Valve Stenoses, Aortic
Conditions
Keywords
TAVI, TAVR, transcatheter aortic valve replacement, transcatheter aortic valve implantation, aortic stenosis, vascular access, primary access, secondary access
Brief summary
Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.
Interventions
OTHERAccess site
The SAFER-TAVI trial is randomized study comparing secondary access via a transradial versus transfemoral approach among patients undergoing transfemoral TAVI for aortic valve disease. Secondary access is gained along with primary access at the commencement of the TAVI procedure and is used for aortography before and after valve deployment and for assessment of the primary femoral access site after closure to confirm haemostasis. For patients assigned to radial access, the radial sheath will be removed using a radial band at the end of the procedure. For patients assigned to femoral access, the puncture site will be obtained under ultrasound guidance and fluoroscopic landmark identification. Unless contraindicated, the use of vascular closure devices will be recommended for all femoral cases. The choice of closure device is at the discretion of the operator. Catheters used in the access groups will be 5 or 6 French size at the discretion of the operator.
Sponsors
The Alfred
Epworth Healthcare
Cabrini Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
SAFER-TAVI trial is a multicentre registry-nested, randomised controlled trial comparing transradial versus transfemoral secondary access in patients undergoing transfemoral TAVI for aortic valve disease.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Undergoing transfemoral TAVI with any commercially available transcatheter heart valve * Suitable radial and secondary femoral access
Exclusion criteria
* Primary arterial access via surgical cut-down * Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist * Previously failed attempt to access bilateral radial arteries. * Patient on hemodialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All clinically relevant bleeding and all vascular complications | 30 days | The composite of all clinically relevant bleeding (defined as Bleeding Academic Research Consortium \[BARC\] type ≥2) and vascular complications (Valve Academic Research Consortium \[VARC3\] criteria) at 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All clinically relevant bleeding (BARC ≥2), overall and by access site | 30 days | Using BARC criteria |
| All vascular complications, overall and by access site | 30 days | Using VARC-3 criteria |
| All-cause death | 30 days | Using VARC-3 criteria |
| Stroke | 30 days | Using VARC-3 criteria |
| Myocardial infarction | 30 days | Using VARC-3 criteria |
| Major adverse cardiovascular events | 30 days | The composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke |
| Length of stay post-procedure | 30 days | Length of stay post-procedure measured in time (days) from procedure to discharge |
| Overall procedure duration | 1 day | TAVI procedure duration measured in time (minutes) |
| Radiation dose | 1 day | Radiation dose measured as air kerma in milligrays |
| Conversion rate to alternative vascular access site | 30 days | Conversion rate to alternative vascular access site |
| Tertiary site utilised to treat vascular complication | 30 days | Tertiary site utilised to treat vascular complication |
| Failure to perform angiogram of primary access site at completion of TAVI | 1 day | Failure to perform angiogram of primary access site at completion of TAVI |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORAntony Walton, MBBS
The Alfred and Epworth Healthcare
PRINCIPAL_INVESTIGATORDion Stub, MBBS, PhD
The Alfred and Cabrini Health
Outcome results
None listed