Primary percutaneous coronary intervention (PPCI) and thrombolysis (TL) represent two alternative reperfusion strategies for ST-elevation acute myocardial infarction (STEMI) patients. In many randomised clinical trials,1 PPCI has been shown to be superior to TL in reducing mortality, re-infarction and stroke. These benefits are linked with a much higher early mechanical reperfusion rate (90 %, compared with the pharmacological reperfusion rate which is about 50 %), the ability to simultaneously treat the underlying stenosis, and a lowering of the risk of severe bleeding. The European Society of Cardiology (ESC) STEMI treatment guidelines published in 2008 and updated in 20102 recommend PPCI as the preferred treatment whenever:
- the first medical contact (FMC)–balloon time is less than 90–120 minutes;
- the interventionist is experienced (i.e., performs more than 75 percutaneous coronary interventions [PCIs] per year); and
- the patient is treated in a high-volume centre (one that performs more than 36 PPCIs per year).
2008 European Survey
To obtain realistic data about how patients with acute myocardial infarction (AMI) were treated in Europe, a survey of 51 ESC countries was conducted in 2008.3 In each country, data were collected about that country, any existing national STEMI or PCI registries, STEMI epidemiology and treatment, and PCI and PPCI centres and procedures. For 30 countries, results from a national and/or regional registries were included in the survey.
The survey found that the annual incidence of hospital admissions for any AMI varied between 90 and 312 per 100,000 population per year, the incidence of STEMI alone ranging from 44 to 142 per 100,000 population. The dominant reperfusion strategy was PPCI in 16 countries and TL in eight countries. PPCI was being used in 5–92 % of all STEMI patients and TL in 0–55 % of all STEMI patients. Some form of reperfusion treatment (PPCI or TL) was being used in 37–93 % of STEMI patients. In countries where TL was the dominant reperfusion strategy, significantly fewer reperfusions were being performed as a whole. The number of PPCIs per million population per year varied between 20 and 970. The mean population served by a single PPCI centre varied between 0.3 and 7.4 million. In countries offering PPCI services to the majority of their STEMI patients, each centre covered a population of between 0.3 and 1.1 million. In-hospital mortality of all consecutive STEMI patients varied between 4.2 % and 13.5 %, between 3.5 % and 14 % for patients treated by TL, and between 2.7 % and 8 % for patients treated by PPCI. The time reported from symptom onset to FMC varied between 60 and 210 minutes; in TL-treated patients, FMC–needle time varied between 30 and 110 minutes; in PPCI-treated patients, FMC–balloon time varied between 60 and 177 minutes.
The survey confirms that STEMI patients’ access to reperfusion therapy and the use of PPCI and/or TL vary considerably between European countries. The annual incidence of hospital admissions for AMI in Europe is around 1,900 patients per million population, with an incidence of STEMI of about 800 per million. A nationwide PPCI strategy for STEMI results in more patients being offered reperfusion therapy. Northern, western and central Europe already have well-developed PPCI services, offering PPCI to 60–90 % of all patients. Southern Europe and the Balkans are still predominantly using TL. Where this is the case, a higher proportion of patients are left without any reperfusion treatment. The survey results also suggest that countries with a mean population of 750,000 per PPCI centre that perform 600 PPCIs annually per million population should be able to meet the needs of all their STEMI patients. Countries in which nearly all existing PCI centres offer 24-hour seven-days-a-week (24/7) PPCI services appear to exhibit the best results. Overall, the survey confirms that there is a substantial heterogeneity of practices in Europe and that there are many opportunities to improve care.
