SHOCkwave lithotripsy for patients with peripheral arterial disease: the SHOCC study

Abstract

Objective: To assess the 6-month patency and clinical outcomes after endovascular treatment of lower limb atherosclerotic lesions in patients with peripheral arterial disease presenting with severe claudication or chronic limb threatening ischaemia (CLTI) using intravascular lithotripsy (IVL). Methods: A prospective multicentre cohort study was carried out in eight centres in the UK. Consecutive patients with CLTI or lifestyle-limiting claudication treated with IVL as a primary vessel preparation based on operator’s preference were included. Follow-up occurred at discharge, 30 days and 6 months with clinical and duplex assessments. A subset of patients underwent computed tomographic angiographic (CTA) lesion analysis pre-/post-IVL to assess plaque consistency/morphology using three-dimensional reconstruction of the CTA. Results: Overall, 91 patients (mean age 73 years, 72% male; 81% with CLTI) were enrolled in the study between September 2021 and March 2023 (21 took part in the CTA plaque imaging substudy). All patients with claudication had presented with severe lifestyle-limiting claudication and had calf claudication at <20 metres; those with CLTI all presented with Rutherford stage 5 or 6 disease. Immediate procedural success was 100%; 15 (16%) underwent a hybrid intervention. Mean target lesion peripheral artery calcification scoring system (PACCS) grade was 3.31±1.01. At the latest available follow-up (mean 183±75 days) there were 10 deaths (11%), one access complication (1%), two major cardiovascular events (2%) and eight major amputations (9%). A total of 22 re-interventions (24%) and freedom from clinically derived target lesion revascularisation at 6 months was 96% (95% CI 0.88% to 0.99%). Automated 3D plaque subgroup analysis (n=21) revealed >50% remodelling in calcium load within the plaque in 15 plaques (71%), only two dissections (9.5%) and a significant decrease in median plaque calcium load volume (from 7.8 cm3 preoperatively to 5.4 cm3 postoperatively). Conclusion: IVL is a safe and efficacious option for vessel preparation with high procedural success rates, acceptable medium-term complications and freedom from re-intervention.