Calcium Modification During Peripheral Intervention With a Novel Intravascular Lithotripsy System: An Institutional...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Vascular Surgery

Background:

• Endovascular treatment for severely calcified stenotic lesions benefits from calcium modification techniques.
• Intravascular lithotripsy (IVL) uses pulsatile sonic energy to fracture superficial and deep vascular calcium, optimizing subsequent therapies like stent implantation.
• The Shockwave Javelin peripheral IVL catheter is a novel forward IVL platform designed for challenging, calcified lesions.

Purpose of the Study:

• To describe the clinical and procedural characteristics of the initial experience with the Shockwave Javelin peripheral IVL catheter.
• To evaluate the outcomes of using the Javelin IVL catheter in patients with complex, calcified peripheral arterial lesions.

Main Methods:

• A retrospective analysis of the first 10 patients (16 lesions) treated with the Javelin IVL catheter.
• Primary outcome: device success (delivery, advancement, pulsing, retrieval).
• Safety outcomes: in-hospital death and procedural complications.

Main Results:

• Device success was achieved in 15 out of 16 lesions.
• No arterial dissections were observed immediately following Javelin IVL, though 3 occurred after subsequent balloon dilatation.
• No in-hospital mortality or other postprocedural complications were noted.

Conclusions:

• The Javelin peripheral IVL catheter demonstrates high device success rates in complex peripheral arterial stenoses.
• The device safely facilitates access to additional therapies for heavily calcified peripheral lesions.
• Further studies are needed to fully define the safety and effectiveness of Javelin IVL.