Three-year outcomes with the fully repositionable and retrievable lotusTM transcatheter aortic replacement valve in 120 high-risk surgical patients with severe aortic stenosis: Results from the REPRISE II CE-mark study.

BACKGROUND The repositionable and fully retrievable LotusTM Valve (Boston Scientific, Marlborough, MA, USA) was designed to provide precise positioning and minimize paravalvular leak (PVL) in patients with severe aortic stenosis. This analysis will present the first report of 3-year outcomes from the REPRISE II CE-Mark study. METHODS The REPRISE II study is a prospective, single-arm trial that enrolled patients with symptomatic severe calcific aortic stenosis who are at high or extreme surgical risk (based on STS Score or Heart Team assessment) at 14 centers in Europe and Australia. Follow-up is continuing through 5 years. RESULTS Among 120 enrolled patients, the mean age was 84.4+/-5.3 years, 57% (68/120) were female, and mean STS Score was 7.1+/-4.6. All patients were successfully implanted with a Lotus Valve. The primary performance endpoint of 30-day mean aortic valve pressure gradient was 11.5+/-5.2mmHg, and was significantly less than the performance goal of 18mmHg (P<0.001). The primary safety endpoint of 30-day allcause mortality was 4.2%. Two-year clinical follow-up data or death was available for all patients. At 2 years, the Kaplan-Meier rate of allcause mortality was 16.9% (n=20) and disabling stroke was 3.5% (n=4). There were no repeat procedures for valve-related dysfunction, valve migration, embolization, or TAV-in-TAV. Two additional patients received a new permanent pacemaker (PPM) between 1 and 2 years (complete heart block on day 432 and symptomatic bradycardia on day 673) for a total 2-year PPM rate of 34.2% (n=40). By independent core lab adjudication, the 2-year mean aortic valve gradient was 12.3+/-6.2mmHg and mean aortic valve area was 1.7+/-0.5cm2. A total of 90.5% patients had no or trivial PVL at 2 years and 9.5% had mild paravalvular regurgitation; no patient had moderate or severe PVL. CONCLUSION The Lotus Valve has demonstrated negligible PVL, good sustained hemodynamics, and low rates of death and stroke at 2 years. The 3-year results