Interventional procedure overview of radiofrequency ablation for palliation of painful spinal metastases
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.
Article | Number of patients/follow-up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
|---|---|---|---|
Angileri, SA, Granata G, Savoldi, AP et al. (2020) Cooled radiofrequency ablation technology for painful bone tumors Acta bio-medica : Atenei Parmensis; 91 (10s); e2020007 | Case report | OsteoCool RF Ablation System on a patient with a painful bone metastasis localized in the 5th lumbar vertebra showed encouraging results. The radiofrequency ablation of bone metastases with palliative aim represents an excellent treatment option, as it is a minimally invasive and safe procedure, and can be repeated multiple times. | Case report |
Dupuy De, Hong R, Oliver B et al (2000). Radiofrequency ablation of spinal tumors: temperature distribution in the spinal canal. Technical Innovation. AJR:175, 1263-66. | Review | This innovative new approach provides not only pain palliation but also local tumour control, thus avoiding additional therapy such as radiation or surgery. | Review |
Filippiadis D, Kelekis A (2021) Percutaneous bipolar radiofrequency ablation for spine metastatic lesions. European Journal of Orthopaedic Surgery and Traumatology | Review on imaging guided percutaneous bipolar radiofrequency ablation. | Percutaneous radiofrequency ablation of vertebral lesions is a reproducible, successful and safe procedure. Ablation should be combined with vertebral augmentation in all cases. In order to optimize maximum efficacy a patient and a lesion-tailored approach should both be offered focusing upon clinical and performance status along with life expectancy of the patient as well as upon lesion characteristics. | Review |
Gazis A, Beuing O, Jollenbeck B et al (2012). Bipolar radiofrequency ablation of spinal neoplasms in late stage cancer disease. A report of three cases. SPINE 37, 1, pp E64–E68. | Case series N=3 patients with metastases of the spine had bipolar radiofrequency ablation. | Ablation of tumours adjacent to neural structures is feasible. Spinal cord damage can be avoided by planning. | Larger studies with longer follow-up included in evidence summary. |
Goetz MP, Callstrom MR, Charboneau JW, et al. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6. | Case series N= 43 patients with painful osteolytic metastases (pelvis, rib, sacrum, other) involving bone were treated with image guided RFA using a multi-tip needle. Median follow-up 16 weeks. | Pain and opioid usage significantly decreased. Transient incontinence in 1, second degree skin burn in 1 and a fracture in 1 were reported. | Tumours located in various sites and not just spinal metastasis. Paper does not explicitly state if cement was used or not. |
Gronemeyer DH, Schirp S, Gevargez A. (2002). Image-guided radiofrequency ablation of spinal tumors: preliminary experience with an expandable array electrode. Cancer J 8:33–9. | Case series N=10 (21 vertebral lesions) spine metastases were treated with radiofrequency ablation. Vertebroplasty done in only 4 cases. Follow-up average 5.8 months. | 90% of patients reported pain relief, disability reduced by 27%, neurological function preserved in 9, general health stabilised in 6 and improved in 3. | Results not reported separately for RFA alone. |
Gevargez A, Groenemeyer DH. Image-guided radiofrequency ablation (RFA) of spinal tumors. Eur J Radiol. 2008 Feb;65(2):246-52. | Case series 10 patients with unresectable spine metastases were treated with RFA. Vertebroplasty was performed in 4 patients. Follow-up 5.8 months. | RFA was successfully performed in all. Needles were placed accurately under image guidance, and a controlled lesion was created. Pain and back pain-related disability was clearly reduced, and neurologic function was preserved or stabilized. | Results not presented separately for RFA and RFA plus vertebroplasty. |
Hillen TJ, Anchala P, Friedman MV et al. (2014) Treatment of metastatic posterior vertebral body osseous tumors by using a targeted bipolar radiofrequency ablation device: technical note. Radiology;273(1):261-7. | Retrospective study N= 26 patients (47 tumors) with painful metastatic posterior vertebral body tumors, some radiation therapy resistant had RFA Follow-up 1 month. | Targeted RFA with a newly developed articulating device is both feasible and safe for the treatment of painful posterior vertebral body metastatic tumors | Not clear if cement augmentation was used. |
Kai G, Chuan L and Fang L (2015). Minimally invasive treatments of spinal metastases: Vertebroplasty, radiofrequency ablation and radiation therapy. Chinese Journal of Tissue Engineering Research. DOI: 10.3969/j.issn.2095-4344.2015.16.029 | Review of 3 kinds of minimally invasive treatments for spinal metastases. | Vertebral cement augmentation efficiency is 80-90%. Radiofrequency ablation and radiation can kill the tumour but cannot rebuild the vertebral stability. Therefore, the combination of different technologies can improve the therapeutic effect on spinal tumours. Above all, there is not a perfect minimally invasive treatment for spinal metastases | Review |
