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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. 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). 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. 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.

ObjectivesWhile procedure length is considered an important metric for cardiothoracic surgical procedures, the relationship between procedure length and adverse events (AEs) in congenital cardiac catheterizations has little published data available. Furthermore, most existing congenital cardiac catheterization risk prediction models are built on logistic regression models. This study aimed to characterize the relationship between case length and AE occurrence in congenital cardiac catheterization while adjusting for known risk factors and to investigate the potential role of non-linear analysis in risk modeling.DesignAge, case type, and procedure duration were evaluated for relationships with the primary outcome using logistic regression. Non-linearity of the associations with continuous risk factors was assessed using restricted cubic spline transformations.Setting and participantsAll diagnostic and interventional congenital cardiac catheterization cases performed at Boston Children’s Hospital between January 1, 2014 and October 31, 2019 were analyzed.Main outcome measureThe primary outcome was defined as the occurrence of any clinically significant (level 3/4/5) AE.ResultsA total of 7011 catheterization cases met inclusion criteria, with interventional procedures accounting for 68% of cases. Median case duration was 97 min. A multivariable model including age, procedure type, and case duration showed a significant relationship between case duration and AE occurrence (OR 1.07 per 10 min increase, 95% CI 1.06 to 1.09, p<0.001).ConclusionsThis study demonstrated the importance of procedure duration as a potential frontier for procedure risk management. Better understanding of the role of procedure duration in cardiac catheterizations may provide opportunities for quality improvement in patient safety and resource planning.

Sedation/anesthesia is critical to cardiac catheterization in the pediatric/congenital heart patient. We sought to identify current sedation/anesthesia practices, the serious adverse event rate related to airway, sedation, or anesthesia, and the rate of intra-procedural conversion from procedural sedation to the use of assisted ventilation or an artificial airway. Data from 13,611 patients who underwent catheterization at eight institutions were prospectively collected from 2007 to 2010. Ninety-four (0.69 %) serious sedation/airway-related adverse events occurred; events were more likely to occur in smaller patients (<4 kg, OR 4.4, 95 % CI 2.3–8.2, p  < 0.001), patients with non-cardiac comorbidities (OR 1.7, 95 % CI 1.1–26, p  < 0.01), and patients with low mixed venous oxygen saturation (OR 2.3, 95 % CI 1.4–3.6, p  < 0.001). Nine thousand three hundred and seventy-nine (69 %) patients were initially managed with general endotracheal anesthesia, LMA, or tracheostomy, whereas 4232 (31 %) were managed with procedural sedation without an artificial airway, of which 75 (1.77 %) patients were converted to assisted ventilation/general anesthesia. Young age (<12 months, OR 5.2, 95 % CI 2.3–11.4, p  < 0.001), higher-risk procedure (category 4, OR 10.1, 95 % CI 6.5–15.6, p  < 0.001), and continuous pressor/inotrope requirement (OR 11.0, 95 % CI 8.6–14.0, p  < 0.001) were independently associated with conversion. Cardiac catheterization in pediatric/congenital patients was associated with a low rate of serious sedation/airway-related adverse events. Smaller patients with non-cardiac comorbidities or low mixed venous oxygen saturation may be at higher risk. Patients under 1 year of age, undergoing high-risk procedures, or requiring continuous pressor/inotrope support may be at higher risk of requiring conversion from procedural sedation to assisted ventilation/general anesthesia.

To stratify diverse procedure types into categories with similar radiation exposure in cardiac catheterization for congenital heart disease. Radiation exposures for a comprehensive list of specific procedure types and stratification of outcomes based on radiation risk are not currently available. Data between January 2014 and December 2015 were collected on all cases performed at sites participating in C3PO-QI (Congenital Cardiac Catheterization Outcomes Project-Quality Improvement Initiative) and 9 centers were included. Using expert consensus, 40 unique procedure types were defined by diagnostic characteristics or the intervention(s) performed, and dose area product (DAP) per kilogram of body weight (µGy × m 2 /kg) was summarized. Using empiric and consensus methods, three radiation risk categories were created. A total of 11,735 cases were included for analysis. Thirteen ( n  = 7918) procedure types with median DAP/kg < 100 were categorized in the low radiation exposure category (median DAP/kg 39). The medium exposure category ( n  = 1807) consisted of 16 procedure types with median DAP/kg values ranging 100 to < 200 (overall median DAP/kg 131). Finally, the high radiation exposure category ( n  = 1073) consisted of 11 procedure types with median DAP/kg ≥ 200 (overall median DAP/kg of 231). The radiation exposure risk categories created in this multi-center dataset are a critical step towards the development of a robust risk adjustment methodology for radiation exposure in catheterization for congenital heart disease.

