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Edwards Lifesciences' SAPIEN 3 RESILIA Valve Shows Strong One-Year Outcomes in TAVI Trial

• Edwards Lifesciences reports that patients treated with the SAPIEN 3 RESILIA valve experienced outstanding one-year outcomes, including lower mortality rates. • The PARTNER II trial, involving over 9,000 patients, demonstrated low reintervention rates and larger effective orifice areas with the SAPIEN 3 Ultra RESILIA valve. • The study found no paravalvular leak in 84.4% of cases using the SAPIEN 3 Ultra RESILIA valve, indicating improved valve performance and patient outcomes. • These real-world data reinforce the benefits of the SAPIEN valve platform, particularly in low surgical risk patients with longer life expectancies.

Edwards Lifesciences announced positive one-year outcomes from its PARTNER II trial, demonstrating the effectiveness of the SAPIEN 3 RESILIA heart valve in transcatheter aortic valve implantation (TAVI). The trial, which examined over 9,000 patients, revealed significantly lower mortality rates and improved overall outcomes for patients receiving the SAPIEN 3 Ultra RESILIA valve. These results are set to be published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions and presented at PCR London Valves 2024.
The SAPIEN 3 Ultra RESILIA valve is designed to replace diseased heart valves without the need for open-heart surgery. The PARTNER II trial (NCT01314313) utilized data from the STS/ACC TVT Registry, a comprehensive database managed by the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS). This registry tracks patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures.

Key Findings from the PARTNER II Trial

The study highlighted several key benefits for patients receiving the SAPIEN 3 Ultra RESILIA valve:
  • Low Mortality Rates: Patients experienced extremely low mortality rates one year post-implantation.
  • Reduced Reintervention: The rate of reintervention was notably low, indicating the valve's durability and long-term performance.
  • Larger Effective Orifice Areas: The valve demonstrated larger effective orifice areas, which improve blood flow and cardiac function.
  • Minimal Paravalvular Leak: A significant 84.4% of cases showed no paravalvular leak, a critical factor in preventing complications and improving patient outcomes.

Expert Commentary

Larry Wood, vice president at Edwards Lifesciences, emphasized the significance of these findings: "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. 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."
Gilbert Tang, surgical and academic director of the structural heart programme for the Mount Sinai Health System, added, "This is the first large-population study that showed the latest generation SAPIEN 3 Ultra RESILIA valve results in improved one-year survival after transcatheter aortic valve replacement versus prior generation valves, given it reduces mild or greater paravalvular leak. This finding particularly affected low surgical risk patients, where the impact would matter more because of their longer life expectancies."

Implications for TAVI Procedures

The positive results from the PARTNER II trial, along with the earlier RHEIA trial (NCT04160130) focusing on TAVI in women, underscore the continued advancements in transcatheter valve technology. These findings suggest that the SAPIEN 3 Ultra RESILIA valve offers a significant improvement over previous generations, particularly for low-risk patients who stand to benefit most from long-term durability and reduced complications.
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Highlighted Clinical Trials

RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)

NCT04160130Active, Not RecruitingNot Applicable
Optimapharm
Posted 11/29/2019

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Reference News

[1]
Edwards Lifesciences announces positive results in one year TAVI trial
clinicaltrialsarena.com · Nov 25, 2024

Edwards Lifesciences reports outstanding one-year outcomes and lower mortality rates with its SAPIEN 3 RESILIA heart val...

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