What Are the Best Tools to Prepare the Calcified Artery ...
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What Are the Best Tools toPrepare the Calcified Artery?
Atherectomy, SerrationAngioplasty, Scoring, Lithotripsy
Ehrin J. Armstrong MD MSc FACC FSCAI FSVM
Professor of Cardiology
University of Colorado
Denver, CO USA
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DisclosureSpeaker name:
.................................................................................
I have the following potential conflicts of interest to report:
x 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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Importance of Vessel Preparation for CalcifiedLesions• Calcified lesions remain a significant barrier to optimal vessel
preparation.
• Difficulty in obtaining optimal luminal gain.
• More likely to cause severe dissection.
• Independent predictor of lesion failure, esp for DCBs
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Orbital Atherectomy
• Offset crown that modifies calcific plaque.
• Provides some debulking, increases compliance of vessel.
Peripheral
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Differential Sanding and Centrifugal Force
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Dealing with Calcification
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Dealing with Calcification 2.0 mm Crown
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Shammas et al, J Endovasc Ther 2012;19:480-488
• 50 patients with CLI• Randomized to POBA or orbital atherectomy + POBA
• All lesions with >25% angiographic calcium
• Mean lesion length 69 vs. 91 mm
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• Procedural success 93% for OA, 82% for POBA
• Bailout stenting 7% vs. 14%
• One year freedom from TLR 93% vs. 89%.
Shammas et al, J Endovasc Ther 2012;19:480-488
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Balloon Diameter
(mm)
Balloon Length (mm)
Guidewire Compatibility
Sheath Size (F)
Number of Strips
2.5, 3.0, 3.5
400.014" 6 380
120Catheter Length: 150cm
Serration Technology provides effective and stable lumen gain
• Effective: achieving nominal lumen diameter• Stable: resulting in minimal dissection
Indication for Use:
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
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Mechanism of Action: Serration Angioplasty
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for Effective and Stable Lumen Gain
Serrating Elements use “Point Force”
• Applies 1,000x the force compared to POBA
• Enables low pressure inflation (6 ATM*)
3 Linear Serrated Strips (120˚ apart)
• Symmetrical Stress Relief ensures equal pressure across treatment segment
• Opens resistant lesions
*PRELUDE-BTK Study: 6ATM Average Maximum Pressure
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PRELUDE-BTK Study Completed: (n=49)
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Inclusion Exclusion
Rutherford 3, 4 or 5 (< 20% of subjects enrolled with R3) Rutherford 1, 2, or 6
RVD between 2.5 – 3.5 Previously implanted stent
Up to 2 lesions within infrapopliteal tibial arteries CTO > 12 cm
Stenosis > 70% Evidence of acute thrombus
Lesion(s) length < 12 cm Atherectomy
De-novo, or non-stented restenotic lesions 2 lesions in 1 vessel, only 1 qualifies
Objective
Study Design
Core Lab Assessment
Follow-up
Assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.
Single Arm, Prospective Multi-center Study with atherosclerotic lesions in the
infrapopliteal arteries and/or Critical Limb Ischemia (CLI).
Corelab assessments Angiogram OCT, IVUS
Co-PIs
30 day & 6 month100% data monitoring by local CRO
Drs. Andrew Holden & Michael Lichtenberg
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Case Example: Proximal & Distal Posterior Tibial
Pre-Procedure Inflation #2 Post Final
Stenosis: 80%Lesion Length: 119.96mm
Residual Stenosis: 22%Lesion Length: 152.64mmDissection: No
PRELUDE-BTK Study: Case Example 07-001
3.0 x 120 SerranatorMax ATM: 6
Performed by Dr. Klaus Hertting
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Scoring Balloon Angioplasty
• High performance balloon for precision, power, and safety
• Minimal slippage
• More dilatation force
• Low dissection rate
• Optimized vessel prep
• Score plaque
• Score calcium
• PANTHER study• 101 patients
• Overall patency 83.9% at 12 months
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Angiosculpt Example
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Intravascular Lithotripsy (IVL): Localized Lithotripsy to Treat Cardiovascular Calcium
Peripheral IVL Catheters
Inspired by urological applications, but designed for cardiovascular system
Lithotripsy
30 years of safety data
in kidney stone treatment
Sonic Pressure Waves preferentially impact hard tissue,
disrupt calcium, leave soft tissue undisturbed
Cardiovascular Lithotripsy
Miniaturized and arrayed Lithotripsy Emitters for
localized lithotripsy at the site of the vascular calcium
Optimized for the Treatment of
Cardiovascular Calcium
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Shockwave IVL System Components
The Shockwave IVL System consists of an IV pole-mountable generator, a connector cable, and a catheter that houses an array of lithotripsy emitters enclosed in an integrated balloon.
IVL
Generator
COMPACT & RECHARGABLE
Portable, IV-pole Mountable
Battery-Powered
No External Connections
IVL Connector
Cable
SIMPLE & QUICK
Smart Magnetic Connection
Push-Button Activated
IVL Catheter
INTUITIVE & SAFE
OTW System
Any .014” Guidewire
Standard PTA Technique
180 Lithotripsy Pulses
Integrated
PTA
Balloon
Lithotripsy
Emitters
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Peripheral IVL Catheter Specs
DIAMETER (mm)
LENGTH (mm)
Max Pulse Count GUIDEWIRE
COMPATIBILITY (in)
SHEATH COMPATIBILITY
WORKINGLENGTH
(cm)
3.5-6.0 60 300 0.014 6F 110
6.5-7.0 60 300 0.014 7F 110
DIAMETER (mm)
LENGTH (mm)
Max Pulse Count GUIDEWIRE
COMPATIBILITY (in)
SHEATH COMPATIBILITY
WORKINGLENGTH
(cm)
2.5-4.0 40 160 0.014 5F 135
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Summary and Conclusions
• Calcium remains a barrier to optimal endovascular therapy
• Multiple options for vessel preparation in calcium• Atherectomy
• Serration balloon angioplasty
• Scoring balloon angioplasty
• Intravascular lithotripsy
• Need data for combining these therapies with subsequent treatments