Author + information
- Robert Gooley1,
- Stephen G. Worthley2,
- Robert Whitbourn3,
- Joseph Montarello4,
- Andrew Newcomb5,
- Dominic Allocco6 and
- Ian Meredith7
- 1MonashHeart, Monash Health, Melbourne, Victoria, Australia
- 2Genesis Healthcare, Sydney, Victoria, Australia
- 3St Vincent's Hospital Melbourne, south yarra, Victoria, Australia
- 4Royal Adelaide Hospital, Adelaide, South Australia, Australia
- 5St. Vincent's Hospital (Melbourne), Melbourne, Victoria, Australia
- 6Boston Scientific, Maple Grove, Minnesota, United States
- 7Boston Scientific Corporation, Marlboro, Massachusetts, United States
The mechanically-expanded Lotus Valve is repositionable and fully retrievable, which facilitates controlled, precise positioning, resulting in minimal paravalvular aortic regurgitation. Here we report final 5 year outcomes from the REPRISE I feasibility study. This represents the longest available follow-up to date for patients treated with the Lotus Valve.
The prospective, single-arm REPRISE I study was a feasibility study that evaluated the use of the 23mm Lotus Valve for transcatheter aortic valve replacement (TAVR) in patients with symptomatic, severe calcific aortic valve stenosis at high risk for surgical intervention.
The Lotus Valve was implanted in 11 patients (100% female; mean age, 83.0±3.6 years; mean STS score, 4.9%±2.5%). All (11/11) patients were successfully implanted with a Lotus Valve with no procedural mortality. The survival rate was 100% up to 2 years, 90.9% at 3 years, 72.7% at 4 years, and 63.6% at 5 years (4/11 patients died, including cardiovascular death in 1 patient). Five-year clinical follow-up was available for 6/7 (85.7%) surviving patients. The cumulative major stroke rate at 5 years was 9.1% (major stroke on day 3 in 1 patient). Conduction disturbance requiring new permanent pacemaker implantation remained at 4 patients. There were no repeat hospitalizations for valve-related symptoms or cardiac decompensation. Mean aortic gradient at 5 years was 14.1±4.1 mmHg (vs 53.9±20.9 mmHg at baseline, P<0.001; vs 13.7±3.7 mmHg at discharge, P=0.744). Mean effective aortic orifice area at 5 years was 1.6±0.4 cm2 (vs 0.7±0.2 cm2at baseline, P<0.001; vs 1.5±0.2 cm2 at discharge, P=0.835). Five years after TAVR, 4/6 patients (66.7%) were New York Heart Association (NYHA) Class I, 1 patient (16.7%) was NYHA Class II, and 1 patient (16.7%) was NYHA Class III. Paravalvular aortic regurgitation, as evaluated by an independent echocardiographic core laboratory, was absent or trace in all evaluable patients.
Final 5-year data from the REPRISE I feasibility study demonstrate sustained hemodynamic performance and minimal paravalvular regurgitation.
STRUCTURAL: Valvular Disease: Aortic