Association Between Remote Monitoring and Interstage Morbidity and Death in Patients With Single-Ventricle Heart Disease Across Socioeconomic Groups.

BACKGROUND: Despite improvements in survival over time, the mortality rate for infants with single-ventricle heart disease remains high. Infants of low socioeconomic status (SES) are particularly vulnerable. We sought to determine whether use of a novel remote monitoring program, the Cardiac High Acuity Monitoring Program, mitigates differences in outcomes by SES. METHODS AND RESULTS: Within the Cardiac High Acuity Monitoring Program, we identified 610 infants across 11 centers from 2014 to 2021. All enrolled families had access to a mobile application allowing for near-instantaneous transfer of patient information to the care team. Patients were divided into SES tertiles on the basis of 6 variables relating to SES. Hierarchical logistic regression, adjusted for potential confounding characteristics, was used to determine the association between SES and death or transplant listing during the interstage period. Of 610 infants, 39 (6.4%) died or were listed for transplant. In unadjusted analysis, the rate of reaching the primary outcome between SES tertiles was similar (P=0.24). Even after multivariable adjustment, the odds of death or transplant listing were no different for those in the middle (odds ratio, 1.7 [95% CI, 0.73-3.94) or highest (odds ratio, 0.997 [95% CI, 0.30, 3.36]) SES tertile compared with patients in the lowest (overall P value 0.4). CONCLUSIONS: In a large multicenter cohort of infants with single-ventricle heart disease enrolled in a digital remote monitoring program during the interstage period, we found no difference in outcomes based on SES. Our study suggests that this novel technology could help mitigate differences in outcomes for this fragile population of patients.

Adjusting for Congenital Heart Surgery Risk Using Administrative Data.

BACKGROUND: Congenital heart surgery (CHS) encompasses a heterogeneous population of patients and surgeries. Risk standardization models that adjust for patient and procedural characteristics can allow for collective study of these disparate patients and procedures. OBJECTIVES: We sought to develop a risk-adjustment model for CHS using the newly developed Risk Stratification for Congenital Heart Surgery for ICD-10 Administrative Data (RACHS-2) methodology. METHODS: Within the Kids' Inpatient Database 2019, we identified all CHSs that could be assigned a RACHS-2 score. Hierarchical logistic regression (clustered on hospital) was used to identify patient and procedural characteristics associated with in-hospital mortality. Model validation was performed using data from 24 State Inpatient Databases during 2017. RESULTS: Of 5,902,538 total weighted hospital discharges in the Kids' Inpatient Database 2019, 22,310 pediatric cardiac surgeries were identified and assigned a RACHS-2 score. In-hospital mortality occurred in 543 (2.4%) of cases. Using only RACHS-2, the mortality mode had a C-statistic of 0.81 that improved to 0.83 with the addition of age. A final multivariable model inclusive of RACHS-2, age, payer, and presence of a complex chronic condition outside of congenital heart disease further improved model discrimination to 0.87 (P < 0.001). Discrimination in the validation cohort was also very good with a C-statistic of 0.83. CONCLUSIONS: We created and validated a risk-adjustment model for CHS that accounts for patient and procedural characteristics associated with in-hospital mortality available in administrative data, including the newly developed RACHS-2. Our risk model will be critical for use in health services research and quality improvement initiatives.

Machine Learning to Predict Interstage Mortality Following Single Ventricle Palliation: A NPC-QIC Database Analysis.

