BIDMC Radiology Fellowship Conference Percutaneous Vertebral Augmentation Kyphoplasty

BIDMC Radiology Fellowship Conference Percutaneous Vertebral Augmentation: Kyphoplasty, Vertebroplasty John C. Keel, M. D. Medical Director, Spine Center at BIDMC Physical Medicine and Rehabilitation April 2012

Primum non nocere. Tourtier JP, Cottez, S. N Engl J Med 366; 3 January 19, 2012

Acute Paraplegia After Vertebroplasty Caused by Epidural Hemorrhage. J Bone Joint Surg Am. 2007; 89: 1827 -31.

Disclosure I have no financial interests or relationships to disclose.

Off-Label Use PMMA mixed with barium is off-label. (PMMA was only recently approved for spine use in 2004 -2005. )

“Disclosure” “Doctors With a Special Interest in Back Pain Have Poorer Knowledge About How to Treat Back Pain” Spine 2009; 34 (11); 1218 -1226

CME Objectives • Review osteoporosis, vertebral fracture risk • Understand details, risks and benefits of vertebral augmentation procedure “Wh y” -to “How ” • Summarize related guidelines and other evidence-based Intro to “Should we” material • Apply knowledge to short and long term management of patients with vertebral compression fractures

Vertebral Augmentation • Vertebroplasty (1984): Injection of material (usually PMMA cement) into vertebral body • Kyphoplasty (1998): Injection after manipulation involving cavity creation • Indicated for painful compression fractures – osteoporosis – cancer

Qualified Personnel 1. BC/BE physician 1. 2. 3. 6 months of training involving cross-sectional imaging 4 months of training involving interventional procedures or equivalent experience 2. Performance of successful vertebroplasties in at least 5 patients as the primary operator, under the supervision of a qualified physician, and without complications 3. Relevant knowledge and skill of spine, radiation, etc. PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.

Osteoporosis Defined The most common bone disease in humans WHO diagnostic classification: • BMD at the hip or spine that is less than or equal to 2. 5 standard deviations below the young normal mean reference population – (T-score -2. 5 or less) Clinical diagnosis can be made based on history of fragility fracture Characterized by: – – – • • low bone mass deterioration of bone tissue disruption of bone architecture compromised bone strength increase in the risk of fracture Osteopenia = low bone mass: BMD T-score -1 to -2. 5 Normal = T-score greater than -1

Osteoporosis Defined • Primary – Type 1: post-menopausal, age 50 -70 • estrogen loss • trabecular bone affected more (prevalent in the spine) – Type 2: age-related, age >70 years • aging • trabecular and cortical bone affected • Secondary: factors are legion

Secondary Osteoporosis Lifestyle factors Low calcium intake High caffeine intake Alcohol (3+/day) Smoking Vitamin D insufficiency High salt intake Inadequate physical activity Falling Excess vitamin A Aluminum (antacids) Immobilization Thinness Genetic Hypogonadal Endocrine Diabetes Gastrointestinal Hematologic Rheumatic/Autoimm Miscellaneous/Medications…. Glucocorticoids (≥ 5 mg/d of prednisone or equivalent for ≥ 3 mo)

Osteoporosis Incidence/Prevalence 700, 000 osteoporotic vertebral compression fractures annually in the USA 300, 000 osteoporotic hip fractures/year, by comparison 250, 000 osteoporotic wrist fractures/year, by comparison National Health and Nutrition Examination Survey III (NHANES III): • 10 million + Americans have osteoporosis • 33. 6 million have low bone density of the hip • ~1 in 2 Caucasian women will have osteoporosis-related fracture/ lifetime • ~1 in 4 -5 men also will have osteoporosis-related fracture/ lifetime

