The Health Information and Quality Authority has published the results of a health technology assessment (HTA) of intermittent pneumatic compression (IPC) for people with severe peripheral arterial disease who are not candidates for revascularisation via angioplasty or surgical intervention. IPC has been proposed as a treatment that can be used in addition to best medical management and is designed to increase blood flow in the lower limbs to relieve pain, promote wound healing and decrease the risk of amputation.IPC devices consist of an inflatable cuff, or series of cuffs, that wrap around the affected leg and apply controlled cyclical compression for a set duration.

The Authority conducted a systematic review and critical appraisal of the evidence on the use of IPC treatment in this population. The Authority’s assessment found that there is a lack of high quality studies examining the clinical effectiveness of IPC in this patient group. Available results from lower quality studies suggest that the intervention may be associated with improved limb salvage rates, wound healing and pain management. However, all identified studies involved small numbers of patients and had significant methodological limitations. No serious adverse events related to the use of IPC were reported. Additional well designed studies are required to reliably demonstrate the clinical effectiveness of IPC in these patients.

Dr Máirín Ryan, Director of Health Technology Assessment in HIQA, said: “Although some promising results have been seen to date, there is a lack of high quality, reliable evidence to support the widespread adoption of this technology. From the limited data that is available, IPC appears to be a potentially beneficial treatment for people at risk of amputation who are not candidates for revascularisation, but until reliable evidence is generated in the context of well designed research studies, this treatment remains unproven.”

The HTA report has been submitted to the Health Service Executive (HSE) for consideration. 

Further Information: 

Marty Whelan, Head of Communications and Stakeholder Engagement, Health Information and Quality Authority, 086 2447 623, mwhelan@hiqa.ie

Notes to the Editor: 

• HIQA is the statutory organisation in Ireland with a responsibility to carry out national health technology assessments (HTAs) and to develop guidelines for the conduct of HTAs across our healthcare system.
• Peripheral arterial disease (PAD) is the restriction of arterial blood flow to the extremities due to atherosclerotic plaque formation, stenosis, embolism or thrombus formation. Risk factors for the development of the disease include smoking, diabetes, hypertension and hypercholesterolemia. Severe peripheral arterial disease can result in critical limb ischemia, with symptoms such as leg pain at rest, slow-healing or non-healing wounds and tissue necrosis, which may result in amputation of the affected limb.
• Revascularisation is the optimal treatment for patients with critical limb ischemia. Alternative treatments for patients who are unsuitable for angioplasty or surgical intervention are limited, with approximately 50% undergoing primary amputation and 50% receiving medical treatment only. Intermittent pneumatic compression (IPC) has been proposed as a treatment that can be used in addition to best medical care with a view to preventing amputation, relieving pain and promoting wound healing by increasing arterial blood flow in distal limbs.
• IPC devices consist of an inflatable cuff, or series of cuffs, that wrap around the affected leg and apply controlled compression by means of a power unit that is programmed to cyclically inflate to a set pressure for a set duration. The treatment is recommended to be used by the patient in the home setting for up to six hours per day. Treatment may be spread across a number of sessions during the day with the patient in a sitting position.
• IPC has already been used to treat a limited number of patients with critical limb ischemia in the Irish healthcare system. As of December 2012, there were 15 patients receiving IPC treatment in the HSE West region. At present, no new requests for referrals are being accepted pending a decision on funding of this treatment, which will be taken with consideration of the results of this health technology assessment.
• No randomised controlled trials, non-randomised controlled trials or prospective controlled before-and-after studies examining the outcomes of amputation-free survival, mortality, limb salvage or wound healing were identified. One retrospective observational study involving 48 patients reported significant improvements in limb salvage and wound healing. One prospective observational study involving 31 patients reported improvements in health related quality of life and claudication distance (distance walked before the onset of pain [initial claudication distance], or distance achieved before the person can no longer walk [absolute claudication distance]) using sequential compression of the calf and foot, but there was some uncertainty about the severity of disease in this group. Both these studies were judged to have significant methodological limitations. Six case series were also identified that reported some encouraging results in terms of limb salvage, wound healing and pain relief. Case series carry a high risk of bias and the absence of a control group limit their ability to reliably estimate the effect of interventions.