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Polymethylmethacrylate Pulmonary Embolism Following Kyphoplasty

Authors:

Abstract

We report a case of polymethylmethacrylate cement pulmonary embolism (PE) that occurred two days following a minimally invasive kyphoplasty procedure. Our patient developed non-specific rib pain postoperatively followed by dyspnea, prompting presentation to the emergency department. The polymethylmetacrylate cement was visualized on initial chest radiograph and further characterized using computed tomography. The patient was admitted and anticoagulation started, later having an uncomplicated hospital course. The polymethylmethacrylate cement has a well-documented history of leakage and other postoperative complications. Cement PE, while rare, can present similarly to a thrombotic PE and requires adequate long-term anticoagulation with close follow-up.
UC Irvine
Clinical Practice and Cases in Emergency Medicine
Title
Polymethylmethacrylate Pulmonary Embolism Following Kyphoplasty
Permalink
https://escholarship.org/uc/item/5295w6gj
Journal
Clinical Practice and Cases in Emergency Medicine, 3(3)
ISSN
2474-252X
Authors
Morris, Oliver
Mathai, Josephin
Weller, Karl
Publication Date
2019
DOI
10.5811/cpcem.2019.4.42324
License
CC BY 4.0
Peer reviewed
eScholarship.org Powered by the California Digital Library
University of California
Clinical Practice and Cases in Emergency Medicine 226 Volume III, no. 3: August 2019
Case RepoRt
Polymethylmethacrylate Pulmonary Embolism
Following Kyphoplasty
Oliver Morris, DO
Josephin Mathai, DO
Karl Weller, DO
Section Editor: Christopher Sampson, MD
Submission history: Submitted January 13, 2019; Revision received March 22, 2019; Accepted April 2, 2019
Electronically published May 20, 2019
Full text available through open access at http://escholarship.org/uc/uciem_cpcem
DOI: 10.5811/cpcem.2019.4.42324
We report a case of polymethylmethacrylate cement pulmonary embolism (PE) that occurred two
days following a minimally invasive kyphoplasty procedure. Our patient developed non-specic rib
pain postoperatively followed by dyspnea, prompting presentation to the emergency department. The
polymethylmetacrylate cement was visualized on initial chest radiograph and further characterized
using computed tomography. The patient was admitted and anticoagulation started, later having an
uncomplicated hospital course. The polymethylmethacrylate cement has a well-documented history
of leakage and other postoperative complications. Cement PE, while rare, can present similarly to
a thrombotic PE and requires adequate long-term anticoagulation with close follow-up. [Clin Pract
Cases Emerg Med. 2019;3(3):226-228.]
INTRODUCTION
Vertebral compression fractures make up approximately
one half of all osteoporotic fractures in the United States
(U.S.), affecting over 700,000 people per year.1 Patients with
compression fractures often experience severe pain that may
limit mobility, increase morbidity, and can be a signicant
source of healthcare resource utilization. Multiple treatment
modalities have been used including medical management,
pain management, physical therapy, bracing, and surgery. The
surgical therapies consist of minimally invasive techniques
such as percutaneous balloon kyphoplasty and vertebroplasty,
where a cement polymer is injected into the vertebrae to
stabilize the osseous structure. There are estimated to be over
25,000 kyphoplasty and vertebroplasty procedures performed
in the U.S. each year, and they can be associated with severe
intra- and postoperative complications.2 This case report
highlights one of the rarer but often more severe complications,
polymethylmethacrylate (PMMA) pulmonary embolism (PE).
CASE REPORT
A 43-year-old male construction worker with a history
of chronic back pain and recent kyphoplasty two days prior,
presented to the emergency department (ED) for the second
time that day for dyspnea. The patient had been seen in the ED
earlier in the day by another provider for nonspecic lower back
and ank pain that was medically treated with improvement of
St. Lucie Medical Center, Department of Emergency Medicine, Port St. Lucie, Florida
symptoms. A few hours after arriving home, the patient became
dyspneic and returned to the ED for evaluation.
