Routine Postdilation Improves TAVI Valve Geometry and Hemodynamics Without Increasing Safety Risks: DUOTAP Trial
Austria: A randomized clinical trial published in JAMA Cardiology found that routine postdilation significantly improves transcatheter heart valve (THV) geometry and hemodynamic performance after transcatheter aortic valve implantation (TAVI) without increasing procedure-related adverse events. The findings support routine postdilation as a potential strategy for optimizing valve performance in appropriately selected patients with severe aortic stenosis (AS).
The DUOTAP randomized clinical trial, led by Maximilian Autherith (Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Austria) and colleagues, provides randomized evidence that postdilation can reduce valve asymmetry and improve expansion and function.
Asymmetric expansion of prosthetic valves following TAVI has been associated with prosthetic dysfunction and mortality. Although previous observational studies suggested that postdilation could improve valve geometry, randomized evidence supporting its efficacy and safety remained limited.
To investigate this, researchers conducted a single-center, single-blinded randomized clinical trial at the Medical University of Vienna between January 2025 and April 2026.
The trial enrolled 148 patients with severe AS undergoing transfemoral TAVI using a balloon-expandable THV. Participants were randomized equally into two groups: routine postdilation (74 patients) and no postdilation (74 patients). Patients with high-risk features on preprocedural computed tomography (CT) or coronary angiography were excluded.
The intervention involved repeat balloon inflation using the original delivery balloon at the same filling volume, while the control group underwent a sham procedure. Researchers assessed valve geometry using fluoroscopy and CT, alongside hemodynamic performance, paravalvular leak (PVL), hypoattenuated leaflet thickening (HALT), and procedural safety.
The findings revealed the following:
- Reduced valve asymmetry: Routine postdilation lowered the THV asymmetry index by 70% compared with the control group (1.2% vs 2.8%).
- Improved valve expansion: CT measurements demonstrated significantly larger valve areas at the inflow, midframe, and outflow levels following postdilation.
- Better hemodynamic performance: The intervention group had a significantly higher Doppler Velocity Index, indicating improved valve performance.
- Fewer valve abnormalities: HALT and mild or greater PVL occurred significantly less frequently among patients receiving postdilation.
- Comparable procedural safety: No significant differences in procedure-related adverse events were observed between the groups.
The study was limited by its single-center design and insufficient statistical power to assess uncommon safety events or clinical outcomes. Additionally, the CT protocol did not comprehensively evaluate reduced leaflet motion or leaflet thrombosis. Long-term valve durability and clinical benefits remain uncertain.
The researchers concluded that routine postdilation improves THV geometry and hemodynamic performance without increasing procedural complications. However, larger multicenter trials and extended follow-up are needed to determine whether these improvements translate into better long-term valve durability and patient outcomes.
Reference:
Autherith M, Singer K, Hauptmann L, et al. Efficacy and Safety of Routine Postdilation in Balloon-Expandable Transcatheter Aortic Valve Implantation Platform: The DUOTAP Randomized Clinical Trial. JAMA Cardiol. Published online November 03, 2026. doi:10.1001/jamacardio.2026.5260
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