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

2021

401-413

2021 Feb 22

1876-7605

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.

10.1016/j.jcin.2020.10.054

JACC Cardiovasc Interv

33602437

Comparison of Outcomes of Pediatric Catheter Ablation by Anesthesia Strategy: A Report from the NCDR IMPACT Registry.

2021

2021 Jun 17

1941-3084

<p>- Anesthesia strategies for pediatric ablation procedures include general anesthesia (GA) and monitored anesthesia care (MAC). The effects of anesthesia strategy on arrhythmia inducibility and procedural outcomes have not been investigated. - A multicenter retrospective study was performed, utilizing data from the NCDR IMPACT Registry. Data from subjects 1-21 years undergoing elective first-time electrophysiology study (EPS) for evaluation of documented SVT, EAT, or PVC/VT from 4/1/16-12/31/19 were included, excluding cases with WPW, congenital heart disease, and/or cardiomyopathy. The primary outcome was a negative EPS, defined as failure to induce the clinical tachyarrhythmia. Secondary outcomes included ablation success and adverse events (AE). - 6621 subjects from 78 centers were evaluated: 49% male; mean age 13.3±3.8 years. GA was utilized in 5913 (89%), with MAC in 708 (11%). A negative EPS occurred in 9% of cases overall, with no difference by anesthesia strategy (9% GA vs. 10% MAC, p=0.2). In SVT and EAT, there was no significant difference in likelihood of a negative EPS by anesthesia strategy. In PVC/VT, there was a higher rate of negative EPS under GA (28% GA vs. 16% MAC, p=0.02), translating to a higher rate of non-ablation (34% GA vs. 14% MAC, p&lt;0.001). In multivariable models, GA was associated with negative EPS in PVC/VT (OR 2.2, 95% CI 1.1-4.4, p=0.03), but not in SVT or EAT. Acute ablation success was not different between strategies (94% GA vs. 94% MAC, p=0.2). Major AE were rare, with no differences between GA and MAC. - In this first report on pediatric ablation data in IMPACT, there were no differences between GA and MAC in SVT or EAT inducibility, acute ablation success, or major AE. GA was associated with higher rates of non-inducibility and non-ablation in PVC/VT cases. A MAC strategy should be considered for PVC/VT ablation in the pediatric population.</p>

10.1161/CIRCEP.121.009849

Circ Arrhythm Electrophysiol

34137629

Operator-Directed Procedural Sedation in the Congenital Cardiac Catheterization Laboratory.

2019

2019 Apr 05

1876-7605

<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>

10.1016/j.jcin.2019.01.224

JACC Cardiovasc Interv

30981573

Surgical and Catheter-Based Reinterventions Are Common in Long-Term Survivors of the Fontan Operation.

2017

2017 Sep

1941-7632

<p><strong>BACKGROUND: </strong>There are limited follow-up studies examining surgical and catheter-based reinterventions in long-term survivors of the Fontan operation.</p>

<p><strong>METHODS AND RESULTS: </strong>All 773 patients who underwent Fontan at our institution between 1992 and 2009 were retrospectively reviewed. Current information regarding post-Fontan intervention was available for 70%. By 20 years after Fontan, 65% of patients had experienced either surgical or transcatheter intervention. The median time to first reintervention was 9.8 years. Freedom from reoperation was 69% at 15 years and 63% at 20 years. The most common operations were pacemaker placement and Fontan revision. Risk factors for pacemaker placement included systemic left ventricle (hazard ratio [HR], 2.2; P=0.006) and lateral tunnel Fontan (HR, 4.3; P=0.001). Freedom from interventional catheterization was 53% at 15 years and 50% at 20 years. The most common procedures performed were fenestration closure and pulmonary artery intervention. Catheter intervention for anatomic indications was associated with Fontan after 2002 (HR, 2.1; P=0.007), Norwood operation (HR, 2.3; P=0.001), and longer cardiopulmonary bypass time (HR, 1.1 per 10 minutes; P=0.001). Catheter intervention for physiological indications was associated with prolonged post-Fontan pleural drainage (HR, 4.0; P&lt;0.001) and hypoplastic left heart syndrome (HR, 2.0; P=0.01).</p>

<p><strong>CONCLUSIONS: </strong>In this study of Fontan survivors, two thirds of patients required surgical or catheter-based reintervention by 20 years. Families should be counseled that the Fontan is typically not the final stage of single-ventricle palliation.</p>

10.1161/CIRCINTERVENTIONS.116.004924

Circ Cardiovasc Interv

28851719

Effect of Fontan-Associated Morbidities on Survival With Intact Fontan Circulation.

