The Congenital Cardiac Catheterization Project on Outcomes (C3PO) was established to develop outcome assessment methods for pediatric catheterization.
Six sites have been recording demographic, procedural and immediate outcome data on all cases, using a web-based system since February 2007. A sample of data was independently audited for validity and data completeness. In 2006, participants categorized 84 procedure types into 6 categories by anticipated risk of an adverse event (AE). Consensus and empirical methods were used to determine final procedure risk categories, based on the outcomes: any AE (level 1 to 5); AE level 3, 4, or 5; and death or life-threatening event (level 4 or 5). The final models were then evaluated for validity in a prospectively collected data set between May 2008 and December 31, 2009. Between February 2007 and April 2008, 3756 cases were recorded, 558 (14.9%) with any AE; 226 (6.0%) level 3, 4, or 5; and 73 (1.9%) level 4 or 5. General estimating equations models using 6 consensus-based risk categories were moderately predictive of AE occurrence (c-statistics: 0.644, 0.664, and 0.707). The participant panel made adjustments based on the collected empirical data supported by clinical judgment. These decisions yielded 4 procedure risk categories; the final models had improved discrimination, with c-statistics of 0.699, 0.725, and 0.765. Similar discrimination was observed in the performance data set (n=7043), with c-statistics of 0.672, 0.708, and 0.721.
Procedure-type risk categories are associated with different complication rates in our data set and could be an important variable in risk adjustment models for pediatric catheterization.
"All comparisons were adjusted first for the total dose of L-DOPA and then for age, gender, weight, daily dose of L-DOPA and disease duration. Theses prespecified adjustments were made using non-parametric analysis of covariance (Bergersen et al., 2011). In view of our study's exploratory nature and small sample size, we did not adjust for multiple comparisons. "
"p < 0.01). Third, high-risk procedures  (Supplemental Table 4) were associated with double and quadruple the odds of life-threatening events; the OR was 2.3 (95 % CI 1.3–4.1, p = 0.003) for category 3 procedures and 4.2 (95 % CI 2.4–7.4, "
[Show abstract][Hide abstract] ABSTRACT: Continued advancements in congenital cardiac catheterization and interventions have resulted in increased patient and procedural complexity. Anticipation of life-threatening events and required rescue measures is a critical component to preprocedural preparation. We sought to determine the incidence and nature of life-threatening adverse events in congenital and pediatric cardiac catheterization, risk factors, and resources necessary to anticipate and manage events. Data from 8905 cases performed at the 8 participating institutions of the Congenital Cardiac Catheterization Project on Outcomes were captured between 2007 and 2010 [median 1,095/site (range 133–3,802)]. The incidence of all life-threatening events was 2.1 % [95 % confidence interval (CI) 1.8–2.4 %], whereas mortality was 0.28 % (95 % CI 0.18–0.41 %). Fifty-seven life-threatening events required cardiopulmonary resuscitation, whereas 9 % required extracorporeal membrane oxygenation. Use of a risk adjustment model showed that age <1 year [odd ratio (OR) 1.9, 95 % CI 1.4–2.7, p < 0.001], hemodynamic vulnerability (OR 1.6, 95 % CI 1.1–2.3, p < 0.01), and procedure risk (category 3: OR 2.3, 95 % CI 1.3–4.1; category 4: OR 4.2, 95 % CI 2.4–7.4) were predictors of life-threatening events. Using this model, standardized life-threatening event ratios were calculated, thus showing that one institution had a life-threatening event rate greater than expected. Congenital cardiac catheterization and intervention can be performed safely with a low rate of life-threatening events and mortality; preprocedural evaluation of risk may optimize preparation of emergency rescue and bailout procedures. Risk predictors (age < 1, hemodynamic vulnerability, and procedure risk category) can enhance preprocedural patient risk stratification and planning.
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"Furthermore, it is a relatively young and rapidly evolving field. Although some groups share similar nomenclature systems or coding lists, the field has not yet adopted a comprehensive and universally accepted nomenclature system for CCP . Nevertheless, a common language, or system of nomenclature, is imperative as the study will be carried out in several centres in France. "
[Show abstract][Hide abstract] ABSTRACT: Background
Radiation can be used effectively for diagnosis and medical treatment, but it can also cause cancers later on. Children with congenital heart disease frequently undergo cardiac catheterization procedures for diagnostic or treatment purposes. Despite the clear clinical benefit to the patient, the complexity of these procedures may result in high cumulative radiation exposure. Given children’s greater sensitivity to radiation and the longer life span during which radiation health effects can develop, an epidemiological cohort study is being launched in France to evaluate the risks of leukaemia and solid cancers in this specific population.
The study population will include all children who have undergone at least one cardiac catheterization procedure since 2000 and were under 10 years old and permanent residents of France at the time of the procedure. Electronically stored patient records from the departments of paediatric cardiology of the French national network for complex congenital heart diseases (M3C) are being searched to identify the children to be included. The minimum dataset will comprise: identification of the subject (file number in the centre or department, full name, sex, date and place of birth), and characteristics of the intervention (date, underlying disease, type of procedure, technical details, such as fluoroscopy time and dose area product, (DAP), which are needed to reconstruct the doses received by each child). The cohort will be followed up through linkage with the two French paediatric cancer registries, which have recorded all cases of childhood leukaemia and solid cancers in France since 1990 and 2000, respectively. Radiation exposure will be estimated retrospectively for each child. 4500 children with catherizations between 2000 and 2011 have been already included in the cohort, and recruitment is ongoing at the national level. The study is expected to finally include a total of 8000 children.
This French cohort study is specifically designed to provide further knowledge about the potential cancer risks associated with paediatric cardiac catheterization procedures. It will also provide new information on typical dose levels associated with these procedures in France. Finally, it should help improve awareness of the importance of radiation protection in these procedures.
BMC Public Health 03/2013; 13(1):266. DOI:10.1186/1471-2458-13-266 · 2.26 Impact Factor
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