Sponsorship Statement: This supplement has been sponsored by Takeda UK Ltd. Sponsorship included all print and production costs of the supplement, plus support of the meeting where the discussions took place and support in the writing of the papers. Takeda UK Ltd did not take part in the discussions held at the meeting and editorial control of this supplement resides with the authors and the journal. The supplement underwent peer review and was also reviewed by the faculty and Takeda UK Ltd for accuracy.
National Health Service (NHS) costs in England grew from about £40 billion in the year 2000 to £100 billion today. That is, they have approximately doubled in real terms within a decade. However, the current economic climate in the UK has led to increasing cost awareness in the NHS. NHS managers have been charged with making £15–20 billion efficiency savings by 2015.1 Although the health service will not lose funding, GPs are under pressure to prescribe low-cost generic medicines wherever possible.2
This brief paper considers how such cost pressures may affect the use of angiotensin receptor blockers (ARBs) in the NHS, given that although losartan is the first drug in this class to become generic in March 2010, others will quickly follow suit. Valsartan loses patent protection in 2011, with candesartan and irbesartan following in 2012.
Indications for ARB use
Recent data indicate that candesartan is presently the most widely used ARB in England, accounting for almost a third of all ARB prescriptions. This is in part because it has been competitively priced compared with other ARBs. In average prescription cost terms, candesartan has in recent years enjoyed an approximate 25% price advantage over its main high-volume competitor (table 1).
Table 1. Costs and percentage share of prescriptions associated with ARBs (England, 2008)
At present, there are variations with respect to the licensed indications for ARBs in the UK. All drugs in the class are licensed for the treatment of hypertension whereas only three (candesartan, losartan and valsartan) are indicated for chronic heart failure. Valsartan alone is licensed for use post-myocardial infarction (MI) in patients with left ventricular systolic dysfunction (LVSD). Irbesartan and losartan are the only ARBs presently approved for the treatment of nephropathy in patients
with type 2 diabetes mellitus.
However, it is often assumed that all ARBs are equivalent. If this is believed uncritically, then NHS pharmaceutical advisers and economists may be influenced exclusively by price considerations. The advent of generic level price competition ‘class effect’ prescribing, such that all drugs within a class are assumed to have identical safety and efficacy profiles,3 in some instances could undermine public interests in both continuity of care and the optimisation of individual and/or population level health outcomes.
Broader implications of changing ARB presciptions
Usher-Smith has highlighted the challenges involved in switching patients’ medicines for purely cost-saving purposes.2, 4 He reported his experience within a PCT that encouraged switching established patients from losartan to candesartan in 2005–2006 on cost grounds. Such a policy had originally been estimated to generate a national three-year saving of £128 million. However, in August 2007, the price of losartan was decreased, resulting in reduced actual annual savings. This illustrates the point that the outcomes of cost-reducing measures may be dependent upon unpredictable market adjustments that can undermine their cost-effectiveness even though in this particular instance a significant drop in blood pressure was seen after patients switched to candesartan. This could have been a drug-related effect, or alternatively the effect of enhanced case management associated with the effort of supporting switching. In general, it is the case that moving patients who are well established on one medicine to another demands not only increased clinician time, but also risks undermining their confidence in their clinician and reducing adherence rates. Further, if the drugs are not fully interchangeable this may have additional consequences on outcomes and (in time) overall care/service costs.
In this context, the ‘Real-Life’ study5 discussed by Meredith in this supplement looked retrospectively at candesartan and losartan use in primary care centres in Sweden. It found there was no difference in blood pressure (BP) reduction when comparing the losartan and candesartan groups (although more patients in the losartan arm required a thiazide to achieve the same BP reduction), but that candesartan use was associated with a significantly lower risk of cardiovascular events compared with losartan. The results published to date do not make it possible to quantify the reduced economic burden associated with candesartan use in this context. However, they do raise the possibility that short-term financial gains associated with a general switch to losartan therapy before other ARBs lose patent protection might be offset by factors linked, say, to reduced 24-hour BP control.
Conclusions
Making the best possible use of health resources is an important end. Yet factors other than price advantage alone should be considered before accepting policy decisions to switch patients automatically from one therapeutic agent to another. Care should be taken not to ignore clinically significant utility variations within the ARBs; since these drugs are both effective and relatively free from side effects, they may become more widely used in future as prices fall across the board.
Research such as that by Usher-Smith2 and Kjeldsen et al.5 indicates that the routine ‘switching’ of patients from one drug to another, based on short-term unit price differences alone, might prove counter-productive. Such policies are only defensible when there is robust evidence both that the switch is beneficial and that it justifies the time and effort needed to support patients adequately during the transition from a familiar medicine to a new one. Switching should be backed by evidence regarding relevant population health outcomes
relative to the overall costs incurred and the financial resources released for alternative use.
Conflict of interest
DGT received a fee from Takeda for his involvement in this project, which was shared with a postgraduate student who kindly provided background analysis. MD received an honorarium from Takeda for his contribution to this supplement.
Key messages
The NHS is under pressure to contain costs through the prescribing and supply of low-cost generic medicines whenever appropriate
Losartan is the first angiotensin receptor blocker (ARB) to come off-patent (in March 2010). This may prompt some primary care trusts (PCTs) and practices to switch patients who are currently taking other ARBs to generic losartan
There is evidence that different ARBs have pharmacologically distinct actions, which may differentially affect patient outcomes. Switching patients may not reduce financial costs as much as initially anticipated due to additional clinician time and effort needed to manage patients and because, from an economic perspective, long-term health outcomes may be impaired
A patient-centred, evidence-based approach is needed, rather than one uncritically focused on unit drug costs.
References
NHS 2010–2015: from good to great. Preventative, people-centred, productive. www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_109876
Usher-Smith JA, Ramsbottom T, Pearmain H, Kirby M. Evaluation of the cost savings and clinical outcomes of switching patients from atorvastatin to simvastatin and losartan to candesartan in a primary care setting. Int J Clin Pract 2007;61(1):15–23.
Meredith PA, Murray LS, McInnes GT. Comparison of the efficacy of candesartan and losartan: a meta-analysis of trials in the treatment of hypertension. J Hum Hypertens 2009;1–7. Advance online publication, 17 December 2009; doi:10.1038/jhh.2009.99.
Usher-Smith JA, Ramsbottom T, Pearmain H, Kirby M. Evaluation of the clinical outcomes of switching patients from atorvastatin to simvastatin and losartan to candesartan in a primary care setting: 2 years on. Int J Clin Pract 2008;62(3):480–4.
Kjeldsen SE, Stålhammar J, Hasvold P, Bodegard J, Olsson U, Russell D. Effects of losartan vs. candesartan in reducing cardiovascular events in the primary treatment of hypertension. J Hum Hypertens 2009. Advance online publication, 5 November 2009; doi:10.1038/jhh.2009.77.
Disclaimer: UK prescribing information current at the date of publication of this supplement can be found by downloading the PDF. Medinews Cardiology Limited advises healthcare professionals to consult up-to-date Prescribing Information and the full Summary of Product Characteristics available from the manufacturers before prescribing any product. Medinews Cardiology Limited cannot accept responsibility for any errors in prescribing which may occur.
If we consider gastro-oesopageal endoscopy as a similar procedure to transoesophageal echocardiography (TEE) then we might be alarmed at the 30-day mortality of 1:2,000 reported by Quine et al.1 I am not a practitioner of either of those arts, but I am putting on my anaesthetist cap to respond to the article by Mankia et al. discussing intravenous opiate/benzodiazepine sedation in this issue of the journal (see pages 125-7). The endoscopy death rate is especially concerning if you compare the fact that anaesthesia was considered to have been totally responsible for death in less than 1:10,000 operations in the UK.2 Mankia et al. quite rightly suggest that there should be guidelines concerning the safe use of intravenous sedation in TEE, and should be congratulated for highlighting this matter. I would suggest that their gastrointestinal endoscopy colleagues have a lot of experience on which to draw from.
Gastroenterology guidelines
The British Society of Gastroenterology (BSG) guidelines suggest that the opiate is used before the benzodiazepine.3 The BSG guidelines also suggest a maximum dose of 5 mg midazolam and 50 mg pethidine. Mankia et al. seem to permit 10 mg midazolam and 75 mg pethidine in their proposed protocol. Such doses would seem excessive unless you have confidence in your ability to provide assisted ventilation. In the survey nobody appears to have used more than 50 mg pethidine and, therefore, practitioners appear to set their own sensible cut-off points. In gastroscopy, sedation is often avoided, however, the TEE is of a much larger diameter and, therefore, presumably, causes more discomfort and this needs to be taken into account.
