A Real-World Comparison of 1-Year Survival and Expenditures for Transcatheter Aortic Valve Replacements: SAPIEN 3 Versus CoreValve Versus Evolut R
A Real-World Comparison of 1-Year Survival and Expenditures for Transcatheter Aortic Valve Replacements: SAPIEN 3 Versus CoreValve Versus Evolut R
复制标题
DOI：
10.1016/j.jval.2020.10.022
复制
发表时间：
2021-04-01
期刊：
影响因子：
4.5
通讯作者：
Kodera, Satoshi
中科院分区：
文献类型：
--
作者：
Haruhisa, Fukuda;Kiyohara, Kosuke;Kodera, Satoshi
目的：用于经导管主动脉瓣置换术（TAVR）的新型球囊可膨胀和自膨胀瓣膜已经开发出来，但很少有研究使用国家级数据检查与这些装置相关的结果。本研究旨在通过对真实世界数据的分析，阐明TAVR治疗主动脉瓣狭窄的临床和经济结果。方法：这项回顾性队列研究的数据来自2016年4月至2018年3月日本各地接受Edwards SAPIEN 3、Medtronic CoreValve或Medtronic Evolut R瓣膜经股动脉瓣膜置换术的主动脉瓣狭窄患者。在住院期间、1个月、3个月、6个月和1年检查每种瓣膜类型的起搏器植入、死亡率和医疗费用。采用广义线性回归模型和Cox比例风险模型来检验瓣膜类型与预后之间的关系。结果：我们分析了145家医院的7244例TAVR病例（SAPIEN: 5276例，CoreValve: 418例，Evolut R: 1550例）。SAPIEN 3、CoreValve和Evolut R调整后的1年支出分别为79 402美元、76 125美元和75 527美元；SAPIEN 3比其他瓣膜更昂贵（P < 0.05）。CoreValve和Evolut R的起搏器植入风险比（95%置信区间）显著高于CoreValve和Evolut R
Objectives: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data.Methods: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes.Results: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P