Vascular Risk Management in Wales

Transcription

1 Vascular Risk Management in Wales A report from the Vascular Project Group March 2010 Professor Julian Halcox Professor of Cardiology University of Wales Cardiff 1

2 Contents Page CHAIR S INTRODUCTION 4 EXECUTIVE REPORT 1. Background 5 2. Recommendations for implementation of a systematic CVD prevention strategy 2.1 Overview of main issues Recommendation for review of current service provision Recommendations for service model development Identification of those at risk Management of those with and at risk of developing CVD Further practical and logistical considerations Proposed Service Model Flow-chart Conclusions 15 SUPPORTING DOCUMENTATION 1. Background 1 2. Supporting Statements 3 3 Identification What is Vascular Disease? Vascular Risk Assessment What is vascular risk assessment? How should vascular risk assessment be performed? : Recommendations Who should conduct vascular risk assessment? Recommendations Where should vascular risk assessment be undertaken? Recommendations 7 4. Management of CVD Risk Practical considerations Management strategies for prevention of CVD; Recommendations Public Engagement Recommendations Current complexities and limitations: Principles of vascular assessment 14 7 Economic case for vascular risk assessment policy 15 2

3 APPENDICES Appendix 1: Terms of Reference Vascular Project Group 16 Chair and membership Appendix 2: Cardiovascular Disease Symptom Triage Algorithm 19 Appendix 3: ESC Relative Risk Tables 20 Appendix 4: Theories of Behaviour Change - Carolyn Lester 21 3

4 Chair s introduction Cardiovascular Disease (CVD) is one of the major public health challenges facing Wales in the 21 st century. The majority of the morbidity and mortality from CVD is a consequence of degenerative arterial disease (atherosclerosis and arteriosclerosis) which causes heart attack, stroke and heart failure. Importantly, a marked social gradient in the burden of cardiovascular disease exists in Wales, with individuals from more socially disadvantaged backgrounds disproportionally affected. Arterial disease is caused by a number of well-characterised risk factors. These may be fixed (including gender, ethnicity, a family history of premature CVD and increasing age) or modifiable (including smoking, poor diet, a sedentary lifestyle, high blood pressure, an adverse lipid profile, diabetes and obesity). These factors typically promote the progression of atherosclerosis over a period of many years before the disease presents clinically, with remarkably similar underlying mechanisms involved across the entire continuum of disease from its initiation through to the development of end stage arterial disease. Substantial evidence exists that attention to modifiable risk factors will improve outcomes both in those with (secondary prevention) and without (primary prevention) clinically apparent CVD. This can be achieved through healthy lifestyle modification and, where appropriate, use of specific drugs including statins, antihypertensive therapy and antiplatelet agents. Although the intensity of preventive therapy will be escalated as risk rises and may vary to some extent according to the nature of the risk factor profile and clinical disease status, a broadly consistent management approach is required across the continuum. Several national and international guidelines have been developed for CVD risk management in clinical practice. Those most relevant to CVD prevention in Wales include UK guidance from NICE and the Joint British Societies and specific guidance from the AWMSG, the Cardiac Disease NSF for Wales and Designed for the Management of Diabetes Mellitus across Wales: Consensus Guidelines. These documents provide high quality evidence-based advice for clinical decision-making and selection of clinically effective and cost-effective therapies for CVD prevention. Creating a society in which making healthy lifestyle choices is easy and affordable should be a fundamental priority for reducing the burden of CVD in the population. Strong consideration should be given to incorporating healthy lifestyle and pharmacologic strategies for higher risk individuals into wider governmental public health initiatives in Wales with the aim of reducing health inequalities in cardiovascular disease and diabetes. The vascular project group (see appendix 1) recognises that in addition to broad-based lifestyle approaches to improve CVD risk in the population, it is essential to implement a strategy to identify and treat those members of the population who are at high CVD risk. Substantial evidence suggests that these individuals are likely to benefit from a more intensive medical management strategy, often involving prescription of pharmacological agents of proven clinical efficacy and cost effectiveness. This document outlines the priorities and initial recommendations for the development of a systematic, coordinated service model for CVD risk identification and management for the population of Wales that will compliment wider population-based healthy life initiatives. Professor Julian Halcox Chair, Vascular Project Group 4

5 EXECUTIVE REPORT 1. Background There is a very high burden of cardiovascular disease (CVD) in Wales. Over 11,000 deaths per year are attributable to diseases of the circulatory system, including approximately a third of premature deaths in men and a quarter of premature deaths in women. Premature cardiovascular events affecting individuals under the age of 75 years are common. There is a marked social gradient in the prevalence of CVD, particularly presentation with premature events, resulting in a disproportionally high burden of disease associated with greater levels of socioeconomic deprivation. The risk of CVD is influenced by a number of well-recognised factors including increasing age, male gender, ethnicity, high blood pressure, cholesterol levels, smoking and diabetes mellitus. Other factors such as obesity, socioeconomic status, a family history of premature CVD, alcohol intake, chronic kidney disease and inflammatory disease are also important. Well-validated risk-assessment models which incorporate many of these factors can be used to determine an individual s risk of developing CVD over the next 10 years and to classify them into Low (<10%), Intermediate (10-20%) or High (>20%) risk. Because the mechanisms responsible for the progression of arterial disease are remarkably similar throughout the natural history of the disease process, it should be possible to employ a consistent management framework for CVD prevention across the disease continuum in the population. It is essential to identify those individuals with and at highest risk of developing CVD who will derive greatest benefit from more intensive approaches to risk reduction including prescription of proven drug therapies. Initiation of healthy lifestyle modifications (e.g. smoking cessation, increasing physical activity levels) and drug treatments, in those with clinical CVD or at high risk (e.g. to reduce blood pressure and/or cholesterol) can improve the risk factor profile and will reduce future CVD risk All individuals should be encouraged to make healthy lifestyle choices and it is the policy makers responsibility to support the development of a society in which healthy choices are easy and affordable. Thus, development of a comprehensive national strategy for CVD risk reduction with seamless integration and coordination of activities within and between community health services, primary care and secondary care is required. This should improve the level of detection of those at risk and also improve the clinical effectiveness and efficiency of service delivery. Resources should be prioritised with a view to reducing health inequalities. We believe that the following recommendations will provide the basis for improved identification of those with and at risk of CVD and the development of a more comprehensive CVD risk management strategy for improved CVD prevention in Wales 5

6 2.Recommendations for implementation of a systematic CVD prevention strategy 2.1 Main Issues Development of a systematic and coordinated national strategy for CVD prevention will be an ambitious undertaking with major logistical and financial implications that will require high-level project management and adequate resourcing. The highest priority is to ensure that those individuals already known to have clinical CVD or to be at high risk of clinical CVD are optimally managed. The next highest priorities are to identify those likely to have previously undetected clinical disease, followed by implementation of a more systematic risk assessment process with the aim of identifying the majority of individuals at increased risk of CVD. Concurrently it is essential that preventive management services including delivery of healthy lifestyle support and pharmacological intervention are coordinated within a consistent multidisciplinary management framework that will deliver economies of scale and reduce redundancy of effort. Recognising the dramatic adverse social gradient in the prevalence of premature CVD, it would be advisable that priority should be given to investment in CVD prevention services in more socioeconomically deprived areas. Furthermore, developments should be informed by output from ongoing research initiatives for example Prosiect Sir Gar in Carmarthenshire, the BHF Hearty Lives initiative in Gwent. Strong consideration should be given to commissioning further strategic research initiatives that will support improvement in CVD prevention strategy. 2.2 Recommendation for Review of Current Service Provision There are many existing systems of care for CVD prevention in both primary care and secondary care. These include multidisciplinary diabetes care teams, hypertension clinics, cardiac rehabilitation services and primary care services e-g. smoking cessation services, exercise referral, nurse-led risk management clinics. There are also numerous public health initiatives that address issues relevant to cardiovascular risk reduction both directly and indirectly such as Health Challenge Wales and Creating an Active Wales, which should be linked into the CVD prevention framework. The existence of so many different delivery systems for CVD prevention may lead to inconsistency in the nature and also quality of care. Furthermore, there is also an opportunity to minimise potential redundancy of effort by improving communication and coordination of activity between the various teams and professionals in a given area that have a prevention remit. Thus, the vascular project group recommend a systematic review of the provision of care and support relevant to prevention of CVD in Wales. In particular, this should include a review of the existing systems within the new NHS Health Boards in Wales. The findings of this review should be used as a basis for developing and implementing a practical and systematic strategy for: 6

