD, and include elements such as malnutrition and functional status. Incorporating these measures into surgical decision-making can reduce surgical delays in older individuals at low risk and help target interventions in those at high risk, transforming care for thousands of older adults with IBD.

Clinical significance of high monocyte counts for the continuous treatment with nintedanib

BackgroundNintedanib is now widely used to treat interstitial lung disease (ILD). Adverse events, which occur in not a few patients, make it difficult to continue nintedanib treatment, but the risk factors for adverse events are not well understood.MethodsIn this retrospective cohort study, we enrolled 111 patients with ILDs treated with nintedanib and investigated the factors involved in starting dosage reduction, withdrawal, or discontinuation within 12 months, even with appropriate symptomatic treatment. We also examined the efficacy of nintedanib in reducing the frequency of acute exacerbations and the prevention of pulmonary function reduction.ResultsPatients with high monocyte counts (> 0.454 × 109/L) had a significantly higher frequency of treatment failure, such as dosage reduction, withdrawal, or discontinuation. High monocyte count was as significant a risk factor as body surface area (BSA). Regarding efficacy, there was no difference in the frequency of acute exacerbations or the amount of decline in pulmonary function within 12 months between the normal (300 mg) and reduced (200 mg) starting dosage groups.ConclusionOur study results indicate that patients with higher monocyte counts (> 0.454 × 109/L) should very careful about side effects with regard to nintedanib administration. Like BSA, a higher monocyte count is considered a risk factor for nintedanib treatment failure. There was no difference in FVC decline and frequency of acute exacerbations between the starting doseage of nintedanib, 300 mg and 200 mg. Considering the risk of withdrawal periods and discontinuation, a reduced starting dosage may be acceptable in the patients with higher monocyte counts or small body sizes.

Adverse Events After Surgical Treatment of Adult Diaphyseal Forearm Fractures: a Retrospective Analysis of 470 Patients.

The incidence of and risk factors for adverse events after internal fixation of diaphyseal forearm fractures have not been well defined in the current literature. The objective of this study was to estimate the incidence of adverse events after diaphyseal forearm fracture surgery in adults and explore potential risk factors for adverse events. We conducted a retrospective, multicenter, cohort study in which we evaluated all diaphyseal forearm fractures between 2009 and 2019 in patients presenting to 4 trauma hospitals in southern Finland. Patients <16 years of age and fracture-dislocations were excluded. There were 470 patients included in this study. Patient records were evaluated to identify and analyze adverse events. There were 202 patients with both-bone fractures, 164 patients with isolated ulnar fractures, and 104 patients with isolated radial fractures. In total, 146 patients (31%) experienced an adverse event; 83 (18%) had major adverse events (persistent or requiring surgical intervention). The patients underwent procedures performed by 185 different surgeons. The median number of operations for a single surgeon was 2 (range, 1 to 12). The most common major adverse events were plate and screw-related issues (6%), nonunion (5%), persistent nerve injuries (4%), and refractures (4%). Higher body mass index, Gustilo-Anderson type-II open fractures, both-bone fractures, isolated radial fractures, and operations performed by junior residents were found to be risk factors for adverse events in the multivariable analysis. Adverse events after diaphyseal forearm fracture surgery are common. We recommend concentrating these operations in a limited team of surgeons and restricting inexperienced surgeons from operating on these fractures without supervision. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Demographical risk factors of adverse events following immunisation of CoronaVac in Jambi, Indonesia

Background and purpose: Slow uptake of COVID-19 vaccination might be associated with the adverse events after vaccination. This study aims to evaluate the association between demographical factors and COVID-19 vaccine adverse events in Jambi, Indonesia Methods: We conducted a cross-sectional study with a total population sampling. Data were collected with a structured questionnaire. We included adults vaccinated for the first dose with CoronaVac in Putri Ayu Public Health Center between March 15th and June 3rd, 2021, accounted for 522 persons. Statistical analysis was done using IBM SPSS 26.0. Multivariate logistic regression analysis was used to analyze the predictive models. Results: This Out of 522 respondents included, immune reactions (34.1%) were the most common adverse effects reported by the respondents. Multivariate analysis showed that respondents with no family members or friends exposed to COVID-19 are less likely to experience puncture site reaction with an OR of 0.28 (95%CI: 0.09-0.92; p=0.036). Those with no history of mental disorders were also less likely to experience the adverse event with an OR of 0.12 (95%CI: 0.024-0.62; p=0.011). As for other reactions, those in the 26-35 years old category are more likely to experience other adverse event reactions with an OR of 11.62 (95%CI: 1.5-89.92; p=0.019). Conclusion: Based Younger respondents tend to experience more other reaction of COVID-19 vaccine adverse events than the older groups. We also found that those with no family or friends who contracted COVID-19 and no history of mental disorders are less likely to experience puncture site reaction adverse events.

