Coronary Calcium Modification

D R N A J E E B U L L A H S O F I
L P S I N S T I T U T E O F C A R D I O L O G Y
Coronary Calcium Modification

Introduction
 Coronary artery calcification (CAC) results in reduced vascular
compliance, abnormal vasomotor responses, and impaired
myocardial perfusion.
 The presence of CAC is associated with worse outcomes in the
general population and in patients undergoing revascularization
 Two recognized types of CAC are
1. Atherosclerotic (Intimal)
2. Medial artery calcification.

 Inflammatory mediators and elevated lipid
content within atherosclerotic lesions
induce osteogenic differentiation of VSMCs.
 Conversely, CAC in the media is associated
with advanced age, diabetes, and chronic
kidney disease (CKD). Previously thought
to be a benign process, medial calcification
contributes to arterial stiffness, which
increases risk for adverse cardiovascular
events.

 The extent of CAC strongly correlates with the degree of atherosclerosis and the rate of future
cardiac events.
 The extent of CAC correlates with plaque burden.
 Stable coronary lesions are associated with more calcium than unstable lesions.
 Microcalcifications in the fibrous cap might promote cavitation-induced plaque rupture.
Additionally, calcific nodules might disrupt the fibrous cap, leading to thrombosis.
 Recurrent plaque rupture and hemorrhage with subsequent healing might result in the
development of obstructive fibrocalcific lesions and are frequently found in patients with stable
angina and sudden coronary death.

 Asymptomatic persons without traditional risk factors but with a documented CAC score 400
HU might have a worse cardiovascular prognosis than those with 3 risk factors but no CT-
detected CAC.
 As a result, the most recent AmericanCollege of Cardiology/American Heart Association
guidelines note that noninvasive measurement of CAC score is reasonable for cardiovascular risk
assessment in asymptomatic patients at intermediate risk (those with a 10% to 20% rate of
coronary events over 10 years; class IIa, Level of Evidence: B)

Modalities for Detection of Micro & Macrocalcification
Nakahara T et al., JACC Cardiovasc Imaging. 2017 May;10(5):582-593

Nakahara T et al., JACC Cardiovasc Imaging. 2017 May;10(5):582-593
Modalities for Detection of Micro & Macrocalcification

Detection, Localization, and Quantification of Coronary Calcium by
Various Imaging Modalities
Coronary angiography,
coronary computed tomography
(CT), intravascular ultrasound
(IVUS), radiofrequency (RF)
intravascular ultrasound-virtual
histology (IVUS-VH),and optical
coherence tomography (OCT)
can all detect and attempt to
localize and quantify calcium,
albeit with very different
diagnostic accuracies

Interventional adjuncts to balloon angioplasty for modification of
calcified lesions
Tomey MI, Sharma SK.,Curr Cardiol Rep. 2016 Feb;18(2):12

Interventional adjuncts to balloon angioplasty for modification of
calcified lesions
In patients with de novo calcified
lesions for whom PCI is indicated
clinically, lesion modification via
rotational or orbital atherectomy is
appropriate in order to facilitate
procedural success when calcification
is severe. If calcification severity is
intermediate or indeterminate by
angiography, intravascular imaging
with IVUS or OCT may be useful for
reclassification.

 Polyethylene terephthalate (PET)
 Frequently used for post-dilation of DES to ensure appropriate stent
deployment.
 Also used to predilate calcified coronary lesions.
 Have little change in volume, even at high pressures concentrating dilating force
at the calcified lesion site.
 Exert more dilating force against a lesion than compliant balloons for a given
balloon size and inflation pressure.
 Greater forces can be applied focally without overstretching other parts of
diseased segment.
1. Non Compliant (NC) Balloons

Advantages
1. Effective in severe ISR due to stent
under-expansion
2. Can be safely used in severely calcified
coronary lesions for lesion preparation
when conventional balloons fail
3. Reduced risk of balloon rupture, vessel
damage & coronary perforation
Non Compliant (NC) Balloons

