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n                                I N S I G H T S F R O M N AT I O N A L S O C I E T I E S
EuroIntervention 2012;8:P80-P85 




                                         Regional differences and Italian charter to expand the
                                         primary angioplasty service
                                         Leonardo De Luca1, MD, PhD; Alberto Cremonesi2, MD; Antonio Marzocchi3, MD; Giulio Guagliumi4*, MD

                                         1. Division of Cardiology, Department of Cardiovascular Sciences, European Hospital, Rome, Italy; 2. GVM Care and Research,
                                         Interventional Cardio-Angiology Unit, Cotignola, RA, Italy; 3. Istituto di Cardiologia, Università degli Studi, Policlinico S.
                                         Orsola-Malpighi, Bologna, Italy; 4. Division of Cardiology, Cardiovascular Department, Ospedali Riuniti, Bergamo, Italy




                                         Abstract                                                                     Introduction
                                         Italy was one of the first countries in Europe to perform primary percuta-   Italy’s healthcare system is regarded as the second best in the
                                         neous coronary intervention (p-PCI) and some regions are still a model       world and, according to the Central Intelligence Agency world
                                         for the ST-elevation myocardial infarction (STEMI) network organisa-         fact book, has the world’s 19th highest life expectancy (80.9 years
                                         tion. However, in Italy, as in other European countries, some regional       in 2004)1. Healthcare spending in Italy accounted for 9.0% of
                                         disparities have emerged which are related to geographical, economic,        gross domestic product in 2006 (about 2,600 US dollars per cap-
                                         organisational and structural issues. Although some regions have excel-      ita) of which about 75% is public2. The public part is the National
                                         lent STEMI networks, others still have to develop a model which will         Health Service (SSN: Servizio Sanitario Nazionale) which is
                                         allow each STEMI patient to receive the best reperfusion treatment.          organised under the Ministry of Health and is administered on
                                            Seven areas where patient clinical needs are not met were identi-         a regional basis.
                                         fied as primary “Stent for Life” targets in Italy: five main regions in         Italy’s National Health Service is statutorily required to guaran-
                                         the south of Italy, namely Campania, Sicilia, Puglia, Basilicata and         tee the uniform provision of comprehensive care throughout the
                                         Calabria, and two major areas in the north, the districts of Piemonte        country. However, this is complicated by the fact that, constitution-
                                         and Veneto. In this review we describe socio-political issues and oro-       ally, responsibility for healthcare is shared between the central gov-
                                         graphic barriers to implementation of STEMI guidelines that have             ernment and the 20 regions. As a result, there are large and growing
                                         been identified and some hints on what we have done in each target           differences in regional health service organisation and provision,
DOI: 10.4244 / EIJV8SPA14




                                         region in order to expand the p-PCI service.                                 and ever-increasing regional disparities.




                                         *Corresponding author: Division of Cardiology, Cardiovascular Department, Ospedali Riuniti di Bergamo, Largo Barozzi 1,
                                         IT-24128 Bergamo, Italy. E-mail: guagliumig@gmail.com

                                         © Europa Edition 2012. All rights reserved.

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                                                                                                                                                                      EuroIntervention 2012;8:P80-P85
Primary percutaneous coronary intervention in                                                               2008   2009         ∆%          2010       ∆%
Italy                                                                                                      24,101 25,455       5.6%        27,931     9.7%
Italy was one of the first countries in Europe to perform primary                        9,064
                                                                           8,175 8,270
percutaneous coronary intervention (p-PCI) and some regions are                                                                                            7,761
still a model for the ST-elevation myocardial infarction (STEMI)                                                                                   6,863
                                                                                                                                   5,593   5,855
network organisation. Data from the Italian Society of Invasive                                  5,366 5,499 5,513
                                                                                                                     4,705 4,823
Cardiology (SICI-GISE) showed that approximately 28,000 p-PCI
were performed by the 260 cathlabs located across the country in
2010 (an increase of 9.7% compared to 2009) with an average of
465 primary PCI/million inhabitants/year (Figure 1)3.
   However, in Italy, as in other European countries4, some regional
                                                                             North-West              North-East           Centre            South and islands
disparities have emerged which are related to geographical, eco-
                                                                                                                                   2008      2009          2010
nomic, organisational and structural issues. Although some regions
(e.g., Emilia-Romagna, Liguria, Lombardia, Toscana) have excel-
                                                                         Figure 1. Number of p-PCIs in four different Italian macro-areas in
lent STEMI networks5, others still have to develop a model which
                                                                         the last three years (data from SICI-GISE).
will allow each STEMI patient to receive the best reperfusion treat-
ment, resulting in an annual rate of p-PCI well below the national
average and the standards (600/million inhabitants/year) recom-
mended by the European Association of Percutaneous                       tion was made using different electronic forms with access limited by
Cardiovascular Interventions (EAPCI) and the European Society of         personal passwords. The survey assessed the organisation of the
Cardiology (ESC) (Figure 2)6.                                            regional system of care together with local resource availability, with
                                                                         specific attention given to the distance from a hub centre. The survey
The RETE IMA Web survey                                                  ended in December 31, 2008, and covered 701 hospitals admitting
The RETE IMA Web survey was launched in 2007 by GISE in col-             STEMI patients, 157 (22.4%) with uninterrupted access (24 hours/7
laboration with the Italian Federation of Cardiology, with the aim of    days) to the catheterisation laboratory (2.67 per million inhabitants).
evaluating the current state of the regional system of care for STEMI    An operative network was present in 36/103 (35.9%) provinces, with
in Italy. Interventional cardiologists and the personnel of the emer-    important geographic variability (Figure 3)7. Among hospitals with-
gency medical system (EMS) participated in the survey7. Data collec-     out a full-time p-PCI facility, only 46% were within a regional system




