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

Area of Science:

• Cardiology
• Medical Devices
• Electrophysiology

Background:

• Fluoroscopic guidance is standard for device implantation, leading to patient and operator radiation exposure.
• Previous studies demonstrated feasibility of single-lead pacemaker implantation without fluoroscopy.

Purpose of the Study:

• To assess the feasibility and reliability of biventricular device implantation using solely an electroanatomic navigation system.
• To evaluate the safety and efficacy of non-fluoroscopic guidance for cardiac resynchronization therapy (CRT) device implantation.

Main Methods:

• Sixty-one patients with heart failure received CRT devices (CRT-P or CRT-D).
• Procedures were performed with or without fluoroscopy (Rx+ or Rx0).
• The EnSite Velocity system reconstructed cardiac anatomy and activation using multiple electrode points for guidance in the Rx0 group.

Main Results:

• Successful lead positioning was achieved in 92% (24/26) of patients in the non-fluoroscopy group.
• No procedural complications or post-implantation lead dislodgement occurred within 1 month.
• Procedure times decreased significantly as operators gained experience with the non-fluoroscopic technique.

Conclusions:

• Non-fluoroscopic guidance with the EnSite Velocity system is feasible, effective, and safe for CRT-P/CRT-D implantation.
• This approach significantly reduces fluoroscopy exposure, offering technical and clinical advantages.