Just-released studies shine more positive light on TAVR in terms of durability five years out and long-term survival, with women outpacing men by about 15 percent.
Longitudinal durability of the Sapien 3 Transcatheter Heart Valve (Edwards) is “excellent,” according to a recent study in JAMA Cardiology. It was the first to look at outcomes 5 years out. The research team found “relative stability at the three- and five-year marks for patients, and moderate to severe transvalvular regurgitation showed up in 89 patients after TAVR and continued to increase.”
Reintervention occurred in just one patient following SAVR and 30 following TAVR. Thus, the trial demonstrated longitudinal durability using population hemodynamic trends, case reviews of reinterventions and patients with large adverse changes between echocardiograms.
“A starting point” for TAVR durability is what a pair of cardiologists called the results in an accompanying editorial. "In this elderly group of patients,” wrote Stephen Little, MD, and Michael Reardon, MD, both of Houston Methodist Hospital, “it is unlikely that we will see structural valve deterioration in TAVR valves if they behave similarly to surgical valves because death will compete with structural valve deterioration in this high-risk population," they wrote Little and Reardon said. They suggest the 10-year data from Sapien's intermediate- and low-risk trials will truly answer the question.
And it turns out women are outdoing men when it comes to TAVR outcomes. This week a study in JACC: Cardiovascular Interventions showed that despite encountering more short-term post-TAVR complications, women have long-term survival rates about 15 percent higher than. Women do have a greater risk of stroke.
Of 47,188 patients studied, 16 percent of women died compared to 19.4 percent of men. When only cases with at least three years of follow-up were included—cutting the study group to about 6,000—women were at a 14 percent reduced risk of all-cause mortality.
So why do the numbers swing slightly in favor of women? The research team offered three potential explanations:
- Women had a lower risk of moderate to severe aortic insufficiency post-TAVR;
- Men had more comorbidities despite being, on average, a year younger than females; and
- Women’s hearts are more favorable to cardiac remodeling.
While women demonstrated better survival than men over time, their risk of stroke was 23 percent higher at one year. This could be tied to the greater likelihood that women receive balloon-expandable versus self-expanding valves compared to men, but further research is necessary. The team also suggested further research to determine if women may benefit from embolic protection devices during TAVR.