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Vertebral Augmentation for Osteoporotic Compression Fractures
Journal of Clinical Densitometry: Assessment & Management of Musculoskeletal Health, vol. 19, no. 1, 89e96, 2016 Ó Copyright 2016 by The International Society for Clinical Densitometry 1094-6950/19:89e96/$36.00 http://dx.doi.org/10.1016/j.jocd.2015.08.013
Special Section: Vertebral Fractures
Vertebral Augmentation for Osteoporotic Compression Fractures Bradford J. Richmond* Department of Diagnostic Radiology, Section of Musculoskeletal Radiology, Cleveland Clinic, Cleveland, OH, USA
Abstract Vertebral augmentation procedures such as vertebroplasty and kyphoplasty were developed to reduce pain and improve quality of life for patients with osteoporotic vertebral compression fractures. However, the use of vertebral augmentation has been debated and questioned since its inception. This article addresses some of these issues. Key Words: Vertebral fractures; Vertebral augmentation; Vertebroplasty; Kyphoplasty.
polymethyl methacrylate (PMMA) allergy, or lytic metastases breaching into the spinal canal (9).
Who Should Have Vertebral Augmentation Failure of conservative management, including rest, medications for pain, and physical therapy, if appropriate, for 6 wk (1) in a patient with intractable pain secondary to a vertebral fracture is an indication for vertebral augmentation (VAG). Failure of treatment and persistent pain associated with the fractures are associated with depression, vascular and pulmonary complications, and decreased activity leading to decreased quality of life (2). Evaluation of quality of life issues is performed by one of several visual and analog scales (3). The initial evaluation of the patient should be an X-ray. Radiographs alone cannot be used to determine the need for VAG because they can identify a fracture but are not necessarily specific for etiology (4). The finding of vertebra plana should be considered a non-OVCF until a biopsy rules out neoplasm (1). Magnetic resonance imaging (MRI) should be performed before the decision for a VAG procedure. Patients who cannot have an MRI should have a computed tomography (CT) with sagittal reconstruction to evaluate the fracture. Bone scan may also be used with tomography to evaluate for intense uptake indicating a fracture (5,6). Patients with lytic bone metastases and stable traumatic vertebral fractures of the vertebral body are also candidates for VAG (7,8). VAG is contraindicated in patients with either pathologic or iatrogenic coagulation disorders, sepsis or vertebral osteomyelitis,
Vertebroplasty VAG initially was used for nonosteoporotic fractures and has since become a tool for treating OVCF’s. Vertebroplasty (VP) was first reported in 1987 by Galibert (7) for stabilization of a C2 hemangioma. The procedure was later used for hemangiomas, malignancies (10) and traumatic fractures (Magerl A3.1, 3.2, 3.3; burst), and (AO, A1eA3) (11). Today the technique of VP depends on the anatomic vertebral level to be treated. In the cervical and upper thoracic spine, an anterolateral or transoral approach with a 15gauge infusion needle is typically used. This technique is used to treat angiomas and neoplasm, for example, multiple myeloma (11,12) and metabolic bone disease syndromes (13). VP in the thoracic spine is generally performed using a 13-gauge needle with a transpedicular or posterolateral approach. Eleven- or 10-gauge infusion needles are used in the lumbar spine with either a transpedicular or posterolateral approach (14). In general, the VP entails using a cutting needle to infuse PMMA into the vertebral body. After a local anesthetic is administered, the needle with trocar is introduced as close to the center of the vertebral body as possible. The injection of 2e10 mL of cement is variable of PMMA, or until twothirds of the anterior vertebral height is filled with cement (1); the trocar is replaced, and the needle is withdrawn. Replacing the trocar reduces the likelihood of cement being dragged through the pedicle and/or leaking out of the vertebral body (Fig. 1).
Received 06/24/15; Accepted 08/14/15. *Address correspondence to: Dr Bradford J. Richmond, MD, MS, FACR, CCD, Department of Diagnostic Radiology, Cleveland Clinic, Cleveland, OH 44107. E-mail: [email protected]
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Fig. 1. Axial (A) and Sagittal (B) image of a Computed Tomography scan demonstrated the filling os trabecular spaces with methacrylate after vertebroplasty. The technique was originally performed under general anesthesia; however, VP is now most frequently performed with local anesthesia and/or conscious sedation. Initially, patients were admitted to the hospital for 2 d of observation after this procedure, but today, a period of observation of up to 24 h as an outpatient is standard. The patient is generally ambulatory shortly after the procedure.
immediately after inflation, and transient hyperalgesia (21). Vertebral refracture after cement fragmentation is a rare complication (22). Delayed failure of KP may be the result of an incorrect assessment of the original compression fracture. Extension into the posterior elements of the original fracture increases the risk of cement leak or bone fragment retropulsion (23).
Kyphoplasty
The Vertebral Cleft
Kyphoplasty (KP) was developed in an attempt to improve height restoration of the fractured vertebral body compared with VP. For KP, the needle is introduced if the infusion needle is the same as used for VP. Balloon tamps are introduced through the needle and inflated to make a cavity (ies) in the vertebral body (9,14). PMMA can then be introduced into the cavity under lower pressure to fill the cavity (15). Performing KP within 28 d of the initial fracture was most effective for height restoration, but delayed KP, O28 d after fracture, reduces cement leakage (16) (Fig. 2 and 4). KP began using general anesthesia. Conscious sedation can be used when performing KP (17). A study comparing unipedicular vs bipedicular injection with KP demonstrated no difference in clinical outcomes but improved height restoration with the bipedicular technique (18). However, unipedicular injections led to shorter procedures. Radiofrequency KP, another alternative approach, uses radiofrequency to produce ultra-high viscosity cement (19). A short-term study found that radiofrequency KP led to improvements in vertebral height restoration and Cobb angle correction using KP (20). Complications of KP include balloon rupture or end plate fracture during inflation, decreased height restoration
The vertebral cleft is an important radiographic sign secondary to fracture of the anterior vertebral body that results in better height restoration with VAG. The cleft is a cavity in the vertebral body, either gas or fluid-filled nonunion fracture (24), with pseudoarthrosis. KP was determined to have less contrast leakage than VP with a vertebral cleft (25). CT and MRI are most sensitive for identifying the vertebral cleft (26). Radiographic confirmation of vertebral body height changes with flexion and extension views before VAG in patients with vertebral clefts predicts the ability to restore height from the procedure (27).
