| Coverage Policy Manual | |
| Policy #: | 1999012 |
| Category: | Medicine |
| Initiated: | June 1999 |
| Last Review: | May 2023 |
|
|
|
|||||||||||
| Vertebroplasty, Percutaneous | |
|
|
|
| Description: |
Percutaneous vertebroplasty (PVP) is an interventional radiology technique involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. The technique has been investigated as an option to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture or in those with osteolytic lesions of the spine (e.g., multiple myeloma, metastatic malignancies). Percutaneous vertebroplasty has also been investigated as an adjunct to surgery for aggressive vertebral body hemangiomas, as a technique to limit blood loss related to surgery. The technique has been used in all levels of the vertebrae, i.e., cervical, thoracic, and lumbar.
Osteoporotic Vertebral Compression Fracture
Osteoporotic compression fractures are a common problem, and it is estimated that up to one half of women and approximately one quarter of men will have a vertebral fracture at some point in their lives. However, only about one third of vertebral fractures actually reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or a month. However, a minority of patients will exhibit chronic pain following osteoporotic compression fracture that presents challenges for medical management. Chronic symptoms do not tend to respond to the management strategies for acute pain such as bed rest, immobilization/bracing device, and analgesic medication, sometimes including narcotic analgesics. The source of chronic pain after vertebral compression fracture may not be from the vertebra itself but may be predominantly related to strain on muscles and ligaments secondary to kyphosis. This type of pain frequently is not improved with analgesics and may be better addressed through exercise or physical therapy. Improvements in pain and ability to function are the principal outcomes of interest for the treatment of osteoporotic fracture.
Vertebral Body Metastasis
Metastatic malignant disease involving the spine generally involves the vertebral bodies, with pain being the most frequent complaint. While radiation and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain vertebral body strength, which may necessitate supportive bracing to minimize the risk of vertebral body collapse during healing. Improvements in pain and function are the primary outcomes of interest for treatment of bone malignancy with percutaneous vertebroplasty.
Vertebral Hemangiomas
Vertebral hemangiomas are relatively common lesions noted in up to 12% of the population based on autopsy series; however, only rarely do these lesions display aggressive features and produce neurological compromise and/or pain. Treatment of aggressive vertebral hemangiomas has evolved from radiation therapy to surgical approaches using anterior spinal surgery for resection and decompression. There is the potential for large blood loss during surgical resection, and vascular embolization techniques have been used as adjuncts to treatment to reduce blood loss. Percutaneous vertebroplasty has been proposed as a way to treat and stabilize some hemangioma to limit the extent of surgical resection and as an adjunct to reduce associated blood loss from the surgery.
Percutaneous Vertebroplasty
Vertebroplasty is a surgical procedure that involves the injection of synthetic cement (e.g., polymethylmethacrylate, bis-glycidal dimethacrylate [Cortoss]) into a fractured vertebra (Bae, 2012). It has been suggested that vertebroplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers.
*Note: Percutaneous kyphoplasty is addressed in a separate policy (policy No. 2003024).
Regulatory Status
Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval.
Polymethylmethacrylate bone cement was available as a drug product before enactment of the FDA's device regulation and was at first considered what the FDA terms a "transitional device." It was transitioned to a class III device requiring premarketing applications. Several orthopedic companies have received approval of their bone cement products since 1976. In 1999, polymethylmethacrylate was reclassified from class III to class II, which requires future 510(k) submissions to meet "special controls" instead of "general controls" to assure safety and effectiveness. Thus, use of polymethylmethacrylate in vertebroplasty represented an off-label use of an FDA-regulated product before 2005. In 2005, polymethylmethacrylate bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V were cleared for marketing by the FDA through the 510(k) process for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures.
In 2009, Cortoss® (Stryker) Bone Augmentation Material was cleared for marketing by the FDA through the 510(k) process. Cortoss® is a nonresorbable synthetic material that is a composite resin-based, bis-glycidyl dimethacrylate. The FDA classifies this product as a polymethylmethacrylate bone cement.
In 2010, the Parallax® Contour® Vertebral Augmentation Device (ArthroCare) was cleared for marketing by FDA through the 510(k) process. There have been several other augmentation and bone expander devices (e.g., Balex® Bone Expander System, Arcadia® Ballon Catheter, Kyphon Element® Inflatable Bone Tamp) that were also cleared for marketing by FDA through the 510(k) process. These devices create a void in cancellous bone that can then be filled with bone cement. FDA product code: HXG.
Coding
Effective in 2015, there are new CPT codes that combine the vertebroplasty procedure with all of the necessary imaging guidance:
22510: Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic
22511: lumbosacral
22512: each additional cervicothoracic or lumbosacral vertebral body (List separately in addition to code for primary procedure
|
|
|
|
|
Policy/ Coverage: |
Effective August 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Primary coverage criteria is met for vertebroplasty for the following indications:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Vertebroplasty for any other condition not noted above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
For contracts without Primary Coverage Criteria, vertebroplasty for patients for any other condition not noted above as meeting Primary Coverage Criteria is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Effective Prior to August 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Primary coverage criteria is met for vertebroplasty for the following indications:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Vertebroplasty for any other condition not noted above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
For contracts without Primary Coverage Criteria, vertebroplasty for patients for any other condition not noted above as meeting Primary Coverage Criteria is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Effective Prior to May 2017
Primary coverage criteria is met for vertebroplasty for the following indications:
Vertebroplasty for any other condition not noted above does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, vertebroplasty for patients for any other condition not noted above as meeting Primary Coverage Criteria is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
|
|
|
|
| Rationale: |
This policy is based on an Arkansas Blue Cross Blue Shield Technology Assessment done after requests for coverage of the procedure. At that time coverage was extended for vertebroplasty with off-label use of polymethylmethacrylate for patients with pain secondary to metastatic disease to the vertebrae when pain was uncontrolled by more standard therapy. Consideration for coverage would be given to patients with symptomatic hemangioma of a vertebrae when standard therapy (eg, surgery) was not feasible. Other indications meeting Primary Coverage Criteria have been added as medical literature has been reviewed.
