Continuity and innovation: the yin and yang of interventional cardiology

Presidential criss-cross

Continuity and innovation can look like opposing and incompatible terms but, on the contrary, they are necessary and complementary components of the life of countries or individuals. Democratic associations follow the same rule, continuity in pursuing their long-term goals, innovations in their methods and in their leadership, ensured by a periodical renewal of the elected officers. This year marks the second change in presidency of our young association, potentially a revolution since five of the seven members of the Executive Board change, leaving only the outgoing President as Past President, and the incoming President to ensure continuity. We decided that the best way to ensure that the newly appointed officers were aware of the status of the various EAPCI activities was a full day meeting focused on the key projects. We were ambitious enough to call it a strategic board –not just an update on current state of affairs– but an open discussion on long-term future plans and we were pleased to see great commitment from previous and future EAPCI Board members who accepted, together with many Committee Chairs and Vice-Chairs, to spend a summer week-end near London to shape the future of the EAPCI. The importance of this meeting for the ESC was underlined by the presence of its Past-President, Roberto Ferrari, with Sophie Squarta and Marielle de la Torre helping us go through the complex regulations of the ESC. In the next pages we will try to convey the essence of the discussion and announce some of the decisions taken.

Membership and relationship with national interventional societies and working groups

What we have done... EAPCI has seen a phenomenal growth in the last two years, doubling its membership to 3,167 as of July 1st, with Italy and the UK leading the process. We noticed growth often coincided with the organisation of joint meetings at the main congresses of the National Interventional Societies, with the participation of representatives of the EAPCI, which we discussed in our last column on Europe. The feasibility of a process of automatic membership was considered, in spite of this rapid growth, because the current membership represents less than 10% of the total number of interventionalists for some of the large European countries such as France and Germany. The question of a fee for membership was also discussed.

What we will do... There was general consensus that it is too early to adopt a membership fee policy. A different proposal met with a large agreement, the creation of an independent EAPCI Fellowship, only offered to members with high standing for their academic or clinical achievements. A mandate was given to Javier Escaned to prepare a list of requirements to become “FEAPCI”, implementing a strict selection process. It is expected that a prestigious fellowship will also attract attention and interest in non-European, but affiliated countries. The discussion at this point turned to ways of enhancing communication with the various National Societies. The successful example of other associations inviting national presidents to a well-planned yearly meeting was considered worthwhile. There was also agreement that issues around the new education and certification platform in development (see below) should be the focus of the first meeting to be held in Spring next year.

Stent for Life

What we have done... Recent achievements were illustrated by Steen Kristensen, Chairman of the Stent for Life Initiative. There was a rapid increase in the utilisation of primary angioplasty in the first six countries targeted: Serbia and Bulgaria have doubled the number of P-PCI at more than 500/million inhabitants; large regions of Spain like Catalonia have implemented a universal P-PCI program; Turkey, under the direct supervision of the Ministry of Health, has developed an elaborated network program with plans to widen availability and build new laboratories in underserved areas; France has completed asurvey in urban and rural areas showing improved outcome with direct referral to P-PCI centres. The newly participating countries (Italy, Romania, Egypt, Portugal) will be welcomed by an initiation package summarising the various steps to activate a program, from the identification of a unique number to activate the emergency service to the various modalities followed to allow diagnosis in ambulance and the construction of a hospital network with low door to balloon time and trained operators. A UK communications company is developing tailored patient awareness campaigns to meet the needs of the individual participating countries, with a focus on the reduction of the longest delay, from symptoms onset to call. The day before the Board meeting a round table organised by Carlo Di Mario and hosted by the Italian Embassy in London, saw representatives from 13European countries, doctors, health managers, politicians, join together to discuss status, problems and initiatives. Participants were impressed by the revolutionary pace of change, introduced by Sir Roger Boyle (responsible for the cardiovascular program at the UK Department of Health during 10 years), the implementation of universal P-PCI programs, the efficiency of rapid nurse led diagnosis and prompt transfer to P-PCI centres offered by the London Ambulance Services under Dr. Mark Whitbread, the completeness of data offered by the MINAP and CCAD databases as shown by the BCIS Audit Leader, Peter Ludman and the former BCS President, Huon Gray. The President of the Italian Association of Invasive Cardiology GISE, Giulio Guagliumi, described the patchy situation within Italy, where islands of excellency with complete P-PCI programs centrally coordinated by the emergency services (Lombardy, Emilia Romagna, Tuscany), contrast with the less organised geographical areas throughout the country. The health service in Italy is managed at a regional level, and the powerful help offered by participation in a supra-national initiative like Stent for Life has been useful in changing regulations and organisations in two of the largest regions, Campania and Sicily, as was illustrated by DeLuca and Nicosia. Dr. Kurt Huber, on behalf of the European Commission SANCO, closed the meeting by confirming the attention devoted at a EU level to this initiative, announcing the participation of the Vice-President, Mr Antonio Tajani, at a Stent for Life symposium organised August 28th at 8:30 am during the ESC congress in Paris.

