Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua.
Cardiology Department, Faculty of Medicine, Minya University, Minya, Egypt.
J Cardiovasc Med (Hagerstown). 2018 Nov;19(11):655-663. doi: 10.2459/JCM.0000000000000705.
New-generation transcatheter heart valves have been developed to reduce complications of transcatheter aortic valve implantation (TAVI). With this study we sought to compare procedural and 30-day outcomes of the new-generation repositionable Boston Scientific Lotus (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) transcatheter heart valves.
A total of 315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI with Lotus or ES3 included in two large Italian registries were considered for this analysis. After propensity matching, 93 matched pairs of patients were included. Outcomes were evaluated according to Valve Academic Research Consortium-2 definition at discharge and 30 days.
There were no differences in baseline characteristics, except for lower mean aortic gradient and larger mean aortic annulus in the ES3-treated patients. Valve Academic Research Consortium-2 defined device success was high and comparable between groups (97.8 for Lotus vs. 98.9% for ES3, P = 0.09). The frequency of moderate/severe paravalvular leak was low and similar for both devices (2.2 vs. 1.1%, P = 0.10). At 30 days, both groups showed low all-cause mortality (5.4 vs. 1.1%, P = 0.10) and rates of disabling stroke (3.2 vs. 1.1%, P = 0.31). New pacemaker implantation was more common after Lotus deployment (31.7 vs. 10.5%, P < 0.001).
Transfemoral TAVI with both Lotus and ES3 resulted in favorable clinical and hemodynamic procedural and 30-day outcomes. Rates of significant paravalvular leak were low with both devices. The Lotus valve was associated with higher risk of pacemaker implantation.
新一代经导管心脏瓣膜的研发旨在降低经导管主动脉瓣植入术（TAVI）的并发症。本研究旨在比较新一代可重定位的波士顿科学 Lotus（Lotus）瓣膜和球囊扩张的爱德华兹 Sapien 3（ES3）经导管心脏瓣膜的手术过程和 30 天结果。
共有 315 例因严重症状性主动脉瓣狭窄而行经股 TAVI 的患者分别在两个大型意大利登记处接受 Lotus 或 ES3 治疗，其中 93 对患者接受倾向匹配。根据 Valve Academic Research Consortium-2 定义评估出院时和 30 天的结果。
两组患者的基线特征无差异，但 ES3 组患者的平均主动脉瓣跨瓣压差较低，主动脉瓣环平均直径较大。 Valve Academic Research Consortium-2 定义的器械成功率高且两组间相当（Lotus 组为 97.8%，ES3 组为 98.9%，P=0.09）。两组中度/重度瓣周漏的发生率均较低且相似（2.2%对 1.1%，P=0.10）。30 天时，两组的全因死亡率均较低（5.4%对 1.1%，P=0.10），致残性卒中发生率也相似（3.2%对 1.1%，P=0.31）。Lotus 组心脏起搏器植入更为常见（31.7%对 10.5%，P<0.001）。
经股 TAVI 采用 Lotus 和 ES3 均可获得良好的临床和血流动力学手术过程和 30 天结果。两种器械的重度瓣周漏发生率均较低。Lotus 瓣膜与更高的起搏器植入风险相关。
