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Noridian Draft LCDNoridian Draft LCDVertebroplasty & PVAVertebroplasty & PVA
July 13, 2010
Fargo, ND
• Presenters – Corey Teigen, MD – Sean Tutton, MD FSIR
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Overview of PresentationOverview of Presentation
• Past Research Studies
• Shortfalls of the 2009 NEJM studies
• Current Research Studies: Looking Forward
• Intervention vs. Conservative Care
• SIR’s Clinical Suggestions
• Questions
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Past Research StudiesPast Research Studies
• Effective Pain Relief– McGraw et al. (2002)
– Voormolen et al. (2006)
– Prather et al. (2006)
– Wardlaw et al. FREE trial (2009)
• Low Complications– Layton et al. (2007), Diamond et al. (2006)
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FREE Secondary Endpoints: Back Pain and Analgesics
0
1
2
3
4
5
6
7
8
-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13
0
10
20
30
40
50
60
70
80
90
-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13
p=0.01
p=0.002 p=0.04p=0.3
p=0.11
Follow-up (months)
Gro
up
me
an
s a
nd
95
% C
I
Follow-up (months)
Pe
rce
nt
an
d 9
5%
CI
Treatment p<0.0001Treatment*visit p<0.0001
Pain ReductionPain Reduction0-10 VAS0-10 VAS
Patients on narcoticsPatients on narcoticsCodeine or strongerCodeine or stronger
Kyphoplasty
Nonsurgical
Pain relief was accompanied by less use of narcotic analgesics
MDT Confidential
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0
10
20
30
40
50
-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13
100
FREE Secondary Endpoints: SF-36 Beyond 1 Month
SF-36 Physical component summary (PCS) scoreSF-36 Physical component summary (PCS) scoreQuality of life weighted on physical abilitiesQuality of life weighted on physical abilities
Norm for females >70 years (Sweden) ~38*
Estimated MCID 3.5 points*
*Sullivan, Soc Sci Med 1995
*Copay, Spine J 2008
Follow-up (months)
Gro
up
mea
ns
an
d 9
5% C
I
Kyphoplasty
Nonsurgical
Treatment p<0.0001Treatment*visit p<0.0001
3.5 points over the year
MDT Confidential
MCID = Minimum Clinically Important Difference
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2009 2009 NEJM NEJM Studies Studies • Enrollment—Power
– Low enrollment limited ability to reach statistical significance—selection bias
– 1,813 patients screened in Kallmes study and 131 underwent randomization
– if ~ 8 more pts. enrolled in Kallmes, statistically significant improvement would have been demonstrated (p <0.05)
• Kallmes—Crossover after 1 month– 43% crossed over to VP (statistically significant!)
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2009 2009 NEJM NEJM Studies Studies
• Patient Selection—both studies had fractures 6 months–1 year old– 36.6% of patients in Kallmes Study
• Recent MRI/BS needed for proper patient selection
• Buchbinder et al.: Single site/Single provider• Interventionalist did not have ability to
evaluate patients for appropriateness
12 month Pain outcomes (ITT analysis)
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RCT Overlay: Pain From FREE, CAFE, Kallmes, Buchbinder
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1
2
3
4
5
6
7
8
9
-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13Follow-up (Months)
Ba
ck
Pa
in S
co
re (
Me
an
an
d 9
5%
CI)
BKP (CAFE)NSM (CAFE)BKP (FREE)NSM (FREE)VP (INVEST)Sham(INVEST)VP(Buchbinder)Sham(Buchbinder)
10 Buchbinder – both arms (red)track with FREE NSM arm (blue dashes)
Kallmes – sham arm (green dashes)trending back to FREE NSM arm (blue dashes)
VP Sham Treatment and Control Groups Approximately the Same as KP NSM Control Group
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RCT Overlay: RMDQ From FREE, CAFE, Kallmes, Buchbinder
0
4
8
12
16
20
24
-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Follow-up (Months)
Ro
lan
d-M
orr
is S
core
(M
ean
an
d 9
5% C
I)
BKP (CAFE)
NSM (CAFE)BKP (FREE)
NSM (FREE)VP (INVEST)
Sham(INVEST)VP(Buchbinder)
Sham(Buchbinder)
Buchbinder – both arms (red)track with FREE NSM arm (blue dashes)
VP Sham Treatment and Control Groups Approximately the Same as KBK NSM Control Group
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Current Research: Looking Current Research: Looking ForwardForward
• VERTOS II, PRCT 202 patients• Pain < 6 wks, edema on MRI• Percutaneous Vertebroplasty (PV) vs.