Preprocedural Considerations Before a patient is given anesthesia for VP or KP, several factors must be considered including whether the patient has lung and/or cardiac disease, infection (28), whether the patient is ambulatory, what medications the patient is using, and whether there is a history of poor nutrition or drug addiction (29). A history of PMMA allergy can result in bone cement implantation syndrome described as a rare complication of VAG. The syndrome results in a delayed postprocedural
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Fig. 2. Axial (A) and sagittal (B) image demonstrating the filling of spaces resulting in balloon dilatation with subsequent filling of the cavity with methacrylate under lower pressure. Note the defined appearance of the cement with no cement in the trabecular space. decrease in blood pressure, decreased arterial pO2, bradycardia, low cardiac output, right ventricular decreased output, and increased pulmonary artery pressure. Cardiac arrest can result from all the vascular changes or may happen acutely (29,30).
cement pulmonary embolism and cardiac perforation (42,43), extremity vascular embolism, and other thrombi. Nerve and spinal cord injuries have also been reported. Research has shown that KP is associated with a higher incidence of leaks into the intervertebral disc vs VP because of the tamp effect on end plates during KP (9).
Potential Complications of Cement Leakage Embolism of the thoracic vertebral segmental artery (31) and pulmonary artery (30), dorsal foot artery (32), and renal artery has been reported as a potential complication of cement leakage in patients treated with VP or KP (33). Right ventricular cement embolism after KP has recently been reported (34) resulting in cardiac tamponade (34). Pulmonary embolism secondary to cement leakage from VP or KP may be delayed and either symptomatic or asymptomatic (35,36). Cement leakage through the pedicle after removal of the trocar may result in paraparesis (37,38). Use of high viscosity cement can reduce the leakage of cement during VP (39,40). A cadaveric vertebral body study concluded that heat generated from PMMA was not sufficient to damage spinal nerves, if leakage occurred (41) (Figs. 3e5). Cement leakage has been found to occur in up to 41% of KP procedures and up to 71% of VP procedures; the rate of cement leakage is higher with VP because of the higher infusion pressure associated with this procedure (39). In most cases, this leakage is benign and causes no clinical symptoms. However, a transient radicular pain has been described with leakage into the neural foramen or in close proximity to the nerve root. The pain generally resolves in 24 h (41). Serious events related to cement leakage include
Fig. 3. Note the cement leakage posterior through the cortex resulting in neural foraminal narrowing. The calcified aorta is on the left.
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Fig. 4. Cement leakage anterior to the L1 vertebral body, extending in a cephalad direction and crossing the adjacent disk and vertebral body. Anterior leakage can laso result in aortic of bowel fistulas. AT L5 the cement partially extends into the pedicale.
Choice of Sedation For patients !65 yr undergoing a simple VP with fewer than 3 levels treated, conscious sedation can be considered. Multiple level VP and KP should be performed under general anesthesia. Possible reactions to PMMA, including anaphylaxis, need to be considered when choosing the type of sedation to be used. Monitoring for pulmonary embolism and immediate treatment should be available (44).
VP vs KP Since the introduction of KP, researchers have been questioning whether KP or VP is more effective in providing pain relief, restoring vertebral height, and reducing the kyphotic angle. Questions have also arisen regarding the costeffectiveness of each technique and which procedure has the lowest risk of cement leakage. Both techniques VP and KP have been found proven to be effective for pain reduction (45e47); however, there are few head-to-head studies in large populations comparing the efficacy of VP and KP for pain relief. A meta-analysis found both techniques effective for pain relief at 12 mo. KP may be more effective than VP in patients with osteoporotic vertebral
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Fig. 5. Cement in L3 has normal appearance.. Cement injection at L1/L2 was partially into the L1/L2 disk with leakage into a vein. Cement injection at T12 resulted in end plate leakage of contrast into the T12/L1 disk. compression fractures (OVCFs) that have a significant height loss (48). For patients with biconcave fractures, KP and VP were equally effective in reducing pain and disability scores, but KP may restore height more effectively than VP (49). Additionally, in a review of the literature, Kasperk et al (50) found patients with degenerative disc disease may not have complete pain relief with VAG. Reports of height restoration with KP vary and are greater than with VP (51). However, the restoration of height may be less important than other aspects of these techniques. For instance, reduction of the kyphotic angle is believed to be a more important effect of KP and VP (52,53). The cost-effectiveness of KP and VP has also been under debate. One study found that the initial costs of VAG were greater for KP than VP, but both were more cost-effective than conservative treatment in the Medicare population, regardless of age (54). VP was found to be more cost-effective than KP in the inpatient setting, but performing VP or KP in the outpatient setting significantly reduces costs regardless of the procedure used (55). Outpatient costs in a VA study were lower with VP than with KP (56). Several studies have assessed various aspects of the KP-vsVP debate. In a review of the literature, Stevenson et al (57) found that although VP and KP both reduced pain, VP was
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Vertebral Augmentation for Osteoporotic Compression Fractures more cost-effective than KP. However, KP increased vertebral height to a greater extent than VP. KP initially increased vertebral body height significantly more than VP, after repetitive loading, the difference was negated. The authors also found that both techniques were effective for pain relief from compression fractures; additionally, complications associated with KP or VP were !2% for compression fractures and 10% for treated malignant vertebral bodies (58). To avoid the potential risk of procedure-related infection, preprocedure and intraprocedure use of broad-spectrum antibiotics is recommended (59).
