Edwards Sapien 3 TAVR Platform Evaluated at 5 Years for Patients With Small Annuli

June 5, 2024—Edwards Lifesciences announced results from an analysis of data from the PARTNER trials examining outcomes of transcatheter aortic valve replacement (TAVR) in patients with a small annulus.

The data included 5-year follow-up of > 1,300 low- and intermediate-risk patients implanted with the company’s Sapien 3 TAVR device. The findings demonstrated excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex, stated Edwards.

These data were presented during the late-breaking clinical sessions at New York Valves 2024: The Structural Heart Summit held June 5-7 in New York, New York.

In the analysis, contemporary patient data with long-term follow-up from the PARTNER 3 randomized controlled trial and the PARTNER II S3i trial were examined to determine if higher 30-day mean gradients and rates of prosthesis-patient mismatch (PPM) translated to poorer long-term outcomes of death, disabling stroke, or heart failure–related hospitalization.

According to the company, the analysis demonstrated no association between clinical outcomes or valve durability and severe PPM or higher mean gradients (ie, > 20 mm Hg). Overall, this cohort of patients had extremely low rates of reintervention and high survival out to 5 years. Previously presented data from the PARTNER 3 trial showed the highest reported survival rate in low-risk patients seen in any pivotal trial, noted the Edwards press release.

Rebecca Hahn, MD, commented on the findings in the company press release on behalf of the PARTNER trial investigators. “This important data set highlights the risk of relying on a singular hemodynamic parameter, such as mean gradient as a surrogate for valve dysfunction,” stated Dr. Hahn. “When selecting the best treatment option, we must evaluate measures that matter to patients, such as death, disabling stroke, quality of life, and reintervention.”

Dr. Hahn is Professor of Medicine at Columbia University Irving Medical Center, Chief Scientific Officer of the Echo Core Lab at the Cardiovascular Research Foundation, and Director of Interventional Echocardiography at the Columbia Structural Heart & Valve Center in New York, New York.

Dr. Hahn continued, “This 5-year follow-up of low- and intermediate-risk patients demonstrated no association of a mean gradient > 20 mm Hg or PPM with these key outcomes for the Edwards Sapien 3 platform. These are important findings for clinicians in determining the best treatment for patients.”