Burden of Osteoporotic Fractures All osteoporotic fracture types: • • • 432, 000 hospital admissions ~2. 5 million medical office visits ~180, 000 nursing home admissions (annually in the USA) $17 billion cost for 2005 for comparison: – total costs of breast cancer ($13 billion) – total cost of heart disease ($19 billion) • $6 billion for the indirect value of lost productivity (patient, caregivers)

Fracture Risk

Free online Not validated for spine BMD (Just “Google” FRAX. Also at http: //www. shef. ac. uk/FRAX. )

Bone Mineral Density Testing • Dual-energy x-ray absorptiometry (DXA), looks at hip and spine • Measures: – grams of mineral per square centimeter scanned (g/cm 2) – compared to the expected BMD for the patient’s age and sex (Z-score) – compared to “young normal” adults of the same sex (T-score) • One standard deviation equals ~10 -15% of the BMD value in g/cm 2 • In premenopausal women, men less than 50 years of age and children, the WHO BMD diagnostic classification should not be applied

Fall Risk: Most osteoporotic fractures result from falls

National Osteoporosis Foundation Guidelines • Recommendations apply to postmenopausal women and men age 50 and older • Counsel on the risk of osteoporosis and related fractures • Check for secondary causes • For individuals age 50 and older: – calcium - at least 1, 200 mg per day – vitamin D 800 -1, 000 IU per day • Recommend regular weight-bearing and muscle-strengthening exercise to reduce the risk of falls and fractures • Advise avoidance of tobacco smoking and excessive alcohol intake (Just “Google” NOF. Also at http: //www. nof. org. )

NOF Guidelines: BMD Testing • BMD testing: all women age 65 and older and men age 70 and older • Postmenopausal women and men age 50 -69, recommend BMD testing when you have concern based on their risk factor profile • Recommend BMD testing to those who have had a fracture, to determine degree of disease severity • For patients on pharmacotherapy, it is typically performed two years after initiating therapy and every two years thereafter; however, more frequent testing may be warranted in certain clinical situations

NOF Guidelines: BMD Treatment • Initiate treatment in those with fractures (hip or vertebral, clinical or morphometric) • Initiate therapy in those with BMD T-scores ≤ -2. 5 at the femoral neck or spine by dual-energy x-ray absorptiometry (DXA), after appropriate evaluation • Initiate treatment in postmenopausal women and men age 50 and older with low bone mass (T-score between -1. 0 and -2. 5, osteopenia) at the femoral neck or spine and a 10 -year hip fracture probability ≥ 3% or a 10 -year major osteoporosis-related fracture probability ≥ 20% based on the US-adapted WHO absolute fracture risk model (FRAX®; www. NOF. org and www. shef. ac. uk/FRAX). • NOF lists current FDA-approved pharmacologic options

NOF Guidelines: Physical Medicine & Rehabilitation • • • Focus on function Consider medication cognitive effects Training/safety with functional tasks Assistive devices Consider home environment Complete exercise recommendation

NOF Guidelines: Physical Medicine & Rehabilitation • Avoid forward bending and exercising with trunk in flexion, especially in combination with twisting • Avoid long-term immobilization • Recommend partial bed rest (with periodic sitting and ambulating) only when required and for the shortest periods possible

NOF Guidelines: Physical Medicine & Rehabilitation • Orthoses • Pain control • Vertebroplasty, kyphoplasty

Free online

Other indications for augmentation: Important topics not covered in this lecture: • Spine tumors • Burst fractures

Compression Fracture: Definition and Diagnosis • History/ exam – These are sensitive and specific: • percussion with closed fist elicits pain • pain with assuming supine position – Pain that is worse when upright, relieved when finally recumbent, does not improve after a warmup • X-ray – ~15% height loss meets some literature definitions – but this is not always required in clinical reality…. • MRI with STIR is best for assessing the timing • Bone scan is a backup choice for assessing fracture acuity • CT – I always get a CT to look for any cortical or pedicle fractures or potential leaks (3)

Tricks • Become adept at interpreting imaging yourself. • A fracture that is read as “stable” or “subacute” or “chronic” per radiology report verbiage may still be appropriate for augmentation treatment.

