Procedure-Type Risk Categories for Pediatric and Congenital Cardiac Catheterization
Department of Cardiology, Children’s Hospital Boston, 300 Longwood Avenue, Boston, MA, USA. Circulation Cardiovascular Interventions
(Impact Factor: 6.22).
03/2011; 4(2):188-94. DOI: 10.1161/CIRCINTERVENTIONS.110.959262
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.
Available from: Francis Vasseur
- "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. "
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ABSTRACT: After more than 50 years of treating Parkinson's disease with l-DOPA, there are still no guidelines on setting the optimal dose for a given patient. The dopamine transporter type 1, now known as solute carrier family 6 (neurotransmitter transporter), member 3 (SLC6A3) is the most powerful determinant of dopamine neurotransmission and might therefore influence the treatment response. We recently demonstrated that methylphenidate (a dopamine transporter inhibitor) is effective in patients with Parkinson's disease with motor and gait disorders. The objective of the present study was to determine whether genetic variants of the dopamine transporter type 1-encoding gene (SLC6A3) are associated with differences in the response to treatment of motor symptoms and gait disorders with l-DOPA and methylphenidate (with respect to the demographic, the disease and the treatment parameters and the other genes involved in the dopaminergic neurotransmission). This analysis was part of a multicentre, parallel-group, double-blind, placebo-controlled, randomized clinical trial of methylphenidate in Parkinson's disease (Protocol ID:2008-005801-20; ClinicalTrials.gov:NCT00914095). We scored the motor Unified Parkinson's Disease Rating Scale and the Stand-Walk-Sit Test before and after a standardized acute l-DOPA challenge before randomization and then after 3 months of methylphenidate treatment. Patients were screened for variants of genes involved in dopamine metabolism: rs28363170 and rs3836790 polymorphisms in the SLC6A3 gene, rs921451 and rs3837091 in the DDC gene (encoding the aromatic L-amino acid decarboxylase involved in the synthesis of dopamine from l-DOPA), rs1799836 in the MAOB gene (coding for monoamine oxidase B) and rs4680 in the COMT gene (coding for catechol-O-methyltransferase). Investigators and patients were blinded to the genotyping data throughout the study. Eighty-one subjects were genotyped and 61 were analysed for their acute motor response to l-DOPA. The SLC6A3 variants were significantly associated with greater efficacy of l-DOPA for motor symptoms. The SLC6A3 variants were also associated with greater efficacy of methylphenidate for motor symptoms and gait disorders in the ON l-DOPA condition. The difference between motor Unified Parkinson's Disease Rating Scale scores for patients with different SLC6A3 genotypes was statistically significant in a multivariate analysis that took account of other disease-related, treatment-related and pharmacogenetic parameters. Our preliminary results suggest that variants of SLC6A3 are genetic modifiers of the treatment response to l-DOPA and methylphenidate in Parkinson's disease. Further studies are required to assess the possible value of these genotypes for (i) guiding l-DOPA dose adaptations over the long term; and (ii) establishing the risk/benefit balance associated with methylphenidate treatment for gait disorders.
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Available from: Laurie Armsby
- "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, "
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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.
Electronic supplementary material
The online version of this article (doi:10.1007/s00246-013-0752-y) contains supplementary material, which is available to authorized users.
Available from: Dominique Laurier
- "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. "
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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.
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