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NICE has recently published draft updated guidance recommending the use of dual-chamber pacemakers as an option for treating some people with abnormally slow heart rhythms (bradycardia) caused by sick sinus syndrome without atrioventricular block, and who have started to show symptoms of the disease.

Bradycardia is defined as a heart rate of less than 60 beats per minute. If untreated it can cause problems such as faints, falls, dizziness, confusion, palpitations, difficulty breathing, congestive heart failure or death.

Bradycardia can be caused by a range of factors including diseases such as sick sinus syndrome and atrioventricular block, age, ischaemic heart disease, heart valve disorders and heart failure.

Sick sinus syndrome happens when the heart’s sinus node, a small area of the right upper chamber of the heart (atrium) which acts as the heart’s natural pacemaker, doesn’t produce the electrical impulses the heart needs to beat at the normal rate.

Atrioventricular block happens when the flow of electrical impulses from the sinus node are slowed or blocked.

Implantation of a pacemaker device is the only effective treatment for bradycardia because of sick sinus syndrome without any evidence of atrioventricular block once it becomes symptomatic.

A pacemaker is a small, battery-powered device that is connected to the surface of the heart by tiny wire leads. Dual-chamber pacemakers are connected to both the right atrium and right ventricle (lower chamber), whereas single-chamber devices are connected to either the right atrium or ventricle only.

The primary aim of permanent pacing is to prevent the heart from beating too slowly. An important secondary aim is to reproduce, as far as possible, the function of the heart's normal electrical conduction system, which coordinates the way the heart muscle contracts.

NICE has previously recommended a single-chamber pacemaker for people who have symptomatic bradycardia caused by sick sinus syndrome without any evidence of impaired atrioventricular conduction.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The Committee heard from the clinical experts that the treatment of symptomatic bradycardia has changed since the publication of the original NICE guidance on dual-chamber pacemakers. Usual clinical practice now is that dual-chamber devices are implanted in patients with pure sinus node disease. This avoids the need to re-operate to implant a dual-chamber device should people go on to develop atrioventricular block.

“The Committee concluded that the risk of unpleasant and severe complications involved in having to re-operate is significant. They therefore felt that implanting a dual-chamber pacemaker as the initial treatment option for these patients would offer significant clinical benefits and be a cost effective use of NHS resources.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.   

Final guidance on the use of dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome without atrioventricular block is expected to be published in November 2014.

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the draft guidance on dual-chamber pacemakers for symptomatic bradycardia

1. The draft guidance will be available athttp://www.nice.org.uk/guidance/indevelopment/gid-tag362 from Friday 17 October 2014. Embargoed copies are available from the NICE press office on request.

Summary of the evidence for clinical effectiveness

1. Several new trials have been published since the publication of TA88. In particular, DANPACE was a large high-quality trial, providing the best evidence base for this appraisal. This indicated that that dual chamber pacemakers were associated with a statistically significant reduction in the need for re-operation compared with single chamber atrial pacemakers.
2. Clinical experts noted that for pure sinus node disease dual-chamber devices were now usually implanted since the publication of DANPACE, because of the possibility of progression to atrioventricular block (requiring re-operation).

Summary of the evidence for cost effectiveness

1. In sensitivity and scenario analyses, most ICERs were under £20,000 per QALY gained. The Committee agreed that the base-case ICER of approximately £6000 per QALY gained was likely to be higher in clinical practice because there is no difference in the effectiveness of dual-chamber pacing for outcomes including heart failure. Dual-chamber pacemakers also have higher acquisition costs; however this cost is likely to be partially offset by the reduced need for re-operation.
2. The Committee agreed that there were high levels of uncertainty in the Assessment Group base-case ICERs, as a list price for the devices was not available to use in the model. However, the Committee was reassured by the threshold analysis that the price difference between dual and single chamber atrial pacemakers had to be increased substantially, and to a level unlikely to be seen in clinical practice, before dual chamber pacemakers would not be cost effective at a maximum acceptable ICER of £20,000 per QALY gained.
3. The Committee concluded that the most plausible ICER was likely to be under £20,000 per QALY gained.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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