Aortic Valve Stenosis
Conditions
Keywords
Balloon-expandable TAVI prostheses, Fluoroscopic imaging, Computed tomography, Post-Dilatation, Double-Tap
Brief summary
Asymmetrical and inadequate expansion of transcatheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bioprosthetic valve dysfunction (BVD) and death. Post-dilatation using the original delivery system balloon at the identical filling volume after deployment of balloon-expandable THVs represents an invasive strategy to potentially optimize expansion and reduce asymmetry of balloon-expandable THVs. Currently, the efficacy and safety of routine post-dilatation has never been assessed in a randomized controlled fashion. The present randomized controlled DUOTAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, hemodynamics, durability, and associated clinical outcomes in patients with severe aortic stenosis.
Detailed description
This study is a randomized controlled trial investigating the effect of routine post-dilatation, using the original delivery balloon at nominal volume, in patients scheduled for and receiving a balloon-expandable THV at the Medical University of Vienna. Consecutive adult patients with severe degenerative AS scheduled for a balloon expandable THV will be prospectively enrolled at a university-affiliated tertiary center in Austria. Eligibility and decision for TAVI will be determined by a multidisciplinary Heart Team. All patients who are willing to participate will then be randomly assigned in a 1:1 ratio to undergo a) routine post-dilatation using the original delivery balloon at nominal volumes or b) no post-dilatation after THV deployment. Methods: The DUOTAP trial is an investigator-driven, prospective, single-blinded, randomized, controlled trial performed at the Medical University of Vienna. In patients assigned to the intervention group post-dilatation will be performed right after deployment of the THV. The balloon will be re-inserted into the deployed THV and after initiation of rapid ventricular pacing the balloon will be inflated at the level of the deployed TAVI prosthesis and then will be immediately deflated again. The duration of rapid ventricular pacing and additional balloon deployment is in the range of a few seconds. Pre-specified study visits: V0 (Pre-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score; V1 (TAVI): Fluoroscopic assessment of THV asymmetry, diameters and heights; V2 (Pre-discharge): Routine blood and urine analysis, Echocardiography; V3 (1 month Post-TAVI): Assessment of safety endpoints via phone follow-up; V4 (3 months Post-TAVI): Assessment of cross-sectional THV area on computed tomography (CT); V5 (1 year Post-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (Serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score; V6 (5 years Post-TAVI): Medical history and physical evaluation (concomitant diseases, risk factors, medication, EuroSCORE-II, height, weight, age, sex, blood pressure, heart rate, ECG, symptoms), Routine blood and urine analysis (Serum creatinine, NT-proBNP, electrolytes, full blood count, etc.), Echocardiography, KCCQ overall score Outcome: Outcomes (see below) will be assessed peri-procedural, at 1 month, at 3 months, at 1 year and at 5 years post TAVI.
Interventions
OTHERPost-dilatation
Nominal post-dilatation using the original delivery balloon
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe AS * AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board * Anatomical feasibility to receive a balloon-expandable THV * Age 65 years or older * Informed consent
Exclusion criteria
* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated) * Bicuspid aortic valve anatomy * Valve-in-valve procedure * Severe calcification of the aortic annulus protruding into the left ventricular outflow tract and predisposing for annular rupture * Significant stenosis of the left main or proximal left anterior descending artery with substantial risk of hemodynamic instability during rapid ventricular pacing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| THV-asymmetry index | Peri-procedural | The THV-asymmetry index will be calculated from freeze-frame fluoroscopic images as: \[(longer THV height/shorter THV height) - 1\] × 100. Minimum value: 0 Maximum value: NA Higher values indicate more asymmetry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| THV diameters at inflow, midframe and outflow and THV heights at the inner and outer curve | Peri-procedural | THV diameters will be measured on freeze-frame fluoroscopic images. Minimum value: 0 Maximum value: NA Measured in millimeter. Higher values indicate better THV expansion. THV heights will be measured on freeze-frame fluoroscopic images. Minimum value: 0 Maximum value: NA Measured in millimeter. Lower values indicate better THV expansion. |
| THV asymmetry index from pre- to post-dilatation in the treatment group | Peri-procedural | The THV-asymmetry index will be calculated from freeze-frame fluoroscopic images as: \[(longer THV height/shorter THV height) - 1\] × 100; Minimum value: 0 Maximum value: NA; Higher values indicate more asymmetry. |
| THV diameters at inflow, midframe and outflow and THV heights at the inner and outer curve from pre- to post-dilatation in the treatment group. | Peri-procedural | THV diameters will be measured on freeze-frame fluoroscopic images. Minimum value: 0 Maximum value: NA Measured in millimeter. Higher values indicate better THV expansion. THV heights will be measured on freeze-frame fluoroscopic images. Minimum value: 0 Maximum value: NA Measured in millimeter. Lower values indicate better THV expansion. |
| Residual trans-prosthetic gradient | One day, one year and five years | Residual trans-prosthetic gradient on transthoracic echocardiography; Minimum value: 0 Maximum value: NA; Measured in mmHg; Lower values indicate better THV hemodynamics. |
| Doppler Velocity Index | One day, one year and five years | Doppler Velocity Index assessed on transthoracic echocardiography; Minimum value: 0 Maximum value: 1; Higher values indicate better THV hemodynamics. |
| Paravalvular Regurgitation | One day, one year and five years | ≥mild paravalvular regurgitation on transthoracic echocardiography |
| Cross-sectional THV area | Three months | Cross-sectional THV area on cardiac CT scans; Minimum value: 0 Maximum value: NA; Measured in millimeter²; Higher values indicate better THV expansion |
| Hypo-attenuated leaflet thickening | Three months | Hypo-attenuated leaflet thickening on computed tomography |
| Major periprocedural complications | 30 days | Assessment of: * periprocedural death; * any type of stroke; * procedure- or valve related hospitalization; * type ≥2 bleeding; * major vascular complication; * new conduction system disorders requiring pacemaker implantation; * major cardiac structural complication; * other acute procedural and technical valve related complications (conversion to open surgery, unplanned use of mechanical circulatory support, implantation of multiple THV valves during the index hospitalization, valve malposition). All defined according to the Valve Academic Research Consortium 3 criteria |
Countries
Austria
Outcome results
None listed