Key result
Lotus valve TAVI is linked to low mortality and PVL but high PPM rates.
Why the study?
The Lotus valve system offers a unique seal minimizing paravalvular leak but has a high rate of new pacemaker implantation, prompting design improvements.
The Lotus valve system minimizes paravalvular leak but is associated with high pacemaker rates, prompting the development of the Lotus Edge system to address this limitation.
High PPM rates with Lotus TAVI warrant device-specific caution; leaves open need for randomized comparisons with contemporary valves.
INTRODUCTION: The Lotus valve system (Boston Scientific, Marlborough, Massachusetts, USA) consists of a braided wire Nitinol™ frame with three bovine pericardial leaflets. The valve is deployed by controlled mechanical expansion which allows recapturing/repositioning and full retrievability. Areas covered: While this system offers a unique seal, which conforms to irregular surfaces, thereby minimizing paravalvular leak, its main downfall is a high rate of new pacemaker implantation. This had been partially addressed with the design of the Depth Guard™ mechanism to optimize deployment by early anchoring and limiting the depth of implant. Further developments in the Lotus valve's structure and design lay the foundations for the new Lotus Edge™ valve which is designed to maintain the benefits of the first-generation of the device, while improving deliverability and optimizing deployment with the aim to reduce pacemaker implantation rates. Expert commentary: Data from clinical trials show that TAVI with the Lotus valve system is associated with low rates of all-cause mortality and paravalvular leak although with high rates of permanent pacemaker requirement. Therefore, continuing modifications in device design such as the Lotus Edge™ valve with the addition of the Depth Guard™ are highly awaited with a view to decrease pacemaker rates.
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Solomonica et al. (2018) conducted a review in Aortic valve disease. Lotus valve system and Lotus Edge valve was evaluated. TAVI with the Lotus valve system is associated with low rates of all-cause mortality and paravalvular leak but high rates of permanent pacemaker requirement.
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