Effective in 2006, there are CPT codes specific to this procedure:
ICD Procedure Code
In October 2004, a specific ICD-9 procedure code was added for kyphoplasty –
81.66 – Kyphoplasty (descriptor changed 10/1/08 to Percutaneous vertebral augmentation)
Prior to that, 78.49 might have been used to describe kyphoplasty.
This policy was originally based on a 2000 TEC Assessment (1) and updated with TEC Assessments in 2004, (2) 2005, (3) 2008, (4) 2009, (5) and 2010. (6) 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 7 to 9 on a visual analogue scale ([VAS] or similar score proportionate to the highest possible score]) to 2 to 4, typically within 1 day of receiving the procedure. Such pain relief appears to be lasting in the 4 studies that reported long-term outcomes, although most of the studies had large losses to follow-up. (7-10) Only 1 study of 24 patients by Berlemann et al. retained most of the patients at the end of long-term follow-up. (8) This study showed continued pain relief out to 1 year after the procedure. In terms of other outcomes, results generally showed improvement after kyphoplasty. Coumans et al. (7) reported statistically significant improvements in several subscores of the short form-36 (SF-36), including physical function, mental health, pain, vitality, and social function. Ledlie et al. (11) showed that the proportion of patients fully ambulatory increased after the procedure, but the study had progressive losses to follow-up over time. Crandall et al. (9) showed decreases in the amount of medication use over time. In terms of adverse outcomes, leakage of the cement outside of the vertebral body is common, occurring between 6% and 38% in 6 studies that reported its occurrence. Two nonrandomized studies that compared kyphoplasty to conservative management for treatment of osteoporotic fractures, Kasperk et al. and Komp and colleagues, showed that patients receiving kyphoplasty had greater improvements in pain and function. (12,13) In these 2 studies, the control groups showed minimal improvement in pain and function over the period of observation, which contrasts with the comparative study of percutaneous vertebroplasty, in which the control group improved over time. Differences in patient presentation and selection for treatment could be responsible for the differences observed. These studies point out the uncertainty of the natural history of vertebral fractures and that controlled studies would help determine the efficacy of kyphoplasty. The early literature review also identified a publication on treatment of pathologic compression fractures in which kyphoplasty and spinal radiosurgery were combined. (14)
Beginning in 2009, data from randomized clinical trials (RCTs) began appearing in the literature. This policy is now focused on RCTs data. Additionally, while originally a part of the TEC assessment, the indication of osteolytic destruction due to metastasis was removed in 2009 and now is only reviewed in this policy and follows in its own section.
Outcomes of Treatment
For treatment of osteoporosis and malignancy with percutaneous kyphoplasty, 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 health-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.
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 kyphoplasty over and above any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared to an alternative such as continued medical management.
In all clinical situations, adverse effects related to complications from kyphoplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected polymethylmethacrylate (PMMA).
In 2009, Wardlaw et al. reported on the findings of a multisite, RCT in which 300 adult participants with 1 to 3 painful osteoporotic vertebral fractures of less than 3 months’ duration were assigned to undergo kyphoplasty or conservative care. (15) This study was designed to examine short-term 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 8 countries. Participants needed to have back pain of no more than 3 months’ duration and the presence of at least one but no more than 3 acute vertebral fractures. Participants were evaluated at baseline, then at 1 and 12 months after the procedure. The primary outcome was the difference in change from baseline to 1 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 1 month of follow-up. Scores for the primary outcome, 1-month change in SF-36 PCS score, were significantly higher for those in the kyphoplasty group. The difference between the 2 groups was 5.2 points (95% confidence interval [CI]: 2.9–7.4; p <0.0001). Participants in the kyphoplasty group also reported greater improvements in quality of life and Roland Morris disability score. 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. Differences between the groups were no longer apparent at 12 months; possibly due to natural healing of fractures.
The major limitation of the study was the lack of a sham procedure. Nonspecific or placebo effects can be quite large for an invasive procedure such as kyphoplasty. (16,17) In addition, there was no blinding in this trial. 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, continuous measures can miss responders. The authors acknowledge that their participants at baseline had substantially reduced quality of life compared with other patients with chronic disease, which may have affected their results.
Due to the sham effect observed in the recent trials of vertebroplasty, results from a non-sham-controlled trial, as published by Wardlaw et al., (15) are questionable as the placebo effect may be substantial, on the order of 6 to 7 mm on a 100-mm scale, for invasive procedures. (16-19) Even larger effects (10%) were observed in the vertebroplasty trials reported by Buchbinder et al. and Kallmes et al. (20,21)
Berenson and colleagues reported the results of an international randomized multicenter clinical trial. (22) They enrolled 134 patients with cancer who were at least 21 years of age. Participant had at least one and not more than 3 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 1 month as measured by the Roland Morris Disability Questionnaire (RMDQ). Treatment allocation was not blinded, and the primary outcome at 1 month was analyzed using all participants with data both at baseline and at 1 month. Participants needed to have a pain score of at least 4 on a 0-10 scale. Crossover to the balloon kyphoplasty arm was allowed after 1 month. The authors report scores in the kyphoplasty and nonsurgical groups of 17.6 and 18.2, respectively and 9.10 and 18.0 at 1-month follow-up. P-value for the between group difference in scores p=0.0001.
Due to the lack of comparative trials of sufficient size and rigor, 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 2 RCTs, it is difficult to separate out placebo and natural history effects from actual efficacy. Although not including the Berenson et al. study, the 2010 TEC Assessment concluded that the scientific evidence did not permit conclusions concerning the effects of kyphoplasty on net health outcome for osteoporotic vertebral fractures.(23)
Vertebral Body Metastasis
In the early literature reviews, 3 case series were reviewed evaluating a total of 52 patients. (24-26) Outcome measures varied among these 3 studies, but all showed improvements either in 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.
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 (6 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.
Physician Specialty Society and Academic Medical Center Input
In response to requests, input was received from 6 physician specialty societies (1 unsolicited) and 2 academic medical centers while this policy was under review in 2008. Unsolicited input was received from another physician specialty society. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. All reviewers disagreed with the proposed policy, referring to a body of evidence from uncontrolled studies that support use of kyphoplasty.
After consideration of the uniform clinical input, 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 show that vertebroplasty or kyphoplasty 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 bed rest, kyphoplasty may be considered a reasonable treatment option in patients with vertebral fractures who fail to improve after 6 weeks of conservative therapy.
After reviewing the literature, there is insufficient evidence to permit conclusions on the use of kyphoplasty for an acute vertebral fracture. The scientific evidence does not permit conclusions about the impact on net health outcome; comparative studies are needed. There are no additional data to alter these conclusions.
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, which is available online at: http://www.aaos.org/Research/guidelines/SCFguideline.asp. 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.
A 2008 TEC Assessment found that although many case series had been published, there was a lack of rigorous comparative trials of vertebroplasty and kyphoplasty. (4) 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 TEC criteria.
The updated 2009 and 2010 TEC Assessments (5,6) concluded; due to the lack of comparative trials of sufficient size and rigor, 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 1 randomized controlled trial, it is difficult to separate out placebo and natural history effects from actual efficacy. It was concluded that the evidence for kyphoplasty did not meet TEC criteria, because the scientific evidence did not permit conclusions concerning the effects of kyphoplasty on net health outcome for osteoporotic vertebral fractures
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. (27) 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. (28)
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.” (29) 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.