7 Identification of those with existing CVD and at high risk of developing CVD for whom a more intensive approach to prevention (including use of appropriate evidence-based medications) will be of greatest clinical benefit and most cost-effective Standardising management protocols and optimising communication and coordination of multidisciplinary delivery of preventive care between specialities within the hospital environment and also between hospital, primary care and community health services. Coordinating and integrating public health measures for CVD prevention more effectively with community services, primary care and hospital services to reduce redundancy of effort Improving continuity and quality of care across the entire disease spectrum. Prioritising investment in service development in the most socioeconomically deprived areas that have the greatest burden of CVD Identifying and prioritising key areas for research and development 2.3 Recommendations for CVD Prevention service model development The following recommendations are divided into 2 sections: 1. How to identify patients with and at high risk of developing CVD and 2. How to manage individuals in order to reduce their risk of developing CVD or recurrent events in those with existing disease Identification of those with and at high risk of CVD We recommend the development of a systematic, coordinated CVD risk assessment programme to benefit the long-term health of the population of Wales. The highest priority is to identify patients with established clinical cardiovascular disease (coronary artery disease, heart failure, peripheral vascular disease, cerebrovascular disease). These individuals can firstly be identified from existing primary care disease registers and by focused questioning during clinical assessment about symptoms that may be due to CVD which will require further evaluation (see algorithm appendix 2). The next highest priority is to identify those patients who do not yet have established clinical CVD but are at very high risk of developing it over the next 10 years for example patients with diabetes mellitus, familial dyslipidaemia or those considered to be at high global CVD risk (>20% over the next 10 years) on the basis of their risk factor profile. The next highest priority is to develop and implement a more comprehensive strategy to identify those with an increased CVD risk in the population. We recommend that a 7

8 regionally coordinated systematic approach to cardiovascular risk assessment should be implemented. This should be complimented by opportunistic assessment initiatives designed to reach those that do not or cannot engage with standard clinical care systems. A variety of possible settings, including community pharmacy, should be fully explored. We recommend that those individuals aged years should undergo formal CVD risk assessment unless they are already known to have established CVD or to be at increased risk of CVD (e.g. due to previously identified diabetes, familial dyslipidaemia, high-risk hypertension or an adverse combination of risk factors). According to UK government analyses, the most cost-effective strategy is to commence a national CVD risk assessment strategy from the age of 40. Those with a family history of premature CVD before the age of 60 should undergo formal risk assessment at an earlier age. CVD risk should be assessed, where possible in a single visit by fully trained staff using the Joint British Societies Risk Assessment Tool as endorsed by recent NICE guidance. This uses the age, gender, smoking status, blood pressure lipid profile and fasting glucose to calculate a 10year risk of suffering a major CVD event (Heart attack or stroke) adjusted for ethnicity and family history of premature CVD where appropriate. It also recommends consideration of the influence of obesity, triglycerides, chronic kidney disease and inflammatory disease. Symptoms suggestive of underlying CVD should also be sought during this assessment. o Individuals who are found to have increased relative risk for their age and therefore with a high lifetime risk of CVD (despite their formally calculated risk of CVD events over the next 10 years being below 20%) should be identified. Such individuals are greatly overrepresented amongst those presenting with premature CVD (<60y of age). This is because age is such an important determinant of risk over the next 10y in current risk assessment calculators. The group wishes to draw attention to the major limitation of considering a 10y time frame for risk management in younger individuals. This will require specific consideration if a systematic risk management programme is to maximise its potential to reduce socioeconomic health inequalities as well as the burden of premature CVD in Wales. Consideration of an individual s lifetime risk of developing disease is vital when adverse risk factors are identified at a young age. Their risk can be well illustrated using the European Society of Cardiology relative risk table. This can be used as a means of reinforcing the importance of appropriate preventive measures in those younger individuals with adverse risk factor profiles who are often not calculated to be at high absolute risk over the next 10 years using JBS or QRISK tools, but have a very high relative and lifetime risk of CVD compared to their peers with optimal risk factor profiles. (Appendix 3). The practical issues of such an approach must be carefully planned and advice and treatment provided much be evidence based and cost-effective. There is an active program of research in Cardiff University exploring strategies to improve assessment and communication of risk that will help inform service development and staff training. o There is extensive ongoing work in the UK in the field of risk assessment and important new developments are anticipated in the near future. Therefore we recommend a formal impact assessment of the JBS2 (Framingham) and QRISK2 8

9 models and regular review of recommendations in the light of data accruing from England s NHS-vascular check programme, the development and ongoing work of the Sir Gar project, evolving NICE guidelines and cost. o The group recognise that the potential costs of implementing a full systematic national CVD assessment program are likely to be very high, as evidenced by the vascular checks program in England. Therefore, consideration should be given to an alternative strategy including an initial screening assessment that includes all features of the full assessment with the exception of blood testing. The full assessment could then be performed selectively in those most likely to be at high risk due to the presence of important risk identifiers including obesity, hypertension, smoking or a family history of premature CVD or diabetes. However, this approach has not been validated in prospective studies and should undergo a formal impact assessment before considering implementation. For example, the Framingham study group has developed a new CVD risk assessment algorithm that does not require laboratory tests. This appears to have good utility for detection of those at increased risk, but will require further validation before wider implementation. The results of a full CVD risk assessment that have been conducted within a formal programme should be held in primary care together with a clear written record of what recommendations have been made. A full record of risk assessments that have been conducted outside of the primary care setting should be made with implementation of appropriate systems and safeguards to prevent unnecessary and inappropriate duplication of effort. Individuals who have undergone CVD risk assessment should be provided with a brief personalised written report that includes relevant healthy lifestyle advice. Higher risk individuals that require more intensive preventive therapy including pharmacotherapy or investigation and management of specific clinical CVD should be managed under the supervision of their primary care physician with referral to specialist services where appropriate. With regard to the striking adverse social gradient in CVD, the group recommends that resource allocation be prioritised to support service development in more socioeconomically disadvantaged areas that have the highest disease burden Recommendations for Management of those with and at increased risk of developing CVD The principles of management for the prevention of CVD events in high risk patients are similar regardless of whether the patient has developed clinical disease (e.g. coronary artery disease, cerebrovascular disease and /or peripheral vascular disease) or are considered to be at high risk due to presence of a single major risk factor (e.g. diabetes mellitus, familial dyslipidaemia, high-risk hypertension) or because of an estimated 10y risk of >20% following global risk assessment. Advice regarding how to follow a healthy lifestyle should be provided to all individuals, particularly those with increased lifetime risk of CVD events. Messages should be consistent across all platforms with formal systems of communication developed 9

