- Email: [email protected]
Endovascular surgery in Europe
International Congress Series 1272 (2004) 102 – 108
www.ics-elsevier.com
Endovascular surgery in Europe Piergiorgio Cao *, Paola De Rango Struttura Complessa di Chirurgia Vascolare, Policlinico Monteluce, Via Brunamonti, 06122 Perugia, Italy
Keywords: Endovascular practice; Randomized controlled trials; Vascular registries
1. Introduction The diminishing invasiveness of therapeutic procedures is a natural and desirable consequence of medical research. In this perspective, catheter-based endovascular techniques have advanced significantly over the past three decades. Vascular surgeons have become more interested in these developments involving an increasing number of vascular diseases, and are now rapidly gaining in training widening practice opportunities. However, technology improvements will substantially diminish the need to perform open vascular reconstructions. Surgeons are being confronted with a variety of specialty groups (e.g., cardiologists, interventional radiologists, etc.) who intend to provide independent vascular services. Europe showed great enthusiasm and immediate suitability for endovascular innovations. Although there is a growing body of evidence suggesting that this new treatment modality is associated with less trauma to the patient, providing outcomes competitive with open vascular surgery, concerns about the evaluation, applicability and long-term durability of new technology with respect to the traditional gold standard remain. Furthermore, there may be a tendency for economic and ego gratification to guide decisions, that may outweigh the quality of patient care. 2. Specialists involved The development of endovascular techniques has forced vascular specialists to collaborate and interact. Cardiologists, vascular surgeons, interventional radiologists and angiologists involved in this field, consider the endovascular procedure as their task and conflicts may develop. In some vascular centers, a partnership between vascular surgeons and radiologists has been developed since the era of abdominal aortic aneurysm (AAA) endoluminal repair. The cooperation between radiologists and surgeons is becoming stronger than between surgeons and cardiologists, there are several reasons
* Corresponding author. Tel.: +39-75-573-2876; fax: +39-75-578-3194. E-mail address: [email protected] (P. Cao). 0531-5131/ D 2004 Elsevier B.V. All rights reserved. doi:10.1016/j.ics.2004.04.079
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
103
to explain this: the most important is based on the fact that radiologists, compared with the cardiologists, are less directly involved in patient clinical care and consequently the professional competition with vascular surgeons is less pronounced. In theory, collaboration among specialists is realistic in Europe because in the majority of cases, physicians are not directly paid by the patients but receive a salary, the main obstacle to teamwork being represented by the wish of the single physician for visibility and prestige. Nevertheless, there are an increasing number of vascular surgeons who acquired all the skills necessary to perform endovascular procedures and are working independently. Cooperation between vascular specialists in Europe was implemented by the organization of collaborative bodies. In 1985, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) was founded by the joining of forces of two formerly independent European societies: the European College of Angiography (ECA) and the European Society of Cardiovascular and Interventional Radiology (ESCVIR). Today CIRSE has 1400 members from about 50 countries. The objectives of the Society, which meets regularly, are principally to provide education and an exchange of scientific information for all physicians practicing or interested in cardiovascular and interventional radiology, to implement the role of cardiovascular and interventional radiology as a subspecialty. 3. The problem of training An important issue in endovascular practice is the lack of a formal program of training or accreditation in endovascular techniques. In Europe, quality assurance of vascular surgical training is not the responsibility of a centralized European authority, but is a matter in which the different countries have autonomous regulations. Consequently, different targets for duration, contents, and general principles for training in vascular surgery have been set. These differences are more pronounced for endovascular practice. The unification of countries into the European Union (EU) has changed this perspective because there is an increasing impetus towards a mutual recognition of education between member states. Currently, all the physicians involved in endovascular procedures have undergone formal training and are certified in their respective specialties but they are not certified in the associated specialties: surgeons are usually not trained in interventional radiology and radiologists and cardiologists are not trained in vascular surgery care. However, it has to be acknowledged that many European countries are developing cross-specialty training and accreditation [1]. Most physicians presently acquire additional knowledge and skills by visiting other centers or by attending one or more training courses available throughout Europe. The problem is that the nature, aims, and quality of such courses are variable, ranging from single-day device-specific workshops to comprehensive diploma courses that offer theoretical and practical training in all aspects of a particular technique. Recently, new initiatives and foundations have been promoted to support education and collaboration in these fields throughout Europe. The European Vascular and Interventional Training Academy (EVITA) was promoted as a joint initiative of CIRSE, ESVS (European Society of Vascular Surgery) and FIRE (the Foundation for Research and Education of CIRSE), in order to strengthen the joint forces of both vascular surgeons and interventional
104
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
