Contribution for the characterization and performance improvement of primary angioplasty in Portugal

Abstract

Introduction Geoffrey Hartzler was the pioneer of primary angioplasty (P-PCI) when he treated the first patient with acute ST-segment elevation myocardial infarction (STEMI) in 1981. It would be about a decade before Cindy Grines and Bill O’Neill demonstrated that P-PCI was superior to fibrinolysis and would take nearly two decades until the guidelines considered P-PCI as a class I indication for the treatment of STEMI. Since the beginning of fibrinolysis studies it is widely known that the time from the onset symptoms to reperfusion was decisive for the success of the therapy. Also in P-PCI, the total ischemia time span has an impact on the results. Since this technique is much more demanding both from the logistic point of view and the availability of trained teams, the time factor plays a fundamental role in the results. Despite the scientific evidence of the benefits of reperfusion in STEMI, a significant proportion of patients worldwide still remain out of revascularization. Even in the Western more developed countries, many patients do not have access to P-PCI. In Europe there is an important heterogeneity in the practice of P-PCI, with high performance levels in the north and suboptimal levels in the south. The “Stent for Life Initiative” (SFL) was created in this context to reduce the differences among the various countries through measures to increase patient access to P-PCI. Identical initiatives were developed in the United States of America. Although in Portugal there is an interventional cardiology network that covers almost the whole country, and a good network of roads which allow a reasonable access (less than two hours) to P-PCI, in the middle of the last decade, it was one of the European countries with one of the lowest P-PCI rates. It was also observed that in Portugal only a small percentage of STEMI patients asked for help through 112. Most of them travelled to secondary hospitals, without primary angioplasty, therefore requiring secondary transportation, with a meaningful impact on treatment delay. Given the strong prognostic implications of total ischemia time (between the onset of symptoms and the time of reperfusion therapy), it is important not only to monitor all these timings, but also to identify where the main barriers to a good system performance are and to plan actions in order to improve quality indicators of the P-PCI in Portugal. The rapid technical progress in the areas of medical devices and pharmacology, along with the strong growth in the number of procedures, increased the need for recording data from the real world. The implementation in 2002 of the registries of the Portuguese Society of Cardiology (PSC), allowed a wide scrutiny of interventional cardiology practice and the management of acute coronary syndromes. The continuous recording of interventions, and the benchmark between national and international centres, are fundamental tools for the knowledge of the current situation of interventional cardiology and for the decision making. No less important is the scientific potential which the Portuguese Society of Cardiology registries program really represent. Objectives The main objectives were: 1. To evaluate the trends of P-PCI overtime in Portugal together with evaluation of performance indicators. 2. To identify quality indicators of P-PCI in Portugal, particularly the conundrum of delay in P-PCI access, in both the patient and the system delay components. Methods 1. A retrospective study based on the data of questionnaires distributed to Portuguese interventional cardiology centres (1992-2003) was performed in order to assess the earlier trends of PCI in Portugal. 2. The period of 2002/2003 was a landmark in the Portuguese interventional cardiology due to the beginning of the National Registries of the Portuguese Society of Cardiology. Retrospective evaluations of prospectively collected data from the National Registry of Interventional Cardiology (ClinicaTrials.gov identifier NCT01867801) and from the National Registry of Acute Coronary Syndromes (ClinicaTrials.gov identifier NCT01642329) from 2002 to 2013 were performed in order to assess the evolution of PCI in Portugal and particularly P-PCI. These data were complemented with official data from the General Directorate of Health for the years under review. 3. In-hospital mortality as a surrogate of quality indicators among centres. The presence (or absence) of cardiac surgery was also compared. 4. In order to assess the patient and system delay components, a prospective crosssectional study (Momentos) was carried out during one month per year (2011-2014), in all interventional cardiology centres in Mainland Portugal and integrated in the “Via Verde Coronaria”. Data of 994 patients suspected of having STEMI with less than 12 hours of evolution and proposed to P-PCI, who were admitted to 18 Portuguese centres of interventional cardiology were collected for a one-month period, every year from 2011 to 2014. Patient delay was defined as the time from symptom onset to first medical contact (FMC). It was considered a continuous variable and was expressed in minutes. System delay was defined as the time from first contact with the health care system to the initiation of reperfusion therapy. This variable was analysed as continuous or categorical variable (cut-off value 90 minutes). “Door-to-Balloon time” (D2B) was defined as the time from entrance at the P-PCI centre to the moment of reperfusion and was evaluated as well as continuous or categorical variable (cut-off value of 60 min). Following the “Momento Zero” study (2011) a public awareness campaign for the symptoms of heart attack and to how to call for help in order to improve the patient delay (“Act Now – Save a Life”, from the SFL initiative). Educational programs were implemented for professionals aimed at improving the performance on Acute Coronary Syndromes management and treatment. Univariate analysis and logistic regression models of multivariate analysis were used to determine the predictors of “patient delay” and “system delay” overtime. Exponential beta coefficients (exp (beta)), and 95% confidence intervals (CIs) were reported for continuous variables. Odds Ratio (OR) and 95% confidence intervals (CIs) were reported for categorical variables. The analysis was conducted at a 5% level of significance. Results 1. From 1992 to 2001 the evaluation questionnaires distributed in Portuguese interventional cardiology centres showed an increase of 1,193% in coronary interventions in comparison to 1992, with a total of 8,465 procedures and a rate of coronary interventions of 848 per million population in 2003. During this period, this PCI rate per million population in Portugal was lower than the mean European rate (848 vs. 1194). 