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Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases

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Abstract

Background

Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM.

Methods

Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval.

Results

Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported.

Conclusion

RFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

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Author information

Authors and Affiliations

  1. Vascular Institute of Virginia, LLC, 14085 Crown Ct., Woodbridge, VA, 22193, USA

    Sandeep Bagla

  2. University of Kansas Medical Center, Kansas City, KS, USA

    Dawood Sayed

  3. New York Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA

    John Smirniotopoulos

  4. Providence Sacred Heart Medical Center and Children’s Hospital, Spokane, WA, USA

    Jayson Brower

  5. Seton Medical Center, Austin, TX, USA

    J. Neal Rutledge

  6. Suburban Hospital, Bethesda, MD, USA

    Bradley Dick

  7. St. Mark’s Hospital, Salt Lake City, UT, USA

    James Carlisle

  8. University of Southern California, Los Angeles, CA, USA

    Ilya Lekht

  9. San Diego Imaging, San Diego, CA, USA

    Bassem Georgy

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  1. Sandeep Bagla
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Corresponding author

Correspondence to Sandeep Bagla.

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Conflicts of interest

Sandeep Bagla reports other from DFINE Inc. during the conduct of the study. Dawood Sayed reports personal fees from DFINE Inc. outside the submitted work. Jayson Brower reports other from DFINE Inc. outside the submitted work. J. Neal Rutledge reports non-financial support from DFINE Inc. during the conduct of the study; personal fees from DFINE Inc. outside the submitted work. James Carlisle reports grants from DFINE Inc. during the conduct of the study. Ilya Lekht reports grants from null during the conduct of the study. Bassem Georgy reports other from DFINE Inc. during the conduct of the study and other from DFINE Inc. outside the submitted work.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Bagla, S., Sayed, D., Smirniotopoulos, J. et al. Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases. Cardiovasc Intervent Radiol 39, 1289–1297 (2016). https://doi.org/10.1007/s00270-016-1400-8

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  • DOI: https://doi.org/10.1007/s00270-016-1400-8

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