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Rx of Acute Compression Fractures with
Balloon Kyphoplasty
Presented to the IMF
J h
os ua A. Hirsch, MD FSIR
Chief: Minimally Invasive Spine Surgery
Director: Interventional Neuroradiology/Endovascular Neurosurgery
MGH
Asst. Prof: Harvard Medical School
MASSACHUSETTS
GENERAL HOSPITAL

Disclosures:
· Cardinal--consultant/minor shareholder
· Medtronic --consultant/minor shareholder
· Steering Committee--KAVIAR trial
· DSMB--CEEP trial
· Off label use of product will be presented
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·
One of my first patients
had a retropulsed
fragment. I did the
procedure because my
neurosurgical colleague
pushed me to and she
understood the
additional risks. This 85
year old lady had
complete pain relief and
called the newspap
ppers,
TV stations
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GENERAL HOSPITAL

Physical Impact of VCF
Age 50
Age 75
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National Osteoporosis Foundation

Vertebral fracture: Associated
conditions
Postmenopausal
women over the
Prominent thoracic
age of 55
kyphosis
Low bone mass
Loss of
of 2 or more
evaluations suggest
inches in height
vertebral fracture
Diagnosis of
Glucocorticoid therapy
osteoporosis
(7.5 mg prednisolone)
MASSACHUSETTS
GENERAL HOSPITAL
1.
Ismail AA et al. Osteoporos Int. 1999;9:206213.

History
· 1987-French authors reported percutaneous
injection of PMMA in the vertebral column
for painful hemangiomas
pg
· 1993-Dr. Claude Depriseter-Debussche gave
a presentation at the ASNR
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History
· Interventional Neuroradiologists at he University of
Virginia heard the presentation and were consulted,
by chance, for an appropriate case
· Jensen et al presented their data on 30 pts. with 48
compression fractures at the 1997 ASNR and
subsequently published in the AJNR
·
*Galibert P, Deramond H, Rosat P. Preliminary Note on the Treatment of Vertebral Angiomas by Percuatenous Acrylic
Ve
V rteb
e
roplasty. Neurochirurgie 1987;33
1987; :1
: 66-
66 168
16
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GENERAL HOSPITAL

Epidemiology of osteoporosis I
· Osteoporosis is a systemic skeletal disease
characterized by compromised bone
t
s
t
reng h
th, which predisposes the affect d
e
bone to fracture.1
MASSACHUSETTS
GENERAL HOSPITAL
1.
National Institutes of Health. 2000;17:136.

Pathology of vertebral fractures
· In osteoporotic patients, vertebral fractures
more commonly occur spontaneously or as
the result of minimal trauma resulting from
spinal loading during day-to-day activities,
such as bending forward, lifting objects, and
li bi
t i 123
climbing stairs1,2,3
MASSAC
1.
HUS
Cooper CETTS
et al. J Bone Min Res. 1992;7:221227.
GENERAL
2.
Frost HOSPITAL
HM. Orthop Clin North Am. 1981;12:671681.
3.
Parfitt AM, Duncan H. In: Rothman RH, Simeone FA, eds. The Spine. 2nd Edition. Philadelphia: WM Saunders;1982:775905.

Multiple Myeloma
Epidemiology
·
Estimated 15,980+ new cases per
60
year about 1% of all new cancer
Men
50
cases1
00)
Women
0,0
·
Estimated 75,000 100,000 living
40
with MM in US2
/10
es 30
as
·
Typically afflicts the elderly, males, C(
and more African-Americans than ce
than 20
en
Whites by 2 to 13
cidIn 10
·
11,406 deaths from MM in 2005
about 2% of all deaths from
0
cancer1
4
9
4
9
4
9
4
9
4
9
4
85+
30-3
35-3
40-4
45-4
50-5
55-5
60-6
65-6
70-7
75-7
80-8
Age
Source: SEER 1975-2001, National Cancer Institute
MASSACHUSETTS
GENERAL
1. American HOSPITAL
Cancer Society, Cancer Facts and Figures 2005
2. International Myeloma Foundation, 2006.
3. Sirohi, et al. The Lancet. 2004;363:875-887.

