- Email: [email protected]
ACR Appropriateness Criteria Management of Vertebral Compression Fractures
ACR Appropriateness Criteria Management of Vertebral Compression Fractures Charles T. McConnell Jr, MDa, Franz J. Wippold II, MDb, Charles E. Ray Jr, MD, PhDc, Barbara N. Weissman, MDd, Peter D. Angevine, MDe,f, Ian Blair Fries, MDg,h, Langston T. Holly, MDi,j, Baljendra S. Kapoor, MB, BSk, Jonathan M. Lorenz, MDl, Jonathan S. Luchs, MDm, John E. O’Toole, MDn,f, Nandini D. Patel, MDo, Christopher J. Roth, MDp, David A. Rubin, MDq
This is an updated review of management of vertebral compression fracture for both benign osteoporotic and malignant causes. Vertebral compression fracture radiologic imaging evaluation is discussed. A literature review is provided of current indications for vertebral augmentation with percutaneous vertebroplasty and kyphoplasty as well as medical management. Limitations and potential benefits of these procedures are discussed. Variant tables describing various clinical situations are also provided to assist in determining appropriate use of these treatments for patient care. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a wellestablished consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to formulate recommendations for imaging or treatment. Key Words: Appropriateness criteria, vertebral compression fracture, vertebroplasty, kyphoplasty, osteoporosis, management, treatment, MR J Am Coll Radiol 2014;11:757-763. Copyright © 2014 American College of Radiology
SUMMARY OF LITERATURE REVIEW Introduction
Vertebral augmentation is a generic term referring to percutaneous vertebroplasty (VP) and balloon-assisted kyphoplasty [1]. They are procedures used for the palliation of pain related to vertebral compression a
Good Samaritan Hospital, Cincinnati, Ohio.
fractures. Vertebral compression fractures can be caused by osteoporosis, direct acute trauma in an otherwise healthy vertebra, and neoplasms. Neoplasms causing vertebral compression fractures include: (1) primary bone neoplasms (hemangiomas, giant cell tumors), (2) infiltrative neoplasms (multiple myeloma, lymphoma), m
Metropolitan Diagnostic Imaging Group, Garden City, New York.
b
Mallinckrodt Institute of Radiology, Saint Louis, Missouri.
n
c
University of Illinois Hospital and Health Sciences System, Chicago, Illinois.
o
d
Brigham & Women’s Hospital, Boston, Massachusetts. e Columbia University Medical Center, New York, New York.
p
f American Association of Neurological Surgeons, Rolling Meadows, Illinois/ Congress of Neurological Surgeons, Schaumburg, Illinois.
Corresponding Author: Charles T. McConnell, Jr, MD Attn:Dept of Radiology Good Samaritan Hospital 375 Dixmyth Ave Cincinnati, OH 45220-2475; e-mail: [email protected].
g
Bone, Spine and Hand Surgery, Chartered, Brick, New Jersey.
h
American Academy of Orthopaedic Surgeons, Rosemont, Illinois.
i
University of California Los Angeles Medical Center, Los Angeles, California.
j
American Association of Neurological Surgeons, Rolling Meadows, Illinois/ Congress of Neurological Surgeons, Schaumburg, Illinois.
k
Cleveland Clinic Foundation, Cleveland, Ohio.
l
University of Chicago Hospital, Chicago, Illinois.
ª 2014 American College of Radiology 1546-1440/14/$36.00 http://dx.doi.org/10.1016/j.jacr.2014.04.011
Rush University Medical Center, Chicago, Illinois.
Fairfax Radiology Consultants PC, Fairfax, Virginia.
q
Duke University Medical Center, Durham, North Carolina. Washington University School of Medicine, Saint Louis, Missouri.
Reprint requests to: [email protected]. The ACR seeks and encourages collaboration with other organizations on the development of the ACR Appropriateness Criteria through society representation on expert panels. Participation by representatives from collaborating societies on the expert panel does not necessarily imply individual or society endorsement of the final document. No conflict of interest was reported.
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and (3) metastatic neoplasms [1-3]. Osteoporotic vertebral compression fractures are the most commonly encountered fractures that require augmentation; they are the focus of this narrative. Postmenopausal women represent the majority of patients at risk for developing osteoporotic fractures of any type, and vertebral compression fractures represent 25% of osteoporotic fractures [4-6]. Painful vertebral compression fractures may cause a marked decline in physical activity and quality of life, leading to general physical deconditioning. This decline, in turn, may prompt further complications related to poor inspiratory effort (atelectasis and pneumonia) and venous stasis (deep venous thrombosis and pulmonary embolism) [1]. Successful management of painful vertebral compression fractures has the potential for improving quality of life, increasing the expectancy of an independent and/or productive life, and preventing superimposed medical complications. Some have suggested that management of painful vertebral compression fractures may also have a cost benefit for society as a whole; however, assessment of any potential societal benefits is difficult owing to the inexactness of methods for quantifying pain-related disability. Management Overview
The traditional first-line treatment of painful vertebral compression fractures is conservative management, which includes medical management with or without methods of immobility [7]. Most pain-related symptoms from vertebral compression fractures are resolved with this management [7,8]. Successful medical management also involves appropriate screening for osteoporosis and appropriate follow-up treatment. (See the ACR Appropriateness Criteria topic on “Osteoporosis and Bone Mineral Density” [9]). Vertebral augmentation in the form of VP and balloon-aided kyphoplasty has been used for managing painful vertebral compression fractures that are refractory to conservative management. The threshold for performing vertebral augmentation has declined as a result of its expanded use within the medical community, the rapidity of clinical response, and the relatively low procedural risk. Indeed, some authors have advocated prophylactic VP [10,11]. In addition, an increasing number of studies have described successful results using vertebral augmentation for painful refractory malignant fractures and symptomatic myelomatous vertebral replacement [12,13]. More invasive modifications, such as open kyphoplasty, have also been described for managing complex fractures that pose a relative contraindication for traditional VP. The increasingly widespread clinical applications and proposed indications for vertebral augmentation have fueled debate on the use, medical costeffectiveness, and societal cost-effectiveness of these procedures.