There is high risk of mortality between stage I and stage II palliation of single ventricle heart disease. This study aimed to leverage advanced machine learning algorithms to optimize risk-prediction models and identify features most predictive of interstage mortality. This study utilized retrospective data from the National Pediatric Cardiology Quality Improvement Collaborative and included all patients who underwent stage I palliation and survived to hospital discharge (2008-2019). Multiple machine learning models were evaluated, including logistic regression, random forest, gradient boosting trees, extreme gradient boost trees, and light gradient boosting machines. A total of 3267 patients were included with 208 (6.4%) interstage deaths. Machine learning models were trained on 180 clinical features. Digoxin use at discharge was the most influential factor resulting in a lower risk of interstage mortality (p < 0.0001). Stage I surgery with Blalock-Taussig-Thomas shunt portended higher risk than Sano conduit (7.8% vs 4.4%, p = 0.0002). Non-modifiable risk factors identified with increased risk of interstage mortality included female sex, lower gestational age, and lower birth weight. Post-operative risk factors included the requirement of unplanned catheterization and more severe atrioventricular valve insufficiency at discharge. Light gradient boosting machines demonstrated the best performance with an area under the receiver operative characteristic curve of 0.642. Advanced machine learning algorithms highlight a number of modifiable and non-modifiable risk factors for interstage mortality following stage I palliation. However, model performance remains modest, suggesting the presence of unmeasured confounders that contribute to interstage risk.

Risk Stratification for Congenital Heart Surgery for ICD-10 Administrative Data (RACHS-2).

BACKGROUND: As the cardiac community strives to improve outcomes, accurate methods of risk stratification are imperative. Since adoption of International Classification of Disease-10th Revision (ICD-10) in 2015, there is no published method for congenital heart surgery risk stratification for administrative data. OBJECTIVES: This study sought to develop an empirically derived, publicly available Risk Stratification for Congenital Heart Surgery (RACHS-2) tool for ICD-10 administrative data. METHODS: The RACHS-2 stratification system was iteratively and empirically refined in a training dataset of Pediatric Health Information Systems claims to optimize sensitivity and specificity compared with corresponding locally held Society of Thoracic Surgeons-Congenital Heart Surgery (STS-CHS) clinical registry data. The tool was validated in a second administrative data source: New York State Medicaid claims. Logistic regression was used to compare the ability of RACHS-2 in administrative data to predict operative mortality vs STAT Mortality Categories in registry data. RESULTS: The RACHS-2 system captured 99.6% of total congenital heart surgery registry cases, with 1.0% false positives. RACHS-2 predicted operative mortality in both training and validation administrative datasets similarly to STAT Mortality Categories in registry data. C-statistics for models for operative mortality in training and validation administrative datasets-adjusted for RACHS-2-were 0.76 and 0.84 (95% CI: 0.72-0.80 and 0.80-0.89); C-statistics for models for operative mortality-adjusted for STAT Mortality Categories-in corresponding clinical registry data were 0.75 and 0.84 (95% CI: 0.71-0.79 and 0.79-0.89). CONCLUSIONS: RACHS-2 is a risk stratification system for pediatric cardiac surgery for ICD-10 administrative data, validated in 2 administrative-registry-linked datasets. Statistical code is publicly available upon request.

Predictors and outcomes of heart block during surgical stage I palliation of patients with a single ventricle: A report from the NPC-QIC.

BACKGROUND: Mortality in cohorts with a single ventricle remains high with multiple associated factors. The effect of heart block during stage I palliation remains unclear. OBJECTIVE: The purpose of this study was to study patient and surgical risks of heart block and its effect on 12-month transplant-free survival in patients with a single ventricle. METHODS: Patient, surgical, outcome data and heart block status (transient and permanent) were obtained from the National Pediatric Cardiology Quality Improvement Collaborative single ventricle database. Bivariate analysis was performed comparing patients with and without heart block, and multivariate modeling was used to identify variables associated with block. One-year outcomes were analyzed to identify variables associated with lower 12-month transplant-free survival. RESULTS: In total, 1423 patients were identified, of whom 28 (2%) developed heart block (second degree or complete) during their surgical admission. Associated risk factors for block included heterotaxy syndrome (odds ratio [OR] 6.4) and atrial flutter/fibrillation (OR 3.8). Patients with heart block had lower 12-month survival, though only in patients with complete heart block as opposed to second degree block. At 12 months of age, 43% (12/28) of patients with heart block died and were more likely to experience mortality at 12 months than patients without block (OR 4.9; 95% confidence interval 1.4-17.5; P = .01). CONCLUSION: Although rare, complete heart block after stage I palliation represents an additional risk of poor outcomes in this high-risk patient population. Heterotaxy syndrome was the most significant risk factor for the development of heart block after stage I palliation. The role of transient block in outcomes and potential rescue with long-term pacing remains unknown and requires additional study.

