Thoracoscopic epicardial radiofrequency ablation for atrial fibrillation (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Thoracoscopic epicardial radiofrequency ablation for atrial fibrillation

Atrial fibrillation is a condition that affects the heart, causing an irregular pulse. It occurs when the electrical impulses controlling the heartbeat become disorganised, so that the heart beats irregularly and too fast. When this happens, the heart cannot efficiently pump blood around the body. This may cause symptoms such as palpitations, chest pain or discomfort, shortness of breath, dizziness and fainting. Atrial fibrillation increases the risk of blood clots and stroke. In thoracoscopic epicardial radiofrequency ablation, selected areas of the heart are destroyed using heat, with the aim of preventing the occurrence or conduction of abnormal electrical activity. The procedure is done through small incisions in the chest and using a camera.

The National Institute for Health and Clinical Excellence (NICE) is examining the thoracoscopic epicardial radiofrequency ablation for atrial fibrillation 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 the thoracoscopic epicardial radiofrequency ablation for atrial fibrillation.

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.

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The Advisory Committee will then prepare draft guidance which will be the basis for NICE's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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

Closing date for comments: 21 October 2008
Target date for publication of guidance: January 2008

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

1	Provisional recommendations
1.1	There is evidence of efficacy for thoracoscopic epicardial radiofrequency ablation for atrial fibrillation (AF) in the short term and in small numbers of patients. The assessment of cardiac rhythm during follow-up varied between studies, and some patients were concomitantly treated with anti-arrhythmic medication. Evidence on safety shows a low incidence of serious complications but this is also based on a limited number of patients. Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2	Clinicians wishing to undertake thoracoscopic epicardial radiofrequency ablation for AF 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). *[[details to be completed at publication]]*
1.3	Patient selection for thoracoscopic epicardial radiofrequency ablation for AF should involve a multidisciplinary team including a cardiologist and a cardiac surgeon, both with training and experience in the use of intraoperative electrophysiology.
1.4	The procedure should only be carried out by surgeons with specific training and experience in both thoracoscopic surgery and radiofrequency ablation.
1.5	The NHS Information Centre for Health and Social Care runs the UK Central Cardiac Audit Database (CCAD), and is developing a database for this procedure. Clinicians should collect data on the procedure and submit them to the database when it becomes available (www.ccad.org.uk).
1.6	NICE encourages further comparative research into the treatment and management of AF, with clearly defined outcomes. NICE may review this procedure on publication of further evidence.
2	The procedure
*2.1*	*Indications* *and current treatments*
2.1.1	AF is irregular and rapid beating of the atria. It is the most common type of cardiac arrhythmia. The incidence of AF increases with age.
2.1.2	AF can be classified as paroxysmal, persistent or permanent, depending on duration of episodes and response to treatment. AF can cause fatigue, palpitations, chest pain, shortness of breath and fainting. There is an increased risk of death and stroke.
2.1.3	Medication for AF may aim either to maintain a normal cardiac rhythm or control the rate of the ventricular response, and to reduce the risk of thromboembolism (which may cause stroke). Ablation procedures are used when drug therapy is either not tolerated or is ineffective.
*2.2*	*Outline of the procedure*
2.2.1	Thoracoscopic epicardial radiofrequency ablation is carried out with the patient under general anaesthesia. Two or more small incisions are made in the chest wall into which surgical instruments and a thoracoscope are introduced. The right lung is deflated and the right pulmonary veins are accessed via blunt dissection. A bipolar radiofrequency device is inserted through a catheter and positioned around the atrium adjacent to the pulmonary veins. Radiofrequency energy is applied to create full thickness ablation in the myocardium, with the aim of electrically isolating the pulmonary veins. Intraoperative electrophysiological testing may be used to check whether isolation has been achieved. The procedure is repeated on the left pulmonary veins.
2.2.2	The left atrial appendage may be excised during the procedure, to minimise the risk of subsequent thromboembolic events.
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/IP716overview.
*2.3*	*Efficacy*
2.3.1	In three case series of 70, 26 and 22 patients with paroxysmal or persistent AF, 93% (65/70), 81% (21/26) and 91% (20/22) were in sinus rhythm at follow-up ranging from 6 to 18 months.
2.3.2	In the case series of 70 patients, 43%, 23% and 14% of patients with paroxysmal AF (n = 42) were using anti-arrhythmic medication at 3, 6 and 12 months, respectively (absolute numbers not reported). In the same study, 61%, 26% and 38% of patients with persistent AF (n = 28) were using anti-arrhythmic medication at 3, 6 and 12 months respectively (absolute numbers not reported). In two case series of 27 and 26 patients, 65% (15 of the 23 patients with follow-up of at least 3 months) and 57% (12 of the 21 patients in sinus rhythm at 6-month follow-up), respectively, were no longer using anti-arrhythmic medication. In the case series of 22 patients, 91% (20/22) had not used anti arrhythmic medication for at least 6 months after the procedure.
2.3.3	The Specialist Advisers considered key efficacy outcomes to include reduced use of anti-arrhythmic medication and decreased burden of AF for patients with paroxysmal AF. One Specialist Adviser stated that the procedure's long-term efficacy was uncertain.
*2.4*	*Safety*
2.4.1	The case series of 70 patients reported two major complications: 1 patient required revision surgery 10 days postoperatively because of fistula formation between the left atrium and the oesophagus, and another required angioplasty and stent insertion for stenosis of the circumflex coronary artery 6 weeks after the procedure. A case series of 27 patients reported one case each of right pneumothorax and suspected pericarditis. In the case series of 26 patients, 1 patient required aspiration of pleural effusion.
2.4.2	The Specialist Advisers stated that theoretical and anecdotal adverse events included freedom from sinus tachycardia, injury to the heart or adjacent structures, bleeding from the atrial appendage, coronary artery occlusion, pulmonary vein stenosis and increased risk of arrhythmias postoperatively.
*2.5*	*Other comments*
2.5.1	The fact that that some patients had concomitant excision of the left atrial appendage and others did not complicated interpretation of the evidence.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

September 2008

This page was last updated: 30 March 2010