On physical examination, he appeared to be mildly
tachypneic. His blood pressure was 105/71 millimeters of
mercury, pulse 86 beats per minute (BPM), respiratory rate
20 breaths per minute, and oxygen saturation of 95% on room
air. He did not appear to be in respiratory distress with no
accessory muscle use. Lungs were clear to auscultation but
mildly diminished. He exhibited no wheezing, rhonchi, or
rales. The heart sounds were regular, with no audible murmur.
Abdomen was soft and nontender, with positive bowel sounds.
There was no midline spinal tenderness. He had several well-
healing, non-erythematous paraspinal puncture wounds from
the kyphoplasty procedure two days prior. The rest of his
physical exam was unremarkable.
Initial workup consisted of basic metabolic panel, complete
blood count, troponin, electrocardiogram (ECG) and a chest
radiograph (CXR). When we applied the Wells criteria for PE,
the patient scored 1.5 for having had a surgery in the previous
four weeks. This score put him in the low-risk group with a 1.3%
chance of PE.1 The ECG showed a normal sinus rhythm at 85
BPM. The CXR revealed pulmonary cement embolism with mild
vascular crowding and atelectasis at the lung bases (Image 1).
With this nding, a computed tomography angiography of the
chest was ordered, which revealed cement in distal pulmonary
arteries consistent with cement emboli along with patchy,
Volume III, no. 3: August 2019 227 Clinical Practice and Cases in Emergency Medicine
Morris et al. Polymethylmethacrylate PE Following Kyphoplasty
Image 1. Chest radiograph of a 43-year-old male depicting
multiple hyperdense opacities (arrows) with vascular crowding
and atelectasis at lung bases.
Image 2. Computed tomographic angiogram of the chest of
a 43-year-old male depicting hyperdense material in distal
pulmonary arteries (arrows) consistent with cement emboli.
ground-glass opacity worrisome for inltrate (Image 2). The
patient was immediately treated with heparin and admitted to the
hospital for continued management. While there, he was treated
according to guidelines for thrombotic PEs and started on six-
month warfarin therapy. He was discharged home two days later.
DISCUSSION
Kyphoplasty and vertebroplasty are two common surgical
techniques used in stabilization and repair of vertebral
compression fractures. The procedures are similar in that
they use a cement, such as PMMA, which is injected into the
vertebral body and allowed to harden. Kyphoplasty differs
by rst employing a balloon that is inated in the vertebral
body prior to the cement injection. This allows for height
restoration of the affected vertebrae. The procedures themselves
are minimally invasive, but the efcacy of kyphoplasty and
vertebroplasty in osteoporotic vertebral fractures continues to
be controversial. Two randomized, placebo-controlled trials
found no signicant benet over conservative management.2,3,4,5
In 2010, as part of its clinical practice guidelines, the American
Academy of Orthopaedic Surgeons strongly recommended
against vertebroplasty for patients who present with an
osteoporotic spinal compression. Since taking that stance, there
have been several newer, unblinded trials and meta-analyses
published that contradict the initial ndings..
6,7,8
Cement extravasation is the most common and well-
known complication of both vertebroplasty and kyphoplasty
CPC-EM Capsule
What do we already know about this clinical
entity?
Polymethymethacrylate pulmonary
embolism is a rare but known complication
of kyphoplasty. It has been reported
in orthopaedic literature but rarely in
emergency medicine.
What makes this presentation of disease
reportable?
There have been very few reports of this
disease entity in emergency medicine
literature, so increasing awareness of post-
kyphoplasty complications is essential.
What is the major learning point?
The novelty of this disease, along with the
morbidity and mortality if left untreated,
makes early recognition important.
How might this improve emergency
medicine practice?
Early recognition of polymethylmethacrylate
pulmonary embolism can lead to better
patient outcomes.
Clinical Practice and Cases in Emergency Medicine 228 Volume III, no. 3: August 2019
Polymethylmethacrylate PE Following Kyphoplasty Morris et al.
REFERENCES
1. McCall T, Cole C, Dailey A. Vertebroplasty and kyphoplasty: a
comparative review of efcacy and adverse events. Curr Rev
Musculoskelet Med. 2008;1(1):17-23.
