Cost-Effectiveness of Implantable Cardioverter-Defibrillators in Surgically Repaired Tetralogy of Fallot.

Implantable cardioverter-defibrillators (ICDs) are increasingly used in patients with congenital heart disease, most commonly in surgically repaired Tetralogy of Fallot (rTOF). Studies have examined patient outcomes after ICD implantation; however, the cost-effectiveness of ICDs in rTOF is unknown. We sought to evaluate the cost-effectiveness of typical medical management plus ICD (TMM + ICD) for primary prevention of sudden cardiac death (SCD) compared to typical management alone (TMM) in high-risk patients with rTOF. We created a Markov model to compare costs and quality of life (QOL) of TMM + ICD vs TMM for a hypothetical adolescent with rTOF and higher than average risk of SCD over 20 years. Model parameters were derived from the literature and institutional data. We assumed that SCD risk increased from 0.4%/year to 1.2%/year over 20 years, that the ICD was 99% effective in preventing SCD, and a frequency of ICD replacement of 11 years. We used sensitivity analyses to explore uncertainty around model assumptions. Costs were $62,895 for TMM + ICD and $19,004 for TMM. The incremental cost-effectiveness ratio for TMM + ICD was $53,386/quality-adjusted life-year (QALY) which is below threshold of $100,000/QALY that is usually considered cost-effective. The model was sensitive to SCD risk, costs of ICD implantation and management, cost of ICD replacement, and utilities of living with rTOF and of ICD implantation. Based on risk of SCD, cost of device implantation and management including complications, and our current understanding of the impact of ICD implantation on patient QOL, ICD therapy for primary prevention of SCD in rTOF can constitute a cost-effective strategy.