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

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.