Vertebral augmentation

Last updated

Percutaneous vertebroplasty
Aufbau Kypho.jpg
Typical interventional suite setup for kyphoplasty
ICD-9-CM 81.65
MedlinePlus 007512

Vertebral augmentation, including vertebroplasty and kyphoplasty, refers to similar percutaneous spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra in order to relieve back pain caused by a vertebral compression fracture. After decades of medical research into the efficacy and safety of vertebral augmentation, there is still a lack of consensus regarding certain aspects of vertebroplasty and kyphoplasty.

Contents

Procedure

Vertebroplasty and kyphoplasty are the two most common procedures for spinal augmentation. These medical terms are classical compounds of the suffix -plasty meaning "molding or shaping surgically" (from Ancient Greek plastós "molded, formed") and the prefixes vertebro- "vertebra" (from Latin vertebra "joint, joint of the spine") and kypho- "humped; stooping forward" (from Ancient Greek kyphos "crooked"). [1]

Vertebroplasty

Vertebroplasty is typically performed by a spine surgeon or interventional radiologist. It is a minimally invasive procedure and patients usually go home the same or next day as the procedure. Patients are given local anesthesia and light sedation for the procedure, though it can be performed using only local anesthetic for patients with medical problems who cannot tolerate sedatives well.

During the procedure, bone cement is injected with a biopsy needle into the collapsed or fractured vertebra. The needle is placed with fluoroscopic x-ray guidance. The cement (most commonly poly methyl methacrylate (PMMA), although more modern cements are used as well) quickly hardens and forms a support structure within the vertebra that provide stabilization and strength. The needle makes a small puncture in the patient's skin that is easily covered with a small bandage after the procedure. [2]

Kyphoplasty

Cement in a vertebra as seen on plain Xray. VertcementX.png
Cement in a vertebra as seen on plain Xray.

Kyphoplasty is a variation of a vertebroplasty which attempts to restore the height and angle of kyphosis of a fractured vertebra (of certain types), followed by its stabilization using injected bone cement. The procedure typically includes the use of a small balloon that is inflated in the vertebral body to create a void within the cancellous bone prior to cement delivery. Once the void is created, the procedure continues in a similar manner as a vertebroplasty, but the bone cement is typically delivered directly into the newly created void. [3]

In a 2011 review Medicare contractor NAS determined that there is no difference between vertebroplasty and kyphoplasty, stating, "No clear evidence demonstrates that one procedure is different from another in terms of short- or long-term efficacy, complications, mortality or any other parameter useful for differentiating coverage." [4]

Effectiveness

As of 2019, the effectiveness of vertebroplasty is not supported. [5] [6] A 2018 Cochrane review found no role for vertebroplasty for the treatment of acute or sub-acute osteoporotic vertebral fractures. [7] The subjects in these trials had primarily non-acute fractures and prior to the release of the results they were considered the most ideal people to receive the procedure. After trial results were released vertebroplasty advocates pointed out that people with acute vertebral fractures were not investigated. [8] [9] A number of non-blinded trials suggested effectiveness, [10] but the lack of blinding limits what can be concluded from the results and some have been criticized because of being funded by the manufacturer. [8] One analysis has attributed the difference to selection bias. [11]

Some have suggested that this procedure only be done in those with fractures less than 8 weeks old; [12] however, analysis of the two blinded trials appear not to support the procedure even in this acute subgroup. [13] Others consider the procedure only appropriate for those with other health problems making rest possibly detrimental, those with metastatic cancer as the cause of the spine fracture, or those who do not improve with conservative management. [14]

Evidence does not support a benefit of kyphoplasty over vertebroplasty with respect to pain, but the procedures may differ in restoring lost vertebral height, and in safety issues like cement extravasation (leakage). [8] As with vertebroplasty, several unblinded studies have suggested a benefit from balloon kyphoplasty. [15] [16] As of 2012, no blinded studies have been performed, and since the procedure is a derivative of vertebroplasty, the unsuccessful results of these blinded studies have cast doubt upon the benefit of kyphoplasty generally. [17]