For treatment of osteoporosis and malignancy with percutaneous vertebroplasty (PVP), the primary beneficial outcomes of interest are relief of pain and improvement in ability to function. Ex vivo cadaver studies reporting bone strength as a surrogate outcome measure have been reported but are not included in this evaluation of health outcomes. In treatment of aggressive hemangioma, the primary benefits of PVP include relief of pain and reduction of blood loss associated with surgical treatment.
Pain and functional ability are subjective outcomes and, thus, may be susceptible to placebo effects. Furthermore, the natural history of pain and disability associated with these conditions may be variable. Therefore, controlled comparison studies would be valuable to demonstrate the clinical effectiveness of PVP over and above any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared to alternatives such as continued medical management.
In all clinical situations, adverse effects related to complications from PVP are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected PMMA.
There have been medical literature searches over the years with very few reports of randomized controlled trials or long-term outcomes. In a nonrandomized study, Diamond (2003) reported patients undergoing PVP had immediate pain relief from the procedure. However, at 6 weeks’ follow-up and at 6–12 months’ follow-up there was no difference between the group undergoing PVP and another group of patients that had not undergone PVP.
Alvarez and colleagues (2006) prospectively compared 101 percutaneous vertebroplasty patients to 27 conservatively managed patients who refused vertebroplasty. The authors reported improvements in pain, function, and general health scores at 3 months post-vertebroplasty but function was not significantly different at 6 months and 1 year between groups. Diamond and colleagues (2006)compared 88 vertebroplasty patients to 38 conservatively managed patients and reported significant improvements in pain after 6 weeks in vertebroplasty patients. However, no differences were seen between groups at 1 and 2 years. These non-randomized studies do not demonstrate beneficial long-term outcomes and do not address issues of placebo effects.
The VERTOS 1 study was a small randomized clinical trial of 34 patients reported by Voormolen et al in 2007. Patients had been refractory to medical management for at least 6 weeks and no longer than 6 months. The authors noted that many patients had been referred for vertebroplasty following failed conservative treatment and did not want to be randomized to the optimized medication control group or chose to crossover to vertebroplasty after only 2 weeks of conservative treatment. Thus, the follow-up in the study was very short. Vertebroplasty was found to decrease analgesic use (1.9 to 1.2 vs. 1.7 to 2.6 in the optimized medication group) and result in a 19% improvement in the Roland-Morris Disability Questionnaire (vs. -2% in controls) 2 weeks following the procedure. Excluding 2 patients (11%) who had adjacent vertebral compression fractures by the 2-week follow-up, mean visual analogue scores (VAS) for pain decreased from 7.1 to 4.4 (vs. 7.6 to 6.4 for controls). Patients who crossed over from conservative management to vertebroplasty had improvements after the procedure.
Six published case series studies have been identified that reported on at least 100 patients. Some studies included patients with vertebral fractures due to malignancy, but these patients’ outcomes were not reported separately. The studies varied with respect to the duration of the pain prior to the procedure. These case series showed generally consistent improvement in pain scores and other functional scores when compared to baseline; all showed decreases in pain from an initial starting value between 7–9 on the VAS to about 2–4 after the procedure. Such pain relief appears to be lasting in the 3 studies that reported long-term outcomes, although most of the studies had large losses to follow-up. Evidence regarding the durability of benefit is weakened by the losses to follow-up reported in most studies, but suggests effectiveness at least to 2 years. The major limitation of this body of evidence is that there is no control group; thus, placebo effects and natural history may account for some of the apparent benefits of treatment. (McGraw 2002, Alvarez 2005, Do 2005, Kobayashi 2005, Trout 2005, Layton 2007)
The largest of the case series reported results from a prospectively collected database with 552 patients from a large academic department (Layton 2007). The database consisted of baseline and postoperative measures, with follow-up by telephone at 1 week and 1, 6, 12, and 24 months (89%, 84%, 75%, 67%, and 62% patients at follow-up, respectively). The average age of the patients was 74 years (range of 28-96 years). Eighty-four percent of the procedures were performed for compression fractures related to osteoporosis, with an average duration of symptoms before treatment of 3.6 months. New compression fractures were observed following 23% (156) of the procedures; of these, 106 (68%) underwent an additional vertebroplasty procedure. Vertebroplasty was reported to decrease pain levels at rest and during activity by 50% or more (VAS of 4.5 to 1.7, and 8.4 to 3.6, respectively) beginning 2 hours after surgery; 87% of patients reported a decrease in pain. The Roland-Morris disability score improved from 18.4 at baseline to 10.8 at 1-week follow-up, and remained near this level throughout follow-up. Medication use was reported to decrease in over 66% of patients.
