Title: Balloon Kyphoplasty
1Balloon Kyphoplasty
- Treatment of Vertebral Compression Fractures
- Eustaquio O Abay II, MD, MS
- Clinical Asst Professor, Neurosurgery, UKSM-W
2Osteoporosis
- Osteoporosis is a systemic skeletal disease
characterized by compromised bone strength that
predisposes the affected bone to fracture.
National Institutes of Health. 200017136.
3 Epidemiology
- In the U.S., 700,000 vertebral compression
fractures (VCFs) occur each year, more than the
number of hip and wrist fractures combined.2 - Approximately 150,000 people in the U.S. are
hospitalized due to pain and medical management
associated with VCFs (average hospital stay of 8
days), resulting in costs in excess of 1.6
billion annually.2 - Osteoporosis-related disability confines patients
to more immobile days in bed than stroke, heart
attack or breast cancer.1 - Estimated national direct expenditures (hospitals
and nursing homes) for osteoporotic and
associated fractures are 17 billion in 2001 (47
million each day) and the cost is rising,
according to the National Osteoporosis
Foundation.
1. National Osteoporosis Foundation 2. Cooper C
et al. J Bone Min Res. 19927221227.
4Identifying Vertebral Fractures
- Approximately two thirds of all vertebral
fractures go undiagnosed, in part due to
difficulty determining cause of symptoms. - Vertebral fractures are often asymptomatic.
- Pain ranges from mild to severe and may be
chronic, but may disappear over several weeks. - It is important to diagnose vertebral fractures,
to understand the value of lateral spine
radiographs, and to consider ordering additional
radiographs if initial films do not show fracture.
Gold et al. The Downward Spiral of Vertebral
Osteoporosis, A Monograph, June 2003
5Vertebral Fracture Associated Conditions
Postmenopausal women gt age 55
Prominent thoracic kyphosis
Low BMD
Loss of 2 or more inches in height
Diagnosis of osteoporosis
Glucocorticoid therapy( 7.5 mg prednisolone)
Ismail AA et al. Osteoporos Int. 19999206213.
6Radiologic Assessment
- A lateral spine X-ray examination is a method
that can be used to screen for the presence of
vertebral compression fractures. - STIR sequence MRI can be useful to determine
index and/or plain radiograph culprit. - Palpating each spinous process to rule out disc
pain as the underlying culprit would also be of
value in the initial assessment of the patient to
differentiate between back pain and vertebral
compression fracture pain.
7Radiologic Assessment
8 weeks post fracture
First week post fracture
MRI T2 Image
Courtesy of B. Boszczyk R. Bierschnieder, BG
Unfallklinik, Dept. of Neurosurgery, Murnau,
Germany
8Vertebral Fracture Progression
- Some fractures may collapse acutely while others
collapse progressively over time.
Lyritis et al. (1989) Clin Rheum Suppl 2(8)66-69
9Location of Vertebral Fractures
- Are most commonly located at the midthoracic
region (T7T8) and the thoracolumbar junction
(T12L1)1 - Midthoracic regionthoracic kyphosis is most
pronounced and loading (stress) during flexion is
increased - Thoracolumbar junctionthe relatively rigid
thoracic spine connects to the more freely mobile
lumbar segments2 - Correspond to the most mechanically compromised
regions of the spine
Nevitt MC et al. Bone. 199925613619. Cooper C
et al. J Bone Min Res. 19927221227.
10Vertebral Fractures Three types
- Wedge fractures are most common
Wedge
Biconcave
Crush
Genant HK et al. J Bone Miner Res.
1993811371148.
11Long-term Consequences
12Decreased Quality of Life
- Physical and functional performance lower in
patients with VCF 1,2 - Restricted ADL - patients need assistance from
family or hired help - Sleep disturbances
- Early satiety
- Patients suffer psychosocial consequences 3
- anxiety, depression, low self-esteem, and
alteration in social role
1. Lyles et al. (1993) Am J Med 94 595-601
2. Silverman SL (1992) Bone 13, S27-S31
3. Gold DT (1996) Bone 3 S185-S189
13Pulmonary Function
- Pulmonary function (FEV1) is significantly
reduced in patients with osteoporotic VCF vs.
non-osteoporotic patients with low back pain.
Normal Posture
Stooped Posture
Schlaich C, et al. (1998) Osteoporosis Intl
8261-267
14Future Fracture Risk
- After first VCF, risk of subsequent VCF is
increased - 5-fold after first VCF
- 12-fold after 2 or more VCFs
- 75-fold after 2 or more VCFs and low bone mass
(below the 33rd percentile)
Ross et al. (1991) Annals of Internal Med. 114
(11) 919-923
15Risk of fracture from steroid use
- Users of oral glucocorticoids have a 2.6-fold
increase risk of fracture
van Staa TP et al. J Bone Miner Res.
