Higher Risk Of Adverse Events Research Articles

Mild haemoglobin drop and clinical outcomes in acute coronary syndrome patients: finding from the BleeMACS registry.

Haemoglobin drop is common in acute coronary syndrome (ACS) patients and correlates with poor prognosis. However, the association between mild haemoglobin drop and adverse clinical outcome remains insufficiently investigated. This study aimed to examine the association between in-hospital haemoglobin drop and risk for adverse clinical outcomes in ACS patients, especially those with mild drop. Included patients from the BleeMACS (Bleeding complications in a Multicenter registry of patients discharged after an Acute Coronary Syndrome) registry were categorized into three groups by the presence and amount of in-hospital haemoglobin drop (non-drop, mild drop and severe drop). The cut-off point between mild drop and severe drop is ≥ 3 g/dL. Multivariate Cox regression was used to assess the association between haemoglobin drop and major adverse cardiac endpoints (MACE). Patients taking potent P2Y12 inhibitors were selected for the additional analysis. Propensity score matching was used to avoid selective bias in the additional analysis. Of 6911 patients, 4949 patients (71.6%) experienced in-hospital haemoglobin drop. Compare with non-drop group, patients with haemoglobin drop had higher risk of MACE [adjusted hazard ratio (HR) = 1.36, 95% CI: 1.03-1.80 for mild drop group; adjusted HR = 1.70, 95% CI: 1.07-2.68 for severe drop group]. Patients in mild drop group were less likely to receive potent P2Y12 inhibitors at discharge (mild drop group vs. severe drop group vs. non-drop group: 10.9% vs. 10.7% vs. 23.8%). After propensity score matching adjustment among patients with potent P2Y12 inhibitors, patients in mild drop group were not associated with an increased risk of MACE than those in non-drop group (adjusted HR = 1.52, 95% CI: 0.49-4.72). In-hospital haemoglobin drop was common in ACS patients and associated with a higher risk for adverse events. Reduced prescription for potent P2Y12 inhibitors may be responsible for poor prognoses among patients with mild haemoglobin drop.

Incidence of Retinal Detachment, Macular Edema, and Ocular Hypertension after Neodymium:Yttrium-Aluminum-Garnet Capsulotomy: A Population-Based Nationwide Study—The French YAG 2 Study

To estimate the incidence and assess the risk factors associated with 3 adverse events (AEs) after neodymium:yttrium-aluminum-garnet posterior capsulotomy (Nd:YAG-caps): ocular hypertension (OHT), macular edema (ME), and retinal detachment (RD). Observational cohort study using a nationwide claims database. Adults who underwent Nd:YAG-caps between 2014 and 2017, with no ocular disease history in the year before. Patients who underwent Nd:YAG-caps were identified using data from the French national representative sample and followed up for 12 months postprocedure. The time to AE was assessed using the Kaplan-Meier method. Factors associated with AE were assessed using Cox models. Neodymium:YAG-caps epidemiology, patients' characteristics, proportion of patients with AE, and hazard ratios (HRs) associated with variables identified as factors associated with AEs. During the study period, 6210 patients received Nd:YAG-caps (7958 procedures). The mean age (± standard deviation) at Nd:YAG-caps was 75.0 (± 10.3) years. The 3-month and 12-month overall AE rates (≥ 1 AE of interest) were 8.6% and 13.3%, respectively. Among patients with ≥ 1 AE of interest, 68.4% of AEs occurred within 3 months post-Nd:YAG-caps. Three-month rates were ≈5% for OHT and ME. Retinal detachment remained ≤ 0.5% over follow-up. Cox models showed that patients with Nd:YAG-caps performed within 1 year after cataract surgery had a higher risk of AEs than those with later Nd:YAG-caps (hazard ratio [HR], 1.314 [1.034-1.669], P= 0.0256), notably ME (HR, 1.500 [1.087-2.070], P = 0.0137). Diabetic patients were more at risk of OHT (HR, 1.233 [1.005-1.513], P= 0.0448) and ME (HR, 1.810 [1.446-2.266], P < 0.0001) than nondiabetic patients. Patients with Nd:YAG-caps performed between 1 and 2 years after cataract surgery were more at risk of OHT than patients with later Nd:YAG-caps (HR, 1.429 [1.185-1.723], P= 0.0002). According to a national claims database, OHT and ME were the most frequent AEs of interest post-Nd:YAG-caps, mainly observed within 3 months postprocedure, highlighting the need for a close follow-up during this period or a delayed capsulotomy. Diabetes and an early Nd:YAG-caps after cataract surgery were among the main drivers for AE occurrence. Proprietary or commercial disclosure may be found after the references.

