The Step-by-Step Use of Re-Entry Devices Craig M. Walker, MD, FACC, FACP Founder and Medical Director Cardiovascular Institute of the South Houma, LA Clinical Professor of Medicine Tulane University School of Medicine New Orleans, LA

Craig M. Walker, MD Consulting Fees: Spectranetics Corporation Ownership Interest (Stocks, Stock Options, or other Ownership Interests): IDEV Technologies, Inc. Cardiva Medical, Inc. Medtronic, Inc.

Disclosures Medical/Scientific Boards Speaker’s Bureau IDEV Technologies Spectranetics vasamed Consultant Cook Medical IDEV Technologies Stockholders Cardiva Vasamed Speaker’s Bureau Abbott AstraZeneca Atrium Medical Bristol-Myers- Squibb/Sanofi Cardiva DSI/Lilly Forest Pharmaceuticals IDEV Technologies PamLabs Spectranetic Takeda PVD Training Spectranetics Bard

Challenges of Intraluminal Approach (Preferred) Penetration of CTO fibrous cap Presence of collaterals Lack of Guidewire tip maneuverability Tough, calcified lesions

Subintimal Angioplasty Wire Based Advantages Disadvantages Relatively quick Relatively simple Does not require expensive equipment (just a catheter and hydrophilic guidewire) Reasonable success rates Difficult reentry in calcified or diffusely diseased arteries May extend dissection beyond end of occlusion and lengthen treatment segment May occlude collaterals

Subintimal Angioplasty Wire Based Place tip of sheath close to origin of occlusion and near proximal collateral Point catheter at the plaque/wall interface, pointing opposite the largest collateral or side branch Probe with Glidewire – tip will catch and a loop will form Advance loop carefully Bolia, Bell Clin Radiel, 1980, 40, 225 Lipsitz, JVS 37, 2009, pp 386-394

Subintimal Angioplasty Wire Based Smooth dissection plane Advance catheter once loop fully formed (try to keep the loop no more than 2cm distal to the catheter to keep loop small) Once catheter support is advanced, advance the wire again

Subintimal Angioplasty Wire Based Contrast administered through sheath will show distal reconstitution Successful re-entry in 75-87% - typical tactile sensation as guidewire passes into true lumen Balloon angioplasty of entire occlusion length Stent for suboptimal result If guidewire does not reenter, do not extend dissection plane more distally

True Lumen Return Goals (Controlled Re-entry) Increase angioplasty success rate Reduce side branch occlusion Reduce overall treated length Reduce procedure-related variables such as time, contrast-use, ancillary devices, etc. Success rate for the Pioneer is about 85% according to in-house database on reported cases when used as indicated. Common reasons for failure are inadequate placement of the subintimal guidewire beyond the occlusion, sub-optimal imaging of the target vessel or inability to advance the Pioneer distal to the occlusion due to anatomical restrictions. Reduced side branch occlusion and overall treated length are achieved by controlled re-entry into the target vessel. Common techniques of using a Glidewire and Glidecatheter, or other “dottering” techniques oftentimes rely on chance to re-enter the vessel. Average time of use with the Pioneer catheter from time to opening package from removing Pioneer catheter from patient after successful use is 8-10 minutes.

Re-entry Techniques Outback catheter Flouroscopic guided Simple device Low profile

Re-entry Techniques Outback catheter LTD version available since 2005. Success rates range Shin et al. U of Pittsburgh, (Soc Clin Vasc Surg 2009) 64% technical success Zeller et al. Bad Krozingen, (LINC 2010) 92% technical success

Outback® LTD Orientation Markers “L” marker = Locate Position image intensifier to show Outback® adjacent to true lumen Point “L” marker toward ture lumen

Outback® LTD Orientation Markers “T” marker = Tune Move image intensifier to orthogonal (90°) view. Assure Outback® in ‘in-line’ with true lumen Fine tune Outback® to display full “T” ( ) marker

Pioneer Plus

Pioneer Plus Catheter Catheter length: 120 cm For use with the Volcano IVUS console. Integrated 64-element, phased array IVUS with 20 MHz transducer* Solid state versus mechanical IVUS The catheter is compatible with only the Volcano (formerly Jomed) IVUS console. This platform was chosen because it allowed full integration of the IVUS sensor within the Pioneer Plus catheter which reduced the overall diameter. The Volcano Transducer’s 64 elements are lined around the diameter of the catheter versus Boston Scientific which has only one element. The single element design requires a larger catheter to accommodate the spinning of the drive shaft. As the BSCI IVUS catheter rotates to obtain the image, the Pioneer catheter diameter would have to be larger to accommodate it. The 20 MHz sensor was designed for coronary applications; however, its 16 mm field of view is adequate for peripheral TLR (true lumen return) applications. The higher the MHz the lower the tissue penetration and the smaller field of view.

Pioneer Plus Catheter Needle and IVUS Transducer Needle exits catheter ~7mm below IVUS transducer IVUS transducer 7 mm Needle exit

Pass guidewire to true lumen Pioneer Plus Catheter Step 1: Guidewire entrapment Step 2: Catheter insertion Step 3: Catheter rotation Step 4: Deploy needle Step 5: Pass guidewire to true lumen Step 6: Remove catheter

Pioneer Plus Catheter

Pioneer Plus Catheter

Pioneer Plus Catheter

Pioneer Plus Catheter

Pioneer Plus Catheter

True Lumen Return Application Pioneer Plus Catheter IVUS image from within a dissection of the SFA True Lumen with Chroma Flo Feature Intima The ChromaFlo feature on the Volcano IVUS console is helpful in identifying the true lumen of a vessel if blood flow is present. The lumen of the vessel is positioned at 12:00 on the IVUS image. If adequate flow in the vessel is not present, an injection of agitated contrast can be used to enhance to ChromaFlo image. Increased flow will also change color on the screen from red to orange to yellow and possibly white (as velocity increases). The area of red below the catheter in this image is noise and does not represent flow. If there is question as to whether the vessel is an artery or vein, venous flow will be increased by flexing and extending the foot and arterial flow will not be affected. Injection of contrast or saline can also determine arterial flow. When the Volcano IVUS catheter is rotated, the anatomy moves. When the BSCI IVUS catheter is rotated, the anatomy is stationary. Pioneer Plus Catheter in Subintimal Space

Re Entry Devices Pioneer Plus Outback 6-French Compatible Two Guidewires IVUS guidance Set needle Depth 3,5,7 mm Outback 6-French Compatible One Guidewires Fluoroscopic guidance Needle depth controlled manually and may vary

Newer devices Spot catheter (NOT FDA APPROVED) Blunt tipped FLASK SHAPED balloon catheter with straight needle tipped hypotube Centers the exit lumen of the balloon to guide hypotube to true lumen Purchased by Boston Scientific Renamed to OffRoad catheter FDA approval pending

OffRoad™ Re-Entry Catheter System Product Overview Two Components: Directional Balloon & Micro-Catheter Lancet 5.4mm Directional Balloon anchors and directs the system Micro-Catheter Lancet engineered for crossing and re-entry into the true lumen 70 and 100 cm lengths Purpose Designed for precise true lumen re-entry from subintimal space Status Pending FDA 510K Clearance The OffRoad Re-Entry Catheter System is an investigational device only. Not available for sale.

Conclusions Subintimal recanalization can be a quick and simple approach to SFA Occlusion Effective in majority of cases Re Entry Devices address the most common reason for failure – inability to re-enter the true lumen of the distal vessel.