Myval TAVR valve non-inferior to Sapien 3 after 1 year—pacemaker implants the biggest difference
The Myval transcatheter heart valve (THV) is non-inferior to the Sapien 3 transcatheter heart valve (THV) after one year, according to new transcatheter aortic valve replacement (TAVR) data published in The Lancet.[1]
India-based Meril Life Sciences has been manufacturing its Myval heart valves for years. The devices are already approved and available in both India and Europe, though they have not yet gained U.S. Food and Drug Administration approval. The Sapien 3 THV from Edwards Lifesciences, meanwhile, represents one of the most commonly used TAVR devices in the United States.
The study’s authors aimed to learn more about how the two balloon-expandable TAVR devices compare with one another. They tracked data more than 1,000 TAVR patients who underwent treatment at one of three university hospitals in Denmark from June 2020 to November 2023. The median age was 81.6 years old, median Society of Thoracic Surgeons risk score was 2.3 and 40% of patients were female.
While 514 patients received a Myval or Myval Octacor THV, another 517 received a Sapien 3 or Sapien 3 Ultra THV. The study’s primary endpoint—a composite of death, stroke, moderate or severe aortic regurgitation or moderate or severe hemodynamic THV deterioration after one year—was seen in 14% of patients treated with a Myval device and 13% of patients treated with a Sapien 3 device. First-time pacemaker implantation, meanwhile, was more common in patients who received a Myval THV (19%) than those who received a Sapien 3 THV (10%).
The Sapien 3 Ultra TAVR valve. Image courtesy of Edwards Lifesciences.
“The safety and efficacy of new THVs should be compared with that of best-in-practice, contemporary THVs,” wrote first author Christian Juhl Terkelsen, DMSc, a clinical professor with the department of clinical medicine at Aarhus University in Denmark. “To our knowledge, Myval is the first THV showing non-inferiority with SAPIEN 3 THVs at one year, although it increases the risk of first-time pacemaker implantation, which requires further evaluation.”
The authors also touched on LANDMARK, another ongoing clinical trial focused on the Myval THV. A LANDMARK subanalysis tracking 30-day outcomes was published in EuroIntervention in early 2025, but one-year data from that trial has not yet been reported.
Meril Life Sciences helped fund this analysis. However, they “had no role in study design, data collection, data analysis, data interpretation or the writing of this report.”
Click here to read the full study.
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.