Edwards Lifesciences has unveiled promising one-year data for its latest SAPIEN 3 Ultra RESILIA valve at PCR London Valves 2024. The findings, also featured in the Journal of the American College of Cardiology, highlight the valve’s superior performance compared to its predecessors.
Outstanding Clinical Results
A comprehensive analysis involving over 9,000 propensity-matched patients from the STS/ACC TVT Registry revealed that recipients of the SAPIEN 3 Ultra RESILIA valve experienced significantly better outcomes. These patients demonstrated extremely low mortality rates, minimal need for reintervention, and superior valve performance metrics, including larger effective orifice areas and lower echo-derived gradients across all valve sizes. Notably, 84.4% of cases reported no paravalvular leak, underscoring the valve’s enhanced safety and efficacy.
Patient Quality of Life Improves
Patients receiving the SAPIEN 3 Ultra RESILIA valve, with an average STS score of 3.6 and an average age of 77, enjoyed substantial quality of life benefits. The Kansas City Cardiomyopathy Questionnaire scores increased by an average of 31 points, indicating significant improvements in symptoms and physical function. Additionally, patients experienced a reduced hospital stay of just one day, with 93% being discharged directly to their homes, facilitating a quicker return to normal activities.
- Enhanced survival rates compared to previous valve models
- Lower reintervention requirements
- Improved hemodynamic performance with larger orifice areas and lower gradients
- High incidence of no paravalvular leaks, ensuring better valve stability
Larry Wood, Edwards’ corporate vice president, emphasized that these real-world data reinforce the valve’s track record of delivering excellent patient outcomes, rapid recovery, and improved quality of life. The extensive evidence base, supported by over a decade of clinical experience with RESILIA tissue, underscores the valve’s reliability and effectiveness in treating aortic valve conditions.
Dr. Gilbert Tang highlighted the study as the first large-population research demonstrating improved one-year survival rates with the latest generation SAPIEN 3 Ultra RESILIA valve compared to earlier models. This advancement is particularly impactful for low surgical risk patients, who stand to benefit more due to their longer life expectancies.
Edwards Lifesciences continues to lead in structural heart innovation, driven by a commitment to enhancing patient lives through cutting-edge technologies and strong clinical evidence. The company’s dedication to improving heart valve therapies ensures that patients receive the best possible care, with advancements that translate into tangible health benefits and quality of life improvements.
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