The slow incremental use of midazolam should be stressed as important, using bolus injections of only 2 mg, and half that in those over 75 years, with a minimum three minute interval between subsequent bolus injections. Local anaesthetic throat sprays are commonly used in TEE, however, they should ideally not be used in the sedated patient as the loss of the gag reflex increases the dangers.
The use of intravenous fluids to resuscitate six patients and the need to use flumazenil in two patients is concerning as it indicates a relatively high number of problems occurring in only 151 cases.
Importance of monitoring
Any guideline should stress the importance of deciding who is monitoring the patient. If the operator is concentrating on the echocardiogram then they must be assumed to be distracted and, therefore, another person, who is fully trained in resuscitation, needs to be watching the patient and the saturated oxygen levels. The BSG guidelines suggest a minimum of two assistants during gastrointestinal endoscopy. Trainees should be supervised by senior staff and be considered as additional to the minimum number of staff present.
Careful pre-assessment and patient selection has contributed to improved patient safety in anaesthesia and should also be adopted in sedation procedures.4 It does not mean you refuse the patient the procedure required, more that those who have early warning of problems are also prepared to tackle any impending crisis.
Three centres routinely had an anaesthetist present, which was three more than I expected. What is important for the other centres is that the on-call anaesthetists know where the unit is situated and where the resuscitation equipment is sited.
It is important that the British Society of Echocardiography (BSE) produce UK-specific guidelines or recommend a pre-existing protocol as soon as possible.
Conflict of interest
None declared.
Editors’ note
The article by Mankia et al. on safe combined intravenous opiate/benzodiazepine sedation for transoesophageal echocardiography can be found on pages 125-7.
References
1. Quine MA, Bell GD, McCloy RF, Charlton JE, Devlin HB, Hopkins AA. Prospective audit of upper gastrointestinal endoscopy in two regions of England: safety, staffing and sedation methods. Gut 1995;36:462–7.
2. Aitkenhead AR. Injuries associated with anaesthesia. A global perspective. Br J Anaesth 2005;95:95–109.
Andrew Nicolaides
Director of the Vascular Screening and Diagnostic Centre, Emeritus Professor of Vascular Surgery at Imperial College, London, and Chairman of the Cardiovascular Disease Educational and Research Trust
Vascular Screening and Diagnostic Centre, 30 Weymouth Street, London, W1G 7BS.
Cardiovascular disease is the biggest killer in the UK causing 198,000 deaths per year, and stroke is the most common cause of disability in women. Can individuals at increased risk be identified and can heart attacks and strokes be prevented?
Traditional methods of risk assessment for cardiovascular events use conventional risk factors to calculate risk often expressed as the 10-year Framingham Risk Score (10y FRS). However, these methods are far from perfect. Although they identify high-risk groups, if followed up these high-risk groups contain at best only a fraction of the events that will occur in the subsequent 10 years. In the Prospective Cardiovascular Munster (PROCAM) study 6.5% of the population were classified as high risk (10-year risk >20%), 14% as intermediate risk (10-year risk 10–20%) and 79.5% as low risk (10-year risk <10%). At 10 years, 33% of all the myocardial infarctions (MIs) occurred in the high-, 35% in the intermediate- and 32% in the low-risk group. This is because the low-risk group was very large and at least 30% of those who developed MI did not have any of the conventional risk factors.
Screening and improved selection of individuals for more effective prevention is now possible because:
(a) preclinical (silent) atherosclerotic plaques may develop in the arteries slowly over several decades before they rupture or obstruct an artery becoming clinically manifest
(b) screening methods are now available for detecting the presence and stability of such plaques
(c) current prophylaxis with aggressive risk factor modification can reduce morbidity and mortality from MI and stroke by 50%.
Two methods are currently popular: coronary artery calcium scoring (CACS) using multi-slice computed tomography (CT)-scanning known as electron beam tomography (EBT), and ultrasonic arterial scanning (figure 1). Both provide information that can improve the 10y FRS.
Figure 1. Ultrasound arterial scans showing a normal carotid bifurcation with blood flow shown in red (left) and a bifurcation with a plaque outlined by a red dotted line (right)
CACS using multi-slice
CT-scanning
Six prospective studies have demonstrated that CACS is an independent predictor of future coronary events,1 i.e. it provides information over and above that of the 10y FRS. The risk of annual fatal MI for CACS less than 100 is low (<0.4%), for CACS 100–400 it is moderate (1.3%) and for CACS 400 or higher it is high (2.4%). However, it cannot identify those with non-calcific unstable plaques, which are responsible for most heart attacks.1 Also, the finding of a high CACS in the absence of any significant coronary artery stenosis (>50%) is common, indicating the need to improve predictive ability.
On the basis of the available data the American College of Cardiology Foundation and American Heart Association have stated in their guidelines1 that screening is of limited value in individuals at low risk (10y FRS <10%). However, in individuals at intermediate risk (10y FRS 10–20%) the finding of CACS of 400 or higher would increase the risk to that noted with diabetes or peripheral arterial disease,2 altering clinical-decision making. Individuals with a high 10y FRS (≥20%) should be treated aggressively according to the current National Cholesterol Education Program (NCEP) III guidelines and do not require additional testing.2
A disadvantage of CACS is that it is expensive, and the high radiation dose associated with it does not allow repeated testing. Also, CACS does not provide information on stroke risk.
Screening with ultrasound
High-resolution ultrasound can provide images of the arterial wall and plaques with measurements of intima-media thickness (IMT), plaque thickness and area at a resolution of 0.2 mm, and plaque echodensity. Although IMT can be used to study the effect of risk factor modification in large groups, and has become a validated biomarker,3 it is only marginally better than conventional risk factors in identifying individuals at increased risk. However, new ultrasonic arterial wall measurements, such as the presence and thickness of plaques4-6 and plaque echolucency6-8 not only in the carotid but also in the common femoral artery, are stronger predictors of risk with a relative risk (RR) of 3.0 to 5.0.
Two prospective studies have shown that carotid plaque area is a better predictor of future MI than IMT.9,10 In the Tromsø study,9 IMT, total plaque area and plaque echolucency were measured in 6,226 men and women aged 25 to 84 years with no previous MI followed for six years. The adjusted RR (95% confidence interval [CI]) between the highest plaque area tertile versus no plaque was 1.56 (1.04 to 2.36) in men and 3.95 (2.16 to 7.19) in women. The adjusted corresponding RR (95% CI) for IMT was 1.73 (0.98 to 3.06) in men and 2.86 (1.07 to 7.65) in women. Plaque echolucency (low collagen content) indicating plaque instability was also associated with increased risk of MI. In the study performed in Canada,10 carotid plaque areas from 1,686 individuals followed for up to five years were categorised into four quartiles. The combined five-year risk of stroke, MI and vascular death by quartiles of plaque area was: 5.6%, 10.7%, 13.9% and 19.5%. Thus, the presence, size and type of preclinical plaques are emerging as having a strong association with coronary heart disease and stroke. They can be used to re-classify those in intermediate and low 10y FRS groups into higher or lower risk.
In our own ongoing study, 2,000 individuals over the age of 40 are being screened for conventional risk factors, clinical and preclinical cardiovascular disease and followed-up for five years.11 Both carotid and both common femoral bifurcations are scanned with ultrasound. In the low 10y FRS group, 42% of asymptomatic individuals have atherosclerotic plaques. In another recent study using ultrasound, carotid plaques were found in 34% of individuals at low 10y FRS and CACS of zero.12
Advantages of screening with ultrasound are the relatively low cost and absence of radiation. It can be performed in 30 minutes. In addition, it can be repeated at six-monthly intervals or annually providing information on plaque progression or regression. An added benefit of ultrasound is that with the addition of an extra 5–10 minutes, men over the age of 65 years can be screened for the presence of abdominal aortic aneurysm, as recently recommended by the National Institute for Health and Clinical Excellence (NICE).
A rational screening plan
Individuals with low 10y FRS: should be screened with ultrasound. Absence of plaques, found in 60% of individuals in this low-risk group, will confirm the low risk and further follow-up with ultrasound will not be necessary for three to four years. However, the presence of plaques, found in the other 40%, will result in re-classification to a higher risk and will prompt the clinician, not only to advise on risk factor modification, but also to look for non-conventional risk factors, such as elevated homocysteine. Two recent prospective randomised-controlled trials in individuals with known cardiovascular disease have demonstrated that lowering homocysteine with vitamin supplements has reduced the risk of ischaemic stroke by 25%.13,14
Individuals with an intermediate 10y FRS: should be initially screened with ultrasound. Those with plaques are advised to have aggressive risk factor modification. They are told that plaques should not be allowed to progress and that regression, which with treatment to target can occur in 28%, is associated with a 50% reduction in risk.10 They are also advised to have an annual electrocardiogram (ECG) stress test. If plaques are absent then CACS may be performed. The latter will allow re-classification to a lower- or higher-risk group with confidence.
