The Treatment of Compression Fractures by the Anesthesiologist: Vertebroplasty and Kyphoplasty

Director of Center for Pain Medicine Director of St. Francis Pain Center Department of Anesthesiology St. Francis Pain and Spine Center St. Francis Hospital Wilmington, Delaware

Philip S. Kim, MD

steoporosis is manifested by low mineral density or by the presence of fragility fractures. The occurrence of an atraumatic vertebral fracture is sufficient enough to establish a diagnosis of osteoporosis. In 1996, the incidence of osteoporotic vertebral compression fractures was 700,000, which surpasses the combined fractures of the ankle and the hip.1 For several decades, vertebral compression fractures were thought to be benign and self-limited. This view evolved from at least two-thirds of fractures never being reported by patients to their physicians.2 If diagnosed, most patients underwent conservative treatment. Polymethylmethacrylate (PMMA) has been used in orthopedic treatment and dentistry to fill voids and grout. Specific uses include fixation in total joint arthroplasty. In spine surgery, PMMA has been used to reconstruct defects from open corpectomy and transpedicular application of PMMA to improved screw purchase in osteoporotic bone. The first reported use of percutaneous application of PMMA was performed in 1984 by Galibert et al.3 for C2 hemangioma.4 The use of modified angioplasty balloon to reduce a vertebral fracture and create a cavity for the placement of PMMA was described by Mark Reiley.5,6 Over decades, the technique of percutaneous vertebral 63

augmentation has evolved with large-bore needles and modified PMMA.

PATHOPHYSIOLOGY AND PATIENT EVALUATION

Vertebral compression fractures occur due to weakened bone, causing severe pain and morbidity. These compression fractures are typically induced by osteoporosis, tumors, or traumatic injury. Typically, these fractures occur where load bearing is the greatest. Certain factors and habits which may frequently result in a loss of bone mass frequently may lead to osteoporosis. These factors include women of increased age, lack of calcium and vitamin D in the diet, and the high intake of cigarettes and coffee.7 Vertebral compression fractures typically occur spontaneously or as a consequence of minimal trauma, resulting from spinal loading during daily activities such as bending, lifting, and climbing stairs.8 The most common locations are the midthoracic region (T7-8) and the thoracolumbar junction (Figure 1).8 These correspond to areas of the spine where there is the greatest burden during these common daily activities. When thoracic kyphosis develops, the midthoracic region receives tremendous load during

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Figure 1. Incidence of vertebral fractures in the spine. Reprinted from Nevitt M, et al.,9 with permission from Elsevier.

flexion of the spine leading to potential compression fractures. Secondary contributors to osteoporosis include hypercalcemia, abnormal thyroid, and renal functions.7 Users of oral glucocorticoids have a 2.6-fold increase risk of fracture10 (Figure 2). Osteolytic metastases and myeloma can cause the destruction of vertebral bodies and fractures leading to pain and disability. Patients with advanced cancer can present with bone metastases to the vertebral bodies. The incidence of metastatic lesion to the spine depends on the primary cancer: 80% of patients with prostate cancer, 50% with breast cancer, 30% with lung, thyroid, or renal cell cancer.11 Rarely, benign tumors such as spinal osteoid osteoma and aneurismal bone cysts can lead to instability and painful compression fractures. Vertebral augmentation can be used to reinforce and stabilize fractures related to tumors. The multiple consequences of vertebral fractures can lead to increased morbidity and mortality. Pain and disability increases with kyphosis and vertebral compression fracture.12 The physical consequences include pulmonary compromise (Figure 3). Studies suggest that there is decreased lung capacity and reduced pulmonary function with vertebral height loss and decreased lung volume.14 As the spine changes with significant kyphosis, the downward angulation of the ribs leads to the 12th rib resting on the iliac crest. This results in the abdomen protruding and can lead to symptoms of distension, constipation, early satiety, and eructation. Above all, the forward position of the thoracic spine leads to

Figure 3. The kyphotic spine. Reprinted from Gold DT,13 with permission from Elsevier.

