Vessel Preparation Prior to DCB and Stenting: How to Do It.
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1 Vessel Preparation Prior to DCB and Stenting: How to Do It. LINC 2018 January 30 February 2, 2018 Leipzig, Germany Brian DeRubertis, MD, FACS Associate Professor of Surgery UCLA Division of Vascular Surgery
2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Company Abbott Vascular Affiliation/Financial Relationship Scientific Advisory Board Consulting agreement Speakers fees / Honorarium Medtronic Scientific Advisory Board Consulting agreement Speakers fees / Honorarium REALITY Trial National Co-PI Boston Scientific CLI Advisory Board Cook Medical Proctoring and Case Review Honorarium
3 Percutaneous Lower Extremity Intervention: Evolution in Technique and Treatment Paradigm SFA Full Metal Jacket likely not the best treatment strategy anymore Diverse range of options for SFA treatment has seen a shift away from balloon/stent Increasing number of treatment options have ushered in greater focus on technique Technique now individualized to patient or lesion 3
4 What Is Vessel Preparation? Improving luminal gain to deliver an implant Altering residual mechanical forces in vessel Debulking calcium or barriers to diffusing INPACT DCB Supera Stent ABSORB Stent 4
5 Evolving Concept of Vessel Preparation Cutting Balloon CSI Atherectomy TurboHawk Chocolate PTA Angioscuplt Intravascular Lithotripsy
6 When is Vessel Prep Most Important? Drug-coated Balloons in complex lesions Interwoven Nitinol Stent implantation Bioresorbable Technology
7 Vessel Prep in conjunction with DCB LEVANT Global 1 IN.PACT Global Full Clinical Cohort 2 IN.PACT Global Long Lesion 3 IN.PACT Global CTO 4 IN.PACT Global ISR 5 Follow-up 460 subjects Interim Site-reported 1406 subjects Complete followup Core Labadjudicated 157 subjects Complete followup Core Labadjudicated 126 subjects Complete followup Core Labadjudicated 131 subjects Complete followup Core Labadjudicated Key Lesion Characteristics Length (cm) CTO (%) Ca 2+ (%) 10.1cm 30.9% 34.2% 12.1cm 35.5% 68.7% 26.4cm 60.4% 71.8% 22.9 cm 100.0% 71.2% 17.2cm 34.0% 59.1% Primary Patency FF TLR/CD-TLR 91.0% 92.0% % 91.1% 94.0% 84.4% 88.2% 88.7% 92.9% Bail-out Stent (%) 27.6% 25.3% 40.4% 46.8% 14.5% 1. Presented by Laurich C, SVS Chicago Presented by Jaff M, VIVA Las Vegas Presented by Scheinert D, PCR Paris Presented by Tepe G, CX London 2016.] 5. Presented by Brodmann M, VIVA Las Vegas 2015.
8 Vessel Prep in conjunction with DCB Impact of Calcium on Results of DCBs 1. Fanelli F, et al. Cardiovasc Interv Radiol 37: (2014).
9 Vessel Prep in conjunction with DCB Atherectomy is associated with extremely low bailout stent rates and may modify plaque surfaces to allow better drug delivery with DCB
10 Vessel Prep in conjunction with DCB DEFINITIVE-AR Design Patients Multicenter Location Lesion Description Angio Core lab Duplex Core lab 12mo Primary Patency 12mo Freedom TLR Bailout Stent Rate DEFINITIVE AR Randomized; DA+DCB vs DCB alone 121 (98% Claudicant) Yes SFA Yes (11.2cm, registry arm of severely Ca++) Yes Yes 91% (>10cm); 70% (Severe Ca++); 93% all No N/A 12
11 Patency Vessel Prep in conjunction with DCB DEFINITIVE AR: 12-mo Patency by Angio 1 1. DEFINITIVE AR: A Pilot Study of Antirestenosis Treatment. 12-month Results: Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency presented by Zeller T, VIVA Las Vegas
12 14 Randomized Patients 150, Rutherford 2-4 Multicenter Location Vessel Prep in conjunction with DCB REALITY Prospective registry of atherectomy + DCB Yes (10 U.S. sites, 3 German sites) SFA/pop Lesion Description Yes (>6-25cm US, >6 Germany, PACS 3-4 ) Angio Core lab Duplex Core lab IVUS Core lab Histology Core lab 12mo Primary Patency 24mo Freedom TLR Bailout Stent Rate REALITY Study Yes Yes Yes Yes Yes Yes Yes
13 15 Vessel Prep in conjunction with DCB
14 Vessel Prep in conjunction with DCB Hawk-1-M Post-DA INPACT DCB POST DCB Goals of Vessel Preparation when treating with DCBs: 1. Debulk residual mechanical forces the lead to need for bailout stenting Improve drug delivery and diffusion into arterial wall
15 Vessel Prep in conjunction with DCB Cadaveric fempop arteries treated with orbital atherectomy under simulated blood flow model Pretreatment lesion composition affected paclitaxel absorption (5.5- fold decrease with each calcified quadrant) Treated segments revealed thinner intima, 45% less plaque calcification, higher paclitaxel absorption and deeper paclitaxel penetration.
16 When is Vessel Prep Most Important? Drug-coated Balloons in complex lesions Interwoven Nitinol Stent implantation Bioresorbable Technology
17 Vessel Prep for Woven Nitinol Stents Supera Stent (Abbott Vascular) When nominally deployed: 1 91% 12mo Primary Patency 94% 36mo Freedom from TLR 1 Data from Superb Trial, Presented at VIVA 2015
18 Vessel Prep for Woven Nitinol Stents Vessel prep strategy may be considered much more aggressive than DCB prep where focus is on drug delivery and avoiding vessel injury Mildly Stacked Nominal Stacked Elongated
19 Vessel Prep for Woven Nitinol Stents
20 Vessel Prep for Woven Nitinol Stents CTO
21 Vessel Prep for Woven Nitinol Stents
22 Vessel Prep for Woven Nitinol Stents Residual focal waists Options: Short NC balloon Atherectomy Scoring ballooon Cutting balloon Pave & Crack Predilate with 6x250 Armada35
23 Vessel Prep for Woven Nitinol Stents PRE POST High-magnification Slow deployment 5.5x120 Supera (x2)
24 Emerging Technology for Vessel Preparation Shockwave Shockwave Intra-vascular Lithotripsy Significant lumen gain while minimizing vessel wall injury Applicability to DCBs, interwoven stents and scaffolds
25 Conclusions Increasing number of effective tools for the SFA/pop means that we can optimize and individualize treatment for specific lesion types Vessel preparation is becoming increasingly recognized as important for optimizing outcomes Strategies for vessel prep are especially important for increasing drug delivery in more complex lesions and prior to deployment of certain types of scaffolds
26 Vessel Preparation Prior to DCB and Stenting: How to Do It. LINC 2018 January 30 February 2, 2018 Leipzig, Germany Brian DeRubertis, MD, FACS Associate Professor of Surgery UCLA Division of Vascular Surgery
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