Newest TAVR valve from Edwards linked to better 1-year outcomes than its predecessors
The Sapien 3 Ultra Resilia transcatheter aortic valve replavement (TAVR) valve from Edwards Lifesciences is outperforming the company’s previous balloon-expandable valves a full year after treatment, according to new real-world data presented at PCR London Valves 2024.
Edwards officially launched the Sapien 3 Ultra Resilia valve, a combination of its Resilia tissue technology with its Sapien 3 Ultra TAVR device, in 2022 after receiving approval from the U.S. Food and Drug Administration. Researchers previously confirmed the new valve was associated with improved 30-day outcomes compared to the Sapien 3 and Sapien 3 Ultra devices. This follow-up analysis, simultaneously published in JACC: Cardiovascular Interventions, focused on one-year outcomes.[1]
The study’s authors used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry to compare 4,598 TAVR patients treated with the Sapien 3 Ultra Resilia valve with 4,598 TAVR patients treated with the Sapien 3 or Sapien 3 Ultra valve. After one year, the Sapien 3 Ultra Resilia was associated with an all-cause mortality rate of 7.6%, significantly lower than the 9.7% seen in patients who received a Sapien 3 or Sapien 3 Ultra. In addition, the newest valve had fewer cases of mild or greater paravalvular leak (PVL) and fewer life-threatening bleeding events than the older treatment options.
Researchers also found that the Sapien 3 Ultra Resilia was consistently linked with positive improvements in quality of life and short hospital stays. In addition, they added, 93% of patients receiving the valve were able to go home immediately after hospital discharge.
“This is the first large-population study that showed the latest generation Sapien 3 Ultra Resilia valve results in improved one-year survival after TAVR versus prior-generation valves, given it reduces mild or greater PVL,” co-author Gilbert Tang, MD, MSc, MBA, surgical and academic director of the structural heart program for the Mount Sinai Health System and professor and vice-chair of innovation in cardiovascular surgery at the Icahn School of Medicine at Mount Sinai, said in a prepared statement. “This finding particularly affected low-surgical risk patients, where the impact would matter more because of their longer life expectancies.”
“These strong, real-world data continue to demonstrate that patients treated with a Sapien valve experience excellent outcomes with rapid recovery and improved quality of life,” added Larry Wood, corporate vice president with Edwards and president of the company’s TAVR and surgical structural heart division.
Tang et al. plan on following these patients for many more years to better understand the long-term impact of its newest TAVR valve.
Click here to read the full analysis in JACC: Cardiovascular Interventions, an American College of Cardiology journal.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.