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Targeted Radiofrequency Ablation (t-RFA) of Malignant Spine Lesions Before Cement Augmentation Using Novel Bipolar Navigational Device 2013

Category Interventional Bassem Georgy
Purpose Report early clinical experience of t-RFA followed by cement augmentation in malignant lesions of the spine using a novel bipolar RF ablation system, purpose built for minimally invasive procedures in the axial skeleton. Materials & Methods 25 spinal lesions in 15 patients with different malignant etiologies were included after IRB approval. The STAR Tumor Ablation System includes a robust, articulating, navigational osteotome, containing an extensible electrode. The device is bipolar and contains two thermocouples (TC) positioned at 10 and 20 mm from center of the ablation zone to permit real-time monitoring of the ablation zone. RF warmed cement augmentation via the same guiding cannula was performed after lesion ablation. Results All procedures were performed safely with no complications or thermal injury.  Ablation time ranged from 1.5-6 minutes. Maximum recorded temperature was 65 °C at the distal TC and 50 °C at the proximal TC (10 and 20 mm from the center of the ablation zone, respectively). TCs on the electrode were used to confirm re-establishment of core temperature prior to cement augmentation. Post procedure CT showed no significant cement leakage.  Average VAS scores dropped from 7 pre-procedure to 4.7 post-procedure. Average ODQ scores improved from 25.8 to 18 post-procedure. Post procedure images when available showed Decreased tumor volume and decreased metabolic activity was confirmed by MRI and PET scan, respectively. Conclusion Targeted RF Ablation followed by RF warmed high viscosity cement augmentation was performed successfully in this series of malignant spinal lesions. Improvement in pain and functional status was noted in all patients. The STAR Tumor Ablation System permitted minimally invasive access to all lesions, regardless of location.  Proximal and distal TCs allowed accurate monitoring of the temperature inside the vertebral body to avoid complications of nearby vital structures. Targeted delivery of high viscosity cement following  ablation via the same guiding cannula provided vertebral stability. References N/A