Atrial Fibrillation, Peripheral Vascular Disease, Vascular Access Complications
Conditions
Keywords
Femoral vein puncture
Brief summary
This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .
Detailed description
The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Multiple femoral vein cannulation is mandatory for this procedure. There are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. As high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication. Real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. In the field of AF treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. In this setting, the use of ultrasound use is not well studied. The current study is to confirm whether real time ultrasound-guided femoral vein cannulation for PVI can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. Two seethes for each femoral vein is going to be cannulated. The study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. Also time for cannulation, number of puncture attempts, need of X-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.
Interventions
DEVICEReal-time ultrasound-guided puncture
A 7 megahertz ultrasound linear probe will be used.
OTHERAnatomical landmark guided puncture
Anatomical landmark puncture
Sponsors
Kenichiro Yamagata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.
Exclusion criteria
* Patients with prior known vascular access problems or priory included to the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major complications | After the puncture up to 12 weeks | Total patient number of vascular complications requiring surgical treatment, retroperitoneal hematoma requiring blood transfusion or hemoglobin drop of 3 \>g/dl, strong pain at the groin, prolonging hospital stay and requiring hospital admission after discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unsuccessful femoral vein cannulation | Immediately after the puncture | Number of patients with unsuccessful femoral vein cannulation defined as crossing over to the other randomized method or change of operator to cannulate all wires. |
| Number of puncture attempts | Immediately after the puncture | Number of puncture attempts to cannulate all wires. |
| Total puncture time | Immediately after the puncture | Time from giving anesthesia to the groin till confirming all wires in the infra vena cava with the X-ray. |
| Number of artery mis-punctures | Immediately after the puncture | Number of artery mis-punctures attempts to cannulate all wires. |
| Use of X-ray for successful wire cannulation | Immediately after the puncture | If there is a need of X-ray to cannulate the wire into the infra vena cava. |
Countries
Czechia, Japan
Outcome results
None listed