2017

2017 Mar 16

1879-1913

<p>Although survival after the Fontan operation has improved, little is known about the burden of major medical morbidities associated with the modern total cavopulmonary connection (TCPC). A total of 773 consecutive patients who underwent a first Fontan operation at our institution between 1992 and 2009 were retrospectively reviewed. All subjects underwent TCPC (53% lateral tunnel, 47% extracardiac conduit). Median length of follow-up was 5.3&nbsp;years (interquartile range 1.4 to 11.2), and 30% had follow-up &gt;10&nbsp;years. Freedom from a composite medical morbidity outcome (protein-losing enteropathy, plastic bronchitis, serious thromboembolic event, or tachyarrhythmia) was 47% at 20&nbsp;years (95% confidence interval [CI] 38 to 55). Independent risk factors for morbidity included pre-Fontan atrioventricular valve regurgitation (hazard ratio [HR] 1.7, 95% CI 1.2 to 2.4, p&nbsp;= 0.001), pleural drainage &gt;14&nbsp;days (HR 1.5, 95% CI 1.01 to 2.2, p&nbsp;= 0.04), and longer cross-clamp time (HR 1.2 per 10&nbsp;minutes, 95% CI 1.06 to 1.3, p&nbsp;= 0.004) at the time of TCPC. Surgical era, Fontan type, and ventricular morphology were not associated with the composite outcome. Presence of Fontan-associated morbidity was associated with a 36-fold increase in the risk of subsequent Fontan takedown, heart transplantation, or death (95% CI 17 to 76, p &lt;0.001). For patients without any component of the composite outcome, freedom from Fontan failure was 98% at 20&nbsp;years (95% CI 96 to 99). Medical morbidities after TCPC are common and significantly reduce the longevity of the Fontan circulation. However, for those patients who remain free from the composite morbidity outcome, 20-year survival with intact Fontan circulation is encouraging.</p>

10.1016/j.amjcard.2017.03.004

Am. J. Cardiol.

28385177

Long-term survival after the Fontan operation: Twenty years of experience at a single center.

2017

2017 Mar 06

1097-685X

<p><strong>OBJECTIVE: </strong>Existing studies of patients palliated with the Fontan operation are limited by heterogeneous patient populations and incomplete follow-up. This study aimed to describe long-term post-Fontan survival in a modern patient cohort.</p>

<p><strong>METHODS: </strong>All 773 patients who underwent a first Fontan operation at our institution between 1992 and 2009 were reviewed. The primary outcome was the composite endpoint of Fontan takedown, heart transplantation, or death before 2013.</p>

<p><strong>RESULTS: </strong>Follow-up rate was 99.2%. Survival with intact Fontan circulation was 94% at 1&nbsp;year (95% confidence interval [95% CI], 92%-95%), 90% at 10&nbsp;years (95% CI, 88%-92%), 85% at 15&nbsp;years (95% CI, 82%-88%), and 74% at 20&nbsp;years (95% CI, 67%-80%). Distinct risk factors were identified for early (≤1&nbsp;year) and late composite outcomes. Independent risk factors for early outcome included prolonged pleural drainage (hazard ratio [HR], 4.4; P&nbsp;&lt;&nbsp;.001), intensive care unit stay&nbsp;&gt;1&nbsp;week (HR, 2.4; P&nbsp;&lt;&nbsp;.001), Fontan before 1997 (HR, 3.3; P&nbsp;&lt;&nbsp;.001), preoperative atrioventricular valve regurgitation (HR, 2.0; P&nbsp;&lt;&nbsp;.001), and longer crossclamp time (HR, 1.3 per 10&nbsp;minutes; P&nbsp;&lt;&nbsp;.001). Late outcome was predicted by atrioventricular valve regurgitation prior to Fontan (HR, 2.0; P&nbsp;≤&nbsp;.001), and post-Fontan ICU stay&nbsp;&gt;1&nbsp;week (HR, 2.4; P&nbsp;&lt;&nbsp;.001).</p>

<p><strong>CONCLUSIONS: </strong>Long-term mortality after Fontan operation remains substantial. Risk factors for death or loss of Fontan circulation differ between the early and late postoperative periods. Long-term survival has not improved appreciably over the last decade, suggesting that alternatives to the Fontan are warranted.</p>

10.1016/j.jtcvs.2017.01.056

J. Thorac. Cardiovasc. Surg.

28341469

Improving Cardiac Surgical Site Infection Reporting and Prevention By Using Registry Data for Case Ascertainment.

2016

190-9

2016 Jan

1552-6259

<p><strong>BACKGROUND: </strong>The use of administrative data for surgical site infection (SSI) surveillance leads to inaccurate reporting of SSI rates [1]. A quality improvement (QI) initiative was conducted linking clinical registry and administrative databases to improve reporting and reduce the incidence of SSI [2].</p>

<p><strong>METHODS: </strong>At our institution, The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) and infection surveillance database (ISD) were linked to the enterprise data warehouse containing electronic health record (EHR) billing data. A data visualization tool was created to (1) use the STS-CHSD for case ascertainment, (2) resolve discrepancies between the databases, and (3) assess impact of QI initiatives, including wound alert reports, bedside reviews, prevention bundles, and billing coder education.</p>

<p><strong>RESULTS: </strong>Over the 24-month study period, 1,715 surgical cases were ascertained according to the STS-CHSD clinical criteria, with 23 SSIs identified through the STS-CHSD, 20 SSIs identified through the ISD, and 32&nbsp;SSIs identified through the billing database. The rolling 12-month STS-CHSD SSI rate decreased from 2.73% (21 of 769 as of January 2013) to 1.11% (9 of 813 as of December 2014). Thirty reporting discrepancies were reviewed to ensure accuracy. Workflow changes facilitated communication and improved adjudication of suspected SSIs. Billing coder education increased coding accuracy and narrowed variation between the 3 SSI sources. The data visualization tool demonstrated temporal relationships between QI initiatives and SSI rate reductions.</p>

<p><strong>CONCLUSIONS: </strong>Linkage of registry and infection control surveillance data with the EHR improves SSI surveillance. The visualization tool and workflow changes facilitated communication, SSI adjudication, and assessment of the QI initiatives. Implementation of these initiatives was associated with decreased SSI rates.</p>

10.1016/j.athoracsur.2015.07.042

Ann. Thorac. Surg.

26410159