2. Laratta JL, Shillingford JN, Lombardi JM, et al. Utilization of
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Inpatient Sample. J Spine Surg. 2017;3(3):364-70.
3. Buchbinder R, Golmohammadi K, Johnston RV, et al. Percutaneous
vertebroplasty for osteoporotic vertebral compression fracture.
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4. Savage JW, Schroeder GD, Anderson PA. Vertebroplasty and
kyphoplasty for the treatment of osteoporotic vertebral compression
fractures. J Am Acad Orthop Surg. 2014;22(10):653-64.
5. Klazen CA, Lohle PN, Vries J, et al. Vertebroplasty versus
conservative treatment in acute osteoporotic vertebral compression
fractures (VERTOS II): an open-label randomised trial. The Lancet.
2010;376(9746):1085-92.
6. Guarnieri G, Masala S, Muto M. Update of vertebral cementoplasty
in porotic patients. Interv Neuroradiol. 2015;21(3):372-80.
7. Yuan WH, Hsu HC, Lai KL. Vertebroplasty and balloon kyphoplasty
versus conservative treatment for osteoporotic vertebral
compression fractures: A meta-analysis. Medicine (Baltimore).
2016;95(31):e4491.
8. Yaltirik K, Ashour AM, Reis CR, et al. Vertebral augmentation by
kyphoplasty and vertebroplasty: 8 years experience outcomes and
complications. J Craniovertebr Junction Spine. 2016;7(3):153-60.
9. Papanastassiou ID, Filis A, Gerochristou MA, et al. Controversial
issues in kyphoplasty and vertebroplasty in osteoporotic vertebral
fractures. Biomed Res Int. 2014;2014:934206.
10. Papanastassiou P, Phillips FM, Van Meirhaeghe J, et al.
Comparing effects of kyphoplasty, vertebroplasty, and non-surgical
management in a systematic review of randomized and non-
randomized controlled studies. Eur Spine J. 2012;21(9):1826-43.
11. Krueger A, Bliemel C, Zettl R, et al. Management of pulmonary
cement embolism after percutaneous vertebroplasty and
kyphoplasty: a systematic review of the literature. Eur Spine J.
2009;18(9):1257-65.
with rates as high as 41% and 18%, respectively.9,10 This
leakage can cause damage to surrounding nerve and tissues,
irritation of nerve roots, PE, and even reports of cardiac
tamponade. The literature research revealed that the risk
of PE ranges from 3.5-23%, with vertebroplasty leakages
being more common and more signicant..
11 Treatment in
these cases has not been well dened, but the consensus is
to proceed according to guidelines of thrombotic PEs. Initial
heparinization and six months of continuous warfarin therapy
is recommended in symptomatic peripheral and asymptomatic
central PE along with admission for clinical observation and
close follow-up. In rare instances of central symptomatic PE,
surgical embolectomy may be considered..
11
CONCLUSION
This report highlights the importance of recognizing
cement PE in a postoperative kyphoplasty patient presenting
for non-specic chest complaints in an otherwise healthy
individual and minimal PE risk factors.
Documented patient informed consent and/or Institutional Review
Board approval has been obtained and led for publication of this
case report.
Address for Correspondence: Oliver J. Morris, DO, St. Lucie Medical
Center, Department of Emergency Medicine, 1800 SE Tiffany Ave,
Port St. Lucie, FL 34652. Email: oliver.morris@hcahealthcare.com.
Conicts of Interest: By the CPC-EM article submission agreement,
all authors are required to disclose all afliations, funding sources
and nancial or management relationships that could be perceived
as potential sources of bias. The authors disclosed none.
Copyright: © 2019 Morris et al. This is an open access article
distributed in accordance with the terms of the Creative Commons
Attribution (CC BY 4.0) License. See: http://creativecommons.org/
licenses/by/4.0/
... However, the prevalence of severe complications related to VAP could be as high as 12.5-36.8% [108][109][110][111][112]. The most common complications encountered are cement leakage and new OVCFs at the adjacent level. ...
