12/5/2016. New Frontiers in Flow Diversion. Concepts for endovascular treatment of aneurysms. Disclosures:

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1 New Frontiers in Flow Diversion Disclosures: Pipeline & Onyx proctor Advisory Board : Intreped, Premier, Shield project Principal Investigator: PUFS, Intreped, Swift Prime, Premier, Barrel, Aspire National PI: Shield trial Research collaboration: Pipeline Shield Technology Project Coiling? Concepts for endovascular treatment of aneurysms Balloon assisted coiling Stent and Coiling Flow Diversion 1

2 Before FD we had to overlap low coverage stents homemade flow diverter What is Flow Diversion? Flow diverter alone vs. How to improve our outcomes? / Balloon mounted stent Flexible self-expanding stent Flow diverter CLINICAL STUDIES ON PED: PITA *PUFS *ASPIRE *INTREPED *PREMIER *SHIELD COMING SOON!!! * Trials Rush University participated Chicago experience 2

3 Complete occlusion rate Comparison of FD to Stent Coiling IntrePED 1 PUFs 2 Assisted Coiling Meta Stent- Analysis 3 71% (12-24 mo f/up) 86% (12 mo f/up) 61% Neuroform Stent Registry % (progressive thrombosis at 12.9 mo avg f/up) Enterprise Stent Registry 40% 5 Recurrence rate 0% 0% 14% 27.7% Not reported M&M 8.3% 5.6% 5.3% 8.1% 4.8% 6 Neurologic death 3.8% 2.8% 2.1% (periprocedural) (periprocedural) 3.2% 2% 6 (periprocedural) 1. IntrePED Presentation by Dr. David Kallmes, SNIS Conference, July 28, Becske T, Kallmes DF, Saatci I, et al. Pipeline for Uncoilable or Failed Aneurysms: Results from a Multicenter Clinical Trial. Radiology. Published online before print February 15, 2013, doi: /radiol Shapiro, Becske, Sahlein, Babb, Nelson. Stent-supported aneurysm coiling: A literature survey of treatment and follow-up. AJNR Am J Neuroradiol 33:159-63, Jan Fiorella, Albuquerque, Woo, Rasmussen, Masaryk, McDougall. Neuroform stent assisted aneurysm treatment: evolving treatment strategies, complications and results of long term follow-up. J NeuroIntervent Surg (2009), doi: /jnis Mocco et al. Delayed thrombosis or stenosis following Enterprise-assisted stent-coiling: Is it safe? Midterm results of the interstate collaboration of Enterprise stent coiling. Neurosurgery, Vol 69, No 4, Oct Mocco et al. Treatment of intracranial aneurysms with the Enterprise stent: a multicenter registry. J. Neurosurg. Vol 110, January, Flow diversion of large and/or giant & wide-necked ICA aneurysms in PUFs 95.2% Aneurysm Occlusion Rate (@5years) 5.6% M&M PUFs FDA Summary of Safety and Effectiveness Data (SSED) Pooled DATA from PED trials 1092 patients 1221 aneurysms 12 mm size 6mm neck (mean) Complete occlusion: Retreatment 3% 75% 180 days 85.5% 1 year 93.4% 3 years 95.2% 5 years Major M&M 7.1% 3

4 Complication reported with flow-diversion Thromboembolic events Delayed aneurysm rupture Parenchymal hemorrhages Perforators or side branch occlusion In-stent thrombosis Background Thromboembolism is one of the most common endovascular complications Factors Contributing to Stent Thrombosis Stent Thrombogenicity Material and Designs (open vs. closed cell) Surface coating Bio- Adjunctive therapiescompatibility (drug, radiation) Patient/Lesion Factors Vessel size, Lesion length Plaque characteristics or athero Intrinsic platelet/ coagulation activity Multiple stents or Stent length Blood Flow Procedure-Related Factors Morphometric and/or morphologic abnormalities (under-expansion / dissection, incomplete apposition, thrombus, tissue protrusion), Mechanical vessel injury Antithrombotic therapy Kereiakes D., et. al., Rev Cardiovasc Med. 2004;5(1):9-15 4

