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. 2023 May 19;2(4):100969.
doi: 10.1016/j.jscai.2023.100969. eCollection 2023 Jul-Aug.

First Human Use of Shockwave L6 Intravascular Lithotripsy Catheter in Severely Calcified Large Vessel Stenoses

J D Corl  1 , Douglas Flynn  1 , Timothy D Henry  1 , Dean J Kereiakes  1
Affiliations

First Human Use of Shockwave L6 Intravascular Lithotripsy Catheter in Severely Calcified Large Vessel Stenoses

J D Corl et al. J Soc Cardiovasc Angiogr Interv. .

Abstract

Background: Intravascular lithotripsy (IVL) modifies superficial and deep vascular calcium by delivering pulsatile sonic pressure energy that fractures calcium in situ with the consequent enhancement of transmural vessel compliance, limitation of fibroelastic recoil, and optimization of stent implantation. To date, the use of IVL as an adjunct to facilitate stent implantation has been limited by large target vessel size and eccentricity of calcium distribution.

Methods: The Shockwave L6 IVL balloon delivery system includes 6 sonic energy emitters mounted on the shaft of a 30.0-mm long balloon with diameters ranging from 8.0 to 12.0 mm. The balloon nominal pressure is 4 atm. We describe first human use of this novel IVL delivery system to facilitate covered stent implantation in severely calcified stenoses involving the distal abdominal aorta and bilateral iliac arteries.

Results: Full IVL balloon expansion was achieved at low pressures (3 atm), despite the severity of calcification, with subsequent safe and effective covered stent implantation.

Conclusions: The Shockwave L6 balloon seems to expand the application of IVL to the treatment of severely calcified large vessels, such as the abdominal aorta and iliac arteries.

Keywords: calcium modification; peripheral vascular intervention; vascular calcification.

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Figures

None
Graphical abstract
Central Illustration
Central Illustration
Shockwave L6 peripheral IVL balloon catheter. (A) Three channels with 6 emitters along the shaft of the 30 mm balloon. (B) Shockwave L6 sonic energy profile, which is more uniformly intense along the length of the balloon than observed with (C) the Shockwave M5/M5+ peripheral IVL balloon sonic energy profile. The L6 IVL balloon has a unique sonic energy profile. Panel C reproduced with permission from Kereiakes et al.
Figure 1
Figure 1
Abdominal aorta procedural components and imaging. (A, B) Computed tomography angiography (CTA) of abdominal aorta and iliac arteries. (C) Diagnostic angiogram abdominal aorta. (D) Intravascular lithotripsy (IVL) of abdominal aorta using a 12.0- × 30.0-mm Shockwave L6 balloon. (E) Deployment of 11.0- × 39.0-mm Viabahn VBX balloon expandable covered stent. (F) Final angiogram of abdominal aorta after IVL and stent deployment.
Figure 2
Figure 2
Diagnostic imaging of bilateral iliac arteries. (A) Diagnostic angiogram of the right common iliac artery (CIA). (B) Diagnostic angiogram of left CIA. (C) Intravascular ultrasound (IVUS) of severe, heavily calcified stenosis in the right CIA. (D) IVUS of the right CIA reference vessel. (E) IVUS of severe, heavily calcified stenosis in the left CIA. (F) IVUS of the left CIA reference vessel.
Figure 3
Figure 3
Preinterventional and postinterventional angiograms. (A) Preinterventional angiogram of the bilateral iliac arteries. (B) Final angiogram of the bilateral common iliac arteries (CIA) after intravascular lithotripsy (IVL) using a 12.0- × 30.0-mm Shockwave L6 balloon with deployment of an 11.0- × 39.0-mm Viabahn VBX balloon expandable covered stent in each CIA and stent after dilation using a 12.0-mm balloon.
See this image and copyright information in PMC

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