SAPIEN 3 Ultra RESILIA Valve Delivers Sustained Clinical Excellence Across Large Real-World Patient Population

A comprehensive analysis of over 9,000 propensity-matched patients from the STS/ACC TVT Registry reveals that Edwards Lifesciences’ latest SAPIEN 3 Ultra RESILIA valve continues to achieve superior one-year clinical outcomes compared to its predecessor generations. These findings, presented at PCR London Valves 2024 and published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, underscore the consistent performance advantages of the newest-generation device.

Clinical Performance: The Numbers Tell the Story

The propensity-matched analysis demonstrates that recipients of the SAPIEN 3 Ultra RESILIA valve achieved notably favorable results across multiple clinical parameters. Patients in the cohort, averaging 77 years of age with a mean STS risk score of 3.6, experienced extremely low mortality rates and minimal reintervention requirements during the one-year follow-up period. The data further revealed larger effective orifice areas and reduced echo-derived gradients across all valve sizes relative to earlier SAPIEN iterations, with 84.4% of patients achieving freedom from paravalvular leak—a significant advancement in valve design and performance.

Patient Recovery and Quality of Life

Beyond hemodynamic metrics, the SAPIEN 3 Ultra RESILIA valve demonstrated meaningful improvements in patient-reported outcomes. The study population achieved a clinically significant average 31-point increase in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, reflecting substantial improvements in symptom burden and functional capacity. Hospital length of stay averaged just one day, with 93% of patients discharged directly to their homes, underscoring the expedited recovery profile enabled by transcatheter aortic valve replacement (TAVR) technology.

Clinical Perspective: Implications for Risk Stratification

According to Dr. Gilbert Tang, MD, MSc, MBA, Surgical and Academic Director of the Structural Heart Program at Mount Sinai Health System, this represents the first large-population study demonstrating improved one-year survival with the SAPIEN 3 Ultra RESILIA valve relative to prior-generation devices, particularly through reduction of mild or greater paravalvular leak. Dr. Tang emphasized that this benefit holds particular significance for lower surgical-risk patients, whose extended life expectancies amplify the long-term advantages of superior valve performance.

Design Innovation: RESILIA Tissue Platform

The sustained clinical excellence reflects more than a decade of accumulated experience with Edwards’ RESILIA tissue technology, combined with refinements in the latest SAPIEN 3 Ultra RESILIA generation. The ongoing evidence base—encompassing multiple years of follow-up data—continues to validate the platform’s safety and efficacy profile in diverse patient populations undergoing TAVR.

Strategic Significance

These real-world outcomes reinforce Edwards Lifesciences’ position as a leader in structural heart innovation. The data substantiate the company’s commitment to advancing transcatheter technologies that deliver rapid recovery, improved quality of life, and sustained clinical performance for patients across varying risk profiles.

The STS/ACC TVT Registry represents a collaborative effort between the Society of Thoracic Surgeons and the American College of Cardiology to track transcatheter valve outcomes.