Valvular & structural heart disease
Efficacy and Safety of Routine Postdilation in Balloon-Expandable Transcatheter Aortic Valve Implantation Platform: The DUOTAP Randomized Clinical Trial
Primary result · Fluoroscopic THV asymmetry indexResult — go to the resultGeometric mean ratio 0.30 95% CI 0.18–0.47Authors' conclusion
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.
Study context
- Population
- Patients with severe aortic stenosis (AS) suitable for transfemoral transcatheter aortic valve implantation (TAVI) with a balloon-expandable transcatheter heart valve (THV) and without high-risk features on preprocedural CT or coronary angiographyunderwent randomization
- Participants
- 148 patients
- Comparison
- Routine postdilation vs no postdilation
- Interventionn = 74
- Controln = 74
- Primary endpoint
- Fluoroscopic THV asymmetry index
- Follow-up
- Periprocedurally (fluoroscopy)
Methodological detailsrandomized in a 1:1 ratio, stratified by THV size, sham procedure in the control group, high-volume tertiary referral center
- Randomized in a 1:1 ratio
- Stratified by THV size
- Sham procedure in the control group
- High-volume tertiary referral center
Primary result
As reported in the abstract
Geometric mean ratio
0.30
95% CI 0.18–0.47
P < 0.001
By group
Secondary outcomes
Baseline characteristics
- Median [IQR] age
- 81 [77-85] years
- Female
- 69 [46.6%]
- Male
- 79 [53.4%]
- Median EuroSCORE-II
- 2.3%
THV diameters on fluoroscopy
- Numerically larger THV diameters on fluoroscopy with intervention
THV areas at the inflow, midframe, and outflow level on CT · 3 months
- Significantly larger THV areas at the inflow, midframe, and outflow level on CT with intervention
Hypoattenuated leaflet thickening (HALT) and mild or worse paravalvular leak (PVL)
- HALT and mild or worse PVL significantly less frequent in the intervention group
Doppler Velocity Index
- Doppler Velocity Index significantly higher in the intervention group
Safety
Procedure-related adverse events · 30 days
- No differences in procedure-related adverse events between groups
- χ 2 test: P = .36
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →