scholarly journals Procedural Risk in Congenital Cardiac Catheterization (PREDIC 3 T)

Author(s):  
Brian P. Quinn ◽  
Mary Yeh ◽  
Kimberlee Gauvreau ◽  
Fatima Ali ◽  
David Balzer ◽  
...  

Background Advancements in the field, including novel procedures and multiple interventions, require an updated approach to accurately assess patient risk. This study aims to modernize patient hemodynamic and procedural risk classification through the creation of risk assessment tools to be used in congenital cardiac catheterization. Methods and Results Data were collected for all cases performed at sites participating in the C3PO (Congenital Cardiac Catheterization Project on Outcomes) multicenter registry. Between January 2014 and December 2017, 23 119 cases were recorded in 13 participating institutions, of which 88% of patients were <18 years of age and 25% <1 year of age; a high‐severity adverse event occurred in 1193 (5.2%). Case types were defined by procedure(s) performed and grouped on the basis of association with the outcome, high‐severity adverse event. Thirty‐four unique case types were determined and stratified into 6 risk categories. Six hemodynamic indicator variables were empirically assessed, and a novel hemodynamic vulnerability score was determined by the frequency of high‐severity adverse events. In a multivariable model, case‐type risk category (odds ratios for category: 0=0.46, 1=1.00, 2=1.40, 3=2.68, 4=3.64, and 5=5.25; all P ≤0.005) and hemodynamic vulnerability score (odds ratio for score: 0=1.00, 1=1.27, 2=1.89, and ≥3=2.03; all P ≤0.006) remained independent predictors of patient risk. Conclusions These case‐type risk categories and the weighted hemodynamic vulnerability score both serve as independent predictors of patient risk for high‐severity adverse events. This contemporary procedure‐type risk metric and weighted hemodynamic vulnerability score will improve our understanding of patient and procedural outcomes.

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Andrew C Glatz ◽  
Natalie M Jayaram ◽  
Michael L O’Byrne ◽  
Yan Li ◽  
Paul S Chan ◽  
...  

Background: The association between institutional procedural volume and outcomes has been demonstrated for many procedures within the field of cardiology, but whether this relationship pertains to congenital cardiac catheterization is unknown. Methods: Using the IMPACT® (Improving Pediatric and Adult Congenital Treatment) Registry, we identified all catheterizations between 2011 and 2013 at 64 U.S. centers. Programs were categorized as small (<150 cases/year), medium (150 to 300 cases/year), large (300-500 cases/ year), and very large (>500 cases/ year). Hierarchical logistic regression, adjusted for patient and procedural characteristics, was used to determine the association between annual procedural volume and occurrence of a major adverse event (cardiac arrest; arrhythmia requiring permanent pacemaker; tamponade; air embolus; embolic stroke; device malposition, thrombus, or embolization; new requirement for dialysis; event requiring extracorporeal membrane oxygenation or left ventricular assist device; unplanned cardiac, vascular, or other surgery; or subsequent cardiac catheterization). Results: Among 64 hospitals, there were 19 small, 15 medium, 19 large, and 11 very large programs. Among 33,825 catheterizations, a major adverse event occurred in 711 (2.1%). In unadjusted analysis, major adverse events differed based upon annual volume, with a major adverse event occurring in 79 (2.8%) cases at small, 145 (2.3%) cases at medium, 234 (2.1%) cases at large, and 253 (1.9%) cases at very-large programs (p=0.01). After adjusting for patient and procedural risk factors, there was no association between annual procedure volume and occurrence of a major adverse event (odds ratio 0.96 [95% Confidence Interval=0.90, 1.04] per increase in annual volume of 100, p=0.32). There was no interaction between procedure-type risk group and volume on outcomes (p=0.49). Conclusions: Although the unadjusted risk of adverse events was lower in centers performing more catheterizations for congenital heart disease, this association between center volume and outcomes did not persist after adjustment for patient and procedural case-mix. The hospital sample size and low event rate may have limited our ability to detect significant differences.


