Department of Cardiac Surgery, Cardiologique de Haut Lévèque - (CHU) de Bordeaux, France.
Department of Internal Medicine (Cardiology), Yale University School of Medicine, New Haven, Connecticut.
Am J Cardiol. 2024 Jul 15;223:147-155. doi: 10.1016/j.amjcard.2024.04.013. Epub 2024 Apr 17.
There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed tomography-measured annular perimeter of ≤72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary end point was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, the all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm for TAVR and 1.6 ± 0.5 cm for surgery and the mean gradient was 8.0 ± 4.1 versus 12.7 ± 6.0 mm Hg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of patients who underwent TAVR and 33.2% of patients who underwent surgery, p <0.001. In conclusion, in women with small annuli, the clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group and fewer pacemakers in the surgical group.
在患有主动脉瓣狭窄和小主动脉瓣环的女性中,经导管主动脉瓣置换术(TAVR)或手术的随机对照试验数据有限。我们评估了主动脉瓣置换后的 2 年临床和血液动力学结果,以了解急性瓣膜性能以及早期和中期临床结果。这项事后分析汇总了参加随机、前瞻性、多中心 Evolut 低风险和外科置换与经导管主动脉瓣植入术(SURTAVI)中风险试验的女性。纳入了低或中手术风险且经计算机断层扫描测量的瓣环周长≤72.3mm 的严重主动脉瓣狭窄女性,并接受自膨式、瓣上 TAVR 或手术。主要终点为 2 年全因死亡率或致残性卒中发生率。该研究纳入了 620 名女性(TAVR 组 323 名,手术组 297 名),平均年龄为 78 岁。2 年时,TAVR 的全因死亡率或致残性卒中发生率为 6.5%,手术组为 8.0%,p=0.47。TAVR 的起搏器使用率为 20.0%,手术组为 8.3%,p<0.001。TAVR 组 2 年时的有效瓣口面积为 1.9±0.5cm,手术组为 1.6±0.5cm,平均梯度分别为 8.0±4.1mmHg 和 12.7±6.0mmHg(均 p<0.001)。TAVR 组有 10.9%的患者和手术组有 33.2%的患者出院时存在中度或重度患者-假体不匹配,p<0.001。总之,在小瓣环女性中,自膨式、瓣上 TAVR 和手术的 2 年临床结果相似,TAVR 组的血液动力学更好,手术组的起搏器更少。
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