More rigorous investigating needed to improve maternity safety

My Post (16)Coroners could be given powers to investigate stillbirths and help improve maternity safety, Health Secretary Jeremy Hunt has said. Currently, coroners only have jurisdiction to investigate deaths of babies who were alive at birth. The announcement comes after a recent report showed that three-quarters of birth-related deaths or brain injuries might have been avoided (Royal College of Obstetricians and Gynaecologists (RCOG), 2017).

Hunt also revealed that independent investigations are to be offered to families who suffer stillbirth or life-changing injuries to their babies. The Healthcare Safety Investigation Branch will look at 1000 cases each year to find out what went wrong and why, and encourage system improvements that will lead to fewer deaths and injuries in the future.

Health Secretary Jeremy Hunt said:

‘The tragic death or life-changing injury of a baby is something no parent should have to bear, but one thing that can help […] is getting honest answers quickly from an independent investigator. Too many families have been denied this in the past, adding unnecessarily to the pain of their loss.

‘Countless mothers and fathers who have suffered like this say that the most important outcome for them is making sure lessons are learnt so that no-one else has to endure the same heartbreak. These important changes will help us to make that promise in the future.’

Alongside the devastating impact of death or serious injury to mother or child at birth, maternity incidents dominate the NHS’ litigation expenditure. Half of the £1 billion negligence claims the NHS paid out in 2016/17 were in maternity services, largely due to the high value of claims arising from brain injuries at birth (NHS Resolution, 2017).

The Government’s maternity safety plans will also see its ambition to halve the number of stillbirths and deaths among neonates and mothers brought forward from 2030 to 2025 (Department of Health, 2017), saving an estimated 4000 lives.

The rate of premature births is also hoped to fall from 8% to 6% by 2025.

Gill Walton, chief executive officer and general secretary at the Royal College of Midwives (RCM), said:

‘Midwives are in a unique position to help achieve this, as they are the one healthcare professional whom all women will see during their pregnancy and birth, and therefore have a clear role in ensuring care is coordinated, safe and, most importantly, personal.

‘Much has been done already through an array of initiatives to improve the safety of maternity care, and this revised strategy will give everyone involved in maternity care the opportunity to reflect on past successes and focus on key areas where more still needs to be done.’

The RCOG ‘Each Baby Counts’ programme has used local investigations into stillbirths, neonatal deaths and brain injuries to inform national data and identify lessons learned across maternity services. One-quarter of local reports were deemed inadequate by the RCOG, with many NHS institutions listed as not sufficiently investigating incidents and learning from mistakes in their maternity services.

Commenting on the proposals, Professor Lesley Regan, RCOG president, added:

‘We are delighted that the Government has agreed to expand the RCOG’s Each Baby Counts programme, which has been hugely successful in securing the trust of both the midwifery and obstetric communities, with 100% of Trusts involved in providing maternity services engaging in this important work.

‘We are committed to sharing the expertise we have gained […] and our understanding of the complex interplay of factors that lead to stillbirths, neonatal deaths and brain damage during term labour, to work with partners such as NHS Improvement to expand the work and reach of the Maternal and Neonatal Safety Collaborative and the Healthcare Safety Investigation Branch as they undertake their investigations.

‘Expansion of the national strategy to include a focus on preterm birth and brain injury will likewise help provide a more complete picture of maternity safety, strengthening our evidence base to help us deliver ever more effective care’.

References

Department of Health. Safer Maternity Care: The National Maternity Safety Strategy— Progress and Next Steps. London: The Stationery Office; 2017

NHS Resolution. Annual report and accounts 2016/17. London: The Stationery Office; 2017

Royal College of Obstetricians and Gynaecologists. Each Baby Counts: 2015 Summary Report. London: RCOG; 2017

Taken from British Journal of Midwifery, published February 2018.

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Valvular heart disease: new evidence and updated guidelines

My Post (14)Following new evidence in recent years, updated guidelines have been published for the management of valvular heart disease (VHD) by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS). Since the last iteration of the Guidelines, randomised trials on percutaneous interventional techniques and risk-stratification regarding timing of intervention in VHD have made new recommendations necessary. Following new evidence in recent years, updated guidelines have been published for the management of valvular heart disease (VHD) by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS). Since the last iteration of the Guidelines, randomised trials on percutaneous interventional techniques and risk-stratification regarding timing of intervention in VHD have made new recommendations necessary.

ESC Chairperson, Professor Helmut Baumgartner said:

‘Since the 2012 Guidelines, a large amount of new data have accumulated, particularly in the field of catheter interventional treatment of valvular heart disease.’

Valvular heart disease

VHD is a leading cause of morbidity and mortality worldwide, and refers to conditions where the heart’s valves do not work properly (British Heart Foundation (BHF), 2017). This in turn can affect flow of blood to the heart. The estimated prevalence of VHD in developed countries is 2.5% (Lung and Vahanian, 2014). Causes of VHD can be congenital or acquired, with prevalence increasing markedly in those over 65 years of age (Lung and Vahanian, 2017).