Center Reputation and Experience Relate to Industry Payments to Congenital Heart Disease Providers.

BACKGROUND: The Physician Payments Sunshine Act was enacted to understand financial relationships with industry that might influence provider decisions. We investigated how industry payments within the congenital heart community relate to experience and reputation. METHODS: Congenital cardiothoracic surgeons and pediatric cardiologists were identified from the Open Payments Database. All payments from 2013 through 2017 were matched to affiliated hospitals' U.S. News & World Report (USNWR) rankings, The Society of Thoracic Surgeons-Congenital Heart Surgery Public Reporting Star Ratings, and Optum Center of Excellence (COE) designation. Surgeon payments were linked to years since terminal training. Univariable analyses were conducted. RESULTS: The median payment amount per surgeon ($71; interquartile range [IQR], $41-$99) was nearly double the median payment amount per cardiologist ($41; IQR, $18-$84; P < .05). For surgeons, median individual payment was 56% higher to payees at USNWR top 10 children's hospitals ($100; IQR, $28-$203) vs all others ($64; IQR, $23-$140; P < .001). For cardiologists, median individual payment was 26% higher to payees at USNWR top 10 children's hospitals ($73; IQR, $28-$197) vs all others ($58; IQR, $19-$140; P < .001). Findings were similar across The Society of Thoracic Surgeons-Congenital Heart Surgery star rankings and Optum Center of Excellence groups. By surgeon experience, surgeons 0 to 6 years posttraining (first quartile) received the highest number of median payments per surgeon (17 payments; IQR, 6.5-28 payments; P < .001). Surgeons 21 to 44 years posttraining (fourth quartile) received the lowest median individual payment ($51; IQR, $20-132; P < .001). CONCLUSIONS: Industry payments vary by hospital reputation and provider experience. Such biases must be understood for self-governance and the delineation of conflict of interest policies that balance industry relationships with clinical innovation.

Failure to Rescue as an Outcome Metric for Pediatric and Congenital Cardiac Catheterization Laboratory Programs: Analysis of Data From the IMPACT Registry.

Background Risk-adjusted adverse event (AE) rates have been used to measure the quality of pediatric and congenital cardiac catheterization laboratories. In other settings, failure to rescue (FTR) has demonstrated utility as a quality metric. Methods and Results A multicenter retrospective cohort study was performed using data from the IMPACT (Improving Adult and Congenital Treatment) Registry between January 2010 and December 2016. A modified FTR metric was developed for pediatric and congenital cardiac catheterization laboratories and then compared with pooled AEs. The associations between patient- and hospital-level factors and outcomes were evaluated using hierarchical logistic regression models. Hospital risk standardized ratios were then calculated. Rankings of risk standardized ratios for each outcome were compared to determine whether AEs and FTR identified the same high- and low-performing centers. During the study period, 77 580 catheterizations were performed at 91 hospitals. Higher annual hospital catheterization volume was associated with lower odds of FTR (odds ratio: 0.68 per 300 cases; P=0.0003). No association was seen between catheterization volume and odds of AEs. Odds of AEs were instead associated with patient- and procedure-level factors. There was no correlation between risk standardized ratio ranks for FTR and pooled AEs (P=0.46). Hospital ranks by catheterization volume and FTR were associated (r=-0.28, P=0.01) with the largest volume hospitals having the lowest risk of FTR. Conclusions In contrast to AEs, FTR was not strongly associated with patient- and procedure-level factors and was significantly associated with pediatric and congenital cardiac catheterization laboratory volume. Hospital rankings based on FTR and AEs were not significantly correlated. We conclude that FTR is a complementary measure of catheterization laboratory quality and should be included in future research and quality-improvement projects.

