March 2021 | Educational Supplement
interventionalnews.com
This educational supplement has been sponsored by Medtronic
Product details
Spotlight on the OsteoCool RF ablation system The OsteoCool radiofrequency (RF) ablation system is indicated for the palliative treatment of spinal metastases, using cooled radiofrequency ablation technology. It allows physicians to treat patients confidently and consistently with reproducible precision.
It is predictable
You can create large-volume lesions without excessive heating at the active tip. The system: n Minimises the potential for char with internally-cooled ablation probes n Includes a thermocouple that monitors tissue temperature around the distal tip of the probe At a target temperature of 70°C at the distal tip, the probes ablate for the pre-set time and yield predictable ablation zones.
Know where the heat is going
Coaxial, bipolar technology delivers radiofrequency energy to the site consistently. Key features include:
Ablation zone sizes and times
n A lgorithms designed to perform optimally in bone n Bone access kit that defines anterior and posterior ablation boundaries n Confidence in ablation zone mapping
Customise your ablation options
The OsteoCool system offers flexibility, with a wide range of ablation scenarios for your patient and procedural needs. OsteoCool RF ablation probes can be used simultaneously: n Simultaneous ablation of adjacent or multiple levels in the spine n Simultaneous ablation using two probes, such as bipedicular spine tumour ablation n A blation using one probe: 7mm, 10mm, 15mm, and 20mm active tip sizes
n M ultiple introducer gauge options n T rack ablation
Indications and risks
The OsteoCool RF ablation system is intended for ablation of benign bone tumours such as osteoid osteomas, and for the palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. It is also intended for coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy. Risks of the system include damage to surrounding tissue through iatrogenic injury as a consequence of electrosurgery, pulmonary embolism, and nerve injury— including thermal injury and puncture of the spinal cord or nerve roots, potentially resulting in radiculopathy, paresis, and paralysis. The OsteoCool bone access kits are indicated for percutaneous access to bone. All tradenames are property of Medtronic, LLC.
Ablation with one and two probes
All rights reserved. Published by BIBA Publishing, London T:+44 (0)20 7736 8788, publishing@bibamedical.com. The opinions expressed in this supplement are solely those of Medtronic and the featured physicians and may not reflect the views of Interventional News.
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Early experience
OsteoCool RF ablation system
Watching a “small Canadian invention” transform cancer care: Insights from an OsteoCool pioneer
Detailing her early experience with the OsteoCool system, Elizabeth David, MD, FRCPC, delights in retelling the history of the radiofrequency ablation (RFA) device, which was initially designed in Canada and trialled in her institution. Referring to the OPuS One clinical trial, she tells Interventional News: “It was wonderful to see our early experience replicated in this multicentre, multinational trial.” BONE METASTASES AND THEIR sequela, including pain and deformity, are a common problem afflicting many patients living with cancer. Pain from bone metastases is the most common type of pain that patients with cancer endure. The prevalence of bone metastases in lung, gastrointestinal (GI), uterine, bladder, and renal primaries is 15– 30%; it is close to 70% in patients afflicted with breast and prostate primaries. The prevalence is rising due to an overall increase in primary malignancies and improved patient survival from new systemic therapies. Rapid pain relief, maintenance of mobility, and preservation of skeletal structural alignment is essential in maintaining a patient’s quality of life and functional status. Modern-day treatments often require a collaborative, multidisciplinary approach. The first steps are typically designed to optimise pain control through the use of opioids and other adjuvant classes of medications. This approach can be effective, but can cause decline in functional status if more targeted actions are not employed. Such treatments typically begin with radiation and possibly surgical management in selected cases. With new systemic therapies, patients may outlive these approaches and progress in previously radiated areas. In addition, histologies that can be radioresistant, such as GI, renal cell carcinoma (RCC), melanoma, sarcoma, and thyroid primaries can recur post-radiation as survival increases. Locoregional options in the bone have historically relied on radiation. Conventional unipolar thermal ablative devices employed in other targets, such as the liver and the kidneys, often have difficulty with the high impedance encountered in bone. The OsteoCool device addresses these difficulties with a simple bipolar design that allows the current to travel a short distance along the tip of the needle instead of through the entire patient. The device design also addresses the challenges of high impedance, which typically requires very high power to overcome, and allows for a consistent energy deposition with predictable ablation zones. Ablations can be performed with either March 2021
a single needle or two needles body radiation therapy (SBRT) simultaneously (for larger and RF ablation-assisted targets). OsteoCool probes are vertebroplasty/cementoplasty designed with different length sequentially, especially in active tips, which allow for biologies that are can be radioflexibility in the size of the resistant. The optimal algorithm desired ablation, and come for different primaries at in 7mm, 10mm, 15mm, and different locations will require 20 mm sizes. Thermocouples further studies, but this approach are also provided to ensure Elizabeth David, MD, is promising. The scale of the the temperature of nearby FRCPC OsteoCool trial allowed us sensitive structures can be to definitively evaluate the monitored if required. The tip is internally effectiveness of this technique with respect cooled to minimise charring, and allows for to pain relief, both in the short-term and in heat dispersion throughout the target. It is the long-term. It was also gratifying to realise small enough to easily be placed through a that this was safe and effective even in a 13-gauge bone cannula so that ablation can typically frail patient population. be performed immediately prior to cement This device was initially designed by a augmentation. Ablation times are short at 15 group of Canadian engineers from Baylis Medical who worked with physicians at my institution to perfect the equipment. We were early adopters of this technology and have been very pleased with our patient outcomes thus far. We quickly realised that pain relief was rapid and durable. It was wonderful to see our early experience replicated in this multicentre, multinational trial. In our single institution experience, we also found that the rate of posterior cement leaks had decreased and that the volume of cement we could inject into each target had increased when we used RF ablation prior to cement augmentation. We hope to continue to test minutes. The ability to treat a tumour and then this device in larger trials and definitely immediately stabilise the area with cement demonstrate the potential of this technology. is quite advantageous, especially in weightWe were thrilled when Medtronic bearing regions such as the spine and pelvis. became involved, as we knew distribution The treatment is effective, flexible, and fast. would be scaled up and that many more Although radiation is quite effective in patients worldwide would have access to addressing pain from bone metastases, it does this technology. It is great to see this small take several weeks to work (typically two to Canadian invention grow up and become four weeks), can occasionally create a pain a transformative medical device that will flare, and may result in instability, especially hopefully help many patients living with in weight-bearing structures. RF ablationcancer. assisted cement augmentation, in contrast, treats and stabilises in one setting, and pain Elizabeth David, MD, FRCPC, is an relief is almost immediate and durable as interventional radiologist at Sunnybrook demonstrated in the OPuS One clinical Health Sciences Centre, University of study. In fact, at our institution we often treat Toronto, Toronto, Canada, and is a primary high-risk lytic targets with both stereotactic investigator in the OPuS One clinical study.
Pain relief was rapid and durable. It was wonderful to see our experience replicated in this multicentre, multinational trial.”
OPuS One clinical trial
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OPuS One
“Compelling” OPuS One trial results confirm the role of percutaneous ablation in musculoskeletal metastases
Rapid reduction in pain score with the OsteoCool RF ablation system
The primary endpoint was reduction in worst pain score at the three months follow-up compared to baseline, which was achieved in this full cohort dataset. Speaking on behalf of all investigators involved in this study, RF ablation for musculoskeletal metastases is significantly underutilsied, and we are really excited by this result. Pain was assessed Jason Levy, MD, FSIR, discusses the positive findings from the OPuS One using the Brief Pain Inventory (BPI); worst clinical trial, and reflects on what this means for interventional radiologists treating pain score is one question among several in patients with metastatic bone disease. After announcing to the medical community the BPI questionnaire, and is scored from in an "Abstract of the Year" presentation at the Society of Interventional Radiology zero to 10, with 10 representing “pain as bad Annual Scientific Meeting (SIR; 20–26 March, online) that patients have sustained, as you can imagine”. Lower scores indicate long-term pain relief following treatment with the OsteoCool radiofrequency (RF) less pain. ablation system (Medtronic), he enthuses: “We need to continue to educate the More importantly than this headline oncology community regarding the benefits of percutaneous ablation.” result, though, we also found that pain, pain interference, and quality of life all statistically improved at every THE FULL COHORT DATA FROM In addition to pain, data time point collected. the OPuS One clinical trial was recently osseous metastases can The rapid improvement presented at the SIR 2021 Annual Scientific cause fractures and is one of the most impactful Meeting, where it was awarded Abstract some pretty debilitating results of the study. In of the Year. The trial evaluated the use of symptoms, such as spinal comparison, radiation can result the OsteoCool RF ablation system as a cord or neurovascular in up to four to six weeks of palliative treatment for patients with painful compression. Radiation pain before relief.2 Moving pain metastatic bone disease. The findings from treatments have been relief up from four to six weeks this full dataset align with those from earlier commonly used for osseous post treatment to three days intermediary analyses; results of the first metastases, but they do after ablation serves to maintain 100 patients treated with the OsteoCool RF not always provide pain performance status, the ability ablation system, published in November 2020 relief, they can take weeks Jason Levy, MD, FSIR to stay on systemic protocol, in the Journal of Vascular and Interventional to occur, and they can set a and the avoidance of the vicious cycle Radiology (JVIR),1 also demonstrated a rapid patient up for fractures down the road. When of pain.3 In addition, we and statistically significant improvement in the effects of their treatment are delayed for did not see any sacrifice of pain scores. We can now say with confidence weeks, in this population of palliative care long-term pain control as the that the OsteoCool system provides patients, that may consist of a significant results were sustained at the sustained, long-term relief. proportion of that patient's life. Ascertaining final time point collected at the ability of RF ablation with the OsteoCool twelve months. system to provide quick and long-lasting pain relief for these patients was therefore A safe procedure important. Very few adverse effects The OsteoCool RF ablation system has occurred amongst our final 510k regulatory clearance from the US cohort. When we are dealing Food and Drug Administration (FDA) in the with osseous metastases, USA, a Conformité Européene (CE) mark what we have to really in Europe, and a Health Canada Licence in concern ourselves with, Canada. The goal of our study was to collect more than just the pain, real-world outcomes among a cohort of is the fractures and the patients from these geographies treated with neurologic events. You really the OsteoCool RF ablation system for either: do not see in the radiation metastatic malignant lesions in a vertebral oncology literature an body, painful metastatic lesions involving absence of delayed skeletalThe OPuS One trial was a multicentre, bone, and/or benign bone tumours such as related events, meaning that international (US, Europe, Canada), osteoid osteoma. anywhere from 5 to 39% prospective study designed to assess the The study focus was malignant metastases, will go on to fracture.4–7 Not ability of RF ablation to improve pain and and only one benign tumour out of the 206 a single patient treated in quality of life in patients with metastatic patients was included. Additionally, the study the OPuS One clinical study musculoskeletal disease. The inclusion collected patient outcomes—such as pain went on to experience a criteria of the OPuS One clinical trial allowed relief, quality of life, and function—which fracture or neurologic event. for metastases with a lytic component in the were evaluated using validated assessment This safety profile thoracic or lumbar spine and pelvis. measures. can likely be linked
Given these impactful findings, there should be consideration for the implementation of RF ablation earlier in the treatment paradigm.”