Some vertebroplasty practitioners and some health care professional organizations continue to advocate for the procedure. [18] [19] [20] In 2010, the board of directors of the American Academy of Orthopaedic Surgeons released a statement recommending strongly against use of vertebroplasty for osteoporotic spinal compression fractures, [21] while the Australian Medical Services Advisory Committee considers both vertebroplasty and kyphoplasty only to be appropriate in those who have failed to improve after a trial of conservative treatment, [22] with conservative treatment (analgesics primarily) being effective in two-thirds of people. [23] The National Institute for Health and Care Excellence similarly states that the procedure in those with osteoporotic fractures is only recommended as an option if there is severe ongoing pain from a recent fracture even with optimal pain management. [24]

Vertebral body stenting, also known by the brand Kiva, is a similar procedure which also has poor evidence to support its use. [6]

Adverse effects

A CT image of cement used in kyphoplasty that has entered the spinal channel and is pressing on the spinal cord resulting in neurological symptoms VertcementCT2.png
A CT image of cement used in kyphoplasty that has entered the spinal channel and is pressing on the spinal cord resulting in neurological symptoms

Some of the associated risks are from the leak of acrylic cement to outside of the vertebral body. Although severe complications are extremely rare, infection, bleeding, numbness, tingling, headache, and paralysis may ensue because of misplacement of the needle or cement. This particular risk is decreased by the use of X-ray or other radiological imaging to ensure proper placement of the cement. [2] In those who have fractures due to cancer, the risk of serious adverse events appears to be greater at 2%. [23]

The risk of new fractures following these procedures does not appear to be changed; however, evidence is limited, [17] and an increase risk as of 2012 is not ruled out. [25] Pulmonary cement embolism is reported to occur in approximately 2-26% of procedures. [26] It may occur with or without symptoms. [26] Typically, if there are no symptoms, there are no long term issues. [26] Symptoms do occur in about 1 in 2000 procedures. [22] Other adverse effects include spinal cord injury in 0.6 per 1000. [22]

Prevalence

In the United States in 2003 approximately 25,000 vertebroplasty procedures were paid for by Medicare. [27] As of 2011/2012 this number may be as high as 70,000-100,000 per year. [28]

History

Vertebroplasty had been performed as an open procedure for many decades to secure pedicle screws and fill tumorous voids. However, the results were not always worth the risk involved with an open procedure, which was the reason for the development of percutaneous vertebroplasty.

The first percutaneous vertebroplasty was performed in 1984 at the University Hospital of Amiens, France to fill a vertebral void left after the removal of a benign spinal tumor. A report of this and 6 other patients was published in 1987 and it was introduced in the United States in the early 1990s. Initially, the treatment was used primarily for tumors in Europe and vertebral compression fractures in the United States, although the distinction has largely gone away since then. [29]

Society and culture

Cost

The cost of vertebroplasty in Europe as of 2010 was ~2,500 Euro. [23] As of 2010 in the United States, when done as an outpatient, vertebroplasty costs around US$3300 while kyphoplasty costs around US$8100 and when done as an inpatient vertebroplasty cost ~US$11,000 and kyphoplasty US$16,000. [30] The cost difference is due to kyphoplasty being an in-patient procedure while vertebroplasty is outpatient, and due to the balloons used in the kyphoplasty procedure. [31] Medicare in 2011 spent about US$1 billion on the procedures. [28] A 2013 study found that "the average adjusted costs for vertebroplasty patients within the first quarter and the first 2 years postsurgery were $14,585 and $44,496, respectively. The corresponding average adjusted costs for kyphoplasty patients were $15,117 and $41,339. There were no significant differences in adjusted costs in the first 9 months postsurgery, but kyphoplasty patients were associated with significantly lower adjusted treatment costs by 6.8–7.9% in the remaining periods through two years postsurgery." [32]

