How to Avoid Complications in Kyphoplasty - the Rule of Four
Keywords:
Rule of Four; Kyphoplasty; Osteoporosis; Vertebral Fractures; ComplicationsAbstract
Purpose. There is no consensus on the number of levels that may be treated in a single kyphoplasty session; some authorities suggest up to four vertebrae while others have augmented more levels in one session. The purpose of this study is to define the optimal number of vertebrae that may be treated on a single operative session in a safe manner.
Methods. We retrospectively studied the patients that underwent kyphoplasty during a 7-year period (2010-2016) from a single surgeon. 70 consecutive patients were identified (mean 65 years). Overall 224 vertebrae were cemented in 82 operative sessions. Perioperative complications, 10-day morbidity, pain and kyphotic angle were analyzed. We used Stata version 9.1 for statistical analysis.
Results. Three serious (life threatening or lethal) adverse events were encountered during the 10-day perioperative period, related with multilevel prolonged operations (more than 4 levels) (p<0.001). The only other factor that was marginally correlated was the presence of vertebrae plana (p: 0.06). Cement leak was observed in 44% (leakage per session not per vertebrae), correlating with the number of augmented levels (23.3% in 1-2 levels, 51.5% in 3 and 64.7% with more levels, odds ratio 2.53, p=0.005). Pain improved from 8.2 points to 4.4 points postoperatively (p<0.001) and kyphotic angle from 22.9 degrees to 20.8 degrees (p<0.001).
Conclusion. Up to 4 levels may be safely treated with kyphoplasty in one session. Augmentation of more vertebrae especially in debilitating patients suffering from pathologic fractures leads to more cement leakage and may predispose to major complications.
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References
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2. Papanastassiou ID, Phillips FM, Van Meirhaeghe J, et al. Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies. Eur Spine J 2012;21(9):1826-43.
3. Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2016;388(10052):1408-16.
4. 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 2009;373(9668):1016-24.
5. Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010;25(376(9746)):1085-92.
6. Papanastassiou ID, Filis A, Aghayev K, et al. Adverse prognostic factors and optimal intervention time for kyphoplasty/vertebroplasty in osteoporotic fractures. Biomed Res Int 2014;2014:925683.
7. Papanastassiou ID, Aghayev K, Berenson JR, et al. Is vertebral augmentation the right choice for cancer patients with painful vertebral compression fractures? J Natl Compr Canc Netw 2012;10(6):715-9.
8. Papanastassiou ID, Eleraky M, Murtagh R, et al. Comparison of Unilateral versus Bilateral Kyphoplasty in Multiple Myeloma Patients and the Importance of Preoperative Planning. Asian Spine J 2014;8(3):244-52.
9. Tian QH, Wu CG, Xiao QP, et al. Percutaneous vertebroplasty of the entire thoracic and lumbar vertebrae for vertebral compression fractures related to chronic glucocorticosteriod use: case report and review of literature. Korean journal of radiology 2014;15(6):797-801.
10. Audat ZA, Hajyousef MH, Fawareh MD, et al. Comparison if the addition of multilevel vertebral augmentation to conventional therapy will improve the outcome of patients with multiple myeloma. Scoliosis and spinal disorders 2016;11:47.
11. Papanastassiou ID, Vrionis FD. Is early vertebroplasty/kyphoplasty justified in multiple myeloma given the rapid vertebral fracture progression? The spine journal : official journal of the North American Spine Society 2016;16(7):833-4.
12. Hussein MA, Vrionis FD, Allison R, et al. The role of vertebral augmentation in multiple myeloma: International Myeloma Working Group Consensus Statement. Leukemia 2008;22(8):1479-84.
13. Mailli L, Filippiadis DK, Brountzos EN, et al. Clinical outcome and safety of multilevel vertebroplasty: clinical experience and results. Cardiovascular and interventional radiology 2013;36(1):183-91.
14. Curatolo E, Reuter M, Samad A, et al. Cascading Adjacent Level Vertebral Compression Fractures Necessitating a Series of Eleven Kyphoplasties. Case reports in orthopedics 2015;2015:395875.