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Sustained pain relief
OsteoCool RF Ablation system
to polymethyl methacrylate (PMMA) RF ablation should be cement, which was used in the majority considered earlier in the of procedures. It should be noted that no treatment paradigm symptomatic cement leakages The results of the OPuS One occurred. This mimics the study are compelling. Given results Dr David discusses in these impactful findings, her institutional experience there should be consideration [see page 3]. PMMA provides for the implementation of mechanical stabilisation RF ablation earlier in the in axial weight-bearing treatment paradigm. If RF bones and reduces or even ablation were to be used eliminates fracture risk. earlier in a patient's treatment In addition to mechanical plan, it could potentially stabilisation, PMMA provides offer even more of a additional palliative effects.8 treatment effect, in addition Single fraction external beam to providing pain relief. If Two probe ablation for an radiation, multi fraction we can get to these patients osseous metastatic tumour external beam radiation, and earlier, when they have lytic usung the OsteoCool RF stereotactic body radiation bone-breaking disease, we ablation system therapy (SBRT) all carry a may avoid the complications risk of future fractures.9–11 of fractures and other skeletal-related events that have been shown Ablation and radiation: "Not to have a morbidity effect,20 in addition to a mutually exclusive" pain effect. Multiple series have shown that We initiated the trial due to the skeletal-related events are associated with underutilisation of percutaneous ablation higher mortality, so this is important for us to (PA), despite prior research demonstrating its try to move the needle to try to get this done effectiveness and disregarding its inclusion earlier in the treatment paradigm. as an option in the National Comprehensive RF ablation and PA should be considered in Cancer Network (NCCN) guidelines.12–18 more patients than current practice patterns in The OPuS One trial represents the largest most institutions. While not every patient is prospective study on any ablation treatment a candidate for ablation, many are candidates for musculoskeletal metastases and adds to but do not have the valuable therapy offered. our increasing knowledge that percutaneous Optimal candidates have lytic metastases ablation is a safe and effective palliative such as lung, breast, renal, hepatocellular, therapy for musculoskeletal metastases. The or colon cancer. Anyone that has a vertebral current standard of care is radiation; far fewer body fracture without cord compromise patients are treated with PA. should be considered for ablation with As shown in our results, RF ablation PMMA cement. Vertebral augmentation with does enjoy some benefits over radiation, kyphoplasty or vertebroplasty is already in including time-to-relief. RF ablation also the NCCN guidelines as part of the algorithm does not require discontinuation or even for spine metastases, and RF ablation is alteration in the systemic protocol. Systemic mentioned as an option for bone pain. Even chemotherapy was not required to be held patients with more widespread disease may for the RF ablation procedure in OPuS One. benefit if the pain is focal or there is risk of While RF ablation has real-world advantages, an impending fracture. In OPuS One, we bone-related cancer pain treatments should treated up to two painful sites, but in many not be considered in a vacuum. RF ablation real-world practices, up to four sites are therapy can be, and often is, combined treated. We need to continue to educate the with other treatments, including radiation. It is very common to combine RF ablation with radiation; the use of the OsteoCool RF ablation system does not affect the ability to radiate a bone post-treatment. The two are not mutually exclusive. In fact, Mario Di Stasio (S Salvatore Hospital, University of L’Aquila, L’Aquila, Italy) et al assessed the combination of RF ablation followed by radiation therapy versus radiation alone where the combined group had far superior results in overall pain relief, complete pain relief, and need for retreatment.19
Bone-related cancer pain treatments should not be considered in a vacuum. RF ablation therapy can be [...] combined with other treatments.”
March 2021
oncology community regarding the benefits of PA. Finally, future research taking the work of Di Stasio and colleagues15 to a larger comprehensive randomised controlled study comparing consolidation of RF ablation with radiation versus radiation alone in the palliative setting would be another direction to improve our patients’ outcomes. Jason Levy, MD, FSIR, is an interventional radiologist at Northside, Forsyth, and Cherokee Hospitals, Atlanta, USA.
