INTRODUCTION

In the present article are presented the results of the activity Registry of the Working Group of Hemodynamics and Interventional Cardiology for 2001. With this report, the Registry celebrates its eleventh consecutive year of publication in the Revista Española de Cardiología.1-10 As in previous years, data were received from almost all the hospitals with activity, both public and private. Consequently, we view this data as representative of the activity carried out in Spain.

METHODS

The registry data were collected by means of a questionnaire (Annex 1) sent to all the hemodynamics laboratories in the country. This questionnaire had some modifications with respect to previous questionnaires and could be completed by hard copy, computer diskette, or online through the web page of the working group. The Izasa Company collaborated in the distribution and collection of questionnaires and the Board of Directors of the working group was responsible for data analysis.

RESULTS

Infrastructure and resources

One hundred and three hospitals participated in this registry (Annex 2). This represents an increase of 3% with respect to last year. A total of 97 centers carry out their activity in adult patients (12 in both adult and pediatric patients) and 6 centers are exclusively pediatric.

Adult hospitals

The 97 adult centers have a total of 134 hemodynamic units, of which 117 (87%) are digital. The number of centers and laboratories in relation to the population was 2.36 centers and 3.26 units per million inhabitants, slightly lower than the mean values reported in the European registry of 199511 (2.5 and 3.4, respectively). Twenty-seven centers have two or more hemodynamic units. Eighty-six percent of the centers have some system of automatic coronary quantification. A total of 40 centers are private (41%) and the other 57 belong to the national health system (59%).

Ninety-seven percent of the hospitals have diagnostic and interventional activity, and 3% have only diagnostic activity. Sixty-four percent of the centers have a team on call 24 hours. Seventy-nine percent (77/97) perform cardiac surgery. This percentage has decreased for two consecutive years due to the opening of new units without surgical facilities. In 17 centers, interventions without cardiac surgery are performed in the hospital.

With respect to staff, 273 physicians work in these laboratories (2.8/center; range, 1-7), an increase of 9.2% with respect to last year. There are 6.6 especialistas/106 inhabitants, which is lower than the mean of 8 specialists/106 inhabitants in the European registry of 1995.11 The number of nurses/radiological technicians was 410 (332/78, respectively), with a mean of 4.2 per center (range, 1-14).

Pediatric hospitals

Six centers have only pediatric activity, with 7 units (all digital). All perform interventions and 5 of them (83%) have a team on call 24 hours. The total staff consists of 12 physicians (2/center, range, 1-3) and 10 nurses/radiological technicians (1.6/center; range, 1-3).

Diagnostic activity

In 2001, 95 430 diagnostic studies were performed in Spain, which is an increase of 8% with respect to 2000.10 Of these procedures, 79 607 were coronariographies, which showed an increase of 8.4%. The frequency of coronariography was 1947/106 inhabitants. The distribution of diagnostic studies in 2001 and their evolution in the last 9 years are shown in Figure 1. Aside from the increase in the number of coronariographies, it should be noted that there was a decrease in the number of diagnostic studies in pediatric patients. The radial approach was used in 1685 procedures (2.1%) and percutaneous vascular closure devices (including diagnostic and therapeutic procedures) in 9331 cases, of which 5936 (64%) used collagen and 3250 (35%), suture.

Fig. 1. Evolution of the number and type of diagnostic studies performed between 1993 and 2001.

Eleven centers (11.3%) carried out more than 2000 coronariographies/year, 41 centers (42.2%) carried out more than 1000 coronariographies/year, and 32 centers (32.9%) performed fewer than 500 coronariographies/year (Figure 2). Five hundred ninety-four coronariographies were made per hemodynamics unit, lower than the last available overall European figure (1995,11 709 coronariographies/unit), but an increase of 2% with respect to 2000. The number of coronariographies per operator and year, 291, remained stable. The data for 2000 from some neighboring countries are shown in Table 1 (courtesy of Dr. Bernhard Meier), in which it is evident that in Spain fewer coronariographies/106 inhabitants and coronariographies per unit are performed than in countries like Germany, France, the United Kingdom, and Portugal, but the number of coronariographies per operator is similar.

Fig. 2.Distribution of centers by the number of coronariographies.

A large variation was seen in the number of coronariographies per million inhabitants in the different autonomic communities of Spain. Data are shown by autonomic community in Table 2.

Among the intracoronary diagnostic techniques, the greatest increment was seen in intracoronary echography, of which 1655 procedures were made, with an increase of 37% with respect to last year. To a lesser extent, the use of intracoronary pressure guidewires also increased. There were 1330 cases with an increase of 12% with respect to 2000. An intracoronary Doppler guidewire was used in 110 cases and, for the third consecutive year, no angioscopic procedure was recorded (Figure 3).