Background: Surgical and transcatheter bioprosthetic valves (BPVs) in the pulmonary position in patients with congenital heart disease may ultimately fail and undergo transcatheter reintervention. Angiographic assessment of the mechanism of BPV failure has not been previously described. Aims: The aim of this study was to determine the mode of BPV failure (stenosis/regurgitation) requiring transcatheter reintervention and to describe the angiographic characteristics of the failed BPVs and report the types and efficacy of reinterventions. Materials and Methods: This is a retrospective single-center review of consecutive patients who previously underwent pulmonary BPV placement. (surgical or transcatheter) and subsequently underwent percutaneous reintervention from 2005 to 2014. Results: Fifty-five patients with surgical. (41) and transcutaneous pulmonary valve. (TPV) (14) implantation of BPVs underwent 66 catheter reinterventions. The surgically implanted valves underwent fifty reinterventions for indications including 16 for stenosis, seven for regurgitation, and 27 for both, predominantly associated with leaflet immobility, calcification, and thickening. Among TPVs, pulmonary stenosis. (PS) was the exclusive failure mode, mainly due to loss of stent integrity. (10) and endocarditis. (4). Following reintervention, there was a reduction of right ventricular outflow tract gradient from 43 ± 16 mmHg to 16 ± 10. mmHg (P < 0.001) and RVp/AO ratio from 0.8 ± 0.2 to 0.5 ± 0.2 (P < 0.001). Reintervention with TPV placement was performed in 45. (82%) patients. (34 surgical, 11 transcatheter) with no significant postintervention regurgitation or paravalvular leak. Conclusion: Failing surgically implanted BPVs demonstrate leaflet calcification, thickness, and immobility leading to PS and/or regurgitation while the mechanism of TPV failure in the short- to mid-term is stenosis, mainly from loss of stent integrity. This can be effectively treated with a catheter.based approach, predominantly with the valve-in-valve technique.

Validation of the technique in animal models1 was followed by clinical application of balloon angioplasty in children with obstructions of the proximal pulmonary arteries in the setting of congenital cardiac disease as an alternative to surgical intervention.2 Improvement in the diameter of the involved vessel, combined with a reduction in right ventricular pressure and normalization of pulmonary perfusion, in most cases with minimal complications, led to the rapid acceptance and application of the technique.3 Initial attempts to use balloons to dilate more distal obstructions, however, were limited due to the size and stiffness of the available balloons. In vitro testing of the Genesis XD 19/29 stent demonstrates more flexibility, less foreshortening, lower profile when crimped on a balloon, and superior radial strength compared to the Palmaz 308.49 Clinical use has further revealed two important clinical advantages, first that stent cells can be crossed and dilated to access and restore flow to jailed vessels, and second, that redilation is possible with minimal foreshortening, expanding to adult size (Table 6).

Radiation reduction in the pediatric cardiac catheterization laboratory is well-suited for targeted quality improvement (QI) interventions. Transcatheter atrial septal defect (ASD) closure was chosen for this QI project based on a homogenous procedural population and inter-operator variability in radiation usage, with the aim to reduce radiation exposure during ASD device closure by 50% over 1 year. The aim for this project was defined and a Key Driver Diagram (KDD) was created with three domains for change: modification of procedural practice, reporting and monitoring/feedback, and team engagement. All patients undergoing attempted transcatheter ASD closure were considered for inclusion. The primary outcome, % reduction in median radiation dose (DAP/Kg), was determined through comparison with a historical cohort. Additional radiation metrics, procedural characteristics, and adverse events (AE) were compared to the historical cohort. Radiation exposure (DAP/kg) was reduced by 55% with a median dose reduction from 26 (15, 61) in a historical cohort to 12 (6, 22) in the intervention population (p <0.001). Fluoroscopy time and cine acquisition utilization significantly decreased. Procedure time, procedural success (defined as successful delivery of the device) and AE did not increase in the QI cohort. Successful practice changes included standardized procedural strategies to limit fluoroscopy and cine acquisition, improved fluoroscopic practice, engagement of the multidisciplinary team, and feedback with data reporting by electronic and in-person reminders. In conclusion, application of QI methodologies such as KDD with engagement of a multidisciplinary team can effectively reduce radiation in the pediatric catheterization laboratory.