Impact of Telemonitoring on Health Status.

BACKGROUND: Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure. METHODS AND RESULTS: Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38-4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18-5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30-6.00; P=0.03). CONCLUSIONS: Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212.

Acute Success of Balloon Aortic Valvuloplasty in the Current Era: A National Cardiovascular Data Registry Study.

OBJECTIVES: The aim of this study was to evaluate practice patterns and outcomes of a contemporary group of patients undergoing balloon aortic valvuloplasty (BAV) for congenital aortic stenosis (AS). BACKGROUND: BAV is the most common treatment for isolated congenital AS. METHODS: Within the IMPACT (Improving Pediatric and Adult Congenital Treatments) Registry, all BAV procedures performed between January 2011 and March 2015 were identified. Procedures were separated into those performed for critical versus noncritical AS. Outcomes were stratified into optimal, adequate, and inadequate, with optimal and adequate outcomes defining "successful" procedures. Multivariate logistic regression was used to identify patient and procedural characteristics associated with unsuccessful BAV. Mortality and adverse events rates were compared across patient cohorts. RESULTS: Of the 1,026 isolated BAV procedures captured in IMPACT, 718 (70%) were "successful." Success rates were 70.9% for noncritical AS (n = 916) and 62.7% for critical AS (n = 110). Multivariate analysis revealed that prior cardiac catheterization, mixed valve disease, baseline aortic valve gradient >60 mm Hg, baseline aortic insufficiency greater than mild, presence of a trainee, and multiple balloon inflations were associated with unsuccessful BAV in the noncritical AS cohort. There were no factors associated with unsuccessful procedures in the critical AS group. No procedural deaths occurred, but 2.4% of patients did not survive to hospital discharge. Adverse events occurred in 15.8% of all cases and were more frequent in procedures performed for critical AS (30.0% vs. 14.1%; p < 0.001). CONCLUSIONS: BAV is an effective treatment for congenital AS with low rates of mortality and adverse events. Patients with critical AS have a higher risk for procedure-related adverse events.

Modeling Major Adverse Outcomes of Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Catheterization: Observations From the NCDR IMPACT Registry (National Cardiovascular Data Registry Improving Pediatric and Adult Congenital Treatment).

BACKGROUND: Risk standardization for adverse events after congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR's (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment). METHODS: Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%. RESULTS: The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination, with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent, with a slope of 0.97 (standard error, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95). CONCLUSIONS: The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement.

Frequency of medical emergency team activation prior to pediatric cardiopulmonary resuscitation.

BACKGROUND: Medical Emergency Teams (METs) are designed to respond to signs of clinical decline in order to prevent cardiopulmonary arrest and reduce mortality. The frequency of MET activation prior to pediatric cardiopulmonary resuscitation (CPR) is unknown. METHODS: Within the Get With The Guidelines-Resuscitation Registry (GWTG-R), we identified children with bradycardia or cardiac arrest requiring CPR on the general inpatient or telemetry floors from 2007 to 2013. We examined the frequency with which CPR outside the ICU was preceded by a MET evaluation. In cases where MET evaluation did not occur, we examined the frequency of severely abnormal vital signs at least 1hour prior to CPR that could have prompted a MET evaluation but did not. RESULTS: Of 215 children from 23 hospitals requiring CPR, 48 (22.3%) had a preceding MET evaluation. Children with MET evaluation prior to CPR were older (6.8±6.5 vs. 3.1±4.7 years of age, p<0.001) and were more likely to have metabolic/electrolyte abnormalities (18.8% vs. 5.4%, p=0.006), sepsis (16.7% vs. 4.8%, p=0.01), or malignancy (22.9% vs. 5.4%, p<0.001). Among patients who did not have a MET called and with information on vital signs, 55/141 (39.0%) had at least one abnormal vital sign that could have triggered a MET. CONCLUSION: The majority of pediatric patients requiring CPR for bradycardia or cardiac arrest do not have a preceding MET evaluation despite a significant number meeting criteria that could have triggered the MET. This suggests opportunities to more efficiently use MET teams in routine care.

