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HEARING SUMMARY

 

15th September 1999

Hearings continued today with evidence from three expert witnesses: Dr Eric Silove, Paediatric Cardiologist, Birmingham Children’s Hospital; and Professor Mark de Leval and Mr Jaroslav Stark of Great Ormond Street Hospital. Dr Silove and Mr Stark are members of the Inquiry’s Expert Group. Today’s theme was operative treatment and care for babies born with congenital heart defects. The witnesses focussed on the development of the arterial switch operation which was first undertaken in the mid 1960s and became more prevalent during the 70s and 80s in the UK. They noted the reduction in the age of babies undergoing this particular operation, discussed the risks and potential benefits associated with it and how these were explained to parents. They highlighted the difficulty in calculating accurate mortality percentages for a new operation. Then they discussed the learning curve for surgeons introducing new operative procedures and the benefits of learning from colleagues already proficient in the new techniques. Professor de Leval commented on a study he has recently undertaken looking at the effect of human factors on the outcome of paediatric cardiac surgery. Mr Stark showed the Inquiry a series of slides to illustrate the developments in paediatric cardiac surgery, including advances in surgical techniques, equipment, drugs and co-operation between members of the multi-disciplinary team, which have led to reduced mortality figures. They went on to discuss the supra-regional status of paediatric cardiac surgery and the optimum volume of work carried out by individual supra-regional centres. The afternoon session concluded with a look at Professor de Laval’s 1994 analysis of a cluster of surgical failures.

FULL TRANSCRIPT

 

 

   1                    Day 50, 15th September 1999
   2   (9.40 am)
   3                SEMINAR:
   4            CONGENITAL HEART DEFECTS:
   5         SURGICAL OPTIONS, INNOVATIONS and RISKS
   6   THE CHAIRMAN: Good morning, everyone. Good morning
   7     Mr Langstaff.
   8   MR LANGSTAFF: Good morning, sir. Sir, today we have two
   9     cardiac surgeons and Dr Silove to help us with the
  10     particular problems of surgery, the factors that affect
  11     surgery, and we are pleased to say, recent research that
  12     Professor de Leval has been doing.
  13        A word of explanation for the wider audience, who
  14     will anticipate, I think, that Professor de Leval has
  15     more than his surgical expertise to offer in general
  16     terms to the Inquiry, because he of course was involved
  17     in a report at an earlier stage into the actual surgery
  18     conducted at Bristol.
  19        We anticipate that we will hear from him at
  20     a later stage on what one might call the "Bristol
  21     specific" issues, and those matters of fact with which
  22     he was involved.
  23        He has been called today, in particular because he
  24     has, as will become apparent when he gives his evidence,
  25     done a considerable amount of work into risk factors in
0001
   1     surgery. He has developed the use of the CUSUM analysis
   2     in looking at individual surgeons' performance, and
   3     considerable work in whether near misses may have
   4     something to say in respect of improving surgical
   5     outcome.
   6        Although he is called as an expert today, again --
   7     this is addressed to the wider public -- he is not one
   8     of the panel of experts who is involved in the clinical
   9     case review which is under way at the moment, and that
  10     is from an abundance of caution, because, of course, of
  11     his past involvement in looking at and expressing his
  12     view upon a number of the Bristol cases. So he is not,
  13     today, giving evidence about any specific Bristol case;
  14     he is giving evidence generally as to cardiac surgery,
  15     in that he has a uniquely valuable contribution to make.
  16        Sir, with that introduction and explanation,
  17     I hope, to those listening to this both in the chambers
  18     outside and at a distance, may I invite both Professor
  19     de Leval and Mr Stark to take the oath, and then I shall
  20     invite each of them to tell us a bit about themselves.
  21        Professor de Leval?
  22           PROFESSOR de LEVAL (SWORN):
  23           MR JAROSLAV STARK (SWORN):
  24   MR LANGSTAFF: First, Professor de Leval. You are Professor
  25     Marc de Leval?
0002
   1   PROFESSOR de LEVAL: Correct.
   2   MR LANGSTAFF: Would you tell us a bit about yourself and
   3     your experience, and please do not be too modest.
