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Multicenter Study
. 2021 Feb 22;14(4):401-413.
doi: 10.1016/j.jcin.2020.10.054.

Outcomes of Operator-Directed Sedation and Anesthesiologist Care in the Pediatric/Congenital Catheterization Laboratory: A Study Utilizing Data From the IMPACT Registry

Michael L O'Byrne  1 , Kevin F Kennedy  2 , James M Steven  3 , Kevin D Hill  4 , Reid C Chamberlain  4 , Marisa E Millenson  5 , Christopher L Smith  6 , Yoav Dori  6 , Matthew J Gillespie  6 , Jonathan J Rome  6 , Andrew C Glatz  7
Affiliations
Multicenter Study

Outcomes of Operator-Directed Sedation and Anesthesiologist Care in the Pediatric/Congenital Catheterization Laboratory: A Study Utilizing Data From the IMPACT Registry

Michael L O'Byrne et al. JACC Cardiovasc Interv. .

Abstract

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.

Keywords: congenital heart disease; health services research; outcomes research; pediatrics.

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Conflict of interest statement

Funding Support and Author Disclosures Dr. O’Byrne has received research support from the National Institutes of Health/National Heart, Lung, and Blood Institute (grant K23 HL130420-01). Dr. Hill has received research support from the National Centers for Advancing Translational Sciences (grant U01TR-001803-01). Dr. Chamberlain is supported by the National Institute of General Medical Sciences and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (grant T32GM086330). The specific study was supported by the American College of Cardiology Foundation. It was reviewed by the IMPACT registry research and publications committee during its planning, as was the resulting manuscript. However, the funding agencies had no role in the planning or execution of the study, nor did they edit the paper as presented. The paper represents the opinions of the authors alone. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1:
Figure 1:
Study population
Figure 2:
Figure 2:. Hospitals included in the study
This stacked bar graph depicts the total number of cases using operator-directed sedation (ODS gold) and anesthesia care (AC blue) at each hospital included in the study sorted by decreasing total annual case volume (y-axis). These 28 hospitals reflect 29% of the total cases in the IMPACT® registry.
Figure 3:
Figure 3:. Trends in ODS utilization over the study period
The proportion of cases performed using ODS (black diamonds boxes, brackets reflect 95% confidence intervals) at IMPACT® hospitals over the study period. That percentage decreased significantly over the study period (p<0.001).
Figure 4:
Figure 4:. Ratios of observed to expected major adverse events
Ratio of observed to expected outcomes (O/E ratio) for operator directed sedation (gold) and general anesthesia (blue) cases are depicted along with the top bound of 95% confidence intervals. Cases divided according to categories of CRISP score as per recent CHD-SCAI/SPA/CCAS recommendations.
Central Figure:
Central Figure:. Multivariable model for risk of major adverse events
This Forest plot demonstrates that after adjusting for measurable confounders (light blue diamonds) use of anesthesiologist care was associated with increased odds of major adverse events (yellow diamond). 95% Confidence intervals are depicted as brackets.
See this image and copyright information in PMC

Comment in

References

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