Jun 24, 2026 · 14 min · 7 segments
The TCTMD journalists talk about 10-year TAVI data, a FLOW subanalysis, and women's heart centers in Europe. NY Valves co-director David Cohen joins as a guest.
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Yael MaxwellHost
David CohenGuest
Laura McEwenPanelist
Todd NealPanelist
Yeah, so I wrote recently about some new 10-year TAVI data that came out in Jack.
One paper had the long-term follow-up from the PARTNER 2A trial of patients with intermediate-risk severe aortic stenosis who were randomized to TAVI with a sapient XT valve or SAVR.
That showed at 10 years a higher risk of mortality and aortic valve re-intervention in the TAVI arm.
Then there was a second paper which had the 10-year follow-up of study that used propensity scores to match the SAVR patients from that trial partner 2A with patients undergoing TAVI with a third-generation sapient 3-valve as part of an intermediate risk registry.
And that study showed no differences in mortality or aortic valve re-interventions between the TAVI and surgery groups.
So there was that interesting discrepancy between the two studies in the findings.
And it was explained, seemed to be explained by the fact that there were improvements in the sapien-3 valve.
And also in the registry, there was routine use of CT for pre-procedural planning in that study.
So kind of interesting insights from these two analyses into longer-term TAVI results.
Pat, I know everyone's been looking forward to longer term data on the TAVI front, but what are some of the challenges with following these patients out for that long?
Well, for these particular studies, there were a lot of limitations kind of noted by the people I spoke with, in particular, the fact that neither of these studies was initially planned to have follow-up going out to 10 years.
But after the trials were underway, the FDA mandated additional follow-up and kind of identified that 10-year mark as a key threshold.
So the patients in these studies had to be reconsented to be followed out from five to 10 years.
So that really kind of limited what could be learned from these particular analyses in terms of the long-term TAVI results.
So the newer trials in younger and lower risk patients have been planned with 10 year follow-up from the start.
So it looks like those will give probably a better idea about how well TAVI will hold up over a decade or more.
Yeah, so I wrote recently about some new 10-year TAVI data that came out in Jack.
One paper had the long-term follow-up from the PARTNER 2A trial of patients with intermediate-risk severe aortic stenosis who were randomized to TAVI with a sapient XT valve or SAVR.
That showed at 10 years a higher risk of mortality and aortic valve re-intervention in the TAVI arm.
Then there was a second paper which had the 10-year follow-up of study that used propensity scores to match the SAVR patients from that trial partner 2A with patients undergoing TAVI with a third-generation sapient 3-valve as part of an intermediate risk registry.
And that study showed no differences in mortality or aortic valve re-interventions between the TAVI and surgery groups.
So there was that interesting discrepancy between the two studies in the findings.
And it was explained, seemed to be explained by the fact that there were improvements in the sapien-3 valve.
And also in the registry, there was routine use of CT for pre-procedural planning in that study.
So kind of interesting insights from these two analyses into longer-term TAVI results.
Pat, I know everyone's been looking forward to longer term data on the TAVI front, but what are some of the challenges with following these patients out for that long?
Well, for these particular studies, there were a lot of limitations kind of noted by the people I spoke with, in particular, the fact that neither of these studies was initially planned to have follow-up going out to 10 years.
But after the trials were underway, the FDA mandated additional follow-up and kind of identified that 10-year mark as a key threshold.
So the patients in these studies had to be reconsented to be followed out from five to 10 years.
So that really kind of limited what could be learned from these particular analyses in terms of the long-term TAVI results.
So the newer trials in younger and lower risk patients have been planned with 10 year follow-up from the start.
So it looks like those will give probably a better idea about how well TAVI will hold up over a decade or more.
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