2000159931000.
16Mortality
- Study of Osteoporotic Fractures cohort study
Women 65 years (n9,515) with or without
vertebral fracture - Conclusions
- Women with prevalent vertebral fracture had a 23
higher age-adjusted mortality rate - VCF patients are two to three times more likely
to die of pulmonary causes - Most common cause of death was pulmonary disease,
i.e., COPD and pneumonia
Kado DM et al. Arch Intern Med.
199915912151220.
17Balloon Kyphoplasty
- Stabilizes the Fracture and Corrects Spinal
Deformity caused by one or more VCFs
18The Procedure
- Minimally invasive
- Bilateral, 1cm incisions
- Typically one hour per treated fracture
- General or local anesthesia
- Most are performed under general anesthesia
- Can be performed under local anesthesia, often
supplemented with conscious sedation. - Among 155 prospectively enrolled patients in
Kyphon U.S. study, only 1 complication was
related to anesthesia. - May require an overnight hospital stay
Kyphon U.S. Study. Data on file at Kyphon Inc.
19Case Study
Patient 91 YO FemaleDiagnosis Primary
osteoporosisFracture Reduced L-1, 4 months old
19o
3o
15mm
28mm
Courtesy of Alexander Hadjipavlou, M.D., Crete,
Greece
20Case Study
Patient 78 YO FemaleDiagnosis Primary
osteoporosisFracture Reduced L-1 L-2 6 weeks
old
L1-L2 Height Restoration
(L3 Treated 6 Wks Prior)
Courtesy of Frank Phillips, MD, Chicago, IL
21Experience to Date
- Over insert number fractures in insert number
patients treated worldwide since 1998 - Patient Outcomes include
- Vertebral body height restoration
- Angular correction of deformity
- Significant reduction in pain
- Reduced number of days in bed
- Improved quality of life
- Improvement in activities of daily living
- Improvement in mobility
- High rate of patient satisfaction
22Data Sources
- Kyphon U.S. Study
- Multicenter prospective single-arm study
documenting the outcomes of kyphoplasty - 155 patients enrolled, 100 completed at 2 yr.
follow-up - Peer-reviewed Published Literature
- Literature review (prospective and retrospective)
of 1342 fractures treated with kyphoplasty
23Correction of Vertebral Body Deformity
- Studies report the following radiographic
outcomes post kyphoplasty - Percent lost vertebral body height restored
- Percent vertebral body height increased
- Angular deformity correction
24Correction of Vertebral Body Deformity
- Three studies analyzed how many fractures in the
study populations were reducible (that is,
achieved a measurable correction). - In the U.S. study, reducible refers to
measurable fractures where at least 15 of
predicted height was lost due to fracture. - In Lieberman et al (2001) a fracture was
reducible if at least 10 of lost vertebral body
height was restored with balloon kyphoplasty. - Phillips et al. (2003) defined reducible as a
decrease in local angulation of at least 5
degrees.
Lieberman et al (2001) Spine 26 2, 1631-1638
Phillips et al (2003) Spine 28, 19 2260-2267
Kyphon U.S. Study. Data on file at Kyphon Inc.
25Percent Lost Height Restored
- Based on the mean height measurement of the
closest, unfractured vertebrae above and below
the treated level.
- Anterior, midline, and sometimes posterior
measurements are taken.
26Example Percent Lost Height Restored
Lost Height Restored (24 20) / (30 - 20)
or 4/10 40
27Percent Lost Height Restored
NR Not Reported
Kyphon U.S. Study. Data on file at Kyphon Inc.
