Do the advantages of performing 500 operations annually justify the disruption associated with the potential closure of 3 centres in England?

Mr Martin Mansell: Good evening, ladies and gentlemen. I am Martin Mansell. In 5 seconds I cease being the President of the Medico-Legal Society. I am delighted to introduce our new President, whom you know, Linda Lee, and I am now going to hang the sacred medal of honour around Linda’s neck so that it is all official. Good luck.

The President: Thank you very much. (Applause)

I am sure you would all like to join me in thanking Martin for an exceptional two years as President. He has been absolutely fabulous and has done much to improve the Society in the two years he has been at the helm, and I only hope I can do half the job he has done. Thank you, Martin. (Applause)

This year we are breaking with tradition (to start the new term with a Presidential address) because we had a fantastic opportunity to have two very eminent cardiac surgeons here tonight to debate. The debate was the brainchild of two of our Council members, Bertie Leigh and His Honour Michael Brooke QC. Very sadly Michael died earlier this year. He was a staunch supporter of the Society and he will be very much missed, and we dedicate this debate to his memory. A full obituary will be published in the Medico-Legal Journal.

I would now like to welcome our guests, Mr Sethia and Mr Hamilton.

Mr Babulal Sethia is a very celebrated Consultant Cardiac Surgeon. He has been a Consultant Cardiac Surgeon at the Royal Brompton Hospital in London since 1999, specialising in surgery for congenital heart disease.

He was an expert witness to the Bristol Royal Infirmary Inquiry, assisted the GMC in their assessment of Mr Dhasmana’s cases, and has acted as an expert witness over the past 20 years.

He has developed a programme relating to global health at the Royal Society of Medicine as part of his remit as a Trustee of the Society.

Mr Sethia has taught and operated in a variety of overseas locations during the past 25 years and has also been an Examiner in Cardiac Surgery for the Intercollegiate Examination Board of the Surgical Royal Colleges, and I would also like to congratulate him on becoming President of the Royal Society of Medicine in July of this year.

Mr Leslie Hamilton is another very distinguished Consultant Cardiac Surgeon. He was appointed in 1991 to lead paediatric cardiac surgery (including heart transplantation) in Newcastle, and he did that until 2007, when it had always been his career plan to stop doing children’s cardiac surgery and to operate only on adults. He says that was in his mid-50s, so we can all guess his age. Mr Hamilton also gave evidence to the Bristol Inquiry when he was a “very young” surgeon.

His very impressive CV records many achievements, including his role as a former President of the Society for Cardiothoracic Surgery in Great Britain and Ireland (SCTS) and Vice Chair of the Steering Group on the “Safe and Sustainable” review – he says he still has the scars to show for it!

Ladies and gentlemen, our debate this evening is:

“Do the advantages of performing 500 operations annually justify the disruption associated with the potential closure of 3 centres in England?”

which was alternatively titled:

“Paediatric Cardiac Surgery: the need for reform – is bigger better?”

I will call on Mr Hamilton to open the debate.

Mr Hamilton: Madam President, I have not been to this Society before, so it is indeed a huge honour to be here. My answer to your question posed in the motion for debate is a very specific “yes”, and I think the best way I can deal with that is to take you through the history of the development of our specialty.

In May 1953 John Gibbon, an American, performed the first successful open heart operation in the world using cardiopulmonary bypass. He had spent his life (his dream) inventing this machine and he did four cases of closure of an atrial septal defect, the simplest operation we do nowadays. Three of the patients died – 75% mortality. He was so devastated he stopped; he never operated again; and yet he was the founding father of our specialty – so the pressure on paediatric cardiac surgeons has been there from the beginning.

In the beginning (in the 1950s) there was only congenital heart surgery. The 1960s saw the invention of artificial valves and valve replacements. The 1970s saw the introduction of coronary artery bypass surgery and it then became the overwhelming operation around the world that cardiac surgeons did. The Royal College of Surgeons, in the 1980s, saw the need to restrict the development of paediatric cardiac surgery to specialised centres. Sadly they didn’t get the political support to see that through.

I take you fast-forward to the late 1980s. Professor Marc deLeval, a surgeon at Great Ormond Street, of international reputation, had introduced the arterial switch operation; the operation for blue babies that has to be done in the first few weeks of life, so it is technically demanding. He had good results in the first 50 or so cases and then had “a really bad run”, as we call it in surgery; he had 6 deaths out of 10 cases. He was devastated, but because he was in a big unit with a big volume of cases he was able to get back on his feet again. He had the support of his colleagues and he got back on board, which you can do with support in a bigger unit.

The arterial switch was the Achilles’ heel in Bristol. The situation in Bristol was that it was a small unit with a small throughput only doing maybe half a dozen arterial switches a year. The two older surgeons should not have been asked to undertake these technically demanding operations, but because there were only two of them, that is what happened.

As a result we had the Bristol Inquiry, chaired by Sir Ian Kennedy and published in 2001; you will be familiar with that. There were 198 recommendations from the Bristol Inquiry, only 7 to do with paediatric cardiac surgery. It was all about the NHS. Four of those 7 were about having bigger centres, bigger volumes of cases and bigger teams. So that was the fundamental conclusion at that stage.

In 2001 we also had Kidderminster, the biggest disaster to hit decision-making in the NHS. One of the local consultants battling to keep the local A&E Department open overturned a large Labour majority – political decision-making then was paralysed. One of the biggest tragedies, in my view, is that we are here almost 15 years later and still no decision has been taken. Bristol was a small unit; the diagnosis was clear, the treatment was clear, and yet 15 years later nothing has happened. Indeed, there is yet another Bristol Inquiry happening at the moment.

The next stage was another review in 2003 led by Jim Monro, who was the President of the Society for Cardio Thoracic Surgery (SCTS) at the time. They looked at the situation and concluded that we needed bigger units and bigger centres. Because most units at that stage had one or two surgeons, they said we should have a minimum of three surgeons, not because they thought that was ideal but because they thought that would force change. Yet again politicians ignored it, they said, “We are minded to take all the other recommendations but not the one about bigger centres”. So at that stage all that happened was units started to play games and appoint extra surgeons, even though they didn’t have the workload to do that.

Roger Boyle, the first Heart Tsar, did fantastic work dealing with the long waiting lists in adult cardiac surgery. He got that sorted out, but saw paediatric cardiac surgery as unfinished business and felt that was what he needed to tackle next. He got all the units together in 2006, the Department of Health, cardiologists, surgeons, anaesthetists from every unit, in a room, locked the door and said “We have to sort this out”. At the end of the meeting everyone agreed that we would be better, we could provide better quality of care, with bigger centres. He said at the end of the meeting “Right, I have got your support. I need to know if you will support me through these difficult decisions, because we are going to ask some centres to stop doing surgery”. He said “I need to know now. Put your hands up if you disagree, because I don’t want anybody out marching with placards or parents going to court, or anything else. I need to know that you are not going to do that”. Nobody put their hand up. In spite of this the politicians put it on the “too difficult” shelf and nothing happened.

In 2008 Bruce Keogh (now Professor Sir) was President of SCTS. The Executive were very concerned about issues happening in units around the country; nothing could be made public, but there were concerns so the Executive asked Sir Bruce to write to the Minister and say “Something has to be done. We have to have a decision and make some progress”. He then got appointed as Medical Director of the NHS. On his first morning in Richmond House the Minister walked in and handed him his own letter back and said, “Sort that out”.

So the Safe and Sustainable Review was established. Bruce, at the time when it was set up, challenged the profession. He said “If you don’t sort this out this time it will be a stain on the soul of the profession”. The politicians, especially Andrew Lansley, Secretary of State at the time, kept out of it, rightly. Any time he was asked he said, “This is a clinically led review and the decision will be made by the Commissioners”. The 10 senior Commissioners, the specialist Commissioners in the NHS, were the decision-making body (the JCPCT: Joint Committee of Primary Care Trusts). The politicians are always asking for clinical leadership. Here was clinical leadership in spades, because the Clinical Steering Group was composed of the Presidents or the leaders of all the professional bodies dealing with children with heart disease and parent representatives as well. I was on that because I was President of SCTS by then and I was representing the surgeon. The steering group felt it was right to set standards that would improve the service, knowing that all units would not be able to meet the standards, but they wanted to set them high so we could improve the service.

Sir Ian Kennedy, with his background knowledge, was asked to visit all the centres with a team of independent specialists and score them against the standards set by the Standards Group, chaired by Bill Brawn, the most senior and most distinguished paediatric cardiac surgeon in this country. The unit in Birmingham which he had set up would be viewed by many as a model unit. They commissioned an independent literature review to look for evidence about the size of units. Mr Sethia I am sure will tell you there is no evidence. Because the number of units haven’t changed yet, of course there is no evidence.

There is abundant evidence in other specialities. You have seen the stroke review in London. Following professional opinion they have gone from 30 units treating stroke down to 8 and shown a big improvement in results. Carotid endarterectomy surgery, abdominal aortic aneurysm surgery, colorectal surgery, oesophageal surgery all have shown an improvement in bigger centres with a clear relationship between volume and outcome. So there is lots of evidence in other specialties. It makes sense – the more you do the better you are.

In our specialty the evidence showed that there was a relationship between volume and outcome with more complex operations that have to be done in infants early in life. So there is that evidence. I hope Mr Sethia will accept that. What there isn’t, and I will accept the point, which I am sure he will make, is that there is no cut-off; there is nothing to say what size the units should be and how many cases they should do. So the Standards Group, chaired by Bill Brawn, had to use pragmatism and professional opinion, and they said, “If we are going to provide a sustainable service there should be a minimum of 4 surgeons in each centre”.

One of Ian Kennedy’s recommendations at the Bristol Inquiry was that the profession should decide how many surgeons and how many cases. So they considered the number of cases and they said okay, 2–3 cases a week might be the minimum for a surgeon to maintain their skills. On the basis that people in the NHS functioned for 43 weeks a year this makes 100–125 cases per surgeon, so 400–500 per centre. Looking at the mathematics, that came out to 6 or 7 centres in the country (compared to the 11 at the time). This was the figure which went out to consultation as part of the process for the Safe and Sustainable Review.

Then we had the Judicial Review from the Royal Brompton (challenging the consultation process), which was overturned on appeal, and then we had the decision by the JCPCT to reconfigure the service to have seven units. Despite everybody having concluded at the beginning it was the right thing to do, that having bigger (and therefore fewer) centres was the right thing to do, nobody wanted their unit to change.

Then we had the Health Overview and Scrutiny Committees from local government, and another Judicial Review in the courts (from Leeds about the decision-making process). We had a new Secretary of State by this time who (I hesitate to say) perhaps didn’t really understand what was going on, and then we had the involvement of the Independent Reconfiguration Panel. Now, I would put it to you that 99.9% of doctors in the NHS have never heard of the Independent Reconfiguration Panel (IRP). The IRP had never done a national review before; they had no experience or knowledge of congenital heart surgery; but in three months they said the whole Safe and Sustainable Review, which had taken three years, was rubbish and should be overturned. Jeremy Hunt agreed.

