What are the gender-related patient profile differences between patients receiving transcatheter heart valve replacement?

" So, as you know, women are often underdiagnosed and underrepresented in most of the clinical trials. And we have differences between men and women in terms of presentation, clinical presentations, anatomy of the aortic valve, as well as outcomes.

So to make it brief, women often come later, at a later stage at the hospital with more myocardial damage, LDF, concentric left ventricular hypertrophy. So the outcomes may be different between men and women as a consequence.

On top of that, if we look at the anatomy, more fibrosis, less calcium for the women. So all in one, we needed something to better assess the outcomes in a full woman population. We had data from RHEIA, but pulling the data from RHEIA and PARTNER 3 could lead to a better understanding of these outcomes.

Could you tell us about the trials' study designs and patient populations?

We pulled two studies, PARTNER 3. That was a US study comparing TAVI with SAPIEN 3, a balloon-expandable platform, to surgery with any commercially available device. And the enrollment ended in 2019.

At that time, we started RHEIA, which is a European study, full women cohort—only 30% of women in PARTNER 3, 100% of women in RHEIA. And we compared exactly the same thing: TAVI with a SAPIEN 3 or SAPIEN 3 Ultra platform, balloon-expandable platform, to surgery with any commercially available device.

What were the key findings?

The primary endpoint was assessed at one year, a composite of all-cause death, stroke, and rehospitalization, whether it be related to the valve, the procedure, or heart failure.

Yeah, so what we learned—and it was more a confirmation of the findings of both trials—at one year, the transcatheter harm, TAVI with a balloon-expandable platform, was superior to surgery, with a P-value extremely significant in terms of a combination of death, stroke, and rehospitalization. The main driver was rehospitalization. But if we dissect the components of the primary endpoint, numerically, there were more deaths, more strokes in the surgical arm, but without statistical significance.

We also assessed hemodynamics, and this was reassuring because we had very large EOAs. Because when you have women, most of the time you have small annuli, and we had large EOAs and low gradients in this population, and that was reassuring.

How should these findings impact clinical practice?

As I said, women rarely come to the hospital. They come less often to the hospital as compared to men because they are underdiagnosed and undertreated. As a consequence, they get less—they should deserve surgery, and they don’t get that.

What we learned from that pooled analysis is that the outcomes after TAVI are quite positive. Positive for women. It’s a safer procedure, shorter procedure, better recovery, short hospital stay. So all in one, it could be a preferred therapeutic option for women who rarely end up to surgery.

What further study is needed in this area?

So I think two axes of research: The first one is an extended follow-up to confirm the findings and see if we have different findings at 2, 3, 4, 5 years. And the second line of research could be a comparison of devices in that population of women with an extended follow-up. Then that would be the next exploration, I think, for the future.”