PERSONAL STATEMENT OF PROFESSOR ROGER GREENHALGH

Transcription

1 PERSONAL STATEMENT OF PROFESSOR ROGER GREENHALGH The Optical Management of Abdominal Aortic Aneurysm has been my interest for many years, commencing with the UK Small Aneurysm Trial which was based upon a pilot study within the Vascular Society of Great Britain and Ireland which defined the grey area of aneurysm diameter as from cm. Many surgeons were prepared to leave an aneurysm until it reached 5.5 cm or grew more than 1 cm per year or became tender. This became the protocol which has been the basis of a number of trials and population screening programmes. The UK Small Aneurysm Trial showed that there was no benefit from early surgery and that aneurysms could be followed until they were 5.5 cm, largely because of the rupture rate of 1% per year in the UK. The ADAM Trial in the United States also confirmed a low rupture rate of 0.5% per year on a similar protocol. The UK Small Aneurysm Management Committee formed the basis of the Trial Management Committee of the Endovascular Aneurysm Repair (EVAR) Trials of which I was privileged to be lead applicant. The Trial design included from the very first, the realisation that fitness was of key importance, thus EVAR Trial I tested the new procedure of Endovascular Aneurysm Repair against Open Repair in patients who are otherwise fit for Open Repair. In EVAR II, Endovascular Aneurysm Repair and Best Medical Treatment were compared with Best Medical Treatment alone. The findings of these Trials are now well known and were published in 2004 and The DREAM Trial supported the findings of EVAR I with a similar

2 protocol. The ACE and OVER Trials in France and the U.S.A respectively are also underway with similar protocols to EVAR I. Thus far, the findings of all of the Trials have been very similar, notably with low operative mortality. For EVAR I it was 1.7% and 4.7% for Open Repair. The EVAR Trial Management Committee took pains to be in equipoise and have no particular bias. Indeed, we were surprised with the results of EVAR II. We had perhaps the expectation of the value of endovascular repair was most anticipated. My personal views support the appraisal report but this is hardly surprising as the appraisal team have based much of their analysis on EVAR Trial I. In short, I understand that using the Markov model, overall, endovascular repair is not cost effective at present. In my view, this is not the end of the story. This appraisal has gone some distance to show that there is a subgroup of patients who are cost effective and for others that may not be. I largely agree with the recommendations of the Appraisal Group, especially that we must continue the follow-up of the EVAR Trials and intend to do so until We are aware of the difficulty of interpretation of the EVAR II Trial data and the arguments for per protocol analysis. We intend to follow the EVAR I and EVAR II until 2010 and give a final report on endpoints at that stage. We shall also perform per protocol analysis for both Trials and discuss the legitimacy of per protocol analysis in EVAR Trial II. 2

3 I have personal reservations about the watchful waiting against EVAR proposed Trial because of the expected low rupture rate for aneurysms of cm as shown in the UK Small Aneurysm Trial and the ADAM Trial and because of the expected 30 day mortality from EVAR at 1.7%. It is extremely unlikely that early endovascular intervention will be beneficial in my personal view. I am therefore not expecting a positive outcome from the so-called PIVOTAL and CAESAR Trials which are commercially driven. Like the Appraisal Committee, I think that the anatomical suitability at base line before repair and the fitness of the patient at baseline should be used to develop a sliding scale of suitability for endovascular repair and strongly support that research in this direction should be encouraged. I am also aware that practice has changed since the beginning of the EVAR Trials. I make no apology for the early testing of endovascular aneurysm repair and randomised control trial from Nevertheless, it is now time to review current practice, particularly current intervention rates, length of stay, lack of use of intensive care and critical care and particularly the current use of statins and ace inhibitors all of which impact in favour of improved cost effectiveness. I support the setting up of a National Vascular Registry but underline that a vascular registry and a randomised controlled trial are not mutually exclusive. Both are required. The Registry of Endovascular Treatment of Aneurysms (RETA) in Sheffield was created between the Vascular Surgical Society and the British Society of Interventional Radiology (BSIR). This Registry kindly monitored the learning curve of vascular 3

4 surgeons and radiologists to work together for 20 procedures before they were allowed to enter the EVAR Trials. Entry to the EVAR Trials was completely open, provided these criteria were satisfied. This led to a 41 centre low operative mortality, whilst national operative mortality figures of 10.2% were reported during a similar period. The randomised controlled trials had a total follow up of data and tested a protocol in terms of renal, cardiac and respiratory factors as well as insisting that surgeons and radiologists were trained and working together. This package led to the low mortality. The entry to the EVAR Trials was also helped by linking funding of EVAR device with randomisation and careful documentation. The National Vascular Registry could benefit from funding of EVAR device being linked to mandatory documentation. However, documentation alone is not good enough to achieve a low mortality. It is necessary to apply the protocol of respiratory renal and cardiac factors, patient fitness and anatomical factors as in the EVAR Trials to ensure a low mortality. Just to document national practice would not ensure that low mortality. This matter is of extreme importance to the National Screening Committee for Abdominal Aortic Aneurysm. If this is not noted, mortality could be unacceptably high and patients might have been better not to have their aneurysms found in the first place. This cannot be allowed to happen. Having seen the result of EVAR Trials, I am persuaded that endovascular aneurysm repair has certain advantages in that it can be performed under local anaesthetic with short stay, little pain and the technique is still evolving and improving and so are the devices. It would be a travesty if the progress 4

5 achieved in endovascular repair should terminate by a totally negative appraisal at this stage. Also, I accept that it is vital to understand which group of patients is likely to be cost effective. I read with interest the Personal Statement of Anne Cheetam. I think the view of patients and their relatives is absolutely crucial and I am in favour of the creation of a British Aneurysm Patients Association, driven by patients for this purpose. I would happily support Ms Cheetam in this venture. To that end, my Group has performed patient preference studies alongside cost effectiveness studies. They have worked with the Picker Institute in Oxford and together studied according to the Picker Institute protocol, a population of patients in Leicester in association with Professor Ros Naylor and Gloucester, in association with Mr Jonothan Earnshaw. **************************************************************************************** **************************************************************************************** ******************************************** The views of the patients are absolutely essential and in my view, should be placed alongside the cost to the nation. Finally, I would like to thank all of the UK surgeons and radiologists who collaborated in the EVAR Trials as trial participants, without whose efforts this appraisal would have been more difficult. 2 June