Cardiac interventions: a 2007 update

Advisory report | 18-01-2007

The majority of such symptoms arise when blood vessels in the coronary artery system develop a stenosis, as a result of calcification. This is referred to as coronary heart disease. This restricts the blood flow to part of the heart muscle, which then dies from lack of oxygen. There is also a range of other, less commonly occurring disorders, such as: cardiac arrhythmias, heart valve insufficiencies, aneurysms of the thoracic and abdominal aorta, chronic heart failure and congenital cardiac defects.

The treatment of coronary problems aims to relieve the stenoses, and to restore blood flow through the coronary arteries (revascularisation). The most common approach involves either a coronary artery bypass graft (CABG) or a percutaneous coronary intervention (PCI). The latter procedure is also referred to in the Netherlands as “dotteren” (named after C.T. Dotter, one of the pioneers who developed the procedure). A wide range of treatment options are available for the other disorders.

From time to time, of course, all such treatments are affected by new developments, such as the availability of new techniques. Accordingly, it is essential that quality, accessibility, and efficiency be constantly monitored. This prompted the Minister of Health, Welfare and Sport to ask the Health Council of the Netherlands to produce an advisory report concerning the best treatment options. The first two questions to be answered, therefore, are:

• Given the current level of knowledge, which special interventions offer the best options for the treatment of cardiovascular diseases?
• In the interests of safeguarding quality, accessibility, and efficiency, what conditions should be attached to the use of these procedures?

However, this is not the only area to be affected by new developments. One of these is the introduction of the new health care system in the Netherlands. In that context, the Minister wanted to know whether there was a need to review the current system for providing permits for specialized medical procedures. The government is currently issuing Planning Decrees for procedures that fall within the scope of the Special Medical Procedures Act (WBMV). The Minister would like to know whether deregulation in this area is possible. Accordingly, the third question is as follows:

• Is it advisable to scrap the permit requirement for those cardiac interventions which are still subject to the WBMV assessment regime?

General recommendations

The response to the three requests for advice has generated summaries of the current state of knowledge associated with each of the treatment options, and of the best quality assessment and management regime. It has also listed the general trends and points of special interest in the field of special cardiac interventions. A summary of the five major recommendations is given below. This is followed by separate discussions of the individual disorders and therapies, addressing the best approach and the most appropriate permit policy in each case.

1 Expand the number of specialised treatment centres

An examination of the full range of treatments for patients with cardiovascular disease reveals a steady, occasionally rapid increase in the number of treatments and interventions that are both available and in actual use.

This is partly the result of growing incidence, i.e. the number of new cases seen each year is rising. This trend is associated with the aging of the population, as more elderly age groups experience a higher incidence of symptoms of cardiovascular disease. In addition, there is an increasing incidence of specific disorders, such as diabetes mellitus, which in turn further exacerbate the risk of cardiovascular diseases. On the other hand, the increased number of interventions for cardiovascular disease is also a result of the expanded range and increasing success of therapeutic options, particularly in the past ten years. This has enabled greater numbers of elderly patients and patients with additional diseases (comorbidity) to be treated more prudently and effectively. There was also an increase in the range of technical options available, as witnessed by the development of the implantable cardioverter defibrillator (ICD), the cardiac resynchronisation therapy pacemaker (CRT-P), and the use of systems designed to partially or completely replace the pumping function of the heart (ventricular assist devices). In addition, the timing of the intervention has shifted. These days, it is much more likely to take place at an earlier stage in the disease process. There is also a much greater focus on opportunities for improving the quality of the period of life remaining to individuals with heart disease. This applies, for instance, to patients in the final stages of chronic heart failure.

This increase in the number of patients with cardiovascular diseases and in the range of treatment options available to them demands an unremitting focus on expanding the number of specialised treatment centres. The central pillars in all of this are quality, efficiency, and accessibility.