Relationship between hospital procedure volume and complications following congenital cardiac catheterization: A report from the IMproving Pediatric and Adult Congenital Treatment (IMPACT) registry.

BACKGROUND: The association between institutional volume and outcomes has been demonstrated for cardiac catheterization among adults, but less is known about this relationship for patients with congenital heart disease (CHD) undergoing cardiac catheterization. METHODS: Within the IMPACT registry, we identified all catheterizations between January 2011 and March 2015. Hierarchical logistic regression, adjusted for patient and procedural characteristics, was used to determine the association between annual catheterization lab volume and occurrence of a major adverse event (MAE). RESULTS: Of 56,453 catheterizations at 77 hospitals, an MAE occurred in 1014 (1.8%) of cases. In unadjusted analysis, a MAE occurred in 2.8% (123/4460) of cases at low-volume hospitals (<150 procedures annually), as compared with 1.5% (198/12,787), 2.0% (431/21,391), and 1.5% (262/17,815) of cases at medium- (150-299 annual procedures), high- (300-499 annual procedures), and very-high-volume (≥500 procedures annually) hospitals, respectively, P<.001. After multivariable adjustment, this significant relationship between annual procedure volume and occurrence of an MAE persisted. Compared to low-volume programs, the odds of an MAE was 0.55 (95% CI 0.35-0.86, P=.008), 0.62 (95% CI 0.41-0.95, P=.03), and 0.52 (95% CI 0.31-0.90, P=.02) at medium-, high-, and very-high-volume programs, respectively. CONCLUSIONS: Although the risk of MAE after cardiac catheterization in patients with CHD is low at all hospitals, it is higher among hospitals with fewer than 150 cases annually. These results support the notion that centers meeting this threshold volume for congenital cardiac catheterizations may achieve improved patient outcomes.

The Supply and Demand of the Cardiovascular Workforce: Striking the Right Balance.

As the burden of cardiovascular disease in the United States continues to increase, uncertainty remains on how well-equipped the cardiovascular workforce is to meet the challenges that lie ahead. In a time when health care is rapidly shifting, numerous factors affect the supply and demand of the cardiovascular workforce. This Council Commentary critically examines several factors that influence the cardiovascular workforce. These include current workforce demographics and projections, evolving health care and practice environments, and the increasing burden of cardiovascular disease. Finally, we propose 3 strategies to optimize the workforce. These focus on cardiovascular disease prevention, the effective utilization of the cardiovascular care team, and alterations to the training pathway for cardiologists.

Missed opportunities in use of medical emergency teams prior to in-hospital cardiac arrest.

