Keywords
INTRODUCTION
For the last 14 years, the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology has been publishing the results of its registry in the Revista Española de Cardiología. One of the most important tasks of this working group has been implementation of this registry, which has been collecting data continually since 1990. The registry of the Working Group on Cardiac Catheterization is the most up-to-date, complete, and rigorous record of interventional procedures performed in Spain. It collects data from both the public and private sectors and, at present, is the most complete registry of its kind in Europe.
The registry of the Working Group on Cardiac Catheterization and Interventional Cardiology aims to be the main source of information on diagnostic and interventional procedures performed by cardiac catheterization laboratories in Spain, changes
over the years, and differences between Spanish autonomous regions. The data from the registry serve as a reference to guide decisions in all health care settings and so improve health care in aspects such as investigation, prevention, treatment, and assignment of resources.
This 15th report published in the Revista Española de Cardiología presents, as in previous years,1-14 data from all public centers and almost all private centers. The data can therefore be considered as representative of catheterization procedures and percutaneous coronary interventions (PCI) in Spain.
METHODS
Data were collected for the registry by sending a questionnaire (Appendix 1) to all cardiac catheterization laboratories in Spain. This questionnaire underwent minor changes compared to previous ones and could be completed on a hardcopy printout, or electronically with a computer disk or via the Working Group's website. In recent years, the Governing Board of the Working Group has encouraged the use of the online form available from the group's website (www.hemodinamica.com). In this register for 2005, 76 centers (59% of respondents) used the Internet to report their data. As in previous years, the company Izasa collaborated both in the distribution and collection of the questionnaires, and the Governing Board of the Working Group was in charge of data analysis and responsible for the present publication.
The population data used for the different calculations of population-adjusted rates per million inhabitants, both at the national and regional level, were obtained from the estimates obtained from the Spanish National Institute of Statistics (January 1, 2005) through their webpage (http://www.ine.esine.es). Spain was estimated to have a population of 44 108 503 inhabitants in 2005.
Given the diversity of health care in Spain, public centers were taken to be those that, regardless of their source of funding, cater to a certain catchment area of the population within the public health care system.
Although it is relatively easy to compare the activity in Spain over the last 15 years, it is harder to compare the activity in Spain with that in the rest of Europe. Currently, there is no exhaustive and reliable European registry to match the Spanish one, and the partial data available are published with a delay of at least 3 years. Even so, comparisons between the situation in Spain and the rest of Europe are of interest, and in this article we discuss the most recently published data from the European registry (corresponding to 2002 and 2003).15,16
RESULTS
Infrastructure and Resources
One hundred and twenty-eight hospitals (Appendix 2) carrying out catheterization procedures in 2005 participated in the registry, comprising all public centers (72 hospitals) and 92% of the private ones (46 of 50) performing such activities. Of these 128 centers, 118 carried out procedures mainly in adult patients, 18 of these also admitted pediatric patients, and 10 centers treated pediatric patients only.
Hospitals for Adults
The 118 centers for adults have a total of 154 catheterization laboratories, of which 149 (97%) are fully computerized. The number of hospitals and laboratories works out at 2.7 and 3.5, respectively, per million inhabitants. Two or more catheterization laboratories are available in 36 centers. Overall, 41 centers are in the private sector (39.0%); the 77 remaining form part of the public health network (65.0%). Diagnostic and catheterization procedures are carried out in 99% of the hospitals. An emergency team is on standby 24 hours a day in 57% of the centers (59% of the public centers and 51% of the private ones). Heart surgery is available in 75% of the centers (n=89). In 29 of the centers that perform coronary interventions, heart surgery is not available in the same hospital. In the analysis of personnel, 367 physicians were working in 2005 (3.11/center; 8.3 specialists/106 inhabitants). This is similar to but slightly higher than in 2004 (when there were 8.01 specialists/106 inhabitants) and the most recent but nevertheless out-of-date figure for Europe for 1995 of 8 specialists per million inhabitants.17 The 104 hospitals reported 437 registered nurses and 109 x-ray technicians, corresponding to a mean number of nursing staff or x-ray technicians of 5.25 per center and 3.5 per laboratory (mean of 3.9 nurses or x-ray technicians per laboratory in the public sector).
Pediatric Hospitals
Ten of the centers included in the registry reported treating pediatric patients only, with 10 laboratories (all of which were computerized). All of these perform catheterization procedures and 50% also have an emergency team on standby 24 hours a day. These laboratories have 2.1 specialists and 2.4 nurses/x-ray technicians per center.
Diagnostic Procedures
In 2005, 117 245 diagnostic procedures were carried out in Spain, a 5.1% increase compared to 200414; 103 646 of these procedures were coronary angiograms, representing a 5.9% increase. This rate of growth was similar to the average European growth between 2001 and 2002 (7%) and between 2002 and 2003 (5%).