Kam NM, Maingard JM, Kok HK et al (2017). Combined vertebral augmentation and radiofrequency ablation in the management of spinal metastases: an update. Curr. Treat. Options in Oncol. 18: 74. | Radiofrequency ablation have shown success in reducing pain and improving function in patients with symptomatic spinal metastases. Both vertebral augmentation and RFA are recognised as excellent alternative in patients with spinal metastases. | Opinion statement. | |
Kotecha R, Schiro BJ, Sporrer J et al. (2020) Radiation therapy alone compared with radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial. Trials; 21 (1); 964 NCT04375891 | RCT protocol Patients with spine metastasis from T5-L5, randomized in a 2:1 ratio to either radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA) and EBRT or EBRT alone. | Primary objective is whether RFA/PVA in addition to EBRT improves pain control compared to palliative EBRT alone, defined as complete or partial pain relief (measured using the Numerical Rating Pain Scale [NRPS]) at 3 months. Secondary objectives are whether combined modality treatment improves the rapidity of pain response, duration of pain response, patient reported pain impact, health utility, and overall QOL. | Combined treatment (radiotherapy plus RFA/PVA compared with radiotherapy) Protocol only |
Madaelil TP, Wallace AN, Jennings JW (2016). Radiofrequency ablation alone or in combination with cementoplasty for local control and pain palliation of sacral metastases: preliminary results in 11 patients. Skeletal Radiol; 45:1213-1219. | Retrospective study N=11 RFA procedures done to treat 16 sacral metastases. RFA alone was done in 3 and cementoplasty was done in 63% (7/11) cases. Follow-up 4.7 months. | The median pain score decreased from 8 at baseline to 3 at 1 month following RFA (p= 0.004). No acute or long-term complications were noted. | Larger studies with longer follow-up included in summary of evidence. |
Mehta TI, Heiberger C, Kazi S, et al (2020). Effectiveness of Radiofrequency Ablation in the Treatment of Painful Osseous Metastases: A Correlation Meta-Analysis with Machine Learning Cluster Identification. J Vasc Interv Radiol; 31:1753-62. | Systematic review and meta-analysis N=14 studies (426 patients with recalcitrant pain). | Median pain reduction after RF ablation was 67% over median follow-up of 24 weeks (R2 ¼ .66, 95% confidence interval -0.76 to -0.55, I2 = 71.24%, fail-safe N = 875) with 44% pain reduction within 1 week. A low-heterogeneity subgroup was identified with median pain reduction after RF ablation of 70% over 12 weeks (R2 = -.75, 95% confidence interval -0.80 to -0.70, I2 = 2.66%, fail-safe N = 910). Addition of cementoplasty after RF ablation did not significantly affect pain scores. Primary tumour type and tumour size did not significantly affect pain scores. A particular, positive association between pain after RF ablation and axial tumors was identified, implying possible increased palliative effects for RF ablation on axial over appendicular lesions. | RFA for osseous metastases (not just spinal metastasis… only 4 studies related to spinal metastasis were included). |
Sagoo NS, Haider AS, Chen AL, Vannabouathong C, Larsen K, Sharma R, Palmisciano P, Bin Alamer O, Igbinigie M, Wells DB, Aoun SG, Passias PG, and Vira S. Radiofrequency ablation for spinal osteoid osteoma: A systematic review of safety and treatment outcomes. Surgical Oncology. 2022;42:101747 | Systematic review on radiofrequency ablation (RFA) for painful spinal osteoid osteoma (OO). 14 studies (354 patients) | The estimated pain reduction on the numerical rating scale was 6.85/10 (95% confidence intervals [95%CI] 4.67–9.04) at a 12–24-month follow-up; and 7.29/ 10 (95% CI 6.67–7.91) at a >24-month follow-up (range 24–55 months). Protective measures (e.g., epidural air insufflation or neuroprotective sterile water infusion) were used in 43/354 (12.1%) patients. Local tumour progression was seen in 23/354 (6.5%) patients who were then successfully re-treated with RFA or open surgical resection. Grade I-II complications such as temporary limb paraesthesia and wound dehiscence were reported in 4/354 (1.1%) patients. No Grade III-V complications were reported. | Not spinal metastasis. |
Saravana-Bawan S, David E, Sahgal A et al. (2019) Palliation of bone metastases—exploring options beyond radiotherapy. Ann Palliat Med;8(2):168-177. | Review | This educational review discusses safety, technique and indications for emerging technology in the area of locoregional treatment of bone metastases in conjunction with vertebral augmentation including RFA. | Review |
Yuntong M, Wallace AN, Madaelil TP et al (2016). Treatment of osseous metastases using the Spinal Tumor Ablation with Radiofrequency (STAR) system. e: Expert review of medical devices. 13 (12), 1137–1145. | Review of epidemiology, pathophysiology, natural history, and traditional management of metastatic bone disease and Spinal Tumor Ablation with Radiofrequency (STAR) System for treatment of osseous metastases. | Although evidence supporting the efficacy of RFA for the treatment of bone metastases is limited to case series, it is a reasonable therapy when other options have been exhausted, especially given the safety and minimal morbidity of the procedure. The STAR Tumor Ablation System has expanded the anatomic scope of bone metastases that can be safely and effectively treated with percutaneous ablation. | Review |
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