2 Patient safety and treatment quality: a national registration system

The practice of specialised and relatively expensive forms of medicine such as open heart surgery, interventional cardiology, and the treatment of cardiac arrhythmias and congenital disorders, demands a sharply focused quality assurance policy. Accordingly, treatment centres will have to comply with certain minimum requirements regarding the number of qualified therapists, the available infrastructure, and an annual number of procedures that is consistent with a prudent approach to the work in hand. Individual professionals are expected to keep their qualifications for their healthcare duties current, by means of training, refresher courses, and by updating their skills. In the case of individual centres, every aspect of quality must be assessed by means of periodic external reviews. This type of quality control has already been introduced into the Netherlands.

However, the Netherlands still lacks a national registration system for data from all cardiac surgery centres and Percutaneous Coronary Intervention (PCI) centres. A registration system of this kind would make the treatment results per centre and per individual therapist more transparent. It would also enable these results to be assessed against accepted quality standards. Making the system more public and more transparent would bring benefits in terms of the quality of the procedures involved, and their safety for patients. Countries such as the United States and the United Kingdom have adopted similar systems (Public Report Cards), and have found them to be extremely useful. Another good example is the Danish National Register for cardiac surgery and PCI (Dansk Hjerte Register). This system contains full data on treatment and results, and it is accessible for public inspection.

A system of this kind needs to be developed in the Netherlands. It is up to those in the profession to establish such a system, and the government should facilitate the process. Participation in a registration system should be made compulsory, indeed it should be incorporated into the permit requirements.

3 Encourage integrated treatment

Until recently, in the case of patients with a coronary heart disease, it was usual for the heart surgeon to establish the indication for surgical intervention, in close consultation with the referring cardiologist. Next came the rapid, independent development of interventional cardiology, in which percutaneous catheter interventions (PCI and the use of stents – metal tubes inserted into blood vessels) partly replaced open heart surgery. Even then, however, it was still usual for cases to be discussed by a joint cardiac team. In the current permit system, and in accordance with professional guidelines, permission to carry out PCI procedures (also known as “dotteren”) is conditional on the presence of a cardiac surgery department within the same hospital.

However, the success of technical developments in the field of PCI has led to a situation in which emergency operations are less often necessary. Accordingly, experiments have been conducted in which PCI was carried out at hospitals in which cardiac surgery services were not available on-site, but were provided by a nearby heart surgery centre.

Cardiac teams normally conduct joint case evaluations in order to arrive at an appropriate treatment plan, however the decoupling of cardiac surgery and PCI described above makes this process more difficult. This is undesirable, for various reasons.

Firstly, current developments in interventional cardiology mean that the range of indications is being extended to include more complex procedures, and higher-risk patients. As a result of this, it appears that the percentage of emergency operations carried out is on the increase once again. This in turn makes it all the more desirable that a cardiac surgeon should be available, for both dialogue and surgery.

Secondly, developments in the field of cardiac arrhythmias (particularly in ICD implantation) actually require frequent consultation between the interventional cardiologist, the electrophysiologist, and the heart surgeon. This should result in selecting the best possible treatment strategy for the individual patient. A similar development can be seen in patients with chronic heart failure, where a range of treatment options is available. The same is true of patients with congenital cardiac defects who also require further procedures during adulthood. Furthermore, there is an ever increasing range of opportunities and situations in which the intervention involves both the heart surgeon and the interventional cardiologist. The logistics associated with integrated interventions of this kind are often very complex in nature. This requires prudent multidisciplinary consultations, and carefully tailored planning.

For these reasons, there is a growing need for heart patients to be treated in centres that are able and have the resources to provide all complex forms of care. Accordingly, integrated care in specialised centres should also become a major focal point in the policy. Environments such as this allow for close collaboration between those representing the various disciplines involved. It also allows them to fine-tune the details of the treatment with the relevant paramedical staff. This enables treatment to be better tailored to the “disease life-cycle” affecting individual heart patients. Rather than following a fixed procedure, this approach provides for an optimal treatment strategy in each stage of the disease process. This also means that patients themselves are involved in all aspects of the process. Furthermore, they are kept fully informed about the full range of treatment options available, including their advantages and drawbacks.