Valve stenosis, or narrowing, refers to a valve that does not open fully, which will obstruct or restrict the flow of blood (BHF, 2017). As the heart has to pump harder in order to force the blood past the narrowing, it can put extra strain on the heart (BHF, 2017). By contrast, valve regurgitation, or leaky valve, concerns a valve that is not able to close properly, and so will allow blood to leak backwards (BHF, 2017). Again, this can put strain on the heart, but this is because the heart has to work harder to pump the required volume of blood (BHF, 2017). While many people may not experience any noticeable physical effects, commonly reported symptoms include:

  • Breathlessness
  • Swelling of the ankles and feet
  • Fatigue (BHF, 2017).

Echocardiography

As was discussed in a recent issue of the British Journal of Cardiac Nursing, echocardiography is the gold standard to confirm a diagnosis of VHD, as well as to assess its severity and prognosis (Hall, 2017). It is also key to assess valve morphology and function, as well as to evalu¬ate the feasibility and indications of a specific intervention. Aortic stenosis is the most common VHD, leading to surgery or catheter intervention in Europe and the United States (US). Its growing prevalence is attributable to the ageing population. Echocardiography is used to:

  • Confirm the presence of aortic stenosis
  • Assess the degree of valve calcification, left-ventricle function and wall thickness
  • Detect the presence of other associated valve disease or aortic pathology
  • Provide prognostic information.

Baumgartner said:

‘In aortic stenosis, there have been five randomised clinical trials comparing surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) as well as large-scale registry data.’

The Guidelines strongly recommend early therapy in symptomatic patients with severe aortic stenosis. Exceptions are given to patients with severe comorbidities indicating a survival of less than a year, and patients in whom there are severe comorbidities, or their general condition at an advanced age make it unlikely that the intervention will improve their quality of life or survival.

SAVR and TAVI

SAVR is recommended in patients at low surgical risk, while TAVI is recommended in patients not suitable for surgery. For patients at increased surgical risk, the decision between SAVR and TAVI should be made by the heart team of surgeons and cardiologists, with TAVI being favoured in older patients suitable for transfemoral access.

The Guidelines stress that aortic valve interventions should only be performed in heart valve centres that include both cardiology and cardiac surgery on site. For asymptomatic patients, SAVR is indicated in those with severe aortic stenosis and systolic left-ventricular function not owing to another cause.

Baumgarter noted:

‘There is new evidence regarding predictors of outcome in asymptomatic patients with valvular heart disease and on antithrombotic therapy in this patient population among other innovations. This definitely required an update of management recom¬mendations.’

Baumgartner emphasised that risk score and age are not the only factors affecting the decision to use SAVR or TAVI:

‘The choice of surgical aortic valve replacement or transcatheter aortic valve implantation is not simply based on a risk score or age—the heart team must weigh the risks and benefits of both procedures, particularly in the intermediate risk situation. Discussion should include age, comorbidities, anatomy, and out¬comes of the centre for surgery and transcatheter intervention.’

Risk-stratification

Risk-stratification is an essential means of decision-making in this patient population in order to establish the risk of intervention compared with the expected natural history of VHD. The Guidelines call for the development of better risk-stratification tools, particularly for the decision between surgery and catheter intervention and for the avoidance of futile interventions.

In asymptomatic patients with VHD, studies suggest early surgery may improve outcomes. However, deciding when to intervene is controversial. For example, asymptomatic patients with aortic stenosis, who have pulmonary hypertension have been introduced into the criteria for being selected for surgery, following studies which showed it was a predictor of poor outcomes. But on the other hand, conflicting studies on the prognostic value of exercise echocardiographic parameters indicate the removal of asymptomatic patients with aortic stenosis and mitral regurgitation from the selection criteria.

Recommendations on the use of antithrombotic therapy have also been updated. Antithrombotic management should address effective control of modifiable risk factors for thromboembolism in addition to the prescription of antithrombotic drugs. The Guidelines state that there are now sufficient data to recommend non-vitamin K antagonist oral anticoagulants as an alternative to vitamin K antagonists in patients with atrial fibrillation who have aortic valve disease or mitral regurgitation. They do, however, point out that non-vitamin K antagonist oral anticoagulants remain contraindicated in patients with mechanical valves and in mitral stenosis.

Conclusion

These new Guidelines from ESC and EACTS represent a much-needed update on the management of VHD. They take into consideration new evidence on risk-stratification and the timing of intervention, as well as on percutaneous intervention techniques. They are aimed at both cardiologists and surgeons, and as Professor Volkmar Falk, EACTS Chairperson, highlights, it is important that both specialties follow the recommendations:

‘This is a joint guideline between cardiologists and surgeons. It is absolutely essential that both specialties follow the same recommendations because we are treating the same patients. Decisions in structural valve disease must be taken by a heart team of cardiologists and surgeons.’

References 

Baumgartner H, Falk V, Bax JJ et al. 2017. 2017 ESC/ EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739- 2791. https://doi.org/10.1093/eurheartj/ehx391

British Heart Foundation. Heart valve disease. 2017. http://tinyurl.com/yat7vjzt (accessed 15 December 2017)

Hall A. Suspected mitral valve disease: clinical assessment. Br J Cardiac Nurs. 2017;12(11):538- 546. https://doi.org/10.12968/bjca.2017.12.11.538

Lung B, Vahanian A. Epidemiology of acquired valvular heart disease. Can J Cardiol. 30(9):962-970. https://doi.org/10.1016/j.cjca.2014.03.022

Taken from British Journal of Cardiac Nursing, published December 2017.