2021 ◽  
Vol 10 (23) ◽  
pp. 5648
Author(s):  
Marian Mikus ◽  
Thomas Welchowski ◽  
Ehrenfried Schindler ◽  
Martin Schneider ◽  
Nathalie Mini ◽  
...  

Background: Children with congenital heart disease require repeated catheterization. Anesthetic management influences the procedure and may influence outcome; however, data and recommendations are lacking for infants. We studied the influence of sedation versus general anesthesia (GA) on adverse events during catheterization for children <2 years old. Methods: We conducted a monocentric, retrospective study of all catheterization procedures (2008–2013). High-severity adverse event (HSAE) rates were compared using propensity-score-adjusted models, including pre- and intra-procedural variables. Results: 803 cases (619 patients) (368 (46%) GA, 435 (54%) sedation) with a mean age of 6.9 ± 6.1 months were studied. The conversion rate (GA after sedation) was 18 (4%). Hospital stay was 4.9 ± 4.0 and 4.1 ± 2.5 (p = 0.01) after GA or sedation, respectively. HSAE occurred in 75 (20%) versus 40 (9%) (p < 0.01) in GA versus sedation procedures, respectively. Risk factors (multivariable analysis) were older patients (p = 0.05), smaller weights (p < 0.01), palliated status (OR 3.2 [1.2–8.9], p = 0.02), two-ventricle physiology (OR 7.3 [2.7–20.2], p < 0.01), cyanosis (OR 4.6 [2.2–9.8], p < 0.01), pulmonary hypertension (OR 5.6 [2.0–15.5], p < 0.01), interventional catheterization (OR 1.8 [1.1–3.2], p = 0.02) and procedure-type risk category 4 (OR 28.9 [1.8–455.1], p = 0.02). Sedation did not increase the events rate and decreased the requirement for hemodynamic support (OR 5.2 [2.2–12.0], p < 0.01). Conclusion: Sedation versus GA for cardiac catheterization in children <2 years old is safe and effective with regard to HSAE. Sedation also decreases the requirement for hemodynamic support. Paradoxical effects (older age and two-ventricle physiology) on risk have been found for this specific age cluster.


2020 ◽  
Vol 90 ◽  
pp. 19-31
Author(s):  
D. V. Zobkov ◽  
◽  
A. A. Poroshin ◽  
A. A. Kondashov ◽  
◽  
...  

Introduction. A mathematical model is presented for assigning protection objects to certain risk categories in the field of fire safety. The model is based on the concepts of the probability of adverse effects of fires causing harm (damage) of various extent and severity to the life or health of citizens, and the acceptable risk of harm (damage) from fires. Goals and objectives. The purpose of the study is to develop the procedure for assigning protection objects to a certain category of risk of harm (damage) based on estimates of the probability of fires with the corresponding severity consequences, to determine the acceptable level of risk of harm (damage) due to the fires, to calculate and develop numerical values of criteria for assigning objects of protection to the appropriate risk categories. Methods. The boundaries of the intervals corresponding to certain risk categories are determined by dividing the logarithmic scale of severity of adverse effects of fires into equal segments. Classification methods are used to assign objects of protection to a specific risk category. Results and discussion. Based on the level of severity of potential negative consequences of a fire, risk categories were determined for groups of protection objects that are homogeneous by type of economic activity and by functional fire hazard classes. The risk category for each individual object of protection is proposed to be determined using the so-called index of "identification of a controlled person" within a group of objects that are homogeneous by type of economic activity and class of functional fire hazard. Depending on the risk category, the periodicity of planned control and supervision measures in relation to the specific object of protection under consideration is determined, taking into account its socio-economic characteristics and the state of compliance with fire safety requirements by the controlled person. Conclusions. To develop criteria for classifying protection objects that are homogeneous in terms of economic activity and functional fire hazard classes, the probability of negative consequences of fires, that are causing harm (damage) of various extent and severity to the life or health of citizens, and the acceptable risk of causing harm (damage) as a result of fires, is used. The risk category for each individual object of protection is determined taking into account socio-economic characteristics of the object that affect the level of ensuring its fire safety, as well as the criteriaof integrity of the subordinate person that characterize the probability of non-compliance with mandatory fire safety requirements at the object of protection. Calculations are made and numerical values of criteria for assigning protection objects that are homogeneous in terms of economic activity and functional fire hazard classes to a certain category of risk are proposed. Key words: object of protection, probability of fire, acceptable level of risk, risk category, dangerous factor of fire, death and injury of people.