... New OVCFs of cemented vertebrae after VAP were about 63%, and the greater the anterior vertebral height obtained, the greater the risk of refracture occurring [18]. Other cement-related complications, including pulmonary embolism, spinal cord burn, adjacent vertebrae collapse and cement migration, were not rare [110,114,115]. Besides, patients who received VAP should be informed about the clinical effect and the subsequent anti-OP treatment was also administered to reduce the risk of new OVCFs [116]. ...
Chapter
Full-text available
Osteoporosis management is effective in decreasing vertebral fracture risk. The assessment of vertebral fracture risk is used to identify patients with high fracture risk for anti-osteoporotic treatment, especially for those who have not yet fractured. Several pharmacological agents are available to lower vertebral fracture risk by reducing bone resorption or/and stimulating bone formation. Aside from surgical treatment for fresh vertebral fracture or fracture nonunion in elderly patients, recent studies indicated that management of osteoporosis plays a vital role in boosting vertebral fracture union, preventing progressive vertebral collapse and decreasing the refracture risk. In this chapter, we focus on the treatment of osteoporosis, acute vertebral fractures and nonunion, as well as the evaluation of clinical efficacy by bone quality and bone turnover markers after treatment.
... In addition, the prevalence of severe complications related to VAP could be as high as 12.5%-36.8% [20][21][22][23][24] . ...
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Objective: Although the majority of available evidence suggests that vertebroplasty and kyphoplasty can relieve pain associated with vertebral compression fractures (VCFs) and improve function, some studies have suggested results are similar to those of placebo. The purpose of this meta-analysis was to compare the outcomes of vertebroplasty and kyphoplasty with conservative treatment in patients with osteoporotic VCFs. Methods: Medline, Cochrane, and Embase databases were searched until January 31, 2015 using the keywords: vertebroplasty, kyphoplasty, compression fracture, osteoporotic, and osteoporosis. Inclusion criteria were randomized controlled trials (RCTs) in which patients with osteoporosis, and VCFs were treated with vertebroplasty/kyphoplasty or conservative management. Outcome measures were pain, function, and quality of life. Standardized differences in means were calculated as a measure of effect size. Main results: Ten RCTs were included. The total number of patients in the treatment and control groups was 626 and 628, respectively, the mean patient age ranged from 64 to 80 years, and the majority was female. Vertebroplasty/kyphoplasty was associated with greater pain relief (pooled standardized difference in means = 0.82, 95% confidence interval [CI]: 0.374–1.266, P < 0.001) and a significant improvement in daily function (pooled standardized difference in means = 1.273, 95% CI: 1.028–1.518, P < 0.001) as compared with conservative treatment. The pooled estimate indicated vertebroplasty/kyphoplasty was associated with higher quality of life (pooled standardized difference in means = 1.545, 95% CI: 1.293–1.798, P < 0.001). Subgroup analysis of 8 vertebroplasty studies and 2 kyphoplasty studies that reported pain data, however, indicated that vertebroplasty provided greater pain relief than conservative treatment but kyphoplasty did not. Conclusion: Vertebroplasty may provide better pain relief than balloon kyphoplasty in patients with osteoporotic VCFs, both may improve function, and their effect on quality of life is less clear.
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Kyphoplasty (KP) and vertebroplasty (VP) have been successfully employed for many years for the treatment of osteoporotic vertebral fractures. The purpose of this review is to resolve the controversial issues raised by the two randomized trials that claimed no difference between VP and SHAM procedure. In particular we compare nonsurgical management (NSM) and KP and VP, in terms of clinical parameters (pain, disability, quality of life, and new fractures), cost-effectiveness, radiological variables (kyphosis correction and vertebral height restoration), and VP versus KP for cement extravasation and complications profile. Cement types and optimal filling are analyzed and technological innovations are presented. Finally unipedicular/bipedicular techniques are compared. Conclusion. VP and KP are superior to NSM in clinical and radiological parameters and probably more cost-effective. KP is superior to VP in sagittal balance improvement and cement leaking. Complications are rare but serious adverse events have been described, so caution should be exerted. Unilateral procedures should be pursued whenever feasible. Upcoming randomized trials (CEEP, OSTEO-6, STIC-2, and VERTOS IV) will provide the missing link.
