Reply:

R.V. Chandra; J. Maingard; H. Asadi; L.-A. Slater; J.A. Hirsch

doi:10.3174/ajnr.A5781

We thank Braillon and Bewley for their interest in our article, “Vertebroplasty and Kyphoplasty for Osteoporotic Vertebral Fractures: What Are the Latest Data?” The stated aim of this article was to provide an update to clinicians on the evolution of evidence for reduction in pain and disability from vertebroplasty and kyphoplasty for osteoporotic vertebral fractures and, in particular, highlight the limitations of the various prospective randomized controlled trials (RCTs). The most recent trial, A Randomised Sham-Controlled Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures (VERTOS IV)¹ had not been published at the time this review was conducted. Notably, there are important differences in the enrolled patient cohorts between A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures (VAPOUR) and VERTOS IV, which again highlight the challenge in the interpretation of outcomes from these procedures.²

Apart from the RCTs, there are also strong signals of benefit from large national or insurance-based-claims datasets from Germany, Sweden, France, Taiwan, and the United States.^{3⇓⇓⇓⇓⇓–9} In one of the largest analyses of more than 2 million patients during 10 years from the US Medicare dataset, there was a strong signal of reduced mortality after vertebral augmentation compared with medical management.⁸ This signal of survival benefit has been replicated in further analysis of German⁵ and Taiwanese⁷ health insurance datasets. In addition, various national and medical societies have varied in their interpretation of the evidence, depending on when they examined the literature.^10⇓–12 Most notably, the National Institute for Health and Care Excellence, which provides evidence-based guidance and advice to the National Health Service in the United Kingdom, recommends vertebroplasty and kyphoplasty as treatment options for patients with severe pain after a recent osteoporotic vertebral compression fracture and concluded that it was reasonable to assume that the procedures reduce mortality.¹³

Akin to many other areas in medicine, clinicians must integrate their clinical expertise with patient values and interpretation of the research evidence to provide optimized and meaningful care. For years, the results from the various RCTs have shown that vertebroplasty and kyphoplasty are best considered for patients with severe pain and disability and only after rigorous clinical and advanced imaging selection. Moreover, earlier treatment (potentially <3 weeks from fracture onset) may provide the best chance of benefit. Important questions remain unanswered; for example, what are the implications of the progressive height loss evident in untreated-versus-cemented levels in VERTOS IV and VAPOUR? Does this prevention of height loss help explain the mortality benefit observed in almost all claims-based studies? We concur with Braillon and Bewley that new patients should be included in further RCTs to clarify the role of these procedures or included in large registries in which data can be pooled and additional meaningful conclusions reached.

References

1.↵
2. Firanescu CE,
3. de Vries J,
4. Lodder P, et al
. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ 2018;361:k1551 doi:10.1136/bmj.k1551 pmid:29743284
Abstract/FREE Full Text
2.↵
2. Clark W,
3. Bird P,
4. Gonski P, et al
. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2016;388:1408–16 doi:10.1016/S0140-6736(16)31341-1 pmid:27544377
CrossRef PubMed
3.↵
2. Edidin AA,
3. Ong KL,
4. Lau E, et al
. Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and nonoperative management in the Medicare population. Spine 2015;40:1228–41 doi:10.1097/BRS.0000000000000992 pmid:26020845
CrossRef PubMed
4.↵
2. Kanis JA,
3. Oden A,
4. Johnell O, et al
. Excess mortality after hospitalisation for vertebral fracture. Osteoporos Int 2004;15:108–12 doi:10.1007/s00198-003-1516-y pmid:14598026
CrossRef PubMed
5.↵
2. Lange A,
3. Kasperk C,
4. Alvares L, et al
. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine 2014;39:318–26 doi:10.1097/BRS.0000000000000135 pmid:24299715
CrossRef PubMed
6.↵
2. Lau E,
3. Ong K,
4. Kurtz S, et al
. Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am 2008;90:1479–86 doi:10.2106/JBJS.G.00675 pmid:18594096
Abstract/FREE Full Text
7.↵
2. Lin JH,
3. Chien LN,
4. Tsai WL, et al
. Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J 2017;17:1310–18 doi:10.1016/j.spinee.2017.05.001 pmid:28483705
CrossRef PubMed
8.↵
2. Ong KL,
3. Beall DP,
4. Frohbergh M, et al
. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty “sham” trials? Osteoporos Int 2018;29:375–83 doi:10.1007/s00198-017-4281-z pmid:29063215
CrossRef PubMed
9.↵
2. Zampini JM,
3. White AP,
4. McGuire KJ
. Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty. Clin Orthop Relat Res 2010;468:1773–80 doi:10.1007/s11999-010-1279-7 pmid:20177836
CrossRef PubMed
10.↵
2. Barr JD,
3. Jensen ME,
4. Hirsch JA, et al
; Society of Interventional Radiology, American Association of Neurological Surgeons, Congress of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, American Society of Spine Radiology, Canadian Interventional Radiology Association, Society of Neurointerventional Surgery. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the 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), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol 2014;25:171–81 doi:10.1016/j.jvir.2013.10.001 pmid:24325929
CrossRef PubMed
11.↵
2. Chandra RV,
3. Meyers PM,
4. Hirsch JA, et al
; Society of NeuroInterventional Surgery. Vertebral augmentation: report of the Standards and Guidelines Committee of the Society of NeuroInterventional Surgery. J Neurointerv Surg 2014;6:7–15 doi:10.1136/neurintsurg-2013-011012 pmid:24198272
FREE Full Text
12.↵
2. Tsoumakidou G,
3. Too CW,
4. Koch G, et al
. CIRSE guidelines on percutaneous vertebral augmentation. Cardiovasc Intervent Radiol 2017;40:331–42 doi:10.1007/s00270-017-1574-8 pmid:28105496
CrossRef PubMed
13.↵
National Institute for Health and Care Excellence. Technology appraisal guidance TA279. Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. April 24, 2013; https://www.nice.org.uk/guidance/ta279. Accessed July 14, 2018.

