Vol.48 - Número 2, Abril/Junio 2019 Imprimir sólo la columna central

Stent-Save a Life! Initiative Argentina

 

ALFONSINA CANDIELLO, IGNACIO M. CIGALINI, PEDRO ZANGRONIZ,
ALEJANDRO GARCÍA ESCUDERO, LEONARDO RIPA, LEANDRO LASAVE,
FERNANDO COHEN, ANDRÉS PASCUA, SANTIAGO COROLEU, LORENA VILLAGRA, ERNESTO DURONTO, JORGE BELARDI.
En representación de los centros participantes de la
Iniciativa Stent-Save a Life! Argentina.
(1428) CABA. Buenos Aires, Argentina
E-mail
Recibido 06-MAY-2019 – ACEPTADO después de revisión el 27-MAYO-2019.
There are no conflicts of interest to disclose.

 

ABSTRACT

The Stent-Save a Life! Initiative (SSL) is a European program that seeks to improve access of patients with acute myocardial infarction with ST-segment elevation (STEMI) to reperfusion therapies according to guideline recommendations, thus reducing morbidity and mortality. Objectives: To describe the results of the first three years of the SSL Initiative in Argentina.
Methods: A mapping was carried out initially to analyze the local situation and a Door-to-Balloon Program (DBP) was developed for centers with primary percutaneous coronary intervention (pPCI) capability.
Results: The lack of reperfusion culture with poor in-hospital organization was a common point in both public and private centers, triggering the development of the DBP. Since March-2016 to March-2018, 3041 patients with STEMI were included in 38 centers. Of these, 610 (20%) had their first medical contact (FMC) in emergency medical services. After excluding 184 (6%) patients without coronary lesions, reperfusion therapy was performed in 93% of the cases, mainly by pPCi. The total ischemic time was 117 minutes, with differences according to FMC. In-hospital mortality was 7%.
Conclusions: Identification of barriers and the enhancement of in-hospital organization represent the first step to improve the care of STEMI patients. Integrated work is necessary to develop networks adapted to the local reality of each center and region.
Key words: Acute myocardial infarction. Reperfusion. Angioplasty. Mortality.

 

INTRODUCTION
Reperfusion treatment in patients with ST-segment elevation myocardial infarction (STEMI) is time-dependent, with mortality being lower as the culprit artery is reperfused earlier [1,2]. However, a significant number of patients do not obtain this benefit due to the lack of access to a properly organized health care system [3].

Primary angioplasty (PTCA) is the reperfusion treatment of choice, as long as it is performed within the times advised by clinical guidelines and by experienced operators [1,4]. For the patients that lack access to it, clinical guidelines recommend the administration of thrombolytic agents followed by systematic referral to immediate rescue angioplasty (TCA) or to perform coronary angiography and possible TCA in case of positive reperfusion within 2-24 h as part of a pharmacological and invasive strategy [1,5]. It has been proven that for this to occur, treatment should be made through the creation of networks connecting hospitals with different levels of complexity, through an efficient Emergency Medical Service (EMS), as the proportion of reperfused patients reduces the delays to treatment, and consequently, morbidity and mortality [6,7].

The Stent-Save a Life! (SSL) Initiative is a European program with unique features, by which all actors participating in the treatment of patients with STEMI work to fulfill the mission of “improving access to a reperfusion treatment that would meet the recommendations by clinical guidelines, thus reducing morbidity and mortality”. It represents the next installment of the Stent for Life Initiative created in year 2008, as a coalition between the European Society of Cardiology, the European Association of Percutaneous Cardiovascular Interventions, and the EuroPCR, developed in 23 countries, mainly in Europe. After the success of this program, it was decided to expand its mission globally under the new name of SSL, adjusting it to the reality and specific demands of different regions in the world.

In Argentina, cardiovascular diseases represent the main cause of morbidity and mortality, being responsible for 30% of all deaths; therefore, scientific societies are working to reduce cardiovascular mortality by 25% for year 2025. To achieve this, one of the scenarios to intervene is STEMI, as it represents one of the main causes of mortality and loss in years of healthy life due to premature death or disability [8].

The goal of this paper is presenting the results of the first three years of work of the SSL Initiative Argentina, divided into two stages: a first one of mapping and identification of local obstacles and a second stage of actions conducted to reduce some of these.

