Intravascular lithotripsy for calcified arteries in peripheral arterial disease should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
Clinicians wanting to do intravascular lithotripsy for calcified arteries in peripheral arterial disease should:
Inform the clinical governance leads in their healthcare organisation.
Ensure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Take account of NICE's advice on shared decision making, including NICE's information for the public.
Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.
Regularly review data on outcomes and safety for this procedure.
Patient selection should be done by a vascular multidisciplinary team including interventional radiologists and vascular surgeons.
NICE encourages further research into intravascular lithotripsy for calcified arteries in peripheral arterial disease. Research should include:
details of patient selection, including the location and degree of stenosis
details of additional interventions
longer-term outcomes, including mortality and amputation
patient-reported outcomes including quality of life
the need for revascularisation and amputation.
Why the committee made these recommendations
There is a moderate amount of evidence, including data from a randomised controlled trial, which suggests the procedure is safe. The evidence shows that blood vessel diameter is increased after the procedure, but because intravascular lithotripsy is sometimes done alongside other procedures it is difficult to know whether this is directly because of the intravascular lithotripsy procedure. The evidence suggests that the procedure is associated with a reduced need for a stent to keep the vessel open. But there is not enough long-term evidence, or evidence about how many amputations will be prevented by having this procedure. More evidence is also needed on patients' quality of life.
There may be groups of people who would particularly benefit from this procedure. These could include people with smaller vessels or with calcified arteries in a location unsuitable for a stent, but more evidence is needed.