10 between the various professional groups responsible for delivering such advice. Professionals providing advice should be fully trained and ideally have training and experience in the use of motivational interviewing methods. High risk patients should receive intensive support to help optimise their lifestyle including the provision of exercise referral, dietary advice, weight management and smoking cessation services where relevant. These could be provided in a variety of venues e.g. primary care or community pharmacies. It will be important to build on existing healthy lifestyle advice and support services and engage with public health initiatives to optimise coordination and efficient delivery of appropriate support programs within regions. Careful consideration should be given to the development of better referral mechanisms into such programmes. Importantly, this should impact positively on the risk of developing a number of other important diseases in addition to CVD, for example diabetes and cancer, and they should not be viewed exclusively as CVD prevention services. Such an approach should maximise effectiveness of these services by reducing redundancy of effort and delivering consistency of the advice. Drug treatment should be considered for High risk individuals as follows o Statins should be prescribed in accordance with NICE/AWMSG guidance o Drug treatment should be initiated for treatment of persistently elevated raised blood pressure treatment in accordance with NICE/AWMSG guidance o Antiplatelet therapy should be administered in patients with clinical CVD. Aspirin 75mg daily is standard antipatelet therapy for secondary prevention in stable patients, with different regimens implemented according to the nature of the underlying disease (e.g. post-stroke or acute coronary syndrome) and co morbidity (e.g. see 2009 AWMSG guidance for antiplatelet therapy) o Recent evidence and advice suggests that antiplatelet therapy should not be used routinely for the primary prevention of CVD events. However, management decisions should be made by physicians on an individual patient basis after consideration of potential benefits and risks. o Use of additional therapy such as ACE-inhibition, beta blockers and N-3 supplements in patients with coronary disease, or hypoglycaemic agents and ACE-inhibitors in patients with diabetes should be in accordance with relevant National Guidance (NICE/AWMSG/Welsh Diabetes Consensus Guidelines) o The decision to prescribe medications for prevention of CVD should follow an informed discussion about risks and benefits with the individual patient. Due consideration should be given to both clinical- and cost-effectiveness of such an approach as emphasised in NICE and AWMSG guidance. o Any wider systematic assessment programme could result in an increase in numbers of patients receiving drug therapy: poor concordance and the possibility of inappropriate prescribing could increase waste, harm and inappropriate variation of care unless measures to counter these are built in to the strategy at the beginning o Poor concordance with long-term preventive medication is a well recognised problem. Thus, increasing emphasis on effective medication reviews (face-toface), measuring prescribing against CVD outcomes/hospital admissions and patient education (understanding their therapies with regard to length of treatment, likely side effects, risk reduction etc and the opportunity to refuse) and use of validated patient decision aids will be necessary and the subject of ongoing impact assessment and quality improvement. 10

11 Services for prevention of CVD across the new LHBs should be well coordinated between primary and secondary care and between specialities in secondary care to improve quality standards and efficiency of service delivery through economies of scale whilst minimising redundancy of effort. Individual specialist services will remain responsible for disease-specific management issues. 2.4 Practical and Logistical Considerations Formal consideration should be given to the following issues: The recent WAG-commissioned AWARD review of recent literature addressing CVD prevention in primary care highlighted several key issues (Segrott J et al Reducing health inequalities: a primary care approach to tackling vascular disease, AWARD Year 5 Project Report, May 2009). Best practice should incorporate i) a systematic approach to identification of those at increased risk maximising the potential for utilisation of primary care databases; ii) a coordinated multidisciplinary delivery of preventive interventions including both lifestyle and pharmacological approaches; iii) to tackle inequalities in CVD, consideration should be given to targeting risk management programs to areas of greatest disease burden, engaging in a culturally appropriate way with individuals from different ethnic backgrounds who are at increased risk and investing in research into the development of behavioural and lifestyle interventions. Modelling of the potential costs and benefits of implementing a National systematic programme should be undertaken before initiation. This should include practical implications of the need to develop new assessment services and the likely impact on the workload of existing services (both due to performing more risk assessments and managing more new patients found to be at increased risk). Although the Quality and Outcomes Framework in primary care provides a strong existing platform for identification and management of those with disease and established conditions that place individuals at high risk such as diabetes and hypertension, there is currently limited capacity and provision within the existing system to address the challenge of a comprehensive, systematic level risk assessment and management program in the population. To ensure improved case finding careful consideration should be given to ensuring the completeness of disease registers through QOF review visits and the use of public health support to explore expected local prevalence and incidence versus that recorded on primary care systems. Consideration should be given to assess the additional workload in primary care that will result from increased numbers of vascular assessments and the need for management of newly-identified high risk patients. Also opportunities for partnership working with community and public health services as well as charitable organisations and Industry should be explored. Clear standards of engagement with non-nhs partners (e.g. Charities and the Pharmaceutical Industry) must be established. 11

12 Prioritisation of resources should focus on coordinating and optimising preventive care in those already known to have clinical CVD or to be at high risk, followed by increasing investment in development of preventive services in more socioeconomically deprived areas with higher CVD burden. The Welsh Assembly Government and the British Heart Foundation have recently provided generous funding to implement an All-Wales cascade testing program to improve identification and treatment of individuals with familial hypercholesterolaemia. An expert steering group has been established to manage the national roll-out of this program. Although this is a genetics-based screening program for a highly specific condition, there are many potential parallels with a routine CVD risk assessment program; i.e. identification of high-risk individuals and formal initiation of coordinated CVD prevention measures in those found to be at risk. Thus, it is likely that many valuable practical lessons will be learnt from this process which should be fed back to inform the development of a broader global CVD prevention program in Wales. Local schemes should be devised to target specific groups who may be less willing or able to engage with traditional healthcare delivery systems e.g. travellers, the unemployed, prisoners etc. Alternative venues (e.g. community pharmacies, mobile assessment units etc) should be considered. It will be critical that assessments performed in these units are performed by staff with adequate training and using the same protocols, standards and governance structure for assessment and management used in primary or secondary care. Systems should be in place to ensure that those who have already undergone a recent vascular risk assessment, and therefore not requiring further assessment, can be identified by vascular assessment teams working in different venues to reduce duplication. Data management is a critical issue. It is important to ensure evaluation is built in to any Vascular Risk Assessment Project so that data needs and capture methods as well as quality assurance can be determined pre-implementation. Therefore, consideration should be given to developing a centrally held database. This database could in future years form the basis of a Welsh vascular assessment algorithm. Mechanisms for data evaluation and audit should be established including consideration of the potential for novel clinical research. In addition issues of consent for use of data for research purposes should be clarified and robust data protection measures should be in place prior to implementation. Consideration should be given to asking that the new Public Health Wales Trust manage public engagement, implementation, data collection and evaluation of the vascular assessment project. Experience in launching the bowel screening programme in Wales suggests that a national launch is more likely to achieve improved uptake compared with staggered launches. 12

13 Equity of access to services and consistency in care is essential to achieve effective implementation of such a strategy and deliver a service fit for purpose. Access to the Inequalities in Health Fund and engagement with the chronic conditions management program should be encouraged along with improved coordination of existing services/resources to create a coordinated Welsh CVD Prevention Network encompassing public health, clinical services and academia should be prioritised. Research being undertaken within recent key Welsh CVD prevention initiatives, including Prosiect Sir Gar in Carmarthenshire and the BHF-funded Hearty Lives program in Gwent, should be supported and output used to inform and evaluate development of innovative new approaches to CVD prevention. Additionally, we strongly encourage further strategic support from WAG/NISCHR (National Institute of Social Care and Health Research) for CVD prevention research initiatives, including utilisation of the SAIL database and development of coordinated bids from national Registered Research Groups. 9. Proposed Service Model for the Management of Vascular Risk Assessment in Wales The proposed service model has been developed to incorporate the recommendations outlined in this report in an attempt to strengthen the approach to vascular disease risk management in Wales and improve consistency, communication, data collection and audit, education of staff and public engagement and education. The diagram on the following page depicts the preferred vascular service management model and how it fits with the chronic conditions management model. 13

14 Complex and Unstable secondary prevention (DM / CHD / PVD / Stroke / Renal) Complex Primary Prevention (FH, Complex DM/HTN Secondary Care Model Common diagnosis & treatment = Consistent Service / Management Model Same Process Same Treatment Same Opportunities Same Outcome Clear Communication Primary Care Model Routine Secondary and Primary Prevention, CVD Risk Assessment Healthy Lifestyle Management GP / Community Pharmacy / Work Place / 14

15 3. Conclusions CVD places a major clinical, social and economic burden on the population of Wales. The impact of the most common major circulatory disorders can be minimised by improving the identification of those individuals in the population with and at high risk of disease and implementing well-validated preventive management strategies. Firstly, we recommend that improving the coordination and consistency of multidisciplinary preventive care delivery across hospital specialities and between primary and secondary care. This will serve to improve the quality of care and realise efficiencies of scale for comprehensive CVD prevention within the new Welsh Healthcare management structure. Secondly, we recommend that a more systematic national vascular risk assessment service be developed. This will serve to increase identification of individuals at risk of CVD or with previously undiagnosed clinical CVD, in whom timely implementation of preventive strategies will reduce the burden of CVD events. Thirdly, we recommend the development of a comprehensive national CVD prevention framework that integrates and coordinates CVD prevention services and initiatives across secondary and primary care, community and public health services and academia. Implementation of these recommendations prioritises the optimisation of preventive care for those at the very highest risk of CVD events and the development of a comprehensive preventive care system that will address the health inequalities that are so clearly evident from the current Welsh CVD statistics.

