DATA in BRIEF of: Interventional Cardiac Catheterization in Neonatal Age: Results in a Multi-centre Italian Experience

A comprehensive description of morbidity and mortality as well as risk factors of interventional cardiac catheterization performed in neonatal age was reported in our paper recently published on the International Journal of Cardiology (IJCA28502; PII: S0167-5273(20)30384-3; DOI: 10.1016/j.ijcard.2020.04.013). Eight Italian high-volume centres of Paediatric Cardiology were involved in this observational, retrospective data collection and analysis. In this dataset, clinical and procedural characteristics of 1423 newborns submitted to 1551 interventional cardiac catheterization procedures were analyzed. Primary outcomes were considered procedure and in-hospital mortality as well as major adverse event and procedural failure rates. Secondary outcomes were considered minor adverse events and need for blood transfusion. Targets of this data analysis were: 1) to evaluate the overall major risk factors of interventional cardiac catheterization; 2) to identify the most hazardous interventional procedures; 3) to assess possible trends of individual procedures as well as their outcome over time; 4) to find possible relationships between the volume activity of any centre and the procedure and follow-up outcome. In particular, this Data in Brief companion paper aims to report the specific statistic highlights of the multivariable analysis (binary logistic regression) used to assess the impact of any potential risk factors on the type of procedure over a short-term follow-up.


a b s t r a c t
A comprehensive description of morbidity and mortality as well as risk factors of interventional cardiac catheterization performed in neonatal age was reported in our paper recently published on the International Journal of Cardiology ( IJCA28502; PII: S0167-5273(20)30384-3; DOI: 10.1016/j.ijcard.2020.04.013 ). Eight Italian high-volume centres of Paediatric Cardiology were involved in this observational, retrospective data collection and analysis. In this dataset, clinical and procedural characteristics of 1423 newborns submitted to 1551 interventional cardiac catheterization procedures were analyzed. Primary outcomes were considered procedure and in-hospital mortality as well as major adverse event and procedural failure rates. Secondary outcomes were considered minor adverse events and need for blood transfusion. Targets of this data analysis were: 1) to evaluate the overall major risk factors of interventional cardiac catheterization; 2) to identify the most hazardous interventional procedures; 3) to assess possible trends of individual procedures as well as their outcome over time; 4) to find possible relationships between the volume activity of any centre and the procedure and follow-up outcome. In particular, this Data in Brief companion paper aims to report the specific statistic highlights of the multivariable analysis (binary logistic regression) used to assess the impact of any potential risk factors on the type of procedure over a shortterm follow-up.

Value of the data
• Interventional cardiac catheterization is an increasing approach to treat newborns with critical congenital heart disease. No data about risk stratification of interventional procedures in this subset of patients are so far reported in literature. Our dataset aims to evaluate the intrinsic risk of trans-catheter interventional approach as well as the potential risk factors involved in any individual procedure performed at this age. • The nationwide cohort dataset recently published in the related research article provides specific information on morbidity and mortality of newborns submitted to interventional cardiac catheterization. The Authors showed that the morbidity (major adverse events and procedural failure) is significantly related to the complexity of the intended procedure while the in-hospital mortality significantly depends on the clinical characteristics and hemodynamic stability of the patient. These data may be useful to cardiologists involved in the management of newborns affected by congenital heart disease to clearly understand patient's risk profile of any interventional procedure.
• The safety and effectiveness data of trans-catheter approach reported in this Data in Brief paper and its related research article may hopefully promote further developments in transcatheter treatment of neonates with critical congenital heart disease. "Ad hoc"-planned future researches aiming to specifically compare percutaneous and surgical approaches in this subset of patients will give further useful information to set the future guide-lines of management of critical, neonatal-onset cardiac malformations. • Defining careful risk profile of newborns in whom an interventional cardiac catheterization is planned allows to improve pre-procedure counselling with parents and care-givers as well as gives further insights about the short-term prognosis of these frail patients. These data will hopefully improve timing and type of interventional approach (percutaneous vs surgical vs hybrid) in this frail subset of patients.