Stenosis, or narrowing, of the branches of the pulmonary artery is a type of CHD that, if left untreated, may lead to significant complications. Ideally, interventions to treat stenosis occur before significant complications or long-term sequelae take place, often within the first 2 years of life. Treatment depends on specifics of the condition, the presence of other malformations, and age of the child. Research and recent innovation to address these shortcomings have provided physicians with safer and more effective methods of treatment. This has further continued to push the ceiling of pulmonary arterial stenosis treatment available for patients. Despite continuous advancement in angioplasty – such as conventional and cutting balloon – and stenting, each treatment method is not without its unique limitations. New technological developments such as bioresorbable stents can accommodate patient growth and pulmonary artery stenosis treatment. As more than a decade has passed since the review by Bergersen and Lock, this article aims to provide a contemporary summary and investigation into the effectiveness of various therapeutic tools currently available, such as bare metal stents and potential innovations including bioresorbable stents.

This review includes a brief discussion, from the perspective of the pediatric cardiologist, of the rationale for creation and maintenance of multi-institutional databases of outcomes of the treatment of patients with congenital and paediatric cardiac disease, together with a history of the evolution of such databases, and a description of the current state of the art. A number of projects designed to have broad-based impact are currently in the design phase, or have already been implemented. Not surprisingly, most of the efforts thus far have focused on catheterization procedures and interventions, although some work examining other aspects of paediatric cardiology practice is also beginning. This review briefly describes several European and North American initiatives related to databases for pediatric and congenital cardiology including the Central Cardiac Audit Database of the United Kingdom, national database initiatives for pediatric cardiology in Switzerland and Germany, various database initiatives under the leadership of the Working Groups of The Association for European Paediatric Cardiology, the IMPACT Registry™ (IMproving Pediatric and Adult Congenital Treatment) of the National Cardiovascular Data Registry® of The American College of Cardiology Foundation® and The Society for Cardiovascular Angiography and Interventions (SCAI), the Mid-Atlantic Group of Interventional Cardiology (MAGIC) Catheterization Outcomes Project, the Congenital Cardiac Catheterization Project on Outcomes (C3PO), the Congenital Cardiovascular Interventional Study Consortium (CCISC), and the Joint Council on Congenital Heart Disease (JCCHD) National Quality Improvement Initiative. These projects, each leveraging multicentre data and collaboration, demonstrate the enormous progress that has occurred over the last several years to improve the quality and consistency of information about nonsurgical treatment for congenital cardiac disease. The paediatric cardiology field is well-poised to move quickly beyond outcome assessment and benchmarking, to collaborative quality improvement.

Patients with pulmonary vein stenosis (PVS) often require frequent transcatheter pulmonary vein (PV) interventions for management of restenosis. Predictors of serious adverse events (AEs) and need for high-level cardiorespiratory support (mechanical ventilation, vasoactive support, and/or extracorporeal membrane oxygenation) 48 h after transcatheter PV interventions have not been reported. This is a single-center retrospective cohort analysis of patients with PVS who underwent transcatheter PV interventions from 3/1/2014 to 12/31/2021. Univariate and multivariable analyses were performed using generalized estimating equations to account for within-patient correlation. 240 patients underwent 841 catheterizations involving PV interventions (median 2 catheterizations per patient [1,3]). At least one serious AE was reported in 100 (12%) cases, the most common of which were pulmonary hemorrhage ( n  = 20) and arrhythmia ( n  = 17). There were 14 severe/catastrophic AEs (1.7% of cases) including three strokes and one patient death. On multivariable analysis, age less than 6 months, low systemic arterial saturation (< 95% in patients with biventricular [BiV] physiology, < 78% in single ventricle [SV] physiology), and severely elevated mean PA pressure (≥ 45 mmHg in BiV, ≥ 17 mmHg in SV) were associated with SAEs. Age less than 1 year, hospitalization prior to catheterization, and moderate–severe RV dysfunction were associated with high-level support after catheterization. Serious AEs during transcatheter PV interventions in patients with PVS are common, although major events such as stroke or death are uncommon. Younger patients and those with abnormal hemodynamics are more likely to experience serious AEs and require high-level cardiorespiratory support after catheterization.