Edwards Sapien TAVR Devices Evaluated in Large, Real-World Studies

March 11, 2024—Edwards Lifesciences announced results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards Sapien valve platform.

First, a study of the Edwards Sapien 3 Ultra Resilia valve, the company’s latest transcatheter aortic valve replacement (TAVR) technology, found 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 were revealed during a podium presentation at CRT 2024, the Cardiovascular Research Technologies annual meeting held March 9-12 in Washington, DC. The study was simultaneously published by Curtiss T. Stinis, MD, et al in JACC: Cardiovascular Interventions.

According to the company, the study included real-world evidence of patients from the TVT Registry. Investigators compared the outcomes of > 10,000 patients across > 800 sites in the United States treated with the Sapien 3 Ultra Resilia valve to patients receiving Sapien 3 Ultra and Sapien 3 valves using procedural and hemodynamic data and clinical outcomes for propensity-matched cohorts.

The investigators found that all Edwards TAVR platforms demonstrated excellent PVL results. Notably, there was a statistically significant reduction in PVL for the 29-mm Sapien 3 Ultra Resilia valve compared to the 29-mm Sapien 3, with 88.3% of patients exhibiting no PVL and only 10.7% of patients exhibiting mild PVL.

Additionally, the Sapien 3 Ultra Resilia valve was 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.

In the second study, presented during a late-breaking clinical trials session at CRT 2024, small Edwards Sapien TAVR devices demonstrated equally excellent outcomes at 3 years compared to larger Sapien TAVR valve sizes. The late-breaking clinical results included an analysis of 8,100 propensity-matched patients across > 800 sites in the United States.

The investigators reported that patients treated with a 20-mm Edwards Sapien valve demonstrated excellent all-cause mortality and stroke outcomes at 3 years, equivalent to those receiving 23-, 26-, and 29-mm Sapien valve sizes.

Regarding mortality indicators, the investigators concluded that although PVL and new permanent pacemaker implantation were both associated with increased mortality, the relationship between postprocedural echo-derived mean gradients and clinical outcomes is nonlinear and more complex.

Amr Abbas, MD, is Principal Investigator of the small Sapien valve study.

“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,” commented Dr. Abbas in the company’s press release. Dr. Abbas is Professor of Medicine at Oakland University William Beaumont School of Medicine and Director of Structural Heart at Corewell Health East, William Beaumont University Hospital in Royal Oak, Michigan.