3D Cardiovascular Navigation System: Accuracy and Reduction in Radiation Exposure in Left Ventricular Lead Implant

INTRODUCTION: Cardiac resynchronization therapy implants entail significant radiation exposure for patients and physicians. A novel 3D electromagnetic cardiovascular navigation system (MediGuide™) was designed to superimpose the real-time location of sensors embedded in delivery tools on prerecorded coronary sinus (CS) venograms while adjusting for patient movement and variations in heart rate under different C-arm angulations. We studied the accuracy and efficacy of MediGuide™ in reducing radiation exposure during LV lead implants. METHODS AND RESULTS: Fluoroscopy durations and radiation exposures were measured in 6 canines undergoing both conventional and MediGuide™-guided LV lead implants. The in vivo accuracy of MediGuide™ was evaluated by obtaining CS venograms at 3 different C-arm angulations at 3 different heart rates and measuring the separation between the projected sensor icon of a MediGuide™ sensor-enabled guidewire and the encompassing branch on prerecorded venograms. RESULTS: Mediguide™-guided implants resulted in significant reductions in fluoroscopy time (52 ± 120 [median 6] vs 129 ± 118 [median 90] sec, P < 0.001) and radiation exposure (13.8 ± 32.4 [median 1.7] vs 49.2 ± 45.3 [median 27.2] μGym(2) , P = 0.03) compared to conventional implants. LV lead delivery time was not significantly different between the 2 implant techniques (P = 0.27). The mean separation between the projected guidewire sensor icon and its encompassing branch was 0.48 ± 0.94 (median 0.00) mm. System accuracy was not affected by variations in heart rate or C-arm angulations. CONCLUSION: The novel 3D cardiovascular navigation system enabled accurate and reliable tracking of sensor-enabled tools at varying heart rates and C-arm angulations with minimal need for fluoroscopy guidance, significantly reducing fluoroscopy time and radiation exposure.