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PLACQUE MODIFICATION DEVICES AND COMPLEX LESIONS ARTHUR LEE MD KAISER PERMANENTE Kaiser Southbay Interventional Cardiology... PLACQUE MODIFICATION TREAT SPECIFIC RESISTANT LESIONS TO

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PLACQUE MODIFICATION

DEVICES AND

COMPLEX LESIONS

ARTHUR LEE MD KAISER PERMANENTE

Kaiser Southbay Interventional Cardiology

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TREAT SPECIFIC RESISTANT LESIONS

TO ALLOW PASSAGE OF DEVICES

IMPROVE PROCEDURE SUCCESS

AND LOWER PROCEDURE TIME

IMPROVE LONG TERM OUTCOMES

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LESION PREPARATION

Virmani R, Farb A, Burke AP Coronary angioplasty from the

perspective of atherosclerotic plaque: Morphologic predictors

of immediate success and restenosis Am Heart

J 1994;127:163–79

• Patients with

diabetes, renal failure and hypertension

• Older patients who

fail medical therapy

Challenging Lesions

• Plaque modification

to improve vessel compliance

Vessel Compliance

• Enable full stent expansion, which is related to a reduction

in ISR, TLR, and stent thrombosis

Clinical Outcomes

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Flextome® Cutting Balloon® Device

Conventional Angioplasty + Microsurgical Technology

ATHEROTOMES

• Affixed to a nylon non-compliant balloon

• Expand radically as balloon is inflated to

score arterial plaque

Maverick® Catheter platform

Atherotome:

microsurgical blade with flex points

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Porcine artery model

Mechanism of Action

Atherotome

0.014” Wire

Relative Size

Bonan, J Invasiv Cardiol, 1999; 11: 230 Photo taken by Boston Scientific Results of pre-clinical studies are not predictive of clinical

performance Clinical results may vary

• Atherotome creates microsurgical incision in the vessel wall

• Weakened areas can then be dilated at lower pressures, changing lesion compliance

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AngioSculpt PTCA

three rectangular spiral struts works in tandem with a semi-compliant balloon to prep the target lesion for DES

of the device size to vessel size (2–20 atm)

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Better Stent Expansion with Angiosculpt

• Final stent luminal dimensions are an important

predictor of better long-term results4

• Pre-dilatation yields a 33%–50% greater luminal gain

than direct stenting or pre-dilatation with a conventional angioplasty balloon catheter (p>0.004)1

• Pre-dilatation resulted in a post-stent luminal area ≥5.0

mm2 89% of the time, compared to only 74% with direct stenting or pre-dilatation with a conventional

angioplasty balloon catheter (p<0.001)1

• Larger post-stent luminal dimensions than direct

stenting or pre-dilatation with a conventional balloon regardless of the type of lesion plaque morphology (i.e., soft, fibrotic, calcific or mixed plaque) 1

1 Costa JR, Mintz GS, Carlier SG et al Nonrandomized Comparison of Coronary Stenting Under IVUS

Guidance of Direct Stenting Without Predilation Versus Conventional Predilation With a Semi-Compliant

Balloon Versus Predilation With a New Scoring Balloon Am J Cardiol, 2007; 100:812-817

042015

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Increasing Complexity and Calcification

of PCI Patients

32.0

2022242628303234

ACC/AHA LESION

CLASSIFICATION

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A Closer Look – RCA Example

Rotablator® Atherectomy System, POBA, and Stent

Images courtesy of Georg Gaul, MD, FESC, Vienna, Austria

Results from case studies are not predictive of results in other cases Results in other cases may vary

After Rotablator®

Atherectomy

After Pre-Dilation

After Stenting

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On-handle speed control

• Low (80K) and High Speed (120K)

