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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
104
3D US guided access to femoral artery
2D US guided access to femoral artery
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, Netherlands
first pass success
successful entry in femoral artery within one skinbreak and without needle redirections
Time frame: during procedure/surgery
imaging time
time from putting probe on skin to start procedure (in seconds)
Time frame: during procedure/surgery
procedure time
time from puncturing skin until entry in femoral artery (in seconds)
Time frame: during procedure/surgery
total number of punctures
new skin breaks needed for completion of procedure
Time frame: during procedure/surgery
number of needle redirections
total number of needle withdrawals \>5mm but without needing new skin puncture
Time frame: during procedure/surgery
12 o clock entry
entrance to femoral artery at exactly 12 o clock (antero-medial)
Time frame: during procedure/surgery
needle visualization
rated from good-adequate-poor
Time frame: during procedure/surgery
operator satisfaction
likert scale 1-5 with 1 no satisfaction and 5 completely satisfied
Time frame: during procedure/surgery
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