Neuroradiology ServiceChef: Mario MUTO

Cardarelli HospitalNaples - ITALY

Preliminary experience with VERTEBRAL BODY STENTING SYSTEM (VBS) SYNTHES for the treatment of Osteoporotic & Traumatic Vertebral

Compression Fracture (VCF): a follow-up at 12 months in 20 cases.

Guarnieri G.,Ambrosanio G., Zeccolini F.,Capobianco E.,Muto M.

XIX SYMPOSIUM NEURORADIOLOGICUMThe World Congress of Diagnostic &

Therapeutic Neuroradiology

VP-BKP Considerations• VP and KP are well established minimally

invasive treatment options for the relief of back pain in pts with Osteoporotic or Traumatic Vertebral Compression Fracture

• Both have the ability to reduce the kyphotic angle and restore vertebral height.

• Studies demonstrated the ability of VP to restore vertebral height to a certain degree even if VP has no intrinsic mechanical method to restore vertebral height

• BKP is able to restore vertebral height by means of a balloon tamp. Only 34% of BKP don’t result in an appreciable reduction in kyphotic angle or restoration of height

•Incomplete fracture reduction •Significant loss of reduction after balloon tamp deflation, prior to cement injection

VP-BKP LIMITSPossible procedural disadvantages

Durability of Fracture Reduction• Verlaan et al (Spine 2005)

• Reduction of endplate fractures was not maintained

New expandible system• Spineworks • VBS Synthes• Osseofix • Spine jack• DFINE RF Kyphoplasty

VBS by SINTHES: The rational• To avoid loss of height after balloon deflation

• It uses an expandable scaffolding structure similar to vascular stents, utilizing a specially designed catheter-mounted stent which can be implanted extra- or transpedicularly and expanded with the use of an inflatable balloon inside the vertebral body

+ +

under local anesthesia under fluoroscopy guidance

by bi-peduncolar approach

Within 2 weeks

15 Osteoporotic VCFs1 pt at level T112 pts at level T122 pts at Level L25 pts at level L35 pts at level L4

5 Traumatic A1 Magerl VCFs1 pts at level T122 pt at Level L12 pt at Level L3

2 young pts affected by A1 VCFs treated also by CERAMENT

F. 75ys porotic VCF of L2

1 year f.u

F. 77ys porotic VCF of L3

F 55ys Traumatic A1 Mg. Cl. Fr. T12

1year f.u

F. 55ys Traumatic Fr. At L1

1year f.u

F 35ys Traumatic A1 Mg. cl Fr L1 within 2 days by CERAMENT

1year f.u

F 57ys Traumatic A1 Mg. cl Fr L3 within 2 weeks

F,35ys A1 Mg. Traumatic Fr L3 treated more than 4 weeks + CERAMENT

One case failure

1 year f.u.

15 Osteoporotic VCFs1 pt at level T112 pts at level T122 pts at Level L25 pts at level L35pts at level L4

5 Traumatic A1 Magerl VCFs1 pts at level T122 pt at Level L12 pt at Level L3

In 19/20 pts VBS was successfully performed and led to an excellent outcome with clinical improvement

No vascular,extraforaminal or epidural leakage or other adverse events were observeda reduction of 4 scores in the VAS evaluation and a 40% reduction in the ODS scoreNone new vertebral fracture at adjacent metamers were observed at 12 months follow-up

RESULTS

One case failure without vert. augmentation in A1 fr. Performed more than 4 weeks after trauma, a sclerotic reaction was present

The height in the fractured vertebral body was increased in 12 of 20 VCFs,

with an avarage of 1.5 mm

Discussion•The VBS System is intended either for the reduction of osteoporotic vertebral compression fractures either for the creation of a void in cancellous bone in the spine from level T10 to L5 that offers, like BKP, once placed the stent, a cavity of injection of highly viscous PMMA bone cement reducing the rate of leakage and thrombo-embolic complications•Indications: osteoporotic vertebral compression fracture from T10 – L5 , without involvement of the posterior vertebral edge with kyphotic angulation of more than 15°, and in combination with internal fixation•Contraindications: The fractures that need internal fixation, split fractures, complete burst fracture , the transverse bicolumn fracture or when there is a posterior disruption osseous

Vertebral body shape could be restored. Also impressed central parts of the bony endplate could be elevated by using a convergent approach through the pedicles.There was no colllaps of the vertebral bodyafter removing the catheter-balloons

Vertebral body stenting.A Cadaveric studyBKP versus VBS

Thanks to the intra-operative load-bearing capability of the stent, during VBS,there is a significantly higher preservation of initially gained height, as well as kyphotic angular changes of the vertebrae; the stent substantially retains the size of the created cavity inside the vertebra after balloon deflation. •There was a significant loss of reduction after balloon deflation in BKP compared to VBS,•Biomechanical tests showed no significant stiffness and failure load differences between systems.•The height loss after balloon deflation is significantly decreased by using VBS compared to BKP

ConclusionsExpanding the VBS stents inside the collapsed vertebra offers height restoration with antalgic effect .

The mechanical construct restores the height while at the same time offering a cavity for injection of highly viscous PMMA bone cement without increase of the rate of new vertebral fracture post-VP.

It is indicated in VCFs to prevent new adjacent vertebral fracture due to biomechanical alteration

It’ s necessary the correct and symmetric Stent placement into vertebral bodyA long term follow-up is recommended

• Tipo di cemento• Tipo e diametro aghi• Dettagli tecnici • Cemento alta viscosita??bass apressione• Come s fanno misurazioni• Probabili domande