                                                                                                                            % +150




                           N                                                                                                         0
                     700
                                                                                                                                   –50
                     600

                     500

                     400

                     300

                     200

                     100

                       0




Figure 2. Primary PCI per 1,000,000 inhabitants in different Italian regions (data from SICI-GISE, year 2010). In the upper part of the graph:
delta % compared to 2009 in each single region.



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                                  of care. ECG was available in 72% of the national territory, telemedi-    realities in territorial networks for STEMI present in Italy, we
                                  cine in 50%. Pre-hospital fibrinolysis was available in 16% of the        developed selective regional action plans offering a contribution in
                                  country. Overall, 92.4% of the Italian population resides within 60       background and network plan development, qualified at the national
                                  minutes of a hub centre.                                                  level, in alliance with recognised external organisations. In order to
                                     These data suggest that the lack of STEMI networks is not related      ensure access to p-PCI and the success of the SFL Initiative we
                                  to the need for infrastructures such as cathlabs or coronary care units   looked for the combined support and participation of many stake-
                                  (CCUs), but is linked more to organisational and political issues.        holders and partners, including interventional cardiologists, clinical
                                                                                                            cardiologists, emergency medical systems, government representa-
                                  Stent for Life in Italy                                                   tives, industry, advocacy groups and patients themselves.
                                  SICI-GISE signed the Stent for Life (SFL) Declaration for Italy at           Seven areas with unmet clinical needs were identified as primary
                                  the ESC Annual Congress in August 20108. From that time on, we            SFL targets in Italy, based on population and the results of the
                                  wrote all SFL documents tailored for Italy and the GISE green             RETE IMA Web survey: five main regions in the south of Italy,
                                  paper, a consensus document on STEMI network development.                 namely, Campania, Sicilia, Puglia, Basilicata and Calabria (the lat-
                                  Then we organised the kick-off meeting of SFL ITALIA which was            ter included in the project from January 2012), and two major areas
                                  held in Rome on April 8th 2011, that involved around 100 key opin-        in the north, the districts of Piemonte and Veneto (Figure 4).
                                  ion leaders and health commission representatives coming from the         Approximately 21 million inhabitants are potentially involved
                                  initiative’s target regions. During the meeting and later, we ana-        (35% of the total population).
                                  lysed and mapped health plans, reimbursements and STEMI sys-                 In all of these regions we are working to implement local STEMI
                                  tems of care, identified barriers for p-PCI use, and designed possible    treatment guidelines, identifying and eliminating specific barriers
                                  plans of action at a local level. Considering the different existing      to those guidelines. In a few months of activity we had several




                                  Figure 3. RETE IMA Web: operative network present in Italy in 2008 (from reference 7, with permission)



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                                                                                                                                                           EuroIntervention 2012;8:P80-P85
Figure 4. Target regions of SFL Italia (red bullets) identified on the basis of RETE IMA Web survey and number of inhabitants.




meetings with health commissions in some of the target regions              making every effort in terms of EMS staff training, with certified
which embraced the SFL project and assigned a task to reorganise            courses on advanced life support and ECG lectures, and on EMS
their STEMI systems of care.                                                structure improvement by equipping the vast majority of ambu-
   Below we have detailed some socio-political issues and oro-              lances with ECG teletransmission.
graphic barriers to the implementation of STEMI guidelines that                In this target region of SFL Italy, we are conducting a survey on
have been identified, and some hints on what we have done in each           the health costs of STEMI reperfusion in partnership with the
target region in order to expand the p-PCI service.                         CERGAS, Bocconi University of Milan. This survey will analyse
                                                                            the impact, in terms of cost/effectiveness before and after the set-
SICILIA                                                                     up, and implementation of a network for p-PCI (this project is the
Sicilia, located in the south-east of Italy, is the largest island in the   subject of another article in the present supplement).
Mediterranean Sea. Along with the surrounding minor islands, it
constitutes the Sicilian autonomous region. The terrain of inland           CAMPANIA
Sicilia is mostly hilly. In Sicilia there are nine provinces (five mil-     Campania, located in southern Italy, has a population of around 5.8
lion inhabitants) and only two metropolitan areas: Palermo, that            million people, making it the second most populous region of Italy;
has a larger urban zone of about 900,000 people, and Catania with           its total area of 13,590 km² makes it the most densely populated
650,000 people. Thirty CCUs and 19 cathlabs (2,415 p-PCIs in                region in the country. The region is divided into five provinces:
2010) are present, with quite a homogeneous distribution over the           Naples, Benevento, Avellino, Caserta and Salerno. Over half of the
entire territory. The EMS is underused (less than 20% of calls)             population is resident in the province of Naples, Naples being the
and carries the patient to the nearest hospital, especially in rural        capital city of Campania, where there is a population density of
areas.                                                                      2,626 inhabitants per km2. Within the province, the highest density
   A few months after the kick-off of the SFL programme in Italy,           can be found along the coast where it reaches 13,000 inhabitants
Sicilia issued a regional decree law on the organisation of their           per km2 in the city of Portici, one of the most densely populated
STEMI network. In this regional law, based on a green paper pro-            cities on the planet. The mountainous interior is fragmented into
duced by the steering committee of SFL Italia, all specific duties          several massifs, rarely reaching 2,000 metres, whereas close to the
and requirements of the EMS, emergency room, CCUs and cathlabs              coast there is the volcanic massif of Vesuvio (1,277 m). In this
involved in the network, together with standards and data collection        region, there are 47 CCUs and 20 cathlabs (10 with 24 hours/7 days
for quality control, were clearly stated. The STEMI network is              facilities), performing 1,760 p-PCIs per year. The number of CCUs
scheduled to start officially in July 2012. In the meantime, the            and cathlabs is adequate but not well distributed across the territory.
regional health government and four macro-area committees are               The number of ambulances is inadequate, with physician staff on