Lieberman et al (2001) Spine 26 2, 1631-1638
Theodorou et al (2002) J Clin Imaging 261-5
28Percent Vertebral Body Height Increased
- Estimates of total, pre-fractured vertebral
body height - Percent vertebral body height is based on the
mean measurement of the closest unfractured
vertebrae above and below the treated level. - Using the same example, 30mm becomes 100
29Percent Vertebral Body Height Increased
Garfin et al (2001) Spine 261511-1515
Ledlie et al. (2003) J Neurosurg (Spine 1) 98
36-42
Theodorou et al (2002) J Clin Imaging 261-5
30Correction of Angular Deformity
- Measured using the Cobb Method
- Theodorou et al. (2002) (n24)
- Local angular deformity decreased from 26º to 16º
- Phillips et al. (2003) (n52)
- Mean local angular deformity correction was 8.8º
(range, 0-29º) - Among reducible fractures (5º improvement), mean
angular deformity correction was 14º
Phillips et al (2003) Spine 28, 19 2260-2267
Theodorou et al (2002) J Clin Imaging 261-5
31Case Study Correction of Angular Deformity
Immediate post- fracture
Post-fracture 4 days
Post-kyphoplasty
Kyphosis 25º
Kyphosis 10º
Kyphosis 16º
Lieberman et al. (2001) Spine 26 2, 1631-1638
32Balloon KyphoplastyClinical Outcomes
33Clinical Outcomes
- Studies report the following clinical outcomes
post kyphoplasty - Correction of vertebral body deformity
- Significant reduction in pain
- Improvement in quality of life
- Improvement in ability to perform activities of
daily living - Low complication rate
34Reduction in Pain
- Following Balloon Kyphoplasty, patients report
significant pain reduction at short-term
follow-up, sometimes within hours of the
procedure. - In a retrospective analysis (Garfin et al
(2001)), patients discontinued use of narcotics
for fracture-related pain, changing to
over-the-counter analgesics post operatively. - Coumans et al. (2003) prospectively followed 78
consecutive patients for 12 to 18 months and
reported substantial improvement (plt0.001) in
bodily pain as measured by SF-36. Results
persisted at three months.
Theodorou et al (2002) J Clin Imaging
261-5 Coumans JV, Reinhardt MK, Lieberman I
(2003) J Neurosurg (Spine 1) 9944-50
Garfin SR, Yuan HA, Reiley MA (2001). Spine
261511-1515
35Reduction in Pain
- In the prospective multicenter U.S. study, there
was an average of 60 reduction in pain at one
week follow-up. Results persisted for two years
(n100).
Kyphon U.S. Study. Data on file at Kyphon Inc.
36Quality of Life
- Studies show that geriatric patients quickly
return to a higher activity level after balloon
kyphoplasty, gaining more independence at both
short and long-term follow-up. - In the U.S. study, SF-36 results were seen at one
month in 7 out of 8 domains (all but general
health).
- Results persisted or improved during the two year
follow-up. (N100)
Kyphon U.S. Study. Data on file at Kyphon Inc.
37Quality of Life SF-36 Survey
- Coumans et al (2003)
- Prospective study, 78 pts, 188 procedures
- Marked improvement in 7 domains only general
health did not improve. - Sustained at 18 mo f/u
Coumans et al. (2003) J Neurosurg (Spine 1)
9944-50
38Activities of Daily Living
- Improvements in SF-36 physical function scores at
seen in the prospective study by Coumans et al.
(2003) - Other measures in the clinical literature include
ambulatory status, function, days of bed rest,
and limited activity days.
Coumans et al. (2003) J Neurosurg (Spine 1)
9944-50
39Ambulatory Status
- Ledlie et al (2002) (n79)
- 80 were fully ambulatory at one week follow-up.
- 27 of the pts. followed at one year maintained
full ambulatory status. - 90 of all patients who were wheelchair-bound
pre-operatively were ambulatory at one week
follow-up.
Ledlie et al. (2003) J Neurosurg (Spine 1) 98
36-42
40Function
- Coumans et al 15 improvement in Oswestry
Disability Index (ODI) at early f/u - Persisted at 12 and 18 month f/u
Coumans et al. (2003) J Neurosurg (Spine 1)
9944-50
41Bed Rest and Limited Activity
- Prospective multicenter U.S. Study
- Measured number of days in bed during month prior
to receiving kyphoplasty and number of days of
limited activity due to back pain. - Results at f/u (statistically significant)
- 100 reduction in median days spent in bed.
Results maintained at two year f/u. - 64 reduction in median number of days
interrupted due to back pain at one and three
month f/u and 93 reduction at one and two year
f/u.
Kyphon U.S. Study. Data on file at Kyphon Inc.
42Risk of Subsequent Fracture
- Komp et al (2004)
- A controlled, prospective study
- 21 patients underwent balloon kyphoplasty and 19
underwent conservative treatment. - Patient populations were similar in age, gender,
fracture history, and other risk factors. - After six months, 7 out of 19 evaluable balloon
kyphoplasty patients had new fractures (37),
whereas 11 out of 17 conservatively-treated
patients (67) had new fractures. - Conclusions
- Incidence of adjacent and non-adjacent fracture
in both arms corresponds to other published data. - A larger study is needed to assess risk of
subsequent fracture.