Fig. 3. Historical evolution (1995-2001) of intracoronary diagnostic techniques.

Coronary intervention

In 2001, 31 290 percutáneas coronary interventions (PCI) were carried out, with an increase of 15.4% with respect to last year; 761 PCIs per million inhabitants (Figure 4) were carried out, more than in the last published European registry, 199612 (599 angioplasties/106 inhabitants). However, the number was much lower than in countries that were leaders in this field in 1996, like Germany (1358/106 inhabitants.12 The mean number of interventions per center with interventional activity was 333 and the mean number per unit was 239 (the European mean in 1995 was 203).11 The number of interventions per operator was 114 (European mean in 1995 of 78). In Table 1 are also shown the data of the countries mentioned above for interventional activity in 2000. It can be seen that due to the elevated PCI/coronariography ratio of Spain, we are at a higher level that Portugal or the United Kingdom in PCI/106 inhabitants, although distant from others like France or Germany.

Fig. 4. Historical evolution of the number of PCI.

The percentage of PCIs per coronariography in 2001 was 39% (37% in 2000). In 7.8% of cases, at least one restenotic lesion was approached during the procedure. In 8445 cases, multivessel PCI was performed (27%) and in 74% of cases (23 144), PCI was performed ad hoc in the diagnostic session. The radial approach to PCI was used in 1098 cases (3.5%).

The number of PCIs per center is shown in Figure 5. It should be noted that, despite the increase in the number of centers, 47.4% of the centers performed fewer than 200 interventions/year, and 67% less than 400. The number of PCIs per million inhabitants in the different autonomic communities is shown in Table 2, maintaining the differences already observed in the diagnostic studies.

Fig. 5.Distribution of centers in relation to the number of PCIs.

In 7012 procedures, glycoprotein IIb/IIIa inhibitors were used as coadjuvant pharmacological treatment, which was an absolute (49%) and relative increase (22.4% of interventions vs 17% in 2000 and 12.4% in 1999). Abciximab was used in 71.1%, tirofiban in 16.1%, and eptifibatide in 12.8%. However, the use of support methods with the interventions continues to be low, intra-aortic balloon counterpulsation being used in 581 cases and percutaneous cardiopulmonary bypass in 7 cases.

With respect to the overall results of coronary intervention, figures are similar to earlier years, 94.5% success, 3.2% uncomplicated failure, and 2.3% failure with complications, including 1% mortality (54% in cardiogenic shock), 1.2% acute myocardial infarction, and 0.08% emergency surgery.

Intervention in acute myocardial infarction

Three thousand eight hundred forty-five PCI procedures were performed in acute myocardial infarction, which was an increase of 22.9% with respect to 2000 and of 12.3% for all interventional procedures (Figure 6). Of these cases, 59.7% were primary angioplasties (68.7% in 2000 and 76.4% in 1999), 28.7% rescue (31.3% in 2000) and 11.5% facilitated (elective in the first 24 h of acute infarction, after thrombolytic treatment, Figure 7). Excluding the cases of rescue and facilitated angioplasty, 2297 primary angioplasties were performed, with an increase with respect to last year of 148 cases (6.8%), less than the percent increase in PCIs overall. If we consider that it is estimated that about 41 000 patients/year would be hospitalized for acute myocardial infarction in Spain,13 although not all meet the requisite for treatment with primary angioplasty, only a small percentage would benefit from this technique, in spite of clear evidence of its benefit.14,15 Only 10 centers performed more than 100 PCIs in the acute phase of myocardial infarction. Fifty centers performed fewer than 25 procedures/year (Figure 8). In a situation of cardiogenic shock, 501 angioplasties were performed, 13% of the cases in acute infarction (8.7% last year). In these cases of cardiogenic shock the mortality was 29%.

Fig. 6. PCI in acute myocardial infarction. Historical evolution (1994-2001).

Fig. 7. PCI in acute myocardial infarction. Distribution among primary, rescue, or facilitated and percentage of total PCIs since 1995.

Fig. 8. PCI in acute myocardial infarction. Distribution of centers by number of procedures performed.

Stents

Stents have been the most frequently used devices in coronary interventions. Stents were used in 27 586 procedures and in 88.1% of the coronary interventions. This is an increase of 5006 cases (22.1%) with respect to 2000. In addition, 88.1% of the PCIs were performed with stents vs 77.2% in 2000. The stent/procedure relation was 1.25. The evolution of stent implantation in recent years is shown in Table 3.

