I'm sure United Healthcare would love to kill kyphoplasty & vertebroplasty and claim they don't work to save money. But they happen to have a very nice
summary of positive evidence in their coverage determination for 2019, indicating that despite their obvious bias as insurance companies against any unnecessary procedures that don't work and would cost them money, they have to keep covering these procedures:
"In the KAST trial, Beall et al. (2018) assessed the effect of 2 different augmentation procedures (balloon kyphoplasty and implant-based approach) on unplanned readmission rates due to significant adverse effects. Forty (27.8%) patients with implants had 69 SAEs associated with readmission compared to 44 (31.2%) patients with BK having 103 events. The risk for all SAEs leading to readmission was 34.4% lower with the implant than for BK (95% confidence interval = 11.1%, 51.7%; P < 0.01). Multivariate analysis showed that the risk of SAEs associated with readmission was decreased in subjects treated with the implant compared to BK, and increased in patients with prior histories of vertebral compression fractures (VCFs) or significant osteoporosis. The augmentation approaches compared in this study have similar pain relief and quality of life effects; the implant showed a lower risk of readmissions. The authors noted that the sample size is underpowered, although the results remain significant.
Boonen et al. (2011) compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. The authors reported that kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24- month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10, p < .0001); the difference between groups remained statistically significant at 24 months (-0.80 points, 95% CI -1.39 to -0.20, p = .009). There was no statistically significant difference between groups in the number of patients (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (~18%) within the second year. The authors commented that
compared with nonsurgical management, kyphoplasty rapidly reduced pain and improved function, disability, and quality of life without increasing the risk of additional vertebral fractures. They concluded that the differences from nonsurgical management are statistically significant when averaged across 24 months; most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all-time points.
In a multicenter, randomized controlled trial [Cancer Patient Fracture Evaluation (CAFÉ) study], Berenson et al. (2011) evaluated the efficacy and safety of balloon kyphoplasty compared with non-surgical management for patients with cancer who have painful vertebral compression fractures. Patients (n=134) aged 21 and over with cancer and painful vertebral compression fractures were randomly assigned by a computer-generated minimization randomization algorithm to kyphoplasty (n=70) or non-surgical management (n=64). Investigators and patients were not masked to treatment allocation. The primary endpoint was back-specific functional status measured by the Roland-Morris disability questionnaire (RDQ) score at 1 month. Outcomes at 1 month were analyzed by modified intention to treat, including all patients with data available at baseline and at 1 month follow-up. Patients in the non-surgical management group (control) were allowed to crossover to receive kyphoplasty after 1 month. The mean RDQ score in the kyphoplasty group changed from 17·6 at baseline to 9·1 at 1 month (mean change -8·3 points, 95% CI -6·4 to - 10·2; p<0·0001). The mean score in the control group changed from 18·2 to 18·0 (mean change 0·1 points; 95% CI - 0·8 to 1·0; p=0·83). At 1 month, the kyphoplasty treatment effect for RDQ was -8·4 points (95% CI -7·6 to -9·2; p<0·0001).
The authors concluded that for painful VCFs in patients with cancer, kyphoplasty is an effective and safe treatment that rapidly reduces pain and improves function. Percutaneous Vertebroplasty and Kyphoplasty Page 11 of 16 UnitedHealthcare Oxford Clinical Policy Effective 01/01/2019 ©1996-2019, Oxford Health Plans, LLC
In a randomized controlled trial (FREE trial) at 21 sites and eight countries, Wardlaw et al. (2009) assessed the efficacy and safety of balloon kyphoplasty. Adults with one to three acute vertebral fractures were eligible for enrolment. Patients (n= 300) were assigned by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0-100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomized participants were included in the analysis. Mean SF-36 PCS score improved by 7.2 points (95% CI 5.7-8.8), from 26.0 at baseline to 33.4 at 1 month, in the kyphoplasty group, and by 2.0 points (0.4-3.6), from 25.5 to 27.4, in the non-surgical group (difference between groups 5.2 points, 2.9-7.4; p<0.0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (hematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure.
The authors conclude that balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option. The FREE study was limited by the inclusion of less than 80% of randomized patients in its final analysis, and an imbalance in drop-outs by treatment arm.
In a retrospective analysis Zhang et al. (2015) evaluated a total of 73 patients who underwent percutaneous vertebroplasty (n=38) or kyphoplasty (n=35) for the management of Kummel disease. Visual analogue score (VAS) was used to evaluate pain. The anterior vertebral height was measured. The operative time, the incidence of cement leakage and the costs were recorded. In both the percutaneous vertebroplasty and kyphoplasty group, the VAS and anterior vertebral height significantly improved at 1-day postoperatively (P < 0.05), and the improvement sustained at the final followup (P > 0.05). Between the PVP and PKP groups, there were no significant differences in VAS and the anterior vertebral height at 1-day postoperatively and at the final followup (P > 0.05). The operating time and expense in the PKP group were higher than the PVP group (P < 0.001). Cement leakages in the PKP group were fewer than PVP group (P < 0.05).The authors concluded that PVP is a faster, less expensive option that still provides a comparable pain relief and restoration of vertebral height to PKP for the treatment of Kummel disease.
