Transcript PowerPoint Background Lecture

BIDMC Radiology Fellowship Conference
Percutaneous Vertebral Augmentation:
Kyphoplasty, Vertebroplasty
John C. Keel, M.D.
Medical Director, Spine Center at BIDMC
Physical Medicine and Rehabilitation
April 2012
Primum non nocere.
Tourtier JP, Cottez, S. N Engl J Med 366;3 January 19, 2012
Acute Paraplegia After
Vertebroplasty
Caused by Epidural Hemorrhage.
J Bone Joint Surg Am.
2007;89:1827-31.
Disclosure
I have no financial interests or
relationships to disclose.
Off-Label Use
PMMA mixed with barium is off-label.
(PMMA was only recently approved
for spine use in 2004-2005.)
“Disclosure”
“Doctors With a Special Interest in Back Pain
Have Poorer Knowledge About How to Treat
Back Pain”
Spine 2009; 34 (11);1218-1226
CME Objectives
• Review osteoporosis, vertebral fracture risk
• Understand details, risks and benefits of vertebral
augmentation procedure
• Summarize related guidelines and other evidence-based
Intro to “Should we”
material
• Apply knowledge to short and long term management of
patients with vertebral compression fractures
Vertebral Augmentation
• Vertebroplasty (1984): Injection of material
(usually PMMA cement) into vertebral body
• Kyphoplasty (1998): Injection after
manipulation involving cavity creation
• Indicated for painful compression fractures
– osteoporosis
– cancer
Qualified Personnel
1.
BC/BE physician
1.
2.
3.
6 months of training involving cross-sectional imaging
4 months of training involving interventional procedures
or equivalent experience
2.
Performance of successful vertebroplasties in at least 5 patients
as the primary operator, under the supervision of a qualified
physician, and without complications
3.
Relevant knowledge and skill of spine, radiation, etc.
PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.
Osteoporosis Defined
The most common bone disease in humans
WHO diagnostic classification:
• BMD at the hip or spine that is less than or equal to 2.5 standard deviations
below the young normal mean reference population
–
(T-score -2.5 or less)
Clinical diagnosis can be made based on history of fragility fracture
Characterized by:
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low bone mass
deterioration of bone tissue
disruption of bone architecture
compromised bone strength
increase in the risk of fracture
Osteopenia = low bone mass: BMD T-score -1 to -2.5
Normal = T-score greater than -1
Osteoporosis Defined
• Primary
– Type 1: post-menopausal, age 50-70
• estrogen loss
• trabecular bone affected more (prevalent in the spine)
– Type 2: age-related, age >70 years
• aging
• trabecular and cortical bone affected
• Secondary: factors are legion
Secondary Osteoporosis
Lifestyle factors
Low calcium intake
High caffeine intake
Alcohol (3+/day)
Smoking
Vitamin D insufficiency
High salt intake
Inadequate physical activity
Falling
Excess vitamin A
Aluminum (antacids)
Immobilization
Thinness
Genetic
Hypogonadal
Endocrine
Diabetes
Gastrointestinal
Hematologic
Rheumatic/Autoimm
Miscellaneous/Medications….
Glucocorticoids (≥ 5 mg/d of prednisone or equivalent for ≥ 3 mo)
Osteoporosis Incidence/Prevalence
700,000 osteoporotic vertebral compression fractures annually in the USA
300,000 osteoporotic hip fractures/year, by comparison
250,000 osteoporotic wrist fractures/year, by comparison
National Health and Nutrition Examination Survey III (NHANES III):
• 10 million + Americans have osteoporosis
• 33.6 million have low bone density of the hip
• ~1 in 2 Caucasian women will have osteoporosis-related fracture/ lifetime
• ~1 in 4-5 men also will have osteoporosis-related fracture/ lifetime
Burden of Osteoporotic Fractures
All osteoporotic fracture types:
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432,000 hospital admissions
~2.5 million medical office visits
~180,000 nursing home admissions (annually in the USA)
$17 billion cost for 2005
for comparison:
– total costs of breast cancer ($13 billion)
– total cost of heart disease ($19 billion)
•
$6 billion for the indirect value of lost productivity (patient, caregivers)
Fracture Risk
Free online
Not validated for spine BMD
(Just “Google” FRAX. Also at http://www.shef.ac.uk/FRAX.)
