Year : 2018 | Volume
: 32 | Issue : 3 | Page : 123--124
Percutaneous vertebroplasty: Current controversy
Department of Pain Medicine, Pain Clinic of India Pvt. Ltd., Margao, Goa; Department of Pain Medicine, KEM Hospital, Mumbai, Maharashtra, India
Dr. Kailash Kothari
2005/A, Cosmic Heights Bhakti Park, Wadala East, Mumbai - 400 037, Maharashtra
|How to cite this article:|
Kothari K. Percutaneous vertebroplasty: Current controversy.Indian J Pain 2018;32:123-124
|How to cite this URL:|
Kothari K. Percutaneous vertebroplasty: Current controversy. Indian J Pain [serial online] 2018 [cited 2020 Jan 26 ];32:123-124
Available from: http://www.indianjpain.org/text.asp?2018/32/3/123/249109
Percutaneous vertebroplasty was done first for a hemangioma of the cervical vertebra in mid-1980s. Since then, this procedure is being used in painful osteoporotic fractures, metastatic painful vertebrae (secondary and multiple myeloma), and in painful hemangioma. This procedure is very popular and is done worldwide for these conditions. In the past, there are multiple papers which established the role and benefits of percutaneous vertebroplasty in such painful conditions. There were studies showing benefits by comparing the procedure with conservative treatments in acute vertebral compression fractures.
In painful osteoporotic fractures, approximately two-thirds can be treated with conservative management which includes but not limited to bed rest, medications including nonsteroidal anti-inflammatory drug (NSAID) and opioids along with antiosteoporotic drugs. The remaining population may go in further progressive compression fractures and usually have moderate-to-severe pain. In these patients, percutaneous vertebroplasty plays an important role in providing excellent long-term results by reducing pain, improving functions and reducing opioid and NSAID intake. In malignant cases, pain due to compression fractures and metastatic disease is usually relieved with chemotherapy and radiotherapy, but in some cases, percutaneous vertebroplasty is required along with these therapeutic treatments.
Magnetic resonance imaging and computed tomography scan evaluation are important to identify the vertebrae which are more likely to respond to vertebroplasty. In some cases, bone scan can be helpful. There is some recent evidence that patient having very severe compression fracture (vertebra plana) may also benefit from vertebroplasty.
Even after years of experience and multiple evidence, the debate is still very much on, about the usefulness of vertebroplasty. Buchbinder et al. did a randomized trial in which they injected polymethyl methacrylic cement in one group, and in other group, they did a sham procedure by injecting a local anesthetic over the pedicle. The result showed that both groups had similar pain relief, and there was no statistically significant difference in pain relief and quality of life.
The other study Investigational Vertebroplasty Efficacy and Safety Trial by Kallmes et al. also compared vertebroplasty group to control group. In control group, only local anesthetic was injected, and the patient was exposed to some verbal and physical activity like pressure on the back without needle insertion. They found no difference in both groups – in pain relief on ten-point pain rating scale and functional Roland–Morris Disability scale.
These findings have huge impact on established protocols, especially followed by the pain physicians all over the globe, for the management of vertebral compression fractures. There are multiple articles written criticizing these studies.
Criticism of these studies as follows:
Critics question the limited number of patients in these studies. This may be one important factor why the results are not being accepted universallyHigh refusal rate – patients who refused to be randomized, points to the fact (speculation) that these are the patients who are in most severe pain and who wanted the best treatment option available. This may significantly affect the overall resultsPatients included with pain intensity scale as low as 3/10 (average was 6.9 ± 2) and fractures with age as old as 1 year was included. These two factors itself may lead to poor results with vertebroplasty as these patients with low pain score, and greater fracture age are less likely to respond to the vertebroplasty procedure. Kallmes et al. included almost 38% of the patients with the mean age of fracture was more than 27 weeks (14% >27 weeks and 24% >40 weeks). In prior studies, there is a good evidence that the ideal time for the vertebral augmentation procedure is 6-week postfracture when medical therapy is not effective to relieve patients' pain. There is Level I evidence that says that the pain relief, analgesic use, and functional improvement are much superior to the conservative medical management. However, there is a contrary opinion by Kaufmann et al. who found vertebroplasty can produce good pain relief independent on the age of the fracture. In Vertos II study (2010), they included patients with severe pain (>5/10 on 0–10 scale) and acute fracture (<6 weeks), and they proved that there is a significant difference in pain relief and quality of life between two groups. In 2011, in a meta-analysis, authors found no significant difference in similar two groups. Hence, there is very much contradictory evidence on the role of vertebroplastyIs the amount of the polymethylmethacrylate cement injected is sufficient? Few papers question the volume injected is insufficient and may be the cause of poor result in patients undergoing vertebroplasty; however, it may not be a correct assumption as there are reports which suggest that volume actually does not matter. Even small volume may produce very good analgesic effect due to the effect of hyperthermia-induced nerve ablation and fixing the fracture sufficiently. Larger volume may be associated with more adverse effectsIs sham procedure appropriate? What leads to the quick improvement in the sham group? Is facet joint arthropathy pain responding to local anesthetic injection resulting in the pain relief? These are the few questions raised by the critics. The results may point to the fact that the facet pain may be an important source of pain in mechanically disturbed spine due to a vertebral compression fracture. Performing the facet joint block with local anesthetic with or without steroids may filter out patients who probably do not need an invasive procedure like vertebroplasty.