15. Zhai W, Jia Y, Wang J, et al. The clinical effect of percutaneous kyphoplasty for the treatment of multiple osteoporotic vertebral compression fractures and the prevention of new vertebral fractures. International journal of clinical and experimental medicine 2015;8(8):13473-81.
16. Uemura A, Numaguchi Y, Matsusako M, et al. Effect on partial pressure of oxygen in arterial blood in percutaneous vertebroplasty. AJNR American journal of neuroradiology 2007;28(3):567-9.
17. Papanastassiou ID, Filis AK, Gerochristou MA, et al. Controversial issues in kyphoplasty and vertebroplasty in malignant vertebral fractures. Cancer control : journal of the Moffitt Cancer Center 2014;21(2):151-7.
18. Okazaki T, Nakagawa H, Yagi K, et al. Bone scintigraphy for the diagnosis of the responsible level of osteoporotic vertebral compression fractures in percutaneous balloon kyphoplasty. Clinical neurology and neurosurgery 2017;152:23-7.
19. Carragee EJ, Cheng I. Minimum acceptable outcomes after lumbar spinal fusion. The spine journal : official journal of the North American Spine Society 2010;10(4):313-20.
20. Tsoumakidou G, Too CW, Koch G, et al. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovascular and interventional radiology 2017;40(3):331-42.
21. Venmans A, Klazen CA, Lohle PN, et al. Percutaneous vertebroplasty and pulmonary cement embolism: results from VERTOS II. AJNR American journal of neuroradiology 2010;31(8):1451-3.
22. Gosev I, Nascimben L, Huang PH, et al. Right ventricular perforation and pulmonary embolism with polymethylmethacrylate cement after percutaneous kyphoplasty. Circulation 2013;127(11):1251-3.
23. Lee SH, Kim WH, Ko JK. Multiple pulmonary cement embolism after percutaneous vertebroplasty. QJM 2013;106(9):877-8.
24. Liu FJ, Ren H, Shen Y, et al. Pulmonary embolism caused by cement leakage after percutaneous kyphoplasty: a case report. Orthop Surg 2012;4(4):263-5.
25. Llanos RA, Viana-Tejedor A, Abella HR, et al. Pulmonary and intracardiac cement embolism after a percutaneous vertebroplasty. Clin Res Cardiol 2013;102(5):395-7.
26. Sifuentes Giraldo WA, Lamua Riazuelo JR, Gallego Rivera JI, et al. Cement pulmonary embolism after vertebroplasty. Reumatol Clin 2013;9(4):239-42.
27. Pannirselvam V, Hee HT. Asymptomatic cement embolism in the right atrium after vertebroplasty using high-viscosity cement: a case report. Journal of orthopaedic surgery 2014;22(2):244-7.
28. Tran I, Gerckens U, Remig J, et al. First report of a life-threatening cardiac complication after percutaneous balloon kyphoplasty. Spine 2013;38(5):E316-8.
29. Nussbaum DA, Gailloud P, Murphy K. A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site. Journal of vascular and interventional radiology : JVIR 2004;15(11):1185-92.
30. Herndon JH, Bechtol CO, Crickenberger DP. Fat embolism during total hip replacement. A prospective study. The Journal of bone and joint surgery American volume 1974;56(7):1350-62.
31. Kim KC, Ritter MA. Hypotension associated with methyl methacrylate in total hip arthroplasties. Clinical orthopaedics and related research 1972;88:154-60.
32. Phillips H, Cole PV, Lettin AW. Cardiovascular effects of implanted acrylic bone cement. British medical journal 1971;3(5772):460-1.
33. Duncan JA. Intra-operative collapse or death related to the use of acrylic cement in hip surgery. Anaesthesia 1989;44(2):149-53.
34. Ereth MH, Weber JG, Abel MD, et al. Cemented versus noncemented total hip arthroplasty--embolism, hemodynamics, and intrapulmonary shunting. Mayo Clinic proceedings 1992;67(11):1066-74.