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                                  board but without ECG teletransmission in the vast majority of                 ing the number of p-PCIs performed (minimum of 330 p-PCIs/106
                                  cases and not connected to a central hub.                                      inhabitants/year in Verona and maximum of 684 p-PCIs/106 inhab-
                                     At the end of 2010, the regional health government issued a decree          itants/year in the province of Rovigo) probably related to different
                                  for a reassessment of the hospital and territorial network for STEMI           levels of organisation of STEMI networks and recourse to EMS and
                                  care. After several meetings with local health commissioners, SFL              ECG teletransmission. In this region SFL is identifying local barri-
                                  Italia promoted the institution of a regional commission for the defi-         ers for using established STEMI routes and implementing the
                                  nition of single provincial protocols for the STEMI network, assess-           recourse to p-PCI, and is instituting a permanent and reliable sys-
                                  ment of actual status of EMS, development of ECG teletransmission              tem for data collection and analysis.
                                  and training of EMS staff. This year, a pilot project on the STEMI
                                  network is planned to start in the province of Avellino.                       PUGLIA AND BASILICATA
                                                                                                                 Situated at the south-eastern tip of the Italian peninsula, Puglia cov-
                                  AREAS OF PIEMONTE AND VENETO                                                   ers over 19,000 km2 in a succession of broad plains and low-lying
                                  Piemonte, located in the north-western part of the peninsula, is the           hills. The only mountainous area, the Gargano promontory, does
                                  second largest of Italy’s regions after Sicilia, with an area of               not exceed 1,150 m and is to be found in the north of Apulia, which
                                  25,402 km2 and a population of about 4.4 million. The population               is the least mountainous region in Italy. Apulia is divided into six
                                  density in Piemonte is lower than the national average (on average             provinces: Bari, Foggia, Taranto, Brindisi, Lecce and Barletta-
                                  174 inhabitants per km2, rising to 335 inhabitants per km2 in the prov-        Andria-Trani (the latter instituted in 2009). The population density
                                  ince of Turin, the capital city of the region). The geography of Pie-          in Apulia is just above the national average: in 2008 it was equal to
                                  monte is 43.3% mountainous (it is surrounded on three sides by the             211 inhabitants per km2. Foggia is by far the least densely populated
                                  Alps), along with extensive areas of hills (30.3%) and plains (26.4%).         province (96 inhabitants per km2), whereas Bari (regional capital) is
                                  Piemonte, divided into eight provinces, has 30 CCUs (16 hubs and 14            the most densely populated province (308 inhabitants per km2).
                                  spokes) and 25 cathlabs well distributed in the territory. In 2010,            Apulia has 17 cathlabs which performed 1,687 p-PCIs in 2010.
                                  4,896 STEMI patients were hospitalised, with only 2,130 p-PCIs per-               Basilicata, also known as Lucania, is the most mountainous
                                  formed. Although this region has well established and documented               region in the south of Italy, with 47% of its area of 9,992 km2 cov-
                                  routes for STEMI patients and ECG teletransmission is fairly diffuse           ered by mountains, whereas 45% is hilly and 8% is made up of
                                  in the EMS ambulances, time delays are still suboptimal and pre-               plains. The region can be thought of as the “instep” of Italy, with
                                  hospital diagnosis is underused (with the exception of the provinces           Calabria functioning as the “toe” and Apulia the “heel”. The region
                                  of Novara and Cuneo).                                                          covers about 10,000 km2 and in 2010 had a population of about
                                     In May 2011 the Piemonte region conducted a two-month survey                600,000. The population density is very low compared to that of
                                  on the routes and modalities of access to hospital of STEMI patients,          Italy as a whole: 59.1 inhabitants per km² compared to a national
                                  their modalities of reperfusion treatment and consequent outcomes.             density of 200.4 in 2010. The region is divided into two provinces:
                                  This registry showed that the hospital access of patients was via              Potenza (regional capital) and Matera. Nowadays, Basilicata has
                                  EMS in 51% of cases, that p-PCI was performed in 78% of cases,                 just one cathlab which performed only 61 p-PCIs in 2010. Pre-
                                  and that 18% of patients did not receive any reperfusion treatment,            hospital thrombolysis is widely applied in this region, but coronary
                                  with an overall in-hospital mortality of 4.3%.                                 angiography after lysis is still underused.
                                     After these data, with the support of SFL, a task force for the imple-         Although these two regions issued a regional law for the institu-
                                  mentation of the STEMI network in the metropolitan area of Turin, as a         tion of STEMI networks several years ago, and regional EMS is
                                  pilot regional area, was established, and a web-based registry for moni-       supplied with 100% of ambulances equipped with ECG teletrans-
                                  toring the quality of performances in the STEMI setting was instituted.        mission (more than 306,000 ECG were teletransmitted in the last
                                     Veneto is located in the north-eastern part of Italy. It is the eighth      six years in Apulia), the majority of STEMI patients, especially in
                                  largest region in Italy, with a total area of 18,398.9 km2, and its popula-    suburban areas, are transported to the nearest hospital, regardless of
                                  tion is about five million, ranking fifth in Italy. Veneto can be divided      the presence or absence of cathlab facilities.
                                  into four areas: the northern mountainous Alpine zone (29% of the total           SFL Italia organised several meetings with local health and EMS
                                  area), the hill zone (14% of surface), the lower plain, and the coastal ter-   committees and produced a document to be presented at regional
                                  ritory. Of the seven provinces of the region, the province of Padua is the     government level on the reassessment of regional networks involving
                                  most populous and has the greatest density, with 424.81 persons per km2.       EMS, non-PCI hospitals and PCI centres in order to implement p-PCI
                                     Veneto has 21 cathlabs which performed 2,022 p-PCIs in 2010.                services effectively.
                                  Analysing several data from administrative records, regional and
                                  national registries, it emerged that: 1) the incidence of STEMI in             CALABRIA
                                  this region is lower compared to the national average, being approx-           Calabria is at the very south of the Italian peninsula, to which it is
                                  imately 700/106 inhabitants/year; 2) the mean number of p-PCIs,                connected by the Monte Pollino massif, while on the east, south and
                                  although it has increased in recent years, is still suboptimal (59% of         west it is surrounded by the Ionian and Tyrrhenian seas. The region is a
                                  STEMI treatment); 3) there is a wide regional heterogeneity regard-            long and narrow peninsula and covers 15,080 km2 with a population of



