Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Department of Cardiovascular Surgery, Keio University School of Medicine, Tokyo, Japan.
Catheter Cardiovasc Interv. 2021 May 1;97(6):E875-E886. doi: 10.1002/ccd.29259. Epub 2020 Sep 14.
To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self-expanding and balloon-expandable transcatheter heart valves (THVs) in patients with a small aortic annulus.
Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli.
In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third-generation THVs. Propensity score matching was used to adjust baseline clinical characteristics.
The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0-11.9] vs. 12.0 [IQR: 9.9-16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01-1.46] vs. 1.08 [IQR: 0.90-1.28] cm /m , p < .001}. However, no significant differences were reported in the incidence of severe prosthesis-patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all-cause mortality (log-lank test, p = .81).
TAVR for patients with a small annulus using third-generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all-cause mortality at 1 year was similar between both groups.
比较经股动脉入路使用自膨式和球囊扩张式经导管主动脉瓣置换术（TAVR）治疗小主动脉瓣环患者的安全性、疗效和血液动力学。
很少有研究直接比较使用第三代经导管心脏瓣膜（THV）的 TAVR 结果，重点关注小主动脉瓣环患者。
在一项多中心 TAVR 注册研究中，我们分析了 576 例小主动脉瓣环且接受第三代 THV 经股动脉 TAVR 治疗的患者数据。采用倾向评分匹配调整基线临床特征。
整体队列中器械成功率为 92.0%（Evolut R：92.1% vs. Sapien 3：92.0%，p=0.96）。TAVR 后 1 年，Evolut R 治疗组的平均压力梯度（mPG）较低，有效指数瓣口面积（iEOA）较高（匹配队列中 mPG：9.0[四分位距（IQR）：6.0-11.9] vs. 12.0[IQR：9.9-16.3]mmHg，p<0.001；iEOA：1.20[IQR：1.01-1.46] vs. 1.08[IQR：0.90-1.28]cm/m2，p<0.001）。然而，1 年时严重瓣周漏和主动脉瓣反流的发生率无显著差异。此外，两组在全因死亡率方面均显示出相似的结果（对数秩检验，p=0.81）。
对于小主动脉瓣环的患者，使用第三代 THV 的 TAVR 与高器械成功率相关。与 Sapien 3 相比，Evolut R 在小主动脉瓣环和体表面积患者的血液动力学性能方面似乎更优，TAVR 后 1 年。然而，两组在 1 年时的全因死亡率相似。