radiologists in the treatment of vascular diseases. The format of EVITA, conceived as a purely educational annual meeting, is based on workshops including hands-on training, panel discussions, live case transmission, and state-of-the-art lectures. Results of these recently established initiatives are under observation. In Europe, as in the United States, industries have a key role in the research of new technologies for endovascular treatment of arterial diseases. Their contribution is performed either through research projects directly managed by industries, or by financial support to single institutions for conducting clinical studies. The downside is that, as the market changes, economic pressure in specific departments and among individuals will increase. Ideally, funding for research should come from official bodies, such as Local Government Authorities and European Union Administration. This type of funding is largely insufficient because of bureaucratic difficulties and scarcity of available grants, therefore industries may have a fundamental role in supporting vascular research. In general, industries respect the independent role of the researcher and an optimal balance between innovation, patient care, and business can be achieved. Recently, CIRSE supported the creation of FIRE, an independent research and education foundation, a non-profit organization, which promotes and supports research and education in diagnosis and treatment in Cardiovascular and Interventional Radiology. Sponsoring of basic research, pilot studies, large multicenter randomized trials, endovascular registries and educational development are the principal objectives of FIRE. 4. Regulatory bodies Industry pressure and financial reward may lead to uncontrolled adoption of endovascular techniques available with possible scant evaluation causing improper patient care. Medical device regulation generates divergent criticism: Food and Drug Administration (FDA) in the United States is more often regarded as too restrictive. In contrast, the general opinion of EU device regulation is usually considered too lax. In the United States, there are different types of stents and endografts with different characteristics, and more than a dozen companies are actively marketing these in different stages of clinical use or investigating them for FDA approval. On the other hand, throughout Europe, regulations exist to prevent the use of new devices until their safety and effectiveness have been proved. On 1 January 1995, a new European directive covering implantable medical devices became effective. This requires all medical devices to bear a CE mark from 14 June 1998. The CE marking, which is the abbreviation for ‘European Conformity’, indicates that the device meets all the essential requirements and other applicable provisions that have been imposed upon it by means of European directives, and that the product has been subject to the appropriate conformity assessment procedures. The CE marking system has the requirement to demonstrate safety of the medical device for an intended use, prior to commercialization. Many countries in the European Union have implemented these directives. CE marking is not a quality-mark. First, it refers to the safety rather than the quality of a product, secondly CE marking is mandatory for the product that applies, whereas most quality markings are voluntary.
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
105
The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 18 countries of the European Economic Area (EEA). The advantage of this policy is that there is only one set of requirements and procedures to comply with the designing and manufacturing of a product within the entire EEA. The various and conflicting national regulations are eliminated. Differently from FDA approval that implies Phase I and Phase II studies, the European directive covers only safety, not efficacy, and concern remains about the uniformity of safety standards imposed by individual countries. 5. Online surveys, vascular registries and randomized trials Economic forces are certainly driving towards the less invasive modes, which are presumed to be less expensive. Patients and physicians are contributing to the impression that endovascular procedures should be preferred because of their perception that less is better. Outcome studies and cost analysis need to be done before the attractive conclusion that ‘less invasive’ is ‘cheaper’ as well as ‘better’ can be drawn. In the last years, the Industries supported a proposal made by the Editorial Board of the journal Vascular News to conduct a survey to monitor vascular and endovascular activity in Europe: the European Vascular and Endovascular Monitor (EVEM), updated quarterly by online questionnaires. The main objective of EVEM is to regularly inform and advise members on changes in vascular and endovascular practice in Europe, via updated reports. Data from EVEM 2003 showed that endovascular procedures in Europe are mostly performed by vascular surgeons and radiologists together (67%) or by vascular surgeons alone (29%). EVEM showed that endovascular procedures have increased in the last 2 years and constitute about 12% of all aortic or carotid repairs, and about 55% of infrainguinal vascular procedures. Interesting changes and trends in endovascular applications can be expected in further EVEM reports. Limitations of EVEM reports are that data are given on a retrospective basis and that there is no effective control on information reliability. However, the numbers are periodically matched with the numbers of devices sold by the different companies operating in any single European country. Recent figures from EVEM are reported in Table 1. Dedicated Vascular Registries have been established in European countries to ensure that evolving endovascular techniques can be monitored [2 –4]. Several vascular registries (see Table 2) have been in use for many years, the Swedish Vascular Registry (SwedVasc) is the oldest and the Eurostar the most widely known.
