Royal Victoria Hospital, 274 Grosvenor Road, Belfast, BT12 6BA United Kingdom.
J Invasive Cardiol. 2022 May;34(5):E380-E389. doi: 10.25270/jic/21.00205. Epub 2022 Apr 8.
To define the optimal implantation of the Sapien 3 (Edwards Lifesciences) transcatheter heart valve (THV), this study systematically analyzed the predeployment fluoroscopic THV position and correlated this to clinical outcomes.
This was an observational study of 279 patients treated with the Sapien 3 THV. Fluoroscopic imaging was used to categorize patients into low (n = 147), intermediate (n = 86), and high (n = 46) implantation zones. These zones were based on the relationship of the balloon marker and radiolucent line of the valve frame (line of lucency) to the annular plane at deployment. The primary outcome was the rate of permanent pacemaker implantation (PPI) at 30 days. The secondary outcomes were the rates of new left bundle-branch block (LBBB) in-hospital and all-cause mortality at 1 year.
In the high, intermediate, and low groups, 30-day PPI rates were 4.3%, 8.1%, and 8.8% (P=.62); in-hospital LBBB rates were 10.9%, 26.7%, and 32.0% (P=.02); and all-cause mortality rates at 1 year were 3.1%, 7.3%, and 12.5% (P=.14), respectively. No differences were observed with respect to procedural success/complications or THV performance between the groups.
This study demonstrates fewer conduction abnormalities for Sapien 3 valves positioned within a higher zone defined fluoroscopically by the line of lucency and balloon marker.
为了确定 Sapien 3（爱德华兹生命科学公司）经导管心脏瓣膜（THV）的最佳植入位置，本研究系统分析了预部署时的透视 THV 位置，并将其与临床结果相关联。
这是一项对 279 例接受 Sapien 3 THV 治疗的患者进行的观察性研究。透视成像用于将患者分为低（n=147）、中（n=86）和高（n=46）植入区。这些区域是基于球囊标记物和瓣膜框架的不透射线线（透光线）与部署时的环形平面之间的关系来确定的。主要结果是 30 天内永久性起搏器植入（PPI）的发生率。次要结果是 1 年内新发左束支传导阻滞（LBBB）的发生率和全因死亡率。
在高、中、低组，30 天 PPI 发生率分别为 4.3%、8.1%和 8.8%（P=.62）；住院期间 LBBB 发生率分别为 10.9%、26.7%和 32.0%（P=.02）；1 年全因死亡率分别为 3.1%、7.3%和 12.5%（P=.14）。各组之间在手术成功率/并发症或 THV 性能方面没有差异。
本研究表明，在透光线和球囊标记物界定的较高区域内定位的 Sapien 3 瓣膜，其传导异常较少。
