Interventional procedure consultation document

Percutaneous laser atherectomy as an adjunct to balloon angioplasty (with or without stenting) for peripheral arterial disease

Treating peripheral arterial disease using a laser and an inflatable balloon to unblock arteries

Blood vessels (arteries) in the legs can become blocked by the build-up of fatty deposits on the inner surface. This can cause leg pain when walking or at rest and, in advanced cases, foot ulcers and gangrene.

For this procedure, a laser attached to a flexible plastic tube (a catheter) is inserted into a blood vessel in the leg and moved to the site of the blockage to burn away the deposits. A balloon is then inserted and inflated to widen the artery at the site of the blockage. An expandable mesh tube (stent) may also be inserted to keep the artery open.

The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous laser atherectomy as an adjunct to balloon angioplasty (with or without stenting) for peripheral arterial disease 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 laser atherectomy as an adjunct to balloon angioplasty (with or without stenting) for peripheral arterial disease.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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).

Through its guidance NICE is committed to promoting race and disability equality, 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 interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that 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: 26 July 2012

Target date for publication of guidance: November 2012

1   Provisional recommendations

1.1   Current evidence on the efficacy and safety of percutaneous laser atherectomy as an adjunct to balloon angioplasty (with or without stenting) for peripheral arterial disease is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.

1.2   Patient selection should be carried out by a vascular multidisciplinary team including a vascular surgeon and a vascular interventional radiologist. The multidisciplinary team should consider carefully whether using percutaneous laser atherectomy as an adjunct to balloon angioplasty (with or without stenting) for peripheral arterial disease is likely to have any benefits over conventional recanalisation by balloon angioplasty (with or without stenting) alone. 

2   The procedure

2.1   Indications and current treatments

2.1.1   Chronic atherosclerotic peripheral arterial disease commonly causes narrowing or blockage of lower limb arteries. Symptoms include intermittent claudication, ischaemic rest pain, ulceration and gangrene.

2.1.2   Cardiovascular risk factor modification is fundamental to the management of peripheral arterial disease. For patients with severely reduced walking distance or critical limb ischaemia, revascularisation procedures such as balloon angioplasty, stenting or surgery (bypass grafts or endarterectomy) can be used.

2.2   Outline of the procedure

2.2.1   The aim of percutaneous laser atherectomy as an adjunct to balloon angioplasty (with or without stenting) for peripheral arterial disease is to achieve recanalisation when balloon angioplasty and/or stenting alone are considered not to be technically feasible or sufficiently safe.

2.2.2   Using local anaesthesia and fluoroscopy, a laser device (with or without a guidewire) is advanced through the artery to the narrowing or blockage. The laser emits pulses of laser light to vaporise the blockage. This is carried out as an adjunct to recanalisation using balloon angioplasty. A stent may then be inserted to treat the stenosis and to prevent embolism and restenosis.

2.2.3   Several types of laser devices are available 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/918/overview

2.3   Efficacy

2.3.1   A randomised controlled trial of 116 patients treated by pulsed laser atherectomy plus balloon angioplasty, by continuous-wave laser atherectomy plus balloon angioplasty, or by balloon angioplasty alone, reported that treated arterial segments were patent on angiography at 1-year follow-up in 45%, 36% and 50% of patients respectively (patient numbers and significance not stated).

2.3.2   A case series of 318 patients (411 lesions) treated by laser atherectomy plus balloon angioplasty reported primary patency (defined as uninterrupted patency with no procedures performed on the treated segment or at its margins) in 34% of patients (patient numbers not reported) at 1-year follow-up.

2.3.3   A non-randomised controlled study of 215 patients reported that there was improvement in American Heart Association limb status grade classification of 1 grade in 19% (24/127) of patients, 2 grades in 20% (25/127) of patients, and 3 grades in 10% (13/127) of patients after laser atherectomy plus balloon angioplasty at 36-month follow-up.