4 Organise cardiac care on a regional basis

As stated, in centres for the treatment of cardiac patients, close collaboration between the various specialists and specialisms involved is both desirable and necessary. Accordingly, care institutions will need to be better attuned to one another in the near future, in terms of their contributions to the treatment of heart patients within a single region. This certainly applies to the provision of care to patients suffering from acute infarctions. Situations of this kind demand optimum teamwork between PCI centres, other hospitals with acute care facilities, GPs, and ambulance services. A regional approach of this kind must also involve well organised, close collaboration between PCI centres without heart surgery facilities of their own, and heart surgery centres that will provide the requisite surgical backup. Another benefit of the regionalisation of cardiac care is that it enables chronic heart failure patients to be timely diagnosed and treated.

5 Maintain central control via the permit policy

Much of the care provided to patients with cardiovascular disease consists of interventions that are both acute and highly complex in nature. These often require extensive and costly human and material infrastructure. Such care must be provided efficiently, with a view to obtaining the best possible results, while preventing the associated costs from spiralling out of control. In the past, this requirement led to a situation in which centres for cardiac surgery and interventional cardiology were made subject to the provisions of the Special Medical Procedures Act (WBMV). Accordingly, the provision of this type of care requires a permit, which is granted by the government.

This instrument (the Planning Decree for special cardiac interventions) allows central government, in the person of the Minister of Health, Welfare and Sport, to exercise control over the quality and accessibility of such care (VWS02). This approach was a major factor in optimising the actual care provided to heart patients, both in terms of quality and geographical distribution.

The Minister has now asked whether it is possible, and indeed desirable, for direct government involvement in this matter to be either restricted or terminated completely. For each type of cardiac treatment, recommendations have been made concerning the desirability of maintaining this type of government control, or of dispensing with it completely. In general terms also, this question deserves careful consideration. The conclusion is that there are strong arguments against deregulation and in favour of maintaining the permit requirement for cardiac centres.

In the first place, the indications for treatment are still in a phase of rapid change, as a result of major developments in interventional cardiology, the treatment of cardiac arrhythmias, heart valve surgery, the treatment of heart failure, aortic surgery, and the care for adults with congenital cardiac defects.

Secondly, it is essential that there be accessible care facilities capable of offering round-the-clock care, since patients with an acute disorder now make up an increasing percentage of the total (especially coronary disorders, aneurysms of the thoraco-abdominal aorta, cardiac arrhythmias and heart failure). If this is to be achieved, regulation is indispensable.

Thirdly, there is an unequivocal and direct association between the number of procedures performed by an institution/therapist each year, and the results obtained. This necessitates the use of a quality policy in which a concentration of care facilities acts as a safeguard for the ability to meet stated quality criteria, such as a minimum number of procedures.

Fourthly, the granting of a permit can be linked to the mandatory use of a registration system for treatment outcome data. The availability of performance indicators is an essential ingredient of an effective quality policy.

Dispensing with the current permit policy would make it much more difficult to achieve these objectives. Accordingly, the general recommendation is that the current assessment and control regime should be maintained.

Recommendations per type of treatment

Currently, what are the best options for the treatment of the various types of cardiovascular disease? Is it possible to dispense with the permit requirement in these areas? These questions are answered below, for each individual disorder in turn. First, however, we will examine the issue of percutaneous coronary interventions. As a result of the extensive development that this area has undergone in recent years, such procedures merit separate consideration.

Treatment involving percutaneous coronary interventions (PCI)

During the last 20 years, another revascularisation technique has been developed in addition to the ‘classical’ surgical procedure (coronary artery bypass grafting - CABG). Known as balloon dilatation or PCI, this is performed by the cardiologist. In this procedure, intervention cardiologists make considerable use of stents. They may also use various other techniques to re-open a blocked vessel. These percutaneous coronary interventions (PCI’s) produce good results, with only a limited risk of complications. One problem is that, after a time, the treated artery may develop new stenoses (re-stenosis). This is seen in five percent to fifty percent of patients. The degree of risk involved is highly dependent on patient-based clinical factors, and on characteristics specific to the procedure in question.