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                                                                                                                                                      EuroIntervention 2012;8:P80-P85
just over two million. Calabria is divided into five provinces: Cat-      Conflict of interest statement
anzaro, Reggio, Vibo Valentia, Crotone and Cosenza. The capital           The authors have no conflict of interest to declare.
city is Catanzaro but the most populated city is Reggio. Some 42%
of Calabria’s area is mountainous, 49% is hilly, while plains occupy      References
only 9% of the region’s territory.                                        	 1.	 http://www.photius.com/rankings/healthranks.html
   Calabria has seven cathlabs (concentrated in two provinces) which      	 2.	http://www.photius.com/rankings/world_health_performance_
performed 589 p-PCIs in 2010. Recently, the local health commis-          ranks.html
sion issued a decree on the STEMI network. The objectives of SFL,         	 3.	www.gise.it
that included this region in the project just a few months ago, are: 1)   	 4.	 Widimsky P, Wijns W, Fajadet J, de Belder M, Knot J,
to institute a close cooperation between the regional governments,        Aaberge L, Andrikopoulos G, Baz JA, Betriu A, Claeys M, Danchin N,
hospitals, EMS and other related bodies in order to achieve the appro-    Djambazov S, Erne P, Hartikainen J, Huber K, Kala P, Klinceva M,
priate implementation of p-PCI programmes; and 2) to create local         Kristensen SD, Ludman P, Ferre JM, Merkely B, Milicic D, Morais J,
registries on the incidence, treatment and outcomes of hospitalised       Noc M, Opolski G, Ostojic M, Radovanovic D, De Servi S,
STEMI patients that might serve as quality control.                       Stenestrand U, Studencan M, Tubaro M, Vasiljevic Z, Weidinger F,
                                                                          Witkowski A, Zeymer U; European Association for Percutaneous
Future plans                                                              Cardiovascular Interventions. Reperfusion therapy for ST elevation
In the coming months further meetings with some local health com-         acute myocardial infarction in Europe: description of the current
missioners have been scheduled in order to illustrate in detail the       situation in 30 countries. Eur Heart J. 2010;31:943-57.
initiative and the plans of action, and to support local health com-      	 5.	 Knot J, Widimsky P, Wijns W, Stenestrand U, Kristensen SD,
missions for planning and/or implementing p-PCI networks.                 Van’ T Hof A, Weidinger F, Janzon M, Nörgaard BL, Soerensen JT,
Finally, a new three-month data collection of the entire Italian net-     van de Wetering H, Thygesen K, Bergsten PA, Digerfeldt C,
work system (second edition of the Rete IMA Web registry) will            Potgieter A, Tomer N, Fajadet J. How to set up an effective national
start soon after a software update, in strict co-operation with the       primary angioplasty network: lessons learned from five European
Italian EMS.                                                              countries. EuroIntervention. 2009;5:299,301-9.
                                                                          	 6.	De Luca L, Marzocchi A, Guagliumi G. The Stent for Life
Conclusion                                                                project in Italy. J Cardiovasc Med. 2011;12:850-5.
The state of territorial networks for STEMI treatment in Italy is         	 7.	 Marzocchi A, Saia F, Bolognese L, Tamburino C, Giordano A,
heterogeneous and at the same time puzzling. There are some               Ramondo A, Sangiorgi GM, Tomai F, Cavallini C, Sardella G,
regions with well-developed and pioneering network systems and            Cortesi  Di Pasquale  De Servi S. Networks of care for
                                                                                  P,                 G,
other areas without a structured system of care for STEMI patients.       ST-elevation myocardial infarction in Italy. Results of the RETE
  The strategic plan of SFL in Italy is to develop a selective approach   IMA WEB survey. G Ital Cardiol (Rome) 2011;12:354-64.
and implement an action programme to increase patient access to           	 8.	Kristensen    SD. European perspectives in cardiology. The
p-PCI in some target regions.                                             Stent for Life Initiative. Circulation. 2012;125:f25-f27.