 They improve vessel compliance by creating discrete longitudinal incisions in the atherosclerotic plaque, enabling
greater lesion expansion and reducing recoil while preventing uncontrolled dissections.
 Delivers a controlled fault line during dilatation to ensure that the crack propagation ensues in an orderly fashion.
 Balloon inflation is at lower inflation pressures (4-8 atmospheres).
 Cause less injury to target vessel.
 Decrease neoproliferative response therefore less in-stent restenosis.
 Blades, which are fixed longitudinally on outer surface of a non-complaint balloon, expand radially and deliver
longitudinal incisions in plaque relieving its hoop stress.
 Unique design protect vessel from edges of atherotomes when it is deflated.
 This minimizes risk of trauma to vessel as balloon is passed to and from target lesion.
2. Cutting Balloons

3. AngioSculpt: Scoring Balloon
 AngioSculpt Scoring Balloon Catheter is a modification of cutting balloon technique.
 It has a flexible nitinol scoring element with three rectangular spiral struts which work in
tandem with a semi-compliant balloon to score the target lesion.
 Balloon inflation focuses uniform radial forces along the edges of the nitinol element,
scoring the plaque and resulting in a more precise and predictable outcome.
 Nitinol-enhanced balloon deflations provide for excellent rewrap and recross capabilities.
 Used successfully in treating fibro-calcific, bifurcation and ostial lesions.
 Yield 33%-50% greater luminal gain when used for pre-dilatation prior to stenting.
 Used to treat patients in whom stent implantation is not desirable - including small vessels, in-
stent restenosis, bifurcation side-branch.

4. Rotational Atherectomy: General Concepts
 RotA devices use a rotating diamond-coated elliptical brass burr that pulverizes a portion of
fibrous, calcified plaque, modifies plaque compliance, and leaves a smooth, nonendothelialized
surface with intact media.
 The RA device employs a diamond-coated elliptical burr, which can reach rotational speeds as
high as 200,000 rpm, abrading hard tissue into smaller particles (<10 mm) while deflecting off
softer elastic tissue
 Based on the principle of differential atherectomy, namely selective atherectomy of the fibrous
and calcified plaque
 Successful RotA results in creation of a smooth vessel lumen, suitable for the successful
performance of balloon angioplasty and stenting at the site of the lesion

Differential atherectomy
The concept of differential atherectomy: the rotablation preferentially ablates inelastic, calcified,
atherosclerotic
.

 In the pre-stent era, use of RA alone was
associated with increased neointimal hyperplasia,
restenosis, and repeat revascularization, most
likely due to platelet activation and thermal injury
 Patients with calcified lesions undergoing RA are at
increased risk for thrombus formation and slow or
no reflow, with increased rates of periprocedural MI
 Thus, RA cannot routinely be recommended in
calcified lesions if full balloon expansion is
anticipated before DES implantation.
 The latest PCI guidelines state that RA is a
reasonable strategy in calcified lesions that are not
crossable by a balloon catheter or adequately
dilated before stent implantation (Class IIa, Level of
Evidence: C)
 ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment
for Complex Native Coronary Artery Disease) trial was performed
to determine whether lesion preparation with RA
before paclitaxel-eluting stent (PES) implantation
provides benefits compared with PES with balloon pre-
dilation alone in calcified lesions.
 Despite an early acute lumen gain advantage with RA,
9-month angiographic follow-up revealed higher late
loss in the RA group. Rates of restenosis, target lesion
revascularization, definite stent thrombosis, and
MACE were not significantly different between the
groups.

Histology cross-sections post balloon (left) and post Rota (right)

Rotational Atherectomy: Complications
 Myocardial infarction
 Emergency CABG
 Coronary artery dissection
 No reflow phenomenon, due to
peripheral embolization,
 Perforation or severe coronary
artery spasm
Wire bias can occur in tortuous vessels, increasing the risk of perforation

Rotational Atherectomy: Contraindications
 Coronary dissection
 Severe thrombosis
 Severe tortuosity
 Vein grafts due to the increased risk of dissection and distal
embolization

Rotational Ablator System Failure
 Despite mechanical complexity of system ,device failure is a rare event
 Majority of device failure is due to use of the device outside the
standard operations.
 These are
1. burr entrapment
2. burr detachment
3. burr installing
4. guide wire fracture

Burr entrapment Burr Detachment
 Can occur if a burr slips across the lesion
without the burring (coefficient of friction
is less at the high speed than at the rest )
 Ledge of the calcium behind the elliptical
burr causes “Kokesi” effect
 It may get entrapped in the tortuous
segment of the lesion
 Associated with excessive force applied to
remove non spinning burr from tortuous
artery
 To avoid this ,do not use burrs with <
0.004” clearance for the GC
 If clearance is less than 0.004” then slow
inactivated withdrawal of burr is best
method to enter GC
 While exchanging the burr verify that GC is
in co axial position with the artery so burr
doesn't get trapped onto tip.

