NODULAR CALCIUM & IVL

8TH JUNE 2023

BHOJRAJ TIWARI
 Flow of Presentation
• Coronary Calcium presence- Reality Check
• What’s Current Data and its long term outcome in severe Calcified lesions
• Types of Calcium present in Coronary Artery
• What is CN/NC
• Types of CNs and behavior
• How it is formed
• What are possible treatment options
• Rota MOA, with Data, Limitations if Any
• OA MOA with Data, Limitations If any
• IVL MOA with Data, Limitations if Any
• Q&A
• Conclusion

2 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.

 Because SW is all About Calcium Management Organization ,
TOP Facts about Calcium
• Calcium plays an important role in your body’s functions
• Your body doesn’t produce calcium
• You need vitamin D to absorb calcium
• Calcium is even more important for women
• The recommended amount depends on your age
• Lack of calcium can lead to other health issues
• Calcium supplements can help you get the right amount
• Too much calcium can have negative effects
- Increase your risk of kidney stones. Too much calcium can cause deposits of
calcium in your blood. This is called hypercalcemia

3 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.

 Dr. Ajay Kirtane

4
5
 Impact of Coronary Calcium
Leads to Stent Under-expansion

The greater the arc, length, or thickness

of calcium, the greater the likelihood of stent
under-expansion1

Stent under-expansion is associated with an

increase in ischemic events at 1 year2

1. Mintz, G; I. J Am Coll Cardiol Imaging 2015;8(4): 461-71. 2. Généreux P, et al. JACC 2014; 63(18);1845-54
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6 SPL 64626 - Coronary IVL Speakers Deck. 2021

 Impact of Coronary Calcium
Inhibits Vascular Compliance
Calcific plaque is at least 4-5 times less
compliant than cellular plaque

IVUS demonstrating
circumferential calcification

Alfonso F et al, J Am Coll Cardiol. 1994.

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7 SPL 64626 - Coronary IVL Speakers Deck. 2021

 Impact of Coronary Calcium
Worsens Long-Term Outcomes

Meta-analysis reviewed the

w/ Severe w/o Severe impact of severely calcified*
CAC CAC P Value lesions on patient outcomes
(N=1291) (N = 5005) across 7 contemporary PCI
studies – found that it was an
Mortality 10.8% 4.4% <0.001 independent predictor of worse
outcomes at 3yrs

Combined Endpoint:
MI & Death 22.9% 10.9% <0.001
MI, Death & 31.8% 22.4% <0.001
Revascularization

*Severe Calcium: radiopacities noted without cardiac motion before contrast, generally compromising both sides of arterial lumen
Bourantas, et al. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-
level pooled analysis of 7 contemporary stent trials. BMJ 2014; 100: 1158-1164.

8 SPL 64626 - Coronary IVL Speakers Deck. 2021

 Impact of Coronary Calcium
Severity Correlated with Outcomes

POOLED ANALYSIS from HORIZONS-AMI and ACUITY

1-year outcomes in ACS stratified by extent of angiographic Ca2+ (n=6,855)

Genereux et al, J Am Coll Cardiol. 2014.

Designed in Partnership with Optima Education Ltd & VP Education

9 SPL 64626 - Coronary IVL Speakers Deck. 2021

 People more likely to get coronary artery calcification if they have

• Kidney disease,
• Diabetes,
• Bad cholesterol ,
• High BMI,
• Family history of coronary artery calcification,
• Blood pressure,
• Cigarette smoking or using tobacco products,
• Older age,
• Parathyroid hormone irregularities,
• High phosphate levels,
• High calcium level.

10 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.

SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.
12 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.
 But Why do they get Coronary artery calcification

• After age 40, calcium from your bloodstream can settle in parts of your body.
• Damaged, inflamed or repaired arteries are more likely to attract calcium deposits
• Ca2+ gets concentrated due to membrane damage .
• Ca+ ion binds to phospholipids present in Membrane .
• Phosphatase generates phosphate group. This Ca & Phosphate binding cycle
is repeated , generating a micro-crystal, which propagate more calcium
deposit

13 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.

SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.
SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.
 Few Calcification Definitions Basis IVUS
– Superficial calcification: The leading edge of the acoustic shadowing appears within
the shallowest 50% of the plaque plus media thickness
– Deep calcification : The leading edge of the acoustic shadowing appears within the
deepest 50% of the plaque plus media thickness
– Eccentric calcification : Calcium arch <180 degrees
– Concentric calcification: Calcium arch ≥180 degrees
– Napkin ring calcification: Severe circumferential calcification close to 360 Degree.
– Eccentric calcified nodule/nodular calcification: CN/NC without calcification at
the opposite site of calcified nodule/nodular calcification.
– Concentric Calcified nodule/nodular calcification : CN/NC calcification at the
opposite site of calcified nodule/nodular calcification. Mix lesion was identified as
concentric calcification.
– Calcium fracture by IVUS was defined as a gap of calcium and direct exposure of
calcium to the lumen at the gap
– Reference Vessel : The proximal and distal reference segments with the maximum lumen
and least amount of plaque within 5 mm proximal or distal to the lesion
16
 Types Of Coronary Artery Calcification, Simple Algorithm and
suggested tools

Concentric Ca2+ Eccentric Ca2+ Nodular Ca2+ Very Thick Concentric Ca2+ Uncrossable Ca2+

IVL IVL IVL sometimes Combination ROTA if needed IVL

Combination

At the end of the session, we will revisit our algorithm

and check if it make sense or not
17 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.
 Sudden Cardiac Death Facts

– SCD without previous histories of coronary heart disease had acute thrombosis in more
than 50% of cases
– The most common causes of acute coronary thrombosis are plaque rupture (65%),
followed by plaque erosion (30%),
– For plaque rupture, a disruption of the thin fibrous cap overlying a necrotic core is
considered the trigger for thrombus formation
– Whereas in plaque erosion, there is an acute luminal thrombus in direct contact with
the intima, which exhibits an absence of endothelial cells
– Necrotic Core: Clinically vulnerable plaque , a structure of which contains dead cells
that have undergone a type of cell death known as necrosis
– Fibrous Plaque: thickening of wall of artery as a result of accumulation of smooth
muscle cell and fibrous tissue in the Intima

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 Lets Start learning about Nodular Calcium

19
 Calcified Nodules: What do we Know?

• Despite advances in technology and techniques,

calcified nodules continue to be challenging due
to a lack of prospective data to help guide
decision-making
• To date, calcified nodules have resulted in worse
procedural and long-term clinical outcomes
because, despite modification in some cases, the
underlying pathology of the nodule’s
development remains active and can result in
protrusion of the nodule through the stent
following the initial successful PCI

* Morofuji et al (2020): Impact of CN in patients requiring RA

20 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 How Calcific Nodules Are Created & Progress
Calcified nodules
• occur at sites of increased torsional stress1
• higher prevalence of necrotic core calcium
compared to adjacent regions2
• flanked proximally and distally by hard,
collagen-rich calcium2
• believed to result from fragmentation of
plates or sheets of calcium3

Two histological types

• Eruptive CN: small dense fragments or nodules of calcium
Diastolic Systolic (accentuates with fibrous cap disruption and luminal thrombus.
tortuosity and torsional
stress) • Non-Eruptive Nodular calcification: small dense fragments or
nodules of calcium with smooth intact fibrous cap.

1) Mori H, et al. JACC Cardiovasc Imaging. 2018 Jan;11(1):127-142. 2) Torii S, et al. J Am Coll Cardiol. 2021 Apr 6;77(13):1599-1611. 3)Virmani R, et al. Arterioscler
Thrombosis Vasc Biol 2000;20:1262-1275. Designed in Partnership with Optima and VP Education.

21 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Two Histological Types of Calcific Nodules

Eruptive Nodular: small dense fragments or nodules of Non-Eruptive Nodular: small dense fragments or
calcium with fibrous cap disruption and luminal thrombus. nodules of calcium with smooth intact fibrous cap.