References 1. Levy, J, et al, Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol, 2020. 31(11): p. 1745–1752. 2. Johnstone, C and S T Lutz, External beam radiotherapy and bone metastases. Ann Palliat Med, 2014. 3(2): p. 114–22. 3. von Moos, R., et al, Improving quality of life in patients with advanced cancer: Targeting metastatic bone pain. Eur J Cancer, 2017. 71: p. 80–94. 4. Mehta, N, Zavitsanos, P J, et al, Local failure and vertebral body fracture risk using multifraction stereotactic body radiation therapy for spine metastases. Adv Radia Oncol, 2018. 3, 245–251. 5. Sahgal, A, Whyne, C M, et al, Vertebral compression fracture after stereotactic body radiotherapy for spinal metastases, Lancet Oncol, 2013. 14, e310–320. 6. Rose, P S, Laufer, I, et al, Risk of fracture after single fraction image-guided intensity-modulated radiation therapy to spinal metastases, J Clin Oncol, 2009. 27, 5,075–5,079. 7. Cunha, M V, Al-Omair, A, et al, Vertebral compression fracture (VCF) after spine stereotactic body radiation therapy (SBRT): Analysi of predictive factors, Int J Radiat Oncol Biol Phys, 2012. 84, e343–349. 8. Berenson, J, et al, Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol, 2011. 12(3): p. 225–35. 9. Cunha, M V, et al, Vertebral compression fracture (VCF) after spine stereotactic body radiation therapy (SBRT): Analysis of predictive factors. Int J Radiat Oncol Biol Phys, 2012. 84(3): p. e343–9. 10. Rose, P S, et al, Risk of fracture after single fraction imageguided intensity-modulated radiation therapy to spinal metastases. J Clin Oncol, 2009. 27(30): p. 5075–9. 11. Sahgal, A, et al, Vertebral compression fracture after stereotactic body radiotherapy for spinal metastases. Lancet Oncol, 2013. 14(8): p. e310–20. 12. NCCN Clinical Practice Guidelines in Oncology—Bone Cancer. National Comprehensive Cancer Network Guidelines®, 2020. Version 1.2021. 13. Anchala, P R , et al, Treatment of metastatic spinal lesions with a navigational bipolar radiofrequency ablation device: A multicenter retrospective study. Pain Physician, 2014. 17(4): p. 317–27. 14. Dupuy, D E, et al, Percutaneous radiofrequency ablation of painful osseous metastases: A multicenter American College of Radiology Imaging Network trial. Cancer, 2010. 116(4): p. 989–97. 15. Goetz, M P, et al, Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol, 2004. 22(2): p. 300–6. 16. Guenette, J P, et al, Solitary painful osseous metastases: correlation of imaging features with pain palliation after radiofrequency ablation—A multicenter american college of radiology imaging network study. Radiology, 2013. 268(3): p. 907–15. 17. Hoffmann, R T, et al, Radiofrequency ablation in combination with osteoplasty in the treatment of painful metastatic bone disease. J Vasc Interv Radiol, 2008. 19(3): p. 419–25. 18. Zheng, L., et al, A preliminary study of the safety and efficacy of radiofrequency ablation with percutaneous kyphoplasty for thoracolumbar vertebral metastatic tumor treatment. Med Sci Monit, 2014. 20: p. 556–63. 19. Di Staso, M, et al, A feasibility study of percutaneous Radiofrequency Ablation followed by Radiotherapy in the management of painful osteolytic bone metastases. Eur Radiol, 2011. 21(9): p. 2004–10. 20. Saad, F, et al, Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer, 2007. 110, 1,860–1,867.
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Case report
Case report: Treating expansile L1 breast cancer metastases with the OsteoCool RF ablation system
Jason Levy, MD, FSIR, presents a radiofrequency ablation (RFA) case he performed with colleagues at his institution, Northside Hospital, in Atlanta, Georgia.
The disease
Metastatic bone disease occurs in 60% to 80% of cancer patients. For patients who have been diagnosed with spinal metastases, 79% report pain. This type of pain is usually progressive and significantly reduces quality of life.
Patient history
In this case report, the patient was a 56-yearold woman with a primary breast cancer that had progressed to multilevel spine metastases, with her L1 vertebrae most severely affected. Her pain started three months prior to the initial radiology consultation, and became intractable, limiting ambulation—she reported a pain score of nine out of 10, despite a fentanyl patch and administration of oral opioids. There were no changes in bladder or bowel habits, no radiculopathy, and no leg weakness.
