The Department of Health and the Welsh Assembly Government have asked the National Institute for Clinical Excellence (NICE or the Institute) to conduct an appraisal of myocardial perfusion scintigraphy for the diagnosis and management of coronary artery disease and provide guidance on its use to the NHS in England and Wales. The Appraisal Committee has had its first meeting to consider both the evidence submitted and the views put forward by the representatives nominated for this appraisal by professional organisations and patient/carer and service user organisations. The Committee has developed preliminary recommendations on the use of myocardial perfusion scintigraphy for the diagnosis and management of coronary artery disease.

This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website).

Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation.

The process the Institute will follow after the consultation period is summarised below. (For further details, see the Guide to the Technology Appraisal Process on the Institute's website).

• The Appraisal Committee will meet again to consider the original evidence and this Appraisal Consultation Document in the light of the views of the formal consultees.
• At that meeting, the Committee will also consider comments made on the document by people who are not formal consultees in the appraisal process.
• After considering feedback from the consultation process, the Committee will prepare the Final Appraisal Determination (FAD) and submit it to the Institute.
• Subject to any appeal by consultees, the FAD may be used as the basis for the Institute's guidance on the use of the appraised technology in the NHS in England and Wales.

The key dates for this appraisal are:

Closing date for comments: Friday 15 August 2003
Second Appraisal Committee meeting: Wednesday 27 August 2003

Details of membership of the Appraisal Committee are given in Appendix A and a list of the sources of evidence used in the preparation of this document is given in Appendix B.

Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation.

Myocardial perfusion scintigraphy using single photon emission computed tomography (SPECT) is recommended for use in the diagnosis and management of coronary artery disease, particularly under the circumstances described in 1.2 and 1.3.

SPECT before coronary angiography is recommended as the preferred initial diagnostic tool in people with a low likelihood of coronary artery disease and a low risk of future cardiac events.

SPECT is also recommended as the preferred initial diagnostic tool in people for whom stress electrocardiography poses particular problems of poor sensitivity or difficulties in interpretation, including women, patients who have undergone revascularisation procedures, patients with cardiac conduction defects (for example, left bundle branch block), people with diabetes and people for whom treadmill exercise is difficult or impossible. SPECT is also recommended in addition to stress electrocardiography in the assessment of prognosis following myocardial infarction.

Coronary artery disease (CAD) is the commonest cause of death in England and Wales. CAD is characterised by the development of lipid-laden coronary arterial plaques, which reduce the blood supply to the heart muscle. Significant CAD is defined as a stenosis (narrowing) of more than 70% of the diameter of at least one major epicardial artery segment or more than 50% diameter stenosis in the left main coronary artery.

Angina (chest pain) is the most common symptom of CAD. It is usually provoked by exercise and relieved by rest. Angina of rapidly increasing frequency, or experienced at rest, is called unstable angina. CAD can also lead to heart attack (myocardial infarction, MI) and sudden cardiac death. MI is characterised by severe chest pain persisting for at least 20 minutes, a rise in cardiac enzymes in the serum and/or an abnormal electrocardiogram (ECG).

It is estimated that there are about 2.65 million people in the UK who suffer from CAD, and of these 1.2 million have had an MI. Prevalence of CAD is lower in women than in men, increases with age, and varies across the UK and between different population groups. It is estimated that there were 275,000 heart attacks in the UK in 2001, and that 335,000 new cases of angina are diagnosed each year.

Preventative strategies for reducing the frequency of CAD include smoking cessation, diet modification, exercise, and treating conditions that exacerbate progression of the disease, such as hyperlipidaemia, hyperglycaemia, hypertension and blood hyper-coagulability. Medical treatment includes the use of nitrates, beta-adrenergic blockers and/or calcium channel blockers. In severe CAD, revascularisation may be required, using surgical procedures such as coronary artery bypass grafting (CABG) or via the use of percutaneous coronary intervention (PCI), commonly with the insertion of an intraluminal coronary stent.