   4   PROFESSOR de LEVAL: I came to Great Ormond Street in 1972
   5     and I was appointed there as a consultant surgeon in
   6     1974. I have been there since, as a consultant and now
   7     as a Professor of Cardiothoracic Surgery.
   8        I have spent the last 25 years dealing with the
   9     heart surgery of children, and also introducing and
  10     developing a transplantation programme at Great Ormond
  11     Street.
  12        Besides that, I have been involved in a number of
  13     research projects, basic research, clinical research,
  14     and more recently I have been interested in the role and
  15     impact of human factors on the outcomes of surgery,
  16     which is probably the reason for my being here today.
  17   MR LANGSTAFF: Mr Stark?
  18   MR STARK: I graduated in 1958 at Charles University in
  19     Prague. I came for further training to Great Ormond
  20     Street in 1965. I had a brief spell doing research in
  21     paediatric cardiology in Boston and Harvard, and in 1971
  22     I was appointed a consultant in paediatric
  23     cardiothoracic surgery at Great Ormond Street.
  24        As my colleague and friend Mr de Leval said, in
  25     1974 he joined me in our efforts to do what we did at
0003
   1     that time. I was involved in trying to develop infant
   2     cardiac surgery which, in the early 1970s, was really in
   3     its infancy and the risk of those operations was high.
   4     I retired in January this year.
   5        In the last couple of years I became interested
   6     and involved in data collection because I thought this
   7     was really a prerequisite for us to develop possible
   8     guidelines or standards. That has been one of my main
   9     interests in the last couple of years.
  10   MR LANGSTAFF: I want to focus in particular upon a number
  11     of issues and questions, but perhaps first, if you would
  12     begin from the surgeon's perspective in telling us about
  13     the development of and the difficulties in development
  14     of the arterial switch operation. You have a screen to
  15     your right. Would it be helpful to have a diagram on
  16     the screen?
  17   PROFESSOR de LEVAL: If you have a diagram of the
  18     transposition of the great arteries, it might be useful.
  19   MR LANGSTAFF: We have two diagrams, so I will show you them
  20     both first so you can see them. The first is ES 1/12.
  21   PROFESSOR de LEVAL: I understand Dr Silove has gone through
  22     the technicality of the procedures yesterday, so there
  23     is no point in going through that again today.
  24   MR LANGSTAFF: Yes.
  25   THE CHAIRMAN: If I may just, in addition to welcoming our
0004
   1     experts, make one plea, that of course we will be using
   2     highly technical language during the day, and we have to
   3     make sure that we make a transcription of what you say
   4     for the benefit of all who will come to read it later,
   5     so may I ask that one bears in mind the fact that there
   6     is a transcriber and when one uses technical terms,
   7     maybe go a little more slowly, without at the same time
   8     interrupting your flow of thought, I hope.
   9   DR SILOVE: May I just interrupt? I thought it might be
  10     easier to do the operation than to demonstrate it on the
  11     screen, and I did it in the most simple terms
  12     yesterday. You might want to just do that again.
  13   PROFESSOR de LEVAL: The treatment of transposition started
  14     in the mid-1960s and there were two challenges. The
  15     first one was to be able to do an open-heart operation
  16     on a small infant; the second one was to design
  17     a procedure, a surgical procedure, aiming at treating
  18     the transposition.
  19        The transposition, as Dr Silove said yesterday, is
  20     a condition where the aorta arises from the right
  21     ventricle and the pulmonary artery from the left, so the
  22     procedures which were described in the early 1960s were
  23     procedures which consisted in treating the transposition
  24     by doing another transposition. They were transposing
  25     the way the blood returns to the heart so as to correct
0005
   1     the way the blood goes out of the heart. Do you
   2     understand that? Those procedures were called the
   3     Mustard and the Senning procedures.
   4        So when I joined Mr Stark at Great Ormond Street
   5     in 1972 and 1974, we were doing the Mustard procedure
   6     and then the Senning procedure. The results had
   7     improved quite significantly, to a point that the
   8     mortality in the late 1970s/early 1980s was probably --
   9     would you say about 5 per cent, Jaro?
