The mechanically expandable LOTUS Valve and LOTUS Edge transcatheter aortic valve systems

ABSTRACT

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.

KEYWORDS:

• TAVI
• TAVR
• aortic stenosis
• mechanical expansion
• paravalvular leak
• pacemaker

Acknowledgments

The authors want to thank Vicki M. Houle, PhD, Manager II, Global Scientific Affairs, Interventional Cardiology & Structural Heart, Boston Scientific, for the help in manuscript proofreading.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.