BlueCross and BlueShield of Montana Medical Policy/Codes
Percutaneous Vertebroplasty, Percutaneous Kyphoplasty, and Percutaneous Sacroplasty
Chapter: Surgery: Procedures
Current Effective Date: July 18, 2013
Original Effective Date: June 25, 2002
Publish Date: July 18, 2013
Revised Dates: March 1, 2005, July 21, 2005, August 1, 2006, June 9, 2009, March 26, 2012; April 11, 2013
Description

Percutaneous vertebroplasty (PPV) and percutaneous kyphoplasty are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. Both techniques have been investigated as options to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture, or in those with osteolytic lesions of the spine, i.e., multiple myeloma or 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.  

Percutaneous Vertebroplasty

It has been proposed that vertebroplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other possible mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers, since PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process.

Percutaneous Kyphoplasty

Balloon kyphoplasty is a variant of vertebroplasty, which uses a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body as close as possible to its natural height before injection of the PMMA. Radiofrequency kyphoplasty is a modification of balloon kyphoplasty. In this procedure, ultrahigh viscosity cement is injected into the fractured vertebral body, and radiofrequency is used to achieve the desired consistency of the cement. The ultrahigh viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture.  

Like vertebroplasty, the analgesic effect that kyphoplasty may provide could be attributed to a number of possible mechanisms of effect, including stabilization of the vertebral body and thermal damage to intraosseous nerve fibers.

Percutaneous Sacroplasty

Sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical, entails guided injection of PMMA through a needle inserted into the fracture zone. While first described in 2001 as a treatment for symptomatic sacral metastatic lesions, (1, 2) it is most often described as a minimally invasive procedure employed as an alternative to conservative management (3-5) for sacral insufficiency fractures (SIFs). SIFs are the consequence of excessive stress on weakened bone and are often the cause of low back pain among the elderly population. Osteoporosis is the most common risk factor for SIF.

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.

Vertebral/Sacral Body Metastasis

Metastatic malignant disease involving the spine generally involves the vertebrae/sacrum, 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 strength in the vertebrae/sacrum, which may necessitate supportive bracing to minimize the risk of vertebral/sacral collapse during healing.

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 or percutaneous cementoplasty have been proposed as ways to treat and stabilize some hemangiomas to limit the extent of surgical resection and as an adjunct to reduce associated blood loss from the surgery.

Sacral Insufficiency Fracture (SIF)

Spontaneous fracture of the sacrum in patients with osteoporosis was described by Lourie in 1982 and presents as lower back and buttock pain with or without referred pain in the legs. (6, 7) Although common, SIFs can escape detection due to low provider suspicion and poor sensitivity on plain radiographs, slowing the application of appropriate intervention. Similar interventions are used for sacral and vertebral fractures including bed rest, bracing, and analgesics. Initial clinical improvements may occur quickly; however, the resolution of all symptoms may not occur for 9 to 12 months. (6, 8)

Regulatory Status

Vertebroplasty and Kyphoplasty are surgical procedures and, as such, are not subject to U.S. Food and Drug Administration (FDA) approval. PMMA bone cement was available as a drug product prior to 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 October 1999, PMMA 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.

The use of PMMA in kyphoplasty represented an off-label use of an FDA-regulated product prior to July 2004. In July 2004, KyphX® HV-RTM bone cement was given 501(k) marketing clearance by the FDA for the treatment of pathologic fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. 

The use of PMMA in vertebroplasty represented an off-label use of an FDA-regulated product prior to 2005. In 2005, PMMA bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V were issued 510(k) marketing clearance for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

The FDA issued a “Public Health Web Notification: Complications related to the use of bone cement in vertebroplasty and kyphoplasty procedures”. This notification is intended to inform the public about reports on safety and to encourage hospitals and other user facilities to report adverse events related to bone cement malfunctions either directly to manufacturers or to MedWatch, the FDA’s voluntary reporting program.

Kyphoplasty requires the use of an inflatable bone tamp. One such tamp, the KyphX® inflatable bone tamp, received 510(k) marketing clearance from the FDA in July 1998.