Individuals with a high 10y FRS: are advised to have aggressive risk factor modification according to the current guidelines. Screening with ultrasound in order to follow plaque progression or regression is optional. However, this and the associated plaque images provide a strong incentive to persevere with prophylactic therapy as compliance can be challenging.
The strategy outlined above uses a combination of conventional risk factors with ultrasound, which is in the forefront of non-invasive, inexpensive imaging modalities for screening asymptomatic individuals. It should go a long way towards achieving the government target of reducing heart attacks and strokes by 40%15 because it identifies many individuals at increased risk that would be missed by 10y FRS.
Setting up cardiovascular screening services or centres throughout the country should be seriously considered. The major investment would not be in the equipment, which is now relatively inexpensive and portable, but in trained staff. Asymptomatic individuals should be referred to such centres by their own physicians. This should avoid inappropriate use of the services. The referring doctor should be responsible for making the decisions on targeted preventive measures based on the individual’s clinical and imaging assessment.
A final consideration is that ultrasound could prove a potent tool in lifestyle
modification, as there is nothing more powerful than asymptomatic individuals
experiencing a real-time image of their arteries showing atherosclerotic deposits.
Such deposits are the end result of all risk factors, known, emerging and yet
unknown including genetic.
Conflict of interest
None declared.
References
1. Greenland P, Bonow RO, Brundage BH et al. ACCF/AHA expert consensus document on coronary artery calcium scoring. Circulation 2007;115:402–26.
2. Third report of the NCEP Expert Panel on detection, evaluation and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report. Circulation 2002;106:3143–421.
3. Lorenz MW, Marcus HS, Bots ML, Rosvall M, Sitzer M. Prediction of clinical cardiovascular events with carotid intima-media thickness. Circulation 2007;115:459–67.
4. Ebrahim S, Papacosta O, Whincup P et al. Carotid plaque, intima media thickness, cardiovascular risk factors, and prevalent cardiovascular disease in men and women: the British Regional Heart Study. Stroke 1999;30:841–50.
5. Hollander M, Bots ML, Iglesias del Sol A et al. Carotid plaques increase the risk of stroke and subtypes of cerebral infarction in asymptomatic elderly. The Rotterdam Study. Circulation 2002;105:2872–7.
6. Schmidt C, Fagerberg B, Hulthe J. Non-stenotic echolucent ultrasound-assessed femoral artery plaques are predictive for future cardiovascular events in middle-aged men. Atherosclerosis 2005;181:125–30.
7. Honda O, Sugiyama S, Kugiyama K et al. Echolucent carotid plaques predict future coronary events in patients with coronary artery disease. J Am Coll Cardiol 2004;43:177–84.
8. Seo Y, Watanabe S, Ishizu T et al. Echolucent carotid plaques as a feature in patients with acute coronary syndrome. Circ J 2006;70:1629–34.
9. Johnsen SH, Mathiesen EB, Joakimsen O et al. Carotid atherosclerosis is a stronger predictor of myocardial infarction in women than in men: a 6-year follow up study of 6226 persons: the Tromsø study. Stroke 2007;38:2873–80.
10. Spence JD, Eliasziw M, DiCicco M, Hackam DG, Galil R, Lohmann T. A tool for targeting and evaluating vascular preventive therapy. Stroke 2002;33:2916–22.
11. Griffin M, Nicolaides AN, Tyllis TH et al. Carotid and femoral arterial wall changes and the prevalence of clinical cardiovascular disease. Vascular Medicine 2009;14:227–32.
12. Lester SJ, Eleid MF, Khandheria BK, Hurst RT. Carotid IMT thickness and coronary artery calcium score as indications of subclinical atherosclerosis. Mayo Clin Proc 2009;84:229–33.
13. Lonn E, Yusuf S, Arnold JM et al. Homocysteine lowering with folic acid and B vitamins in vascular disease. N Engl J Med 2006;354:1567–77.
14. Saposnik G, Ray JG, Sheridan P, McQueen M, Lonn E. Homocysteine-lowering therapy and stroke risk, severity and disability. Stroke 2009;40:1365–72.
15. Department of Health. Coronary heart disease national service frameworks. London: DoH, 2000.
A new guideline has been published by the National Institute for Health and Clinical Excellence (NICE) and the National Clinical Guidelines Centre for Acute and Chronic Conditions on the early management of unstable angina and non-ST elevation myocardial infarction (NSTEMI).
They note that although cardiovascular deaths are declining, there were still over 40,000 patients with NSTEMI acute coronary syndromes admitted to hospital in England and Wales in 2009. With worrying increases in the incidence of key risk factors – obesity, diabetes, and the tendency for people to take less exercise – the management of these conditions remains a high priority.
As its starting point, the guideline recommends that as soon as a diagnosis of unstable angina or NSTEMI has been made, and aspirin and antithrombin drugs have been offered, patients should be formally assessed for their individual risk of future adverse cardiovascular events using an established risk scoring system that predicts six-month mortality, such as the GRACE (Global Registry of Acute Coronary Events) score. Then treatments should be given according to whether the patient is at high, intermediate or low risk of future events, taking into account the risk of adverse events (particularly bleeding).
The guideline also advises that angiography should be conducted (if no contra-indications), with follow-on percutaneous coronary intervention (PCI) within 96 hours of first admission to hospital in patients who have an intermediate or higher risk of cardiac events (predicted six-month mortality above 3.0%). Angiography should be performed as soon as possible for patients who are clinically unstable or at high ischaemic risk.
Ischaemia testing should be considered before discharge for patients whose condition has been managed conservatively and who have not had coronary angiography.
The guideline also emphasises the importance of providing patients with comprehensive information about their diagnosis and arrangements for follow-up. It further recommends that patients are given advice about the provision of cardiac rehabilitation programmes and about how lifestyle changes, such as giving up smoking, being physically active and eating a Mediterranean diet, can help prevent a future cardiovascular event.
For full guidance, visit http://guidance.nice.org.uk/CG94. This guideline updates and replaces recommendations for the early management of unstable angina and NSTEMI from NICE technology appraisal guidance 47 and 80.
It is hoped that a new National Institute for Health and Clinical Excellence (NICE) guideline on recent onset chest pain will lead to a reduction in cardiovascular deaths.
The guideline, jointly developed with the National Clinical Guidelines Centre for Acute and Chronic Conditions, represents a significant change in practice in some key areas of diagnosing acute coronary sydromes (ACS) and angina.
The focus of the new guideline is on the diagnosis of chest pain which is suspected to be of cardiac origin, so that appropriate treatment can be provided.
It notes that chest pain is experienced by some 20–40% of the general population at some time during their lives, and accounts for up to 1% of visits to GPs, approximately 700,000 visits (5%) to emergency departments and up to 25% of emergency admissions to hospital.
The guideline has two separate diagnostic pathways. The first is for patients with acute chest pain who may have an ACS and the second is for those with intermittent stable chest pain of suspected cardiac origin who may have stable angina.
Recommendations in the guideline for people with suspected ACS include:
Take a resting 12-lead ECG as soon as possible. When people are referred, send the results to hospital before they arrive if possible. Recording and sending the ECG should not delay transfer to hospital.
Do not exclude ACS when people have a normal resting 12-lead ECG.
Do not routinely administer oxygen, but monitor oxygen saturation using pulse oximetry as soon as possible, ideally before hospital admission, to guide the use of supplemental oxygen.
Do not assess symptoms of an ACS differently in different ethnic groups.
Recommendations for people with intermittent stable chest pain who may have stable angina include:
Diagnose stable angina based on either clinical assessment alone or where there is uncertainty, clinical assessment plus diagnostic testing.
If people have features of typical angina based on clinical assessment and their estimated likelihood of coronary artery disease (CAD) is greater than 90%, further diagnostic investigation is unnecessary and should be managed as angina.
Unless clinical suspicion is raised based on other aspects of the history and risk factors, exclude a diagnosis of stable angina if the pain is non-anginal and first consider causes of pain other than angina (such as gastrointestinal or musculoskeletal pain).
In people without confirmed CAD, in whom a diagnosis of stable angina cannot be made or excluded based on clinical assessment alone, estimate the likelihood of CAD, taking into account the clinical assessment and the resting 12-lead ECG. Arrange further diagnostic testing according to the estimated likelihood of CAD.
Do not use exercise ECG to diagnose or exclude stable angina for people without known CAD.
For full guidance, visit http://guidance.nice.org.uk/CG95. This clinical guideline partially updates NICE technology appraisal guidance 73.
