Over a 9-year period, 1st January 2009 to 31st December 2017 inclusive, 38,103 cardiac catheterizations were submitted to the CCISC registry on patients under 18 years old. Due to missing or incorrectly entered demographic data, 1,117 cases (2.9%) were excluded from further analysis leaving a study cohort = 36,986. The median (IQR) age of the study cohort was 3.3 years (0.6–9.9 years). Two-third (69%) of cases were performed beyond the first birthday and 5.9% during the neonatal period. The median (IQR) weight was 14.0kg (6.7–30.6 kg). The number (%) patients weighing < 2.5kg = 1,171 (3.1%), between 2.5-5 kg = 5,377 (14.5%) and > 5 kg = 30,448 (82%). Elective procedures comprised 90.3% of cases with a further 6.7% as emergency procedures and post-operative cases accounting for 3% (1.7% elective, 1.3% urgent).
There were 50 cases (0.14%) of cardiac perforation. A comparison of the baseline demographics, diagnostic category and procedure type are presented in Table 1. Patients who experienced a cardiac perforation during the catheterization are more likely to be younger, of lower weight, and undergoing a non-elective intervention. As the diagnostic and procedure categories are nominal data and some of the data entries would be very small with very large differences in the sample sizes, it is not possible to perform further analysis as to which category is most significant. However, a simple review of the data highlights “Radio-frequency perforation of the pulmonary valve” as being a potential outlier.
Table 1
Comparison of demographics, diagnosis and procedural types of patient with cardiac perforation and those with no cardiac perforation.
| No Perforation (n = 36,936) | Yes Perforation (n = 50) | p value | Statistical method |
Age (years) (mean, s.d.) Median (IQR) | 5.52 (5.6) 3.3 (0.6–10. | 3.07 (5.35) 0.15 (0–4.2) | p < 0.01 | Mann-Whitney U test |
Weight (kg) (Mean, s.d.) Median (IQR) | 21.9 (20.7) 14.0 (6.7–30.9) | 14.6 (23.2) 3.5 (2.7–14.5) | p < 0.01 | Mann- Whitney U test |
< 2.5kg (%) | 1,163 (3.1%) | 9 (18%) | p < 0.01 | Χ2 |
2.5-5 kg (%) | 5,357 (14.5%) | 21 (42%) |
> 5 kg (%) | 30,416 (82%) | 20 (40%) |
Sex (%M) | 19,207 (52%) | 27 (54%) | p = 0.78 | Χ2 |
Pre-procedure ECMO | 37 (0.1%) | 2 (4%) | p = 0.01 | Χ2 |
Procedure type |
Diagnostic procedure n, (%) | 13783 (37.4%) | 4 (8%) | p < 0.01 | Χ2 |
Interventional procedure | 22766 (61.8%) | 44 (88%) |
Hybrid procedure | 288 (0.8%) | 2 (4%) |
Procedure urgency |
Elective | 33,647 (90%) | 30 (60%) | p < 0.01 | Χ2 |
Emergency | 2,475 (6.6%) | 18 (34%) |
Post-op | 1,105 (3.4%) | 2 (4%) |
Diagnosis |
Atrial Septal Defect | 2988 (8.1%) | 1 (2%) | p < 0.01 | Χ2 |
Aortic/ Pulmonary valve stenosis | 4321 (11.7%) | 18 (36%) |
Single Ventricle Physiology | 5260 (14.2%) | 10 (20%) |
Arrhythmia | 769 (2.1%) | 4 (8%) |
Other | 23592 (63.9%) | 17 (34%) * |
Procedure category |
Atrial septostomy/ stent | 10782 (2.9%) | 11(22%) | p < 0.01 | Χ2 |
Pulmonary valve perforation | 42 (0.1%) | 7 (14%) |
Cardiac Biopsy | 4967 (13.4%) | 3 (6%) |
Aortic/ Pulmonary Valvuloplasty | 2650 (7.2%) | 10 (20%) |
RVOT/ MPA stent | 824 (2.2%) | 5 (10%) |
Electrophysiology study | 711 (1.9%) | 4 (8%) |
Other | 26600 (7.2%) | 10 (20%) ** |
CRISP Score (Mean, s.d.) | 5.13 (3.41) | 10.66 (3.97) | p < 0.01 | Student t-test |
* Other included: 3 patients with Tetralogy of Fallot, 2 with Total Anomalous Pulmonary Venous Connections and 1 patient each with - Interrupted Aortic Arch with Ventricular Septal Defect, Left Ventricular aneurysm, Cardiomyopathy, Pulmonary Vascular Obstructive Disease, Atrio-Ventricular Septal Defect, Cardiac Tumour, Double Outlet Right Ventricle, Mitral Valve Stenosis, Heart Transplant, Common arterial trunk, Idiopathic Pulmonary Arterial Hypertension, Pulmonary Atresia with Ventricular Septal Defect & Major Aorto-Pulmonary Collateral Arteries. |
** Other included: 2 Diagnostic Cardiac Catheterisations, 2 Balloon Angioplasty of Systemic Veins and 1 each of Balloon Angioplasty of Branch Pulmonary Artery, Patent Ductus Arteriosus Stent Insertion, Pulmonary Vein Angioplasty, Central Venous Catheter Insertion, Atrial Septal Defect closure, Stent Insertion Branch Pulmonary Artery. |
Table 1: Comparison of demographics, diagnosis and procedural types of patient with cardiac perforation and those with no cardiac perforation.