16 SUPPORTING DOCUMENTATION 1. Background Vascular diseases (coronary heart disease [CHD], stroke, diabetes mellitus and chronic kidney disease) are the leading cause of morbidity and mortality in Wales and other developed countries. They are an important cause of premature death and ill health and a major contributor to the adverse social gradient in health with British Heart Foundation (BHF) data demonstrating up to a 3- fold difference in the incidence of CHD and stroke between the most and least socioeconomically deprived groups in the UK. According to British Heart Foundation data, diseases of the heart and circulatory system accounted for over a third of all deaths in Wales (11,000 deaths) in About half of all deaths from CVD are from CHD and over a quarter are from stroke. CVD is also one of the main causes of premature death: a third (32%) of premature deaths in men and nearly a quarter (23%) of premature deaths in women. CHD causes over 5,500 deaths a year in Wales: approximately one in five deaths in men and one in six deaths in women. This compares to: just under 2,000 deaths a year from lung cancer and less than 1,000 deaths from colo-rectal cancer. Premature death rates from CHD (deaths under the age of 75) for men and women in Wales are higher than the UK average, and are similar to rates found in the North of England. Although these rates have fallen by more than 52% for women, and by 49% for men since 1996, the number of people living with CHD and other circulatory disease is rising, especially in older age groups. In the UK among those aged 75 and older, it has risen by around a half (48%) in men and 18% in women since the late 1980s. Approximately 115,000 people living in Wales have had a heart attack and 122,000 people are suffering or have suffered from angina (the commonest form of CHD). Much is known about the causes of arterial CVD, which include several important modifiable factors (most importantly smoking, raised blood pressure, lipid abnormalities, diabetes mellitus, obesity, poor diet, lack of physical exercise and adverse psychological, social and economic influences) and a small number of unmodifiable factors (such as age, gender, ethnicity and a family history of premature CVD). Most importantly, a substantial body of high quality evidence exists to show that through early identification of those at risk and by using simple, effective and inexpensive therapeutic lifestyle and pharmacological interventions vascular disease can be prevented, delayed or even reversed. On the 7th January 2008 the UK Prime Minister, Mr Gordon Brown, announced plans in England to deliver a national programme to detect evidence of vascular disease in people between years of age. The National Screening Committee (NSC) does not support a national population screening programme for vascular disease but does support the introduction of a more systematic process for the identification of people at high risk and implementation of evidence-based protocols to manage CVD risk in the population. The HSC published The Handbook for Vascular Risk Assessment in March 2008 to inform and support a more structured approach to the development of a service model for England. The Minister for Health and Social Services in Wales, Mrs Edwina Hart AM OStJ MBE, established an all Wales vascular project group (VPG) in December 2008, chaired by Professor Julian Halcox, Professor of Cardiology, Cardiff University School of Medicine and Consultant Cardiologist at the University Hospital of Wales to consider and advise how Wales could strengthen its current 1

17 approach to identifying and managing the risk of vascular disease and to work towards developing an agreed service model for Wales. The VPG established 5 work streams and leads to support their work: Work Stream 1 Work stream 1 focused on Risk Assessment and Protocol Development and was chaired by Professor Steve Bain, Professor in Diabetes, Swansea University. The main task of the group was to produce a set of recommendations to inform the final report based on current evidence and to identify which risk assessment tool would be most appropriate to be adopted in Wales. Work Stream 2 Work stream 2 focused on How to manage at risk patients leading to a formal implementation strategy and was chaired by Dr Alan Rees, Consultant Diabetologist, University Hospital of Wales, Cardiff. The main task of the group was to produce a set of recommendations around the management of people at risk of vascular disease to inform the final report, based on current evidence. Work Stream 3 Work stream 3 focused on Social Engagement: improving access to the population and was chaired by Dr Gill Richardson, Consultant in Public Health, National Public Health Service for Wales. The main task of the group was to produce a set of recommendations to provide direction about how to market the future implementation of vascular risk assessment policy using the appropriate evidence base. Work Stream 4 Work stream 4 focused on the Where and How to conduct vascular risk assessment: primary care/pharmacies/work place/other and was chaired by Dr Armon Daniels, General Practitioner, Cardiff. The main task of the group was to produce a set of evidence based recommendations to determine where and how we should provide vascular risk assessment in Wales. Work Stream 5 Work stream 5 focused on developing recommendations for the implementation of an abdominal aortic aneurysm screening service for Wales and has been addressed in an independent report through the chair Dr Dafydd Thomas, Consultant Anaesthetist, Swansea. The questions of where and how vascular assessment and management should be undertaken and how to improve the public engagement in this process have not been subjects covered in national guidelines. These are critically important issues for local commissioners to consider in responding to national policy. In particular, work stream 4 has considered the issue with reference to current NICE guidelines and the National Screening Committee (NSC) recommendations. It has examined the experiences of setting up vascular assessment in neighbouring areas. Its recommendations have been set in the context of the other work streams. 2

18 2. Supporting Statements The updated Cardiac Disease National Service Framework for Wales, June 2009 states that those responsible for the planning and funding of community NHS services should consider the need for risk assessment programmes for population groups who may be unwilling or unable to access services in general practice, including people who are house-bound. NHS organisations within a Cardiac Network may wish to work together on risk assessment programmes for particular vulnerable and hard to reach groups. The primary care resource centres outlined in Designed for Life could provide the focus for such programmes. Programmes run by community pharmacies could be another approach, using the flexibility within the 2005 Pharmacy Contract. 1 Wherever risk assessment programmes are run, they should be provided to the same standard and by staff with the appropriate skills and competencies. (HcS 2, 14, 16) The National Institute for Clinical Excellence (NICE) published Clinical Guideline 67 in 2008 which recommends that a systematic approach should be adopted to identify people, aged who are likely to be at high risk of cardiovascular disease. The Quality and Outcomes framework encourages structured, evidence based care for patients identified as having risk factors (such as hypertension) or certain chronic diseases (such as stroke or transient ischaemic attack). Practice based registers are populated by case finding approaches. Many practices undertake opportunistic screening and structured risk assessment but there remains scope for strengthening such systems. All GPs are engaged with the Quality & Outcomes Framework (QOF) under the general medical services contract. This year, the QOF will include two Quality Indicators that deal directly with vascular assessment and management in newly diagnosed hypertensive patients. Private providers have undertaken opportunistic vascular assessment in a variety of settings including primary care, community pharmacies and the workplace. This work, though valuable, has been limited in its success and has therefore failed to reduce inequalities in health resulting from vascular disease. The vascular project group endorses the view that a larger scale, more comprehensive and systematic programme of vascular assessment is required to reduce health inequalities and prevent the consequences of vascular disease in Wales. This report details the final recommendations of the expert group for the Minister for Health and Social Services to consider. 3. Identification and management of individuals at risk of CVD events The main priority is to identify those individuals who already have evidence of clinical CVD and those who are at highest risk of developing the conditions over the next 10 years and before the age of 75. Substantial clinical evidence suggests that these individuals derive the greatest clinical benefit from a more aggressive approach to preventive management which will typically involve implementation of healthy lifestyle measures and use of cost-effective drug therapy. The next highest priority is to identify those without clinical CVD disease, but at high risk of developing the disease over the next 10 years and those at high lifetime risk. It is well recognised that age-adjusted CVD rates are disproportionately high in areas with high levels of socioeconomic deprivation. These 1 The National Health Service (Pharmaceutical Services) Regulation 2005 Number 641, ISBN Available from: 3