Effects of zoledronic acid on osteosarcoma progression and metastasis: systematic review and meta-analysis.

Zoledronic Acid (ZA) has been shown to inhibit Osteosarcoma (OSA) progression in preclinical studies. However, the use of ZA as an intervention for OSA treatment and management remains controversial. A systematic review and meta-analysis of randomized-controlled trials comparing the use of ZA with standard treatment vs. standard treatment alone for OSA patients after resection was conducted. Primary outcomes assessed event-free survival (EFS) and overall survival (OS) rates, while secondary outcomes assessed impact of ZA on metastatic spread, histological response and adverse events occurrence. A literature search was conducted using EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials. The Cochrane risk of bias tool (version 2) was used to assess trial quality. RevMan v5.4 was used for the meta-analysis. The between-trial heterogeneity was assessed using the Chi2 test and the I2 statistic and the GRADE methodology was utilized to assess certainty of evidence. Two studies were considered eligible for qualitative synthesis and meta-analysis. ZA had no benefit on EFS (HR, 0.95; 95% CI, 0.48-1.88; p-value 0.88), however, when compared to standard treatment it reduced OS (HR, 1.98; 95% CI, 1.49-2.64; p-value < 0.00001). ZA did not deter lung metastasis (RR, 2.56; 95% CI, 0.35-18.60; p-value 0.35), and neither did it increase good histological response (RR, 0.97; 95% CI, 0.90-1.05; p-value 0.48). ZA treatment was associated with higher risk of adverse events. Based on existing data, the use of ZA as adjuvant therapy is not recommended for the treatment of OSA patients.

525 PROGNOSTIC RELEVANCE OF DEMOGRAPHIC FACTORS IN CARDIAC MAGNETIC RESONANCE-PROVEN ACUTE MYOCARDITIS. A COHORT STUDY

Abstract Aims Acute myocarditis (AM) is a heterogeneous condition with variable estimates of survival. Contemporary criteria for the diagnosis of clinically suspected AM enable non-invasive assessment, resulting in greater sensitivity and more representative cohorts. We aimed to describe the demographic characteristics and long-term outcomes of patients with AM diagnosed using non-invasive criteria. Methods and Results A total of 199 patients with cardiac magnetic resonance (CMR)-confirmed AM were included. The majority (n=130, 65%) were male and the average age was 39±16 years. Half of patients were White (n=99, 52%) with the remainder from Black and Minority Ethnic (BAME) groups. The most common clinical presentation was with chest pain (n=156, 78%), with smaller numbers presenting with breathlessness (n=25, 13%) and arrhythmias (n=18, 9%). Patients admitted with breathlessness were sicker and more often required inotropes, steroids, and renal replacement therapy (p&amp;lt;0.001, p&amp;lt;0.001, and p=0.01, respectively). Over a median follow-up of 53 (IQR 34–76) months, 11 patients (6%) experienced an adverse outcome, defined as a composite of all-cause mortality, resuscitated cardiac arrest, and appropriate implantable cardioverter defibrillator (ICD) therapy. Patients in the arrhythmia group had a worse prognosis, with a nearly 7-fold risk of adverse events (hazard ratio [HR] 6.97; 95% Confidence Interval [CI] 1.87–26.00, p=0.004). Sex and ethnicity were not significantly associated with the outcome. Conclusions AM is highly heterogeneous with an overall favourable prognosis. Three quarters of patients with AM present with chest pain and this is associated with a benign prognosis. AM presenting with life-threatening arrhythmias is associated with higher risk of adverse events.

Prevalence of adverse events during ticagrelor versus clopidogrel treatment and its association with premature discontinuation of dual antiplatelet therapy in East Asian patients with acute coronary syndrome.