BACKGROUND: Hospitals often employ Medical Emergency Teams (METs) to respond to patients with acute physiological decline so as to prevent deaths from in-hospital cardiac arrest (IHCA). We determined the frequency of missed opportunities for MET evaluation, defined as no MET evaluation prior to IHCA despite evidence of severe vital sign abnormalities ≥1 hour preceding cardiac arrest. METHODS: Within Get With The Guidelines-Resuscitation, we identified 21,913 patients from 274 hospitals with IHCA on general inpatient or telemetry floors who would be eligible for a MET evaluation prior to IHCA. We determined the proportion of patients with missed opportunities for MET evaluation, defined as no MET evaluation before IHCA despite at least 1 severe vital sign abnormality (pulse >150 or <30, respiratory rate >35 or <8, systolic blood pressure <80, and oxygen saturation <80%) 1, 2, and 4 hours before IHCA. The relationship between a hospital's proportion of missed opportunities for MET evaluation and its risk-standardized rate of survival to discharge for IHCA (derived using hierarchical linear regression models) was then evaluated. RESULTS: Overall, few (3,814 [17.4%]) patients with IHCA had a preceding MET evaluation, and the odds of a MET evaluation varied by >80% across hospitals (median, 14.6% [interquartile range, 9.1%-22.2%]; median odds ratio, 1.82). Vital sign data were available for 13,115 (72.5%) of the 18,099 patients without MET evaluation. Of these patients, 5,243 (40.0%), 4,078 (31.1%), and 1,767 (13.4%) had at least 1 severe vital sign abnormality ≥1, 2, and 4 hours before IHCA, respectively. Hospitals with the highest proportion of unevaluated patients despite severe vital sign abnormalities 2 and 4 hours preceding cardiac arrest had the lowest IHCA survival rate (correlation of -0.14 [P = .04] and -0.16 [P = .01], respectively). CONCLUSIONS: Although METs are designed to prevent IHCA, many patients with severe vital sign abnormalities prior to IHCA did not have a MET evaluation, and hospitals with higher rates of unevaluated patients had lower IHCA survival. These findings suggest missed opportunities to efficiently use METs in current practice.

The Association Between Complementary and Alternative Medicine and Health Status Following Acute Myocardial Infarction.

BACKGROUND: Complementary and alternative medicines (CAM) are commonly used in patients with cardiovascular disease. Although there is lack of evidence regarding the benefit of CAM on cardiovascular morbidity and mortality, health-status benefits could justify CAM use. HYPOTHESIS: Adoption of mind-body CAM after acute myocardial infarction (AMI) is associated with improved health status, though other forms of CAM are not associated with health-status improvement. METHODS: Patients with AMI from 24 US sites were assessed for CAM use (categorized as mind-body, biological, and manipulative therapies) prior to and 1 year after AMI. Among patients who reported not using CAM prior to their AMI, association of initiating CAM on patients' health status at 1 year after AMI was assessed using Angina Frequency and Quality of Life domains from the Seattle Angina Questionnaire and the Short Form-12 Physical and Mental Component scales. Multivariable regression helped examine association between use of different CAM therapies and health status. RESULTS: Among 1884 patients not using CAM at the time of their AMI, 33% reported initiating ≥1 forms of CAM therapy 1 year following AMI: 62% adopted mind-body therapies, 42% adopted biological therapies, and 15% began using manipulative therapies. In both unadjusted and adjusted analyses, we found no association between different types of CAM use and health-status improvement after AMI. CONCLUSIONS: There was no association between CAM use and health-status recovery after AMI. Until randomized trials suggest otherwise, these findings underscore the importance of focusing on therapies with proven effectiveness after AMI.

Procedural characteristics and adverse events in diagnostic and interventional catheterisations in paediatric and adult CHD: initial report from the IMPACT Registry.

OBJECTIVES: To report procedural characteristics and adverse events on data collected in the registry. BACKGROUND: The IMPACT--IMproving Paediatric and Adult Congenital Treatment--Registry is a catheterisation registry of paediatric and adult patients with CHD undergoing diagnostic and interventional cardiac catheterisation. We are reporting the procedural characteristics and adverse events of patients undergoing diagnostic and interventional catheterisation procedures from January, 2011 to March, 2013. METHODS: Demographic, clinical, procedural, and institutional data elements were collected at the participating centres and entered via either a web-based platform or software provided by American College of Cardiology-certified vendors, and were collected in a secure, centralised database. Centre participation was voluntary. RESULTS: During the time frame of data collection, 19,797 procedures were entered into the IMPACT Registry. Procedures were classified as diagnostic only (35.4%); one of six specific interventions (23.8%); other or multiple interventions (40.7%); and were further broken down into four age groups. Anaesthesia was used in 84.1% of diagnostic procedures and 87.8% of interventional ones. Adverse events occurred in 10.0% of diagnostic and 11.1% of interventional procedures. CONCLUSIONS: The IMPACT Registry is gathering data to set national benchmarks for diagnostic and certain specific interventional procedures. We are seeing little differences in procedural characteristics or adverse events in diagnostic procedures compared with interventional procedures overall, but there is significant variation in adverse events amongst age categories. Risk stratification and patient acuity scores will be required for further analysis of these differences.

