Objective: To perform a systematic review and a meta-analysis of the effects of balloon atrial septostomy on peri-operative brain injury in neonates with transposition of the great arteries.
Data source: We conduct a systematic review of the literature to identify all observational studies that included neonates born with transposition of the great arteries who had peri-operative evidence of brain injury.
Study selection and data extraction: The search strategy produced three prospective and two retrospective cohort studies investigating the association between balloon atrial septostomy and brain injury totalling 10,108 patients. In two studies, the outcome was represented by the presence of a coded diagnosis of a clinically evident stroke at discharge, whereas in three studies the outcome was represented by the finding of pre-operative brain injury identified by magnetic resonance scans.
Data synthesis: The overall brain injury rate for neonates who underwent balloon atrial septostomy versus control patients was 60 of 2273 (2.6%) versus 45 of 7835 (0.5%; pooled odds ratio, 1.90; 95% confidence intervals, 0.93-3.89; p = 0.08). A subgroup analysis of the three studies that used pre-operative brain injury as the primary outcome found no significant association between balloon atrial septostomy and brain injury (pooled odds ratio, 2.70; 95% confidence intervals, 0.64-11.33; p = 0.17). Balloon atrial septostomy frequency was 22.4% (2273 of 10,108), with reported rates ranging from 20% to 75%.
Conclusion: Our analysis shows that balloon atrial septostomy is not associated with increased odds for peri-operative brain injury. Balloon atrial septostomy should still be used for those patients with significant hypoxaemia, haemodynamic instability, or both.