2019 ◽  
Vol 14 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Viswam Subeesh ◽  
Eswaran Maheswari ◽  
Hemendra Singh ◽  
Thomas Elsa Beulah ◽  
Ann Mary Swaroop

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.


2020 ◽  
Vol 01 ◽  
Author(s):  
Carla Pires ◽  
Ana Fernandes

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.


Author(s):  
Noriko Morioka ◽  
Masayo Kashiwagi

Despite the importance of patient safety in home-care nursing provided by licensed nurses in patients’ homes, little is known about the nationwide incidence of adverse events in Japan. This article describes the incidence of adverse events among home-care nursing agencies in Japan and investigates the characteristics of agencies that were associated with adverse events. A cross-sectional nationwide self-administrative questionnaire survey was conducted in March 2020. The questionnaire included the number of adverse event occurrences in three months, the process of care for patient safety, and other agency characteristics. Of 9979 agencies, 580 questionnaires were returned and 400 were included in the analysis. The number of adverse events in each agency ranged from 0 to 47, and 26.5% of the agencies did not report any adverse event cases. The median occurrence of adverse events was three. In total, 1937 adverse events occurred over three months, of which pressure ulcers were the most frequent (80.5%). Adjusting for the number of patients in a month, the percentage of patients with care-need level 3 or higher was statistically significant. Adverse events occurring in home-care nursing agencies were rare and varied widely across agencies. The patients’ higher care-need levels affected the higher number of adverse events in home-care nursing agencies.


Cancers ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 24
Author(s):  
Gerald McGwin

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Leiherer ◽  
A Muendlein ◽  
C.H Saely ◽  
R Laaksonen ◽  
M Laaperi ◽  
...  

Abstract   The Coronary Event Risk Test (CERT) is a validated cardiovascular risk predictor that uses circulating ceramide concentrations to allocate patients into one of four risk categories. This test has recently been updated (CERT-2), now additionally including phosphatidylcholine concentrations. The purpose of this study was to investigate the power of CERT and CERT-2 to predict cardiovascular mortality in patients with cardiovascular disease (CVD). We investigated a cohort of 999 patients with established CVD. Overall, comparing survival curves (figure) for over 12 years of follow up and the predictive power of survival models using net reclassification improvement (NRI), CERT-2 was the best predictor of cardiovascular mortality, surpassing CERT (NRI=0.456; p=0.01) and also the 2019 ESC-SCORE (NRI=0.163; p=0.04). Patients in the highest risk category of CERT as compared to the lowest category had a HR of 3.63 [2.09–6.30] for cardiovascular death; for CERT-2 the corresponding HR was 6.02 [2.47–14.64]. Among patients with T2DM (n=322), the HR for cardiovascular death was 3.00 [1.44–6.23] using CERT and 7.06 [1.64–30.50] using CERT-2; the corresponding HRs among non-diabetic subjects were 2.99 [1.20–7.46] and 3.43 [1.03–11.43], respectively. We conclude that both, CERT and CERT-2 scores are powerful predictors of cardiovascular mortality in CVD patients, especially in those patients with T2D. Performance is even higher with CERT-2. Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 12 ◽  
pp. 204209862110128
Author(s):  
Hanan Khalil ◽  
Dimi Hoppe ◽  
Nabil Ameen

Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety


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