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

Abstract

AIM

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

 

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 VFs 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 (VHR) by comparing pre-interventional with post-interventional imaging.

 

RESULTS                 

92 vertebrae were treated (58 lumbar, 34 dorsal), 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 VHR was observed between simple and complex VFs groups.

 

CONCLUSIONS:

Vesselplasty represents a safe and effective technique for the treatment of both “simple” and “complex” painful VFs, granting a significant reduction of symptoms, excellent cement leakage control and proper VHR.

Full Text

Introduction

In the last decades, there has been an exponential rise in the number of vertebral augmentation procedures (VAP) for the treatment of VFs, with the development of more advanced techniques. All those interventions cause excellent results, with reduced rates of complications and better cost-benefit ratio compared to open surgical procedures [1-3].

The VAP term comprises several treatment options, that can be subdivided in simple percutaneous vertebroplasty (PVP), percutaneous kyphoplasty (PKP) and percutaneous implant techniques (PIT) [4]; all those techniques aim to reduce and possibly eliminate pain symptoms by consolidation of the fracture and, whenever is possible, to restore para physiological vertebral body height with injection of bone-filling material (BFM) under image guidance [4].

Although BFM injection is thoroughly monitored via fluoroscopy imaging, it can leak outside the vertebrae into the adjacent spaces in 7-30% of VAPs [5-7].

It has been demonstrated a correlation between high volume injections of BFM and its leakage; the presence of cortical bone defects of the vertebra represents an additional risk factor for the occurrence of this complication and in many studies, to prevent an undesired BFM leakage in the epidural space with potential serious complications, patients with posterior wall defects were excluded [8].

Many devices have been developed during the years to reduce the incidence of this complication; in our retrospective study, we share our experience in the use of the vesselplasty technique (Vessel-X, Dragon Crown Medical Co., Ltd Shandong, China), a dedicated PIT with a container made of polyethylene terephthalate (PET), a non-stretchable material with 100-μm porosity, which is able to restore vertebral body height (VBH) and prevent BFM leakage, for  when the pressure inside the container is greater than the surrounding resistance, BFM starts to interdigitate through the pores equally in all directions, without concentrating in the locus of minor resistance of the vertebral body (Fig. 1).

 

Methods and Materials

Patients

In our study, 66 patients (16M, 50F, with a mean age of 73.1y) with 92 painful dorsolumbar vertebral body fractures resistant to conservative management were included in the study; of those, 56 were related to a severe condition of osteoporosis, 4 of traumatic nature, 4 associated with multiple myeloma and 2 patients with metastatic breast cancer.

Patients with active infection, a fracture or an abnormal vertebral body that is not causing pain or clinical problem, very old fractures, coagulopathy, spinal cord or nerve impingement causing radicular pain, osteoblastic metastasis, bone metastasis extended in epidural space and who already underwent other vertebral augmentation procedures were excluded.

Patients with endplates interruption and/or posterior wall defect documented with magnetic resonance (MR) and/or computed tomography (CT) were part of a subgroup called “complex”, which had VFs related to osteoporosis (N=19), traumatic fracture (N=3), multiple myeloma (N=2) and metastatic breast cancer (N=2).

24 patients underwent a multilevel procedure in the same intervention (3 levels N=2; 2 levels N=22).

Numerical Rating Scale (NRS) score and Oswestry disability index (ODI) have been evaluated 1 day before procedure and at 1, 6 and 12 months after.

Imaging follow-up was performed at 1, 6 and 12 months from the intervention with MRI, while CT was performed at 1 and 12 months.

 

Imaging analysis

Pre-operative VBH was obtained by measuring anterior, central and posterior portions height with MRI and\or CT; post-operative VBH was calculated immediately after implantation of Vessel-X with fluoroscopic images and at 1, 6 and 12 months from the intervention with MRI and at 1 and 12 months with CT.

VHR was calculated by measuring the difference between pre and post-operative height, with control measurement of the adjacent untreated vertebral bodies as reference.

 

Procedure

Procedures have been performed in our dedicated angiosuite under local anesthesia and ongoing antibiotic prophylaxis according to CIRSE guidelines [4].

Patient was placed in prone position and, under fluoroscopic guidance, the target vertebra was centered and the arc rotated to display the chosen transpedicular path. Then, the trocar, a spinal needle of 8-G and of variable length (90-150mm), was advanced until it reached the body of the vertebra.

The target position lies immediately after the posterior wall in lateral projection and towards the midline in A–P projection, at midway between the two endplates.

