Original Title: 1-Year Outcomes with the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients with Severe Aortic Stenosis Results of the REPRISE II Study. Reference: Ian T. Meredith et al. J Am Coll Cardiol Intv. 2016;9(4):376-384.
This analysis represents the first report at one year of 120 patients enrolled in the REPRISE II trial (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System–Evaluation of Safety and Performance).
The new valve Lotus (Boston Scientific, Marlborough, Massachusetts) is completely repositionable and retrievable, its design facilitates precise implantation and early function during release, with a minimum paravalvular regurgitation rate in patients with severe aortic stenosis.
The study included 120 symptomatic considered at high surgical risk or downright inoperable, from 14 centers in Australia and Europe.
Population mean age was 84.4 ± 5.3 years with an STS score of 7.1 ± 4.6 (Society of Thoracic Surgeons).
Implantation was successful in all patients and clinical follow up at one year was available for 99.2% of the population (119 of 120).
Mean transvalvular gradient at one year after procedure was 12.6 ± 5.7 mm Hg, with an area of 1.7 ± 0.5 cm2. 88.6% did not present aortic regurgitation, or it was trivial, which was assessed by an independent Core lab.
All-cause mortality rate was 10.9%, disabling stroke was 3.4% and major bleeding was 5.9%. 31.9% of patients required a definite pacemaker after valve implantation.
Conclusion
At one year follow up, the Lotus valve showed an excellent hemodynamic profile with no severe or moderate regurgitation and good clinical evolution.
Editorial Comment
This valve facilitates complete repositioning and even the possibility to fully resheath, in addition to an adaptive outer seal that gives this device one of the lowest paravalvular regurgitation rates in the market.
More extensive follow up and randomized studies against the Edwards or CoreValve devices should follow.