Real-World Use of Edwards' Sapien 3 TAVR System Evaluated in SOURCE 3 Registry Data

May 16, 2017—Edwards Lifesciences announced that new 1-year data from the SOURCE 3 Registry, a large European postapproval study of the company's Sapien 3 transcatheter heart valve, demonstrated positive patient outcomes, including high survival rates and low rates of stroke and paravalvular leak. The 1,946-patient data were presented by Olaf Wendler, MD, at EuroPCR 2017 in Paris, France, and will be published in European Heart Journal.

According to Edwards Lifesciences, SOURCE 3 is a monitored and adjudicated prospective registry that is studying the use of the Sapien 3 valve in a real-world commercial setting, treating patients with severe, symptomatic aortic stenosis. The Sapien 3 valve has been available in Europe since 2014. The majority of patients in the SOURCE 3 Registry were treated via transfemoral access, and more than half were treated under conscious sedation. Patients were enrolled at 80 centers across 10 countries between July 2014 and October 2015. They will be followed for 5 years.

The company stated that at 1 year, patients treated via the transfemoral access route had a high survival rate (88.2%) and a very low disabling stroke rate (1.1%). In addition, these patients experienced a low rate of moderate paravalvular leak (2.7%) and no severe paravalvular leak.

In Edwards' announcement, Dr. Wendler commented, "These real-world outcomes with the Sapien 3 valve in a commercial setting continue to support the compelling clinical case for transcatheter aortic valve replacement, and, once again, demonstrate consistency in clinical practice between pivotal studies and global commercial experience." Dr. Wendler is Professor of Cardiac Surgery at King's College Hospital in London, United Kingdom.