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Cardiology
Practice Review
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Making Education Easy
Issue 4 - 2016
Welcome to the fourth issue of Cardiology Practice Review.
In this issue:
>>ESC/EAS guideline for dyslipidaemia
>>ESC/EACTS guideline for atrial
fibrillation
>>European standards to prevent
repeat heart attacks
>>Severe aortic stenosis at
low-intermediate surgical risk:
a BMJ guideline
>>Discrepancies in cardiovascular
screening guidelines
>>ESC Position Paper on cancer drugs
and cardiovascular toxicity
>>AHA releases new sugar guidelines
for children
>>AHA calls for guidelines on sleep
disorders and CV risk
>>CPAP: no CV benefit in obstructive
sleep apnoea
>>1 October PBS price reductions
>>PBAC recommends sacubitril with
valsartan
>>TGA vacancies
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Research Review
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This new Review covers news and issues relevant to clinical practice in cardiology. It will bring you the latest
updates, both locally and from around the globe, in relation to topics such as new and updated treatment
guidelines, changes to medicines reimbursement and licensing, educational, medicolegal issues, professional
body news and more.
In this issue we bring you updated European Society of Cardiology clinical practice guidelines for the management
of dyslipidaemia, atrial fibrillation and prevention of repeat heart attacks. A group of guideline developers and the
BMJ have collaborated to launch “rapid recommendations,” starting with guidance on the treatment of patients
with severe symptomatic aortic stenosis and low-to-intermediate surgical risk. From the US, the American Heart
Association has released new sugar guidelines for children, and has called for guidelines on sleep disorders and
cardiovascular risk. And finally on the back cover you will find a summary of upcoming local and international
educational opportunities including workshops, webinars and conferences.
We hope you enjoy this new Research Review publication and look forward to hearing your comments and feedback.
Kind Regards,
Dr Janette Tenne
Medical Research Advisor
[email protected]
Clinical Practice
ESC/EAS guideline for the management of dyslipidaemias
The European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) have published
a new guideline addressing the management of dyslipidaemia. The new guideline highlights the need to
lower lipid levels at a population level and in high-risk individuals. Combination treatment (ezetimibe and a
statin) is recommended in patients with treatment-resistant high cholesterol. An individual LDL cholesterol
target is recommended based on risk (defined by comorbidities and 10-year risk of fatal cardiovascular
disease). This differs to US guidelines that recommend a statin for all high-risk patients – even those with
low cholesterol. The new guideline also recommends that all patients, regardless of risk, should achieve
a minimum 50 percent reduction in LDL cholesterol.
The guideline also addresses PCSK9 inhibitors, noting they can be considered in patients with persistent
high LDL cholesterol on a statin and ezetimibe. However, PCSK9 inhibitors are extremely expensive and
therefore their use may be limited in some countries. These medications have been approved by the TGA
in Australia for use in patients with familial hypercholesterolaemia, but have not been funded by the PBS
yet, so can only be dispensed on private script.
Additionally, the guideline gives more importance to lifestyle and nutrition than the previous guideline, with
goals for body mass index and weight. There is no longer a requirement for fasting before screening for
lipid levels, given new evidence that non-fasting blood samples give similar cholesterol results.
Eur Heart J. 2016 Aug 27. [Epub ahead of print]
Download the guideline http://tinyurl.com/h5u8khq
Atrial Fibrillation
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Clinical Practice
ESC/EACTS guideline for the management of atrial fibrillation
The ESC has published a new guideline on atrial fibrillation (AF) developed in collaboration with
the European Association for Cardio-Thoracic Surgery (EACTS) and endorsed by the European
Stroke Organisation.
There is now more emphasis on early detection of asymptomatic ‘silent’ AF. Diagnosis of AF
requires an ECG, with the prognostic value of atrial high rate episodes picked up by implanted
devices unclear at present. Silent, undiagnosed AF is a common cause of stroke, and the guideline
recommends both opportunistic and targeted intensive ECG screening for AF in all patients over
the age of 65 or with other risk factors for AF such as OSA, HT, CAD, obesity or diabetes, and
especially in those patients with a history of stroke or transient ischaemic attack.
