Interventional procedures consultation document - Percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for atrial fibrillation

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

 

Interventional Procedure Consultation Document

Percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for atrial fibrillation

Atrial fibrillation is a condition that affects the heart, causing an irregular heartbeat. It increases the risk of blood clots in the heart and stroke. Electrical impulses (originating from the atria, the small chambers of the heart) control the heartbeat. In atrial fibrillation these impulses become disorganised, so that the heart beats irregularly and too quickly. When this happens, the heart cannot efficiently pump blood around the body. This may cause symptoms such as palpitations, chest pain, shortness of breath, dizziness and fainting. In percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation, selected areas of the heart are destroyed using heat, with the aim of preventing the abnormal electrical impulses responsible for atrial fibrillation. The procedure is carried out through a special catheter which is inserted into the lower chest area and guided to the outer part of the heart.

 

The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous (non-thoracoscopic) epicardial catheter 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 percutaneous (non-thoracoscopic) epicardial catheter 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: 25 November 2008

Target date for publication of guidance: February 2009

 

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 Current evidence on the safety and efficacy of percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for atrial fibrillation (AF) is inadequate in quantity. Therefore this procedure should only be used with special arrangements for clinical governance and consent.
1.2

Clinicians wishing to undertake percutaneous (non-thoracoscopic) epicardial catheter 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 The procedure should only be carried out by interventional electrophysiologists with specific training in accessing the pericardial space and performing complex ablation procedures.
1.4 The procedure should only be carried out in units with arrangements for emergency cardiac surgery support in case of complications. 
1.5 The NHS Information Centre for health and social care runs the UK Central Cardiac Audit Database, and clinicians should enter details about all patients undergoing percutaneous (non‑thoracoscopic) epicardial catheter radiofrequency ablation for AF onto this database (www.ccad.org.uk).
1.6 Clinicians are encouraged to enter patients into research studies that aim to provide more information about patient selection, the use of this procedure as an adjunct to other procedures, freedom from AF in the long term and relief of associated symptoms, and the safety profile of the procedure. NICEmay review the procedure on publication of further evidence.
2 The procedure
2.1 Indications and current treatments
2.1.1 Atrial fibrillation is the most common type of cardiac arrhythmia, and is caused by the irregular and rapid beating of the atria. It can be classified as paroxysmal, persistent or permanent, depending on episode duration and response to treatment. Patients with AF may be asymptomatic or may have symptoms such as palpitations, dizziness, breathlessness and fatigue. Atrial fibrillation is associated with increased risk of embolic stroke from atrial thrombus. Anticoagulation treatment is used to reduce this risk. Antiarrhythmic medication is used either to help maintain a normal rhythm following successful cardioversion or to help reduce the heart rate. Ablation procedures can be used when drug therapy is either not tolerated or is ineffective.
2.2 Outline of the procedure
2.2.1 The procedure is carried out with the patient under sedation or general anaesthesia. The pericardial space is accessed by a subxiphoid needle puncture under fluoroscopic guidance. A guidewire is introduced through the needle and a sheath is advanced over the guidewire so that the tip is placed inside the pericardial sac. The sheath is aspirated to check for bleeding. A radiofrequency catheter is inserted into the sheath. After electrophysiological mapping to determine target sites for ablation, radiofrequency energy pulses are applied to the epicardium
2.2.2 During the procedure, catheter position is monitored with a three-dimensional mapping system to avoid collateral damage. Saline is placed in the pericardial space to reduce the risk of oesophageal injury, and steroids are administered to reduce the risk of pericarditis.
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/IP261overview.
2.3 Efficacy
2.3.1 In a case series, five patients had percutaneous epicardial catheter radiofrequency ablation after failed endocardial ablation. Four patients were AF free and not on antiarrhythmic medication at 2 month, 6 month, 13 month and 15 month follow-up, respectively. The fifth patient was AF free but on antiarrhythmic medication at 4 month follow-up.
2.3.2 A case report of a patient with persistent AF (refractory to antiarrhythmic medication and with two previous failed electrical cardioversions) reported that the patient was symptom free at 1 month postoperatively. 
2.3.3 One Specialist Adviser thought that the key efficacy outcome was freedom from AF. One Specialist Adviser commented that there was uncertainty about the efficacy of the procedure because of the small number of cases reported in the literature.
2.4 Safety
2.4.1 In the case series of five patients, one patient developed haemopericardium during the percutaneous epicardial puncture, which was successfully drained. In another patient, a tachycardia originating from the left inferior pulmonary vein was observed during the procedure but this was successfully terminated with delivery of further epicardial and endocardial radiofrequency pulses.
2.4.2 The Specialist Advisers considered that potential safety concerns included myocardial puncture; pericarditis; coronary artery damage; perforation of the right ventricle; damage to the oesophagus, bronchi and phrenic nerve; gastric puncture; and damage to abdominal vessels and organs when accessing the pericardial space. One Specialist Adviser described an anecdotal report of death because of gastric injury resulting from percutaneous epicardial implantation of pacing leads. Another commented that there was uncertainty about the long-term safety of the procedure.
3 Further information
3.1 NICE has published a clinical guideline on AF and interventional procedures guidance on several procedures for AF, with or without cardiac surgery. NICE is developing interventional procedures guidance on thoracoscopic epicardial radiofrequency ablation for AF and percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for ventricular tachycardia. For more information see www.nice.org.uk.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

September 2008

This page was last updated: 30 March 2010