Are we alone in England in thinking the bigger centres would produce better results? No. The Netherlands, some years ago, had 7 units; they said “We should go to 3”. Their politicians didn’t have the courage to do that. Scotland had 2 units, one in Glasgow, one in Edinburgh. They said, “That’s silly; we should have one”, You can imagine the controversy the decision between Glasgow and Edinburgh, but they decided to do that and went for one unit in Glasgow. Wales said “We can’t justify a unit for our population” – they teamed up with Bristol. Sweden: now, Sweden is an amazing example. They had 4 centres. They said “We need 2”, and they looked at them, they judged all the centres and they closed 2 of them, the one in the capital and one just outside the capital. They kept two in the south of the country. Can you imagine any Secretary of State in this country closing Great Ormond Street, the Brompton and Evelina Children’s Hospital? No. But that is what they did in Sweden. In Ontario they have gone from 5 units down to 1 unit, with an improvement in results. So we are not alone. In France they have a similar population to us in the UK. They have 11 centres. They had worked out they needed 7 centres, and I was invited to speak at the French meeting. They were impressed with the similar thinking in England. In Germany they have got about 40 units claiming to do congenital heart surgery. Only 3 do more than 400 cases, and they know they have to change.

So, Madam President, why do we need to change? Why should we have bigger centres? Well, we need succession planning within units. In your training as a paediatric cardiac surgeon (in contrast to all the surgical specialties) you haven’t done most of the operations that you are going to be doing as a Consultant by the time you are appointed. So you need succession planning, you need to be brought along as a junior and then as a new consultant.

We need bigger teams to have resilience in the system. One of the problems we have had in the past is if a senior surgeon suddenly retires, goes sick, emigrates, gets an offer of big money from the States, it disrupts a whole centre.

We need 24-hour cover 7 days a week. At the moment we don’t expect and we can’t ask surgeons to operate semi-electively on the weekend if they are on a 1 in 3 rota. So if a baby comes in on a Thursday or Friday needing an operation that isn’t desperately urgent but can wait, they have to wait till Monday or Tuesday, and that then cancels operations for Monday or Tuesday. That is no way to run a service. We should be providing surgery 7 days a week – and this requires a bigger team.

We need support for each other. I have mentioned the emotional and the physical pressures in doing the job probably unique amongst surgical specialties. So we need to be able to support each other, and we need bigger teams for that, and we need mentoring.

Now, let me give you an indication of the stature of my opponent Mr Sethia. You heard in the President’s introduction, when I was first appointed to Newcastle I was on my own, because my colleague left shortly after (I hope nothing to do with my arrival). B (Mr Sethia) used to come up from Birmingham and assist me when I was doing the first of every new operation which I hadn’t done during my training at Great Ormond Street and Leeds. So we need support – which should be in house.

So, in conclusion, Madam President, (I know my time is almost up), I am sure Mr Sethia will tell you there is no need for change. The results from the national database, the CCAD, Central Cardiac Audit Database project which is one of the best in the world, will seem to tell you that everything is fine, we don’t need to change. I am sorry; it is not fine. The numbers in each unit are relatively small: the numbers for each operation are even smaller and the numbers for each surgeon are even smaller again. The statistics are weak and it is not valid, in my view, to say that everything is fine at the moment just by looking at the website Indeed, if you look at the NICOR website, the National Institute for Cardiovascular Outcomes Research, you will see there is an interesting debate going on at present about outcomes and results which are outside the statistical limits.

We have seen huge improvements from the 75% mortality for 4 ASD cases back in the 1950s, and that has come about through better understanding of anatomy, of surgery, of perfusion and of anaesthetics. Probably the one area where we still have a lot to gain is in intensive care. In the past, and probably up until the present, middle grade non-specialist doctors looked after children. That is not what I would want for my child. I think we need to have units that are big enough to justify having a cardiac intensive care consultant 24 hours a day, and that means bigger units. The next increment in the improvement in quality of care, I would submit, will be with bigger centres.

The motion tonight talks about closing cardiac centres. It was never suggested that any unit would close. All will continue to provide cardiology; they would just transfer the surgery and concentrate the surgery into bigger teams in bigger units.

The motion talks about disruption. We are a small specialty, with 25 to 30 surgeons in the country. It might mean one or two or three surgeons moving. We may be too precious in medicine; we expect to be able to spend our whole career in one place. Maybe that is unrealistic in the current modern world.

And the advantages? Better outcomes (not just mortality), I am not just arguing for advantages. I would put it to you that the current system is unsustainable. The profession has said that for years, and I don’t think we can go on with the size of teams that we have at the moment; we need bigger teams; and one of the sad things, in my view, is that there is a lot of reconfiguration needed across the whole of the NHS – treatments have changed over the years. We are still providing care the way we used to and we need to change. Many people in the other specialties are watching the review of children’s heart surgery to see how it could be done, so if we fail with this I think it is going to have implications right across the NHS.

Madam President, I think it has been inspired timing for this debate because the next review, set up by Jeremy Hunt after the Safe and Sustainable review, published their consultation standards this week. I am delighted to report that they have stuck to the minimum of 4 surgeons and 125 cases per surgeon; so 500 cases is what we should aim for.

Madam President, thank you. (Applause)

The President: Thank you, Mr Hamilton. Mr Sethia.

Mr Sethia: Thank you, Madam President, ladies and gentlemen. It has been interesting to listen to Mr Hamilton’s selective review of the history of our specialty, although it was quite a lot of fun helping him when he was starting out in the specialty.

Some of you may know the work of Arthur William Edgar O’Shaughnessy, a poet and herpetologist; he has four lizards named after him; and he is famous for writing different poems, one of which starts:

We are the music makers,

And we are the dreamers…

And subsequently he wrote:

One man, with a dream, at pleasure

Shall go forth and conquer a crown.

Was he referring to Mr Hamilton, who has been dreaming about the future of cardiac surgery, or perhaps Alex Salmond, who had a dream for the independence of Scotland, and we have seen where that got him.

