Safety and efficacy of percutaneous vesselplasty (Vessel-X) in the treatment of symptomatic thoracolumbar vertebral fractures

Cover Image

Cite item

Full Text

Abstract

AIMS: to assess radiological and clinical outcomes, in terms of safety and efficacy, of symptomatic vertebral fractures with and without posterior wall and\or both endplates involvement, treated with vesselplasty technique (Vessel-X, Dragon Crown Medical Co., Ltd Shandong, China).

MATERIALS AND METHODS: We retrospectively evaluated 66 Patients who underwent 92 vesselplasty procedures, performed for the treatment of symptomatic vertebral body fractures from March 19 to September 2020. We divided the fractures in two subgroups: 36 vertebral fractures with posterior wall and/or both endplates involvement, which we defined complex, while all the others were defined simple. Numerical Rating Scale (NRS) and Oswestry Disability Index (ODI) values has been registered 1 day before the procedure and at 1, 6 and 12 months follow-up. We also evaluated vertebral height restoration by comparing pre-interventional with post-interventional imaging.

RESULTS: 92 vertebrae were treated (58 lumbar, 34 thoracic), with 24 multilevel procedures. We observed a technical success rate of 100%, without major complications; a single case of asymptomatic paravertebral cement leak was reported. Both simple and complex subgroups registered a significative statistical difference in NRS and ODI between preoperative and at 1, 6 and 12 months (p <0.05). A significant statistical difference was demonstrated in vertebral height comparing pre-operative and post-operative data (p <0.05). No significant difference in vertebral height restoration was observed between simple and complex vertebral fractures groups.

CONCLUSIONS: Vesselplasty represents a safe and effective technique for the treatment of both simple and complex painful vertebral fractures, granting a significant reduction of symptoms, excellent cement leakage control and proper vertebral height restoration.

About the authors

Salvatore Masala

University of Foggia

Email: salva.masala@tiscali.it
ORCID iD: 0000-0003-0032-7970

MD

Italy, Foggia

Adriano Lacchè

University of Foggia

Email: adrianolacche@gmail.com
ORCID iD: 0000-0003-1782-8624

MD

Italy, Foggia

Chiara Zini

University of Foggia

Email: zini.chiara@gmail.com
ORCID iD: 0000-0003-3456-4106

MD

Italy, Foggia

Domenico Mannatrizio

University of Foggia

Email: dr.mannatrizio@gmail.com
ORCID iD: 0000-0003-3365-7132

MD

Italy, Foggia

Stefano Marcia

University of Foggia

Email: stemarcia@gmail.com
ORCID iD: 0000-0002-2118-9864

MD

Italy, Foggia

Matteo Bellini

University of Foggia

Email: matteo.bellini@icloud.com
ORCID iD: 0000-0002-1704-6246

MD

Italy, Foggia

Giuseppe Guglielmi

University of Foggia

Author for correspondence.
Email: giuseppe.guglielmi@unifg.it
ORCID iD: 0000-0002-4325-8330

