NEW YORK (Reuters Health) – The fully retrievable HLT Meridian valve appears safe and effective for transcatheter aortic-valve replacement (TAVR), according to results from the multicenter RADIANT trial.
“I think that the full retrievability capabilities of the Meridian valve system represent the most interesting differential aspect of this new transcatheter valve,” Dr. Josep Rodes-Cabau of Quebec Heart and Lung Institute, Laval University, in Quebec City, Canada, told Reuters Health by email.
The HLT Meridian valve is a self-expanding transcatheter valve system that can be fully expanded and implanted in its final position and subsequently retrieved if its position or performance is unsatisfactory.
Dr. Rodes-Cabau and colleagues from two centers in Canada and two centers in the U.S. evaluated the early feasibility of TAVR with the Meridian valve in 25 patients with severe aortic stenosis at high surgical risk.
Initial valve deployment and implantation were successful in all cases, but the initial valve positioning proved suboptimal (too high or too low) in 40% of the patients.
Valve retrieval was successful in all those cases, and the valve was implanted in the correct position in all but three patients overall (88%), the researchers report in Circulation: Cardiovascular Interventions, online July 31.
The procedure was completed in these three patients using a commercial valve system.
There were no cases of valve embolization, coronary obstruction, or procedural death.
Post-TAVR echocardiography showed a low mean residual gradient (10 mm Hg) and a large valve area (1.9 cm3) with only none-trace (76%) or mild (24%) aortic regurgitation.
The 30-day rates of death and nondisabling stroke were 8% each, and there were no cases of disabling stroke, major vascular complications, bleeding, or myocardial infarction.
Five patients required permanent pacemaker implantation, including two of the three patients who were converted to commercial valve implants.
“The use of a fully retrievable transcatheter valve may be important in cases with doubts about possible coronary obstruction, sizing issues, etc.,” Dr. Rodes-Cabau said. “In case of suboptimal result, the valve could be retrieved and replaced by another valve with different size or abort the procedure in case of coronary obstruction. This is important in the era when TAVR is going to expand towards the treatment of low-risk patients.”
The authors note that several iterations of the Meridian valve system are underway, including changes to facilitate valve positioning and an expanded range of valves sizes.
HLT, Inc. funded the trial, employed two authors and had financial ties to two others, including Dr. Rodes-Cabau.
Circ Cardiovasc Interv 2019.