The cost of CAD to the UK healthcare system in 1999 was estimated in the Assessment Report (see Appendix B) to be £1.7 billion; the total annual cost was around £7 billion when informal care and productivity losses were included. More than 378,000 inpatients were treated for CAD in NHS hospitals in 2000/2001. Approximately 28,500 CABG and 39,000 PCI procedures are performed each year in the UK.

The individual likelihood for CAD can be estimated from age, gender, ethnic group, family history, existence of symptoms, associated comorbidities and the results of tests such as resting electrocardiography (rECG). rECG is a commonly used test because it is readily available in primary care and is inexpensive, but because it does not exclude CAD, it is of limited diagnostic value. Stress ECG (sECG) and coronary angiography (CA) are commonly used in clinical practice for the diagnosis of CAD.

sECG is usually recorded while the person exercises on a treadmill. If exercise is not possible, cardiovascular stress can be induced by pharmacological agents, for example adenosine or dobutamine. However, sECG has been considered a poor diagnostic test in low-risk populations and can lead to non-diagnostic (indeterminate) results.

In CA, a cardiac catheter is manipulated into the heart from a vein or artery in a limb. A contrast medium is injected through this catheter, and progress of the medium is monitored by a rapid series of X-rays. CA provides mainly anatomical information and is used to measure the degree of stenosis. It is considered the 'gold standard' for defining the site and severity of coronary artery lesions. However, CA findings are not always a reliable indicator of the functional significance of a coronary stenosis. Routine use of CA without prior non-invasive testing is not advisable, because of its high cost and associated mortality and morbidity. Potential complications include non-fatal MI (0.1%), cerebrovascular accidents (0.1%) and death (0.1-0.2%).

Other frequently used non-invasive techniques include myocardial perfusion scintigraphy (MPS) and echocardiography. Imaging techniques such as magnetic resonance imaging and positron emission tomography are used less frequently.

MPS involves the intravenous injection of small amounts of a radioactive tracer to evaluate perfusion of living cardiac muscle via the coronary arteries after stress and at rest. After injection, the tracer is extracted by cardiac muscle cells, and its distribution within the myocardium is imaged using a gamma camera. Three tracers are commercially available in the UK: thallium?201 thallous chloride, technetium?99m 2-methoxy-isobutyl-isonitrile, and technetium?99m 1,2-bis(bis[2-ethoxyethyl]phosphino)ethane. MPS provides more detailed information about myocardial function than sECG and CA, and it is non-invasive. Cardiovascular stress can be induced by exercise as in sECG, but is most commonly induced by pharmacological agents.

MPS was originally developed as a planar imaging technique, but single photon emission computed tomography (SPECT) is usually used in current clinical practice. In SPECT, the camera rotates around the patient for 10-20 minutes and the raw data are processed to obtain tomographic images of the myocardium. The stress and rest images are normally separated by 3-4 hours, but the total patient contact time for stress induction, injection and image acquisition is approximately 45 minutes.

Homogeneous uptake of tracer throughout the myocardium indicates the absence of clinically significant infarction or coronary stenosis. A defect in the stress images that normalises in the rest images usually corresponds to a significant coronary stenosis. A defect in both stress and rest images indicates an area with loss of viable myocardium, such as after MI.

Two technical improvements to SPECT were also considered in this appraisal. Attenuation-corrected SPECT compensates for the fact that many emitted photons never reach the detector as a result of interactions with body tissues. ECG-gated SPECT is synchronised with the patient's ECG, thereby minimising artefacts caused by cardiac motion. Also, left ventricular ejection fraction can be measured at rest with ECG-gated SPECT.

The complication rates for SPECT are no different from sECG, and are usually related to exercise or pharmacological stimulation, with a procedure-related mortality of around 0.01% and a morbidity of around 0.02%. The radiation exposure from SPECT is similar to the exposure from uncomplicated CA.

The cost of a SPECT scan is estimated to be around £265, whereas the costs for sECG and CA are £104 and £1103, respectively (2002 NHS reference costs).

The Appraisal Committee considered evidence from a number of sources (see Appendix B).

The Assessment Report and the submissions reviewed the literature and focused on two aspects separately: the diagnostic performance of SPECT, and its long-term prognostic value. For practical and ethical reasons, randomised, blinded clinical trials were not available. Much of the evidence consisted of non-randomised, open observational (both prospective and retrospective) studies, with several studies using a comparative design.