What we will do... When Stent for Life was started by Peter Widimsky under the former EAPCI Past President, William Wijns, the goal was to switch the predominance in the map of Europe in areas of low penetration of P-PCI. Amazingly, next year when a new survey will be carried out, it is likely that this ambitious plan will have already been achieved in many countries. Is it time to stop? The general consensus of the EAPCI Board was no, that it is not time to close down the most successful project of the Association, but rather to widen and accelerate the activities of Stent for Life. It was requested (and agreed) that the Stent for Life Chairman be invited to regularly attend the EAPCI Board meetings as exofficio member. It was recommended that this project, meant to deal with the application of the ESC STEMI Guidelines, see a more active involvement of other ESC constituents. Chris Vrints, current Chairman of the ESC WG on Acute Coronary Syndromes was invited to join the Stent for Life Executive Committee. The publication of the proceedings of the London meeting was approved as an upcoming supplement of EuroIntervention. It was also recommended that a gradual, but progressive expansion of activities occur, with a focus on such European countries as the Russian Federa tion, which has developed sufficient infrastructure in many regions with some successful pilot experiences. The main objective, as requested by many participating countries, is the development of aSTEMI registry able to follow not only the P-PCI cases, with detailed information on timing, but all STEMI patients. There is no conflict between this long-term goal, which will require cooperation and support from the ESC and all national societies, and the immediate need to receive aggregate data to repeat the 2008 survey. The support expressed by Roberto Ferrari, ESC Past President and influential member of the ESC EurObservational Study program Steering Committee, suggests that we may succeed in promoting a STEMI registry as part of the future ESC strategy. It will be important to capitalise on political contacts at a national and EU level to obtain endorsement and support for this initiative.

Registries and studies

What we have done... Plans to link existing national PCI registries and create a European infrastructure usable for documentation of existing activities, understanding of national differences, independent post-marketing surveillance and as an infrastructure for Pan-European studies is a dream that did not materialise. With the help and support of the ESC, however, we succeeded in launching a Pan-European pilot Valve Sentinel registry which has obtained the final agreement of 11 of 13 countries invited, with the UK and Denmark actively exploring ways to overcome the last regulatory obstacles to join. The main driver for success was the presence or the imminent start in most countries of a registry with data entering mandated for reimbursement. While Poland and Italy are sending data from individual centres (as Germany is expected to do for MitralClip implantations), the other nine (potentially 11) countries automatically transfer their database, and the data managers at the Heart House have already received large datasets or specifications to implement data transfer from the majority of them. Since retrospective enrolment from January 2011 is allowed, we expect sufficient data to be received and cleared to report meaningful in-hospital data by early next year.