5 So what is next in flow diversion? Surface modification Intravascular Imaging Low hanging fruit? Thromboembolic complications are multifactorial How to address that? Coronary stents have been modified to decrease their thrombogenicity Neuro intervention could benefit if implants are less thrombogenic or more blood compatible What is Shield Technology? Shield Technology is a surface treatment where an inert, synthetic phosphorylcholine (PC) polymer is covalently bonded to the strands that make up the Pipeline braid. 5

6 What is Phosphorylcholine (PC)? PC is the major component on the surface of red blood cells and therefore treating a device with PC results in physiologic mimicry of the cell membrane. PC coatings have been successfully used on implanted vascular devices for over 14 years Zomaxx/Zodiac Endeavor Phosphorylcholine (PC) Coatings: Synthetic copy of PC headgroup from RBC outer membrane Outer Membrane Inner Membrane N O O P O O The Phosphorylcholine (PC) Headgroup Thrombogenicity of flow diverters in an ex vivo shunt model: effect of phosphorylcholine surface modification. Hagen MW, et al. J Neurointerv Surg CONCLUSIONS: In this preclinical model, phosphorylcholine modification reduces the platelet-specific thrombogenicity of a flow diverter under physiologically relevant flow with and without DAPT. We have further identified increased fibrin-driven thrombogenicity associated with FRED relative to PED. 6

7 OCT for stent evaluation Follow up Strut apposition Strut coverage 7

8 Optical Coherence Tomography (OCT) is an imaging modality able to provide high-resolution images of vessels in vivo While intravascular ultrasound (IVUS) uses backscattered ultrasound, OCT uses reflected light to create cross sectional images of the vessel IVUS OCT The C7-XR OCT Imaging System Dual monitors and remote output for multiple sight lines Imaging Catheter Easy mouse and keyboard control Multiple export options including RW/DVD Small footprint for easy placement Imaging Catheter 3 c.c. purge syringe Quick-connect hub /2.7 F with hydrophilic coating Guidewire exit port Tip marker 2 cm mini-rail 2.7 F shaft Lens Lens marker 8

9 A Simple and Fast Procedure Cross with monorail imaging catheter Inject 10-12cc of contrast The automatically triggered imaging scan is performed in less than five seconds OCT scan from PCA to Basilar IVUS OCT Resolution (axial) µm (lateral) µm 10 µm µm Scan Area mm 6-7 mm Penetration depth Blood removal 4-8 mm Not required mm Required 9

10 Precise Vessel Measurement MCA Lenticulostriate perforators Side branch detection False lumen Intima tear 10

11 Basilar post Pipeline Optical Coherence Tomography - Basilar artery Flow - Diverter Self-expanding Stent 11

12 OCT for the evaluation of new generation stents Bioabsorbable stents. The prospective, multicenter, ABSORB study evaluated the safety and efficacy of a fully absorbable everolimus eluting stent (BVS*) for the treatment of de novo single coronary stenosis. OCT substudy in Rotterdam after implantation, at 6 months and 2 years. BL 6M 2Y *Bioabsorbable Vascular Solutions, Inc, an affiliate of Abbott Laboratories, located in Mountain View, CA Serruys et al. Lancet 2009; 373: Stent endothelialization monitored with intravascular imaging and histology in porcine Results - 4 days Endothelialization : FLEX (5 12mm) vs. FLEX with Shield (5 12mm) vs. Solitare (5 20mm) (1Fr.=0.1mm) 10 th Fr. 100 th Fr. 200 th Fr. 280 th Fr. FLEX 1 Shield 1 Solitare 1 12

13 Endothelialization of device over time in a porcine model Day 0 Day 7 Day 14 Day 21 Day 0 Day 7 Day 14 Day 21 13

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