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22 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Calcific Nodules Present Across the Anatomy
Most Often Located at Areas of High Torsional Stress

Proximal to
mid LAD

Proximal to
mid RCA

Proximal LCx

1) Virmani R, et al. Arterioscler Thrombosis Vasc Biol 2000;20:1262-1275. 2) Mori H, et al. JACC Cardiovasc Imaging. 2018 Jan;11(1):127-142. 3) Torii S, et al. J Am Coll
Cardiol. 2021 Apr 6;77(13):1599-1611.

23 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Calcified Nodule (CN) Vs Nodular calcification (NC) Definitions

– For SCD, the least frequent cause is calcified nodule (CN) (5%)
– CN as “a lesion with fibrous cap disruption and luminal thrombus associated with
eruptive, dense, calcific nodules” or an occlusive or nonocclusive platelet/fibrin thrombus
– Evidence of fibrous cap disruption is absent in nodular calcification, whereas, in CN, a
disruption of the fibrous cap is observed with an absence of endothelium, and there is an
overlying platelet/fibrin thrombus.
– Calcification without evidence of collagen can occur within an area of a NC and is thus
called NC calcification, and when calcification involves collagen, it is called collagen (C)
calcification
– More than 60% of Culprit lesions of CN were located in the right coronary artery (RCA)
with many of those located in the middle and the others located in the proximal region of
the artery.
– lesions were located in the bifurcation of the left main trunk (LMT)

Source: Renu Virmani and team’s work with 26 dead Patients

24
 Nodular Calcium: Limitations of Other Technologies
Balloon Therapies
Balloons Cannot
Modify Thick Calcium

NODULAR CALCIUM SUBOPTIMAL STENT EXPANSION

Atherectomy Therapies

Burr Susceptible
to Wire Bias

Designed in Partnership with Optima and VP Education.

25 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Limitations of Conventional Tools in Calcium
Balloon-based Therapies

High pressure balloons preferentially expand

away from calcium, having limited effect on
eccentric calcium. 1

High pressure inflations are predisposed to

major dissection and perforation - often at the
interface between calcium and healthy tissue.1

Balloons are typically unable to modify deep

Cross-sectional view or very thick calcium.1

1 Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Généreux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol 2014;63:1703.
Designed in Partnership with Optima Education Ltd & VP Education

26 SPL 64626 - Coronary IVL Speakers Deck. 2021

 Limitations of Conventional Tools in Calcium
Atherectomy Therapies

Ablation is contact dependent;

unable to modify calcium in
Requires dedicated wire. larger lumens and deep
calcium.1-2

Thermal injury promotes platelet Unable to protect side branch

activation leading to increased with a second guide wire.1-2
risk of clotting.3

Distal embolization is associated Potential to transect wire and

with slow flow / no reflow and for large dissection and/or
peri-procedural MI.1-2 perforation, especially in
tortuous anatomy.1-2
1 Tomey et al, J Am Coll Cardiol Intv. 2014
2 Okamoto et al, Eurointervention. 2019.
3 Reisman et al. Analysis of heat generation during rotational atherectomy using different operational techniques. Catheterization and Cardiovascular Diagnosis. 1998 Aug;44(4):453-5.
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27 SPL 64626 - Coronary IVL Speakers Deck. 2021

SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.
 IVL Offers Mechanistic Benefits in Nodular Calcium

Circumferential modification
of calcium from superficial
to deep

Fracture

Designed in Partnership with Optima and VP Education.

29 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 ROTA Data

30
 Clinical impact of calcified nodule in patients with heavily calcified
lesions requiring rotational atherectomy: CCI Jan-2021
Toru Morofuji 1, Shoichi Kuramitsu 1, Tomohiro Shinozaki 2, Hiroyuki Jinnouchi 1, Shinjo Sonoda 3,