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13 regional differences and italian charter to expand the primary angioplasty service

  • 1. n I N S I G H T S F R O M N AT I O N A L S O C I E T I E S EuroIntervention 2012;8:P80-P85 Regional differences and Italian charter to expand the primary angioplasty service Leonardo De Luca1, MD, PhD; Alberto Cremonesi2, MD; Antonio Marzocchi3, MD; Giulio Guagliumi4*, MD 1. Division of Cardiology, Department of Cardiovascular Sciences, European Hospital, Rome, Italy; 2. GVM Care and Research, Interventional Cardio-Angiology Unit, Cotignola, RA, Italy; 3. Istituto di Cardiologia, Università degli Studi, Policlinico S. Orsola-Malpighi, Bologna, Italy; 4. Division of Cardiology, Cardiovascular Department, Ospedali Riuniti, Bergamo, Italy Abstract Introduction Italy was one of the first countries in Europe to perform primary percuta- Italy’s healthcare system is regarded as the second best in the neous coronary intervention (p-PCI) and some regions are still a model world and, according to the Central Intelligence Agency world for the ST-elevation myocardial infarction (STEMI) network organisa- fact book, has the world’s 19th highest life expectancy (80.9 years tion. However, in Italy, as in other European countries, some regional in 2004)1. Healthcare spending in Italy accounted for 9.0% of disparities have emerged which are related to geographical, economic, gross domestic product in 2006 (about 2,600 US dollars per cap- organisational and structural issues. Although some regions have excel- ita) of which about 75% is public2. The public part is the National lent STEMI networks, others still have to develop a model which will Health Service (SSN: Servizio Sanitario Nazionale) which is allow each STEMI patient to receive the best reperfusion treatment. organised under the Ministry of Health and is administered on Seven areas where patient clinical needs are not met were identi- a regional basis. fied as primary “Stent for Life” targets in Italy: five main regions in Italy’s National Health Service is statutorily required to guaran- the south of Italy, namely Campania, Sicilia, Puglia, Basilicata and tee the uniform provision of comprehensive care throughout the Calabria, and two major areas in the north, the districts of Piemonte country. However, this is complicated by the fact that, constitution- and Veneto. In this review we describe socio-political issues and oro- ally, responsibility for healthcare is shared between the central gov- graphic barriers to implementation of STEMI guidelines that have ernment and the 20 regions. As a result, there are large and growing been identified and some hints on what we have done in each target differences in regional health service organisation and provision, DOI: 10.4244 / EIJV8SPA14 region in order to expand the p-PCI service. and ever-increasing regional disparities. *Corresponding author: Division of Cardiology, Cardiovascular Department, Ospedali Riuniti di Bergamo, Largo Barozzi 1, IT-24128 Bergamo, Italy. E-mail: guagliumig@gmail.com © Europa Edition 2012. All rights reserved. P80
  • 2. SFL in Italy n EuroIntervention 2012;8:P80-P85 Primary percutaneous coronary intervention in 2008 2009 ∆% 2010 ∆% Italy 24,101 25,455 5.6% 27,931 9.7% Italy was one of the first countries in Europe to perform primary 9,064 8,175 8,270 percutaneous coronary intervention (p-PCI) and some regions are 7,761 still a model for the ST-elevation myocardial infarction (STEMI) 6,863 5,593 5,855 network organisation. Data from the Italian Society of Invasive 5,366 5,499 5,513 4,705 4,823 Cardiology (SICI-GISE) showed that approximately 28,000 p-PCI were performed by the 260 cathlabs located across the country in 2010 (an increase of 9.7% compared to 2009) with an average of 465 primary PCI/million inhabitants/year (Figure 1)3. However, in Italy, as in other European countries4, some regional North-West North-East Centre South and islands disparities have emerged which are related to geographical, eco- 2008 2009 2010 nomic, organisational and structural issues. Although some regions (e.g., Emilia-Romagna, Liguria, Lombardia, Toscana) have excel- Figure 1. Number of p-PCIs in four different Italian macro-areas in lent STEMI networks5, others still have to develop a model which the last three years (data from SICI-GISE). will allow each STEMI patient to receive the best reperfusion treat- ment, resulting in an annual rate of p-PCI well below the national average and the standards (600/million inhabitants/year) recom- mended by the European Association of Percutaneous tion was made using different electronic forms with access limited by Cardiovascular Interventions (EAPCI) and the European Society of personal passwords. The survey assessed the organisation of the Cardiology (ESC) (Figure 2)6. regional system of care together with local resource availability, with specific attention given to the distance from a hub centre. The survey The RETE IMA Web survey ended in December 31, 2008, and covered 701 hospitals admitting The RETE IMA Web survey was launched in 2007 by GISE in col- STEMI patients, 157 (22.4%) with uninterrupted access (24 hours/7 laboration with the Italian Federation of Cardiology, with the aim of days) to the catheterisation laboratory (2.67 per million inhabitants). evaluating the current state of the regional system of care for STEMI An operative network was present in 36/103 (35.9%) provinces, with in Italy. Interventional cardiologists and the personnel of the emer- important geographic variability (Figure 3)7. Among hospitals with- gency medical system (EMS) participated in the survey7. Data collec- out a full-time p-PCI facility, only 46% were within a regional system % +150 N 0 700 –50 600 500 400 300 200 100 0 Figure 2. Primary PCI per 1,000,000 inhabitants in different Italian regions (data from SICI-GISE, year 2010). In the upper part of the graph: delta % compared to 2009 in each single region. P81