We are in the era of evidence-based medicine. The new evidence sometimes disrupts the older beliefs and standard protocols. Similar evidence are being erupted in the past few years which questions the usefulness of vertebroplasty in vertebral compression fractures. There are people who lobby for and against this technique. In these studies, the authors have not taken into consideration of other long-term effects of the vertebral compression fractures such as problems with mobility, digestion, and breathing, leading to earlier mortality. These physical and emotional adverse effects of vertebral compression fractures can be prevented by vertebroplasty and kyphoplasty. Other important factors to consider are a reduction in patients suffering in short and medium term, less use of analgesics thereby reducing their adverse effects, reduction in the cost by reducing hospital stay, and reducing the loss of days at work. The studies with contrary evidence cannot undo the large data and evidence in support of vertebroplasty and kyphoplasty, which are already existing. To conclude, we need more studies with better methodology, which includes all aspects of patient well-being to decide what is best for our patients. Meanwhile, we must continue using vertebroplasty in patients with severe debilitating pain with evidence of unhealed fractures on imaging studies, who are not responding to conservative management including facet joint block.
|1||Galibert P, Deramond H, Rosat P, Le Gars D. Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty. Neurochirurgie 1987;33:166-8.|
|2||Jensen ME, McGraw JK, Cardella JF, Hirsch JA. Position statement on percutaneous vertebral augmentation: A consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. AJNR Am J Neuroradiol 2007;28:1439-43.|
|3||Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and kyphoplasty: A systematic review of 69 clinical studies. Spine (Phila Pa 1976) 2006;31:1983-2001.|
|4||Diamond TH, Bryant C, Browne L, Clark WA. Clinical outcomes after acute osteoporotic vertebral fractures: A 2-year non-randomised trial comparing percutaneous vertebroplasty with conservative therapy. Med J Aust 2006;184:113-7.|
|5||Young C, Munk PL, Heran MK, Lane MD, Le HB, Lee S, et al. Treatment of severe vertebral body compression fractures with percutaneous vertebroplasty. Skeletal Radiol 2011;40:1531-6.|
|6||Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, et al. Arandomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009;361:557-68.|
|7||Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. Arandomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361:569-79.|
|8||Hussain A, Erdek M. Vertebroplasty augmentation procedures: Examining the controversy. Pain Physician 2013;16:E483-90.|
|9||Smith SJ, Vlahos A, Sewall LE. An objection to the New England journal of medicine vertebroplasty articles. Can Assoc Radiol J 2010;61:121-2.|
|10||McGirt MJ, Parker SL, Wolinsky JP, Witham TF, Bydon A, Gokaslan ZL, et al. Vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures: An evidenced-based review of the literature. Spine J 2009;9:501-8.|
|11||Kaufmann TJ, Jensen ME, Schweickert PA, Marx WF, Kallmes DF. Age of fracture and clinical outcomes of percutaneous vertebroplasty. AJNR Am J Neuroradiol 2001;22:1860-3.|
|12||Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): An open-label randomised trial. Lancet 2010;376:1085-92.|
|13||Staples MP, Kallmes DF, Comstock BA, Jarvik JG, Osborne RH, Heagerty PJ, et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: Meta-analysis. BMJ 2011;343:d3952.|
|14||Boszczyk B. Volume matters: A review of procedural details of two randomised controlled vertebroplasty trials of 2009. Eur Spine J 2010;19:1837-40.|
|15||Röder C, Boszczyk B, Perler G, Aghayev E, Külling F, Maestretti G, et al. Cement volume is the most important modifiable predictor for pain relief in BKP: Results from SWISSspine, a nationwide registry. Eur Spine J 2013;22:2241-8.|
|16||Kaufmann TJ, Trout AT, Kallmes DF. The effects of cement volume on clinical outcomes of percutaneous vertebroplasty. AJNR Am J Neuroradiol 2006;27:1933-7.|
|17||Wilson DJ, Owen S, Corkill RA. Facet joint injections as a means of reducing the need for vertebroplasty in insufficiency fractures of the spine. Eur Radiol 2011;21:1772-8.|