Flu vaccination guidance updated for older patients

My Post (13)Public Health England (PHE) has updated its national immunisation guidance following evidence that adjuvanted trivalent influenza vaccines (aTIVs) work better for older patients than other flu jabs (PHE, 2017a).

The Green Book (PHE, 2017a), which features the latest information on vaccines and vaccination procedures in the UK, has been amended after the Joint Committee on Vaccination and Immunisation (JCVI) recommended aTIV, FLUAD®, for the 2018–19 flu season in its October meeting.

The Committee agreed that use of aTIVs in those aged 65 years and over is ‘more effective’ than current nonadjuvanted vaccines and ‘highly costeffective’ (JCVI, 2017).

Dr George Kassianos, national immunisation clinical lead for the Royal College of General Practitioners, said:

‘I very much welcome this guidance by the JCVI. Year on year, it is becoming more and more evident that conventional non-adjuvanted influenza vaccines do not provide sufficient protection for our older patients, particularly in years dominated by the influenza A(H3N2) virus, which dominated the flu season last year and the year before. Use of this adjuvanted vaccine is expected to result in fewer infections, fewer GP consultations and hospital admissions, and a significantly reduced winter burden on the NHS.

‘On the basis of the recent JCVI Meeting minutes outlining the clinical and cost-effectiveness evidence in elderly patients, GP practices are now able to seriously consider the adjuvanted flu vaccine for their patients aged 65 years and over for the 2018–19 flu season.’

Sharon Graham, senior lecturer in nursing at Staffordshire University and a former practice nurse, said:

‘In primary care we need to ensure that we can offer the most effective prevention against influenza to our patients aged over 65 years. This JCVI guidance will, I hope, help vaccinating health professionals to make the best choice of flu vaccine for next year’s season.’

Reasons behind the decision

Last year, PHE (2017b) declared conventional non-adjuvanted influenza vaccines provided little or no protection for over 65s in the 2016–17 flu season in the UK. This was recognised by the JCVI, who acknowledged ‘low influenza effectiveness’ in those aged 65–74 years throughout seasons affected by the A(H3N2) flu strain, and ‘non-significant vaccine effectiveness’ for all types of influenza in the over 75s (JCVI, 2017).

By comparison, the JCVI said aTIVs have ‘better immunogenicity and effectiveness’ in the elderly. While vaccine effectiveness decreases with increasing age and immunosenescence, a study from British Columbia used multivariate analysis to show vaccine effectiveness of around 60% in the elderly for aTIVs (Van Buynder et al, 2013). Almost half of the patients enrolled were aged over 85 years. Conversely, non-adjuvanted trivalent influenza vaccine was deemed ineffective. This is not uncommon, ineffectiveness of non-adjuvanted trivalent influenza vaccines in this patient population has been previously reported (Treanor et al, 2012).

A systematic review and meta-analysis of trivalent inactivated vaccine adjuvanted with MF59 found it was effective in reducing several influenza-related outcomes among the elderly, especially hospitalisations due to influenza-related complications (Domnich et al, 2017). It was also reported to be superior to non-adjuvanted vaccines.

Evidence presented at the European Scientific Working group on Influenza (ESWI) meeting in Riga, Latvia last September, revealed 1700 flu-related deaths could be prevented in those aged over 65 years who switched to an aTIV (Nguyen et al, 2017). Additionally, estimations by the researchers show as many as 195 600 cases of flu could be avoided. According to the researchers, this could reduce the number of GP visits by 21,800.

Research consultant and lead author of the study, Dr Van Hung Nguyen, said:

‘The model demonstrated that the adjuvanted vaccine had an incremental cost-effectiveness ratio of £3540 per quality-adjusted life year if used preferentially in those aged 65 years of age and over in the UK.

‘This is well within, and actually considerably below, the National Institute of Health and Clinical [sic] Excellence’s guideline threshold of £20 000 per quality-adjusted life year for medicines.’

Dr Marco Barbieri, from the Centre for Health Economics at the University of York, said:

‘Health economic analyses consistently show that more effective flu vaccines are very good value in older patients.

‘They reduce the number of GP consultations, A&E visits and episodes of serious illness and, of course, they help older people to remain healthy and independent.’ Commenting on the research presented at the ESWI, he said: ‘These data suggest that use of an adjuvanted influenza vaccine is a cost-effective option for the NHS immunisation programme.’

Mathematical modelling by PHE indicates the adjuvanted vaccine would be highly cost-effective in both the 65–74 and 75 year and over age groups, even under conservative estimates (PHE, 2017a).

Marketing authorisation of FLUAD®

The aTIV FLUAD® gained marketing authorisation in the UK in August 2017. It has been licensed in some countries in Europe since 1997 and in the US since 2015. According to its manufacturer, Seqirus, aTIV has superior seroconversion rates (the time period during which a specific antibody develops and becomes detectable in the blood) in the elderly, and superior geometric mean titres (the central number in a geometric progression of the concentration of a solution as determined by titration) in clinical risk groups against all three influenza vaccine types, compared to non-adjuvanted inactivated influenza vaccines.

Dr Russell Basser MD, chief medical officer of Seqirus, said:

‘We understand the devastating human impact of influenza infection in adults aged 65 years and older, the substantial societal impact of influenza, as well as the cost to the NHS in preventable GP appointments and preventable hospitalisations.

