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 Issue 63
Implantable cardioverter defibrillators
A clinical trials register for Europe
NICE Citizens Council

Implantable cardioverter defibrillators

The National Institute for Clinical Excellence (NICE) has recommended that implantable cardioverter defibrillators should be routinely considered for patients who have survived ventricular fibrillation or ventricular tachycardia with haemodynamic compromise for secondary prevention of arrhythmic death. It also recommends it in certain patients who have not yet had a serious arrhythmic event but who are at high risk of sudden cardiac death as primary prevention. This second group comprises mainly patients who have survived a myocardial infarction. Only a tiny minority of these patients is currently being investigated and treated with implantable defibrillators.

After an infarction,

  • impaired ventricular function with an ejection fraction of 35% or less

  • non-sustained ventricular tachycardia (three beats or more) on ambulatory 24 hour monitoring

  • inducible ventricular tachycardia at electrophysiological testing

  • identify a subgroup of patients at high risk of sudden death.

Paradoxically, antiarrhythmic drugs increase the risk of death and should be avoided in patients with significantly impaired ventricular function.

Two prospective randomised controlled trials of preventive strategies have shown the benefit of the implantable cardioverter defibrillator in this high risk group. The multicentre automatic defibrillator trial, or MADIT, compared the implantable cardioverter defibrillator with best medical treatment, which included amiodarone in 74% of the control group. It was a relatively small study, justified by its sequential trial design.

The multi-centre unsustained tachycardia, or MUSIT, compared an electrophysiology guided strategy with no antiarrhythmic therapy. The strategy involved serial drug testing - antiarrhythmic drugs were given, and the electrophysiology study repeated to determine if ventricular tachycardia could still be induced.

Both these trials have shown that implantable cardioverter defibrillators confer a relative risk reduction of 54%-60% in all-cause mortality. Using this evidence the American College of Cardiology, American Heart Association, National Institute of Clinical Excellence, and European Society of Cardiology have all recommended using an implantable cardioverter defibrillator as a primary prevention strategy in such high risk patients. In addition, NICE recommends that screening programmes should be put in place so that these patients can be identified.

Best guesses suggest that after an infarction about 1% of screened patients should be considered for cardioverter defibrillator implantation. There are 300 000 myocardial infarctions each year in the United Kingdom; over half the patients survive. Using these assumptions, over 1500 patients each year should be considered for an implantable cardioverter defibrillator as a primary prevention strategy if the recommendations made by NICE are adopted many patients should be screened after infarction. About 24 000 should undergo ambulatory monitoring; 16%, or about 4000, should undergo electrophysiological study, and 1%, or about 250, should have a cardioverter defibrillator implanted.

Increasing the number of patients being investigated and treated according to the guidance from NICE will need many additional resources.

Ref: web

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A clinical trials register for Europe

For more than a decade, clinical trialists and their sponsors have been saying that they want all controlled clinical trials tagged and listed somewhere while they are in progress preferably on an international register that's simple to use, searchable, and free to anyone who wants to know who is studying what and where.

No one doubts that registering ongoing controlled trials is a good idea. The Americans have made an excellent start with their publicly funded register (www.clinicaltrials.gov).The United Kingdom's Medical Research Council and the NHS Research and Development Programme have made important progress through a meta-register of controlled trials (www.controlled-trials.com), established by Current Controlled Trials, a publisher.

Last year the European Science Foundation, an umbrella organisation, advised all its member organisations to register controlled trials through www.controlled-trials.com and to assign each of them a unique international standard randomised controlled trial number (ISRCTN).

The European Science Foundation meeting decided to push for registration to be linked to funding as it already is for many controlled trials in the United Kingdom, where the MRC releases funds only for trials registered on controlled-trials.com and identified by an international standard randomised controlled trial number.

The foundation will review progress in six months and challenge the European Commission to follow through its repeated calls for trials to be registered. In the United States a sustained campaign by patient groups led to a change in the law.

Ref: web

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NICE Citizens Council

NICE has a new Citizen’s Council. They considered the question: 'What should NICE take into account when making decisions about clinical need?' They decided, in no particular order:

  • How bad is the pain and how severe are the symptoms?

  • Is it potentially fatal?

  • Is it contagious?

  • Are there no alternative treatments available?

  • What is the long-term effect of the condition on the individual?

  • What are the chances of good clinical outcome?

  • What is the number of patients affected?

  • What is the effect of the disease on the quality of life for the individual patient?

  • What is the effect of the disease on the length of life for the individual?

  • What are the psychological effects of the condition?

  • What is the level of disability and/or independence of the individual?

  • Is the condition time limited?

  • Are there fluctuations in the individual's condition?

  • Is the disease or the condition cosmetic?

  • What are the side-effects encountered by the patient?

  • Is there any stigma related to the condition?

  • What are the resources available, such as cost and equipment?

Ref: NICE web pages


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Last updated:

Copyright 2003 | Norman Vetter


Send mail to njvetter@hotmail.com with questions or comments