The motion, Madam President, suggests that we should have two elements to the debate. One focuses, as Mr Hamilton has expanded upon, on 500 cases per year, and the other the disruption, the tearing apart of what we have by reducing the number of centres, at least in England. I suggest to you – and I am very mindful that I am addressing many lawyers in the audience today, so I will have to be a bit cautious how I put this, but I suggest to you that we should deal with evidence. We shouldn’t deal with dreams, we shouldn’t deal with hearsay, we should deal with hard facts.

The father of evidence-based medicine in this country is probably Professor Archie Cochrane, who wrote an extraordinary monograph, published in 1972, called Efficiency and Effectiveness: Reflections on Health Systems (sic), and he taught us the importance of measuring what we do and then subjecting it to intense scrutiny.

What our patients require, what they ask for, is excellence in quality; and good governance, ladies and gentlemen, provides excellence in quality. That is what patients ask for and that is what I, as a parent of 4 children, require if my child has hospital treatment.

So let’s go back to the history. The history encompasses my generational experience from the time I became a Consultant in Birmingham in 1987 to the current day, not dissimilar from Mr Hamilton’s career when he worked in congenital heart surgery. When I was at Great Ormond Street before 1987 and subsequently when I moved to Birmingham the mortality rate for congenital heart disease overall was about 25%. You have heard something about the evolution of a specific operation, the arterial switch operation, where mortality in the early 1980s was hovering around as much as 30% in some units, although there was variability, even within London, between the different units. Oh, you will say, this is an inevitable part of a learning curve.

Well, things have changed over 20 years. Mr Hamilton told you about changes in health care, changes in the personnel looking after patients, the perfusionists, anaesthesia and perhaps most especially in intensive care. What has happened in the UK over the past 20 years is that the overall mortality, which is measured on a monthly basis, has fallen to about 2% overall in round figures, a huge, huge improvement, before any reorganisation, in the 10 centres currently providing this type of care.

The mortality, you might say, is better in other places, and big American units are often quoted as being evidence for this. There are units in the United States that may do 800/900/1000 cases. The Boston Children’s Hospital, perhaps the pre-eminent of these units, doing well over 1000 cases a year, albeit with 8 surgeons, 72 cardiologists and a whole host of infrastructural support, a budget that probably eclipses the national budget of Wales, and other things.

So let’s be pragmatic about this and, instead of saying we have to reorganise as a result of Mr Hamilton’s and others’ dreams, let’s celebrate what we are achieving in the UK and specifically in England here today. It has been a major achievement, and mostly in Birmingham, where I was actually a colleague of Bill Brawn, to whom Mr Hamilton has referred. He and I, within a very short period of time, just two of us, were party to changing the overall results of that unit in a period of less than 5 years from the time I and he started in the late 1980s. If you look at the data – you were told about NICOR, the national database, which records all paediatric cardiac surgical and medical interventional procedures; a 14 unit survey by this activity, one of which is a private institution only achieving about 150 cases per year, 2 are in Ireland and therefore perhaps irrelevant to this particular debate, and 1 in Scotland, also irrelevant for the purposes of the National Health Service in England; but if you look at the risk adjusted data (data, I emphasise) as applied to this information, there is no difference between the units undertaking these sorts of procedures right across the country.

So something has changed. We are not talking about nothing has changed; something has changed. The situation is markedly different. I remember babies dying 25 years ago. They will live today. They will live because of all the factors that I have already mentioned to you.

If you look at the published evidence, it can be difficult to unpick. Most, if not all of the evidence is actually retrospective. 90% of the evidence in a recent review carried out by the School of Health and Related Subject Science Research in Sheffield showed that there is no link between volume and outcome in congenital heart surgery. That contrasted with a paper, for example, from David Spiegelhalter, a well-known statistician, who reviewed data in 2002 and concluded that in a unit doing 40 operations a year, mainly arterial switch and a condition called AV septal defect, the outcomes would be 25–30% worse than in units doing 120 procedures a year. Note: 40 vs 120, not 500.

And if we look at the American data, if we want to learn from some of the famous units there, take a unit like UCSF, University College San Francisco, and compare it with Atlanta, compare it with Portland Oregon. Their yardsticks are a mortality of 3.6 per cent. Children’s Hospital of Philadelphia, another hugely famous unit doing over 800 cases a year, records a mortality of 3.7 per cent.

Now, I have to emphasise mortality because mortality is the only data that we have. Yes, we need to collect more data; we need to do it prospectively. We need to collect data on morbidity, and we are starting to do that, but the evidence does not suggest that we should suddenly change tack and change the number of units or the way that we deliver much of what we do already.

What about the other pragmatic issues? You heard about the pragmatism in the deliberations of the standards setting board.

Let’s talk about money. Money is sort of important these days. You will be aware perhaps of the “Nicholson Challenge”, so-called Nicholson Challenge, in the health system which requires the service in the UK to save £20 billion over 5 years; put another way, a productivity output increase of 5% a year, according to John Appleby at The King’s Fund, just round the corner from here. It is not feasible in the current way of working, absolutely not possible.

The estimates of the cost of the exercise that Mr Hamilton and his associates propose are varied; they range from £12.1 million to £30.6 million for this exercise. But why should we spend that money if there are going to be no demonstrable benefits for patients at the outset?

There are issues relating to staffing. A survey from the British Congenital Cardiac Association suggested that up to 40% of staff might be lost in the reorganisation of units. We don’t go to work with units just because they are famous units. There are many reasons that determine whether or not you want to work in a given place. My personal decision to leave Birmingham after 12 years as a Consultant there and move down to the Brompton was definitely influenced by the fact that I had loved working at the Brompton when I was a junior trainee.