Management Options
Conservative Management. Conservative management is the initial conventional treatment of painful vertebral compression fractures [7]. It includes medical management with or without methods of immobility. Medications include nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics. However, these medications have complications. Gastrointestinal hemorrhage, ulcerative perforations, and death occur in 1.5% of the patients annually, with 40% of chronic users having endoscopically proven ulcers [14,15]. Narcotics for noncancer pain management can lead to constipation (41%), nausea (32%), somnolence (29%), and addiction, with all patients exhibiting at least 1 adverse effect [16]. Most patients with osteoporotic vertebral compression fractures have spontaneous resolution of pain, even without medication [7,17-19]. Since the inception of vertebral augmentation in the late 1980s, its minimally invasive procedures have been reserved for patients who have failed conservative therapy. Failure can be defined as pain refractory to oral medications (NSAIDs and/or narcotics) [20-24]. However, failure can also be defined as a contraindication to such medications or a requirement for parenteral narcotics and hospital admission. A recent multispecialty Position Statement and the ACR Practice Guideline for the Performance of Vertebral Augmentation have addressed this topic [25,26]. Preprocedural Imaging. The ideal preprocedural imaging has not been identified [27,28]. For some authors, focal spinous process pain on palpation, correlated with radiographs of the vertebral column, is a satisfactory indication for the procedure. Spine radiographs, however, are often nonspecific with respect to the patient’s age or cause of the fracture [29]. Alternatively, others have recommended that MRI be done before the procedure. MRI, especially using a short tau inversion recovery (STIR) sequence, is sensitive for detecting acute fractures and may differentiate synchronous fractures. MRI is also useful in distinguishing recent from chronic vertebral fractures in patients with multiple deformities and confusing clinical examinations [30,31]. Recent fractures exhibit edema, which can be detected by STIR MRI for up to 3 months after the fracture occurs [32,33]. Minimally deforming fractures that are overlooked by conventional radiographs but detected on MRI may be a cause of clinical failure of VP [27]. The benefits of MRI for preprocedural planning and guiding the puncture site have also been reported [27,34,35]. The use of MRI for evaluating benign and malignant fractures has also been well documented [36]. Thus, to ensure appropriate treatment, MRI evaluation should be considered before any planned vertebral augmentation in patients with a history of malignancy or atypical clinical features. The benefit of MRI must be weighed against its cost [28]. CT is usually reserved for a
McConnell et al/Vertebral Compression Fractures 759
detailed analysis of fractures that extend to the posterior column of the vertebra or for evaluating the integrity of pedicles and the posterior cortex prior to VP [2,37]. Percutaneous Vertebroplasty. Vertebral augmentation in the form of VP has been used for managing osteoporotic vertebral compression fractures since the 1980s in Europe and since the early 1990s in the United States. It involves injecting low-viscosity cement directly into the vertebral body, using a unipedicle or bipedicle needle. The procedure has had significant success, with 89%e93% of patients having reduced pain and painrelated morbidity, and 40% having complete resolution of pain often immediately postprocedure [38,39]. This translates to improved ambulation (up to normal activity) in 56%e95% of patients [40-42]. Women and patients age <75 years seem to benefit the most [42,43]. Kyphoplasty results largely parallel VP results, and the differences will be noted in later discussion. With respect to pain relief, several studies have shown that VP reduces mean pain estimates based on a visual analogue scale (VAS; scale range: 0-10) by approximately 5 points, with prevertebroplasty scores ranging from 8.1 to 8.4 and a reduced range of 2.6-3.0 postvertebroplasty [3,44-46]. The authors of this metaanalysis of 5 studies published a similar analysis of >1,400 patients; the mean VAS range was reduced from 5.4-9.1 to 1.5-4.9 [7,40,41,47,48]. Each study had a statistically significant (P < .05) improvement in the VAS pain scale [7,40,41,47,48]. With respect to the duration of pain relief, it is well documented that vertebral augmentation is becoming more beneficial than conservative management, with respect to pain relief, quality of life, and mobility at all time intervals between the day of procedure to 1 year [49]. The reported benefits of vertebral augmentation after 1 year, however, subside and patients show little difference from those who underwent conservative medical management [50-52]. However, controversy exists with respect to the overall benefit of VP, based largely on the conclusions of 2 highprofile, randomized controlled trials. These independent, prospective, randomized controlled trials compared VP with a sham control group [17,53]. The total number of patients with adequate follow-up in both studies was 202 (103 in the VP group and 99 in the control group). Both limbs in both studies had reduced pain, with a trend toward better pain control in the VP group [17,53]. However, both studies concluded that the VP group did not show a statistical clinical advantage over the control group [17,53]. The Investigational Vertebroplasty Safety and Efficacy Trial (INVEST) used lidocaine injection through a transpedicular needle as its control [17]. The study by Buchbinder et al [53] did not instill any medication in the control group. These results have stirred a debate between critics and supporters of the two studies [54]. Criticism has focused
Variant 1. Elderly woman with a recent recurring benign, painful 25% loss-of-height compression fracture. Previous fracture healed spontaneously with conservative management Treatment/ Procedure Rating Comments Advanced radiologic imaging
6
Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
8
A patient with a history of recurring pain may benefit from further imaging.