The Adjacent Fracture Question A concern of using cement to treat vertebral fractures is whether the stiffness of the treated vertebral body will cause compression fracture of an adjacent vertebral body. In a small study of adjacent vertebral fractures in patients who underwent KP or VP, there were equal numbers of adjacent fractures in patients treated with VP and those treated with KP, suggesting that the presence of cement from either technique was not related to adjacent fracture. The authors concluded that the presence of cement from either technique was not related to adjacent fracture. The authors did find a correlation between a T-score of 3 or lower with the development of adjacent fractures (60). Patients with low bone mineral density, body mass index, and vitamin D levels were associated with higher rates of additional vertebral fractures after VP (61). In a study that compared the adjacent fracture rate in patients treated with conservative therapy and those treated with KP, there was no additional risk of adjacent fracture after KP (58). Similarly, Fribourg et al (62) retrospectively reviewed the charts of patients who had undergone KP and found no difference in the incidence of adjacent vertebral fractures compared with the incidence in untreated patients. However, another study found that among 17 patients treated with KP (almost exclusively bilateral injections), 5 developed adjacent fractures, whereas among 19 patients treated with VP (unilateral injections), there were no adjacent fractures at 3 mo. The American College of Radiology appropriateness criteria reviewed the literature finding that delayed fractures adjacent to VAG were reported in several studies ranging from 2.5 to 17.3% (63). Degenerative disk disease may affect load transfer, but peripheral cement placement in the degenerative disc vertebral body may reduce the fracture risk for adjacent vertebral bodies (64). In a study by Hart et al, VP or KP of vertebral bodies in the cranial vertebral body adjacent to a postoperative spinal fusion was prophylactically performed in 28 elderly osteoporotic patients expected to be at high risk for fracture. Of the 28 patients who had VAG, VP, and KP, 2 fractures occurred with no greater loss of height than the cement. The authors concluded, in this population, it is cost-effective to perform VAG in 1 levels cranial to a spinal fusion (65).
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Biopsy During VP and KP Disease processes such as multiple myeloma and metastatic disease may mimic osteoporosis in the appearance of low bone mass. Biopsy can provide assurance that no pathologic process is present when performing VAG. In one study, 692 patients who underwent VP or KP over a 7-yr period also had a biopsy during the procedure. Among the study patients, 44 were known to have a malignancy before the procedure, but the vertebral body biopsy demonstrated a malignancy in only 25 of these patients. However, 2 previously undiagnosed malignancies were identified with biopsy. The authors concluded that biopsy should be routinely performed during VP and KP procedures (66,67). Biopsy is especially important for patients undergoing KP for the first time for the treatment of assumed osteoporotic fracture refractive to conservative therapy (68).
Choice of Cement PMMA is the most commonly used cement for VAG. The cement has high viscosity, and 2 other cement preparations with lower viscosity are also used clinically. Yang and Zou reviewed the literature to compare all commercially available cements. Because of decreased load transfer, stress shielding, and adjacent fracture rate, a coralbased cement was found to be the most effective. All other parameters were the same except for a low elastic modulus for the coral-based cement (69). Calcium sulfate cement have better bioactivity, allows for bone ingrowth, with improved bone healing when compared with PMMA (70). Radiation exposure is a significant consideration for any technique that uses fluoroscopy and CT. One study demonstrated a significant decrease in radiation exposure to both patients and physicians when a modified syringe technique for cement injection was used vs the delivery system provided by the manufacturer (71).
Stenting Stenting is an adjunct to KP attempting to improve and sustain restoration of vertebral height of the OVCF. Klezl et al were the first to report using a stent to treat compression fracture or incomplete burst fracture. With this procedure, the initial surgical technique is the same as that used for a transpedicular approach for KP, except a K-wire is used in this system. The K-wire acts as a guide for a metallic stent that is placed over the Kyphon balloon (Kyphon, INC, Sunnvale, CA). No additional deformities occurred after the procedure in these initial 20 study patients, but the authors did allude to unreported cases of stent migration (72). Vertebral Jack, a novel device, unfolds to restore vertebral body height. Cement is then injected (73) Cement distribution is also improved because a higher volume of cement is injected, thus improving load distribution. Assisted technology to restore vertebral height can be used for malignant fractures, OVCF, and traumatic fractures (best
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94 results in younger patients) (74). Muto points out the use of assisted technology increases the cost of the VAG procedure. In conclusion, VAG using either VP or KP has been debated since the inception of these procedures, and debates whether VP or KP is best for pain relief and functionality continue to this day. There is a group of physicians who believe that conservative medical treatment is still the best choice for OVCF. A review of the literature consistently provides evidence that pain relief with VP and KP is equivalent to or better than medical therapy initially and that this pain relief persists longer. However, highly criticized randomized controlled trials claimed that VP was no better than sham surgery (75) or local anesthetic infusion around pedicles and soft tissues, the Investigational Vertebroplasty Safety and Efficacy Trial (76). In the debate over VP vs KP, nonrandomized studies have found that height restoration of compressed vertebral bodies is greater with KP than VP, although minimal and results in improved Cobb angle, positively affecting the patient’s quality of life. KP is also significantly more expensive than VP in the inpatient and outpatient population. Debates over VAG, VP vs KP, and medical treatment for OVCFs are not likely to be definitely settled in the near future. VAG procedures, especially VP, have increased as a treatment choice for OVCF for the appropriately selected patient. VAG in the first year after the procedure has been shown to be cost-effective compared with conservative treatment. Local, regional, national practice patterns, and insurance reimbursement rates will determine which, if any, VAG procedure may be used in the future.