Table 1 Procedures in Western Europea Procedures
Total no.
Endovascular
(%)
Open repair
(%)
Carotid AAA Thoracic aneurysm and dissection Infrainguinal
100,728 74,467 9841 169,245
11,142 9645 3342 93,192
11 13 40 55
89,586 65,002 6499 76,053
89 87 60 45
a
Based on EVEM report, September 2003.
106
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
In general the voluntary nature of all the registries raises questions about the completeness and accuracy of the returned data [5]. Furthermore, when compared with Randomized Controlled Trials (RCTs), vascular registries show lower levels of evidence and lack of monitoring for patient data. However, registries seem extremely useful to answer pertinent questions regarding the ‘real world’ of clinical practice and have the advantage to provide information faster than RCTs. These clinical questions may relate to the mortality associated to the endovascular procedure, complications, and the risk of conversion to open repair. In addition, the risk of systemic, arterial and device-related complications can be assessed in a large study population [6,7]. Reports from recent dedicated vascular registries have been found extremely useful for identifying anatomic and patient-related risk factors and device failures [8,9]. The cost-effectiveness of a registry is difficult to define in strict economical terms; however, the cost per registered case appears negligible compared with the overall cost of treating a vascular patient, and definitely less than costs associated with RCTs. More detailed information on this issue can be found in another chapter of this book. RCTs remain the ‘gold-standard’ for the assessment of any new intervention. Randomizing a new technology against conventional treatment may jeopardize the results if carried out too early. However, delaying the start of randomization may cause risk of loss of clinical equipoise, i.e. the surgeon or the patient will no longer accept conventional treatment. After some initial logistic delays, different RCTs comparing efficacy of endovascular repair of AAA with open surgery are now well underway in Europe. Trials organizers have in general made great efforts to ensure that centers involved are proficient so there is little or no learning curve effect about which to be concerned. Countries with ongoing trials on aortic repair include the UK EVAR 1 (Endovascular Abdominal Aortic Aneurysm Repair) trial and EVAR 2 trial (evaluating high-risk patients), the French Aneurysme Chirurgie de l’aorte contre Endoprothe`se (ACE) trial, the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial (Table 3) [10 – 12], and recently trials on endoluminal treatment of small aneurysms have been planned. Ongoing RCTs in Europe on carotid stenting include: in the United Kingdom, the CAVATAS II/ICSS (International Carotid Stenting Study); in France the EVA 3S, and in Germany the SPACE (Stent-protected Percutaneous Angioplasty of the Carotid Artery with Endarterectomy) trial. Table 2 Vascular registries in Europe
National
International
Registry
Country
Procedures
Swedvasc Hellenic Angio Spanish hospital, Karbase
Sweden Greece Spain, Denmark
Swiss National RETA EUROCAST EUROSTAR EVEM
Switzerland UK European European European
vasc and endovasc vasc and endovasc vasc and endovasc, vasc and endovasc vasc and endovasc aortic endograft carotid aortic endograft vasc and endovasc
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
107
Table 3 Randomized clinical trials on endovascular surgery in Europe
Carotid
Aortic
Trial
Country
Status
CAVATAS Leicester CAVATAS II/ICSS EVA 3S SPACE DREAM EVAR 1 EVAR 2
UK UK UK France Germany The Netherlands UK UK