Medicare response

In response to the NEJM articles and a medical record review showing misuse of vertebroplasty and kyphoplasty, US Medicare contractor Noridian Administrative Services (NAS) conducted a literature review and formed a policy regarding reimbursement of the procedures. NAS states that in order to be reimbursable, a procedure must meet certain criteria, including, 1) a detailed and extensively documented medical record showing pain caused by a fracture, 2) radiographic confirmation of a fracture, 3) that other treatment plans were attempted for a reasonable amount of time, 4) that the procedure is not performed in the emergency department, and 5) that at least one year of follow-up is planned for, among others. The policy, as referenced, applies only to the region covered by Noridian and not all of Medicare's coverage area. The reimbursement policy became effective on 20 June 2011. [4] A 2015 comparative study of Medicare patients with vertebral compression fractures found that those who received balloon kyphoplasty and vertebroplasty therapies experienced lower mortality and overall morbidity than those who received conservative nonoperative management. [33]

Promotion

In 2015, it was reported by The Atlantic that a person associated with a medical device company that sells equipment related to the kyphoplasty procedure had edited the Wikipedia article on the subject to promote claims about its efficacy. [34] Assertions about the positive effects of kyphoplasty have been found to be unsupported or disproven, according to independent researchers. [35]

Related Research Articles

<span class="mw-page-title-main">Interventional radiology</span> Medical subspecialty

Interventional radiology (IR) is a medical specialty that performs various minimally-invasive procedures using medical imaging guidance, such as x-ray fluoroscopy, computed tomography, magnetic resonance imaging, or ultrasound. IR performs both diagnostic and therapeutic procedures through very small incisions or body orifices. Diagnostic IR procedures are those intended to help make a diagnosis or guide further medical treatment, and include image-guided biopsy of a tumor or injection of an imaging contrast agent into a hollow structure, such as a blood vessel or a duct. By contrast, therapeutic IR procedures provide direct treatment—they include catheter-based medicine delivery, medical device placement, and angioplasty of narrowed structures.

<span class="mw-page-title-main">Kyphosis</span> Medical condition

Kyphosis is an abnormally excessive convex curvature of the spine as it occurs in the thoracic and sacral regions. Abnormal inward concave lordotic curving of the cervical and lumbar regions of the spine is called lordosis. It can result from degenerative disc disease; developmental abnormalities, most commonly Scheuermann's disease; Copenhagen disease, osteoporosis with compression fractures of the vertebra; multiple myeloma; or trauma. A normal thoracic spine extends from the 1st thoracic to the 12th thoracic vertebra and should have a slight kyphotic angle, ranging from 20° to 45°. When the "roundness" of the upper spine increases past 45° it is called kyphosis or "hyperkyphosis". Scheuermann's kyphosis is the most classic form of hyperkyphosis and is the result of wedged vertebrae that develop during adolescence. The cause is not currently known and the condition appears to be multifactorial and is seen more frequently in males than females.

<span class="mw-page-title-main">Lumbar spinal stenosis</span> Medical condition of the spine

Lumbar spinal stenosis (LSS) is a medical condition in which the spinal canal narrows and compresses the nerves and blood vessels at the level of the lumbar vertebrae. Spinal stenosis may also affect the cervical or thoracic region, in which case it is known as cervical spinal stenosis or thoracic spinal stenosis. Lumbar spinal stenosis can cause pain in the low back or buttocks, abnormal sensations, and the absence of sensation (numbness) in the legs, thighs, feet, or buttocks, or loss of bladder and bowel control.

<span class="mw-page-title-main">Back injury</span> Damage or wear to bones, muscles or other tissues of the back

Back injuries result from damage, wear, or trauma to the bones, muscles, or other tissues of the back. Common back injuries include sprains and strains, herniated discs, and fractured vertebrae. The lumbar spine is often the site of back pain. The area is susceptible because of its flexibility and the amount of body weight it regularly bears. It is estimated that low-back pain may affect as much as 80 to 90 percent of the general population in the United States.