PKP has a significant advantage over PVP in term of the fewer cement leakages.
In a retrospective analysis, Burton et al. (2011) evaluated outcomes of cancer patients with painful vertebral compression fractures treated with either percutaneous vertebroplasty or kyphoplasty. A total of 407 cancer patients had 1,156 fractures that had been treated with percutaneous vertebroplasty or kyphoplasty; the majority of patients had pathological fractures due to multiple myeloma, or osteoporotic fractures. The authors reported that surgery provided significant relief from pain and several related symptoms. Surgery provided significant relief from pain and several related symptoms. Symptomatic, serious complications requiring open surgery occurred in two cases (<0.01%).
The authors concluded that the use of VP or KP in treating painful VCFs in cancer patients has good efficacy and an acceptably low complication rate.
The National Institute for Health and Care Excellence (NICE) 2013 (reviewed and confirmed 2016) technology guidance appraisal on percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures
recommends percutaneous vertebroplasty, and percutaneous balloon kyphoplasty without stenting, as options for treating osteoporotic vertebral compression fractures only in people who: have severe ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management, and in whom the pain has been confirmed to be at the level of the fracture by physical examination and imaging.
Deibert et al. (2016) conducted a longitudinal cohort investigation of the development of symptomatic adjacent level compression fractures following balloon-assisted kyphoplasty (BAK). Seventy-seven of 726 patients (10.6%) underwent a second BAK procedure on average 350 days following the initial procedure (range 21 to 2,691 days). Third and fourth procedures were less common, treated in 11 and 3 patients, respectively. Forty-eight of 77 patients (62%) suffered a fracture at a level immediately adjacent to the index level at mean time of 256 days. Remote level fractures were treated at a mean time of 489 days, but no statistical difference was noted. There was no statistically significant difference between tobacco use, BMI, and chronic steroid use between patients suffering from remote and adjacent level VCFs. Specific risk factors for remote versus adjacent level fractures could not be determined. This was not a population based study and the true incidence of subsequent fractures after BAK might be underestimated by this analysis.
In a randomized clinical trial of 115 subjects, Evans et al. (2016) found
kyphoplasty and vertebroplasty equally effective in substantially reducing pain and disability in patients with vertebral body compression fractures.
Zhang et al. (2018) conducted a meta-analysis to evaluate whether percutaneous vertebroplasty or balloon kyphoplasty for osteoporotic vertebral compression fractures increase the incidence of new vertebral fractures. Twelve studies and 1,328 patients were included; 768 underwent a surgical procedure, and 560 received non-operative treatments. For new-level vertebral fractures, the meta-analysis found no significant difference between the 2 Percutaneous Vertebroplasty and Kyphoplasty Page 12 of 16 UnitedHealthcare Oxford Clinical Policy Effective 01/01/2019 ©1996-2019, Oxford Health Plans, LLC methods, including total new fractures (P = 0.55) and adjacent fractures (P = 0.5). For pre-existing vertebral fractures, there was no significant difference between the 2 groups (operative and non-operative groups) (P = 0.24). Additionally, there was no significant difference in bone mineral density, both in the lumbar (P = 0 .13) and femoral neck regions (P = 0.37), between the 2 interventions. The analysis did not reveal evidence of an increased risk of fracture of vertebral bodies, especially those adjacent to the treated vertebrae, following augmentation with either method compared with conservative treatment.
In a review of pain, quality of life and safety outcomes of balloon kyphoplasty compared to other surgical techniques and non-surgical management for vertebral compression fractures (VCF), a task force of the American Society of Bone and Mineral Research (ASBMR) evaluated ten unique trials (1,837 participants).