completed stopped ongoing ongoing ongoing ongoing ongoing ongoing
6. Conclusions The multidisciplinary approach and the relatively easy CE marking process led to a widespread endovascular surgery in Europe. Endovascular specialists collaboration in Europe is somewhat encouraged by the perception of a faster learning curve in performing the procedure; organization of collaborative societies and multidisciplinary meetings sponsored by manufacturers can contribute to this. Online surveys as well as dedicated registries have an important role in gathering data, testing new techniques, and monitoring outcomes of endovascular procedures in Europe, while waiting for the results of the ongoing RCT trials. Constant and accurate control on endovascular practice is essential to ensure balance between patient benefit and industrial pressure. References [1] P. Cao, F. Verzini, P. De Rango, Endovascular surgery in Europe, in: P. Glovitzky (Ed.), Perspectives in Vascular Surgery, vol. 15, No. 1,Westminster Publications, 2003, pp. 15 – 22. [2] P. Harris, Eurostar: the need to audit new generations devices separately, in: R.M. Greenhalgh, J.T. Powell, A.W. Mitchell (Eds.), Vascular and Endovascular Opportunities, Saunders, London, 2000, pp. 237 – 247. [3] S.M. Thomas, et al., on behalf of the Vascular Surgical Society of Great Britain and Ireland and the British Society of Interventional Radiologists, Short-term (30 day) outcome of endovascular treatment of abdominal aortic aneurysm: results from a prospective Registry of Endovascular Treatment of Aneurysms (RETA), Eur. J. Vasc. Endovasc. Surg. 21 (2001) 57 – 64. [4] M.R.H.M. Van Sambeek, on behalf of the EUROCAST Registry Steering Committee, The EUROCAST Registry of carotid stenting, in: R.M. Greenhalgh, J.T Powell, A.W. Mitchell (Eds.), Vascular and Endovascular Opportunities, Saunders, London, 2000, pp. 123 – 127. [5] L.P. Jensen, T. Troeng, Vascular registries—are they worth the effort? Eur. J. Vasc. Endovasc. Surg. 20 (2000) 225 – 226. [6] J. Buth, et al., on behalf of the Eurostar Collaborators: early complications and endoleaks after endovascular abdominal aortic aneurysm repair, Report of a multicentre study, J. Vasc. Surg. 31 (2000) 134 – 146. [7] P.L. Harris, et al., Incidence and risk factors of late rupture, conversion and death after endovascular repair of infrarenal aortic aneurysms: the EUROSTAR experience, J. Vasc. Surg. 32 (2000) 739 – 749. [8] J. Buth, et al. (on behalf of the EUROSTAR Collaborators), Outcome of endovascular abdominal aortic aneurysm repair in patients considered unfit for an open procedure: a report on the EUROSTAR experience, J. Vasc. Surg. 35 (2002) 211 – 221. [9] C. van Marriewijk, et al., Significance of endoleaks after endovascular repair of abdominal aortic aneurysms: the EUROSTAR experience, J. Vasc. Surg. 35 (2002) 461 – 473. [10] R.M. Greenhalgh, et al., for the UK EVAR Trial Participants, The UK EndoVascular Aneurysm Repair
108
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
(EVAR) trials: background and methodology, in: R.M. Greenhalgh, J.T. Powell, A.W. Mitchell (Eds.), Vascular and Endovascular Opportunities, Saunders, London, 2000, pp. 215 – 227. [11] J.-P. Becquemin, et al., for the ACE trialists, Abdominal aortic aneurysms—surgical versus endoluminal repair: the French prospective randomized (ACE) trial, in: R.M. Greenhalgh, J.T. Powell, A.W. Mitchell (Eds.), Vascular and Endovascular Opportunities, Saunders, London, 2000, pp. 234 – 236. [12] M. Prinssen, E. Buskens, J.D. Blankesteijn, The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, J. Cardiovasc. Surg. 43 (2002) 379 – 384.
