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Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device

Sponsor: Hospices Civils de Lyon

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 technique should be used as first-line treatment. The subclavian route is performed by puncture without direct visualisation of the vein, and therefore presents a risk of complications such as pneumothorax. The cephalic route has few complications, but requires lengthy and tedious dissection and considerable experience. According to the literature, the failure rate is between 20 and 30%. For axillary vein puncture, several options have been described: blind, scopy-guided with venography and ultrasound-guided. Ultrasound-guided axillary puncture has been proposed for several years, but is currently not widely used. According to the literature, this technique seems to have a high success rate with a low complication rate, particularly with regard to the risk of pneumothorax. There are currently two ultrasound-guided axillary puncture techniques. The 'intra-pocket' axillary puncture technique involves performing a puncture after making the incision using a special ultrasound probe (shaped like a golf club), placed in contact with the pectoral muscle. Percutaneous" axillary puncture, on the other hand, is performed using a standard linear vascular ultrasound probe. Here the puncture is performed before the incision and the probe is placed in contact with the skin. According to the literature currently available, the ultrasound-guided 'intra-pocket' technique appears to have a better success rate than the ultrasound-guided 'percutaneous' technique (95-99% success rate vs. 90-95%). The investigators recently conducted the ACCESS study, a prospective, single-centre, randomised, open-label study comparing echo-guided 'intra-pocket' axillary puncture with the conventional cephalic vein dissection technique. the investigators demonstrated that this technique has a higher success rate than cephalic vein dissection, with a significant time saving (success rate: 99 vs. 87% (p=0.01), procedure time: 33.8 vs. 46.9 min,p= 0.005). Our project is therefore to carry out a multicentre randomised trial to confirm these promising initial results and to assess the efficacy and safety of 'intra-pocket' echo-guided axillary venipuncture compared with 'percutaneous' echo-guided axillary venipuncture and the reference technique of cephalic dissection during implantation of a DEIC.

Official title: 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.

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