Interventional procedure consultation document

Percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices

Removing plaque from arteries in the legs using a small rotating blade

Debris that builds up in the large blood vessels of the leg leads to narrowing of the vessels and reduced blood flow, which can result in leg pain or the development of foot ulcers.

In this procedure, a special cutting device is used inside diseased blood vessels with the aim of removing the excess debris.

The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 23 November 2010

Target date for publication of guidance: February 2010

1   Provisional recommendations

1.1  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.

1.2  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 (available from www.nice.org.uk/IPGXXXpublicinfo).
• Audit and review clinical outcomes of all patients having percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices (see section 3.1).

1.3  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.

2   The procedure

2.1  Indications and current treatments

2.1.1  Femoropopliteal arterial lesions are common in patients with symptomatic peripheral arterial disease (PAD) of the lower limbs. The most usual symptom is intermittent claudication. If disease progresses to cause ischaemic rest pain, ulceration or gangrene, then amputation may be required.

2.1.2  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.

2.2   Outline of the procedure

2.2.1  Percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices aims to improve arterial flow by removing atheromatous plaque that is restricting blood flow.

2.2.2  With the patient under local anaesthesia, a guidewire is inserted percutaneously into the femoral artery. The atherectomy catheter is introduced over the guidewire. 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 treatment may be undertaken by balloon angioplasty or stenting of the atherectomised segment before removal of the sheath.

2.2.3  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, available at www.nice.org.uk/guidance/IP/816/Overview

2.3   Efficacy

2.3.1  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.

2.3.2  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.

2.3.3  The case series of 601 patients reported that no need for further target lesion revascularisation was achieved 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).

2.3.4  A case series of 34 patients reported an improvement in clinical PAD of 1 or more grades (on the Inter-Society Consensus [TASC] 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.

2.3.5  The case series of 275 patients reported that for all primary percutaneous atherectomy procedures (without adjuvant 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).

2.3.6  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.

2.4   Safety

2.4.1  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). Atheroembolism (treated with atherectomy [not otherwise described] of the embolised plaque) was reported in 5% (1/18) of procedures in a case series of 16 patients.

2.4.2  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.

2.4.3  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.

2.4.4  The Specialist Advisers considered theoretical adverse events to include distal embolisation, limb loss, puncture site bleeding/haematoma and device-related complications.

3   Further information

3.1  This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

October 2010

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}