• Objectives: To evaluate the incidence and clinical impact of calcified nodule (CN) in patients with heavily
calcified lesions requiring rotational atherectomy (RA).
• Background: It remains unclear whether CN impacts adversely on clinical outcomes in patients with heavily
calcified lesions
• Methods: Between January 2011 and February 2014, 264 patients after second-generation drug-eluting stent
(DES) implantation following RA were retrospectively enrolled. The primary endpoint was the cumulative 5-year
incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, clinically driven
target lesion revascularization (CDTLR), and definite stent thrombosis (ST).
• Results:
• CN was observed in 128 patients (48.5%) with heavily calcified lesions.
• Cumulative 5-year incidence of MACE was significantly higher in the CN group than in the non-CN group
(35.4% vs. 18.8%, , p < .001)
• Higher rate of CDTLR 23.2% in CN group vs. 7.9% in Non-CN group
• Higher rate of ST 7.0% CN vs. 0.93% Non-CN .
• Independent risk factors of 5-year MACE included haemodialysis, ostial lesion, left ventricular ejection fraction
and right coronary artery lesion .
31 • Conclusions: CN PCI resulting in unfavourable long-term clinical outcomes after RA.
 Nodules Treated with RA Result in Worse Long-Term Outcomes

Morofuji T, et al. Catheter Cardiovasc Interv. 2021 Jan 1;97(1):10-19.

32 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Characteristics/Pattern of CN/NC Detected by IVUS (DoCE) in Patients with Heavily
Calcified Lesions Who Underwent Rotational Atherectomy- JIC- 2023
Ploy Pengchata,1 Rungtiwa Pongakasira,2 Namthip Wongsawangkit,2 Asa Phichaphop,

• Objectives: To study characteristics and pattern of a CN and/or NC IVUS on the DoCE in patients with
calcifed lesions who underwent rotational atherectomy.
• Background: The characteristics and pattern of a CN and/or NC on clinical outcome remain unknown.
• Methods: Enrolled patients who underwent RA. IVUS imaging was mandatory. The primary outcome was
cumulative of DoCE, defined as the composite of cardiovascular death, myocardial infarction, and clinically-
driven target lesion revascularization
• Results:
• 200 patients enrolled. 5 Years follow up
• The cumulative DoCE was significantly higher in the CN/NC group than that in the non-CN/NC group (20.7%
vs. 8.8%, p = 0.022).
• MSA≤ 5.5 mm2 were correlated with a significantly higher cumulative DoCE
• CN/NC was the independent predictor for the cumulative DoCE (HR = 2.96, 95% CI 1.08–8.11, p = 0.035).
• Patients with an eccentric CN/NC had a significantly higher cumulative DoCE compared to those CN/NC with
concentric calcification.
• Conclusions: The presence of a CN/NC in patients with heavily calcified lesions who underwent RA-assisted
PCI was found to be associated with increased cumulative 5 year DoCE, especially in patients with an
33 eccentric CN/NC..
 Clinical Outcomes RA in CN/NC cases IVUS F/u 5 years

• In contrast, the patient who had wire bias opposite to eccentric CN/NC had
increased 5 year DoCE.
• 60% of the patients with eccentric CN/NC and wire bias opposite to CN/NC
had increased 5 year DoCE.
• Conclusions : The presence of a calcified nodule or nodular calcification in
patients with heavily calcified lesions who underwent RA assisted PCI was
found to be associated with increased cumulative DoCE, especially in patients
with an eccentric calcified nodule or nodular calcification and wire bias
opposite to the calcified nodule

34 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.

 OA Data

35
 Orbital Atherectomy Major Trials/Registry

36
 COAST & ORBIT-III

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38 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.
 IVL Data

39
40
 Dispelling the Nodular Myths

Myth:
Atherectomy Is the Ideal
Tool for Modifying Nodular
Calcium

Clinical Evidence:
IVL Can Safely and
Effectively Modify Nodular
Calcium

41 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Safety and Effectiveness of Coronary Intravascular Lithotripsy for
Treatment of Calcified Nodules
By ZIAD ALI , JACC: CARDIOVASCULAR INTERVENTIONS, VOL. -, NO. -, 2023

• CN had a larger reference diameter (CN 3.07 0.45 vs non-CN 2.92)

