Outline Vertebroplasty and Kyphoplasty: Who, What, and When

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1 Outline Vertebroplasty and Kyphoplasty: Who, What, and When Douglas C. Bauer, MD University of California San Francisco, USA Vertebral fracture epidemiology, consequences and diagnosis Kyphoplasty and vertebroplasty: what are they and how are they done? Outcomes Efficacy Safety Research funding from Amgen, Novartis, P and G, Roche Epidemiology Consequences: Future Fracture Risk 7, vertebral compression fractures (VCFs) occur each year in the U.S., more than the number of hip and wrist fractures combined. 2 >15,/year hospitalized due to pain and medical management associated with VCFs. 2 Average hospital stay of 8 days in 1992 Costs in excess of $1.6 billion annually Osteoporosis-related disability confines patients to more immobile days in bed than stroke, heart attack or breast cancer. 1 Risk factors for VCF: age, BMD, BMI, falling, smoking, low calcium intake 1. National Osteoporosis Foundation 2. Cooper C et al. J Bone Min Res. 1992;7: One or more vertebral fracture increases risk of subsequent vertebral fracture: 5-fold after first VCF 12-fold after 2 or more VCFs Vertebral fracture is a strong indication for preventive therapy (i.e. anti-resorptive or anabolic) Ross et al. (1991) Annals of Internal Med. 114 (11): Page 1

2 Pain and Decreased Quality of Life Mortality Pain typically lasts 2-12 weeks Physical and functional performance lower in patients with vertebral fracture 1,2 Restricted ADL Sleep disturbances Early satiety Psychosocial consequences 3 anxiety, depression, low self-esteem, and alteration in social role Long-term outcomes poorly studied 1. Lyles et al. (1993) Am J Med 94: Silverman SL (1992) Bone 13, S27-S31 3. Gold DT (1996) Bone 3: S185-S189 Study of Osteoporotic Fractures: Women 65 years (n=9,47) with or without vertebral fracture Prospective follow-up, cause-specific mortality Conclusions Women with prevalent vertebral fracture had a 23% higher age-adjusted mortality rate 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;159; Identifying Vertebral Fractures Approximately two thirds of all vertebral fractures go undiagnosed, in part due to difficulty determining cause of symptoms. Vertebral fractures may be asymptomatic. Pain ranges from mild to severe and may be chronic, but typically resolves over 2-12 weeks Radiologic Assessment Lateral spine X-ray examination is the standard test to identify vertebral compression fractures. Differentiation between back pain from vertebral compression fracture and disk disease or osteoarthritis often difficult Correlate radiographic findings with exam STIR sequence MRI can be useful to determine cause and/or acuity of plain radiograph abnormality. Increasing IVA use will identify more unexpected vertebral fractures Gold et al. The Downward Spiral of Vertebral Osteoporosis, A Monograph, June 23 Page 2

3 Radiologic Assessment Outline First week post fracture 8 weeks post fracture MRI: T2 Image Vertebral fracture epidemiology, consequences and diagnosis Kyphoplasty and vertebroplasty: what are they and how are they done? Outcomes Efficacy Safety Courtesy of B. Boszczyk & R. Bierschnieder, BG Unfallklinik What Your Patients See and Hear: The Procedure Vertebroplasty uses cement only (no balloon), no attempt to increase vertebral height 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. May require an overnight hospital stay Page 3

4 Outline Vertebral fracture epidemiology and diagnosis Kyphoplasty and vertebroplasty: what are they and how are they done? Outcomes Efficacy Safety Kyphoplasty and Vertebroplasty Literature Uncontrolled studies or historical controls Case-series Registries (Kyphon) One randomized controlled trials vs. nonsurgical management Summary of Non-randomized Studies Beneficial effects on Vertebral body height and angular deformity Pain Quality of life Ambulatory status Physical function Asypmtomatic cement extravasation common Safe and well tolerated, but Risk of Subsequent Fracture Concern that rigid cement alters biomechanics Case reports of new adjacent fractures after procedure Komp et al (24) Prospective, non-randomized study 21 patients underwent balloon kyphoplasty and 19 underwent conservative treatment. Patient populations were similar in age, gender, fracture history After 6 months, 7 out of 19 evaluable balloon kyphoplasty patients had new fractures (37%), whereas 11 out of 17 conservatively-treated patients (67%) had new fractures. Too small to analyze adjacent fractures. Komp, et al. (24) J Miner Stoffwechs 11(Suppl 1):13-16) Page 4

5 What About Randomized Trials? FREE Results NIH trial with sham-therapy abandoned Multi-centered randomized trial funded by Kyphon (FREE) Up to 3 acute VF (< 3 months old) Confirmed by x-ray and MR Randomized to balloon kyphoplasty (n=149) vs. usual non-surgical care (n=151) Outcomes: pain, QOL, function and new VF after 3 and 12 months (24 mo pending) Wardlaw et al, Lancet 29 Subjects 72 years old, 77% female 96% primary osteoporosis Previous exposures 17% steroids 33% bisphosphonates Duration of symptoms 6 weeks on average Fracture location 22% T5-T9 62% T1-L2 16% L3-L5 Physical Component Summary (SF36) Back Pain ( to 1 Visual Analogue Scale) p= Follow-up (months BKP NSM Follow-up (months) BKP NSM Page 5

6 Days of Limited Activity in the Previous 2 Weeks Using Any Analgesics p= Follow-up (months) BKP NSM Percent p= Nonsurgical Kyphoplasty At 12 months, 6 fewer days of limited activity Kyphoplasty in kyphoplasty group group had, on average, 6 fewer days of limited activity during the 12 months Baseline 1 month 12 month Using Narcotic Analgesics FREE Complications Percent p= p= Nonsurgical Kyphoplasty Similar number of CV events, infections and deaths Cement extravasation in 27% (asymptomatic) Subsequent VF: 33% with kyphoplasty and 25% with non-surgical therapy (p=.22) About 8% in both groups treated with bisphosphonate or PTH Adjacent fractures not reported (too few events) Baseline 1 month 12 month Page 6

7 Summary and Conclusions Vertebral fractures associated with significant disability and high risk of subsequent fractures Should be aggressively treated with effective antiresorptive (or anabolic) therapy Kyphoplasty and vertebroplasty associated with reduced pain and disability in non-randomized studies Serious complications rare, but do occur Single unblinded kyphoplasty trial found reductions in pain and disability, less apparent after 12 mo. Effect on subsequent fractures unknown, preliminary data reassuring Unanswered issues: vertebroplasty vs. kyphoplasty, optimal selection, long-term outcomes Summary and Conclusions (2) Unresolved questions: Treat only severe symptomatic fractures? Duration of symptoms? Wait 4-6 weeks? Prevention of progressive kyphosis? Long-term outcomes? Suggested use: severe acute pain or >6 weeks of persistent symptoms, but await RCTs before widespread adoption Page 7