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Best Spine Articles 2015 Brian D. Steinmetz, DO, FAAPMR Interventional Spine & Sports Medicine OSS Health Orthopedic & Spine Specialists York, PA Conflicts/Disclosures • Nothing to disclose Thanks to Justin Waltrous, MD for his contribution to preparation of this article summary Background • Steep rise in transforaminal epidural steroid injections from the year 2000 to 2011 • Particulate steroids traditionally used given perceived efficacy; however, spinal cord ischemia documented with triamcinolone, methyprednisolone and betamethasone acetate/phosphate • Non-Particulate steroid (dexamethasone) has not been demonstrated to cause spinal cord ischemia • Necessary to study head to head efficacy of particulate vs non-particulate steroids Methods • Study completed in two academic centers in Montreal, Canada • Carried out between 12/2010 and 1/2013 and patients selected from ED or outpatient center with lumbosacral radicular pain • One of three physicians, 1 anesthesiologist and 2 physiatrists, evaluated patients Methods • Inclusion criteria: • >18 years old • More radicular than lumbar pain • MRI findings of a herniation correlating to pain distribution • Exclusion criteria: • • • • • • • Contraindication to procedure Cauda equina syndrome Tumors, infection, or inflammatory etiology of back pain Previous surgery ESI in past 3 months Workers comp or disability insurance claims Pregnancy or nursing • Medications allowed as needed • Other treatments (like PT) discouraged Methods • Following anesthetic test dose of 1ml of 2% lidocaine: • One group 6mg betamethasone (1mL) • Second group received 7.5mg dexamethasone in 0.25mL saline (total of 1mL) • Injectate blinded to patient and treating physicians • Injection could be repeated at 1 month or later with same steroid, no cross over • Decision to inject 1 or 2 levels up to treating physician Results • Demographic characteristics similar across groups • 76 TFESI series, 99 total injected levels • L5=46, S1=43, L4=7, L3=3 Results Results Results Results Results Results Complications • Most significant complication was dural puncture in one injection improved with blood patch, no long term side effects related to steroid use • Complication rates similar to other studies Discussion • Similar results to recent studies by El Yahchouchi et al. (2013) and Kennedy et al. (2014) regarding non-inferiority of dexamethasone. • Conflicting with Park et al. (2010) – triamcinolone superior • O’Donnell et al. (2008) used non-equivalent steroid doses – triamcinolone superior Limitations • Biggest limitation is they did not reach statistical power • Probably best utilized in a future Metaanalysis Conclusion • A third study suggesting non-inferiority of dexamethasone for lumbar transforaminal epidural steroid injections • I switched to Dex last year as first line • Will consider particulate for impressive shortterm responders requiring a second injection – Informed consent regarding particulate risk Questions? Thanks to Simon Shapiro, DO for his contribution to preparation of this article summary Introduction • To improve safety of cervical interlaminar ESIs, the contralateral oblique (CLO) view has been proposed as a compliment or alternative to the lateral view to assess needle depth • No study has assessed the optimal angle and predictability of the projection of the needle tip in the CLO view • No study has compared the CLO view to the lateral view Materials/Methods • All patients scheduled for cervical interlaminar ESIs with available MRI • No contrast allergies or posterior surgeries included • 20g Tuohy needle placed with saline loss of resistance technique • Fluoroscopic images in AP, lateral, 30⁰, 40⁰, 45⁰, 50⁰, isointense, measured angle 30 Degree Oblique 30 Degree Oblique 53 Degree Oblique 53 Degree Oblique Results • • • • • 24 subjects completed study 15 men, 9 women 36 to 76 years old, mean 53 years old 9 injections C6-7, 15 at C7-T1 Mean measured CLO on MRI was 53⁰ (48-56⁰) at C6-7 and 52⁰ (50-57⁰) at C7-T1 • Mean ligamentum flavum thickness was 1.8mm at injection level Results Results Results • Of the 13 needles placed in AP zone 2: – 10 projected in lateral zones 2 or 3 and 2 were not visualized • Of the 9 needles placed in AP zone 1: – 6 projected in lateral zones 2 or 3 and 1 was not visualized Limitations • Relatively small sample size • No attempt to optimize patient position for lateral view (downward shoulder traction, swimmers view) Conclusions Questions? Thanks to Amir Tahaei, MD for his contribution to preparation of this article summary Background • HF10, involves application of 10KHz, short duration (30 micro Seconds), Low Amplitude (1-5 mA) • Traditional SCS stim frequency 40-60Hz • No perceptible paresthesia with HF10 like traditional SCS • No need for paresthesia mapping during trial typical of traditional SCS SENZA-RCT study • Safety and efficacy of HF10 SCS to traditional SCS in patient with back and leg pain • Multicenter, Randomized, Controlled • Pivotal trial (Per FDA: pivotal study is a definitive study in which evidence gathered to support the safety and effectiveness evaluation of the medical device for its intended use) Study Design • Primarily assess non inferiority and then superiority of HF10 K SCS to traditional SCS • Chronic and intractable back and leg pain • Refractory to conservative management for 3 months • Average Back or leg pain of 5 /10 on VAS • ODI 41 to 80/100, and appropriate candidate for implant surgery • Exclusion criteria: Active disruptive psychological or psychiatric disorder, or other condition with improper perception of pain, mechanical instability in Flex/Ext Xray, prior SCS experience Study • Randomized in 1:1 to HF10 (Senza system, Nevro Corp USA), vs commercially available (Boston Scientific) • Randomized per gender and primary pain area • Both has two 8-contacts leads and a rechargeable IPG placed • Due to practical consideration, study subjects, and investigators were not masked Interventions • SCS trial for up to 14 days • 40% or greater pain reduction for permanent placement (less than 50% endpoint requirement) • Oral analgesia stabilization 28 days before enrollment • Traditional SCS in parallel at ~T8 with paresthesia mapping • HF10 SCS overlapping near midline T9 T10 spanning T8 to T11, no mapping Outcome assessment • • • • • • • Assessment in Baseline, 1, 3, 6, 9 and 12 months VAS, ODI, Global assessment Adverse event Neurological assessment (Motor, Sensory, reflex) Responders or non-responders Remitters (pain VAS =<2.5), non-remitters Assess non-inferiority, if not inferior then assess superiority Results • Randomized subjects: – 13.6 years since diagnosis – mean age 54.9 – 86.6% previous back surgery – 77.1% failed back – 88.3% on opioids • Baseline VAS: – back pain: 7.6 +1.2 – Leg pain: 7.3+1.4 Results • 3 months: – Back Pain: • 84% back pain responder in HF10 • 43.8% in traditional SCS (P<0.001) – Leg Pain: • 83.1% leg pain responders in HF10 • 55.5% in traditional (P<0.001) Results • 12 Months: – Back pain: • 80% responders in HF10 • 50% in traditional SCS (P<0.001) – Leg Pain: • 80% responders in HF10 • 50-55% in traditional SCS (P<0.001) Results • 12 Months: – Remitters: • 67% were back and leg pain remitters in HF10 • Back pain 35% and leg pain 40% in traditional SCS (P<0.001) – VAS decrease: • Back Pain: – 67% in HF10 – 44% in traditional SCS • Leg Pain: – 70% in HF10 – 49% in traditional SCS Results • 12 months: – Opioids: • 35.5% off opioid therapy in HF10 • 26.4% in traditional SCS (P=0.41) – Patient satisfaction: • 55.4% in HF10 • 32.3% in traditional SCS • Significant improvements in ODI and Global Assessment of Function favoring HF10 • No uncomfortable stimulation in HF10 versus 46.5% in traditional group Results • 12 months: ODI improved by 16.5 in HF10, versus 13 for traditional SCS • 12 months: Disability decreased 62.9% in HF10, versus 45.7% for traditional SCS (P=0.03) • 12 months: Global assessment of functioning 70.8% in HF10, versus 59.3% for traditional SCS (P=0.15) Adverse effects • Adverse effects comparable • lead migration: – HF10 3.0% – Traditional SCS 5.2% Discussion • Both traditional and HF10 SCS demonstrated safety and efficacy • Low incidence of study related adverse effects over 12 months (4-7.2%). • Success of HF10 is superior traditional SCS for both leg and back pain • Back pain coverage nearly 2x that of traditional SCS Discussion • HF10 SCS: 2/3 of patients achieved remitter (VAS<2.5) in back and leg pain, and 1/3 of patients decreased or eliminated opioid analgesic usage at 12 months • Dramatic improvement of ADL, and quality of life Discussion • This article mirrors a previous observational study of HF10 in Europe Limitations • No masking of investigators • 30-45 mins of recharging daily in HF10 vs 5.2 times recharging for 2.3 hours monthly in traditional SCS • Programming was not measured in this study Conclusion • HF10 therapy provides the first randomized, controlled trial demonstrating superiority of HF10 over traditional SCS for treatment of chronic back and leg pain • Paresthesia free, no need for intra-operative paresthesia mapping, better tolerated • Game Changer? Questions? Background • Previous Medicare database studies have demonstrated increased all cause mortality in conservatively managed patients compared to patients after cement augmented vertebral compression fractures (VCFs) • Goal to compare non-surgically managed VCF to balloon kyphoplasty (BKP) and