  • 3. n EuroIntervention 2012;8:P80-P85 of care. ECG was available in 72% of the national territory, telemedi- realities in territorial networks for STEMI present in Italy, we cine in 50%. Pre-hospital fibrinolysis was available in 16% of the developed selective regional action plans offering a contribution in country. Overall, 92.4% of the Italian population resides within 60 background and network plan development, qualified at the national minutes of a hub centre. level, in alliance with recognised external organisations. In order to These data suggest that the lack of STEMI networks is not related ensure access to p-PCI and the success of the SFL Initiative we to the need for infrastructures such as cathlabs or coronary care units looked for the combined support and participation of many stake- (CCUs), but is linked more to organisational and political issues. holders and partners, including interventional cardiologists, clinical cardiologists, emergency medical systems, government representa- Stent for Life in Italy tives, industry, advocacy groups and patients themselves. SICI-GISE signed the Stent for Life (SFL) Declaration for Italy at Seven areas with unmet clinical needs were identified as primary the ESC Annual Congress in August 20108. From that time on, we SFL targets in Italy, based on population and the results of the wrote all SFL documents tailored for Italy and the GISE green RETE IMA Web survey: five main regions in the south of Italy, paper, a consensus document on STEMI network development. namely, Campania, Sicilia, Puglia, Basilicata and Calabria (the lat- Then we organised the kick-off meeting of SFL ITALIA which was ter included in the project from January 2012), and two major areas held in Rome on April 8th 2011, that involved around 100 key opin- in the north, the districts of Piemonte and Veneto (Figure 4). ion leaders and health commission representatives coming from the Approximately 21 million inhabitants are potentially involved initiative’s target regions. During the meeting and later, we ana- (35% of the total population). lysed and mapped health plans, reimbursements and STEMI sys- In all of these regions we are working to implement local STEMI tems of care, identified barriers for p-PCI use, and designed possible treatment guidelines, identifying and eliminating specific barriers plans of action at a local level. Considering the different existing to those guidelines. In a few months of activity we had several Figure 3. RETE IMA Web: operative network present in Italy in 2008 (from reference 7, with permission) P82
  • 4. SFL in Italy n EuroIntervention 2012;8:P80-P85 Figure 4. Target regions of SFL Italia (red bullets) identified on the basis of RETE IMA Web survey and number of inhabitants. meetings with health commissions in some of the target regions making every effort in terms of EMS staff training, with certified which embraced the SFL project and assigned a task to reorganise courses on advanced life support and ECG lectures, and on EMS their STEMI systems of care. structure improvement by equipping the vast majority of ambu- Below we have detailed some socio-political issues and oro- lances with ECG teletransmission. graphic barriers to the implementation of STEMI guidelines that In this target region of SFL Italy, we are conducting a survey on have been identified, and some hints on what we have done in each the health costs of STEMI reperfusion in partnership with the target region in order to expand the p-PCI service. CERGAS, Bocconi University of Milan. This survey will analyse the impact, in terms of cost/effectiveness before and after the set- SICILIA up, and implementation of a network for p-PCI (this project is the Sicilia, located in the south-east of Italy, is the largest island in the subject of another article in the present supplement). Mediterranean Sea. Along with the surrounding minor islands, it constitutes the Sicilian autonomous region. The terrain of inland CAMPANIA Sicilia is mostly hilly. In Sicilia there are nine provinces (five mil- Campania, located in southern Italy, has a population of around 5.8 lion inhabitants) and only two metropolitan areas: Palermo, that million people, making it the second most populous region of Italy; has a larger urban zone of about 900,000 people, and Catania with its total area of 13,590 km² makes it the most densely populated 650,000 people. Thirty CCUs and 19 cathlabs (2,415 p-PCIs in region in the country. The region is divided into five provinces: 2010) are present, with quite a homogeneous distribution over the Naples, Benevento, Avellino, Caserta and Salerno. Over half of the entire territory. The EMS is underused (less than 20% of calls) population is resident in the province of Naples, Naples being the and carries the patient to the nearest hospital, especially in rural capital city of Campania, where there is a population density of areas. 