Dronedarone included in new appraisal consultation document
An independent Appraisal Committee has revised NICE’s original recommendation that dronedarone should not be used to treat atrial fibrillation (AF) after considering comments received at public consultation on the previous draft guidance. Recent draft guidance published on 30th March recommends the limited use of the drug as a second-line treatment in people with additional cardiovascular risk factors whose AF has not been controlled by first-line therapy (usually including beta blockers).
The guidance states: “Although the committee did not change their conclusion that dronedarone is not as effective as other anti-arrhythmic drugs in preventing the recurrence of AF, it accepted evidence that the drug did not lead to an increase in the risk of mortality, unlike the anti-arrhythmics with which it was compared. The Appraisal Committee also noted comments from patients and clinical experts received during consultation on the previous draft that all current anti-arrhythmic drugs, but particularly amiodarone, had side effects which had a significant impact on quality of life with long term use. Overall, the Committee concluded that dronedarone was likely to result in fewer adverse effects than amiodarone”.
NICE recommends that until it issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
Framingham no longer superior risk assessment tool in lipid modification guideline
The National Institute for Health and Clinical Excellence (NICE) has announced that it is withdrawing advice in its in lipid modification guideline to use the Framingham risk assessment tool for cardiovascular risk assessment, saying that it is not clear that it is superior to other tools. Healthcare professionals will now instead decide which risk assessment tool is most suitable for their needs.
NICE says it was aware when the guideline was published in May 2008 that the evidence on cardiovascular risk estimation was developing rapidly, and so recommended that further research was needed on how best to estimate cardiovascular disease risk. After the publication in 2009 of more evidence comparing the QRISK tool with other risk estimation tools, it has now been decided that there is insufficient evidence to allow for a clear decision in recommending one cardiovascular risk estimation method over another.
Neither intensive blood pressure reduction, or adding a fibrate to a statin, appear to be justified in patients with diabetes at high risk of cardiovascular disease, according to studies reported at the American College of Cardiology meeting held in Atlanta, US, in March. But more encouraging news came in the form of a new percutaneous procedure that should prevent the need for mitral valve surgery.
ACCORD/INVEST: do not aim for normal blood pressure in diabetes patients with CAD
The results of two trials comparing intensive versus more conventional blood pressure lowering in patients with diabetes at high cardiovascular risk have suggested that intensive treatment is not necessary and may be harmful in this population.
In the ACCORD BP (Action to Control Cardiovascular Risk in Diabetes – Blood Pressure) trial, while intensive blood pressure treatment did reduce the risk of stroke, it failed to reduce the overall risk of cardiovascular events in patients and was associated with an increase in adverse events due to antihypertensive therapy.
And in the INVEST (International Verapamil SR-Trandolapril) study, tight blood pressure control was no more effective in preventing major events than standard blood pressure treatment and, in some cases, it actually appeared harmful.
ACCORD
Presenting the ACCORD results, Dr William Cushman, (Veterans Affairs Medical Center, Memphis, USA) explained that previous studies have shown that treating patients with diabetes to achieve a systolic blood pressure of less than 140 to 150 mmHg reduces cardiovascular events. The ACCORD BP trial was conducted to investigate whether it would be beneficial to reduce blood pressure even further.
In the trial, 4,733 patients with type 2 diabetes, high blood pressure, and either pre-existing cardiovascular disease or at high risk for developing it were randomly assigned to a target systolic blood pressure of either less than 120 mmHg or less than 140 mmHg. A wide variety of blood-pressure-lowering medications were used to achieve therapeutic goals.
During the study, systolic blood pressure levels averaged 119 mmHg in the intensive-therapy group and 134 mmHg in the standard-therapy group. After a follow-up averaging five years, there was no significant difference between the two groups in the combined rate of non-fatal myocardial infarction (MI), non-fatal stroke, or cardiovascular death. However, the risk of stroke was significantly lower in the intensive-therapy group (36 vs. 62 strokes).
Serious complications that could be attributed to blood pressure lowering occurred in 77 patients in the intensive-therapy group and 30 patients in the standard-therapy group. In addition, some laboratory measures of kidney function were worse in the intensive-therapy group, but there was no difference in the rates of kidney failure.
Dr Cushman commented: “The stroke results were expected based on previous clinical trials, but we were surprised there was not an overall cardiovascular benefit given the large study size and the nearly 15 mmHg difference in systolic blood pressure”.
The ACCORD results have also been published in the April 29th issue of the New England Journal of Medicine. In an accompanying editorial, Dr Peter M Nilsson (University Hospital, Malmö, Sweden) says that: “The main conclusion to draw from this study must be that a systolic blood pressure target below 120 mmHg in patients with type 2 diabetes is not justified by the evidence”.
INVEST
The INVEST trial randomised 6,400 patients with diabetes and coronary artery disease (CAD) to blood-pressure-lowering therapy based either on a calcium-channel blocker or a beta blocker, plus an ACE inhibitor and/or a thiazide diuretic. The target was a blood pressure of less than 130/85 mmHg.
For the current analysis, patients were categorised according to the degree of blood pressure control actually achieved. Patients with a systolic blood pressure of 140 mmHg or higher – almost one-third of patients – were classified as ‘Not Controlled’. Those with a systolic blood pressure below 130 mmHg were classified as ‘Tight Control’ and those with a systolic blood pressure in between were classified as ‘Usual Control’.
During a follow-up period equivalent to more than 16,893 patient-years, researchers found that patients in the ‘Not Controlled’ group had nearly a 50% higher combined risk of death, MI, or stroke when compared with the ‘Usual Care’ group, and those in the ‘Tight Control’ group had a similar risk to those in the ‘Usual Control’ group.
But further analysis showed that lowering systolic blood pressure below 130 mmHg significantly increased the risk of all-cause death when compared to ‘Usual Care’, an increase that became apparent about 30 months into the study and persisted for an additional five years of follow-up. When researchers then analysed blood pressure in 5 mmHg increments in the ‘Tight Control’ group, they discovered that a systolic blood pressure below 115 mmHg was associated with increased mortality.
Lead investigator Dr Rhonda Cooper-DeHoff (University of Florida, Gainesville, USA) said: “Diabetic patients with CAD in whom blood pressure is not controlled have an increased risk for unfavourable cardiovascular outcomes, so the message to lower systolic blood pressure below 140 mmHg is still important. However, it is not necessary to lower systolic blood pressure below 130 mmHg to reduce that risk. Most importantly, reducing systolic blood pressure below 115 mmHg may be associated with increased mortality,” she added.
ACCORD Lipid Trial – no benefit of fibrates in diabetes
Adding a fibrate to a statin in patients with type 2 diabetes did not further improve survival or other key cardiovascular outcomes, in the ACCORD Lipid Trial.
“Overall, the results of the ACCORD Lipid Trial do not support use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular disease in high-risk patients with type 2 diabetes,” said lead investigator Dr Henry Ginsberg (Columbia University College of Physicians and Surgeons, New York, USA).
Patients who began the study with both triglyceride levels in the top third and high-density lipoprotein (HDL) cholesterol levels in the bottom third may have benefited from combination therapy, when compared to other study participants.
The trial included 5,518 patients with type 2 diabetes and either pre-existing cardiovascular disease or at least two additional cardiovascular risk factors who were randomly assigned to treatment with simvastatin plus fenofibrate, or to simvastatin plus a placebo.
After a five-year follow-up, researchers found that the combination therapy was safe but did not significantly reduce the combined rates of cardiovascular death, non-fatal heart attack or non-fatal stroke, the study’s primary outcome, when compared to simvastatin alone (table 1).
Table 1. ACCORD LIPID study: primary outcome
The full ACCORD Lipid results have been published in the April 29th issue of The New England Journal of Medicine.
NAVIGATOR – what role for valsartan and nateglinide in prevention of diabetes and cardiovascular disease?
“Most experts believed that nateglinide would prevent diabetes and that valsartan would reduce cardiovascular events in this population,” said lead investigator, Dr Robert Califf (Duke University, Durham, USA). “Interestingly, with respect to nateglinide, we found the opposite. The results with valsartan confirmed previous studies that showed a reduction in diabetes. It was disappointing that there was no reduction in cardiovascular events but in such a large study, with patients on other therapies that are known to impact cardiovascular disease, this lack of event reduction is consistent with other studies,” he added.
Table 1. NAVIGATOR: valsartan versus placebo outcomes
In the study 9,306 patients with glucose intolerance and either cardiovascular risk factors or established cardiovascular disease were randomised to either nateglinide (up to 60 mg three times a day before meals) or placebo, and to either valsartan (up to 160 mg daily) or placebo. All patients were required to participate in a lifestyle programme, with the goal of maintaining a 5% weight loss, increasing physical activity to an average of 30 minutes five days a week, and to follow a low-fat diet.
