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Edwards Lifesciences (NYSE:EW) today announced the results from an analysis of data from the PARTNER Trials examining outcomes of transcatheter aortic valve replacement (TAVR) 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 (PPM) 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 (i.e., >20 mmHg.) 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.
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