www.ics-elsevier.com
Endovascular surgery in Europe Piergiorgio Cao *, Paola De Rango Struttura Complessa di Chirurgia Vascolare, Policlinico Monteluce, Via Brunamonti, 06122 Perugia, Italy
Keywords: Endovascular practice; Randomized controlled trials; Vascular registries
1. Introduction The diminishing invasiveness of therapeutic procedures is a natural and desirable consequence of medical research. In this perspective, catheter-based endovascular techniques have advanced significantly over the past three decades. Vascular surgeons have become more interested in these developments involving an increasing number of vascular diseases, and are now rapidly gaining in training widening practice opportunities. However, technology improvements will substantially diminish the need to perform open vascular reconstructions. Surgeons are being confronted with a variety of specialty groups (e.g., cardiologists, interventional radiologists, etc.) who intend to provide independent vascular services. Europe showed great enthusiasm and immediate suitability for endovascular innovations. Although there is a growing body of evidence suggesting that this new treatment modality is associated with less trauma to the patient, providing outcomes competitive with open vascular surgery, concerns about the evaluation, applicability and long-term durability of new technology with respect to the traditional gold standard remain. Furthermore, there may be a tendency for economic and ego gratification to guide decisions, that may outweigh the quality of patient care. 2. Specialists involved The development of endovascular techniques has forced vascular specialists to collaborate and interact. Cardiologists, vascular surgeons, interventional radiologists and angiologists involved in this field, consider the endovascular procedure as their task and conflicts may develop. In some vascular centers, a partnership between vascular surgeons and radiologists has been developed since the era of abdominal aortic aneurysm (AAA) endoluminal repair. The cooperation between radiologists and surgeons is becoming stronger than between surgeons and cardiologists, there are several reasons
* Corresponding author. Tel.: +39-75-573-2876; fax: +39-75-578-3194. E-mail address: [email protected] (P. Cao). 0531-5131/ D 2004 Elsevier B.V. All rights reserved. doi:10.1016/j.ics.2004.04.079
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
103
to explain this: the most important is based on the fact that radiologists, compared with the cardiologists, are less directly involved in patient clinical care and consequently the professional competition with vascular surgeons is less pronounced. In theory, collaboration among specialists is realistic in Europe because in the majority of cases, physicians are not directly paid by the patients but receive a salary, the main obstacle to teamwork being represented by the wish of the single physician for visibility and prestige. Nevertheless, there are an increasing number of vascular surgeons who acquired all the skills necessary to perform endovascular procedures and are working independently. Cooperation between vascular specialists in Europe was implemented by the organization of collaborative bodies. In 1985, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) was founded by the joining of forces of two formerly independent European societies: the European College of Angiography (ECA) and the European Society of Cardiovascular and Interventional Radiology (ESCVIR). Today CIRSE has 1400 members from about 50 countries. The objectives of the Society, which meets regularly, are principally to provide education and an exchange of scientific information for all physicians practicing or interested in cardiovascular and interventional radiology, to implement the role of cardiovascular and interventional radiology as a subspecialty. 3. The problem of training An important issue in endovascular practice is the lack of a formal program of training or accreditation in endovascular techniques. In Europe, quality assurance of vascular surgical training is not the responsibility of a centralized European authority, but is a matter in which the different countries have autonomous regulations. Consequently, different targets for duration, contents, and general principles for training in vascular surgery have been set. These differences are more pronounced for endovascular practice. The unification of countries into the European Union (EU) has changed this perspective because there is an increasing impetus towards a mutual recognition of education between member states. Currently, all the physicians involved in endovascular procedures have undergone formal training and are certified in their respective specialties but they are not certified in the associated specialties: surgeons are usually not trained in interventional radiology and radiologists and cardiologists are not trained in vascular surgery care. However, it has to be acknowledged that many European countries are developing cross-specialty training and accreditation [1]. Most physicians presently acquire additional knowledge and skills by visiting other centers or by attending one or more training courses available throughout Europe. The problem is that the nature, aims, and quality of such courses are variable, ranging from single-day device-specific workshops to comprehensive diploma courses that offer theoretical and practical training in all aspects of a particular technique. Recently, new initiatives and foundations have been promoted to support education and collaboration in these fields throughout Europe. The European Vascular and Interventional Training Academy (EVITA) was promoted as a joint initiative of CIRSE, ESVS (European Society of Vascular Surgery) and FIRE (the Foundation for Research and Education of CIRSE), in order to strengthen the joint forces of both vascular surgeons and interventional
104
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
