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Effect of center catheterization volume on risk of catastrophic adverse event after cardiac catheterization in children.

ABSTRACT: Procedural volume has been shown to be associated with outcome in cardiac catheterization and intervention in adults. The impact of center-level factors (such as volume) and their interaction with subject- and procedure-level factors on outcome after cardiac catheterization in children is not well described. We hypothesized that higher center catheterization volume would be associated with lower risk of catastrophic adverse events.We studied children and young adults 0 to 21 years of age undergoing one or more cardiac catheterizations at centers participating in the Pediatric Health Information Systems database between 2007 and 2012. Using mixed-effects multivariable regression, we assessed the association between center catheterization volumes and the risk of a composite outcome of death and/or initiation of mechanical circulatory support within 1 day of cardiac catheterization adjusting for patient- and procedure-level factors.A total of 63,994 procedures performed on 40,612 individuals from 38 of 43 centers contributing data to the Pediatric Health Information Systems database were included. The adjusted risk of the composite outcome was 0.1%. Increasing annual catheterization laboratory volume was independently associated with reduced risk of the composite outcome (odds ratio per a 100-procedure/y increment 0.78 [95% CI 0.65-0.93], P < .006). Younger age at catheterization, previous cardiac operation in the same admission as the catheterization, preprocedural vasoactive medications, and hemodialysis were also independently associated with an increased risk of adverse outcomes.Higher cardiac catheterization laboratory volume was associated with reduced risk of catastrophic adverse outcome in the immediate postcatheterization period in children. The observed benefit of catheterization at a larger volume center may be attributable to transmissible best practices or inextricable benefits of larger systems.

SUBMITTER: O'Byrne ML

PROVIDER: S-EPMC4451573 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Effect of center catheterization volume on risk of catastrophic adverse event after cardiac catheterization in children.

O'Byrne Michael L ML Glatz Andrew C AC Shinohara Russell T RT Jayaram Natalie N Gillespie Matthew J MJ Dori Yoav Y Rome Jonathan J JJ Kawut Steven S

American heart journal 20150303 6

<h4>Background</h4>Procedural volume has been shown to be associated with outcome in cardiac catheterization and intervention in adults. The impact of center-level factors (such as volume) and their interaction with subject- and procedure-level factors on outcome after cardiac catheterization in children is not well described. We hypothesized that higher center catheterization volume would be associated with lower risk of catastrophic adverse events.<h4>Methods</h4>We studied children and young ...[more]

PMID: 26027620

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Project description:BackgroundCardiac catheterization is the standard of care procedure for diagnosis, choice of therapy, and longitudinal follow-up of children and adults with pulmonary hypertension (PH). However, the procedure is invasive and has risks associated with both the procedure and recovery period.ObjectivesThe purpose of this study was to identify risk factors for catastrophic adverse outcomes in children with PH undergoing cardiac catheterization.MethodsWe studied children and young adults up to 21 years of age with PH undergoing 1 or more cardiac catheterization at centers participating in the Pediatric Health Information Systems database between 2007 and 2012. Using mixed-effects multivariable regression, we assessed the association between pre-specified subject- and procedure-level covariates and the risk of the composite outcome of death or initiation of mechanical circulatory support within 1 day of cardiac catheterization after adjustment for patient- and procedure-level factors.ResultsA total of 6,339 procedures performed on 4,401 patients with a diagnosis of PH from 38 of 43 centers contributing data to the Pediatric Health Information Systems database were included. The observed risk of composite outcome was 3.5%. In multivariate modeling, the adjusted risk of the composite outcome was 3.3%. Younger age at catheterization, cardiac operation in the same admission as the catheterization, pre-procedural systemic vasodilator infusion, and hemodialysis were independently associated with an increased risk of adverse outcomes. Pre-procedural use of pulmonary vasodilators was associated with reduced risk of composite outcome.ConclusionsThe risk of cardiac catheterization in children and young adults with PH is high relative to previously reported risk in other pediatric populations. The risk is influenced by patient-level factors. Further research is necessary to determine whether knowledge of these factors can be translated into practices that improve outcomes for children with PH.