The use of PMMA in sacroplasty represents an off-label use of an FDA-regulated product (bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V) as the 510(k) marketing clearance was for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Sacroplasty was not included.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Medically Necessary

BCBSMT may consider percutaneous vertebroplasty or percutaneous kyphoplasty medically necessary for:

  • The treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy and rest) for at least six weeks; OR
  • The treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Investigational 

BCBSMT considers percutaneous vertebroplasty and percutaneous kyphoplasty experimental, investigational and unproven for all other indications, including but not limited to use in acute vertebral fractures due to osteoporosis or trauma.

Percutaneous sacroplasty is considered experimental, investigational and unproven for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies or multiple myeloma.

Rationale

For treatment of osteoporosis and malignancy with percutaneous vertebroplasty, kyphoplasty, or sacroplasty, the primary beneficial outcomes of interest are relief of pain and improvement in ability to function. Kyphoplasty may also result in restoration of lost vertebral body height with associated reduction in kyphotic deformity. Potential health outcomes related to kyphotic deformity include pulmonary or gastrointestinal compression and associated symptoms, and vertebral compression fractures may be associated with lower related quality of life. 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 percutaneous vertebroplasty 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 vertebroplasty, kyphoplasty and sacroplasty 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 vertebroplasty, kyphoplasty, and sacroplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected polymethylmethacrolate (PMMA).

This policy was originally based on a 2000 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment. (9) Subsequent BCBSA TEC Assessments were released in 2004, 2005, 2008, 2009 and 2010. (10-16)

Percutaneous Vertebroplasty

Evidence on percutaneous vertebroplasty consists of a number of randomized clinical trials (RCTs), two of which included a sham control, and many case series. Originally, the available data were observational. The largest of the case series reported results from a prospectively collected database with 552 patients from a large academic department. (17) Evidence from observational studies were generally consistent in showing significant decreases in pain from an initial preoperative level of eight to nine on a visual analog scale (VAS, or similar score proportionate to the highest possible score) to two to four, typically within one day of receiving the procedure. Such pain relief appeared to be lasting in the limited studies that reported long-term outcomes. In terms of adverse outcomes, leakage of the cement outside of the vertebral body was a common event, occurring in between 19% and 72% in studies that reported its occurrence. 

Beginning in 2007, data from RCTs began appearing in the literature. This policy is now focused on RCT data.

RCTs of Vertebroplasty versus Medical Management with Sham Controls

In 2009, two randomized trials compared vertebroplasty to a medical management using a sham placebo control (that included local anesthetic), which mimicked the vertebroplasty procedure up to the point of cement injection. (18, 19) Buchbinder and colleagues reported results of a four-center, randomized, double-blind, sham-controlled trial that was designed to determine short-term efficacy and safety of vertebroplasty for alleviating pain and improving physical functioning in persons with painful osteoporotic vertebral fractures. A total of 78 participants with one or two painful osteoporotic vertebral fractures of duration less than one year were assigned to undergo vertebroplasty or sham procedure (i.e., injection of local anesthetic into the facet capsule and/or periosteum). (18) Ninety-one percent of participants completed six-months of follow-up. The participants, investigators (other than the radiologists performing the procedure), and outcome assessors were blind to the treatment assignment.

Recruitment took place within the practices of both general practitioners and specialists from hospital inpatient and emergency departments. In general, participants were required to have back pain of no more than 12 months and the presence of at least one but no more than two recent vertebral fractures. Participants were evaluated at baseline, then with a mailed questionnaire at one week and one, three, and six months after the procedure. The primary outcome was overall pain (over the course of the previous week) measured on a 0 to 10 VAS, with 1.5 representing the minimal clinically important difference. A sample size of 24 per group was calculated to provide 80% power with two-sided α 0.05 to show a 2.5-point post-procedure difference assuming a three-point standard deviation (SD). All analyses were performed according to intention-to-treat principles. Results are presented as difference from baseline. For the primary outcome of overall pain, the authors reported no significant difference in VAS pain score at three months. With reductions in pain and improvements in quality of life observed in both groups, the authors concluded vertebroplasty provided no benefit.