Komp, et al. (2004) J Miner Stoffwechs 11(Suppl
1)13-16 (German)
43Low Complication Rate
- U.S. Study no serious procedure-related
complications in 214 fractures in 155 patients
treated - One patient experienced an intraoperative
arrhythmia (PSVT)
Kyphon U.S. Study. Data on file at Kyphon Inc.
Lit review See bibliography at end of
presentation
44Procedure-Related Complication Rates
- Literature review conducted describes the results
for 897 Balloon Kyphoplasty patients and 2408
vertebroplasty. - Overall procedure-related complication rate
refers to bone cement and non-bone cement related
complication rates combined. - Results statistically significantly in favor of
Balloon Kyphoplasty in the following areas - Overall procedure-related complication rate
- Bone cement procedure-related complication rate
Data on file at Kyphon Inc. References listed at
end of presentation.
45Overall Procedure-Related Complication Rate
- Overall procedure-related complication rate for
balloon kyphoplasty-treated patients was 0.89
versus 5.44 for vertebroplasty (p0.0009). - Statistically significant difference also
demonstrated in sub-analyses of fractures due to
osteoporosis or cancer.
46Bone Cement Procedure-Related Complication Rates
- The total bone cement procedure-related
complication rate for balloon kyphoplasty was
0.22 versus 3.07 for vertebroplasty (p0.0008).
- The calculation of bone cement-related
complications excluded asymptomatic cement
extravasations.
47Bone Cement Procedure-Related Complication Rates
- The combination of compaction of cancellous bone,
cavity creation, and controlled cement delivery
suggests the difference in adverse events is
caused by cement extravasation. - Compaction of Cancellous Bone Balloon inflation
compacts the cancellous bone, disrupts internal
venous pathways and fills fracture lines,
reducing leak pathways. - Cavity Creation and Controlled Bone Cement
Delivery Upon balloon removal, an intervetebral
cavity is left behind, allowing for the delivery
of a known volume of doughy bone cement (KyphX
HV-R?) under low pressure and fine manual
control.
Phillips et al. (2002) Spine 272173-2179 Togawa
et al. (2003) Spine 281521-1527
48Adverse Events
- Although the complication rate with Balloon
Kyphoplasty has been demonstrated to be low, as
with most surgical procedures, there are risks
associated with Balloon Kyphoplasty, including
serious complications. Serious adverse events,
some with fatal outcome, associated with the use
of acrylic bone cements include cardiac arrest,
cerebrovascular accident, myocardial infarction,
and pulmonary embolism. - Other reported adverse events relevant to the
anatomy being treated with acrylic bone cements
include deep or superficial wound infection,
fistula, hematoma, hemorrhage, heterotopic new
bone formation, nerve entrapment due to extrusion
of bone cement beyond the region of its intended
use, pyrexia due to allergy to bone cement,
short-term conduction irregularities,
thrombophlebitis, and transitory fall in blood
pressure. - Physicians should review the product Instructions
for Use for a full discussion of the risks.
49Patient Satisfaction U.S. Study
- Reports patient satisfaction with the outcomes of
the kyphoplasty procedure - Measured on a scale of 1 20
- 1 completely dissatisfied
- 20 completely satisfied
RESULT 17.5 at one week and maintained at 2 yrs
Kyphon U.S. Study. Data on file at Kyphon Inc.
50Conclusion
- VCFs occur more than hip and wrist fractures
combined. - Balloon kyphoplasty is an available option
associated with a low complication rate for
patients suffering from painful VCFs. - Balloon kyphoplasty can provide fracture
stabilization and correction of spinal deformity. - Patients experience significant reduction in pain
and improvement in mobility, thus increasing
overall quality of life.
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treated with kyphoplasty
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compression fractures 1-year clinical outcomes
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treatment of osteolytic vertebral compression
fractures as a result of multiple myeloma. J Clin
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and kyphoplasty for painful vertebral body
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osteoporotic compression fractures. Spine
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fracture by means of kyphoplasty Prospective
comparative study of 19 surgically and 17
conservatively treated patients. J Miner
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Percutaneous polymethylmethacrylate
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comparative study of 19 surgically and 1
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Study. Data on file at Kyphon Inc. - Lane JM, Johnson CE, Khan SN, et al. (2002)
Minimally invasive options for the treatment of
osteoporotic vertebral compression fractures.
Orthop Clin N Am 33431-438 - Ledlie J, Renfro M (2003) Balloon kyphoplasty
One-year outcomes in vertebral body height
restoration, chronic pain, and activity levels. J
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