There are at least 2 ongoing multicenter randomized trials on percutaneous vertebroplasty. Investigational Vertebroplasty Efficacy and Safety Trial (INVEST) is a placebo-controlled trial (sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases) that is expected to enroll nearly 300 patients by 2009 (NCT00068822). VERTOS II plans to assess cost-effectiveness (pain reduction, quality of life, complications, secondary fractures, and mortality) of vertebroplasty compared to conservative therapy in 200 patients with acute osteoporotic compression fractures (NCT00232466). There is an ongoing trial in France comparing balloon kyphoplasty and vertebroplasty in subacute osteoporotic vertebral fractures (NCT00749086. Details of these studies can be accessed at www.clinicalrial.gov.
A 2007 joint position from the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology (“the Societies”) states that, “percutaneous vertebral augmentation with vertebroplasty and kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures when performed in a manner in accordance with published standards. These procedures are offered only when traditional medical therapy has not provided pain relief or pain is substantially altering the patient’s lifestyle.” (McGraw 2007)
2008 Update
Although comparative studies with long-term outcomes are lacking, numerous case series, including large prospective reports, consistently show that vertebroplasty may alleviate pain and improve function in patients with vertebral fractures who fail to respond to conservative treatment (at least 6 weeks with analgesics, physical therapy, and rest). Given the absence of alternative treatment options and the morbidity associated with extended bedrest, vertebroplasty may be considered a reasonable treatment option in patients with vertebral fractures who fail to improve after 6 weeks of conservative therapy.
2009 Update
Buchbinder (2008) published a protocol for a randomized controlled trial to determine the efficacy and safety of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures and to determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years. They anticipate enrollment of 200 participants with one or two recent painful osteoporotic vertebral fractures.
Gray (2009) reported a retrospective study of 3 groups of patients. Group 1 (n=328) underwent 1 single-level vertebroplasty procedure; Group 2 (n=226) underwent a single procedure in which 2 or more vertebral levels were treated; Group 3 (n=101) underwent 2 or more separate vertebroplasty procedures. There was no significant difference in pain relief and mobility improvement in patients treated for multiple synchronous or metachronous vertebral compression fractures in comparison with those treated for solitary isolated fractures.
There is an ongoing phase III trial at Mayo that has completed recruiting. The randomized controlled trial is called the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST), NCT00068822, with an enrollment of 294. Baseline pain and disability levels in the interventional and control group have been reported by Kallmes (2009).
Masala (2008) reported significant pain relief for patients receiving vertebroplasty for treatment of intractable vertebral back pain resulting from gross osteolytic lesion due to multiple myeloma involvement. Sixty-four patients had an average preprocedural pain level of 8.04 +/-1.4. Average pain levels at 1 and 6 months post procedure were 1.82 +/- 1.84 and 1.92 +/- 1.68 respectively. Tseng (2008) reported 57 patients (78 vertebrae) retrospectively who received PMMA vertebroplasty for pain relief from spinal metastatic tumor. The mean value of the VAS significantly decreased one day after vertebroplasty. There was a 21.8% bone cement extravasation without neurological impairment. No new or adjacent vertebral fracture has occurred in more than 2 years follow-up.
2010 Update
In September 2010, The American Academy of Orthopaedic Surgeons (AAOS) Board of Directors issued a clinical practice guideline for treatment of symptomatic osteoporotic spinal compression. The guidelines offer a strong recommendation against vertebroplasty for treatment of spinal compression fractures. Review of this guideline does not prompt a change in the coverage statement.
2012 Update
A search of the MEDLINE database was conducted through March 2012. The following is a summary of the relevant literature identified.
Staples and colleagues conducted a patient-level meta-analysis of the 2 sham-controlled trials to determine whether vertebroplasty is more effective than sham in specific subsets of patients (Staples, 2011). This subset analysis focused on duration of pain (< 6 weeks vs. > 6 weeks) and severity of pain (score < 8 or >8 on an 11-point numerical rating scale). Included in the analysis were 209 participants (78 from the Australian trial and 131 from the U.S. trial); 27% had pain of recent onset and 47% had severe pain at baseline. The primary outcome measures, pain scores and function on the RMDQ at 1 month, were not significantly different between groups. Responders’ analyses were also conducted based on a 3-unit improvement in pain scores, a 3-unit improvement on the RMDQ, and a 30% improvement in each of the pain and disability outcomes. The only difference observed between groups was a trend for a higher proportion of the vertebroplasty group to achieve at least 30% improvement in pain scores (RR: 1.32, 95% CI: 0.98 to 1.76, p=0.07), a result that may have been confounded by the greater use of opioid medications in that group. Overall, this analysis does not support the hypothesis that selected subgroups of patients, including those with pain of 6 weeks’ duration or less or those with severe pain, would benefit from vertebroplasty.
VERTOS II, reported by Klazen et al. in 2010, was an open-label prospective randomized trial of 202 patients at 6 hospitals in the Netherlands and Belgium (Klazen, 2010). Participants with at least one painful osteoporotic vertebral fracture of a duration of 6 weeks or less were assigned to undergo vertebroplasty or conservative management (i.e., bed rest, analgesia, and cast and physical support). Ninety-three participants received vertebroplasty, while 95 received conservative management; 81% of participants completed 1-year follow-up. The trial was designed to assess the efficacy of vertebroplasty compared to conservative management for the treatment of osteoporotic vertebral compression fractures. There was no blinding of participants, investigators, or outcome assessors to treatment assignment, due to the lack of a sham procedure.
