U.S Study: SAPIEN 3 Beats Mortality Predictions in High and Intermediate Risk Patients

Transcatheter Heart valve maker, Edwards Lifesciences Corporation points us at 30-day outcomes for high- and intermediate-risk patients treated with the SAPIEN 3 transcatheter aortic valve as presented at the American College of Cardiology’s (ACC) 64th Annual Scientific Session in San Diego.

Background

The SAPIEN 3 valve is Edwards’ most advanced transcatheter aortic valve, and can be delivered through a low-profile 14 French expandable sheath (eSheath). It also has an outer sealing skirt designed to minimize paravalvular leak. The SAPIEN 3 valve can be implanted via the transfemoral approach through an incision in the leg, as well as alternative access approaches. It was approved in Europe in January 2014 for the treatment of high-risk and inoperable patients with severe aortic stenosis. It is not approved for the treatment of intermediate risk patients in Europe. The valve is an investigational device not yet available commercially in the United States.

Presented as part of the late-breaking clinical trials at the ACC congress, this is the first report of SAPIEN 3 data in the United States to include intermediate risk transcatheter aortic valve replacement (TAVR) patients. In total the SAPIEN 3 high-risk cohort enrolled 583 patients at 29 U.S. sites; the intermediate risk cohort enrolled 1,076 patients at 51 U.S. sites. Both studies were single-arm, non-randomized cohorts of the PARTNER II Trial.

SAPIEN 3 demonstrated the lowest all-cause mortality rates of any of the PARTNER studies, as well as excellent clinical outcomes on the other components of the primary endpoint measures of stroke and paravalvular regurgitation.

Investigator comments 

“These results of more than 1,600 patients treated with the SAPIEN 3 valve demonstrate the most significant progress in the development of TAVR and the SAPIEN family of valves since the first PARTNER study was initiated in 2007,” said Susheel Kodali, M.D., director, Heart Valve Program, at NewYork-Presbyterian/Columbia University Medical Center and assistant professor of medicine at the Columbia University College of Physicians and Surgeons. Kodali is the co-principal investigator for the SAPIEN 3 studies. “With average ages in the 80s, the high-risk and intermediate-risk patients in the study had strikingly low mortality rates of 2.2 and 1.1, respectively, despite predicted 30-day mortality that was much higher. Additionally, the rates of significant paravalvular leaks were low in both cohorts – 3.0 for high-risk and 4.2 for intermediate – which represented meaningful improvements over prior studies with earlier generation devices.”

Source: PR Newswire

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