The Stent for Life Initiative
The Stent for Life (SFL) Initiative was launched jointly by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and EuroPCR in 2008. National cardiac societies from Bulgaria, France, Greece, Serbia, Spain and Turkey signed the SFL Declaration at the ESC Congress in Barcelona in 2009. The aim of the SFL Initiative is to improve the delivery of, and STEMI patient’s access to, life-saving PPCI and thereby reduce mortality and morbidity. Countries with an unmet medical need for the optimal treatment of STEMI and countries where the use of PPCI can be encouraged, and thereby the quality of care improved, were invited to join the SFL Initiative. Currently, 10 countries participate in the initiative – Bulgaria, Egypt, France, Greece, Italy, Portugal, Romania, Serbia, Spain and Turkey – and more are interested in becoming affiliated.
The main strategic objectives of the SFL Initiative are:
- to design and implement national action programmes to increase PPCI access to more than 70 % of all STEMI patients;
- to achieve PPCI rates of more than 600 per million population per year; and
- to offer a 24/7 PPCI service in PPCI centres in order to cover the needs of the STEMI patient population.
In 2009, Knot et al. published an article describing the management of STEMI in five European countries: Austria, the Czech Republic, Denmark, the Netherlands and Sweden.4 The article highlighted several key factors necessary for the successful implementation of PPCI programmes and effective PPCI network building. These critical success factors were identified based on the experience of the five best-practice countries.
Building 24/7 Infrastructure and Networks
Across Europe, the majority of STEMI patients present to community hospitals that do not have PPCI facilities, therefore the need for well-functioning regional pre-hospital systems for early diagnosis and immediate transport to a PPCI centre is acute. Patients diagnosed by pre-hospital electrocardiogram (ECG) and transferred directly to a PPCI centre have a lower mortality. The difficulty of providing timely access to appropriate facilities within the recommended timeframe (less than 90–120 minutes from FMC to initiation of reperfusion) is one of the major barriers to PPCI delivery. A survey has shown that the widespread adoption of PPCI could be limited by potential transport delays and practical issues regarding the transfer of patients from non-PCI hospitals to PPCI centres.6
The formation of regional networks involving emergency medical services (EMS), non-PCI hospitals and PPCI centres is necessary to implement PPCI services effectively. Such regional networks should cover an area comprising a population of approximately 0.5 million (0.3–1 million); a smaller area could lead to a suboptimal workload and thus suboptimal treatment effectiveness, while a larger area may cause PCI centre overload. This can be achieved only by respecting the right of local hospitals and local cardiologists to take care of their patients after primary PCI is completed and the patient is stabilized. Tertiary transport to the local hospital nearest to the patient’s home should be encouraged. The number of PPCI centres necessary to cover the needs of the STEMI population in one country should be defined by the national society of cardiology and the national ministry of health. PPCI national or regional networks should be established and transportation protocols implemented. Non-PCI hospitals should have a qualified cardiologist available 24/7 so that they are able to provide appropriate care for AMI patients.
Learning from the best-practice countries’ experience, the key objective of the SFL Initiative in SFL countries is to develop action plans in order to build effective PPCI networks covering each country’s STEMI population needs, as defined by an SFL national task force in co-operation with each national government.
Most SFL countries have chosen to follow a regional approach in their management of STEMI and implementation of PPCI programmes, and have thus developed and put in place specific collaboration protocols and guidelines for transfer to PPCI centres.
Such a regional approach has been chosen in Spain, Greece, France and Turkey.7 In Spain, six PPCI networks have been established in the autonomous communities of Navarra, Murcia, the Balearic Islands, Galicia, Catalonia and Castile-La Mancha. Since 2008, there has been an overall increase of 18 % in the number of PPCIs performed in the country (12,079 in 2008, 13,395 in 2009 and 14,248 in 2010). The population with access to a STEMI network has increased to 15.6 million (33.2 % of the Spanish population). The mean annual rate of PPCI in Spain has increased to 235 procedures per million population in 2010 compared with 216 procedures per million in 2009 (range 65–427).5
Greece has succeeded in establishing PPCI networks in Attica and in the south-western part of the country. As a result, the PPCI rate has risen to 20 % countrywide compared with 8 % in 2008. The most significant regional increase has been in Attica, which represents almost 50 % of the total population, where there has been an increase of 40 %.