There was considerable variability in pain scores, which may in part be due to a lack of minimum pain score at entry. The primary outcome measure was the mean difference in VAS from baseline. For some continuous outcomes, such as pain, there is a magnitude of improvement that is clinically meaningful on an individual level; someone achieving that minimal change can be considered a responder. Under these circumstances, a fundamental limitation of continuous effect measures is failing to identify the proportion of patients experiencing a meaningful clinical response. (20)  Since a clinically meaningful important improvement has been established, the proportion of patients responding is an informative outcome that can supplement and extend the comparison of mean differences. (21) Moreover, when considered in this manner, response or meaningful improvement (2.5 on the VAS) in overall pain at one, three, and six months tended to be more frequent with vertebroplasty—respective relative risks (RRs) of 1.2 (95% confidence interval [CI]: 0.7 to 2.0), 1.5 (95% CI: 0.9 to 2.6), and 1.3 (95% CI: 0.8 to 2.1). However, detecting an increase in clinical response rates often requires larger numbers of patients. For example, detecting an increase in response from 40% (sham) to 60% with 80% power would have required a sample exceeding 200 participants. In addition, at entry, many participants had experienced pain longer than three months, (22) suggesting that the VAS may not be as responsive as other measures for these patients. (22) This adds to the uncertainty as to whether a mean change in VAS will capture clinically meaningful improvement.

Kallmes et al. conducted a multicenter, randomized, double-blind, sham-controlled trial in which 131 participants with one to three painful osteoporotic vertebral fractures were assigned to undergo vertebroplasty or sham procedure (injection of local anesthetic into the facet capsule and/or periosteum). (19) Participants had back pain for no more than 12 months and had a current pain rating of at least three on VAS at baseline. Participants were evaluated at baseline, then again at various time points to one-year post-procedure. Ninety-seven percent completed a one month follow-up, and 95% completed three months. The primary outcomes were scores on the Roland-Morris Disability Questionnaire (RMDQ) and average back pain intensity during the preceding 24 hours at one month, with a reduction of 30% on the RMDQ and VAS pain considered a clinically meaningful difference. (23) The study initially had 80% power to detect differences in both primary and secondary outcomes with 250 patients, with a two-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 endpoints at one month, there were no significant between group differences. There was a trend toward a higher clinically meaningful improvement in pain at one month (30% reduction from baseline) in the vertebroplasty group (64% vs. 48%, respectively; p=0.06). At three 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.

Staples and colleagues conducted a patient-level meta-analysis of two sham-controlled trials to determine whether vertebroplasty is more effective than sham in specific subsets of patients. (24) 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 Roland Morris Disability Questionnaire (RMDQ) at one month, were not significantly different between groups. Responders’ analyses were also conducted based on a three-unit improvement in pain scores, a three-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 six weeks’ duration or less or those with severe pain, would benefit from vertebroplasty.

 RCTs of Vertebroplasty versus Medical Management without Sham Controls

VERTOS II, reported by Klazen et al. in 2010, was an open-label prospective randomized trial of 202 patients at six hospitals in the Netherlands and Belgium. (25) Participants with at least one painful osteoporotic vertebral fracture of a duration of six 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 one-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.

Participants were recruited after referral from their primary care provider for spine radiography because of back pain. In general, participants were required to be at least 50 years of age or older, have compression fracture with height loss of the vertebral body of at least 15% on x-ray of the spine, the level of fracture was Th5 or lower back with pain of a duration of six weeks or less with a severity of at least five on the VAS. Participants were clinically evaluated at baseline, one day, one week, one month, three months, six months and 12 months after treatment. Primary outcome was pain relief at one month and 12 months measured on a 10-point VAS scale. A sample size of 100 per group was calculated to provide 80% power with an alpha of 0.05 to show a 25% difference in pain relief. All analyses were performed according to intention-to-treat principles. Clinically significant pain relief was defined as 30% change on the VAS (0-10 scale).

One hundred and one participants were enrolled into the treatment group and 101 into the control arm; 81% completed 12 months’ follow-up. Except for the primary outcome, difference in mean pain score from baseline at three months and 12 months, vertebroplasty resulted in greater pain relief than did medical management at one month and one year; there were significant between group differences at one month (2.6; 1.74 to 3.37, p<0.0001) and at one year (2.0; 1.13 to 2.80, p<0.0001). Survival analysis showed significant pain relief was quicker (29.7 vs. 115.6 days) and was achieved in more patients after vertebroplasty than after conservative management. There was cement leakage in 72% of patients after vertebroplasty with all patients remaining asymptomatic, and at a mean of 11.4 months’ follow-up, there was no significant difference in number of new fractures between groups, with 18 new fractures in 15 patients who had vertebroplasty compared to 30 new fractures in 21 participants undergoing medical management.

