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News and Controversies in Vertebral Augmentation - AJNR News Digest
June 2013
Introduction

News and Controversies in Vertebral Augmentation

Alessandro Cianfoni

Alessandro Cianfoni

In 1987, Deramond and Galimbert introduced the vertebral augmentation (VA) technique, which spread widely as an effective procedure to treat painful vertebral compression fractures (VCFs). In 2009, the New England Journal of Medicine published the INVEST and Australian trials,1,2 the first  two randomized blind-sham procedure-controlled trials on VA. The conclusions drawn by these authors were surprising: VA in osteoporotic VCFs was effective but comparable to a sham anesthetic procedure, and therefore mostly related to a placebo effect. Despite microscopic scrutiny and criticism raised by the scientific community on several controversial aspects of these studies, the echo in the lay press was immediate and very loud, and in a short time it seemed that VA was coming to the end of its days. Yet the physicians dealing with the clinical problem of a painful VCF could make little use of the results of the trials, short of offering their patients an unlikely sham procedure.

In the meantime, FREE and VERTOS II, two other trials—on the use of balloon kyphoplasty (BKP) and vertebroplasty, respectively—appeared in the Lancet in 2009 and 2010.3,4 Those trials were randomized and controlled but open label, with the treatment in the control arm being not a sham procedure but the best conservative management. These studies showed benefit for the patients undergoing VA, and offered results and conclusions more applicable to clinical practice, where the physicians could choose between two possible clinical options for their patients. While we are looking forward to the publication of VERTOS IV5—a new placebo-controlled randomized trial on VA—an interesting, recently published article by Luetmer and  Kallmes,6 the latter the leading investigator of the INVEST trial, reports that despite clinical referrals for VA at their institution (the Mayo Clinic) having decreased since the publication of their trial, they continue to offer the procedure to a high proportion of referred patients.

Certainly, the intense debate over these studies has promoted a new critical spirit in looking at the VA procedure—at its rationale, indications, and effects, raising ever new questions on this widely used and yet mysterious technique (What is the real mechanism of pain alleviation in VA? Which patients are most likely or unlikely to benefit from it, and why?). Questions keep on being asked and not always clearly answered on the relative indications, similarities, differences, and advantages of the two main VA techniques, vertebroplasty and BKP.

Finally, years of experience with the technique have brought some operators to explore side roads, resulting in some original applications of modifications of the technique. While there has been, in recent years, a wave of interest in the horizons of and publications on the use of VA in neoplastic spine diseases,7-11 the vast majority of these procedures are still performed on osteoporotic VCFs.

It is the scope of this AJNR News Digest to offer a selection of  interesting, and in some cases, controversial, articles published in AJNR during the last two years on  different aspects of VA applied to the osteoporotic spine. 

The first article12 analyzes the natural history and course of pain in patients with painful VCFs treated conservatively. Despite the majority of patients experiencing spontaneous resolution of pain over time, a significant percentage of patients do not recover and remain affected by chronic pain. The authors advocate the delayed use of VA in this group of patients.

The second article13 also deals with patients who have persistence of pain but, in this case, after a technically successful VA. Do these cases represent procedure failures? It is usually quite difficult to ascertain the cause or site of origin of the residual pain in such patients, and here, the authors attempt to locate it with a physical exam under fluoroscopy and through diagnostic block procedures. Their results raise our attention to the facet and sacroiliac joints as common pain generators in these patients.

Two more studies, both from the same group, attempt to assess the importance of vertebral mobility, as diagnosed with flexion-extension plain film radiographs, in patients undergoing a VA procedure. In one study14 they conclude that it is the presence of vertebral mobility, more than the VA technique used, whether balloon-assisted or not, that determines the final achievement of vertebral height restoration. It is important to note that though of some possible intuitive advantage, height restoration has not been definitely proven as a clinically relevant aspect of the VA. Their second study15 controversially reports that in patients without vertebral mobility, a technique called vertebral perforation, which consists of insertion and subsequent removal of a needle in the vertebral body without cement injection (a more invasive form of the sham procedures used in the INVEST and Australian trials?), achieves pain reduction, while patients with vertebral mobility need cement injection (a true VA) for pain amelioration. These results force us not to stop thinking about which are the truly right indications for VA, which are not, and which tests to use to select them. In fact, vertebral mobility as diagnosed with dynamic spine plain films might uncover only one aspect of the constellation of elements potentially important for correct patient selection.

And finally, two articles, with confidence, suggest a more deliberate use of the technique, specifically that of cement injection.

Adjacent level fracture after a VCF is a commonly encountered and spontaneous event, but referring clinicians are frequently worried about the possible “domino effect” after VA in patients with severe osteoporosis, also based on some studies reporting such increased risk. Recent data from

the VERTOS II patients report no increased risk of adjacent level fracture after a VA. The fifth article16 of this selection advocates the injection of cement in the vertebral body above and below the VCF level to treat with VA as an effective way to prevent adjacent-level vertebral fractures and repeated interventions.