2. According to the prospective and multicenter evaluation of the RNCI and the official data of the Directorate-General for Health, in 2013, 3,524 P-PCIs were performed, representing an increase of 315% compared to 2002. In 2002, P-PCI represented 16% of the total number of PCI, and in the years 2012-2013 they represented 25%. Between 2002 and 2013 the number of procedures per million inhabitants increased from 106 to 338 and rescue angioplasty decreased from 71%, in 2002, to 16%, in 2006, and to 2%, in 2013. During the study period, the use of drug eluting stents increased from 10% to 70%. After 2008, there was an increased use of aspiration thrombectomy, reaching 47% in 2013. The use of glycoproteins IIb / IIIa inhibitors decreased from 73% in 2002 to 24% in 2013. The radial access increased from 8% in 2008 to 55% in 2013. 3. Between 2002 and 2006, hospital mortality from coronary angioplasty in hospitals without cardiac surgery compared to hospitals with surgery 0.3% in both cases among patients with chronic angina; 1.5% and 1.0% (ns) respectively in patients with acute coronary syndromes; 4.0% and 5.0% (ns) in patients with acute ST-segment elevation myocardial infarction and no cardiogenic shock; 50.9% and 53.4% (ns) in patients with cardiogenic shock. 4. In the study “Momentos”, conducted monthly between 2011 and 2014, there were no significant differences in patient delay (114 min in 2011 and 119 min in 2015). The multivariable analysis identified five predictors of patient delay: age ≥ 75 (Exp(beta) 1.28; CI95% 1.10-1.50; p=0.001), onset symptoms during the night (Exp(beta) 1.26; CI95% 1.10-1.45; p=0.001), and primary healthcare unit before first medical contact (Exp(beta) 1.75; CI95% 1.41-2.16; p<0.001) were indicators of longer time and call 112-EMS (Exp(beta) 0.84; CI95% 0.71-1.00; p=0.045) and transportation by National Institute of Medical Emergency (INEM) to the P-PCI facility (Exp(beta) 0.71; CI95% 0.59-0.84; p<0.001) were indicators of a shorter patient delay. There were also no significant changes in the “system delay” (115 min in 2011 and 127 min in 2014) and D2B (54 min in 2011 and 64 min in 2014) during the study period. Only 27% of patients had a system delay ≥ 90 min. The system delay of less than 90 min was achieved in only 13% of patients undergoing secondary transportation versus 33% of cases where no transfer was required. The multivariate analysis identified four predictors of “system delay”: age ≥ 75 years (OR 2.57, CI 95% 1.50-4.59, p = 0.001), attendance a unit without P-PCI (OR 4.08; CI 95% to 2.75-6.10, p <0.001), call 112 (OR 0.47, CI95% 0.32-0.68, p <0.001) and “Centro” region (OR 3.43, CI 95% 1.60-8.31, p = 0.003). Conclusions The registries of Portuguese Society of Cardiology (PSC) allow a better knowledge of the activity of Portuguese cardiology in general and primary angioplasty in particular. The data collected allowed us to characterize the Portuguese intervention practice in Portugal and to plan a strategy to improve the performance. It was possible to verify that the practice of elective and primary coronary angioplasty performed in hospitals without on-site surgery is a safe practice, with results similar to those obtained in hospitals with surgery. The implementation of centres in peripheral regions, without cardiac surgery, allowed the P-PCI to be a reality in practically the entire national territory. Although at the beginning of this millennium both the Portuguese distribution of P-PCI centres and the road network were satisfactory, Portugal was one of the European countries with lower P-PCI implementation, which led PSC to join the SFL initiative. Despite the weak initial implementation, between 2002 and 2013 the rate of coronary angioplasty per million people increased by a factor of 3. Rescue angioplasty was overcome by primary angioplasty in 2006. New trends in the treatment of acute myocardial infarction with ST-segment elevation were observed, with the use of drug eluting stents and radial access, with rates similar to the European average. Despite a public awareness campaign for the symptoms of myocardial infarction and the need for calling the emergency number 112 in such circumstances (“Act Now – Save a Life” SFL initiative), in the four years the patient’s delay was not significantly reduced. Given the difficulty in achieving significant progress in reducing time to first medical contact through classic campaigns, it is important to analyse which factors are strongly associated with longer delays and to try to build campaigns and actions that are more focused on these more difficult populations. In our study, it was observed that the elderly and the onset of symptoms during the night period was associated with an increase in “patient delay”. Inversely, asking for help through 112 and being transported by National Institute for Medical Emergencies (INEM) was associated with a shorter time. The “Door-to-Balloon” time (D2B) represents only a small part of the total ischemic time. In Portugal the D2B is within the values recommended by the guidelines but unfortunately most patients did not have access to an earlier reperfusion, mainly as a result of the need for secondary transportation (about half of them entered hospitals without interventional cardiology). There were also no significant changes in the “system delay” during the study period. A higher percentage of patients achieved a system delay of less than 90 min when no secondary transportation was required. Four predictors of system delay were identified: age greater than 75 years, attending hospitals without P-PCI, no call to 112, and living in the “Centro region”. Ideally, patients should be treated with P-PCI but it will be mandatory to evaluate and monitor system delays in order for patients to have access to the best therapy that in each case requires and to see if P-PCI is used in a timely manner (where it may clearly be superior to fibrinolysis). The data collected throughout the SFL initiative was associated with the implementation of a number of specific educational programs for patients and professionals aimed at improving system-wide performance.