More Patient-Prosthesis Mismatch With TAVI in Women, but 5-Year Survival Unaffected

WASHINGTON, DC—While patient-prosthesis mismatch (PPM) is not a desired outcome after TAVI, it does not seem to have an impact on long-term mortality in women, a multicenter analysis suggests.

Compared with men, women had a higher likelihood of predicted and echocardiographically measured severe PPM, but their 5-year survival rates were no different, said Karim Al-Azizi, MD (Baylor Scott & White Health, Plano, TX), in a featured clinical research session at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions.

To TCTMD, Al-Azizi said the data are important to the conversation of lifetime management of aortic stenosis, though he emphasized that the study includes patients at intermediate and high risk for surgery with shorter lifespans.

“We want to see more of this data in low surgical risk patients that will live longer,” he said.

In a prior analysis of intermediate- and high-risk patients undergoing TAVI, Al-Azizi and colleagues found no difference in mortality at 5 years between those who had severe PPM versus moderate or no PPM.

While PPM has been linked to adverse clinical outcomes with SAVR, the data thus far, including an echo core-lab analysis of the PARTNER 2A trial, suggest no significant effect on hospitalization or mortality when it occurs after TAVI. Additionally, there is quality of life (QoL) data suggesting that PPM after TAVI isn’t as impactful as it is when it occurs after surgery, said Al-Azizi.

Still, avoiding PPM as much as possible should be the goal, and Al-Azizi said the real lesson being learned from real-world cohorts is the importance of having all possible data to help in matching the right valve with the right patient.

Self-Expanding Surprise

For the study, Al-Azizi and colleagues looked retrospectively at 3,016 patients (mean age 80 years; 44% women) who underwent TAVI at one of six hospitals in the Baylor Scott & White Healthcare System in Texas between 2012 and 2021. Balloon-expandable valves (Sapien, Sapien XT, or Sapien 3; Edwards Lifesciences) were used in 74% of patients.

Rates of predicted severe PPM were 1.7% in women and 0.1% in men (P < 0.001), and those of measured severe PPM were 7.3% and 5.4%, respectively (P = 0.033).

Among female patients, the rate of predicted moderate PPM was 31.3% in the balloon-expandable valve group versus 8.2% in the self-expanding group, with rates of 22.9% and 11%, respectively, for measured moderate PPM.

Looking at 5-year survival, there were nonsignificant differences for the comparison of no predicted PPM versus moderate PPM and for no predicted PPM versus severe PPM. The same was true for measured PPM, again with no impact on survival to 5 years.

There was a slight trend toward lower unadjusted survival at 5 years in women who received a self-expanding valve and who had measured moderate PPM versus no PPM (P = 0.0230). This was seen despite self-expanding valves being associated with better hemodynamics and lower rates of PPM. The trend disappeared after risk adjustment.

With only 26% of the cohort having received a self-expanding valve, Al-Azizi said the numbers are too small to extrapolate much from the finding. SMART, which is the largest trial of patients with small annuli and 90% of whose participants were women, has made a strong case for self-expanding valves in female patients; it showed these devices to be associated with significantly less bioprosthetic-valve dysfunction than balloon-expandable valves, although the hard endpoints between the valves are similar to 2 years.

Session co-moderator Sanjit Jolly, MD (Hamilton Health Sciences/Population Health Research Institute, Canada), questioned whether the study may have been underpowered for mortality and wondered whether a larger cohort might shed more light on the self-expanding valve trend. At least one large analysis, from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry, has implicated severe PPM in higher rates of rehospitalization and mortality after TAVI.

Al-Azizi said while “trends are trends,” it might be worth exploring further in larger datasets.

The real-world analysis also highlights PPM’s impact on 5-year survival by sex.

“When we looked at the survival curves between males and females for overall measured PPM, males tended to do actually worse with overall measured PPM as compared to females, unlike what we have understood in the past,” Al-Azizi noted. He added that the analysis shows the importance of the contribution of real-world data to the ongoing understanding of individualizing treatment options for patients with aortic stenosis.

As TCTMD has previously reported, there are some ongoing studies comparing SAVR with root enlargement versus TAVR specifically in women to see if it makes a difference in PPM.

“The question is, is larger better? Well, theoretically yes, but the key question here is the balloon-expandable and self-expanding valve interaction,” Al-Azizi said. He added that, at least from this analysis, it appears that while the valves perform slightly differently, those differences don’t translate to long-term survival differences for women that would be considered unacceptable in comparison to surgery.