Burr Installing
 When there is significant resistance to
rotation.
 Kinking of the air hose
 Over tightening of the “Y” connector
 B: A ratio 1.0
 Aggressive advancement in tight lesions
 Spasm in the platform zone
 Operation without saline infusion
Guidewire Fracture
 Result of excessive rotation of the
burr in angulated and tortuous
arteries
 Long ablation time
 Formation of loop of which fractures
as operator pulls on the wire to
remove the loop

How to minimize the problem
 Keep the GW out of small branches.
 Reposition the GW frequently during the
excessively long ablations.
 Fasten the wire clip properly.
 Avoid prolapsing the guide wire tip.
 Inject contrast to demonstrate the flow
around the guide wire
Retrieval Of Fractured Wire
 Fractured guide wire portions can be
retrieved with the different types of
SNARES and retrieval BASKETS or
FORCEPS
 If unsuccessful and of no hemodynamic
consequences can be left alone with
conservative medical management

Longitudinal calcified LAD lesion
A. Localised calcified longitudinal lesion of the left anterior descending artery before the origin of the first diagonal
branch (black arrow).
B. Restoration of vessel patency with the combination of rotational atherectomy and drug eluting stent (white
arrow).

Calcified ostial RCA lesion
A. Calcified ostial lesion in the right coronary artery (black arrow).
B. Restoration of vessel patency with the combination of rotational atherectomy and drug-eluting stent (white
arrow).

Orbital Atherectomy
 Orbital atherectomy(OA) exerts a differential ablative effect on hard and soft surfaces, producing
particles <2 mm in size.
 This recently U.S. Food and Drug Administration-approved system consists of a diamond-
coated crown, which orbits over the atherectomy guidewire in an elliptical path, exerting a
centrifugal force on the vessel wall.
 In contrast to RA, the ablative element is located laterally on the coil, which consists of 3
helically-wound wires that can be compressed with the application of pressure like a spring.
 The device allows the physician to control ablation depth, with increasing rotational speed
(ranging from 60,000 to 120,000 rpm) translating to a larger orbit of rotation.
 In addition, orbital motion might allow for greater blood flow with less heat generation and
thermal injury during the procedure.

Comparison of Rotational & Orbital Atherectomy

LASER CORONARY ATHERECTOMY
 Pulsed excimer or holmium laser energy generates transient high-pressure waves, which can
dilate resistant lesions through a photoacoustic mechanism.
 Studies evaluating laser coronary atherectomy (LCA) in calcified and noncalcified lesions show
inconsistent results and the potential for procedural complications such as vessel dissection
(especially with superficial calcium) and perforation and higher rates of restenosis.
 Restenosis rates following laser angioplasty are not lower than with Baloon Angioplasty alone.
 IVUS has not shown qualitative or quantitative evidence of substantial calcium ablation by LCA.
Nonetheless, LCA has a role in calcified lesions to shatter calcium behind previously implanted
stent struts in cases of marked stent underexpansion.

Disrupt CAD 1 Trial
Objective :To assess the safety and performance of the Shockwave
Medical Coronary Rx Lithoplasty® System

Endpoints
Primary Performance Endpoint
 Clinical Success defined as residual stenosis
(<50%) after stenting with no evidence of
in-hospital MACE
Primary Safety Endpoint:
 MACE within 30 days defined as: Cardiac
death, MI or TVR

60 patients enrollment completed in Sep 2016
Investigational Sites

Pre-procedure Angiographic Findings core lab adjudicated

Procedural Characteristics
*1.5mm PTCA balloon was allowed to facilitate OCT imaging

• Clinical success defined as residual stenosis <50% after stenting with no evidence of in-hospital MACE.
• Device success defined as successful device delivery and Lithoplasty treatment at the target lesion
Primary Performance Outcomes