Vessel-X was then positioned and filled with BFM (mean quantity = 3.3± 0.8 mL/vertebra).

After the injection of BFM, Vessel-X loses its tubular shape in favor of a cylindrical conformation until a predefined size is reached.

The BFM maximum pressure inside the container, before it starts to spread outside, is related to the relative resistance of the surrounding bone density, which is different between fresh and old fractures, or young and osteoporotic bone. Once this pressure is reached, it starts to penetrate the micropores interdigitating between the trabecular spaces and stabilizing the container with subsequent lifting of the vertebra endplates.

Technical success was defined as correct placement and implant of Vessel-X (Figure 2).

 

Statistical analysis

NRS and ODI score values descriptive statistics like mean, standard deviation, median and interquartile range, before and at 1, 6 and 12 months follow-up.

To detect statistically significant change of NRS and ODI in the post-treatment period and to compare the results with the pre-treatment period, both paired t test and Wilcoxon matched-pairs signed rank test were used. 

The null hypothesis of no difference between observed before and after the treatment was then assumed for each series of scores.

All of the analyses were performed using Matlab (The MathWorks Inc., Natick – MA – USA).

 

Results

92 vertebrae have been treated (58 lumbar, 34 dorsal; range D5-L5) using Vessel-X with a technical success rate of 100%.

Bipedicular approach was the preferred method at lumbar levels, while monopedicular approach was performed in dorsal vertebrae.

A multilevel procedure was performed in 24 patients (triple level in 2 patients; 2 levels N=22).

No major complication occurred; we observed in both MRI and CT control at 1 month a single case of asymptomatic paravertebral leak in a L1 traumatic complex fracture with no involvement of the spinal canal or the nerve roots.

No new fractures in the adjacent vertebral bodies to those treated were reported during follow-up period of 12 months.

In the 10 patients with pathological and traumatic fractures, MRI scan at 6 and 12 months confirmed the absence of bone marrow edema in the target vertebra and the adjacent ones.

We observed a significant decrease in ODI values from a preoperative mean of 73.2±7.9 to mean values of 14.1±3.3 at 1 month, 13.8±3.6 at 6 months and 14.0±2.9 at 12-months follow-up (p<0.05). (Fig. 3)

Preoperative mean NRS of 7.3±1.2 dropped to 1.8±1.3 after 1 month, 2.1±0.8 at 6 months and 1.7±1.0 at 12 months (p<0.05). (Fig. 4)

No statistically significant difference was observed in the two VFs subgroups.

Mean preoperative anterior vertebral body height was 11.3±2.2mm (range 7-15 mm) and increased to 14.0±1.7mm (range 10-19 mm) after the procedure (p<0.05).

Mean preoperative central vertebral body height was 11.9±2.5mm (range 6-17 mm) and increased to 16.1±1.8mm after the procedure (p<0.05).

Mean preoperative posterior vertebral body height was 16.4±2.5mm (range 10-22 mm) and increased to 19.5±1.6mm (range 23-16 mm) after the procedure (p<0.05).

There were no statistically significant differences in terms of VHR between the simple and complex VFs subgroups.

In the VBs treated with bilateral access, a more homogeneous distribution of BFM than in the monopedicular approach was observed. However, there was no difference in term of VBH restoration between bipedicular and monopedicular group.

 

Discussion

One of the main complications of vertebral augmentation procedures is represented by undesired cement leakage outside the target vertebral body. A large meta-analysis conducted by Zhan Y. et al., showed an incidence rate of cement leakage for percutaneous vertebroplasty of 54.7% and of 18.4% for percutaneous balloon kyphoplasty [9].

To reduce the risk of cement leakage, many devices have been developed including Vessel-X. In our study, short-term follow-up results are promising; the complete technical success with just a single case of an asymptomatic cement leakage (1.08%) reported indicates that vesselplasty is a safe and effective technique in VFs treatment, including those with endplates and/or posterior wall interruption that are at a high-risk for adverse events. No clinically significant side effects, infection or neural damages were observed.

Additionally, intradiscal cement leak has been shown to increase the risk of subsequent new fractures of adjacent vertebral bodies [10-16]; in our study, no intradiscal cement leak occurred and no subsequent fracture has been demonstrated at 12-months follow-up. We believe this is related to Vessel-X properties of a controlled BFM distribution due to a homogeneous spread through its mesh pores, in contrast to other PIT devices in which the cement expansion privileges the fracture weakest areas, causing leakage [17, 18].

Beyond complications prevention, vesseplasty has shown very good clinical results, supported by the significant reduction in NRS and ODI values at follow-up evaluations.

