Object

Peripheral vascular disease (PVD) is a major cause of morbidity and mortality with increasing need for interventional therapies. Vascular calcification decreases the success of a vascular intervention, enhances risk of complications, and may impair the effect of antiproliferative therapy. Intravascular lithotripsy (IVL) using pulsatile sonic pressure waves to modify intimal and medial calcium is a promising approach for those patients.

Purpose

A single center, prospective all-comers registry for patients undergoing peripheral lithotripsy was established. Periprocedural safety events, angiographic data, as well as short term and long term follow up clinical data were evaluated.

Methods

Between December 2018 and January 2021 all consecutive patients receiving peripheral lithotripsy at our center were analyzed. Clinical and angiographic data were evaluated. Angiographic images were analyzed using a semi-automatic software for quantitative vessel analysis.

Results

85 lesions were treated in 61 limbs with IVL in 51 patients with Rutherford class 2-5. Most lesions (68%) were localized in the SFA. Mean calcified lesion length was 102,5 mm (10-390 mm), with a median PACCS sore of 3 (1;3), indicating a highly calcified status. In 58 % IVL was used as a standalone therapy. We were able to reach acute luminal gain of 2.6 mm, resulting in stenosis reduction of 42,1%. Mean ABI (ankle brachial index) improved significantly (p<0.0001) from 0.6 to 0.8 immediate after the intervention and remained stable after 6 months.

Conclusion

This large real-world data of peripheral IVL reports compelling safety in a complex, difficult to treat patient cohort. For the first time clinical follow up data demonstrated a sustained significantly improved ABI after 6 months. This innovative approach will gain more interest in future.