A methodologic strength of this study is the study’s focus on acute fracture, a subset of those with osteoporotic vertebral compression fractures, while other studies (Buchbinder et al. 2009 [18]; Kallmes et al. 2009 [19]) enrolled participants with pain out to one year. The inclusion of both chronic and acute fractures may mask the efficacy of the procedure in one subset. Klazen and colleagues also provided an a priori definition of clinically significant change in pain as one that registered a 30% difference on the 10-point VAS.(25)  These data were incorporated as events in a survival analysis as part of the analysis of the primary outcome.

A subsequent report from the VERTOS II study described the 12-month natural history of pain in patients in the conservative treatment arm. (26) Patients in the control arm were followed until pain relief was achieved, defined as a VAS score of three 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 three 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.(27)  Patients had painful osteoporotic vertebral compression fractures that were refractory to analgesic therapy for at least four weeks and less than one 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 one week and two, six, 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 one 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 six 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 one patient (2.6%) in the vertebroplasty group and six patients (15.4%) in the conservative management group. In one patient, epidural cement leakage caused severe lower extremity pain and weakness that was treated with bilateral laminectomy and evacuation of bone cement.

Rousing et al. (28) reported on a non-blinded randomized trial in which participants were randomized to either vertebroplasty or conservative management. These participants had no conservative therapy prior to enrolling in the trial. The study enrolled 40 participants with acute fractures and 10 with subacute (2–8 weeks). While immediate pain relief was observed in the vertebroplasty group, reductions in pain from baseline to three-month follow-up were similar in the two groups. The authors concluded that conservative management should be used in the acute phase. The primary limitations of this study include its small size and incomplete pain assessment at the baseline visit.

The VERTOS study was a small randomized clinical trial of 34 patients. (29) Patients had been refractory to medical management for at least six weeks and no longer than six 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 two 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 resulted in a 19% improvement in the RMDQ (vs. -2% in controls) two weeks following the procedure. Excluding two patients (11%) who had adjacent vertebral compression fractures by the two-week follow-up, mean VAS scores 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.

Despite the completion of five RCTs, including two with sham control, the efficacy of vertebroplasty for painful osteoporotic compression fractures remains uncertain. The two randomized, sham-controlled trials concluded that vertebroplasty showed no significant benefit above sham for painful osteoporotic fractures. However some uncertainty remains around the interpretation of their conclusions. While the use of a sham procedure is a major methodologic strength to control for nonspecific (placebo) effects, the sham used in the trial is not without controversy, as it might be considered an active control, given that the effect of injecting local anesthetic in the facet capsule and/or periosteum is unknown. Without a clear understanding of the short- and long-term effects of the injection on pain, questions will remain. Also, both trials were underpowered to observe and compare the proportion of participants experiencing a clinically meaningful difference in pain, which is the most clinically relevant outcome measure. Furthermore, the responder outcome measures in both trials showed trends toward an improvement in the rate of meaningful clinical response, although the differences between groups were not statistically significant.

In contrast, the four RCTs without sham control report that vertebroplasty is associated with significant improvements in pain. Three of the four trials were small, and the studies included populations with different time periods of symptoms and different prior treatments. It is possible that the effect reported in these non-sham controlled trials is due to a placebo effect, given that these studies were not blinded and the outcome of pain is a subjective, patient-reported outcome that is prone to the placebo effect. It is also possible that the differences in these trials represents a true treatment effect and that the sham control had a therapeutic effect in reducing short-term pain, thus obscuring any impact of vertebroplasty.

Other Studies

Although not randomized, there was one other comparative study specifically aimed at patients with acute fracture. Diamond et al. enrolled 79 consecutive patients with acute vertebral fractures. (30) All patients were offered vertebroplasty, and those who declined were followed as a comparison group. The two groups had balanced baseline characteristics. At 24 hours, the group undergoing vertebroplasty (n=55) had much improved pain compared to the control group (n=24). However, at six weeks and between six and 12 months, there were no differences between groups in pain scores. The control group had an identical mean pain score to the vertebroplasty group at the end of follow-up. Similar findings were shown for the Barthel index of physical functioning. At long-term follow-up, there was still slightly higher functioning in the group undergoing vertebroplasty but no difference in the percent improvement from baseline between groups. The authors interpreted these findings as demonstrating that vertebroplasty produced faster resolution of symptoms than conservative management, as was shown in the Klazen trial.

