Key result
Routine postdilation reduces THV asymmetry ~70% vs sham control during TAVI.
Why the study?
In patients with severe AS undergoing TAVI, asymmetric valve expansion is linked to prosthetic dysfunction and death. Although observational studies suggested that postdilation optimizes valve geometry, randomized evidence was lacking.
Does routine postdilation using the original delivery balloon reduce the fluoroscopic transcatheter heart valve asymmetry index in patients with severe aortic stenosis undergoing transfemoral TAVI with a balloon-expandable platform?
RCT (n=148)
Single-blinded
1:1 ratio, stratified by THV size
No
Does routine postdilation using the original delivery balloon reduce the fluoroscopic transcatheter heart valve asymmetry index in patients with severe aortic stenosis undergoing transfemoral TAVI with a balloon-expandable platform?
Routine postdilation during balloon-expandable TAVI significantly reduces transcatheter heart valve asymmetry, lowers rates of hypoattenuated leaflet thickening and paravalvular leak, and improves hemodynamics without increasing procedural adverse events.
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“By providing randomized evidence that THV asymmetry is modifiable intraprocedurally, the DUOTAP trial challenges the concept of THV geometry as a passive consequence of valve deployment and supports geometry optimization as an actionable therapeutic target during contemporary TAVI procedures. Whether these mechanistic and hemodynamic benefits translate into improved valve durability and long-term clinical outcomes remains to be assessed.”
“double tap postdilation seems a reasonable strategy which should be adopted more widely – if not routinely, then at least more often.”
Routine postdilation may be considered to optimize THV geometry in balloon-expandable TAVI; first RCT extends observational data with safety confirmation.
Importance In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI), asymmetric valve expansion can estimate prosthetic dysfunction and death. Postdilation has shown promising results in optimizing valve geometry in observational studies; however, randomized evidence is currently lacking. Objective To determine the efficacy of routine postdilation on transcatheter heart valve (THV) geometry and hemodynamic performance, and associated safety outcomes. Design, Setting, and Participants DUOTAP was a single-center, single-blinded randomized clinical trial. Recruitment took place from January 2025 to April 2026 and end points were assessed periprocedurally (fluoroscopy) at 30 days (adverse events) and at 3 months (computed tomography [CT]). The trial was conducted at a high-volume tertiary referral center, the Medical University of Vienna, Austria. Included patients had severe AS suitable for transfemoral TAVI with a balloon-expandable THV and without high-risk features on preprocedural CT or coronary angiography and were randomized in a 1:1 ratio, stratified by THV size, to routine postdilation vs no postdilation. These data were analyzed from July 2026 to September 2026. Intervention Routine postdilation using the original delivery balloon at the identical filling volume. A sham procedure was performed in the control group. Main Outcomes and Measures The fluoroscopic THV asymmetry index served as primary end point. Further fluoroscopic and CT-derived measures of valve geometry, hypoattenuated leaflet thickening (HALT), paravalvular leak (PVL), and THV hemodynamics on echocardiography, and freedom from major procedural adverse events served as secondary end points. Results Overall, 148 patients (median [IQR] age, 81 [77-85] years; 69 female [46.6%] and 79 male [53.4%]; median EuroSCORE-II, 2.3%) underwent randomization (n = 74 intervention vs n = 74 control). Intervention yielded a 70% lower THV asymmetry index compared with control (median: 1.2% vs 2.8%; geometric mean ratio: 0.30; 95% CI, 0.18-0.47; P < .001), with consistent effects across prespecified subgroups, induced by frame height reduction across the outer curve. Additionally, intervention yielded numerically larger THV diameters on fluoroscopy and significantly larger THV areas at the inflow, midframe, and outflow level on CT. HALT and mild or worse PVL were significantly less frequent and the Doppler Velocity Index was significantly higher in the intervention group. No differences in procedure-related adverse events between groups were recorded (χ 2 test: P = .36). Conclusions and Relevance In this randomized clinical trial, postdilation led to reduced THV asymmetry, optimized geometry, and improved hemodynamic performance, without increasing procedure-related adverse events. These results support the use of routine postdilation to optimize THV geometry and hemodynamics in suitable patients. Trial Registration ClinicalTrials.gov Identifier: NCT07477002
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Autherith et al. (2026) conducted an RCT in Severe aortic stenosis undergoing transfemoral TAVI with a balloon-expandable transcatheter heart valve (n=148). Routine postdilation using the original delivery balloon at the identical filling volume vs. No postdilation (sham procedure) was evaluated on Fluoroscopic transcatheter heart valve (THV) asymmetry index (Geometric mean ratio 0.30, 95% CI 0.18-0.47, p=<0.001). Routine postdilation reduced the fluoroscopic THV asymmetry index by 70% vs sham control (median 1.2% vs 2.8%; geometric mean ratio 0.30; 95% CI, 0.18-0.47; P<.001).
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