One-year data highlighting the performance of the Sapien 3 Ultra Resilia (Edwards Lifesciences) transcatheter aortic valve implantation (TAVI) system were presented at PCR London Valves 2024 (24–26 November, London, UK) and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
An analysis of data from more than 9,000 propensity-matched patients in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry demonstrated that those who received the newest generation Sapien 3 Ultra Resilia valve experienced outstanding one-year outcomes that continuously surpassed recipients of the earlier generation Sapien 3 and Sapien 3 Ultra valves. Patients receiving the Sapien 3 Ultra RESILIA valve 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.
“These strong, real-world data continue to demonstrate that patients treated with a Sapien valve experience excellent outcomes with rapid recovery and improved quality of life,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “These data add to the immense body of evidence with multiple years of follow up on the Edwards Sapien valve platform and more than 10 years of clinical experience with the Resilia tissue.”
Patients in the Sapien 3 Ultra Resilia valve cohort, who had an average STS score of 3.6 and average age of 77, experienced meaningful quality of life benefits with a clinically significant average 31-point increase in Kansas City Cardiomyopathy Questionnaire (KCCQ) 2 score and one-day length of hospital stay with 93% discharged to their homes.
“This is the first large-population study that showed the latest generation Sapien 3 Ultra Resilia valve results in improved one-year survival after TAVI versus prior generation valves, given it reduces mild or greater paravalvular leak,” said Gilbert Tang (Mount Sinai Health System, New York, USA). “This finding particularly affected low surgical risk patients, where the impact would matter more because of their longer life expectancies.”