A subsequent report from the VERTOS II study described the 12-month natural history of pain in patients in the conservative treatment arm (Venmans, 2011). Patients in the control arm were followed until pain relief was achieved, defined as a VAS score of 3 or less. Results were analyzed by Kaplan-Meier survival analysis. By 12-month follow-up, 57 of 95 patients (60%) were considered to have sufficient pain relief, with most experiencing sufficient pain relief in the first 3 months. Comparison by logistic regression analysis with the 38 patients (40%) who still had pain (VAS > 4) at 12 months did not reveal any significant differences between the groups for the clinical and imaging factors that were evaluated.
In 2011, Farrokhi and colleagues reported a randomized trial that compared vertebroplasty with optimal medical management in 82 patients (Farrokhi, 2011). Patients had painful osteoporotic vertebral compression fractures that were refractory to analgesic therapy for at least 4 weeks and less than 1 year. The patients and the physicians involved in the treatment of the patients were not aware of the treatment that the other group was receiving. Control of pain and improvement in quality of life were measured by independent raters before treatment and at 1 week and 2, 6, 12, 24, and 36 months after the beginning of treatment. Radiological evaluation to measure vertebral body height and correction of deformity was performed before and after treatment and after 36 months of follow-up. At 1 week, the mean VAS score decreased from 8.4 to 3.3 in the vertebroplasty group and from 7.2 to 6.4 in the conservative management group, with between group differences that remained significant through 6 months of follow-up. Group differences on the Oswestry lower back pain score were significantly lower in the vertebroplasty group throughout the 36 months of the study. New symptomatic adjacent fractures developed in 1 patient (2.6%) in the vertebroplasty group and 6 patients (15.4%) in the conservative management group. In 1 patient, epidural cement leakage caused severe lower extremity pain and weakness that was treated with bilateral laminectomy and evacuation of bone cement.
In 2011, Edidin et al. reported mortality risk in Medicare patients who had vertebral compression fractures and had been treated with vertebroplasty, kyphoplasty or nonoperatively (Edidin, 2011). This study was industry-funded. Using the U.S. Medicare data set, they identified 858,978 patients who had vertebral compression fractures between 2005 and 2008. The data set included 119,253 kyphoplasty patients and 63,693 vertebroplasty patients. Survival was calculated from the index diagnosis date until death or the end of follow-up (up to 4 years). Cox regression was used to evaluate the joint effect of multiple covariates, which included gender, age, race/ethnicity, patient health status, type of diagnosed fracture, site of service, physician specialty, socioeconomic status, year of diagnosis, and census region. After adjusting for covariates, patients in the operated cohort (vertebroplasty or kyphoplasty) were found to have a higher adjusted survival rate (60.8%) than patients in the nonoperated cohort (50.0%) and were 37% less likely to die. The adjusted survival rates for vertebroplasty or kyphoplasty were 57.3% and 62.8%, respectively, a 23% lower relative risk for kyphoplasty. As noted by the authors, a causal relationship cannot be determined from this study.
A systematic review of the safety and efficacy of vertebroplasty in malignancy was reported by Chew et al. in 2011 (Chew, 2011). Thirty relevant studies were identified, totaling 987 patients. Included in the review were a single randomized controlled trial and 7 prospective studies. Most centers reported treating no more than 4 vertebrae per session. Pain reduction ranged between 20% to 79%. Five deaths were attributable to vertebroplasty, 2 from chest infections following general anesthesia, 1 from a cement pulmonary embolus, and 2 from sepsis after emergency spinal decompression. Another 19 patients suffered a serious complication related to the procedure, with 13 requiring emergency spinal decompression. Reports of complications occurred in studies with a mean cement volume of more than 4 mL, suggesting a possible association between the volume of cement injected and adverse events.
Results of these studies do not prompt a change in the coverage statement.
2013 Update
A literature search was conducted through April 2013. There was no new literature identified that would prompt a change in the coverage statement. In 2012, a joint practice guideline on the performance of vertebral augmentation was published by the American College of Radiology (ACR), the American Society of Neuroradiology (ASN), the American Society of Spine Radiology (ASSR), the Society of Interventional Radiology (SIR), and the Society of Neurointerventional Surgery (SNIS). (37) This guideline addresses vertebral augmentation in general and refers to all percutaneous techniques used to achieve internal vertebral body stabilization, including vertebroplasty, balloon kyphoplasty, radiofrequency ablation and coblation, mechanical void creation, and injection of bone graft material or bone substitutes. The ACR, ASN, ASSR, SIR, and SNIS consider vertebral augmentation to be an established and safe procedure and provide guidelines for appropriate patient selection, qualifications and responsibilities of personnel, specifications of the procedure, equipment quality control, and quality improvement and documentation.
2014 Update
A search of the MEDLINE database conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
Kallmes et al conducted a multicenter, randomized, double-blind, sham-controlled trial (INVEST) in which 131 participants with 1 to 3 painful osteoporotic vertebral fractures were assigned to undergo vertebroplasty or sham procedure (injection of local anesthetic into the facet capsule and/or periosteum) (Kallmes, 2009). Participants had back pain for no more than 12 months and had a current pain rating of at least 3 on VAS at baseline. Participants were evaluated at baseline, then again at various time points to 1 year postprocedure. Ninety-seven percent completed a 1-month follow-up, and 95% completed 3 months. The primary outcomes were scores on the Roland-Morris Disability Questionnaire (RMDQ) and average back pain intensity during the preceding 24 hours at 1 month, with a reduction of 30% on the RMDQ and VAS pain considered a clinically meaningful difference.(21) The study initially had 80% power to detect differences in both primary and secondary outcomes with 250 patients, with a 2-sided alpha of 0.05 on the basis of a 2.5-unit advantage for vertebroplasty over placebo on the RMDQ and 1.0-point difference on VAS. After recruitment difficulty and interim analysis on the first 90 participants, target sample size was decreased to 130 participants with 80% power for primary aims maintained. All primary analyses were performed according to intention-to-treat principles and results presented as mean score for the RMDQ and pain intensity.