OCT Tertile Analysis By Calcium Burden

CONCLUSIONS
 DISRUPT CAD Study successfully enrolled a population with Complex, Calcified, Obstructive
Coronary disease.
 Lithoplasty balloon-based therapy resulted in 98% device success and facilitated 100% stent
delivery.
 Demonstrated low MACE rate (5.0%) with minimal vascular complications.
 Angiographic analysis demonstrated high acute gain & low residual stenosis.
 OCT sub-study showed clear evidence of circumferential calcium fracture as the mechanism for
vessel dilatation prior to stent placement.
 OCT sub-study demonstrated high luminal acute gain independent of the degree of calcification
in this hard to treat population.

 The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery
calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery
Disease)
 We next sought to confirm the safety and effectiveness of IVL for these lesions.
Background

Study Design
 Disrupt CAD II study was a prospective
multicenter, single-arm post-approval
study conducted at 15 hospitals in 9
countries
 Study was designed to assess the safety and
performance of the Coronary IVL System to
treat calcified, stenotic, de novo coronary
lesions before stenting
Methods
 Patients with severe CAC with a clinical
indication for revascularization underwent
vessel preparation for stent implantation with
IVL.
 Optical coherence tomography substudy was
performed to evaluate mechanism of action of
IVL, quantifying CAC characteristics &
calcium plaque fracture.
 Angiography and optical coherence
tomography, and major adverse cardiac
events were adjudicated.

End Points
Primary end point
 In-hospital major adverse cardiac events
(cardiac death, MI, or target vessel
revascularization)
Secondary end points
 Clinical success: defined as the ability of IVL to
produce a residual diameter stenosis <50% after
stenting with no evidence of in-hospital MACE.
 Angiographic success: defined as success in
facilitating stent delivery with <50% residual
stenosis and without serious angiographic
complications (severe dissection impairing flow
[type D–F], perforation, abrupt closure,
persistent slow flow, or no reflow).

Baseline and Clinical Demographics

Results
 Between May 2018 and March 2019, 120
patients were enrolled.
 Severe CAC was present in 94.2% of
lesions.
 Successful delivery and use of the IVL
catheter was achieved in all patients..
 The post-IVL angiographic acute luminal
gain was 0.83±0.47 mm, and residual
stenosis was 32.7±10.4%, which further
decreased to 7.8±7.1% after drug-eluting
stent implantation.
 Primary end point occurred in 5.8% of
patients, consisting of 7 non–Q-wave
Myocardial infarctions.
 There was no procedural abrupt closure,
slow or no reflow, or perforations.
 In 47 patients with post-percutaneous
coronary intervention optical coherence
tomography, calcium fracture was identified
in 78.7% of lesions with 3.4±2.6 fractures
per lesion, measuring 5.5±5.0 mm in length

Shockwave IVL for lesion modification of severe CAC
IVL: Intravascular Lithotripsy; CAC: Coronary artery calcification

Clinical and Angiographic Outcomes

OCT: Optical coherence tomography; IVL: Intravascular Lithotripsy; CAC: Coronary artery calcification
OCT images of Shockwave IVL for lesion modification of severe CAC

OCT: Optical coherence tomography; IVL: Intravascular Lithotripsy
OCT Characteristics of Calcium Fracture Induced by IVL

Conclusions
 In patients with severe CAC who require coronary revascularization, IVL was
safely performed with high procedural success and minimal complications and
resulted in substantial calcific plaque fracture in most lesions.

Principles of Intravascular Lithotripsy
Lithotripsy technology in the coronary arteries for the treatment of
coronary calcification was first performed in 2016
IVL equipment. (A) Pulse-generating console attached to the wand device used to connect console to
lithotripsy balloon. (B) Lithotripsy balloon highlighting the balloon high-energy pulse generating transducers

 The IVL catheter contains multiple lithotripsy emitters enclosed within a balloon.
 The emitters convert electrical energy, delivered by an external pulse generator, into transient
acoustic circumferential pressure pulses, or sonic pressure waves, that selectively fracture
calcium within the vascular plaque, thereby altering vessel compliance.
 The balloon catheter is advanced to the target lesion in the typical fashion over a standard 0.36-
mm (0.014) coronary guidewire. The balloon is attached to the external pulse generator.
 After the balloon is inflated at low pressure (4 atm) to avoid barotrauma, a burst of 10 pulses of
high energy is delivered over 10 seconds followed by further balloon dilatation (at 6 atm) before
deflation of the balloon. This process can be repeated at a target lesion to a total of 8 cycles per
balloon (80 pulses).

