Edwards Lifesciences has announced that 30-day data from its European post-approval study of the 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 (17–20 May, Paris, France) by Olaf Wendler, professor of cardiothoracic surgery at King’s College Hospital, London, UK.
The SOURCE 3 Registry, a monitored and adjudicated prospective registry, is studying use of the low-profile 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% 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 TAVI 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 centres in Europe performing transcatheter aortic valve implantation (TAVI). Patients were enrolled in 10 countries between July 2014 and October 2015 and will be followed for five years. This represents the first large, multicentre 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 anaesthesia.
The Sapien 3 valve has been available in Europe since 2014. The Edwards Sapien family of valves are the most studied transcatheter heart valves in history and have been used in the treatment of more than 150,000 patients globally.
Wendler is a consultant to Edwards Lifesciences.