Project description:Objective The rate and predictors of respiratory adverse events (RAEs) during transport discharged from operating room after interventional cardiac catheterization in children remain unclear. This study aimed to investigate the incidence and predictors, and to construct a nomogram for predicting RAEs during transport in this pediatric surgical treatment. Methods This prospective cohort study enrolled 290 consecutive pediatric patients who underwent ventricular septal defects (VSD), atrial septal defects (ASD), and patent ductus arteriosus (PDA) between February 2019 and December 2020. Independent predictors were used to develop a nomogram, and a bootstrap resampling approach was used to conduct internal validation. Composite RAEs were defined as the occurrence of at least 1 complication regarding laryngospasm, bronchospasm, apnea, severe cough, airway secretions, airway obstruction, and oxygen desaturation. Results The rate of RAEs during transport was 23.1% (67 out of 290). Multivariate analysis identified age (vs. ≤3 years, adjusted odds ratio (aOR) = 0.507, 95% conﬁdence interval (CI), 0.268–0.958, P = 0.036), preoperative upper respiratory tract infections (URI, aOR = 2.335, 95% CI, 1.223–4.460, P = 0.01), type of surgery (vs. VSD, for ASD, aOR = 2.856, 95% CI, 1.272–6.411, P = 0.011; for PDA, aOR = 5.518, 95% CI, 2.425–12.553, P < 0.001), morphine equivalent (vs. ≤0.153 mg/kg, aOR = 2.904, 95% CI, 1.371–6.150, P = 0.005), atropine usage (aOR = 0.463, 95% CI, 0.244–0.879, P = 0.019), and RAEs during extubation to transport (aOR = 5.004, 95% CI, 2.633–9.511, P < 0.001) as independent predictors of RAEs during transport. These six candidate predictors were used to develop a nomogram, which showed a C-statistic value of 0.809 and good calibration (P = 0.844). Internal validation revealed similarly good discrimination (C-statistic, 0.782; 95% CI, 0.726–0.837) and calibration. Decision curve analysis (DCA) also demonstrated the clinical usefulness of the nomogram. Conclusion The high rate of RAEs during transport reminds us of the need for more medical care and attention. The proposed nomogram can reliably identify pediatric patients at high risk of RAEs during transport and guide clinicians to make proper transport plans. Our findings have important and meaningful implications for RAEs risk prediction, clinical intervention and healthcare quality control.

Project description:BackgroundCoronary artery disease (CAD) is influenced by genetic variation and traditional risk factors. Polygenic risk scores (PRS), which can be ascertained before the development of traditional risk factors, have been shown to identify individuals at elevated risk of CAD. Here, we demonstrate that a genome-wide PRS for CAD predicts all-cause mortality after accounting for not only traditional cardiovascular risk factors but also angiographic CAD itself.MethodsIndividuals who underwent coronary angiography and were enrolled in an institutional biobank were included; those with prior myocardial infarction or heart transplant were excluded. Using a pruning-and-thresholding approach, a genome-wide PRS comprised of 139 239 variants was calculated for 1503 participants who underwent coronary angiography and genotyping. Individuals were categorized into high PRS (hiPRS) and low-PRS control groups using the maximally selected rank statistic. Stratified analysis based on angiographic findings was also performed. The primary outcome was all-cause mortality following the index coronary angiogram.ResultsIndividuals with hiPRS were younger than controls (66 years versus 69 years; P=2.1×10-5) but did not differ by sex, body mass index, or traditional risk-factor profiles. Individuals with hiPRS were at significantly increased risk of all-cause mortality after cardiac catheterization, adjusting for traditional risk factors and angiographic extent of CAD (hazard ratio, 1.6; 95% CI, 1.2-2.2; P=0.004). The strongest increase in risk of all-cause mortality conferred by hiPRS was seen among individuals without angiographic CAD (hazard ratio, 2.4; 95% CI, 1.1-5.5; P=0.04). In the overall cohort, adding hiPRS to traditional risk assessment improved prediction of 5-year all-cause mortality (area under the receiver-operating curve 0.70; 95% CI, 0.66-0.75 versus 0.66; 95% CI, 0.61-0.70; P=0.001).ConclusionsA genome-wide PRS improves risk stratification when added to traditional risk factors and coronary angiography. Individuals without angiographic CAD but with hiPRS remain at significantly elevated risk of mortality.