Clinical evidence raises the issues regarding the high risk of adverse events and serious bleeding in East Asian patients receiving standard-dose ticagrelor treatment. We sought to evaluate the association between adverse events and their associations with premature discontinuation of dual antiplatelet therapy (DAPT). We enrolled East Asian patients presented with acute coronary syndrome who took DAPT with 90-mg ticagrelor (n = 270) or 75-mg clopidogrel (n = 674). During 1-month treatment, antiplatelet effect was evaluated with the VerifyNow P2Y12 assay, and the occurrence of Bleeding Academic Research Consortium (BARC) bleeding and modified Medical Research Council (mMRC) dyspnea was assessed with the dedicated questionnaire. During 1-month follow-up, patients on ticagrelor showed the higher risks of bleeding (any BARC type: 45.6% vs. 23.6%; odds ratio [OR], 2.71 and BARC 1 or 2 type: 45.2% vs. 22.1%; OR, 2.90, respectively) and dyspnea (26.3% vs. 13.6%; OR, 2.25) compared with those on clopidogrel. In a receiver-operating characteristics curve analysis to predict bleeding risk, ticagrelor showed a lower cutoff of low platelet reactivity (LPR) (P2Y12 reaction unit [PRU] ≤ 20) than clopidogrel (PRU ≤ 110). Early occurrence of bleeding episode was significantly associated with LPR phenotype (OR, 2.68), not type of P2Y12 inhibitor. In multivariate analysis, type of P2Y12 inhibitor (ticagrelor vs. clopidogrel: OR, 2.19) and bleeding episode (OR, 2.94) were independent predictors for dyspnea occurrence. During 1-year follow-up, DAPT with ticagrelor showed a higher risk of premature discontinuation compared to DAPT with clopidogrel (27.8% vs. 4.7%; adjusted HR, 8.84), which risk appeared frequent during the first month (14.4%) during DAPT with ticagrelor. Early occurrence of bleeding and dyspnea synergistically increased a risk of DAPT non-adherence, irrespective of type of P2Y12 inhibitor. This analysis is the first evidence to show the different cutoff of low platelet reactivity during the reversible (ticagrelor) versus irreversible P2Y12 inhibitor (clopidogrel). Early occurrence of bleeding and dyspnea is very common during standard-dose ticagrelor treatment in East Asian patients, which show a close association with premature DAPT discontinuation. [https://www.clinicaltrials.gov], identifier[NCT046 50529].

Early treatment with a sodium-glucose co-transporter 2 inhibitor in high-risk patients with acute heart failure: Rationale for and design of the EMPA-AHF trial

The aim of the EMPA-AHF trial is to clarify whether early initiation of a sodium-glucose co-transporter 2 inhibitor before clinical stabilization is safe and beneficial for patients with acute heart failure (AHF) who are at a high risk of adverse events. The EMPA-AHF trial is a randomized, double-blind, placebo-controlled, multicentre trial examining the efficacy and safety of early initiation of empagliflozin (10 mg once daily). In total, 500 patients admitted for AHF will be randomized 1:1 to either empagliflozin 10 mg daily or placebo at 47 sites in Japan. Study entry requires hospitalization for AHF with dyspnoea, signs of volume overload, elevated natriuretic peptide, and at least one of the following criteria: estimated glomerular filtration rate <60 mL/min/1.73 m2; already taking ≥40 mg of furosemide daily before hospitalization; and urine output of <300 mL within 2 hours after an adequate dose of intravenous furosemide. Patients will be randomized within 12 hours of hospital presentation, with treatment continued up to 90 days. The primary outcome is the clinical benefit of empagliflozin on the win ratio for a hierarchical composite endpoint consisting of death within 90 days, heart failure rehospitalization within 90 days, worsening heart failure during hospitalization, and urine output within 48 hours after treatment initiation. The EMPA-AHF trial is the first to evaluate the efficacy and safety of early initiation of empagliflozin in patients with AHF considered to be at high risk under conventional treatment.

Prevalence and associated factors of self-reported medical errors and adverse events among operating room nurses in China.