The number of percutaneous coronary interventions (particularly balloon angioplasty) has increased more rapidly than was foreseen in a 1995 Health Council report on this subject. This procedure is increasingly being used in connection with arterial stenoses. It was anticipated that by 2000 a total of 12,000 PCIs would be carried out, however, the actual figure was 17,000. By 2005, this number had increased to 32,000. This figure is expected to increase still further during the next few years, to well over 40,000 interventions by 2010.

The main cause of this increase is that PCI has replaced surgical intervention (CABG) in patients with single-vessel stenosis, as well as those with multivessel stenosis. The use of stents has been a major development in this regard. This is due to the benefits of this technique in terms of reducing the risk of a recurrence of the stenosis (re-stenosis).

The growth in percutaneous coronary interventions has been accompanied by an increased requirement for a more effective dialogue and closer cooperation between interventional cardiologists and heart surgeons. This is a prerequisite for the integrated treatment of patients with complex disorders and a high level of risk. Accordingly, every effort should be made to achieve this goal. Despite the ever increasing opportunities for using PCIs, surgical interventions (CABG) can still provide better long-term treatment results for some patients (survival benefit, reduced risk of repeat interventions). It is essential that there be effective consultation in this regard, also involving the patient.

Here too, maintaining the requirements concerning the minimum number of procedures and the availability of interventional cardiologists remains essential. Clear criteria have been formulated for assessing the quality of PCI centres. The Health Council endorses the minimum figure of 600 procedures per annum, and the requirement that at least four interventional cardiologists should be available.

In addition, the anticipated increase to 40,000 PCIs means that capacity in the Netherlands needs to be expanded. An increase of this kind can best be carried out in stages. This means that, during the first phase (up to 2009), the remaining capacity of current centres (about 11,500 procedures) will be fully utilised. During this period, no new centres will be established. In the second phase (post 2009), the situation will need to be reassessed, to determine whether there is a requirement to expand capacity still further. If that does indeed prove to be the case, then a decision can be taken to establish new centres.

The latter option will have to be prepared and implemented at regional level. This will facilitate close collaboration at the level of primary health care (GPs and ambulance services) and secondary health care (PCI centres and cardiac centres with on-site heart surgery facilities).

If this process is to operate efficiently, then it is advisable that the current permit policy be continued. In that context, an advisory committee including government representatives and the professionals involved could be set up to assess the initiatives of candidate centres in the light of the regional vision.

The treatment of cardiac arrhythmias

Patients with cardiac arrhythmias now have a wide range of treatment options. These include antiarrhythmic surgery (maze procedure), invasive cardiology and electrophysiological therapy (catheter ablation, ICD implantation, and the use of resynchronisation pacemakers). Over the past 15 years, these treatments have substantially improved the prognosis of patients. Developments in clinical electrophysiology have been particularly important in this regard. In addition to elucidating the mechanisms which give rise to arrhythmias, researchers in this field have charted their various clinical forms (mapping). Catheter techniques and cardiac imaging have also played an important part in this improvement.

At the same time, the greatly expanded range of options means that fully integrated cardiac centres are now essential. In such institutions, heart surgeons and cardiologists collaborate to deliver the best possible treatment to patients with cardiac arrhythmias.

While the range of treatment options has increased, so has the incidence of this condition. In particular, there has been a sharp increase in the number of elderly patients with atrial fibrillation. Indeed, this condition has now become a major pubic health problem. Fortunately, the past ten years have seen substantial improvements in treatment results, both for patients with atrial fibrillation and those with ventricular arrhythmias.

Another development concerns the use of ICD’s in patients with arrhythmias who have survived an acute infarction, and who are at risk of suffering acute cardiac arrest (sudden death). In addition to its use in preventing a return of ventricular arrhythmias, an ICD is now also being successfully used in patients who are at risk of ventricular fibrillation (prophylactic ICD implantation). Chronic heart-failure patients who are at risk of sudden death from ventricular fibrillation now have the option of resynchronisation therapy (CRT, often in combination with an ICD).