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. (31) 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 four 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. (32)  Thirty relevant studies were identified, totaling 987 patients. Included in the review were a single randomized controlled trial and seven prospective studies. Most centers reported treating no more than four vertebrae per session. Pain reduction ranged between 20% to 79%. Five deaths were attributable to vertebroplasty, two from chest infections following general anesthesia, one from a cement pulmonary embolus, and two 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.

Practice Guidelines and Position Statements

In 2010, the American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved a new clinical practice guideline on the treatment of osteoporotic spinal compression fractures. The Board approved a strong recommendation against the use of vertebroplasty for patients who “present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically “intact.” In coming out with a strong recommendation, the committee expressed their confidence that future evidence is unlikely to overturn the existing evidence. As a note, these recommendations were based on a literature review through September 2009; therefore, the Klazen et al. trial was not included in the systematic review.

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.” (33)

Guidelines from the American College of Radiology (ACR, 2006) consider percutaneous vertebroplasty appropriate for painful osteoporotic or neoplastic vertebral compression fracture(s) refractory to medical therapy. (34) It is noted that when fewer than 95% of percutaneous vertebroplasty in an institution are performed for the above indication, it should prompt a review of practices related to selection of patients for this procedure. The guidelines also list absolute contraindications of asymptomatic vertebral body compression fractures, including patient improving on medical therapy; nonfractured vertebral levels; prophylaxis in osteoporotic patients (unless being performed as part of a research protocol); osteomyelitis of the target vertebra; myelopathy originating at the fracture level; uncorrectable coagulopathy; allergy to bone cement or opacification agent. Relative contraindications are listed as radiculopathy in excess of local vertebral pain, caused by a compressive syndrome unrelated to vertebral collapse (occasionally preoperative percutaneous vertebroplasty can be performed before a spinal decompressive procedure); asymptomatic retropulsion of a fracture fragment causing significant spinal canal compromise; asymptomatic tumor extension into the epidural space; ongoing systemic infection.

The ACR published guidelines on the management of vertebral compression fractures in 2010. (35) While generally supportive of vertebroplasty and kyphoplasty in specified conditions, the guidelines state that “conservative management is the first-line and gold standard treatment of painful vertebral compression fractures….Most patients with osteoporotic vertebral compression fractures, even without medication, have spontaneous resolution of pain within 4 to 6 weeks from the initial onset of pain. From the inception of vertebral augmentation in the late 1980s, its minimally invasive procedures have been reserved for patients who have failed conservative therapy. Failure can be defined as pain refractory to oral medications (NSAIDs and/or narcotic) over 6-12 weeks. However, failure can also be defined as contraindications to such medications or a requirement for parenteral narcotics and hospital admission.”

Indications and contraindications similar to those provided by the ACR were described by the Society of Interventional Radiology (SIR) in 2003. (36)

Percutaneous Kyphoplasty

Originally the available data were observational. Evidence from observational studies were generally consistent in showing significant decreases in pain from an initial preoperative level of seven to nine on a visual analogue scale ([VAS] or similar score proportionate to the highest possible score) to two to four, typically within one day of receiving the procedure. Such pain relief appeared to be lasting in the four studies that reported long-term outcomes, although most of the studies had large losses to follow-up. (37-40)

In terms of other outcomes, results generally showed improvement after kyphoplasty. For example, Coumans et al. (37) reported statistically significant improvements in several sub-scores of the short form-36 (SF-36), including physical function, mental health, pain, vitality, and social function. Crandall et al. (39) showed decreases in the amount of medication use over time and Ledlie et al. (41) showed that the proportion of patients fully ambulatory increased after the procedure. Two nonrandomized studies that compared kyphoplasty to conservative management for treatment of osteoporotic fractures showed that patients receiving kyphoplasty had greater improvements in pain and function. (42, 43)

In terms of adverse outcomes, the most common adverse outcome reported in these studies was leakage of the cement outside of the vertebral body, occurring between 6% and 38% in six studies that reported its occurrence. The early literature review also identified a publication on treatment of pathologic compression fractures in which kyphoplasty and spinal radiosurgery were combined. (44) In a 2008 Blue Cross Blue Shield (BCBS) Technical Assessment (TEC) found that although many case series had been published, there was a lack of rigorous comparative trials of kyphoplasty. (14)  Since case series studies are subject to many sources of bias and are generally not reliable evidence of efficacy, it was concluded that the evidence for kyphoplasty did not meet BCBS TEC criteria.

