Multicenter Randomised Controlled Trial: Benefit of Intra-pocket Echo-guided Axillary Puncture Compared With Percutaneous Echo-guided Axillary Puncture and Cephalic Vein Dissection for the Primary Implantation of Intracardiac Electronic Devices.

Official Summary

The implantation of an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted. The procedure involves inserting one or more intra-cardiac leads using venous access. Navigation in the heart chambers is guided by fluoroscopy. Each lead is connected to a box that is placed under the skin in the deltopectoral groove. The venous vascular approach or venous access is a key stage. It can be time-consuming and a source of complications (haematoma, pneumothorax, nerve damage, catheter malfunction). There are several methods of vascular access: cephalic vein dissection, subclavian vein puncture guided by anatomical landmarks, axillary puncture guided by scopy (X-rays) or intraoperative ultrasound. The implantation of an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted. The procedure involves inserting one or more intra-cardiac leads using venous access. Navigation in the heart chambers is guided by fluoroscopy. Each lead is connected to a box that is placed under the skin in the deltopectoral groove. The venous vascular approach or venous access is a key stage. It can be time-consuming and a source of complications (haematoma, pneumothorax, nerve damage, catheter malfunction). There are several methods of vascular access: cephalic vein dissection, subclavian vein puncture guided by anatomical landmarks, axillary puncture guided by scopy (X-rays) or intraoperative ultrasound. The most commonly used venous access for DEIC implantation in Europe today is cephalic vein dissection (60%). The subclavian vein is used in 21% of cases and the axillary vein in 19%. There is currently no recommendation as to which techni

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 900 participants

Interventions

• PROCEDURE: Intervention 1: Cephalic vein dissection — After an incision in the deltopectoral groove and careful dissection of the superficial fatty layer, the cephalic vein is revealed and separated from its tissue attachments over a distance of approximately 2 centimetres before being cannulated in order to introduce the necessary guides. The electronic device will be fitted using the guides introduced in this way.
• PROCEDURE: Intervention 2 : Percutaneous echo-guided axillary route — A standard vascular linear ultrasound probe is placed in a single-use sterile sheath. The probe is brought into contact with the skin and we then perform a needle puncture of the vein under ultrasound control. Once the puncture or punctures have been successful, a guide is inserted into the vein and the incision is made after the puncture. The electronic device will be fitted using the guides introduced in this way.
• PROCEDURE: Intervention 3 : Intrapocket ultrasound-guided axillary route — A special ultrasound probe (shaped like a hiccup) is placed in a single-use sterile sheath. After making an incision in the deltopectoral groove and dissecting the fatty layer, the probe is placed in contact with the pectoral muscle to visualise the axillary vein. Needle puncture of the vein is performed under ultrasound guidance. Once the puncture is successful, a guide is inserted into the vein. The electronic device will be fitted using the guides introduced in this way.

Primary Outcomes

• Success rates of the three procedures (During the intervention)

Secondary Outcomes

• Vascular access time (During the intervention)

Trial Locations

• CHU Clermont-Ferrand, Clermont-Ferrand, France
• Hôpital F. MITTERRAND, Dijon, France
• Lyon-Croix Rousse, Lyon, France
• Lyon-Louis Pradel, Lyon, France
• Hôpital privé Jacques Cartier, Massy, France
• CH Annexy-Genevois, site Annecy, Metz, France
• CHU de Saint Etienne - Hôpital Nord, Saint-Priest-en-Jarez, France

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