 The balloon sizing is based on the desired stent size for that target lesion (ie, 1:1 for the reference
vessel diameter) and is often guided by the use of intravascular imaging, which is recommended
to guide optimal lesion preparation.
 Following application of IVL, it is usually recommended that noncompliant balloon dilatation be
performed before stent implantation to ensure adequate lesion preparation and ability to dilate
the target lesion.
 The IVL coronary balloons are all 12 mm in length and range from 2.5 mm to 4.0 mm diameter
in 0.5-mm increments. All the currently available IVL balloons (Shockwave Medical,
Fremont,CA) have a tip profile of 0.58 mm (0.02300) and a crossing profile of 1.07 mm
(0.04200).

Typical indications for use of Intravascular Lithotripsy
1. Coronary calcification noted on fluoroscopy or noninvasive imaging (ie,
computed tomography coronary angiogram)
2. Evidence of an Undilatable lesion despite high-pressure noncompliant
balloon dilatation as lesion preparation
3. Evidence of stent Underexpansion, either angiographically or on
intravascular imaging
4. Evidence of Heavy calcification noted on intravascular imaging, either optical
coherence tomography or intravascular ultrasonography

Indications for IVL
(A) Intracoronary calcification noted on angiographic
fluoroscopy (arrows)
(B) An undilatable lesion noted despite lesion
preparation with a high-pressure noncompliant balloon
(arrow)
(C) Stent underexpansion despite postdilatation with a
very-high-pressure noncompliant balloon (arrow)
(D) Evidence of circumferential deep calcification noted
on optical coherence tomography

Advantages of IVL compared with other methods of calcium modification
1. Provides a more controlled means of calcium modification
2. Avoids no reflow as seen in atherectomy
3. Allows maintenance of simultaneous guidewire placement for bifurcation lesions (eg,
left main stem)
4. Has the ability to modify calcification without further vessel injury with minimal
trauma on soft tissue
5. Less technically demanding compared with atherectomy and hence has a short
learning curve to become familiar with the technology

Disadvantage of IVL compared with other methods of calcium modification
1. Bulky balloon making delivery to the target lesion troublesome (often
requiring heavy guidewire and guide extension catheter use)
2. May not be able to cross a lesion without the need for atherectomy

Specific clinical scenarios in which IVL has a defined role
1. Undilatable lesions, despite high-pressure balloon dilatation
2. Calcification on intravascular imaging
3. Bifurcation lesion, especially left main coronary artery
4. Stent underexpansion, despite high-pressure balloon dilatation
5. Rotational atherectomy failure
6. Rotational atherectomy facilitated
7. Chronic total occlusion PCI
8. Peripheral use to aid large-bore vascular access; for example,
transcatheter aortic valve replacement

 Calcified and undilatable lesions carry risks of stent underexpansion and
subsequent restenosis or thrombosis.
 Traditionally, atherectomy has been the treatment of choice for lesion
preparation, particularly where noncompliant balloons, cutting balloons, or so-
called buddy cutting balloon techniques have been unsuccessful.
 The use of IVL allows lesion preparation and subsequent stent implantation, with
good stent expansion shown on intravascular imaging.
1. IVL used in an undilatable lesion

IVL used in an undilatable lesion
(A) Severe mid–right coronary artery (RCA) stenosis
(arrow)
(B) Evidence of dog-bone effect (arrow) despite high-
pressure balloon dilatation
(C) Application of IVL with complete balloon expansion
(arrow)
(D) Final angiographic result after stent implantation

2. OCT-guided use of IVL for calcium modification for lesion preparation
(A) Severe proximal left anterior
descending (LAD) stenosis
(arrowheads)
(B) Evidence of
circumferential, deep, and
long calcification on OCT
(C) Application of IVL (arrows)

