Study supports use of Edwards TAVR in women

Edwards Lifesciences (NYSE: EW)+ today announced data supporting the use of its transcatheter aortic valve replacement (TAVR) […]

Edwards Lifesciences (NYSE: EW)+ today announced data supporting the use of its transcatheter aortic valve replacement (TAVR) in women.

The PARTNER trials look at the outcomes of TAVR in patients with small annulus, with a focus on women. Medtronic recently had similar positive outcomes from the SMART trial, a head-to-head study with Edwards.

Through five-year follow-up of more than 1,300 low- and intermediate-risk Sapien 3 valve patients, Edwards reported strong clinical outcomes and valve durability, irrespective of the patient’s annulus size or sex. The company presented its data at New York Valves 2024: The Structural Heart Summit.

Investigators examined contemporary patient data with long-term follow-up from the PARTNER 3 and PARTNER 2 S3i trials. They aimed 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. Overall, the cohort had extremely low rates of reintervention and high survival out to five years.

“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 VP and group president, TAVR 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.”

Original Article (https://www.massdevice.com/study-supports-edwards-tavr-in-women/)