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

The purpose of this prospective randomized study was to compare the safety and efficacy of the cephalic approach versus a contrast-guided extrathoraci c approach for placement of endocardial leads. Despite an increased inciden ce of lead fracture, the intrathoracic subclavian approach remains the domi nant approach for placement of pacemaker and implantable defibrillator lead s. Although this complication can be prevented by lead placement in the cep halic c ein or by lead placement in the extrathoracic subclavian or axillar y vein, these approaches have not gained acceptance. A total of 200 patient s were randomized to undergo placement of pacemaker or implantable defibril lator 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 compar ed to 64 of 100 patients using the cephalic approach. In addition to a high er initial success rate, the extrathoracic subclavian vein medial approach was determined to be preferable as evidenced by a shorter procedure time an d less blood loss. There was no difference in the incidence of complication s. In conclusion, these results demonstrate that lead placement in the extr athoracic subclavian vein guided by contrast venography is effective and sa fe. It was also associated with no increased risk of complications as compa red with the cephalic approach. These findings suggest that the contrast-gu ided approach to the extrathoracic portion of the subclavian vein should be considered as an alternative to the cephalic approach.