New Peripheral CTO Crossing & Reentry Technologies in the

Complex Cases Subhash Banerjee, MD

Associate Professor of Medicine University of Texas Southwestern Medical Center

Chief, Division of Cardiology VA North Texas Health Care System

Dallas, TX

Disclosures • I have the following financial relationships to disclose:

• Type of relation:

– Consultant:

• Covidien (moderate)

• Medtronic (moderate)

– Institutional research grants:

• Gilead

– Ownership interest:

• HygeiaTel

• Mdcare Global (spouse)

• *Type of relation: Consultancy, employment, honoraria, other compensation

• *Level of remuneration: high (over $50,000 yearly), moderate ($10-50,000), modest (< $10,000)

Talking points

Peripheral CTO: prevalence & treatment challenges

Peripheral CTO crossing devices: Viance® & Enteer®

TruPath®

Final results of the PFAST & Re-Open Trials

Duration ≥3 months1

40-50% patients with symptomatic PAD have an arterial CTO2

Most commonly in the infra-inguinal location1

Nearly 50% of SFA lesions present as CTO2

CTO more common in DM2 & CLI1

Often multi-level CTO are present3

Lower Extremity Arterial CTO

1Norgren L et al. J Vasc Surg. 2007; 2Banerjee et al. JACC 2012; 3Banerjee et al. Card. Rev. Med. 2011

Crossing of peripheral CTO is the most common reason for: Failed intervention (13-34%)

Complications (~15%)

Penetration of fibrous cap

Enter distal target vessel True lumen entry

Use of re-entry device

Navigate collaterals & side-branches

Long segment/multi-level occlusions

Lack of crossing device maneuverability Pushability

Torque control

Trapping

Guide-wire control

Treatment Challenges of LE CTO

Jacobs et al. J Vasc. Surg. 2006; 43(6): 1291

Approved

Devices

Frontrunner® Safe-Cross® Crosser® Wildcat® TruePath®

Technique Blunt micro-

dissection Guidance, ablation

and crossing

High frequency mechanical

vibration

Rotational spinning

Self-rotating guide wire

Length 82 cm, 132 cm 175 cm, 275 cm 146 cm 110 cm 165 cm

Sheath 6F 6F 5F, 6F (rapid exchange)

6F 6F

Support

catheter 4.5 F micro-guide

No support catheter

1.8 mm Usher support catheter

No support catheter

No support catheter

Guide wire 0.035 inch 0.014 inch and

0.035 inch 0.014 inch and

0.018 inch 0.035 inch 0.018 inch

Crossing

profile

0.99 mm with actuating jaws that

open to 2.3 mm 0.89 mm 1.1 mm 2.0 mm 0.43 mm

Viance® & Enteer® CTO crossing & re-entry system

Distal Catheter Tip (atraumatic, 0.037”)

0.014” guidewire (300 cm)

135 cm shaft (2.3F) 0.035 OD: compatible with most support catheters

Viance® Peripheral Blunt Micro-dissection Catheter

Ratchet handle for fast-spin & tactile feel

Multi-wire coiled shaft for true 1:1 torque

Mechanism of Action - Fast Spin Device Locates Microchannels in CTO

8 |

The spinning motion of the Viance™ Crossing Catheter reduces orthogonal friction: 1. Finds microchannels through

a CTO 2. Provides blunt dissection

through a CTO 3. Use of a directional

“steering” wire

The Enteer™ Re-entry System Re-enter True Lumen from Sub-intimal Channel

Offset exit ports for Stingray CTO Re-Entry

Guidewire

Stingray CTO Re-Entry Guidewire Probe

Self-orienting balloon has flat shape

2.9F shaft profile

Compatibility:0.014" guidewire6F guide catheter

Initial unsuccessful attempt

Contralateral CFA access 6F Crossover sheath Primary GW/support catheter crossing

Poor distal filling Gradual escalation of Symptoms after failed attempt

Primary crossing with Viance catheter

Right lateral view

Subintimal passage and re-entry with Enteer

Successful TP trunk re-entry with Enteer catheter & wire Followed by IVUS confirmation

IVUS confirmation of distal true lumen access

Compressed true lumen atheroma

Sub-intimal space s/p balloon dilation

Final result after distal SFA & TP trunk stenting

6x40mm Nitinol Self-expanding stent implantation

Two 3x20 mm & 3x18 mm overlapping coronary DES implantation

Significant improvement in patient symptoms at 3m F/U

Viance & Enteer Peripheral CTO Crossing Solutions

Strengths • Controlled advancement • Predictable distal tip

handling - alter tip strength & pushability

• No external controller • ATK & BTK options • Shorter procedural duration • Lower complications

Limitations • “Over-spinning” • Flush ostial occlusions

require a “steering guide wire”

• Limited aspiration capability

No capital equipment

Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs)

Design: Prospective, multi-center non-randomized clinical trial

Primary Safety Endpoint: Major Adverse Event (MAE) at 30d: Death, unplanned major amputation, perforation & TLR

Primary Effectiveness Endpoint: Technical Success: Distal true lumen access

Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs)

105 Subjects (failed wire crossing)

39 Subjects Screen Failures

66 Subjects with CTOs

21 Subjects Enteer Cases

45 Subjects Viance Cases

Rutherford category 3-4=73% CTO length=19.5 ± 10.8 cm SFA CTO=65% BTK CTO=32%

PFAST: Primary Safety Endpoint

Major Adverse Event Rate at 30 Days Overall

(n= 66)

Overall MAE 3.0% (2/66)

Death 0.0%

Unplanned Amputation 0.0%

Target Lesion Revascularization

Bypass Surgery

Percutaneous Intervention

1.5% (1/66)

0.0%

1.5% (1/66)

Perforation 1.5% (1/66)

PFAST: Primary Effectiveness Endpoint

Technical Success

Overall (n= 66) 85% (56/66)

Viance Only Cases (n= 45) 84% (38/45)

Enteer Cases (n= 21) 86% (18/21)

TruPath® Peripheral CTO Crossing Device

Designed to cross fibro-calcific CTO

Diamond-coated distal tip rotates at 13,000 rpm on a 0.018” guidewire

Requires no capital equipment

Extension capability to 335 cm

ReOpen Trial: TruePath™

98.8

80.0

0

20

40

60

80

100

Device success (n=85) Freedom 30d MAE (n=85)

%

Femoro-popliteal (FP)/BTK CTO with initial failed guide-wire crossing

Primary endpoint: success of crossing

Secondary endpoint: safety at 30-days

CTO length = 166 mm

SFA = 71.8%

Popliteal/FP= 15.3%

Tibial= 12.9%

A Multicenter Experience Evaluating Chronic Total Occlusion Crossing with the TruePath™ (Prospective Multi-center Trial)

Failed guidewire attempt

Concluding Message

Peripheral CTO can be effectively tackled with predictably high success rates and low complications

Viance®/Enteer® & TruPath® device facilitated CTO crossing into the distal true lumen in >80% of cases after primary guidewire failure