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96 62. Fribourg D, Tang C, Sra P, et al. 2004 Incidence of Subsequent Vertebral Fracture after Kyphoplasty. Spine 29(20): 2270e2276. 63. McConnell CT, Wippold FJ 2nd, Ray CE Jr, et al. 2014 ACR Appropriateness Criteria Management of Vertebral Compression Fracture. J Am Coll Radiol 8:757e763. 64. Kosmopoulos V, Keller TS, Schizas C. 2009 Early stage disc degeneration does not havd an appreciable affect on stiffness a,nd load transfer following vertebroplasty and kyphoplasty. Eur Spine J 18:59e68. 65. Hart RA, Prendergast MA, Roberts WG, et al. 2008 Proximal junctional acute collapse cranial to multi-level lumbar fusion: a cost analysis of prophylactic vertebral augmentation. The Spine J 8(6):875e881. 66. Zhang L, Li J, Yang H, et al. 2013 Histological evaluation of bone biopsy results during PVP or PKP of vertebral compression fractures. Oncol Lett 5:135e138. 67. Pneumaticus SG, Triantafyllopoulos GK, Chatziioannou S, et al. 2010 Routine needle biopsy during vertebral augmentation procedures. Is it necessary? Eur Spine J 19: 1894e1898. 68. Allen RT, Kum JB, Weidner N, et al. 2009 Biopsy of Osteoportic Vertebral Compression Fractures During Kyphoplasty. Spine 14(14):1486e1491. 69. Yang H, Zou J. 2011 Filling Materials Used in Kyphoplasty and Vertebroplasty for Vertebral Compresson Fracture:
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72. 73.
74. 75. 76.
A Literature Review. Artif Cells Blood Subsit Immobil Biotechnol 39:87e91. Yang HL, Zhu XS, Chen L, et al. 2012 Bone healing response to a synthetic calcium sulfate/beta-tricalcium phosphate graft material in a sheep vertebral body defect model. J Biomed Mater Res B Appl Biomater 100(7):1911e1921. Ortiz AO, Natarajan V, Gregorius DR, et al. 2006 Significantly Reduced Radiation Exposure to Operators during Kyphoplasty and Vertebroplasty Procedures: Methods and Techniques. Amer J Neuroradiol 27:989e994. Klezl Z, Majeed H, Bommireddy R, et al. 2011 Early results after vertebral body stenting for fractures of the anterior column of the thoracic spine. Injury 42(10):1938e1942. Sietsma MS, Hosman AJ, Verdonschot NJ, et al. 2009 Biomechanical Evaluation of the Vertenbral Jack Tool and the Inflatable Bone Tamp for Reduction of Osteoporotic Spine Fractures. Spine 34(18):E640eE644. Muto M, Marcia S, Guarnieri G, et al. 2015 Assisted techniques for cementoplasty: Why should we do it? Eur J of Radiol 84(5):783e788. Buchbinder R, Osborne RH, Ebeling PR, et al. 2009 A randomized Trial of Vertebroplasty for Painful Osteoportic Vertebral Fractures. NEJM 361:557e568. Kallmes DF, Comstock BA, Heagerty PJ, et al. 2009 A Randomized Trial of Vertebroplasty for Osteoportic Spinal Fractures. NEJM 361:569e579.
Journal of Clinical Densitometry: Assessment & Management of Musculoskeletal Health
Volume 19, 2016
Special Section: Vertebral Fractures
Vertebral Augmentation for Osteoporotic Compression Fractures Bradford J. Richmond* Department of Diagnostic Radiology, Section of Musculoskeletal Radiology, Cleveland Clinic, Cleveland, OH, USA
Abstract Vertebral augmentation procedures such as vertebroplasty and kyphoplasty were developed to reduce pain and improve quality of life for patients with osteoporotic vertebral compression fractures. However, the use of vertebral augmentation has been debated and questioned since its inception. This article addresses some of these issues. Key Words: Vertebral fractures; Vertebral augmentation; Vertebroplasty; Kyphoplasty.
polymethyl methacrylate (PMMA) allergy, or lytic metastases breaching into the spinal canal (9).
