Prospective Randomized Comparison of the Safety and Effectiveness of Placement of Endocardial Pacemaker and Defibrillator Leads Using the Extrathoracic Subclavian Vein Guided by Contrast Venography Versus the Cephalic Approach

Abstract

The purpose of this prospective randomized study was to compare the safety and efficacy of the cephalic approach versus a contrast-guided extrathoracic approach for placement of endocardial leads. Despite an increased incidence of lead fracture, the intrathoracic subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator leads. Although this complication can be prevented by lead placement in the cephalic vein or by lead placement in the extrathoracic subclavian or axillary vein, these approaches have not gained acceptance. A total of 200 patients were randomized to undergo placement of pacemaker or implantable defibrillator leads via the contrast-guided extrathoracic subclavian vein approach or the cephalic approach. Lead placement was accomplished in 99 of the 100 patients randomized to the extrathoracic subclavian vein approach as compared to 64 of 100 patients using the cephalic approach. In addition to a higher initial success rate, the extrathoracic subclavian vein medial approach was determined to be preferable as evidenced by a shorter procedure time and less blood loss. There was no difference in the incidence of complications. In conclusion, these results demonstrate that lead placement in the extrathoracic subclavian vein guided by contrast venography is effective and safe. It was also associated with no increased risk of complications as compared with the cephalic approach. These findings suggest that the contrast-guided approach to the extrathoracic portion of the subclavian vein should be considered as an alternative to the cephalic approach.

Incidence of venous obstruction following insertion of an implantable cardioverter defibrillator. A study of systematic contrast venography on patients presenting for their first elective ICD generator replacement

“…It is remarkable that early symptomatic venous obstruction is clinically rarely Venous obstruction after ICD recognized. A recent prospective study, which followed 200 patients for a mean of 540 days after device implantation reported only two patients with clinically recognized acute subclavian vein thrombosis [18].…”

Axillary vein puncture using fluoroscopic landmarks: a safe and effective approach for implantable cardioverter defibrillator leads

“…Furthermore, axillary vein has been demonstrated to be an effective method with less acute complications and less lead failures in the longer term compared with subclavian access, especially for PM implantation [10][11][12][13][14][15][16][17][18][19]. However, data on axillary vein approach for ICD implantation are limited.…”

Comparison of the Axillary Venous Approach and Subclavian Venous Approach for Efficacy of Permanent Pacemaker Implantation

“…5 This method is relatively safe, effective and has the additional benefit of documenting the patency of the venous system. However, problems occur in relation to contrast and the possibility of pneumothorax because of unknown vessel depth.…”