3 Committee considerations

3 Committee considerations

The evidence


NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 10 sources, which was discussed by the committee. The evidence included 1 systematic review and meta-analysis, 1 randomised controlled trial (reported in 2 papers), 1 prospective single-arm trial, 2 retrospective cohort studies, 1 prospective single centre registry and 2 case reports. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in table 5 of the overview.


The professional experts and the committee considered the key efficacy outcomes to be: quality of life, vessel patency, amputation rate, amputation-free survival, procedural success, revascularisation rate and need for a stent.


The professional experts and the committee considered the key safety outcomes to be: embolisation, perforation, dissection, worsening of pain and long-term procedure failure.


Patient commentary was sought but none was received.

Committee comments


Most of the evidence was on femoropopliteal lesions, but there was some evidence on iliac lesions. There are several ongoing studies, including 1 on arteries below the knee.


Clinical experts explained that the procedure is only used for chronic limb ischaemia and would not be used in an acute setting.


The clinical experts advised that there is no clear consensus for assessing the degree of calcification in a peripheral artery.


Studies that used intravascular lithotripsy to allow access for an endovascular cardiac procedure were not included in the evidence for this guidance.


There is a company-funded registry of people having the procedure in the UK. But this is no longer recruiting.


There is an unmet need for a safe and effective endovascular option for treating heavily calcified arterial lesions when surgery is unsuitable.

ISBN: 978-1-4731-5614-2

  • National Institute for Health and Care Excellence (NICE)