You heard about training. The national requirement for Consultant Surgeons in this field in England is no more than two or three individuals a year over a lifetime of 30 years in practice. Can’t we train them with the volume of work we do at the moment? I suggest not only that we can, but we have evidence for that. All three congenital heart surgeons in Newcastle, Mr Hamilton’s unit, for example, are ex-trainees under my direction.

What about the wishes of the patients? The patients don’t want to travel miles and miles away for the same level of quality. They want good quality, yes; I said that right at the start; but if they can get it local to them they will go for that. The suggestion in the review that Mr Hamilton alluded to, where there would be three tiers of centres, suggests that 80% of patients would only have to travel once to a surgical unit. This is patently inaccurate. Patients have to travel more than once to a surgical unit for their treatment, if only for preliminary consultation, explanation of the risks and benefits of the procedure and subsequently for the treatments that follow on from that. So the information is incorrect.

So let’s predict the future. First of all, what about adults with congenital heart disease? We haven’t mentioned that; Mr Hamilton hasn’t picked up on that. The original Munro Report, to which he alluded, in 2003 anticipated, as did the European survey at that time, albeit now outdated, that the number of cases would be 250–300 cases per unit, both paediatric and adult congenital cases. There is a lot of literature which suggests that adults should be treated by surgeons and others who have experience with congenital heart problems, not by the surgeons who do coronary artery surgery, and so on.

So, if you lump all this data together, from the current 4500 thousand or so surgical episodes in congenital heart surgery in this country (by which I mean England) at the moment we can anticipate a massive expansion over the next 10–15 years. Some estimates will put this at between 8000 and 10,000 episodes, a more than doubling of the current activity level. How are we going to manage that if we have taken away a whole lot of the resource in terms of those units that Mr Hamilton is referring to? Or are we going to make those units so big, mega units you might say, that we try to solve it that way, albeit with the disadvantages I have alluded to? Well, the one mega unit in the paediatric field is Boston Children’s and the way that it functions is by essentially dividing it into two bits, because huge units become simply unmanageable.

We need prospective data – I have already said about that – but we also need to think how can we improve with what we have got? One area of that relates to foetal diagnosis. Ten years ago about 23% of cases in paediatric surgery were diagnosed antenatally. It is now about 40%, and there is evidence in some conditions to suggest that the quality of care given to patients is improved if they know about what is ahead well before a baby is born. These are the sorts of quality improvements that patients care about and our job as surgeons is to address the needs of the patient in every dimension of quality that is possible.

So, Madam President, I put it to you that what patients want is whole patient care, the continuity from antenatal life, through childhood, through adolescence, through adult life. You might describe that as a vertical model of care, a model of care that is being adopted more and more by units around the world. They of course want quality. Those that run hospitals demand economic value, as do the politicians, and I will leave you with a thought, again from Archie Cochrane, whom I mentioned earlier. He tells a story in his book about a visit to a crematorium in South Wales where he saw a man with what he describes as “a curiously contented look” standing outside the front gate, and he asked him “Sir, why are you looking so contented?” and the reply was, you know, “I am reflecting…”, he said, “…on how it is that so much goes in and so little comes out”. I put it to you, that is exactly what has been happening with this whole process, which, as you have heard, has gone on for so many years. What we need to do is to plan for the future, certainly not decimate the units that we already have and, as for the numbers, if the evidence shows that we can define an exact number that is ideal for patient care and all the other things you have heard about, then so be it. But at the moment the evidence isn’t there, and therefore, Madam President, I move against this motion. Thank you very much. (Applause)

The President: I now call upon Mr Hamilton to say a few words in reply.

Mr Hamilton: Evidence: clearly there can’t be evidence of an improved quality of care until we change. We know there is evidence. As I mentioned, in the small infants having the more complex operations there is good evidence in our specialty and, as those rarer conditions are a fixed proportion of the overall workload, the only way that you can have bigger volumes of these operations, for which there is already evidence, is by having a bigger overall workload, because it is a fixed proportion.

We want to improve the quality. Yes, I agree with Mr Sethia, mortality has come down. That is the measure we have used. That is no longer the measure we should be using for quality of care. We need to start looking at morbidity, as we are agreed on, but the only way we can do that sensibly is to have bigger centres where there is more opportunity to look at the outcomes in more detail.

Mr Sethia has mentioned the risk stratified data that we have in the UK. In adults we have a very good risk scoring system called EuroSCORE. We can work out fairly well the risk for that particular patient. We can use that to compare one centre against another. We have been desperately trying to develop that in paediatrics over the years, and yes, the most recent data produced by NICOR from the CCAD database is risk adjusted. It is called PRAiS and the “P” stands for “Partial”, a computer programme for risk model using routine audit data, because we don’t really understand all the risk factors. So we can’t use the data to make decisions that everything is fine. We’re deluding ourselves.

Mr Sethia talked about training. Where do we send most of our trainees to finish off their training? The big volume centres. He has brought in the adults with congenital heart disease. That’s the classic move of all those who are wanting to stop change, because the adults have very different needs. Yes, some of them will need two or three operations over their lifetime but the surgery is very different, it is not of the complexity that the children need and most of the care that the adult congenital patients need is follow-up by the cardiologist, not surgery, and much of the surgical intervention they would need in the future will be provided by the cardiologist with interventional techniques. So I don’t buy it and Ian Kennedy in the Bristol report was very clear that we need to stop mixing up children with adults. That is why in the Safe and Sustainable Review we did not include adults, because they are very different, their needs are very different and we need to focus on the children because they are the ones who have had a bad deal in the past.