In recent decades, the prominence of medical errors (MEs) and adverse events (AEs) is fueled by several studies performed across the world. Correspondingly, a high prevalence of medical errors and adverse events have been reported. Operating room nurses (ORNs) were indispensable members of the operating process, and any kind of MEs or AEs from ORNs may cause serious results and even death to the patients. However, to the best of our knowledge, the prevalence and associated factors of MEs and AEs were never reported among ORNs in China, which is the largest country in population and health services quantity in the world. This is a cross-sectional study, which was conducted among ORNs in China, and 787 valid questionnaires were analyzed in this study. MEs, AEs, gender, age, married status, religious belief, academic degree, manager or not, working years, working hours/week, physical disease, and mental health were evaluated in this study. MEs were evaluated by eight questions about the occurrence of eight kinds of MEs for the ORNs. For ORNs with MEs, further questions about clinical harm to the patients were interviewed, which analyzed AEs. Kessler 10 was used to evaluate the ORNs' mental health. Logistic regression was conducted to examine the factors associated with MEs and AEs. The prevalence of MEs and AEs was 27.7 and 13.9% among ORNs, respectively. The most frequent MEs that occurred among ORNs were from surgical instruments (9.1%), disinfection (9.0%), equipment and consumables (8.9%), and specimen management (7.8%). MEs were positively associated with lower working years, poor mental health, and physical disease. The physical disease was positively associated with AEs. The prevalence of perceived MEs and AEs was at a higher level than other kinds of nurses. Fresh ORNs with physical and mental health problems were the risk population for MEs, and ORNs with physical disease were at a higher risk for AEs. All the findings implied that MEs and AEs were an important issue for ORNs, and ORNs with physical and mental health problems should be paid attention to control MEs and AEs.

Impact of Pre-operative Opioid Use on Racial Disparities in Adverse Outcomes Post Total Knee and Hip Arthroplasty.

The growing opioid epidemic in the USA has underlying racial disparities dimensions. Also, studies have shown that patients from minority racial groups are at higher risk of adverse events following major orthopedic surgery. The aim of our study was to determine whether pre-operative opioid-use disorders (OUDs) impacted racial disparities in the likelihood of patients experiencing adverse post-operative outcomes following TKA and THA. Data about patients undergoing TKA and THA were collected from the 2005-2014 National Inpatient Sample databases. Regression modeling was used to assess the impact of OUDs on odds of adverse outcomes comparing racial groups. The adverse outcomes included any in-hospital post-surgical complications, prolonged length of stay (LOS), and nonhome discharge. In our fully adjusted regression models using White patients as the reference group, we found that OUDs were associated with racial disparities in prolonged LOS and nonhome discharge. In the non-OUD group, Black patients had significantly higher odds of longer LOS (OR: 1.35, 95% CI: 1.26-1.46, p-value: < 0.0001), whereas those with history of OUD had non-significantly lower odds of longer LOS (OR: 0.94, 95% CI: 0.69-1.29, p-value: 0.71). Similarly, for the outcome of nonhome discharges, Black patients in the non-OUD group had significantly higher odds (OR: 1.31, 95% CI: 1.21-1.43, p-value: < 0.0001) and those with a history of OUD had non-significantly lower odds (OR: 0.91, 95% CI: 0.64-1.29, p-value: 0.59). Significant racial disparities are present in adverse events among patients in the non-OUD group, but those disparities attenuated in the OUD group.

Prognostic implication of coronary slow flow assessed by cTFC in patients with myocardial infarction with Non-obstructive coronary arteries

BackgroundCoronary slow flow (CSF) is common and linked to worse cardiovascular events and life-threatening arrhythmias. However, the clinical implication of CSF among myocardial infarction with the non-obstructive coronary artery (MINOCA) has never been studied. We aimed to evaluate the impact of CSF on the MINOCA population. MethodsPatients diagnosed with MINOCA were consecutively selected. The corrected TIMI frame count (cTFC) was used to evaluate the coronary flow. CSF was defined as cTFC greater than 27 frames per second (FPS) in any of the three coronary arteries. Major adverse cardiovascular events (MACE) are the primary endpoint. Cox regression analysis was used to evaluate the association between CSF and MACE. ResultsA total of 158 patients with MINOCA were enrolled, of which 54 (34.2%) patients had CSF. Forty incidents of MACE occurred during the median 28 months of follow-up. The MACE incidence was higher among patients who presented with CSF than the normal coronary flow patients (35.2% vs. 20.2%, p = 0.040). In the Kaplan-Meier analysis, CSF patients had significantly higher rates of MACE (log-rank P = 0.034). Multivariate Cox regression analysis showed that CSF was an independent predictor linked to an increased hazard of MACE (adjusted HR, 2.76; 95% CI, 1.34–5.67; P = 0.006). ConclusionThe presence of CSF is associated with a higher risk of adverse events and is an independent predictor of clinical outcomes among patients with MINOCA. This result suggests that CSF might serve as a robust tool to stratify MINOCA patients.

