Department of Health Care Administration and Management, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Department of Food Science, Otsuma Women's University, Tokyo, Japan.
Value Health. 2021 Apr;24(4):497-504. doi: 10.1016/j.jval.2020.10.022. Epub 2020 Dec 19.
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.
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.
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 < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively.
SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users.
为经导管主动脉瓣置换术（TAVR）开发了新版本的球囊扩张式和自膨式瓣膜，但很少有研究使用国家级数据来评估这些器械相关的结果。本研究旨在通过分析真实世界的数据来阐明日本主动脉瓣狭窄患者 TAVR 的临床和经济结果。
本回顾性队列研究使用了 2016 年 4 月至 2018 年 3 月期间在日本接受经股动脉 TAVR 的主动脉瓣狭窄患者的数据，患者使用了 Edwards SAPIEN 3、美敦力 CoreValve 和美敦力 Evolut R 瓣膜。在住院期间和 1 个月、3 个月、6 个月和 1 年时，检查了每种瓣膜类型的起搏器植入、死亡率和医疗支出。使用广义线性回归模型和 Cox 比例风险模型来评估瓣膜类型与结局之间的关联。
我们分析了 7244 例 TAVR 病例（SAPIEN 3：5276 例，CoreValve：418 例，Evolut R：1550 例），涉及 145 家医院。SAPIEN 3、CoreValve 和 Evolut R 的 1 年支出分别为 79402 美元、76125 美元和 75527 美元；SAPIEN 3 的支出明显高于其他瓣膜（P <.05）。CoreValve 和 Evolut R 的起搏器植入风险比（95%置信区间）明显高于 SAPIEN 3（分别为 2.61 [2.07-3.27] 和 1.80 [1.53-2.12]）（P <.001）。CoreValve 和 Evolut R 的死亡率风险比（95%置信区间）分别为 1.11 [0.84-1.46] 和 1.22 [0.97-1.54]，均无统计学意义。
与 CoreValve 和 Evolut R 相比，SAPIEN 3 的使用者一般具有更低的起搏器植入和死亡率，但支出更高。
