This study evaluated the safety and efficacy of the new repositionable self-expanding valve. The primary end point was all-cause mortality and stroke at 30 days. 60 patients were included and the possibility for reposition was used 22 times between 12 recaptures and 10 re-sheathed of the valve.

All maneuvers were carried out successfully. A 30 days no deaths or stroke were observed, with a rate of severe aortic regurgitation of 3.4% and the need for permanent pacemaker 11.7%.

Conclusion

Evolut R CoreValve security and system performance were established, repositioning was well tolerated when necessary, with low rate of severe aortic regurgitation and decreased need for permanent pacemaker.

Ian Meredith
2015-05-20

Original title: 6-month outcomes following TAVI with a novel repositionable self-expanding bioprosthesis – CoreValve Evolut R CE Study.