‘We believe that our strong and robust data on FLUAD®’s clinical efficacy, real-world effectiveness, and well-established safety profile, built up over 20 years of use, demonstrates convincingly that this adjuvanted influenza vaccine has clear advantages for adults aged 65 years and over when compared to existing conventional non-adjuvanted vaccines. We consider that FLUAD® can make a major contribution in reducing the burden of influenza on the health services, locally, regionally, and nationally.’

The company has recently announced a major investment in its Liverpool influenza vaccine manufacturing plant. This will allow-end-to-end manufacture of vaccines at the UK site, meeting growing demand and strengthening reliability of supply of FLUAD® for UK and global markets.

References

Domnich A, Arata L, Amicizia D, et al. 2017. Effectiveness of MF59-adjuvanted seasonal influenza vaccine in the elderly: A systematic review and meta-analysis. Vaccine. 35(4):513- 520

Joint Committee on Vaccination and Immunisation. 2017. Draft minute of the meeting on 4th October 2017. London: JCVI

Nguyen VH, Kelly C, Mansi JA. 2017. UK health economic model demonstrates use of adjuvanted trivalent seasonal influenza vaccine in older adults to be highly cost-effective [abstract]. Presented at the Sixth ESWI Influenza Conference, Riga, Latvia, 2017 September 10–13. http://eswi.org/ influenzaconferences/wp-content/uploads/ sites/13/2017/09/Nguyen_Kelly_Mansi.pdf (accessed 2 February 2018)

Public Health England. 2017a. Influenza: The Green Book. London: The Stationery Office

Public Health England. 2017b. Influenza vaccine effectiveness (VE) in adults and children in primary care in the United Kingdom (UK): provisional end-of- season results 2016-17. London: The Stationery Office

Treanor JJ, Talbot HK, Ohmit SE, et al. 2012. Effectiveness of seasonal influenza vaccines in the United States during a season with circulation of all three vaccine strains. Clin Infect Dis. 55(7):951-9

Van Buynder PG, Konrad S, Van Buynder JL, et al. 2013. The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly. Vaccine. 31(51):6122-8

Taken from Nurse Prescribing, published January 2018.

The use of anti-inflammatory canakinumab could reduce risk of heart attack

My Post (9)Results from a recent trial of the anti-inflammatory drug canakinumab have revealed it could help reduce risk of heart attack and mark the biggest breakthrough in cardiovascular treatment since statins.

The Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS) looked at people who previously suffered from a heart attack and tested whether administration of canakinumab  could reduce inflammation and reduce risk of future cardiovascular events (Ridker et al. 2017).

Speaking at the European Society of Cardiology Congress in Barcelona, where the findings were presented, Professor Paul Ridker of Harvard Medical School, said:

‘These findings represent the end game of more than two decades of research, stemming from a critical observation: half of heart attacks occur in people who do not have high cholesterol. For the first time, we’ve been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk.’

According to Ridker this has far-reaching implications:

‘It tells us that by leveraging an entirely new way to treat patients—targeting inflammation—we may be able to significantly improve outcomes for certain very high-risk populations, he said.’

Outlining the trial

The trial was conducted by researchers from a wide range of international organisations, including the Center for Cardiovascular Disease Prevention and the Cardiovascular Division at Brigham and Women’s Hospital, Harvard Medical School, Boston; Novartis in East Hanover, NJ, and Basel, Switzerland; the Federal University of São Paulo; Universitätsmedizin Berlin; and the Academic Medical Center of the University of Amsterdam.

Participating centres in 39 countries enrolled patients who had a history of heart attack and an elevated blood level of high-sensitivity C-reactive protein. It is believed raised levels of this protein may lead to further heart attacks.

Participants received doses of 50 mg, 150 mg or 300 mg of either canakinumab or placebo. These were administered subcutaneously every 3 months. Patients were excluded from the study if they had any of the following:

  • History of chronic or recurrent infection
  • Previous cancer other than basal-cell skin carcinoma
  • Suspected or known immunocompromised state
  • History or high risk of tuberculosis or disease related to the human immunodeficiency virus
  • Ongoing use of other systemic anti-inflammatory treatments.

The 10,016 participants recruited to the study were then monitored over the next 4 years. The researchers predominantly wanted to see whether participants suffered from additional heart attacks or stroke, or died from cardiovascular disease during this time.

In total, 1,490 participants experienced the main combined outcome of heart attack, stroke, or death from cardiovascular disease within the 4 years monitored. Within the placebo group, there was an average of 4.5 of these main events per year per 100 people. The treatment groups revealed there was no statistically significant difference between the 50 mg group, compared with placebo. The 150 mg group indicated a 15% lower risk compared with placebo (3.86 events per year per 100 people), while the 300 mg group showed a 14% lower risk (3.90 events per year per 100 people). The researchers concluded that 150 mg of canakinumab taken every 3 months led to a significant reduction in recurrent cardiovascular events compared with placebo.

Considering the results

The potential implications for medicine of this study are considerable, with mainstream media hailing it as a remarkable breakthrough (BBC 2017) and calling canakinumab a ‘new wonder drug’ (Donnelly 2017). For a drug traditionally used in the treatment of arthritis it certainly makes for great headlines. However, there are a number of considerations that must be taken into account before the drug is hailed as the medical advancement some have claimed.