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Background: Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice. Objectives: To update the available evidence of the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures. Search methods: We updated the search of CENTRAL, MEDLINE and Embase and trial registries to 15 November 2017. Selection criteria: We included randomised and quasi-randomised controlled trials (RCTs) of adults with painful osteoporotic vertebral fractures, comparing vertebroplasty with placebo (sham), usual care, or another intervention. As it is least prone to bias, vertebroplasty compared with placebo was the primary comparison. Major outcomes were mean overall pain, disability, disease-specific and overall health-related quality of life, patient-reported treatment success, new symptomatic vertebral fractures and number of other serious adverse events. Data collection and analysis: We used standard methodologic procedures expected by Cochrane. Main results: Twenty-one trials were included: five compared vertebroplasty with placebo (541 randomised participants), eight with usual care (1136 randomised participants), seven with kyphoplasty (968 randomised participants) and one compared vertebroplasty with facet joint glucocorticoid injection (217 randomised participants). Trial size varied from 46 to 404 participants, most participants were female, mean age ranged between 62.6 and 81 years, and mean symptom duration varied from a week to more than six months.Four placebo-controlled trials were at low risk of bias and one was possibly susceptible to performance and detection bias. Other trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding.Compared with placebo, high- to moderate-quality evidence from five trials indicates that vertebroplasty provides no clinically important benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success at one month. Evidence for quality of life and treatment success was downgraded due to possible imprecision. Evidence was not downgraded for potential publication bias as only one placebo-controlled trial remains unreported. Mean pain (on a scale zero to 10, higher scores indicate more pain) was five points with placebo and 0.7 points better (0.3 better to 1.2 better) with vertebroplasty, an absolute pain reduction of 7% (3% better to 12% better, minimal clinical important difference is 15%) and relative reduction of 10% (4% better to 17% better) (five trials, 535 participants). Mean disability measured by the Roland-Morris Disability Questionnaire (scale range zero to 23, higher scores indicate worse disability) was 14.2 points in the placebo group and 1.5 points better (0.4 better to 2.6 better) in the vertebroplasty group, absolute improvement 7% (2% to 11% better), relative improvement 9% better (2% to 15% better) (four trials, 472 participants).Disease-specific quality of life measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (scale zero to 100, higher scores indicating worse quality of life) was 62 points in the placebo group and 2.3 points better (1.4 points worse to 6.7 points better), an absolute imrovement of 2% (1% worse to 6% better); relative improvement 4% better (2% worse to 10% better) (three trials, 351 participants). Overall quality of life (European Quality of Life (EQ5D), zero = death to 1 = perfect health, higher scores indicate greater quality of life) was 0.38 points in the placebo group and 0.05 points better (0.01 better to 0.09 better) in the vertebroplasty group, absolute improvement: 5% (1% to 9% better), relative improvement: 18% (4% to 32% better) (three trials, 285 participants). In one trial (78 participants), 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; 95% CI 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute difference: 9% more reported success (11% fewer to 29% more); relative change: 40% more reported success (33% fewer to 195% more).Low-quality evidence (downgraded due to imprecision and potential for bias from the usual-care controlled trials) indicates uncertainty around the risk estimates of harms with vertebroplasty. The incidence of new symptomatic vertebral fractures (from six trials) was 48/418 (95 per 1000; range 34 to 264)) in the vertebroplasty group compared with 31/422 (73 per 1000) in the control group; RR 1.29 (95% CI 0.46 to 3.62)). The incidence of other serious adverse events (five trials) was 16/408 (34 per 1000, range 18 to 62) in the vertebroplasty group compared with 23/413 (56 per 1000) in the control group; RR 0.61 (95% CI 0.33 to 1.10). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.Our subgroup analyses indicate that the effects did not differ according to duration of pain (acute versus subacute). Including data from the eight trials that compared vertebroplasty with usual care in a sensitivity analyses altered the primary results, with all combined analyses displaying considerable heterogeneity. Authors' conclusions: We found high- to moderate-quality evidence that vertebroplasty has little clinical benefit in terms of pain for treating acute or subacute osteoporotic vertebral fractures in routine practice when compared with a sham procedure. Results were consistent across the studies irrespective of the average duration of pain.Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the high- to moderate-quality evidence that shows no important benefit of vertebroplasty and its potential for harm.
