Use of Shockwave® intravascular lithotripsy in the treatment of calcific peripheral vascular disease of the crural vessels: a protocol for a systematic review

Abstract

Background: The prevalence of chronic limb-threatening ischaemia due to crural peripheral arterial disease is increasing. Crural disease can be challenging to treat with angioplasty and is associated with poorer patient outcomes. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic waves to target arterial wall calcification, causing microfractures and increasing lumen gain. It has shown promising results in early clinical trials. This is a protocol for a systematic review of the studies on the use of IVL in the treatment of calcified crural vessels. Methods: A systematic review will be conducted on the use of IVL in patients with calcified crural lesions in accordance with PRISMA guidelines. A search of OVID Medline and EMBASE databases will be carried out for studies of patients with crural peripheral arterial disease undergoing endovascular revascularisation, where IVL was part of the procedure. The primary endpoint of the review will be the safety of IVL, defined as the rate of Major Adverse Limb Events (MALE) and Major Adverse Cardiac Events (MACE). The efficacy of IVL will be the secondary outcome and will be evaluated in terms of technical and clinical outcomes. The Rayyan web tool for systematic reviews will be used for study screening and selection. Data extraction will be performed using a dedicated Excel spreadsheet. The risk of bias of included studies will be assessed using tools recommended by Cochrane for randomised and non-randomised studies. The assessment of evidence quality and strength of recommendation will be performed using the GRADE approach. Ethics and dissemination: This is a systematic review and meta-analysis of published literature data and does not require prior ethical approval. Requests for unpublished data from authors of included studies will comply with the UK General Data Protection Regulation (GDPR). We aim to disseminate the results of this study in peer-reviewed journals and conferences.