19 areas should be prioritised for investment as a comprehensive national CVD prevention service is developed. 3.1 What is vascular disease? Vascular disease includes conditions such as coronary heart disease, stroke, diabetes and kidney disease which have common causative and often modifiable risk factors such as smoking, high blood pressure, dyslipidaemia, impaired glucose regulation (impaired fasting glucose, impaired glucose tolerance) obesity, poor diet and physical inactivity. Certain risk factors are non-modifiable e.g. age, gender, ethnicity and family history. However, these non-modifiable risk factors heavily influence an individual s susceptibility to premature atherogenesis. Those with CVD or symptoms suggestive of CVD should be investigated and managed according to specific disease management pathways. Similarly, those already known to be at high risk of CVD due the presence of important clinical risk factors including diabetes, hypertension and hyperlipidaemia should be managed according to standard management algorithms which are briefly summarised later in this document. It is important to note that the underlying disease process of atherosclerosis is similar across the continuum of disease from those with just risk factors to those with advanced clinical disease. As such, the approach to prevention of progression of disease is essentially consistent across this continuum and consists of healthy lifestyle modifications and, in high-risk individuals, preventive drug therapy such as lipid lowering agents and antihypertensive therapy. It is clear that many individuals at high risk of CVD are unaware of this situation. Well-established systems of vascular risk assessment have been developed that allow healthcare professionals to assess an individual s CVD risk which can be used to help guide lifestyle and treatment choices that can reduce future risk of suffering CVD events. 3.2 Vascular Risk Assessment What is vascular risk assessment? Vascular risk assessment is a systematic process of assessing an individual s risk of developing vascular disease related major clinical events, specifically MI, stroke and cardiovascular death. This can be done by identification of those with existing disease or those without CVD that have an adverse constellation of CVD risk factors that places them at increased risk. Results of the initial assessment can be used by the clinician to communicate the degree and nature of risk to the individual and in partnership with them develop and implement a specific management strategy to reduce their risk and where necessary investigate and treat those with suspected clinical CVD or concerning levels of risk factors How should vascular risk assessment be performed? Recommendations: Individuals should be invited in writing for assessment. Adequate follow up systems for nonresponders should be in place, using alternative means of communication and approach if necessary. 4

20 Consideration should be given to using general practitioner computerised records with appropriate patient consent, to identify the target groups for assessment In order to improve accessibility and uptake of risk assessment a choice of venues and providers should be considered Consideration should be given for conducting an initial assessment to further identify individuals who have previously undiagnosed vascular disease or others who are low risk of developing vascular disease who may not require further clinical assessment within the vascular risk assessment programme. This could be undertaken using a questionnaire, which should be well designed and validated where possible, together with anthropometric assessment and measurement of blood pressure. Those with suspected clinical CVD will require further review by the primary care physician and where appropriate referral for specialist investigation and treatment. Vascular risk assessment should be undertaken according to a standardised process. Information collected should include age, gender, ethnicity, family history of premature CVD (in a first degree relative <60y), seated blood pressure, fasting lipids (A full profile if possible but total and HDL cholesterol are a minimum requirement), fasting glucose +/-HbA1c, anthropometric data (height, weight, BMI, waist circumference), smoking status. Our recommended assessment tool would be three-pronged: o 1. Questionnaire to include age, sex, family history, ethnicity & cigarette smoking. This could be based on a standardised diabetes risk assessment tool for example QDScore or FINDRISC. Data collected from Prosiect Sir Gar will help inform development of this strategy. (Minimal) physical examination to include blood pressure, heart rate and regularity of rhythm (to assess possibility of atrial fibrillation), weight/height (body mass index; BMI) and (measured) waist circumference. Additional questions could assess average weekly alcohol intake, typical physical activity levels and the quality of the diet. Information should also be collected regarding the presence of other clinical conditions associated with increased CVD risk (CKD, COPD, Inflammatory rheumatic disease, erectile dysfunction, polycystic ovarian syndrome). o 2. An additional questionnaire to raise the suspicion of cardiovascular symptoms that require further assessment (Appendix 3). o 3. (Fasting) blood testing to measure lipid and glucose levels. High Risk individuals should be identified as follows o Those with or suspected of having clinical CVD o Those with or suspected of having diabetes mellitus o Those with or suspected familial dyslipidemia or a very high risk lipid profile (Total:HDL cholesterol ratio 6) o Those with high risk hypertension (BP 160/ 100mmHg or BP 140/ 90 with evidence of target organ damage or dysfunction retinopathy, renal impairment/proteinuria, left ventricular hypertrophy) o Those with an estimated 20% 10y risk of suffering a major CVD event. o Consideration should be given to those individuals below the age of 60 who are not at high risk over the next 10 years but have an adverse risk factor profile that confers a high lifetime risk of CVD. These individuals can be identified with the help of the ESC relative risk chart (Appendix 2) 5

21 The choice of selection tool is important. There is currently considerable debate about the most appropriate model to use for the UK population. Current NICE guidance recommends that the Framingham risk assessment model be used with adjustment for important factors that are not included in the model (ethnicity, family history of premature CVD, obesity, CKD, inflammatory rheumatological disease and socioeconomic circumstances) that may help reclassify those with an intermediate risk that may not be fully characterised by the Framingham model. The QRISK2 assessment tool has recently been determined in a large UK primary care database. Whilst this appears to be a more accurate predictive tool for assessment of risk in the UK population, the level of risk identified is usually significantly lower than that identified using the Framingham score. Whilst a more accurate score is welcomed in terms of its ability to identify risk more comprehensively and accurately for a contemporary UK population, many more individuals who would previously have been considered to be high risk would no longer be classified as such using the QRISK2 model. This will have the consequence of reducing the numbers of people in the population for whom a more aggressive management strategy would be recommended which may reduce the potential for prevention of CVD at a population level. Furthermore, this is likely to have a particularly significant adverse impact on the potential reduction of premature CVD events as younger individuals with adverse risk factor profiles with a high lifetime risk typically do not have a high 10year risk score. The QRISK2 model is also more complex requiring inclusion of many more factors than the Framingham score and may be less suitable for use in a wider-range of settings (community pharmacies, mobile facilities, occupational facilities etc) Consideration should be given to the process of blood testing; near-patient testing of lipid profile and diabetes metric including glucose levels should be considered. This has the potential to avoid issues of phlebotomy provision, sample transport costs, diagnostic laboratory processing burden and cost. Standardised near patient testing must be conducted using equipment with robust quality assurance processes involving local hospital pathology laboratory expertise in all aspects of point of care testing. The involvement of an external certification body in accreditation and the need for appropriate quality control procedures should be considered. (additional testing in individuals at higher risk of diabetes may be required with glucose tolerance testing. In the future this may involve routine testing of HbA1C) The group recognises that undertaking a full CV risk assessment in the entire population >40y is a major undertaking both logistically and economically. Consideration of limiting blood testing to those with one or more high-risk identifiers following a pre-screening assessment (Symptoms suggestive of CVD, age >55y, smoker, overweight or obese, family history of premature CVD or diabetes, BP>130/>85mmHg) as those without any of these factors are very unlikely to be at high risk. The impact of taking this approach should be formally assessed before implementation Who should conduct vascular risk assessment? Recommendations: Currently most assessment of CVD risk is undertaken in primary care by GPs and practice nurses or by hospital specialists (e.g. cardiology, endocrinology, nephrology etc). Whilst the group feels that the information regarding individuals CVD risk status and advice/management 6

22 strategy should be held in primary care, other professionals could provide a valuable contribution to a national CVD risk management service. All staff providing risk assessment should be adequately trained and supervised. There is currently no widespread standardised system for vascular risk management, thus training and supervision of staff involved in delivering vascular risk management should be high quality and to a consistent standard. (For further information see php) Established training systems should be explored and expanded with engagement of charitable and voluntary organisations (e.g. British Heart Foundation, Diabetes UK, other charities, faith groups, community groups etc) in promoting vascular assessment and ongoing support will be desirable. Specific initiatives to overcome clinical prejudice may be required (e.g. with obesity and smoking). It is desirable to explore cost-effective training programmes for clinicians that might require refresher training. CRB checks and Hepatitis B vaccination (if undertaking phlebotomy) for staff who undertake vascular assessment Comprehensive workforce management systems with appropriate clinical governance arrangements are required. Primary care should be provided with the information from vascular assessment relating to their registered patients. Consideration should be given to providing information electronically wherever possible thereby reducing the need to re-enter information. Recognition must be made that current IT compatibility in NHS Wales will result in an inability to simply transfer data from screening site to GP patient record and the transfer will have a resource implication for Primary Care. Robust data-protection measures must be employed to prevent loss of or unauthorised access to clinically sensitive patient data. A secure record of individuals who have had assessments made as part of a nationally funded program should be kept in order to minimise potential for duplication of effort. Consideration should be given to using established computerised systems for programme management, risk assessment and also for collection of data for audit and research Where should vascular risk assessment be undertaken? Identification of those with and at risk of vascular disease should ideally be undertaken through a large-scale systematic strategy. However, recognising that a significant number of individuals may be missed by a more traditional primary care practice-based approach with opportunistic strategies added on. Those at high risk may be identified in primary care by: General practice (GP) identification of those already known and managed via disease registers Identification of those not managed through GP disease registers but prescribed medications to reduce their risk of vascular disease (e.g. for lipid and blood pressure lowering) 7

