1. In this randomized clinical trial of patients with aortic stenosis (AS),routine postdilation yielded a significantly lower transcatheter heart valve (THV) asymmetry index compared with no postdilation, consistent across prespecified subgroups.
2. Routine postdilation intervention resulted in numerically larger THV diameters on fluoroscopy at the inflow, midframe, and outflow levels on CT scan.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Transcatheter aortic valve implantation (TAVI) emerged as a treatment option for severe aortic stenosis. Postdilation of THVs following THV implantation during TAVI is a promising but underexplored management strategy to optimize prosthesis geometry, which is a strong determinant of valve function and hemodynamics. The DUOTAP study aimed to evaluate the efficacy and safety of routine postdilation, specifically in terms of optimizing THV geometry and hemodynamic performance. Among 148 severe AS patients who received TAVI in 2025 and 2026, the results of the study showed that routine postdilation resulted in markedly improved symmetry in THV geometry, which was found to be consistent across stratified subgroups. In addition, patients who received routine postdilation showed improvements across several measures of hemodynamic function including significantly larger THV areas at the inflow, midframe, and outflow level on CT, lower frequency of hypo-attenuated leaflet thickening and mild or worse paravalvular leak, and a higher Doppler Velocity Index. Despite concerns for potential adverse events associated with postdilation, there was no statistically significant difference in the frequency of adverse events between groups.The results of this study should be interpreted in light of the study’s limitations, particularly its single-center design, which may limit the generalizability of the findings. Additionally, the trial did not assess long term clinical outcomes. As such, while the results of this study suggest that regular postdilation should be a routine post-operative management strategy in AS patients who have received TAVI, further long terms studies are needed to further explore the whether improvements in valve geometry and hemodynamic performance can translate into improved clinical outcomes
Click here to read the study in JAMA (Journal of the American Medical Association).
Relevant Reading: Routine post-dilatation at nominal volume to optimise the expansion of balloon-expandable valves: the DOUBLE-TAP study
In-Depth [randomized controlled trial]: This study, DUOTAP, was a single-center single-blinded randomized clinical trial at the Medical University of Vienna in Austria. Recruitment of participants occurred from January 2025 to April 2026; eligible patients had severe AS suitable for transfemoral TAVI with a balloon-expandable THV and had no high-risk features on preprocedural CT or coronary angiography. Patients were randomized in a 1:1 ratio to routine postdilation vs no postdilation, stratified by THV size. Endpoints were analyzed periprocedurally, at 30 days, and at 3 months.
The study included 148 patients (median age, 81 [77-85] years; 79 male [53.4%], 69 female [46.6%]; median EuroSCORE-II, 2.3%) who were randomized (74 intervention group, 74 control group). The primary endpoint was the THV asymmetry index assessed on fluoroscopy after THV implantation. Postdilation resulted in a lower THV asymmetry index compared with no postdilation (median [IQR], 1.2% [0.5%-2.4%] vs 2.8% [1.8%-5.1%]), showing a 70% reduction in valve asymmetry (geometric mean ratio, 0.30; 95% CI, 0.18-0.47; p<0.001). Results remain consistent when adjusted for valve size (95% CI 0.19-0.48, p<0.001), in the as-treated analyses (95% CI 0.18-0.45, p<0.001), and when assessed in the cusp-overlap view (95% CI 0.25-0.58, p<0.001). Secondary endpoints included THV heights across the inner and outer curves, THV diameters at the inflow, midframe, and outflow levels, CT-derived cross-sectional THV area and presence of hypo-attenuated leaflet thickening (HALT), and hemodynamic endpoints such as transprosthetic mean pressure gradient (mPG), Doppler Velocity Index (DVI), and the presence and severity of PVL. Among these, THV height across the outer curve (p=0.03), cross-sectional THV areas across the inflow (p=0.01), midframe (p=0.005), outflow (p=0.009), HALT frequency (p=0.04), DVI (p=0.001), and prevalence/severity of PVL (p=0.05) differed significantly between the intervention and control groups.. In terms of safety risk assessment, the VARC-3 safety endpoint frequency was not statistically significant across the two groups (p=0.36).
Citation: Autherith M, Singer K, Hauptmann L, Torrefranca C, Jantsch C, Koschatko S, et al. Efficacy and Safety of Routine Postdilation in Balloon-Expandable Transcatheter Aortic Valve Implantation Platform: The DUOTAP Randomized Clinical Trial. JAMA Cardiol. 2026 Nov 3. doi: 10.1001/jamacardio.2026.5260. Epub ahead of print. PMID: 42976368; PMCID: PMC13732541.
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