Results of an analysis of data from the PARTNER trials examining outcomes of transcatheter aortic valve implantation (TAVI) in patients with a small annulus were shared during a late-breaking trial session at New York Valves 2024 (5–7 June, New York, USA).
The results showed that, through five-year follow up of more than 1,300 low and intermediate risk patients receiving the Sapien 3 valve (Edwards Lifesciences) there were excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex.
As part of this analysis, contemporary patient data with long-term follow up from the PARTNER 3 randomised 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 hospitalisation.
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.
“This important dataset highlights the risk of relying on a singular haemodynamic parameter such as mean gradient as a surrogate for valve dysfunction,” said Rebecca Hahn (Columbia University Irving Medical Center, New York, USA), 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 20mmHg 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 US Food and Drug Administration (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,” Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart, was quoted as saying in a press release issued by Edwards Lifesciences. “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.”