OCT-guided use of IVL for calcium modification for lesion preparation
(D) Evidence of calcium
fractures on OCT (arrowheads)
(E) Evidence of calcium fractures/fissures
on OCT (arrowheads)
(F) Excellent final
angiographic result
(arrowheads)

Cut-off values for the prediction of angiographic in-stent restenosis (ISR) on a segmental basis.
 The immediate mechanical result of left
main PCI has a strong influence on
outcomes, with the minimum luminal
area after PCI correlating strongly with
adverse events.
 This finding has led to the adaptation of
the so-called 5, 6, 7, 8 Rule as target areas
to be achieved in the ostial left circumflex,
the left anterior descending, the polygon of
confluence, and the left main proximal to
the polygon of confluence.
Minimal stent area cut-off values for left main stem PCI

 In the presence of a calcified left main lesion, IVL modifies coronary calcification,
unlike noncompliant balloon dilatation, restoring vessel compliance, increasing
stent expansion, and achieving better stent artery apposition.
 Compared with atherectomy, IVL allows the maintenance of additional coronary
guidewires to allow simultaneous access to the separate daughter vessels,
avoiding the risk of acute vessel closure leading to periprocedural myocardial
infarction.
 This technique is particularly useful in the presence of impaired left ventricular
function, which often exists in patients with significant left main disease.
1. 3. Bifurcation lesion, Particularly Left main stem intervention using IVL

1. 3. Bifurcation lesion, Particularly Left main stem intervention using IVL
(A) Severe calcified disease in a trifurcating left main
stem including the ostium of the LAD, LCx, and
intermediate (arrow)
(B) Application of IVL in the left main stem–LAD
junction with maintenance of simultaneous guidewire
protecting daughter branches (arrow)
(C) Evidence of calcium fracture in ostial LAD on OCT
(arrows)
(D) Excellent final angiographic result; note presence
of left ventricular support use during the procedure

 Stent underexpansion leads to a high incidence of both early adverse outcomes with Stent
thrombosis and an increased risk of In-stent restenosis leading to subsequent repeat target
vessel revascularization.
 Poor lesion preparation is a common mechanism leading to stent underexpansion. Optimal stent
expansion can be especially challenging in calcific lesions despite the use of appropriately sized
high-pressure noncompliant balloons.
 Furthermore, typical conventional treatment options are limited to high-pressure noncompliant
balloon inflation once stent implantation has been performed and there is stent underexpansion
despite appropriate inflation pressures.
4. IVL for stent underexpansion

 In the setting of stent underexpansion or where stent underexpansion has led to restenosis, IVL
application has become a useful technique to alter vessel compliance by fracturing both the
intimal and medial calcification that previously inhibited stent expansion.
 When IVL is used acutely after stent deployment, the effects on drug delivery and drug polymer
characteristics are currently unknown, but may be deleterious. These effects may include issues
related to drug polymer integrity and stent integrity leading to future stent corrosion

(A) Stent underexpansion after PCI in RCA ISR
(arrow)
(B) Wasting of the very-high-pressure balloon (arrow)
(C) Application of IVL in underexpanded segment
shows complete balloon dilatation (arrow)
(D) Excellent final angiographic result with complete
stent expansion

 Rotational atherectomy acts preferentially by ablating hard, inelastic material, such as calcified
plaque, that is less able to stretch away from the advancing burr in a process termed Differential
cutting, which is often determined by wire bias.
 For this reason, rotational atherectomy may be unsuccessful in debulking the entire burden of
calcification in the presence of deep circumferential calcification, and hence may not be able
to assist in increasing vessel compliance sufficiently for adequate stent expansion.
 Given its mechanism of action of fracturing calcium in a circumferential fashion, IVL may be a
suitable alternative where rotational atherectomy has failed to treat the lesion successfully to
allow improved lesion compliance
5. IVL for Rotational Atherectomy Failure

(A) Severe proximal LAD stenosis with heavy calcification (arrow)
(B) Wasting of a high-pressure noncompliant balloon used for lesion preparation (arrow)
(C) Successful rotational atherectomy with a 1.75-mm burr

(D) Evidence of an undilatable lesion despite rotational atherectomy and noncompliant balloon predilatation (arrow)
(E) Application of 3.5-mm IVL in the undilated segment with complete balloon dilatation (arrow)
(F) Excellent final angiographic result with complete stent expansion after optimization

6. Rotational atherectomy–facilitated IVL-assisted procedure
(A) Severe proximal RCA stenosis in a patient after coronary artery bypass grafting (arrow)
(B) Inability to pass a low-profile balloon despite guide extension catheter support (arrow)
(C) Rotational atherectomy with a 1.5-mm burr.