radiologists in the treatment of vascular diseases. The format of EVITA, conceived as a purely educational annual meeting, is based on workshops including hands-on training, panel discussions, live case transmission, and state-of-the-art lectures. Results of these recently established initiatives are under observation. In Europe, as in the United States, industries have a key role in the research of new technologies for endovascular treatment of arterial diseases. Their contribution is performed either through research projects directly managed by industries, or by financial support to single institutions for conducting clinical studies. The downside is that, as the market changes, economic pressure in specific departments and among individuals will increase. Ideally, funding for research should come from official bodies, such as Local Government Authorities and European Union Administration. This type of funding is largely insufficient because of bureaucratic difficulties and scarcity of available grants, therefore industries may have a fundamental role in supporting vascular research. In general, industries respect the independent role of the researcher and an optimal balance between innovation, patient care, and business can be achieved. Recently, CIRSE supported the creation of FIRE, an independent research and education foundation, a non-profit organization, which promotes and supports research and education in diagnosis and treatment in Cardiovascular and Interventional Radiology. Sponsoring of basic research, pilot studies, large multicenter randomized trials, endovascular registries and educational development are the principal objectives of FIRE. 4. Regulatory bodies Industry pressure and financial reward may lead to uncontrolled adoption of endovascular techniques available with possible scant evaluation causing improper patient care. Medical device regulation generates divergent criticism: Food and Drug Administration (FDA) in the United States is more often regarded as too restrictive. In contrast, the general opinion of EU device regulation is usually considered too lax. In the United States, there are different types of stents and endografts with different characteristics, and more than a dozen companies are actively marketing these in different stages of clinical use or investigating them for FDA approval. On the other hand, throughout Europe, regulations exist to prevent the use of new devices until their safety and effectiveness have been proved. On 1 January 1995, a new European directive covering implantable medical devices became effective. This requires all medical devices to bear a CE mark from 14 June 1998. The CE marking, which is the abbreviation for ‘European Conformity’, indicates that the device meets all the essential requirements and other applicable provisions that have been imposed upon it by means of European directives, and that the product has been subject to the appropriate conformity assessment procedures. The CE marking system has the requirement to demonstrate safety of the medical device for an intended use, prior to commercialization. Many countries in the European Union have implemented these directives. CE marking is not a quality-mark. First, it refers to the safety rather than the quality of a product, secondly CE marking is mandatory for the product that applies, whereas most quality markings are voluntary.
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
105
The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 18 countries of the European Economic Area (EEA). The advantage of this policy is that there is only one set of requirements and procedures to comply with the designing and manufacturing of a product within the entire EEA. The various and conflicting national regulations are eliminated. Differently from FDA approval that implies Phase I and Phase II studies, the European directive covers only safety, not efficacy, and concern remains about the uniformity of safety standards imposed by individual countries. 5. Online surveys, vascular registries and randomized trials Economic forces are certainly driving towards the less invasive modes, which are presumed to be less expensive. Patients and physicians are contributing to the impression that endovascular procedures should be preferred because of their perception that less is better. Outcome studies and cost analysis need to be done before the attractive conclusion that ‘less invasive’ is ‘cheaper’ as well as ‘better’ can be drawn. In the last years, the Industries supported a proposal made by the Editorial Board of the journal Vascular News to conduct a survey to monitor vascular and endovascular activity in Europe: the European Vascular and Endovascular Monitor (EVEM), updated quarterly by online questionnaires. The main objective of EVEM is to regularly inform and advise members on changes in vascular and endovascular practice in Europe, via updated reports. Data from EVEM 2003 showed that endovascular procedures in Europe are mostly performed by vascular surgeons and radiologists together (67%) or by vascular surgeons alone (29%). EVEM showed that endovascular procedures have increased in the last 2 years and constitute about 12% of all aortic or carotid repairs, and about 55% of infrainguinal vascular procedures. Interesting changes and trends in endovascular applications can be expected in further EVEM reports. Limitations of EVEM reports are that data are given on a retrospective basis and that there is no effective control on information reliability. However, the numbers are periodically matched with the numbers of devices sold by the different companies operating in any single European country. Recent figures from EVEM are reported in Table 1. Dedicated Vascular Registries have been established in European countries to ensure that evolving endovascular techniques can be monitored [2 –4]. Several vascular registries (see Table 2) have been in use for many years, the Swedish Vascular Registry (SwedVasc) is the oldest and the Eurostar the most widely known.