23 These individuals may not require further risk stratification within the vascular assessment programme as most should have already been identified as being at high risk. However, they are likely to require ongoing assessment and management of their risk factors as part of their routine care. Further consideration should be given to identifying those not yet identified as being at risk and who may not be registered with a GP using other sources of information (e.g. electoral roles, local council records. Other means of communication (e.g. , mobile phone text) should be considered where written communication has not been successful. Alternative venues for assessment (mobile assessment units, community pharmacies, occupational health centres etc) should be considered to improve access for those who are less likely to engage with standard healthcare systems including the homeless, unemployed, travellers, prisoners and those with occupational pressures. Opportunistic assessment in public spaces and during large public events could be considered. Data collection and protection is paramount in remote locations and a robust system must be in place before remote screening and data collection is commenced. Consideration should be given to ensure that (electronic) systems are in place to ensure that the information collected can be communicated to the primary care team responsible for the clinical care of the individuals assessed in these settings. The choice of venues and preparation of mobile units should be made subject to compliance with a minimum specification of quality standards and after consideration of the needs of a local population. The needs of different groups for example black and ethnic minorities or individuals who cannot get time off work should be considered to improve reach within these groups. Venues should be safe, clean and private and the assessment should be based on consistent standard operating procedures. Appropriate venues with private, quiet environment for face-to-face conversation. Measurements such as taking blood pressure should be done in such a setting to ensure the readings are confidential and reliable. Mobile vascular assessment units will have the potential to respond to the needs of local communities and undertake vascular assessment in a variety of settings to achieve maximum reach. Potential venues identified for vascular assessments which were likely to have appropriate staffing and supervision structures include: Hospitals GP surgeries Community Pharmacy Walk-in clinics Work places Job centres 8

24 Other community based venues were proposed as offering advantages in accessing different hard to reach groups for more opportunistic assessment including: Football/rugby grounds, Sports and Social Clubs, Church halls, Mosques and Temples Patients homes Leisure centres Supermarkets and Shopping centres Royal Welsh Show /Eisteddford Commercial venues as part of awareness days Pubs Railway/Bus Stations All venues should be capable of undertaking a full vascular assessment in the context of a one-stop assessment to increase uptake and motivation to adjust lifestyle. Systems should be in place to reduce wasting of resources through unnecessary repetition of assessments at different venues. A choice of times and venues would improve the chances of attracting those individuals who are difficult to engage. Materials produced by the centre should have information which identifies it as part of the Wales Vascular Assessment programme Adequate facilities for hand washing/sterilisation are required Health and safety policies including infection control, storage and disposal of clinical waste, needle stick injuries and spillages should be in place Piloting of novel approaches should be considered in order to allow troubleshooting and refinement of the model. Consideration should be given to establishment of such initiatives in more socioeconomically deprived areas. This process should be informed by information gathered from ongoing initiatives such as Prosiect Sir Gar and the BHF-funded Hearty lives program (which is a national multi-centre initiative with a significant component based in Gwent) 4. Management of CVD risk 4.1 Practical considerations Staff at assessment centres should be capable of providing feedback on vascular risk, recognising that this risk is a continuum, and that providing appropriate health promotion advice to someone who is at lower vascular risk may prevent consequences in the future. They should also be able to recognise those with a high index of suspicion of clinical disease requiring and those with high risk of CVD that may require specialist investigation and/or drug intervention in order to identify and communicate need for prompt and appropriate medical review. 9

25 Lifestyle advice must be provided in a consistent way for all those at risk of vascular disease with those identified as being at high-risk requiring specific intervention aimed at tackling: Smoking Obesity Healthy eating Excess alcohol consumption Exercise, including exercise referral where appropriate Those with increased global CVD risk include those with the following conditions that may require specialist treatment: Specific conditions such as: Coronary Artery Disease (CAD) Stroke Peripheral Arterial Disease (PAD) Diabetes Mellitus Hypertension Hyperlipidaemia Disease specific management of those with clinical CVD and diabetes is covered in current guidance for example NICE, National Service Framework for Diabetes in Wales Delivery Strategy 2003, Diabetes Consensus Guidelines (2008), All Wales Medicine Strategy Group. Although this is not the focus for this report, appropriate clinical management of these conditions is key to the improvement of individual quality of life. However, whilst considering strategy to optimise and standardise prevention strategies in these individuals provides an opportunity to improve the organisation and delivery of cardiovascular disease prevention across the clinical spectrum of secondary/tertiary care specialities and primary care providers. In particular, there is an ideal opportunity to review the delivery system for preventive management across the primary/secondary care interface and also to consider how best to integrate prevention initiatives being undertaken within conventional medical settings with broader public health initiatives. The coalition of risk factors which predisposes individuals to premature atherogenesis is broadly similar, irrespective of which vascular tree is involved e.g. Coronary heart disease (CHD), cerebrovascular disease (CVS) or peripheral vascular disease (PVD). Overall, within the population, there is a continuum of risk. The risk of developing clinically manifest disease over a 10 year period can be estimated using various statistical risk engines the majority being derived from the Framingham risk equation. As age is a major determinant of risk, one disadvantage of this approach is that risk calculations may be biased towards the elderly and underestimates life long risk in the younger age group e.g. 40 to 50 year olds. To some extent, this bias can be compensated by calculating relative risk in certain categories of people (see Appendix 3 ESC relative risk chart). For example a 42 year old male smoker with a CF5 Postcode, a systolic blood pressure of 145mm Hg, body mass index of 31kg/m 2 a TC:HDL ratio of 6 would be estimated to be at low risk of CVD (7% over the next 10 years) using the QRISK 2 algorithm. However, it is well recognised that his adverse risk profile places him very high lifetime risk beyond the 10-year timeframe considered by the risk assessment tool, which must not be ignored during the consultation. Using the European CVD risk chart the same 10

26 profile identifies he is at approximately 5-6 times greater risk and an individual who is likely to benefit greatly form appropriate healthy lifestyle measures, even though he does not currently meet the criteria for preventive medication based on his absolute level of risk over the next 10 years. It is important to note that certain conditions that place an individual at very high risk, exclude the need for formal CVD risk calculation and often require pharmacotherapy from a young age. These include diabetes mellitus, hypertension with evidence of end-organ dysfunction and familial dyslipidaemia. The Minister, in partnership with the BHF, has already agreed to fund cascade testing for Familial Hypercholesterolaemia in Wales. This vitally important initiative will identify a large number of the population with this critical risk factor for premature CVD, that will benefit from early initiation of preventive interventions. Such individuals may require pharmacotherapy from childhood. Wales is leading the UK in this field and data collected in this program will help inform development of a wider UK FH management strategy. 4.2 Management strategies for individuals at risk of CVD; Recommendations Individuals with pre-existing vascular disease (CHD, CVD or PVD), individuals with diabetes, chronic kidney disease and individuals with Familial Hypercholesterolaemia are by definition in a high-risk category and all modifiable risk factors should be treated in an coordinated manner. The management of such individuals include changes in lifestyle such as healthy eating, increased physical activity and stopping smoking. Other risk factors may require pharmacotherapy and include dyslipidaemia, blood pressure, dysglycaemia and antiplatelet therapy. The strategies for treatment are well established in published national guidelines (e.g. NICE, JBS2 etc). The general principle being that the intensity of treatment should be graded according to the risk of the individual. Very high-risk individuals (e.g. acute coronary syndrome) require the most intensive approach and the targets are more aggressive. There will need to be detailed descriptions of how the various levels of risk identified during the initial assessment of an individual in each venue should lead to referral into other care settings including primary care, secondary care and/or other specialist services. Lifestyle Issues: These are complex and include a mixture of societal and medical considerations. Food policy, education, taxation etc are the responsibilities of the Body Politic but will have a major influence on the health of the population. The Diabesity epidemic (Diabetes and Obesity) is the result of societal and demographic changes and requires a political/public health approach to its solution. In general, dietetic services are under resourced, as are exercise referral schemes, but the long-term cost effectiveness of these strategies for primary prevention of CVD is currently uncertain. (Many English PCTs are opting for more cost-effective alternatives to nurse-run or dietetic services e.g. Health Trainers, so dietetic services being under-resourced is a barrier that can be circumvented depending on the delivery model adopted). Promotion of Healthy living advice and dietetic advice using the latest technology e.g. mobile phones/internet should be explored as well as partnership with existing charities and special interest groups e.g. The British Heart Foundation, Diabetes UK, Heart UK and the Blood Pressure Association We recommend statin treatment and antihypertensive therapy be prescribed according to NICE/AWMSG guidance for patients with and at high risk of CVD and with elevated blood 11