In this issue

Download PDF

Email Article

Citation Tools

Purchase

Cited By...

No citing articles found.

More in this TOC Section

Show more LETTERS

[1] 1.↵

Firanescu CE,
de Vries J,
Lodder P, et al
. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ 2018;361:k1551 doi:10.1136/bmj.k1551 pmid:29743284
Abstract/FREE Full Text

[3] Firanescu CE,

[4] de Vries J,

[5] Lodder P, et al

[6] 2.↵

Clark W,
Bird P,
Gonski P, et al
. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2016;388:1408–16 doi:10.1016/S0140-6736(16)31341-1 pmid:27544377
CrossRef PubMed

[8] Clark W,

[9] Bird P,

[10] Gonski P, et al

[11] 3.↵

Edidin AA,
Ong KL,
Lau E, et al
. Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and nonoperative management in the Medicare population. Spine 2015;40:1228–41 doi:10.1097/BRS.0000000000000992 pmid:26020845
CrossRef PubMed

[13] Edidin AA,

[14] Ong KL,

[15] Lau E, et al

[16] 4.↵

Kanis JA,
Oden A,
Johnell O, et al
. Excess mortality after hospitalisation for vertebral fracture. Osteoporos Int 2004;15:108–12 doi:10.1007/s00198-003-1516-y pmid:14598026
CrossRef PubMed

[18] Kanis JA,

[19] Oden A,

[20] Johnell O, et al

[21] 5.↵

Lange A,
Kasperk C,
Alvares L, et al
. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine 2014;39:318–26 doi:10.1097/BRS.0000000000000135 pmid:24299715
CrossRef PubMed

[23] Lange A,

[24] Kasperk C,

[25] Alvares L, et al

[26] 6.↵

Lau E,
Ong K,
Kurtz S, et al
. Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am 2008;90:1479–86 doi:10.2106/JBJS.G.00675 pmid:18594096
Abstract/FREE Full Text

[28] Lau E,

[29] Ong K,

[30] Kurtz S, et al

[31] 7.↵

Lin JH,
Chien LN,
Tsai WL, et al
. Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J 2017;17:1310–18 doi:10.1016/j.spinee.2017.05.001 pmid:28483705
CrossRef PubMed

[33] Lin JH,

[34] Chien LN,

[35] Tsai WL, et al

[36] 8.↵

Ong KL,
Beall DP,
Frohbergh M, et al
. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty “sham” trials? Osteoporos Int 2018;29:375–83 doi:10.1007/s00198-017-4281-z pmid:29063215
CrossRef PubMed

[38] Ong KL,

[39] Beall DP,

[40] Frohbergh M, et al

[41] 9.↵

Zampini JM,
White AP,
McGuire KJ
. Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty. Clin Orthop Relat Res 2010;468:1773–80 doi:10.1007/s11999-010-1279-7 pmid:20177836
CrossRef PubMed

[43] Zampini JM,

[44] White AP,

[45] McGuire KJ

[46] 10.↵

Barr JD,
Jensen ME,
Hirsch JA, et al
; Society of Interventional Radiology, American Association of Neurological Surgeons, Congress of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, American Society of Spine Radiology, Canadian Interventional Radiology Association, Society of Neurointerventional Surgery. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the 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), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol 2014;25:171–81 doi:10.1016/j.jvir.2013.10.001 pmid:24325929
CrossRef PubMed

[48] Barr JD,

[49] Jensen ME,

[50] Hirsch JA, et al

[51] 11.↵

Chandra RV,
Meyers PM,
Hirsch JA, et al
; Society of NeuroInterventional Surgery. Vertebral augmentation: report of the Standards and Guidelines Committee of the Society of NeuroInterventional Surgery. J Neurointerv Surg 2014;6:7–15 doi:10.1136/neurintsurg-2013-011012 pmid:24198272
FREE Full Text

[53] Chandra RV,

[54] Meyers PM,

[55] Hirsch JA, et al

[56] 12.↵

Tsoumakidou G,
Too CW,
Koch G, et al
. CIRSE guidelines on percutaneous vertebral augmentation. Cardiovasc Intervent Radiol 2017;40:331–42 doi:10.1007/s00270-017-1574-8 pmid:28105496
CrossRef PubMed

[58] Tsoumakidou G,

[59] Too CW,

[60] Koch G, et al

[61] 13.↵
National Institute for Health and Care Excellence. Technology appraisal guidance TA279. Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. April 24, 2013; https://www.nice.org.uk/guidance/ta279. Accessed July 14, 2018.

Main menu

User menu

Search

American Journal of Neuroradiology

Reply:

References

In this issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

News and Updates

Resources

Opportunities

American Society of Neuroradiology

Main menu

User menu

Search

Reply:

References

In this issue

Citation Manager Formats

Jump to section

Related Articles

Cited By...

More in this TOC Section

Similar Articles

News and Updates

Resources

Opportunities

American Society of Neuroradiology