Multiple Myeloma
Fractures
· Over 70% of patients have bone pain at diagnosis
and half have back pain.1
· 55 - 70% have VCFs or history of vertebral body
abnormalities.2
· 15 - 30% develop new VCFs annually.3
· About half of patients with at least one osteoly
pytic
lesion develop pathologic fractures within 9 months.4
1.
McClosekey, et al. Br J Hematol. 1998;100:317-325.
MASSACHUSETTS
2.
Ray et al. J Bone Mineral Research. 1997;12:24-35.
GENERAL HOSPITAL
3.
McCloskey, et al. Drugs. 2001;61:1253-1274.
4.
Berenson, et al. NEJM. 1996;334:488-493.

Detection of vertebral fracture
· Because of the complex etiology of back
pain, osteoporotic fractures may not be
suspected or considered,
p, even in the
presence of severe back pain not
attributable to any other cause
· Imaging can be extremely helpful
· MRI
· Bone scan+/
+/-CT where unable to get MRI
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GENERAL HOSPITAL

Patient history often reveals risk
factors
t
i k f
t
1
Oral glucocorticoid use
Most common risk factors1
Oral glucocorticoid
Early menopause
Unintentional weight loss
and malnutrition
Other factors
34%
36%
10%
20%
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GENERAL HOSPITAL
1.
Tannenbaum C et al. J Clin Endocrin Metab. 2002;87:44314437.

Risk of fracture from steroid use
· Users of oral l
g
t
ucocor iticoid
ids have a 2.6-fl
fo d
ld
increase risk of fracture
of
fracture
Risk
vertebral
Oral glucocorticoid Age- and gender-
users
matched controls
(n=244,235)
(n=244,235)
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GENERAL
van Staa HOSPITAL
TP et al. J Bone Miner Res. 2000;15:9931000.

Increasing incidence with age
gg
· At menopause, women experience a rapid
acceleration of bone loss.
· At 80, it is estimated that almost 80% of
women have osteopenia or osteoporosis
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The kyphotic spine
· Height loss
· Upright posture becomes
impossible
· Pulmonary volume loss
due to anterior wedging
of the spine
· 12th rib rests on the iliac
crest
· Narrowed gap between
ribs and ilium
· Protruding abdomen
Normal
Kyphotic
· Distension, constipation,
early satiety, eructation
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Vertebral fractures
weaken physical function
nction
· Restricted activities of daily living eg
e.g.
cooking, washing, driving, resulting in
patients needing
pg assistance from family or
hired help
· Essentially can't do ADLs
· Increased incidence of sleep disturbances
MASSAC
1.
HUS
Leidig G ETTS
et al. Bone Miner. 1990;8:217219.
GENERAL
2.
Cook HOSPITAL
DJ et al. Arth Rheum. 1993;36:750756.
3.
Fink HA et al. Osteoporos Int. 2003;14:6976.

Psychosocial consequences
· The pain and deformity secondary to
osteoporosis can reduce the ability of
individuals to fulfill their accustomed social
roles
· Clinical fractures resulting from osteoporosis
contribute to social isolation
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Depression and women with
osteoporosis
· The relationship between depression and
osteoporosis was first identified in the mid-to-
late 1980s from semi-structured interviews in
which postmenopausal women with
osteoporosis and vertebral fractures
td
reported feeliling f
f
ear l
u , h
l
ope ess,
d
an
depressed1
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GENERAL HOSPITAL
1.
Gold DT et al. J Am Geriatr Soc. 1989;37:417422.

Osteoporosis diminishes
self-esteem and self-image
· The MORE trial showed a significant
association between the number of
prevalent
p
vertebral fractures and reduced
self-esteem, as reflected by body image1
· Reduced self-esteem has a strong negative
impact on overall quality of life in patients
with compression fractures
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GENERAL HOSPITAL
1.
Silverman SL et al. Arthritis Rheum. 2001;44:26112619.

