Femoral Artery Injury, Ultrasound Therapy; Complications
Conditions
Keywords
3D Ultrasound, vascular access, Transcatheter aortic valve implantation
Brief summary
Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.
Interventions
DEVICE3D US
3D US guided access to femoral artery
DEVICE2D US
2D US guided access to femoral artery
Sponsors
Eindhoven University of Technology
Catharina Ziekenhuis Eindhoven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
randomized clinical trial with two arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adult age (\>18 years) * Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery * Written Informed consent
Exclusion criteria
* Unable to obtain informed consent * Vascular access via alternative approach (radial/subclavian) or surgical cutdown
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| first pass success | during procedure/surgery | successful entry in femoral artery within one skinbreak and without needle redirections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure time | during procedure/surgery | time from puncturing skin until entry in femoral artery (in seconds) |
| total number of punctures | during procedure/surgery | new skin breaks needed for completion of procedure |
| number of needle redirections | during procedure/surgery | total number of needle withdrawals \>5mm but without needing new skin puncture |
| imaging time | during procedure/surgery | time from putting probe on skin to start procedure (in seconds) |
| needle visualization | during procedure/surgery | rated from good-adequate-poor |
| operator satisfaction | during procedure/surgery | likert scale 1-5 with 1 no satisfaction and 5 completely satisfied |
| 12 o clock entry | during procedure/surgery | entrance to femoral artery at exactly 12 o clock (antero-medial) |
Countries
Netherlands
Contacts
Primary ContactHarm Scholten, MD
Backup ContactArthur Bouwman, PhD
Outcome results
None listed