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Transcatheter aortic valve replacement with the Lotus valve system
Colin M Barker1, Michael J Reardon2
1Department of Cardiology and Reardon Department of Cardiovascular Surgery, Houston Methodist Hospital, Houston, TX 77030, USA.
Future Cardiology
|August 25, 2018
Summary
Transcatheter aortic valve replacement using the Lotus valve system is a safe and effective option for high-risk patients. This mechanical valve demonstrated non-inferior outcomes compared to self-expanding valves in the REPRISE III trial.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for intermediate to high-risk patients.
- The Lotus valve system is a unique, mechanically expanded TAVR device featuring a nitinol frame and adaptive seal.
Purpose of the Study:
- To evaluate the safety and effectiveness of the Lotus valve system in high-risk patients undergoing TAVR.
- To compare the Lotus valve system against a self-expanding valve in this patient population.
Main Methods:
- The REPRISE III trial compared the Lotus valve system to a self-expanding valve in high-risk patients.
- Primary safety and effectiveness endpoints were assessed.
Main Results:
- The Lotus valve system demonstrated non-inferior outcomes for both primary safety and effectiveness endpoints compared to self-expanding valves.
- The device's adaptive seal effectively minimized paravalvular regurgitation.
Conclusions:
- The Lotus valve system is a viable TAVR option for high-risk patients.
- Future research will explore its use in lower-risk patients and those with complex anatomies like bicuspid aortic valves and mitral annular calcification.
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