This document discusses techniques for treating complex tibial chronic total occlusions (CTOs). It notes that tibial CTOs are more challenging than superficial femoral artery occlusions due to calcification, limited re-entry options, and difficulty visualizing distal vessels. New guidewires, support catheters, re-entry devices, and CTO crossing devices can help cross tibial CTOs. Acute procedural success can be achieved with angioplasty, cryoplasty, atherectomy, drug-coated balloons, or drug-eluting stents, but long-term patency with angioplasty alone is poor. Novel techniques and devices have increased the number of previously untreatable tibial C

1. Complex Tibial CTO Techniques Tony Das MD FACC Director, Peripheral Interventions Dallas, Texas

2. Das Disclosures 2010 Abbott Vascular Research/Education Angioslide Consultant Bard Vascular Education Boston Scientific Research Cordis Endovascular Consultant/Education/Research CSI Consultant/Equity/Education WL Gore Education IDEV Consultant/Equity/Education Spectranetics Consultant/Education VIVA Board member/Grant support Educational grafts consist of PVD and Carotid proctorship support

3. Evaluating Tibial CTO’s Best case-distal visualization

4. How are Infrapopliteal CTO’s different than SFA occlusions? Often calcified Unable to reliably use subintimal technique Re-entry options are limited More emphasis on true lumen crossing Angled takeoffs of AT and PT Distal vessels often not well seen http://youtu.be/o2aXxrbIeFI

5. RIM Catheter Support or Glidecatheter Crossover sheath 65-90 cm Direct visualization to the foot Direct Local Imaging

6. Guidewires for BTK CTO Persuader 3,6,9 (Medtronic) Miracle Bros 4.5, 6, 9 (Abbott) Confianza wire (Abbott) Runthough wire (Terumo) _____________________________ V-18 control wire (BSC) Glidewire gold (Terumo)

7. Complex Tibial CTO Techniques Guidewires and support catheters 0.014in coronary CTO wires/ Quickcross Re-entry devices Differential dissection CTO devices for BTK PTA/Cryoplasty/Laser/Atherectomy/Stent Tibial retrograde options

8. Tibial CTO with PTA only Leipzig Registry data. A. Schmidt et al. Catheter CardiovascInterv 2010 Low patency rates with PTA alone: Restenosis 68.8% @3 mo

9. Drug Eluting Balloon BTKLeipzig Trial Results InPactAmphirion Paclitaxel eluting balloon 104 patients/ 109 limbs Mean lesion length: 173 +/- 87 mm

10. PTA with Cryoplasty

11. CLI and Cryoplasty The BTK CHILL Trial was a prospective, multi-center registry N= 111 patients with CLI treated with cryoplasty. 67% Diabetics 35% Occlusions Procedural success was 97%. Limb salvage at 6-months was 93%. Das T, et al. .J EndovascTher. 2007 Dec;14(6):753-62.

12. Laser for BTK CTO

13. CLI and Laser Atherectomy The LACI Trial was a prospective, multi-center registry of laser assisted angioplasty N= 145 CLI patients . Poor surgical candidates 66% Diabetics 92% Occlusions Procedural success was 86%. Limb salvage at 6 months was 92%. Laird, Zeller, Gray, et al, J EndovascTher 2006

14. BTK DES

15. BTK Cypher DES 6 month Data

16. ACHILLES Study- Multicenter randomized Cypher BTK to PTA Average Lesion Length: 27mm+/- 20mm Adapted from LINC 2011 presentation

17. BTK CTO and Atherectomy

18. Diamondback 360˚ Orbital Atherectomy System Saline infusion port 15 cm travel

19. Unique Mechanism of Action Centrifugal Force 2.0 mm crown at 80k RPMs 2.0 mm crown at 200k RPMs CF=mass*rotational speed2 radius of the orbit

20. Tibial Frontrunner Technique

23. BTK New CTO Devices 65 y/o M with CAD, DM, non healing ulcer R. LE for 4 months (lateral 4th and 5th toes) ABI: 0.3R and 0.7L at rest Referred for angiography CTO SFA, Popliteal and Tibial

24. Peroneal artery occlusion

25. Uncrossable with Guidewire

26. The CROSSER™ System Generator Converts AC power into high frequency current Piezoelectric crystals within the Transducer convert high frequency current into vibrational energy Foot Switch activates System CROSSER Catheter Nitinol core wire transmits mechanical vibration to the metal tip of the Catheter at 20,000 cycles/second 20 micron amplitude (stroke depth)

27. PTA and Final Result

28. Occluded TibialVessel Access Technique

29. Diamondback 1.5mm Classic

30. Repeat Angiogram (9/10) 6mo

31. Direct Access to DP at foot

32. Micropuncture Access

34. Retrograde Recanalization

35. Retrograde PTA from foot

36. Final Result

37. BTK Re-entry TechniqueTibial occlusion with ulcer 78 year old M w/ history of Occluded Fem-pop with non-healing ulcer No obvious direct runoff vessel to the foot Ulcer on 3rd and 4th toes ABI of 0.3 and toe pressure of 30 mmHg

38. Initial Angiogram- Failed Graft Tony Das, MD

39. Trapped wire in subintimalspace BTK What to do next? A. Continue subintimal tract B. Consider changing to different wire C. Considering other devices Frontrunner Outback Crosser Other? D. Abort Case E. PTA SFA/popliteal

40. OK what now?

41. BTK Re-entry Technique Tony Das, MD

42. 5.9F profile device 6F sheath .014”guidewire 120 cm length 22 gauge cannula 7mm long cannula

44. Tornus 2.1Fr Tornus 2.6Fr The role of CTO devices BTK

45. Newer CTO devices Tornus 2.1Fr Tornus 2.6Fr Clockwise: ReeKross, CiTop, Wildcat, CrossBoss, Stingray Others: ReVascualar RVT 0.016in drill, SI Therapies: Re-entry Balloon

46. Summary Previously unapproachable tibial CTO’s can be addressed novel wires, alternative access routes, newer true lumen crossing devices, and CTO re-entry devices Acute procedural success includes PTA, cryoplasty, possibly atherectomy, and consideration for DEB and stents (DES) Long-term results for PTA alone are dismal, but may lead to wound healing Very few cases are truly “undoable”