Multiple vertebral fractures are
associated with probable
depression
15
P0.001
*
*
12
Scale
h
n
(%)
h
6 9
wit
ients
epressio
i
score
*
D
6
Pat
*
(GDS) 3
eriatricG
0
1
2
3
Number of prevalent
vertebral fractures
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GENERAL HOSPITAL
Silverman SL. Unpublished data.

Vertebral fracture is associated
with higher mortality rates
· SOF cohort study: Women 65 years
(n=9,515) with or without vertebral fracture
· Conclusions: Women with prevalent
vertebral fracture had a 23% higher age-
adjusted mortality rate1
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1.
Kado DM et al. Arch Intern Med. 1999;159;12151220.

Increased Mortality
Relative Risk of Death in 3.8 yrs
8.64X
6.68X
1X
Age
Age--Matched
Matched
Hip Fracture
Spine
Control
Fracture
Cauley et al., Osteoporosis International 2000
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GENERAL HOSPITAL

THE HUMAN COST
Downward Spiral
©2000-2001 Kyphon Inc. All rights reserved.
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GENERAL HOSPITAL

Patient Selection
·
Pre-Rx imaging - MRI (Sagittal
STIR sequence*
sequence ), Plain
Plain films,
Technetium-99m nuclear
medicine bone scan
·
MRI
Acute compression fractures:
Hi
Hypointense T1
T1-weih
ig t
hted
Hyperintense STIR
*Baker LL, Goodmand
Goodm
SB
SB et
et al
al. Benign
Benign versus
versus
pathologic compression fractures of vertebral
bodies:assessment with SE, CS and STIR MR imaging.
Radiology 1990;174:495-502
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Straightforward
g
PV...
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Unipedicular app
ppproach PV
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GENERAL HOSPITAL

Orthopedic Fracture Care
Why have we been content
tl
to leave th
the
i
sp ne in a
physiologically and biomechanically
compromised condition?
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GENERAL HOSPITAL

Deformity Progression
yg
16º
25º
kyphosis
kyphosis
Aug 31, 2000
Sept 3, 2000
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Lieberman et al., Spine 2001
GENERAL HOSPITAL

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Placement of Bone Cement
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KyphX® Products
Uni-directional
Balloon
Directionality
Bi-directional
Indicator
Balloon
Indicator
Exit Marker
Marker Band
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GENERAL HOSPITAL

KyphX® LatitudeTM Curette
Articulating Tip
Exit Marker
Thumbwheel
Cannula Stop
Score Line
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GENERAL HOSPITAL

KyphX® LatitudeTM Curette
Sequence of Use
·
Balloon expansion may
py be
hindered by sclerotic and
partially healed bone
Using imaging guidance,
advance the KyphX
yp
Latitude Curette through
the cannula
MASSACHUSETTS
GENERAL HOSPITAL

KyphX® LatitudeTM Curette
Sequence of Use
·
Position curette tip within
the cavity created by initial
inflation. Rotate
thumbwheel to move
device tip to desired angle
Carefully score the sclerotic
bone either by using a side-to-
side motion
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SP--an amazing lady
gy!
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GENERAL HOSPITAL

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Express Kyphoplasty
The line ext
i
ens on th t
a I most frequentltly use
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GENERAL HOSPITAL

Express Kyp
pyphoplasty
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GENERAL HOSPITAL

Extreme augmentation: Sacrop
gplasty
·
79 year old woman
·
2 month progressive history of
incapacitating low back pain
·
questionable loss of height of
L2 vertebral body on plain film
·
Referred by PMD for possible
vertebroplasty
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GENERAL HOSPITAL

MRI L/S SPINE
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Imaging
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SACROPLASTY
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SACROPLASTY
PRE
POST
POST
POST
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POST-SACROPLASTY
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A careful foray...
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GENERAL HOSPITAL

26 year old with recent onset back p
ypain
QuickTimeTM and a
QuickTimeTM and a
ncompressed) decompressor
compressed) decompressor
eeded to see this picture.
eded to see this picture
QuickTimeTM and a
picture.
QuickTime
and
mpressed) decompressor
ded to see this picture.
QuickTimeTM and a
TIFF (Uncompressed) decompresso
are needed to see this picture.
MASSACHUSETTS
GENERAL HOSPITAL

