This article is more than 5 years old. Information may no longer be current.
Lotus valve may prove valuable option for patients undergoing TAVR
Click Here to Manage Email Alerts
PARIS — Thirty-day outcomes from the REPRISE II trial demonstrate low mortality, no embolization and very little aortic regurgitation in patients with severe aortic stenosis who were treated with the new Lotus transcatheter valve.
Data presented here at EuroPCR included the first 60 patients enrolled in the REPRISE II trial.
Several novel features
According to Ian T. Meredith, AM, PhD, trial investigator with Monash Heart, Southern Health and Monash University, Melbourne, features of the Lotus valve system (Boston Scientific) include a preloaded deliver system; simple handle design; a central radiopaque marker to aid precise positioning; controlled deployment; and an adaptive seal designed to minimize paravalvular leak.
Also, “Unlike any other valve at the moment, the Lotus is fully retrievable and recapturable at 100% of the delivery,” Meredith said during a press conference. “It is often said that a valve is repositionable and recapturable, but not when the valve is 100% deployed. It is indeed possible to go home for lunch when the valve is deployed and come back and disconnect it from the delivery system after lunch. This is an important concept because it is something very different from what has come before.”
REPRISE II
For the prospective, single-arm, multicenter REPRISE II trial, Meredith and colleagues aimed to determine the safety and performance of the Lotus valve for transcatheter aortic valve replacement in symptomatic patients with severe calcific aortic stenosis considered high risk for surgical valve replacement. Patients were aged at least 70 years, had documented calcified native aortic stenosis, were at high surgical risk, and had symptomatic aortic valve stenosis with NYHA Class ≥II and an aortic annulus size of 19 mm to 27 mm.
The valve was successfully implanted in all 60 patients.
Compared with before the procedure, at 30 days Meredith reported that patients had a substantially reduced mean aortic gradient (47.5 ± 17.2 mm Hg vs. 11.3 ± 5.2 mm Hg) and increased effective orifice area (0.6 ± 0.2 cm2 vs. 1.7 ± 0.4 cm2). Device mortality was low (1.7%) and there was no embolization, ectopic valve deployment or need to implant a transcatheter aortic valve (TAV) in a TAV. Also of note, aortic regurgitation was negligible and clinical event rates were consistent with those reported for other valves.
“These results suggest the Lotus valve, a differentiated, second-generation TAVR device, may well be a valuable addition to the armamentarium for treatment of severe symptomatic aortic stenosis in patients ineligible for surgery,” Meredith said. – by Brian Ellis
For more information:
Meredith I. Presented at: EuroPCR; May 21-24, 2013; Paris.
Perspective
Back to Top
Christoph K. Naber, MD, PhD
The Lotus valve is a very interesting and appealing concept. In fact, I see it as a good engineering idea. It appears so far to be associated with no major concern, but we have very limited data. It is clear that we will have other players in the transcatheter valve field besides the established ones, Sapien (Edwards Lifesciences) and CoreValve (Medtronic), although there are new developments from these companies on the horizon. So the Lotus valve is one of the new valves in which we clearly need more data.
Click Here to Manage Email Alerts