strain of the posterior elements of the thoracic spine as the patient attempts to straighten his or her spine. As seen by the investigator, the forward expansion of the abdomen leads to forward loading of the lumbar sacral spine thereby exacerbating discogenic pain. The limited ability of the sacrum to flex and extent may load the sacroiliac joint and cause pain. Weakened physical function can lead to restricted daily activities resulting in required assistance from family or hired help. The psychosocial consequences of the limitation of activities are seen with their reduced ability to fulfill their accustomed social roles and dependency on others. This leads to poor self-esteem, depression, and social isolation.12,13,15 There is also increased incidence of sleep disturbances. The number of depressive symptoms rises with the increased number of fractures. Studies reveal high mortality and reduced quality-of-life years with vertebral compression fractures.12 In addition to a detailed history and examination, imaging evaluations are standard in confirming the diagnosis of acute compression fractures. The radiologic findings on plain films may show subtle height loss changes. Comparison films are helpful to determine acute versus chronic fractures. Unfortunately, occult vertebral fractures are common with false-negative rates of 27-45% by radiologists.16 Magnetic resonance imaging (MRI) is the study of choice with T1 and STIR sagittal sequences. Acute vertebral compression fractures are revealed with marrow edema within the vertebral body. Assessment of spinal canal compromise and fractures of the pedicles are important. Computed tomographic (CT) scan may be a useful alternative combined with a nuclear bone scan when the patient is not a good candidate for MRI. Bone scan may be helpful in fractures more than 3-4 months in age where there is no marrow edema on MRI.

TREATMENT GOALS
Figure 2. Risk of fracture from steroid use.10

The treatment goals of vertebral compression fractures include pain management, rest, rehabilitation, and

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Figure 4. Vertebroplasty. Courtesy of Stryker (Allendale, NJ).

restoration of mechanical stability. Pain management usually involves use of opioids and nonsteroid anti-inflammatories. Medical management may also include treatments for osteoporosis: calcium, vitamin D, bisphosphonates, or nasal miacalcin. Prolonged bed rest may allow the compression fracture to stabilize but can lead to loss of muscle strength, fatigue, and bone density in elderly patients.17 Other concerns of patients in prolonged bed rest are pressure sores and deep vein thrombosis in older patients. Back braces may offer support and stabilize the vertebral compression fractures. Limited contact orthoses such as the tri-pad Jewett extension brace are commonly used. Many patients do not tolerate the braces, citing discomfort and difficulty when putting on and removing them. Rehabilitation should be planned to strengthen bone density and increase core strength. Mechanical instability of vertebral fractures with neurologic compromise is possible. Open surgery such as anterior decompression and stabilization may be needed. Stable painful compression fractures may be treated by vertebral augmentation either vertebroplasty or kyphoplasty. The mechanism of pain relief associated with vertebroplasty and kyphoplasty is unknown. Fractured vertebral bodies lose both strength and stiffness. Strength is related to the ability of the vertebral body to bear load and stiffness limits micromotion within the compromised vertebral body. Restoration of stiffness and strength is augmented by placement of PMMA, reducing painful micromotion.18 Large amounts of cement are needed to restore stiffness and less for strength.18 Other mechanisms of pain relief may involve the thermal and cytotoxic reaction of PMMA. It has been hypothesized that the heat of polymerization causes thermal necrosis of neural tissue, explaining pain relief in patients. In vivo studies mapping temperatures from poly-

merization may rise greater than 501C leading to potential damage to interosseous nerves, periosteal nerves.19 Temperature may also play a role in slowing tumor growth and apoptosis in osteoblasts exposed to 481C for 10 minutes or more. The cytotoxicity of PMMA may also have an antitumoral effect and could be potentially neurotoxic.20 Vertebroplasty is the percutaneous placement of cement in fractured trabecular bone leading to an internal cast20 (Figure 4). The standard indication is for painful compression fractures refractory to medical therapy. The typical causes include osteoporosis, metastatic disease, multiple myeloma, and osteonecrosis. The contraindications are systemic and local infection, uncorrectable coagulopathy, retropulsion of vertebral body or tumor, posterior wall destruction, and radicular symptoms. Benefits for the patients are increased range of motion with pain relief. The procedure is typically done under monitored anesthesia care and as an outpatient procedure. The alternatives are poor. These are conservative medical management, that is, opioid therapy, physical therapy, bracing, and potential open surgery fixation. The cement is placed through fluoroscopically or CT-guided trocars. The most common access is the transpedicular approach. Other approaches can be para pedicular, anteriolateral (cervical), and posterior (sacral). The complications may include the following: infection, bleeding, pulmonary embolus, local trauma, paralysis, and even death. Fortunately, these complications are rare. Kyphoplasty has been introduced as an alternative approach21 (Figure 5). It is considered a balloon-assisted vertebroplasty. This procedure involves percutaneous placement of a balloon in the vertebral body. Through the same large bore needle, bone cement is placed into the cavity created by the balloon. The balloon is intended to restore vertebral body height in addition to creating the cavity.