I leave you with what Mr Sethia has referred to on several occasions as “my dream”. Yes, it has been a dream all the way through my career, because I have been convinced that the next incremental change will not be in mortality, because that is already very low, but it will be in morbidity, the length of stay and all the other quality markers we should be using. He suggested that I was the only one who had the dream. Well, I leave you with the evidence that the Case for Change document that was produced as part of the Safe and Sustainable Review accepted the need for bigger centres and it had support from the Society for Cardiothoracic Surgery, which I was representing, the Royal College of Surgeons England, the Paediatric Intensive Care Society, the Academy of Royal Medical Colleges, the British Cardiovascular Society, the British Heart Foundation, the Children’s Heart Foundation, representing all the parent groups, Little Hearts Matter, the Royal College of Nursing, and the Royal College of Paediatrics and Child Health. So not only my dream but lots of other people’s dreams as well. Thank you.

The President: Mr Sethia, would you like a few words before I throw it open to the floor?

Mr Sethia: I certainly would, yes. Thank you very much. We can’t have evidence until we change!! Really? We have got evidence from years, many years. The Society’s Surgical Register was first established by Terence English in 1977 and there are individual units, of which perhaps Southampton is the pre-eminent, that have collected data for more than 30 years. So why do we have to wait to get evidence? We are getting evidence all the time and NICOR is collecting that and collating the evidence that we have, and yes, I’ve said this already, we need to gather more evidence and work on the basis of evidence.

Your comments on rare conditions: yes, every treatment option or every treatment plan starts somewhere. When Bill Brawn and I started the first programme for a condition called hypoplastic left heart in 1992, the first programme in this country, we were unique in the country. Until then the mortality for this condition was 100%. In our hands in the early days it was about 60%, and then it was 40%, and now in the best units doing this sort of work it is somewhere between 10 and 15% in terms of acute mortality, and yet we’re finding out about the longer term sequelae, the morbidity issues, and also the co-morbidities that attend many of these congenital heart conditions that hadn’t entirely been appreciated until now.

You want, Mr Hamilton, to take out the adults. I am sorry, I am talking about human beings; I am talking about people, I am not talking about just numbers of operations. Numbers of operations are a part of a patient’s journey, albeit a hugely significant experience for the individual patient, but our patients – and we see lots of adults with congenital heart disease who have been followed up over 40, 50, even 60 years now – these patients want continuity of care. They are familiar with the people with whom they are dealing. Yes, people change because some retire, but they value that, and they value the experience, the expertise, the understanding of the physiology, and the anatomical variance that our sort of work brings to this.

So, yes, we have some points of agreement. Yes, we need to collect data. But you haven’t told me anything that suggests that on the basis of the current evidence the motion, namely that we should reduce the number of centres from 10 in England to 7, carries far. Neither have you given me evidence to suggest that there is a magic figure of 500, which you have described as being because it supports four surgeons. I am not worried about what the surgeon’s workload is in this thing. I am here to treat the patients, as you are, I know, and we all are, and if I have to work a bit harder, so be it. But, remember, this numbers game is dangerous. If you just talk numbers you factor out many other things; you factor out experience and the decision-making of what to do. As you get older, as you know, I think, as you have found out in your own experience, your input into the decision-making process is equally as important as your technical ability per se. I mean, you talk about these relatively simple cases in adult surgery. I can assure you that some of the cases we see have had 4, 5, 6 operations, some of which last 12, 18, 24 hours. Thirty-seven hours is my personal record at the Royal Brompton Hospital, albeit working with a colleague. You don’t convince me that this expertise should be diluted by the proposals that are brought to the table.

So, Madam President, nothing I have heard supports the contention that we should vote in favour of this motion. Thank you very much.

The President: Thank you. Right, it is over to you to continue the debate.

Discussion

Mrs Brahams: Diana Brahams. I am a lawyer and I listened with interest to your debate being swayed from one side to the other. Mr Sethia, you said that in the very best units the results were even better. I was interested in that because you actually accepted that some units are better than others. Now, there is no doubt they aren’t always better than others at all times. Maybe they get better at certain kinds of operation, but presumably the implication is that there must be some places which are superior. Do you accept that?

Mr Sethia: There is variability in the performance of units, and when you look at the data that is published on this particular subject none of the studies use time as a continuous variable. You have to collect that data prospectively and you have to compensate for time, and yes, if you look at the NICOR data, you will find tiny points of a percentage difference year on year between the performances, in terms of mortality, of units. That is perfectly true, but other things influence this as well. The sickness of the patients that present to the unit is perhaps the most dominant, certainly in the 2014 Sheffield study, in terms of determining survival outcomes. So, yes, we are all different and there is going to be some variation in performance. The issue is does that lie within an acceptable frame of things? If it is unacceptable, we already have mechanisms in place to identify it and then to look through it, evaluate it, and do something about it, and, as Mr Hamilton knows, this has been invoked in paediatric cardiac surgery in recent times. So yes, we are not consistent. It’s a bit like cooking really; it doesn’t always come out exactly the same way, but hopefully not far off.

Mr Hamilton: No surgeon that I know in any surgical specialty would go to the results, the published results, to choose if they had to take their child to a hospital. They would go to a hospital that sees and does a big volume of that operation. Mr Sethia has mentioned hypoplastic left heart. That is a very good example. They led the way in Birmingham, but, because it was the “real man’s” operation at that stage in paediatric cardiac surgery, everybody wanted to do it. So we had the ridiculous situation of units around the country doing 2 or 3 or 4 of these operations a year; it was a disaster. We need big volume centres and that is where I would take my child, and that is where any other surgeon would take their child for treatment.

The President: Thank you.