Predictors for adverse events following intravesical botulinum toxin injections in men.

Intravesical botulinum toxin A (BTX-A) has been long established as treatment for overactive bladder and neurogenic bladder dysfunction. However, most published data are reported amonga female cohort. Adverse events such as intermittent self-catheterization (ISC) and urinary tract infections (UTIs) play a large role in discontinuation of therapy. There is currently limited information regarding predictive factors to appropriately counsel male patients. We retrospectively collected data on male patients undergoing their first intravesical BTX-A therapy from January 2016 to July 2021 in two high-volume centers. Data included demographics, past medical and surgical history, and urodynamic parameters. Patients were excluded if they had a long-term catheter or ISC before initiation of therapy. A total of 69 men were included in the study with a median age of 66 years. There were 18 patients with neurogenic bladder dysfunction. Thirty men had urge incontinence secondary to radical prostatectomy or bladder outflow surgery. Overall rates of ISC were 43.5%. Predictors for ISC included a baseline postvoid residual (PVR) ≥ 50 mL (odds ratio [OR]: 4.2, 95% confidence interval [CI]: 1.36-13.03, p = 0.01), BTX-A dose >100 units (OR: 4.2, 95% CI: 1.36-13.0, p = 0.01). Stress urinary incontinence was protective against ISC (OR: 0.20, 95% CI: 0.04-1.00, p = 0.049) as well as history of prostatectomy/bladder outflow obstruction (BOO) surgery (OR: 0.16, 95% CI: 0.05-0.47, p < 0.001). A multivariable logistic regression model with these factors yielded a c-statistic of 0.80 (optimism-adjusted = 0.75). An enlarged prostate was the only predictor for UTI amongour male cohort (OR: 8.0, 95% CI: 2.03-31.5, p = 0.003). This is the first study assessing risk factors of adverse events amongmen following BTX-A injection. High PVR and BTX-A dose of >100U were predictors of requiring ISC after BTX-A. Stress incontinence, previous radical prostatectomy, and BOO surgery were all protective against needing ISC post-BTX-A. An enlarged prostate was associated with development of UTI. These factors can be used to assist in counseling male patients regarding their risk of ISC and UTI.

The value of cardiac MRI in the risk stratification in patients with hypertrophic cardiomyopathy

Objective: To explore the value of cardiac magnetic resonance imaging (CMR) in the risk stratification of hypertrophic cardiomyopathy (HCM). Methods: HCM patients who underwent CMR examination in Fuwai Hospital between March 2012 and May 2013 were retrospectively enrolled. Baseline clinical and CMR data were collected and patient follow-up was performed using telephone contact and medical record. The primary composite endpoint was sudden cardiac death (SCD) or and equivalent event. The secondary composite endpoint was all-cause death and heart transplant. Patients were divided into SCD and non-SCD groups. Cox regression was used to explore risk factors of adverse events. Receiver operating characteristic (ROC) curve analysis was used to assess the performance and the optimal cut-off of late gadolinium enhancement percentage (LGE%) for the prediction of endpoints. Kaplan-Meier and log-rank tests were used to compare survival differences between groups. Results: A total of 442 patients were enrolled. Mean age was (48.5±12.4) years and 143(32.4%) were female. At (7.6±2.5) years of follow-up, 30 (6.8%) patients met the primary endpoint including 23 SCD and 7 SCD equivalent events, and 36 (8.1%) patients met the secondary endpoint including 33 all-cause death and 3 heart transplant. In multivariate Cox regression, syncope(HR=4.531, 95%CI 2.033-10.099, P<0.001), LGE% (HR=1.075, 95%CI 1.032-1.120, P=0.001) and left ventricular ejection fraction (LVEF) (HR=0.956, 95%CI 0.923-0.991, P=0.013) were independent risk factors for primary endpoint; Age (HR=1.032, 95%CI 1.001-1.064, P=0.046), atrial fibrillation (HR=2.977, 95%CI 1.446-6.131, P=0.003),LGE% (HR=1.075, 95%CI 1.035-1.116, P<0.001) and LVEF (HR=0.968, 95%CI 0.937-1.000, P=0.047) were independent risk factors for secondary endpoint. ROC curve showed the optimal LGE% cut-offs were 5.1% and 5.8% for the prediction of primary and secondary endpoint, respectively. Patients were further divided into LGE%=0, 0<LGE%<5%, 5%≤LGE%<15% and LGE%≥15% groups. There were significant survival differences between these 4 groups whether for primary endpoint or secondary endpoint (all P<0.001) and the accumulated incidence of primary endpoint was 1.2% (2/161), 2.2% (2/89), 10.5% (16/152) and 25.0% (10/40), respectively. Conclusion: LGE is an independent risk factor for SCD events as well as all-cause death and heart transplant. LGE is of important value in the risk stratification in patients with HCM.

