■为了确定与抗心律失常药物(AAD)相比,一线或药物初始导管消融的临床和经济意义,法国和意大利的房颤(AF)患者的AADs至消融时间(AAT)较短,使用患者水平模拟模型。
■使用已发表的数据和专家意见,使用患者级模拟模型来模拟房颤患者的临床路径。不良事件(AE)的概率取决于治疗和/或疾病状态。分析1比较了0%的治疗方案,25%,50%,75%或100%的患者进行一线消融,其余患者进行AAD。在分析2中,情景比较了延迟过渡到二线消融1年或2年的影响。
■超过10年,将一线消融从0%增加到100%(与AAD治疗相比)可使中风减少12%,HF住院29%,在这两个国家,心脏复律率下降了45%。随着一线消融率从0%增加到100%,在意大利,每位患者10年的总体费用从13,034欧元增加到14,450欧元,在法国从11,944欧元增加到16,942欧元。对这两个国家来说,与AAD失败后消融延迟的情况相比,二线消融无延迟的情况下的AE较少.增加一线或药物初始导管消融的速率,和较短的AAT,导致节律控制治疗的累积受控患者年数增加。
■该模型包括基于最佳可用临床数据的假设,这可能与现实世界的结果不同,然而,包括敏感性分析以对抗参数歧义。此外,该模型代表了付款人的观点,不包括社会成本,提供保守的方法。
■增加一线或药物初始导管消融,和较短的AAT,可以增加控制房颤患者的比例,减少AEs,抵消了意大利和法国10年总AF成本所需的小额投资。
本研究创建了个体患者水平模拟,以评估导管消融的临床和经济影响。这是治疗房颤(AF)患者的非药物选择。本研究探讨了更新的2020年ESC指南对意大利和法国患者房颤管理的影响,将抗心律失常药物治疗与一线和二线导管消融进行比较。房颤相关不良事件(AE)的差异,如卒中,住院治疗,心脏复律,模型中考虑了出血事件,以告知每位患者的总费用.该模型用50,000名患者模拟进行了测试,以限制随机效应。患者模拟模型的结果表明,与药物治疗相比,一线导管消融的频率从0%增加到100%,这两个国家的AE都减少了,导致每位患者的10年费用略有增加。此外,对于一线药物治疗失败的患者,那些在明年接受二线导管消融的人,而不是延迟一两年,在该模型的第10年中,节律控制治疗的累积受控患者年的发生率最高,而AE发生率最低。总的来说,每个患者的10年费用相似,无论二线消融是无延迟还是延迟1年或2年.总之,增加一线导管消融和早期二线导管消融的使用可以降低不良临床事件的发生率,并增加控制房颤患者的比例,而在10年期间,每例患者费用的投资相似.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
This study created an individual patient level simulation to estimate the clinical and economic implications of catheter ablation, which is a non-pharmacological option to treat patients with atrial fibrillation (AF). This study examines the impact of the updated 2020 ESC guidelines to managing AF in Italian and French patients comparing antiarrhythmic drug treatment to first- and second-line catheter ablation. Differences in AF-related adverse events (AEs) such as stroke, hospitalization, cardioversions, and bleeding events were considered in the model to inform the overall per-patient costs. The model was tested with 50,000 patient simulations to limit random effects. The results of the patient simulation model revealed that as the frequency of utilizing first-line catheter ablation increased from 0% to 100% compared to pharmacological treatment, AEs were reduced in both countries, resulting in a slightly increased 10-year-per-patient cost. Additionally, for patients who fail first-line pharmacological treatment, those who receive second-line catheter ablation in the next year, versus a delay of one or two years, had the highest rate of cumulative controlled patient years on rhythm control therapy and the lowest AE rate by year 10 of the model. Overall, 10-year per-patient costs were similar, regardless of whether second-line ablation was delivered with no delay or a one-or two-year delay. In conclusion, increased use of first-line catheter ablation and earlier second-line catheter ablation can reduce the rates of adverse clinical events and increase the proportion of patients with controlled AF for a similar investment in per-patient costs over 10-years.