Highlighting limitations

As mentioned, the study only looked at patients who have already had heart attacks. This is something many of the media’s headlines failed to convey (NHS Choices 2017). The effect of the drug, therefore, on reducing inflammation in people who have not had a heart attack, remains unknown. Additionally, many newspapers claimed that canakinumab was ‘better than statins’, but this is unhelpful as it does not reflect the nature of the study. It is thought that if canakinumab was licensed as a preventative medication, it is likely it would be given to people who wouldn’t benefit from taking statins (NHS Choices 2017).

Most importantly, before any changes can be made to the current licensing of the drug, further research is needed to confirm both the beneficial effects and the optimal dose. This was highlighted in an editorial by Dr Robert A Harrington of Stanford University published alongside the study (Harrington 2017), who called the clinical benefit of canakinumab ‘modest’. He argues that ‘a better understanding of the risks and benefits of this form of therapy is needed’ and raised concerns about the fatal infections encountered in the trial and sepsis. He also cites concern over the cost of using canakinumab in patients with a previous heart attack.

Cost matters

Canakinumab is currently licensed in the United States to treat systemic-onset juvenile rheumatoid arthritis at a cost of approximately $200,000 per year (Harrington 2017). While this pricing may be suitable for rare diseases, it is unsuitable for common indications such as coronary artery disease. Given the study was funded by Novartis, the manufacturer of the drug, substantial evidence of its benefit is needed before wider licensing of the drug can be considered.

References

BBC News. Anti-inflammatory drug ‘cuts heart attack risk’ [Internet]. London: BBC News; 2017 Aug 28 [cited 2017 Sep 7]. Available from http://www.bbc.co.uk/news/health-41071954

Donnelly L. New wonder drug hailed as biggest breakthrough in fight against heart attacks and cancer [Internet]. London: The Telegraph; 2017 Aug 27 [cited 2017 Sep 7]. Available from http://www.telegraph.co.uk/science/2017/08/27/new-wonder-drug-hailed-biggest-breakthrough-fight-against-heart/

Harrington RA. Targeting inflammation in coronary artery disease. N Eng J Med [Internet]. 2017 Aug 27 [cited 2017 Sep 6]. Available from http://www.nejm.org/doi/full/10.1056/NEJMe1709904

Ridker PM, Everett BM, Thuren T et al. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med [Internet]. 2017 Aug 27 [cited 2017 Sep 6]. Available from http://www.nejm.org/doi/full/10.1056/NEJMoa1707914?query=featured_home&#t=articleTop

NHS Choices. Anti-inflammatory drug may help prevent heart attacks [Internet]. 2017 Aug 30 [cited 2017 Sep 6]. Available from http://www.nhs.uk/news/2017/08August/Pages/Anti-inflammatory-drug-may-help-prevent-heart-attacks.aspx

Taken from British Journal of Cardiac Nursing, published December 2017.

First ESC Focused Update on dual antiplatelet therapy in CHD

My Post (8)The European Society of Cardiology (ESC) has published its first Focused Update on the use of dual antiplatelet therapy (DAPT) in coronary heart disease (CHD) (Valgimigli et al, 2017). Produced in collaboration with the European Society for Cardio-Thoracic Surgery (EACTS), the document addresses recommendations on a medical treatment that has seen conflicting advice over the years.

Conflicting evidence

According to Dr Marco Valgimigli, Chairperson of the ESC/EACTS Task Force, the conflicting evidence surrounding DAPT has resulted in many people calling it a controversial topic:

‘This has led to a great deal of uncertainty in the medical community, particularly regarding the optimal duration of DAPT after coronary stenting,’ he said.

A survey initiated by the European Association of Percutaneous Cardiovascular Interventions sought opinions from the medical community on the evidence relating to DAPT duration after coronary stenting (Valgimigli et al, 2015). It revealed considerable uncertainty over optimal duration of DAPT after stenting and therefore called for updated recommendations for practising physicians to guide treatment decisions.

Neglected populations

Alongside conflicting results in the published literature on DAPT, there is also limited evidence on various patient subsets—such as elderly patients—who may have a greater bleeding risk. Here, the benefits and risks of DAPT may be different to those seen in more selected patient cohorts included in randomised controlled trials. The aim of this Focused Update therefore is to address the current recommendations on DAPT in patients with CHD.

Dual antiplatelet therapy

Being one of the most intensively investigated treatments in cardiovascular medicine, there have been 35 randomised clinical trials of DAPT, including more than 225 000 patients. The first randomised clinical trial to establish the superiority of DAPT over anticoagulant therapy among patients undergoing percutaneous coronary intervention was published in 1996.

Platelets are small particles in the blood that can clump together to form clots; these can go on to cause myocardial infarction or the occlusion of a coronary stent. Antiplatelet agents are a class of drugs that are used to stop platelets from forming these clots. The use of two types of antiplatelet agents to prevent blood clotting is known as DAPT (American Heart Association, 2017).

The number of patients requiring dual antiplatelet therapy consisting of the combination of aspirin and an oral inhibitor of the platelet P2Y12 receptor for adenosine 5’-diphosphate has increased over time. In Europe, it is believed that around 1 400 000 patients per year may have an indication for DAPT after coronary intervention, and 2 200 000 after myocardial infarction.

