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balloon_kyphoplasty

Balloon kyphoplasty

Indications

Balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option 1).

The goals of a kyphoplasty surgical procedure are designed to stop the pain caused by a spinal fracture, to stabilize the bone, and to restore some or all of the lost vertebral body height due to the compression fracture.

During kyphoplasty surgery, a small incision is made in the back through it places a narrow tube. Using fluoroscopy to guide it to the correct position, the tube creates a path through the back into the fractured area through the pedicle of the involved vertebrae.

Using X-ray images, inserts a special balloon through the tube and into the vertebrae, then gently and carefully inflates it. As the balloon inflates, it elevates the fracture, returning the pieces to a more normal position. It also compacts the soft inner bone to create a cavity inside the vertebrae.

The balloon is removed and specially designed instruments under low pressure to fill the cavity with a cement-like material called polymethylmethacrylate (PMMA). After being injected, the pasty material hardens quickly, stabilizing the bone.

Kyphoplasty surgery to treat a fracture from osteoporosis is performed at a hospital under local or general anesthesia. Other logistics for a typical kyphoplasty procedure are:

In vertebroplasty, cement is introduced directly under pressure, without prior balloon inflation. Both techniques can be associated to minimally invasive osteosynthesis in certain indications. In our own practice, we preferably use acrylic cement, for its biomechanical properties and resistance to compression stress. We use calcium phosphate cement in young patients, but only associated to percutaneous osteosynthesis due to the risk of secondary correction loss. The evolution of these techniques depends on improving personnel radioprotection and developing new systems of vertebral expansion.


Balloon kyphoplasty of the upper thoracic spine via an extrapedicular approach is an efficient and safe minimally invasive procedure that may provide immediate and long-term pain relief and improvement in functional ability. It is technically challenging and has the potential for serious complications. With a fundamental knowledge of anatomy, as well as an ability to interpret fluoroscopy images, one can feasibly and safely perform balloon kyphoplasty in the upper thoracic spine 2).


Treatment

Comparing the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10, p < .0001); the difference between groups remained statistically significant at 24 months (-0.80 points, 95% CI -1.39 to -0.20, p = .009). There were two device-related serious adverse events in the second year that occurred at index vertebrae (a spondylitis and an anterior cement migration). There was no statistically significant difference between groups in the number of patients (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (~18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points 3).

For more than 30 years, minimally invasive surgical procedures have been available to stabilize the fractured vertebrae by vertebral augmentation leading to significant pain relief, a distinct improvement in quality of life and decreased mortality for patients suffering from osteoporotic vertebral compression fractures.

Balloon Kyphoplasty for vertebral compression fractures in cancer patients

Balloon Kyphoplasty (BKP) for vertebral compression fractures (VCFs) in cancer patients is more challenging than for osteoporotic ones. Cord compressions are frequent and the incidence of complications ten-fold greater. Polymethylmethacrylate (PMMA) is the gold standard material for BKP but has disadvantages: exothermic reaction, short working time, rapid solidification, absence of osteoconduction. VK100 is a mixture of Dimethyl Methylvinyl siloxane and Barium Sulphate. It is elastic, adhesive to bone, leaves 30 min before solidification without exothermic reaction, and shows a stiffness close to the intact vertebrae. The surgical procedure, called elastoplasty, is similar to a BKP. Clinical results obtained with this new silicone in pathological VCFs have been investigated.

41 cancer patients with symptomatic VCFs (70 vertebral bodies), underwent percutaneous and open elastoplasties. Post-operative leakages, pulmonary embolism (PE) and adjacent fractures were carefully evaluated with neuroimaging. KPS, VAS and Dennis Pain Score were calculated pre- post-operatively and at the last follow-up.

RESULTS: The mean volume of silicone inserted in each vertebra was 3.8 cc. Complications included seven leakages (17%), two asymptomatic PE (4.3%) and 3 post-operative adjacent fractures (7.3%). Median follow-up was 29 months. A significant improvement was observed in KPS, VAS and Dennis Pain Score (p < .0001). The 1-yr survival rate was 76.9%.

Elastoplasty appears a safe and effective palliative treatment of VCFs in oncologic patients. Useful qualities of VK100 are the lack of exothermic reaction and the wider working window. The influence of biomechanical properties of silicone on reduction of adjacent level fractures requires further investigations 4).


BKP can alleviate pain and improve QoL and function in patients with cancer-related VCFs with PVBW defects with no appreciable increase in risk 5).

1)
Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009 Mar 21;373(9668):1016-24. doi: 10.1016/S0140-6736(09)60010-6. Epub 2009 Feb 24. PubMed PMID: 19246088.
2)
Eleraky M, Papanastassiou I, Setzer M, Baaj AA, Tran ND, Vrionis FD. Balloon kyphoplasty in the treatment of metastatic tumors of the upper thoracic spine. J Neurosurg Spine. 2011 Mar;14(3):372-6. doi: 10.3171/2010.11.SPINE09909. Epub 2011 Jan 21. PubMed PMID: 21250808.
3)
Boonen S, Van Meirhaeghe J, Bastian L, Cummings SR, Ranstam J, Tillman JB, Eastell R, Talmadge K, Wardlaw D. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011 Jul;26(7):1627-37. doi: 10.1002/jbmr.364. PubMed PMID: 21337428.
4)
Telera S, Pompili A, Crispo F, Giovannetti M, Pace A, Villani V, Fabi A, Sperduti I, Raus L. Kyphoplasty with purified silicone VK100 (Elastoplasty) to treat spinal lytic lesions in cancer patients: A retrospective evaluation of 41 cases. Clin Neurol Neurosurg. 2018 Jun 15;171:184-189. doi: 10.1016/j.clineuro.2018.06.018. [Epub ahead of print] PubMed PMID: 29929175.
5)
Molloy S, Sewell MD, Platinum J, Patel A, Selvadurai S, Hargunani R, Kyriakou C. Is balloon kyphoplasty safe and effective for cancer-related vertebral compression fractures with posterior vertebral body wall defects? J Surg Oncol. 2016 Mar 21. doi: 10.1002/jso.24222. [Epub ahead of print] PubMed PMID: 26996273.
balloon_kyphoplasty.txt · Last modified: 2020/02/01 09:56 by administrador