Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices.

Study Overview
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Brief Summary
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Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique. The purpose of this study is to compare the efficacy and safety of ultrasound-guided axillary vein access versus cephalic venous cutdown for implantation of endovenous CIED. Half of patients is implanted using an ultrasound-guided axillary vein puncture. The other half is implanted using a cephalic vein cutdown. After venous access is achieved, implantation procedure is identical in the two arms.

Official Title
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Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices

Conditions
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Pacemaker, Implantable Cardioverter-defibrillator

Intervention / Treatment
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* Device: Ultrasound-guided axillary vein access
* Device: Cephalic vein access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Indication for endovenous pacemaker or cardioverter-defibrillator (single or double room) Exclusion Criteria: History of previously implanted endocardial lead Indication for cardiac resynchronization therapy Impossibility of venous access Unable/unwilling to provide informed consent Pregnant or breastfeeding woman Participating in another clinical study which can interfere with this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided axillary vein access<br>This group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access. | Device: Ultrasound-guided axillary vein access<br>* Venous access is performed through ultrasound-guided axillary vein puncture and Seldinger technique. After venous access is obtained, a guide-wire is advanced through the access needle, and the tip of the guide-wire is positioned in the right cardiac atrium.<br>|
| Active Comparator: Cephalic vein access<br>This group of patients will receive the cardiac implantable electronic device with cephalic venous access. | Device: Cephalic vein access<br>* Venous access is performed through a cephalic vein cutdown approach. After venous access is obtained, a guide-wire is advanced and the tip of the guide-wire is positioned in the right cardiac atrium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of venous access | This outcome is measured by the operator during the intervention. It is the ability to successfully cannulate the vein and have all needed guidewire in the right atrium using the assigned venous access technique. The outcome is a binary value: success or failure. | Intervention time (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to venous access | Time from cutaneous incision to reach the right atrium with all needed guidewire using the assigned venous access technique | Intervention time (day 0) | 
| Procedure duration | Time from cutaneous incision to skin suture | Intervention time (day 0) | 
| Fluoroscopy time | Duration of fluoroscopy use during intervention | Intervention time (day 0) | 
| X-Ray exposure | X-ray exposure during intervention, measured in mGycm2 | Intervention time (day 0) | 
| Complication | All implant related complications including brachial plexus palsy, major pocket hematoma (hematoma requiring evacuation or transfusion or prolonged hospitalization), pneumothorax, hemothorax, pericardial effusion, lead dislodgement, device infection, venous thrombosis. | Intervention time (day 0) | 
| Cardiac implantable electronic device (CIED) related infection | Local and systemic signs of CIED related infection will be monitored during follow-up. The definition and classification of CIED related infection are based on the current guideline and expert consensus statement. | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, implantable cardioverter-defibrillator, axillary vein, cephalic vein, ultrasound