Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL

Study Overview
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Brief Summary
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Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable cardioverter-defibrillator implantations.

Detailed Description
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Rationale: axillary, cephalic and subclavian venous accesses are commonly used in pacemaker and implantable cardioverter defibrillator implantations. Axillary puncture and cephalic vein surgical cutdown are both recommended in international guidelines due to low risk of pneumothorax and chronic lead complications. Sometimes cephalic vein is not available. Today axillary puncture is performed under fluoroscopic view and some complications still exist with this venous access as pneumothorax and arterial puncture. Axillary vein direct visualization can be obtained with standard venography or with ultrasound. With direct visualization and puncture of the axillary vein under ultrasound guidance venography with radiocontrast could be avoided. Less radiation exposure for patient and operator and direct visualization of the needle are possible with lower periprocedural complications using ultrasound. Despite the great interest for ultrasound guided axillary puncture up today we have few data on its feasibility. Our hypothesis is that ultrasound guided axillary access is more safe and more feasible than the standard fluoroscopic technique. We decided to enroll all the patients undergoing standard transvenous pacemaker or cardioverter implantable defibrillator. We randomize the patients with 1:1 fashion to axillary venous access under fluoroscopic guidance or to ultrasound guided axillary venous access. Obiectives: to asses safety, feasibility of the ultrasound guided venous puncture. Main Endpoint: composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.

Official Title
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Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation

Conditions
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Arrhythmias, Cardiac, Venous Puncture, Implantable Defibrillator User, Pacemaker Complication, Vascular Access Complication, Fluoroscopy; Adverse Effect

Intervention / Treatment
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* Procedure: Ultrasound Guided Axillary Venous Access
* Procedure: Fluoroscopy-Guided Axillary Venous Access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations Age > 18 years Exclusion Criteria: Leadless pacemaker or subcutaneous ICD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Guided Axillary Access<br>Direct visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture. | Procedure: Ultrasound Guided Axillary Venous Access<br>* Direct visualization of axillary vein will be obtained with ultrasound sterile linear probe.<br>|
| Active Comparator: Fluoroscopic Guided Axillary Access<br>Standard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks. | Procedure: Fluoroscopy-Guided Axillary Venous Access<br>* Fluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days. | Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days. | One month after index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, ICD, arrhythmias, Cardiac Implantable Electronic Device, Vascular access, Venous puncture, Ultrasound, Fluoroscopy