Comparaison de la valeur prédictive d’un test de performance physique standardisé à celle du phénotype de fragilité selon Fried pour les événements indésirables chez les octogénaires

The population of adults aged 80 years and older is heterogenous with some being robust and others having a higher risk for adverse events. This study compares the predictive value of two tools used to identify older adults who are at higher risk for adverse outcomes: frailty phenotype according to Fried and a standardized physical performance test. The BELFRAIL population-based cohort of 567 community-dwelling adults aged 80 years and older living in Belgium. Fried frailty phenotype and physical performance test (gait, chair stand, standing balance tests and putting on and off a cardigan). The predictive value of the two tools in predicting mortality (up to 5.1 ± 0.25 years), hospitalization (3.0 ± 0.25 years) and decline in activities of daily living (after 1.7 ± 0.21 years) was compared using reclassification statistics and decision curve analysis. Frail participants according to Fried phenotype and those in the lowest quartile of the physical performance test score had higher risk for mortality and hospitalization. Harrell C and area under operator curve were similar (< 0.70). Reclassification statistics and net benefit in decision curve analysis showed no significant difference between the two tools in identifying higher risk for mortality, hospitalization and functional decline. In a cohort of community-dwelling adults 80 years and older a standardized physical performance test was as good as the Fried frailty phenotype in identifying higher risk for adverse outcomes.

Endoscopic submucosal dissection in colorectal neoplasia performed with a waterjet system-assisted knife: higher en-bloc resection rate than conventional technique.

Colorectal endoscopic submucosal dissection (ESD) is burdened by its associated high risk of adverse events and long procedure time. Recently, a waterjet-assisted knife was introduced to simplify and speed up the procedure. The aim of this study was to evaluate the efficacy and safety of waterjet-assisted ESD (WESD) compared to that of the conventional ESD (CESD) technique. The charts of 254 consecutive patients who underwent colorectal ESD between January 2014 and February 2021 for colorectal neoplasms were analyzed. The primary outcome was the en-bloc resection rate. Secondary outcomes were complete and curative resection rates, the need to switch to a hybrid ESD, procedure speed, the adverse event rates, and the recurrence rates. Approximately 174 neoplasias were considered, of which, 123 were removed by WESD and 51 by CESD. The en-bloc resection rate was higher in the WESD group (94.3% vs. 84.3%). Complete resection rates and curative resection rates were similar. The need to switch to a hybrid ESD was greater during CESD (39.2% vs. 13.8%). Procedure speed and adverse event rates were similar. During follow-up, one recurrence occurred after a WESD. WESD allows a high rate of en-bloc resections and less frequently requires a rescue switch to the hybrid ESD compared to CESD.

Risk Factors for Arrhythmic Death, Overall Mortality, and Ventricular Tachyarrhythmias Requiring Shock After Myocardial Infarction

The VEST (Vest Prevention of Early Sudden Death Trial) showed a trend toward decreased sudden death and lower overall mortality with a wearable cardioverter-defibrillator (WCD) in the postmyocardial infarction (post-MI) period. However, it is unclear which patients should receive WCD therapy. We aimed to identify the risk factors for arrhythmic death, all-cause mortality, and ventricular tachyarrhythmias requiring appropriate shock to identify patients most likely to benefit from a WCD. The VEST trial included patients with acute MI with ejection fraction ≤35%. Using logistic regression, 7 risk factors were evaluated for association with arrhythmic death, all-cause mortality, and appropriate shock. Among 2,302 participants, 44 had arrhythmic death (1.9%) and 86 died of any cause (3.7%). Among 1,524 participants randomized to WCD, 20 experienced appropriate shock (1.3%) over 90days. In the multivariable analyses, lower systolic blood pressure (SBP; odds ratio [OR] 1.64 per 10mm Hg) and higher heart rate at discharge (OR 1.19 per 10beats/min) were associated with arrhythmic death. Lower SBP (OR 1.37) and higher heart rate (OR 1.10) were associated with all-cause mortality. Higher heart rate (OR 1.20) was associated with appropriate shock. Patients with both SBP ≤100 and heart rate ≥100 were at increased odds of arrhythmic death (OR 4.82), all-cause mortality (OR 3.10), and appropriate shock (OR 6.13). In patients with acute MI and reduced ejection fraction, lower SBP and higher heart rate at discharge were strongly associated with arrhythmic death and all-cause mortality. In conclusion, these risk factors identify a select group at high risk of adverse events in a setting where WCD therapy is reasonable.

Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data.

