Kuo Chia-Cheng, Chang Hsiao-Huang, Leu Hsin-Bang, Chen I-Ming, Chen Po-Lin, Lin Su-Man, Chen Ying-Hwa
Division of Cardiovascular Surgery, Department of Surgery.
School of Medicine, National Yang Ming Chiao Tung University.
Acta Cardiol Sin. 2023 May;39(3):449-456. doi: 10.6515/ACS.202305_39(3).20221109A.
The superiority of the new-generation self-expanding Evolut R compared with the first-generation CoreValve with regards to outcomes after transcatheter aortic valve replacement (TAVR) is unclear. The aim of this study was to investigate the hemodynamic and clinical performance of Evolut R compared with its direct predecessor, CoreValve, in a Taiwanese population.
This study included all consecutive patients who underwent TAVR with either CoreValve or Evolut R between March 2013 and December 2020. Thirty-day Valve Academic Research Consortium-2 (VARC-2)-defined outcomes and hemodynamic performances were investigated.
There were no significant differences in baseline demographic characteristics between the patients receiving CoreValve (n = 117) or Evolut R (n = 117). Aortic valve-in-valve procedures for failed surgical bioprosthesis and procedures under conscious sedation were performed significantly more often with Evolut R. Pre-dilatation was performed significantly more often and contrast media volume was significantly higher with CoreValve. Stroke (0% vs. 4.3%, p = 0.024) and the need for emergent conversion to open surgery (0% vs. 5.1%, p = 0.012) were significantly lower in Evolut R than in CoreValve recipients. Evolut R significantly reduced 30-day composite safety endpoint (4.3% vs. 15.4%, p = 0.004).
Advancements in transcatheter valve technologies have resulted in improved outcomes for patients undergoing TAVR with self-expanding valves. With the new-generation Evolut R, device success was high and the 30-day composite safety endpoint was significantly reduced after TAVR compared with CoreValve.
在经导管主动脉瓣置换术（TAVR）后，新一代自膨胀式Evolut R与第一代CoreValve相比在预后方面的优势尚不清楚。本研究的目的是在台湾人群中调查Evolut R与其直接前身CoreValve相比的血流动力学和临床性能。
本研究纳入了2013年3月至2020年12月期间接受CoreValve或Evolut R进行TAVR的所有连续患者。研究了30天瓣膜学术研究联盟-2（VARC-2）定义的预后和血流动力学性能。
接受CoreValve（n = 117）或Evolut R（n = 117）的患者在基线人口统计学特征上无显著差异。使用Evolut R进行失败的外科生物假体的主动脉瓣中瓣手术和清醒镇静下的手术明显更频繁。CoreValve进行预扩张的频率明显更高，造影剂用量也明显更多。Evolut R组的卒中发生率（0%对4.3%，p = 0.024）和紧急转为开放手术的需求（0%对5.1%，p = 0.012）明显低于CoreValve组。Evolut R显著降低了30天综合安全终点（4.3%对15.4%，p = 0.004）。
经导管瓣膜技术的进步使接受自膨胀瓣膜TAVR的患者预后得到改善。使用新一代Evolut R，手术成功率高，与CoreValve相比，TAVR后30天综合安全终点显著降低。