Risk Factors
The total CRISP score is significantly different between those patients who had a cardiac perforation compared with those without. A simple logistic regression analysis confirmed that a higher total CRISP score was predictive of cardiac perforation (OR = 0.73 per unit increase in CRISP score, and 819 over entire range, p < 0.01, Receiver Operating characteristic area under the curve [AUC] = 0.84). Multiple logistic regression analysis was performed using three factors (procedure type, age and diagnostic category). An effective likelihood ratio test demonstrated that procedure type and age (p < 0.01, OR per unit = 1.1, 4.3 over entire range) independently contributed to risk of perforation. Radiofrequency perforation of pulmonary valve was identified as the only significantly different procedure associated with greater risk of cardiac perforation (p < 0.01, AUC = 0.84). Further multiple logistic regression analysis using procedure type, diagnostic category and weight again demonstrated that only procedure type was independently predictive of cardiac perforation (p < 0.01, AUC = 0.87). Table 2 presents the Odds Ratio of cardiac perforation for each procedural category using the lowest risk category as a control group (“Other”). Radiofrequency perforation of pulmonary stands out as having an OR = 443 whilst cardiac biopsy has no significant observed increased risk.
Table 2
Incidence of cardiac perforation for specific procedure categories
Procedure Category | Incidence | Odds Ratio | p value |
Atrial septostomy/ stent | 0.1% (11/10,793) | 27.3 | p < 0.01 |
Radio-frequency pulmonary valve perforation | 14% (7/49) | 443 | p < 0.01 |
Cardiac biopsy | 0.06% (3/4,970) | 1.61 | p = 0.47 |
Aortic / pulmonary balloon valvuloplasty | 0.38% (10/2,660) | 10.0 | p < 0.01 |
RVOT / MPA stent | 0.6% (5/289) | 16.1 | p < 0.01 |
Electrophysiology study | 0.6% (8/719) | 15.0 | p < 0.01 |
Other | 0.04% (10/26,610) | control | |
Table 2: Incidence of cardiac perforation for specific procedure categories
Outcomes
Cardiac perforation is associated with a much higher risk of a further serious adverse event including hemopericardium (40%), prolongation of hospital admission (32%), cardiac arrest (6%), second organ damage (4%), requirement of haemodynamic support (30%) or blood transfusion (28%) (Table 3). Cardiac perforation was also associated with an increased requirement of unplanned ECMO (14%) and a significantly higher risk of death from a complication occurring during cardiac catheterization (14%). In total 28/50 (56%) patients required a further procedure following cardiac perforation – 5 emergency pericardioentesis, 1 non-emergency pericardiocentesis, 9 emergency surgical interventions, 6 non-emergency surgical interventions and 7 emergency unspecified procedures.
Table 3
Comparison of patient outcomes between patients with cardiac perforation and those with no cardiac perforation.
| No Perforation (n = 36,936) | Yes Perforation (n = 50) | p value | Statistical Method |
SAE requiring emergent procedure (n, %) | 201 (0.5%) | 21 (42%) | p < 0.01 | Χ2 |
Hemopericardium | 13 (0.04%) | 20 (40%) | p < 0.01 | Χ2 |
2nd Organ damage | 40 (0.11%) | 2 (4%) | p < 0.01 | Χ2 |
Unplanned ECMO | 44 (0.12%) | 7 (14%) | p < 0.01 | Χ2 |
Seizures | 13 (0.04) | 0 (0%) | | |
Transfusion | 160 (0.43%) | 14 (28%) | p < 0.01 | Χ2 |
Haemodynamic support | 302 (0.82%) | 15 (30%) | p < 0.01 | Χ2 |
Stroke | 15 (0.04%) | 0 (%) | NS | |
LOS extended (n, %) | 260 (0.7%) | 16 (32%) | p < 0.01 | Χ2 |
Cardiac arrest < 24hrs post procedure | 58 (0.16%) | 3 (6%) | p < 0.01 | Χ2 |
Death due to complication | 26 (0.07%) | 7 (14%) | p < 0.01 | Χ2 |
Table 3: Comparison of patient outcomes between patients with cardiac perforation and those with no cardiac perforation.