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Figure 5. Kyphoplasty. Courtesy of Medtronic (Sunnyvale, CA).

After reviewing published literature, a position statement on percutaneous vertebral augmentation by American Society of Interventional and Therapeutic Neuroradiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology have determined that the clinical response rate comparing kyphoplasty and vertebroplasty are similar.21 There is no proven advantage of kyphoplasty compared with vertebroplasty with regard to pain relief, height restoration, and complication rate.21

TECHNIQUE
Vertebroplasty and Kyphoplasty rely on small incisions to place large-bore needles with radiographic guidance with fluroscopy or CT guidance. These procedures are either done under general anesthesia or monitored anesthesia care. The procedure itself is not painful especially if local anesthesia is placed, but the duration of the procedure and position of the patient may necessitate at least intravenous sedation. Comorbidities such as poor cardiac dysfunction may need to be monitored. In patients with poor medical condition, medical clearance is advised. Anticoagulations are stopped before the procedure. Preoperative antibiotics are usually given as with many surgical implants. Sterile surgical preparation and draping are done.

The critical step is to have an understanding and visualization of the fractured vertebra.
The critical step is to have an understanding and visualization of the fractured vertebra. Poorly osteoporotic bone, especially in large patients, may offer a challenge. Spinal deformities such as scolosis may hamper proper visualization of the bone landmarks to perform the proce-

dure successfully. If the bone is not visualized with confidence under fluoroscopy, the case should be aborted. CT guidance is then suggested. The landmarks necessary to perform the procedure under fluoroscopy are the pedicles, vertebral bodies, and disc space in the anterior-posterior, lateral, and oblique views. There are multiple approaches to access the thoracic and lumbar fractures vertebral body.21 The most common is posterior tranpedicular approach. Bipedicular needles are usually placed at each level. Another approach is the parapedicular. For cervical, the anteriolateral view is needed, a similar approach to cervical discography. For sacral fracture, a posterior approach is taken. This investigators approach to lumbar and thoracic fractures is to square the endplates of the fractured vertebral bone on an anterior-posterior view. On the oblique view, the pedicle is identified with clear definition of the medial border. The skin and tissue for the planned entry site are anesthetized with a local anesthetic. The needle will be placed at eye of the scotty dog and placed straight down the barrel. The needle is gently tapped with a hammer staying lateral to the medial edge of the pedicle. Constant visualization of the needle is needed with fluoroscopy to stay away and lateral to the spinal canal. Needle position is usually anterior to the third of vertebral body on lateral view. PMMA is prepared to allow polymerization in a viscous consistency that still allows passage through the needle. This reduces risk of extravasation. When confirmed in position on the anterior-posterior and lateral views, the prepared PMMA is injected slowly watching its spread within the vertebral body, under constant fluoroscopy. When the spread is seen heading to the posterior third, the injection is completed. As vertebroplasty, the same approach is taken with kyphoplasty. When access to the vertebral body is complete, a guide pin is placed where a large bore (8 gauge) cannula is placed. Through this cannulae, an inflatable bone tamp or balloon is advanced. A bipedicular approach is recommended. When both balloons are inflated and the fracture is realigned, a cavity is created. This is where PMMA is placed.

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Standards and guidelines in the vertebroplasty can be found in the American College of Radiologys Standards for the Performance of Percutaneous Vertebroplasty and the Society of Interventional Radiologys Quality Improvement Guidelines for Percutaneous Vertebroplasty.22