Risk factors for malignancy and serious infection in patients with inflammatory bowel disease: a retrospective analysis.

Patients with inflammatory bowel disease (IBD) are at increased risk of malignancy and infection compared to the general population. We aim to identifyrisk factors for malignancy or serious infection in our IBD cohort. Patients with IBD from a single tertiary referral centre were included. Demographic and clinical details, including immunosuppressant exposure, were collected and medical records retrospectively screened for adverse events, including malignancy or infection requiring hospitalisation. Logistic regression was used to evaluate risk factors for adverse events. Five hundred and forty-nine patients with IBD (340 Crohn disease (CD) and 209 ulcerative colitis (UC)) were studied. Forty-eight malignancies, including 39 (81.3%) non-melanoma skin cancers, 3 (6.3%) haematologic malignancies and 6 (15.4%) solid-organ malignancies, were identified, and 92 cases of serious infection were detected. IBD duration (odds ratio (OR) = 1.08; 95% confidence interval (CI) = 1.03-1.13) and ileocolonic CD (OR = 4.96; 95% CI = 1.13-21.71) were associated with increased odds of overall cancer. Compared with patients not previously exposed to the given class of immunosuppression assessed, the development of overall malignancy was not higher with thiopurine exposure (OR = 1.00; 95% CI = 0.50-2.24) or anti-tumour necrosis factor-alpha (TNF-α) exposure (OR = 0.78; 95% CI = 0.37-1.64). Similarly, compared with patients not exposed, infection risk was not affected by thiopurine (OR = 0.74; 95% CI = 0.46-1.20) or anti-TNF exposure (OR = 0.60; 95% CI = 0.38-0.95). Factors including ileocolonic CD and increasing IBD duration were associated with higher malignancy risk in this cohort. Compared with non-exposure, patients exposed to thiopurines were not at increased risk of malignancy or serious infection. Similarly, patients exposed to anti-TNF treatment did not experience increased rates of malignancy or serious infection compared to patients not exposed to this treatment.

Investigation of Combined Carotid Endarterectomy and Coronary Artery Bypass Graft Surgery Outcomes and Adverse Event Risk Factors in the Vascular Quality Initiative.

The purpose of this study was to investigate outcomes of simultaneous CEA and CABG utilizing the Vascular Quality Initiative (VQI). Additionally, we seek to investigate risks for both perioperative and long-term mortality and adverse neurological outcomes. All carotid endarterectomies in the VQI between January 2003 and May 2022 were queried. We identified 171,816 CEA in the database. We extracted 2 cohorts from these CEA. The first group was patients who underwent simultaneous carotid endarterectomy (CEA) and coronary artery bypass (CABG) (N = 3137). The second group encompassed patients who underwent CABG or percutaneous coronary artery angioplasty/stent within 5 years of ultimately undergoing CEA (N = 27,387). We investigated the following outcomes in a multivariable fashion: 1. Risks for mortality in long term follow-up for both cohorts combined; 2. Risks for ischemic event in the cerebral hemisphere ipsilateral to the CEA site after index hospital admission in follow up for both cohorts combined. Tertiary outcomes are also investigated in the manuscript. On multivariable analysis, patients undergoing simultaneous combined CEA and CABG had equivalent long-term survival to patients who underwent coronary revascularization within 5years of ultimately undergoing CEA. Five-year survival is noted to be 84.5% vs 86% with a Cox regression non-significant P-value (.203). Significant multivariable risks for reduced long term survival (P < .03 for all) included: advancing age (HR 2.48/year); smoking history (HR 1.26); Diabetes (HR 1.33); history of CHF (HR 1.66); history of COPD (HR 1.54); baseline renal insufficiency at the time of surgery (HR 1.30); anemia (HR1.64); lack of preoperative aspirin (HR 1.12); and lack of preoperative statin (HR 1.32); lack of patch placement at CEA site (HR 1.16); perioperative MI (HR 2.04); perioperative CHF (1.66); perioperative dysrhythmia (HR 1.36); cerebral reperfusion injury (HR 2.23); perioperative ischemic neurological event (HR 2.48); and lack of statin at discharge (HR 2.04). Amongst patients with documented neurological status in follow up, combined CEA and CABG had over 99% freedom from ischemic cerebral event ipsilateral to the CEA site after discharge. Combined CEA and CABG provides excellent long-term mortality prevention in patients with co-existing severe coronary and carotid atherosclerosis. Simultaneous CEA and CABG provides equivalent stroke prevention and long-term survival to both a cohort of patients undergoing coronary revascularization within 5years of CEA and patients undergoing isolated CEA or CABG in the literature. The two most impactful modifiable risk factors towards long-term stroke and mortality prevention for patients undergoing simultaneous CEA-CABG are patch placement at CEA site and adherence to statin medication therapy.

