0. 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

1. 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.

2. 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

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

4. 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

5. 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

6. 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

7. 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

8. 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.

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

10. 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

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

12. 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

25. Pioneer Plus

26. 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.

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

28. 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

29. Pioneer Plus Catheter

30. Pioneer Plus Catheter

31. Pioneer Plus Catheter

32. Pioneer Plus Catheter

33. Pioneer Plus Catheter

34. 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

35. 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

36. 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

37. 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.

40. 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.