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

2. 2 Overview 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

3. 3 Past 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)

4. 4 FREE Secondary Endpoints: Back Pain and Analgesics Follow-up (months) Group means and 95% CI Follow-up (months) Percent and 95% CI Treatment p<0.0001 Treatment*visit p<0.0001 Pain Reduction 0-10 VAS Patients on narcotics Codeine or stronger Kyphoplasty Nonsurgical Pain relief was accompanied by less use of narcotic analgesics MDT Confidential

5. 5 FREE Secondary Endpoints: SF-36 Beyond 1 Month SF-36 Physical component summary (PCS) score Quality 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) Group means and 95% CI Kyphoplasty Nonsurgical Treatment p<0.0001 Treatment*visit p<0.0001 3.5 points over the year MDT Confidential MCID = Minimum Clinically Important Difference

6. 6 2009 NEJM 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!)

7. 7 2009 NEJM 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

8. 12 month Pain outcomes (ITT analysis)

9. 9 RCT Overlay: Pain From FREE, CAFE, Kallmes, Buchbinder 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

10. 10 RCT Overlay: RMDQ From FREE, CAFE, Kallmes, 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

11. 11 Current Research: Looking Forward 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)

12. 12 Current 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)

13. Current Research: VERTOS II 13

14. 14 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

15. 15 Impact of Vertebral Deformity Reduced pulmonary function Leech Am Rev Respir Dis 1990, Culham Spine 1994, Schlaich Osteoporos Int 1998 Altered gait, reduced gait velocity, poor balance Gold Bone 1996, Sinaki Osteoporos Int 2005 Early satiety, gastric distress, frailty Silverman Arthritis Rheum 1992 Reduced physical function, loss of QOL Silverman 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 mortality Kado Arch Int Med 1999, Johnell Osteoporos Int 2004, Kado Annals Intern Med 2007, Kado Annals Intern Med 2009 Risk similar to hip fracture 4  9% FVC  per VCF 1 Effects Are Independent of Acute Back Pain Impaired 5 y after last VCF 2 In pts with 3+ VCFs, QOL loss similar to CAD, PAD, DM 3 Independent of BMD* MDT Confidential

16. 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 years of first diagnosis than matched controls without VCFs

17. 17 Patients With a Greater Number of VCFs Have a Significantly Higher Mortality Rate Source: Kado Arch Intern Med 1999 MDT Confidential

18. 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 Ratio 1 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

19. 19 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

20. 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)

21. 21 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

22. 22 Thank you! Questions ?