Oral anticoagulation remains a major treatment component in AF, and, apart from patients at the
lowest risk of stroke (women and men without any clinical risk factors), most others will derive a
net clinical benefit from anticoagulation.
Patients with a single stroke risk factor (CHA 2DS2-VASc score of 2 for women and 1 for men)
should be considered for anticoagulation, taking account of individual characteristics and
patient preferences; men with a CHA 2DS2-VASc score of 2 and women with a score of 3 should
be recommended for anticoagulation. Non vitamin-K oral anticoagulants (NOACs) are now
recommended as the first-line anticoagulant in eligible patients as a result of their better safety profile.
Patients with valvular AF (moderate-severe mitral stenosis or mechanical heart valves – NB: new
definition) are ineligible for NOAC therapy, as are patients with severe chronic kidney disease,
and should be treated with vitamin-K antagonists, maintaining a high time in therapeutic range.
Aspirin and other antiplatelets have no role in stroke prevention. Preventing major bleeding
events in anticoagulated AF patients is extremely important. To reduce the risk of bleeding, the
guideline provides a list of modifiable bleeding risk factors that clinicians should minimise in
anticoagulated patients, but a specific bleeding score is no longer recommended. Importantly,
bleeding and stroke risk factors overlap and patients at high risk of bleeding are likely to benefit
from anticoagulation.
The guideline also provides suggestions for initiation and/or resumption of treatment after
ischaemic strokes and after intracranial haemorrhage. These difficult decisions should be taken
by interdisciplinary teams.
Symptoms should be assessed by the modified EHRA score, including AF-related tiredness and
breathlessness, which are common symptoms in AF patients. Catheter ablation is now reaching the
mainstream of AF management and data underpinning its use have expanded in number and quality.
Catheter ablation is the rhythm control therapy of choice in patients with symptomatic recurrences
of AF on antiarrhythmic drug therapy, and emerges as a valid first-line alternative to anti-arrhythmic
drugs in selected patients with symptomatic paroxysmal AF.
Eur Heart J. 2016 Aug 27. [Epub ahead of print]
Read the full guideline http://tinyurl.com/jtn5meb and the media release http://tinyurl.com/hmlswbo.
European standards to prevent repeat heart attacks launched
European standards to prevent repeat heart attacks have been published in the European Journal
of Preventive Cardiology. The standards were defined by the ESC.
The consensus document outlines the steps patients and healthcare professionals can take to
prevent recurrent heart attacks:
1. Quit smoking
2. Undertake regular physical activity
3. Eat healthy food
4. Take prescribed medication to protect coronary vessels, and to control risk factors such as
high blood pressure and cholesterol
According to the EUROASPIRE survey, after an acute myocardial infarction 16% of patients smoke,
38% are obese and 60% report little or no physical activity. Only half of patients are advised to
participate in a cardiac rehabilitation programme, of whom just 80% actually attend. European
guidelines on cardiovascular disease prevention outline blood pressure and cholesterol targets
but these are still missed.
Prevention of recurrent heart attacks should begin immediately after the first event, while patients
are still in hospital. This should be given equal priority to treating the initial heart attack. Patients
should be referred to outpatient cardiac rehabilitation to reinforce lifestyle messages and encourage
adherence to behaviour change and medications.
Eur J Prev Cardiol. 2016 Sep 6. [Epub ahead of print]
Read the article http://tinyurl.com/jxh2bnj and media release http://tinyurl.com/jbc5gws.
www.researchreview.com.au
TAVI or SAVR for patients with severe,
symptomatic, aortic stenosis at low to
intermediate surgical risk: a clinical
practice guideline
With the goal of incorporating important trial results into clinical
practice as quickly as possible and shortening the time it takes
to revise guidelines, a group of guideline developers and the
BMJ have collaborated to launch “rapid recommendations,”
starting with guidance on the treatment of patients with
severe symptomatic aortic stenosis and low-to-intermediate
surgical risk.