4 4 2
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate.
on the scientific validity of the trials. These authors mostly criticize the relatively small sample size, the use of lidocaine in the INVEST trial, and the high crossover from the control group to the VP group, in addition to a possible superimposed placebo effect [54]. This high cross-over may indicate patient dissatisfaction beyond the placebo effect in the control group, and it may be compounded by the relatively small sample sizes [54]. An additional caveat predicted previously [2] is that patients with significant pain, and those who are most likely to respond significantly to VP, may also be reluctant to participate in a trial with a 50% chance of undergoing a sham procedure. Supporters of the findings of the 2 trials mention that these are the highestlevel trials investigating VP to date [54]. However, despite this controversy, use of vertebral augmentation procedures increased from 2001 through 2008 [55]. The trend for increased use is likely attributable to individual physician experience on the efficacy of vertebral Variant 2. Elderly man with painful first spontaneous compression fracture who has limited his ADLs. No neurologic symptoms are present Treatment/ Procedure Rating Comments Advanced radiologic imaging
8
Conservative medical treatment Vertebroplasty
8 5
Kyphoplasty
5
Surgical referral
2
Significant information, such as the etiology of the fracture, can be obtained from crosssectional imaging.
Use this procedure if the patient fails conservative management. Use this procedure if the patient fails conservative management.
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate. ADL ¼ activities of daily living.
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Variant 3. Middle-aged active man with a T7 burst fracture and a history of recent trauma. The new fracture is impeding his ADLs. Patient also complains of newonset right lower-limb tingling Treatment/ Procedure Rating Comments Advanced radiologic imaging Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
Variant 5. Elderly independent woman, with new painful fracture limiting ADLs, and previous successful vertebroplasty Treatment/Procedure Rating Comments Advanced radiologic imaging
8
Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
6
9 5 3 3 9
Given the neurologic complications, consider a surgical evaluation and MR imaging.
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate. ADL ¼ activities of daily living.
augmentation as well as numerous and ever-increasing alternative research studies showing its benefit. In particular, the additional reported benefits of vertebral augmentation include vertebral deformity improvement, improvement in activities of daily living (ADLs), and improved respiratory function and survival [56-60]. Also, the rapidity of pain relief allowing for early mobilization after VP is often a reported benefit, especially in elderly patients with limited life expectancy and treatment options [61,62]. A growing body of evidence also supports vertebral augmentation for refractory malignant fractures [12,13,63]. Although the reported complications ranged from only 1% to 3.9%, they varied depending on: (1) the specific definitions of complications, (2) the degree of clinical and imaging follow-up, and (3) the collective definitions (amalgamation) of complications. Frequently mentioned complications included: cement leak (asymptomatic or symptomatic), cement pulmonary embolism (asymptomatic or symptomatic), and bleeding/hematoma, infection, and neurological deficit (transient or permanent). Delayed complications included fractures involving other vertebral levels in 2.5%e17.3% of cases Variant 4. Elderly woman with painful subacute, hyperkyphotic compression fracture unresponsive to conservative treatment (NSAIDS) with continued loss of ADLs Treatment/Procedure Rating Comments Advanced radiologic imaging Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
8 3 8 7 4
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate. ADL ¼ activities of daily living; NSAIDS ¼ nonsteroidal anti-inflammatory drugs.
Prior to intervention, perform imaging to rule out malignancy.
5 5 1
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate. ADL ¼ activities of daily living.
(subject to the length and degree of follow-up, the definitions, and the imaging quality), with 43%e49% and 51%e57% of these fractures occurring in distant or adjacent vertebral bodies, respectively [39,40,53,64-67]. It is unknown whether additional fractures are truly long-term complications of the procedure (contributed in part by the procedure) or the natural history and/or the progression of osteoporosis, and assessment is difficult without prospective randomized trials involving large numbers of subjects [2]. Addressing the issue of additional fractures in VP patients, Buchbinder et al [53] devised a randomized, controlled, prospective study in a small sample size. In this study, patients were randomized to a VP group and a sham/placebo group. In a 6-month follow-up, 8.6% (n¼3 of 35) of the VP group and 11.1% (n¼4 of 36) of the placebo group had secondary vertebral fractures. Other studies reported repeat fractures in 27%e33% of patients after VP, with low body mass index, bone mineral density, and vitamin D levels as contributing risk factors for additional fractures [68,69]. Kyphoplasty. Kyphoplasty is a derivation of VP. It involves a percutaneous unipedicle or a bipedicular approach with the insertion of a balloon dilation catheter which is then inflated to restore vertebral body height and create a space for a low-pressure injection of high-viscosity bone cement. Proponents of this procedure emphasize the benefits of better deformity correction over VP. As with traditional VP, it can be achieved Variant 6. Elderly chronically bedridden man with a painful compression fracture that has failed conservative management Treatment/Procedure Rating Comments Advanced radiologic imaging Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
8 2 8 8 3
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate.
McConnell et al/Vertebral Compression Fractures 761
Variant 7. Elderly woman with malignant subacute, painful compression fracture refractory to conservative management Treatment/Procedure Rating Comments Advanced radiologic imaging Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
9 2 7 7 6
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate.