P2Y12 inhibitors range from safer drugs, such as ticlopidine or clopidogrel, to the more potent and predictable, such as ticagrelor or prasugrel. The decision on when to initiate a P2Y12 inhibitor depends on both the specific drug and the disease.

DAPT reduces the risk of stent thrombosis from occurrences ranging from acute to late events. It also reduces the rate of spontaneous myocardial infarction after percutaneous coronary intervention and myocardial infarction.

For patients with stable CHD treated with percutaneous coronary intervention, the default P2Y12 inhibitor is considered to be clopidogrel. It is also commonly the default drug for patients with indication to concomitant oral anticoagulation, and in patients with acute coronary syndromes in whom ticagrelor or prasugrel are contraindicated. Ticagrelor or prasugrel is recommended in people with acute coronary syndromes unless drug-specific contraindications exist.

Recommendations for DAPT

A Task Force made up of selected medical experts carried out a comprehensive review of the published evidence for management of CHD according to ESC Committee for Practice Guidelines policy, and approved by the EACTS. A critical evaluation of diagnostic and therapeutic procedures took place, including assessment of the risk–benefit ratio. The level of evidence and the strength of the recommendation of particular management options were then weighed and graded according to predefined scales.

The Focused Update recommends a default DAPT duration of 12 months for patients with acute coronary syndrome. This is irrespective of revascularisation therapy, whether through medical therapy, percutaneous coronary intervention or coronary artery bypass surgery. In patients with high bleeding risk, 6 months of DAPT should be considered. Therapy over 12 months may be considered in patients with acute coronary syndrome who have tolerated DAPT without a bleeding complication.

The Task Force felt that the need for a short DAPT regimen should no longer justify the use of bare metal stents instead of newer generation drug-eluting stents. An assessment of the individual patient’s ischaemic risks versus bleeding risks should be used to establish duration of DAPT rather than the type of stent used.

For patients with CHD being treated with percutaneous coronary intervention who are believed to be stable, the duration of DAPT should be 1–6 months, depending on the bleeding risk. This is irrespective of the type of metallic stent implanted. For patients whose ischaemic risk is thought to be greater than the risk of bleeding, the Focused Update recommends a longer DAPT duration. The Task Force felt that there were insufficient data to recommend DAPT in patients with stable CHD treated with coronary artery bypass graft surgery.

The most controversial issue cited was the need for a prolonged DAPT regimen (anything over 12 months) in patients with acute coronary syndrome treated with percutaneous coronary intervention. This is owing to concern over ensuring benefits while diminishing risks.

‘This is a setting in which one needs to think twice about how to maximise the benefits over the risks,’ said Dr Valgimigli. ‘The most novel and important message here is that DAPT is a regimen to treat a patient, not the previously implanted stent. This is crucial and the community needs to adapt to this new treatment paradigm.’

Differing types and durations of DAPT therapy have not been seen as necessary for male and female patients, instead calling for a similar approach to care. Additionally, no difference in therapy is required for patients with diabetes.

Dr Valgimigli said:

‘The Task Force advocates a personalised medicine approach where each treatment and its duration is individualised as much as possible. The document highlights who should, and should not, receive long-term treatment, while at the same time outlining how to maximise the expected benefits over the risks.’

Conclusion

This year marks the 21st anniversary of the first randomised clinical trial that established the superiority of DAPT over anticoagulant therapy among patients undergoing percutaneous coronary intervention. However, differing advice on optimal duration of DAPT after coronary stenting makes this Focused Update long overdue—though it should go some way to guiding treatment decisions. BJCN

References

American Heart Association. 2017. What is Dual Antiplatelet Therapy (DAPT) [Internet]? Available from http://tinyurl.com/yajb9wmx

Valgimigli M, Costa F, Byrne R, Haude M, Baumbach A, Windecker S. Dual antiplatelet therapy duration after coronary stenting in clinical practice: results of an EAPCI survey. EuroIntervention. 2015;11(1):68-74. https://doi.org/10.4244/EIJV11I1A11

Valgimigli M, Bueno H, Byrne RA et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J; 2017. https://doi.org/10.1093/eurheartj/ehx419. [Epub ahead of print]

Taken from British Journal of Cardiac Nursing, published December 2017.

New cross-specialty guidelines on peripheral arterial diseases

My Post (3)New guidelines on peripheral arterial diseases (PADs) have been jointly published by the European Society of Cardiology (ESC) and European Society for Vascular Surgery (ESVS) (Aboyans et al, 2017). These guidelines mark the first time that ESC recommendations on PADs have been developed as a collaborative effort between cardiologists and vascular surgeons. Management of hypertension is achieved through a combination of medication regimen and lifestyle changes. However, the results of the studies examining the level of adherence among hypertensives indicated that the target was not achieved. Saarti et al (2015) found that the level of adherence for medication regimen is 29.1%.

What are PADs?

Over 40 million people in Europe are affected by PADs (Fowkes et al, 2013)—a term used to describe all arterial diseases except those affecting the coronary arteries and aorta. Peripheral arterial diseases include atherosclerotic disease of the extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries.

Multidisciplinary approach

The Task Force was led by ESC Chairperson, Professor Victor Aboyans, and ESVS Co-Chairperson, Professor Jean-Baptiste Ricco. Building on recommendations laid out in the 2011 ESC guidelines (Tendera et al, 2011), it was felt by both societies that a multidisciplinary approach for the management of patients was needed.