2,626 inhabitants per km2. Within the province, the highest density A few months after the kick-off of the SFL programme in Italy, can be found along the coast where it reaches 13,000 inhabitants Sicilia issued a regional decree law on the organisation of their per km2 in the city of Portici, one of the most densely populated STEMI network. In this regional law, based on a green paper pro- cities on the planet. The mountainous interior is fragmented into duced by the steering committee of SFL Italia, all specific duties several massifs, rarely reaching 2,000 metres, whereas close to the and requirements of the EMS, emergency room, CCUs and cathlabs coast there is the volcanic massif of Vesuvio (1,277 m). In this involved in the network, together with standards and data collection region, there are 47 CCUs and 20 cathlabs (10 with 24 hours/7 days for quality control, were clearly stated. The STEMI network is facilities), performing 1,760 p-PCIs per year. The number of CCUs scheduled to start officially in July 2012. In the meantime, the and cathlabs is adequate but not well distributed across the territory. regional health government and four macro-area committees are The number of ambulances is inadequate, with physician staff on P83
  • 5. n EuroIntervention 2012;8:P80-P85 board but without ECG teletransmission in the vast majority of ing the number of p-PCIs performed (minimum of 330 p-PCIs/106 cases and not connected to a central hub. inhabitants/year in Verona and maximum of 684 p-PCIs/106 inhab- At the end of 2010, the regional health government issued a decree itants/year in the province of Rovigo) probably related to different for a reassessment of the hospital and territorial network for STEMI levels of organisation of STEMI networks and recourse to EMS and care. After several meetings with local health commissioners, SFL ECG teletransmission. In this region SFL is identifying local barri- Italia promoted the institution of a regional commission for the defi- ers for using established STEMI routes and implementing the nition of single provincial protocols for the STEMI network, assess- recourse to p-PCI, and is instituting a permanent and reliable sys- ment of actual status of EMS, development of ECG teletransmission tem for data collection and analysis. and training of EMS staff. This year, a pilot project on the STEMI network is planned to start in the province of Avellino. PUGLIA AND BASILICATA Situated at the south-eastern tip of the Italian peninsula, Puglia cov- AREAS OF PIEMONTE AND VENETO ers over 19,000 km2 in a succession of broad plains and low-lying Piemonte, located in the north-western part of the peninsula, is the hills. The only mountainous area, the Gargano promontory, does second largest of Italy’s regions after Sicilia, with an area of not exceed 1,150 m and is to be found in the north of Apulia, which 25,402 km2 and a population of about 4.4 million. The population is the least mountainous region in Italy. Apulia is divided into six density in Piemonte is lower than the national average (on average provinces: Bari, Foggia, Taranto, Brindisi, Lecce and Barletta- 174 inhabitants per km2, rising to 335 inhabitants per km2 in the prov- Andria-Trani (the latter instituted in 2009). The population density ince of Turin, the capital city of the region). The geography of Pie- in Apulia is just above the national average: in 2008 it was equal to monte is 43.3% mountainous (it is surrounded on three sides by the 211 inhabitants per km2. Foggia is by far the least densely populated Alps), along with extensive areas of hills (30.3%) and plains (26.4%). province (96 inhabitants per km2), whereas Bari (regional capital) is Piemonte, divided into eight provinces, has 30 CCUs (16 hubs and 14 the most densely populated province (308 inhabitants per km2). spokes) and 25 cathlabs well distributed in the territory. In 2010, Apulia has 17 cathlabs which performed 1,687 p-PCIs in 2010. 4,896 STEMI patients were hospitalised, with only 2,130 p-PCIs per- Basilicata, also known as Lucania, is the most mountainous formed. Although this region has well established and documented region in the south of Italy, with 47% of its area of 9,992 km2 cov- routes for STEMI patients and ECG teletransmission is fairly diffuse ered by mountains, whereas 45% is hilly and 8% is made up of in the EMS ambulances, time delays are still suboptimal and pre- plains. The region can be thought of as the “instep” of Italy, with hospital diagnosis is underused (with the exception of the provinces Calabria functioning as the “toe” and Apulia the “heel”. The region of Novara and Cuneo). covers about 10,000 km2 and in 2010 had a population of about In May 2011 the Piemonte region conducted a two-month survey 600,000. The population density is very low compared to that of on the routes and modalities of access to hospital of STEMI patients, Italy as a whole: 59.1 inhabitants per km² compared to a national their modalities of reperfusion treatment and consequent outcomes. density of 200.4 in 2010. The region is divided into two provinces: This registry showed that the hospital access of patients was via Potenza (regional capital) and Matera. Nowadays, Basilicata has EMS in 51% of cases, that p-PCI was performed in 78% of cases, just one cathlab which performed only 61 p-PCIs in 2010. Pre- and that 18% of patients did not receive any reperfusion treatment, hospital thrombolysis is widely applied in this region, but coronary with an overall in-hospital mortality of 4.3%. angiography after lysis is still underused. After these data, with the support of SFL, a task force for the imple- Although these two regions issued a regional law for the institu- mentation of the STEMI network in the metropolitan area of Turin, as a tion of STEMI networks several years ago, and regional EMS is pilot regional area, was established, and