Deniz Huseyin Baris, Caro J Jaime, Ward Alexandra, Moller Jorgen, Malik Farzana
Caro Research Institute, Concord, Massachusetts 01742, USA.
J Cardiovasc Med (Hagerstown). 2008 Jan;9(1):43-50. doi: 10.2459/JCM.0b013e328013cd28.
This study sought to estimate the economic implications of managing bradycardia due to sinoatrial node disease or atrioventricular block with dual compared to single-chamber ventricular pacemakers from an Italian government perspective. Dual-chamber pacemakers lower the risk of developing atrial fibrillation and pacemaker syndrome.
A discrete event simulation of a patient's course for 5 years following pacemaker implantation. Each patient may experience the following: complications, pacemaker syndrome, atrial fibrillation, stroke, or death. Risk functions were based on published data from the Canadian Trial of Physiologic Pacing and Mode Selection Trial in Sinus-Node Dysfunction. Identical patients were simulated after receiving a single or dual-chamber pacemaker. Quality-adjusted life-years (QALYs) and direct medical costs were estimated (2004 Euros). Benefits and costs were discounted at 3%.
The model predicts that implanting the dual-chamber device in 1000 patients will prevent 36 patients from developing atrial fibrillation, 168 from developing severe pacemaker syndrome, but will lead to 13 additional hospitalizations with complications over 5 years. Health benefits are achieved at an incremental cost of 23 euros per patient, and 0.09 QALY, yielding an incremental cost-effectiveness ratio of euro 260 euros/QALY. Sensitivity analysis shows that device replacement rates due to pacemaker syndrome have the biggest impact on the final results.
In the long term, higher initial costs of the dual-chamber device may be offset by a reduction in costs associated with reoperations and atrial fibrillation.
本研究旨在从意大利政府的角度评估,与单腔心室起搏器相比,使用双腔起搏器治疗因窦房结疾病或房室传导阻滞所致心动过缓的经济影响。双腔起搏器可降低发生心房颤动和起搏器综合征的风险。
对起搏器植入术后患者5年病程进行离散事件模拟。每位患者可能经历以下情况:并发症、起搏器综合征、心房颤动、中风或死亡。风险函数基于加拿大生理性起搏试验和窦房结功能障碍模式选择试验的已发表数据。对接受单腔或双腔起搏器的相同患者进行模拟。估计质量调整生命年(QALY)和直接医疗费用(2004年欧元)。收益和成本按3%进行贴现。
该模型预测,为1000名患者植入双腔设备将预防36名患者发生心房颤动,168名患者发生严重起搏器综合征,但在5年内会导致额外13例因并发症住院。以每位患者增加23欧元成本和0.09 QALY的代价获得健康收益,增量成本效益比为260欧元/QALY。敏感性分析表明,因起搏器综合征导致的设备更换率对最终结果影响最大。
从长远来看,双腔设备较高的初始成本可能会被再次手术和心房颤动相关成本的降低所抵消。