Triedman John K, Pfeiffer Patricia, Berman Adam, Blaufox Andrew D, Cannon Bryan C, Fish Frank A, Perry James, Pflaumer Andreas, Seslar Stephen P
Boston Children's Hospital, Boston, Mass, USA.
Congenit Heart Dis. 2013 Sep-Oct;8(5):393-405. doi: 10.1111/chd.12050. Epub 2013 Mar 13.
Robust risk-adjustment algorithms are often necessary if data from clinical registries is to be used to compare rates of important clinical outcomes between participating centers. Although such algorithms have been successfully developed for surgical and catheter-based cardiac interventions in children, outcomes of pediatric and congenital catheter ablation have not been modeled with respect to case mix.
A working group was appointed by the Pediatric and Congenital Electrophysiology Society to develop a risk-adjustment algorithm for use in conjunction with a modernized, multicenter registry database. Expert consensus was used to develop relevant outcome measures, an inclusive list of possible predictors, and estimates of associated incremental risk. Historical data from the Pediatric Radiofrequency Ablation Registry was reanalyzed using multivariate regression to create statistical models of ablation outcomes.
Acute ablation failure and serious adverse event rates were modeled as outcomes. Statistical modeling was performed on 4486 cases performed in 19 centers. For ablation failure rate, a simple model including general category of arrhythmia mechanism and presence of structural congenital heart disease accounted for ∼71% of outcome variance. The model was useful for identification of between-center variability in the historical data set. Although expert consensus predicted the need for a more complex model, predicted univariate effects were similar to those generated by statistical modeling. Serious adverse events were too infrequent to permit statistical association with any predictive variable, but could be compared with the mean rate observed among all centers.
A substantial component of the intercenter variability of acute ablation outcomes in a historical database of pediatric and congenital ablation patients may be accounted for by a simple statistical model, exposing variations in outcome specific to centers. This will be a useful initial model for use a modern registry for pediatric catheter ablation outcomes.
如果要利用临床登记处的数据来比较参与中心之间重要临床结局的发生率,强大的风险调整算法通常是必要的。尽管此类算法已成功应用于儿童外科手术和基于导管的心脏介入治疗,但儿科和先天性导管消融的结局尚未根据病例组合进行建模。
儿科和先天性电生理学会任命了一个工作组,以开发一种风险调整算法,用于与现代化的多中心登记数据库结合使用。通过专家共识来制定相关结局指标、一份包含所有可能预测因素的清单以及相关增量风险的估计值。使用多元回归对儿科射频消融登记处的历史数据进行重新分析,以创建消融结局的统计模型。
将急性消融失败率和严重不良事件发生率作为结局进行建模。对19个中心进行的4486例病例进行了统计建模。对于消融失败率,一个简单的模型,包括心律失常机制的一般类别和结构性先天性心脏病的存在,解释了约71%的结局变异。该模型有助于识别历史数据集中中心之间的差异。尽管专家共识预测需要一个更复杂的模型,但预测的单变量效应与统计建模产生的效应相似。严重不良事件发生频率过低,无法与任何预测变量进行统计学关联,但可以与所有中心观察到的平均发生率进行比较。
在儿科和先天性消融患者的历史数据库中,急性消融结局的中心间差异的很大一部分可能由一个简单的统计模型来解释,从而揭示各中心特定的结局差异。这将是一个用于儿科导管消融结局现代登记处的有用初始模型。