Early patient experience with an electro-anatomic navigation system dedicated to device lead implantation: feasibility and safety.

Introduction: Fluoroscopy-guided pacing lead placement has well-recognized limitations and risks. We studied the safety and feasibility of using a novel electromagnetic navigation system specifically designed to guide pacemaker and implantable cardioverter defibrillator lead placement. Methods: Twenty-four patients (mean age of 54 ± 34 years) underwent the study protocol; 16 before electrophysiology study and eight before device implantation. The navigational deflectable sheath assembly was introduced via the subclavian vein and advanced to seven prespecified targets within the right heart chambers. The time taken to reach each target site was measured. Results: All seven prespecified targets were successfully reached by 21 of 24 patients (88%). The total time required to complete the study protocol ranged from 3.21 to 15.25 minutes (average 8.9 minutes), with an associated mean fluoroscopy time of 50 ± 36 seconds. In three of the 24 patients, this navigation system was successfully used to guide right ventricular pacing lead placement. The average total procedure time for these devices was 97.8 minutes (excluding the study protocol), with an average associated fluoroscopy time of 6.93 minutes. These procedures were well tolerated and no periprocedural complications were noted. Conclusions: This study suggests that this novel electro-anatomic navigation system is a viable and safe alternative to traditional fluoroscopy-guided lead implantation. Further studies are required to determine the absolute reduction in radiation exposure and increased efficiency relative to current standard fluoroscopic techniques. PACE 2012; 35:385–391)