Single-Center Experience With the LOTUS Edge Transcatheter Heart Valve

Background: Before its voluntary recall, the mechanically expandable LOTUS Edge transcatheter heart valve (THV) offered a number of unique features, notably sealing against paravalvular leak (PVL) and the ability to be fully deployed, re-captured, and re-deployed. Methods: We performed a detailed review of all patients at our institution who underwent transcatheter aortic valve replacement (TAVR) using the LOTUS Edge THV from 2019 to 2020. We describe procedural and in-hospital outcomes. Results: In brief, 59 patients underwent TAVR using the LOTUS Edge, of whom 18 were high-risk (most of whom had moderate or severe left ventricular outflow tract [LVOT] calcium), 36 were intermediate-risk enrolled in the REPRISE IV trial (one of whom had a bicuspid valve), and 5 were low-risk bicuspid patients enrolled in the LRT trial. Conduction disturbances were common (new left bundle branch block in 64.4%), with high rates of new permanent pacemaker (PPM) implantation across all risk groups (16.9%). Overall, stroke occurred in 11.9% of patients, and in 3/5 low-risk bicuspid patients, but occurred less frequently in patients with cerebral embolic protection. Conclusions: In our experience, in patients with heavy LVOT calcium burden and/or bicuspid valves, the LOTUS Edge THV offered excellent seal against PVL. However, the high rates of periprocedural stroke and new PPM implantation were a concern. (C) 2021 Published by Elsevier Inc.

Automated summary

The study reviewed patients who underwent TAVR using LOTUS Edge THV from 2019 to 2020, showing that the THV provided an excellent seal against PVL in patients with heavy LVOT calcium burden or bicuspid valves. However, concerns were raised regarding high rates of periprocedural stroke and new PPM implantation.