27 pressure where possible for the majority of patients. This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, as emphasised by NICE, clinical guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer and it should be recognised that it may not be appropriate for all patients. Diabetes should be managed according to NICE guidance and recently published Designed for the Management of Adults with Diabetes Mellitus across Wales: Consensus Guidelines (2008). Other high-risk individuals will be identified by conventional risk estimations. A larger group will be identified as having intermediate risk (10 to 20% over 10 years). This group may pose the biggest challenge, as most people after the age of 60 including women will be in this intermediate risk group. Intervention in this group is a strategy known as the Primary Prevention of Vascular Disease. Whether lifestyle changes alone are sufficient or whether particular individual needs pharmacotherapy will depend on individual patient criteria, clinical judgements of the physician and the wishes of the patient. There are data, derived from observations in the Heart Protection Study which suggest that treatment with 40mg of simvastatin is a highly cost-effective(< 1,000/QALY) means of preventing major CVD events in individuals with intermediate risk, based on recent generic costs of this drug. It is not currently recommended that statin treatment be given to those at intermediate risk. Antiplatelet therapy o Antiplatelet therapy is strongly recommended for secondary prevention of events in those with CVD and should be prescribed according to disease specific guidance and the specific clinical circumstances. In brief, aspirin should be used routinely for secondary prevention according to established guidelines, with addition of a second antiplatelet agent according to established guidance for management of patients with Stroke and coronary disease presenting with Acute Coronary Syndrome (ACS) and/or undergoing percutaneous coronary intervention. Advice regarding the intensity and duration of dual anti-platelet therapy for secondary prevention should generally be provided by the specialist team. o Recent evidence calls into question the role of aspirin for primary prevention of CVD events, in contrast to previously established NICE and JBS2 guidance; i.e. for those with 10year CVD risk >20% providing blood pressure is adequately controlled. Therefore, we recommend that aspirin not be prescribed routinely for primary prevention in high-risk patients. We acknowledge that in certain circumstances individual physicians may consider use of aspirin, with caution, for the primary prevention of CVD events in those with very high CVD risk and a low bleeding risk. o A role for Clopidogrel or dipyridamole as monotherapy for primary prevention of CVD events is not established and not licensed. 12

28 Local Enhanced Service (LES) should be considered to support development of optimal clinical systems for CVD prevention in primary care. Risk management services should be coordinated, as the general principles of management are similar for high-risk primary prevention patients and those with established disease regardless of which vascular bed(s) is affected. There should be seamless coordination of efforts between primary and secondary care and between specialities in secondary care. The new LHB structure should provide an improved management structure to deliver bettercoordinated services. The potential for more effective utilisation of public health initiatives and community health services should be explored for ongoing management of patients at increased risk. Empowerment: Implicit in the recommendations of the VPG is the principle that each patient must take responsibility for his/her lifestyle choices, adherence to healthy eating and/or smoking advice and adherence to pharmacotherapy. Individuals have a right to receive advice and support but they also have the responsibility to work in partnership with healthcare professionals. The earlier there is agreement to work together in the disease pathway the better the outcomes. There should be an unambiguous emphasis on individual patient empowerment and responsibility as evidence suggests that well motivated and well informed individuals are more likely to achieve better concordance with lifestyle and medication recommendations and better risk factor control. An early assessment of the individuals motivation to change his/her behaviour must be made as early as possible in order to appropriately target resources. It might be useful to note that patient empowerment and responsibility is often only achieved once healthcare professionals have themselves accepted their own responsibility to support a patient by considering the patient s needs and preferences and giving them an opportunity to make informed decisions about their care and treatment. Often patients don t take responsibility because they are not empowered, informed or motivated. Motivation can be enhanced or inculcated and is seen as a latent force rather than something some people have and others do not. Regarding motivation, it is also worth noting that an individual s motivation to change is notoriously difficult to assess and often inaccurate without the proper guidance and / or training, and thereby liable to accentuate health inequalities in vulnerable individuals. 5. Public Engagement Recommendations: There should be consideration of offering only part of the full screening tool (i.e. the option of restricting the blood test assessment) based on the risk assessed by questionnaire and focused physical examination. This approach, although pragmatic and potentially costeffective is not currently evidence-based. Therefore the potential impact of the loss of blood testing data on overall risk assessment (including issues of relative versus absolute risk) should be formally assessed. The assessment pathway and branches should be clearly understood by those involved. 13

29 Consideration should be given to integrating/overlap with Health Challenge Wales branding, so that the link between this programme and wider national healthy lifestyle issues can be made. If the Vascular Risk Project is agreed by WAG there is likely to be value in reconvening the Public Engagement Work Stream Group to advise on methods of promoting public and professional engagement. Engagement of Health Professional Specialist Bodies, Employers, Community Groups, Users (including Voluntary / Groups / Faith Groups) should also be considered in development and promotion of any campaign. Programmes should be based on common factors in Behaviour Change Theories (see appendix 4). Consideration should be given to establishing a multi-faceted approach to engagement including primary care, pharmacy, occupational health, community centres and health initiatives amongst the unemployed and homeless. Engagement and marketing/promotion should be targeted at sectors of population based on evidence of effectiveness and sub-group analysis of the expressed needs and influences for each sector: General population Those requiring specific engagement a.vulnerable groups* b. High risk groups** Consideration should be given to the development and piloting of marketing materials to those segments of society for which they will be used use stakeholder groups to inform (including Welsh-speaking and Asian language groups). The impact of these initiatives should be formally assessed The launch of the programme should be on a national scale and involve a publicity campaign, The timing of the launch should be coordinated so as not to clash and compete with other large scale health initiatives in Wales *Prisons, travellers, armed forces, ethnic minorities, mental illness, learning/sensory disability, homeless **Linked to socio-economic deprivation, sedentary occupations & unemployed, certain ethnic minorities, long term mental health patients 6. Current complexities and limitations: Principles of vascular assessment A vascular assessment programme should aim to reduce inequalities in health. Opportunistic assessment has been found to target the worried well. In Individuals who are harder to engage and 14

