Kerckhoff Heart Center, Bad Nauheim, Germany.
York Health Economics Consortium, York, UK.
BMC Health Serv Res. 2024 Nov 26;24(1):1474. doi: 10.1186/s12913-024-11967-0.
Three recent randomized controlled trials demonstrated that, in patients with symptomatic paroxysmal atrial fibrillation (PAF), first-line pulmonary vein isolation with cryoballoon catheter ablation reduces atrial arrhythmia recurrence compared to initial antiarrhythmic drug (AAD) therapy. This study aimed to evaluate the cost-effectiveness of first-line cryoablation compared to first-line AADs from a German healthcare payer perspective.
Individual patient-level data from 703 participants with untreated PAF enrolled into three randomized clinical trials (Cryo-FIRST, STOP AF First and EARLY-AF) were used to derive parameters for the cost-effectiveness model (CEM). The CEM structure consisted of a hybrid decision tree and Markov model. The decision tree (one-year time horizon) informed initial health state allocation in the first cycle of the Markov model (40-year time horizon; three-month cycle length). Health benefits were expressed in quality-adjusted life years (QALYs). Cost inputs were sourced from German diagnosis-related groups and the Institute for the Hospital Remuneration System (InEK). Costs and benefits were discounted at 3% per annum.
Cryoablation was cost-effective, incurring ~ €200 per patient while offering an increase in QALYs (~ 0.18) over a lifetime. This produced an average incremental cost-effectiveness ratio of ~ €1,000 per QALY gained. Individuals were expected to receive ~ 1.2 ablations over a lifetime, regardless of initial treatment. However, those initially treated with cryoablation as opposed to AADs experience 0.9 fewer re-ablations and a 45% reduction in time spent in AF health states.
Initial rhythm control with cryoballoon ablation in symptomatic PAF is a cost-effective treatment option in a German healthcare setting.
三项近期的随机对照试验表明,在有症状阵发性心房颤动(PAF)的患者中,与初始抗心律失常药物(AAD)治疗相比,使用冷冻球囊导管消融进行一线肺静脉隔离可降低心房心律失常的复发率。本研究旨在从德国医疗保健支付者的角度评估一线冷冻消融与一线 AAD 的成本效益。
使用未接受治疗的 PAF 患者的 703 名参与者的个体患者水平数据,这些数据来自三项随机临床试验(Cryo-FIRST、STOP AF First 和 EARLY-AF),以得出成本效益模型(CEM)的参数。CEM 结构由混合决策树和马尔可夫模型组成。决策树(一年时间范围)为马尔可夫模型的第一个循环(40 年时间范围;三个月循环长度)中的初始健康状态分配提供信息。健康效益用质量调整生命年(QALYs)表示。成本投入来自德国诊断相关组和医院薪酬系统研究所(InEK)。成本和效益按每年 3%贴现。
冷冻消融具有成本效益,每位患者的费用约为 200 欧元,同时在一生中增加了约 0.18 个 QALYs。这产生了每获得一个 QALY 的平均增量成本效益比约为 1000 欧元。无论初始治疗如何,预计一生中需要进行约 1.2 次消融。然而,与初始接受 AAD 治疗相比,那些初始接受冷冻消融治疗的患者,其再次消融的次数减少了 0.9 次,AF 健康状态的时间减少了 45%。
在德国医疗保健环境中,对于有症状的 PAF,使用冷冻球囊消融进行初始节律控制是一种具有成本效益的治疗选择。