Tricks • If an x-ray shows a fracture read as “new, ” that could mean new since last x-ray 5 years ago…. • Use prior C/A/P CT’s, etc. , to get a sneaky spine fracture timeline….

Case #1 Which level is fractured? X-Ray MRI with STIR

Case #2 Patient has pacemaker, cannot have MRI. X-Ray Bone Scan (may be + 2 years)

Case #3 CT delineates the bony cortex.

Case #3 Nearly the same slice on MRI.

Case #3 An acute fracture is typically dark on T 1 and bright on STIR.

Case #4 Vertebra plana, with bright T 2 streak, suggests Kummel’s disease.

Case #4 Nearly the same slice on CT.

Case #5 An acute fracture is typically dark on T 1 and bright on STIR. It may be bright on T 2 as well, as seen here.

Case #5 Nearly the same slice on MRI with STIR.

Case #6 Chronic healed fractures with no difference in T 1 or T 2.

Case #6 Chronic healed fractures with no difference in STIR.

Case #7 Chronic healed fractures with no difference in T 1 or T 2.

Case #7 Chronic healed fractures with no difference in STIR.

Case #8 Called to see inpatient with “new” T 12 fx per report. You scan records: 2012 X-ray 2010 slice from C/A/P CT The T 12 fracture is chronic in that it has been there since 2010.

Case #9 Complex anatomy

Case #9 Complex anatomy CT with 3 D reconstructions

Case #9 Complex anatomy En face view in procedure – tricky with no landmarks!

Natural History of VCF • Many are clinically silent, discovered later • Usually heal without intervention in ~12 weeks • Up to 1/3 have delayed healing • Compression may progress

Compression Fracture Sequelae • • Pain Neurological deficit Spinal deformity Gait and balance disorder Impaired lung function Increased risk of future fracture Increased rate of mortality Worse 2 and 5 -year bodily function measures compared to hip fractures • Greater 4 -5 year mortality compared to hip fractures

Compression Fracture Sequelae • Protuberant abdomen/ “kissing rib syndrome” • Difficulty fitting clothes due to kyphosis, protuberant abdomen • Height loss • Reflux • Early satiety • Weight loss • Fear of fracture and falling • Impaired activities of daily living (eg, bathing, dressing) • Depression • Sleep disturbance • Difficulty bending, lifting, descending stairs, cooking

It is not uncommon for a patient to be admitted to a hospital for treatment, discharged, and readmitted to treat complications with medical resources used at each stage. The result can be a downward-spiral of complications, functional decline, and a higher risk of death as a result of the VCF…. Zampini, et. al. These sequelae are also all potential risks of “conservative care. ”

Treatment “Ladder” Broad range: • Doing “nothing” • Physical treatments, therapy • Modalities • Exercise • Orthoses, assistive devices • Medications • Imaging and other tests • Injections • Minimally invasive procedures….

Jewett Brace www. rehab. research. va. gov

Vertebral Augmentation • Vertebroplasty (1984): Injection of material (usually PMMA cement) into vertebral body • Kyphoplasty (1998): Injection after manipulation involving cavity creation • Indicated for painful compression fractures – osteoporosis – cancer

Indications 1. Painful osteoporotic or neoplastic vertebral compression fracture(s) refractory to medical therapy. 2. Symptomatic vertebral body microfracture (as documented by magnetic resonance imaging [MRI] or nuclear imaging, and/or lytic lesion seen on CT) without obvious loss of vertebral body height. PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.

