Lithoplasty- also an option for calcified BTK vessels?

Update on the Shockwave BTK Study

Thomas Zeller, MD

Disclosure

Speaker name: Thomas Zeller

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I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

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Challenges Associated with Problematic Calcium: Below the Knee

Most BTK vessels undergo significant elastic recoil following angioplasty1

1) Baumann et al, Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia, J Endovasc Ther 2014

2) Guzman et al, Tibial artery calcification as a marker of amputation risk in patients with PAD, JACC 2008

3) Zettervall et al, Association of arterial calcification with CLI in patients with PAD, J Vasc Surg 2017

4) Mustapha et al, One-Month Duplex Ultrasound Evaluation of Vessel Recoil After Tibial Peripheral Vascular Intervention for Critical Limb Ischemia Predicts 12m TLR, AMP 2017

29% av. vessel

recoil 15m after

POBA

97% vessels

had >10% recoil

15m after POBA

Medial calcification

Arterial Stiffness Vessel recoil

Medial calcification produces vessel recoil and restenosis2,3,4

Restenosis

POBAInitial

Angiogram

Angiogram

after 15m

Localized Lithotripsy to Treat Vascular Calcium

Lithotripsy

30 years of safety data

in kidney stone treatment

Sonic Pressure Waves preferentially

impact hard tissue, disrupt calcium, leave

soft tissue undisturbed

Lithoplasty Technology

Miniaturized and arrayed Lithotripsy

Emitters for localized lithotripsy at

the site of the vascular calcium

Optimized for the treatment of

vascular calcium

Lithotripsy Emitters

Shockwave Peripheral Intravascular Lithotripsy (IVL) System

Generator

Connector Cable

Lithoplasty Catheter

IVL: Hard on Hard Calcium, Soft on Soft Tissue

DISRUPT PAD Study:

Femoropopliteal Disease

• Two-phase, prospective, non-randomized, multi-center study

• Monitoring with 100% source document verification

• Independent angiographic and duplex ultrasound core labs

• Independent clinical events committee

Objective: To study the safety and effectiveness of the Shockwave Medical IntrvascularLithotripsy System in the treatment of calcified, stenotic infrainguinalperipheral arteries.

DISRUPT PAD I35 subjects, 3 sites

Jan 2014 – Sep 2014

DISRUPT PAD II60 subjects, 8 sites

Jun 2015 – Dec 2015

DISRUPT PAD I/II: Patient Demographics and Angiographic Findings†

Patients Included

Rutherford 2 33.7% (32)

Rutherford 3 65.3% (62)

Rutherford 4 1.1% (1)

Rutherford 5 -

CalcificationModerate 44.2% (42)

Severe 54.7% (52)

AngiographicFindings

RVD (mm) 5.3

Lesion length 71.9

Calcified length 92.5

CTO 18.9% (18)

DISRUPT PAD I/IIN = 95

DISRUPT PAD & DISRUPT BTK categorized calcified lesions as per PARC definitions. Both studies utilized independent core labs and clinical events committees.DISRUPT BTK data based on European studies.

†Core lab adjudicated

DISRUPT PAD I/II: Safety & Effectiveness†

Safety

Dissections1% (1) Grade D or greater

1% (1) stent placed

Embolization0 Embolic Events

8% EPD Usage

Perforations, abrupt closure, slow/no reflow or thrombosis

0 Complications

Effectiveness

Residual

Stenosis23.8%

Acute Gain 2.9mm

Follow-Up

30 days100% Freedom from TLR

100% Patency

6 months96.8% Freedom from TLR

76.7% Patency

DISRUPT PAD & DISRUPT BTK categorized calcified lesions as per PARC definitions. Both studies utilized independent core labs and clinical events committees.DISRUPT BTK data based on European studies.

DISRUPT PAD I/IIN = 95

†Core lab adjudicated

DISRUPT BTK Study: Infrapopliteal Disease

Design

Key eligibility criteria

• Rutherford category 1-5 infrapoplitealdisease

• Infrapopliteal lesions ≥50% stenosis

• RVD 2.5–3.5 mm, ≤150 mm length

• Moderate and severe calcification by angiography

Endpoints

Procedural

• Primary Effectiveness: Acute reduction in % diameter stenosis

Follow up: 30 days

• Major adverse events (Death, MI, TLR, amputation)

Objective: To study the safety and performance of the Shockwave Medical Lithoplasty®

System in the treatment of calcified, stenotic infrapoplitealperipheral arteries.

