BACKGROUND Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited. OBJECTIVES This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study. METHODS The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S. CENTERS Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. RESULTS An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR. CONCLUSIONS The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance.

中文翻译：

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Evolut 低风险 TAVR 双尖瓣研究的 3 年结果。


背景 经导管主动脉瓣置换术 （TAVR） 对 2 年以上二叶式主动脉瓣狭窄的低手术风险患者的结局是有限的。目的 本研究旨在评估 Evolut 低风险二尖瓣研究的 3 年临床和超声心动图结果。方法 Evolut 低风险二尖瓣研究是一项前瞻性、多中心、单臂研究，在美国 25 个中心进行 二叶式主动脉瓣解剖结构（所有亚型）手术风险低的严重主动脉瓣狭窄患者接受了 TAVR 与自膨式环上 Evolut R 或 PRO （Medtronic） 生物假体。一个独立的临床事件委员会裁定了所有死亡和终点相关的不良事件，一个中央超声心动图核心实验室评估了血流动力学终点。结果 2018 年 12 月至 2019 年 10 月对 150 例患者进行了一次尝试植入。平均年龄 70.3 ± 5.5 岁，48% （72/150） 的患者为女性，胸外科医师协会预测死亡风险评分平均值为 1.3% （Q1-Q3： 0.9%-1.7%）。Sievers 1 型是主要的二叶形态 （90.7%，136/150）。全因死亡率或致残性卒中的 Kaplan-Meier 发生率在 1 年时为 1.3% （95% CI： 0.3%-5.3%），在 2 年时为 3.4% （95% CI： 1.4%-8.1%），在 3 年时为 4.1% （95% CI： 1.6%-10.7%）。3 年新永久性起搏器植入率为 19.4% （95% CI： 12.4%-29.6%）。TAVR 后 2 年和 3 年没有中度或重度瓣周主动脉瓣反流的实例。结论 Evolut 低风险双尖牙症研究的 3 年结果表明，全因死亡率或致残性卒中率低，血流动力学表现良好。