Vertebral Body Augmentation

Transcription

1 Vertebral Body Augmentation Nitin Sekhri MD Department of Anesthesiology Department of Radiology Westchester Medical Center Maria Fareri Children's Hospital Assistant Professor of Anesthesiology New York Medical College

2 About WMCHealth

3 Vertebral Body Compression Fractures Vertebral fractures are often painful and lead to reduced quality of life and disability (1.5 million osteoporotic fractures occur every year ) Fractures can be significant for 2 reasons Acute limiting pain from the fracture Irreversible changes in the spine

4 Vertebral Body Compression Fractures Osteoporotic vertebral compression fractures (OVCFs) are the most common complication of osteoporosis Osteoporotic fractures are usually Wedge shaped Kanis Bone. 1992;13:S1. doi: / (92)

5 Physical Exam Closed Fist Test Diagnosis o Sensitivity 87% / Specificity 90% Supine Test Imaging MRI o STIR CT Scan X-Ray Bone Scan Vertebral compression fractures--new clinical signs to aid diagnosis. Langdon J1, Way A, Heaton S, Bernard J, Molloy S. Ann R Coll Surg Engl Mar;92(2): doi: / X Epub 2009 Dec 7.

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13 Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures 131 patients with 1-3 painful osteoporotic vertebral compression fractures Vertebroplasty vs simulated procedure Primary outcome: Disability Questionnaire (higher score=greater disability) and patient s rating of pain

14 Age > Fractures T4-L5 Inclusion Criteria Inadequate Pain Relief with standard therapy NRS >3 Less 1 year old fracture as indicated by the duration of pain Uncertain Age MRI

15 Results No difference between groups (68 vs 63) Both had significant reduction in pain at 1 week, 1 month, 3 months, and 6 months 3 months (2.6 points in VP group, 1.9 in control group) Similar improvements in both groups with physical functioning, QOL, and perceived improvement

16 Pain NRS >3 Less than 1 year old Issues As indicated by the duration of pain Mean Duration 16 weeks non-op Mean Duration 20 weeks Op Only for fractures of unclear age Confirmation with MRI showing marrow edema

17 Fracture Reduction Evaluation (FREE) trial Efficacy and safety of balloon kyphoplasty compared with nonsurgical care for vertebral compression fracture: a randomised controlled trial Lancet March 2009

18 FREE Trial Patients with 1-3 acute vertebral fractures 149 patients randomized to KP, 151 controls Primary outcome: change from baseline to 1 month in SF-36 physical component score (PCS) Also measured: QOL, safety up to 12 months

19 FREE Trial Mean PCS score improved 7.2 points (0-100 scale) in KP group and only 2 points in control group at 1 month More patients in control group needed walking aids, back braces, PT, analgesics KP: greater improvement in QOL KP : 2.9 less days of restricted activity at 1 mo

20 KP Control base 1month 12month base 1month 12mo Walking aid/brace 71% 33% 26% 72% 61% 41% Bedrest (>1d/14d) 58% 23% 4% 64% 42% 8% Combo analgesic 58% 41% 24% 56% 57% 29% Opioid 16% 5% 4% 12% 8% 5%

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25 Vertebral Compression Fractures 1,038,956 VCF patients 141,343 BKP 75,364 VP With propensity matching Non-operated cohort o VS. BKP: 55%: VS VP 25% o significantly higher adjusted risks of pneumonia, myocardial infarction/cardiac complications, DVT, and urinary tract infection than the BKP cohort o BKP cohort also had significantly lower risks of morbidity than the VP cohort Edidin, Avram Allan, et al. "Morbidity and mortality after vertebral fractures: Comparison of vertebral augmentation and nonoperative management in the Medicare population." Spine (2015):

26 BKP vs. VP Mortality: same study BKP 19% lower adjusted Mortality Pain Relief 87% (VP) vs 92% (BKP) Cement Leak 41% and 9% (0.09% symptomatic) o VP has been reported 3%-75% Kyphoplasty there is better documentation of gains in patient functionality and quality of life BKP 10-20% $$ Taylor RS, Taylor RJ, Fritzell P. Balloon kyphoplasty and vertebroplasty for vertebral compression fractures: a comparative systematic review of efficacy and safety. Spine. 2006;31: Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis.taylor RS, Fritzell P, Taylor RJ Eur Spine J Aug; 16(8):

27 16.2 mo vs mo p= 0.45 Adjacent Fractures Percutaneous Vertebroplasty Is Not a Risk Factor for New Osteoporotic Compression Fractures: Results from VERTOS II C.A.H. Klazen, American Journal of Neuroradiology September 2010, 31 (8) ; DOI:

28 New Fractures New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population BUT Equivalent to the general osteoporotic population that had a previous vertebral fracture

29 Spinal Metastatic Bone Disease The national cost burden for patients with MBD was estimated at $12.6 billion 17% of the $74 billion in total direct medical cost estimated by the National Institutes of Health Radiofrequency ablation and vertebral augmentation for palliation of painful spinal metastases has been shown to decrease pain burden safely and increase function

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35 [In regards to VP] level I evidence that vertebroplasty provides superior pain control over medical management in the first 2 weeks, and level II III evidence that within the first 3 months there are superior outcomes in analgesic use, disability, and general health With regards to kyphoplasty, there was level II III evidence of improvement in daily activity, physical function, and pain control at 6 months, compared to medical management. Vertebral compression fractures: a review of current management and multimodal therapy, CC Wong, MJ McGirt - Journal of multidisciplinary healthcare, 2013

36 Take Home Points VCF occur commonly and have significant morbidity and mortality associated with them Treatment with BKP can be safe and effective Emerging technology such as RFA with BKP with XRT can possibly have improved outcomes vs. traditional RT

37 Thank you!