Article
Background: Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice. Objectives: To update the available evidence of the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures. Search methods: We updated the search of CENTRAL, MEDLINE and Embase and trial registries to 15 November 2017. Selection criteria: We included randomised and quasi-randomised controlled trials (RCTs) of adults with painful osteoporotic vertebral fractures, comparing vertebroplasty with placebo (sham), usual care, or another intervention. As it is least prone to bias, vertebroplasty compared with placebo was the primary comparison. Major outcomes were mean overall pain, disability, disease-specific and overall health-related quality of life, patient-reported treatment success, new symptomatic vertebral fractures and number of other serious adverse events. Data collection and analysis: We used standard methodologic procedures expected by Cochrane. Main results: Twenty-one trials were included: five compared vertebroplasty with placebo (541 randomised participants), eight with usual care (1136 randomised participants), seven with kyphoplasty (968 randomised participants) and one compared vertebroplasty with facet joint glucocorticoid injection (217 randomised participants). Trial size varied from 46 to 404 participants, most participants were female, mean age ranged between 62.6 and 81 years, and mean symptom duration varied from a week to more than six months.Three placebo-controlled trials were at low risk of bias and two were possibly susceptible to performance and detection bias. Other trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding.Compared with placebo, high- to moderate-quality evidence from five trials (one with incomplete data reported) indicates that vertebroplasty provides no clinically important benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success at one month. Evidence for quality of life and treatment success was downgraded due to possible imprecision. Evidence was not downgraded for potential publication bias as only one placebo-controlled trial remains unreported. Mean pain (on a scale zero to 10, higher scores indicate more pain) was five points with placebo and 0.6 points better (0.2 better to 1 better) with vertebroplasty, an absolute pain reduction of 6% (2% better to 10% better, minimal clinical important difference is 15%) and relative reduction of 9% (3% better to14% better) (five trials, 535 participants). Mean disability measured by the Roland-Morris Disability Questionnaire (scale range zero to 23, higher scores indicate worse disability) was 14.2 points in the placebo group and 1.7 points better (0.3 better to 3.1 better) in the vertebroplasty group, absolute improvement 7% (1% to 14% better), relative improvement 10% better (3% to 18% better) (three trials, 296 participants).Disease-specific quality of life measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (scale zero to 100, higher scores indicating worse quality of life) was 62 points in the placebo group and 2.75 points (3.53 worse to 9.02 better) in the vertebroplasty group, absolute change: 3% better (4% worse to 9% better), relative change: 5% better (6% worse to 15% better (two trials, 175 participants). Overall quality of life (European Quality of Life (EQ5D), zero = death to 1 = perfect health, higher scores indicate greater quality of life) was 0.38 points in the placebo group and 0.05 points better (0.01 better to 0.09 better) in the vertebroplasty group, absolute improvement: 5% (1% to 9% better), relative improvement: 18% (4% to 32% better) (three trials, 285 participants). In one trial (78 participants), 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; 95% CI 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute difference: 9% more reported success (11% fewer to 29% more); relative change: 40% more reported success (33% fewer to 195% more).Moderate-quality evidence (low number of events) from seven trials (four placebo, three usual care, 1020 participants), up to 24 months follow-up, indicates we are uncertain whether vertebroplasty increases the risk of new symptomatic vertebral fractures (70/509 (or 130 per 1000; range 60 to 247) observed in the vertebroplasty group compared with 59/511 (120 per 1000) in the control group; RR 1.08 (95% CI 0.62 to 1.87)).Similarly, moderate-quality evidence (low number of events) from five trials (three placebo, two usual care, 821 participants), indicates uncertainty around the risk of other serious adverse events (18/408 or 76 per 1000, range 6 to 156) in the vertebroplasty group compared with 26/413 (or 106 per 1000) in the control group; RR 0.64 (95% CI 0.36 to 1.12). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.Our subgroup analyses indicate that the effects did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Including data from the eight trials that compared vertebroplasty with usual care in a sensitivity analyses altered the primary results, with all combined analyses displaying considerable heterogeneity. Authors' conclusions: Based upon high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty for treating acute or subacute osteoporotic vertebral fractures in routine practice. We found no demonstrable clinically important benefits compared with placebo (sham procedure) and subgroup analyses indicated that the results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks.Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the high- to moderate-quality evidence that shows no important benefit of vertebroplasty and its potential for harm.