Diagnostic imaging of the spine: Radiographic findings
Expansile L1 mixed lytic and blastic metastases Retropulsion and moderate narrowing of canal Microfractures and extension into both pedicles Disease diffused throughout spine, with L1 most severely affected Fndings corresponded to patient's pain level on physical exam.
RF ablation procedure
The procedure was performed with the OsteoCool radiofrequency (RF) ablation system for the palliative treatment of metastatic malignant lesions in a vertebral body. Coaxial, bipolar technology delivers RF energy to the site. The internally cooled ablation probes control temperature and help
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Diagnostic imaging of the spine
keep RF heating within the desired treatment area. This reduces potential thermal damage to adjacent tissue. Two probes can be used simultaneously for added efficiency, and to achieve larger ablation zones.
Important safety information for the OsteoCool RF ablation system
The OsteoCool RF ablation system is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. The system is contraindicated in patients with heart pacemakers or other electronic device implants, and contraindicated in vertebral body levels C1–C7. The OsteoCool bone
[The] patient reported pain improvement from nine out of 10 to seven out of 10 four hours postprocedure.”
access kits are indicated for percutaneous access to bone.
Sedation and access
Administered 2g cefazolin intravenously immediately pre-procedure Performed conscious, monitored sedation under radiologist supervision With fluoroscopic guidance, obtained bilateral transpedicular access to the L1 vertebral body, using an 8G access needle Sized the ablation zone using bone access introducer and drill.
Ablation
Initiated bilateral RF ablation using two OsteoCool 20mm active tip probes Right probe heated rapidly and shut off— imaging revealed probe tips in very close proximity Exchanged right-sided 20mm for 10mm active tip probe Ablated left-sided 20mm probe for 10mm active tip probe Ablated left side for 15 minutes, right side for 7.5 minutes Due to pedicle involvement, track ablation was performed on right, then left pedicle Track ablation lasted approximately 20 seconds—bilateral access to pedicle was maintained. March 2021
OsteoCool RF Ablation system
Initial probe placement: Initial distance between probes was closer than the sugested 8 to 10mm.
Subsequent probe placement: Simultaneous ablation allows two probes to be positioned closely enough to produce large ablation zones.
Images following vertebral augmentation. Left: Axial-planar view. Right: Lateral view.
Vertebral augmentation
Used same percutaneous bone access for Kyp hon balloon kyphoplasty Created cavity using coaxial 15mm Kyphon Xpander II balloons Removed balloons Placed barium-impregnated PMMA Xpede bone cement into vertebral body, using fluoroscopic visualisation\Final images showed good interdigitisation and filling, with no evidence of significant leakage Removed cannulas Applied sterile dressing The patient tolerated the procedure well, with no immediate complications.
Follow-up
Patient reported a pain improvement from nine out of 10 to seven out of 10 four hours post-procedure Patient reported pain of six out of 10 during a follow-up phone call 24 hours post-discharge Pain reduced to three out of 10 at twoweek clinic visit Discussed case and treatment plan with oncology and radiation oncology Initiated multifraction radiotherapy one week post-RF ablation, due to presence of epidural disease March 2021
Important safety information for Kyphon balloon kyphoplasty
Kyphon Xpede bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include haemangioma and giant cell tumour. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height. The complication rate with Kyphon balloon kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (for example, cement extravasation), including serious complications; though rare, some of these may be fatal.
Combination therapy—radiation therapy and radiofrequency ablation—may be used
At the physician's discretion, radiofrequency ablation and radiation therapy may be
Coaxial, bipolar technology delivers RF energy to the site. The internally-cooled ablation probes control temperature and help keep RF heating within the desired treatment area. This reduces potential thermal damage to adjacent tissue. Two probes can be used simultaneously for added efficiency, and to achieve larger ablation zones.”
considered for the same patient. In this metastatic breast cancer L1 lesion case, combination therapy was chosen, and external beam radiation added due to the extent of the epidural tumour. Jason Levy is an interventional radiologist at Northside, Forsyth, and Cherokee Hospitals, Atlanta, USA. See pages 4–5 for his commentary on the OPuS One results.
OPuS One clinical trial
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