Overall, 2326 coronary angiograms per million inhabitants were performed. This figure is still notably greater than the European average of 3357 coronary angiograms per million inhabitants and similar to European countries such as Greece, Portugal, or Hungary, although we should remember that the most recent data from the European registry to be published correspond to 2002.18 The difference between Spain and other countries such as Germany (7791/106 inhabitants), Austria (5131/106 inhabitants), or France (3547/106 inhabitants) is still apparent.18 Figure 1 presents the distribution of diagnostic procedures in 2005 and how this distribution has changed since 1993. The tendency in past years for the increase in the number of coronary angiograms to level off has continued, with a smaller increase of 5.9% compared to 6.6% between 2003 and 2004. A decrease in the number of diagnostic procedures was also observed compared to registry data from previous years.
Figure 1. Change in the number and type of diagnostic procedure done between 1995 and 2005.
The number of procedures with radial approach continues to increase. Indeed, this approach was used in 31 662 procedures (27.4%), which represents an increase of 56% with respect to the previous year. Percutaneous vascular closure devices (including diagnostic and therapeutic procedures) were used in 31 509 cases (an increase of 16% compared to 2004), of which 19 296 (62%) were with collagen, 8019 (25%) with suture, and 4194 with other systems (13%).
More than 1000 coronary angiograms per year were done in 48 centers (40.7%), and 11 of these hospitals (9.3% overall) carried out more than 2000 coronary angiograms per year. On the other hand, 44 centers (37.3%) performed fewer than 500 coronary angiograms per year (Figure 2). Only 6 of these hospitals were in the public sector (8%). There were 993 diagnostic procedures per center and 737 per laboratory, that is almost the same number as in 2004. The average number of diagnostic procedures per laboratory is still below the European average for 2001 of 1019 procedures per laboratory.18 In the public sector, 950 diagnostic procedures were performed per laboratory. The number of coronary angiograms per center (878) was 3% lower than in 200414 and is still below the already dated figure for 1997 in most western European countries.19,20 It is also less than the 934 coronary angiograms per center recorded by the European registry for 1999.20 It must be emphasized that, whereas centers in the private sector carried out 207 coronary angiograms per center, there were on average 1236 coronary angiograms per center in the public sector.
Figure 2. Distribution of centers according to the number of coronary angiograms performed.
As in previous years, the growth in diagnostic studies reported in 2005 was due to the increased number of coronary angiograms. The number of procedures for congenital heart disease also increased notably (3%; 721 procedures), whereas the number of procedures in patients with valve disease decreased and the number of other diagnostic procedures increased.
In 2005, the notable differences between different autonomous regions of Spain in the number of coronary angiograms per million inhabitants remained. Figure 3 shows the data by Spanish autonomous region. The number of coronary angiograms per million inhabitants varied by 1444 per million inhabitants between the region with the highest number and the region with the lowest number (an increase in variation of 100 coronary angiograms compared to the range for 2004).
Figure 3. Distribution of coronary angiograms per million inhabitants by autonomous region.
The 2 main intracoronary diagnostic techniques--intracoronary ultrasound imaging and procedures with intracoronary pressure guidewires--were used less compared to 2004. A total of 2871 intracoronary ultrasound imaging procedures were done (1% less than in 2004). Intracoronary pressure guidewires were used in 1138 procedures (16% less than in 2003). Intracoronary Doppler flow guidewires were used in almost half as many interventions as in the previous year (51 procedures). Intracoronary diagnosis accounted for 8% of interventional procedures (compared to 3.8% in the European registry for 200215).
Percutaneous Coronary Intervention
During 2005, 51 689 PCI were done, an increase of 13.6% compared to the previous year, with 1161 PCI per million inhabitants (Figure 4). This figure is close to the latest data published from the European registry, corresponding to 200315 (1283 angioplasties/106 inhabitants). With reference to the European registry, the number of PCI per million inhabitants in Spain is comparable to the number in countries such as Denmark, Finland, or Italy in 2002, but a long way below other countries such as Germany, Belgium, Austria, or France, which easily exceeded 1500 PCI per million inhabitants in 2001. There were on average 438 PCI per hospital and 325 per laboratory. On average, each interventional cardiologist performed 153 interventions. The European average for PCI per catheterization laboratory was 325 in 2001.18 There were on average 615 PCI per center in the public sector, corresponding to 422 per laboratory and 182 per cardiologist.
Figure 4. Change in the number of percutaneous coronary interventions between 1980 and 2005.