via a unipedicle (single-balloon) or classically bipedicle (double-balloon) approach [70]. There is less clinical experience with kyphoplasty than with conventional VP [11]. Three studies that directly compared VP with kyphoplasty showed no significant difference in outcome (based on results and complications), with the same type of complications occurring in both [39,66,71]. Technically, kyphoplasty may have some merit for certain conditions, such as vertebral burst fractures with or without neurological symptoms, as it may offer a more controlled angular and fracture correction with cement deposition when compared with VP alone [38,39,72]. In addition, some authors believe that kyphoplasty is superior to conventional VP height restoration [38,39,72]. Due to space created by balloon dilation within the vertebral body before injection, less cement leakage has also been noted for kyphoplasty when compared with VP [73]. A recent study also suggested a small overall benefit of kyphoplasty over VP (and conservative management) with respect to life expectancy [74]. Open Kyphoplasty. Open kyphoplasty is the most invasive variant of vertebral augmentation. It involves using kyphoplasty with a surgical component that may include laminectomy, decompression, short-segment vertebral osteosynthesis, and/or short posterior internal fixation [48,75]. Fuentes et al [75] discussed treatment of 16 patients with neurological symptoms in which all showed improved symptoms, and 88% had resolution of their symptoms. Another study of 21 patients showed that pain improved up to 3 months after the procedure and then reached a plateau [48]. This trend was also reflected by the percentage of patients who had residual disability of 88%, 35%, and 36% at 1, 3, and 12 months, respectively [48]. The experience with this procedure is limited and seems to be specific to traumarelated burst fractures, possibly in younger nonosteoporotic populations with neurological symptoms [48,75]. However, the use of hardware in the osteoporotic population can be difficult owing to the poor anchorage in weak osteoporotic vertebral bodies [1,2]. See Variant tables 1 through 7 for examples of recommended clinical use of these examinations and procedures.
SUMMARY
Conservative management is the traditional first-line management for osteoporotic compression fractures. Use of vertebral augmentation is controversial, owing to two previous independent level-1 trials that demonstrated no clinical validity for VP over the sham control groups. Conclusions from these studies have divided the medical community with respect to the efficacy of vertebral augmentation. Despite this controversy, increased use of vertebral augmentation for managing painful osteoporotic and malignant vertebral fractures has been the trend, with the literature favoring patient outcomes over those found with conservative medical management up to 1 year. If VP is recommended for osteoporosis or malignant fractures, it should be used for patients who have failed or cannot tolerate conservative or traditional management. Kyphoplasty data are less extensive but have shown similar results to VP for uncomplicated vertebral compression fractures. Kyphoplasty may have an advantage over traditional VP in complex cases (eg, burst fractures with neurological compromise) or fractures in which height restoration or deformity correction may be beneficial. This slight mechanical advantage over VP may also affect long-term outcomes. More level-1 studies are needed to determine the medical and societal cost of the palliative effect on pain-related morbidity associated with osteoporotic vertebral compression fractures. Smaller-sample studies and use trends indicate vertebral augmentation has benefits over conservative medical management for the first year. Additional information on ACR Appropriateness Criteria is available at: www.acr.org/ac. REFERENCES 1. Radvany MG, Murphy KJ, Millward SF, et al. Research reporting standards for percutaneous vertebral augmentation. J Vasc Interv Radiol 2009;20:1279-86. 2. Kallmes DF, Jensen ME. Percutaneous vertebroplasty. Radiology 2003;229:27-36. 3. McGirt MJ, Parker SL, Wolinsky JP, Witham TF, Bydon A, Gokaslan ZL. Vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures: an evidenced-based review of the literature. Spine J 2009;9:501-8. 4. Lane NE. Epidemiology, etiology, and diagnosis of osteoporosis. Am J Obstet Gynecol 2006;194:S3-11. 5. Siris ES, Brenneman SK, Barrett-Connor E, et al. The effect of age and bone mineral density on the absolute, excess, and relative risk of fracture in postmenopausal women aged 50-99: results from the National Osteoporosis Risk Assessment (NORA). Osteoporos Int 2006;17:565-74. 6. Kim DH, Vaccaro AR. Osteoporotic compression fractures of the spine; current options and considerations for treatment. Spine J 2006;6: 479-87.
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64. Han IH, Chin DK, Kuh SU, et al. Magnetic resonance imaging findings of subsequent fractures after vertebroplasty. Neurosurgery 2009;64: 740-4; discussion 44-5.
48. Pflugmacher R, Agarwal A, Kandziora F, K-Klostermann C. Balloon kyphoplasty combined with posterior instrumentation for the treatment of burst fractures of the spinee1-year results. J Orthop Trauma 2009;23: 126-31.
65. Hierholzer J, Fuchs H, Westphalen K, Baumann C, Slotosch C, Schulz R. Incidence of symptomatic vertebral fractures in patients after percutaneous vertebroplasty. Cardiovasc Intervent Radiol 2008;31: 1178-83.
49. Voormolen MH, Mali WP, Lohle PN, et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol 2007;28:555-60.
66. Lovi A, Teli M, Ortolina A, Costa F, Fornari M, Brayda-Bruno M. Vertebroplasty and kyphoplasty: complementary techniques for the treatment of painful osteoporotic vertebral compression fractures. A prospective non-randomised study on 154 patients. Eur Spine J 2009;(18 Suppl 1):95-101.
50. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res 2011;26:1627-37.
67. Pitton MB, Herber S, Koch U, Oberholzer K, Drees P, Duber C. CTguided vertebroplasty: analysis of technical results, extraosseous cement leakages, and complications in 500 procedures. Eur Radiol 2008;18: 2568-78.
51. 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. 52. 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. 53. 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. 54. Clark W, Lyon S, Burnes J. Trials of vertebroplasty for vertebral fractures. N Engl J Med 2009;361:2097-8; author reply 99-100. 55. Goz V, Koehler SM, Egorova NN, et al. Kyphoplasty and vertebroplasty: trends in use in ambulatory and inpatient settings. Spine J 2011;11:737-44. 56. Diederichs G, Engelken F, Marshall LM, et al. Diffuse idiopathic skeletal hyperostosis (DISH): relation to vertebral fractures and bone density. Osteoporos Int 2011;22:1789-97. 57. Evans AJ, Kip KE, Boutin SM. Prospective assessment of pain and functional status after vertebroplasty for treatment of vertebral compression fractures. J Neurointerventional Surgery 2009;1:66-70.
