Zero x-ray cardiac resynchronization therapy device implantation guided by a nonfluoroscopic mapping system: A pilot study

BACKGROUND: Fluoroscopic guidance is the standard tool used in device implantation. This means that both the patient and the operator are exposed to radiation, which may sometimes be high. The possibility of single-lead permanent pacemaker implantation without fluoroscopy has already been demonstrated. OBJECTIVE: The aim of our study was to investigate the feasibility and reliability of biventricular device implantation guided only by an electroanatomic navigation system. METHODS: Sixty-one patients with heart failure underwent implantation of a cardiac resynchronization therapy (CRT) device with or without defibrillator (CRT-D; CRT-P). The procedure was performed with or without fluoroscopy guidance (Rx+; Rx0). In the latter case, the EnSite Velocity system was used; this system is able to reconstruct the anatomy and activation of the cardiac chambers by simultaneously collecting a "cloud" of anatomical points from multiple electrodes. RESULTS: Lead positioning was achieved in 24 of 26 patients undergoing CRT implantation without fluoroscopy (92% success). No complications were observed during the procedure and no catheter dislodgment occurred the day after the implantation or during 1-month follow-up. Procedure time progressively decreased from 136 minutes in the first case to 59 minutes in the last one, suggesting that operators gradually gained confidence while using the new technique. CONCLUSION: Our study demonstrates the feasibility, efficacy, and safety of lead positioning guided only by the nonfluoroscopic EnSite Velocity mapping system without the use of fluoroscopy in CRT-P or CRT-D implantation. The benefits in terms of significantly reduced fluoroscopy exposure are associated with technical and clinical advantages.