Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
JAMA. 2021 Sep 21;326(11):1034-1044. doi: 10.1001/jama.2021.13346.
There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk.
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.
TAVR for bicuspid vs tricuspid aortic stenosis.
Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics.
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%]).
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.
在低手术风险的患者中，经导管主动脉瓣置换术（TAVR）治疗二叶式主动脉瓣狭窄的结局数据有限。
比较低手术风险患者中 TAVR 治疗二叶式与三叶式主动脉瓣狭窄的结局。
设计、设置和参与者：这是一项基于注册的队列研究，纳入了 684 家美国中心进行的 TAVR 患者。参与者于 2015 年 6 月至 2020 年 10 月期间被纳入胸外科医师学会（STS）/美国心脏病学会经导管瓣膜治疗登记处。在 159661 例患者（7058 例二叶式，152603 例三叶式）中，有 37660 例（3243 例二叶式和 34417 例三叶式）低手术风险患者（定义为 STS 风险评分<3%）被纳入分析。
二叶式与三叶式主动脉瓣狭窄的 TAVR。
主要结局为 30 天和 1 年死亡率和卒中等。次要结局包括手术并发症和瓣膜血流动力学。
在 159661 例患者（7058 例二叶式；152603 例三叶式）中，分析了 3168 对匹配低手术风险的二叶式和三叶式主动脉瓣狭窄患者的倾向性评分（平均年龄 69 岁；69.8%为男性；平均[标准差]STS 预测死亡率风险，二叶式为 1.7%[0.6%]，三叶式为 1.7%[0.7%]）。30 天死亡率（0.9%比 0.8%；风险比[HR]，1.18[95%CI，0.68-2.03]；P=0.55）和 1 年死亡率（4.6%比 6.6%；HR，0.75[95%CI，0.55-1.02]；P=0.06）或 30 天卒中等次要结局在二叶式和三叶式组之间没有显著差异（1.4%比 1.2%；HR，1.14[95%CI，0.73-1.78]；P=0.55）和 1 年卒中等次要结局（2.0%比 2.1%；HR，1.03[95%CI，0.69-1.53]；P=0.89）。二叶式和三叶式组在手术并发症、瓣膜血流动力学（主动脉瓣跨瓣压差：13.2mmHg 比 13.5mmHg；绝对差值[RD]，0.3mmHg[95%CI，-0.9 至 0.3mmHg]）和中度或重度瓣周漏（3.4%比 2.1%；绝对 RD，1.3%[95%CI，-0.6%至 3.2%]）方面也没有显著差异。
在这项基于注册的初步研究中，对低手术风险且接受主动脉瓣狭窄 TAVR 治疗的二叶式和三叶式主动脉瓣狭窄患者进行了倾向性评分匹配，两组患者在 30 天或 1 年的死亡率或卒中等主要结局方面没有显著差异。由于存在选择偏倚的可能性和缺乏二叶式主动脉瓣狭窄的手术治疗对照组，需要进行随机试验来充分评估 TAVR 治疗低手术风险的二叶式主动脉瓣狭窄患者的疗效和安全性。
