Arrhythmia Watch

An Educational Resource for Cardiac Rhythm Management

Dronedarone gets thumbs up from NICE in New Appraisal Consultation Document

The NICE appraisal committee’s preliminary recommendation is to endorse Multaq® as a first choice therapeutic option after beta-blockers, which are the initial therapeutic option in the NICE clinical guidelines.  Based on this recommendation, Multaq® should be prescribed in non-permanent AF patients with at least one of the following cardiovascular risk factors: hypertension requiring drugs of at least two different classes, diabetes mellitus, previous transient ischemic attack, stroke or systemic embolism, left atrial diameter of 50mm of greater, LVEF less than 40% or age 70 years or older and who do not have unstable New York Heart Association (NYHA) class III or IV heart failure.

This patient population corresponds to the patients included in the ATHENA study ¹, the largest study ever performed with an anti-arrhythmic drug in atrial fibrillation and the only study to have ever demonstrated a positive impact on cardiovascular (CV) morbidity and mortality.

In ATHENA, dronedarone reduced the risk of cardiovascular hospitalization or death by a significant 24% vs. placebo on top of standard of care including beta-blockers (p<0.001) with no difference in the rate of serious adverse events (19.9% vs 21.1% respectively; p = 0.31).

The Arrhythmia Alliance welcomed the decision by NICE to recommend approval of dronedarone as a second line treatment option for Atrial Fibrillation (AF) patients, reversing its previous draft guidance.

NICE’s Appraisal Committee recognised that dronedarone can and should occupy a currently vaca(2nt place in the care pathway, and that for a large and growing number of patients it could represent the only treatment option open to them.

Trudie Lobban, CEO of the Atrial Fibrillation Association which is campaigning for dronedarone to be approved said: “For thousands of AF patients this news will give them new hope that they will be able to lead a fulfilled and productive life. NICE’s decision is triumph of common sense and will restore patient and healthcare professionals faith in NICE processes and evidence hearing. They took into account the value of the drug to patients whose lives have been crippled with either the symptoms of AF or the side effects of other treatments.  It is important that symptomatic AF patients have access to specialist consultants who will be aware of the benefits of this new drug.

“I would like to thank all the patients, carers and clinicians who took the time to respond to the earlier Appraisal Consultation Document by NICE which ensured that a review was held and evidence from leading arrhythmia clinicians and AF patients was heard. Without their support many thousands of AF sufferers would be left without hope.”

Professor John Camm, Head of the Department of Cardiac & Vascular Sciences at St George’s, University of London, a Trustee of AFA and President of Arrhythmia Alliance said: “This decision will please many clinicians working in our field. It enables us to have the authority to prescribe dronedarone and gives us an additional treatment for patients who may have run out of options. I want to thank the NICE committee for being so responsive to requests to review all the evidence.”

Multaq® will be commercially available in the UK from Tuesday, March 30, 2010.

Multaq® has a fixed dose regimen of twice daily 400 mg tablets to be taken with morning and evening meals. Treatment with Multaq® does not require a loading dose and can be initiated in an outpatient setting. Most common adverse reactions are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and skin rash.

The European Commission granted marketing authorization for Multaq® in November 2009. Multaq® is indicated in the EU in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. ² The use of Multaq® in unstable patients with NYHA class III and IV heart failure is contraindicated. Because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with Left Ventricular Ejection Fraction (LVEF) <35%, the use of Multaq® is not recommended in these patients.

Multaq® is currently available in the U.S., Canada, Switzerland, Germany, Denmark, Ireland, Norway and Finland and is being launched in most European countries in 2010.

The NICE process for Multaq®

• The stakeholder consultation period for this ACD closes on 22 April
• Stakeholder comments submitted to NICE on this ACD will be considered at the Appraisal Committee Meeting on 26 May
• If a Final Appraisal Determination (FAD) is produced following the Appraisal Committee Meeting it would be expected in early July
• If the FAD is not appealed, publication of Final Guidance would be expected sometime between July and September.