In Turkey, a pilot project with 18 regional STEMI networks was launched around the main PCI centres. The number of PPCIs performed per year has increased from 324 per million population in 2009 to 453 per million population in 2010.
Serbia is a good example of a national approach to the implementation of the SFL Initiative. With strong support from the government, a national programme for the implementation of the STEMI treatment guidelines was approved. Since joining the SFL Initiative in August 2009, Serbia has increased its annual number of PPCIs from 230 procedures per million inhabitants in 2008 to 337 per million in 2009 and 440 per million in 2010. Preliminary data suggest an increase of 18 % in PPCIs in 2011. In addition, there was a notable decrease, between 2008 and 2009, in the percentage of STEMI patients not receiving any reperfusion therapy.
Transport Issues and Time Delays
The primary transport of STEMI patients by EMS from the FMC site to hospital should always bypass the nearest non-PCI hospital as well as the accident and emergency department or intensive care unit in the PCI centre. Experience shows that well-trained nurses or paramedics may achieve similar effectiveness to physicians in the triage and transport of AMI patients. In other words, EMS staff training is more important than EMS staff structure. All EMS ambulances should be equipped with resuscitation facilities and the necessary medications. The patient must be taken from the EMS vehicle directly to the catheterisation laboratory. This can only be achieved if the cath lab has been informed in advance of the arrival of a STEMI patient. Immediately after the diagnosis has been established, the cath lab should be informed and given the patient’s approximate time of arrival. Thus delays can be minimised and the recommended timeframe (less than 90–120 minutes from FMC to initiation of reperfusion) can be achieved for the vast majority of patients.
Public Knowledge about Heart Attack Symptoms and Treatment
The timely delivery of treatment is equally dependent on the patients’ ability to recognise heart attack symptoms and act quickly. The general population’s knowledge regarding the symptoms of AMI and unstable angina pectoris, the absolutely key role of time (every minute counts), their country’s unique national emergency phone number, AMI treatment (including PPCI) and basic cardiopulmonary resuscitation is probably the most important part of the entire process. SFL countries have reported a lack of public knowledge in this field. Extensive surveys were launched in Portugal and France to define the need for public education. Both surveys confirmed that the public awareness of acute coronary syndrome (ACS) symptoms and the need to call EMS quickly is low. In Portugal, 77 % of patients with ACS arrive at hospital by their own means of transport, e.g. by taxi or private vehicle. In France, less than 50 % of patients with ACS called the EMS directly.
To address this issue, the SLF Initiative has recently developed a public awareness campaign with the slogan ‘ACT NOW. SAVE A LIFE’. This campaign aims to educate patients to act quickly and to call the unique national emergency phone number in order to be transferred by ambulance to a PPCI centre, bypassing the nearest hospital without PPCI facilities. Bulgaria, Portugal, Spain and Turkey are SFL pilot countries where the ‘ACT NOW. SAVE A LIFE’ campaign has been rolled out. Egypt, France, Italy and Romania have already implemented widespread public education campaigns to educate the public about the symptoms of ACS and the need to call the EMS quickly. The impact of the ‘ACT NOW. SAVE A LIFE’ campaign will be measured and a case study will be published in 2012.
Since the SFL Initiative was launched, several activities have been initiated in the participating countries. Preliminary reports suggest that major increases have been seen in the numbers of PPCIs performed. Improvements in STEMI mortality rates have also been observed. A detailed report describing the situation of STEMI treatment in Europe will be presented at the ESC Congress in August 2012 in Munich.
Close co-operation between the key healthcare stakeholders has proved to be very effective in achieving the appropriate implementation of PPCI programmes in SFL countries. The SFL Initiative has proved to be an effective model of collaboration combining support and participation from interventional cardiologists, government representatives, EMS, industry partners and patients.