Shockwave IVL Performs Consistently in Concentric, Eccentric, and Nodular Calcium

TCT 2022 Controversies in Calcium: An Open-Minded Debate on Approaches to Nodular Calcium

Definition and Pathogenesis of Calcific Nodules

Systolic (accentuates tortuosity and torsional stress)

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

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.

Two Histological Types of Calcific Nodules

eruptive and non-eruptive calcified nodules eruptive and non-eruptive calcified nodules

Limitation Of Other Technologies In Nodular Calcium

balloon therapies balloon therapies

IVL Offers Mechanistic Advantages in Nodular Calcium

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Nodules Treated with Atherectomy Result in Worse Long-Term Outcomes

mace results graph mace results graph

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

Pooled Analysis from Disrupt CAD I-IV: OCT Sub-studies

sub studies chart sub studies chart mobile

*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.

 

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

IVL in Lesions with Calcified Nodules

Pooled Data from the Disrupt CAD I-IV Studies

calc lesions chart calc lesions chart mobile

*At minimum lumen area
^At maximum calcium site

 

Designed in Partnership with Optima and VP Education.
SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

IVL in Lesions with Calcified Nodules

Pooled Data from the Disrupt CAD I-IV Studies

pooled data from the disrupt cad i-iv studies pooled data from the disrupt cad i-iv studies

Designed in Partnership with Optima and VP Education.
SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023.

Acute Procedural Safety: Final Angiographic and 30-day Clinical Outcomes

IVL was safe with a low risk of perforations, dissections and slow/no flow

angio 3 day charts angio 3 day charts mobile

OCT Images Show Patterns of Stent Expansion post-IVL in Nodular Calcium

IVL Acoustic Shockwaves May Affect Calcium Deep To The Calcified Nodules Allowing For Concentric Stent Expansion In 77% Of Calcified Nodular Lesions

Concentric expansion

concentric expansion vs. eccentric expansion
34%

Deformed eruptive calcified nodule

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concentric expansion
43%

Deformed nodular calcification

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Eccentric expansion*

eccentric expansion
23%

Non-deformed nodular calcification

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concentric expansion vs. eccentric expansion

Concentric stent expansion in majority of calcified nodular lesions

*Large MSA Ensure Good Clinical Outcomes Despite Eccentric Stent Expansion

OCT Images of IVL Show Concentric Stent expansion with deformed eruptive Calcified Nodules

ivl progressions images ivl progressions images

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

OCT Images of IVL Show Concentric Stent Expansion with Deformed Nodular Calcification

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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

OCT Images of IVL Show Eccentric Stent Expansion with non-Deformed Nodular Calcification

ivl progressions images ivl progressions images

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

IVL is Consistent in Lesions With & Without Calcific Nodules

Consistent MSA & Stent Expansion Post-IVL and Stenting Despite the Presence of Nodular Calcium

pooled data from the disrupt cad-iv oct sub-studies pooled data from the disrupt cad-iv oct sub-studies

Pooled data from DISRUPT CAD I-IV OCT sub-studies; MLA, minimum lumen area; MSA, minimum stent area; and MCS, maximum calcium site
Ali Z.A. Patient-pooled analysis of DISRUPT CAD OCT sub-studies (Conference presentation). TCT 2021 Orlando, FL, USA.

2-Year Outcomes

pooled data from the disrupt cad-iv oct sub-studies pooled data from the disrupt cad-iv oct sub-studies

*N=1 ST event at POD 22

IVL in Calcific Nodules

Good Initial Insights But Still More to Learn

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  • 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.

Review the Full Nodular OCT Presentation at 30 days and 2 years

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