Article
Vertebroplasty (VP) is a percutaneous mini-invasive technique developed in the late 1980s as antalgic and stabilizing treatment in patients affected by symptomatic vertebral fracture due to porotic disease, traumatic injury and primary or secondary vertebral spine tumors. The technique consists of a simple metameric injection of an inert cement (poly-methyl-methacrylate, PMMA), through a needle by trans-peduncular, parapeduncular or trans-somatic approach obtaining a vertebral augmentation and stabilization effect associated with pain relief. The technique is simple and fast, and should be performed under fluoroscopy or CT guidance in order to obtain a good result with low complication rate. The aim of this paper is to illustrate the utility of VP, the indications-contraindications criteria, how to technically perform the technique using imaging guidance, and the results and complications of this treatment in patients affected by symptomatic vertebral compression fracture. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
Article
Background: Percutaneous vertebroplasty is widely used to treat acute and subacute painful osteoporotic vertebral fractures although recent placebo-controlled trials have questioned its value. Objectives: To synthesise the available evidence regarding the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures. Search methods: We searched CENTRAL, MEDLINE and EMBASE up to November 2014. We also reviewed reference lists of review articles, trials and trial registries to identify any other potentially relevant trials. Selection criteria: We included randomised and quasi-randomised controlled trials (RCTs) including adults with painful osteoporotic vertebral fractures of any duration and comparing vertebroplasty with placebo (sham), usual care, or any other intervention. As it is least prone to bias, vertebroplasty compared with placebo was the primary comparison. Major outcomes were mean overall pain, disability, disease-specific and overall health-related quality of life, patient-reported treatment success, new symptomatic vertebral fractures and number of other serious adverse events. Data collection and analysis: At least two review authors independently selected trials for inclusion, extracted data, performed 'Risk of bias' assessment and assessed the quality of the body of evidence for the main outcomes using GRADE. Main results: Eleven RCTs and one quasi-RCT conducted in various countries were included. Two trials compared vertebroplasty with placebo (209 randomised participants), six compared vertebroplasty with usual care (566 randomised participants) and four compared vertebroplasty with kyphoplasty (545 randomised participants). Trial size varied from 34 to 404 participants, most participants were female, mean age ranged between 63.3 and 80 years, and mean symptom duration varied from a week to more than six months.Both placebo-controlled trials were judged to be at low overall risk of bias while other included trials were generally considered to be at high risk of bias across a range of criteria, most seriously due to lack of participant and study personnel blinding.Compared with placebo, there was moderate quality evidence based upon two trials that vertebroplasty provides no demonstrable benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success. At one month, mean pain (on a scale 0 to 10, higher scores indicate more pain) was 5 points with placebo and 0.7 points better (1.5 better to 0.15 worse) with vertebroplasty, an absolute pain reduction of 7% (15% better to 1.5% worse) and relative reduction of 10% (21% better to 2% worse) (two trials, 201 participants). At one month, mean disability measured by the Roland Morris Disability Questionnaire (scale range 0 to 23, higher scores indicate worse disability) was 13.6 points in the placebo group and 1.1 points better (2.9 better to 0.8 worse) in the vertebroplasty group, absolute improvement in disability 4.8% (12.8% better to 3.3% worse), relative change 6.3% better (17.0% better to 4.4% worse) (two trials, 201 participants).At one month, disease-specific quality of life measured by the QUALEFFO (scale 0 to 100, higher scores indicating worse quality of life) was 2.4 points in the placebo group and 0.40 points worse (4.58 better to 5.38 worse) in the vertebroplasty group, absolute change: 0.4% worse (5% worse to 5% better), relative change 0.7% worse (9% worse to 8% better (based upon one trial, 73 participants). At one month overall