68. Mazzantini M, Carpeggiani P, d’Ascanio A, Bombardieri S, Di Munno O. Long-term prospective study of osteoporotic patients treated with percutaneous vertebroplasty after fragility fractures. Osteoporos Int 2011;22:1599-607. 69. Tanigawa N, Kariya S, Komemushi A, et al. Percutaneous vertebroplasty for osteoporotic compression fractures: long-term evaluation of the technical and clinical outcomes. AJR Am J Roentgenol 2011;196: 1415-8. 70. Papadopoulos EC, Edobor-Osula F, Gardner MJ, Shindle MK, Lane JM. Unipedicular balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures: early results. J Spinal Disord Tech 2008;21:589-96. 71. Hiwatashi A, Westesson PL, Yoshiura T, et al. Kyphoplasty and vertebroplasty produce the same degree of height restoration. AJNR Am J Neuroradiol 2009;30:669-73. 72. Carbognin G, Sandri A, Girardi V, et al. Treatment of type-A3 amyelic thoracolumbar fractures (burst fractures) with kyphoplasty: initial experience. Radiol Med 2009;114:133-40.
58. Gerling MC, Eubanks JD, Patel R, Whang PG, Bohlman HH, Ahn NU. Cement augmentation of refractory osteoporotic vertebral compression fractures: survivorship analysis. Spine (Phila Pa 1976) 2011;36:E1266-9.
73. De Negri P, Tirri T, Paternoster G, Modano P. Treatment of painful osteoporotic or traumatic vertebral compression fractures by percutaneous vertebral augmentation procedures: a nonrandomized comparison between vertebroplasty and kyphoplasty. Clin J Pain 2007;23:425-30.
59. Kotwica Z, Saracen A. Early and long-term outcomes of vertebroplasty for single osteoporotic fractures. Neurologia i Neurochirurgia Polska 2011;45:431-5.
74. Edidin AA, Ong KL, Lau E, Kurtz SM. Life expectancy following diagnosis of a vertebral compression fracture. Osteoporos Int 2013;24: 451-8.
60. Tanigawa N, Kariya S, Komemushi A, Nakatani M, Yagi R, Sawada S. Added value of percutaneous vertebroplasty: effects on respiratory function. AJR Am J Roentgenol 2012;198:W51-4.
75. Fuentes S, Blondel B, Metellus P, Adetchessi T, Gaudart J, Dufour H. Open kyphoplasty for management of severe osteoporotic spinal fractures. Neurosurgery 2009;64:350-4; discussion 54-5.
This is an updated review of management of vertebral compression fracture for both benign osteoporotic and malignant causes. Vertebral compression fracture radiologic imaging evaluation is discussed. A literature review is provided of current indications for vertebral augmentation with percutaneous vertebroplasty and kyphoplasty as well as medical management. Limitations and potential benefits of these procedures are discussed. Variant tables describing various clinical situations are also provided to assist in determining appropriate use of these treatments for patient care. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a wellestablished consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to formulate recommendations for imaging or treatment. Key Words: Appropriateness criteria, vertebral compression fracture, vertebroplasty, kyphoplasty, osteoporosis, management, treatment, MR J Am Coll Radiol 2014;11:757-763. Copyright © 2014 American College of Radiology
SUMMARY OF LITERATURE REVIEW Introduction
Vertebral augmentation is a generic term referring to percutaneous vertebroplasty (VP) and balloon-assisted kyphoplasty [1]. They are procedures used for the palliation of pain related to vertebral compression a
Good Samaritan Hospital, Cincinnati, Ohio.
fractures. Vertebral compression fractures can be caused by osteoporosis, direct acute trauma in an otherwise healthy vertebra, and neoplasms. Neoplasms causing vertebral compression fractures include: (1) primary bone neoplasms (hemangiomas, giant cell tumors), (2) infiltrative neoplasms (multiple myeloma, lymphoma), m
Metropolitan Diagnostic Imaging Group, Garden City, New York.
b
Mallinckrodt Institute of Radiology, Saint Louis, Missouri.
n
c
University of Illinois Hospital and Health Sciences System, Chicago, Illinois.
o
d
Brigham & Women’s Hospital, Boston, Massachusetts. e Columbia University Medical Center, New York, New York.
p
f American Association of Neurological Surgeons, Rolling Meadows, Illinois/ Congress of Neurological Surgeons, Schaumburg, Illinois.
Corresponding Author: Charles T. McConnell, Jr, MD Attn:Dept of Radiology Good Samaritan Hospital 375 Dixmyth Ave Cincinnati, OH 45220-2475; e-mail: [email protected].
g
Bone, Spine and Hand Surgery, Chartered, Brick, New Jersey.
h
American Academy of Orthopaedic Surgeons, Rosemont, Illinois.
i
University of California Los Angeles Medical Center, Los Angeles, California.
j
American Association of Neurological Surgeons, Rolling Meadows, Illinois/ Congress of Neurological Surgeons, Schaumburg, Illinois.
k
Cleveland Clinic Foundation, Cleveland, Ohio.
l
University of Chicago Hospital, Chicago, Illinois.
ª 2014 American College of Radiology 1546-1440/14/$36.00 http://dx.doi.org/10.1016/j.jacr.2014.04.011
Rush University Medical Center, Chicago, Illinois.
Fairfax Radiology Consultants PC, Fairfax, Virginia.
q
Duke University Medical Center, Durham, North Carolina. Washington University School of Medicine, Saint Louis, Missouri.
Reprint requests to: [email protected]. The ACR seeks and encourages collaboration with other organizations on the development of the ACR Appropriateness Criteria through society representation on expert panels. Participation by representatives from collaborating societies on the expert panel does not necessarily imply individual or society endorsement of the final document. No conflict of interest was reported.