The percentage of PCI done as a result of coronary angiography findings in 2005 was 49.8% (44.3% in 2004), which was higher than the European average for 2003 (36%).16 At least one restenotic lesion was treated during the intervention in 5.5% of the cases. In 2005, 13 955 multivessel procedures were performed, corresponding to 27% of all PCI. This percentage was very similar to the figure of 29% reported for 2004, but much greater than the figure of 17% reported for the European registry in 2003.16 Likewise, no substantial differences were observed compared to 2004 for the percentage of procedures done in the same session as the diagnostic procedure (74%, 38 355 procedures).
The radial approach in PCI was used in 13 947 cases (26.9%), 88% more than in 2004. There were 1306 PCI involving grafting; 83.0% of which were saphenous vein grafts and the remainder (17.0%) corresponded to mammary artery grafts. Overall, 1464 PCI were carried out in the left main coronary artery, which was protected in 72% of cases.
Figure 5 shows the distribution of centers according to the number of PCI. As in previous years, a high number of centers were still carrying out fewer than 500 PCI per year (59%), or even fewer than 300 PCI per year (43%). Twelve centers carried out more than 1000 PCI in 2005. Figure 6 shows the number of PCI per million inhabitants in the different autonomous regions; the differences already indicated regarding diagnostic procedures were also observed for PCI. It is important to point out that, as in the case of coronary angiograms, in certain autonomous regions, the high percentage of PCI is due to the fact that patients from neighboring regions are treated in their centers.
Figure 5. Distribution of centers according to the number of percutaneous coronary interventions done in 2005.
Figure 6. Distribution of percutaneous coronary interventions per million inhabitants by autonomous region.
Glycoprotein IIb/IIIa inhibitors were used as adjuvant drug therapy in 11 757 procedures, representing a decrease of 12.5% compared to 2005. It is impossible to tell what percentage of patients received glycoprotein IIb/IIIa inhibitors before the interventional procedure as this information is not collected in the registry, perhaps because it is not considered part of the activity of the laboratory or even because these agents were withdrawn hours before the intervention. This figure should therefore perhaps be considered as the lower limit for use in Spain in 2005. Abciximab was used in 71% of interventions, tirofiban in 27%, and eptifibatide in 1.8%. Intraaortic balloon counterpulsation was used in 840 cases and percutaneous cardiopulmonary bypass in 13 cases.
For the overall outcomes of PCI, the figures remained similar to those of previous years; 95.5% were successful, 2.9% failed without complications, and 1.5% failed with complications. The breakdown of complications was as follows: 0.5% died, 0.9% suffered acute myocardial infarction (AMI), and 0.1% required emergency surgery.
Percutaneous Coronary Intervention in Acute Myocardial Infarction
A total of 8341 PCI procedures for AMI were carried out, representing an increase of 13.8% compared to 2004 and 16.1% of the total interventio nal procedures (Figure 7). In the European registry of 2003, the percentage of PCI procedures for AMI was 17% of all PCI.16
Figure 7. Percutaneous coronary interventions done for acute myocardial infarction. Changes between 1994-2004.
Overall, 61.2% of the cases involved primary PCI (63% in 2004), 21.2% rescue PCI (20.8% in 2004), and 17.6% facilitated PCI (15.9% in 2004) (Figure 8). Of the facilitated coronary angioplasties, 86% were considered "delayed" as they were carried out after the acute phase of the AMI. The 5101 primary angioplasty procedures represented an increase with respect to 2004 of 9.9%. This number of primary angioplasty procedures would correspond to approximately 12.5% of the estimated total number of 40 000 patients in Spain admitted each year to hospital with AMI.21,22 Despite the recommendations made in the most recent clinical guidelines,23 primary angioplasty is still not the treatment of choice for AMI in Spain. Overall, 103 centers carried out PCI for AMI. Although the average number of interventions per center was 81, the actual numbers varied widely (Figure 9); 30 centers performed more than 100 PCI in the acute phase of the infarction whereas 42% of the centers carried out fewer than 50.
Figure 8. Percutaneous coronary interventions (PCI) done for acute myocardial infarction. Distribution of the type of intervention carried out and changes in percentages of total coronary interventions between 1995 and 2005.
Figure 9. Distribution of centers according to the number of percutaneous coronary interventions for acute myocardial infarction.
Figure 10 shows the distribution of PCI for AMI per million inhabitants by autonomous region. Radial approach was used in 1747 procedures (representing 20.9% of the total number). Percutaneous coronary intervention was carried out during cardiogenic shock in 811 cases, representing 9.7% of all PCI for AMI.
Figure 10. Distribution of percutaneous coronary interventions for acute myocardial infarction per million inhabitants by autonomous region.