Contraindications Absolute Contraindications • Asymptomatic vertebral body compression fractures. • Active osteomyelitis of the target vertebra. • Uncorrectable coagulopathy. • Allergy to bone cement or opacification agent. Relative Contraindications • Radiculopathy in excess of local vertebral pain, caused by a compressive syndrome unrelated to vertebral collapse. Occasionally preoperative vertebroplasty can be performed before a spinal decompressive procedure. • Retropulsion of a fracture fragment causing severe spinal canal compromise. • Epidural tumor extension with significant encroachment on the spinal canal. • Ongoing systemic infection. • Patient improving on medical therapy. • Prophylaxis in osteoporotic patients (unless being performed as part of a research protocol). • Myelopathy originating at the fracture level. PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.

Balloon tamp in vertebra plana fracture

Risks/Complications

American College of Radiology. 2009.

Benefits Published Success Rates Threshold for Review 70% to 92% <60% Osteoporos 80% to is 95% <70% Neoplastic PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.

Procedure Techniques 1. Transpedicular 2. Extrapedicular Not covered here: • Subpedicular • Cervical

Needle driving method Wong W, Mathis JM. Vertebroplasty and kyphoplasty: techniques for avoiding complications and pitfalls. Neurosurg Focus 18 (3): E 2, 2005.

Transpedicular

Transpedicular

Transpedicular

En Face View

Biopsy

Drill and Curette

Balloon Tamps

Cement Injection

Extrapedicular

Extrapedicular

Biopsy

En Face View

Extrapedicular Wong W, Mathis JM. Vertebroplasty and kyphoplasty: techniques for avoiding complications and pitfalls. Neurosurg Focus 18 (3): E 2, 2005.

Balloon Tamps

Cement

Selected Evidence and Outcomes

Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. • • • one to three acute vertebral fractures 21 sites in eight countries 138 participants in the kyphoplasty group 128 controls follow-up at 1 month Mean SF-36 PCS score improved by 7· 2 points (95% CI 5· 7– 8· 8), from 26· 0 at baseline to 33· 4 at 1 month, in the kyphoplasty group, and by 2· 0 points (0· 4– 3· 6), from 25· 5 to 27· 4, in the nonsurgical group (difference between groups 5· 2 points, 2· 9– 7· 4; p<0· 0001). D. Wardlaw, S. Cummings, J. Van Meirhaeghe, L. Bastian, J. Tillman, J. Ranstam, R. Eastell, P. Shabe, K. Talmadge, S. Boonen. The Lancet, Volume 373, Issue 9668, Pages 1016 -1024.

Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial The Lancet, Volume 373, Issue 9668, Pages 1016 -1024 D. Wardlaw, S. Cummings, J. Van Meirhaeghe, L. Bastian, J. Tillman, J. Ranstam, R. Eastell, P. Shabe, K. Talmadge, S. Boonen Kyphoplasty resulted in: • decreased pain • decreased narcotic use • improved walking • improved quality of life

Recent controversy: NEJM published two RCTs 1. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009. 361(6): 557‐ 568. 2. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009. 361(6): 569‐ 79. • These were negative studies (Aug 6, 2009)

Recent controversy, NEJM RCTs: Problems: Assessment of fracture acuity • bone scan • clefts • 1 year • Kallmes et al. utilized MRI or bone scan only in cases in which the fracture age was uncertain

Recent controversy, NEJM RCTs: Problems: Enrollment • Kallmes et al. study, – 1812 patients were initially screened, yet only 131 were entered into the study. • Buchbinder et al. required 4. 5 years to – accrue 78 patients at four high volume centers, reporting that 141 who satisfied all inclusion criteria declined randomization.

NEJM RCTs: Problems: Enrollment • Selection bias • Enrollment goals not met

NEJM RCTs: Problems: Control • Sham procedure instead of standard nonprocedural care • Used facet/periosteal blocks as sham

Left L 4 medial branch nerve block, demonstrating extent of flow of 0. 1 m. L contrast. The outline of the mamillary process is seen. A periosteal block is not a sham….