For the primary end points at 1 month, there were no significant between group differences. There was a trend toward a higher clinically meaningful improvement in pain at 1 month (30% reduction from baseline) in the vertebroplasty group (64% vs 48%, respectively; p=0.06). At 3 months, 43% from the control group vs 12% in the vertebroplasty group crossed over (p<0.001). The crossovers did not affect study outcomes, as they occurred after the primary outcome assessment. However, significantly more participants in the control group chose to cross over than in the vertebroplasty group. By 1 year, 16% of patients who underwent vertebroplasty and 60% of control subjects had crossed over to the alternative procedure (p<0.001) (Comstock, 2013). As-treated analysis found no significant difference in RMDQ or pain scores between the 2 groups. ITT analysis found a modest 1-point difference in pain rating, but no significant difference in RMDQ. There was a significant difference in the percentage of patients showing a 30% or greater improvement in pain (70% of patients randomized to vertebroplasty vs 45% of patients randomized to the control group).
Yi et al assessed the occurrence of new vertebral compression fractures after treatment with cement augmenting procedures (vertebroplasty or kyphoplasty) versus conservative treatment in an RCT with 290 patients (363 affected vertebrae) (Yi, 2014). Surgically treated patients were discharged the next day. Patients treated conservatively (pain medication, bed rest, body brace, physiotherapy) had a mean length of stay of 13.7 days. Return to usual activity occurred at 1 week for 87.6% of operatively treated patients and at 2 months for 59.2% of conservatively treated patients. All patients were evaluated with radiographs and magnetic resonance imaging at 6 months and then at yearly intervals until the last follow-up session. At a mean follow-up of 49.4 months (range, 36-80), 10.7% of patients had experienced 42 new symptomatic vertebral compression fractures. There was no significant difference in the incidence of new vertebral fractures between the operative (18 total; 9 adjacent, 9 nonadjacent) and conservative (24 total; 5 adjacent, 16 nonadjacent, 3 same level) groups, but the mean time to a new fracture was significantly shorter in the operative compared with nonoperative group (9.7 vs 22.4 months).
Practice Guidelines and Position Statements
In 2012, a joint practice guideline on the performance of vertebral augmentation was published by the American College of Radiology (ACR), the American Society of Neuroradiology (ASN), the American Society of Spine Radiology (ASSR), the Society of Interventional Radiology (SIR), and the Society of Neurointerventional Surgery (SNIS). Methods to achieve internal vertebral body stabilization include vertebroplasty, balloon kyphoplasty, radiofrequency ablation and coblation, mechanical void creation, and injection of bone graft material or bone substitutes. The ACR, ASN, ASSR, SIR, and SNIS consider vertebral augmentation to be an established and safe procedure and provide guidelines for appropriate patient selection, qualifications and responsibilities of personnel, specifications of the procedure, equipment quality control, and quality improvement and documentation. This guideline addresses vertebral augmentation in general and refers to all percutaneous techniques used (ACR-ASNR-ASSR=SIR-SNIS, 2013).
These societies (ACR, ASN, ASSR, SIR, SNIS) published a joint position statement on percutaneous vertebral augmentation in 2014. It is the position of the societies that percutaneous vertebral augmentation with the use of vertebroplasty or kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures, when performed in a manner in accordance with public standards. The document also states that these procedures are offered only when nonoperative medical therapy has not provided adequate pain relief or pain is significantly altering patients’ quality of life (Barr, 2014).
In a 2014 quality improvement guideline from SIR, failure of medical therapy is defined as follows (Baerlocher, 2014):
In 2013, ACR updated their appropriateness criteria on the management of compression fractures. The criteria for management of these fractures state that most vertebral compression fractures are resolved within 4 to 6 weeks with the more conservative first-line treatment including the use of nonsteroidal anti-inflammatory drugs and possibly narcotic medications, and that vertebroplasty should be reserved for patients who either have failed or cannot tolerate traditional conservative treatment (ACR, 2014).
The United Kingdom’s National Institute for Health and Care Excellence (NICE) concluded in 2003 that the current evidence on the safety and efficacy of vertebroplasty for vertebral compression fractures appears adequate to support the use of this procedure to provide pain relief for people with severe painful osteoporosis with loss of height and/or compression fractures of the vertebral body (NICE, 2003). The guidance recommends that the procedure be limited to patients whose pain is refractory to more conservative treatment. Their 2013 technology appraisal guidance TA279 states that percutaneous vertebroplasty and percutaneous balloon kyphoplasty are recommended as treatment options for treating osteoporotic vertebral compression fractures in persons having severe, ongoing pain after a recent unhealed vertebral fracture, despite optimal pain management and whose pain has been confirmed through physical exam and imaging to be at the level of the fracture (NICE, 2013).