The number of ICD and CRT treatments is expected to double during the next few years (from 2,100 in 2005 to 4,500 in 2010). The existing 16 centres have sufficient capacity to accommodate this growth. The anticipated growth in the number of catheter ablations (from well over 2,500 in 2005 to 4,500 by 2010) can initially be accommodated by the 11 existing centres that already have a permit. Capacity can be further expanded by upgrading the permits granted to the three existing centres that are restricted to ICD implantation.

In view of the rapid pace of development affecting the indications and techniques for cardiac arrhythmias, it is advisable to retain the permit requirement for treatment centres for the time being. In order to pursue a focused quality policy, it is necessary to set requirements for those centres where cardiac arrhythmias are treated. In addition to the presence of heart surgeons who specialise in antiarrhythmic surgery, there are a number of other stipulations. At least four cardiologists/electrophysiologists must be available, and the centre must conduct at least 60 ICD/CRT implantations and 60 catheter ablations per annum.

Treatment of coronary artery stenoses

Stenoses of the coronary arteries were traditionally treated by means of coronary surgery. Patients with stenoses of this kind experience severe chest pains (angina pectoris). They may also suffer an acute infarction. During open-heart surgery, small arteries taken from the patient’s chest, or from their lower arm or leg, are used to create a by-pass. By this means, the blood flow is restored (revascularisation). This classic operation (coronary artery bypass grafting - CABG) produces excellent results, but it still involves a certain surgical risk. The usual procedure for all patients for whom an operation of this kind is indicated, is to hold a joint meeting of the heart team, involving the cardiologist and the surgeon.

Comparative studies of coronary surgery and PCI show that, in patients with single-vessel and double-vessel stenoses, PCI (involving the use of stents) produces results that are just as good as those obtained by means of CABG. For this reason, preference is usually given to a PCI, given the limited risk of mortality and complications. Nevertheless, CABG has been shown to give better results in some patients with multivessel stenosis. A recent study, which analysed and compared the results of CABG and PCI, showed that, in the long-term, even patients with two-vessel disease and three-vessel disease have longer survival if they have an initial CABG. This approach enables repeated procedures (in connection with re-stenosis) to be avoided. This would suggest that, prior to carrying out a procedure (elective or otherwise), therapists should consult the patient when determining which procedure is to be preferred in that individual case.

About 16,000 open-heart operations and 32,000 PCI procedures are now carried out in the Netherlands each year. There has been no further increase in the number of coronary operations performed in recent years, while there continues to be a marked growth in the number of PCIs performed. At international level, the trend shows a decline in the number of CABGs.

One major new development is the combined use of interventional cardiology and coronary surgery, both being carried out in one treatment procedure (integrated intervention). This may involve a combination of PCI and coronary surgery, and/or heart-valve procedures, and/or procedures associated with arrhythmias. The advantage is a reduced surgical risk to these patients, who usually have a complex pathology.

For many years there was a lack of capacity in the Netherlands, which led to long waiting times for CABGs. Now, however, patients have good geographical accessibility to coronary surgery. Furthermore, virtually all centres now have waiting times of less than two months.

Accordingly, the situation pertaining to cardiac surgery in the Netherlands is stable, and poses few problems for patients. Nevertheless, it is still advisable to pursue a focused quality control policy, which also retains the permit requirement for centres. One remaining deficiency of this policy is that it does not provide for a centralised, public, national registration system for the results of open-heart surgery. A system of this kind would enable the results obtained by individual surgeons and centres to be assessed against the background of accepted standards.

The follow quality requirement governing the admittance of centres should be retained: at least 600 heart operations per annum, with each surgeon performing a minimum of 150 procedures per annum. Given the current collective labour agreements concerning workload, this means that at least four surgeons should be available within each centre.