conservative therapy (CT)• PV offered better pain relief at 1 day, 1 week,
1 month, 3 months, 6 months and 1 year• PV determined to be cost-effective• New effects similar in both groups (p =0.28)
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Current Research: VERTOS IICurrent Research: VERTOS II• Results:• VAS scores PV vs CT• 1 day (VAS 3.7 vs 6.7; P<0.001)• 1 week (VAS 3.5 vs 5.6; P<0.001)• 1 month (VAS 2.5 vs. 4.9; P<0.001)• 3 months (VAS 2.5 vs. 3.9; P=0.025)• 6 months (VAS 2.3 vs. 3.9; P=0.014)• 1 year (VAS 2.2 vs. 3.8; P=0.014)
Current Research: VERTOS II
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Research Studies: Summary Research Studies: Summary
• Previous research demonstrates VP and KP are safe and effective procedures
• New research continues to support therapy for properly selected patients
• Cost effective vs. conservative mgmt.
• Better than conservative care
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Impact of Vertebral Deformity
• Reduced pulmonary functionLeech Am Rev Respir Dis 1990, Culham Spine 1994, Schlaich Osteoporos Int 1998
• Altered gait, reduced gait velocity, poor balanceGold Bone 1996, Sinaki Osteoporos Int 2005
• Early satiety, gastric distress, frailtySilverman Arthritis Rheum 1992
• Reduced physical function, loss of QOLSilverman Bone 2001, Hallberg Osteoporos Int 2004, Oleksik Osteoporos Int 2005,
van Schoor Osteoporos Int 2005 • Chronic back pain
Nevitt Annals Int Med 1998, Pluijm J Bone Miner Res 2000 • Increased future fracture risk
Ross Osteoporos Int 1993, Lindsay Osteooporos Int 2001, Lunt Bone 2003, Lindsay JAMA 2005
• Excess mortalityKado Arch Int Med 1999, Johnell Osteoporos Int 2004, Kado Annals Intern Med 2007, Kado Annals Intern Med 2009
Risk similar to hip fracture4
9% FVC per VCF1
Effects Are Independent of Acute Back Pain
Impaired 5 y after last VCF2
In pts with 3+ VCFs, QOL loss similar to
CAD, PAD, DM3
Independent of BMD*
MDT Confidential
16
Higher Mortality Found in Medicare Patients With VCFs Than
in Matched Controls
Lau J Bone Joint Surg 2008
MDT Confidential
VCF patients have a 40% (absolute) higher mortality within 8 yearsof first diagnosis than matched controls without VCFs
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Patients With a Greater Number of VCFs Have a Significantly Higher Mortality Rate
Source: Kado Arch Intern Med 1999
MDT Confidential
Functional Outcomes of 5,766 VCF Patients Treated With KP vs. Non-Surgical Management (NSM)
Versus NSM, VCF Patients
Treated with KP
Were more likely to
Be given a routine discharge home
Odds Ratio1
2.59
Be discharged home with homecare
1.51
Were less likely to
Be discharged to a SNF
In Hospital Mortality
0.62
0.59
Zampini Clin Orthop Relat Res 2010
Be discharged to another facility
0.52
1. All p values < 0.05
Had a lower rate of death
All Patients Were Emergent or Urgent Hospital Admissions
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Mortality Risk for Operated and Non-Operated Vertebral Fracture Patients in the U.S. Medicare
Population
• National Medicare sample of 81,662 VCF pts. followed for 2 years
• KP and VP had survival rate of 74.8% at 24 months and non-operated pts. had a survival rate of 67.4% at 24 months (p<0.0001)
• Patients receiving either KP or VP were 44% less likely to die than non-operated pts. (p<0.001)
Manuscript in Progress—Abstract Presented at IOF 2010
Confidential Unpublished Data
Mortality data derived from the Medicare 100% file
At 24 month follow-up KP and VP patients 44% less likely to die than non-operated (p<0.0001)
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Summary Summary
• Data shows efficacy and cost-effectiveness vs. conservative mgmt.
• Intervention improves length and quality of life
• Early 2011: Revised Multi-Society Position Statement
• SIR Practice Guidelines
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Thank you!Thank you!
• Questions ?
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