a web-based registry for moni- supplied with 100% of ambulances equipped with ECG teletrans- toring the quality of performances in the STEMI setting was instituted. mission (more than 306,000 ECG were teletransmitted in the last Veneto is located in the north-eastern part of Italy. It is the eighth six years in Apulia), the majority of STEMI patients, especially in largest region in Italy, with a total area of 18,398.9 km2, and its popula- suburban areas, are transported to the nearest hospital, regardless of tion is about five million, ranking fifth in Italy. Veneto can be divided the presence or absence of cathlab facilities. into four areas: the northern mountainous Alpine zone (29% of the total SFL Italia organised several meetings with local health and EMS area), the hill zone (14% of surface), the lower plain, and the coastal ter- committees and produced a document to be presented at regional ritory. Of the seven provinces of the region, the province of Padua is the government level on the reassessment of regional networks involving most populous and has the greatest density, with 424.81 persons per km2. EMS, non-PCI hospitals and PCI centres in order to implement p-PCI Veneto has 21 cathlabs which performed 2,022 p-PCIs in 2010. services effectively. Analysing several data from administrative records, regional and national registries, it emerged that: 1) the incidence of STEMI in CALABRIA this region is lower compared to the national average, being approx- Calabria is at the very south of the Italian peninsula, to which it is imately 700/106 inhabitants/year; 2) the mean number of p-PCIs, connected by the Monte Pollino massif, while on the east, south and although it has increased in recent years, is still suboptimal (59% of west it is surrounded by the Ionian and Tyrrhenian seas. The region is a STEMI treatment); 3) there is a wide regional heterogeneity regard- long and narrow peninsula and covers 15,080 km2 with a population of P84
  • 6. SFL in Italy n EuroIntervention 2012;8:P80-P85 just over two million. Calabria is divided into five provinces: Cat- Conflict of interest statement anzaro, Reggio, Vibo Valentia, Crotone and Cosenza. The capital The authors have no conflict of interest to declare. city is Catanzaro but the most populated city is Reggio. Some 42% of Calabria’s area is mountainous, 49% is hilly, while plains occupy References only 9% of the region’s territory. 1. http://www.photius.com/rankings/healthranks.html Calabria has seven cathlabs (concentrated in two provinces) which 2. http://www.photius.com/rankings/world_health_performance_ performed 589 p-PCIs in 2010. Recently, the local health commis- ranks.html sion issued a decree on the STEMI network. The objectives of SFL, 3. www.gise.it that included this region in the project just a few months ago, are: 1) 4. Widimsky P, Wijns W, Fajadet J, de Belder M, Knot J, to institute a close cooperation between the regional governments, Aaberge L, Andrikopoulos G, Baz JA, Betriu A, Claeys M, Danchin N, hospitals, EMS and other related bodies in order to achieve the appro- Djambazov S, Erne P, Hartikainen J, Huber K, Kala P, Klinceva M, priate implementation of p-PCI programmes; and 2) to create local Kristensen SD, Ludman P, Ferre JM, Merkely B, Milicic D, Morais J, registries on the incidence, treatment and outcomes of hospitalised Noc M, Opolski G, Ostojic M, Radovanovic D, De Servi S, STEMI patients that might serve as quality control. Stenestrand U, Studencan M, Tubaro M, Vasiljevic Z, Weidinger F, Witkowski A, Zeymer U; European Association for Percutaneous Future plans Cardiovascular Interventions. Reperfusion therapy for ST elevation In the coming months further meetings with some local health com- acute myocardial infarction in Europe: description of the current missioners have been scheduled in order to illustrate in detail the situation in 30 countries. Eur Heart J. 2010;31:943-57. initiative and the plans of action, and to support local health com- 5. Knot J, Widimsky P, Wijns W, Stenestrand U, Kristensen SD, missions for planning and/or implementing p-PCI networks. Van’ T Hof A, Weidinger F, Janzon M, Nörgaard BL, Soerensen JT, Finally, a new three-month data collection of the entire Italian net- van de Wetering H, Thygesen K, Bergsten PA, Digerfeldt C, work system (second edition of the Rete IMA Web registry) will Potgieter A, Tomer N, Fajadet J. How to set up an effective national start soon after a software update, in strict co-operation with the primary angioplasty network: lessons learned from five European Italian EMS. countries. EuroIntervention. 2009;5:299,301-9. 6. De Luca L, Marzocchi A, Guagliumi G. The Stent for Life Conclusion project in Italy. J Cardiovasc Med. 2011;12:850-5. The state of territorial networks for STEMI treatment in Italy is 7. Marzocchi A, Saia F, Bolognese L, Tamburino C, Giordano A, heterogeneous and at the same time puzzling. There are some Ramondo A, Sangiorgi GM, Tomai F, Cavallini C, Sardella G, regions with well-developed and pioneering network systems and Cortesi  Di Pasquale  De Servi S. Networks of care for P, G, other areas without a structured system of care for STEMI patients. ST-elevation myocardial infarction in Italy. Results of the RETE The strategic plan of SFL in Italy is to develop a selective approach IMA WEB survey. G Ital Cardiol (Rome) 2011;12:354-64. and implement an action programme to increase patient access to 8. Kristensen  SD. European perspectives in cardiology. The p-PCI in some target regions. Stent for Life Initiative. Circulation. 2012;125:f25-f27. P85