Follansbee Christopher W, Navarro Laura A, Feingold Brian, Arora Gaurav
Heart Institute, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, 4401 Penn Avenue, Pittsburgh, PA, USA.
Departments of Pediatrics and Clinical and Translational Science, School of Medicine, University of Pittsburgh, 4401 Penn Avenue, Pittsburgh, PA, USA.
Pediatr Cardiol. 2025 Mar 21. doi: 10.1007/s00246-025-03833-5.
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.
植入式心脏复律除颤器（ICD）在先天性心脏病患者中的应用越来越广泛，最常用于法洛四联症手术修复（rTOF）患者。已有研究探讨了ICD植入后的患者结局；然而，ICD在rTOF中的成本效益尚不清楚。我们试图评估在高危rTOF患者中，与单纯典型治疗（TMM）相比，典型药物治疗加ICD（TMM + ICD）用于心脏性猝死（SCD）一级预防的成本效益。我们创建了一个马尔可夫模型，比较TMM + ICD与TMM在一名假设的rTOF青少年且SCD风险高于平均水平的20年期间的成本和生活质量（QOL）。模型参数来自文献和机构数据。我们假设在20年期间SCD风险从每年0.4%增加到每年1.2%，ICD预防SCD的有效性为99%，ICD更换频率为11年。我们使用敏感性分析来探讨模型假设的不确定性。TMM + ICD的成本为62,895美元，TMM的成本为19,004美元。TMM + ICD的增量成本效益比为53,386美元/质量调整生命年（QALY），低于通常被认为具有成本效益的100,000美元/QALY阈值。该模型对SCD风险、ICD植入和管理成本、ICD更换成本以及rTOF患者和ICD植入患者的效用敏感。基于SCD风险、设备植入和管理成本（包括并发症）以及我们目前对ICD植入对患者QOL影响的理解，ICD治疗用于rTOF患者SCD的一级预防可构成一种具有成本效益的策略。
