Outline Vertebroplasty and Kyphoplasty: Vertebral fracture - PowerPoint PPT Presentation

Outline Vertebroplasty and Kyphoplasty: • Vertebral fracture epidemiology, consequences and diagnosis Who, What, and When • Kyphoplasty and vertebroplasty: what are they and how are they done? Douglas C. Bauer, MD • Outcomes University of California – Efficacy San Francisco, USA – Safety No Disclosures Epidemiology What Would You Do? 68 WF with OP on bisphosphonate with 4 wks of severe • 700,000 vertebral compression fractures midline back pain. In ER new T8 fx on X-ray, tx vicodin (VCFs) occur each year in the U.S. q 4hr. Activity limited to sitting/standing. Options? – More than hip and wrist fractures combined. 2 • >150,000/year hospitalized for VCFs. 2 1) Medical management, intensify 20% 20% 20% 20% 20% narcotics, PT • Osteoporosis-related disability: more days in bed than stroke, heart attack or breast 2) Medical management, add calcitonin, PT cancer. 1 3) Referral for facet injection, PT • Risk factors for VCF: age, BMD, BMI, falling, 4) Referral for kyphoplasty smoking, low calcium intake 5) Referral for vertebroplasty 1. National Osteoporosis Foundation 10 2. Cooper C et al. J Bone Min Res . 1992 1) 2) 3) 4) 5) Countdown Page 1

Consequences: Future Fracture Risk Pain and Decreased Quality of Life • Pain typically lasts 2-12 weeks • VCF increases risk of • Physical and functional performance lower subsequent vertebral fracture: in patients with vertebral fracture 1,2 – 5-fold after first VCF – Restricted ADL – Sleep disturbances – 12-fold after 2 or more VCFs • Psychosocial consequences 3 • Vertebral fracture is a strong – anxiety, depression, low self-esteem, and indication for preventive therapy alteration in social role (i.e. anti-resorptive or anabolic) • Long-term outcomes poorly studied 1. Lyles et al. (1993) Am J Med 94: 595-601 2. Silverman SL (1992) Bone 13, S27-S31 Ross et al. Annals of Internal Med 1991 3. Gold DT (1996) Bone 3: S185-S189 Mortality Identifying Vertebral Fractures • Approximately two thirds of all vertebral • Study of Osteoporotic Fractures: Women ≥ 65 fractures go undiagnosed, in part due to years (n=9,407) with or without vertebral fracture difficulty determining cause of symptoms. • Prospective follow-up, cause-specific mortality • Vertebral fractures may be asymptomatic. • Conclusions • Pain ranges from mild to severe and may – Women with prevalent vertebral fracture had a be chronic, but typically resolves over 2-12 23% higher age-adjusted mortality rate weeks – VCF patients are two to three times more likely to die of pulmonary causes – Most common cause of death was pulmonary disease, i.e., COPD and pneumonia Kado DM et al. Arch Intern Med . 1999 Page 2

Radiologic Assessment Radiologic Assessment • Lateral spine X-ray examination is the 8 weeks post fracture First week post fracture standard test MRI: T2 Image • Differentiation between back pain from vertebral compression fracture and disk disease or osteoarthritis often difficult – Correlate radiographic findings with exam • STIR sequence MR can be useful to determine cause and/or acuity of plain radiograph abnormality Courtesy of B. Boszczyk & R. Bierschnieder, BG Unfallklinik Vertebral Fractures: Three Types Outline • Vertebral fracture epidemiology, • Wedge fractures are most common consequences and diagnosis • Kyphoplasty and vertebroplasty: what are they and how are they done? • Outcomes – Efficacy – Safety Wedge Biconcave Crush Genant HK et al. J Bone Miner Res . 1993;8:1137–1148. Page 3

What Your Patients See and Hear: Kyphoplasty vs. Vertebroplasty • Vertebroplasty uses cement only (no balloon), no attempt to increase vertebral height • Both minimally invasive – Bilateral, 1cm incisions • Typically one hour per treated fracture • General or local anesthesia – Most are performed under general anesthesia – Can be performed under local anesthesia, often supplemented with conscious sedation • Seldom require an overnight hospital stay Kyphoplasty and Vertebroplasty Outline Literature • Vertebral fracture epidemiology and diagnosis • Uncontrolled studies or historical controls • Kyphoplasty and vertebroplasty: what are • Case-series they and how are they done? • Registries (Kyphon) • Outcomes • Randomized controlled trials – Efficacy – Safety Page 4