1. This new appraisal document is not the final NICE guidance on Multaq®.  A consultation period is ongoing until April 22nd, 2010. The appraisal committee will meet again to consider the evidence on May 26, 2010. After this meeting the Committee will prepare the final appraisal determination (FAD) for Multaq®.

References

1. Hohnloser S.H, Crijns H.J.G.M., van Eickels M, et al. Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation, N Engl J Med 2009; 360:668-78.
2. European Medicines Agency. European Public Assessment Report.  Doc. Ref.: EMA/625172/2009; EMEA/H/C/1043

Early initiation of dronedarone feasible

The data comes from a post-hoc analysis of pooled data from the EURIDIS and ADONIS sinus rhythm maintenance trials and assessed the impact of initiation of dronedarone therapy on safety and efficacy within two days after stopping amiodarone.

The analysis included 223 patients previously treated with amiodarone, in which Multaq (dronedarone) or placebo was initiated in a subgroup of 154 patients (Multaq = 98, placebo = 56) within two days of discontinuing amiodarone. The subgroup represents 18 percent of the patients enrolled in the EURIDIS and ADONIS studies (7.9% treated with Multaq) and was compared with a group of patients who had no prior treatment with amiodarone (n=1014). Groups were compared on the primary study endpoint, time to first recurrence of AF/AFL as well as incidence of adverse events.

In this subgroup, dronedarone decreased AF/AFL recurrence compared to placebo (HR=0.64 [95% CI 0.44-0.95], P=0.022) which is consistent with the overall study results in which dronedarone decreased the rate of AF recurrence by HR=0.75 [95% CI 0.65-0.87], P=0.001. The rate of serious adverse events was low and similar across groups with no episodes of torsades de pointes reported. There were more bradyarrhythmic events in patients treated with dronedarone (3.1%) compared to placebo (0%) and drug discontinuation due to QTc-prolongations (dronedarone = 7.9% versus placebo = 3.6% with QTc >500 msec) in the patients previously treated with amiodarone, as expected from the pharmacodynamic profile of the drugs.¹

“The data presented today suggest it may be possible to initiate Multaq following discontinuation of amiodarone in paroxysmal and persistent patients within two days, while maintaining efficacy at preventing AF recurrence. Caution should be given to heart rate and QTc intervals prior to consideration of early initiation of dronedarone. ,” said Peter Kowey, M.D., FACC, Chief of the Division of Cardiovascular Diseases at the Main Line Health System, Wynnewood, Pennsylvania. “These results are hypothesis generating and indicate that a prospective trial is warranted which is currently being put in place sponsored by the manufacturers.”

Reference

1. Kowey, P. “Impact of Dronedarone Started Rapidly After Amiodarone Discontinuation” abstract. ACC 2010.

Video: Magnetic resonance imaging (MRI) compatible devices

IQ ranks among the strongest predictors of cardiovascular disease

Now, a large study funded by the UK’s Medical Research Council, which set out to gauge the relative importance of IQ alongside other risk factors, has found that lower intelligence scores were associated with higher rates of cardiovascular disease and total mortality at a greater level of magnitude than found with any other risk factor except smoking.(1)

The findings, published in the European Journal of Cardiovascular Prevention and Rehabilitation, are derived from the West of Scotland Twenty-07 Study, a population study designed to investigate the influence of social factors on health. The present analysis was based on data collected in 1987 in a cohort of 1145 men and women aged around 55 and followed up for 20 years. Data were collected for height, weight, blood pressure, smoking habits, physical activity, education and occupation; cognitive ability (IQ) was assessed using a standard test of general intelligence.

When the data were applied to a statistical model to quantify the associations of nine risk factors with cardiovascular mortality, results showed that the most important was cigarette smoking, followed by low IQ. Similar results were apparent when the health outcome was total mortality.

