Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Department of Cardiology and Angiology I, Heart Center Freiburg, Faculty of Medicine, University of Freiburg, Hugstetter Str. 55, 79104, Freiburg, Germany.
Eur J Health Econ. 2019 Jun;20(4):625-632. doi: 10.1007/s10198-018-1023-x. Epub 2019 Jan 2.
Aortic stenosis (AS) is the most common valvular heart disease, with a dismal prognosis when untreated. Recommended therapy is surgical (SAVR) or transcatheter (TAVR) aortic valve replacement. Based on a retrospective cohort of isolated SAVR and TAVR procedures performed in Germany in 2015 (N = 17,826), we examine the impact of treatment selection on in-hospital mortality and total in-hospital costs for a variety of at-risk populations. Since patients were not randomized to the two treatment options, the two endpoints in-hospital mortality and reimbursement are analyzed using logistic and linear regression models with 20 predefined patient characteristics as potential confounders. Incremental cost-effectiveness ratios were calculated as a ratio of the risk-adjusted reimbursement and mortality differences with 95% confidence intervals obtained by Fieller's theorem. Our study shows that TF-TAVR is more costly that SAVR and that cost differences between the procedures vary little between patient groups. Results regarding in-hospital mortality are mixed. SAVR is the predominant procedure among younger patients. For patients older than 85 years or at intermediate and higher pre-operative risk TF-TAVR seems to be the treatment of choice. Incremental cost-effectiveness ratios (ICER) are most favorable for patients older than 85 years (ICER €154,839, 95% CI €89,163-€302,862), followed by patients at higher pre-operative risk (ICER €413,745, 95% CI €258,027-€952,273). A hypothetical shift from SAVR towards TF-TAVR among patients at intermediate pre-operative risk is associated with a less favorable ICER (€1,486,118, 95% CI €764,732-€23,692,323), as the risk-adjusted mortality benefit is relatively small (- 0.97% point), while the additional reimbursement is still eminent (+€14,464). From a German healthcare system payer's perspective, the additional costs per life saved due to TAVR are most favorable for patients older than 85 and/or at higher pre-operative risk.
主动脉瓣狭窄（AS）是最常见的心脏瓣膜病，如果不治疗，预后不良。推荐的治疗方法是外科（SAVR）或经导管（TAVR）主动脉瓣置换术。基于 2015 年在德国进行的一项孤立的 SAVR 和 TAVR 手术回顾性队列研究（N=17826），我们研究了治疗选择对各种高危人群的住院死亡率和总住院费用的影响。由于患者未随机分配到两种治疗方案，因此使用逻辑和线性回归模型分析了住院死亡率和报销这两个终点，其中 20 个预先确定的患者特征作为潜在混杂因素。增量成本效益比是通过费勒定理获得的风险调整后报销和死亡率差异的比值，置信区间为 95%。我们的研究表明，TF-TAVR 比 SAVR 更昂贵，并且两种手术之间的成本差异在患者群体之间差异不大。关于住院死亡率的结果是混合的。SAVR 是年轻患者的主要手术。对于 85 岁以上或中高危的患者，TF-TAVR 似乎是首选治疗方法。增量成本效益比（ICER）对 85 岁以上的患者最有利（ICER€154839，95%CI€89163-€302862），其次是术前风险较高的患者（ICER€413745，95%CI€258027-€952273）。如果在术前风险中等的患者中，SAVR 向 TF-TAVR 的假设转变，那么 ICER 就不太有利（ICER€1486118，95%CI€764732-€23692323），因为风险调整后的死亡率获益相对较小（-0.97 个百分点），而额外的报销仍然显著增加（+€14464）。从德国医疗保健系统支付者的角度来看，由于 TAVR 而每挽救一条生命的额外成本对 85 岁以上和/或术前风险较高的患者最为有利。
