Interventional procedures consultation document for percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for ventricular tachycardia
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for ventricular tachycardia
|Ventricular tachycardia is a life-threatening heart condition. It occurs when the electrical impulses controlling the heartbeat become erratic, causing the heart to beat too quickly. When this happens, the heart cannot efficiently pump blood around the body. Ventricular tachycardia, if left untreated, may cause sudden cardiac death. In percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation, selected areas on the outside of the heart are destroyed using heat, with the aim of preventing abnormal electrical impulses responsible for ventricular tachycardia from occurring. The procedure is carried out by inserting a special catheter into the sac around the heart and using it to deliver heat to selected areas of heart muscle where abnormal electrical impulses responsible for the ventricular tachycardia are detected.|
The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for ventricular tachycardia 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 ventricular tachycardia.
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:
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.
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.|
|1.1||The evidence on percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for ventricular tachycardia (VT) is limited to a small number of patients, but it shows that the procedure is efficacious in carefully selected individuals and raises no major safety issues, in the context of a condition which is potentially life-threatening. Therefore, the procedure may be used with normal arrangements for clinical governance and audit, but with special arrangements for consent.|
|1.2||During the consent process clinicians should ensure that patients understand the risks of potentially serious complications, including damage to the heart or coronary arteries.|
|1.3||Patient selection and treatment should be carried out only by a team specialising in the treatment of cardiac arrhythmias which includes experts in interventional electrophysiology and ablation.|
|1.4||The procedure should only be carried out by interventional electrophysiologists with specific training in accessing the pericardial space and performing complex ablation procedures.|
|1.5||The procedure should only be carried out in units with arrangements for emergency cardiac surgical support in case of complications.|
|1.6||NICE encourages further research into and publication of the outcomes and potential serious complications of percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for VT in larger numbers of patients, and may review the procedure on publication of further evidence.|
|2.1||Indications and current treatments|
|2.1.1||Ventricular tachycardia is caused by abnormal electrical circuits originating from diseased areas of the ventricular myocardium. It usually results in a rapid heartbeat, preventing effective ventricular refill and adequate cardiac output. Untreated VT is usually life-threatening.|
|2.1.2||Depending on the type of VT, patients may be managed by antiarrhythmic drugs. Patients who have recurrent VT episodes may require an implantable cardiac defibrillator (ICD) or endocardial catheter ablation to destroy diseased areas of the ventricular myocardium and interrupt the abnormal electrical circuits.|
|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.|
|2.2.3||Patients can have a combined procedure that includes electrophysiological mapping and ablation by both endocardial and epicardial approaches.|
|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/IP709overview.|
|2.3.1||In a case series of 48 patients, epicardial ablation eliminated VT inducing circuits in 94% of patients (17/18 had epicardial ablation, mean follow-up 25 months). In a case series of 14 patients, an epicardial VT circuit was mapped in 7 patients and was successfully terminated with epicardial ablation in all patients (mean follow-up 14 months). In a case series of 10 patients, VT-inducing circuits were eliminated in 8 (no episodes of syncope at 18-month follow-up).|
|2.3.2||The Specialist Advisers stated that key efficacy outcomes included termination of VT (acutely and making it non-inducible), lack of VT recurrence, and reduction in the need for ICDs. One Adviser thought there was some uncertainty about which type of cooling system to use in the procedure.|
|2.4.1||No deaths directly attributable to the procedure have been reported in the literature. There were three deaths because of progression of severe heart failure. One patient in a case series of 48 patients died from decompensated congestive heart failure several weeks after successful epicardial ablation. Two patients in a case series of 20 patients died because of progressive heart failure during follow-up (mean 12 months).|
|2.4.2||In a case series of 20 patients, one patient developed arteriovenous fistula formation needing surgical repair. In the same study, another patient developed an atrioventricular block.|
|2.4.3||In a case series of 10 patients, one patient developed haemopericardium needing drainage. In the same study three patients developed pericardial friction rub without haemopericardium.|
|2.4.4||In a case series of 48 patients, three patients developed transient pericarditis that resolved within 1 week. In a second case series of 10 patients, two patients reported acute thoracic pain needing analgesia.|
|2.4.5||In a case series of 10 patients, 5 patients were in heart failure during the procedure, and one of these needed urgent heart transplantation after the procedure.|
|2.4.6||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.|
|3.1||The National Patient Safety Agency runs the National Reporting and Learning System (NRLS), and clinicians should report any serious adverse events relating to use of this procedure to the NRLS (www.npsa.nhs.uk/nrls/)|
|3.2||NICE is developing interventional procedures guidance on percutaneous (non-thoracoscopic) epicardial catheter radiofrequency ablation for atrial fibrillation. For more information see www.nice.org.uk.|
Chairman, Interventional Procedures Advisory Committee
This page was last updated: 30 March 2010