The relative strengths of the association were measured by an “index of inequality”, which summarised the relative risk of a health outcome (cardiovascular death) in the most disadvantaged (high risk) people relative to the most advantaged (low risk). This relative index of inequality for the top five risk factors was found to be 5.58 for cigarette smoking, 3.76 for IQ, 3.20 for low income, 2.61 for high systolic blood pressure, and 2.06 for low physical activity.

The investigators note “a number of plausible mechanisms” whereby lower IQ scores could elevate cardiovascular disease risk, notably the application of intelligence to healthy behaviour (such as smoking or exercise) and its correlates (obesity, blood pressure). A further possibility, they add, “is that IQ denotes ‘a record’ of environmental insults” (eg, illness, sub-optimal nutrition) accumulated throughout life.

Commenting on the public health implications of the findings, the study’s principal investigator Dr David Batty said that the individual skills reflected in a person’s IQ may be important in the management of personal cardiovascular risk.(2)

“From a public health perspective, there is the possibility that IQ can be increased, with some mixed results from trials of early learning and school readiness programmes,” said Dr Batty. “It may also be worthwhile for health promotion campaigns to be planned with consideration of individual cognition levels.”

He also noted that IQ may well be one important factor behind the place of social class as a fundamental determinant of inequalities in health. So far, said Dr Batty, explanations for such socio-economic gradients in health have traditionally focused on access to resources (such as education and income), physical exposures at home and at work (such as housing conditions and toxins), and health related behaviours (such as smoking and diet). But studies show that such factors do not fully explain class-based differentials in health. A low IQ, he explained, as suggested in this study, may be a further independent explanation.

References and notes

1. Batty GD, Deary IJ, Benzeval M, Der G. Does IQ predict cardiovascular disease mortality as strongly as established risk factors? Comparison of effect estimates using the West of Scotland ‘Twenty-07′ cohort study. Eur J Cardiovasc Prev Rehabil 2010, 17:24–27; DOI: 10.1097/HJR.0b013e328321311b
2. Dr David Batty is a Wellcome Trust-Funded Research Fellow from the Medical Research Council Social & Public Health Science Unit in Glasgow and the University of Edinburgh Centre for Cognitive Ageing and Cognitive Epidemiology.

• The West of Scotland Twenty-07 Study is funded by the UK Medical Research Council.
• The European Journal of Cardiovascular Prevention and Rehabilitation is a journal of the European Society of Cardiology. The European Society of Cardiology (ESC) represents more than 62,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.

Robust response to NICE decision on dronedarone

Last December’s appraisal consultation document  (ACD) (which can be accessed here), is not NICEs final guidance on this technology, and following the initial consultation period, there will be another publicly held Appraisal Committee meeting in Manchester on 24^th February 2010. This meeting will consider comments from the consultees, which includes dronedarone manufacturers, sanofi-aventis, as well as professional /specialist and patient/carer groups, such as Heart Rhythm UK (HRUK) and the Arrhythmia Alliance, Atrial Fibrillation Association, and others. The Committee will also consider comments made by non-consultees and will then prepare the final appraisal determination (FAD), which subject to appeal by consultees, may be used as the basis for NICEs guidance on using dronedarone in England and Wales.

In its initial consideration the Appraisal Committee also assessed the submission by the Evidence Review Group (ERG) which was prepared by the Centre for Reviews and Dissemination (CRD) and the Centre for Health Economics (CHE), University of York. They decided that they could not give the drug a positive recommendation based on their assessments of cost effectiveness.

Critics of the ruling argue that dronedarone, while costing more (about £2/day) than other agents, such as amiodarone, offers patients a better short-term side effect profile. The protests were spearheaded by the Daily Express (27 January) who voiced concerns from a number of Members of Parliament, notably Mark Hunter, Liberal Democrat MP for Cheadle who was quoted saying, “At the end of the day, dronedarone, represents a huge step forward for heart patients. It’s a breakthrough drug and if it can benefit all these people, then it’s got to be worthy of reassessment by NICE”.

A group of over 170 doctors are also reported to have written in protest to NICE calling on it to reverse its verdict, claiming that the expense (of dronedarone) is neglible compared with the burden of the effects of atrial fibrillation to the NHS.