Narrowly focused, the guidelines contain age-stratified
recommendations to help guide clinicians. For patients younger
than 65 years, there is a strong recommendation for surgical
aortic valve replacement (SAVR) over transcatheter aortic
valve insertion (TAVI). For patients aged between 65 and
74 years there is a weak recommendation for SAVR over TAVI.
For patients 75 and older, there is a strong recommendation
for TAVI over SAVR in the oldest age group (85 years and
above) and a weak recommendation for TAVI between ages 75
and 84. The major uncertainty is the durability of TAVI valves
which drives recommendations in favour of SAVR in younger
patients. If transfemoral TAVI is not possible, SAVR is preferred
to transapical TAVI, according to the guidance.
BMJ. 2016 Sep 28;354:i5085.
Download a copy of the guideline http://tinyurl.com/jtfsvmb.
Discrepancies in cardiovascular
screening guidelines
A new review has found that considerable discrepancies in
cardiovascular screening guidelines still exist, with no consensus
on optimum screening strategies or treatment threshold.
The researchers searched the MEDLINE and CINAHL databases
for guidelines published between May 3 2009 and June 30 2016.
They also searched the following guideline-specific databases:
National Guideline Clearinghouse in the US, National Library for
Health Guidelines Finder in the UK, Canadian Medical Association
Clinical Practice Guidelines Infobase and Guidelines International
Network International Guideline Library.
Two reviewers screened titles and abstracts to identify guidelines
from Western countries containing recommendations for
cardiovascular risk assessment for healthy adults. Two reviewers
independently assessed rigor of guideline development using the
Appraisal of Guidelines for Research and Evaluation II instrument,
and one extracted the recommendations.
Of the 21 guidelines, 17 showed considerable rigor of
development. These recommendations address assessment
of total cardiovascular risk (5 guidelines), dysglycaemia
(7 guidelines), dyslipidaemia (2 guidelines), and hypertension
(3 guidelines). All but one recommendation advocates for
screening, and most include prediction models integrating
several relatively simple risk factors for either deciding on further
screening or guiding subsequent management. However, no
consensus on the strategy for screening, recommended target
population, screening tests, or treatment thresholds exists.
Ann Intern Med. 2016 Sep 13. [Epub ahead of print]
Read the abstract http://tinyurl.com/zwdrylb.
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Cardiology Practice Review
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Elderly (≥70 years) CHF patients
deserve an age proven blocker1,2
NEBILET reduced the risk of all cause mortality or cardiovascular
hospitalisation in a broad range of elderly CHF patients*1,2
* vs placebo P= 0.039; patients ≥ 70 years regardless of age, gender or left
ventricular ejection fraction
NEBILET: Age proven in elderly (≥70 years) CHF patients1,2
CHF= Chronic Heart Failure
PBS Information: Restricted benefit. Moderate to severe heart failure.
Refer to PBS Schedule for full restricted benefit information.
Please review full Product Information before prescribing.
The Product Information can be accessed at www.menarini.com.au/pi
Nebilet® (nebivolol hydrochloride) tablets 1.25 mg, 5 mg, 10 mg. INDICATIONS: Essential hypertension. Stable chronic heart failure (CHF) as an adjunct to standard
therapies in patients 70 years or older. CONTRAINDICATIONS: Hypersensitivity to the active or any of the excipients; liver insufficiency or liver function impairment; acute
heart failure; cardiogenic shock or episodes of heart failure decompensation requiring IV inotropic therapy; sick sinus syndrome, including sino-atrial block; second
and third degree heart block (without a pacemaker); history of bronchospasm (e.g. including COPD) and/or asthma; untreated phaeochromocytoma; metabolic acidosis;
bradycardia (HR < 60 bpm prior to starting therapy); hypotension (systolic BP < 100 mmHg); severe peripheral circulatory disturbances. PRECAUTIONS: Avoid abrupt
cessation unless clearly indicated – reduce dosage gradually over 1-2 wks; refer to full PI. If it must be withdrawn abruptly, close observation is required. Anaesthesia;
untreated congestive heart failure, unless stabilised; bradycardia; peripheral circulatory disorders (e.g. Raynaud’s disease, intermittent claudication); first degree heart
block; Prinzmetal’s or variant angina; lipid and carbohydrate metabolism – does not affect glucose levels in diabetic patients, but may mask symptoms of hypoglycaemia.
