Background:Frailty is associated with a higher risk for adverse outcomes after aortic valve replacement (AVR) for severe aortic valve stenosis, but whether or not frail patients derive differential benefit from transcatheter (TAVR) versus surgical (SAVR) AVR is uncertain.Methods:We linked adults ≥65 years old in the US CoreValve HiR trial (High-Risk) or SURTAVI trial (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) to Medicare claims, February 2, 2011, to September 30, 2015. Two frailty measures, a deficit-based and phenotype-based frailty index (FI), were generated. The treatment effect of TAVR versus SAVR was evaluated within FI tertiles for the primary end point of death and nondeath secondary outcomes, using multivariable Cox regression.Results:Of 1442 (linkage rate =60.0%) individuals included, 741 (51.4%) individuals received TAVR and 701 (48.6%) received SAVR (mean age 81.8±6.1 years, 44.0% female). Although 1-year death rates in the highest FI tertiles (deficit-based FI 36.7% and phenotype-based FI 33.8%) were 2- to 3-fold higher than the lowest tertiles (deficit-based FI 13.4%; hazard ratio, 3.02 [95% CI, 2.26–4.02], P<0.001; phenotype-based FI 17.9%; hazard ratio, 2.05 [95% CI, 1.58–2.67], P<0.001), there were no significant differences in the relative or absolute treatment effect of SAVR versus TAVR across FI tertiles for all death, nondeath, and functional outcomes (all interaction P>0.05). Results remained consistent across individual trials, frailty definitions, and when considering the nonlinked trial data.Conclusions:Two different frailty indices based on Fried and Rockwood definitions identified individuals at higher risk of death and functional impairment but no differential benefit from TAVR versus SAVR.

中文翻译：

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衰弱在确定经导管与外科主动脉瓣置换术获益中的作用

背景：衰弱与主动脉瓣置换术 (AVR) 治疗严重主动脉瓣狭窄后不良后果的风险较高相关，但尚不确定衰弱患者是否从经导管 (TAVR) 与手术 (SAVR) AVR 中获得不同的益处。方法：我们将 2011 年 2 月 2 日至 2015 年 9 月 30 日美国 CoreValve HiR 试验（高风险）或 SURTAVI 试验（中危患者的手术或经导管主动脉瓣置换术）中年龄≥65 岁的成年人与 Medicare 索赔联系起来。产生了两种虚弱措施，即基于赤字和基于表型的虚弱指数 (FI)。使用多变量 Cox 回归，在主要终点死亡和非死亡次要结局的 FI 三分位内评估 TAVR 与 SAVR 的治疗效果。结果：在 1442 名（关联率 = 60.0%）个体中，741 名（51. 4% 的人接受了 TAVR，701 人 (48.6%) 接受了 SAVR（平均年龄 81.8±6.1 岁，44.0% 为女性）。尽管最高 FI 三分位数（基于缺陷的 FI 36.7% 和基于表型的 FI 33.8%）的 1 年死亡率比最低三分位数（基于缺陷的 FI 13.4%；风险比 3.02）高 2 到 3 倍[95% CI, 2.26–4.02],P <0.001；基于表型的 FI 17.9%；风险比，2.05 [95% CI，1.58–2.67]，P <0.001），SAVR 与 TAVR 的相对或绝对治疗效果在所有死亡、非死亡和功能结局（所有交互作用P > 0.05）。结果在各个试验、虚弱定义以及考虑非关联试验数据时保持一致。结论：基于 Fried 和 Rockwood 定义的两个不同虚弱指数确定了死亡和功能障碍风险较高的个体，但 TAVR 与 SAVR 的获益没有差异。