Balloon atrial septostomy (BAS) is an essential catheterization procedure for congenital heart lesions. Recently, a balloon catheter for static BAS was approved for the first time in Japan as an alternative to the conventional pull-through BAS. Despite the expected increase in the use of static BAS, reports on its safety are scarce worldwide.Methods and Results: Data on static and pull-through BAS registered in a national registry between 2016 and 2018 were collected. During the study period, 247 sessions of static BAS and 588 sessions of pull-through BAS were performed on a total of 674 patients. Patients who underwent static BAS were older (P<0.001). The incidence of serious adverse events (4.3% vs. 0.9%, P=0.03) and the overall incidence of adverse events (8.1% vs. 3.2%, P=0.03) were higher in static BAS than in pull-through BAS. Among patients who underwent static BAS, the risk factor for adverse events was a body weight <3 kg at the time of the procedure (odds ratio: 4.3 [confidence interval: 1.7-11], P=0.003). This nationwide study revealed differences in patient background between static and pull-through BAS, as well as a higher incidence of adverse events related to static BAS. Patients weighing <3 kg are at high risk for adverse events after static BAS and may require surgical and circulatory support backup.

Treatment of asymptomatic gallstones in children with hereditary spherocytosis requiring splenectomy

BackgroundGallstones are common in hereditary spherocytosis (HS) and other chronic hemolytic diseases, with most affected patients being asymptomatic. Whether and how asymptomatic gallstones should be treated is controversial. MethodsWe conducted a retrospective cohort study of pediatric patients with HS and asymptomatic gallstones to compare the clinical outcomes between the observation group (followed up with gallstones in situ) and the intervention group (cholecystectomy or cholecystolithotomy). The primary outcome was the composite of adverse outcomes, including gallstone-associated, gallbladder surgery-associated, and splenectomy-associated events. Secondary outcomes included the changes in the size and number of gallstones and the recurrence of gallstones. ResultsFifty-two patients were included (38 in the observation group and 14 in the intervention group), with a mean follow-up length of 5.2 years. Patients in the intervention group had a lower incidence of primary outcomes (7.1% vs. 42.1%) than patients in the observation group (OR, 0.12; 95%CI, 0.01–0.99). Patients with gallstones >5 mm in diameter had the highest risk of adverse events (47.4%). In the observation group, gallstone growth, disappearance, and stability were observed in 19.4%, 29.0%, and 51.6% of splenectomized HS patients, respectively. Small gallstones (diameter ≤5 mm) or sludge were more likely to be associated with disappearance (P = 0.04). ConclusionsMost asymptomatic gallstones grow or persist in splenectomized HS patients for an extended period. Surgical treatment of asymptomatic gallstones in HS patients requiring splenectomy is associated with a lower risk of adverse outcomes. Levels of evidenceIII (retrospective comparative study).

Prophylactic tamsulosin can reduce the risk of urinary retention after surgery in male patients: A systematic review and meta-analysis

The meta-analysis aimed to estimate the efficacy of prophylactic tamsulosin on postoperative urinary retention (POUR) in male patients. Papers were searched in the PubMed, Embase, Web of Science, and Cochrane Library databases with predetermined keywords up to March 1, 2022. The studies reporting the preventive efficacy of prophylactic tamsulosin on POUR among men were identified. Pooled risk ratios (RRs) were calculated based on the random-effects model. Meta-regression was performed to explore potential sources of heterogeneity. There were 11 studies with 1,046 patients in the tamsulosin group and 1,113 patients in the control group. The risk of POUR was significantly lower in the tamsulosin group (123/1,046 [11.8%] vs. 238/1,119 [19.0%]; RR = 0.61; 95% confidence interval [CI] 0.43 to 0.87; P = 0.006; heterogeneity: I 2 = 57%; P = 0.009). Administration of tamsulosin was related to higher risk of adverse events (57/688 [8.3%] vs. 33/624 [5.3%]; RR = 1.68; 95% CI: 1.13 to 2.48; P = 0.010; heterogeneity: I 2 = 33%; P = 0.20). The level of evidence and mean age of the included patients were identified as the potential sources of heterogeneity. The present meta-analysis indicated that prophylactic tamsulosin helps in preventing POUR and younger patients might benefit more from this preventive regimen. Administrating tamsulosin was also associated with a possibly higher risk of adverse events.