Stents were implanted in 966 grafts, 85.9% saphenous and 14.1% mammary; 343 stents were implanted in the trunk of the left coronary, protected in 38.8% of cases and unprotected in 61.2%.

Finally, 11 280 stent procedures were made directly, without balloon pre-dilatation, in 40.9% of cases vs 8778 (38.9%) last year.

Other percutaneous intervention devices

In spite of the hegemony of coronary stent, other percutaneous intervention devices are used. Of them, the balloon was the only device used in PCI in 2385 cases (7.2%), vs 17.3% last year. Directional atherectomy was used in 114 procedures in 9 centers, double the number of the previous year, and rotational atherectomy in 445 cases in 33 centers, which was a decrease of 3.5% with respect to last year (Table 4). Among other PCI devices, the increase in the use the cutting balloon, which was applied in 423 cases (240% increment), and thrombus extraction devices, used in 329 procedures (304% increment), should be highlighted. Other techniques used were distal protection devices (43 cases), transmyocardial laser (8 cases), alcoholization of the septal branch (20 cases), and fistula embolization (14 cases).

Finally, the use of beta system brachytherapy increased in 2001. From 23 cases treated in 2000, in 2001 there were 105 patients with 107 lesions treated, 33 de novo and 74 restenoses. Success was achieved in 97%, with 2% of non-fatal AMI and 1% mortality.

Non-coronary interventions in adults

In 2001, 478 valvuloplasties were performed in adults at 52 centers, a decrease of 2.9% with respect to 2000 (Figure 9). There was no significant variation in the number of mitral valvuloplasties, of which 452 were performed. In addition, 9 aortic valvuloplasties and 17 pulmonary valvuloplasties were carried out.

Fig. 9. Historical evolution of the number of mitral valvuloplasty procedures since 1990.

In the 452 case s of mitral valvuloplasty, a 93.2% success rate was obtained, with 3.3% uncomplicated failures and 3.5% major complications (3.1% severe mitral insufficiency, 0.2% cardiac tamponade, and 0.2% deaths).

Atrial septal defect was closed with a percutaneous device in 161 cases, an increase of 60% over the year before. The procedure was successful in 126 cases (89.4%), with uncomplicated failures in 13 (9.2%) and complica tions in 2 (1.4%).

Interventions in pediatric patients

Although there was a decrease in the number of diagnostic cases with respect to the previous year for the second consecutive year, there was a large increase in the number of interventional procedures, with 943 procedures performed in 23 centers. This was an increase of 15.4% with respect to 2000 and included above all dilatations (347 cases), closure of atrial septal defects (134), and closure of ductus arteriosus (157). The techniques most often used are summarized in Figure 10.

Fig. 10. Distribution of pediatric interventions.

CONCLUSIONS

One of the most important missions of the Working Group of Hemodynamics and Interventional Cardiology of the Sociedad Española de Cardiología is to present information about annual activity in Spain to the cardiological community.

In the area of ischemic heart disease there has been an increase in activity, both diagnostic and therapeutic, although the level of activity in Spain is still distant from that of more active countries, like France and especially Germany. However, the level of interventional activity is similar to or higher than that other European countries, like Portugal or the United Kingdom. There were no large differences in the number of coronariographies and PCIs per operator compared with the countries mentioned, but Spain had markedly fewer coronariographies per unit. When the number of PCIs per unit are considered, these differences decrease and even disappear since Spain has an elevated PCI/coronariography ratio. On the other hand, there was a large variability between autonomic communities in the number of procedures, whether diagnostic or therapeutic.

Among the diagnostic intracoronary techniques, the 37% increase in the use of intravascular echography with respect to the previous year is noteworthy and, to a lesser extent, the use of intracoronary pressure guidewires, which consolidated with an increase of 12% after a large increase in 2001.

With respect to interventional procedures, in 27% PCIs were performed in multiple vessels, with stents being implanted directly in 40.9% of cases and stents being used in 88.2% of the procedures. Glycoprotein IIb/IIIa inhibitors were used in 22.4%.

There was a growth of 22.9% in the use of angioplasty in acute myocardial infarction compared with 2000, although primary angioplasty increased by only 6.8%.

Finally, the number of valvuloplasties performed in adult patients stabilized, as a result of the stabilization of the number of mitral valvuloplasties. In contrast, a 15.4% increase in interventional activity in pediatric patients was recorded.

Correspondence: Dr. J.M. Hernández García.

Sierra de Grazalema, 32, bloque 10, ático E. 29016 Málaga. España.