<span class="mw-page-title-main">Spondylosis</span> Degeneration of the vertebral column

Spondylosis is the degeneration of the vertebral column from any cause. In the more narrow sense it refers to spinal osteoarthritis, the age-related degeneration of the spinal column, which is the most common cause of spondylosis. The degenerative process in osteoarthritis chiefly affects the vertebral bodies, the neural foramina and the facet joints. If severe, it may cause pressure on the spinal cord or nerve roots with subsequent sensory or motor disturbances, such as pain, paresthesia, imbalance, and muscle weakness in the limbs.

<span class="mw-page-title-main">Degenerative disc disease</span> Medical condition

Degenerative disc disease (DDD) is a medical condition typically brought on by the normal aging process in which there are anatomic changes and possibly a loss of function of one or more intervertebral discs of the spine. DDD can take place with or without symptoms, but is typically identified once symptoms arise. The root cause is thought to be loss of soluble proteins within the fluid contained in the disc with resultant reduction of the oncotic pressure, which in turn causes loss of fluid volume. Normal downward forces cause the affected disc to lose height, and the distance between vertebrae is reduced. The anulus fibrosus, the tough outer layers of a disc, also weakens. This loss of height causes laxity of the longitudinal ligaments, which may allow anterior, posterior, or lateral shifting of the vertebral bodies, causing facet joint malalignment and arthritis; scoliosis; cervical hyperlordosis; thoracic hyperkyphosis; lumbar hyperlordosis; narrowing of the space available for the spinal tract within the vertebra ; or narrowing of the space through which a spinal nerve exits with resultant inflammation and impingement of a spinal nerve, causing a radiculopathy.

<span class="mw-page-title-main">Spondylolisthesis</span> Displacement of one spinal vertebra compared to another

Spondylolisthesis is the displacement of one spinal vertebra compared to another. While some medical dictionaries define spondylolisthesis specifically as the forward or anterior displacement of a vertebra over the vertebra inferior to it, it is often defined in medical textbooks as displacement in any direction. Spondylolisthesis is graded based upon the degree of slippage of one vertebral body relative to the subsequent adjacent vertebral body. Spondylolisthesis is classified as one of the six major etiologies: degenerative, traumatic, dysplastic, isthmic, pathologic, or post-surgical. Spondylolisthesis most commonly occurs in the lumbar spine, primarily at the L5-S1 level, with the L5 vertebral body anteriorly translating over the S1 vertebral body.

<span class="mw-page-title-main">Spinal adjustment</span>

Spinal adjustment and chiropractic adjustment are terms used by chiropractors to describe their approaches to spinal manipulation, as well as some osteopaths, who use the term adjustment. Despite anecdotal success, there is no scientific evidence that spinal adjustment is effective against disease.

A burst fracture is a type of traumatic spinal injury in which a vertebra breaks from a high-energy axial load, with shards of vertebra penetrating surrounding tissues and sometimes the spinal canal. The burst fracture is categorized by the "severity of the deformity, the severity of (spinal) canal compromise, the degree of loss of vertebral body height, and the degree of neurologic deficit." Burst fractures are considered more severe than compression fractures because long-term neurological damage can follow. The neurologic deficits can reach their full extent immediately, or can progress for a prolonged time.

Middle back pain, also known as thoracic back pain, is back pain that is felt in the region of the thoracic vertebrae, which are between the bottom of the neck and top of the lumbar spine. It has a number of potential causes, ranging from muscle strain to collapse of a vertebra or rare serious diseases. The upper spine is very strong and stable to support the weight of the upper body, as well as to anchor the rib cage which provides a cavity to allow the heart and lungs to function and protect them.

<span class="mw-page-title-main">Vertebral compression fracture</span> Medical condition

A compression fracture is a collapse of a vertebra. It may be due to trauma or due to a weakening of the vertebra. This weakening is seen in patients with osteoporosis or osteogenesis imperfecta, lytic lesions from metastatic or primary tumors, or infection. In healthy patients, it is most often seen in individuals suffering extreme vertical shocks, such as ejecting from an ejection seat. Seen in lateral views in plain x-ray films, compression fractures of the spine characteristically appear as wedge deformities, with greater loss of height anteriorly than posteriorly and intact pedicles in the anteroposterior view.