Beginning in 2009, data from randomized clinical trials (RCTs) began appearing in the literature. This policy is now focused on RCT data.

Osteoporotic Compression Fractures

In 2009, Wardlaw et al. reported on the findings of an industry-sponsored multisite RCT in which 300 adult participants with one to three painful osteoporotic vertebral fractures of less than three months’ duration were assigned to undergo kyphoplasty or conservative care. (45)  Twenty-four month results of this study were reported by Boonen et al. in 2011. (46)   This study was designed to examine efficacy and safety of kyphoplasty for the treatment of acute vertebral compression fractures. There was no blinding in this trial. Participants were recruited from 21 sites in eight countries. Participants needed to have back pain of no more than three months’ duration and the presence of at least one but no more than three acute vertebral fractures. Participants were evaluated at baseline, then at 1, 3, 6, 12, and 24 months after the procedure. The primary outcome was the difference in change from baseline to one month in the SF-36 physical component summary (PCS) between the kyphoplasty and control groups.

A total of 138 participants who underwent kyphoplasty and 128 control patients completed one month of follow-up. Scores for the primary outcome, one-month change in SF-36 PCS score, were significantly higher for those in the kyphoplasty group. The difference between the two groups was 5.2 points (95% confidence interval [CI]: 2.9–7.4; p <0.0001). Data were available from 232 patients (77%) at 24 months. Kyphoplasty was associated with greater improvements in SF-36 PCS scores at six-month follow-up (3.39 points), but not at 12 or 24 months. Greater improvement in back pain was observed over 24 months for kyphoplasty (-1.49 points) and remained statistically significant at 24 months. Participants in the kyphoplasty group also reported greater improvements in quality of life and Roland Morris disability score at short-term follow-up. At 12 months, fewer kyphoplasty patients (26.4% vs. 42.1%) had received physical therapy or walking aids, back braces, wheelchairs, miscellaneous aids, or other therapy.  Fewer kyphoplasty patients used opioid medications through six months (29.8% vs. 42.9%) and fewer pain medications through 12 months (51.7% vs. 68.3%). While not a study outcome, the authors also noted that patients who received kyphoplasty had approximately 60 fewer days of restricted activity during the year than controls. Other differences between the groups were no longer apparent at 12 months; possibly due to natural healing of fractures. At 24 months, there was no significant difference between groups in the number of patients with new radiographic vertebral fractures (47.5% for kyphoplasty, 44.1% for control). Two device-related serious adverse events (a spondylitis and an anterior cement migration) were reported.

Berenson and colleagues reported the results of an international randomized multicenter clinical trial in 2011. (47) They enrolled 134 patients with cancer who were at least 21 years of age. Participants had at least one and not more than three painful vertebral compression fractures (VCF). (These appear to be due to osteoporosis, rather than from a metastatic lesion.) The primary outcome was change in functional status from baseline at one month as measured by the Roland Morris Disability Questionnaire (RMDQ). Treatment allocation was not blinded, and the primary outcome at one month was analyzed using all participants with data both at baseline and at one month. Participants needed to have a pain score of at least four on a 0-10 scale. Crossover to the balloon kyphoplasty arm was allowed after one month. The authors report scores in the kyphoplasty and nonsurgical groups of 17.6 and 18.2 at baseline, respectively, and 9.10 and 18.0 at one-month follow-up. P-value for the between group difference in scores p=0.0001.

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. (48) 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 four 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.

Conclusions: Two moderate-sized unblinded RCTs report short-term benefits for kyphoplasty on pain and other outcomes in patients with painful osteoporotic fractures. Similar results are seen in numerous case series that report large short-term improvements in pain following kyphoplasty. There are no sham-controlled RCTs that have been completed for this technique.