Bone Mineral Density Testing
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Dual-energy x-ray absorptiometry (DXA), looks at hip and spine
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Measures:
– grams of mineral per square centimeter scanned (g/cm2)
– compared to the expected BMD for the patient’s age and sex (Z-score)
– compared to “young normal” adults of the same sex (T-score)
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One standard deviation equals ~10-15% of the BMD value in g/cm2
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In premenopausal women, men less than 50 years of age and children, the
WHO BMD diagnostic classification should not be applied
Fall Risk: Most osteoporotic fractures result from falls
National Osteoporosis Foundation Guidelines
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Recommendations apply to postmenopausal women and men age 50 and older
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Counsel on the risk of osteoporosis and related fractures
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Check for secondary causes
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For individuals age 50 and older:
– calcium - at least 1,200 mg per day
– vitamin D 800-1,000 IU per day
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Recommend regular weight-bearing and muscle-strengthening exercise to
reduce the risk of falls and fractures
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Advise avoidance of tobacco smoking and excessive alcohol intake
(Just “Google” NOF. Also at http://www.nof.org.)
NOF Guidelines: BMD Testing
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BMD testing: all women age 65 and older and men age 70 and older
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Postmenopausal women and men age 50-69, recommend BMD testing when
you have concern based on their risk factor profile
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Recommend BMD testing to those who have had a fracture, to determine
degree of disease severity
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For patients on pharmacotherapy, it is typically performed two years after
initiating therapy and every two years thereafter; however, more frequent testing
may be warranted in certain clinical situations
NOF Guidelines: BMD Treatment
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Initiate treatment in those with fractures (hip or vertebral, clinical or
morphometric)
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Initiate therapy in those with BMD T-scores ≤ -2.5 at the femoral neck or spine
by dual-energy x-ray absorptiometry (DXA), after appropriate evaluation
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Initiate treatment in postmenopausal women and men age 50 and older with low
bone mass (T-score between -1.0 and -2.5, osteopenia) at the femoral neck or
spine and a 10-year hip fracture probability ≥ 3% or a 10-year major
osteoporosis-related fracture probability ≥ 20% based on the US-adapted WHO
absolute fracture risk model (FRAX®; www.NOF.org and
www.shef.ac.uk/FRAX).
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NOF lists current FDA-approved pharmacologic options
NOF Guidelines: Physical Medicine & Rehabilitation
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Focus on function
Consider medication cognitive effects
Training/safety with functional tasks
Assistive devices
Consider home environment
Complete exercise recommendation
NOF Guidelines: Physical Medicine & Rehabilitation
• Avoid forward bending and exercising with
trunk in flexion, especially in combination
with twisting
• Avoid long-term immobilization
• Recommend partial bed rest (with periodic
sitting and ambulating) only when required
and for the shortest periods possible
NOF Guidelines: Physical Medicine & Rehabilitation
• Orthoses
• Pain control
• Vertebroplasty, kyphoplasty
Free online
Other indications for augmentation:
Important topics not covered in this lecture:
• Spine tumors
• Burst fractures
Compression Fracture:
Definition and Diagnosis
•
History/ exam
– These are sensitive and specific:
• percussion with closed fist elicits pain
• pain with assuming supine position
– Pain that is worse when upright, relieved when finally recumbent, does not
improve after a warmup
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X-ray
– ~15% height loss meets some literature definitions
– but this is not always required in clinical reality….
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MRI with STIR is best for assessing the timing
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Bone scan is a backup choice for assessing fracture acuity
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CT
– I always get a CT to look for any cortical or pedicle fractures or potential leaks
(3)
Tricks
• Become adept at interpreting imaging
yourself.
• A fracture that is read as “stable” or
“subacute” or “chronic” per radiology
report verbiage may still be appropriate for
augmentation treatment.