What we will do... The consensus was that the Association must ensure the success of the Valve registry with its capillary network of officers and members covering all countries as well as its friendly relationship with the National Interventional Societies. This first attempt in Europe to establish a truly independent registry reporting results obtained with a new technology is important when countries are deciding on the adoption and reimbursement policies for this expensive new treatment. Reliable figures for the main complications collected by unbiased investigators in large series of patients using unequivocal definitions are data complementary to randomised trials, helpful to establish indications, define procedural risk, and assess long-term benefit. There is work to be done to ensure the adoption of more uniform datasets following the VARC definitions, and data monitoring is a challenge only in part helped by the presence of national systems in place. The potential for sub-studies (long-term durability was mentioned by Stephan Windecker) and the establishment of a network for future research was mentioned as a valuable spill over from this project.

Synergies with existing research initiatives of the ESC, like the STEMI registry for Stent for Life and, more interestingly, the establishment of a Research Foundation were also discussed. The Association, as a branch of the ESC with cross liability, was advised in the past to avoid direct involvement in research studies. More recently, the ESC Treasurer David Wood was asked to elaborate a plan to start a Research Foundation linked to the Heart House. There was general support within the Board for this project. It was felt that existing sources finance device or drug-oriented commercial studies or concentrate on non-clinical research while many strategy trials are not conducted because of lack of resources limiting the possibility to obtain vital information to guide treatment and inform guidelines. A practical example mentioned by George Sianos and Marie-Claude Morice was the randomised trial on clinical benefits of CTO recanalisation promoted by the EuroCTO Club. Many National Societies or National Interventional Societies act as sponsors of such trials, and raise money from industry and/or charities. European interventional cardiology has a tradition in the conduct of these trials, and the association should support these initiatives, facilitating the establishment of international networks and providing support for the complex financial plans and organisational rosters requested by the EU for their research projects. Lobbying for a greater share of this money to be reserved to truly European research projects in interventional cardiology was unanimously considered as a strategic priority for EAPCI.

Education and training

What we have done... The initiative taken during the first 2009 Board of the Di Mario Presidency to start a web based platform for certification of interventional training following approved European standards has helped to steer the plans of the entire ESC in this direction. The vast educational resources already available in escardio.org will be integrated in a professional platform for Associations and Working Groups interested in providing services for their younger members to certify their training path. Lino Goncalves, Chairman of the EAPCI Education Committee, was appointed to encourage the development of this platform. He described the various steps required to identify the provider with the best chances to meet the high specifications requested for a very flexible platform, able to certify attendance of courses, results of multiple choice questionnaires, number and characteristics of interventions performed as first and second operator, evaluation of supervisors. The expectation is that the platform will become operative after the ESC Congress 2013.

What we will do... Jean Fajadet promised full support for the critical steps still missing to fill the platform with educational content, and to ensure the support of the National Societies. The professional standards of the platform must be very high, helping Fellows and Supervisors to enter in a seamless and user-friendly way the information required. The importance of the cooperation between PCROnline and the upcoming Textbook of Interventional Cardiology was stressed.

Role of EAPCI in the EuroPCR and ESC congresses

What we have done... The record numbers attending EuroPCR in the last two years (>12,000 participants) mirrors the growth of the ESC congress itself with new record numbers expected in Paris this year. We can proudly announce that the two largest congresses of interventional cardiology and general cardiology are now held in Europe and the EAPCI has a major role in the organisation of both. The work done in shaping the interventional program of the ESC congress has been clarified in a previous President’s column. For EuroPCR, 11 program committee members have been identified along with presidents of the various National Societies, and Jean Marco announced that future EAPCI Presidents will become exofficio members of the EuroPCR Board of Directors for the duration of their Presidency. Also, for the PCRLondon Valves course, an agreement has been reached concerning those experts identified by the EAPCI to become Course Directors.

What we (together) will do... There are challenges in the presence of a separate congress organisation not directly accountable to the elected leadership of the Association. Still, as Jean Fajadet said, “We are all the same people”, a clear recognition of the ability of the EuroPCR leadership to involve new people and acknowledge the talent and the expertise of others. Not a single voice within the Board expressed concern, and there was unanimous support to a strategy of continuous cooperation.