Project description:BackgroundAdalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult rheumatoid arthritis (RA), and subsequently approved for pediatric treatment of various autoimmune diseases in children of different ages. Due to genetic differences between children and adults in terms of physiology and immunity, there is a need to explore the safety of adalimumab in children in the real world. The aim of this study is to identify potential adverse event (AE) signals associated with the use of adalimumab in pediatric patients (<18 years old) using data from the FDA Adverse Event Reporting System (FAERS).MethodsAEs associated with adalimumab in pediatric patients reported in the FAERS database from the first quarter (Q1) of 2017 to the third quarter (Q3) of 2022 were systematically gathered. Reporting odds ratio (ROR), the proportional reporting ratio (PRR), the information component (IC), and the empirical Bayes geometric mean (EBGM) were used to assess the relationship between adalimumab and AEs in children.ResultsOut of 8,363,304 reports collected from the FAERS database during the study period, 3819 reports on children on adalimumab were identified. Adalimumab-related AEs reports were concentrated on 10 toxicity areas and a total of 202 positive signals were detected, of which injection site papule (ROR = 261.97) and intestinal fistula (ROR = 122.09) had the strongest signals. Unexpected significant AEs, including intestinal obstruction, immunodeficiency, abdominal abscess, and Takayasu's arteritis might also occur. In comparison with patients of all ages in the same time window, the median onset time of children was shorter (99 vs. 149 days). Most of the AE cases occurred in children within the first 1 (1.71%), 2 (8.12%), and 3 months (8.39%) and had early failure types after adalimumab initiation. Methotrexate, folic acid, prednisone, azathioprine, and mesalamine were the top five drugs used concomitantly for adalimumab-associated AEs.ConclusionsWhen adalimumab is used in children, especially in the first 3 months of treatment, in addition to the AEs recorded in the drug package insert, close attention should be paid to the new potential AEs off-label to ensure the safety of adalimumab in children.

Project description:BACKGROUND:Cardiac catheterization is the gold standard for assessment and follow-up of patients with pulmonary hypertension (PH). To date, there are limited data about the factors that influence the risk of catastrophic adverse events after catheterization in this population. METHODS AND RESULTS:A retrospective multicenter cohort study was performed to measure risk of catastrophic adverse outcomes after catheterization in children and young adults with PH and identify risk factors for these outcomes. All catheterizations in children and young adults, aged 0 to 21 years, with PH at hospitals submitting data to the IMPACT (Improving Adult and Congenital Treatment) registry between January 1, 2011, and December 31, 2015, were studied. Using mixed-effects multivariable regression, we assessed the association between prespecified subject-, procedure-, and center-level covariates and the risk of death, cardiac arrest, or mechanical circulatory support during or after cardiac catheterization. A total of 8111 procedures performed in 7729 subjects at 77 centers were studied. The observed risk of the composite outcome was 1.4%, and the risk of death before discharge was 5.2%. Catheterization in prematurely born neonates and nonpremature infants was associated with increased risk of catastrophic adverse event, as was precatheterization treatment with inotropes and lower systemic arterial saturation. Secondary analyses demonstrated the following: (1) increasing volumes of catheterization in patients with PH were associated with reduced risk of composite outcome (odds ratio, 0.8 per 10 procedures; P=0.002) and (2) increasing pulmonary vascular resistance and pulmonary artery pressures were associated with increased risk (P<0.0001 for both). CONCLUSIONS:Young patients with PH are a high-risk population for diagnostic and interventional cardiac catheterization. Hospital experience with PH is associated with reduced risk, independent of total catheterization case volume.

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Effect of center catheterization volume on risk of catastrophic adverse event after cardiac catheterization in children.

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Effect of center catheterization volume on risk of catastrophic adverse event after cardiac catheterization in children.

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