From Chocolate to Hawk: Vessel Preparation for Improved

Outcomes

D. Chris Metzger, MD

Wellmont CVA Heart & Vascular Institute

Kingsport, TN, USA

What do We Mean by Vessel Prep?

We want to pre-treat the lesion safely such that we leave definitive therapy options wide open AND increase their effectiveness

BTK our Vessel prep may be stand alone therapy

For femero-popliteal lesions we want to maximize drug delivery to the vessel wall, while minimizing dissection and maximizing lumen (IF DCB is strategy, help it work best)

What Does Vessel Prep before DCB Mean?- 2

In my opinion, it does NOT necessarily mean atherectomy

Vessel Prep Goals:

Pretreat such that 1:1 DCB doesnt dissect

Remove impediments to drug delivery

Avoid drug loss on way to lesion

Maximize DCB expansion & vessel contact

Minimize dissections & issues w/ Prep, Rx

One goal: Maximize luminal gain while minimizing dissection

Does the lesion look like it needs or would benefit from atherectomy before DCB?

If yes, individualized atherectomy w/ dEPD

If not, perform PTA or specialty PTA with balloon 1mm DCB, on roadmap

LONG, slow inflations; no geographic miss

1.1:1 DCB with good technique

Accept less than perfect results; only stent prn

If stenting, still need vessel prep (interwoven or nitinol)

My Vessel Prep Algorithm

Limitations of Endovascular Therapy

Flow Limiting

Dissection

1Lesion Length

2

Calcium

3Provisional

Stenting

4

4 Key factors continue to pose a challenge to the use of endovascular approaches as primary therapy

Limitations of Endovascular TreatmentFlow Limiting Dissection1

1. Rosenfield, K., et al. (2015). N Engl J Med 373(2): 145-153.

2. Bard Lutonix Instructions for Use, BAW1387400r3.

3. Schroeder, H., et al. (2017). Circulation.

4. Zeller T, LINC Leipzig, Germany 2017.

5. Krishnan, P., et al. (2017). Circulation.

6. Tepe, G., et al. (2015). Circulation 131(5): 495-502.

7. Brodmann, M. VIVA 2015.

8. Tepe, G. Charing Cross 2016.

9. Scheinert, D. EuroPCR 2015.

Image courtesy of Dr. Eric Scott

Limitations of Endovascular TreatmentLesion Length

2

Primary patency rates may be calculated differently, and therefore may not be directly comparable. Chart is for illustration purposes only.

Ansel, G. VIBRANT 1 year results. LINC 2010. Rocha-Singh, K. J., et al. (2015). Durability II 3 year data. CCI 86(1): 164-170. Bosiers, M., et al. (2011). DURABILITY 200. J VS 54(4): 1042-1050. Gray, W. A., et al. (2015). STROLL 1 year results. JVIR 26(1): 21-28. Laird, J. R., et al. (2012). RESILIENT 3 year results. JEVT 19(1): 1-9. Dake, M. D., et al. (2016). Zilver PTX 5 year results. Circ.

Innova IFU. Garcia, L., et al. (2015). SUPERB 1 year results. Circ-CI 8(5). Ohki, T., et al. (2016). OSPREY 1 year results. JVS 63(2): 370-376 e371. Lammer, J., et al. (2011). STRIDES 1 year results. JVS 54(2): 394-401. Jaff, M. STROLL 3 year results. ISET 2014. Geraghty, P. J., et al. (2013). VIBRANT 3 year results. JVS 58(2): 386-395 e384.

Increased lesion length is an independent predictor of decreased patency

Limitations of Endovascular TreatmentCalcium

3

Calcium is a potential barrier to optimal drug absorption

Calcium distribution and severity may affect late lumen loss (LLL) and primary patency

Primary patency defined as freedom from restenosis by duplex based on PSVR

Limitations of Endovascular Treatment

Provisional Stenting4

DCB use in real-world registries enrolling more complex disease is associated with increased provisional stenting

Provisional stent rates of 40-47%

1. Rosenfield K, et al. New Engl J Med 373:145-53 (2015).2. Presented by Brodmann M, AMP Chicago, USA 2016.3. Presented by Zeller T, LINC Leipzig, Germany 2017.4. Presented by Lyden S, TCT Washington DC, USA 2016.5. Tepe G, et al. Circ 131:495-502 (2015).

6. Laird J, et al. J Am Coll Cardiol 66:2329-38 (2015). 7. Presented by Brodmann M, VIVA Las Vegas, USA 2015.8. Bard Lutonix Instructions for Use, BAW1387400r3.9. Presented by Tepe G, Charing Cross London, UK 2016.10. Presented by Scheinert D, EuroPCR Paris, France 2015.

Primary patency rates may be calculated differently, and therefore may not be directly comparable. Chart is for illustration purposes only.

