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Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve System: 30-Day Primary Endpoint Results From the REPRISE II Study
Study Questions:
What are the safety and performance profiles of transcatheter aortic valve replacement (TAVR) using the repositionable Lotus valve (Boston Scientific; Natick, MA) for severe, symptomatic, calcific aortic stenosis (AS)?
Methods:
In a prospective, single-arm, multicenter study (REPRISE II [REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System – Evaluation of Safety and Performance II]), 120 high-risk patients (aortic annulus 19-27 mm) underwent transfemoral TAVR with the Lotus valve. The primary device performance endpoint was echocardiographic 30-day mean pressure gradient compared to a prespecified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per the Valve Academic Research Consortium (VARC) criteria.
Results:
Mean age was 84.4 years, 57% were female, 76% were New York Heart Association class III/IV, and mean aortic valve area was 0.7 ± 0.2 cm2. The valve was successfully implanted in all patients with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) underwent permanent pacemaker implantation. The primary device performance endpoint was met as the mean gradient improved from 46.4 ± 15.0 to 11.5 ± 5.2 mm Hg. At 30 days, mortality was 4.2%; disabling stroke was 1.7%; 1 (1.0%) patient had moderate paravalvular regurgitation, and none had severe.
Conclusions:
The REPRISE II study demonstrates safety and effectiveness of the Lotus valve in high-surgical-risk patients with severe AS. The valve could be positioned successfully with minimal paravalvular regurgitation.
Perspective:
The Lotus valve is a bioprosthetic bovine pericardial valve mounted within a nitinol wire frame for use in TAVR. It is repositionable and retrievable, and has a seal mechanism intended to minimize paravalvular regurgitation. This prospective, single-arm, multicenter study suggests that deployment of the valve is safe and feasible, with reasonable short-term mortality. Longer-term outcomes were not assessed.
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