In 2008, NICE issued CG75 on the diagnosis and management of adults with metastatic spinal cord compression. The guideline states that vertebroplasty or kyphoplasty should be considered for the patients who have vertebral metastases and no evidence of spinal cord compression or spinal instability if they have mechanical pain resistant to conventional pain management and vertebral body collapse (NICE, 2008).
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Chen and colleagues reported a non-blinded RCT of vertebroplasty compared with conservative management (Chen, 2014). The study included 89 patients with chronic compression fractures confirmed by MRI and persistent severe pain for 3 months or longer. Evaluation was performed at 1 week and at 1, 3, 6, and 12 months. Over the course of the year, pain scores decreased from 6.5 to 2.5 in the vertebroplasty group and from 6.4 to 4.1 in the control group (p < 0.001). Complete pain relief was reported by 84.8% of patients in the vertebroplasty group compared with 34.9% of controls. The final ODI score was 15.0 in the vertebroplasty group and 32.1 in the conservative management group (p < 0.001), and the final Roland Morris Disability Score was 8.1 for vertebroplasty and 10.7 for controls (p < 0.001).
2017 Update
A literature search conducted through April 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
PERCUTANEOUS VERTEBROPLASTY FOR VERTEBRAL COMPRESSION FRACTURES OF
BETWEEN 6 WEEKS AND 1 YEAR DURATION
Systematic Reviews
A 2015 Cochrane review by Buchbinder and colleagues evaluated the evidence on vertebroplasty for the treatment of vertebral compression fractures (Buchbinder, 2015). Eleven RCTs and 1 quasi-RCT were included in the systematic review. Two trials identified compared vertebroplasty with a sham procedure (n=209 patients; (Buchbinder, 2009; Kallmes, 2009), 6 compared vertebroplasty with usual care (n=566), and 4 compared vertebroplasty with kyphoplasty (n=545). The sham-controlled trials were considered to be at low risk of bias. All other trials were judged to be at high risk of bias due to lack of blinding. Evidence was rated as moderate quality based on the low number of subjects in the sham controlled trials. Meta-analysis of the 2 sham-controlled trials indicated that vertebroplasty does not result in clinically significant improvements in pain, disability, quality of life, or treatment success. Results did not differ for patients with pain durations of 6 weeks or less compared to pain lasting more than 6 weeks. Sensitivity analysis indicated that studies comparing vertebroplasty to conservative management were likely to have overestimated the treatment effect. The rate of serious adverse events did not differ significantly between the vertebroplasty and control groups, but serious adverse events related specifically to the vertebroplasty procedure included osteomyelitis, cord compression, thecal sac injury, and respiratory failure.
Nonrandomized Comparative Studies
In 2011 and 2015, Edidin and colleagues reported mortality risk in Medicare patients who had vertebral compression fractures and had been treated with vertebroplasty, kyphoplasty or nonoperatively (Edidin, 2011; Edidin, 2015). These studies were industry-funded. In the 2015 report, they identified 1,038,956 patients who had vertebral compression fractures between 2005 and 2009. The data set included 141,343 kyphoplasty patients and 75,364 vertebroplasty patients. Survival was calculated from the index diagnosis date until death or the end of follow-up (up to 4 years). Propensity matching was used to control for multiple covariates, which included age, sex, race, census region, socioeconomic status, comorbidities in 12 months prior to diagnosis and type of fracture, and year of fracture. The matched cohort included 100,649 non-operated patients, 36,657 kyphoplasty patients, and 24,313 vertebroplasty patients. Analysis of the whole data set before matching indicated that patients in the non-operated cohort had a 55% (95% CI, 53% to 56%, p<0.001) higher risk of mortality than the kyphoplasty cohort and 25% (95% CI, 23% to 26%, p<0.001) higher mortality than the vertebroplasty cohort. After propensity matching, the risk of mortality at 4 years was 47.2% in the non-operated group compared to 42.3% in the kyphoplasty group (p<0.001) and 46.2% in the vertebroplasty group (p<0.001).
PERCUTANEOUS VERTEBROPLASTY FOR VERTEBRAL COMPRESSION FRACTURES OF LESS
THAN 6 WEEKS
Randomized Controlled Trials
Vertebroplasty vs Medical Management With Sham Controls
Clark and colleagues reported results from the VAPOUR trial (Clark, 2016) VAPOUR was a multicenter double-blind trial of vertebroplasty in 120 patients with vertebral fractures of less than 6 weeks in duration and back pain of at least 7 out of 10 on an NRS. Two authors had participated in the 2009 study published by Kallmes and colleagues, the trial followed a similar protocol. Both outcomes assessors and patients were masked to treatment allocation, and independent statisticians unmasked the data and prepared the trial report. The sham-vertebroplasty procedure included subcutaneous lidocaine but no periosteal numbing. Manual skin pressure and tapping on the needle was performed to simulate the needle advance, and the investigators discussed polymethylmethacrylate (PMMA) mixing and injection during the procedure. The primary outcome, the percentage of patients with an NRS score less than 4 out of 10 at 14 days after the procedure, was met in a greater percentage of patients in the vertebroplasty group (44%) than in the sham control group (21%). This between-group difference was maintained through 6 months.
