Attendees at the Eurostar collaborators meeting at the ESVS XVI Annual Meeting in Istanbul described it as “fantastic. The Eurostar database has grown to become the most comprehensive and reliable source of information about endovascular aneurysm repair available in the world.
Peter Harris opened the meeting by saying that these were exciting times and that maybe after 30 years of miserable results we may now see a breakthrough with EVAR. He was responsible for setting up the debate on endovascular repair of ruptured abdominal aortic aneurysms and putting together an excellent faculty to discuss the practical issues of how to get a hospital organised, how to evaluate ruptured aneurysm repair and the role of Eurostar. He opened the meeting with an introduction on the need for improved results in the treatment of AAA.The second speaker was Brian Hopkinson of Nottingham describing how he does endovascular repair of ruptured abdominal aortic aneurysms. “With all the blood and guts on the floor of open repair I always felt that there must be a better way,”said Hopkinson. He pointed out that in Nottingham the very first patient with a ruptured aneurysm was treated by EVAR – and eight years on the patient is still doing well. He recalled that, in 1994, he carried out EVAR of a ruptured aneurysm that was an instant success and he had done one the previous Tuesday, just prior to the meeting, that also went very well. However, in between these operations, he had all kinds of problems and it was on these that he focused.Hopkinson said that in order to be able to do an emergengy EVAR (eEVAR) you need:
In terms of results Hopkinson said he knew that if patients went to the ward straight after the procedure they had a good prognosis. If they went to the high dependency ward, their prognosis was slightly worse and if they went to intensive care, they had a bad prognosis. There is a preference in Nottingham for aorto-mono-iliac endografts and permissive hypotension.
Jaap Buth of Eindhoven, The Netherlands, then spoke about how he dealt with ruptured aneurysms. He highlighted the need for a team. He pointed out the excessive mortality of open repair for ruptured aneurysms (41%) and for symptomatic non-ruptured AAA (11-14%). Although the results for the endovascular approach vary somewhat (Ohki 16% to Greenberg of the Cleveland Clinic 0%), they indicate that this could be a promising technique.
In Eindhoven they have treated 35 patients with acute or ruptured aneurysms so far with an overall mortality of 21% and in the ruptured subgroup 28%. Also, in Eindhoven, the aorto-mono-iliac technique with crossover bypass is favoured. The Eindhoven view is that a quick execution of the procedure is preferable in terms of stabilising a patient compared to the use of a suprarenal aortic balloon.
Buth has created a protocol to cover ruptured aneurysms and at his hospital their approach is that for all patients that present with a ruptured aneurysm their intension is to treat with EVAR.
Buth said that his results indicate, in the first few months a 28% morality, compared with 46% mortality for open repair. This appears a promising development, but there are logistical problems.
Scientific evidence seems to show a possible superiority for eEVAR, however, Buth emphasised the need for the step-by-step gathering of evidence on how to monitor the success of the procedure.
Peter Harris then posed the question: “If you have a ‘clapped out’patient do you use a balloon occluder?”To this, Brian Hopkinson replied that he puts it in straight away. “But when the patients are in hospital and they are alive, then they have stopped bleeding and what you want is for the patient to settle.”He claimed, “first clot is best clot, contrary to the teaching of the ATLS course. “So in these cases, the balloon does not have a place and time should not be wasted putting in a balloon, especially as when a radiologist put in a balloon it takes half an hour rather than five minutes.
Martin Malina then spoke on the subject of Setting up the Service (Logistics). Malina took the audience step-by-step through the various conditions that need to be arranged. One of the most difficult aspects is to have an experienced endovascualr specialist available at all times.
He said that there needs to be a set up so that it can be a rapid procedure that can take place at any time.
“In the team, the radiologist needs to be experienced in being able to image for endovascular procedures, some of them would miss obvious things if they don’t know any better. The surgeon needs some experience of radiology as well as surgery and the anaesthetist needs to perform the procedure under local anaesthetic not general.
Malina summed up the requirements as:
And then a centre can start to attract patients from around the world.
Registry or RCT
Roger Greenhalgh of London then talked on Evaluating the Results (Registry or RCT). Greenhalgh mentioned that funding had been granted for the EVAR trials in the UK and this allows for the funding of a comprehensive study assessing the outcome of emergency-EVAR (eEVAR).
Greenhalgh’s own preference is to perform a randomised controlled trial (RCT). He pointed out that timing of a RCT is crucial. If organised too late, it may not be acceptable from an ethical point of view to perform such a study. On the other hand, performing a RCT at a stage when expertise is not that well developed, results may be not as good as might have been possible when performing the study at a later time.
He said that there is a need for evaluation, emphasising the need to compare like with like. The excellent results of EVAR also need to be compared with patients having good open repair results.
Issues to be considered:
1. Collaboration of surgeons and radiologists
2. Time for CT scan or not
3. 3D imaging in the night
4. Local anaesthetic or general anaesthetic
5. Shall we relax anatomical criteria
6. ?50% anatomically suitable
7. Does the delay for CT need a randomised controlled trial 8. Should there be a pilot audit first or not
9. Learning curves
According to the UK Small aneurysm trial, 75% of patients with ruptured aneurysms died before arrival.
The final speaker was Corine van Marrewijk (Data Registry Centre), who highlighted the Eurostar-online project. In this project, which was set up by the Internet company KIKA, it is possible for participants and the industry to log in to the Eurostar website (www.eurostar-online.org). The benefits for the participants are that no paperwork is needed anymore to transfer patient data to the registry. Online overviews and statistics for each individual centre will be readily available for the centre itself. For the industrial partners there are three levels of privilege offered by Eurostar. Level 1 provides sophisticated options on product-oriented data, statistics and website exposure of the company. Level 2 has a less sophisticated option with regard to data processing as well as product exposure. Level 3 is a basic facility providing information on a specific device.
According to Jaap Buth, several young doctors from different centres throughout Europe are now working on projects, based on Eurostar data. They come from Scandinavia, Spain and France. The online Eurostar facility became available on November 16. However, it is important that participants first obtain their user codes before they start entering patient data on their centre number.
Cook also ran a symposium on the management of ruptured symptomatic aneurysms and the necessary logistics. Andr© Nevelsteen opened the symposium by saying the operative mortality is 10-12% for open repair, maybe down to 5% or less than 2% in selected centres. However, for ruptured aneurysms it is around 40%, and therefore there is a huge opportunity to improve on this figure. Eric Verhoeven then talked about his experience and results. Brian Hopkinson said, on suitability, that the 43% suitable for eEVAR could become 90%, by having larger necks and with better technology. Verhoeven thought it was closer to 35% of patients suitable for EVAR.
Logistically it is not possible to have that many centres doing eEVAR because companies need to provide the centres with devices on a consignment basis – as the products need to be available there and then. It is not being done electively, therefore there is considerable cost associated with this. Companies must be willing to provide stock so that surgeons can just draw off it. The big issue identified was “How do you define stability when it comes to eEVAR?