Ms Cheng: Hello. My name is Sharon Cheng. I am Director of Children’s Heart Surgery Fund in Leeds and I am Company Secretary of Save Our Surgery Limited. I would just like to ask a question to Leslie, if I may. In Germany in 2012, according to the German Society for Thoracic and Cardiovascular Surgery, there were 73 surgical centres performing congenital heart surgery. Four perform more than 300 congenital operations per year (only 1 did more than 500); 5 more of them perform between 150 and 300; 8 of them perform between 50 and 150. Those 17 account for 82.4% of the total of 4651 congenital operations. The remaining 17.6% were carried out in no less than 56 surgical centres. The mortality rate in 2012 in Germany was 2.33%. So what is Germany doing wrong?

Mr Hamilton: For exactly that reason I was asked to go and speak at both the German Society of Paediatric Cardiology and their Surgical Society because they were so concerned about their set-up. They know it is not sustainable. The mortality figures can hide all sorts of things. They are very concerned that they have such a large number of centres claiming to undertake paediatric cardiac surgery and they want to concentrate their resources. They asked me to go and tell them how we had gone about the paediatric review, the Safe and Sustainable Review, because they felt that was a model of how it could be done. That was before, of course, we had all the legal and IRP challenges. So the Germans are very concerned about their set-up and they have fully accepted the need to reconfigure and they actually think they need about 14 centres for their population in Germany.

Mr Sethia: Yes, but you haven’t told us what we need here in the UK exactly. The data here are already excellent. It doesn’t have the degree of variability that the previous questioner implied it could have; it doesn’t have that. We have mechanisms in place. In Germany, to my knowledge (and please correct me if I am incorrect), they don’t have external scrutiny, external validation of the detail of their results, and I can understand the arguments. It is a bit similar to the United States. When they started collecting data 10–15 years ago they talked about low volume centres sometimes doing less than 10 cases a year, many doing less than 50 cases a year, and they were setting up those against centres doing 300 or more cases a year. We are not having an argument about whether 10 or 20 or 30 cases are right, we are talking about the facts on the ground today and whether we should change what we do in the UK at the moment and accept the consequences thereof. So it is a different scenario and it is in a different environment.

Mr Bertie Leigh: Bertie Leigh. Leslie, I have to declare an interest, having acted for the Brompton and the Leeds challenge, but what I didn’t get any sense of from you was that you recognised that the world has changed since Bristol. In Bristol in the last year they did 47 procedures. Yes, Kennedy said it should be bigger, but you leave out the numbers. Kennedy said that there should be 2 surgeons in each centre and they should each be doing more than 50 cases a year. So he said that centres should be doing 100 cases a year and this was to include adult and general heart disease. When he said you shouldn’t mix up children and adults he was saying you should not mix up congenital heart disease with acquired disease, with ischaemic heart disease. That is what Kennedy was concerned about.

Then you come on to Jim Munro’s survey, and that was done at the same time as EACTS (the European Association for Cardio-Thoracic Surgery) did the all European review, and they both came to the same view that we should have each centre doing between 250 and 300 per year; that was the optimal size; they didn’t say more; and that should include adult congenital heart disease.

Now, your generation of surgeons, Bruce Keogh talking about a stain on the soul of the profession, he was basing himself on what he was talking about, which was a time when the mortality, it was thought, was 20%. Now the mortality has fallen to 2%, which is comparable with anywhere else in the world, and you still haven’t learnt that we have got something precious and that another top-down reform that will destroy centres which are amongst the best in the world has to be justified by evidence. You say you can’t have evidence until you have done it, but look at Wilkie’s study that looked at 55,000 procedures in America in centres ranging from 800 to 20 cases a year, and he said in his summary that size was little better than a coin flip at predicting outcomes, and he talks to you about one super centre with the best mortality at Boston, where they split themselves into two teams, and another super centre at Atlanta, where they have got a mortality of 3.7, which is worse than any centre in England today.

You quote Sweden and say that they have brought their centres down to 2. You don’t add that they have a population of 8 million, so that they would need 4 million to serve each centre, which would be the equivalent of 13 centres in England. You left that out. And you quoted the Dutch analogy, and it is exactly the same; the Dutch analogy would result in an increase in the number of centres in England. Now, what “Safe and Sustainable” did was it recognised that the volume of cases in this country has gone up so exponentially as a result of the achievements of your generation of surgeons and the growth in adult congenital heart disease coming through for surgery later on that in fact if you were just to have 500 cases a year you would not justify closing any centres. Because you still have the experience of the 1990s and you still believe that bigger is better without any evidence, you then dropped the adult congenital centres in order to reduce the total number.

Now, you know as well as I do that “Safe and Sustainable” was going to suggest that the adults should be co-located with the children because these children do not come to the Health Service for an operation, they come for a lifetime of care, and you know as well as I do that the easy wins are to be gained where Bee was talking about. We have got the antenatal diagnosis up from 23 to 40%; it ought to be up to 80%; and the way we are going to do that is to have it integrated with other care, and if you take all the surgeons into one place all the interventional cardiologists will follow them and you know, because it happened when Cardiff sent the surgery to Bristol and when Manchester sent the surgery to Liverpool, that the cardiology centre becomes the sad shadow of its former self. You know that and you know that what we ought to be doing is providing these children with the service for their disease.

Because “Safe and Sustainable” was formulated by surgeons it thought that the day of the operation, which may be the most important day of their life, was in fact the only day that mattered in their lives, and it is not; they now need service which comes from the womb to the tomb, and that is what the NHS should be providing, and if you want to change it and spend money that we have not got in the NHS on doing this you have got to have evidence of something wrong with the present system that your remedy will cure, and you haven’t.