Collaboration between specialisms has meant that there is now a single European document on the management of patients with peripheral arterial diseases. Professor Aboyans said:

‘Working together has enabled us to be comprehensive in our recommendations.’

Speaking to theheart.org | Medscape Cardiology, Aboyans stressed the need for multidisciplinary management of patients with PADs. Given the different areas of the body affected by PADs, it is necessary that other specialties beyond cardiovascular medicine and surgery are involved. An example of this would be in the case of carotid disease.

Aboyans said:

‘Talking about the management of carotid disease, we also need the input of a neurologist; the same for nephrologists or gastroenterologists.

‘We cannot think any more about a patient at a consultation and the surgeon says: “Ok, I’ll operate on you, I’ll fix the problem, and then it’s over,” because this is just the beginning of another story, which is the long-term management and reassessment of these patients, as with coronary risk,’ he added.

Complications of PADs

According to Aboyans, patients suffering from PADs often have difficulty walking— particularly those with arterial disease of the extremities. This is owing to insufficient blood flow to the lower limbs brought on by stenoses or occlusions of the peripheral arteries. This can pose a complication, as many patients may be unaware that they have a more serious condition. This is because they do not suffer from common symptoms of circulatory problems, such as shortness of breath, due to being sedentary.

‘They may have heart failure, but they don’t really complain about shortness of breath, just because they don’t walk any more,’ he said.

The benefit of cross-specialty assessment is therefore apparent. This ensures that all possible areas for concern are taken into consideration.

‘It is really mandatory that, if a patient comes to one specialty, to also have the call with other specialties, and this complementary approach is of benefit to the patients,’ he said.

‘It is one thing to fix the local-territory issue, the other is the cardiovascular health of these patients and, in the end, the prognosis.’

Changes to the guidelines

In putting together these guidelines, a comprehensive review of the published evidence was carried out. The Task Force was made up of experts in the field selected by the ESC. It included representation from the ESVS and European Stroke Organisation (ESO). This ensured all professionals responsible for the medical care of patients with this pathology were involved. The Task Force considered published articles on management of a given condition according to the ESC Committee for Practice Guidelines policy. These were then approved by the ESVS and ESO. A critical evaluation of diagnostic and therapeutic procedures for PADs was carried out, including an assessment of the risk– benefit ratio.

A number of changes have been made since the 2011 guidelines were published and new recommendations set out for the management of PADs. A chapter devoted to the use of antithrombotic drugs has been introduced for the first time. There is also a new chapter on the management of other cardiac conditions frequently encountered in patients with PADs. These include heart failure, atrial fibrillation and valvular heart disease. The chapter on mesenteric artery disease has been entirely revisited. Ricco said:

‘We have updated this chapter with new data showing the interest of endovascular surgery in these often frail patients.’

The Task Force has recommended revascularisation of asymptomatic carotid stenosis only in patients at high risk of stroke. This is despite no new major trials on the management of asymptomatic carotid artery disease since the last guidelines were published. However, there are new data on the long-term risk of stroke in patients with asymptomatic carotid stenosis.

‘The previous guidelines recommended revascularisation for all patients with asymptomatic carotid stenosis, so this is an important change,’ said Aboyans.

‘Trials showing the benefits of revascularisation compared to best medical therapy alone were performed in the 1990s but stroke rates in all patients with asymptomatic carotid stenosis have decreased since then— regardless of the type of treatment— so the applicability of those trial results in the current management of these patients is more questionable.’

There is now a strong recommendation against systematic revascularisation of renal stenosis in patients with renal artery disease. This is following the publication of several trials.

WIfI classification

A new classification system (WIfI) has been proposed as the initial assessment of all patients with ischaemic rest pain or wounds. The system takes into account the three main factors that contribute to the risk of limb amputation, which are:

  • Wound
  • Ischaemia
  • foot Infection.

Professor Ricco emphasised the impor¬tance of the new WIfI classification in lower extremity artery disease.

Guidelines into practice

The new guidelines encourage health professionals to consider its recommendations when exercising their clinical judgment, as well as in the determination and the implementation of preventive, diagnostic or therapeutic medical strategies. However, they make clear that they do not override the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient’s health condition. This should be done in consultation with that patient or the patient’s caregiver where appropriate and/or necessary.

References

Aboyans V, Ricco JB, Bartelink MEL et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extrem¬ity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2017; [Epub ahead of print]. https://doi.org/10.1093/eurheartj/ehx095

Fowkes FG, Rudan D, Rudan I et al. Comparison of global estimates of prevalence and risk fac¬tors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382(9901):1329–1340. https://doi.org/10.1016/S0140-6736(13)61249-0

Tendera M, Aboyans V, Bartelink ML et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32(22):2851–2906. https://doi.org/10.1093/eurheartj/ehr211

Taken from British Journal of Cardiac Nursing, published November 2017.

Leading support for those with mental health issues and learning disabilities

Adobe Spark (3)The Chief Nursing Officer has told mental health and learning disability nurses they need to ‘step up and take the lead’ in delivering ambitions set out by NHS England for mental health and learning disability services. Speaking at the NHS Expo in Manchester, Professor Jane Cummings said:

‘Nurses are creative, they’re innovative, they’re leaders, and they can really drive that change that we all want to see.’