Table 1 Procedures in Western Europea Procedures
Total no.
Endovascular
(%)
Open repair
(%)
Carotid AAA Thoracic aneurysm and dissection Infrainguinal
100,728 74,467 9841 169,245
11,142 9645 3342 93,192
11 13 40 55
89,586 65,002 6499 76,053
89 87 60 45
a
Based on EVEM report, September 2003.
106
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
In general the voluntary nature of all the registries raises questions about the completeness and accuracy of the returned data [5]. Furthermore, when compared with Randomized Controlled Trials (RCTs), vascular registries show lower levels of evidence and lack of monitoring for patient data. However, registries seem extremely useful to answer pertinent questions regarding the ‘real world’ of clinical practice and have the advantage to provide information faster than RCTs. These clinical questions may relate to the mortality associated to the endovascular procedure, complications, and the risk of conversion to open repair. In addition, the risk of systemic, arterial and device-related complications can be assessed in a large study population [6,7]. Reports from recent dedicated vascular registries have been found extremely useful for identifying anatomic and patient-related risk factors and device failures [8,9]. The cost-effectiveness of a registry is difficult to define in strict economical terms; however, the cost per registered case appears negligible compared with the overall cost of treating a vascular patient, and definitely less than costs associated with RCTs. More detailed information on this issue can be found in another chapter of this book. RCTs remain the ‘gold-standard’ for the assessment of any new intervention. Randomizing a new technology against conventional treatment may jeopardize the results if carried out too early. However, delaying the start of randomization may cause risk of loss of clinical equipoise, i.e. the surgeon or the patient will no longer accept conventional treatment. After some initial logistic delays, different RCTs comparing efficacy of endovascular repair of AAA with open surgery are now well underway in Europe. Trials organizers have in general made great efforts to ensure that centers involved are proficient so there is little or no learning curve effect about which to be concerned. Countries with ongoing trials on aortic repair include the UK EVAR 1 (Endovascular Abdominal Aortic Aneurysm Repair) trial and EVAR 2 trial (evaluating high-risk patients), the French Aneurysme Chirurgie de l’aorte contre Endoprothe`se (ACE) trial, the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial (Table 3) [10 – 12], and recently trials on endoluminal treatment of small aneurysms have been planned. Ongoing RCTs in Europe on carotid stenting include: in the United Kingdom, the CAVATAS II/ICSS (International Carotid Stenting Study); in France the EVA 3S, and in Germany the SPACE (Stent-protected Percutaneous Angioplasty of the Carotid Artery with Endarterectomy) trial. Table 2 Vascular registries in Europe
National
International
Registry
Country
Procedures
Swedvasc Hellenic Angio Spanish hospital, Karbase
Sweden Greece Spain, Denmark
Swiss National RETA EUROCAST EUROSTAR EVEM
Switzerland UK European European European
vasc and endovasc vasc and endovasc vasc and endovasc, vasc and endovasc vasc and endovasc aortic endograft carotid aortic endograft vasc and endovasc
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
107
Table 3 Randomized clinical trials on endovascular surgery in Europe
Carotid
Aortic
Trial
Country
Status
CAVATAS Leicester CAVATAS II/ICSS EVA 3S SPACE DREAM EVAR 1 EVAR 2
UK UK UK France Germany The Netherlands UK UK