Diagnostic performance

The diagnostic performance of SPECT was expressed as sensitivity and specificity. Sensitivity is defined as the ratio of true-positive results to all positives (that is, to the sum of true-positive plus false-negative results). Specificity is defined as the ratio of true-negative results to all negatives (that is, to the sum of true-negative plus false-positive results).

The Assessment Report reviewed 21 studies with 100 or more patients that evaluated the sensitivity and specificity of both SPECT and sECG in the diagnosis of CAD compared with CA. Median sensitivity values for SPECT were higher than those for sECG in all studies (SPECT: 81% for the largest subcategory of studies, with a range of 63-93%; sECG: 65% for the largest subcategory of studies, with a range of 42-92%). However, the results were not pooled because of the heterogeneity across the different studies. Median specificity values were similar for SPECT (65%, range 10-90%) and sECG (67%, range 41-88%).

The submission from the professional groups reviewed the diagnostic performance of SPECT only (compared with CA) from 62 studies. Because of differences in inclusion criteria, only two of these studies were also included in the Assessment Report analysis. There was considerable variation in study size, quality and design, but weighted means for sensitivity and specificity were reported to be 86% and 74% respectively. The manufacturer's submission quoted one publication with sensitivity and specificity for SPECT reported as 91% and 89% respectively, and the American College of Cardiologists/American Heart Association Task Force guideline, with average sensitivity and specificity reported as 89-90% and 70-76% respectively.

For the long-term prognostic value of SPECT, the Assessment Report included a systematic review of 46 observational studies.

In the 20 studies that provided general prognostic information, cardiac event rates (defined as cardiac mortality or non-fatal MI) were significantly higher for patients with abnormal SPECT scans than for those with normal scans. An abnormal SPECT result was associated with an annual cardiac event rate of 6.7%, whereas a normal scan was associated with an annual cardiac event rate of 0.7% (data from meta-analyses of 15,000 and 20,963 patients respectively).

The proportion of normal angiograms was lower in patients who were referred to CA after a positive SPECT than in patients referred directly for CA (two studies: 33% versus 43% [4688 patients], and 18% versus 33% [6800 patients] respectively).

However, the rate of subsequent revascularisations was lower for the SPECT-CA strategy (13-27%) than the direct CA strategy (16-44%) (data from three studies with a combined total of approximately 11,000 patients).

In studies where it was possible to analyse the contribution of different clinical parameters to the prediction of clinical outcomes, it was found that SPECT provided independent prognostic information for predicting MI, and had an additional value over clinical and sECG data that was maintained at long-term follow-up.

In several studies that investigated whether an abnormal SPECT scan was a predictor of cardiac death, the relative risk or odds ratios were calculated depending on study design. In all studies an abnormal SPECT scan was described as an independent, main or statistically significant predictor of cardiac death. In four studies, with patient numbers ranging from 176 to 947, the relative risk ranged between 1.1 and 17.6. In two studies, with patient numbers of 248 and 1182, the odds ratios were reported to be 2.8 and 4.8 respectively.

SPECT also provided independent prognostic information in the following subgroups: women (five studies), patients post-MI (four studies), patients who had undergone PCI or CABG (three studies), medically treated patients with left main and/or three-vessel CAD (one study), patients hospitalised with angina who had a normal or non-diagnostic sECG (one study), and patients with diabetes (two studies).

Two studies found ECG-gated SPECT to be more sensitive than non?ECG-gated SPECT, but with slightly lower specificity. Also, ECG-gated SPECT provided incremental prognostic information in patients with known or suspected CAD that was better than perfusion data alone. One study compared SPECT with attenuation-corrected SPECT and reported that attenuation correction had a significant impact on the assessment of the severity and extent of MI.

The search strategy used in the Assessment Report did not identify any studies that evaluated the role of SPECT in the context of rapid access chest pain clinics or in pre-operative risk assessment of patients undergoing major surgery who were potentially at risk of coronary events. However, the professional groups' submission lists 20 studies on SPECT in pre-operative risk assessment, and emphasises the acknowledged role of SPECT for this indication in the USA.