Cummings outlined the important leadership role that mental health nurses have in delivering the Five Year Forward View for Mental Health (NHS England, 2016), and that learning disability nurses have in delivering the Learning Disability Transforming Care programme:

‘I think that nurses and midwives should be at the driving edge of change and improvement. I think there is a wealth of knowledge, a wealth of experience. And there’s a huge amount of skill set that nurses can have to really drive the change that everyone wants to see.’

Five Year Forward View for Mental Health

The Five Year Forward View for Mental Health was launched in February 2016 in an attempt to improve mental health outcomes across the health and care system, and includes an additional £1.4 billion of investment in mental health services by 2020/21. The funding will go towards the creation of 21 000 new posts, including 4600 nurses working in crisis care settings and 1200 nurses and midwives in child and adolescent mental health services. Other policies include giving an extra 1 million patients access to mental health services at an earlier stage, round-the-clock services, and the integration of mental and physical health services for the first time.

Cummings said that improvements to mental health services is one of the ‘national priorities’ for NHS England, emphasising how there is a massive amount of work going on around mental health, with a real focus on improving access to services:

‘We are particularly focusing, through the Maternity Transformation Programme, on perinatal health. As part of that we have a big workstream looking at perinatal mental health and supporting women to cope with any problems they get post birth.’

According to Claire Murdoch, National Director for Mental Health, the priorities of the Five Year Forward View for Mental Health are built on a core set of pre-existing services that are transforming and developing to create an ‘absolute, quiet and steady revolution in mental health care.’

Murdoch echoed Cummings by also calling mental health nurses to ‘step forward and step up.’ However, in order to do this she said nurses need to become vocal about their skills, and experts in co-production and working alongside mental health service users in their own care. As part of plans laid out in the Forward View, Murdoch said the NHS will see an additional 1 million extra patients. This will include 70 000 more children and young people, who will have increased access to specialist eating disorder services within the community.

Murdoch explained how further evidence-based interventions, made earlier in the pathway of illness or distress, will ‘fundamentally change the outcomes for people’s lives so that we don’t create unwittingly long-term patients for the future.’ She added that there will be more tier 4 specialist beds for children and young people suffering from serious mental health problems, particularly in London and the south, where occupancy often outstrips demand. Additional improvements in respite care, crisis houses and home treatment teams were also assured.

According to Murdoch, nurses are leading community mental health teams for children and young people. Working alongside psychologists and doctors, she explained that they are playing a key role in the management of conditions such as eating disorders. Community eating disorders services for young people largely did not exist until last year, and Murdoch commended the mental health nurses, who she said were not only leading those teams, but also breaking new ground in having to work alongside families, the young people themselves, and deliver evidence-based care in completely different settings.

One of the greatest concerns Murdoch highlighted was the current pressure on the mental health crisis care pathway. In particular she stressed the need to prevent beds overspilling into the private sector and long waits in accident and emergency (A&E) departments. However, she announced that nurses have led the way in redesigning the care pathway through the ‘development of intensive current treatment teams’ and the ‘establishment  of the psychiatric liaison teams in A&E and acute hospitals more widely.’

She believes nurses will play a ‘fundamental part’ in ‘bringing an end to inappropriate out-of-area placements.’ An example she cited was in Birmingham, where nurses are working alongside the police to dramatically reduce the use of Section 136 of the Mental Health Act, which allows the police to take a person who appears to be suffering from a mental disorder to a place of safety. She said this has enabled better outcomes for people in distress.

Though she raised concerns that large numbers of nurses are leaving the profession and that recruitment will be an additional challenge, she said ‘there has never been a better time to be a mental health nurse.’ However, she urged mental health nurses to be vocal about their skills, whether that is their skill of assessment or complex working in networks of care.

‘We need to become the experts in co-production and working alongside mental health service users in their own care. We need an effort to come up with a care plan that hasn’t been produced at least in partnership, even at times of great crisis. We need to become the experts in that space. Housing, debt, employment, the physical health care, these are the domains of mental health nurses.’

Transforming care for people with learning disabilities

Alongside improvements to mental health services, a national plan to develop community services and close inpatient facilities for people with learning disabilities has meant better care for this patient group. The focus of the Learning Disability Transforming Care programme is on giving people with learning disabilities the opportunity to live in the setting they think is home. It also aims to stop overmedication and improve access to annual health checks.

Vicki Stobbart, a disability nurse and Executive Director of Nursing and Quality for Guildford and Waverley CCG, said that while learning disability nurses may not be as high profile as other areas of nursing, their impact and value in supporting people with learning disabilities should not be underestimated.

‘Learning disability nurses are the only professional group specifically trained to work with people with learning disabilities,’ said Stobbart. ‘This level of preparation, currently provided at degree level, alongside the breadth, competence and knowledge they develop, makes them a unique and critical component on the delivery of comprehensive skills.’

Alongside presentations on the leadership role of mental health and learning disability nurses, Professor Cummings led a panel discussion with healthcare staff and service users on how nurses can play a key role in the care of mental health and learning disability patients. Organised by NHS England, the Health and Care Innovation Expo saw over 5000 delegates learn about developments and innovations taking place across health and social care.

Looking at the progress made since the launch of the Five Year Forward View, it identified a number of key areas of priority, including urgent and emergency care, primary care and general practice, cancer, and mental health.

Taken from British Journal of Mental Health Nursing, published November 2017.