OBJECTIVES: The objective of this study was to assess contemporary use of operator directed sedation (ODS) and anesthesiologist care (AC) in the pediatric/congenital cardiac catheterization laboratory (PCCL), specifically evaluating whether the use of operator-directed sedation was associated with increased risk of major adverse events.

BACKGROUND: The safety of ODS relative to AC during PCCL procedures has been questioned.

METHODS: A multicenter, retrospective cohort study was performed studying procedures habitually performed with ODS or AC at IMPACT (Improving Adult and Congenital Treatment) registry hospitals using ODS for ≥5% of cases. The risks for major adverse events (MAE) for ODS and AC cases were compared, adjusted for case mix. Current recommendations were evaluated by comparing the ratio of observed to expected MAE for cases in which ODS was inappropriate (inconsistent with those guidelines) with those for similar risk AC cases, as well as those in which ODS or AC was appropriate.

RESULTS: Of the hospitals submitting data to IMPACT, 28 of 101 met inclusion criteria. Of the 7,042 cases performed using ODS at these centers, 88% would be inappropriate. Use of ODS was associated with lower likelihood of MAE both in observed results (p < 0.0001) and after adjusting for case-mix (odds ratio: 0.81; p = 0.006). Use of AC was also associated with longer adjusted fluoroscopy and procedure times (p < 0.0001 for both). The observed/expected ratio for ODS cases with high pre-procedural risk (inappropriate for ODS) was significantly lower than that for AC cases with comparable pre-procedural risk. Across a range of pre-procedural risks, there was no stratum in which risk for MAE was lower for AC than ODS.

CONCLUSIONS: Across a range of hospitals, ODS was used safely and with improved efficiency. Clinical judgment better identified cases in which ODS could be used than pre-procedural risk score. This should inform future guidelines for the use of ODS and AC in the catheterization laboratory.

<p><strong>BACKGROUND: </strong>Previous estimates of life-threatening event (LTE) risk in Wolff-Parkinson-White (WPW) are limited by selection bias inherent to tertiary referral-based cohorts.</p>

<p><strong>OBJECTIVE: </strong>This analysis sought to measure LTE incidence in children with WPW in a large contemporary representative population.</p>

<p><strong>METHODS: </strong>A retrospective cohort study was conducted using claims data from the IBM MarketScan® Research Databases, evaluating WPW patients (age 1-18 years) from any encounter between 1/1/2013 and 12/31/2018. Subjects with congenital heart disease (CHD) and cardiomyopathy (CM) were excluded. The primary outcome was diagnosis of ventricular fibrillation (VF); a composite outcome, LTE, was defined as occurrence of VF and/or cardiac arrest. VF and LTE rates were compared to matched representative non-WPW controls (3:1 ratio).</p>

<p><strong>RESULTS: </strong>Prevalence of WPW was 0.03% (8,733/26,684,581) over median follow-up of 1.6 years (IQR 0.7-2.9). Excluding CHD/CM, 6,946 subjects were analyzed. LTE occurred in 49 subjects, including VF in 20. Incidence of VF was 0.8 events per 1000 person-years, and incidence of LTE was 1.9 events per 1000 person-years. There were no occurrences of VF in controls; rate of LTE was 70 times greater in WPW (0.7%, 95% CI: 0.5-0.9%) than in controls (0.01%, 95% CI: 0-0.02%).</p>

<p><strong>CONCLUSION: </strong>Use of a large claims dataset allowed for evaluation of VF and LTE risk in an unselected pediatric WPW population. The observed range of 0.8-1.9 events per 1000 person-years is consistent with prior reports from selected populations. Comparison of event rates to matched controls confirms and quantifies the significant elevation in VF and LTE risk in pediatric WPW.</p>

<p><strong>BACKGROUND: </strong>The risks and benefits of pharmacologic treatment and operative closure of patent ductus arteriosus (O-PDA) in premature infants remain controversial. Recent series have demonstrated the feasibility of transcatheter PDA closure (TC-PDA) in increasingly small infants. The effect of this change on practice has not been evaluated.</p>

<p><strong>METHODS: </strong>A multicenter observational study of infants treated in neonatal intensive care units in hospitals contributing data to the Pediatric Health Information Systems Database from January 2007 to December 2017 was performed to study trends in the propensities for (1) mechanical closure of PDA and (2) TC-PDA versus O-PDA, as well as interhospital variation in practice.</p>

<p><strong>RESULTS: </strong>A total of 6,214 subjects at 44 hospitals were studied (5% TC-PDA). Subject median gestational age was 25 weeks (interquartile range: 24-27 weeks). Median age at closure was 24 days (interquartile range: 14-36 days). The proportion of all neonatal intensive care unit patients undergoing either O-PDA or TC-PDA decreased (3.1% in 2007 and 0.7% in 2017, P &lt; .001), whereas the proportion in which TC-PDA was used increased significantly (0.1% in 2007 to 29.0% in 2017). Case-mix-adjusted multivariable models similarly demonstrated increasing propensity to pursue TC-PDA (odds ratio [OR] 1.66 per year, P &lt; .001) with acceleration of the trend after 2014 (OR 2.46 per year, P &lt; .001) as well as significant practice variation (P &lt; .001, median OR 4.6) across the study period.</p>

<p><strong>CONCLUSIONS: </strong>In the face of decreasing closure of PDA, the use of TC-PDA increased dramatically with significant practice variability. This demonstrates that there is equipoise for potential clinical trials.</p>