Balloon kyphoplasty in comparison to non-surgical management, was associated with greater reductions in pain, back-related disability, and better quality of life that appeared to lessen over time, but were less than minimally clinically important differences. Risk of new VCF at 3 and 12 months was not significantly different. Individuals with painful VCF experienced symptomatic improvement compared with baseline with all interventions. There were no significant differences between balloon kyphoplasty and percutaneous vertebroplasty in back pain, back disability, quality of life, risk of new VCF or any adverse events. Limitations of the studies included lack of a balloon kyphoplasty versus sham comparison, availability of only one randomized controlled trial of balloon kyphoplasty versus non-surgical management, and lack of study blinding. The Task Force recommends well-conducted randomized trials comparing balloon kyphoplasty with sham to help resolve remaining uncertainty about the relative benefits and harms of this procedure. (Rodriguez et al., 2017)
Chandra et al. (2014) conducted a systematic review on vertebral augmentation and concluded that
kyphoplasty in selected patients is superior to conservative medical therapy in reducing back pain, disability and improving Karnofsky performance status and quality of life for patients with cancer and disabling back pain from a vertebral fracture (AHA Class IIA, Level of Evidence B); vertebroplasty and kyphoplasty are reasonable therapeutic options in selected patients with cancer and severe back pain from a vertebral fracture that is refractory to conservative medical therapy (AHA Class IIA, Level of Evidence B); and vertebroplasty and kyphoplasty are reasonable therapeutic options in selected patients with severe back pain from an osteoporotic vertebral fracture that is refractory to conservative medical therapy. (AHA Class IIA, Level of Evidence B)
Gu et al. (2016) performed a systematic review and meta-analysis of studies comparing the outcomes of vertebroplasty and kyphoplasty in the treatment of vertebral compression fractures, which included prospective nonrandomized, retrospective, comparative and randomized studies. No significant difference was found between vertebroplasty and kyphoplasty in short- and long-term pain and disability outcomes. Further studies are needed to better determine if any particular subgroups of patients would benefit more from vertebroplasty or kyphoplasty in the treatment of vertebral body compression fractures.
Professional Societies
American Association of Clinical Endocrinologists (AACE)/American College of Endocrinology (ACE) In a clinical practice guideline for the diagnosis and treatment of postmenopausal osteoporosis, the AACE and ACE (Camacho et al., 2016) do not recommended vertebroplasty and kyphoplasty as first-line treatment of vertebral fractures given the unclear benefit on overall pain and the potential increased risk of vertebral fractures in adjacent vertebrae. (Grade B, BEL 1; downgraded due to limitations of published studies) Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), Society of NeuroInterventional Surgery (SNIS) The 2014 SIR, AANS, CNS, ACR, ASNR, ASSR, CIRA and the SNIS consensus statement on percutaneous vertebral augmentation states that percutaneous vertebral augmentation with the
use of vertebroplasty or kyphoplasty is a safe, efficacious, and durable procedure inappropriate patients with symptomatic osteoporotic and neoplastic fractures when performed in a manner in accordance with published standards. They further comment that these procedures are offered only when non-operative medical therapy has not provided adequate pain relief or pain is significantly altering the patient’s quality of life. Currently, there is no indication for the use of vertebral augmentation for prophylaxis against future fracture. The indications and contraindications for vertebral augmentation may change in the future as more research and information become available. (Barr, 2014)
American College of Radiology (ACR)
The ACR appropriateness criteria for the management of vertebral compression fractures (2013) notes that conservative management (medical management with or without methods of immobility) is the initial first-line Percutaneous Vertebroplasty and Kyphoplasty Page 13 of 16 UnitedHealthcare Oxford Clinical Policy Effective 01/01/2019 ©1996-2019, Oxford Health Plans, LLC treatment of painful vertebral compression fractures. The ACR defines failure of conservative therapy as pain refractory to oral medications (NSAIDs and/or narcotics) or a contraindication to such medications or a requirement for parenteral narcotics and hospital admission. The ACR observes that the ideal preprocedural imaging has not been identified. The ACR also comments that most patients with osteoporotic vertebral compression fractures have spontaneous resolution of pain, even without medication. Vertebral augmentation has been reserved for patients who have failed conservative therapy. American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS) The ACR, ASNR, ASSR, SIR and SNIS 2014 practice parameter for the performance of vertebral augmentation states that the major indication for vertebral augmentation is the treatment of symptomatic osteoporotic vertebral body fracture(s) refractory to medical therapy or vertebral bodies weakened due to neoplasia.
They comment that although most fractures heal within a few weeks or months, a minority of patients continue to suffer pain that does not respond to conservative therapy. They note that there is no indication for the use of vertebral augmentation for prophylaxis against future fracture.
American Academy of Orthopaedic Surgeons (AAOS)
In its 2010 guidance and evidence report on the treatment of symptomatic osteoporotic spinal compression fractures, the AAOS recommends against vertebroplasty for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact. This recommendation is based on strong evidence regarding two Level I studies that compare vertebroplasty to a sham procedure in which there was no statistically significant difference between the two procedures in pain using the VAS and function using the Roland Morris Disability scale (up to one month and six months respectively). In the same 2010 guidance and evidence report, the
AAOS considers kyphoplasty as an option for patients who present with an osteoporotic spinal compression fracture on imaging on imaging with correlating clinical signs and symptoms and who are neurologically intact. This is based on limited evidence regarding two Level II studies that examined the use of kyphoplasty compared to conservative treatment. In the study of patients with subacute fractures, clinically important benefits in pain were found at 1 week and 1 month, with possibly important effects at 3 and 6 months. There was no clinically important benefit in pain at 12 months. The study also found possibly clinically important benefits in physical function (at 1 and 3 months only) and the SF-36 physical component score (at 1, 3, and 6 months only). Clinically important improvement in quality of life was present at 1 month, and it was possibly clinically important at 3, 6, and 12 months. "
mmm, research drama