Characteristics and safety of interventions and procedures performed during catheterisation of patients with congenital heart disease: early report from the national cardiovascular data registry.

OBJECTIVES: The objective of this study was to report procedural characteristics and adverse events on the data collected in the IMproving Paediatric and Adult Congenital Treatment registry. BACKGROUND: The IMproving Paediatric and Adult Congenital Treatment- registry is a catheterisation registry focussed on paediatric and adult patients with congenital heart disease who are undergoing diagnostic catheterisations and catheter-based interventions. This study reports procedural characteristics and adverse events of patients who have undergone selected catheterisation procedures from January, 2011 to June, 2013. METHODS: Demographic, clinical, procedural, and institutional data elements were collected at participating centres and entered via either a web-based platform or software provided by the American College of Cardiology-certified vendors, and were collected in a secure, centralised database. For the purpose of this study, procedures that were not classified as one of the 'core' IMproving Paediatric and Adult Congenital Treatment procedures originally chosen for additional data collection were identified and selected for further data analysis. RESULTS: During the time frame of data collection, a total of 8021 cases were classified as other procedures and/or multiple procedures. The most commonly performed case types - isolated or in combination with other procedures - were right ventricular biopsy in 3433 (42.8%), conduit/MPA interventions in 979 (12.3%), and systemic pulmonary artery collateral occlusion in 601 (7.5%). For the whole cohort, adverse events of any severity occurred in 957 (12.0%) cases, whereas major adverse events occurred in 113 (1.4%) cases; six patients (0.1%) died in the catheterisation laboratory. CONCLUSIONS: The IMproving Paediatric and Adult Congenital Treatment registry has provided important data on the frequency and spectrum of cardiac catheterisation procedures performed in the present era. For many procedures, more data and work are needed to identify more subtle differences between case categories, especially as it relates to the incidence of major adverse events, and to further develop a risk-adjustment methodology to allow equitable comparisons among institutions.

Adjusting for Risk Associated With Pediatric and Congenital Cardiac Catheterization: A Report From the NCDR IMPACT Registry.

BACKGROUND: As US health care increasingly focuses on outcomes as a means for quantifying quality, there is a growing demand for risk models that can account for the variability of patients treated at different hospitals so that equitable comparisons between institutions can be made. We sought to apply aspects of prior risk-standardization methodology to begin development of a risk-standardization tool for the National Cardiovascular Data Registry (NCDR) IMPACT (Improving Pediatric and Adult Congenital Treatment) Registry. METHODS AND RESULTS: Using IMPACT, we identified all patients undergoing diagnostic or interventional cardiac catheterization between January 2011 and March 2013. Multivariable hierarchical logistic regression was used to identify patient and procedural characteristics predictive of experiencing a major adverse event after cardiac catheterization. A total of 19,608 cardiac catheterizations were performed between January 2011 and March 2013. Among all cases, a major adverse event occurred in 378 of all cases (1.9%). After multivariable adjustment, 8 variables were identified as critical for risk standardization: patient age, renal insufficiency, single-ventricle physiology, procedure-type risk group, low systemic saturation, low mixed venous saturation, elevated systemic ventricular end-diastolic pressure, and elevated main pulmonary artery pressures. The model had good discrimination (C statistic, 0.70), confirmed by bootstrap validation (validation C statistic, 0.69). CONCLUSIONS: Using prior risk-standardization efforts as a foundation, we developed and internally validated a model to predict the occurrence of a major adverse event after cardiac catheterization for congenital heart disease. Future efforts should be directed toward further refinement of the model variables within this large, multicenter data set.