In summary, as studies reviewed in the Assessment Report were carried out under a number of different clinical settings investigating different outcomes, it was not possible to summarise the effectiveness of SPECT in simple quantitative estimates. However, the evidence from the reviewed studies consistently suggested that SPECT provided valuable independent and incremental information predictive of outcome that helped to risk-stratify patients and influence the way in which their condition was managed.

The submissions from the professional groups and the manufacturer included reviews of a larger number of papers and, because of differences in the inclusion criteria, there was little overlap between the studies included in each of the three reviews. Despite the differences in the evidence base of the three reviews, the conclusions drawn were similar.

Cost effectiveness

The Assessment Group, the manufacturer and the professional group reviewed published cost-effectiveness studies. Also, the Assessment Group and the manufacturer provided new economic models.

The diagnostic strategies considered in both models were:

• sECG, followed by SPECT if sECG was positive or indeterminate, followed by CA if SPECT was positive or non-diagnostic (sECG-SPECT-CA)
• sECG, followed by CA if sECG was positive or non-diagnostic (sECG-CA)
• SPECT, followed by CA if SPECT was positive or non-diagnostic (SPECT-CA)
• direct CA (CA).
  

The key results were as follows:

• As prevalence of CAD increased, total cost increased and total number of QALYs gained decreased for each diagnostic strategy.
• At all prevalence levels of CAD the ordering of diagnostic strategies was the same, with sECG-SPECT-CA being the least costly and least effective, and with the lowest average cost per QALY. This implies that an incremental cost is paid for some incremental benefit when SPECT is not included.
• CA was the most costly and most effective strategy in both models and for all prevalence rates of CAD.
• Most incremental cost-effectiveness ratios (ICERs) were higher in the manufacturer's model than in the Assessment Report model. Apart from the ICER for direct CA compared with SPECT-CA at low and 30% prevalence of CAD, all ICERs calculated were less than £24,000

At higher prevalence levels, the ICERs were generally improved. For example, at 80-85% prevalence, the move to the most effective strategy (CA) involved a modest extra cost per additional QALY gained (£942 in the Assessment Report and £4482 in the manufacturer's submission) compared with SPECT-CA.

In a number of sensitivity analyses it was shown that the results varied considerably depending on the sensitivity or specificity values entered for SPECT and sECG. When the impact of the additional independent information provided by SPECT was explored by increasing the proportion of SPECT positives whose condition could be satisfactorily managed medically, ICERs generally decreased. All ICERs increased when the time horizon was less than 15 years. In the subgroup analysis for women the SPECT-CA strategy dominated both the sECG-CA and CA strategies.

Consideration of the evidence

The Committee reviewed the evidence available on the clinical and cost effectiveness of myocardial perfusion scintigraphy for the diagnosis and management of CAD, having considered evidence on the value placed by users on the benefits of myocardial perfusion scintigraphy for the diagnosis and management of CAD, from people with CAD, those who represent them, and clinical experts. It was also mindful of the need to ensure that its advice took account of the efficient use of NHS resources.

The Committee considered the evidence submitted on the diagnostic performance of SPECT indicating that overall it is more sensitive than sECG. However, the Committee appreciated that considerable uncertainty remains over the true values for sensitivity and specificity of SPECT. In particular, trials that assessed these values were subject to referral bias in that only SPECT-positive cases were referred for CA, which was assumed to be the 'gold standard'. Additionally the Committee was aware that CA does not always provide the fullest evaluation of the patient with CAD, particularly where information relating to myocardial perfusion and function are considered important for the establishment of prognosis and management.

The Committee heard from the clinical experts that SPECT is of value at all levels of likelihood for CAD, because it provides both diagnostic and prognostic information of high accuracy. The experts indicated that, if SPECT and sECG were equally accessible in the NHS, there would be a case for the preferential use of SPECT, given its higher diagnostic accuracy compared with sECG. This was especially so in certain groups of patients. However, because of the currently limited availability of SPECT in the UK, the use of SPECT should be particularly directed to patient groups for whom it provides the greatest additional benefit in terms of diagnosis and prediction of prognosis.