vertebroplasty (VP) treated patients Methods • Medicare database study of all ICD-9 codes indicating new vertebral compression fractures from 2005-2009 • 1-year look back period for 12 specific comorbidities and used to determine premorbid health status • Also recorded diagnosis of pneumonia within 90 days of death Methods • Exclusion criteria: – Cement augmentation procedure in look back period – Younger than age 65 (ie disability) – Managed Medicare patients – Spinal fusion in year following VCF Methods • Statistical analysis included Propensity Matching – VP and BKP patients were matched to 3 non-surgical patients most closely matching pre-morbid health for analysis • 4 year morbidity, mortality, treatment risks calculated Results • • • • • 1,038,956 patients met criteria BKP 141,343 (13.6%) VP 75,364 (7.3%) Non-surgical (79.1%) Augmented patients more likely to be Dx with pathologic fracture • Non-surgical more likely to be Dx with traumatic fracture Results • 4 year adjusted mortality: – Non-surgical cohort risk is 55% higher than the BKP cohort and 25% higher than the VP cohort • Non-matched 4 year mortality: – Non-surgical 49.4%, VP 46.2%, BKP 41.8% Results • Compared to BKP at 4 years: – Non-surgical cohort carried higher adjusted risk of pneumonia, MI, DVT, UTI – Non-surgical cohort carried lower adjusted risk of subsequent augmentation/fusion, and pulmonary/respiratory complications • Compared to VP at 4 years: – Non-surgical cohort carried higher adjusted risk of UTI – Non-surgical cohort carried lower adjusted risk of subsequent augmentation/fusion, and pulmonary/respiratory complications, and PE Results • For osteoporotic VCF: – Non-operative carries 70% higher adjusted 4 year mortality risk compared to BKP – BKP carries 17% lower adjusted 4 year mortality risk compared to VP Discussion • Improved risk of mortality may be from improved pulmonary function, earlier mobility, decreased opioid and NSAID use • Differences between BKP and VP may be from height restoration or higher/more controlled cement volume in BKP • Similar results seen in other large population based studies Limitations • Fracture severity was not assessed – More severe fractures, especially in sicker individuals may go untreated • Obesity and smoking not evaluated due to database limitations • Did not look at younger VCF patients Conclusion • Multiple database studies now saying increased mortality if fractures conservatively managed • Should we be more aggressive at offering this? • Counseling should include this in discussion • Is it really the balloon? Questions? Background • Lumbar flexion-extension radiographs are often helpful in evaluating for spondylolisthesis and segmental instability • Study is often limited by quality of X-ray tech and patient tolerance to motion • Various measurement conventions are used for define instability • Most common technique is in standing position Background • Comparison of upright lateral to supine saggital MRI may be useful and has not been formally studied • Objectives: – Compare observed mobility between upright (U) X-ray and saggital MRI (S) (combined, US) – Compare US measurements to lateral flexionextension X-ray (FE) – Identify factors associated with findings on each Methods • Power analysis required 58 patients • 68 consecutive patients with lumbar spondylolisthesis at a single outpatient center • FE films obtained in a single radiology department in a standardized manner • % saggital translation measured by 2 similar published criteria – >8% of the width of the above adjacent vertebra considered unstable F E U S Results • Demonstrated mobility statistically higher in US (7.68±5.34%) compared to FE (4.90±3.82%, p=0.001) • 70.6% had greater mobility with US • 29.4% had greater mobility with FE • Greater translation in U or F compared with E or S • Dynamic instability identified in 42.6% on US compared to 17.6% on FE (P=0.003) Results • Females and shorter stature demonstrated more mobility on FE • Lack of back pain demonstrated increased mobility on FE • No difference with age, weight, BMI, level, grade, type on FE • High BMI, Grade II/III listhesis and isthmic listhesis had greater mobility on US Discussion • Similar findings to a prior study comparing upright X-ray to supine CT • Similar findings to a prior study which showed that extension films added little compared to upright and flexion • Back pain and muscle tension may account for differences compared to supine MRI • Flexion may paradoxically reduce translation in higher grade listhesis in some patients Conclusion • Comparing upright films to supine MRI is high yield for demonstrating instability • May reduce cost, radiation exposure, and patient discomfort Facet Diastasis Questions? Thank you