CLINICAL RESEARCH
More than 100 studies have addressed the clinical outcomes of vertebroplasty.21 The type of studies range from small, retrospective, uncontrolled case series to prospective randomized studies. Literary reviews about the efficacy of vertebroplasty conclude that when used for patients with osteoporotic compression fractures, substantial and immediate pain relief, improved functional status takes place. Minimal short-term complications have been noted. In 2007, there was a position statement on percutaneous vertebral augmentation. This consensus statement, developed by the American Society of Interventional and Therapeutic Neuroradiology, the Society of Interventional Radiology, the American Association of Neurologic Surgeons/Congress of Neurological Surgeons, and the American Society of Spine Radiology, concluded that the evidence supports vertebroplasty as being beneficial for the relief of pain and improved quality of life.21 An example of a study supporting this statement was published in 2002 by Zoarski et al.23 In this study, a Musculoskeletal Outcomes Data Evaluation and Management Scale spinal interventional questionnaire was done. In the study 30 patients with 54 symptomatic osteoporotic vertebral compression fractures had less than satisfactory response to conventional therapies. In contrast, significant postprocedure benefits of vertebroplasty were showed in four Musculoskeletal Outcomes Data Evaluation and Management Scale modules: treatment score (Po 0.0001), pain and disability (Po 0.0001), physical function (P 0.0004), and mental function (P 0.0009). Long-term follow-up continued for 18 months. At the end of the study, 22 of 23 patients remained satisfied with their outcomes. A recent prospective of randomized studies, published in the 2009 New England Journal of Medicine, showed that compared with control groups, vertebroplasty offered no proven advantage.24,25 The Buchbinder et al. and Kallmes et al. studies showed negative results which directly contradicts hundreds of published studies showing positive outcomes. A common initial response to these findings was one of disbelief and surprise. A commentary by North American Spine Society serves to understand and explain the findings. In both studies there are questions regarding patient selection, enrollment, control group, and outcomes. Both studies accepted patients with fractures of less than 1 year and it is known that pain from osteoporotic fractures diminish over time. It is reasonable to conclude that in 3-6 months fracture pain reduces naturally and would then be comparable with relief from vertebroplasty. The enrollment of patients was difficult in the Kallmes et al. study. Eighteen hundred and twelve patients were initially

screened and only 131 entered the study. The pain severity and functional compromise of those patients who refused participation were not reported. Thus, there exists an unquantifiable selection bias in the final patient group. Both control groups in these studies were not really sham groups. Injection of anesthetic into the facet capsule and/or periosteum may have a beneficial effect in patients with facet-mediated pain. Thus, another criticism takes us back to patient selection and outcomes. It is unclear if there was an effort to determine if the back pain originated from the osteoporotic fracture site. With experienced spine care providers, percussion and palpation of the spinous processes is critical to determine the level of maximum tenderness, that is, painful compression fractures. History, physical examination, and imaging are critical to determine if pain is coming from a compression fracture, stenosis, facet, or degenerative disc. The clinical outcomes data for kyphoplasty are not as extensive as vertebroplasty.21 Lieberman et al.26 reported in a phase I efficacy study of kyphoplasty in the treatment of painful compression fractures. Thirty patients showed significant improvements in Short Form (SF)-36 bodily pain scales from 11.6 to 58.7 (P 0.0001). In 2009, a randomized controlled trial comparing nonsurgical treatment of vertebral compressions to balloon kyphoplasty showed the efficacy and safety of the procedure.27 Three hundred patients were randomly selected to receive kyphoplasty versus nonsurgical treatment. Quality-of-life measures, SF-36, and safety measurements were taken over 12 months. Mean improvements in SF-36 physical components were seen. The frequency of adverse effects did not differ between groups. There were two serious complications were noted (hematoma and urinary tract infection).

Currently, there is no published investigation which has compared vertebroplasty to kyphoplasty.

Currently, there is no published investigation which has compared vertebroplasty to kyphoplasty. Thus, the 2007 consensus statement on percutaneous vertebral augmentation developed by the American Society of Interventional and Therapeutic Neuroradiology, the Society of Interventional Radiology, the American Association of Neurologic Surgeons/Congress of Neurological Surgeons, and the American Society of Spine Radiology concludes that the clinical response to kyphoplasty and vertebroplasty are equivalent.21 There is no proven advantage with regard to pain relief, vertebral height restoration, or complication rate.