26 year old with recent onset back p
ypain
QuickTimeTM and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
QuickTimeTM and a
TIFF (Uncompressed) decompressor
are needed to see this i
p t
c ure.
QuickTimeTM and a
QuickTimeTM and a FF (Uncompressed) decompresso
QuickTimeTM and a
TIFF (Uncompressed) decompres
are needed to see this picture.
(Uncompressed) decompressor
are needed to see this picture
re needed to see this picture.
are needed to see this picture.
p
MASSACHUSETTS
GENERAL HOSPITAL

26 year old with recent onset back p
ypain
QuickTimeTM and a
QuickTimeTM and a
IFF (Uncompressed) decompressor
TIFF (Uncompressed) decompress
are needed to see this picture.
are needed to see this picture.
QuickTimeTM and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
QuickTimeTM and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
MASSACHUSETTS
GENERAL HOSPITAL

ACETABULOPLASTY CASE REVIEW:
90yo female with a history
history of breast cancer presenting
with medically intractable right hip pain.
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GENERAL HOSPITAL

ACETABULOPLASTY CASE REVIEW
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ACETABULOPLASTY CASE REVIEW:
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Example of a 70 y
pyear old with MM
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GENERAL HOSPITAL

MM--entirely cy
yystic bone-83yoM
QuickTimeTM and a
QuickTimeTM and a
QuickTimeTM and a
compressed) decompressor
ncompressed) decompressor
ckTimeTM and a
pressed) decompr
QuickTimeTM and a
TIFF (Uncompressed) decompressor
d to see this pictur
are needed to see this picture.
MASSACHUSETTS
GENERAL HOSPITAL

MM-same patient
QuickTimeTM and a
TIFF (Uncompressed) decompressor
QuickTimeTM and a
are needed to see this picture.
TIFF (Uncomp
(pressed) decompressor
are needed to see this picture.
QuickTimeTM and a
F (Uncompressed) decompresso
are needed to see this picture.
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GENERAL HOSPITAL

51 year old with MM-strange
g locations
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GENERAL HOSPITAL

82 year old with breast CA
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GENERAL HOSPITAL

Rx
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GENERAL HOSPITAL

Vertebral augmentation for Cancer
· Dt
Data
t
sugges
k
mar ed pain relilief
· Not as extensive a literature as with osteoporotic
compression
p
fracture
MASSACHUSETTS
GENERAL HOSPITAL

Dudeney and Lieberman Study
Parameters
·
18 patients - 55 levels with myeloma VCF
·
Indication: Painful, multiple myeloma-related VCFs
·
All treated with kyphoplasty
·
Levels T6-L5 (27% at T12 or L1)
·
Mean follow-up 7.4 months
· Journal of Clinical Oncology. 2002;20:2382-2387
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Source: Dudeney, S. and Lieberman, I.H., et al. Journal of Clinical Oncology. 2002;20:2382-2387.

Dudeney and Lieberman Study
Outcomes
SF-36 Scores
64.8
70
55 4
60
.
60
50.6
47.5
50
40.6
40
Pre-Kyphoplasty
31.3
Post-Kyphoplasty
30
23 2
.
21.3
20
10
0
Bodily Pain
Physical
Vitality
Social
P=0.0008
Function
P=0.01
Functioning
P=0.0010
P=0.014
Kyphoplasty provides statistically signific
si
ant
gnificant improvement in Bodily Pain, Physical
Function, Vitality and Social Functioning as measured in SF-36 scores.
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General Health, Mental Health, Role Physical, and Role Emotional scores did not show significant improvement.
Source: Dudeney, S. and Lieberman, I.H., et al. Journal of Clinical Oncology. 2002;20:2382-2387.

Lieberman and Reinhardt Study
Parameters
·
63 patients with osteolytic collapse
· 52 with multiple myeloma
· 11 with osteolytic metastases
·
264 vertebral bodies treated with kyphoplasty
·
Mean follow-up
· 18 weeks in multiple myeloma patients
· 3 weeks in patients with metastases
·
Clinical Orthopaedics and Related Research.
2003;415(S):176-186.
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GENERAL HOSPITAL
Source: Lieberman and Reinhardt. Clinical Orthopaedics and Related Research. 2003;415(S):176-186.