Study prompts calls for Europe-wide salt legislation

The European Society of Cardiology (ESC) has welcomed the data, saying it underlines the urgent need for European Union public health measures to substantially reduce the  population’s salt intake across Europe.

“This study provides excellent ammunition both to convince patients about the benefits of reducing their individual salt intakes and also to persuade the EU of the urgent need to introduce legislation to restrict the salt content of  processed foods,” said ESC spokesman Professor Frank Ruschitzka, a cardiologist and hypertension specialist from the University of Zurich, Switzerland.

“This study represents the evidence that a reduction of salt intake not only lowers blood pressure but also prevents cardiovascular events. The case for population-wide salt reduction is now compelling,” he added.

In the paper, Kirsten Bibbins-Domingo and colleagues, from the University of California, San Francisco, USA, undertook a computer simulation showing the effects of population wide reductions of dietary salt intakes in all adults aged 35 to 85 years in the USA.   Reducing  dietary salt intake by 3 g per day (1200mg less sodium per day) could result in 60,000 to 120,000 fewer cases of heart disease , 32,000 to 66,000 fewer strokes and 54,000 to 100,000  fewer heart attacks.

A reduction in dietary salt of 3g per day, the authors went on to say, would have approximately the same effect on reducing cardiac events as a 50 % reduction in tobacco use, a 5% reduction in body mass index among obese adults or the use of statins to treat people at low or intermediate risk for CHD events.  Furthermore, reducing dietary salt intakes by 3g per day would save  $10 billion to $ 24 billion in annual health care costs.

ESC spokesperson Professor Giuseppe Mancia,  from the University of Milano-Bicocca, St. Gerardo Hospital (Milan, Italy), said the annual health cost savings outlined in the study would be likely to prove a persuasive argument for both the EU and individual European governments.

Recent studies clearly show that salt reduction reduces cardiovascular deaths.⁴ Epidemiological studies have also firmly established that increased intakes of salt directly increase blood pressure.  High salt intakes are believed to exert their detrimental effects by influencing fluid retention, which in turn increases blood pressure. “But it’s important for patients to appreciate that not all cardiovascular problems relating to salt are mediated through hypertension. Salt can have an adverse effect on cardiovascular health, even among people with normal blood pressure,” said Ruschitzka.

Salt intakes across Europe are known to vary widely, ranging from 8.6 g of salt per day  in the UK, to around 12 g salt in Croatia. Even the best intakes, however, are falling  widely short of the  ESC Clinical Practice Guidelines for the Management of Arterial Hypertension (2) , based on WHO data, that recommend that only 5g of salt should be consumed  per day. This amounts to just one teaspoonful.

While individuals may use salt sparingly at home, around 75 % of the salt we eat is already in the food we buy. This, says the ESC, underlines the need for legislation to lay down guidelines. “The reality of international food production in Europe means that such public health initiatives need to be tackled on a European wide basis, rather than an individual country basis,” said Ruschitzka.

Furthermore, added Mancia, concerted action is usually more effective. “It has the advantage of preventing country to country inequalities and furthermore prevents the reinvention of the wheel in each individual country,” he said.

But calls for legislation do not mean that physicians should stop their efforts to  persuade patients to introduce individual changes in lifestyle. Patients, they stress, need to be taught about the importance of reducing salt in their cooking and also for the need to check food labels. People need to learn to appreciate that the salt contents can vary widely even in the same product. Take bread, for example. Recent research from Consensus Action on Salt and Health (CASH, a charity lobbying food manufacturers in the UK) has shown that the highest salt content was 3g salt per 100 g of bread, while the lowest was 0.7 g salt per 100g.

To improve cardiovascular health, salt reduction cannot be undertaken in isolation. “It needs to be remembered that lifestyle measures such as smoking cessation, weight reduction, increased physical exercise, and eating plenty of fruit and vegetables are also important for reducing cardiovascular disease,” said Mancia.

