REPRISE II: TAVR With a Repositionable Transcatheter Heart Valve
A new, fully retrievable and repositionable transcatheter aortic valve replacement (TAVR) system may be safe and effective in symptomatic patients with severe calcified aortic stenosis. Observational data on the device were presented Oct. 31 as part of TCT 2013 in San Francisco.
The study, REPRISE II, was a 120-patient prospective registry evaluating the efficacy and safety of the Lotus Valve System for TAVR. Mean patient age in the registry was 84.4 years and 75.8 percent of patients were in NYHA class III or IV at enrollment. The mean Society of Thoracic Surgeons risk score was 7.1, the mean aortic valve area was 0.7 cm2 and the mean aortic gradient was 46.4 mm Hg.
Results showed successful device implantation and positioning was achieved in all 120 patients and the primary device performance endpoint of the mean aortic valve pressure gradient at 30 days (18 mm Hg performance goal comparator) was met. Thirty-day all-cause mortality was the primary safety endpoint, and at 30 days, the mean aortic gradient decreased from 46.4 mm Hg to 11.5 mm Hg. This was significantly lower than the prespecified performance goal of 18 mm Hg (p<0.001). The 30-day mortality and disabling stroke rates were both low (4.2 percent and 1.7 percent, respectively). There were no thromboembolic events and aortic regurgitation was minimal.
The investigators concluded that the Lotus TAVR device may be an effective treatment option for severe aortic stenosis. "These findings suggest this valve, which is a differentiated, second generation TAVR device, will be a valuable addition for the treatment of severe aortic stenosis," said the lead investigator, Ian T. Meredith, MBBS, PhD, FACC, director of Monash HEART and the executive director of the Monash Cardiovascular Research Centre, and a professor of medicine at Monash University in Melbourne, Australia.
"Location, location, location is even more important in TAVR than it is in real estate," said David R. Holmes, Jr., MD, MACC, a past president of the ACC. "Optimizing the performance of transcatheter aortic valves includes several important aspects. A central and critical need is for optimal position. By optimizing size of the device and its placement, optimal performance can be enhanced. The procedure itself has multiple possibilities for geographic miss. Such geographic miss may result in either paravalvular leak or even device embolization. The Lotus Valve which can be retrieved and re-positioned is a significant advantage in making sure that the final position is optimal."
Additional registry studies and a phase III randomized trial are currently planned to begin in 2014.
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