DISRUPT BTK: Patient Demographics and Angiographic Findings†

Brodmann, M. Presentation, CIRSE, 2017

Baseline Characteristics N = 20

Age, years, mean ± SD 79±9.6

Male Gender, % (n) 70.0% (14)

Diabetes, % (n) 40.0% (8)

Hypertension, % (n) 95.0% (19)

Hyperlipidemia, % (n) 75.0% (15)

Renal Insufficiency, % (n) 40.0% (8)

Coronary Artery Disease, % (n) 40.0% (8)

Current or Former Smoker, % (n) 25.0% (5)

Rutherford Class, % (n)RC 3RC 4RC 5

20.0% (4)5.0% (1)

75.0% (15)

Pre-procedureN=21 lesions, 19 subjects

Tibio-peroneal trunkAnterior tibialPosterior tibialPeronealPopliteal artery below knee

9.5% (2)38.1% (8)38.1% (8)9.5% (2)4.8% (1)

Reference vessel diameter, mm, mean ± SD (range)

3.2 ± 0.6(2.4-4.8)

Lesion length, mm, mean ± SD (range)

52.2 ± 35.8(13.8-144.0)

Calcified length, mm, mean ± SD (range)

72.1 ± 37.6(12.4-172.6)

Calcification, % (n)ModerateSevere

52.4% (11)47.6% (9)

Mean luminal diameter, mm, mean ± SD (range)

.9 ± 0.6(0.0-1.9)

Diameter stenosis, % 72.6%

Moderate Calcification: densities noted only prior to contrast injection.

Severe Calcification: radiopacities noted prior to contrast injection

generally involving both sides of the arterial wall

†Core lab adjudicated

DISRUPT BTK: Safety & Effectiveness†

Brodmann, M. Presentation, CIRSE, 2017

Endpoint % (n)Primary Safety Endpoint: MAE rate @ 30 days 0% (0/20)Primary Effectiveness Endpoint: Acute reduction in % stenosis

46.5% (19/19*)

Secondary Endpoint: Post-IVL residual stenosis of ≤50%

100% (19/19*)

Final ProcedureN=21 lesions, 19 subjects

Mean luminal diameter, mm, mean ± SD (range)

2.4 ± 0.5(1.5-3.6)

Diameter stenosis, % 26.2%Diameter stenosis reduction, % 46.5.%Acute gain, mm, mean ± SD (range)

1.5± 0.5(0.7-2.3)

Dissection 4.8.% (1)

Perforation 0% (0)

Distal embolization 0% (0)

Thrombus 0% (0)

No reflow 0% (0)

Abrupt closure 0% (0)

†Core lab adjudicated

*In 1 patient, the IVL catheter was unable to cross

Case Example

Pre Procedure

RVD = 2.45 mm

Pre %DS = 95.82%

2.75 mm IVL Cath

120 pulses

IVL Procedure

Case Example: Final Result

No vascular complications

No post dilatation

Pre Procedure

RVD = 2.45 mm

Pre %DS = 95.82%

Final Result

%DS = 21.76%

Case Example

Case courtesy of: Prof Marianne Brodmann

Diagnostic

Angiogram

Procedural

Angiogram

Final

AngiogramCalcification

3.3 mm RVD

96% stenosis

47.8 mm length

2.5 x 60 mm IVL Catheter

2.0 x 120 Armada PTA of TP Trunk

17.8% stenosis

Acute gain 2.3 mm

DISRUPT BTK: Summary

• IVL is designed to treat both intimal and medial calcium allowing vessel expansion with minimal angiographic complications

• Acute results show low residual stenosis with minimal vascular complications including no perforations, distal embolization, no reflow or abrupt closure

• 30 day safety results report no MAE including revascularization or amputation.

• Infrapopliteal results in a heavily calcified, CLI population are consistent with fem-pop IVL experience including low residual stenosis and minimal vascular complications.

Lithoplasty- also an option for calcified BTK vessels?

Update on the Shockwave BTK Study

Thomas Zeller, MD