Technical Recommendations

 

DC Bead LUMI are the next generation of the gold- standard DC Bead and the first commercially available radiopaque drug-eluting beads, offering you a new level of control during your TACE procedures and at follow-up

 


The technical considerations presented here are based on feedback from physicians using BTG’s radiopaque beadtechnology in the USA and is designed to help you optimise the use of this unique product technology.
 

Please contact your BTG representative to ensure you receive appropriate in-service training for your first LUMI-TACE case(s) and any ongoing support you require as your experience grows and you incorporate DC Bead LUMI into your everyday practice.

LUMI-TACE with DC Bead LUMI

 
  • With LUMI-TACE, DC Bead LUMI accumulate to give distinct visualisation of embolised vessels, providing an embolisation ‘footprint’
  • Importantly, the beads do not permeate the tumoural tissue, so this ‘footprint’ helps identify areas of under-treatment
  • In cTACE Lipiodol penetrates into the venous system and spreads into tumoural tissue:
    • No information on embolised vessels
    • Tendency to mask viable tumour1

cTACE (Lipiodol)
LipiodolTM permeates throughout tumour, providing no information on embolised vessels

1. Cho YZ et al. Clinical and Molecular Hepatology 2015;21:165-174

LUMI-TACE with DC Bead LUMI

Distinct visualisation of occluded vessels provides embolisation ‘footprint’

Workflow
Pre-embolisation

Bead Size Selection

  • 70-150μm preferred by most users (higher packing density enhances visibility)
  • 100-300μm
DC Bead LUMI™
Size 70-150μm 100-300μm
Label Colour Black Yellow
Volume of Beads 2ml 2ml
Product Code RO2D001 RO2D103

Identify Tumour-Feeding Vessels

Per current practice:

  • 7Fluoroscopy • Single-shot • DSA
  • CBCT if desired/available

Identify Tumour-feeding Vessels

  • Fluoroscopy
  • Single-shot
  • DSA
  • CBCT
    if desired/available
CBCT: Cone-beam Computerised Tomography
DSA: Digital Subtraction Angiography

Dilution

DC Bead LUMI™ to contrast ratio: 1 to 10
Do not add saline Do not add water

Workflow
Administration

Catheter

  • 2.7/2.8Fr catheters are recommended for initial cases and preferred by early-experience users
  • Preclinical testing supports catheter size of 2.4Fr* (for DC Bead LUMI™ 70-150µm only) which may be preferred by experienced users
    * As in instructions for use (IFU)

Catheter Position

  • As selective as possible per Lencioni et al1
  • PAdjust catheter position based on fluoroscopy/single-shot

Suspension + Injection

  • Ensure good suspension and re-suspend frequently
  • Inject at 1ml/minute
  • Use pulse motion
    (short, controlled pulses to match blood flow)

1. Lencioni R et al, Cardiovasc Intervent Radiol. 2012 Oct; 35(5): 980-5.
† Image courtesy NIH with permission. Any reference to NIH or the authors should not be viewed as an endorsement of BTG, its products or services.

Suspension + Injection

Flushing

  • Minimise the time the bead suspension is left in the catheter lumen
  • Flushing the catheter with contrast agent rather than saline might be more effective.
    Follow with saline if desired

Imaging

  • Intermittent single-shot (3-10 images) to visualise bead distribution during LUMI-TACE
  • These images may be useful to adjust catheter position or injection technique

Intra-procedural single-shot fluoroscopy

Workflow
Endpoint

  • The LUMI-TACE embolisation endpoint should be per the current DEBDOX™ Technical Recommendations; near-stasis in artery directly feeding the tumour.1
    • Visual indicators may include coverage of intra-tumoural vessels
  • Continue and repeat infusion rate at 1ml per minute if needed

Single-shot fluoroscopy (two separate cases)

1. Lencioni R et al, Cardiovasc Intervent Radiol. 2012 Oct; 35(5): 980-5.
CBCT: Cone-beam Computerised Tomography

Workflow
Follow-up

Post Procedure

  • Non-contrast CT within 24 hours of LUMI-TACE procedure may be helpful for initial cases to confirm DC Bead LUMI™ coverage
Scanning immediately after bead administration will show both beads and retained contrast. The contrast will wash out with time
CT: Computerised Tomography
MRI: Magnetic Resonance Imaging

Longer Term

  • At longer term follow-up, non-contrast CT will continue to show DC Bead LUMI™ distribution
  • MRI or contrast-enhanced CT will show response/viable tumour

Tumour Presentation
Small Tumours

  • The smallest bead size (currently 70-150µm) should be used
  • Catheter placement should be as super-selective as possible to minimise risk of DC Bead LUMI™ embolising normal liver parenchyma
  • Expect to see DC Bead LUMI™ in feeding vessels, but due to the size of intra-tumoural vessels, it may not be possible to see DC Bead LUMI™ in the vessels inside tumour on X-ray imaging
Visibility of DC Bead LUMI™ is a function of vessel size – lack of visibility inside small tumours may not indicate under-treatment, but may be due to very small vessels within the tumour.

Non-contrast CBCT. Smaller lesion (unknown size, yellow arrows):
Opacification of tumour-feeding arteries.
2.9cm HCC (white arrow): Opacification within tumour

Non-contrast CBCT. 1.2cm HCC (yellow arrow).
Non-contrast CT

Non-contrast CBCT. 2.2cm HCC (yellow arrow).
Non-contrast CBCT

Tumour Presentation
Large Tumours

  • In larger tumours, DC Bead LUMI™ may appear less visible on X-ray imaging due to the lower packing density of beads within a larger perfused area – 2ml of DC Bead LUMI™ may appear less visible due to the greater volume of blood vessels
  • Additional volume of DC Bead LUMI™ may be required to achieve the required embolisation endpoint

 

Large HCC. Non-contrast CBCT

LUMI-TACE
Combined with Ablation


LUMI-TACE Prior to Microwave Ablation

Non-contrast CT post LUMI-TACE prior to ablation

Non-contrast CT after microwave ablation

LUMI-TACE After Microwave Ablation

CT-guided microwave ablation

Post-treatment shows ablation zone and needle track ablation

LUMI-TACE performed 24 hours after ablation. CBCT shows distribution of DC Bead LUMI™ around ablation zone

*‘First’ refers to commercial availability
† The images shown and experience referenced in this piece are based on clinical case experience with the BTG radiopaque bead product in the US. The US Food and Drug Administration on 14 December 2015 cleared this radiopaque embolic bead under the branded name “LC Bead LUMI™” for the treatment of hypervascular tumours and arteriovenous malformations. DC Bead LUMI™ has CE Mark approval as a radiopaque drug-eluting bead. In order to avoid confusion, BTG has replaced any references to LC Bead LUMI™ with DC Bead LUMI™, as it is the radiopaque nature of the product that is being demonstrated.