Edwards Lifesciences (NYSE: EW) announced positive results from two real-world studies evaluating its Sapien transcatheter aortic valve replacement (TAVR) system.
Results came from the TVT Registry data and continued to demonstrate strong outcomes. Edwards presented the data at Cardiovascular Research Technologies (CRT) 2024.
A study of the latest TAVR technology, the Sapien 3 Ultra Resilia valve found lower rates of paravalvular leak (PVL) at 30 days when compared to the Sapien 3 and Sapien 3 Ultra valves. Results also showed lower echo-derived gradients and larger effective orifice areas across all valve sizes.
Edwards’ second study showed that its small Sapien TAVR valves demonstrate equal outcomes at three years compared to larger Sapien valve sizes.
“These real-world data further add to the robust body of evidence on the performance of Edwards Sapien TAVR and highlight the meaningful advancements of the Sapien 3 Ultra Resilia valve, which provides patients with severe aortic stenosis the leading option for true lifetime management of their heart valve disease,” said Larry Wood, Edwards’ corporate VP and group president, transcatheter aortic valve replacement and surgical structural heart.
More on the study results from Edwards
In the first real-world study, researchers compared outcomes of more than 10,000 patients across more than 800 U.S. sites. They looked at recipients of all three types of valves, using procedural and hemodynamic data and clinical outcomes for propensity-matched cohorts.
Edwards reported that all of its TAVR platforms showed excellent PVL results. Notably, it saw a significant reduction in PVL for the 29mm Sapien 3 Ultra Resilia compared to Sapien 3. On that metric, 88.3% of patients exhibited no PVL and only 10% exhibited mild PVL.
Investigators also associated Sapien 3 Ultra Resilia with low rates of all-cause mortality, cardiac death, all stroke, life-threatening bleeding, major vascular complications, and permanent pacemaker implantation in-hospital or at 30 days.
For the second study, Edwards looked at 8,100 propensity-matched patients across more than 800 U.S. sites. It found that patients with a 20mm Sapien valve demonstrated excellent all-cause mortality and stroke outcomes at three years. That proved equivalent to those receiving 23mm, 26mm and 29mm valve sizes.
Among mortality indicators, researchers found that, while PVL and new permanent pacemaker implantation were both associated with increased mortality, the relationship between post-procedural echo-derived mean gradients and clinical outcomes is nonlinear and more complex.
“This examination of these real-world data gives us important insights into the actual performance of small Edwards valves and reaffirms the excellent outcomes for patients receiving SAPIEN TAVR, regardless of valve size,” said Dr. Amr Abbas, professor of medicine at Oakland University William Beaumont School of Medicine, director of structural heart at Corewell Health East, William Beaumont University Hospital and principal investigator in the small Sapien valve study.
