Edwards shares new data highlighting consistency of its TAVR valves in women, patients with small annuli
The balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) valves developed by Edwards Lifesciences are associated with positive, consistent five-year outcomes in patients with a small aortic annulus, according to new late-breaking data presented at New York Valves 2024: The Structural Heart Summit.
The results come from an updated analysis of more than 1,300 low- and intermediate-risk patients who were originally included in the Edwards-funded PARTNER 3 and PARTNER 2 S3i trials. Overall, researchers concluded that the five-year rates of death, disabling stroke and heart failure hospitalization were comparable for patients with and without small annuli.
Edwards data continue ongoing TAVR discussions
The New York Valves presentation comes just two months after Medtronic presented one-year data from the SMART trial, which was specifically designed to explore outcomes in patients with small annuli, at ACC.24, the annual meeting of the American College of Cardiology. Medtronic celebrated the one-year data, emphasizing that its self-expanding Evolut TAVR valves were linked to superior hemodynamic data and a lower rate of moderate or severe prosthesis-patient mismatch (PPM) compared to the Sapien 3 valves. However, SMART did not identify any significant differences in patient outcomes between the two valve types after one year. It remains unclear if the differences identified by Medtronic in SMART will translate to different long-term outcomes, but it has been one of cardiology’s hottest topics in the two months since ACC.24.
This latest late-breaking presentation appears to represent an answer of sorts from Edwards. The company issued a statement specifically highlighting the five-year findings and what they mean for TAVR patients who are women or present with a small annulus.
“This important dataset highlights the risk of relying on a singular hemodynamic parameter such as mean gradient as a surrogate for valve dysfunction,” Rebecca Hahn, MD, a professor of medicine at Columbia University Irving Medical Center, chief scientific officer of the Echo Core Lab at the Cardiovascular Research Foundation and director of interventional echocardiography at the Columbia Structural Heart and Valve Center, said in the statement. “When selecting the best treatment option, we must evaluate measures that matter to patients such as death, disabling stroke, quality of life and reintervention. This five-year follow up of low- and intermediate-risk patients demonstrated no association of a mean gradient greater than 20 mmHg or PPM with these key outcomes for the Edwards Sapien 3 platform.”
“These data are reassuring for patients and clinicians – particularly women who are more likely to receive a smaller valve – that the Sapien platform offers excellent survival and very low reintervention rates at five years,” added Larry Wood, Edwards’ corporate vice president and group president of the company’s TAVR and surgical structural heart divisions.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.