Salt was again on the agenda with World Salt Awareness Week 2010 , (February 1- 7) (3).  The week was run by World Action on Salt and Health (WASH), a global group that works with governments  to highlight the need for widespread introduction of population based salt reduction strategies.

Much can be done to reduce salt intakes through public health policy, say WASH.  They cite the success of Consensus Action on Salt and Health (CASH),  launched in 1996 to encourage  food manufacturing companies in the UK to make voluntary reductions in their  salt content. Since the start of the policy salt intakes among UK adults (calculated from 24-hour urine samples) have fallen from 9.5 to 8.6 g per day.

In July 2009, WASH surveyed over 260 food products available around the world from food manufacturers such as KFC, McDonalds, Kellogg’s, Nestle, Burger King and Subway, finding surprisingly wide spread variations. For example, Kellogg’s All Bran for sale in France, Norway, Sweden and the Netherlands contains 1.30 g salt per 100 g compared to salt levels of 0.65 g per 100g for the product in the US. Such data underlines the urgent need to eradicate country to country inequalities, and bring everyone up to the highest possible standards.

“The paper by Bibbins-Domingo and colleagues is an urgent call to action. Policy makers in the European Community need to implement public health interventions that result in reductions in salt intake now. Reducing the salt content of our unneccesarily oversalted ,processed food is an inexpensive, yet highly effective public health intervention that we can’t afford to miss,“ concluded Ruschitzka.

References

1. Bibbins-Domingo K, Glenn CC, Coxson PG et al. Projected Effect of Dietary Salt Reductions on Future Cardiovascular Disease.  New Engl J Med. 2010 published on line on 20 January 2010 (10.1056/NEJMoa0907355)
2. http://www.escardio.org/guidelines-surveys/esc-guidelines/Pages/arterial-hypertension.aspx
3. www.worldactiononsalt.com
4. Pasquale Strazzullo, Lanfranco D’Elia, Ngianga-Bakwin Kandala, and Francesco P Cappuccio.  Salt intake, stroke, and cardiovascular disease: meta-analysis of prospective studies. BMJ 2009;339:b4567, doi: 10.1136/bmj.b4567 (Published 24 November 2009)

A high prevalence of AF in highly trained cross-country skiers

The event attracts some 12,000 elite cross-country skiers who will line up for this year’s ski marathon, an annual endurance race which will take them through 54 kilometres of snow-covered countryside to the winter sports resort of Lillehammer. Each participant carries a back pack weighing at least 3.5Kg.

The race has been run almost every year since 1932, and in 1976 almost 150 participants were invited to take part in a long-term study designed to discover the extent of latent heart disease in these elite cross-country skiers. Now, after some 30 years, the results of the follow-up study have been published and suggest that long-distance competition skiers – as well as other endurance athletes – are at an unusually high risk of atrial fibrillation.(1) Results showed that participants in the study are at a high risk of atrial fibrillation (AF) without known structural heart disease or other known causes (ie;”lone” AF).

A prevalence of 12.8% found among the skiers who completed the study’s investigations in 1976, 1981 and 2004-2006, when echocardiographic (ECG) and heart rate tests were performed at rest and at exercise. In the general population studies have found the prevalence of AF to be as low as 0.5%, with rates only rising to around 15% in men over the age of 75.

When the study began in 1976 participants were classified according to age – group I 26-33 years, group II 43-50 years, and group III 58-64 years; all had been competing in long-distance skiing events and were in the top 25% for age related performance. When the final follow-up examinations were performed during 2004-2006, a large proportion from group III (28/39) had died, leaving 78 of the original 122 available for further tests and questioning.
This analysis showed that 13 of those 78 skiers (16.7%) had experienced AF at some time during the 28-30 years of follow-up, with a current prevalence of 12.8% AF with no other known heart disease. The latter, say the investigators, “is the highest prevalence yet described in long-term endurance sport practitioners”. In age group I the prevalence was found to be 18.2%. The mean age at which the AF occurred was 58 years.

