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Ann Thorac Surg 2000;69:674-675
© 2000 The Society of Thoracic Surgeons
a Department of Cardiothoracic Surgery, Southampton General Hospital, Southampton, England, UK
Address reprint requests to Dr Monro, Department of Cardiothoracic Surgery, Southampton General Hospital, Tremona Rd, Mailpoint 46, Southampton S016 6YD, England
In the last two years or so the medical profession in England has been seriously shaken by what may be called the "Bristol affair." Although many readers may be aware of what has been going on, some background information is required.
In 1997, following concerns about the results of cardiac surgery in children at the Bristol Royal Infirmary (BRI), the General Medical Council (GMC) conducted a hearing that lasted 8 months and found cardiac surgeons James Wisheart and Janardan Dhasmana and District General Manager John Roylance guilty of serious professional misconduct. Results in children and, in particular, infants undergoing switch procedures and correction of atrioventricular septal defects (AVSD) were shown to be considerably worse than in other units. Furthermore, despite this being pointed out by colleagues, the operations had continued until, following the death of a child in January 1995, they were stopped and another surgeon appointed.
Following the GMC ruling in June 1998, the then Secretary of State for Health, Frank Dobson, ordered an inquiry to be set up under the chairmanship of Professor Ian Kennedy. The terms of reference were "to inquire into the management of the care of children receiving complex cardiac surgical services at the Bristol Royal Infirmary between 1984 and 1995 and relevant related issues. ... "
The inquiry, which is in two phases and likely to cost 12 million pounds sterling, started in March 1999. So far a large number of witnesses have been called and cardiac surgeons and cardiologists from all over England as well as many other doctors and lay people, including relatives of dead children, have given evidence. The second phase, which starts in early 2000, will focus on a number of broad themes with commissioned papers and seminars open to the public and press. The aim is to "make recommendations that could help to secure high quality care across the National Health Service (NHS)." The proceedings of the inquiry have been recorded in detail on the internet (http:www.bristol-inquiry.org.uk).
Although it would be premature and inappropriate to forecast what the inquiry will recommend, as the outcome is still a long way off and there are so many lessons to be learned, now would be a suitable time to make comments on how this whole sorry affair is affecting the practice of paediatric cardiac surgery in particular and medicine as a whole in England and elsewhere.
Probably the most important lesson to be learned is the necessity to keep an accurate record of all operations and their outcome. In the UK a register of all cardiac operations on adults has been kept since 1977. This has provided a baseline for comparison and has shown a marked improvement in results, particularly for infant cardiac surgery in the last twenty years. The overall early mortality for open heart surgery in infants has fallen from more than 30% to less than 10% in this time. This register, which was both pioneering and unique in this country has been criticized particularly by the GMC and the Bristol Inquiry for lack of validation and inaccuracy. However, it should be remembered that in 1977 it was probable that it only ever got started because all participating surgeons and units were promised anonymity and complete confidentiality. Little did they know that 20 years later these confidential papers would be demanded by the Bristol Inquiry. This teaches us another lesson, but perhaps it is time that all units should publish their results anyway. The government may well demand this although theoretically they do have details of all operations in this country but sadly the information is grossly inaccurate.
It therefore behoves all cardiac surgeons, and particularly those operating on children, to have a central database into which every patient who undergoes surgery or intervention is entered. The outcome must be noted and hopefully risk stratification and the detailing of complications will be achieved in due course but initially just early mortality would be a good start. Moves by the British Paediatric Cardiac Association (BPCA) and The Society of Cardiothoracic Surgeons of Great Britain and Ireland (SCTS) will hopefully get this underway by April 2000, with help from the Central Cardiac Audit Database (CCAD). A more detailed and ambitious database has been devised by the Society of Thoracic Surgeons (STS) and the European Association of Cardiothoracic Surgery (EACTS), but it will be difficult to get all surgeons to comply. However, there must be some monitoring of performance and if a surgeon is getting poor results this must be identified and procedures put in place to correct matters. There has been much talk of revalidation of doctors and peer review of performance but it is difficult to see this taking place with most doctors as over-stretched as they are currently.