Lieberman and Reinhardt Study
Myeloma Patient Outcomes
Visual Analog Scale
7
6.18
)01 6
o
0t 5
(
ain 4
P
2.84
3
ated
f-R 2
elS
1
eanM
0 = no pain
0
pre-
e op
op
post-
t op
p<0.0001
MASSACHUSETTS
GENERAL HOSPITAL
Source: Lieberman and Reinhardt. Clinical Orthopaedics and Related Research. 2003;415(S):176-186.

Lieberman and Reinhardt Study
Myeloma Patient Outcomes
Osw estry Disability
yy Index
46.7
50
45
40
30.33
35
e 30
corS 25
an 20
Me 15
10
5
0
Lower score = better
pre-op
pp
post-op
physical function
pp
P=0.0001
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GENERAL HOSPITAL
Source: Lieberman and Reinhardt. Clinical Orthopaedics and Related Research. 2003;415(S):176-186.

Lieberman and Reinhardt Study
Myeloma Patient Outcomes
SF-36 Scores
90
General
80
Physical
Mental
Health
70
60
50
Pre-op
40
Post-op
30
20
10
0
PF
RP
BP
V
SF
RE
MH
GH
P=0.043 P=0.016 P=0.806 P=0.008
P=0.683
P<0.0001* P=0.043 P=0.0003*
*Kyphoplasty provides statistically significant improvement in
Bodily Pain and Physical Function as measured in SF-36 scores.
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GENERAL HOSPITAL
Source: Lieberman and Reinhardt. Clinical Orthopaedics and Related Research. 2003;415(S):176-186.

Percutaneous Vertebroplasty and Kyphoplasty for
Pi
Painf l
u V t
er ebral Body Fractures in Cancer Pt
Pa itients
· Authors: Fourney
· J. Neurosurg (Spine 1). 2003;98:21-30.
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GENERAL HOSPITAL

Fourney Study
Parameters
· 56 patients
· 21 with multiple myeloma
· 35 with bone metastases
· 97 levels treated
· 32 with balloon kyphoplasty
· 65
ith
w
t
ver b
e
l
rop
t
as y
· All patients had intractable pain due to VCFs
· Median duration of symptoms 3.2 months
· Mean follow-up 4.5 months
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GENERAL HOSPITAL
Source: Fourney. J. Neurosurg (Spine 1). 2003;98:21-30.

Fourney Study
Outcomes
· Marked or complete pain relief in 49/58
patients (84%)
· 2
ti
pa
t
en s und
t
erwen
t
repea
d
proce ures for
new fractures
· No change in 5 procedures
· Reduced analgesic use in follow-up
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GENERAL HOSPITAL
Source: Fourney. J. Neurosurg (Spine 1). 2003;98:21-30.

Lane Study
Parameters
· 19 patients with multiple myeloma
· Total of 46 levels treated with kyphoplasty
· Clinical Orthopaedics and Related Research.
2004;426:49-53.
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GENERAL HOSPITAL
Source: Lane, et al. Clinical Orthopaedics and Related Research. 2004;426:49-53.

Lane Study
Outcomes
· 16 of 19 patients showed improvement in
ODI scores
· Mean score improved from 49 to 33 (p <
0.001)
· Partial restoration of anterior vertebral body
height in 76% of vertebral bodies
· No complications
· Results were similar to a comparison group of
patients with osteoporotic VCFs
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GENERAL HOSPITAL
Source: Lane, et al. Clinical Orthopaedics and Related Research. 2004;426:49-53.

Conclusion
· Vertebral fractures are common fractures in
patients with MM
· Vertebral augmentation has been used
successfully to treat compression fractures for
over one decade in the US
· Rx of CA (mets and MM) is increasing
· It is a major focus of my practice
· When sed
u
properly, these techniq e
u can
provide exceptional relief, to previously refractory
patients
MASSACHUSETTS
GENERAL HOSPITAL

Thank You!
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GENERAL HOSPITAL