The study also detected two characteristics in the skiers which may predict their risk of AF: bradycardia and left atril enlargement. Both have been suggested in previous studies as common findings in the hearts of endurance athletes. However, the study found no association between the years of training in cross-country skiing (an average of 36 years in this study) and the occurrence of AF. As a result, the authors advise that there is “still not enough evidence to recommend a specific age to reduce training volume and/or intensity”. However, they do recommend that after the appearance of AF practice should be stopped or reduced “until rhythm control is attained”.

Professor Josep Brugada, President of the European Heart Rhythm Association of the ESC (and Medical Director at the Hospital Clinic in Barcelona), has described their impact as “enormous”, noting that around 5% of all medical expenditure in Europe is related to atrial fibrillation, the most common arrhythmic condition.

So far, only three case-control studies have found a higher prevalence of AF in athletes than in controls. However, a population-based study from 2009 showed that those with the highest level of endurance training also had the highest prevalence of AF.

Studies aiming to find an explanation for a higher AF prevalence have also found that the size of the heart muscle and chambers was larger in athletes than in controls, and this seemed a predictor for AF.

Commenting on the findings from the Birkebeiner study, principal investigator Dr Jostein Grimsmo from the Feiring Heart Clinic in Norway, agreed that enlargement of the heart’s left atrium – along with bradycardia – appeared to be “an important risk factor for AF among long-term endurance cross-country skiers”. This atrial enlargement, he said, is the heart’s adaptation to endurance training.

“As many as 20% of young competitive athletes have been found to have an enlarged left atrium in some studies,” said Dr Grimsmo. “But we are not aware of any documentation of such a high prevalence as we have found either in athletes or in controls under the age of 75!”

“But despite our findings,” he added, “we still can’t say why some athletes end up with AF and others don’t. Genetic factors predisposing to ‘athlete’s heart’, with enlarged cardiac dimensions and a slow heart rate, may be important as risk factors. And while it may be that prolonged endurance training over many years may not always be good for the heart, we do not yet have sufficient evidence to make specific recommendations.”

Notes and references

1. Grimsmo J, Grundvold I, Maehlum S, Arnesen H. High prevalence of atrial fibrillation in long-term endurnace cross-country skiers. Echocardiographic findings and possible predictors. A 28-30 year follow-up study. European Journal of Cardiovascular Prevention and Rehabilitation 2010, 17:100–105; DOI: 10.1097/HJR.0b013e32833226be

• The HYPERLINK  European Journal of Cardiovascular Prevention and Rehabilitation is a journal of the European Society of Cardiology.

Progress in improving stroke care

The National Stroke Strategy is a comprehensive response to the concerns raised by the NAO in its 2005 report on stroke. The strategy has been underpinned by strong national leadership and performance indicators as well as £59 million of central funding over the first two years, £30 million of which was allocated to local authorities specifically to provide support services to stroke patients and their carers. With this clear focus from Ministers and the Department, the NHS is now starting to deliver better care from stroke services, and outcomes for patients are also improving. The NAO estimates that stroke patients’ chances of dying within ten years have reduced from 71 to 67 per cent since 2006.

Patients treated in a specialist stroke unit are more likely to survive, have fewer complications and regain their independence, and all relevant hospitals in England now have such a unit, although the services provided and time spent in the unit vary. Stroke patients should be immediately admitted to a specialist stroke unit; however in 2008 only 17 per cent of stroke patients reached the stroke unit within four hours of arrival at hospital. Brain imaging is also very important for stroke patients but many patients are not given a scan quickly enough and access at weekends and evenings is significantly more limited.

There is better awareness of the symptoms of stroke, and that it is a medical emergency, following the Department’s ‘Stroke: Act FAST’ advertising campaign, launched in February 2009. The number of calls categorised as being a suspected stroke during April to June 2009 increased by 54 per cent in comparison with the same period in 2008.

