Percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices

The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices.

# Guidance
Current evidence on the efficacy of percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices is inadequate in quality. Evidence on safety is inadequate, specifically with regard to the risk of distal embolisation. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Clinicians wishing to undertake percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices (see section 3.1).
Further research into percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices should take the form of well-conducted trials, which should define patient selection, treatment protocols and location and types of arterial lesions treated, and report long-term patency outcomes. NICE may review this procedure on publication of further evidence.# The procedure

# Indications and current treatments
Femoropopliteal arterial lesions are common in patients with symptomatic peripheral arterial disease (PAD) of the lower limbs, usually presenting with intermittent claudication.
Cardiovascular risk factor modification is fundamental to management. For patients with severely impaired walking distance or with critical limb ischaemia, revascularisation procedures such as balloon angioplasty, stenting or bypass grafting can be used.

# Outline of the procedure
Percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices aims to improve arterial flow by removing atheromatous plaque that is restricting blood flow.
With the patient under local anaesthesia, a guidewire is inserted percutaneously into the femoral artery, and the atherectomy catheter is introduced. Catheters of various diameters are available to suit the arterial diameter at the site of the lesion. After appropriately positioning the device, a high-speed rotating cutting blade excises the plaque. Plaque debris is usually collected in a distal nosecone and removed on device withdrawal. Alternatively, depending on the catheter design, the sheathed cutting blade may be advanced over the guidewire beyond the lesion and then exposed so that excision can be undertaken while the device is being withdrawn. Several passes of the catheter may be required. A distal embolic protection device is sometimes used. Adjunctive balloon angioplasty or stenting of the atherectomised segment may be done before removal of the sheath.
Various devices can be used for this procedure.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

# Efficacy
A case series of 601 patients reported that procedural success ( 50% residual stenosis with no death, myocardial infarction, amputation, revascularisation, or major bleeding) was achieved in 95% (778/822) of lesions at 30-day follow-up.
A case series of 275 patients reported that limb amputation was avoided in 93% of patients at 12-month follow-up and 92% of patients at 18-month follow-up (absolute figures not stated). A case series of 60 patients reported that amputation was required in 7% (4/60) of patients at a mean 5-month follow-up. Of these patients, 2 had a patent atherectomy site but continuing ischaemia.
The case series of 601 patients reported that no further target lesion revascularisation was required in 90% of patients at 6-month follow-up (n = 248), and in 80% of patients at 12-month follow-up (n = 87) (absolute figures not stated).
A case series of 34 patients reported clinical PAD improvement of 1 or more grades (on the Trans-Atlantic InterSociety Consensus  II grading system) in 75% (27/36) of procedures at 1-month follow-up and 55% (12/22) of procedures at 12-month follow-up. A case series of 16 patients (17 limbs) with TASC grade C lesions reported that 71% (12/17) had improved symptoms at 1-month follow-up, and 41% (7/17) of limbs remained symptom-free at 6-month follow-up.
The case series of 275 patients reported that for all primary percutaneous atherectomy procedures (without adjunctive balloon angioplasty) the primary patency rate (arterial duplex ratio between proximal adjacent artery and the arterial lesion in question greater than 5.0) was 53% at 18-month follow-up (absolute figures not stated).
The Specialist Advisers listed key efficacy outcomes as adequate luminal channel and long-term patency, limb salvage, improvement in claudication, quality of life and ulcer healing.

# Safety
Periprocedural embolism was reported in 1 out of 1258 procedures in the case series of 601 patients (clinical sequelae were not described) and in 7% (5/70) of procedures in the case series of 60 patients (treated with suction embolectomy or tissue plasminogen activator). Embolism (treated by atherectomy) was reported in 5% (1/18) of procedures in a case series of 16 patients.
Intraoperative arterial wall perforation occurred in 1% (10/1258) of procedures in the case series of 601 patients (clinical sequelae not described). No arterial wall perforation was reported in case series of 60 and 131 procedures.
Graft thrombosis (requiring surgery) following atherectomy at the inflow end of a femorofemoral crossover graft was reported in 1 patient in the case series of 34 patients. Pseudoaneurysm formation (requiring surgery) was reported in 1 patient in the same case series.
The Specialist Advisers considered theoretical adverse events to include distal embolisation, limb loss, puncture site bleeding/haematoma and device-related complications.# Further information
This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).
Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Tools to help you put the guidance into practice and information about the evidence it is based on are also available.
Changes since publication
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2011. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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