2-Year Outcomes After Complete or Staged Procedure for Tetralogy of Fallot in Neonates

Background: There is ongoing debate about the best strategy to treat patients with tetralogy of Fallot (TOF) that are symptomatic in the neonatal period. Objective: We compared the outcomes of complete vs. staged surgery (i.e., initial palliative procedure for possible later complete repair). Methods: We performed a retrospective cohort study using the Pediatric Health Information System (PHIS) database and included patients that underwent complete or staged TOF repair prior to 30 days of age. The primary outcome was death during two-year follow-up after the initial procedure. Inverse probability weighted Cox and logistic regression models were used to examine the association between surgical approach group and mortality, while accounting for patient and hospital level factors. Causal mediation analyses examined the role of intermediate variables. Results: A total of 2363 patients were included (1032 complete and 1331 staged group). There were 239 deaths. Complete neonatal repair was associated with a significantly higher risk of mortality during the two-year follow up [hazard ratio (HR) =1.51, 95% confidence interval (CI) 1.05, 2.06], between 7–30 days after initial procedure (HR= 2.29, 95% CI 1.18, 4.41), and during the initial hospital admission (odds ratio= 1.72, 95% CI 1.15, 2.62). Post-operative cardiac complications were more common in the complete repair group and mediated the differences in 30-day and two-year mortality. Conclusions: Complete surgical repair for neonates with TOF is associated with a significantly higher risk of early and two-year mortality than the staged approach, after accounting for patient and hospital characteristics. Post-operative cardiac complications mediated these findings.