 Placement of the IVL device at the target lesion can be difficult given the bulky nature of the
balloon that houses the transducers. Often a heavy guidewire is needed to provide support for
delivery to the target lesion. Furthermore, a supportive guide catheter and guide extension
catheter may be useful to deliver the balloon to the target lesion.
 A strategy of rotational atherectomy–facilitated delivery of the IVL balloon to the target lesion
has been described in the presence of a calcified, undilatable lesion to which IVL cannot be
delivered despite initial predilatation with low-profile balloons.
 Preparation of the lesion with rotational atherectomy allowed passage of a noncompliant
balloon; however, the lesion was still not fully dilatable, and hence IVL was used to allow
adequate lesion preparation to avoid stent underexpansion.

(D) Ongoing wasting of the undilatable lesion (arrow)
(E) Application of lithotripsy using a 3.5-mm IVL balloon (arrow)
(F) Excellent angiographic result with complete stent expansion.

7. IVL-assisted CTO PCI procedure
(A) RCA CTO with heavy calcification (arrows)
(B) Left-to-right collaterals to the distal RCA (arrow)
(C) Application of a 3.0-mm IVL balloon to allow calcium modification and connection between the
retrograde and antegrade equipment (arrow).

(D) intravascular ultrasonography (IVUS) showing calcification of the proximal RCA
(E) IVUS showing the subintimal space and calcified proximal vessel
(F) Final angiographic result with RCA disobliteration
7. IVL-assisted CTO PCI procedure

 Use of IVL in the peripheral domain has been well recognized and predates the
use of the technology for coronary arterial calcification. Extensive experience
exists in the area of peripheral artery intervention with IVL for peripheral vascular
disease.
 The Disrupt-PAD (Peripheral Artery Disease) I trial, which is a single-arm,
premarket European study that showed the safety and performance of IVL as a
standalone therapy in heavily calcified femoral-popliteal lesions at 6-month
followup.
 The Disrupt-PAD II trial, a multicenter prospective study of heavily calcified,
stenotic, femoropopliteal arteries, showed procedural safety with minimal vessel
injury and minimal use of adjunctive stents in a complex, difficult to- treat
population
8. IVL-assisted large-bore femoral access

 Large-bore vascular access for structural intervention can be problematic when extensive
atherosclerotic calcification is present in the iliofemoral system.
 IVLmayrepresent a straightforward technique to preserve the benefits of reduced morbidity and
mortality of transfemoral transcatheter aortic valve replacement (TAVR) in patients with
calcified peripheral arterial disease.
 Iliofemoral calcification can similarly be problematic in patients indicated for high-risk coronary
revascularization in the setting of poor ventricular function, because it may preclude placement
of large-bore ventricular support catheters.

(A) Iliofemoral angiogram showing a calcified iliac artery with severe stenosis (arrow)
(B) Application of lithotripsy using a 6-mm balloon (arrow)
(C) Passage of the large-bore sheath to facilitate TAVR.

Key Points
1. IVL has been shown to be a safe and feasible alternative method for coronary calcium modification
particularly for calcified, complex lesions.
2. Indications for IVL include coronary calcification noted on angiographic fluoroscopy, the presence of an
undilatable lesion, stent underexpansion, and a heavy calcium burden noted on intravascular imaging.
3. IVL provide a more predictable and controlled means of lesion preparation.
4. IVL can be advantageous in several specific clinical scenarios, particularly left main stem intervention
and when other methods, such as atherectomy, have not been successful.
5. Further clinical research is needed to define the exact benefits of IVL, particularly compared with other
currently available modalities to modify calcium, and to determine its cost-effectiveness as an adjunct
to PCI.

Coronary Calcium Modification

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Coronary Calcium Modification