• Greater acute gain in the CN 1.75 vs non-CN 1.54 mm
• Lesion length was shorter with CN 26.4 mm vs non-CN 32.1 mm .
• Mean lumen areas were larger (CN 4.85 mm2 vs non-CN 4.44 mm2)
• The mean calcium arc CN 170.75 vs non-CN 134.19
• Overall volume of calcium (CN 4,567 mm vs non-CN 3,312 mm) P < 0.0001)
• Greater Calcium fracture with CN 78.7% vs 65.2% in non-CN
• More than 3 fractures in CN lesions 44.7% vs 30.3% in NON-CN lesion .
• The fracture length CN 5.2 mm vs non-CN 3.6 mm
• Number of fractures per lesion CN 3.0 vs non-CN 2.0 were greater in the CN group
• Final MSA was never at the site of maximum calcification (as per OCT) in which
stent expansion was 104.9% in the CN- and 99.4% in the non-CN groups

42 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.

 Safety and Effectiveness of Coronary IVL for Treatment of Calcified
Nodules- Continue
By ZIAD ALI , JACC: CARDIOVASCULAR INTERVENTIONS, VOL. -, NO. -, 2023

• All 100% eruptive nodules were deformable.

• Of the noneruptive nodules 65.0% were deformable and 35.0% were not.
The main findings of this analysis are:
• 1) IVL was highly effective in treating CNs, reducing stenosis to a residual
area of < 15% with an acute gain of 1.8 mm ;
• 2) IVL was safe in CNs, with no major complications;
• 3) There were no differences in residual area stenosis, stent, expansion, or
acute gain between CN and non-CN lesions at the sites of pre-IVL MLA,
maximum calcium arc site, or final minimum stent area; and
• 4) following IVL and stenting, distinct patterns of deformation of CNs were
observed
43 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.
 Concentric Stent Expansion: Deformed Eruptive CN
3 Common Patterns of Stent Expansion
Pre-IVL Post-IVL Post-Stent

Post-IVL
Moderated Poster, TCT 121: Intravascular Lithotripsy is Effective in the Treatment Calcified Nodules: Patient-level Pooled Analysis From the Disrupt CAD OCT Sub-studies,
Ziad A. Ali, TCT 2021

44 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

Eruptive CN: Deformable

Post-IVL Post-stent
 Concentric Stent Expansion: Deformed Nodular Calcification
3 Common Patterns of Stent Expansion
Pre-IVL Post-IVL Post-Stent

Moderated Poster, TCT 121: Intravascular Lithotripsy is Effective in the Treatment Calcified Nodules: Patient-level Pooled Analysis From the Disrupt CAD OCT Sub-studies,
Ziad A. Ali, TCT 2021

46 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

Deformed Protruding Nodule
 Eccentric Stent Expansion: Non-Deformed Nodular Calcification
3 Common Patterns of Stent Expansion

Pre-IVL Post-IVL Post-Stent

Moderated Poster, TCT 121: Intravascular Lithotripsy is Effective in the Treatment Calcified Nodules: Patient-level Pooled Analysis From the Disrupt CAD OCT Sub-studies,
Ziad A. Ali, TCT 2021

48 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

Non-Deformed Protruding Nodule
 Patterns of Stent Expansion in Nodular Calcium
Large MSA Ensure Good Clinical Outcomes Despite Eccentric Stent Expansion

Concentric expansion
Deformed eruptive calcified nodule
34% Eccentric
expansion
23%

Concentric expansion
Deformed nodular calcification
43% Concentric
expansion
77%
Eccentric expansion
Non-deformed nodular
calcification
23%
Concentric stent expansion in
majority of calcified nodular lesions

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50 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Pooled Analysis from Disrupt CAD I-IV: OCT Sub-studies
CAD I CAD II CAD III CAD IV Pooled
Enrollment Dec 2015 – Sep 2016 May 2018 – Mar 2019 Jan 2019 – Mar 2020 Nov 2019 – Apr 2020 Dec 2015 – Apr 2020

Study design Prospective, multi-center, single-arm

ITT (N) 601 1203 3844 645 6286

OCT Analysis* (N) 282 57 106† 71† 262

OCT core laboratory Cardiovascular Research Foundation

New York, NY

Target lesions Severely calcified*, de novo coronary artery lesions

Target lesion RVD 2.5mm – 4.0mm

Target lesion stenosis ≥50% and <100% ≥50% and <100% ≥70% and <100% ≥70% and <100%

*Patient enrollment in OCT sub-studies was open to all sites participating in the Disrupt CAD studies that routinely perform OCT imaging. †Includes patients from the roll-in cohort.