Patients were followed for five years, on average, for development of diabetes and 6.5 years, on average, for cardiovascular disease. Researchers found that valsartan reduced the risk of progression to diabetes by 14%, but did not reduce the cardiovascular end point of death from cardiovascular causes, myocardial infarction, stroke, hospitalisation for heart failure, unstable chest pain, or revascularisation (table 1). Nateglinide failed to reduce both progression to diabetes and cardiovascular risk (table 2).
Table 2. NAVIGATOR: nateglinide versus placebo outcomes
Investigators speculated that the study’s results may have been influenced by how effective the lifestyle programme was in reducing both diabetes progression and cardiovascular risk. By the end of the study, a large number of patients were also taking medications prescribed by their personal physician to inhibit the renin-angiotensin system or to treat abnormal lipid levels or high blood pressure, and this may have lowered overall risk.
The NAVIGATOR results have now been published in the April 22nd issue of the New England Journal of Medicine.
EVEREST – mitral clip as good as heart valve repair surgery
A catheter-mounted device, which acts as a clip to repair leaky heart valves, is a safe and effective alternative to open-chest surgery in selected patients with mitral regurgitation, according to the results of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study). In addition, patients treated with the MitraClip® valve repair system were far less likely to experience a serious complication within 30 days of the procedure.
Lead investigator, Dr Ted Feldman (North Shore University Health System, Evanston, USA) said: “As clinicians, we have seen our patients transformed from highly symptomatic to highly functional with a catheter procedure – and without a long hospital stay or a long recovery period”.
As with other percutaneous procedures, the MitraClip“ device is threaded through the femoral vein in the groin and into the right atrium. A needle puncture in the wall separating the upper chambers of the heart enables the catheter to pass into the left atrium, where the clip is opened up. It is then passed through the mitral valve into the left ventricle. When the heart contracts, the flaps, or leaflets, of the mitral valve fall into the clip, which is then closed, pinning the edges of the leaflets together at their centres. The result is a bow-tie-shaped opening that permits blood flow from the left atrium to the left ventricle during relaxation of the heart, and enables the valve to close more effectively during contraction, rather than allowing leakage of blood backward into the left atrium.
The EVEREST II study was designed to evaluate the safety and effectiveness of the MitraClip“ procedure in comparison with open-chest mitral valve surgery in 279 patients.
Table 1. EVEREST II: safety and efficacy end points
The primary safety end point (a combination of adverse events including death, major stroke, reoperation, urgent/emergent surgery, myocardial infarction, renal failure, and blood transfusions, among others) significantly favoured the MitraClip“ at 30 days (table 1). The need for blood transfusions was the main driver of the safety end point, with a difference of 8.8% vs. 53.2%. The primary efficacy end point, the overall clinical success rate, was numerically higher in the surgery group (see table 1) and the difference met non-inferiority criteria.
Presenting the study, Dr Robert Epstein (Medco Research Institute, New York, USA) explained that when starting warfarin, the dose is normally determined by trial and error, and it can take weeks or even months of repeated blood tests and dose adjustments to determine the right dose for each patient. During that time, patients are at high risk for either thromboembolism from too little warfarin, or bleeding from too much warfarin.
The MM-WES study enrolled 896 US patients who were beginning warfarin therapy and were members of a prescription benefits plan managed by Medco Health Solutions. Shortly after starting warfarin therapy, patients gave a blood sample or a cheek swab, which was genotyped for two key genotypes – CYP2C9 and VKORC1 – which determine how sensitive each patient is to the drug. The ordering physician received a report of the findings as well as clinical information on how to interpret the findings – i.e. whether to increase or decrease the warfarin dose.
The researchers found that, during the first six months of warfarin therapy, patients who had genetic testing were 31% less likely to be hospitalised for any cause, when compared to an historical control group that did not undergo genetic testing. Patients in the gene-testing group were also 29% less likely to be hospitalised for bleeding or thromboembolism.
The cost of genetic testing – approximately US$ 250 to US$ 400, depending on the laboratory – is justified by the savings, according to Dr Epstein. “If we reduce just two hospitalisations per 100 patients tested, that more than compensates for the cost of genotyping,” he said.
Discussant not impressed
Patients taking warfarin who undergo genotyping to determine their warfarin dose had a 30% reduction in hospitalisations in the MM-WES (Medco-Mayo Warfarin Effectiveness) Study.
But discussant of the study, Dr Mandeep Mehra (University of Maryland School of Medicine, Baltimore, USA), criticised the study, saying the historical control group “leaves doubt as to whether the reduction in hospitalisation seen in the genotyping group was actually due to the genotyping results or just that the doctor paid closer attention to these patients”.
Responding to this at a later press conference, Dr Epstein said that the reductions in hospitalisations seen in this study would be more than cost-saving whether it was the genotyping or just the extra attention paid to the patients that brought it about. “If we have a new technology that brings more precision to dosing, then that’s got to be good,” he added.
Concerns over drug-eluting stents in STEMI?
Drug-eluting stents may be associated with an increase in the risk of long-term stent thrombosis and cardiac death compared with bare-metal stents in patients with ST-elevation myocardial infarction (STEMI), according to the results of two new studies.
In the DEDICATION trial, the drug-eluting stent group showed an increased risk of cardiac death at three years compared to the patients who received a bare-metal stent.
And in the PASSION trial, there was no difference between the two types of stents in the composite end point of cardiac death, recurrent myocardial infarction, or target lesion revascularisation at five years, but there was a trend towards very late stent thrombosis in the drug eluting-stent group.
Table 1. DEDICATION: three-year results
The DEDICATION trial involved 626 STEMI patients who received either a bare-metal stent or a drug-eluting stent. Results at eight months, reported previously, showed a trend towards an increased risk of cardiac mortality (mainly from heart failure) with the drug-eluting stent group, and this was still present at the three-year point (table 1), lead investigator Dr Peter Clemmensen (Copenhagen University Hospital, Denmark) reported. Revascularisation rates, however, were significantly lower in the drug-eluting stent arm.
Dr Clemmensen stressed that this study was too small to draw any definite conclusions and the increase in cardiac death might have been due to the play of chance. “We’ve seen a signal here, but before doctors stop using these devices, I would urge them to wait for the results of larger studies,” he said.
PASSION
The PASSION study enrolled 619 patients with STEMI who received either a drug-eluting stent or a bare-metal stent. All patients were given clopidogrel for at least six months and aspirin long-term.
Table 2. PASSION results
At five years, results (table 2) showed there was no statistical difference in the rate of the composite end point (cardiac death, recurrent myocardial infarction or target lesion revascularisation). Definite stent thrombosis was, however, twice as high in the drug-eluting stent group versus the bare-metal stent group, although this was not statistically significant.
CABANA: catheter ablation looks good in AF
Catheter ablation appears to be more effective than drug therapy in treating atrial fibrillation (AF), according to the the CABANA (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation) pilot study.
This study is one of the first to evaluate the feasibility of catheter ablation in patients with more advanced AF and substantial underlying cardiovascular disease, lead investigator Dr Douglas Packer (Mayo Clinic, Rochester, USA) explained.
“These results establish the feasibility and importance of conducting an extended pivotal trial critical for establishing long-term outcomes, mortality, quality of life, and cost of ablation and drug therapy for atrial fibrillation,” he said.
For the study, 60 patients with AF and multiple other cardiovascular issues (hypertension, diabetes, coronary artery disease or heart failure) were randomised to drug therapy or catheter ablation. Results showed that catheter ablation was more effective than drug therapy for preventing recurrent symptomatic AF. Treatment success rates in these patients (some of whom had persistent and long-standing persistent AF), however, were lower than observed in other randomised clinical trials. Late recurrent atrial fibrillation may also diminish the overall effectiveness of ablation therapy, Dr Packer said.
The CABANA pivotal trial will further examine these issues, and is currently recruiting patients.
JETSTENT – rheolytic thrombectomy before stenting in STEMI
Conducting rheolytic thrombectomy (removal of the thrombus) before direct infarct-related artery stenting in patients with ST-elevation myocardial infarction (STEMI) produced better clinical results than performing direct stenting alone, in the JETSTENT trial.
The study included 501 patients and found that significantly more patients receiving rheolytic thrombectomy in addition to direct stenting experienced resolution of their ST-segment elevation in the designated time frame than those patients receiving stenting alone (85.8% vs. 78.8%). There was also a strong trend towards a reduction in infarct size as assessed by one-month scintigraphy in the thrombectomy group (6% vs. 12.6%). The researchers also found a significant decrease in major cardiovascular events for patients randomised to receive rheolytic thrombectomy than patients in the direct stenting alone arm both at one month (3.1% vs. 6.9%) and at six months (11.9% vs. 20.6%).
