1 Noridian Draft LCD Vertebroplasty & PVA July 13, 2010 Fargo, ND Presenters –Corey Teigen, MD –Sean Tutton, MD FSIR.

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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

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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 ?