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In the 148-patient DUOTAP trial, routine postdilation after transfemoral TAVR with a balloon-expandable Sapien valve reduced measured valve asymmetry and was associated with lower rates of more-than-mild paravalvular leak and leaflet thickening. The single-center results do not establish longer valve durability or improved long-term clinical outcomes, and the procedure carries potential risks.
The DUOTAP trial found that routine balloon postdilation after transfemoral TAVR with a balloon-expandable Sapien valve reduced measured valve asymmetry and was associated with less paravalvular leakage and leaflet thickening. The findings, presented November 5 at the 2026 TCT conference and published in JAMA Cardiology, offer evidence about a debated procedural step, but do not show whether it improves long-term outcomes.
Investigators randomized 148 patients with severe aortic stenosis, in equal groups, to receive postdilation or no postdilation after TAVR. The single-blind, single-center study enrolled patients treated through the transfemoral route with a balloon-expandable Sapien platform. Median age was 81 years, and 47% of participants were women.
According to results presented by Maximilian Autherith of the Medical University of Vienna, fluoroscopic analysis showed a 70% reduction in the transcatheter heart valve asymmetry index with postdilation compared with no postdilation. Pre-discharge echocardiography showed a 67% reduction in more-than-mild paravalvular leak, while cardiac CT at three months showed a 63% reduction in hypo-attenuated leaflet thickening, or HALT.
The study also linked postdilation to a higher Doppler velocity index and lower residual trans-prosthetic gradients on echocardiography. CT measurements at three months showed larger valve inflow and midframe areas, as well as an increase in outflow area. The reported percentages describe comparisons between trial groups; they do not establish that every patient benefits or that the differences lead to better health outcomes.
Valve Geometry and TAVR Outcomes
TAVR replaces a narrowed aortic valve using a catheter-delivered prosthesis. If the new valve expands unevenly, it may leave leakage around the valve or higher residual gradients. The DUOTAP findings suggest that reinflating the deployment balloon may improve measured valve shape and some imaging indicators in patients receiving the studied Sapien platform.
That evidence could inform decisions about whether to add postdilation, a step that clinicians have debated because a potential mechanical benefit must be weighed against procedural hazards. The results are relevant to procedural planning, but they are not proof that routine use reduces deaths, symptoms, repeat procedures or other long-term outcomes. They also come from a relatively small trial at one center, so their reach beyond the studied patients and device is not established.
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Why Operators Debate a Second Inflation
Postdilation means reinflating a balloon inside the newly deployed valve. The intended effect is to improve expansion when the prosthesis appears asymmetric. Asymmetry may be associated with residual gradients and paravalvular leak, but operators must also weigh concerns such as annulus rupture, valve migration and disruption of the heart’s conduction system.
DUOTAP excluded patients with high-risk features on CT, bicuspid aortic valves and valve-in-valve procedures, among other criteria. Its results therefore apply to a selected group, not every person undergoing TAVR. In an exploratory, post hoc analysis, investigators saw a possible difference among the small number of patients who had predilation; only 11 participants received it, leaving wide confidence intervals and making the signal difficult to interpret.
“So you don’t want to take it for no reason.”
— Susheel Kodali, MD, NYU Langone Health
Long-Term Benefit and Safety Questions
The trial does not establish whether postdilation improves valve durability, survival, symptoms or other long-term clinical outcomes. The reported imaging measures and early comparisons cannot answer those questions. Researchers also reported a favorable but statistically nonsignificant trend in procedural or early clinical adverse events at 30 days: 24.3% with postdilation versus 31.1% in controls.
New conduction disorders requiring a pacemaker occurred in 20.3% of the postdilation group and 21.6% of controls. These figures do not rule out uncommon harms, including annulus injury or valve migration. The results also do not settle which patients should receive postdilation; the possible difference among patients who had predilation came from only 11 people and was exploratory.
Longer Follow-Up and Patient Selection
The main unresolved step is longer-term follow-up to determine whether the observed differences in valve geometry, leakage and leaflet thickening translate into more durable valves or better clinical outcomes. The source report does not specify a follow-up timeline or describe a planned larger trial.
Meanwhile, clinicians will need to judge how these findings apply to individual patients and other TAVR devices. TCT panelists said imaging, including echocardiography and fluoroscopy, may help identify patients whose valves have not expanded adequately. Further research will be needed to establish how to select patients for postdilation and how its benefits compare with its procedural risks.
Key Questions
What did the DUOTAP trial test?
It compared routine postdilation with no postdilation after transfemoral TAVR using a balloon-expandable Sapien valve in 148 selected patients with severe aortic stenosis.
What differences did investigators report?
Compared with no postdilation, the trial reported a 70% reduction in the valve asymmetry index, a 67% reduction in more-than-mild paravalvular leak and a 63% reduction in HALT on CT at three months. These are group comparisons from this trial, not proof of long-term clinical benefit.
Does DUOTAP show that everyone receiving TAVR should have postdilation?
No. The study tested routine postdilation in a selected group at one center. Clinicians quoted in the report discussed weighing possible benefits against risks and identifying patients who may benefit; the trial did not establish a universal approach.
What risks are associated with postdilation?
The report identifies concerns including annulus rupture, valve migration and disruption of the heart’s conduction system. DUOTAP reported no statistically significant difference in its early adverse-event comparison, but its results do not rule out individual or uncommon complications.
Are long-term benefits known?
No. The report says whether postdilation improves valve durability or long-term clinical outcomes remains unknown. Longer follow-up and further research are needed to answer those questions.
Source: medpagetoday.com
