UC UC SF SF Disclosures: None Vessel Preparation is the Key - - PowerPoint PPT Presentation

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Vessel Preparation is the Key Step For Successful DCB Revascularization

Shant M. Vartanian, MD Assistant Professor of Surgery Division of Vascular and Endovascular Surgery

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Disclosures:

• None

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Biology of Restenosis

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

DCB Drug Delivery

• Avoids metal/polymer induced restenosis
• May distribute antiproliferative more homogenously than
• ther methods
• ~20% lost on the way to the target
• Deposit ~20% at the target
• Collect ~20% on balloon retrieval
• ~40% is lost downstream as particulate

Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. Lippincott Williams & Wilkins; 2009 Aug;2(4):352–8.

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Principles of DCB

• Semi-compliant balloon
• Excipient with an anti-

neoproliferative agent (paclitaxel)

• Excipient allows for delivery
• f lipophilic paclitaxel to

media and adventitia

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Why Vessel Preparation

• Fractures and fissures in the plaque facilitate

drug delivery to media and adventitia

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Why Vessel Preparation

• Change compliance of the lesion
• Long inflation time
• Multiple inflations
• Gentle balloon inflation gives time for the vessel to adapt to

the balloon

• Prevent elastic recoil
• Prevent dissection

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Balloon Angioplasty

• 74 patients
• Randomized PTA of 30 sec vs. 180 sec
• Femoropopliteal lesions
• Similar mix of occlusions, stenosis and lesion

length

Zorger N, Manke C, Lenhart M et al. J Vasc Interv Radiol. 2002 Apr;13(4):355–9.

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Balloon Angioplasty

Zorger N, Manke C, Lenhart M et al. J Vasc Interv Radiol. 2002 Apr;13(4):355–9.

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Why Vessel Preparation

• Change compliance of the lesion
• Long inflation time
• Multiple inflations
• Gentle balloon inflation gives time for the vessel to adapt to

the balloon

• Prevent elastic recoil
• Prevent dissection

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

DCB Trials

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Calcium and Drug Delivery

• 60 de novo SFA lesions treated with DCB
• Stratified results by circumferential distribution of calcium
• Calcium scoring method combined CTA, Fluoro and

IVUS findings

Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, et al. Cardiovasc Intervent Radiol. Springer US; 2014 Aug;37(4):898–907.

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Calcium and Drug Delivery

Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, et al. Cardiovasc Intervent Radiol. Springer US; 2014 Aug;37(4):898–907.

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Methods of Vessel Preparation

• Balloon Angioplasty
• Atherectomy
• Directional
• Rotational
• Cutting Balloon
• Scoring Balloon

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Future Directions

• Directional atherectomy + DCB vs DCB alone
• Multicenter randomized trial

Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. Lippincott Williams & Wilkins; 2009 Aug;2(4):352–8.

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Future Directions

• Turbohawk/Silverhawk atherectomy
• Bayer Paccocath DCB
• Stenosis, restenosis or occlusions
• Lesion length 7-15 cm
• Randomized 102 patients
• Registry arm for severly calcified lesions that were

exclusion criteria for randomization (n = 19)

Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. Lippincott Williams & Wilkins; 2009 Aug;2(4):352–8.

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Future Directions

Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. Lippincott Williams & Wilkins; 2009 Aug;2(4):352–8.

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Future Directions

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Is Vessel Preparation Necessary?

• No vessel preparation steps in European IFU

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Conclusions

• Vessel prep facilitates delivery of drug to the target lesion
• Prep the vessel in ways that maximize luminal gain with

the least amount of trauma

• Long inflation times
• Lesions that are the most difficult to prep are the least

likely to do well with DCB

• New avenues of clinical research examining other means
• f vessel prep before DCB