 

MATERIALS AND METHODS
During year 2015, an analysis was made on the local situation with the goal of learning about the obstacles preventing patients from receiving a quality and timely reperfusion treatment. Web surveys were sent to centers with the capacity to perform TCA or without such capacity, which allowed us to analyze the resources available. The surveys were answered by 292 centers throughout the country (228 with capacity to perform PTCA).

After understanding the most important obstacles, the Door-to-Balloon (PPB by its acronym in Spanish) Program was created, conceived as a process of continuous improvement with the aim of having the participating centers provide a quality reperfusion treatment in accordance with the recommendations by clinical guidelines, regardless of centers being private or public.

Currently, there are 46 centers participating with the ability to perform PTCA in 11 provinces (Buenos Aires, Santa Fe, Catamarca, Santiago del Estero, Corrientes, Córdoba, Chaco, Mendoza, Tucumán, Entre Ríos and Santa Cruz).

The main centers and requirements that they should meet to be able to participate in the program are provided in the Appendix.

In each center, the creation of work teams was encouraged, constituted by all actors intervening in the care of patients with STEMI. All patients with suspicion of STEMI within 48 h since the onset of symptoms were included in a common database with the aim of evaluating the times until treatment. Monthly, each center is sent a global report with the comparison of their door-to-balloon time with the other centers in a blind manner, besides an individual report describing the times until treatment according to the first medical contact (FMC) and making suggestions to improve them. This feedback allows the centers to analyze their performance, and it is a foundation to encourage the creation of local strategies adapted to the reality of each center, generating in turn a culture of reperfusion in their participants.

The most relevant results are presented, corresponding to the first two years of the PPB program operation, which covers the patients attended in 38 participating centers.

 

Statistical analysis
Continuous variables are expressed as mean and standard deviation or median and interquartile range (IQR), depending on their distribution. Categorical variables are expressed as numbers and percentages.

For comparisons between groups the Student’s t test or the Wilcoxon rank-sum test is used, as it corresponds. The comparisons between ratios was made by the Chi square test or Fisher’s exact test, depending on the frequency of the expected values. In all cases, a 5% alpha error was assumed to establish statistical significance. For the statistical analysis, Epi Info 7.2 was applied.


Ethical considerations
All patients signed the informed consent for each participating institution.

 

RESULTS
Mapping phase
The main obstacles identified were:

  1. Argentina has a highly fragmented health care system, and with a scant integration of the sectors constituting it.
  2. As a consequence of this, there are multiple centers and EMS of a different complexity and quality of care, which lack organization and proper resources to facilitate a quick diagnosis and treatment for these patients.
  3. There is a scant culture of reperfusion in the medical community and even the cardiological community, understanding this as a lack of commitment to reperfusing patients within the times advised by clinical guidelines, which makes the treatment of infarction depend on personal initiative or the initiative of particular health care centers.
  4. There are enough centers with hemodynamic labs to contain the demand of care at national level, but these are concentrated in cities with a high population density, leaving an extensive territory uncovered.
  5. There are no basic guidelines at national level to treat these patients; there is no universal phone number for medical care either.
  6. Streptokinase is used as fibrinolytic in more than 95% of cases, non-fibrin-specific fibrinolytic agent, with a lower rate of success.
  7. There are few formal networks: the network of public hospitals in the city of Buenos Aires and the city of Rosario are some examples. These networks arose from the personal concerns to improve the treatment of these patients, and advanced thanks to the effort of those coordinating it.
  8. There is no education in the population about the symptoms suggestive of infarction and the actions to perform to obtain a quick access to the health care system.

Door-to-balloon program
There were 3041 patients with suspicion of STEMI admitted in 38 centers with PTCA 24/7 from the whole country, since March 2016 until March 2018. The basal characteristics of the analyzed population after excluding patients with normal coronary arteries (n=2857) are described in Table 1.

Table 1. Characteristics of the population
VARIABLES n %

N Total
Age (mean ± SD)
Male gender
Cardiovscular risk factors
Hypertension
Dyslipidemia
Smoking
Diabetes Mellitus
Previous TCA
Previous revascularization
2857
61±11
2303

1944
1316
1217
621
372
56


(81%)

(68%)
(46%)
(42%)
(22%)
(13%)
(2%)

 

First medical contact
Twenty percent of patients (n=610) called the Emergency Medical Service (EMS) from their homes and nearly half of them (n=294; 48%) had a pre-admission ECG done. Thirty percent of these cases (n=183) preactivated the hemodynamic lab and 17.3% (n=106) were moved to centers without hemodynamic lab, in spite of having a center with the ability to perform PTCA within the same city. The rest of the patients went by their own means, to centers with the ability to perform PTCA (n=1238, 41%) and no ability to perform PTCA (n=1192, 39%).

