Postapproval SOURCE 3 Registry Evaluates Edwards Sapien 3 TAVR Device in Real-World Use

May 17, 2016—Edwards Lifesciences announced that 30-day data from its European postapproval study of its Sapien 3 transcatheter aortic heart valve replacement (TAVR) device demonstrated positive patient outcomes, including the lowest reported mortality and stroke rates seen in the SOURCE family of registries. Olaf Wendler, MD, presented the new data at the EuroPCR 2016 conference held May 17–20 in Paris, France. Dr. Wendler is Professor of Cardiothoracic Surgery at King's College Hospital in London, United Kingdom.

SOURCE 3, which is a monitored and adjudicated prospective registry, is studying the use of the low-profile Sapien 3 valve in a real-world commercial setting to treat patients with severe, symptomatic aortic stenosis.

According to Edwards, patients in the SOURCE 3 registry who were treated via the transfemoral access route had a high survival rate of 98.1% at 30 days. Additionally, the study found a low stroke rate of 1.2 % in transfemoral access patients.

In the company’s press release, Dr. Wendler commented, “The high survival and low stroke rates seen in the SOURCE 3 registry with the Sapien 3 valve confirm the positive impact TAVR provides in the real-world setting. 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.”

The company advised that 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 5 years. This represents the first large, multicenter report of Sapien 3 TAVR 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), reported Edwards Lifesciences.