Clinical Data Show Positive Long-Term Outcomes for Certain Edwards TAVR Patients

Edwards Lifesciences is sharing encouraging data analysis results from the PARTNER Trials, which examined outcomes of transcatheter aortic valve replacement (TAVR) patients with a small annulus.

Fve-year follow up of more than 1,300 low and intermediate risk SAPIEN 3 valve patients showed excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or gender. As part of the 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.

“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, M.D., 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. These are important findings for clinicians in determining the best treatment for patients.”

“The PARTNER series of robust pivotal trials, all of which included FDA oversight, rigorously followed more than 12,000 patients treated with Edwards SAPIEN valves rendering them excellent data from which to examine the totality of factors that contribute to valve durability and performance,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “These data are reassuring for patients and clinicians—particularly women who are more likely to receive a smaller valve—that the SAPIEN platform offers excellent survival and very low reintervention rates at five years.”

Edwards Lifesciences develops patient-focused innovations for structural heart disease and critical care monitoring.

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