2.3.4   The non-randomised controlled study of 215 patients reported significantly improved mean ankle brachial index at rest for the 167 patients in whom technical success had been achieved (105 patients treated by laser atherectomy plus balloon angioplasty and in 62 patients treated by balloon angioplasty alone). Pressure

indices improved significantly from baseline to 36-month follow‑up in both the laser atherectomy plus balloon angioplasty group (0.34 ± 0.16 to 0.55 ± 0.16; p < 0.001) and the balloon angioplasty alone group (0.33 ± 0.18 to 0.52 ± 0.13; p < 0.001); significance between groups not reported.

2.3.5   The Specialist Advisers listed key efficacy outcomes as an increase in arterial diameter and blood flow, tissue healing, symptom relief, improvement in quality of life, amputation-free survival and reintervention rates.

2.4   Safety

2.4.1   A case series of 40 patients who had laser atherectomy (with or without balloon angioplasty or stenting) reported that 5% (2/40) of patients died within 30 days of the procedure but stated that neither death was related to the revascularisation procedure (no further details reported).

2.4.2   Dissection of the arterial wall occurred in 35% (13/37) of patients treated by pulsed laser atherectomy plus balloon angioplasty, in 20% (8/40) of patients treated by continuous-wave laser atherectomy plus balloon angioplasty, and in 15% (6/39) of patients treated by balloon angioplasty alone in the randomised controlled trial of 116 patients (p = 0.005; but the patient groups to which this applied were not specified).

2.4.3   Vessel perforation occurred in 3% (4/127) of patients treated by laser atherectomy plus balloon angioplasty in the non-randomised controlled study of 215 patients (no further details given).

2.4.4   Complete or partial embolic occlusion of a proximal lower limb artery was reported in 3% (4/127) of patients treated by laser atherectomy plus balloon angioplasty (3 were symptomatic and were treated by local lysis or dilatation), and in 6% (5/88) of patients treated by balloon angioplasty alone (4 were symptomatic and were treated by local lysis or dilatation) in the non-randomised controlled study of 215 patients at mean 36-month follow-up.

2.4.5   Arteriovenous fistula was reported in less than 1% (2/338) of patients in a case series of 338 patients treated by laser atherectomy (alone or plus balloon angioplasty) (‘during or after the procedure’; no further details reported). Arteriovenous fistula was reported in 3% (1/40) of patients within 30 days of the procedure in the case series of 40 patients (‘treated conservatively’; no further details reported).

2.4.6   Pseudoaneurysms at the puncture site were reported in 10 patients in a case series of 312 patients treated by laser atherectomy (with stenting if indicated). These were treated using ultrasound-guided compression. Pseudoaneurysms were reported in 3% (1/40) of patients within 30 days of the procedure in the case series of 40 patients (treated conservatively; no further details reported).  

2.4.7   Warming of tissues at the treatment site, thought to be due to direct thermal effect of the laser treatment (‘during or after’ the procedure), was reported in 64% (215/338) of patients in the case series of 338 patients.

2.4.8   The Specialist Advisers stated that the adverse events reported in the literature were access site complications. They considered thermal injury to be a theoretical adverse event.

2.5   Other comments

2.5.1   The Committee noted that much of the evidence on this procedure is not recent. A limited amount of the older evidence described using laser alone for atherectomy but the more recent evidence focused on its use as an adjunct to balloon angioplasty (with or without stenting). This more recent evidence and the advice of specialists underpinned the decision to evaluate laser recanalisation as an adjunctive procedure.

2.5.1   While the Committee considered the evidence adequate to recommend normal arrangements for the use of percutaneous laser atherectomy as an adjunct to balloon angioplasty (with or without stenting), it remained uncertain about whether its use confers any advantages and, if so, in which patients: this underpinned the recommendation in 1.2.

2.5.3   The Committee was advised that the application of laser technology in percutaneous atherectomy has evolved during the period covered by the published evidence and may continue to do so.

3   Further information

3.1   For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

June 2012

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