Tricks
• If an x-ray shows a fracture read as “new,”
that could mean new since last x-ray 5
years ago….
• Use prior C/A/P CT’s, etc., to get a sneaky
spine fracture timeline….
Case #1 Which level is fractured?
X-Ray
MRI with STIR
Case #2 Patient has pacemaker, cannot have MRI.
X-Ray
Bone Scan
(may be + 2 years)
Case #3
CT delineates the bony cortex.
Case #3
Nearly the same slice on MRI.
Case #3
An acute fracture is typically dark on T1 and bright on STIR.
Case #4
Vertebra plana, with bright T2 streak, suggests Kummel’s disease.
Case #4
Nearly the same slice on CT.
Case #5
An acute fracture is typically dark on T1 and bright on STIR.
It may be bright on T2 as well, as seen here.
Case #5
Nearly the same slice on MRI with STIR.
Case #6
Chronic healed fractures with no difference in T1 or T2.
Case #6
Chronic healed fractures with no difference in STIR.
Case #7
Chronic healed fractures with no difference in T1 or T2.
Case #7
Chronic healed fractures with no difference in STIR.
Case #8 Called to see inpatient with “new” T12 fx per report. You scan records:
2012 X-ray
2010 slice from C/A/P CT
The T12 fracture is chronic in that it has been there since 2010.
Case #9 Complex anatomy
Case #9 Complex anatomy
CT with 3D reconstructions
Case #9 Complex anatomy
En face view in procedure – tricky with no landmarks!
Natural History of VCF
• Many are clinically silent, discovered later
• Usually heal without intervention in ~12 weeks
• Up to 1/3 have delayed healing
• Compression may progress
Compression Fracture Sequelae
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Pain
Neurological deficit
Spinal deformity
Gait and balance disorder
Impaired lung function
Increased risk of future fracture
Increased rate of mortality
Worse 2 and 5-year bodily function measures compared to
hip fractures
• Greater 4-5 year mortality compared to hip fractures
Compression Fracture Sequelae
• Protuberant abdomen/ “kissing rib syndrome”
• Difficulty fitting clothes due to kyphosis, protuberant
abdomen
• Height loss
• Reflux
• Early satiety
• Weight loss
• Fear of fracture and falling
• Impaired activities of daily living (eg, bathing, dressing)
• Depression
• Sleep disturbance
• Difficulty bending, lifting, descending stairs, cooking
It is not uncommon for a patient to be admitted to a hospital for
treatment, discharged, and readmitted to treat complications
with medical resources used at each stage. The result can be a
downward-spiral of complications, functional decline, and a higher
risk of death as a result of the VCF….
Zampini, et. al.
These sequelae are also all potential risks of “conservative care.”
Treatment “Ladder”
Broad range:
• Doing “nothing”
• Physical treatments, therapy
• Modalities
• Exercise
• Orthoses, assistive devices
• Medications
• Imaging and other tests
• Injections
• Minimally invasive procedures….
Jewett Brace
www.rehab.research.va.gov
Vertebral Augmentation
• Vertebroplasty (1984): Injection of material
(usually PMMA cement) into vertebral body
• Kyphoplasty (1998): Injection after manipulation
involving cavity creation
• Indicated for painful compression fractures
– osteoporosis
– cancer
Indications
1.
Painful osteoporotic or neoplastic vertebral compression
fracture(s) refractory to medical therapy.
2.
Symptomatic vertebral body microfracture (as documented by
magnetic resonance imaging [MRI] or nuclear imaging, and/or
lytic lesion seen on CT) without obvious loss of vertebral body
height.
PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.
Contraindications
Absolute Contraindications
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Asymptomatic vertebral body compression fractures.
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Active osteomyelitis of the target vertebra.
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Uncorrectable coagulopathy.
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Allergy to bone cement or opacification agent.
Relative Contraindications
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Radiculopathy in excess of local vertebral pain, caused by a compressive
syndrome unrelated to vertebral collapse. Occasionally preoperative
vertebroplasty can be performed before a spinal decompressive procedure.