Consistent OCT core laboratory evaluation across all OCT sub-studies

1Brinton et al. Circulation 2019;139:834-836, 2Ali et al. J Am Coll Cardiol Img 2017;10:897-906, 3Ali et al. Circ Cardiovasc Interv 2019;12:e008434, 4Hill et al. J Am Coll Cardiol
2020;76:2635-46, 5Saito et al. Circ J 2021;85(6):826-33, 6Kereiakes et al., J Am Coll Cardiol Intv 2021;14:1337-48

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 IVL in 54 Lesions with Calcified Nodules
Pooled Data from the Disrupt CAD I-IV Studies

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 Acute Procedural Safety:Final Angiographic and 30-day Clinical Outcomes
IVL was Safe with a low risk of perforations, dissections and slow/no flow

OCT Pooled OCT Pooled

Core Lab Assessment CEC Adjudicated
N=262 N=262

Final in-stent diameter stenosis 12.2 ± 6.8% 30-d MACE 4.6%

Cardiac death 0.0%

Acute gain, mm 1.6 ± 0.4
All MI 4.6%
Any serious angiographic
0.0%
complications NQWMI 4.6%
Perforation 0.0% Q-wave MI 0.0%
Abrupt closure 0.0% TVR 0.4%
Slow flow 0.0%
Target lesion failure 4.6%
No reflow 0.0%
Stent thrombosis (definite or
0.4%
Distal embolization 0.0% probable)

SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 IVL is Consistent in Lesions With & Without Calcific Nodules
Consistent MSA & Stent Expansion Despite the Presence of Nodular Calcium

CN lesion Non-CN lesion CN lesion Non-CN lesion

12 150%
P = 0.18 P = 0.41 P = 0.12 P = 0.82 P = 0.87 P = 0.91

10

8 8.3 100% 105% 107%

101% 104%
7.9
mm2

%
6 6.5 6.3
6.1 6.0

4 50%

0 0%
MLA MSA Mean stent area Stent expansion @MCS Mean stent expansion
N, lesions 54 194 54 194 54 194 N, lesions 54 194 54 194

Moderated Poster, TCT 121: Intravascular Lithotripsy is Effective in the Treatment Calcified Nodules: Patient-level Pooled Analysis From the Disrupt CAD OCT Sub-studies,
Ziad A. Ali, TCT 2021

55 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Target Lesion Failure
30
Non-CN
Log-rank p-value: 0.32
CN

Target lesion failure (%)

20

13.9%

10 8.0%

0
0 1 6 12 18 24
Months
 In Conclusion: IVL in Calcific Nodules
Good Initial Insights But Still More to Learn

Consistent MSA With/Without Nodules IVL Safely Deforms Nodules Promising Longer-Term Outcomes

What’s Next: More data are needed on nodules in larger, “real-world” cohorts across all
calcium arcs, and the role of combination therapy (i.e. atherectomy + IVL) in order to
determine the optimal nodular strategy.

59 SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

 Questions from Team
• As we have only 12 mm length, what should be pulse strategy to achieve
satisfactory results in nodular Ca+ ? :
• How to deliver IVL if ostial Lcx having nodule ??
• IVL is not effective in Ca+ plate, how to justify this statement ?
• How to identify Nodular calcium in cine?
• Also after IVL usage, visibility tips & tricks to understand it?
• When there is a specular Calcium, what precautions to take to avoid balloon
rupture
• What to do if IVL crossing in nodule is challenging
• We are worried about Protrusive Calcium after each cycle

60 SPL XXXXXX Dispelling the Nodular Myths. Shockwave Medical 2023.