Importance There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, Setting, and Participants Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. Exposures TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and Relevance In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

中文翻译：

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二尖瓣与三尖瓣主动脉瓣狭窄的经导管主动脉瓣置换术与低手术风险患者的死亡率或中风之间的关联。

重要性 关于低手术风险患者经导管主动脉瓣置换术 (TAVR) 治疗二叶主动脉瓣狭窄的结果的数据有限。目的比较 TAVR 与球囊扩张瓣膜治疗低手术风险患者二尖瓣和三尖瓣主动脉瓣狭窄的疗效。在 684 个美国中心接受 TAVR 的患者的基于设计、设置和参与者注册的队列研究。参与者于 2015 年 6 月至 2020 年 10 月在胸外科医师协会 (STS)/美国心脏病学会经导管瓣膜治疗登记处登记。在 159661 名患者（7058 名双尖瓣，152603 名三尖瓣）中，37660 名患者（3243 名双尖瓣和 34417 名患者）手术风险低（定义为 STS 风险评分 <3%）的三尖瓣）被纳入分析。暴露二尖瓣与三尖瓣主动脉瓣狭窄的 TAVR。主要结果和措施 共同主要结果是 30 天和 1 年死亡率和中风。次要结局包括手术并发症和瓣膜血流动力学。结果 在 159 661 例患者（7058 例二尖瓣；152603 例三尖瓣）中，分析了 3168 对倾向匹配的低手术风险二尖瓣和三尖瓣主动脉瓣狭窄患者（平均年龄 69 岁；69.8% 男性；平均 [SD] STS-预测的死亡风险，二尖瓣为 1.7% [0.6%]，三尖瓣为 1.7% [0.7%]）。二尖瓣组和三尖瓣组的 30 天死亡率（0.9% vs 0.8%；风险比 [HR]，1.18 [95% CI，0.68-2.03]；P = .55）和 1年（4.6% 对 6.6%；HR，0.75 [95% CI，0.55-1.02]；P = .06）或 30 天卒中（1.4% 对 1.2%；HR，1.14 [95% CI，0.73-1。78]；P = .55）和 1 年时（2.0% vs 2.1%；HR 1.03 [95% CI, 0.69-1.53​​]；P = .89）。二尖瓣和三尖瓣组在手术并发症、瓣膜血流动力学（主动脉瓣梯度：13.2 mm Hg vs 13.5 mm Hg；绝对风险差 [RD]，0.3 mm Hg [95% CI，-0.9 至 0.3 mm Hg]）和中度或重度瓣周漏（3.4% vs 2.1% ; 绝对 RD，1.3% [95% CI，-0.6% 至 3.2%]）。结. 由于可能存在选择偏倚，并且缺乏对二叶主动脉瓣狭窄进行手术治疗的对照组，