Data Description
This dataset (see also the SUPPPLEMENTARY FILE section) gives relevant details and explanations about the enrolled population/procedures (catheterizations/procedures and adverse events) and statistical analysis techniques (mainly multi-variable analysis). These data are expressed as figures and tables as well as in form of RAW DATA in the SUPPPLEMENTARY FILE section: -the Table 1 describes the different catheterization sessions and interventional procedures performed in our cohort -the Table 2 labels the adverse events (either major or minor) listed in 8 categories: vascular access adverse events, arrhythmias, pericardial effusions, direct intra-cardiac lesions, great vessels damages, technical complications of the procedure, significant hemodynamic compromise and other adverse events -the Table 3 and the Table 4 show multi-variable analyses (binary logistic regression) of the potential risk factors (gender, low-weight, prematurity, genetic syndrome, uni-ventricular heart physiology, hybrid approach, risk category, age ≤7 days and procedure failure) and the major interventional procedures (arterial duct stenting, atretic pulmonary valve perforation, balloon aortic valvuloplasty, balloon pulmonary valvuloplasty, Rashkind atrioseptostomy) in terms of primary and secondary outcomes -the Table 5 describes in each large column the multi-variable analysis (binary logistic regression) of the different potential risk factors in terms of composite outcome (in-hospital mortality, major adverse event and/or failure) of each major procedure, as individually analyzed -the Table 6 compares the first and second half-time periods (20 0 0-20 08 vs 20 09-2017) of our observational dataset in terms of demography, risk factors and interventional procedures -the Figure 1 is the forest plots representation of multi-variable analysis of the potential risk factors ( A ) and the most performed procedures ( B ) on the primary outcomes -the Figure 2 shows, anonymously, the number of trans-catheter interventions for single centre ( A ) and, accordingly, the rate of composite outcome ( B )

Experimental Design, Materials, and Methods
In the related research article [1] , a retrospective detection of all consecutive interventional cardiac catheterizations performed in neonatal age was carried out by the eight Italian highervolume centres involved in the study (Bologna, Genoa, Massa, Milan, Naples, Padua, Rome and Turin). To achieve this dataset, hospital registry and clinical folders were examined. From January 20 0 0 to December 2017, 1423 consecutive newborns were submitted to 1551 interventional cardiac catheterizations, during which 1615 interventions were performed. The term "catheterization" was used to indicate any procedural session, while the term "procedure" was used to report any specific intervention. Primary outcomes were any procedure-related major adverse   , in-hospital mortality and failure of the intended procedure. They were analyzed both individually and as a composite outcome. Secondary outcomes were any procedure-related minor adverse event (MiAE) and need for blood transfusion. Gender, low-weight, prematurity, genetic syndrome, uni-ventricular heart physiology, hybrid approach, risk category, age ≤7 days and failure were analyzed as potential risk factors.
Multi-variable analysis was performed with a binary logistic regression [2] and used to evaluate the independent impact of any risk factor on the outcome of interventional cardiac catheterization, either as a whole or for each specific procedure. Furthermore, the multi-variable analysis was used to evaluate the risk profile of the five more common procedures (arterial duct stenting, atretic pulmonary valve perforation, balloon aortic valvuloplasty, balloon pulmonary valvuloplasty, Rashkind atrio-septostomy) on short-term outcome. The data reported in the Table 6 , comparing the first and the second half observational period were analysed by two-tail chi-square test (for categorical and binary variables) or unpaired twosamples Student's t-test (for continuous variables).
The data were then divided for any centre in order to evaluate, by linear regression test, the impact of the volume of activity of any individual centre on the composite outcome. The same statistical analysis was also made by separating the higher-risk procedures (risk category 4) from the lower ones (risk category 3) [3] .