Hyperthyroidism; COPD/asthma; phaeochromocytoma; various skin rashes; conjunctival xerosis; oculomucocutaneous syndrome; psoriasis; increased sensitivity to
allergens and severity of anaphylactic reactions; galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption; driving vehicles or operating
machines. Pregnancy (Cat C). Lactation. Children and adolescents. Renal and hepatic insufficiency – see Dosage and Administration. INTERACTIONS: Combination not
recommended: Class I antiarrhythmics; calcium channel antagonists (verapamil/dilitiazem); centrally-acting antihypertensives; other beta-blockers (incl. eye drops).
Combination to be used with caution: Class III antiarrhythmic drugs; anaesthetics (volatile); insulin and other oral diabetic medicines; calcium antagonists (dihydropyridine
type); catecholamine depleting agents; baclofen; amifostine; for other combinations requiring careful consideration, see full PI. ADVERSE EFFECTS: Headache, dizziness,
tiredness, fatigue, paraesthesia, constipation, nausea, diarrhoea, cardiac failure aggravated, bradycardia, hypotension, dyspnoea, oedema, slowed AV conduction/
AV-block, bronchospasm. Post-marketing reports of hypersensitivity, angioneurotic oedema, abnormal hepatic function, acute pulmonary oedema, acute renal failure,
myocardial infarction, others see full PI. DOSAGE AND ADMINISTRATION: Once daily dosing, can be given with or without meals, consistent approach is recommended.
Hypertension: 5 mg daily. Renal insufficiency: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 65 years: recommended
starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 75 years: caution must be exercised and these patients monitored closely. Chronic Heart
Failure: The initial up titration should be done gradually at 1-2 wk intervals based on patient tolerability starting at 1.25 mg once daily, increased to 2.5 mg, then to 5 mg
and then to 10 mg once daily. Initiation of therapy and every dose increase should be done under close supervision for at least 2 h. No dose adjustment is required in
patients with mild to moderate renal insufficiency. Use in patients with severe renal insufficiency (serum creatinine ≥ 250 μmol/L) is not recommended. Date prepared
17 December 2015. References: 1. Nebilet Approved Product Information, 14 December 2015. 2. Flather MD et al. Eur Heart J 2005; 26: 215–25.
A. Menarini Australia Pty Ltd. ABN 62 116 935 758, Level 8, 67 Albert Avenue, Chatswood NSW 2067
Medical Information 1800 644 542. NEB-AU-0501 April 2016 • ALMIN.1.2
ALMIN.1.2 Nebilet Journal Advert 190x245 v4.indd 1
www.researchreview.com.au
13/04/2016 10:44:36
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Society and Professional Body News
ESC Position Paper on cancer treatments and
cardiovascular toxicity
CPAP: no CV benefit in patients with obstructive
sleep apnoea and established CVD
A new position paper on cardio-oncology developed by the ESC Committee for Practice
Guidelines has reviewed cardiovascular complications of anticancer therapy. The paper
focuses on nine categories: myocardial dysfunction and heart failure; coronary artery disease;
valvular disease; arrhythmias; arterial hypertension; thromboembolic disease; peripheral
vascular disease and stroke; pulmonary hypertension; and pericardial complications.
An Australian study funded by the National Health and Medical Research Council has
found that therapy with continuous positive airway pressure (CPAP) plus usual care, as
compared with usual care alone, did not prevent cardiovascular events in patients with
moderate-to-severe obstructive sleep apnoea and established cardiovascular disease.
In the study, 2717 adults between 45 and 75 years of age who had moderate-to-severe
obstructive sleep apnoea and coronary or cerebrovascular disease were randomised to
receive CPAP treatment plus usual care (CPAP group) or usual care alone (usual-care
group). The primary end point was a composite of death from cardiovascular causes,
myocardial infarction, stroke, or hospitalisation for unstable angina, heart failure, or
transient ischaemic attack. Secondary end points included other cardiovascular outcomes,
health-related quality of life, snoring symptoms, daytime sleepiness, and mood.