Reperfusion treatment and time until treatment
After excluding 184 patients (6%) without significant coronary artery lesions, coronary angioplasty was the reperfusion treatment established in 92% of patients (Figure 1).

Figure 1. Reperfusion strategy in patients treated by coronary angioplasty (n=2641).
TCA = Angioplasty; PTCA = Primary angioplasty.

 

The median of door-to-balloon time (DBT) of patients treated with PTCA and rescue angioplasty (n=2354) was 60 minutes (IQR 39-91). This time varied according to FMC, being less in those that were admitted to the center with PTCA in ambulance from their homes  [53 (IQR 35-76) min] or referred from another center  [42 (IQR 26-65) min] compared with patients who went spontaneously to centers with PTCA  [81 (IQR 58-117) min, p<0.01].

The time until treatment (from FMC to balloon) in the overall population was 117 min (IQR 77-185), but when analyzed according to FMC, 24.5% (n=104) of patients who arrived by ambulance from their homes were reperfused within 90 minutes from the FMC, 22% (n=192) of those admitted and referred from other centers without TCA were reperfused within 120 minutes from the FMC and 27% (n=293) of those admitted directly to a center with PTCA within 60 min (Figure 2).

Figure 2. Reperfusion times according to the first medical contact (FMC). HD = Hemodynamic lab.
EMS
= Emergency medical services; RecC = Receptor center; RefC = Referral center.

 

In-hospital mortality
Overall in-hospital mortality was 7% (n=200). In Figure 3, in-hospital mortality is shown in detail, according to the reperfusion treatment applied.

Mortality according to the Killip and Kimbal classification was 1.6%, 7%, 24% and 51% for classes A, B, C and D respectively.

 

Figure 3. Overall in-hospital mortality and according to the type of reperfusion treatment applied. PTCA = Primary angioplasty.

 

DISCUSSION
Knowing the reality of care given to patients with STEMI is the first step to determine why often, these do not receive a reperfusion treatment of quality and timely.

In a country with a fragmented health care system and with multiple obstacles as those mentioned above, it is difficult to implement widespread measures without a joint work with the health care authorities to develop an Infarction Code that could be adapted to the reality of each region.

This situation could explain the 9% of overall mortality observed in the Argen-IAM ST Registry, without a clear reduction in comparison to previous registries [9-10].

Each center, city, region or province could have one or more of these obstacles and the possibility of knowing them is the first step to understand local reality and to generate strategic actions that would allow improving treatment with patients with STEMI.

Mapping allowed to learn the most important obstacles and find the points that link public and private centers, in spite of their differences, to start working: the lack of reperfusion culture, and consequently the scant organization within.

The report on the data obtained from patients participating in the Door-to-balloon Program of the SSL Initiative in Argentina constitutes the largest series of patients with STEMI analyzed in our country, which represents an attempt to show the reality from 38 centers with the ability to perform PTCA 24/7. Unlike a standard registry, the SSL Initiative gathers and analyzes systematically the times until the treatment of patients with STEMI within the framework of a continuous improvement program, never before made in our country. The possibility of each center being compared to the others creates a reperfusion culture and action awareness, stimulating the generation of actions to improve results proper.

The current paradigm of management of patients with STEMI is based on regionalizing treatment with the creation of networks and on making the diagnosis of infarction before arriving to the hospital, with the aim of reducing the times until treatment. Clinical guidelines recommend that EMS should be the door of access to the health care system, and advice against patients coming to the centers by their own means, because of the risk of malignant arrhythmias appearing during the trajectory and because those who arrive at the hospital by ambulance from their homes, receive faster care by avoiding having to wait in the ER [1].

This analysis shows that only 20% of patients with suspicion of STEMI called the EMS to request medical care, a figure very below those from other European countries participating in the SSL Initiative [11]. The lack of ECG in some ambulances and the absence of systems established to move patients explain that only 48% of patients attended by the EMS had a diagnostic ECG made, and that 17.3% of patients were moved to a center without TCA, having a center with hemodynamic lab in the same city.