30 are recognised as having more unidentified pathology there is a greater potential health gain from identifying these problems providing those individuals are motivated to change behaviour. Vascular assessment should be undertaken on an appropriate target group. People who are known to have coronary heat disease, cerebrovascular disease, peripheral vascular disease, diabetes and chronic kidney disease are already receiving management for their conditions according to existing care pathways and should be excluded from vascular assessment. Other individuals may also be identifiable as being very low risk by virtue of information contained in their medical records Data from vascular assessment should be stored and shared with the individual and their general practitioner. A centralised database with appropriate access would reduce the chances of duplication of tests but would need to take into consideration data protection, consent to store and use data at assessment. The production of a written report in terms of patient empowerment and engagement is recognised. Mechanisms for the evaluation and audit of data should be established Individuals should receive appropriate advice about vascular risk and lifestyle There is much work already being done in Wales to provide advice and support to people at risk of vascular disease but this is not being done in a consistent and systematic way. The costs to the NHS in Wales of providing vascular assessment should be considered. These costs will depend on the number of people offered assessment, the cost of each assessment and the cost of providing further management to those who have problems identified. Piloting of innovative systems should be initially undertaken, ideally with initial investment in deprived areas, in order to optimise the delivery model and evaluate costs and clinical/cost effectiveness. 7. The economic case for vascular risk assessment policy Economic modelling of the clinical and cost effectiveness of a systematic, coordinated approach to assessing the risk of vascular disease has been undertaken by the NHS Vascular Programme in England. The modelling work has demonstrated high levels of both clinical and cost effectiveness against a range of assumptions when this approach is applied to all those aged years. In England it is estimated that the programme has the potential to eventually: Prevent at least 9,500 heart attacks and stokes a year (2,000 of which would be fatal); Prevent at least 4,000 people a year from developing diabetes; and Detect at least 25,000 people a year earlier with diabetes or kidney disease It is recommended that this modelling is applied to the population of Wales to provide estimates of clinical and cost effectiveness. Professional Framework If we are to strengthen the professional framework it is necessary to integrate provision of primary, secondary and specialist services. 15

31 Appendix 1 Terms of Reference The multidisciplinary Vascular Risk Project Group should review the current provision of vascular risk assessment and management in Wales, to provide expert opinion, advise on policy development in this complex cross cutting policy arena and to recommend a future model/s to reduce the number of people developing vascular disease and complications associated with the early development of long term conditions like diabetes, heart disease, stroke and renal disease. The development of this work should take into account: 1. The reconfiguration of NHS Wales and the new service planning system 2. The strategic development of primary, secondary and tertiary care and management of people with chronic conditions in Wales 3. The strategic development of information management and technology in Wales Specific Tasks This group will: Assess the baseline review of the current status of vascular risk in Wales Identify the current national evidence base against the baseline review of the management of vascular risk, including work on service models developed by the National Screening Committee. Make recommendations to the Minister by June 2009 on the need for and scope and cost of a high quality, appropriate, safe and sustainable vascular risk assessment and management service model for Wales. Method of working The Project Group will set up sub groups to carry out specific tasks The Project Group will establish reference groups for clinical, patient and voluntary sector engagement. The Project Group will report to the Head of Major Health Conditions Branch in the Welsh Assembly Government, who will brief the Minister for Health and Social Services in Wales on progress and the Group s recommendations The Project Group will work via as much as it can and meet according to the required delivery of the project work: 3 monthly initially then 6 monthly once the work programme is agreed and being monitored Project management for the group will be provided by the Lead Coordinator for Vascular Disease for WAG The groups running costs will be met by the Welsh Assembly Government but must not exceed the annual allocation. The Project Group will only meet expenses incurred by non NHS Wales s staff and GP locum fees. 16

32 Chair of the project Group Professor Julian Halcox Professor of Clinical Cardiology at Cardiff University and Honorary Consultant Cardiologist at University Hospital of Wales. A general cardiologist with a specialist interest in prevention of arterial disease. His research interests are wide ranging but focused on understanding mechanisms of accelerated preclinical vascular disease to inform novel therapeutic strategies. He is also very interested in the application and development of non-invasive clinical tools for improving understanding of vascular pathophysiology and CVD risk assessment. He believes his primary role as Chair of Clinical Cardiology in Cardiff University is to strengthen academic links between NHS clinicians and University Scientists within Wales, with a particular emphasis on improving understanding, prevention and treatment of arterial disease. Professor Halcox is: Member of Wales Heart Research Institute Executive Board Director of the newly commissioned Cardiovascular Research Group Cymru (a WORD/ NISCHR -Funded RRG) Chairman of the Heart Research Fund for Wales Vice Chairman of Cardiff University Cardiovascular Sciences Interdisciplinary Research Group Member of the Basic Sciences Nucleus of the European Association for Cardiovascular Prevention and Rehabilitation (European Society of Cardiology) Member of the EACPR EuroPrevent Scientific Program and Prevention Implementaion Committees (2008-) Member of Guidelines Committee EACPR (2007-8) Member of the American Heart Association Council on Atherosclerosis, Thrombosis and Vascular Biology, the Welsh Cardiovascular Society and the Vascular Biology Working Group Fellow of the Royal College of Physicians. Membership Professor Aled Phillips Professor Steve Bain Dr Alan Rees Dr Gill Richardson Dr Armon Daniels Dr Philip Thomas Dr Philip Evans Dr Anne Freeman Mr Dean Williams Dr Anthony Davies Dr Simon Williams Dr David Grant Professor of Nephrology, Cardiff University Professor of Medicine (Diabetes), Swansea University & Chair of Work Stream 1 (Risk Assessment Protocol Development) Consultant Diabetologist, University Hospital of Wales, Chair & Chair of Work Stream 2 (How to Manage At Risk Patients) Consultant in Public Health & Chair Work Stream 3 (Social Engagement) General Practitioner & Chair of Work Stream 4 (Where & How to conduct screening?) Consultant Cardiologist, ABM University NHS Trust Consultant Diabetologist, Cwm Taf NHS Trust Consultant Stroke Physician Consultant Vascular Surgeon General Practitioner, GPC Wales Head of Sport Health & Exercise Science, University of Glamorgan General Practitioner, GPC Wales 17

33 Mrs Eileen Munson Ms Nicola Davis Mr Steve Simmonds Mr Paul Smith Mrs Elaine Tanner Ms Jeannie Wyatt-Williams Mrs Jocelyn Parkes Mr Leighton Veale Mrs Wendy Davies Senior Lecturer University of Glamorgan & Chair of the Welsh Practice Nurse Association Consultant Nurse for Stroke in Primary Care Community Pharmacy Wales BHF Cardiac Rehabilitation Specialist Nurse Clinical Lead - Mid and South West Wales Cardiac Network, Chair - All Wales Cardiac Rehabilitation Working Group BHF Heart Health Co-ordinator, Wales National Exercise Referral Coordinator Principal Policy Advisor, Royal Pharmaceutical Society Policy Advisor, Stroke Association for Wales Director, Stroke Association for Wales Co-opted Work Stream members Professor Rhys Williams Professor in Public Health, Swansea University Dr Meurig Williams Consultant Diabetologist Ms Kerry Morgan Project Manager, Prosiect Sir Gar, Carmarthen Mrs Elizabeth Gould Programmeme Coordinator for Cardiac Networks Coordinating Group Dr Rosemary Fox Deputy Director Screening Services Wales Dr Carolyn Lester Lead for Health Inequalities & Equity, NPHS Professor Lawrence Moore Mr Malcolm Ward Mrs Susan Sroczynska Senior Public Health Nurse Mr Paul Harris Ms Anne Hinchliffe Consultant Pharmacist in Public Health, NPHS Ms Sarah Scutt Specialist Dietitian Dr Gwylim Davies General Practitioner, special interest in Occupational Health Mr Gareth Davies Patient Representative Mrs Janet A Williams Patient Representative The group reports to the Welsh Assembly Government (WAG), Vascular Policy Group whose members include: Professor Mike Harmer Deputy Chief Medical Officer (now Dr Stephen Hunter) Dr Jane Wilkinson Deputy Chief Medical Officer Ms Cathy White Head of Major Health Conditions Dr Karen Gully Senior Medical Officer Mrs Jenny Frost Deputy Chief Scientific Advisor Mr Chris Tudor Smith Head of Health Improvement Division Mrs Helen Howson Head of Community Health & Strategic Development Mrs Helen Husband Lead Co-ordinator for Vascular Disease (NHS Secondee to WAG & Project Manager) 18

34 Appendix 2 Cardiovascular Disease Symptom Triage Algorithm Q. 1 Are you limited in how far you can walk without stopping? Low risk no yes No further enquiry yes Is this problem known to your GP? no Primary Care referral with or without further enquiry to focus referral What stops you? SOB Other Leg / foot pain Chest pain Q. 2 Have you had any problems with healing of wounds on your legs or feet? low risk no yes Primary care referral (incl. ABPI) 19

35 Appendix 3 ESC Relative Risk Tables 20