Noting that these results contrast with those of a previous study (AiMI) which found that, rheolytic thrombectomy did not lead to better reperfusion and was associated with a significantly higher mortality rate at 30 days and six months post-procedure, JETSTENT investigator, Dr David Antoniucci (Careggi Hospital, Florence, Italy) pointed out that the two studies differed in several ways. The JETSTENT study included only patients with angiographically visible thrombus; it used a different technique for thrombus removal; and it has a narrower definition of ST-segment elevation resolution.
Discussing the trial, Dr William O’Neill (University of Miami Miller School of Medicine, USA), said the results highlighted the importance of thrombus burden in STEMI patients. But other panel members believed there was not enough evidence to support the routine use of thrombectomy prior to stenting.
CILON-T: adding cilostazol to clopidogrel and aspirin after stenting
There was no significant benefit in reducing clinical events of adding a third antiplatelet drug – cilostazol – to aspirin and clopidogrel after drug-eluting-stent placement in the CILON-T study. But triple therapy did improve post-treatment platelet reactivity, and the trial was underpowered for hard clinical events.
In the trial, 960 coronary disease patients were given either standard therapy of aspirin and clopidogrel or a triple antiplatelet regimen of aspirin, clopidogrel, and cilostazol for six months after drug-eluting-stent placement.
Results showed that post-treatment platelet reactivity, as measured by P2Y12-receptor reaction units (PRU), decreased from 255.7 in the clopidogrel/aspirin group to 210.7 in the triple therapy arm. But the primary clinical end point (cardiac death, non-fatal myocardial infarction, ischaemic stroke, and target lesion revascularisation) was not significantly different between the two groups (8.5% with triple therapy versus 9.2% with dual therapy; p=0.73).
Lead investigator Dr Hyo-Soo Kim (Seoul National University Hospital, Korea) showed data demonstrating that platelet reactivity was directly correlated with clinical outcome and that patients in the lowest tertile of platelet reactivity (i.e. PRU values of 0 to 184 units) had zero clinical events.
“Based on these results, we believe that PRU measurements may be useful in predicting risks after drug-eluting-stent implantation and that if PRU readings are high, a third antiplatelet drug should be considered,” Dr Kim concluded.
Discussing the study, Dr Robert Harrington (Duke University, Durham, USA) suggested that the trial was underpowered to see differences in clinical outcomes. He also pointed out that cilostazol has gastrointestinal and heart rate side effects, which may not make it the best agent to add in.
Women with MI are under-treated
Women might be more likely to survive a myocardial infarction (MI) if they were treated more like men, with increased use of angioplasty and other invasive techniques, a French study suggests.
The study involved more than 3,000 patients admitted to hospital for an MI. Results showed that women were far less likely than men to go to the cath lab for angiography or angioplasty, and about twice as likely to die within a month. But when the patients were matched by both baseline clinical characteristics and treatments, death rates were similar among men and women.
Presenting the study, Dr Francois Schiele (University Hospital of Besancon, France) said: “When there are no clear contraindications, women should be treated with all recommended strategies, including invasive strategies”.
She explained that several previous studies have suggested that women have a higher risk of death after MI than men, but the reasons have been unclear. Her group analysed data from a regional registry that included all patients treated for an MI in 2006 and 2007. Of the 3,510 patients in the study, 32% were women, and they were, on average, nine years older than men, had more health problems, received fewer effective treatments for MI, and were nearly twice as likely to die, both during the initial hospital stay and over the following month.
After propensity scoring to match patients by baseline characteristics, it was found that despite very similar clinical characteristics, men were 57% more likely than women to undergo coronary angiography. Among ST-elevation MI patients, men were far more likely than women to receive some reperfusion treatment. Thrombolysis was used 72% more often in men and angioplasty was used 24% more often in men.
This new pocket-sized visualisation tool provides ultrasound technology at the point-of-care. Similar in size to a mobile phone and weighing less than one pound, it can give high quality colour images enabling physicians to take a quick look inside the body and detect disease earlier. Vscan™ is marketed by GE Healthcare and has received the CE Mark by the European Union.
Heart failure report published
A comprehensive review of the quality of heart failure care in England Bridging the quality gap: heart failure, has been published by The Health Foundation. It highlights that prevention is key to improving outcomes for people with heart failure and reports that survival rates are improving. But it also draws attention to the slow improvement in services in England compared to international comparators with guidelines not being adequately followed.
“We would welcome more strategic attention to be paid to heart failure, particularly around prevention and screening,” said Stephen Thornton, Chief Executive at the Health Foundation.
The Scottish Intercollegiate Guidelines Network (SIGN) has published new guidance on the management of diabetes. The full guidance is available on www.sign.ac.uk and provides recommendations on:
• lifestyle interventions for people with type 1 and type 2 diabetes
• managing psychosocial issues
• managing type 1 diabetes
• glucose-lowering therapies in people with type 2 diabetes including direction on the use of newer agents such as DPP-4 inhibitors
• managing cardiovascular, kidney and foot diseases
• preventing visual impairment
• managing type 1, type 2 and gestational diabetes during pregnancy.
• Prevention of diabetes and prediabetes are not covered in the guidance.
Study to assess new stent graft system
A new study is assessing the safety and performance of this new stent graft system. The Incraft™ stent developed by Cordis is being assessed in patients with abdominal aortic aneurysm (AAA) in Germany in the INNOVATION trial. AAA is suffered by 27 million people worldwide.
SMC recommends saxagliptin
The Scottish Medicines Consortium (SMC) has recommended saxagliptin (OnglyzaTMθ) for people with type 2 diabetes in Scotland as add-on combination therapy with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control. It is restricted to use in patients only when the addition of sulphonylureas is not appropriate and represents an alternative to other agents, such as thiazolidinediones.
Pacemaker development enables patients to access MRI scans
A second-generation pacing system (Advisa DR MRI™ Surescan™, Medtronic) has been approved for use in MRI machines in the UK. First patients have already been fitted with the new pacemaker in the UK, which enables them to have access to full body scans.
“Existing pacemaker technology meant that MRI scans were not safe for over a quarter of a million patients because of the strong magnetic fields it uses,” said Dr Jonathan Lyne, cardiologist at the Royal Brompton Hospital, London. “These patients will not need more invasive or complicated diagnostic procedures and will lead to speedier and more accurate diagnoses.”
Teach me to pace – the dilemma of the new registrar
What is it like to attend a workshop on bradycardia and pacing? Do trainees really benefit from these short sponsored courses, what’s involved and how can one enrol? These questions our answered by Hammersmith Hospital, Cardiology Registrar, Henry Savage (above). To see his review go to our Arrhythmia Watch website, www.arwatch.co.uk. It’s free to register and read his report alongside other developments in the heart rhythm management area.
IFCC HbA1c reporting guide launched
A new guide to help healthcare professionals better understand the new IFCC units for reporting HbA1c was launched at the Diabetes UK Annual Professional Conference in Liverpool recently.
Produced in association with Diabetes UK, the pocketbook HbA1c in Diabetes – case studies using IFCC units is aimed at nurses, doctors and scientists involved in the management of diabetes in the UK. It summarises the key issues around the switch from DCCTpercentage HbA1c values to the internationally-recognised IFCC units of mmol/mol. Reporting of these units only is scheduled for June 2011 in the UK.
European study shows only half of patients given correct cholesterol targets
Only half of all patients at high risk of heart disease are given correct targets for lowering their cholesterol levels according to a study of 25,250 patients in Germany published online in the European Heart Journal (doi:10.1093/eurheartj/ehq026).
The study investigated the way primary care doctors assessed their patients’ risk factors and other health problems when deciding on cholesterol-lowering targets, and although the research focused on German doctors and their patients, the authors believe that it reflects a similar picture in the rest of Europe.
The researchers found that in the survey of 907 doctors, just over half of male patients (55%) and less than half (49%) of female patients were assigned correct low-density lipoprotein cholesterol targets.
“We believe efforts should be made to make guidelines simpler and easier to understand and follow; instruments to identify high-risk patients more easily should be developed; and special attention should be paid to women and patients without known cardiovascular disease, but with an accumulation of risk factors, since both groups appear frequently to escape the notice of doctors for aggressive cholesterol-lowering treatment,” said Professor Heribert Schunkert (Universitätsklinik Schleswig Holstein, Lübeck, Germany) who led the research.
We continue our series in which Consultant Interventionist Dr Michael Norell takes a sideways look at life in the cath lab…and beyond. In this column, he considers the pitfalls of passwords.
Has it only been for the last 20 years or so that our professional, domestic and financial integrity has required us to protect ourselves with a personal identity number (PIN) or password of some description?