MD, Professor

Italy, Foggia

References

  1. Kushchayev SV, Wiener PC, Teytelboym OM, et al. Percutaneous vertebroplasty: a history of procedure, technology, culture, specialty, and economics. Neuroimaging Clin N Am. 2019;29(4):481–494. doi: 10.1016/j.nic.2019.07.011
  2. Bornemann R, Koch EM, Wollny M, Pflugmacher R. Treatment options for vertebral fractures an overview of different philosophies and techniques for vertebral augmentation. Eur J Orthop Surg Traumatol. 2014;24(Suppl 1):S131–143. doi: 10.1007/s00590-013-1257-3
  3. Flors L, Lonjedo E, Leiva-Salinas C, et al. Vesselplasty: a new technical approach to treat symptomatic vertebral compression fractures. AJR Am J Roentgenol. 2009;193(1):218–226. doi: 10.2214/AJR.08.1503
  4. Tsoumakidou G, Too CW, Koch G, et al. CIRSE guidelines on percutaneous vertebral augmentation. Cardiovasc Intervent Radiol. 2017;40(3):331–342. doi: 10.1007/s00270-017-1574-8
  5. Filippiadis DK, Marcia S, Masala S, et al. Percutaneous vertebroplasty and kyphoplasty: current status, new developments and old controversies. Cardiovasc Intervent Radiol. 2017;40(12):1815–1823. doi: 10.1007/s00270-017-1779-x
  6. Diel P, Röder C, Perler G, et al. Radiographic and safety details of vertebral body stenting: results from a multicenter chart review. BMC Musculoskelet Disord. 2013;14:233. doi: 10.1186/1471-2474-14-233
  7. Vanni D, Galzio R, Kazakova A, et al. Third-generation percutaneous vertebral augmentation systems. J Spine Surg. 2016;2(1):13–20. doi: 10.21037/jss.2016.02.01
  8. Anselmetti GC, Manca A, Marcia S, et al. Vertebral augmentation with nitinol endoprosthesis: clinical experience in 40 patients with 1-year follow-up. Cardiovasc Intervent Radiol. 2014;37(1):193–202. doi: 10.1007/s00270-013-0623-1
  9. Zhan Y, Jiang J, Liao H, et al. Risk factors for cement leakage after vertebroplasty or kyphoplasty: a meta-analysis of published evidence. World Neurosurg. 2017;101:633–642. doi: 10.1016/j.wneu.2017.01.124
  10. Tempesta V, Cannata G, Ferraro G, et al. The new Vessel-X kyphoplasty for vertebral compression fractures: 2-year follow-up of 136 levels. Las Vegas: American Academy of Orthopaedic Surgeons Annual Meeting; 2009.
  11. McCall T, Cole C, Dailey A. Vertebroplasty and kyphoplasty: a comparative review of efficacy and adverse events. Curr Rev Musculoskelet Med. 2008;1:17–23. doi: 10.1007/s12178-007-9013-0
  12. Mroz TE, Yamashita T, Davros WJ, Lieberman IH. Radiation exposure to the surgeon and the patient during kyphoplasty. J Spinal Disord Tech. 2008;21(2):96–100. doi: 10.1097/BSD.0b013e31805fe9e1
  13. Ruiz Santiago F, Santiago Chinchilla A, Guzmán Álvarez L, et al. Comparative review of vertebroplasty and kyphoplasty. World J Radiol. 2014;6(6):329–343. doi: 10.4329/wjr.v6.i6.329
  14. Hiwatashi A, Yoshiura T, Yamashita K, et al. Morphologic change in vertebral body after percutaneous vertebroplasty: follow-up with MDCT. AJR Am J Roentgenol. 2010;195:W207–W212. doi: 10.2214/AJR.10.4195
  15. Grohs JG, Matzner M, Trieb K, Krepler P. Minimal invasive stabilization of osteoporotic vertebral fractures: a prospective nonrandomized comparison of vertebroplasty and balloon kyphoplasty. J Spinal Disord Tech. 2005;18(3):238–242.
  16. Lin EP, Ekholm S, Hiwatashi A, Westesson PL. Vertebroplasty: cement leakage into the disc increases the risk of new fracture of adjacent vertebral body. AJNR Am J Neuroradiol. 2004;25(2):175–180.
  17. Bambang D. Vesselplasty: a novel concept of percutaneous treatment for stabilization and height restoration of vertebral compression fractures. J Musculoskeletal Res. 2008;11(2):71–79. doi: 10.1142/s0218957708001985
  18. Zheng Z, Luk KD, Kuang G, et al. Vertebral augmentation with a novel Vessel-X bone void filling container system and bioactive bone cement. Spine (Phila Pa 1976). 2007;32(19):2076–2082. doi: 10.1097/BRS.0b013e3181453f64
  19. Carlier RY, Gordji H, Mompoint DM, et al. Osteoporotic vertebral collapse: percutaneous vertebroplasty and local kyphosis correction. Radiology. 2004;233(3):891–898. doi: 10.1148/radiol.2333030400
  20. Chen WJ, Kao YH, Yang SC, et al. Impact of cement leakage into disks on the development of adjacent vertebral compression fractures. J Spinal Disord Tech. 2010;23(1):35–39. doi: 10.1097/BSD.0b013e3181981843
  21. Komemushi A, Tanigawa N, Kariya S, et al. Percutaneous vertebroplasty for osteoporotic compression fracture: multivariate study of predictors of new vertebral body fracture. Cardiovasc Intervent Radiol. 2006;29(4):580–585. doi: 10.1007/s00270-005-0138-5
  22. Guarnieri G, Masala S, Muto M. Update of vertebral cementoplasty in porotic patients. Interv Neuroradiol. 2015;21(3):372–380. doi: 10.1177/1591019915582364

Supplementary files

Supplementary Files
Action
1. JATS XML
Download
2. Fig. 1. Vessel-X device, made of a mesh of Polyethylene Terephthalate (PET), a non-stretchable material that has a porosity of 100-μm.

Download (96KB)
Indexing metadata
3. Fig. 2. (a–d): Intraoperatory positioning of Vessel-X device. BMF starts to spread out of the PET container only after it reached its maximum size. (e): VR reconstruction of Vessel-X.

Download (281KB)
Indexing metadata
4. Fig. 3. (a): CT scan: Sagittal reconstruction of a complex vertebral fracture. (b): Post-operative CT control. Vessel-X is perfectly placed without BFM leakage.

Download (117KB)
Indexing metadata
5. Fig. 4. The index is expressed in percentage points and ranges from 0% to 100%, with the lower limit related to the absence of disability and the upper limit to the maximum degree of disability (patients are bed-bound). At pretreatment, the median ODI score was 78% (25th percentile, 70.5%; 75th percentile, 84%); no outliers were identified. At 1 month post-treatment, the median ODI score was 14% (25th percentile, 12.7%; 75th percentile, 17%); no outliers were identified. At 6 months post-procedure, the median ODI score was 13% (25th percentile, 12%; 75th percentile, 16%); no outliers were identified. At 12 months post-procedure, the median ODI score was 13% (25th percentile, 12.4%; 75th percentile, 16%); no outliers were identified. The mean ODI scores decreased from 73.2±7.9 to 14.1±3.3 at 1 month and 13.8±3.6 at 6 months (p < 0.001).

Download (100KB)
Indexing metadata
6. Fig. 5. At pretreatment, NRS scores were mostly concentrated on the upper limits of the scale (median, 8; 25th percentile, 7; and 75th percentile, 8). The distribution of NRS scores in the post-treatment survey at 1 month (median, 2; 25th percentile, 2; and 75th percentile, 3) at 6 months (median, 2; 25th percentile, 2; and 75th percentile, 3), and 12 months (median, 2; 25th percentile, 2; and 75th percentile, 3); no outlier was identified. The mean NRS score was 7.3±1.2 at pre-procedure and decreased to 1.8±1.3 at 1 month, 2.1±0.8 at 6 months, and 1.7±1.0 at 12 months (p < 0.001).

Download (101KB)
Indexing metadata

Copyright (c) 2022 Masala S., Lacchè A., Zini C., Mannatrizio D., Marcia S., Bellini M., Guglielmi G.

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies