News | Heart Valve Technology | May 24, 2016

Sapien 3 Transcatheter Valve Demonstrates Positive Patient Outcomes at 30 Days

More than half of patients in European post-approval study treated with conscious sedation

Edwards, Sapien 3, SOURCE 3 Registry, EuroPCR 2016

May 24, 2016 — Thirty-day data from the European post-approval study of the Edwards Sapien 3 transcatheter aortic heart valve demonstrated positive patient outcomes, including the lowest reported mortality and stroke rates seen in the SOURCE family of registries.

The new data were presented at EuroPCR 2016 by Olaf Wendler, M.D., Ph.D., professor of cardiothoracic surgery at King's College Hospital, London.

The SOURCE 3 Registry, a monitored and adjudicated prospective registry, is studying use of the low-profile Edwards Sapien 3 valve in a real-world commercial setting, treating patients with severe, symptomatic aortic stenosis. Patients treated via the transfemoral access route had a high survival rate of 98.1 percent at 30 days. Additionally, the study found a low stroke rate of 1.2 percent in transfemoral patients.

"The high survival and low stroke rates seen in the SOURCE 3 Registry with the Sapien 3 valve confirm the positive impact TAVR [transcatheter aortic valve replacement] provides in the real-world setting," Wendler said. "These results give us confidence that the excellent outcomes seen in early clinical trials using the Sapien 3 are reproducible by heart teams in routine practice." 

Data from the SOURCE 3 Registry documented the outcomes of 1,947 patients treated at 80 centers in Europe performing TAVR. Patients were enrolled in 10 countries between July 2014 and October 2015 and will be followed for five years. This represents the first large, multi-center report of Sapien 3 valve patient outcomes in a commercial setting, as well as the largest dataset of patients who were treated using conscious sedation with a singular valve platform (1,018 patients). Patients treated under conscious sedation are awake during the procedure and do not receive general anesthesia.

The Edwards Sapien 3 valve has been available in Europe since 2014.

Wendler is a consultant to Edwards Lifesciences.

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