Most of the participants were men who had moderate-to-severe obstructive sleep apnoea
and minimal sleepiness. In the CPAP group, the mean duration of adherence to CPAP
therapy was 3.3 hours per night, and the mean number of apnoea or hypopnoea events
per hour of recording decreased from 29.0 events per hour at baseline to 3.7 events per
hour during follow-up. After a mean follow-up of 3.7 years, a primary end-point event
had occurred in 229 participants in the CPAP group (17.0%) and in 207 participants
in the usual-care group (15.4%) (hazard ratio with CPAP, 1.10; 95% CI, 0.91 to 1.32;
p=0.34). No significant effect on any individual or other composite cardiovascular end
point was observed. CPAP significantly reduced snoring and daytime sleepiness and
improved health-related quality of life and mood.
N Engl J Med. 2016 Sep 8;375(10):919-31
Read the full article http://tinyurl.com/zxqbnfu.
For each type of complication, the authors outlined which patients are at risk, how to
detect and prevent possible side effects, and how to treat and follow up with patients.
For example, coadministration of anthracyclines and trastuzumab in patients with
breast cancer markedly increases the incidence of heart failure. But cardiotoxicity can
be reduced significantly by introducing a drug-free interval between the two agents.
The paper also emphasises the importance of establishing multidisciplinary teams that
include cardiologists, oncologists, nurses, and heart failure and imaging specialists to
provide the best care for cancer patients and survivors. The authors note that ultimately
structured cardio-oncology centres are needed.
Eur Heart J. 2016 Aug 26. [Epub ahead of print]
Download the position paper http://tinyurl.com/zr5h47d.
AHA releases new sugar guidelines for children
For this American Heart Association (AHA) scientific statement, the current scientific
evidence for studies examining the cardiovascular health effects of added sugars on
children was reviewed and graded. The available literature was subdivided into five areas:
effects on blood pressure, lipids, insulin resistance and diabetes mellitus, nonalcoholic
fatty liver disease, and obesity.
Among US children, the associations between added sugars and increased cardiovascular
disease risk factors begin at levels well below current sugar consumption levels.
There is strong evidence to support an association of added sugars with increased
cardiovascular disease risk in children through increased energy intake, increased
adiposity, and dyslipidaemia. The statement recommends that children consume ≤25 g
(100 calories or ≈6 teaspoons) of added sugars per day and children <2 years of age
should avoid added sugars. Although added sugars most likely can be safely consumed
in low amounts as part of a healthy diet, few children achieve such levels, making this
an important public health target.
Circulation. 2016 Aug 22. [Epub ahead of print]
Read the statement http://tinyurl.com/jqqxz8q.
AHA calls for guidelines on sleep disorders and
CV risk
The AHA has released a scientific statement on the impact of short sleep duration and
sleeping disorders on cardiovascular health, published in Circulation.
Based on a review of available epidemiologic data, the AHA panel concluded that
both short- and long-duration sleep and sleep disorders are associated with adverse
cardiometabolic risk profiles and outcomes, and treating such disorders may provide
clinical benefits, especially for blood pressure. In addition, they found that energy balance
is negatively affected by less sleep; however, the impact of sleep disorder treatment
on obesity remains unclear.
The impact of obstructive sleep apnoea and insomnia on cardiovascular disease and
metabolic disorders is substantial. Population-based studies show that individuals with
obstructive sleep apnoea or insomnia are at significantly greater risk for cardiovascular
and cerebrovascular diseases (e.g., arrhythmias, atherosclerosis, coronary heart disease,
heart failure, hypertension, and stroke) and metabolic disorders (e.g., obesity, type 2
diabetes mellitus, and dyslipidaemia) but use of CPAP does not reduce CV events in
these patients (see above) although there may be symptomatic benefit.
Taking into account recommendations put forth by the American Academy of Sleep
Medicine and the Sleep Research Society, the authors also urged the AHA to directly
address sleep behaviour in a public health campaign. This campaign should include
clear guidelines for adequate sleep, as well as suggestions for including sleep disorder
screening in routine health care and in public health settings.