Other outcome measures were significantly improved in the vertebroplasty group at 1 or both of the time points (see Table 1). The benefit of vertebroplasty was found predominantly in the thoracolumbar subgroup, with 48% (95% CI, 27% to 68%) more patients meeting the primary endpoint (61% in the vertebroplasty group vs 13% in the control group). The investigators commented that the thoracolumbar junction is subject to increased dynamic load, and fractures at this junction have the highest incidence of mobility. No benefit from vertebroplasty was found in the non-thoracolumbar subgroup. Post-procedural hospital stay was reduced from a mean of 14 days in the control group to 8.5 days after vertebroplasty, even though physicians who determined the discharge date remained blinded to treatment. In the vertebroplasty group, there were 2 serious adverse events due to sedation and transfer to the radiology table. In the control group, 2 patients developed spinal cord compression; 1 underwent decompressive surgery and the other, not a surgical candidate, became paraplegic.
Leali and colleagues published a short report of a multicenter RCT with 400 patients with osteoporotic thoracic or lumbar vertebral compression fractures who were treated with vertebroplasty or conservative therapy (Leali, 2016). Fractures were treated within 2 weeks of onset of pain. Details of randomization and rate of follow-up were not reported. At 1 day after treatment, the vertebroplasty group had a reduction in pain scores and improvement in physical function, with VAS pain scores decreasing from 4.8 (5.0 max) to 2.3 (p=0.023.) and the Oswestry Disability Index (ODI) improving from 53.6% to 31.7% (p=0.012). Sixty-five percent of patients treated with vertebroplasty had stopped all analgesics within 48 hours. The conservatively group showed no benefit in the first 48 hours, but by 6 weeks VAS and ODI scores were described as similar in the 2 groups (specific data was not reported). Evaluation of this study is limited by the incomplete reporting.
Yang and colleagues compared vertebroplasty to conservative therapy in 135 patients over 70 years of age with severe back pain due to an osteoporotic vertebral fracture after minor or mild trauma (Yang, 2017). Vertebroplasty was performed at a mean of 8.4 days after pain onset. Patients in the conservative therapy group were placed in bedrest for at least 2 weeks after diagnosis with analgesics, followed by bracing and assistive devices. All patients receiving vertebroplasty could stand and walk with a brace at 1 day post-treatment while only 12 (23.5%) patients could stand up and walk after 2 weeks of bedrest. The average duration of bedrest from pain onset was 7.8 ± 4.7 days (range, 2-15 days) in the vertebroplasty group compared to 32.5 ± 14.3 days (range, 14-60 days) in the conservative therapy group. At 1-year follow-up, there was a similar percentage of additional compression fractures, but a significantly higher complication rate in the conservative therapy group (35.3%) compared to the vertebroplasty group (16.1%; p<0.001). Complications included pneumonia, urinary tract infection, deep vein thrombosis, depression, and sleep disorders.
In a sham-controlled RCT, where no anesthetic was injected into the periosteum, there was a significant benefit of vertebroplasty in patients who had severe pain of less than 6 weeks duration following vertebral fracture at the thoracolumbar junction. Other RCTs without sham control have reported that vertebroplasty is associated with significant improvements in pain, earlier improvement in function and reduction in the duration of bedrest compared to conservatively managed patients.
Clinical Trials
Some currently unpublished trials that might influence this review are listed below:
Ongoing
(NCT02370628) Vertebroplasty in the treatment of acute fracture trial (the VITTA Trial); planned enrollment 495; projected completion date April 2018.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Xie et al, in a meta-analysis of RCTs, evaluated efficacy and safety in percutaneous vertebroplasty and conservative treatment for patients with osteoporotic vertebral compression fractures (Xie, 2017). Thirteen studies were selected (total N=1231 patients; 623 to vertebroplasty, 608 to conservative treatment); among them were the two sham-controlled trials described below. Outcomes included pain relief (from 1 week to 6 months), quality of life assessments, and the rate of adjacent-level vertebral fracture. Vertebroplasty was superior for pain relief at 1 week (mean difference [MD], 1.36; 95% CI, 0.55 to 2.17) and 1 month (MD=1.56; 95% CI, 0.43 to 2.70); it was inferior to conservative treatment for pain relief at 6 months (MD = -1.59; 95% CI, -2.9 to -0.27; p<0.05). Vertebroplasty showed improvement over conservative treatment for quality of life, as measured using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (MD = -5.03; 95% CI, 7.94 to -2.12). No statistically significant differences were found between treatments for the rate of adjacent-level vertebral fractures (relative risk: 0.59; 95% CI, 0.43 to 0.81). Limitations included the inclusion of several studies with inadequate blinding and heterogenous reporting of patient characteristics outcomes.
Lin et al reported on mortality risk in elderly patients (>70 years old) who had vertebral compression fractures and were treated with early vertebroplasty (within 3 months) or conservative therapy (Lin, 2017). The data set consisted of 10,785 Taiwanese patients who were selected through the National Health Insurance Research Database, of whom 1773 patients received vertebroplasty, and 5324 did not; a minority of these patients had osteoarthritis. Using conditional Cox proportional hazard modeling to determine the risk of death and respiratory-related issues, the authors found that a “significant difference in survival curves of mortality and respiratory failure” existed between both groups of patients (p<0.05). The incidence of death at 1 year in the vertebroplasty group was 0.46 per 100 person-months (95% CI, 0.38 to 0.56). The incidence of death at 1 year in the non-vertebroplasty group was 0.63 per 100 person-months (95% CI, 0.57 to 0.70). With regard to respiratory failure, hazard ratio between groups was 1.46 (95% CI, 1.04 to 2.05; p=0.028). Limitations of this study included the broad selection of the population, which was not restricted only to patients with osteoporotic lesions. Also, authors were limited by the database, which did not report on pain or functional outcomes.