Furthermore, in this age of "clinical governance" there must be a method by which colleagues can alert health authorities if a surgeon is producing poor results without arousing the sort of antagonism to the ‘whistle blower’ accorded to Dr Bolsin, the anesthetist in Bristol who raised the initial concerns about their poor results. The Department of Health must support the cost of the database and will have to stop units operating if they do not submit their results. The returns from all units should be validated regularly.
In Bristol it was the surgeons (rather like the captain of the ship) who got the blame. However, when the outcome of 100 operations was analyzed by experts, the surgeons were found at fault in only 6. Thus cardiologists, anesthetists, postoperative care and inadequate funding may all have shared in the poor results. Indeed why did pediatricians continue to refer children to children to Bristol when they must have been aware of the poor results? In that this inquiry goes back to 1984 it is not fair to compare the practices with those of today but undoubtedly many surgeons had learning curves, which are not tolerable in this day and age. The Bristol surgeons may have been slower than those in other, more successful, hospitals but they undoubtedly did their best and were very caring, as demonstrated by an action group supporting them. It was in two operations—the arterial switch and repair of AVSD, that their results were particularly poor. Mr Wisheart should have stopped operating earlier and Mr Dhasmana went to visit Birmingham to try and improve his switch technique but without significant success. Indeed once a surgeon has been found to be producing less than adequate results for a certain condition it is extremely difficult to know what to do if stopping performing that operation is not an option. Retraining can be very difficult, where does the surgeon go for this, and who supervises his progress and restarting? Obviously surgeons should be well trained before their appointment but when new techniques come in, how do they learn them? When the switch was first introduced in the late 1970s, the early mortality was about 40% but the pioneers who did these operations persevered, the results improved, and now an early mortality of 5% or less is expected, and anything higher is unacceptable. Similarly the early mortality for the first stage Norwood procedure still approaches 50% in the UK. There have already been marked improvements in this operation but perhaps lowering the mortality now depends more on case selection and perioperative management than surgical technique. Units which have good results with this operation will be referred less attractive cases and, unless careful selection is used, their results will get worse.
The publicity surrounding the Bristol affair, the media attention, increased awareness and parental wish to attach blame to any unsuccessful outcome, all serve to make the practice of pediatric surgery less attractive. Some surgeons will be deterred from taking up the specialty, some may consider dropping it and the temptation will be to not attempt some of the more complex high-risk procedures. This in turn may result in an overall lower mortality and perhaps less cost to the NHS but some children who might have survived will not get their chance.
One aspect that certainly should improve, and indeed already has, is the question of informed consent. Whereas it has been routine for surgeons in the USA to go into all the possible complications that could occur many surgeons in the UK would explain the operation, but not necessarily the risks in detail, or give accurate results of their previous experience. As a result of the Bristol affair, consultant pediatric cardiac surgeons in the UK should get the consent form signed personally and explain the risks together with the results in their hands.
One other fact unearthed by the Bristol affair has been that many hearts and indeed other organs taken at post mortem are still being stored without the parents’ knowledge. A separate inquiry has been set up to sort this out and the legal situation is far from clear. However, whereas it would clearly be better to keep organs only with parents’ permission, there will undoubtedly be less hearts available for anatomical study in future, which in turn will lessen our understanding and therefore may affect the development of further surgical procedures. Certainly many improvements in pediatric cardiac surgery over the last 30 years have been because of better understanding of the anatomy.
It remains to be seen whether the Bristol Inquiry will recommend any adjustment to the number of units doing paediatric cardiac surgery in the UK. The ‘bigger the better’ philosophy does not always hold true as some smaller units that are part of large adult units have for years, and still are, achieving good results but some reduction in the total number may be appropriate. Geography comes into this; indeed Bristol was included in the list of 9 supraregional units in England, more because of its geographical position than total number of operations or good surgery. However, before any pruning of the number of units should happen, it is essential to know the results from each unit, their facilities and how the caseload compares with other hospitals. So we are back to the most important fact to come out of this whole sorry affair and that is the urgent need for accurate and complete databases of all pediatric cardiac surgery.
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