The Committee recognised that in clinical practice, sECG is likely to remain the most commonly used test, especially given the currently limited availability of SPECT. The Committee also recognised that there are circumstances where the information from sECG was important, as in the evaluation of the overall exercise performance of patients with CAD.

The Committee reviewed the cost-effectiveness modelling. They noted that because the difference in QALYs derived between the different investigational strategies was small, and the disutility of CA was not included in the models, the conclusions of cost-utility differences between diagnostic strategies (see Section 4.2.5) should be interpreted with caution. However, the Committee considered that overall SPECT was cost effective across a wide range of clinical situations.

The Committee further considered that, from both the clinical and cost effectiveness points of view, the absolute 'value' of SPECT as an appropriate diagnostic tool depends on the likelihood of the presence of CAD in the target population under investigation. Thus a diagnostic strategy of using SPECT before CA is clearly preferred on cost-effectiveness grounds in individuals with a low likelihood of CAD and consequently low risk of future coronary events. However, as the likelihood of CAD increased, the differences in the incremental cost effectiveness for the different testing strategies decreased. Thus, at high likelihood of CAD, a strategy where direct CA is preferred over SPECT-CA could be considered more appropriate.

The Committee was advised by the experts that SPECT scanning is particularly useful as an initial diagnostic tool in people for whom sECG poses particular problems of poor sensitivity or difficulties with interpretation. These groups include women, patients who have had revascularisation, patients with cardiac conduction defects (such as left bundle branch block) and people with diabetes. SPECT also has an important role in assessment of CAD in patients for whom treadmill exercise is difficult or impossible, and in the full evaluation of prognosis following MI.

The Committee considered that increased provision of SPECT within the NHS over that currently available was desirable on the basis of this guidance. However, it recognised that more widespread use of SPECT would require an implementation strategy that may take several years to fulfil and would need a significant increase in the availability of both equipment and trained staff. The Committee therefore concluded that the increasing use of SPECT should initially be targeted at those groups for whom it provides the greatest benefit in terms of cost effectiveness, as expressed in the guidance section. However, in the Committee's view, SPECT is overall a clinically effective and cost-effective technique for the diagnosis and management of CAD and therefore it recommended that in situations where both sECG and SPECT are equally available, the use of SPECT before CA should be the preferred strategy.

The value of SPECT in relation to other tests of cardiac function such as stress echocardiography, magnetic resonance imaging and positron emission tomography should be investigated in order to inform future assessment of the needs of the NHS for the investigation of CAD patients.

Preliminary views on the resource impact for the NHS

This section outlines the Appraisal Committee's preliminary assessment concerning the likely impact on NHS resources if the recommendations in Section 1 were to be implemented. When guidance is issued, this section is intended to assist NHS planners and managers in its implementation. Therefore the Institute particularly welcomes comments and information from those who would be involved in the implementation of the guidance so that this section can be made as helpful and robust as possible.

According to the British Nuclear Cardiology Society survey, there were about 1200 SPECT scans per million population in the UK in 2000. The average waiting time for a scan was 20 weeks. The submission prepared jointly by the professional groups estimated the optimal level of SPECT provision to be around 4000 SPECT scans per million population per year, calculated on the basis of current revascularisation and CA rates. Furthermore, it suggested that suitable waiting times would be 6 weeks for routine scans and 1 week for urgent tests.

In order to achieve these levels of both adequacy of provision and speed of accessibility, it is estimated that 73 additional gamma cameras would be needed in England and Wales at a capital cost of around £18 million. This is based on providing 2000 scans per annum per gamma camera, and the unit cost of £250,000 per camera.

Because of the current lack of trained personnel, these levels of provision could take longer than 5 years to achieve, and so the total cost to the NHS is likely to be phased over several years. Once the steady state is achieved, based on the provision of 4000 SPECT tests a year, the estimated annual revenue cost would be approximately £27 million (equivalent to £185 per study).

This section presents proposals for implementation and audit based on the preliminary recommendations for guidance in Section 1.