Stents
Stents remain the principal device used in PCI. Stenting procedures were done 49 850 times, accounting for 96.4% of all procedures. The number of stents per procedure was 1.61 (1.51 in 2004) and the total number of units placed was 80 569. Drug-eluting stents were used in 41 352 patients, corresponding to 51.3% of all stents placed. Figure 11 reflects the large variations in extent of use of this type of stent, ranging between 72.8% and 35.7% according to autonomous region.
Figure 11. Distribution of the percentage of drug-eluting stents compared to the total number of stenting procedures by autonomous region.
Finally, 28 670 stents were implanted directly, without balloon predilatation, representing 35.5% of stenting procedures. Twenty-eight percent of the stenting procedures were done without predilatation. The change in the number of stents implanted in recent years is shown in Table 1.
Other Percutaneous Coronary Intervention Devices
Use of directional atherectomy stopped completely in 2005. Rotational atherectomy was used in 460 procedures in 40 centers, representing an increase of 2% in use compared to 2004 (Table 2). Of the other PCI devices, the cutting balloon continues to become more widespread, being used in 1475 procedures, an increase of 9.7%. Devices for extraction of thrombotic material, used in 1732 procedures (an increase of 43%), are also becoming more widespread. As in the previous year, the use of thrombus extraction devices continues to grow at a much faster rate than PCI for AMI, and the use of distal embolization protection devices increased by 20.8% (261 procedures). Alcohol septal ablation was carried out in 51 cases and fistula embolization in 19. Brachytherapy was only used in 10 procedures, all of which were for restenotic lesions, and was successful and free of complications in all cases.
Noncoronary Interventions in Adults
In 2005, 427 valvuloplasties were carried out in adults in 57 centers, thus maintaining the decrease of previous years (7% compared to 2004). This decrease occurred mainly because of the number of mitral valvuloplasties decreased by 9.7% from 391 to 354 (Figure 12). In addition, 14 aortic valvuloplasties and 29 lung valvuloplasties were carried out.
Figure 12. Change in the number of mitral valvuloplasty procedures between 1990 and 2005.
Atrial septal defects were closed with a percutaneous device in 345 patients. Compared to the decrease in these procedures observed between 2003 and 2004, this figure for 2005 represents a substantial increase of 40% compared to 2004. Success was achieved in 93% of the procedures, failure without complications was reported in 2.9%, and complications were reported in 4.1%. Four deaths were reported. There were 182 procedures to close patent foramen ovale and another 7 procedures in adult patients with congenital defects. Renal artery dilatations were carried out in 60 patients. In addition, 34 interventions for aortic coarctation, 10 for aneurysms of the abdominal aorta, and 48 for aneurysms of the thoracic aorta were done, as well as 53 percutaneous myocardial transplantations of stem-cells.
Percutaneous Coronary Interventions in Pediatric Patients
There were 1108 procedures in the pediatric age group in 21 centers, representing an increase of 1.7% compared to 2004; these included dilatations (322 cases), atrial septal defect closure (n=209), and ductus closure (n=186). The most widely used techniques are summarized in Figure 13.
Figure 13. Distribution of pediatric procedures. ASP indicates atrial septal defect.
CONCLUSIONS
The preparation and presentation of the annual report of the Cardiac Catheterization and Coronary Intervention Registry is one of the most important tasks of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology. Both the board members of the Working Group and its members consider the data presented in this registry to be of vital importance to professionals, health authorities, and the general public. The registry is unique within Europe because of its comprehensive up-to-date nature and the quality of the data collected. It therefore provides a valuable overview of an important aspect of cardiovascular disease and should ensure better assignment of health care resources in this field.
In 2005, the diagnostic and therapeutic activity for infarction continued to increase, although the increases are beginning to level off. The radial approach was used in more than 25% of the diagnostic and therapeutic procedures in 2005. Despite these increases, most measures of diagnostic and interventional resource use remain clearly lower than those of the most developed European countries, especially if we take into account that we are comparing our data with data 2 years out of date without accounting for growth in these countries in the intervening period. There is still a lot of variation among the various Spanish autonomous regions regarding diagnostic activity and different aspects of treatment. Although drug-eluting stents are used in more than 65% of all stenting procedures in some autonomous regions, use of these stents in other regions remained below 40% in 2005. The national average for use of this type of stent was 52%.
The decrease in the number of mitral valvuloplasties seen in the previous year also occurred this year. All percutaneous closures of atrial septal defects such as patent foramen ovale increased notably in 2004. The extent of interventional activity in pediatric patients was almost the same as in 2004.
Correspondence: Dr. R. López-Palop.
Vía Láctea, 38. Urb. La Glorieta. Churra. Murcia. España.
E-mail: mlopezs@meditex.es
Further information and other consultations available from http://www.hemodinamica.com