completed stopped ongoing ongoing ongoing ongoing ongoing ongoing
6. Conclusions The multidisciplinary approach and the relatively easy CE marking process led to a widespread endovascular surgery in Europe. Endovascular specialists collaboration in Europe is somewhat encouraged by the perception of a faster learning curve in performing the procedure; organization of collaborative societies and multidisciplinary meetings sponsored by manufacturers can contribute to this. Online surveys as well as dedicated registries have an important role in gathering data, testing new techniques, and monitoring outcomes of endovascular procedures in Europe, while waiting for the results of the ongoing RCT trials. Constant and accurate control on endovascular practice is essential to ensure balance between patient benefit and industrial pressure. References [1] P. Cao, F. Verzini, P. De Rango, Endovascular surgery in Europe, in: P. Glovitzky (Ed.), Perspectives in Vascular Surgery, vol. 15, No. 1,Westminster Publications, 2003, pp. 15 – 22. [2] P. Harris, Eurostar: the need to audit new generations devices separately, in: R.M. Greenhalgh, J.T. Powell, A.W. Mitchell (Eds.), Vascular and Endovascular Opportunities, Saunders, London, 2000, pp. 237 – 247. [3] S.M. Thomas, et al., on behalf of the Vascular Surgical Society of Great Britain and Ireland and the British Society of Interventional Radiologists, Short-term (30 day) outcome of endovascular treatment of abdominal aortic aneurysm: results from a prospective Registry of Endovascular Treatment of Aneurysms (RETA), Eur. J. Vasc. Endovasc. Surg. 21 (2001) 57 – 64. [4] M.R.H.M. Van Sambeek, on behalf of the EUROCAST Registry Steering Committee, The EUROCAST Registry of carotid stenting, in: R.M. Greenhalgh, J.T Powell, A.W. Mitchell (Eds.), Vascular and Endovascular Opportunities, Saunders, London, 2000, pp. 123 – 127. [5] L.P. Jensen, T. Troeng, Vascular registries—are they worth the effort? Eur. J. Vasc. Endovasc. Surg. 20 (2000) 225 – 226. [6] J. Buth, et al., on behalf of the Eurostar Collaborators: early complications and endoleaks after endovascular abdominal aortic aneurysm repair, Report of a multicentre study, J. Vasc. Surg. 31 (2000) 134 – 146. [7] P.L. Harris, et al., Incidence and risk factors of late rupture, conversion and death after endovascular repair of infrarenal aortic aneurysms: the EUROSTAR experience, J. Vasc. Surg. 32 (2000) 739 – 749. [8] J. Buth, et al. (on behalf of the EUROSTAR Collaborators), Outcome of endovascular abdominal aortic aneurysm repair in patients considered unfit for an open procedure: a report on the EUROSTAR experience, J. Vasc. Surg. 35 (2002) 211 – 221. [9] C. van Marriewijk, et al., Significance of endoleaks after endovascular repair of abdominal aortic aneurysms: the EUROSTAR experience, J. Vasc. Surg. 35 (2002) 461 – 473. [10] R.M. Greenhalgh, et al., for the UK EVAR Trial Participants, The UK EndoVascular Aneurysm Repair
108
P. Cao, P. De Rango / International Congress Series 1272 (2004) 102–108
(EVAR) trials: background and methodology, in: R.M. Greenhalgh, J.T. Powell, A.W. Mitchell (Eds.), Vascular and Endovascular Opportunities, Saunders, London, 2000, pp. 215 – 227. [11] J.-P. Becquemin, et al., for the ACE trialists, Abdominal aortic aneurysms—surgical versus endoluminal repair: the French prospective randomized (ACE) trial, in: R.M. Greenhalgh, J.T. Powell, A.W. Mitchell (Eds.), Vascular and Endovascular Opportunities, Saunders, London, 2000, pp. 234 – 236. [12] M. Prinssen, E. Buskens, J.D. Blankesteijn, The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, J. Cardiovasc. Surg. 43 (2002) 379 – 384.