Defero Test 3

Tony Das MD FACCCardiovascular Education Group

Complex Tibial CTO Techniques

Tony Das MD FACC Director, Peripheral Interventions

Dallas, Texas


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


Evaluating Tibial CTO’s

Best case-distal visualization

http://www.youtube.com/watch?v=HiT621PrrO0


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

Tony Das MD FACCCardiovascular Education GroupDirect Local Imaging

RIM Catheter

Support or Glidecatheter

Crossover sheath

65-90 cm

Direct visualization to the foot


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)


Complex Tibial CTO Techniques

Guidewires and support catheters0.014in coronary CTO wires/ Quickcross

Re-entry devices Differential dissection CTO devices for BTK PTA/Cryoplasty/Laser/Atherectomy/Stent Tibial retrograde options


Leipzig Registry data. A. Schmidt et al. Catheter Cardiovasc Interv 2010Low patency rates with PTA alone: Restenosis 68.8% @3 mo

Tibial CTO with PTA only


Drug Eluting Balloon BTKLeipzig Trial Results

InPact Amphirion Paclitaxel eluting balloon

104 patients/ 109 limbs

Mean lesion length: 173 +/- 87 mm

DEB POBA0

10

20

30

40

50

60

70

Restenosis (3 mo) angio

Restenosis (3 mo) angio


PTA with Cryoplasty


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 Endovasc Ther. 2007 Dec;14(6):753-62.

93 97

0

20

40

60

80

100

6 months

Limb Salvage Procedural Success Bypass


Laser for BTK CTO


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 Endovasc Ther 2006

92

86

82

84

86

88

90

92

6 Months

Limb Salvage Procedural Success


BTK DES


BTK Cypher DES 6 month DataAuthor R N TLR 1 Endpoint

ScheinertEuroInterv2006;2:169-174

Y 60 0 vs 23% 0 vs 56%Restenosis

SiablisJ Endovasc Ther2005;12:685-95

N 58 100%Limb

Salvage

4 vs 55%Restenosis

BosiersJ Cardiov Surg. 2006 Apr;47(2):171-6

N 18 94% Limb Salvage

0.38 Late Lumen Loss 0% Restenosis

ComeauEuroPCR 2006

N 30 100% Limb Salvage

97% 1 Patency


ACHILLES Study- Multicenter randomized Cypher BTK to PTA

PTA Cypher05

101520253035404550

Restenosis

Restenosis

Average Lesion Length:

27mm+/- 20mm

Adapted from LINC 2011 presentation


BTK CTO and Atherectomy


Saline infusion port

15 cm travel

Diamondback 360˚ Orbital Atherectomy System


Unique Mechanism of Action Centrifugal Force

2.0 mm crown at 80k RPMs

CF=mass*rotational speed2

radius of the orbit

2.0 mm crown at 200k RPMs


Tibial Frontrunner Technique




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


Peroneal artery occlusion


Uncrossable with Guidewire


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)


PTA and Final Result


Occluded Tibial Vessel Access Technique


Diamondback 1.5mm Classic


Repeat Angiogram (9/10) 6mo


Direct Access to DP at foot


Micropuncture Access



Retrograde Recanalization


Retrograde PTA from foot


Final Result


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


Tony Das, MD

Initial Angiogram- Failed Graft


Trapped wire in subintimal space BTK

What to do next?A. Continue subintimal tractB. Consider changing to different

wireC. Considering other devices

1. Frontrunner2. Outback3. Crosser4. Other?

D. Abort CaseE. PTA SFA/popliteal


Tony Das, MD

BTK Re-entry Technique


5.9F profile device

6F sheath

.014” guidewire

120 cm length

22 gauge cannula

7mm long cannula



The role of CTO devices BTK

Tornus 2.1Fr

Tornus 2.6Fr


Newer CTO devices

Clockwise: ReeKross, CiTop, Wildcat, CrossBoss, Stingray Others: ReVascualar RVT 0.016in drill, SI Therapies: Re-entry Balloon

Tornus 2.1Fr

Tornus 2.6Fr


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”


Defero Test 3

Technology

center registry

limb salvage

0 mm crown

btk

cli

pta

prospective

multi