Themistoclakis Sakis, Tritto Massimo, Bertaglia Emanuele, Berto Patrizia, Bongiorni Maria Grazia, Catanzariti Domenico, De Fabrizio Giuseppe, De Ponti Roberto, Grimaldi Massimo, Pandozi Claudio, Tondo Claudio, Gulizia Michele
Dipartimento Cardiovascolare, Ospedale dell'Angelo, Mestre-Venezia.
G Ital Cardiol (Rome). 2011 Nov;12(11):726-76. doi: 10.1714/966.10545.
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and significantly impact patients' quality of life, morbidity and mortality. The number of affected patients is expected to increase as well as the costs associated with AF management, mainly driven by hospitalizations. Over the last decade, catheter ablation techniques targeting pulmonary vein isolation have demonstrated to be effective in treating AF and preventing AF recurrence. This Health Technology Assessment report of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) aims to define the current role of catheter ablation of AF in terms of effectiveness, efficiency and appropriateness. On the basis of an extensive review of the available literature, this report provides (i) an overview of the epidemiology, clinical impact and socio-economic burden of AF; (ii) an evaluation of therapeutic options other than catheter ablation of AF; and (iii) a detailed presentation of clinical outcomes and cost-benefit ratio associated with catheter ablation. The costs of catheter ablation of AF in Italy were obtained using a bottom-up analysis of a resource utilization survey of 52 hospitals that were considered a representative sample, including 4 Centers that contributed with additional unit cost information in a separate questionnaire. An analysis of budget impact was also performed to evaluate the impact of ablation on the management costs of AF. Results of this analysis show that (1) catheter ablation is effective, safe and superior to antiarrhythmic drug therapy in maintaining sinus rhythm; (2) the cost of an ablation procedure in Italy typically ranges from €8868 to €9455, though current reimbursement remains insufficient, covering only about 60% of the costs; (3) the costs of follow-up are modest (about 8% of total costs); (4) assuming an adjustment of reimbursement to the real cost of an ablation procedure and a 5-10% increase in the annual rate of ablation procedures, after approximately 5-6 years this would result in significant incremental savings for the Italian Healthcare System. In conclusion, catheter ablation of AF is a cost-effective procedure that is inadequately reimbursed in Italy. Insufficient reimbursement may serve as disincentive to perform AF ablation, thereby limiting patient access to this treatment. Considering the healthcare system perspective, higher initial costs for ablation procedures in the short term may be offset by cost savings mainly associated with decreased hospitalizations over time.
心房颤动（AF）是最常见的持续性心律失常，对患者的生活质量、发病率和死亡率有重大影响。随着房颤管理相关成本（主要由住院费用驱动）的增加，预计受影响患者的数量也会上升。在过去十年中，针对肺静脉隔离的导管消融技术已被证明在治疗房颤和预防房颤复发方面是有效的。这份意大利心律失常与心脏起搏协会（AIAC）的卫生技术评估报告旨在从有效性、效率和适宜性方面确定房颤导管消融的当前作用。在广泛回顾现有文献的基础上，本报告提供了：（i）房颤的流行病学、临床影响和社会经济负担概述；（ii）房颤导管消融以外治疗选择的评估；以及（iii）与导管消融相关的临床结果和成本效益比的详细介绍。意大利房颤导管消融的成本是通过对52家医院的资源利用调查进行自下而上的分析得出的，这些医院被视为具有代表性的样本，其中4个中心在单独的问卷中提供了额外的单位成本信息。还进行了预算影响分析，以评估消融对房颤管理成本的影响。该分析结果表明：（1）导管消融在维持窦性心律方面有效、安全且优于抗心律失常药物治疗；（2）意大利一次消融手术的成本通常在8868欧元至9455欧元之间，尽管目前的报销仍然不足，仅覆盖约60%的成本；（3）随访成本适中（约占总成本的8%）；（4）假设将报销调整至消融手术的实际成本，并使消融手术的年增长率提高5 - 10%，大约5 - 6年后，这将为意大利医疗保健系统带来显著的增量节省。总之，房颤导管消融是一种具有成本效益的手术，但在意大利报销不足。报销不足可能会抑制房颤消融手术的开展，从而限制患者获得这种治疗。从医疗保健系统的角度来看短期内消融手术较高的初始成本可能会被主要与随着时间推移住院人数减少相关的成本节省所抵消。
