A new analysis from the Evolut Low Risk Trial is raising important questions about the long-term durability of transcatheter aortic valve implantation (TAVI) in low-risk patients with severe aortic stenosis.
Through 6 years, rates of all-cause mortality and disabling stroke remained statistically similar between TAVI and surgical aortic valve replacement (SAVR). However, the event curves crossed at 5 years, beginning to numerically favor surgery — and by 7 years, a significant difference in aortic valve reintervention rates emerged: 9.8% for TAVI versus 6.0% for surgery.
Investigators also identified a possible culprit: off-guidance postdilation using oversized balloons during implantation, particularly with the 34-mm Evolut R valve. Reintervention rates in those cases reached 19.1%, compared to 4.3% in properly managed cases — though researchers caution this finding remains hypothesis-generating.
Critically, two-thirds of patients who needed reintervention after TAVI ultimately required open-chest surgery — an important consideration when treating younger low-risk patients who may outlive their valve.
Not everyone sees cause for alarm. Data from the NOTION trial showed no increased reintervention signal at 10 years, and some experienced operators report very low reintervention rates in daily practice with the Evolut platform.
The consensus? Shared decision-making and lifetime valve management are more important than ever. 10-year follow-up data will be essential to understand where this story ends.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.