<p>Background Cardiac catheterization is an important but costly component of health care for young patients with cardiac disease. Measurement of variation in their cost between hospitals and identification of the reasons for this variation may help reduce cost without compromising quality. Methods and Results Using data from Pediatric Health Information Systems Database from January 2007 to December 2015, the costs of 9 procedures were measured. Mixed-effects multivariable models were used to generate case-mix-adjusted estimates of each hospital's cost for each procedure and measure interhospital variation. Procedures (n=35&nbsp;637) from 43 hospitals were studied. Median costs varied from $8249 (diagnostic catheterization after orthotopic heart transplantation) to $38&nbsp;909 (transcatheter pulmonary valve replacement). There was marked variation in the cost of procedures between hospitals with 3.5- to 8.9-fold differences in the case-mix-adjusted cost between the most and least expensive hospitals. No significant correlation was found between hospitals' procedure-specific mortality rates and costs. Higher procedure volume was not associated with lower cost except for diagnostic procedures in heart transplant patients and pulmonary artery angioplasty. At the hospital level, the proportion of cases that were outliers (&gt;95th percentile) was significantly associated with rank in terms of cost (Spearman's ρ ranging from 0.37 to 0.89, P&lt;0.01). Conclusions Large-magnitude hospital variation in cost was not explained by case-mix or volume. Further research is necessary to determine the degree to which variation in cost is the result of differences in the efficiency of the delivery of healthcare services and the rate of catastrophic adverse outcomes and resultant protracted and expensive hospitalizations.</p>

<p><strong>OBJECTIVES: </strong>The purpose of this study was to evaluate the association between the method of procedural sedation and outcomes for congenital cardiac catheterization procedures.</p>

<p><strong>BACKGROUND: </strong>The safety of operator-directed sedation (ODS) in the pediatric/congenital cardiac catheterization laboratory has been questioned. To our knowledge, the relative safety of ODS versus general anesthesia (GA) in these cases has not to date been critically evaluated.</p>

<p><strong>METHODS: </strong>A single-center retrospective cohort study was performed to compare the relative safety, cost, and times of catheterization procedures performed with ODS and those performed with GA from a cardiac anesthesiologist. The risk of adverse outcomes was compared using propensity-score-adjusted models. Using the same propensity score, procedure times and relative charges were also compared.</p>

<p><strong>RESULTS: </strong>Over the study period, 4,424 procedures in 2,547 patients were studied. Of these, 27% of cases were performed with ODS. ODS procedures were 70% diagnostic procedures, 17% device closure of patent ductus arteriosus, 5% balloon pulmonary valvuloplasty, and 3% pulmonary artery angioplasty. The risk of adverse event in adjusted models for ODS cases was significantly lower than in GA cases (odds ratio: 0.66; 95% confidence interval: 0.45 to 0.95; p&nbsp;= 0.03). Total room time and case time were also significantly shorter (p&nbsp;&lt; 0.001). Professional (charge ratio: 0.88; p&nbsp;&lt; 0.001) and hospital (charge ratio: 0.84; p&nbsp;&lt; 0.001) charges for ODS cases were also lower than those for GA cases.</p>

<p><strong>CONCLUSIONS: </strong>This study demonstrates that clinical judgment can identify subjects in whom ODS is not associated with increased risk of adverse events. The use of ODS was associated with reduced case times and charges. In combination, these findings suggest that the selective use of ODS can allow for greater efficiency and higher value care without sacrificing safety.</p>

<p><strong>BACKGROUND: </strong>The arterial switch operation (ASO) is the gold standard operative correction of neonates with transposition of the great arteries and intact ventricular septum, with excellent operative survival. The associations between patient and surgeon characteristics and outcomes are well understood, but the associations between variation in preoperative care and outcomes are less well studied.</p>

<p><strong>METHODS: </strong>A multicenter retrospective cohort study of infants undergoing neonatal ASO between January 2010 and September 2015 at hospitals contributing data to the Pediatric Health Information Systems database was performed. The association between preoperative care (timing of ASO, preoperative use of balloon atrial septostomy, prostaglandin infusion, mechanical ventilation, and vasoactive agents) and operative outcomes (mortality, length of stay, and cost) was studied with multivariable mixed-effects models.</p>

<p><strong>RESULTS: </strong>Over the study period, 2159 neonates at 40 hospitals were evaluated. Perioperative mortality was 2.8%. Between hospitals, the use of adjuvant therapies and timing of ASO varied broadly. At the subject level, older age at ASO was associated with higher mortality risk (age &gt;6 days: odds ratio, 1.90; 95% CI, 1.11-3.26; P=0.02), cost, and length of stay. Receipt of a balloon atrial septostomy was associated with lower mortality risk (odds ratio, 0.32; 95% CI, 0.17-0.59; P&lt;0.001), cost, and length of stay. Later hospital median age at ASO was associated with higher odds of mortality (odds ratio, 1.15 per day; 95% CI, 1.02-1.29; P=0.03), longer length of stay ( P&lt;0.004), and higher cost ( P&lt;0.001). Other hospital factors were not independently associated with the outcomes of interest.</p>

<p><strong>CONCLUSIONS: </strong>There was significant variation in preoperative care between hospitals. Some potentially modifiable aspects of perioperative care (timing of ASO and septostomy) were significantly associated with mortality, length of stay, and cost. Further research on the perioperative care of neonates is necessary to determine whether modifying practice on the basis of the observed associations translates into improved outcomes.</p>