35. Aebli N, Krebs J, Davis G, et al. Fat embolism and acute hypotension during vertebroplasty: an experimental study in sheep. Spine 2002;27(5):460-6.
36. Benneker LM, Krebs J, Boner V, et al. Cardiovascular changes after PMMA vertebroplasty in sheep: the effect of bone marrow removal using pulsed jet-lavage. Eur Spine J 2010;19(11):1913-20.
37. Vasconcelos C, Gailloud P, Martin JB, et al. Transient arterial hypotension induced by polymethylmethacrylate injection during percutaneous vertebroplasty. Journal of vascular and interventional radiology : JVIR 2001;12(8):1001-2.
38. Kaufmann TJ, Jensen ME, Ford G, et al. Cardiovascular effects of polymethylmethacrylate use in percutaneous vertebroplasty. AJNR American journal of neuroradiology 2002;23(4):601-4.
2. Papanastassiou ID, Phillips FM, Van Meirhaeghe J, et al. Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies. Eur Spine J 2012;21(9):1826-43.
3. Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2016;388(10052):1408-16.
4. 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 2009;373(9668):1016-24.
5. Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010;25(376(9746)):1085-92.
6. Papanastassiou ID, Filis A, Aghayev K, et al. Adverse prognostic factors and optimal intervention time for kyphoplasty/vertebroplasty in osteoporotic fractures. Biomed Res Int 2014;2014:925683.
7. Papanastassiou ID, Aghayev K, Berenson JR, et al. Is vertebral augmentation the right choice for cancer patients with painful vertebral compression fractures? J Natl Compr Canc Netw 2012;10(6):715-9.
8. Papanastassiou ID, Eleraky M, Murtagh R, et al. Comparison of Unilateral versus Bilateral Kyphoplasty in Multiple Myeloma Patients and the Importance of Preoperative Planning. Asian Spine J 2014;8(3):244-52.
9. Tian QH, Wu CG, Xiao QP, et al. Percutaneous vertebroplasty of the entire thoracic and lumbar vertebrae for vertebral compression fractures related to chronic glucocorticosteriod use: case report and review of literature. Korean journal of radiology 2014;15(6):797-801.
10. Audat ZA, Hajyousef MH, Fawareh MD, et al. Comparison if the addition of multilevel vertebral augmentation to conventional therapy will improve the outcome of patients with multiple myeloma. Scoliosis and spinal disorders 2016;11:47.
11. Papanastassiou ID, Vrionis FD. Is early vertebroplasty/kyphoplasty justified in multiple myeloma given the rapid vertebral fracture progression? The spine journal : official journal of the North American Spine Society 2016;16(7):833-4.
12. Hussein MA, Vrionis FD, Allison R, et al. The role of vertebral augmentation in multiple myeloma: International Myeloma Working Group Consensus Statement. Leukemia 2008;22(8):1479-84.
13. Mailli L, Filippiadis DK, Brountzos EN, et al. Clinical outcome and safety of multilevel vertebroplasty: clinical experience and results. Cardiovascular and interventional radiology 2013;36(1):183-91.
14. Curatolo E, Reuter M, Samad A, et al. Cascading Adjacent Level Vertebral Compression Fractures Necessitating a Series of Eleven Kyphoplasties. Case reports in orthopedics 2015;2015:395875.
15. Zhai W, Jia Y, Wang J, et al. The clinical effect of percutaneous kyphoplasty for the treatment of multiple osteoporotic vertebral compression fractures and the prevention of new vertebral fractures. International journal of clinical and experimental medicine 2015;8(8):13473-81.
16. Uemura A, Numaguchi Y, Matsusako M, et al. Effect on partial pressure of oxygen in arterial blood in percutaneous vertebroplasty. AJNR American journal of neuroradiology 2007;28(3):567-9.
17. Papanastassiou ID, Filis AK, Gerochristou MA, et al. Controversial issues in kyphoplasty and vertebroplasty in malignant vertebral fractures. Cancer control : journal of the Moffitt Cancer Center 2014;21(2):151-7.
