Edwards’ Sapien 3 Ultra Resilia Valve Studied in 1-Year Real-World Data

November 25, 2024—Edwards Lifesciences announced 1-year data evaluating the performance of its Sapien 3 Ultra Resilia transcatheter aortic valve replacement (TAVR) system.

According to the company, the analysis of data from more than 9,000 propensity-matched patients in the Society of Thoracic Surgeons and the American College of Cardiology (STS/ACC) TVT Registry compared 1-year outcomes in patients who received Edwards’ newest generation Sapien 3 Ultra Resilia device versus outcomes in patients who received the company’s earlier generation Sapien 3 and Sapien 3 Ultra TAVR systems.

The data were presented at the PCR London Valves 2024 meeting held November 24-26 in London, United Kingdom, and simultaneously published online by Annapoorna S. Kini, MD, et al in the JACC: Cardiovascular Interventions.

Edwards reported that patients in the Sapien 3 Ultra Resilia valve cohort had an average STS score of 3.6 and average age of 77 years.

As summarized in the company’s press release, Edwards reported that patients receiving the Sapien 3 Ultra Resilia experienced extremely low mortality, low rates of reintervention, larger effective orifice areas, lower echo-derived gradients across all valve sizes and no paravalvular leak in 84.4% of cases.

The patients treated with Sapien 3 Ultra Resilia experienced meaningful quality-of-life benefits with a clinically significant average 31-point increase in Kansas City Cardiomyopathy Questionnaire score and 1-day length of hospital stay with 93% discharged to their homes, noted Edwards.

“This is the first large-population study that showed the latest generation Sapien 3 Ultra Resilia valve results in improved 1-year survival after TAVR versus prior generation valves, given it reduces mild or greater paravalvular leak,” commented Gilbert Tang, MD, in Edwards’ press release. “This finding particularly affected low surgical risk patients, where the impact would matter more because of their longer life expectancies.”

Dr. Tang is Surgical and Academic Director of the Structural Heart Program for the Mount Sinai Health System and Professor and Vice-Chair of Innovation in Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai in New York, New York.