1. Kyphoplasty Benjamin Bonte, MD Interventional pain fellow
Hudson Medical group
8/10/2018

2. Outline Introduction Indications Diagnosis and evaluation
Contraindications
Technique
Complications
Evidence review
Controversies

3. Intro
Kyphoplasty
Injection of acrylic based cement polymer into vertebral body
Correction of vertebral compression fracture
Cavity created before injection with inflatable balloon

4. Indications Osteoporosis (most common) Multiple myeloma
Metastatic disease
Painful hemangiomas within the vertebral body
Others (osteonecrosis of vertebral body)
Benzon C70, p639

5. Osteoporosis (most common indication)
Women>men
Caucasian and Asian women at highest risk due to lower BMD
35% of women 65+
15% of postmenopausal women
500,000 cases of vertebral fractures experienced by women in the USA annually. Men contribute an additional 250,000 vertebral fractures.
Benzon C70, p639
These numbers apply to the US

6. Osteoporosis (most common indication)
Decline in estrogen production after menopause causes loss of 3-7% BMD. 1-2% decline in postmenopausal period
Men also lose trabecular bone at similar rates
BUT they continue to increase cortical bone through periosteal deposition until age 75.
Riggs BL, Melton LJ: The worldwide problem of osteoporosis insights afforded by epidemiology. Bone 17:S505–S511, 1995.
Mosekilde L, Mosekilde L: Sex differences in age-related changes in vertebral body size, density and biomechanical competence in normal individuals. Bone 11:67–73, 1990.

7. Osteoporosis (most common indication)
Primary
Postmenopausal – primarily trabecular bone. Estrogen deficiency, no Ca++ deficiency. Vertebral fractures are prevalent. Risks include smoking, alcohol, lack of weightbearing exercise.
Senile – calcium deficiency, low vit D, no estrogen deficiency, primarily cortical bone. Pelvic/hip, tibia and humerus fractures are prevalent.
Secondary
Hyperthyroidism, hyperparathyroidism, multiple myeloma, Paget’s disease
Iatrogenic
Corticosteroid, furosemide, thyroid supplements, anticonvulsants, heparin, lithium (causes hyperparathyroidism), cytotoxic agents

8. DEXA scan Normal individuals possess BMD of 1 SD from mean.
Osteopenia is between SD below mean
Osteoporosis 2.5 SD below mean
T score is used for diagnosis (compared to average peak BMD)
Z score is age matched
rosisinstitute.org/reading-a-dxa-scan/

9. Other causes Multiple myeloma
Vertebral augmentation can offer pain relief but does not stop tumor growth
Hemangiomas
Generally incidental finding.
Determined by clinical symptoms and imaging.
Metastatic lesions
10% of pts with metastatic tumors develop lesions in the spine.
Thoracic spine is most common
Breast,lung, prostate cancers
MM pt still may need chemo/radiotherapy
Mets can occur anywhere along neuraxis

11. Technique IV access Image guidance IV antibiotic prophylaxis
Cefazolin 1g or clindamycin 600mg within 60 min of incision
Sterile technique
Padding during positioning – avoid osteoporotic rib fractues

12. A – transpedicular approach B – Costopedicular approach
Usually used in lumbar spine
B – Costopedicular approach
C – Paravertebral approach
B/C usually used in thoracic region or when there is pedicle destruction.
Atlas of Pain Medicine Procedures, Ch 39 1

13. Technique Oblique to scotty dog view
Tilt until pedicle is in upper half of vertebral body
Direct needle to superolateral aspect of eye of dog
Frequent checks between AP/Lateral once needle approaches pedicle

14. Technique
Switch out introducer for drill and advance to anterior aspect of vertebral body, 3-4mm posterior to anterior cortical margin
Introduce deflated balloon into cavity.
Monitor pressure with manometry, inflate balloon. Stop inflating when
Max pressure reached OR
Balloon approaches cortical margin OR
Kyphotic deformity corrected

15. Technique Note cephalad/caudad trajectory for thoracic spine
Also note trajectory of pedicles in thoracic spine
Smaller gauge needle? (some suggest 11 gauge in lumber spine, 13 in thoracic)

16. One versus two needles? Controversial
If needle is is midline, may not need second one.
Make this decision before mixing the cement
If needle is is midline, may not need second one.
Make this decision

17. Complications/suboptimal situations
bleeding
Infection
Spinal stenosis
Pulmonary embolism (if in vein)
Local trauma
Fracture of lamina, pedicle, ribs
Cement extrusion
Soft tissue injection
Intradiscal cement extrusion in 5-10% of cases.
Cement extrusion in general is much lower as we inject higher viscosity cement as compared to when this procedure was started.
Needle too medial on left, too lateral on right. If too far lateral, spinal nerve root lives there.
Exothermic reaction which can be painful.

18. Clinical Evidence No study has shown any effect on adjacent segments.
There is no consensus on optimal window (6 weeks-3 months)
MOST systematic reviews conclude that both vertebroplasty and kyphoplasty provide greater pain relief and improved QOL as compared to conservative care.
Controversy:
Buchbinder and Kalmes studies both in NEJM
These two RCTs showed no relief with vertebroplasty compared to active sham.
Heavily criticized
Underpowered, many nonacute fractures, and LOW percentage of eligible patients who chose to participate.
62. Wardlaw D, Cummings SR, Van Meirhaeghe J, et al: Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 373(9668): 1016–1024, 2009.
63. Boonen S, Van Meirhaeghe J, Bastian L, et al: Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res 26(7):1627–1637, 2011.
64. Berenson J, Pflugmacher R, Jarzem PZ, et al: Cancer Patient Fracture Evaluation (CAFE) investigators. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol 12(3):225–235, 2011.
Buchbinder R, Osborne RH, Ebeling PR, et al: A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 361(6):557–568, 2009.
Kallmes DF, Comstock BA, Heagerty PJ, et al: A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 361(6):569–579, 2009.
The Buchbinder et al. study reported that 78 of 219 eligible patients agreed to participate, while in the Kallmes et al. study, only 131 of 431 eligible patients were enrolled

19. There are six high quality, randomized controlled trials (RCTs) comparing VP to conservative care. All six studies reported superiority of VP to conservative care for pain relief at varying time points ranging from 1 week to 1 year.
56–61
Some of these studies also showed an improvement in function ranging from 1 year up to 36 months.59–61
Two RCTs that utilized the visual analogue pain scale as a primary outcome measure reported that KP was superior to conservative care for 1 to 2 years.62–64
With respect to QOL, these studies found KP to be superior to conservative care at follow-up periods ranging from 6 months to 2 years.62–65
A third RCT also reported better improvement in the kyphotic index for the treatment group at 2 years.65

20. Although most prospective studies comparing VP and KP have shown no difference in pain relief and function for up to 1 year, others have reported better results with KP.68,69
Both of the RCT studies evaluating the degree of kyphotic angle correction found KP to be superior to VP, though both types of vertebral augmentation procedures (VAP) were equivalent in the extent of pain relief.73,74 KP has also been found to be safer with respect to reduced cement extravasation when compared to VP.74,75

21. Summary
Kyphoplasty is effective in treating pain and correcting kyphotic deformities.
Most commonly used for osteoporosis, MM and other malignancies.
Kyphoplasty reduces risk of cement extravasation and corrects kyphotic deformities as compared to vertebroplasty.
At least two highly publicized studies contradict the greater body of evidence which supports this – but lack applicability (e.g. most patients in both studies did not have acute or subacute fractures)

22. Thank you!