Frey et al reported on patients treated with percutaneous sacroplasty, particularly the long-term efficacy of sacroplasty vs nonsurgical management (Frey, 2017). This prospective, observational cohort study spanned ten years and comprised 240 patients with sacral insufficiency fractures. Thirty-four patients were treated with nonsurgical methods, and 210 patients were treated with sacroplasty. Pain, as measured by VAS, was recorded before treatment and at several follow-ups. Mean pretreatment VAS for the sacroplasty group was 8.29; for the nonsurgical treatment group, it was 7.47. Both forms of treatment resulted in significant VAS improvement from pretreatment to the 2-year follow-up (p<0.001). However, the sacroplasty treatment group experienced significant VAS score improvement consistently at many of the follow-up points (pretreatment to post [p<0.001]; posttreatment through 2 weeks [p>0.001]; 12 weeks through 24 weeks [p=0.014]; 24 weeks through 1 year [p=0.002]). Meanwhile, the group with nonsurgical treatment only experienced one significant pain improvement score—at the 2-week follow-up posttreatment (p=0.002). One major limitation of this study was that the nonsurgical treatment group was not followed up with at the 10-year mark whereas the sacroplasty group did receive follow-up.
2019 Update
A literature search was conducted through April 2019. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through April 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Hinde et al in a meta-analysis of retrospective and prospective cohort studies, assessed the mortality outcomes of vertebral augmentation versus nonsurgical management in patients with osteoporotic vertebral compression fractures (Hinde, 2020). The meta-analysis included 7 studies (N=2,089,944; 382,070 treated with vertebral augmentation and 1,707,874 treated with nonsurgical management). Vertebral augmentation improved mortality compared with nonsurgical management at both 2- and 5-year follow-up. Limitations included heterogeneity in the number of enrolled patients in included studies as well as differences in health status.
Zhang et al, in a meta-analysis of RCTs, assessed the efficacy of percutaneous vertebroplasty versus conservative treatment for patients with osteoporotic vertebral compression fractures (Zhang, 2020). Ten studies were included, and outcomes consisted of pain relief at 1 week, 1 month, and 6 months; quality of life assessments; and the rate of new vertebral fractures. Compared with conservative treatment, percutaneous vertebroplasty was superior for pain relief at 1 week and 1 month, but not at 3 months. Results varied for quality of life assessments with similar outcomes between percutaneous vertebroplasty and conservative treatments on the Roland-Morris Disability Questionnaire. Limitations included an imbalance in baseline demographics and the clinical characteristics of patients in included studies.
Chang et al, in a meta-analysis of RCTs and cohort studies, evaluated the effectiveness and safety of various interventions, including vertebroplasty versus kyphoplasty or conservative treatment, for treating osteoporotic vertebral compression fractures (Chang, 2021). Thirty-nine studies included vertebroplasty as a comparative arm. Outcomes included scores based on the visual analog scale and Oswestry Disability Index. Vertebroplasty decreased scores on the visual analog scale and Oswestry Disability Index compared with conservative treatment, but had similar outcomes compared with kyphoplasty. The rate of new fractures was similar for vertebroplasty versus conservative treatment and vertebroplasty versus kyphoplasty. Limitations consisted of the differences in indications, data types, follow-up times, and variables in included studies.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2021, the American Society of Pain and Neuroscience (ASPN) published practice guidelines for the interventional management of cancer-associated pain (Aman, 2021). The guideline included a best practice statement that stated "vertebral augmentation should be strongly considered for patients with symptomatic vertebral compression fractures from spinal metastases (evidence level 1-A)." However, ASPN noted that there is little data to suggest the superiority of either vertebroplasty or kyphoplasty when treating malignant vertebral compression fractures.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2022, the American College of Radiology (ACR) revised its Appropriateness Criteria for the use of percutaneous vertebral augmentation in the management of vertebral compression fractures (ACR, 2022). Below shows the appropriateness categories for each variant.
|
|
|
|
| CPT/HCPCS: | |
|
|
|
| References: |
Aman MM, Mahmoud A, Deer T, et al.(2021) The American Society of Pain and Neuroscience (ASPN) Best Practices andGuidelines for the Interventional Management of Cancer-Associated Pain. J Pain Res. 2021; 14: 2139-2164. PMID34295184 American College of Radiology (ACR).(2022) Management of vertebral compression fractures. https://acsearch.acr.org/docs/70545/Narrative/. Published 2022. Accessed March 7, 2023. Bae H, Hatten HP, Linovitz R, et al.(2012) A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up. Spine (Phila Pa 1976). Apr 01 2012; 37(7): 544-50. PMID 21738093 Chang M, Zhang C, Shi J, et al.(2021) Comparison Between 7 Osteoporotic Vertebral Compression Fractures Treatments: Systematic Review and Network Meta-analysis. World Neurosurg. Jan 2021; 145: 462-470.e1. PMID 32891841 Hinde K, Maingard J, Hirsch JA, et al.(2020) Mortality Outcomes of Vertebral Augmentation (Vertebroplasty and/or Balloon Kyphoplasty) for Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis. Radiology. Apr 2020; 295(1): 96-103. PMID 32068503 Zhang L, Zhai P.(2020) A Comparison of Percutaneous Vertebroplasty Versus Conservative Treatment in Terms of Treatment Effect for Osteoporotic Vertebral Compression Fractures: A Meta-Analysis. Surg Innov. Feb 2020; 27(1): 19-25. PMID 31423902 |
|
|
|
|
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
|