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and (3) metastatic neoplasms [1-3]. Osteoporotic vertebral compression fractures are the most commonly encountered fractures that require augmentation; they are the focus of this narrative. Postmenopausal women represent the majority of patients at risk for developing osteoporotic fractures of any type, and vertebral compression fractures represent 25% of osteoporotic fractures [4-6]. Painful vertebral compression fractures may cause a marked decline in physical activity and quality of life, leading to general physical deconditioning. This decline, in turn, may prompt further complications related to poor inspiratory effort (atelectasis and pneumonia) and venous stasis (deep venous thrombosis and pulmonary embolism) [1]. Successful management of painful vertebral compression fractures has the potential for improving quality of life, increasing the expectancy of an independent and/or productive life, and preventing superimposed medical complications. Some have suggested that management of painful vertebral compression fractures may also have a cost benefit for society as a whole; however, assessment of any potential societal benefits is difficult owing to the inexactness of methods for quantifying pain-related disability. Management Overview
The traditional first-line treatment of painful vertebral compression fractures is conservative management, which includes medical management with or without methods of immobility [7]. Most pain-related symptoms from vertebral compression fractures are resolved with this management [7,8]. Successful medical management also involves appropriate screening for osteoporosis and appropriate follow-up treatment. (See the ACR Appropriateness Criteria topic on “Osteoporosis and Bone Mineral Density” [9]). Vertebral augmentation in the form of VP and balloon-aided kyphoplasty has been used for managing painful vertebral compression fractures that are refractory to conservative management. The threshold for performing vertebral augmentation has declined as a result of its expanded use within the medical community, the rapidity of clinical response, and the relatively low procedural risk. Indeed, some authors have advocated prophylactic VP [10,11]. In addition, an increasing number of studies have described successful results using vertebral augmentation for painful refractory malignant fractures and symptomatic myelomatous vertebral replacement [12,13]. More invasive modifications, such as open kyphoplasty, have also been described for managing complex fractures that pose a relative contraindication for traditional VP. The increasingly widespread clinical applications and proposed indications for vertebral augmentation have fueled debate on the use, medical costeffectiveness, and societal cost-effectiveness of these procedures.
Management Options
Conservative Management. Conservative management is the initial conventional treatment of painful vertebral compression fractures [7]. It includes medical management with or without methods of immobility. Medications include nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics. However, these medications have complications. Gastrointestinal hemorrhage, ulcerative perforations, and death occur in 1.5% of the patients annually, with 40% of chronic users having endoscopically proven ulcers [14,15]. Narcotics for noncancer pain management can lead to constipation (41%), nausea (32%), somnolence (29%), and addiction, with all patients exhibiting at least 1 adverse effect [16]. Most patients with osteoporotic vertebral compression fractures have spontaneous resolution of pain, even without medication [7,17-19]. Since the inception of vertebral augmentation in the late 1980s, its minimally invasive procedures have been reserved for patients who have failed conservative therapy. Failure can be defined as pain refractory to oral medications (NSAIDs and/or narcotics) [20-24]. However, failure can also be defined as a contraindication to such medications or a requirement for parenteral narcotics and hospital admission. A recent multispecialty Position Statement and the ACR Practice Guideline for the Performance of Vertebral Augmentation have addressed this topic [25,26]. Preprocedural Imaging. The ideal preprocedural imaging has not been identified [27,28]. For some authors, focal spinous process pain on palpation, correlated with radiographs of the vertebral column, is a satisfactory indication for the procedure. Spine radiographs, however, are often nonspecific with respect to the patient’s age or cause of the fracture [29]. Alternatively, others have recommended that MRI be done before the procedure. MRI, especially using a short tau inversion recovery (STIR) sequence, is sensitive for detecting acute fractures and may differentiate synchronous fractures. MRI is also useful in distinguishing recent from chronic vertebral fractures in patients with multiple deformities and confusing clinical examinations [30,31]. Recent fractures exhibit edema, which can be detected by STIR MRI for up to 3 months after the fracture occurs [32,33]. Minimally deforming fractures that are overlooked by conventional radiographs but detected on MRI may be a cause of clinical failure of VP [27]. The benefits of MRI for preprocedural planning and guiding the puncture site have also been reported [27,34,35]. The use of MRI for evaluating benign and malignant fractures has also been well documented [36]. Thus, to ensure appropriate treatment, MRI evaluation should be considered before any planned vertebral augmentation in patients with a history of malignancy or atypical clinical features. The benefit of MRI must be weighed against its cost [28]. CT is usually reserved for a
McConnell et al/Vertebral Compression Fractures 759