Summary of Non-randomized Risk of Subsequent Fracture Studies Concern that rigid cement alters biomechanics: case • • Beneficial effects observed on reports of new adjacent fractures after procedure – Vertebral body height and angular deformity • Mudano et al (2009) – Pain – Retrospective cohort from large health plan – 45 patients underwent vertebroplasty or kyphoplasty – Quality of life and 164 underwent conservative treatment – Ambulatory status – Adjustment for age, gender, history of osteoporosis – Physical function and comorbidities – Risk of recurrent vertebral fracture higher among • Asymptomatic cement extravasation common surgically treated after 90 d (OR=6.8) and 1 yr (OR=2.9) • Safe and well tolerated, but… – Too small to analyze adjacent fractures Mudano, et al. (2009) Osteoporosis Int 20;819-826 Mortality Benefit? What About Randomized Trials? • Early NIH trial with sham-therapy abandoned • Medicare claims data 2005-08 • First successful multi-centered randomized – Compared to non-surgical treatment, risk of trial funded by Kyphon (FREE) mortality reduced 24% with vertebroplasty and 44% with kyphoplasty – Up to 3 acute VF (< 3 months old) – Adjusted for age, health status, comorbity – Confirmed by x-ray and MR • Medical claims data 2008-11 – Randomized to balloon kyphoplasty – Traditional adjusted analysis: vertebral (n=149) vs. usual non-surgical care (n=151) augmentation reduced mortality 17% – Outcomes: pain, QOL, function and new VF – With propensity scores: no difference after 3 and 12 months (24 mo just reported) Edidin et al, JBMR 2011 Wardlaw et al, Lancet 2009 McCullough et al, Jama Internal Med 2013 Boonen et al, JBMR 2011 Page 5

FREE Results: Back Pain (0 to 10 Visual Analogue Scale) FREE Demographics • Subjects 10 9 – 72 years old, 77% female 8 – 96% primary osteoporosis 7 • Previous exposures 6 Score BKP 5 – 17% steroids NSM 4 – 33% bisphosphonates 3 • Duration of symptoms 2 – 6 weeks on average 1 0 • Fracture location 0 2 4 6 8 10 12 – 22% T5-T9 Follow-up (months) – 62% T10-L2 – 16% L3-L5 FREE Results: Days of Limited FREE Resutls: Physical Activity in the Previous 2 Weeks Component Summary (SF36) 14 40 12 30 10 8 Days BKP Score 20 BKP NSM 6 NSM 4 10 2 0 0 0 3 6 9 12 0 3 6 9 12 Follow-up (months) Follow-up (months) At 12 months, 60 fewer days of limited activity Kyphoplasty group had, on average, 60 fewer days At 12 months, no difference in physical function in kyphoplasty group of limited activity during the 12 months Page 6

FREE Results: Narcotic Use FREE Complications • Similar number of CV events, infections and 80 74 p=0.008 deaths 68 64 • Cement extravasation in 27% (asymptomatic) 60 p=0.46 • Subsequent VF: 33% with kyphoplasty and 46 Percent Nonsurgical Kyphoplasty 25% with non-surgical therapy (p=0.22) 40 34 28 20 0 Baseline 1 month 12 month Vertebroplasty FREE 24 Month Results Vs. Sham Procedure Trials • Persistent benefit at 24 mo • Two similar trials (N=131 and N=71) – VAS back pain score: 2.6 vs. 3.8 (p=0.01) – Up to 2 or 3 acute VF (< 12 months old) • No benefit at 24 mo – Confirmed by x-ray and/or MR – Activity limitation, physical function, narcotic – Randomized to vertebroplasty vs. sham use procedure • Two serious kyphoplasty events: spondylitis – Outcomes: pain, QOL, physical function, and anterior cement migration medication use after 3 or 6 months • New vertebral fractures: 48% vs. 41% (p=0.68) Buchbinder et al, NEJM 2009 Boonen et al, JBMR, 2011 Kallmes et al, NEJM 2009 Page 7

Vertebroplasty vs. Sham: Back Pain Vertebroplasty vs. Sham: QOL Buchbinder et al, NEJM 2009 Buchbinder et al, NEJM 2009 Vertebroplasty Vs. Sham: Pain Vertebroplasty Vs. Sham: SF-36 Kallmes et al, NEJM 2009 Kallmes et al, NEJM 2009 Page 8