Edwards Lifesciences reports results from data analysis from PARTNER trials

Edwards Lifesciences announced the results from an analysis of data from the PARTNER Trials examining outcomes of transcatheter aortic valve replacement patients with a small annulus. Through five-year follow up of more than 1,300 low and intermediate risk SAPIEN 3 valve patients there were excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex. These data were presented during the late-breaking clinical sessions at New York Valves 2024: The Structural Heart Summit. As part of this analysis, contemporary patient data with long-term follow up from the PARTNER 3 randomized controlled trial and PARTNER 2 S3i Trial were examined to determine if higher 30-day mean gradients and rates of prothesis-patient mismatch translated to poorer long-term outcomes of death, disabling stroke or heart failure related hospitalization. The analysis revealed no association between clinical outcomes or valve durability and severe PPM or higher mean gradients. Overall, this cohort of patients had extremely low rates of reintervention and high survival out to five years. As previously presented, the PARTNER 3 Trial demonstrated the highest reported survival rate in low-risk patients seen in any pivotal trial. “This important dataset highlights the risk of relying on a singular hemodynamic parameter such as mean gradient as a surrogate for valve dysfunction,” said Rebecca Hahn, MD, 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, speaking for the PARTNER Trial investigators. “When selecting the best treatment option, we must evaluate measures that matter to patients such as death, disabling stroke, quality of life and reintervention. This five-year follow up of low and intermediate risk patients demonstrated no association of a mean gradient greater than 20 mmHg or prosthesis-patient mismatch with these key outcomes for the Edwards SAPIEN 3 platform.”