4

2 Strategies to Maximize Vessel Prep

Both strategies have the potential to maximize luminal gain AND decrease dissections*

*Both strategies have data to support this

Both strategies may increase the effectiveness of DCBs and improve drug delivery, and have potential as an effective stand-alone BTK Rx

These strategies are specialty balloons (e.g. Chocolate balloon) and (Directional) Atherectomy (e.g. Hawks)

Vessel PreparationChocolate PTA Balloon Catheter

Vessel PreparationChocolate PTA Balloon Catheter

Pressure Relief Grooves

Uniform Dilation Pillows

Nitinol constraining structure

Unique nitinol constraining structure reduces the strain and trauma induced on the vessel wall during inflation through the use of "pillows" and grooves to relieve stress, modify the plaque and uniformly distribute circumferential forces to minimize vessel wall trauma

Potential Solution to minimize vessel dissection

CHALLENGES WITH STANDARD PTA

Uncontrolled PTA

Balloon Inflation

3. Longitudinal (Elongating)

Stress & deformation to

vessel wall = Vessel

Trauma

1. Torsional (Twisting) 2. Radial (Expanding)

Flow limiting vessel dissection

Types of Stresses

Can lead to

CHOCOLATE PTA BALLOON

PTA verses Chocolate PTA inflation

Vessel PreparationChocolate PTA Balloon Catheter

Chocolate Bar Study: OverviewLARGE, PROSPECTIVE, POST MARKET STUDY

Study Dates: June 2012-December 2014

Principal Investigator Jihad Mustapha, MD

Number of Sites 33

Patients Enrolled 488

BTK

With planned follow-up through 6 months226

ATK

With planned follow-up through 12 months262

Inclusion Criteria:

Any ATK or BTK lesion with at least 1 vessel

runoff successfully crossed with a guidewire

Use of atherectomy/re-entry devices

accepted

Exclusion Criteria:

Presence of a flow-limiting dissection at the

target lesion prior to use of the Chocolate*

PTA balloon (secondary to the use of

another device)

Patients with Rutherford 6

Chocolate* PTA balloon not used in

accordance with study protocol (2 min

inflation to at least nominal pressure)

Inclusion Criteria Exclusion Criteria

17

Chocolate Bar StudyPATIENT & LESION CHARACTERISTICS

ATK**

N = 262

BTK

N = 226

Population

Average Age (yrs) 69.7 71.5

Male 61.1% (160) 65.9% (149)

Diabetes 50.4%(132) 58.8% (133)

CLI 32.1% (84) 55.8% (126)

Rutherford 5+ 19.1% (50) 37.6% (85)

Total Occlusion 23.0% (60/261) 41.1% (99/241)

Calcification

None / Mild 36.5% (93/255) 67.7% (155/229)

Moderate 43.5% (111/255) 30.1% (69/229)

Severe 2.2% (5/229) 20.0% (51/255)

Lesion Length Average 83.5 mm 66.0 mm

Chocolate Bar Study OUTCOMES

Procedural SuccessATK**

(n = 262)

BTK

(n = 226)

Freedom from Flow Limiting Dissections* (Site Reported) 97.7% 99%

Freedom from Flow Limiting Dissections* (Adjudicated) 100% 100%

Achieved

Dissection Rate in ContextComparison Across Standard and Specialty PTA

12%8%

0%

12%

20%

1%

Bosiers PTA Arm Odink PTA Arm Chocolate BAR

16% 15%

0%

32%

40%

2%

ABSOLUTE PTA Arm RESILIENT PTA Arm Chocolate BAR

ATK BTK

% Bail-out stents placed

% Flow-limiting dissections

1) Schillinger M, et al. NEJM. 2006;354:1879-1888

2) Laird JR, et al. J Endovasc Ther. 2012;19:1-9

3) Data on file with Medtronic CLR782: Final Study Report The Chocolate BAR by TriReme Medical, LLC

4) Boisers M, et al. J Vasc Surg 2012 55(2):390-398

5) Odink H, et al. J Vasc Inter radio. Apr 2012: 23(4):461-467

Directional Atherectomy

SilverHawk, TurboHawk, HawkOne

plaque excision systems

Vessel Preparation

DEFINITIVE ARDEFINITIVE LE

DEFINITIVE LEStudy Overview

Primary OutcomesClaudicant: Primary Patency by Duplex

Ultrasound at 12 months

(PSVR 2.4 with no clinically-driven

reintervention)

CLI: Freedom From Major Unplanned

Amputation at 12 months

800 Patients

47 Sites

US and Europe

Follow up: 1 year

Prospective Multinational, Single Arm Study

Core-Lab Adjudicated*

Objective: Evaluate the effectiveness of standalone

SilverHawk/TurboHawk plaque excision systems

for endovascular treatment of peripheral arterial

disease in the femoropopliteal and tibioperoneal

arteries

*VasCore DUS Core Laboratory, Boston, MA and SynvaCor Angiographic Core Laboratory, Springfield, IL.

McKinsey, J. F., et al. (2014). JACC Cardiovasc Interv 7(8): 923-933.

DEFINITIVE LE

McKinsey, J. F., et al. (2014). JACC Cardiovasc Interv 7(8): 923-933.

Results

Claudicant

n = 598

CLI

n = 201P-value

All Patients

n = 799

Number of Lesions 743 279 n/a 1022

Mean Length (cm SD) 7.5