NHS hospitals and all clinicians who care for people with CAD should review current diagnostic options available to take account of the guidance set out in Section 1.

To measure compliance locally with the guidance, the following criteria could be used. Further details on suggestions for audit are presented in Appendix C.

A SPECT scan is carried out for individuals in the following circumstances.

• As an initial diagnostic tool before CA for an individual who has a low likelihood of CAD and a low risk of future cardiac events.
• As an initial diagnostic tool for an individual when sECG poses problems of poor sensitivity or difficulties in interpretation
• As an initial diagnostic tool for an individual who has diabetes and for whom treadmill exercise is difficult or impossible.
• To assess prognosis for an individual who has had an MI.

Local clinical audits on the care of patients with CAD also could include criteria for the management of CAD based on the national standards, including standards in the NSF.

The Institute issued guidance on the use of coronary artery stents in April 2000:

National Institute for Clinical Excellence (2000) The use of coronary artery stents in ischaemic heart disease. NICE Technology Appraisal Guidance No. 4. London: National Institute for Clinical Excellence.

This guidance is currently being reviewed and the reviewed guidance is expected to be issued in October 2003. All documents and further details available from: www.nice.org.uk

The Institute issued the guidance on the use of GP IIb/IIIa inhibitors in September 2002:

National Institute for Clinical Excellence (2002) Guidance on the use of glycoprotein IIb/IIIa inhibitors in the treatment of acute coronary syndromes. NICE Technology Appraisal Guidance No. 47. London: National Institute for Clinical Excellence.

All documents and further details available from: www.nice.org.uk

The Institute issued the guidance on the use of drugs for early thrombolysis in October 2002:

National Institute for Clinical Excellence (2002) Guidance on the use of drugs for early thrombolysis in the treatment of acute myocardial infarction. NICE Technology Appraisal Guidance No. 52. London: National Institute for Clinical Excellence. All documents and further details available from: www.nice.org.uk

The Institute issued a clinical guideline on prophylaxis for patients who have experienced a myocardial infarction in April 2001:

National Institute for Clinical Excellence (2001) Prophylaxis for patients who have experienced a myocardial infarction. NICE Inherited Clinical Guideline A. London: National Institute for Clinical Excellence. All documents and further details available from: www.nice.org.uk

The Institute is currently preparing a clinical guideline on heart failure: the diagnosis and management of chronic heart failure in primary and secondary care. This guideline is expected to be issued in July 2003.

The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated Assessment Report, and decide whether the technology should be referred to the Appraisal Committee for review.

It is proposed that the guidance on this technology is reviewed 3 years after the issue date.

Professor David Barnett

Chairman, Appraisal Committee

July 2003

NOTE The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members who took part in the discussions for this appraisal appears below. The Appraisal Committee meets twice a month except in December, when there are no meetings. The Committee membership is split into two branches, with the chair, vice-chair and a number of other members attending meetings of both branches. Each branch considers its own list of technologies and ongoing topics are not moved between the branches.

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website.

Dr A E Ades

MRC Senior Scientist, MRC Health Services Research Collaboration, University of Bristol

Dr Tom Aslan

General Practitioner, Stockwell, London

Professor David Barnett (Chair)

Professor of Clinical Pharmacology, University of Leicester

Dr Sheila Bird

MRC Biostatistics Unit, Cambridge

Professor Rosamund Bryar

Professor of Community & Primary Care Nursing, St Bartholomew's School of Nursing & Midwifery, London

Dr Karl Claxton

Health Economist, University of York

Dr Trevor Gibbs

Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline, Greenford

Mr John Goulston

Director of Finance, St Bartholoemew's Hospital & the London NHS Trust

Professor Philip Home

Professor of Diabetes Medicine, University of Newcastle upon Tyne

Mr Muntzer Mughal

Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust, Chorley

Judith Paget

Ms Anne Smith

Consultant Haematologist, Royal Hallamshire Hospital, Sheffield

Each appraisal of a technology is assigned to a Health Technology Analyst and a Technology Appraisal Project Manager within the Institute.