The major limitation of these RCTs was the lack of a sham procedure. Nonspecific or placebo effects can be quite large for an invasive procedure such as kyphoplasty in which there is not blinding. (49, 50) Due to the possible sham effect observed in the recent trials of vertebroplasty, the validity of results from non-sham-controlled trials are questionable. The placebo effect may be substantial, on the order of 6 to 7 mm on a 100-mm scale, for invasive procedures, (49-52) and even larger effects (10%) were observed in the sham-controlled vertebroplasty trials. (53, 54) The analyses were appropriate; however, it would have been preferable to have the number of participants reporting a clinically meaningful change as the primary outcome. In cases of chronic pain, mean differences in continuous measures may not be reflective of the percent of patients who have a meaningful clinical response.

Due to the concerns about the validity of the available RCTs, it is difficult to come to conclusions regarding the efficacy of kyphoplasty. Despite most case series showing consistent improvements in pain after the procedure, and the same conclusion being reached in the two RCTs, it is not possible to conclude that these improvements are a true treatment effect, or a non-specific, placebo effect. (55)

Vertebral Body Metastasis

In the early literature reviews, three case series were reviewed evaluating a total of 52 patients. (52-58) Outcome measures varied among these three studies, but all showed improvements either 6in VAS pain score, several aspects of physical functioning as measured by SF-36, or improvement in a disability score. There are no RCTs of kyphoplasty for vertebral body metastasis. Because the results of the comparative studies of vertebroplasty suggest possible placebo or natural history effects, case series are insufficient to make conclusions about the effect of kyphoplasty on health outcomes.

Vertebral Hemangiomas

For symptomatic vertebral body hemangioma with aggressive features, no studies reported pre- and post-procedure pain evaluations. Therefore, the findings of all studies that reported more than a single case (six studies, totaling 64 patients) were evaluated. The studies using percutaneous cementoplasty as an adjunct to surgical treatment suggest that the use of percutaneous cementoplasty to treat the vertebral body component of the vascular lesion may contribute to avoiding the substantial blood loss that has been historically described with primary surgical resection (curettage). However, the additional use of other procedures in these studies may make it difficult to attribute the lower blood loss to this procedure. These studies do not provide controlled comparisons of the morbidity of treating hemangiomas with percutaneous cementoplasty as an adjunct to surgery and the morbidity of surgical treatment without cementoplasty.

Practice Guidelines and Position Statements

In 2010 the American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved a new clinical practice guideline on the treatment of osteoporotic spinal compression fractures. The Board approved a weak recommendation for offering the option of kyphoplasty for patients who “present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact”. In coming out with a weak recommendation, the committee expressed that future evidence could overturn the existing evidence and that the quality of the current literature is poor. As a note, these recommendations were based on a literature review through September 2009.

The American College of Radiology published guidelines on the management of vertebral compression fractures in 2010.(35)  While generally supportive of vertebroplasty and kyphoplasty in specified conditions, the guidelines state that “conservative management is the first-line and gold standard treatment of painful vertebral compression fractures….Most patients with osteoporotic vertebral compression fractures, even without medication, have spontaneous resolution of pain within four to six weeks from the initial onset of pain.  From the inception of vertebral augmentation in the late 1980s, its minimally invasive procedures have been reserved for patients who have failed conservative therapy. Failure can be defined as pain refractory to oral medications (NSAIDs and/or narcotic) over 6-12 weeks. However, failure can also be defined as contraindications to such medications or a requirement for parenteral narcotics and hospital admission.”

The 2006 Guidance from United Kingdom’s National Institute for Health and Clinical Excellence (NICE) concluded that the current evidence on the safety and efficacy of balloon kyphoplasty for vertebral compression fractures appears adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit, and clinical governance. (59) NICE also concluded that current evidence on the safety and efficacy of percutaneous cementoplasty for the palliative treatment of bony malignancies is limited but appears adequate to support the use of this procedure in patients for whom other treatments have failed, provided that the normal arrangements are in place for consent, audit, and clinical governance. The aim of the procedure is to reduce pain and stabilize bones. (60)

A position statement 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”) from 2007 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.” (33) The societies determined that the clinical response rate in individuals treated with kyphoplasty is equivalent to that seen in patients treated with vertebroplasty and that there is no proven advantage of kyphoplasty relative to vertebroplasty with regard to pain relief, vertebral height restoration, or complication rate.