Who Should Have Vertebral Augmentation Failure of conservative management, including rest, medications for pain, and physical therapy, if appropriate, for 6 wk (1) in a patient with intractable pain secondary to a vertebral fracture is an indication for vertebral augmentation (VAG). Failure of treatment and persistent pain associated with the fractures are associated with depression, vascular and pulmonary complications, and decreased activity leading to decreased quality of life (2). Evaluation of quality of life issues is performed by one of several visual and analog scales (3). The initial evaluation of the patient should be an X-ray. Radiographs alone cannot be used to determine the need for VAG because they can identify a fracture but are not necessarily specific for etiology (4). The finding of vertebra plana should be considered a non-OVCF until a biopsy rules out neoplasm (1). Magnetic resonance imaging (MRI) should be performed before the decision for a VAG procedure. Patients who cannot have an MRI should have a computed tomography (CT) with sagittal reconstruction to evaluate the fracture. Bone scan may also be used with tomography to evaluate for intense uptake indicating a fracture (5,6). Patients with lytic bone metastases and stable traumatic vertebral fractures of the vertebral body are also candidates for VAG (7,8). VAG is contraindicated in patients with either pathologic or iatrogenic coagulation disorders, sepsis or vertebral osteomyelitis,
Vertebroplasty VAG initially was used for nonosteoporotic fractures and has since become a tool for treating OVCF’s. Vertebroplasty (VP) was first reported in 1987 by Galibert (7) for stabilization of a C2 hemangioma. The procedure was later used for hemangiomas, malignancies (10) and traumatic fractures (Magerl A3.1, 3.2, 3.3; burst), and (AO, A1eA3) (11). Today the technique of VP depends on the anatomic vertebral level to be treated. In the cervical and upper thoracic spine, an anterolateral or transoral approach with a 15gauge infusion needle is typically used. This technique is used to treat angiomas and neoplasm, for example, multiple myeloma (11,12) and metabolic bone disease syndromes (13). VP in the thoracic spine is generally performed using a 13-gauge needle with a transpedicular or posterolateral approach. Eleven- or 10-gauge infusion needles are used in the lumbar spine with either a transpedicular or posterolateral approach (14). In general, the VP entails using a cutting needle to infuse PMMA into the vertebral body. After a local anesthetic is administered, the needle with trocar is introduced as close to the center of the vertebral body as possible. The injection of 2e10 mL of cement is variable of PMMA, or until twothirds of the anterior vertebral height is filled with cement (1); the trocar is replaced, and the needle is withdrawn. Replacing the trocar reduces the likelihood of cement being dragged through the pedicle and/or leaking out of the vertebral body (Fig. 1).
Received 06/24/15; Accepted 08/14/15. *Address correspondence to: Dr Bradford J. Richmond, MD, MS, FACR, CCD, Department of Diagnostic Radiology, Cleveland Clinic, Cleveland, OH 44107. E-mail: [email protected]
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Fig. 1. Axial (A) and Sagittal (B) image of a Computed Tomography scan demonstrated the filling os trabecular spaces with methacrylate after vertebroplasty. The technique was originally performed under general anesthesia; however, VP is now most frequently performed with local anesthesia and/or conscious sedation. Initially, patients were admitted to the hospital for 2 d of observation after this procedure, but today, a period of observation of up to 24 h as an outpatient is standard. The patient is generally ambulatory shortly after the procedure.
immediately after inflation, and transient hyperalgesia (21). Vertebral refracture after cement fragmentation is a rare complication (22). Delayed failure of KP may be the result of an incorrect assessment of the original compression fracture. Extension into the posterior elements of the original fracture increases the risk of cement leak or bone fragment retropulsion (23).
Kyphoplasty
The Vertebral Cleft
Kyphoplasty (KP) was developed in an attempt to improve height restoration of the fractured vertebral body compared with VP. For KP, the needle is introduced if the infusion needle is the same as used for VP. Balloon tamps are introduced through the needle and inflated to make a cavity (ies) in the vertebral body (9,14). PMMA can then be introduced into the cavity under lower pressure to fill the cavity (15). Performing KP within 28 d of the initial fracture was most effective for height restoration, but delayed KP, O28 d after fracture, reduces cement leakage (16) (Fig. 2 and 4). KP began using general anesthesia. Conscious sedation can be used when performing KP (17). A study comparing unipedicular vs bipedicular injection with KP demonstrated no difference in clinical outcomes but improved height restoration with the bipedicular technique (18). However, unipedicular injections led to shorter procedures. Radiofrequency KP, another alternative approach, uses radiofrequency to produce ultra-high viscosity cement (19). A short-term study found that radiofrequency KP led to improvements in vertebral height restoration and Cobb angle correction using KP (20). Complications of KP include balloon rupture or end plate fracture during inflation, decreased height restoration
The vertebral cleft is an important radiographic sign secondary to fracture of the anterior vertebral body that results in better height restoration with VAG. The cleft is a cavity in the vertebral body, either gas or fluid-filled nonunion fracture (24), with pseudoarthrosis. KP was determined to have less contrast leakage than VP with a vertebral cleft (25). CT and MRI are most sensitive for identifying the vertebral cleft (26). Radiographic confirmation of vertebral body height changes with flexion and extension views before VAG in patients with vertebral clefts predicts the ability to restore height from the procedure (27).
Preprocedural Considerations Before a patient is given anesthesia for VP or KP, several factors must be considered including whether the patient has lung and/or cardiac disease, infection (28), whether the patient is ambulatory, what medications the patient is using, and whether there is a history of poor nutrition or drug addiction (29). A history of PMMA allergy can result in bone cement implantation syndrome described as a rare complication of VAG. The syndrome results in a delayed postprocedural
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Fig. 2. Axial (A) and sagittal (B) image demonstrating the filling of spaces resulting in balloon dilatation with subsequent filling of the cavity with methacrylate under lower pressure. Note the defined appearance of the cement with no cement in the trabecular space. decrease in blood pressure, decreased arterial pO2, bradycardia, low cardiac output, right ventricular decreased output, and increased pulmonary artery pressure. Cardiac arrest can result from all the vascular changes or may happen acutely (29,30).
cement pulmonary embolism and cardiac perforation (42,43), extremity vascular embolism, and other thrombi. Nerve and spinal cord injuries have also been reported. Research has shown that KP is associated with a higher incidence of leaks into the intervertebral disc vs VP because of the tamp effect on end plates during KP (9).