Mr Hamilton: Madam President, I think I would need another half an hour to answer all those very powerful points. Let me see where to start. Parents have said they will travel any distance to get the best treatment. We know that from our experience in transplantation. Parents travel from all over the UK to get transplants for their child. So they say to get the best care they will travel. We see that in the States people travel from one side to the other. So having a local service, I am sorry, just does not wash. You mentioned the EACTS report. Back then I was on that writing group. The reason EACTS said 2 was because many countries in Europe had units with 1 surgeon, so they knew if they said 3 it would be impossible, and, even as it was, they said 2 and it was completely ignored. So the EACTS point doesn’t wash either.

The adults: yes, “Safe and Sustainable” said we need to sort out the paediatrics. If you sort out the paediatrics, the adults will fall into place naturally because it uses the same surgeons. Well, actually it is not the same surgeons. If you have got a big team, then I would want some of those surgeons focusing, particularly early in their career, on the neonates, the young ones, the really technically demanding operations, and then as you get older perhaps – and many surgeons would see that – they can do the adult congenital surgery when they get a little bit older, and it is a different stress level for that. So I would accept that argument.

You mentioned Bristol. Well, actually I hoped someone might bring that up. This (holding up document) is the Department of Health’s Response “Learning from Bristol” to each of the recommendations, the seven that were specific to paediatric cardiac surgery. Any unit providing open-heart surgery on very young children – not adults, not older children, very young children – need two surgeons trained in paediatric cardiac surgery to each undertake between 40 and 50 open-heart operations a year. Now, that is in small, young children. That is a huge volume per unit overall. So Kennedy did not talk about the adults. That was in very young children.

Mr Bertie Leigh: Read it again.

Mr Hamilton: Right, I’ll read the paragraph.

Mr Bertie Leigh: That last sentence “…who must each undertake between 40 and 50…”…

Mr Hamilton: Right, I’ll read the paragraph.

Mr Bertie Leigh: “….open-heart [surgery] operations a year”. That is not your 50 of neonates.

Mr Hamilton: No.

Mr Bertie Leigh: There wouldn’t be 80 in neonates for the whole of the South-West region.

Mr Hamilton: “With regard to the very particular circumstances of open-heart surgery on very young children (including neonates and infants), we stipulate that the following standard should apply unless, within six months…”, and so on, “….there must, in any unit providing open-heart surgery on very young children, be two surgeons trained in paediatric surgery who…” are each undertaking 40 and 50 open-heart operations a year. Now, there is no point in talking of adult operations, if you are wanting to focus on the results of neonates and infants; that is just confusing the issue. I am trying to think of some of the other points.

Mr Bertie Leigh: Leslie, you do remember that Kennedy took that from Terry English’s evidence when he said that he thought if you are going to do paediatric cardiac surgery you ought to have two surgeons doing 50 operations. He wasn’t specifically saying…

Mr Hamilton: Yes. That was in the days when most surgeons who were doing paediatric cardiac surgery did adult acquired surgery as well and their intention was to get them to focus on the paediatric cardiac surgery; that is what was behind that.

The President: I think now we will move to perhaps both yours and Mr Sethia’s final remarks, because I am conscious of the time.

Mr Hamilton: Again I come back to my point (and it applies to adult cardiac surgeons as well) that cardiac surgeons have led the way in publishing results, publishing outcomes. No surgeon would go to those outcome tables to choose their surgeon if they needed surgery, they would go to a centre doing a big volume of that particular operation. I don’t need to say anything else.

The President: Thank you. Mr Sethia, the final word from you.

Mr Sethia: Thank you, Madam Chairman. Yes, parents will travel to the moon celestially once Richard Branson has got his jetliner up after all these years, but actually they don’t need to. You have heard the evidence. The results and the possibilities that you have in this country with 10 centres undertaking this work are already world class, they are already excellent. I did not say they couldn’t improve further. Quite the contrary, I said we are always improving, and, as you say, the profession has been a leader in openness. You have been part of that process, but others also contributed hugely to the improvement in standards, not just surgeons but all of us who care not just for a bit of the patient, not just on one occasion but for the whole patient for a whole lifetime.

So, Madam President, so far as the motion is concerned, no evidence for 500 cases as a number; maybe more to come; no evidence for disrupting what parents and patients have already. If it ain’t broke, as Reagan once said, you don’t need to fix it, and we certainly don’t need to fix this configuration in this exercise. Thank you very much. (Applause)

The President: I am now going to call on Bertie to give a vote of thanks. (Laughter)

Mr Bertie Leigh: The reason why I wanted to say thank you to both of you for coming is because Michael Brook very sadly can’t be here. This was Michael’s idea. Michael was the advocate representing the Health Authority in the Bristol Inquiry and one of the things that he was very puzzled about was how people were saying that you ought to have bigger centres and yet one of the smallest centres was Newcastle and it seemed to have some of the best results, and he wanted Leslie to come and explain that paradox to us. I am deeply sorry that he can’t be here, because this was very much his brainchild, and I am also very grateful, Leslie, to you for coming to carry the flag as bravely as you can. We are very impressed, even if we think you are a bit misguided. Bee, of course we are grateful to you, coming from the Brompton so far! (Laughter)

Mr Sethia: Three miles from Great Ormond Street. (Laughter)

Mr Bertie Leigh: I know there have been so many calls on your time at the RSM, which is almost as far. But thank you both very much for giving us a very interesting evening. (Applause)

The President: I would like to present you both with our thanks and our gift, Mr Hamilton and Mr Sethia. You will also get a year’s free membership and I do hope that you will come again to take part in our future debates.

Mr Hamilton: Thank you.

Mr Sethia: Thank you.

The President: It only remains for me to thank everybody for coming tonight. I have to say the good news is that our dinner has now been fixed for June 15th 2015 at the Barber-Surgeons’ Hall, so I expect to see you all there and to mark that in your diary. Thank you.