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Noridian Draft LCD Vertebroplasty & PVA

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  1. Noridian Draft LCDVertebroplasty & PVA July 13, 2010 Fargo, ND • Presenters • Corey Teigen, MD • Sean Tutton, MD FSIR

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

  5. Kyphoplasty Nonsurgical FREE Secondary Endpoints: SF-36 Beyond 1 Month SF-36 Physical component summary (PCS) score Quality of life weighted on physical abilities MCID = Minimum Clinically Important Difference Treatment p<0.0001 Treatment*visit p<0.0001 Norm for females >70 years (Sweden) ~38* Estimated MCID 3.5 points* 3.5 points over the year Group means and 95% CI *Copay, Spine J 2008 *Sullivan, Soc Sci Med 1995 Follow-up (months) MDT Confidential

  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. 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. RCT Overlay: Pain From FREE, CAFE, Kallmes, Buchbinder VP Sham Treatment and Control Groups Approximately the Same as KP NSM Control Group Buchbinder – both arms (red) track with FREE NSM arm (blue dashes) Kallmes – sham arm (green dashes) trending back to FREE NSM arm (blue dashes)

  10. RCT Overlay: RMDQ From FREE, CAFE, Kallmes, Buchbinder VP Sham Treatment and Control Groups Approximately the Same as KBK NSM Control Group Buchbinder – both arms (red) track with FREE NSM arm (blue dashes)

  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. 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

  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. Impact of Vertebral Deformity Effects Are Independent of Acute Back Pain • 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 OsteoporosInt 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 • 9% FVC • per VCF1 Impaired 5 y after last VCF2 In pts with 3+ VCFs, QOL loss similar to CAD, PAD, DM3 Independent of BMD* Risk similar to hip fracture4 15 MDT Confidential

  16. Higher Mortality Found in Medicare Patients With VCFs Than in Matched Controls VCF patients have a 40% (absolute) higher mortality within 8 years of first diagnosis than matched controls without VCFs Lau J Bone Joint Surg 2008 MDT Confidential

  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) Odds Ratio1 All Patients Were Emergent or Urgent Hospital Admissions Be given a routine discharge home 2.59 Were more likely to Be discharged home with homecare 1.51 Versus NSM, VCF Patients Treated with KP Be discharged to a SNF 0.62 Were less likely to Had a lower rate of death Be discharged to another facility 0.59 0.52 In Hospital Mortality Zampini Clin Orthop Relat Res 2010 1. All p values < 0.05

  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 19

  20. 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) Confidential Unpublished Data

  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. Thank you! • Questions ?