Name of the Procedure:

Revascularization, Endovascular, Open or Percutaneous, Lower Extremity Artery(ies), except Tibial/Peroneal; with Intravascular Lithotripsy and Transluminal Stent Placement(s), Includes Angioplasty within the Same Vessel(s), when Performed (HCPCS Code: C9765)

Summary

The procedure is a minimally invasive (or open) method to restore blood flow in the arteries of the lower extremities, excluding the tibial and peroneal arteries. It combines intravascular lithotripsy to break up calcified plaques, balloon angioplasty to widen the artery, and stent placement to keep the artery open.

Purpose

This procedure addresses peripheral artery disease (PAD) where arteries in the lower extremities are narrowed or blocked due to plaque build-up. The goal is to restore proper blood flow, relieve symptoms like pain and cramping, enhance mobility, and prevent severe complications such as tissue death or amputation.

Indications

• Severe claudication (pain or cramping in the legs during activity)
• Critical limb ischemia (severe narrowing or blockage causing severe pain or wounds)
• Non-healing ulcers or sores in the lower extremities
• Risk of lower limb amputation due to advanced PAD
• Failure of other less invasive treatments

Preparation

• Patients may need to fast for 6-8 hours before the procedure.
• Adjustment or temporary discontinuation of certain medications, such as blood thinners, may be required.
• A thorough diagnostic assessment, including imaging tests like ultrasound, CT, or MRI angiography, to map the arterial blockage.

Procedure Description

1. Anesthesia: The patient is given local anesthesia at the insertion site, with the possibility of sedation or general anesthesia depending on the case.
2. Access: A small incision is made to introduce a catheter into the artery.
3. Imaging: An angiogram is conducted to visualize the blockage.
4. Intravascular Lithotripsy: Specialized equipment delivers shock waves to fracture the calcified plaques within the artery.
5. Balloon Angioplasty: A balloon catheter is inflated to expand the artery.
6. Stent Placement: A stent is deployed to keep the vessel open.
7. Validation: A final angiogram ensures the artery is well-opened and blood flow is restored.

Duration

The procedure typically takes 1-3 hours, depending on the complexity and the number of arteries treated.

Setting

The procedure is performed in a hospital, generally in a specialized catheterization lab or a surgical operating room.

Personnel

• Interventional cardiologist or vascular surgeon
• Nurses specialized in interventional procedures
• Anesthesiologist or nurse anesthetist (if sedation or general anesthesia is used)
• Radiologic technologists

Risks and Complications

• Bleeding or hematoma at the catheter insertion site
• Infection
• Allergic reactions to contrast dye
• Blood vessel damage
• Blood clots that may travel elsewhere in the body (embolization)
• Re-narrowing of the artery (restenosis)

Benefits

• Improved blood flow to the affected limb
• Relief from pain and cramping
• Enhanced ability to walk and perform daily activities
• Reduced risk of limb loss due to severe critical ischemia
• Quick recovery times compared to open surgical procedures

Recovery

• Patients typically stay in observation for several hours or overnight.
• Instructions include keeping the insertion site clean and dry.
• Avoiding strenuous activities for a few days.
• Follow-up appointments to monitor healing and blood flow improvement.
• Medications to prevent blood clots and manage cholesterol/blood pressure.

Alternatives

• Medical management with medications (anti-platelets, cholesterol-lowering drugs)
• Supervised exercise therapy
• Other minimally invasive procedures like simple angioplasty without lithotripsy
• Open bypass surgery, which has a longer recovery time but may be necessary for severe cases.

Patient Experience

During the procedure, patients may feel some pressure but usually no significant pain due to anesthesia. Afterward, there might be mild discomfort or bruising at the insertion site. Pain is typically managed with over-the-counter pain relievers. Overall, patients generally experience improved symptoms within days to weeks post-procedure.