Memorising such a catchy or familiar word, an easy sequence of figures or a combination of both, has now become, not only commonplace, but an evolutionary necessity. I presume that it was the electronic revolution that ‘sparked’ the need for this type of validation. Previously, a hastily scribbled signature, which – to the untrained eye – appeared reasonably similar to the scrawl on the back of your credit card, might have sufficed.
Any form of registration, transaction or authorisation is accompanied by your need to transmit, insert or ‘punch in’ an indication that the process in question is not only bona fide but also being vouched for personally with a sign that only you would know. Right now there must be a wealth of electronic interactions available to us, such as when we boot up our laptop, ‘log on’ and register with a website or top up with cash at a hole in the wall.
Surely, all of us must be currently using a dozen or more passcodes of some sort. Add to this the encryption that is now quite rightly part of the transfer of any National Health Service (NHS) information, and the list of events demanding our authentication starts to become unwieldy.
The burden
The question is, do you try and use the same word or number sequence for all your requirements, or do you memorise a constantly expanding variety? I confess that I find these demands on my ever-dwindling mental faculties, an increasing burden. For that reason, I have tried to use the same password for all eventualities. This slightly risky strategy has worked thus far, although admittedly I haven’t checked my bank account today.
Your ‘mother’s maiden name’ appears to be a common word suggested by banks and other institutions in the hope that it will assist the user in verifying a transaction. However, in the era of the extended family it may not be apparent to some individuals as to what this actually was.
This ‘one-word’ approach, while convenient, has been made more difficult because some systems require a password to be changed on a regular basis, e.g. monthly. Adding a digit to the end of your keyword that you simply increase by one every 30 days or so, is an option as long as you can remember what the last one was. I suppose you could always use the name of the month as a password but that strikes me as a bit of a giveaway, and anyway what do you do in 12 months’ time?
As for numeric codes, I currently need to remember at least five (or is it six?) number sequences, in order to use various credit or debit cards, set – or more usually, silence – the house alarm, open our wall safe and unlock my bicycle. I have run out of birthdays or the novel use of other memorable dates that could be entered in reverse order or with each composite figure increased by one. Of course the danger is that if you make the solution too obtuse, you won’t be able to work it out yourself.
The pressure
Whether a word or a number sequence, the pressure is on you when you are instructed after your first failed attempt that you have only two further tries to get the thing right. Otherwise your plastic card is swallowed, your computer will not allow any kind of access for at least five years, and a large hand will spring out from the screen and slap you on the side of the head.
It does not help when the letters or numbers that you have, thus far, painstakingly entered, appear as a lengthening line of large black dots, and, therefore, do not indicate whether or not you have already made that fatal error. Incidentally, I have actually tried typing a line of seven black dots in the ‘enter your password’ field; it doesn’t work. Furthermore, I am sure that as a result of this quite reasonable wish to further my e-knowledge, the computer thought to itself that the operator was clearly an idiot (probably spot on there) and shut down in disgust.
I anticipate that Darwinian principles will mean that Homo sapiens with less capacity to rapidly, and reliably, recall keywords or numbered sequences, will be disadvantaged. Natural selection will mean that there will be preferential survival of the e-fittest, not so much because of the opposable thumb, but more as a result of our ability to manipulate other digits.
The danger
But what is the real danger? What is the genuine concern? It is not about being thought of as having purchased some dodgy DVDs online (allegedly), having your bank account drained or even your bike nicked. It is the ultimate crime of the electronic era, namely the theft of your very identity.
This modern day contravention of natural law is far removed from the simple acquisition of a false passport. The means to possess such a hallowed document was laid out in easy-to-follow steps by Frederick Forsyth in his classic 1971 bestseller “The Day of the Jackal”. Since then the loophole in birth and death certification that allowed this chicanery, has been closed (I hope), but the twenty-first century version of this demeanour goes far deeper.
How can we prove who we are? Holding up a mirror and exclaiming: “Yes; that’s me!”, hardly stands up in court and opening a wallet and spreading out a collection of plastic cards, all with the same embossed name, won’t cut it either. A driving licence or other photographic evidence that puts a name with a face could help, but may already have been falsified. Even colleagues, friends and family, all of whom would swear that “you are who you say you are”, may have been taken in by a long-standing plan cooked up to replace one individual with another.
It is a frightening prospect to imagine that somewhere out there could be another Mike Norell (spelt correctly, I would insist) using my bank account, my password, my computer log-ins and – come to think of it – having unauthorised access to my bicycle. (Believe me; it scares me as much as it does you.) But, I guess as long as he also pays my bills, I shouldn’t complain. He (for I presume this doppelgänger would have to be male) might actually be a wealthy and extraordinarily successful – if a tad unscrupulous financier, in which case it might then be worth me stealing (back) his identity. That should be fairly easy … shouldn’t it?
Finally, in the spirit of dogged enquiry and openness for which this publication is renowned, I now intend to break new ground in journalistic investigation. I am herewith going to publish my universal password, used for all my financial and professional transactions. I will then scour the ether to see whether there are any signs of me emerging in an alternative guise, turning up in questionable circumstances or in other ways being surreptitiously cloned. Here we go; be sure to make a note of it: *******.
Temporary pacing lead insertion in Lanarkshire hospitals between 2005 – 2007
Dear Sirs,
The retrospective study recently reported by Yassin et al. (Br J Cardiol 2010;17:34-5) has some potential confounding factors not reported by the authors. In addition, there is a complete absence of data from their questionnaires, with any appropriate analysis.
The study looks at procedures performed between 2005 and 2007. During this timeframe the numbers of doctors in training were being reduced and doctors in more junior grades did not always possess the same procedural experience as would have been previously expected, related to the impact of foundation training. This is not an indictment of the individual, but more symptomatic of modern training programmes. The timing of thequestionnaire survey is crucial to this. Data collection for the pacing lead insertions was from 30th April 2005 to 30th April 2007.
One would assume the questionnaire survey followed this period – during the changeover to the new framework for training. The dates of the data collection from the survey, however, are not provided. Neither are any data on how many questionnaires were sent out or returned. The authors state that an independent sample t-test was carried out: this is used to compare the mean score of two groups for a given variable – a parametric test. They also state that the questionnaire was formulated to assess competency – this is non-parametric assessment. Furthermore, neither the questionnaire has been provided nor any raw data to support their conclusions. No appropriate statistical test has been performed to support their findings.
The reported data in the text is at odds with their figure with the text stating there was loss of capture in 24 patients with their figure totaling only 20. From the data they have provided and using Fisher’s exact test, there is, in fact, no difference in the rates of loss of capture or wires requiring repositioning. Using Fisher’s exact test, there is, however, a difference in the total rate of complications between the two groups – consultants and non-consultants, and this would be expected and is unsurprising.
In summary, the conclusion from the authors, whilst perhaps being correct in terms of the variety of experience, is completely wrong with regards to any difference in the loss of capture.
Yours faithfully
Euan Cameron
Clinical Research Fellow and Specialty Registrar
The questionnaires were circulated in 2008 to 40 junior doctors all participating in the on-call rota for Acute Medicine in Lanarkshire. Trainees were asked three questions relating to experience in temporary pacing line (TPL) insertion, previous (if any) training in temporary pacing and whether they felt such training would be worthwhile. We received 38 completed questionnaires with the majority (33 of 38) having no prior involvement in a TPL procedure. None of the respondents had received any formal instruction and all agreed there is a need for training if TPL insertion is to remain the responsibility of on-call general physicians.
We did not perform any further statistical analysis of this data nor do we believe there is any need to do so.
Dr Cameron has recognised that this study spanned a period when junior doctor numbers were being reduced. In actual fact, since the implementation of the European Working Time Directive (EWTD) junior doctor exposure to emergency procedures has certainly not improved and, accordingly, we have no reason to suspect the high complication rates observed would be any less today.
He has also highlighted an error in figure 1 with regard to number of loss of capture episodes after junior doctor procedures. The total number of episodes is as stated in the text; 24 (18 junior doctor vs. 6 consultant) and this difference is statistically significant (p=0.034).
We believe our retrospective study has clear objectives and appropriate conclusions. There was a higher incidence of loss of capture when TPLs were inserted by non-consultant grades and there was unanimous agreement amongst junior doctors that training is lacking in this area. Predictable or otherwise, these findings remain extremely valuable when so many district hospitals in the United Kingdom continue to rely on junior and non-cardiology staff for emergency pacing procedures.
