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.

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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.

Experts call on NICE to review TAVI guidelines for aortic stenosis

Adobe Spark (5)Leading experts have urged the National Institute for Health and Care Excellence (NICE) to review its guidelines on the use of transcatheter aortic valve implantation (TAVI) for aortic stenosis to include intermediate-risk patients.

Speaking at a plenary session of the PCR–London Valves conference, experts delivered a focused summary of the new European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) guidelines on valvular heart disease (Baumgartner et al, 2017). This included details of how the guidelines have been updated to lower the threshold for intervention with TAVI to patients at intermediate-risk of surgery. Previous guidance stipulated that TAVI should only be considered for those patients with symptomatic aortic stenosis at high risk of surgery (Vahanian et al, 2017).

Dr Helmut Baumgartner, chair of the taskforce for the European Guidelines, has said the new recommendations mark a profound change to the 2012 guidelines. This is largely owing to the number of randomised controlled trials comparing surgical and transcatheter treatments in the last 5 years. These have looked at intermediate- and low-risk patients treat-ed, not just elderly high-risk patients (Leon et al, 2016). He said:

‘There is much controversy right now over who should undergo surgery and who should undergo per-cutaneous valve implantation, and this is an area in which we have profound changes in what we recommend and have consequently dedicated a large part of the guide-lines to the choice of intervention in symptomatic aortic stenosis.

‘We are now recommending that surgical valve replacement remains the first line of therapy in low-risk patients, and low risk should not only be defined by risk scores, because these have several limitations, but by the lack of frailty and other specific risks for surgery not included in risk scores such as porcelain aorta or sequelae of chest radiation. There are numerous issues that need to be considered before we speak of low-risk patients.’

How NICE guidelines differ

An updated version of NICE’s Interventional Procedures Guidelines (IPG), which considers whether procedures are safe and work well enough for wider use in the NHS, was published a month before the ESC/EACTS guidelines (NICE, 2017). At first glance, it appears not to have revised the indication for TAVI beyond the high-risk patient population, unlike the European guidelines. According to a press advisory from Edwards Lifesciences (2017), NICE said additional trials are needed before TAVI could be considered in patients at inter-mediate risk for surgery:

‘Based on current data, TAVI is recommended in patients with severe symptomatic aortic stenosis who are, according to the heart team considered unsuitable for conventional surgery because of severe comorbidities.

Should NICE guidelines change?

Approximately 1.5 million people in the UK over 65 years suffer from heart valve disease with aortic stenosis (d’Arcy et al, 2016). This represents 2–7% of those over 65 years (Spaccarotella et al, 2011) and 13% of those over 75 years (Nkomo et al, 2006). For many cardiologists, it is believed that expanding the use of TAVI would enable more patients in the UK to have access to the minimally-invasive therapy, rather than have to undergo open-heart surgery.

According to Dr Bernard Prendergast, Consultant Cardiologist at Guy’s and St Thomas Hospital and Course Director/Board Member of PCR London Valves, recent evidence increasingly supports the use of TAVI for intermediate-risk patients. Speaking at the PCR–London Valves conference, he said:

‘There is growing evidence in favour of the use of TAVI for the treatment of intermediate-risk patients with severe symptomatic aortic stenosis. This expanded indication in the ESC/EACTS guidelines paves the way for more patients to receive a true alter-native to open-heart surgery.’

As a result, Prendergast emphasised why NICE should update their guidelines to be in line with the rest of Europe:

‘We are calling for NICE to review their recent IPG in light of these new ESC guidelines in order to address current inequalities in treatment across the UK, and between the UK and most of Europe.’

There is concern that the NICE guidelines leave UK patients at a disadvantage in the treatment of aortic stenosis com-pared with the rest of Europe. Currently, the UK performs far fewer aortic valve implantations than Germany, France, Norway and Sweden.

Clearing up misconceptions

It was hoped in light of the new ESC/EACTS guidelines that this disadvantage would change. However, when NICE was asked if they will be looking into revising their guidelines to recommend TAVI for aortic stenosis for intermediate-risk patients for the writing of this article, they clarified that their guidelines have actually already been extended beyond the high-risk population.

In response to the expert calls for revision and the critical comments quoted in this article, a spokesperson from NICE requested a correction, stating:

‘The new guidance gives standard arrangements for TAVI and does not any longer differentiate between different risk groups. The decision as to which patients are suitable is left to risk assessment by clinicians and the MDT [multidisciplinary team].’

References

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

d’Arcy JL, Coffey S, Loudon MA et al. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: The OxVALVE Population Cohort Study. Eur Heart J. 2016;37(47):3515-3522.

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