Dr Elisabeth George

Technical Lead, NICE project team

Dr Dogan Fidan

Technical Lead, NICE project team

Kathleen Dalby

Project Manager, NICE project team

The following documentation and opinion was made available to the Committee:

A.

The Assessment Report for this appraisal was prepared by the Health Services Research Unit in collaboration with the Health Economics Research Unit, the Department of Public Health, Institute of Applied Health Sciences, and the Cardiology Research Group, University of Aberdeen, and the Department of Bio-Medical Physics and Bio-Engineering, Grampian University Hospitals NHS Trust.

Systematic review of the effectiveness and cost-effectiveness, and economic evaluation, of myocardial perfusion scintigraphy for the diagnosis and management of angina and myocardial infarction.

Graham Mowatt, Luke Vale, Miriam Brazzelli, Rodolfo Hernandez, Alison Murray, Neil Scott, Cynthia Fraser, Lynda McKenzie, Howard Gemmell, Graham Hillis, and Malcolm Metcalfe, May 2003.

The following organisations accepted the invitation to participate in this appraisal. They were invited to make submissions and comment on the draft scope and Assessment Report. They are also invited to comment on the Appraisal Consultation Document (ACD) and consultee organisations are provided with the opportunity to appeal against the Final Appraisal Determination.

I Manufacturer/sponsors:

• Amersham Health
  
• Ashby GB Ltd
  
• Bartec Medical Systems (UK) Ltd
  
• GE Medical Systems
  
• Philips Medical Systems
  
• Siemans
  
• Tyco Healthcare UK Ltd
  

II Professional/specialist and patient/carer groups:

• Action Heart
  
• Association of British Health-Care Industries
  
• British Cardiac Patients Association
  
• British Cardiac Society
  
• British Cardiovascular Interventional Society
  
• British Heart Foundation
  
• British Nuclear Cardiology Society
  
• British Nuclear Medicine Society
  
• Department of Health
  
• Fareham and Gosport Primary Care Trust
  
• Maidstone Weald Primary Care Trust
  
• Royal College of Physicians
  
• Royal College of Radiologists
  
• Society for Cardiological Science and Technology
  
• Welsh Assembly Government
  

III Commentator organisations (without the right of appeal):

• NHS Information Authority
  
• NHS Confederation
  
• NHS Quality Improvement Scotland
  
• Institute of Physics and Engineering in Medicine
  
• Institute of Nuclear Medicine
  
• NHS Purchasing and Supply Agency
  
• Cochrane Heart Group
  

The following individuals were selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups. They participated in the Appraisal Committee discussions and provided evidence to inform the Appraisal Committee's deliberations. They gave their expert personal view on myocardial perfusion scintigraphy for the diagnosis and management of coronary heart disease by attending the initial Committee discussion and/or providing written evidence to the Committee. They are invited to comment on the ACD.

• Dr Constantinos Anagnostopoulos, President, British Nuclear Cardiology Society and Consultant & Honorary Senior Lecturer of Nuclear Medicine, Department of Nuclear Medicine, Royal Brompton Hospital, London
  
• Professor SR Underwood, Professor of Cardiac Imaging, Royal Brompton Hospital, London

An audit on SPECT could be carried out to ensure that the technique is used appropriately.

An audit could be carried out on people with coronary artery disease (CAD) who are referred for coronary angiography (CA) or stress ECG (sECG) and on people with myocardial infarction (MI).

The measure that could be used in an audit of SPECT is as follows.

1. A SPECT scan is carried out for an individual:

a. who has a low likelihood of CAD and a low risk of future cardiac events

b. for whom sECG poses problems of poor sensitivity or difficulties in interpretation

c. who has had an MI

100% of people who meet any of 1a-c

None

Clinicians will need to agree locally on how the likelihood of CAD, the risk of future cardiac events, and the problems of sensitivity or interpretation are documented for audit purposes.

For 1b, people for whom there may be problems of sensitivity or interpretation may include women, people who have had revascu-larisation procedures or who have cardiac conduction defects (for example, left bundle branch block) or people who have diabetes or for whom treadmill exercise is difficult or impossible.

Compliance (%) with each measure described in the table above is calculated as follows.

Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.