In addition, the quality of care has the most to gain from a situation in which cardiac surgery and intervention cardiology are practised within a single centre (fully integrated cardiac centres). If, as a result of special circumstances (including those of a geographical nature), it is decided to establish PCI centres that do not include a heart surgery capability under the same roof (off-site centre), then there should be guarantees regarding effective cooperation with nearby heart surgery centres.

Treatment of valve disorders

Between 1992 and 2005, the number of heart-valve operations carried out in the Netherlands grew from well over 2,000 (19% of all open-heart operations), to around 5,000 (34% of all open-heart operations). The main cause of this increase was an expansion of the indication, which meant that elderly patients could also undergo surgery, more safely and with improved results. The influx of immigrants has also produced an increase in the number of rheumatic valve disorders.

A recent development in the treatment of valve disorders involves the use of combined procedures. This can mean that, in the course of a single operation, valve surgery is combined with arrhythmia surgery, for example. In heart-failure patients with a leaking mitral valve, a valve operation can be combined with coronary bypass surgery, or with a left ventricular reconstruction. This approach yields good results.

The indications for valve surgery, too, are still in a state of flux. One important development is that patients with heart valve deficiencies undergo surgery at an early stage in the disease process. This keeps the pumping function of the heart at a better level, resulting in an improved quality of life for the patient.

Meanwhile, it has also been found that heart-valve deficiencies can be successfully treated using percutaneous techniques, such as valve dilatation or a procedure to correct mitral valve leakage. However, this palliative treatment should still be seen as experimental. The same applies to percutaneous aortic valve implantation.

On average, as a result of all these developments, heart valve procedures have become increasingly complex and potentially risky. This demands a multidisciplinary approach by surgeons and cardiologists. This can best be guaranteed in fully integrated centres. To this end, the current permit policy is an effective instrument.

Treatment of heart failure

Chronic heart failure is a disorder of an aging population. The average age at which individuals are diagnosed with this condition is currently 65 years. The number of patients diagnosed with the clinical syndrome of heart failure is rapidly increasing. This is a product both of the aging of the population and of the increased success of treatments which results in better survival. This is a major (and expensive) public health problem that merits greater consideration. The government should also take note.

Heart failure can result from a range of heart diseases. The course of this disease can be divided into various stages, each of which requires a suitably tailored treatment strategy. In this connection, it is important to adopt a structured treatment plan in which the cardiologist and the surgeon consult one another regarding the best approach in a particular case. Particularly in the later stages of heart failure, special interventions such as ICD implantation and cardiac resynchronisation therapy (CRT) can be considered, as a protection against sudden death. At this point, surgical procedures such as CABG, reconstruction of the left ventricle, and the surgical correction of a mitral valve leakage may also be indicated.

In the final stage of heart failure, when patients have a very short life expectancy, a heart transplant is a highly effective and life-prolonging procedure. However, the limited availability of donor hearts means that this approach can only be used in a very limited number of cases. Nevertheless, it is now possible to bridge the waiting period involved by using a left ventricular assist device. These LVAD systems can also be used for a small group of selected patients as a bridge-to-recovery, enabling their own heart to heal. It can also be used as a definitive therapy in patients who are not eligible for heart transplant surgery (destination therapy).

An even more experimental therapy is the use of human stem cells to bring about the regeneration of the heart muscle, or to reduce the recovery time for patients who have suffered an infarction. However, the clinical results of this approach have been rather variable. Nevertheless, it is important that further research should be conducted into this option. This can best be done in the context of an international collaborative venture, because this complex new medical approach has both cardiological and haematological aspects, which necessitates the cooperation of blood banks and departments for bone marrow transplantation in the university centres.

Treatment of disorders of the thoracic and thoraco-abdominal aorta

Special cardiac interventions also include procedures on the thoracic aorta (that part of this major artery that runs through the chest cavity) and the thoraco-abdominal aorta (the part that runs through the abdominal cavity). Operations on the thoraco-abdominal aorta are usually performed by heart surgeons. Disorders of this major artery can be divided into aneurysms (bulges) and dissections (ruptures). These are life-threatening conditions. The incidence of these disorders increases with advancing age. There are currently no figures for the incidence of such disorders in the Netherlands, but the country’s aging population means that the number of cases can be expected to rise.