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Retropulsion of a fracture fragment causing severe spinal canal compromise.
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Epidural tumor extension with significant encroachment on the spinal canal.
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Ongoing systemic infection.
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Patient improving on medical therapy.
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Prophylaxis in osteoporotic patients (unless being performed as part of a research
protocol).
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Myelopathy originating at the fracture level.
PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.
Balloon tamp in vertebra plana fracture
Risks/Complications
American College
of Radiology. 2009.
Benefits
Published
Success Rates
Threshold for
Review
Neoplastic
70% to 92%
<60%
Osteoporosis
80% to 95%
<70%
PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.
Procedure Techniques
1. Transpedicular
2. Extrapedicular
Not covered here:
• Subpedicular
• Cervical
Needle driving method
Wong W, Mathis JM. Vertebroplasty and kyphoplasty: techniques for avoiding complications and pitfalls.
Neurosurg Focus 18 (3):E2, 2005.
Transpedicular
Transpedicular
Transpedicular
En Face View
Biopsy
Drill and Curette
Balloon Tamps
Cement Injection
Extrapedicular
Extrapedicular
Biopsy
En Face View
Extrapedicular
Wong W, Mathis JM. Vertebroplasty and kyphoplasty: techniques for avoiding complications and pitfalls.
Neurosurg Focus 18 (3):E2, 2005.
Balloon Tamps
Cement
Selected
Evidence and Outcomes
Efficacy and safety of balloon kyphoplasty compared with non-surgical
care for vertebral compression fracture (FREE):
a randomised controlled trial.
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one to three acute vertebral fractures
21 sites in eight countries
138 participants in the kyphoplasty group
128 controls
follow-up at 1 month
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 nonsurgical group (difference between groups 5·2
points, 2·9–7·4; p<0·0001).
D. Wardlaw, S. Cummings, J. Van Meirhaeghe, L. Bastian, J. Tillman, J. Ranstam, R. Eastell, P. Shabe, K. Talmadge,
S. Boonen. The Lancet, Volume 373, Issue 9668, Pages 1016-1024.
Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE):
a randomised controlled trial
The Lancet, Volume 373, Issue 9668, Pages 1016-1024
D. Wardlaw, S. Cummings, J. Van Meirhaeghe, L. Bastian, J. Tillman, J. Ranstam, R. Eastell, P. Shabe, K. Talmadge,
S. Boonen
Kyphoplasty resulted in:
• decreased pain
• decreased narcotic use
• improved walking
• improved quality of life
Recent controversy: NEJM published two RCTs
1. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, et al. A
randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J
Med. 2009. 361(6):557‐568.
2. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. A
randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med.
2009. 361(6): 569‐79.
• These were negative studies
(Aug 6, 2009)
Recent controversy, NEJM RCTs:
Problems: Assessment of fracture acuity
• bone scan
• clefts
• 1 year
• Kallmes et al. utilized MRI or bone scan
only in cases in which the fracture age
was uncertain
Recent controversy, NEJM RCTs:
Problems: Enrollment
• Kallmes et al. study,
– 1812 patients were initially screened, yet only
131 were entered into the study.
• Buchbinder et al. required 4.5 years to
– accrue 78 patients at four high volume
centers, reporting that 141 who satisfied all
inclusion criteria declined randomization.
NEJM RCTs:
Problems: Enrollment
• Selection bias
• Enrollment goals not met
NEJM RCTs:
Problems: Control
• Sham procedure instead of standard nonprocedural care
• Used facet/periosteal blocks as sham
Left L4 medial branch nerve block,
demonstrating extent of flow of 0.1 mL contrast.
The outline of the mamillary process is seen.
A periosteal block
is not a sham….
NEJM RCTs:
Problems: Blinding
• Sedation level
• Insurance bill would reveal
• Patients could tell which group they were
in
• Crossover higher in sham group
NEJM RCTs:
My interpretation of these:
• The “sham procedure” may be an alternative
treatment option or diagnostic block
• Such has been described before:
G Chandler, G Dalley, J Hemmer, T Seely
Gray ramus communicans nerve block: novel
treatment approach for painful osteoporotic
vertebral compression fracture. Southern
medical journal. 01/05/2001; 94(4):387-93.