However, health and social care services are not working as well together as they could. A third of patients are not getting a follow-up appointment within six weeks and only a half of stroke survivors in the NAO’s survey said that they were given advice on further stroke prevention when leaving hospital.
Mr Amyas Morse, head of the National Audit Office, said “Care for people who have had a stroke has significantly improved since we reported in 2005. The publication and early implementation of the stroke strategy have begun to make a real difference and have helped to put in place the right mechanisms to bring about these improvements. There is still work to be done though: the poorer performers must be dragged up to the same standard as the best, so that the gains that have been made are sustained and value for money improved further. The Department should focus on ensuring that health, social care and employment services are working together much more effectively.”

References and Notes

1. There are approximately 110,000 strokes per year in England and about 300,000 people in the UK are living with moderate to severe disabilities as a result of stroke.  It is one of the top three causes of death and the largest cause of disability in England and costs the NHS over £3 billion a year.
2. Since April 2008, NHS performance has been managed against three tiers of “vital signs”. The Department has introduced two Tier 1 Vital Signs indicators for stroke care in the 2008-09 three-year NHS Operating Framework.
3. In November 2005 the NAO reported on stroke care, which concluded that historically stroke had had a low priority within the NHS and that medical and technological developments which could improve patient outcomes were not being implemented widely. The report can be found on the NAO website at http://www.nao.org.uk/publications/0506/reducing_brain_damage.aspx. The Committee of Public Accounts then published a report in June 2006 and requested that the NAO produce a follow-up study on progress in improving stroke care.

Patient Safety First encourages trusts to ‘Count your calls’ to reduce cardiac arrests and death

The first focus week on ‘Count your calls’ encourages trusts to count their cardiac arrest calls and gather key information to help identify and make improvements aimed at reducing the number of in-hospital cardiac arrests and deaths. ‘Count your calls’ is part of Patient Safety First’s reducing harm from deterioration intervention which aims to improve patient safety through the earlier recognition of deterioration in patients.

Marie-Noelle Orzel, Patient Safety First’s deterioration intervention lead and Director of Nursing & Patient Care at Royal Devon & Exeter Foundation Trust says:  “Having clear data is central to being able to make and measure improvements to patients at risk of deterioration and cardiac arrest.  Trusts can determine how to improve safety for their patients by understanding where, when and what type of calls happen, whether they happen to particular patient groups and the reasons why a call is required.”

Patient Safety First provides a practical five-step approach for how trusts can monitor the types of cardiac arrest calls they have: The five steps to ‘Count your calls’ are:

• Where are your cardiac arrest calls or cardiac arrests coming from? This helps to identify potential ‘hotspots’ within the hospital that need targeted work.
• When are your cardiac arrest calls or cardiac arrests occurring? This will help to identify if there are certain days or times that are a specific problem, for example at night or at the weekend.
• Who are the individual patients needing cardiac arrest calls? Are there particular patient groups with high levels of calls or deaths associated with cardiac arrest? Identifying and collecting key  demographic data helps build a picture of any particular patient groups that are associated with calls.
• What happened? What type of call or cardiac arrest was it? What was the immediate outcome? This helps to identify the type of cardiac arrest call or type of cardiac arrest and provides data on the immediate outcome.
• Why was a cardiac arrest call required? This helps to determine whether a cardiac arrest call or cardiac arrest is predictable or unpredictable. Potentially predictable calls can be further classified as preventable or unpreventable.

Patient Safety First is encouraging trusts to take advantage of the range of online resources and tools designed to help them make improvements at a local level – www.patientsafetyfirst.nhs.uk.

‘Count your calls’  is the first of four Patient Safety First focus weeks that will provide trusts with an opportunity to explore their patient safety issues and join online discussions with experts.

The focus weeks include:

• 18^th January – Focus on Deterioration : ‘Count your calls’
• 1^st February – Focus on Human Factors in healthcare
• 1^st March – Focus on Ventilator care bundles: stories of improvement
• 8^th March – Focus on Insulin: ‘Testing a new care bundle for Insulin prescribing’.