Abstract 14030: Characterization of Lipid Profiles, Lipid Management Medications, Medical Resources Utilization and Health Care Outcomes in Medicare Age Patients With COPD in an Academic Center

Introduction: Recent studies have shown dysregulation in lipid metabolism may contribute to various lung diseases including COPD. The lipid profile in patients with COPD is incompletely understood which may affect the clinical outcomes. Objective: To perform elaborative investigation on lipid profile in COPD patients and clinical outcomes Methods: A retrospective database reviews from single academic medical center Results: The study population included 1360 patients, over the age of 65 with a diagnosis of COPD in a 2-year period. The presence of coronary artery disease, cerebrovascular disease, and peripheral artery disease was measured. The variables measured include lipid profile, lipid medications, number of hospitalizations, number of clinic and emergency room visits (Table 1). 38% of COPD patients have cardiovascular disease (CVD) compared to the prevalence of vascular disease in the population as a whole (27%). The average triglyceride (TG) in the patients with COPD was greater than TG in patients without COPD (150 vs. 135, p=.03). 38% of COPD patients with CVD have a TG &gt; 150. 19% of COPD patients with coexisting vascular disease had an LDL &gt;100. Anti-lipid medications in COPD patients were sub-optimally utilized. Conclusions: COPD patients had poorly controlled lipid profile including elevated TG and LDL levels. These patients are at high risk for adverse events that include CVD, frequent ER visits and hospital readmission. The anti-lipid medications were underutilized. It is highly recommended to identify barriers to optimum care and seek resources and strategy to mitigate difficulties in lipid management in patients with COPD to prevent adverse outcomes.

Abstract 13836: Factors Associated With a Complicated Hospital Course in Patients With Spontaneous Coronary Artery Dissection: A Report of the iSCAD Registry

Introduction: Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome in younger patients. Though associated with lower short and long-term mortality, there is still a need to identify the subset of patients who are at a higher risk of adverse events or a more complex hospital course. Methods: Using data from the iSCAD Registry, a multicenter registry of patients with SCAD, univariate and multivariable logistic regression models were created to assess the association between factors related to the index admission and a complicated hospital course. A complicated hospital course was defined as the occurrence of either a recurrent myocardial infarction (MI), cerebrovascular accident (CVA), a new arrhythmia, heart failure requiring diuretics, ≥ 2 angiograms performed, or a hospital admission of more than 5 days. The multivariable logistic regression model was developed using a backward selection approach with exit criteria set at p &gt;0.2. Patients presenting with cardiac arrest were excluded. Results: Of the 414 patients included, 159 patients (38.4%) had a complicated hospital course: 76 patients had a prolonged admission, 27 had a recurrent MI, 1 had a CVA, 39 had an arrhythmia, 13 had heart failure requiring diuretics and 72 had ≥ 2 angiograms in the index admission. The final model showed that patients who had structural complications related to MI, fibromuscular dysplasia (FMD), or a history of cardiomyopathy were more likely to experience a complicated hospital course (Table). Finally, patients on anticoagulation were at a higher risk of having the composite outcome but this may be secondary to the indication for anticoagulation. Conclusions: The presence of structural complications related to MI, a diagnosis of FMD, or a history of cardiomyopathy were associated with an increased risk of a complicated hospital course related to SCAD. Identification of risk factors for a complex inpatient stay may help to tailor the acute care of SCAD patients.

Development and validation of novel multimorbidity indices for older adults.

Measuring multimorbidity in claims data is used for risk adjustment and identifying populations at high risk for adverse events. Multimorbidity indices such as Charlson and Elixhauser scores have important limitations. We sought to create a better method of measuring multimorbidity using claims data by incorporating geriatric conditions, markers of disease severity, and disease-disease interactions, and by tailoring measures to different outcomes. Health conditions were assessed using Medicare inpatient and outpatient claims from subjects age 67 and older in the Health and Retirement Study. Separate indices were developed for ADL decline, IADL decline, hospitalization, and death, each over 2 years of follow-up. We validated these indices using data from Medicare claims linked to the National Health and Aging Trends Study. The development cohort included 5012 subjects with median age 76 years; 58% were female. Claims-based markers of disease severity and disease-disease interactions yielded minimal gains in predictive power and were not included in the final indices. In the validation cohort, after adjusting for age and sex, c-statistics for the new multimorbidity indices were 0.72 for ADL decline, 0.69 for IADL decline, 0.72 for hospitalization, and 0.77 for death. These c-statistics were 0.02-0.03 higher than c-statistics from Charlson and Elixhauser indices for predicting ADL decline, IADL decline, and hospitalization, and <0.01 higher for death (p < 0.05 for each outcome except death), and were similar to those from the CMS-HCC model. On decision curve analysis, the new indices provided minimal benefit compared with legacy approaches. C-statistics for both new and legacy indices varied substantially across derivation and validation cohorts. A new series of claims-based multimorbidity measures were modestly better at predicting hospitalization and functional decline than several legacy indices, and no better at predicting death. There may be limited opportunity in claims data to measure multimorbidity better than older methods.

