14 Appropriateness Criteria for Vertebral Augmentation
Summary
Clinical practice decisions regarding how to treat certain fractures remain heterogeneous and traditionally there has been little consensus of what type of vertebral augmentation procedure should be used to treat specific fracture types. Various medical societies have produced their own recommendations for treating vertebral compression fractures but the most important document that has been developed to establish a clinical care pathway for the treatment of Vertebral compression fractures (VCFs) has been the UCLA/RAND appropriateness criteria recommendations published in 2018 by a multispecialty group of physicians. These criteria included clinical signs and symptoms of VCFs that need vertebral augmentation as well as imaging criteria for choosing vertebral augmentation over nonsurgical management (NSM). There were seven key factors identified that determined the appropriateness of proceeding with vertebral augmentation as opposed to treating with NSM. The treatment choice was strongly influenced by the clinical variables and the difference in patient characteristics. The clinical factors that determined the overall choice of treatment included the clinical exam and imaging findings, the duration of pain, the impact of the VCF on daily functioning, the degree of height reduction, and kyphotic deformity, whether there was progressive vertebral body height loss and the overall evolution of symptoms. The contraindications for performing vertebral augmentation were also narrowed and refined and treatment recommendations were put forth for dealing with the underlying condition (i.e. osteoporosis) that gave rise to the fracture.
14.1 Introduction
VCFs can be related to osteoporosis, trauma, or malignancy. The end result is pain and mobility impairment with a high impact on life quality as well as morbidities resulting in reduced life expectancy. 1 Therapeutic options include NSM (pain medication, bracing, bed rest, etc.) and vertebral augmentation by means of vertebroplasty (VP), balloon kyphoplasty (BKP), or spinal implants (stents, jacks, peek cages, etc.). 1 , 2 The wide variety in the causes and the characteristics of a VCF necessitate a tailored-based therapeutic approach taking into account both the advantages and limitations of each treatment. At the moment, clinical practice decisions are driven by operator’s preference and/or international guidelines, which can be divergent and sometimes contradictory. There is no predictive tool available that will be able to identify the ideal therapeutic approach for a given VCF with specific characteristics. Furthermore, there is a clear lack of appropriateness criteria that will govern a therapy based on the expected benefits that should outweigh the potential complications by a sufficient margin in order to render the technique worth doing. A recent systematic review of evidence-based guidelines for the management of VCFs showed considerable inconsistencies in the treatment recommendations as well as in the recommendations for the diagnostic evaluation and the prevention of future fractures. 3
14.2 Indications, Guidelines, and Recommendations
Standard indications for vertebral augmentation include symptomatic (painful) type A fractures according to the Magerl classification (most commonly type A1 fractures) with bone edema on MRI (▶Fig. 14.1) and/or positive bone scan scintigraphy. The patient should be an adult reporting at least moderate pain (Visual Analog Scale >4 units) at the respective level, with absence of neurologic impairment and no absolute contraindications to therapy (e.g., active infection at the surgical site or the presence of an untreated blood borne infection). 1 , 2 , 4 Depending on the fracture’s specific characteristics, different techniques of vertebral augmentation can be utilized.
Although many scientific organizations have published guidelines regarding the indications for vertebral augmentation, none provides a tailored approach based upon the unique characteristics of a specific vertebral fracture. Furthermore, almost all the documents mention standard VP and balloon augmentation omitting spinal implants, which constitute a paradigm shift away from cement injection performed either with or without using bone tamps. According to the 2013 NICE guidelines and position paper 5, standard VP and balloon augmentation without stenting should be offered to patients with severe ongoing pain and in whom the pain has been confirmed to be at the level of the fracture by physical examination and imaging after a recent, unhealed vertebral fracture that continues to produce significant discomfort despite optimal pain management. 5 According to a position paper released by multiple scientific societies including the Society of Interventional Radiology (SIR), American Society of Neuroradiology (ASNR), American College of Radiology (ACR), American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS), vertebral augmentation remains a proven medically appropriate therapy for treatment of painful VCFs refractory to nonoperative medical therapy and for vertebrae weakened by neoplasia when performed for the medical indications outlined in the published standards. 6 – 10 The American Academy of Orthopaedic Surgeons (AAOS) guidelines are a distinct outlier with recommendations against VP and for BKP as a treatment option for painful VCFs. 11 According to ACR guidelines, both vertebral augmentation techniques are similar and should be offered as a second-line therapy after NSM with balloon augmentation resulting in better angular correction and fracture reduction. 12 The Standards and Guidelines Committee of the SNIS reports that both VP and kyphoplasty are indicated in symptomatic osteoporotic or cancer-related VCFs refractory to medical therapy. 13 The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in the recently published guidelines for vertebral augmentation include in the indications for VP painful osteoporotic fractures, painful vertebrae due to benign tumors or malignant infiltration, Kummels’ disease, symptomatic vertebrae plana, acute stable A1 and A3 fractures according to the Magerl classification, and chronic traumatic fractures (▶Fig. 14.2, ▶Fig. 14.3, ▶Fig. 14.4). In the same document, indications for balloon augmentation include all the aforementioned, but it is reported that the best indication for the technique is a traumatic acute (<7–10 days) fracture (particularly Magerl A1) with a local kyphotic angle less than 15 degrees. 4 The CIRSE guidelines include indications for the application of spinal implants that, according to the authors, can be used in all the indications valid for VP and balloon augmentation. 4 The spine metastatic disease working group suggests that vertebral augmentation can be proposed in the cases in which there is no metastatic epidural spinal cord compression and in the cases of fracture prophylaxis after radiation therapy or after percutaneous ablation for local tumor control. 14 These recommendations are especially important in patients with relatively good prognoses. 14 Additionally, according to the same authors, vertebral augmentation techniques are recommended for first-line pain palliation treatment, related to stable pathologic VCFs. 14 The American Society for Radiation Oncology (ASTRO) guidelines comment that there are no prospective data suggesting that either kyphoplasty or VP would obviate the need for EBRT (external beam radiotherapy) for painful bone metastases, but these two different therapies can certainly be complimentary. 15