18. Okazaki T, Nakagawa H, Yagi K, et al. Bone scintigraphy for the diagnosis of the responsible level of osteoporotic vertebral compression fractures in percutaneous balloon kyphoplasty. Clinical neurology and neurosurgery 2017;152:23-7.
19. Carragee EJ, Cheng I. Minimum acceptable outcomes after lumbar spinal fusion. The spine journal : official journal of the North American Spine Society 2010;10(4):313-20.
20. Tsoumakidou G, Too CW, Koch G, et al. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovascular and interventional radiology 2017;40(3):331-42.
21. Venmans A, Klazen CA, Lohle PN, et al. Percutaneous vertebroplasty and pulmonary cement embolism: results from VERTOS II. AJNR American journal of neuroradiology 2010;31(8):1451-3.
22. Gosev I, Nascimben L, Huang PH, et al. Right ventricular perforation and pulmonary embolism with polymethylmethacrylate cement after percutaneous kyphoplasty. Circulation 2013;127(11):1251-3.
23. Lee SH, Kim WH, Ko JK. Multiple pulmonary cement embolism after percutaneous vertebroplasty. QJM 2013;106(9):877-8.
24. Liu FJ, Ren H, Shen Y, et al. Pulmonary embolism caused by cement leakage after percutaneous kyphoplasty: a case report. Orthop Surg 2012;4(4):263-5.
25. Llanos RA, Viana-Tejedor A, Abella HR, et al. Pulmonary and intracardiac cement embolism after a percutaneous vertebroplasty. Clin Res Cardiol 2013;102(5):395-7.
26. Sifuentes Giraldo WA, Lamua Riazuelo JR, Gallego Rivera JI, et al. Cement pulmonary embolism after vertebroplasty. Reumatol Clin 2013;9(4):239-42.
27. Pannirselvam V, Hee HT. Asymptomatic cement embolism in the right atrium after vertebroplasty using high-viscosity cement: a case report. Journal of orthopaedic surgery 2014;22(2):244-7.
28. Tran I, Gerckens U, Remig J, et al. First report of a life-threatening cardiac complication after percutaneous balloon kyphoplasty. Spine 2013;38(5):E316-8.
29. Nussbaum DA, Gailloud P, Murphy K. A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site. Journal of vascular and interventional radiology : JVIR 2004;15(11):1185-92.
30. Herndon JH, Bechtol CO, Crickenberger DP. Fat embolism during total hip replacement. A prospective study. The Journal of bone and joint surgery American volume 1974;56(7):1350-62.
31. Kim KC, Ritter MA. Hypotension associated with methyl methacrylate in total hip arthroplasties. Clinical orthopaedics and related research 1972;88:154-60.
32. Phillips H, Cole PV, Lettin AW. Cardiovascular effects of implanted acrylic bone cement. British medical journal 1971;3(5772):460-1.
33. Duncan JA. Intra-operative collapse or death related to the use of acrylic cement in hip surgery. Anaesthesia 1989;44(2):149-53.
34. Ereth MH, Weber JG, Abel MD, et al. Cemented versus noncemented total hip arthroplasty--embolism, hemodynamics, and intrapulmonary shunting. Mayo Clinic proceedings 1992;67(11):1066-74.
35. Aebli N, Krebs J, Davis G, et al. Fat embolism and acute hypotension during vertebroplasty: an experimental study in sheep. Spine 2002;27(5):460-6.
36. Benneker LM, Krebs J, Boner V, et al. Cardiovascular changes after PMMA vertebroplasty in sheep: the effect of bone marrow removal using pulsed jet-lavage. Eur Spine J 2010;19(11):1913-20.
37. Vasconcelos C, Gailloud P, Martin JB, et al. Transient arterial hypotension induced by polymethylmethacrylate injection during percutaneous vertebroplasty. Journal of vascular and interventional radiology : JVIR 2001;12(8):1001-2.
38. Kaufmann TJ, Jensen ME, Ford G, et al. Cardiovascular effects of polymethylmethacrylate use in percutaneous vertebroplasty. AJNR American journal of neuroradiology 2002;23(4):601-4.
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Published
2021-04-26
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