Potential Complications of Cement Leakage Embolism of the thoracic vertebral segmental artery (31) and pulmonary artery (30), dorsal foot artery (32), and renal artery has been reported as a potential complication of cement leakage in patients treated with VP or KP (33). Right ventricular cement embolism after KP has recently been reported (34) resulting in cardiac tamponade (34). Pulmonary embolism secondary to cement leakage from VP or KP may be delayed and either symptomatic or asymptomatic (35,36). Cement leakage through the pedicle after removal of the trocar may result in paraparesis (37,38). Use of high viscosity cement can reduce the leakage of cement during VP (39,40). A cadaveric vertebral body study concluded that heat generated from PMMA was not sufficient to damage spinal nerves, if leakage occurred (41) (Figs. 3e5). Cement leakage has been found to occur in up to 41% of KP procedures and up to 71% of VP procedures; the rate of cement leakage is higher with VP because of the higher infusion pressure associated with this procedure (39). In most cases, this leakage is benign and causes no clinical symptoms. However, a transient radicular pain has been described with leakage into the neural foramen or in close proximity to the nerve root. The pain generally resolves in 24 h (41). Serious events related to cement leakage include
Fig. 3. Note the cement leakage posterior through the cortex resulting in neural foraminal narrowing. The calcified aorta is on the left.
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Fig. 4. Cement leakage anterior to the L1 vertebral body, extending in a cephalad direction and crossing the adjacent disk and vertebral body. Anterior leakage can laso result in aortic of bowel fistulas. AT L5 the cement partially extends into the pedicale.
Choice of Sedation For patients !65 yr undergoing a simple VP with fewer than 3 levels treated, conscious sedation can be considered. Multiple level VP and KP should be performed under general anesthesia. Possible reactions to PMMA, including anaphylaxis, need to be considered when choosing the type of sedation to be used. Monitoring for pulmonary embolism and immediate treatment should be available (44).
VP vs KP Since the introduction of KP, researchers have been questioning whether KP or VP is more effective in providing pain relief, restoring vertebral height, and reducing the kyphotic angle. Questions have also arisen regarding the costeffectiveness of each technique and which procedure has the lowest risk of cement leakage. Both techniques VP and KP have been found proven to be effective for pain reduction (45e47); however, there are few head-to-head studies in large populations comparing the efficacy of VP and KP for pain relief. A meta-analysis found both techniques effective for pain relief at 12 mo. KP may be more effective than VP in patients with osteoporotic vertebral
Richmond
Fig. 5. Cement in L3 has normal appearance.. Cement injection at L1/L2 was partially into the L1/L2 disk with leakage into a vein. Cement injection at T12 resulted in end plate leakage of contrast into the T12/L1 disk. compression fractures (OVCFs) that have a significant height loss (48). For patients with biconcave fractures, KP and VP were equally effective in reducing pain and disability scores, but KP may restore height more effectively than VP (49). Additionally, in a review of the literature, Kasperk et al (50) found patients with degenerative disc disease may not have complete pain relief with VAG. Reports of height restoration with KP vary and are greater than with VP (51). However, the restoration of height may be less important than other aspects of these techniques. For instance, reduction of the kyphotic angle is believed to be a more important effect of KP and VP (52,53). The cost-effectiveness of KP and VP has also been under debate. One study found that the initial costs of VAG were greater for KP than VP, but both were more cost-effective than conservative treatment in the Medicare population, regardless of age (54). VP was found to be more cost-effective than KP in the inpatient setting, but performing VP or KP in the outpatient setting significantly reduces costs regardless of the procedure used (55). Outpatient costs in a VA study were lower with VP than with KP (56). Several studies have assessed various aspects of the KP-vsVP debate. In a review of the literature, Stevenson et al (57) found that although VP and KP both reduced pain, VP was
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Vertebral Augmentation for Osteoporotic Compression Fractures more cost-effective than KP. However, KP increased vertebral height to a greater extent than VP. KP initially increased vertebral body height significantly more than VP, after repetitive loading, the difference was negated. The authors also found that both techniques were effective for pain relief from compression fractures; additionally, complications associated with KP or VP were !2% for compression fractures and 10% for treated malignant vertebral bodies (58). To avoid the potential risk of procedure-related infection, preprocedure and intraprocedure use of broad-spectrum antibiotics is recommended (59).
The Adjacent Fracture Question A concern of using cement to treat vertebral fractures is whether the stiffness of the treated vertebral body will cause compression fracture of an adjacent vertebral body. In a small study of adjacent vertebral fractures in patients who underwent KP or VP, there were equal numbers of adjacent fractures in patients treated with VP and those treated with KP, suggesting that the presence of cement from either technique was not related to adjacent fracture. The authors concluded that the presence of cement from either technique was not related to adjacent fracture. The authors did find a correlation between a T-score of 3 or lower with the development of adjacent fractures (60). Patients with low bone mineral density, body mass index, and vitamin D levels were associated with higher rates of additional vertebral fractures after VP (61). In a study that compared the adjacent fracture rate in patients treated with conservative therapy and those treated with KP, there was no additional risk of adjacent fracture after KP (58). Similarly, Fribourg et al (62) retrospectively reviewed the charts of patients who had undergone KP and found no difference in the incidence of adjacent vertebral fractures compared with the incidence in untreated patients. However, another study found that among 17 patients treated with KP (almost exclusively bilateral injections), 5 developed adjacent fractures, whereas among 19 patients treated with VP (unilateral injections), there were no adjacent fractures at 3 mo. The American College of Radiology appropriateness criteria reviewed the literature finding that delayed fractures adjacent to VAG were reported in several studies ranging from 2.5 to 17.3% (63). Degenerative disk disease may affect load transfer, but peripheral cement placement in the degenerative disc vertebral body may reduce the fracture risk for adjacent vertebral bodies (64). In a study by Hart et al, VP or KP of vertebral bodies in the cranial vertebral body adjacent to a postoperative spinal fusion was prophylactically performed in 28 elderly osteoporotic patients expected to be at high risk for fracture. Of the 28 patients who had VAG, VP, and KP, 2 fractures occurred with no greater loss of height than the cement. The authors concluded, in this population, it is cost-effective to perform VAG in 1 levels cranial to a spinal fusion (65).
