Author + information
- Darren Waltersa,b,
- Robert Gooleya,b,
- O. Christopher Raffela,b,
- Liam M. McCormicka,b,
- Anne Cornaillea,b,
- Dominic J. Alloccoa,b and
- Ian Mereditha,b
Background: The LOTUS Edge Valve System was designed to retain the benefits of the first-generation Lotus Valve, but improve delivery through the use of a lower profile, more flexible catheter system and optimize deployment with one-view locking and the new Depth Guard™ feature designed to reduce the risk of valve interaction with the left ventricular outflow tract. The LOTUS Edge Valve System received CE mark in September 2016; this is the first report of clinical outcomes with the new device.
Methods: The LOTUS Edge Feasibility Trial is a single-arm, prospective trial designed to evaluate clinical outcomes with the next-generation LOTUS Edge Valve System in patients with severe symptomatic calcific aortic stenosis. The primary endpoint was technical success, defined as successful implantation of one LOTUS Edge valve in the correct position, with successful retrieval of the delivery system.
Results: At the time of this writing, data are available through hospital discharge or 7 days (whichever came first) for the 21 patients enrolled at 2 Australian centers. All patients (62% female, mean age 84.0±5.1 years, STS Score 4.3±1.5) were successfully implanted with a LOTUS Edge valve: 6/21 (27%) with a 23mm, 7/21 (33%) with a 25mm, and 8/21 (38%) with a 27mm valve. Repositioning was attempted in 16/21 patients and was successful in all cases. Core lab analyses are pending, but based on site-reported data, all (21/21) patients had none or trace aortic regurgitation at hospital discharge. Among all 21 patients, there were no deaths, life-threatening/disabling bleeding, MI, Stage 2/3 acute kidney injury, or repeat procedures at hospital discharge; 1 (4.8%) patient had a disabling stroke and 2 (9.5%) required a new permanent pacemaker (PPM).
Conclusions: This is the first study of the next-generation LOTUS Edge Valve System. Preliminary data suggest conservation of the first-generation Lotus Valve advantages, including generally low clinical event rates and no aortic regurgitation at hospital discharge, with the added benefit of a reduced PPM rate. Complete 30-day clinical and echo core lab results will be available for presentation for the first time at ACC 2017.
Poster Contributions Poster Hall, Hall C
Saturday, March 18, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Interventional Cardiology: TAVR 3
Abstract Category: 17. Interventional Cardiology: Aortic Valve Disease
Presentation Number: 1243-168
- 2017 American College of Cardiology Foundation