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

University Hospital of Ferrara

Status: Completed

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

Treatments: Procedure: Ultrasound Guided Axillary Venous Access; Procedure: Fluoroscopy-Guided Axillary Venous Access

Study type: Interventional

Funder types: Other

Identifiers

NCT05101720

CE-AVEC 555/2021/Sper/AOUFe

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations
• Age > 18 years

Exclusion criteria

• Leadless pacemaker or subcutaneous ICD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Ultrasound Guided Axillary Access

Experimental group

Description:

Direct visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture.

Treatment:

Procedure: Ultrasound Guided Axillary Venous Access

Fluoroscopic Guided Axillary Access

Active Comparator group

Description:

Standard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks.

Treatment:

Procedure: Fluoroscopy-Guided Axillary Venous Access