The transcatheter heart valve (THV) is designed to replace a diseased heart valve without the need for open-heart surgery. Credit: Shutterstock / MAD.vertise

US medical device giant Edwards Lifesciences has said patients are experiencing “outstanding one-year outcomes” and lower rates of mortality after treatment with its SAPIEN 3 RESILIA heart valve.

The transcatheter heart valve (THV) is designed to replace a diseased heart valve without the need for open-heart surgery. Full results from the company’s PARTNER II trial are set to be announced in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions and simultaneously presented at PCR London Valves 2024.

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The trial (NCT01314313) examined the records of more than 9,000 propensity-matched patients in the STS/ACC TVT Registry, a database run by both the American College of Cardiology (ACC), and the Society of Thoracic Surgeons (STS) that gathers patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures.

Among some of the areas examined in the study, patients receiving the SAPIEN 3 Ultra RESILIA valve experienced extremely low mortality, low rates of reintervention, larger effective orifice areas, lower echo-derived gradients across all valve sizes and no paravalvular leak in 84.4% of cases.

Larry Wood, vice president at Edwards Lifesciences, said: “These strong, real-world data continue to demonstrate that patients treated with a SAPIEN valve experience excellent outcomes with rapid recovery and improved quality of life. These data add to the immense body of evidence with multiple years of follow-up on the Edwards SAPIEN valve platform and more than 10 years of clinical experience with the RESILIA tissue.”

It follows shortly after the company announced positive one-year results from the RHEIA trial (NCT04160130), which focused on transcatheter aortic valve implantation (TAVI) in women, comparing it with the outcomes of those receiving Edwards SAPIEN 3 or SAPIEN 3 Ultra valves.

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Gilbert Tang, surgical and academic director of the structural heart programme for the Mount Sinai Health System said: “This is the first large-population study that showed the latest generation SAPIEN 3 Ultra RESILIA valve results in improved one-year survival after transcatheter aortic valve replacement versus prior generation valves, given it reduces mild or greater paravalvular leak.

“This finding particularly affected low surgical risk patients, where the impact would matter more because of their longer life expectancies.”

Elsewhere in the world of aortic and cardiovascular devices, AccurKardia has received breakthrough designation from the US Food and Drug Administration (FDA) for its Aortic Valve Stenosis (AVS) ECG-based artificial intelligence (AI) screening software.