The Effect of Neurostimulation on Patient Relevant Outcomes in Patients With Intermittent Claudication: a Pilot Study

Lower limb peripheral arterial disease (PAD) is common, affecting over 200 million people worldwide and present in 12 to 14% of the global population (20% over the age of 75 years)1. The most common symptom is intermittent claudication, a symptom of muscular lower limb pain brought on by exertion and relieved by rest2.

PAD is the third leading cause of atherosclerotic cardiovascular morbidity, following coronary artery disease and stroke, yet the natural history of the limb in patients with IC is relatively benign with 75% of patients finding that symptoms either remain static or are somewhat improved with no treatment2. It is due to this natural history of the limb that there is an increasing tendency to manage patients with claudication conservatively (ie. Non-invasively).

In patients with intermittent claudication, CV prevention and exercise training are the cornerstones of management3. There is good evidence for enrolment of patients into a supervised exercise programme, providing bot improved walking distance and quality of life, yet widespread provision of such programmes are currently not available within the NHS and further are unlikely to be delivered within the coming years4.

Revascularisation has historically been indicated if daily life activity is severely compromised by the lower limb symptoms and such revascularisation is primarily performed endovascularly with balloon angioplasty +/- stent insertion where needed. The ability to perform endovascular revascularisation is determined by the anatomical location and severity of the lower limb atherosclerosis. Endovascular interventions work best with short focal stenoses rather than longer occlusion where surgical revascularisation is the better option2. Such interventions are invasive and carry risks including risk of amputation and so surgical revascularisation is now rarely performed for intermittent claudication. Further, there is now data available that suggests that early invasive revascularisation in patients with claudication may in the longer term increase the risk of major limb amputation. This means that there is a cohort of patients who have significant claudication symptoms affecting their quality of life who are either (i) not offered revasculairsation or (ii) not prepared to accept the risks of major lower limb revascularisation.

Given this, there is a need to explore further non-invasive methods that could enhance walking distances in patients with IC and thus improve overall quality of life and overall cardiovascular fitness without exposing patients to invasive revascularisations.