Hirsch JA. Vertebral Augmentation. MGH Radiology Rounds. Vol 8 Issue 2. Feb 2010.
Conclusions
We reviewed osteoporosis, incidence, vertebral fracture
risk
We talked about details, risks and benefits of vertebral
augmentation procedure
We summarized related guidelines and other evidencebased material
I hope you will apply knowledge to short and long term
management of patients with vertebral compression
fractures
What can you immediately apply to your practice?
• Smoking screening for all of your patients
• Screen for BMD w/u if incidental fx or risk factor, e.g., if
you see an incidental old fracture
• You are prepared to take all industry courses
• Review and use cited guidelines
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NOF
FRAX
ACR
AAOS VCF
AAOS Guideline 2010
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7.
8.
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10.
11.
Calcitonin nasal 200 U BID alternate nostrils x 4 weeks
(moderate)
Ibandronate and strontium ranelate for prevention (weak)
Inconclusive: Bed rest, CAM, opioids/analgesics
L2 nerve root block for L3 or L4 fx (weak)
Inconclusive: Bracing
Inconclusive: Exercise, PT
Inconclusive: Electrical stimulation
Recommend against vertebroplasty (strong)
Kyphoplasty is an option (weak)
Inconclusive: Reducing kyphosis
“We are unable to recommend for or against any specific
treatment for patients who present with an osteoporotic spinal
compression fracture on imaging with correlating clinical signs
and symptoms and who are not neurologically intact. Strength of
Recommendation: Inconclusive”
THE TREATMENT OF SYMPTOMATIC OSTEOPOROTIC SPINAL COMPRESSION FRACTURES. GUIDELINE AND
EVIDENCE REPORT. American Academy of Orthopaedic Surgeons. 2010.
Bone Health and Osteoporosis:
A Report of the Surgeon General 2004
Health Care Professionals Need To:
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Pay close attention to bone health issues when conducting wellness visits
and treating people with other illnesses.
Emphasize the basics of good bone health during their interactions with
patients, including appropriate nutrition and levels of physical activity.
Recognize “red flags” and risk factors that might signal the potential for
osteoporosis and other bone diseases, and take necessary action or refer
at-risk patients to other providers for the appropriate work-up.
Health care professionals working in emergency departments and
orthopedic practices also have an important role. They must:
Recognize that many bone fractures signal the potential for metabolic bone
disease.
Go beyond fixing patients’ bones by referring them, when appropriate, to
another health care professional for further assessment of the potential for
bone disease.
Topics for further reading:
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Vertebral augmentation for spine tumors
Physical management of osteoporosis
Medical management of osteoporosis
Spinal orthoses
Selected References
1.
Buchbinder R, et al. A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral
Fractures. N Engl J Med 2009;361:557-68.
2.
David F. Kallmes DF, et al. A Randomized Trial of Vertebroplasty for Osteoporotic Spinal
Fractures. N Engl J Med 2009;361:569-79.
3.
DePalma MJ, et al. Vertebroplasty. PMR 2;9: 862-867.
4.
McGirt MJ, et al. Vertebroplasty and kyphoplasty for the treatment of vertebral compression
fractures: an evidenced-based review of the literature. The Spine Journal 9 (2009) 501–508.
5.
Klazen CAH, et al. Vertebroplasty versus conservative treatment in acute osteoporotic
vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010;
376:1085-1092.
6.
National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of
Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2010.
7.
Practice guideline for the performance of vertebroplasty. American College of Radiology. Rev.
2009.
8.
Wardlaw D, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care
for vertebral compression fracture (FREE): a randomised trial. Lancet 2009;373:1016-24.
9.
Zampini JM, White AP, McGuire KJ. Comparison of 5766 Vertebral Compression Fractures
Treated With or Without Kyphoplasty. Clin Orthop Relat Res (2010) 468:1773–1780.
Thank You!
John C. Keel, M.D.
[email protected]
[email protected]