Studies Support Favorable Outcomes With Edwards’ SAPIEN TAVR

Edwards Lifesciences is sharing encouraging clinical trial results that show continued positive outcomes with its SAPIEN valve platform.
 
A study of Edwards’ latest TAVR technology—the SAPIEN 3 Ultra RESILIA valve—demonstrated lower rates of paravalvular leak (PVL) at 30 days, lower echo-derived gradients, and larger effective orifice areas across all valve sizes when compared to the SAPIEN 3 and SAPIEN 3 Ultra valves. The data was published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. In a second study, small Edwards SAPIEN TAVR valves had equally positive outcomes at three years as compared to larger SAPIEN TAVR valve sizes.
 
“These real-world data further add to the body of evidence on the performance of Edwards SAPIEN TAVR and highlight the 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 vice president and group president, transcatheter aortic valve replacement and surgical structural heart.
 
Real-World Results of the SAPIEN 3 Ultra RESILIA Valve
In a study of real-world evidence of patients from the TVT Registry, researchers compared the outcomes of 10,000-plus patients across more than 800 U.S. sites treated with the SAPIEN 3 Ultra RESILIA valve to those receiving SAPIEN 3 Ultra and SAPIEN 3 valves using procedural and hemodynamic data and clinical outcomes for propensity-matched cohorts. All Edwards TAVR platforms demonstrated excellent PVL results, the data show. Notably, there was a statistically significant reduction in PVL for the 29 mm SAPIEN 3 Ultra RESILIA valve as compared to the 29 mm SAPIEN 3, with 88.3% of patients exhibiting no PVL and 10.7% of patients exhibiting mild PVL. The SAPIEN 3 Ultra RESILIA valve was also associated with significantly lower echocardiography-derived mean gradients and larger effective orifice areas across all four valve sizes 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.
 
Late-Breaking Clinical Results Comparing Small Edwards TAVR Valves to Larger Valves
An analysis of 8,100 propensity matched patients across more than 800 U.S. sites found that patients treated with a 20mm Edwards SAPIEN valve demonstrated excellent all-cause mortality and stroke outcomes at three years, equivalent to those receiving 23mm, 26mm, and 29mm SAPIEN valve sizes. Among mortality indicators, researchers concluded 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 Amr Abbas, M.D., 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.
 
Edwards Lifesciences develops patient-focused innovations for structural heart disease and critical care monitoring.