Bipedicular injection of BFM is reported to provide better results in terms of VB stiffness restoration, albeit no significant difference in VB strength, due to the greater volume of BFM applied and the symmetric distribution [18]. When it was possible, we opted for a monopedicular access at the dorsal level and a bipedicular for lumbar procedures, mainly for the higher axial load forces at this level, in which we felt a greater quantity of BFM was required. In terms of VHR, no significant difference between the two approaches emerged.

Regarding VHR, stability over time after the treatment represents an important target. Many studies have shown that after percutaneous kyphoplasty, an important reduction in VBH happens routinely, probably related to an inhomogeneous BFM distribution. PKP procedure requires inflation of a balloon inside the VB and successive withdrawal to allow for injection of cement; this cause a partial collapse of the vertebral body, resulting in negative effects on height restoration [5, 17, 18].

Instead, in standard PVP this event is frequent when the fracture remains unstable; in this case, a new PVP intervention is advocated but it must be noted that the risk of undesired cement leakage is greatly increased [9, 19-22].

In our series we did not observe any perceivable difference in VBH between procedure final control and the follow-up assessment, suggesting how the Vessel-X device offers a good support for the fractured vertebral body preventing its collapse.

Furthermore, vesselplasty guarantees shorter exposure time to ionizing radiation, as for the first 2mL of injected BFM no fluoroscopic control is required; after this quantity, a fluoroscopy check is necessary for every 0.25mL of BFM injected until the desired VBH is reached [17].

Our study presents some limitations: it is a retrospective single-center study and on a relative small simple size. However, our results are encouraging and, if confirmed, it would allow patients with exclusion criteria like interrupted posterior wall to be treated.

 

Conclusion

Vesselplasty technique with Vessel-X may represent an effective and safe option for the treatment of standard and complex VFs.

Due to its design, it guarantees optimal control of BFM distribution with a reduced rate of cement leakage and shorter fluoroscopy time compared to PVP and PKP procedures.

Vessel-X has also shown good clinical results with significant reduction of NRS and ODI values post-treatment.

To further validate these results, however, prospective randomized trials are necessary.

 

 

 

 

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About the authors

Salvatore Masala

Email: salva.masala@tiscali.it

Adriano Lacchè

Email: adrianolacche@gmail.com

Chiara Zini

Email: zini.chiara@gmail.com

Domenico Mannatrizio

Email: dr.mannatrizio@gmail.com

Stefano Marcia

Email: stemarcia@gmail.com

Matteo Bellini

Email: matteo.bellini@icloud.com

Giuseppe Guglielmi

University of Foggia

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

Medical Doctor, Full Professor of Radiology.

Department of Clinical and Experimental Medicine.

