UC UC SF SF Disclosures: • None Vessel Preparation is the Key Step For Successful DCB Revascularization Shant M. Vartanian, MD Assistant Professor of Surgery Division of Vascular and Endovascular Surgery VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO UC UC SF SF Biology of Restenosis DCB Drug Delivery • Avoids metal/polymer induced restenosis • May distribute antiproliferative more homogenously than other 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. VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO 1
UC UC SF SF Principles of DCB Why Vessel Preparation • Semi-compliant balloon • Excipient with an anti- neoproliferative agent (paclitaxel) • Excipient allows for delivery of lipophilic paclitaxel to media and adventitia • Fractures and fissures in the plaque facilitate drug delivery to media and adventitia VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO UC UC SF SF Why Vessel Preparation Balloon Angioplasty • 74 patients • Change compliance of the lesion • Randomized PTA of 30 sec vs. 180 sec - Long inflation time • Femoropopliteal lesions - Multiple inflations - Gentle balloon inflation gives time for the vessel to adapt to • Similar mix of occlusions, stenosis and lesion the balloon length • Prevent elastic recoil Zorger N, Manke C, Lenhart M et al. J Vasc Interv Radiol. 2002 Apr;13(4):355–9. • Prevent dissection VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO 2
UC UC SF SF Balloon Angioplasty 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 Zorger N, Manke C, Lenhart M et al. J Vasc Interv Radiol. 2002 Apr;13(4):355–9. • Prevent dissection VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO UC UC SF SF DCB Trials 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. VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO 3
UC UC SF SF Calcium and Drug Delivery Methods of Vessel Preparation • Balloon Angioplasty • Atherectomy - Directional - Rotational • Cutting Balloon • Scoring Balloon 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. VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO UC UC SF SF Future Directions 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 • Directional atherectomy + DCB vs DCB alone exclusion criteria for randomization (n = 19) • 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. Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. Lippincott Williams & Wilkins; 2009 Aug;2(4):352–8. VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO 4
UC UC SF SF Future Directions Future Directions Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. Lippincott Williams & Wilkins; 2009 Aug;2(4):352–8. VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO UC UC SF SF Is Vessel Preparation Necessary? Conclusions • No vessel preparation steps in European IFU • 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 of vessel prep before DCB VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO 5
Recommend
More recommend