NEJM RCTs: Problems: Blinding • Sedation level • Insurance bill would reveal • Patients could tell which group they were in • Crossover higher in sham group

NEJM RCTs: My interpretation of these: • The “sham procedure” may be an alternative treatment option or diagnostic block • Such has been described before: G Chandler, G Dalley, J Hemmer, T Seely Gray ramus communicans nerve block: novel treatment approach for painful osteoporotic vertebral compression fracture. Southern medical journal. 01/05/2001; 94(4): 387 -93.

Hirsch JA. Vertebral Augmentation. MGH Radiology Rounds. Vol 8 Issue 2. Feb 2010.

Conclusions We reviewed osteoporosis, incidence, vertebral fracture risk We talked about details, risks and benefits of vertebral augmentation procedure We summarized related guidelines and other evidencebased material I hope you will apply knowledge to short and long term management of patients with vertebral compression fractures

What can you immediately apply to your practice? • Smoking screening for all of your patients • Screen for BMD w/u if incidental fx or risk factor, e. g. , if you see an incidental old fracture • You are prepared to take all industry courses • Review and use cited guidelines – – NOF FRAX ACR AAOS VCF

AAOS Guideline 2010 1. Calcitonin nasal 200 U BID alternate nostrils x 4 weeks (moderate) 2. Ibandronate and strontium ranelate for prevention (weak) 3. Inconclusive: Bed rest, CAM, opioids/analgesics 4. L 2 nerve root block for L 3 or L 4 fx (weak) 5. Inconclusive: Bracing 6. Inconclusive: Exercise, PT 7. Inconclusive: Electrical stimulation 8. Recommend against vertebroplasty (strong) 9. Kyphoplasty is an option (weak) 10. Inconclusive: Reducing kyphosis 11. “We are unable to recommend for or against any specific treatment for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are not neurologically intact. Strength of Recommendation: Inconclusive” THE TREATMENT OF SYMPTOMATIC OSTEOPOROTIC SPINAL COMPRESSION FRACTURES. GUIDELINE AND EVIDENCE REPORT. American Academy of Orthopaedic Surgeons. 2010.

Bone Health and Osteoporosis: A Report of the Surgeon General 2004 Health Care Professionals Need To: • • • Pay close attention to bone health issues when conducting wellness visits and treating people with other illnesses. Emphasize the basics of good bone health during their interactions with patients, including appropriate nutrition and levels of physical activity. Recognize “red flags” and risk factors that might signal the potential for osteoporosis and other bone diseases, and take necessary action or refer at -risk patients to other providers for the appropriate work-up. Health care professionals working in emergency departments and orthopedic practices also have an important role. They must: Recognize that many bone fractures signal the potential for metabolic bone disease. Go beyond fixing patients’ bones by referring them, when appropriate, to another health care professional for further assessment of the potential for bone disease.

Topics for further reading: • • Vertebral augmentation for spine tumors Physical management of osteoporosis Medical management of osteoporosis Spinal orthoses

Selected References 1. Buchbinder R, et al. A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures. N Engl J Med 2009; 361: 557 -68. 2. David F. Kallmes DF, et al. A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. N Engl J Med 2009; 361: 569 -79. 3. De. Palma MJ, et al. Vertebroplasty. PMR 2; 9: 862 -867. 4. Mc. Girt MJ, et al. Vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures: an evidenced-based review of the literature. The Spine Journal 9 (2009) 501– 508. 5. Klazen CAH, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010; 376: 1085 -1092. 6. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2010. 7. Practice guideline for the performance of vertebroplasty. American College of Radiology. Rev. 2009. 8. Wardlaw D, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised trial. Lancet 2009; 373: 1016 -24. 9. Zampini JM, White AP, Mc. Guire KJ. Comparison of 5766 Vertebral Compression Fractures Treated With or Without Kyphoplasty. Clin Orthop Relat Res (2010) 468: 1773– 1780.

Thank You! John C. Keel, M. D. jkeel@bidmc. harvard. edu jckeel@gmail. com