For more information visit www.patientsafetyfirst.nhs.uk

Drinking Coffee, Decaf and Tea Regularly Associated With A Reduced Risk Of Diabetes

By the year 2025, approximately 380 million individuals worldwide will be affected by type 2 diabetes¹. Despite considerable research attention, the role of specific dietary and lifestyle factors remains uncertain, although obesity and physical inactivity have consistently been reported to raise the risk of diabetes mellitus. A previously published meta-analysis suggested drinking more coffee may be linked with a reduced risk, but the amount of available information has more than doubled since.

Dr Rachel Huxley, of The George Institute for International Health, University of Sydney, Australia, and colleagues identified 18 studies involving 457,922 participants and assessing the association between coffee consumption and diabetes risk published between 1966 and 2009. Six 
studies involving 225,516 individuals also included information about decaffeinated coffee, whereas seven studies with 286,701 participants reported on tea consumption.

When the authors combined and analyzed the data, they found that each additional cup of coffee consumed in a day was associated with a 7 percent reduction in the excess risk of diabetes.

Individuals who drank three to four cups per day had an approximately 25 percent lower risk than those who drank between zero and two cups per day.

In addition, in the studies that assessed decaffeinated coffee consumption, those who drank more than three to four cups per day had about a one-third lower risk of diabetes than those who drank none. Those who drank more than three to four cups of tea had a one-fifth lower risk than those who drank no tea.

That the apparent protective effect of tea and coffee consumption appears to be independent of a number of potential confounding variables raises the possibility of direct biological effects, the authors write. Because of the association between decaffeinated coffee and diabetes risk, the association is unlikely to be solely related to caffeine. Other compounds in coffee and tea including magnesium, antioxidants known as lignans or chlorogenic acids may be involved, the authors note.
 
If such beneficial effects were observed in interventional trials to be real, the implications for the millions of individuals who have diabetes mellitus, or who are at future risk of developing it, would be substantial, they conclude. For example, the identification of the active components of these beverages could open up new therapeutic options for the primary prevention of diabetes mellitus.

The findings also pose the question of whether patients most at risk for diabetes mellitus may in the future be advised to increase their consumption of tea and coffee in addition to increasing their levels of physical activity. 
Spokesperson for the European Society of Cardiology, Professor Lars Rydén (Sweden), who is a diabetes specialist had the following advice:

“This is a cautiously and carefully conducted meta-analysis which means authors have carefully conducted studies although each are too small to give an answer to the question although they indicate a positive correlation between the consumption of coffee and a decreasing occurrence of diabetes. So the principle is that if you drink coffee whether it is decaffeinated or not, you have less chance of developing diabetes. The data has been strengthened by bringing several studies together. There are sometimes claims that coffee may do harm, that it may increase the propensity to Cardiovascular disease, but there is no evidence for this. The message is that people may drink coffee safely. Coffee from this point of view may actually be of benefit, as well as reducing the risk of getting diabetes – although the reduction is small (around 7%).”

However Prof Rydén warns that lifestyle changes far outweigh a regular coffee intake. 

“Coffee helps, but other things are even more important. Those who are overweight should reduce their bodyweight by 5-10% – not too much – and include physical activity such as a brisk walk for 30 minutes a day. Then those people who are at risk of developing diabetes will reduce this risk by 40-50%. 

It is interesting to consider why a beverage like coffee has a beneficial effect. It is obviously not the caffeine as decaffeinated coffee has the same efficiency as caffeinated coffee. Coffee may contain antioxidants but the studies have not measured the number of chemicals in the blood which is important.”

NOTES

Dr. Huxley is supported by a Career Development Award from the National Heart Foundation of Australia. This work was additionally supported by a grant from the National Health and Medical Research Council of Australia; a Research Career Development Fellowship from the UK Wellcome Trust; and a research grant from Institut Servier, France and Assistance Publique-Hopitaux de Paris.

References:

1. Arch Intern Med. 2009;169[22]:2053-2063