Summary

After consideration of the available evidence, it was concluded that although the scientific evidence does not permit conclusions about the impact on health outcomes and that comparative studies with long-term outcomes are lacking; numerous case series, including large prospective reports, consistently showed that vertebroplasty or kyphoplasty may alleviate pain and improve function in patients with vertebral fractures who fail to respond to conservative treatment (at least six weeks) with analgesics, physical therapy, and rest.  More recent randomized trials that compare kyphoplasty with medical management have also reported benefit, so have not changed these conclusions. Given the absence of alternative treatment options and the morbidity associated with extended bed rest, kyphoplasty may be considered a reasonable treatment option in patients with vertebral fractures who fail to improve after six weeks of conservative therapy, and therefore may be considered medically necessary both for this patient population, as well as for patients who have severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

There is insufficient evidence to permit conclusions on the use of kyphoplasty for an acute (<6 weeks) vertebral fracture. The scientific evidence does not permit conclusions about the impact on net health outcome; sham-controlled comparative studies are needed. There are no additional data to alter these conclusions.

Percutaneous Sacroplasty

Sacroplasty is an evolving technique with numerous methods (short axis, long axis, balloon-assisted short axis, and iliosacral screws). No randomized trials of sacroplasty have been reported. Published evidence is mostly from case reports (61-65) and small case series (all but one enrolling fewer than 13 patients). (66-75) No consensus for best practices has been published. The largest experience is a prospective observational cohort study of 52 consecutive patients undergoing sacroplasty for sacral insufficiency fractures using the short axis technique. (76)  Patients had a mean age of 75.9 years and a mean duration of symptoms of 34.5 days (range: 4-89 days) and mean VAS score of 8.1 at baseline. Improvement on the VAS scale was measured at 30 minutes and 2, 4, 12, 24, and 52 weeks postprocedure. At each interval, statistically significant improvement over baseline was observed and maintained through 52 weeks. Additional literature reports are mostly consistent reporting immediate improvement following the procedure. Due to the small size of the evidence base, harms associated with sacroplasty have not been adequately studied. There are complications of cement leakage with sacroplasty that are not observed with vertebroplasty. Leakage of polymethylmethacrylate (PMMA) into the presacral space, spinal canal, sacral foramen, or sacroiliac joint may result in pelvic injection of PMMA, sacral nerve root or sacral spinal canal compromise, or sacroiliac joint dysfunction.(77)  Performing sacroplasty on Zone one fractures only can minimize these risks.(78)

Summary

Sacroplasty is under development. Varying techniques, patient indications, and small numbers of treated patients leaves uncertainty regarding the impact of sacroplasty on health outcomes and does not permit conclusion on its use for sacral insufficiency fractures or other indications. Therefore, sacroplasty is considered experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

170.2, 198.5, 203.00-203.01, 228.09, 238.6, 733.13, 805.6

ICD-10 Codes
C41.2 - C41.2 , C7B.03 - C7B.03, C79.51 - C79.52,  C90.00 - C90.00, C90.01 - C90.01 C90.02 - C90.02, D16.6 - D16.6, D16.8 - D16.8, D47.Z9 - D47.Z9, D48.0 - D48.0, M48.40XA - M84.38XA, M48.50XA - M84.68XA, D49.2 - D49.2, M81.0 - M81.0, M81.6 - M81.8,   M85.50 - M85.59, M88.0 - M88.9, M89.00 - M89.09, M89.70 - M89.79, S22.000A - S22.089A,  S32.000A - S32.059A
Procedural Codes: 0200T, 0201T, 22520, 22521, 22522, 22523, 22524, 22525, 72291, 72292
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History
July 2005  Code update to add S2362, S2363 
March 2012  Policy Vertebroplasty and Kyphoplasty divided into each their own policy. Medically Necessary statement policy guidelines, rationale, and references updated; No coding changes
April 2013 Kyphoplasty added to policy and Kyphoplasty policy retired.  Policy formatting and language revised.  Policy statements unchanged.  Titled changed from "Percutaneous Vertebroplasty and Sacroplasty" to "Percutaneous Vertebroplasty, Percutaneous Kyphoplasty, and Percutaneous Sacroplasty". 
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Percutaneous Vertebroplasty, Percutaneous Kyphoplasty, and Percutaneous Sacroplasty