The preactivation to the center with hemodynamic lab is a strategy that reduces DBT by enabling, not just the hemodynamic lab team to get to the patient sooner, but also once the patient arrives to the center is taken directly to the catheterization lab, skipping going through the ER [12-13].

These two strategies would explain the lower DBT observed in the patients admitted in the centers with TCA by ambulance referred from another center or from their homes in comparison to those who went spontaneously to the ER.

The DTB time of the patients who went to the ER of centers with hemodynamic labs, could be improved by actions that guarantee a fast performance of ECG, prioritizing the care to patients with symptoms suggesting infarction and thus facilitating a rapid activation of the hemodynamic team.

Although the DBT median of patients admitted by ambulance was less than 60 minutes, for these patients the DBT is just one time component of the system, defined as the time from the FMC to the balloon.

The time of the observed system was suboptimal, as 24.5% of patients who were admitted by ambulance from their homes were reperfused within 90 minutes of the FMC, and 22% of those referred from centers without PTCA, did it within 120 minutes after FMC, as recommended by clinical guidelines [1].

This manifests the absence of networks and deficiencies of our system to coordinate moving patients with STEMI.

Overall in-hospital mortality was 7% and is the least overall mortality reported in our country.

This could be explained as these are centers with TCA, where PTCA was the reperfusion treatment applied on 92.4% of patients and on 88% of cases, performed within 12 h since the onset of symptoms.

Reperfusion treatment is time-dependent, which is proven by in-hospital mortality of 3.7% when PTCA is made within 3 h after the onset of symptoms, 6.1% within 3-6 h and 7.5% within 6-12 h. The RADAC Registry reported an in-hospital mortality for the subgroup of patients with STEMI of 4.3%, but with no report on the times until treatment, so making comparisons is difficult [14].

Beyond the less overall mortality observed, it is important to highlight the low mortality of patients treated with a pharmacological and invasive strategy (3.3%). In an extensive country like Argentina, with centers with PTCA mainly distributed in large cities, the pharmacological and invasive strategy may play a significant role to attempt increasing the number of reperfused patients, and allow increasing the flexibility of referral times. However, this strategy was not applied systematically, and in our population it was used in 2%, data that match the Argen-IAM ST Registry [9].

Using streptokinase could be an obstacle to develop this strategy; nevertheless, countries such as India have managed to develop networks in the Hub and Spoke model, where every region has a receptor hospital with the ability to perform PTCA 24/7 (Hub) and referral centers (Spokes) that according to the distance to the Hub, refer patients to undergo PTCA or a pharmacological and invasive strategy is applied using streptokinase [15]. Models like this have shown to reduce mortality at 1 year by 25% and will be taken as an example to develop networks in countries with low and medium income [16].

 

LIMITATIONS
We should mention as limitation, that this experience was conducted in 38 centers with the ability to perform PTCA 24/7, so the results cannot be generalized.

 

CONCLUSIONS
The SSL Initiative seeks to improve access of patients with STEMI to reperfusion treatment meeting the recommendations by clinical guidelines.

The identification of obstacles preventing patients from being treated timely along with the organization within centers, represent the first step to improve the care for these patients and requires the integrated work by all actors involved.

The active and continuous participation in this type of initiatives will allow developing strategies to create networks of care adapted to the local reality of each center and region.

 

  • Alfonsina Candiello1,2, Ignacio M. Cigalini1,3 , Pedro Zangroniz4, Alejandro García Escudero5, Leonardo Ripa6, Leandro Lasave7, Fernando Cohen8, Andrés Pascua9, Santiago Coroleu10, Lorena Villagra 11, Ernesto Duronto12, Jorge Belardi1.

1 Instituto Cardiovascular de Buenos Aires; 2 Director Stent-Save a Life! Initiative Argentina; 3 Coordinator Stent-Save a Life! Initiative Argentina; 4 Hospital Provincial del Centenario, Rosario; 5 Hospital de Agudos Dr. Cosme Argerich; 6 Hospital Central de Mendoza; 7 Instituto Cardiovascular de Rosario; 8 Hospital Italiano de Buenos Aires; 9 Hospital Italiano de La Plata; 10 Instituto de Cardiología, Santiago del Estero; 11 Sanatorio Pasteur, Catamarca; 12 Fundación Favaloro.

 

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Publication: June 2019



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