Efficacy and safety of Tripterygium wilfordii polyglycosides for diabetic kidney disease: an overview of systematic reviews and meta-analyses

BackgroundRecently, several systematic reviews (SRs) and meta-analyses (MAs) of Tripterygium wilfordii polyglycoside (TWP) have reported significant benefits on diabetic kidney disease (DKD). However, the adoption of TWP for DKD remains uncommon. This study aimed to evaluate and summarize the current evidence on TWP for DKD.MethodsWe searched PubMed, Web of Science, SINOMED, Embase, Cochrane Library, CNKI database, Wan Fang database, and VIP database, up to June 4, 2022. SRs of TWP on DKD were included. Two authors independently assessed eligibility, extracted data, and graded the quality of evidence. We appraised the reporting and methodological quality of the included studies based on the PRISMA statement and AMSTAR 2.ResultsWe included 19 SRs and MAs. Seventeen MAs of proteinuria were identified; all suggested TWP exhibited anti-proteinuria function on DKD. Of these, only 2 were graded as moderate quality of evidence. Eighteen MAs estimated the reno-protective effect of TWP; nine of them showed that TWP improved renal function, including 2 MAs rated as moderate quality of evidence. Eleven SRs showed the serum albumin level was elevated in the TWP group. Of those, four were rated as moderate quality of evidence. Fourteen MAs of the incidence of adverse events were included. Twelve MAs indicated TWP increased the risk of adverse events, of which 4 were graded with moderate quality of evidence. Twenty of the 27 items in the PRISMA checklist were adequately reported with more than 75% compliance among the included SRs, while five of the 12 items in the PRISMA checklist for abstract were found to have less than 50% compliance. The overall reporting quality of SRs published in English was higher than that in Chinese. The methodological quality of the included SRs appraised by AMSTAR-2 ranged from critically low to moderate.ConclusionTWP appears effective for DKD on improving proteinuria and increasing the level of serum albumin, accompanied by a higher risk of adverse events. The evidence would be more credible and valuable to guide decision if the quality of the SRs and primary studies is improved.Systematic review registrationPROSPERO CRD42021249560

Complex Abdominal Wall Reconstruction with Biologic Mesh for Ventral/Umbilical Hernias in Patients with Cirrhosis

Introduction: Patients with cirrhosis undergoing non-liver transplant surgery have a higher risk of adverse events than those without cirrhosis. Methods: This study had retrospective and prospective components, including all cirrhotic patients at our center with complex abdominal wall reconstruction (CAWR) for ventral/umbilical hernia repair with biologic mesh between December 2016 and November 2021. Results: We studied 37 patients with cirrhosis. Their mean age was 57.2 years. 64.9% were male. The median BMI was 28.1 kg/m2. Ascites was present in 83.3% of patients. The other most common comorbidities were alcohol abuse (67.6%), hypertension (37.8%), and diabetes (24.3%). All complications in aggregate occurred in 11 patients (29.7%). Six patients (16.2%) underwent reoperation. Surgical site infection (SSI) occurred in 5 patients (13.5%). Four deaths occurred within 90 days (11.2% cumulative mortality). By 120 days, there were 5 deaths (14.2% mortality, but none due to the operation). Three predictors (mesh size ≥200 sq cm, lysis of adhesions, and VHWG grade ≥3) achieved an area under the receiver operating characteristic curve (AUROC) for SSI of 0.938 and two predictors (BMI ≥35 kg/m2 and preoperative aspirin) yielded an AUROC of 0.825 for 120-day mortality. Conclusion: Our results suggest that CAWR for ventral/umbilical hernias among cirrhotic patients is feasible given a dedicated CAWR team in collaboration with transplant surgeons and a transplant hepatologist. The rates of adverse outcomes were low or at the midpoint of the range of the study-specific estimates.