For future research, the panel recommended including more diverse populations, longerterm follow-up, and accurate and objective measures of sleep behaviour and sleep
architecture. Other sleep disorders such as restless leg syndrome and periodic limb
movement disorder should also be studied to identify a relationship with cardiometabolic risk.
Circulation. 2016 Sep 19. [Epub ahead of print]
Download the statement http://tinyurl.com/hkengyw.
www.researchreview.com.au
NEWS in brief
1 October PBS price reductions
From 1 October, more than 2000 medicines listed on the PBS will incur price
reductions, saving consumers up to $20 per script and taxpayers $900 million over
four years. These savings are the result of the PBS Access and Sustainability Package
reforms which passed Parliament last year.
Search the full list of PBS medicines http://tinyurl.com/j3no4rn.
PBAC recommends sacubitril with valsartan
The PBAC recommended the listing of sacubitril with valsartan for the treatment of
patients with chronic heart failure and a reduced left ventricular ejection fraction
on the basis of acceptable cost effectiveness compared to enalapril. The PBAC
noted the reduced price proposed, the revised PBS expenditure estimates and
considered the proposed two-tier capping levels to be a reasonable basis for the
Risk Sharing Arrangement.
Read more http://tinyurl.com/jc64er9.
TGA statutory advisory committee and specialist
advisor vacancies
The TGA is seeking expressions of interest from professionals with expertise in
relevant scientific and medical fields or appropriate consumer issues to support their
functions as a best practice regulator. They are seeking applications to become core
members on one or more of their statutory advisory committees or act as specialist
expert advisors on specific topics.
Find out more http://tinyurl.com/hpzb7b2.
Subscribe free, visit www.researchreview.com.au and update
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Conferences
Research Review Publications
EuroEcho-Imaging 2016
Acute Coronary Syndrome Research Review
with Professor John French
http://tinyurl.com/gos7bqt
Details: 7-10 December 2016, Leipzig, Germany
Website: http://www.escardio.org/Congresses-&-Events/EuroEcho–Imaging
International Stroke Conference 2017
Details: 22-24 February 2017, Houston, TX, USA
Website: http://tinyurl.com/hn3z54l
American College of Cardiology Scientific Sessions 2017
Atrial Fibrillation Research Review
with Dr Andrei Catanchin
http://tinyurl.com/gpvl4dv
Cardiology Research Review
with Associate Professor John Amerena
http://tinyurl.com/gpxu6bl
Website: https://accscientificsession.acc.org/
Heart Failure Research Review
with Professor Peter Macdonald and Dr John Atherton
http://tinyurl.com/hxxrsv6
Workshops, Webinars and CPD
Interventional Cardiology Research Review
with Associate Professor Craig Juergens
http://tinyurl.com/h3h3wcp
Hypertension: beyond LVH
Product Review - Evolocumab for familial hypercholesterolaemia
http://tinyurl.com/jqnjlhu
Details: 17-19 March 2017, Washington, DC, USA
Details: 1 December 2016, 18:00 to 19:00 CET
Further information available, http://tinyurl.com/h63otmm.
Clinical Review - Xantus, stroke prevention in AF
http://tinyurl.com/jp66gd6
MELBOURNE: Basic bedside ECHO/FCU Workshop
Clinical Review - Atherogenic dyslipidaemia, CV risk and statin therapy
Details: 3-4 December, 2016, The Como, Chapel St, South Yarra, VIC
Further information available, http://tinyurl.com/zkzlelb.
http://tinyurl.com/z2gs8c7
Resuscitation and cardiogenic shock – from drugs
to devices
Details: 5 December 2016, 18:00 to 19:00 CETT
Further information available, http://tinyurl.com/go2nv5m.
Clinical applications and new insights of myocardial
contrast echocardiography
Details: 14 December 2016, 18:00 to 19:00 CET
Further information available, http://tinyurl.com/j3yne3s.
Cardiology
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subscription to receive Cardiology Research Review.
Benefit of CRT optimisation: fiction or reality?
Details: 20 December 2016, 18:00 to 19:00 CET
Further information available, http://tinyurl.com/zvu3d6m.
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