Transcatheter aortic valve replacement (TAVR) with the Sapien 3 Ultra transcatheter heart valve (THV) is associated with substantial reductions in paravalvular leak (PVL) compared to the previous Sapien 3 THV, according to new data published in the American Journal of Cardiology.
Edwards Lifesciences developed the Sapien 3 Ultra THV with PVL in mind. To test this next-generation THV with its predecessor, the Sapien 3 THV, researchers examined data from more than 4,000 patients who participated in one of seven observational studies. Approximately 49% of patients received the Sapien 3 Ultra THV, and the remaining patients received the Sapien 3 THV.
While 52% of TAVR patients were female, the mean patient age was 79.9 years old. The mean Society of Thoracic Surgeons score was 4.4.
Overall, the Sapien 3 Ultra THV was associated with “a significant reduction” in both mild PVL (13.4% vs. 28.4%) and moderate/severe PVL (0.71% vs. 1.71%) when compared to its predecessor. The risk of all-cause mortality, stroke, major bleeding events or permanent pacemaker implantation was similar between the two valves.
The study’s authors believe their work to be the first meta-analysis of its kind.
“Because the current literature suggests a strong association between moderate/severe PVL and adverse outcomes, these important findings require further confirmation in randomized controlled trials that are less susceptible to confounding,” wrote lead author Omar M. Abdelfattah, MD, a specialist with Morristown Medical Center in Morristown, New Jersey, and colleagues. “Further, larger long-term studies are also needed to confirm if the aforementioned hemodynamic improvements translate into better clinical outcomes and long-term hemodynamic durability.”
The full study is available here.
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.