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Biopsy During VP and KP Disease processes such as multiple myeloma and metastatic disease may mimic osteoporosis in the appearance of low bone mass. Biopsy can provide assurance that no pathologic process is present when performing VAG. In one study, 692 patients who underwent VP or KP over a 7-yr period also had a biopsy during the procedure. Among the study patients, 44 were known to have a malignancy before the procedure, but the vertebral body biopsy demonstrated a malignancy in only 25 of these patients. However, 2 previously undiagnosed malignancies were identified with biopsy. The authors concluded that biopsy should be routinely performed during VP and KP procedures (66,67). Biopsy is especially important for patients undergoing KP for the first time for the treatment of assumed osteoporotic fracture refractive to conservative therapy (68).
Choice of Cement PMMA is the most commonly used cement for VAG. The cement has high viscosity, and 2 other cement preparations with lower viscosity are also used clinically. Yang and Zou reviewed the literature to compare all commercially available cements. Because of decreased load transfer, stress shielding, and adjacent fracture rate, a coralbased cement was found to be the most effective. All other parameters were the same except for a low elastic modulus for the coral-based cement (69). Calcium sulfate cement have better bioactivity, allows for bone ingrowth, with improved bone healing when compared with PMMA (70). Radiation exposure is a significant consideration for any technique that uses fluoroscopy and CT. One study demonstrated a significant decrease in radiation exposure to both patients and physicians when a modified syringe technique for cement injection was used vs the delivery system provided by the manufacturer (71).
Stenting Stenting is an adjunct to KP attempting to improve and sustain restoration of vertebral height of the OVCF. Klezl et al were the first to report using a stent to treat compression fracture or incomplete burst fracture. With this procedure, the initial surgical technique is the same as that used for a transpedicular approach for KP, except a K-wire is used in this system. The K-wire acts as a guide for a metallic stent that is placed over the Kyphon balloon (Kyphon, INC, Sunnvale, CA). No additional deformities occurred after the procedure in these initial 20 study patients, but the authors did allude to unreported cases of stent migration (72). Vertebral Jack, a novel device, unfolds to restore vertebral body height. Cement is then injected (73) Cement distribution is also improved because a higher volume of cement is injected, thus improving load distribution. Assisted technology to restore vertebral height can be used for malignant fractures, OVCF, and traumatic fractures (best
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94 results in younger patients) (74). Muto points out the use of assisted technology increases the cost of the VAG procedure. In conclusion, VAG using either VP or KP has been debated since the inception of these procedures, and debates whether VP or KP is best for pain relief and functionality continue to this day. There is a group of physicians who believe that conservative medical treatment is still the best choice for OVCF. A review of the literature consistently provides evidence that pain relief with VP and KP is equivalent to or better than medical therapy initially and that this pain relief persists longer. However, highly criticized randomized controlled trials claimed that VP was no better than sham surgery (75) or local anesthetic infusion around pedicles and soft tissues, the Investigational Vertebroplasty Safety and Efficacy Trial (76). In the debate over VP vs KP, nonrandomized studies have found that height restoration of compressed vertebral bodies is greater with KP than VP, although minimal and results in improved Cobb angle, positively affecting the patient’s quality of life. KP is also significantly more expensive than VP in the inpatient and outpatient population. Debates over VAG, VP vs KP, and medical treatment for OVCFs are not likely to be definitely settled in the near future. VAG procedures, especially VP, have increased as a treatment choice for OVCF for the appropriately selected patient. VAG in the first year after the procedure has been shown to be cost-effective compared with conservative treatment. Local, regional, national practice patterns, and insurance reimbursement rates will determine which, if any, VAG procedure may be used in the future.
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Vertebral Augmentation for Osteoporotic Compression Fractures 27. Yokoyama K, Kawanishi M, Yamad M, et al. 2013 In Not Only Vertebroplasty but also Kyphoplasty, the Resolutiom of Vertebral Deformities Depends on Vertebral Mobility. AJNR 34: 1474e1478. 28. Frost EA, Johnson DM. 2009 Anesthetic Considerations During Vertebroplasty, Lyphoplasty and Intradiscal Electrohermal Therapy. Int Anesthesiol Clin 47(2):45e55. 29. Kalra A, Sharma A, Palaniswamy C, et al. 2013 Diagnosis and Management of Bone Cement Implantation Syndrome: Case Report and Brief Review. Am J Ther 20:121e125. 30. Nussbaum DA, Gailloud P, Murphy K. 2004 A Review of Complications Associate with Vertebroplasty and Kyphoplasty as Reported to The Food and Drug Administration Medical Device Related Web Site. J Vasc Interv Radiol 15:1185e1192. 