Post on 28-May-2018
Lithoplasty- also an option for calcified BTK vessels?
Update on the Shockwave BTK Study
Thomas Zeller, MD
Disclosure
Speaker name: Thomas Zeller
.................................................................................
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