<span class="mw-page-title-main">Bone metastasis</span> Medical condition

Bone metastasis, or osseous metastatic disease, is a category of cancer metastases that result from primary tumor invasions into bones. Bone-originating primary tumors such as osteosarcoma, chondrosarcoma, and Ewing sarcoma are rare; the most common bone tumor is a metastasis. Bone metastases can be classified as osteolytic, osteoblastic, or both. Unlike hematologic malignancies which originate in the blood and form non-solid tumors, bone metastases generally arise from epithelial tumors and form a solid mass inside the bone. Bone metastases, especially in a state of advanced disease, can cause severe pain, characterized by a dull, constant ache with periodic spikes of incident pain.

<span class="mw-page-title-main">Spinal fracture</span> Medical condition

A spinal fracture, also called a vertebral fracture or a broken back, is a fracture affecting the vertebrae of the spinal column. Most types of spinal fracture confer a significant risk of spinal cord injury. After the immediate trauma, there is a risk of spinal cord injury if the fracture is unstable, that is, likely to change alignment without internal or external fixation.

Interventional neuroradiology (INR) also known as neurointerventional surgery (NIS), endovascular therapy (EVT), endovascular neurosurgery, and interventional neurology is a medical subspecialty of neurosurgery, neuroradiology, intervention radiology and neurology specializing in minimally invasive image-based technologies and procedures used in diagnosis and treatment of diseases of the head, neck, and spine.

DFINE, Inc. was an American medical device company with headquarters in San Jose, California. It was known for its development of minimally invasive therapeutic devices built upon a radiofrequency platform for the treatment of spinal diseases. The platform included two applications, the StabiliT Vertebral Augmentation System for the treatment of vertebral compression fractures and the STAR Tumor Ablation System for pain relief treatment of metastatic spinal tumors.

Radiofrequency targeted vertebral augmentation is a form of kyphoplasty that uses radiofrequency heat to control the viscosity of polymethylmethacrylate cement and deliver it into the vertebral body to treat vertebral compression fractures.

Targeted radiofrequency ablation is a minimally invasive procedure to treat severe pain and discomfort caused from metastatic tumors in the vertebral body of the spine. This procedure uses radiofrequency energy to target and ablate a specific spinal tumor, causing it shrink and reduce the pressure on the surrounding nerves and tissues. The procedure minimizes damage to the vertebrae and surrounding tissues. It is used as a palliative therapy rather with the intention of treating the cancer itself.

<span class="mw-page-title-main">Ralph Kayser</span>

Ralph Kayser is a medical specialist in orthopedics and trauma surgery with a particular focus on spinal orthopedics. Furthermore, he is an associate professor at the medical department of the Greifswald Medical School. His particular scientific interest lies in the experimental ultrasound diagnostic and the special spinal surgery, especially in the conservative and minimal-invasive spinal indications.

<span class="mw-page-title-main">Vertebral hemangioma</span> Medical condition

Vertebral hemangiomas or haemangiomas (VHs) are a common vascular lesion found within the vertebral body of the thoracic and lumbar spine. These are predominantly benign lesions that are often found incidentally during radiology studies for other indications and can involve one or multiple vertebrae. Vertebral hemangiomas are a common etiology estimated to be found in 10-12% of humans at autopsy. They are benign in nature and frequently asymptomatic. Symptoms, if they do occur, are usually related to large hemangiomas, trauma, the hormonal and hemodynamic changes of pregnancy (causing intra-spinal bleeding), or osseous expansion and extra-osseous extension into surround soft tissues or epidural region of the spinal canal.

Joshua A. Hirsch is an American interventional pain management physician and radiologist. He specialises in percutaneous vertebroplasty, percutaneous sacroplasty, and minimally invasive spine surgery. Hirsch performs balloon-assisted kyphoplasty and has been credited as performing the first combined percutaneous vertebroplasty/kyphoplasty in Boston. Hirsch has served as chief of minimally invasive spine surgery, director of interventional neuroradiology, chief of the Interventional Spine Service, vice chair of interventional radiology quality and safety and associate departmental quality chair at Massachusetts General Hospital.

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