31. Matouk CC, Krings T, Ter Brugge KG, et al. 2012 Cement Embolization of a Segmental Artery after Percutaneous Vertebroplasty:a Potentially Catastrophic Vascular Complication. Interv Neuroradiol 18:358e362. 32. Panagiotis I, Panagiotis K, Vasilios V. 2014 PMA embolization to the left dorsal foot artery during percutaneous vertebroplasty for spinal metastases. Eur Spine J 23(suppl 2):S187eS191. 33. Chung SE, Lee SH, Kim TH, et al. 2006 Renal cement embolism during percutaneous vertebroplasty. Eur Spine J 15(suppl5):S590eS594. 34. Tran I, Gerckens U, Remig J, et al. 2013 First Report of LifeThreatening Cardiac Complication After Percutaneous Balloon Kyphoplasty. Spine 28(5):E316eE318. 35. Abdul-Jalil Y, Bartels J, Alberti O, et al. 2007 Delayed Presentation of Pulmonary Polymethylmethacrylate Emboli After Percutaneous Vertebroplasty. Spine 32(20):E589eE593. 36. Kollman D, Hoetzenecker K, Prosch H, et al. 2012 Removal of a large cement embolus from the right pulmonary artery 4 years after kyphoplasty: Consideration of thrombogenicity. J Thorac Cardiovasc Surg 143(4):e22ee24. 37. Park SY, Modi HN, Suh SW, et al. 2010 Epidural cement leakage through pedicle violation after balloon kyphoplasty causing paraparesis in osteoportic compression fractures e a report of 2 cases. J Orthop Surg Res 5:54. 38. Ohba T, Ebaata S, Clinton D, et al. 2013 Instability of treated vertebrae after balloon kyphoplasty causing paraparesis in osteoporotic vertebral compression fractures: a report of two cases. Eur Spine J 22(suppl 3):S314eS345. 39. Georgy BA. 2010 Clinical Experience with High-Viscosity Cements for Percutaneous Vertebral Body Augmentation: Occurrence, Degree, and Locationof Cement Leakage Compared with Kyphoplasty. AJNR 21:504e507. 40. Papanastassiou ID, Fikis A, Gerochristou MA, et al. 2014 Controversial Issues in Kyphoplasty and Vertebroplasty in Osteoporotic Vertebra Fractures. Biomed Research International. Biomed Res Int 2014:934206. http://dx.doi.org/10.1155/ 2014/934206. Epub 2014 Mar 4. Review. 41. Wegener B, Zolyniak N, Gulecyuz MF, et al. 2012 Heat distribution of polymerization temperature of bone cement on the spinal canal during vertebroplasty. Int Orthop 36:1025e1030. 42. Lim SH, Kim H, Kim HK, et al. 2008 Multiple cardiac perforations and pulmonary embolism caused by cement leakage after percutaneous vertebroplasty. Eur J od Cardiothorac Surg 33: 509e511. 43. Gosev I, Nascimben L, Huang PH, et al. 2013 Right Ventricular Perforation and Pulmonary Embolism With Polymethylmethacrylate Cement After Percutansous Kyphoplasty. Circulation HA 112:144535. online. 44. Luginbuhl M. 2008 Percutaneous vertebroplasty, kyphoplasty and lordoplasty: implications for the anesthesiologist. Curr Opin Anesthesiol 21:504e513.
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96 62. Fribourg D, Tang C, Sra P, et al. 2004 Incidence of Subsequent Vertebral Fracture after Kyphoplasty. Spine 29(20): 2270e2276. 63. McConnell CT, Wippold FJ 2nd, Ray CE Jr, et al. 2014 ACR Appropriateness Criteria Management of Vertebral Compression Fracture. J Am Coll Radiol 8:757e763. 64. Kosmopoulos V, Keller TS, Schizas C. 2009 Early stage disc degeneration does not havd an appreciable affect on stiffness a,nd load transfer following vertebroplasty and kyphoplasty. Eur Spine J 18:59e68. 65. Hart RA, Prendergast MA, Roberts WG, et al. 2008 Proximal junctional acute collapse cranial to multi-level lumbar fusion: a cost analysis of prophylactic vertebral augmentation. The Spine J 8(6):875e881. 66. Zhang L, Li J, Yang H, et al. 2013 Histological evaluation of bone biopsy results during PVP or PKP of vertebral compression fractures. Oncol Lett 5:135e138. 67. Pneumaticus SG, Triantafyllopoulos GK, Chatziioannou S, et al. 2010 Routine needle biopsy during vertebral augmentation procedures. Is it necessary? Eur Spine J 19: 1894e1898. 68. Allen RT, Kum JB, Weidner N, et al. 2009 Biopsy of Osteoportic Vertebral Compression Fractures During Kyphoplasty. Spine 14(14):1486e1491. 69. Yang H, Zou J. 2011 Filling Materials Used in Kyphoplasty and Vertebroplasty for Vertebral Compresson Fracture:
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A Literature Review. Artif Cells Blood Subsit Immobil Biotechnol 39:87e91. Yang HL, Zhu XS, Chen L, et al. 2012 Bone healing response to a synthetic calcium sulfate/beta-tricalcium phosphate graft material in a sheep vertebral body defect model. J Biomed Mater Res B Appl Biomater 100(7):1911e1921. Ortiz AO, Natarajan V, Gregorius DR, et al. 2006 Significantly Reduced Radiation Exposure to Operators during Kyphoplasty and Vertebroplasty Procedures: Methods and Techniques. Amer J Neuroradiol 27:989e994. Klezl Z, Majeed H, Bommireddy R, et al. 2011 Early results after vertebral body stenting for fractures of the anterior column of the thoracic spine. Injury 42(10):1938e1942. Sietsma MS, Hosman AJ, Verdonschot NJ, et al. 2009 Biomechanical Evaluation of the Vertenbral Jack Tool and the Inflatable Bone Tamp for Reduction of Osteoporotic Spine Fractures. Spine 34(18):E640eE644. Muto M, Marcia S, Guarnieri G, et al. 2015 Assisted techniques for cementoplasty: Why should we do it? Eur J of Radiol 84(5):783e788. Buchbinder R, Osborne RH, Ebeling PR, et al. 2009 A randomized Trial of Vertebroplasty for Painful Osteoportic Vertebral Fractures. NEJM 361:557e568. Kallmes DF, Comstock BA, Heagerty PJ, et al. 2009 A Randomized Trial of Vertebroplasty for Osteoportic Spinal Fractures. NEJM 361:569e579.
Journal of Clinical Densitometry: Assessment & Management of Musculoskeletal Health
Volume 19, 2016