Background: Comparative echocardiographic data on transcatheter aortic valve replacement systems from randomized trials are limited. The REPRISE III trial (Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System – Randomized Clinical Evaluation) is a multicenter, randomized comparison of a mechanically expanded (Lotus) versus self-expanding (CoreValve) transcatheter aortic valve replacement device. This analysis rigorously assesses Doppler-derived valve hemodynamics and the impact on outcomes at 1 year in patients with extreme/high surgical risk treated with Lotus and CoreValve from REPRISE III.

Methods: REPRISE III includes patients with extreme- and high-risk aortic stenosis. Patients were enrolled at 55 centers. All transthoracic echocardiograms with Doppler were obtained following a standard protocol up to 12 months postimplant and analyzed by a core laboratory. Valve size, mean gradient, aortic valve area, and Doppler velocity index and their impact on clinical outcomes are reported. Additional parameters including paravalvular leak were evaluated using a multiparametric approach.

Results: A total of 912 patients were randomly assigned (2:1 ratio; 607 Lotus:305 CoreValve). Median age was 84 years, 51% of the patients were women, and the Society of Thoracic Surgeons score was 6.8±4.1. CoreValve demonstrated lower gradients and larger aortic valve area and Doppler velocity index than Lotus at discharge; the difference decreased in subsequent follow-up up to a year (all P<0.01). Lotus had lower rates of paravalvular leak that persisted over time (P<0.05). Similar outcomes were seen when comparing each valve type by size group (small, medium, large). The hemodynamic differences between valves did not translate into worse clinical outcomes. All-cause mortality was not different between the 2 groups in any of the 3 valve sizes. When comparing patients with normal valve gradients (<20 mm Hg, n=780) with those with abnormal gradients (>20 mm Hg, n=48) in the entire patient population, all-cause mortality was not different. This was also not significant when evaluating each valve type separately. Similarly, there were no differences for aortic valve area >1.1 cm² or <1.1 cm² and for Doppler velocity index >0.35 or <0.35 (all P=not significant).

Conclusions: Lotus had significantly greater freedom from moderate or severe paravalvular leak and smaller valve area and higher gradients than CoreValve. The hemodynamic differences were not associated with any clinical differences in the composite end point of mortality, disabling stroke, and moderate paravalvular leak or with quality of life at 1 year of follow-up.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02202434.

背景：来自随机试验的经导管主动脉瓣置换系统的比较超声心动图数据有限。REPRISE III试验（通过植入莲花瓣膜系统可置换性经皮主动脉瓣置换术–随机临床评估）是对机械扩张（莲花）与自扩张（CoreValve）经导管主动脉瓣置换装置进行的多中心，随机比较。该分析严格评估了使用REPRISE III的Lotus和CoreValve治疗的极端/高手术风险患者中多普勒衍生的瓣膜血流动力学及其对1年结局的影响。

方法： REPRISE III包括患有高危主动脉瓣狭窄的患者。患者在55个中心入组。所有的多普勒经胸超声心动图检查均遵循标准方案，直至植入后12个月，并由核心实验室进行分析。报告了瓣膜大小，平均梯度，主动脉瓣面积和多普勒速度指数及其对临床结果的影响。使用多参数方法评估了包括瓣膜旁渗漏在内的其他参数。

结果：总共912例患者被随机分配（比例为2：1； 607莲花：305 CoreValve）。中位年龄为84岁，其中51％为女性，胸外科医师协会评分为6.8±4.1。与出院时的莲花相比，CoreValve的梯度小，主动脉瓣面积和多普勒速度指数大。在随后的长达一年的随访中，差异有所减小（所有P <0.01）。莲花的瓣周漏率较低，并且随着时间的推移持续存在（P<0.05）。当按尺寸组（小，中，大）比较每种阀门类型时，观察到相似的结果。瓣膜之间的血流动力学差异并未转化为更差的临床结果。在3种瓣膜尺寸的任何一种中，两组之间的全因死亡率没有差异。在整个患者人群中比较正常瓣膜梯度（<20 mm Hg，n = 780）和异常瓣膜梯度（> 20 mm Hg，n = 48）的患者，全因死亡率没有差异。当分别评估每种阀门类型时，这也不重要。同样，主动脉瓣面积> 1.1 cm ²或<1.1 cm ²和多普勒速度指数> 0.35或<0.35也无差异（所有P =不显着）。

结论：与CoreValve相比，Lotus免受中度或严重瓣周漏的自由度更大，瓣膜面积更小，梯度更高。血流动力学差异与死亡率，致死性卒中和中度瓣周漏的综合终点或随访1年的生活质量的任何临床差异均无关联。

临床试验注册： URL：https://www.clinicaltrials.gov。唯一标识符：NCT02202434。