Yen et al figure

Yen et al16

The authors of the sixth study17 originally apply the VA technique to the vertebral posterior elements, spinous processes, and laminae in patients at risk of  fragility fractures undergoing implantation of an interspinous spacer (ISS) for lumbar stenosis and neurogenic claudication. In their study, they report the biomechanical rationale, feasibility, and efficacy of this technique, allowing for the treatment of patients who could potentially benefit but would be otherwise excluded from the implantation of an ISS.

Bonaldi et al figure

Bonaldi et al17

References

  1. Kallmes DF, Comstock BA, Heagerty PJ, et al. A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. N Engl J Med 2009;361:569-79. doi: 10.1056/NEJMoa0900563
  2. Buchbinder R, Osborne RH, Ebeling PR, et al. A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures. N Engl J Med 2009;361:557-68. doi: 10.1056/NEJMoa0900429
  3. Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 2009;373:1016-24. doi: 10.1016/S0140-6736(09)60010-6
  4. Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010;376:1085-92. doi: 10.1016/S0140-6736(10)60954-3
  5. Firanescu C, Lohle PN, de Vries J, et al. from VERTOS IV study group. A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV). Trials 2011;12:93. doi: 10.1186/1745-6215-12-93
  6. Luetmer MT, Kallmes DF. Have Referral Patterns for Vertebroplasty Changed since Publication of the Placebo-Controlled Trials? AJNR Am J Neuroradiol 2011;32:647-48. doi: 10.3174/ajnr.A2371
  7. Georgy B. Metastatic Spinal Lesions: State-of-the-Art Treatment Options and Future Trends. AJNR Am J Neuroradiol 2008;29:1605-11. doi: 10.3174/ajnr.A1137
  8. Berenson J, Pflugmacher R, Jarzem P, et al. Cancer Patient Fracture Evaluation (CAFE) Investigators. 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;12:225-35. doi: 10.1016/S1470-2045(11)70008-0
  9. Hirsch AE, Jha RM, Yoo AJ, et al. The Use of Vertebral Augmentation and External Beam Radiation Therapy in the Multimodal Management of Malignant Vertebral Compression Fractures. Pain Physician 2011;14:447-58
  10. Garland P, Gishen P, Rahemtulla A. Percutaneous vertebroplasty to treat painful myelomatous vertebral deposits—long-term efficacy outcomes. Ann Hematol 2011;90:95-100. doi: 10.1007/s00277-010-1021-2
  11. Munk PL, Murphy KJ, Gangi A, et al. Fire and Ice: Percutaneous Ablative Therapies and Cement Injection in Management of Metastatic Disease of the Spine. Semin Musculoskelet Radiol 2011;15:125-34. doi: 10.1055/s-0031-1275595
  12. Venmans AKlazen CA, Lohle PN, et al. Natural History of Pain in Patients with Conservatively Treated Osteoporotic Vertebral Compression Fractures: Results from VERTOS II. AJNR Am J Neuroradiol 2012;33:519-21. doi: 10.3174/ajnr.A2817
  13. Kamalian SBordia R, Ortiz AO. Post–Vertebral Augmentation Back Pain: Evaluation and Management. AJNR Am J Neuroradiol 2012;33:370-75. doi: 10.3174/ajnr.A2775
  14. Yokoyama K, Kawanishi M, Yamada M, et al. Validity of Intervertebral Bone Cement Infusion for Painful Vertebral Compression Fractures Based on the Presence of Vertebral Mobility. AJNR Am J Neuroradiol 2013;34:228-32. doi: 10.3174/ajnr.A3160
  15. Yokoyama K, Kawanishi M, Yamada M, et al. In Not Only Vertebroplasty but Also Kyphoplasty, the Resolution of Vertebral Deformities Depends on Vertebral Mobility. AJNR Am J Neuroradiol 2013 Feb 7 [Epub ahead of print]. doi: 10.3174/ajnr.A3424
  16. Yen CH, Teng MM, Yuan WH, et al. Preventive Vertebroplasty for Adjacent Vertebral Bodies: A Good Solution to Reduce Adjacent Vertebral Fracture after Percutaneous Vertebroplasty. AJNR Am J Neuroradiol 2012;33:826-32. doi: 10.3174/ajnr.A2898
  17. Bonaldi GBertolini G, Marrocu A, et al. Posterior Vertebral Arch Cement Augmentation (Spinoplasty) to Prevent Fracture of Spinous Processes after Interspinous Spacer Implant. AJNR Am J Neuroradiol 2012;33:522-28. doi: 10.3174/ajnr.A2792

 

Image modified from: Yokoyama K, Kawanishi M, Yamada M, et al. In Not Only Vertebroplasty but Also Kyphoplasty, the Resolution of Vertebral Deformities Depends on Vertebral Mobility.