Occurrence of adverse events after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy in symptomatic uterine fibroids—a retrospective case-control study

Objectives Our study aims at the comprehensive analysis of adverse events (AEs) in patients with symptomatic uterine fibroids (UFs) who underwent magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) in the last 6 years in one of the major Polish centers performing this type of therapy. Methods The presented retrospective case-control study was conducted in the Department of Obstetrics and Gynecology, Pro-Familia Hospital, Rzeszów in cooperation with the Second Department of Obstetrics and Gynecology, Center of Postgraduate Medical Education, Warsaw. The study enrolled 372 women with symptomatic UFs who underwent MR-HIFU and reported AEs during or after the procedure. The occurrence of particular AEs was analyzed. Statistical comparison of two cohorts (patients with and without AEs) was conducted based on epidemiological factors, UF characteristics, fat layer thickness, the presence of abdominal scars and technical parameters of the procedure. Results The overall mean occurrence rate of AEs was 8.9% (n = 33). No major AEs were reported. The only statistically significant risk factor of AEs was the treatment of type II UFs according to Funaki (OR 2.12, CI 95%, p = 0.043). Other investigated factors did not have a statistically significant influence on AE occurrence. Abdominal pain was the most common AE. Conclusion Our data showed that MR-HIFU seemed to be a safe procedure. The AE rate after the treatment is relatively low. According to the obtained data it seems that the occurrence of AEs does not depend on the technical parameters of the procedure and the volume, position and location of UFs. Further prospective, randomized studies and with long follow-up are necessary to confirm the final conclusions.

WED-198 - Baseline hepatocyte ballooning is a risk factor for adverse events in patients with chronic hepatitis B complicated with non-alcoholic fatty liver disease

WED-198 - Baseline hepatocyte ballooning is a risk factor for adverse events in patients with chronic hepatitis B complicated with non-alcoholic fatty liver disease

Procedural outcome and risk prediction in young patients undergoing transvenous lead extraction. A GALLERY subgroup analysis

Abstract Funding Acknowledgements Type of funding sources: None. Background The prevalence of young patients with cardiac implantable electronic devices (CIED) is continuously rising. Along with this development there is a concomitant increase in the incidence of CIED-related complications, such as device-related infections and lead failure. Transvenous lead extraction (TLE) has evolved into an indispensable therapeutic option for such cases. Aim The aim of this study was to analyze patient characteristics and procedural outcomes of young patients undergoing TLE and to identify independent risk factors for adverse events. Methods We performed a subgroup analysis of all patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) who were 45 years or younger at the time of enrollment. Predictor variables for all-cause mortality, procedural complications and procedural failure were assessed via multivariate analyses. Results We identified 160 patients (6.3% of the GALLERY) aged 45 years or younger with a mean age of 35.3±7.6 years and 42.5% (n=68) female patients. Mean body mass index was 25.6±5.4 kg/m2 and the proportion of patient with highly reduced ejection fraction (LVEF &amp;lt;30%) was 11.3%. Comorbidities, such as arterial hypertension (AHT), diabetes mellitus (DM) and chronic kidney disease (CKD) were present in 23.8%, 6.3% and 5.0% of patients, respectively. Leading extraction indication was lead dysfunction in 51.3% of cases, followed by local infections in 20.6% and systemic infections in 16.9%. The most common device to be extracted were implantable cardioverter-defibrillators (ICD) with 52.5%. Mean number of leads per patient was 2.2±1.0. Median age of the oldest indwelling lead was 91.5 [54.75-137.5] months. Median procedural time was 88 [65-151.75] minutes. Overall complication rate was 3.8% with 1.9% minor and 1.9% major complications. Complete procedural success was achieved in 90.6% of cases. Clinical procedural success rate was 98.1%. Procedure-related mortality was 0.0%. All-cause in-hospital mortality was 2.5%, which was mainly due to septic shock. Multivariate analysis revealed CKD as independent predictor for all-cause mortality (OR: 51.48; 95% CI: 1.98-1340.0; p=0.018). Lead age ≥10 years (OR: 14.58, 95% CI: 1.36-156.2; p=0.027) was identified as sole independent risk factor for procedural complication. Conclusion Transvenous lead extraction in young patients is safe and effective with a procedure-related mortality rate of 0.0%. All-cause mortality was mainly driven by patients succumbing to CIED-related sepsis, despite successful extraction. Chronic kidney disease and lead age ≥10 years are relevant risk factors in young patients undergoing TLE.

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 &lt;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.