Mehaffey J Hunter, Kawsara Mohammad, Jagadeesan Vikrant, Hayanga J W Awori, Chauhan Dhaval, Wei Lawrence, Mascio Christopher, Rankin J Scott, Daggubati Ramesh, Badhwar Vinay
Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WVa.
Department of Cardiology, West Virginia University, Morgantown, WVa.
J Thorac Cardiovasc Surg. 2025 Mar;169(3):866-875.e6. doi: 10.1016/j.jtcvs.2024.04.012. Epub 2024 Apr 28.
Recent approval of transcatheter aortic valve replacement (TAVR) in patients at low surgical risk has resulted in a rapid real-world expansion of TAVR in patients not otherwise examined in recent low-risk trials. We sought to evaluate the outcomes of surgical aortic valve replacement (SAVR) versus TAVR in low-risk Medicare beneficiaries.
Using the US Centers for Medicare and Medicaid Services claims database, we evaluated all beneficiaries undergoing isolated SAVR (n = 33,210) or TAVR (n = 77,885) (2018-2020). International Classification of Diseases 10th revision codes were used to define variables and frailty was defined by the validated Kim index. Doubly robust risk adjustment was performed with inverse probability weighting and multilevel regression models, as well as competing-risk time to event analysis. A low-risk cohort was identified to simulate recent low-risk trials.
A total of 15,749 low-risk patients (8144 SAVR and 7605 TAVR) were identified. Comparison was performed with doubly robust risk adjustment accounting for all factors. TAVR was associated with lower perioperative stroke (odds ratio, 0.62; P < .001) and hospital mortality (odds ratio, 0.16; P < .001) compared with SAVR. However, risk-adjusted longitudinal analysis demonstrated TAVR was associated with higher late risk of stroke (hazard ratio, 1.65; P < .001), readmission for valve reintervention (hazard ratio, 1.88; P < .001), and all-cause mortality (hazard ratio, 1.54; P < .001) compared with SAVR.
Among low-risk Medicare beneficiaries younger than age 75 years undergoing isolated AVR, SAVR was associated with higher index morbidity and mortality but improved 3-year risk-adjusted stroke, valve reintervention, and survival compared with TAVR.
经导管主动脉瓣置换术（TAVR）近期已被批准用于手术风险较低的患者，这导致TAVR在现实世界中迅速扩展至近期低风险试验未纳入的患者群体。我们旨在评估手术主动脉瓣置换术（SAVR）与TAVR在低风险医疗保险受益人中的治疗效果。
利用美国医疗保险和医疗补助服务中心的索赔数据库，我们评估了2018年至2020年间所有接受单纯SAVR（n = 33,210）或TAVR（n = 77,885）的受益人。使用国际疾病分类第10版编码定义变量，并通过经过验证的金氏指数定义虚弱程度。采用逆概率加权和多水平回归模型进行双重稳健风险调整，以及竞争风险事件时间分析。确定了一个低风险队列以模拟近期的低风险试验。
共识别出15,749名低风险患者（8144例SAVR和7605例TAVR）。采用考虑所有因素的双重稳健风险调整进行比较。与SAVR相比，TAVR与较低的围手术期卒中发生率（比值比，0.62；P <.001）和医院死亡率（比值比，0.16；P <.001）相关。然而，风险调整后的纵向分析表明，与SAVR相比，TAVR与更高的晚期卒中风险（风险比，1.65；P <.001）、瓣膜再次干预再入院率（风险比，1.88；P <.001）和全因死亡率（风险比，1.54；P <.001）相关。
在年龄小于75岁的低风险医疗保险受益人中，接受单纯主动脉瓣置换术时，SAVR与更高的首次发病和死亡率相关，但与TAVR相比，3年风险调整后的卒中、瓣膜再次干预和生存率有所改善。
