Zenicor Medical Systems has been selected as sole supplier for a screening programme in the UK for atrial fibrillation. The screening programme is the world’s largest randomised controlled trial to discover whether screening systematically for atrial fibrillation, a heart condition responsible for one in ten strokes, and offering optimal treatment reduces the incidence of stroke, premature death and other health risks associated with atrial fibrillation.
Atrial fibrillation is the most common disturbance of the heart rhythm, characterised by an irregular pulse. It affects up to 10 in 100 people over the age of 65, a considerable proportion of whom do not know they have the condition. Atrial fibrillation may not be associated with any symptoms, but is linked to increased risk of stroke, heart attack, dementia and premature death. About 10% of strokes happen in people unaware that they have atrial fibrillation. However, therapy with medication (anticoagulation) is highly effective at reducing the risk.
At present, some GPs look for atrial fibrillation opportunistically by using a diagnostic device such as a hand-held electrocardiogram (ECG) or simply take the pulse of patients who could be visiting for any reason. However, this is not done in a systematic way, and only in some general practices.
The research, led by the University of Cambridge, will involve 120,000 patients, aged over 65, in 300 general practices across England. Patients in 100 practices will undergo screening, and those in 200 practices will not. People who are found to have atrial fibrillation by the screening programme will be offered treatment with anticoagulant drugs to reduce their risk of stroke and heart attack. Both sets of patients will be followed up for five years to see whether screening and treatment leads to fewer strokes, heart attacks and deaths.
The programme of research will include a cost effectiveness analysis to assess whether screening is a good use of NHS resources. Researchers will also observe what goes on in general practices when screening is carried out and interview staff and patients to explore issues around consent to screening and patient concerns.
Lead investigator Professor Jonathan Mant, Professor of Primary Care Research and Head of the Primary Care Unit at the University of Cambridge, said: “We know that a significant proportion of strokes occur in people with undiagnosed atrial fibrillation. Anticoagulation therapy is a very effective treatment that can reduce the risk of stroke by about 65%, so many of these strokes are preventable.”
One problem with the current approach is that some people do not have atrial fibrillation all the time but go into and out of an irregular heart rhythm. In this new research, patients will be loaned a handheld ECG device, provided by Zenicor, to measure a (single lead) ECG twice a day at home for two weeks.
“This novel technique, the first time home screening has been used on this scale in the NHS, will detect intermittent atrial fibrillation that otherwise would be missed in a one-off test at a GP appointment,” said Prof Mant.
Professor Richard Hobbs, Professor of Primary Care Health Sciences at the University of Oxford and Director of the NIHR School for Primary Care Research, said:
“There’s currently not any evidence on whether systematic screening for atrial fibrillation works, so the National Screening Committee is not able to recommend it. Whether or not this research shows that screening is effective and cost effective, it will be a landmark trial that will affect UK screening guidance, and guidance elsewhere around the world.”