Repositionable Lotus valve safe, effective at 30 days

A repositionable and retrievable valve proved safe and effective at 30 days in high-risk patients who underwent transcatheter aortic valve replacement (TAVR). Results from the REPRISE II study were published in the Sept. 30 issue of the Journal of the American College of Cardiology.

REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve SystEm) is a prospective, single-arm, multicenter trial designed to assess the safety and performance of the Lotus Valve System (Boston Scientific). The study enrolled 120 patients at high surgical risk with severe aortic stenosis in 2013 who were implanted with 23 mm or 27 mm valves. The valves are repositionable and retrievable and the system contains an adaptive seal, features that are thought to reduce the risk of paravalvular regurgitation.    

Ian T. Meredith, AM, MBBS, PhD, of MonashHEART in Clayton, Australia, and other REPRISE II researchers looked at mean valve pressure and mortality at 30 days to evaluate performance and safety, respectively.

Patients had a mean age of 84.4 years. More than half were women and 76 percent were New York Heart Association (NYHA) functional class III or IV before treatment. Physicians implanted the valve successfully in all patients and resheathed the device in 26.7 percent of cases, all successfully. One patient died due to cardiac perforation.

The 30-day mean aortic valve pressure gradient dropped from 46.4 to 11.5 mm Hg. There were no cases of device migration, embolization or the need for valve-in-valve therapy.  

The mortality rate at 30 days totaled 4.2 percent and the stroke rate was 5.9 percent, with 1.7 percent of strokes being disabling. At 30 days, 91 percent of patients were NYHA class I or II. Echocardiograms for 96 patients showed 83.6 percent with no or only a trace of regurgitation, one patient with moderate regurgitation and no patients with severe regurgitation. A total of 28.6 percent of patients needed a permanent pacemaker.

“These results conform the safety and efficacy of the device in patients at high surgical risk with severe aortic stenosis,” the REPRISE II team concluded.

In an accompanying editorial, Paul Sorajja, MD, and Wesley Pederson, MD, of the Minneapolis Heart Institute, called the procedural success remarkable. “Nonetheless, deployment success does not equate to clinical success, and the availability of a therapeutic option, by itself, is not justification for its expanded use” to lower-risk patients. They recommended further investigation into stroke with Lotus to ensure that manipulating the aortic valve during retrieval didn’t contribute to its incidence.

The authors recognized that their study had a small sample size, was not randomized and had a short follow-up period. They wrote that REPRISE III, a randomized controlled trial, will address those limitations. REPRISE II was funded by Boston Scientific.