Power on/off switch

• 8 cm axial travel

Electric motor powered handle 6Fr Guide Compatible

Saline Sheath

Saline Infusion Pump

• Mounts directly on to an IV pole

• 20ml ViperSlide per liter

of saline

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Burr Action

Burr spins concentrically on wire Crown oscillates in orbital path

Lumen Sizing Lumen size = burr size Lumen size = f(time, speed,

passes)

Lumen

Results More concentric More eccentric

Grit Size

Rotational vs Orbital Atherectomy

5 µ exposed diamonds 10 µ exposed cutting

surface

Data presented by J Moses at CRF Fellows 2014

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Differential Sanding Healthy elastic tissue flexes away minimizing damage to the

vessel

The Physics that Drive the Orbital Atherectomy System

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Crossing Profile

~0.66 mm (.026”)

Nose Cone

5 mm (.20”)

*CSI Classic Crown Data presented by J Moses at CRF Fellows 2014 Diamondback 360 Coronary Orbital

Atherectomy System IFU

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CSI-OAS

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Defined as death, MI and TVR RA= rotational atherectomy

1 Richert, G presented at TCT2011 2 Abdel-Wahab, et al JACC Cardiovasc Interv 2013 Jan;6(1):10-9

p = 1.0

p = 0.78 p = 0.79 p = 0.73 p= 0.84 p = 0.46

“Although routine RA did not improve DES efficacy, RA remains

an important tool for uncrossable or undilatable lesions and

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ORBIT II Safety Outcomes 1

In Hospital

MACE 9.8% 10.4% 16.4% 19.4%

MI*

Non Q-wave Q- wave

* Based on reported CK-MB > 3X ULN

1 Chambers JW, et Al Diamondback 360 Coronary Orbital Atherectomy System for Treating De Novo, Severely

Calcified Lesions: 2-Year Results of the Pivotal ORBIT II Trial Presented at CRT 2015

2 Moussa ID, et al J Am Coll Cardiol 2013;62:1563-70

Demonstrated that OAS is safe in treating de novo

severely calcified coronary lesions

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Results from different studies are not directly comparable Information provided for educational use only

complications in a world patient

real-population

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ORBIT II TRIAL 2 YEAR OUTCOMES

PROSPECTIVE MULTICENTER TRIAL OF

ORBITAL ATHERECTOMY PRIOR STENTING SINGLE ARM WITHOUT COMPARATOR

90% HIGHLY CALCIFIED LESIONS

HALF OF MACE OCCURRED DURING INDEX

HOSPITALIZATION

BMS DES1 DES2 TVR 15.1 7.7 7.0

TLR 15.1 6.3 5.0

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Technology Timeline

patient…

and that’s just the beginning!

1994

994

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Mechanism of Action

spectrum of morphologies

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LASER APPLICATIONS 2016

STANDARD USE UNDEREXPANDED STENTS

LASER BOMB PROXIMAL CAP TREATMENT WITH CTO

IN STENT RESTENOSIS

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Results sub-optimal

Results from case studies are not predictive of results in other cases Results in other cases may vary

Case images courtesy of Dr Arthur Lee, Santa Clara Valley Medical Center, Kaiser Permanente, San Jose, CA

Clinical Application

Case Example – “Rota Regret”

Single 2.75 mm stent placed

Post Dilatation:

• 3.5x9mm NC balloon x 30 sec @ 22 atm

• 4.0x9mm NC balloon x 30 sec @ 16 atm

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The Way It Is

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Challenge Of Stent Delivery From Calcium

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ROTABLATOR FOR CTO

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LEFT MAIN MODIFICATION

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LEFT MAIN LESION

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ROTA STRATEGY

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FINAL

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FINAL

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CTO AND MULTIPLE DEVICES

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COMPLEX LESION

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COLLATERALS

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SUBINTIMAL

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LASER

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ROTABLATOR

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FINAL

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4 YEARS LATER

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CALCIFIED BIFURCATION

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SUPPORT

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DEVICE CROSSING

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ROTABLATOR

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FINAL

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THANK YOU

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