Percutaneous peripheral ultrasonic angioplasty

Area of Science:

• Vascular Surgery
• Interventional Radiology
• Medical Devices

Background:

• Peripheral vascular disease (PVD) causes severe claudication.
• Superficial femoral and popliteal artery obstructions are common PVD manifestations.
• Percutaneous catheter-based interventions are crucial for PVD management.

Purpose of the Study:

• To evaluate the initial safety and efficacy of percutaneous catheter-delivered ultrasound energy for arterial recanalization.
• To assess the impact of ultrasound energy on arterial stenoses and occlusions.
• To determine the short-term clinical outcomes following combined ultrasound and balloon angioplasty.

Main Methods:

• A prototype 20 kHz ultrasound probe within a 7F catheter was used for recanalization under angiographic guidance.
• Ultrasound energy was applied to four total occlusions and four high-grade stenoses in peripheral arteries.
• Patients underwent combined ultrasound and balloon angioplasty, followed by clinical and Doppler ankle-brachial index (ABI) assessments at 1, 3, and 6 months.

Main Results:

• Three of four total occlusions were successfully recanalized in under 120 seconds.
• Ultrasound energy reduced stenoses by 40% (from 77% to 37%), with further reduction to 20% after balloon angioplasty.
• No immediate complications like emboli or dissection were observed. Five of eight patients maintained patency at six months, but two occlusions recurred within three months.

Conclusions:

• Percutaneous catheter-delivered ultrasound energy shows promise for recanalizing arterial obstructions and reducing stenoses in peripheral arteries.
• The short-term results suggest safety and potential efficacy, but further investigation is required.
• Long-term data is insufficient to conclude on ultrasound's effect on restenosis rates.