COMPLICATIONS
Vertebroplasty and kyphoplasty have identical complications.28 With kyphoplasty, there is a reported spinal

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canal intrusion with the balloon tamp and cortical wall disruption from balloon misplacement. Complications can be divided into medical and anesthesia-related complications, instrumentation, extravasation of PMMA, and adjacent segment spinal fractures. Medical and anesthesia complications are uncommon as these minimal invasive procedures have minimal physiologic impact. In patients with severe cardiovascular compromise, laying in the prone position is difficult. Conversely, performing general anesthesia on these patients becomes a greater challenge. Cases of ileus, myocardial infarction, and congestive heart failure have been reported.4 Careful attention to patient position is paramount as osteoporotic bones have fractured from sternum to ribs. Hemodynamic compromise has been associated with packing of the PMMA during hip replacement surgery. Transient systemic hypotension has been reported with packing cement in vertebroplasty.29 Instrumentation complications exist from placing needles outside the pedicles and into the spinal canal.28 Operator inexperience, poor imaging equipment, and severe spinal deformity are the usual explanations. Uncontrolled bleeding and infection are extremely rare. The most frequently reported complication is PMMA cement extravasation.28 PMMA can exit out of any fracture line or cleft and vertebral venous plexus. Using viscous PMMA impregnated with barium, and under high quality imaging, can reduce the incidence of these problems. The PMMA is injected slowly under live fluoroscopy. Extravasation of cement has flowed into the spinal canal with severe neurologic compromise. The rate of clinically significant leakage has been reported at up to 6%.30 Higher rates of leakage have been identified when trying to treat fractures related to angiomas and metastatic disease, 2.510%.4 It is likely that cortical destruction and occult fracture lines are to blame. PMMA leakage into the disc space may occur due to undetected fracture cleavage lines. Rates of 0-65% have been reported but most are considered clinically insignificant.4 Epidural leakage is more of a concern leading to potential cytotoxic and exothermic damage to nerve roots. Liquid PMMA may leak out into the venous system resulting in a rare case of pulmonary embolus. There is no published report of pulmonary embolus with kyphoplasty. The creation of a void in the vertebral body may compact the cancellous bone causing it to act as a dam and prevent extravasation of the cement. An issue of increased risk of fracture at an adjacent level has been raised. Grados et al.30 found a slight but statistically significant increase in adjacent segment fracture risk in a long-term vertebroplasty follow-up study. It is not known if this is due to placing a hard material, PMMA, in close juxtaposition to the soft, osteoporotic bone of the adjacent vertebral levels. It is also possible that these adjacent fractures represent the natural progression of osteoporosis. Overall, the complication rates of vertebroplasty and kyphoplasty are reported similar.21 Six major complications were reported in 531 patients (1.1%) treated with kypho-

plasty in a multicenter study.31 Four of these had neurologic complications. This is similar to the complication of vertebroplasty (1.3%) when used for osteoporotic fractures. Recommendations and evaluations of complications can be found in the American College of Radiologys Standards for the Performance of Percutaneous Vertebroplasty and the Society of Interventional Radiologys Quality Improvement Guidelines for Percutaneous Vertebroplasty.22

CONCLUSION
Vertebral augmentation with vertebroplasty or kyphoplasty is a medically appropriate treatment for painful vertebral compression fractures refractory to medical therapy.22 Vertebral compression fractures are common and are often debilitating. Although most fractures heal within a few weeks to months, a minority of patients continue to suffer pain that does not respond to conservative therapy. Vertebral compression fractures are often a leading cause of admission to nursing and intermediate care facilities. These patients are rarely provided with open surgical fixation due to the poor quality of bone for surgical fixation and the patients tolerance of the surgery and anesthesia. Percutaneous vertebral augmentation is now established therapy and should be reimbursed by payers as a safe and effective treatment of compression fractures. Newer augmentation techniques are now available to treat sacral fractures and sacroplasty. Robotic assistance and alternative imaging may allow even safer placement of needles with reduced radiation exposure.28 Presently, a number of alternative cements to PMMA are being testing. A number of companies have looked at alternatives to PMMA. A bioresorbable injectable cement called Cordis has been approved by the Food and Drug Administration. This bioactive material closely mimics the mechanical characteristic of bone. Further clinical studies and econometric analysis are being carried out to determine the financial impact on society. Further prospectives and randomized studies are needed to establish the benefits of vertebroplasty and kyphoplasty over standard conservative treatment. See also Supplemental Digital Content 1-5, http://links.lww.com/ASA/A25, http://links.lww.com/ASA/A26, http://links.lww.com/ASA/A27, http://links.lww.com/ASA/A28, and http://links.lww.com/ASA/A29, respectively.

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