While the results of these complex operations have improved over the past ten years, the risk of mortality is still 3 to 10 percent. In the case of emergency procedures, the risk of mortality may be as much as 15 to 25 percent. Serious complications may also occur, such as damage to the brain, spinal cord, and kidneys. If the procedure is carried out in good time, however, the patient’s life expectancy can be substantially increased.

A new development is the use of minimally invasive techniques in aortic surgery, such as the insertion of an endoprosthesis into the aorta. The indication for, and actual performance of such a procedure requires a close cooperation between the cardiac surgeon, vascular surgeon, interventional cardiologist and the anaesthetist. An integrated procedure is the preferred approach here. Placing an endoprosthesis can result in the reduction of postoperative complications. The long-term outcome, however, is still insufficiently clear. The involvement of the mentioned specialists may vary from clinic to clinic, dependent on the expertise that has been built up locally.

Nevertheless, it remains the case that procedures on the thoracic aorta and the thoraco-abdominal aorta are very complex and involve considerable risks. Accordingly, they require special expertise. This in turn means that these procedures must be concentrated in centres which meet high quality requirements. The establishment of a central registration system for these procedures in the Netherlands, by the professionals in question, should provide the impetus for a focused quality policy.

Treatment of congenital cardiac defects

Care for patients with congenital cardiac defects concerns not only children. There are also adult patients who had their disorder surgically corrected at an early age, but who require additional treatment later in life. And some adults need primary treatment for congenital heart defects. Furthermore, a wide range of clinical manifestations are involved. However, the number of cases per type of disorder is limited, and each one demands the use of a specific treatment strategy.

The only way to develop and maintain an adequate level of expertise is to combine the various elements of care involved in a few specialised centres. In 1993, the Health Council recommended that all aspects of such care in the Netherlands (i.e. paediatric cardiology interventions and congenital surgery) should be concentrated in three centres. This has yet to happen. The recommendation is just as valid today as it was in 1993.

At the same time, developments have taken place that underscore the need for a new orientation. In general, over the past ten years, the procedures involved have increased in complexity, which has added to the total workload. Corrective surgery is also being carried out on increasingly younger patients (less than one year old). The number of catheter interventions in young children has also increased. In around 1150 to 1500 children currently born with a congenital cardiac defect each year, well over half of them will undergo one or more procedures. This number is expected to remain stable, given current demographic trends. In addition, there has been a steady increase in the number of adults who underwent surgical correction during childhood and who, many years later, have once again developed symptoms that require specialised care. For their treatment, these adults must continue to have access to congenital cardiologists working in specialised centres.

Accordingly, it continues to be essential for these institutions to comply with the guidelines and recommendations that the professionals in question have drawn up at international level (in particular the EACTS guidelines). In addition, the quality policy should also include provisions for the development of a national registration system for congenital cardiac surgery (based on the Aristotle Score). This could be launched as soon as 1 January 2007. A similar system will also need to be developed for catheter interventions. The essential quality requirements in this connection are: at least three congenital heart surgeons and three paediatric interventional cardiologists per centre; at least 125 procedures per congenital surgeon per annum, of which at least 50 should be performed on infants; per centre at least 100 operations on children of less than one year of age per annum; and at least 50 catheter interventions per annum per (paediatric)cardiologist.

Further concentration of the care for patients with congenital cardiac defects could take place via the process of cluster formation, which is already under way. This could ultimately result in the creation of the three specialised centres envisaged in the recommendations. In that vision, a congenital cardiac care centre would consist of one or more sites. Clear agreements would have to be reached concerning the allocation of tasks (such as: complex heart operations and procedures on infants to be carried out at a single site). According to projections, this process should be completed by about 2010.

It would be useful to set up an advisory committee to assist the Minister of Health, Welfare and Sport with the restructuring and concentration of care for patients with congenital cardiac defects.