TCT 2015: One-year results bear out for Edwards Lifesciences’ Sapien 3 valve

The low rate of complications seen with the next-generation Sapien 3 replacement heart valve made by Edwards Lifesciences (NYSE:EW) at 30 days persisted for a full year, researchers said today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.

One-year data from Irvine, Calif.-based Edwards’ Partner II trial, which enrolled 583 high-risk or inoperable aortic stenosis patients for implantation with the Sapien 3 transcatheter aortic valve implant, showed a follow-up rate at 1 year of 98.6% and an all-cause survival rate of 85.6%. The rate of disabling stokes at 1 year was 2.4%, with no difference between the high-risk and inoperable cohorts, or between devices delivered transfemorally or transapically.

Paravalvular regurgitation rates were 2.7% for moderate regurgitation and 29.1% for mild regurgitation, with no increased mortality in patients with mild regurgitation; there was no incidence of severe regurgitation.

“The combination of new design features, procedural improvements, operator experience, and improved patient selection have all contributed to a low rate of adverse events and a high rate of 1-year survival in TAVI for high-risk and inoperable patients with severe aortic stenosis,” study investigator Dr. Howard Herrmann, of the Perelman School of Medicine at the University of Pennsylvania, said in prepared remarks. “This represents a 50% reduction in mortality in both [high-risk] and [inoperable] patients as compared with the 1st-generation TAVI device.

“This one-year follow-up data support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis,” Herrmann said.

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