detailed analysis of fractures that extend to the posterior column of the vertebra or for evaluating the integrity of pedicles and the posterior cortex prior to VP [2,37]. Percutaneous Vertebroplasty. Vertebral augmentation in the form of VP has been used for managing osteoporotic vertebral compression fractures since the 1980s in Europe and since the early 1990s in the United States. It involves injecting low-viscosity cement directly into the vertebral body, using a unipedicle or bipedicle needle. The procedure has had significant success, with 89%e93% of patients having reduced pain and painrelated morbidity, and 40% having complete resolution of pain often immediately postprocedure [38,39]. This translates to improved ambulation (up to normal activity) in 56%e95% of patients [40-42]. Women and patients age <75 years seem to benefit the most [42,43]. Kyphoplasty results largely parallel VP results, and the differences will be noted in later discussion. With respect to pain relief, several studies have shown that VP reduces mean pain estimates based on a visual analogue scale (VAS; scale range: 0-10) by approximately 5 points, with prevertebroplasty scores ranging from 8.1 to 8.4 and a reduced range of 2.6-3.0 postvertebroplasty [3,44-46]. The authors of this metaanalysis of 5 studies published a similar analysis of >1,400 patients; the mean VAS range was reduced from 5.4-9.1 to 1.5-4.9 [7,40,41,47,48]. Each study had a statistically significant (P < .05) improvement in the VAS pain scale [7,40,41,47,48]. With respect to the duration of pain relief, it is well documented that vertebral augmentation is becoming more beneficial than conservative management, with respect to pain relief, quality of life, and mobility at all time intervals between the day of procedure to 1 year [49]. The reported benefits of vertebral augmentation after 1 year, however, subside and patients show little difference from those who underwent conservative medical management [50-52]. However, controversy exists with respect to the overall benefit of VP, based largely on the conclusions of 2 highprofile, randomized controlled trials. These independent, prospective, randomized controlled trials compared VP with a sham control group [17,53]. The total number of patients with adequate follow-up in both studies was 202 (103 in the VP group and 99 in the control group). Both limbs in both studies had reduced pain, with a trend toward better pain control in the VP group [17,53]. However, both studies concluded that the VP group did not show a statistical clinical advantage over the control group [17,53]. The Investigational Vertebroplasty Safety and Efficacy Trial (INVEST) used lidocaine injection through a transpedicular needle as its control [17]. The study by Buchbinder et al [53] did not instill any medication in the control group. These results have stirred a debate between critics and supporters of the two studies [54]. Criticism has focused
Variant 1. Elderly woman with a recent recurring benign, painful 25% loss-of-height compression fracture. Previous fracture healed spontaneously with conservative management Treatment/ Procedure Rating Comments Advanced radiologic imaging
6
Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
8
A patient with a history of recurring pain may benefit from further imaging.
4 4 2
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate.
on the scientific validity of the trials. These authors mostly criticize the relatively small sample size, the use of lidocaine in the INVEST trial, and the high crossover from the control group to the VP group, in addition to a possible superimposed placebo effect [54]. This high cross-over may indicate patient dissatisfaction beyond the placebo effect in the control group, and it may be compounded by the relatively small sample sizes [54]. An additional caveat predicted previously [2] is that patients with significant pain, and those who are most likely to respond significantly to VP, may also be reluctant to participate in a trial with a 50% chance of undergoing a sham procedure. Supporters of the findings of the 2 trials mention that these are the highestlevel trials investigating VP to date [54]. However, despite this controversy, use of vertebral augmentation procedures increased from 2001 through 2008 [55]. The trend for increased use is likely attributable to individual physician experience on the efficacy of vertebral Variant 2. Elderly man with painful first spontaneous compression fracture who has limited his ADLs. No neurologic symptoms are present Treatment/ Procedure Rating Comments Advanced radiologic imaging
8
Conservative medical treatment Vertebroplasty
8 5
Kyphoplasty
5
Surgical referral
2
Significant information, such as the etiology of the fracture, can be obtained from crosssectional imaging.
Use this procedure if the patient fails conservative management. Use this procedure if the patient fails conservative management.
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate. ADL ¼ activities of daily living.
760 Journal of the American College of Radiology/Vol. 11 No. 8 August 2014
Variant 3. Middle-aged active man with a T7 burst fracture and a history of recent trauma. The new fracture is impeding his ADLs. Patient also complains of newonset right lower-limb tingling Treatment/ Procedure Rating Comments Advanced radiologic imaging Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
Variant 5. Elderly independent woman, with new painful fracture limiting ADLs, and previous successful vertebroplasty Treatment/Procedure Rating Comments Advanced radiologic imaging
8
Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
6
9 5 3 3 9
Given the neurologic complications, consider a surgical evaluation and MR imaging.
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate. ADL ¼ activities of daily living.
augmentation as well as numerous and ever-increasing alternative research studies showing its benefit. In particular, the additional reported benefits of vertebral augmentation include vertebral deformity improvement, improvement in activities of daily living (ADLs), and improved respiratory function and survival [56-60]. Also, the rapidity of pain relief allowing for early mobilization after VP is often a reported benefit, especially in elderly patients with limited life expectancy and treatment options [61,62]. A growing body of evidence also supports vertebral augmentation for refractory malignant fractures [12,13,63]. Although the reported complications ranged from only 1% to 3.9%, they varied depending on: (1) the specific definitions of complications, (2) the degree of clinical and imaging follow-up, and (3) the collective definitions (amalgamation) of complications. Frequently mentioned complications included: cement leak (asymptomatic or symptomatic), cement pulmonary embolism (asymptomatic or symptomatic), and bleeding/hematoma, infection, and neurological deficit (transient or permanent). Delayed complications included fractures involving other vertebral levels in 2.5%e17.3% of cases Variant 4. Elderly woman with painful subacute, hyperkyphotic compression fracture unresponsive to conservative treatment (NSAIDS) with continued loss of ADLs Treatment/Procedure Rating Comments Advanced radiologic imaging Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
8 3 8 7 4
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate. ADL ¼ activities of daily living; NSAIDS ¼ nonsteroidal anti-inflammatory drugs.
Prior to intervention, perform imaging to rule out malignancy.
5 5 1
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate. ADL ¼ activities of daily living.