Audit of AF management at a district general hospital
Dear Sirs,
The recently published audit by Lim et al. identifies the potential and significant areas of weakness in the management of atrial fibrillation (AF).1 Certainly, AF is the commonest sustained cardiac arrhythmia encountered in clinical practice with a prevalence well exceeding 10% in the population aged over 80 years.2 Of particular importance, AF is associated with significant morbidity and mortality and much of this is attributed to a five-fold increased risk of stroke.3 By stratifying risk, patients with AF can be prescribed antithrombotic therapy appropriately and this has been shown to reduce the risk of stroke by up to 64%.4 Lim et al. found only 51% of patients with longstanding AF to have been prescribed appropriate antithrombotic therapy in concordance with the National Institute for Health and Clinical Excellence (NICE) guidelines.5 These findings are consistent with previous results such as those from the ATRIA study. A cross-sectional analysis performed by the ATRIA investigators estimated only 55% of patients to be prescribed appropriate anticoagulation.6 Thus, it has long been recognised that the prescription of anticoagulation is underutilised in AF patients but emphasis needs to be placed on the mechanisms behind this. Lim et al. did not provide information into the characteristics of patients on ‘inappropriate therapy’, such as age, the presence of co-morbidities and use of concomitant medical therapy. It is well recognised that a major factor leading to the underutilisation of anticoagulation therapy is the risk of bleeding complications and physicians have a tendency to overestimate this risk.7,8 As for the stroke risk stratification schemata, the risk of haemorrhagic complications are not uniform for all patients with AF and factors increasing the risk of bleeding include:
Increasing age (particularly age > 75 years)
Concomitant treatment with antiplatelets or non-steroidal anti-inflammatory drugs
Concomitant treatment with other multiple drug therapies
Past history of bleeding problems (peptic ulcer disease or cerebral haemorrhage).
By not including the presence (or absence) of relevant patient factors, Lim et al. are unable to determine whether their observations are a true reflection of inappropriate practice, or whether physicians have informally assessed the risk of treatment and adjusted practice accordingly.
The prescription of anticoagulation should always be based upon the careful balance of benefits and risks of therapy, but in well-selected patients with AF it is safe9 and one of the most effective interventions at our disposal. It is well recognised that anticoagulation remains underutilised and careful attention is required to improve this pattern of behaviour. Perhaps introducing schemata aimed at assessing the risk of bleeding alongside those used to determine stroke risk may help to routinely formalise this decision making process, and thereby improve the use of appropriate antithrombotic therapy.
Yours faithfully
Jaspal S Taggar
GP Registrar
East Midlands Healthcare Workforce Deanery, Nottingham City Hospital Trust, Nottingham, NG5 1PB.
([email protected])
References
1. Lim JCES, Suri A, Sornalingham S, Chua TP. Br J Cardiol 2010;17:89-92.
2. Fitzmaurice DA, Hobbs FDR, Jowett J et al. BMJ 2007;335:383-6.
3. Lip GY, Lim HS. Lancet Neurol 2007;6:981-93.
4. Hart RG, Pearce LA, Aguilar MI. Ann Intern Med 2007;146:857-67.
5. National Collaborating Centre for Chronic Conditions. Atrial fibrillation: national clinical guideline for management in primary and secondary care. London: Royal College of Physicians, 2006
6. Go AS, Hylek EM, Borowsky LH et al.Ann Intern Med 1999;131:927-34.
8. Derevereaux PJ, Anderson DR, Gardner MJ et al. BMJ 2001;323:1-7.
9. Mant J, Hobbs FD, Fletcher K et al; BAFTA investigators; Midland Research Practices Network (MidReC). Lancet 2007;11;370:493-503.
The authors’ reply
For each case audited, we recorded the presence or absence of each of the following potential contraindications to warfarin: haemorrhage, peptic ulcer disease, severe hypertension, drug interactions, dementia, falls, allergy, other. Potential contraindications to aspirin recorded were: haemorrhage, peptic ulcer disease, drug interactions, allergy, other. Any patient who was not on the appropriate thromboprophylactic agent (as determined by the NICE criteria) in the absence of one of these contraindications to that agent was deemed to be on ‘inappropriate thromboprophylaxis’. Cases where a decision could potentially be justified either in favour of or against thromboprophylaxis were labelled ‘difficult clinical decisions’ and were not counted as ‘inappropriate thromboprophylaxis’.
Clearly there may have been some instances where the GP had previously attempted anticoagulation that proved unsuccessful due to a reason not listed above and not apparent from the hospital notes. However, we felt that the majority of potential contraindications were covered by the above and hence that the results did, indeed, reflect inappropriate practice.
Joanna C E-S Lim
ST1 Core Medicine
Department of Cardiology, Royal Surrey County Hospital, Guildford, GU2 7XX.
([email protected])
Tuan Peng Chua
Consultant Cardiologist
Royal Surrey County Hospital, Guildford, and St George’s Hospital, London.
Routine cardioversion for patients with atrial fibrillation
Dear Sirs,
I have been interested in cardioversion for some time – it is often done very poorly in the UK.
I read the recent articles by Fitzmaurice and Sandler (Br J Cardiol 2010;17:55-6 and 88-6). We know that cardioversion success is much greater if patients are prepared for one to three months with amiodarone, (best drug by far for this short-term purpose), as well as warfarin. We know that patch-positioning should be antero-posterior (AP). We know that energies should be 200-300 J, and with a biphasic waveform. We know that it is quite safe for nurses to deliver both sedation and the shock, and we know that the electrophysiology of the atrial myocardium remains ‘hot’ for a period of weeks/months after restoration of sinus rhythm, during which patients should continue amiodarone as well as warfarin, following which there should be a cogent plan for maintenance of sinus rhythm. We also know which patients to cardiovert, with those having impaired left ventricular function, and/or left atrial enlargement, and/or other structural heart disease, being least likely to convert or to stay in sinus rhythm after conversion.
And yet….patients are not selected or prepared properly, the left nipple often receives the bulk of the delivered energy, (I hope this never happens to me), general anaesthetic is used creating much greater costs, great inertia and reluctance to cardiovert patients, and antiarrhythmic drugs are often stopped immediately after sinus rhythm is restored. In other circumstances ‘internal cardioversion’ is deployed after inadequate external cardioversion has failed, creating a small risk for patients, when external cardioversion might have been effective.
It is also important to remember that AFFIRM showed equivalence in mortality for rate and rhythm control. This was demonstrated in quite elderly patients, (mean 77 years), in established atrial fibrillation (AF), and was therefore a study of geriatric cardiology and largely ‘end-stage’ atria. The slightly increased mortality trend in rhythm control was easily explained because warfarin was stopped far too soon after sinus rhythm was restored. Unfortunately, as tends to happen with much publicised trials, the message has gone out that patients with AF should be abandoned to their fate. This fate includes a doubling of mortality risk at all ages, up to a 20-fold increase in healthcare costs, and approximately 40% reduction in quality of life across all SF-36 measures. I have seen patients in their 40s with paroxysmal AF who have been told that treatment for their AF will make no difference, citing AFFIRM.
We don’t stent everyone with a coronary stenosis, we assess it alongside all the other data and arrive at the best treatment option by individualising care. Established AF can be cardioverted, if circumstances suggest that there is a good chance of long-term sinus rhythm, and if cardioversion is prescribed, then conditions should be optimised before, during and afterwards. External cardioversion in the NHS is too often costly and poor quality.
Yours faithfully
Adam P Fitzpatrick
Consultant Cardiologist and Arrhythmologist
Many thanks for your comments, and I think we agree more than it seems. My argument is that cardioversion needs to be considered in light of the patient experience and evidence for its effectiveness rather than being a routine part of the patient journey. I have never argued that cardioversion should not be utilised, just that some thought should be given to its utilisation. We often have patients undergoing multiple attempts at DC version with no justification. You obviously think through your patient selection and preparation which is admirable and a practice which should be encouraged in more units.
David Fitzmaurice
Professor of Primary Care Clinical Sciences
Clinical Sciences Building, The University of Birmingham, Birmingham, B15 2TT.
([email protected])
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Presenting the study, Dr Robert Epstein (Medco Research Institute, New York, USA) explained that when starting warfarin, the dose is normally determined by trial and error, and it can take weeks or even months of repeated blood tests and dose adjustments to determine the right dose for each patient. During that time, patients are at high risk for either thromboembolism from too little warfarin, or bleeding from too much warfarin.
This study is one of the first to evaluate the feasibility of catheter ablation in patients with more advanced AF and substantial underlying cardiovascular disease, lead investigator Dr Douglas Packer (Mayo Clinic, Rochester, USA) explained.
What is it like to attend a workshop on bradycardia and pacing? Do trainees really benefit from these short sponsored courses, what’s involved and how can one enrol? These questions our answered by Hammersmith Hospital, Cardiology Registrar, Henry Savage (above). To see his review go to our Arrhythmia Watch website, 
Has it only been for the last 20 years or so that our professional, domestic and financial integrity has required us to protect ourselves with a personal identity number (PIN) or password of some description?
