Arbelo Elena, De Ponti Roberto, Cohen Lucas, Pastor Laura, Costa Graca, Hempel Marike, Grima Daniel
Arrhythmia Section, Cardiology Department, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.
Institut d'Investigació August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
J Med Econ. 2024 Jan-Dec;27(1):1168-1179. doi: 10.1080/13696998.2024.2399438. Epub 2024 Sep 18.
To determine the clinical and economic implications of first-line or drug-naïve catheter ablation compared to antiarrhythmic drugs (AADs), or shorter AADs-to-Ablation time (AAT) in atrial fibrillation (AF) patients in France and Italy, using a patient level-simulation model.
A patient-level simulation model was used to simulate clinical pathways for AF patients using published data and expert opinion. The probabilities of adverse events (AEs) were dependent on treatment and/or disease status. Analysis 1 compared scenarios of treating 0%, 25%, 50%, 75% or 100% of patients with first-line ablation and the remainder with AADs. In Analysis 2, scenarios compared the impact of delaying transition to second-line ablation by 1 or 2 years.
Over 10 years, increasing first-line ablation from 0% to 100% (versus AAD treatment) decreased stroke by 12%, HF hospitalization by 29%, and cardioversions by 45% in both countries. As the rate of first-line ablation increased from 0% to 100%, the overall 10-year per-patient costs increased from €13,034 to €14,450 in Italy and from €11,944 to €16,942 in France. For both countries, the scenario with no delay in second-line ablation had fewer AEs compared to the scenarios where ablation was delayed after AAD failure. Increasing rates of first-line or drug-naïve catheter ablation, and shorter AAT, resulted in higher cumulative controlled patient years on rhythm control therapy.
The model includes assumptions based on the best available clinical data, which may differ from real-world results, however, sensitivity analyses were included to combat parameter ambiguity. Additionally, the model represents a payer perspective and does not include societal costs, providing a conservative approach.
Increased first-line or drug-naïve catheter ablation, and shorter AAT, could increase the proportion of patients with controlled AF and reduce AEs, offsetting the small investment required in total AF costs over 10 years in Italy and France.
使用患者水平模拟模型，确定在法国和意大利的心房颤动（AF）患者中，与抗心律失常药物（AADs）相比，一线或初治导管消融术，或缩短AADs至消融时间（AAT）的临床和经济影响。
使用患者水平模拟模型，利用已发表的数据和专家意见模拟AF患者的临床路径。不良事件（AEs）的概率取决于治疗和/或疾病状态。分析1比较了以下几种情况：0%、25%、50%、75%或100%的患者接受一线消融治疗，其余患者接受AADs治疗。在分析2中，比较了将二线消融延迟1年或2年的影响。
在10年期间，在两个国家中，将一线消融的比例从0%提高到100%（与AADs治疗相比），中风减少了12%，心力衰竭住院减少了29%，心脏复律减少了45%。随着一线消融率从0%提高到100%，意大利每位患者10年的总成本从13,034欧元增加到14,450欧元，法国从11,944欧元增加到16,942欧元。对于这两个国家，与AADs治疗失败后延迟消融的情况相比，二线消融无延迟的情况不良事件更少。一线或初治导管消融率的提高以及AAT的缩短，导致节律控制治疗中累积控制的患者年数增加。
该模型包含基于现有最佳临床数据的假设，这可能与实际结果不同，不过，已纳入敏感性分析以应对参数的不确定性。此外，该模型代表了支付方的观点，不包括社会成本，提供了一种保守的方法。
增加一线或初治导管消融以及缩短AAT，可能会增加AF得到控制的患者比例并减少不良事件，抵消意大利和法国10年AF总成本所需的少量投资。