(subject to the length and degree of follow-up, the definitions, and the imaging quality), with 43%e49% and 51%e57% of these fractures occurring in distant or adjacent vertebral bodies, respectively [39,40,53,64-67]. It is unknown whether additional fractures are truly long-term complications of the procedure (contributed in part by the procedure) or the natural history and/or the progression of osteoporosis, and assessment is difficult without prospective randomized trials involving large numbers of subjects [2]. Addressing the issue of additional fractures in VP patients, Buchbinder et al [53] devised a randomized, controlled, prospective study in a small sample size. In this study, patients were randomized to a VP group and a sham/placebo group. In a 6-month follow-up, 8.6% (n¼3 of 35) of the VP group and 11.1% (n¼4 of 36) of the placebo group had secondary vertebral fractures. Other studies reported repeat fractures in 27%e33% of patients after VP, with low body mass index, bone mineral density, and vitamin D levels as contributing risk factors for additional fractures [68,69]. Kyphoplasty. Kyphoplasty is a derivation of VP. It involves a percutaneous unipedicle or a bipedicular approach with the insertion of a balloon dilation catheter which is then inflated to restore vertebral body height and create a space for a low-pressure injection of high-viscosity bone cement. Proponents of this procedure emphasize the benefits of better deformity correction over VP. As with traditional VP, it can be achieved Variant 6. Elderly chronically bedridden man with a painful compression fracture that has failed conservative management Treatment/Procedure Rating Comments Advanced radiologic imaging Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
8 2 8 8 3
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate.
McConnell et al/Vertebral Compression Fractures 761
Variant 7. Elderly woman with malignant subacute, painful compression fracture refractory to conservative management Treatment/Procedure Rating Comments Advanced radiologic imaging Conservative medical treatment Vertebroplasty Kyphoplasty Surgical referral
9 2 7 7 6
Note: Rating scale: 1, 2, and 3 ¼ usually not appropriate; 4, 5, and 6 ¼ may be appropriate; 7, 8, and 9 ¼ usually appropriate.
via a unipedicle (single-balloon) or classically bipedicle (double-balloon) approach [70]. There is less clinical experience with kyphoplasty than with conventional VP [11]. Three studies that directly compared VP with kyphoplasty showed no significant difference in outcome (based on results and complications), with the same type of complications occurring in both [39,66,71]. Technically, kyphoplasty may have some merit for certain conditions, such as vertebral burst fractures with or without neurological symptoms, as it may offer a more controlled angular and fracture correction with cement deposition when compared with VP alone [38,39,72]. In addition, some authors believe that kyphoplasty is superior to conventional VP height restoration [38,39,72]. Due to space created by balloon dilation within the vertebral body before injection, less cement leakage has also been noted for kyphoplasty when compared with VP [73]. A recent study also suggested a small overall benefit of kyphoplasty over VP (and conservative management) with respect to life expectancy [74]. Open Kyphoplasty. Open kyphoplasty is the most invasive variant of vertebral augmentation. It involves using kyphoplasty with a surgical component that may include laminectomy, decompression, short-segment vertebral osteosynthesis, and/or short posterior internal fixation [48,75]. Fuentes et al [75] discussed treatment of 16 patients with neurological symptoms in which all showed improved symptoms, and 88% had resolution of their symptoms. Another study of 21 patients showed that pain improved up to 3 months after the procedure and then reached a plateau [48]. This trend was also reflected by the percentage of patients who had residual disability of 88%, 35%, and 36% at 1, 3, and 12 months, respectively [48]. The experience with this procedure is limited and seems to be specific to traumarelated burst fractures, possibly in younger nonosteoporotic populations with neurological symptoms [48,75]. However, the use of hardware in the osteoporotic population can be difficult owing to the poor anchorage in weak osteoporotic vertebral bodies [1,2]. See Variant tables 1 through 7 for examples of recommended clinical use of these examinations and procedures.
SUMMARY
Conservative management is the traditional first-line management for osteoporotic compression fractures. Use of vertebral augmentation is controversial, owing to two previous independent level-1 trials that demonstrated no clinical validity for VP over the sham control groups. Conclusions from these studies have divided the medical community with respect to the efficacy of vertebral augmentation. Despite this controversy, increased use of vertebral augmentation for managing painful osteoporotic and malignant vertebral fractures has been the trend, with the literature favoring patient outcomes over those found with conservative medical management up to 1 year. If VP is recommended for osteoporosis or malignant fractures, it should be used for patients who have failed or cannot tolerate conservative or traditional management. Kyphoplasty data are less extensive but have shown similar results to VP for uncomplicated vertebral compression fractures. Kyphoplasty may have an advantage over traditional VP in complex cases (eg, burst fractures with neurological compromise) or fractures in which height restoration or deformity correction may be beneficial. This slight mechanical advantage over VP may also affect long-term outcomes. More level-1 studies are needed to determine the medical and societal cost of the palliative effect on pain-related morbidity associated with osteoporotic vertebral compression fractures. Smaller-sample studies and use trends indicate vertebral augmentation has benefits over conservative medical management for the first year. Additional information on ACR Appropriateness Criteria is available at: www.acr.org/ac. REFERENCES 1. Radvany MG, Murphy KJ, Millward SF, et al. Research reporting standards for percutaneous vertebral augmentation. J Vasc Interv Radiol 2009;20:1279-86. 2. Kallmes DF, Jensen ME. Percutaneous vertebroplasty. Radiology 2003;229:27-36. 3. McGirt MJ, Parker SL, Wolinsky JP, Witham TF, Bydon A, Gokaslan ZL. Vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures: an evidenced-based review of the literature. Spine J 2009;9:501-8. 4. Lane NE. Epidemiology, etiology, and diagnosis of osteoporosis. Am J Obstet Gynecol 2006;194:S3-11. 5. Siris ES, Brenneman SK, Barrett-Connor E, et al. The effect of age and bone mineral density on the absolute, excess, and relative risk of fracture in postmenopausal women aged 50-99: results from the National Osteoporosis Risk Assessment (NORA). Osteoporos Int 2006;17:565-74. 6. Kim DH, Vaccaro AR. Osteoporotic compression fractures of the spine; current options and considerations for treatment. Spine J 2006;6: 479-87.
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