quality of life measured by the EQ5D (0 = death to 1 = perfect health, higher scores indicate greater quality of life at one month was 0.27 points in the placebo group and 0.05 points better (0.01 worse to 0.11 better) in the vertebroplasty group, absolute improvement in quality of life 5% (1% worse to 11% better), relative change 18% better (4% worse to 39% better) (two trials, 201 participants). Based upon one trial (78 participants) at one month, 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; range 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute risk difference 9% more reported success (11% fewer to 29% more); relative change 40% more reported success (33% fewer to 195% more).Based upon moderate quality evidence from three trials (one placebo, two usual care, 281 participants) with up to 12 months follow-up, we are uncertain whether or not vertebroplasty increases the risk of new symptomatic vertebral fractures (28/143 observed in the vertebroplasty group compared with 19/138 in the control group; RR 1.47 (95% CI 0.39 to 5.50).Similary, based upon moderate quality evidence from two placebo-controlled trials (209 participants), we are uncertain about the exact risk of other adverse events (3/106 were observed in the vertebroplasty group compared with 3/103 in the placebo group; RR 1.01 (95% CI 0.21 to 4.85)). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.Our subgroup analyses provided limited evidence that the effects did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Including data from the six trials that compared vertebroplasty with usual care in a sensitivity analyses inconsistently altered the primary results, with all combined analyses displaying substantial to considerable heterogeneity. Authors' conclusions: Based upon moderate quality evidence, our review does not support a role for vertebroplasty for treating osteoporotic vertebral fractures in routine practice. We found no demonstrable clinically important benefits compared with a sham procedure and subgroup analyses indicated that results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the lack of high quality evidence supporting benefit of vertebroplasty and its potential for harm.
Article
Vertebroplasty and kyphoplasty have been used to treat osteoporotic compression fractures for many years. In 2009, two randomized controlled trials demonstrated limited effectiveness of vertebroplasty over sham treatment; thus, the American Academy of Orthopaedic Surgeons published evidence-based guidelines recommending "against vertebroplasty for patients who present with an osteoporotic spinal compression fracture." However, several other trials have since been published that contradict these conclusions. A recent meta-analysis cited strong evidence in favor of cement augmentation in the treatment of symptomatic vertebral compression fractures.
Article
To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of osteoporotic vertebral compression fractures (VCFs). As of February 1, 2011, a PubMed search (key words: kyphoplasty, vertebroplasty) resulted in 1,587 articles out of which 27 met basic selection criteria (prospective multiple-arm studies with cohorts of ≥20 patients). This systematic review adheres to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. Pain reduction in both BKP (-5.07/10 points, P < 0.01) and VP (-4.55/10, P < 0.01) was superior to that for NSM (-2.17/10), while no difference was found between BKP/VP (P = 0.35). Subsequent fractures occurred more frequently in the NSM group (22 %) compared with VP (11 %, P = 0.04) and BKP (11 %, P = 0.01). BKP resulted in greater kyphosis reduction than VP (4.8º vs. 1.7°, P < 0.01). Quality of life (QOL) improvement showed superiority of BKP over VP (P = 0.04), along with a trend for disability improvement (P = 0.08). Cement extravasation was less frequent in the BKP (P = 0.01). Surgical intervention within the first 7 weeks yielded greater pain reduction than VCFs treated later. BKP/VP provided greater pain relief and fewer subsequent fractures than NSM in osteoporotic VCFs. BKP is marginally favored over VP in disability improvement, and significantly favored in QOL improvement. BKP had a lower risk of cement extravasation and resulted in greater kyphosis correction. Despite this analysis being restricted to Level I and II studies, significant heterogeneity suggests that the current literature is delivering inconsistent messages and further trials are needed to delineate confounding variables.