Shockwave IVL & Nodular Calcium

Shockwave Intravascular Lithotripsy (IVL) modifies both superficial and deep calcium without concerns about lumen size or hydrostatic force.¹

Shockwave IVL for Coronary Artery Disease Shockwave IVL & Concentric Calcium Shockwave IVL & Eccentric Calcium Shockwave C2+
Digital rendering of cross-sectional view of blood vessel showing nodular calcification

Definition and Pathologies of Calcific Nodules 

Presenting as an eruptive calcium protrusion into the lumen, calcified nodules: 

  • Occur at sites of increased torsional stress2 
  • Have a higher prevalence of necrotic core calcium compared to adjacent regions3 
  • Are flanked proximally and distally by hard, collagen-rich calcium4 
  • Are believed to result from fragmentation of plates or sheets of calcium5 

 

1: Kereiakes et al. Principles of Intravascular Lithotripsy for calcific plaque modification. JACC: Cardiovascular Interventions, 14(12), 1275-1292. (2021). doi:10.1016/j.jcin.2021.03.036
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.
4: Virmani R, et al. Arterioscler Thrombosis Vasc Biol. 2000;20:1262-1275.
5: Designed in Partnership with Optima and VP Education. 

Within calcified nodules, there are two histological types: 

  • Eruptive nodular: Small dense fragments or nodules of calcium with a fibrous cap disruption and luminal thrombus 
  • Non-eruptive nodular: Small dense fragments or nodules of calcium with a smooth, intact fibrous cap 

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

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

Hear from top experts on the different technologies available to treat nodular calcium.

Shockwave IVL Provides Powerful Advantages When Treating Nodular Calcium

Traditional treatment methods such as balloon and atherectomy therapies have limitations when treating the unique pathologies associated with calcific nodules. Shockwave IVL’s unique mechanism of action (MOA) allows it to overcome these challenges. The sonic pressure waves created during Shockwave IVL therapy create a localized energy field effect which travels through soft vascular tissue to provide circumferential modification of both superficial and deep calcium. 

OTHER THERAPIES:

Illustration showing the challenges of treating nodular calcium in arteries with balloon and atherectomy therapies, leading to suboptimal stent expansion.

SHOCKWAVE IVL THERAPY:

Illustration comparing a cross-sectional view of calcium modification with intravascular lithotripsy (IVL) and an optical coherence tomography (OCT) image showing a fracture in calcified tissue.

Lesion Effect  Balloon-Based Therapies  Atherectomy  Shockwave IVL 
Not dependent on hydrostatic force  –  + +  + + 
Selectively targets calcium  –  + +  + + 
Able to modify deep calcium  + –  + + 
Independent of wire bias  + +  –  + + 
Independent of lumen size  + +  –  + + 

 

Very favorable: ++
Neutral: +
Not favorable: – 

NODULES TREATED WITH ATHERECTOMY RESULT IN WORSE LONG-TERM OUTCOMES

Four line charts comparing cumulative incidence of adverse cardiac events over five years between patients with and without calcified nodules. Each chart includes two lines: one for 'With calcified nodule' (gray) and one for 'No calcified nodule' (blue)

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

Shockwave IVL in Lesions with Calcified Nodules

POOLED DATA FROM THE DISRUPT CAD I-IV STUDIES

 

Bar chart showing the association of calcified nodules with maximum calcium angles based on the Disrupt CAD Studies. The chart demonstrates that calcified nodules are more frequently associated with concentric calcium at wider angles

SPL 68507 Dispelling the Nodular Myths. Shockwave Medical 2023. Z. Ali TCT 2021.

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

Shockwave IVL acoustic shock waves may affect calcium deep to the calcified nodules, allowing for concentric stent expansion in 77% of calcified nodular lesions.

  • Two cross-sectional intravascular images showing the effects of IVL (Intravascular Lithotripsy) on calcified vessels.

    Concentric expansion:

    34% deformed eruptive calcified nodule
  • Two cross-sectional intravascular images showing the effects of IVL (Intravascular Lithotripsy) on calcified vessels.

    Concentric expansion:

    43% deformed nodule calcification
  • Two cross-sectional intravascular images showing the effects of IVL (Intravascular Lithotripsy) on calcified vessels.

    Eccentric expansion*:

    23% non-deformed nodular calcification

*Large MSA ensure good clinical outcomes despite eccentric stent expansion 

OCT IMAGES OF IVL SHOW CONCENTRIC STENT EXPANSION WITH DEFORMED ERUPTIVE CALCIFIED NODULES

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. Z. Ali et al JACC Int 2023.

OCT IMAGES OF SHOCKWAVE IVL SHOW CONCENTRIC STENT EXPANSION WITH DEFORMED NODULAR CALCIFICATION

Three sequential cross-sectional OCT images and corresponding longitudinal views illustrating stages of intravascular lithotripsy (IVL) treatment on a calcified artery with a nodular calcified lesion

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. Z. Ali et al JACC Int 2023.

OCT IMAGES OF SHOCKWAVE IVL SHOW ECCENTRIC STENT EXPANSION WITH NON-DEFORMED NODULAR CALCIFICATION

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. Z. Ali et al JACC Int 2023.

Shockwave IVL is Consistent in Lesions With and Without Calcific Nodules

Consistent minimal stent area and stent expansion post-Shockwave IVL and stenting despite the presence of nodular calcium.

Two bar graphs comparing minimum lumen area (MLA), minimum stent area (MSA), mean stent area, stent expansion at maximum calcium site (MCS), and mean stent expansion between lesions with calcified nodules and lesions without calcified nodules

 

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

*N=1 ST event at POD 22

 

Shlofmitz, R., (2023, Feb 25-28) The impact of calcified nodules on 2-year clinical outcomes. CRT Annual Meeting, Washington, DC

Shockwave IVL in Calcific Nodules: Good Initial Insights But Still More to Learn 

Composite image showing three key findings related to intravascular lithotripsy (IVL) with calcified nodules.

Review the full nodular OCT presentation at 30 days and two years: 

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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 + Shockwave IVL) in order to determine the optimal nodular strategy.