Italy

References

  1. Kushchayev SV, Wiener PC, Teytelboym OM, Arrington JA, Khan M, Preul MC. Percutaneous Vertebroplasty: A History of Procedure, Technology, Culture, Specialty, and Economics. Neuroimaging Clin N Am. 2019 Nov;29(4):481-494. doi: 10.1016/j.nic.2019.07.011. PMID: 31677725.
  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 Jul;24 Suppl 1:S131-43. doi: 10.1007/s00590-013-1257-3. Epub 2013 Jun 16. PMID: 23771597.
  3. Flors L, Lonjedo E, Leiva-Salinas C, Martí-Bonmatí L, Martínez-Rodrigo JJ, López-Pérez E, Figueres G, Raoli I. Vesselplasty: a new technical approach to treat symptomatic vertebral compression fractures. AJR Am J Roentgenol. 2009 Jul;193(1):218-26. doi: 10.2214/AJR.08.1503. PMID: 19542417.
  4. Tsoumakidou G, Too CW, Koch G, Caudrelier J, Cazzato RL, Garnon J, Gangi A. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol. 2017 Mar;40(3):331-342. doi: 10.1007/s00270-017-1574-8. Epub 2017 Jan 19. PMID: 28105496.
  5. Filippiadis DK, Marcia S, Masala S, Deschamps F, Kelekis A. Percutaneous Vertebroplasty and Kyphoplasty: Current Status, New Developments and Old Controversies. Cardiovasc Intervent Radiol. 2017 Dec;40(12):1815-1823. doi: 10.1007/s00270-017-1779-x. Epub 2017 Aug 30. PMID: 28856402.
  6. Diel P, Röder C, Perler G, Vordemvenne T, Scholz M, Kandziora F, Fürderer S, Eiskjaer S, Maestretti G, Rotter R, Benneker LM, Heini PF. Radiographic and safety details of vertebral body stenting: results from a multicenter chart review. BMC Musculoskelet Disord. 2013 Aug 8;14:233. doi: 10.1186/1471-2474-14-233. PMID: 23927056; PMCID: PMC3751159.
  7. Vanni D, Galzio R, Kazakova A, Pantalone A, Grillea G, Bartolo M, Salini V, Magliani V. Third-generation percutaneous vertebral augmentation systems. J Spine Surg. 2016 Mar;2(1):13-20. doi: 10.21037/jss.2016.02.01. PMID: 27683690; PMCID: PMC5039833.
  8. Anselmetti GC, Manca A, Marcia S, Chiara G, Marini S, Baroud G, Regge D, Montemurro F. Vertebral augmentation with nitinol endoprosthesis: clinical experience in 40 patients with 1-year follow-up. Cardiovasc Intervent Radiol. 2014 Feb;37(1):193-202. doi: 10.1007/s00270-013-0623-1. Epub 2013 May 8. PMID: 23652416.
  9. Zhan Y, Jiang J, Liao H, Tan H, Yang K. Risk Factors for Cement Leakage After Vertebroplasty or Kyphoplasty: A Meta-Analysis of Published Evidence. World Neurosurg. 2017 May;101:633-642. doi: 10.1016/j.wneu.2017.01.124. Epub 2017 Feb 10. PMID: 28192270.
  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. [PMID: 19468894 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 Apr;21(2):96-100. doi: 10.1097/BSD.0b013e31805fe9e1. PMID: 18391712.
  13. Ruiz Santiago F, Santiago Chinchilla A, Guzmán Álvarez L, Pérez Abela AL, Castellano García Mdel M, Pajares López M. Comparative review of vertebroplasty and kyphoplasty. World J Radiol. 2014 Jun 28;6(6):329-43. doi: 10.4329/wjr.v6.i6.329. PMID: 24976934; PMCID: PMC4072818.
  14. Hiwatashi A, Yoshiura T, Yamashita K, Kamano H, Dashjamts T, Honda H. Morphologic change in vertebral body after percutaneous vertebroplasty: follow-up with MDCT. AJR Am J Roentgenol 2010; 195: W207-W212 [PMID: 20729417 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 Jun;18(3):238-42. PMID: 15905767.
  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 Feb;25(2):175-80. PMID: 14970015; PMCID: PMC7974625.
  17. Bambang D. Vesselplasty: a novel concept of percutaneous treatment for stabilization and height restoration of vertebral compression fractures. Journal of Musculoskeletal Research vol. 11, no. 02, pp. 71-79 (2008) https://doi.org/10.1142/s0218957708001985
  18. Zheng Z, Luk KD, Kuang G, Li Z, Lin J, Lam WM, Cheung KM, Lu WW. Vertebral augmentation with a novel Vessel-X bone void filling container system and bioactive bone cement. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2076-82. doi: 10.1097/BRS.0b013e3181453f64. PMID: 17762808.
  19. Carlier RY, Gordji H, Mompoint DM, Vernhet N, Feydy A, Vallée C. Osteoporotic vertebral collapse: percutaneous vertebroplasty and local kyphosis correction. Radiology. 2004 Dec;233(3):891-8. doi: 10.1148/radiol.2333030400. Epub 2004 Oct 14. PMID: 15486209.
  20. Chen WJ, Kao YH, Yang SC, Yu SW, Tu YK, Chung KC. Impact of cement leakage into disks on the development of adjacent vertebral compression fractures. J Spinal Disord Tech. 2010 Feb;23(1):35-9. doi: 10.1097/BSD.0b013e3181981843. PMID: 20065868.
  21. Komemushi A, Tanigawa N, Kariya S, Kojima H, Shomura Y, Komemushi S, Sawada S. Percutaneous vertebroplasty for osteoporotic compression fracture: multivariate study of predictors of new vertebral body fracture. Cardiovasc Intervent Radiol. 2006 Jul-Aug;29(4):580-5. doi: 10.1007/s00270-005-0138-5. PMID: 16565797.
  22. Guarnieri G, Masala S, Muto M. Update of vertebral cementoplasty in porotic patients. Interv Neuroradiol. 2015 Jun;21(3):372-80. doi: 10.1177/1591019915582364. Epub 2015 May 26. PMID: 26015527; PMCID: PMC4757276.

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

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Свидетельство о регистрации СМИ ПИ № ФС 77 - 79539 от 09 ноября 2020 года выдано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).


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