  10   MR STARK: 5 or under.
  11   PROFESSOR de LEVAL: The arterial switch operation was
  12     described. Can we get rid of this diagram if you want
  13     me to do an operation on the screen?
  14   MR LANGSTAFF: Can we provide a blank screen, please?
  15   PROFESSOR de LEVAL: The switch operation had been described
  16     a number of years before, but the first successful
  17     switch was done, I think, by Jatene in the early 1970s.
  18     This is the aorta with the coronary arteries, and
  19     I would put the pulmonary artery next to it although it
  20     is usually behind it.
  21        The switch consists of dividing or transecting the
  22     two great arteries, to switch them around. The key of
  23     the operation is that the coronary arteries, which are
  24     the feeding arteries to the heart, take off very close
  25     to the aortic valve here. You cannot transect the aorta
0006
   1     below the coronary arteries, so those two arteries have
   2     to be taken separately and transferred to the neoaorta,
   3     which is the preliminary artery.
   4        That is the key of the operation in terms of
   5     technical challenge. Very soon after the first few
   6     switches, the surgeons and the cardiologists realised
   7     that there was a variety of distributions of patterns of
   8     those coronary arteries, and that some of them were
   9     easier to deal with than others in terms of being able
  10     to transfer them, technically.
  11   MR LANGSTAFF: Can we for a moment have a look at INQ 6/3?
  12     This is an illustration from a paper of yours which
  13     I have shown because I think it may be helpful.
  14   PROFESSOR de LEVAL: This shows the vessels in proper
  15     relationship with the aorta being in front, the
  16     pulmonary artery being behind. The two coronary
  17     arteries have been removed with a cut of the arterial
  18     wall from the aorta, to be transferred to the pulmonary
  19     artery. This is the main technical point of the
  20     operation.
  21        The other aspect of it is that the operation is
  22     done on new-born infants. You must do the switch
  23     operation ideally below the age of 1 month because the
  24     left ventricle, which is quite thick when you are born,
  25     becomes thinner when the resistances in the pulmonary
0007
   1     circulation fall, which is a normal phenomenon after
   2     birth. The left ventricle, which is asked to perform
   3     against the systemic resistance, the pump in the body,
   4     needs to be thick enough to perform properly. This is
   5     why the operation has to be done in small children.
   6        So the challenge was the technical challenge of
   7     transferring coronary arteries, which are vessels
   8     measuring about 1 mm in diameter or less, and do a long
   9     operation in new-born infants. So there is the problem
  10     of cardiopulmonary bypass, long procedures, technically
  11     challenging, and the post-operative care of those
  12     patients.
  13   THE CHAIRMAN: How long?
  14   PROFESSOR de LEVAL: It depends on the technical complexity,
  15     but the overall procedure can take up to 8 hours.
  16     Taking into consideration the induction of anaesthesia
  17     and insertion of catheters, I think it takes always at
  18     least four hours, at a minimum.
  19        The questions we had in the late 1970s and early
  20     1980s was to decide to "switch from the switch", in
  21     a way: it was to move from the Mustard which in those
  22     days was giving a low mortality, low post-operative
  23     morbidity and in those days at that time we had good
  24     medium term results with the Mustard. So we had to
  25     decide to go for an operation which was more logical,
0008
   1     but this was purely intellectually, with totally unknown
   2     long-term results, expected to be good, and obvious
   3     higher mortality, and there was a problem of having to
   4     go through a learning curve while you could treat those
   5     patients with a low mortality.
   6   MR LANGSTAFF: Do we yet know what the long-term results of
   7     the arterial switch are?
   8   PROFESSOR de LEVAL: It depends what we call "long-term
   9     results". The longest we have is about 15 to 19 years.
  10     Now there is a number of reports, many from France,
  11     where they have looked at the coronary perfusions of
  12     those patients, and there is a high incidence, or
  13     a significant incidence -- I will not say high -- of
  14     coronary problems in those patients who have been
  15     studied. The incidence is difficult to assess because
  16     a number of those patients were investigated because
  17     they were symptomatic, so it is not a blind prospective
  18     study, but there are some problems. And, you know, we
  19     could question, wonder what will be the incidence of
  20     coronary artery disease for example in those patients in
  21     40 years from now. All this is still unknown, but we
  22     know that the delayed results of the Mustard and the
  23     Senning are not as good as expected, and there are
  24     a number of patients who die suddenly, probably from
  25     arrhythmias or from narrowing of the pathways being
0009
   1     inside the atria. So I think in balance now, we are
   2     quite confident that the switch operation is a better
   3     operation.
   4        In the early 1980s we were balancing the early and
   5     the late risks, and one of the questions was, what kind
   6     of lower risk can you afford, assuming that the
   7     long-term results will be better? I do not think that
   8     question has been answered. The acute problem was the
   9     decision to deal with the learning curve. When we
  10     started the switch operation, those who had started
  11     before us started with a mortality of -- I mean, the
  12     person I am quoting is Jan Quaegebeur, who has become
  13     a master of the switch, who started with a mortality of
  14     25 per cent.
  15        The way he started is, he was more or less asked
  16     by his mentor, Dr Brawn, to start the switch because he
  17     was confident that it was the best operation. So it is
  18     the association of a very wise, I think, and
  19     forward-seeing mentor and a very good surgeon, who
  20     started the switch, but they had to go through
  21     a learning curve with a mortality of 25 per cent, which,
  22     within a few years, came down to below 10 and now, in
  23     his results, is probably about 2 or 3 per cent.
  24   MR STARK: I would like to add if I may to the difficulties
  25     of the decision-making in those days. Marc already has
0010
   1     explained a few things. In children, unlike in adults,
   2     you really are looking for the long-term results, which
   3     means 50/60 years and this is why, when we introduce
   4     a new operation on the presumption that the new
   5     operation will be better than the old one, it is very
   6     difficult. I think this, coupled with some of the
   7     complications we were aware of -- and it has been
   8     mentioned that the coronary arteries make late
   9     problems -- it was also the right ventricle outflow
  10     obstruction and the pulmonary obstruction, the flow from
  11     the right ventricle to the lungs, which, with certain
  12     techniques gave a very high incidence.
  13        Then, at the time when, say, our results at Great
  14     Ormond Street showed a mortality of the Senning
  15     operation under 5 per cent, then some of the people who
  16     were pioneers in arterial switch operation, like Jatene
  17     in Brazil, his first survival was, I believe, after
  18     three or four unsuccessful attempts. There was an
  19     excellent French surgeon who made a lot of
  20     contributions, and the first time he lectured to us at
  21     Great Ormond Street, he had 12 or 14 consecutive cases
  22     who had died.
  23        So that was psychologically a very difficult time
  24     for the cardiologists and for the surgeons to make this
  25     change from the old-type operation that we thought the
0011
   1     long-term results probably will not be so good and the
   2     arterial switch operation where we thought the long-term
   3     results probably will be much better. I think now,
   4     20 years later, we are a little bit wiser.
   5   MR LANGSTAFF: Just looking at the early operations, Jatene,
   6     when he began, the French surgeon whom you quote, would
   7     have been in a sense experimenting on the children who
   8     were in their care?
   9   MR STARK: Well, I think one can put it that way, although,
  10     on the other hand, all the new operations you may in
  11     summary call "experiments" because you cannot experiment
  12     on animals because you do not have the animal model, and
  13     even if you had the animal model, we are not, as you
  14     know, allowed to try the operations on animals --
  15     certainly in some countries this is possible but we
  16     cannot do that. So to some extent "experimenting"
  17     sounds a harsh word, but I think it was.
  18   MR LANGSTAFF: In such a case, do you know to what extent
  19     the parent of the child concerned was involved in taking
  20     a decision which might involve the parent being told,
  21     "The last two, the last three operations that I have
  22     done", says the surgeon, "have all failed. On the other
  23     hand, what I can offer you is a chance that your child
  24     will live to a much longer and riper old age"?
  25        Was the parent involved? Did the surgeon in those
0012
   1     days take the decision for the parent? How did it
   2     work?
   3   PROFESSOR de LEVAL: When we were in the transition period
   4     of moving from the Mustard or Sennings to the switch, we
   5     were informing the parents of that change of attitude
   6     and policy, and we were discussing the pros and cons of
   7     those operations on a purely theoretical basis because
   8     we had no hard data, but we had good reasons to believe
   9     intellectually that a good switch was better than a good
  10     Senning. We indicated to them that the risk, the early
  11     risk, was higher, probably, for the switch than for the
  12     Senning but we expected the long-term results to be
  13     better and in balance, the switch to be better.
  14   THE CHAIRMAN: Professor Jarman has a question, but you
  15     finish this answer.
  16   PROFESSOR de LEVAL: I have forgotten where I was.
  17   MR LANGSTAFF: You said you expected the long-term results
  18     to be better.
  19   PROFESSOR de LEVAL: That is right. If I recall, in those
  20     days we ended up the conversation with the parents
  21     sometimes by doing a switch and sometimes by doing
  22     a Senning. That was at the beginning, but as time went
  23     by, we convinced ourselves that the mortality of the
  24     switch was going down and therefore that, in balance, we
  25     were making -- not a plea, but we were influencing the
0013
   1     decision to have the switch.
   2   MR LANGSTAFF: In a sense, that would have to be the case,
   3     because if any new surgical technique is developed which
   4     you as a surgeon would prefer to do, then there is
   5     a disadvantage, is there, in doing a low volume of two
   6     operations rather than a higher volume of one?
   7   PROFESSOR de LEVAL: This is the discussion about volumes,
   8     which is a very difficult one. It is volume of what?
   9     Is it volume of operations you do which is important to
  10     maintain your skill? Is it the number of bypass
  11     operations? Is it the exact number of switches?
  12     I think that the concept of volume is a general concept,
  13     and it is important to indicate what we really analyse.
  14     I think that in all fields there is a correlation
  15     between volume and good performance, but what is the
  16     most important? Is it that we do a switch or that we do
  17     quite a number of operations on small babies? Or can
  18     a surgeon do any operation to maintain his skills?
  19        I think those points are important, because there
  20     is a tendency to look at one diagnosis and if you look
  21     nowadays at the performance of the very good surgeons,
  22     you can just see that some years a surgeon would have
  23     a higher mortality for one condition. So I think it is
  24     difficult to correlate volume with one particular
  25     condition.
0014
   1   THE CHAIRMAN: May I interrupt just a second? I am sure we
   2     are going to pursue the issue of volume, but before we
   3     lose sight of the beginning of switch, Professor Jarman
   4     had a question.
   5   PROFESSOR JARMAN: I am sorry to interrupt. It is difficult
   6     with this setup and it is a difficult question as well.
   7     I realise how difficult it is to develop new operations,
   8     particularly if you cannot operate on animals, but
   9     I just wanted to ask you, had you had a young child of
  10     that age at the time when the operative mortality of the
  11     early operations, the Sennings, was 5 per cent, and
  12     knowing that surgical mortalities were likely to reduce,
  13     what would you have chosen: to go to the new operation
  14     or to have stuck with the older one, for your own child,
  15     personally?
  16   PROFESSOR de LEVAL: The way I went about this myself is
  17     that I could not cope with the learning curve,
  18     basically, so what I have done -- maybe I am a bit
  19     selfish, but I asked someone who had gone through it to
  20     do the operations with me. This is what I did, so
  21     Dr Quaegebeur, who happens to be a surgeon as well, came
  22     to Great Ormond Street to help me starting the switch
  23     operation. This is the way I did go through my learning
  24     curve.
  25        Posteriorly, I think it was probably a good thing
0015
   1     to do, and if I would comment, to try to reduce the side
   2     effects of learning curves is precisely to limit the
   3     number of those who pioneer new procedures, and when
   4     they master it, to have a system whereby the other
   5     people can benefit and reduce their learning curve.
   6        There are two types of learning curve. There is
   7     the learning curve of established people to learn new
   8     procedures, and there is the learning curve for training
   9     for which conventional procedure has to be learned and
  10     taught. I think that the way to go about it is to do it
  11     with someone who has done it. We cannot get rid of
  12     a learning curve completely, but we can certainly
  13     minimise its effects. I felt unable to go through
  14     a 25 per cent learning curve myself, so I have great
  15     admirations for Jan Quaegebeur who did it, but
  16     I personally would not have had the guts do it.
  17   PROFESSOR JARMAN: I am not quite sure that quite answers my
  18     question. Mr Stark?
  19   MR STARK: It is obviously a very difficult question, but
  20     I think it is a very pertinent one. I think precisely
  21     because of this question, we probably started with the
  22     arterial switch operation at Great Ormond Street
  23     a little bit later than other people, and I think it is
  24     very difficult -- it is a theoretical question but you
  25     did not have much time for the decision. If you wanted
0016
   1     to go for an arterial switch operation, as Professor
   2     de Leval explained, it has to be done in the first four
   3     weeks of life, so you cannot dither and wait. I think
   4     probably in the early 1980s I would have opted for
   5     Senning for my child. But then you would say I would be
   6     preventing all the progress, and you would be right.
   7   PROFESSOR JARMAN: Maybe if you were allowed to operate on
   8     animals --
   9   MR STARK: I think it would have helped, but it would still
  10     not solve the problem completely, because I personally
  11     believe, when we talk about learning curves, we
  12     concentrate, perhaps rightly, very much on the surgeon.
  13     But this particular operation, or any operation on an
  14     infant, is such a team effort that a minor slip in
  15     diagnosis, in perfusion, anaesthesia, post-operative
  16     care, can completely negate the result. So although the
  17     surgeon is a prerequisite and you have to have a good
  18     operation, I think it is not everything. I am not sure
  19     I have answered your question.
  20   PROFESSOR JARMAN: You have, thank you.
  21   PROFESSOR de LEVAL: Another way, not to answer that
  22     question completely, but very early we identified that
  23     some of those switches were higher risk than others
  24     because they were coronary arteries, so we tried to know
  25     pre-operatively and select the better cases. For the
0017
   1     first few years we were doing the switches only on the
   2     good cases and we were doing Sennings on the difficult
   3     coronary arteries.
   4        But I still cannot answer your question of what
   5     I would have done as a parent, because it depends on the
   6     information we receive, and I do not think that in the
   7     1980s we were giving the parents the information you
   8     expect today.
   9   THE CHAIRMAN: Mrs Howard has a question.
  10   MRS HOWARD: This may be evident to others, but could you
  11     give me some feel of what you mean by "a good case" in
  12     these early days?
  13   PROFESSOR de LEVAL: I mean a low risk coronary artery, so
  14     we identify some coronary arterial patterns which were
  15     difficult to transfer and carried a higher risk, so for
  16     those patients, we electively put them through a Senning
  17     operation. So when we began on our own, we were doing
  18     a switch on those cases who were expected to give good
  19     results.
  20   MR STARK: I would add, if I may, one other thing. We are
  21     talking about the late 1970s or early 1980s, but I think
  22     the arterial switch operation is both technically
  23     demanding and demanding on the whole team, so it is
  24     possible that this operation should only be performed in
  25     a limited number of centres, because in some of the
0018
   1     papers which I have submitted to you, even 1994/96 in
   2     the State of New York, overall mortality was 10 per
   3     cent. Not very long before the Congenital Cardiac
   4     Surgeons Society in the United States, which encompasses
   5     more or less the best units in the country, the
   6     mortality for the so-called low risk operations was 6 to
   7     13 per cent, but for the rest of the department in the study
		23 to 80 per cent.
   8        That, I think, would indicate that although the
   9     good centres or the centres with low mortality managed
  10     to get over the learning curves, it is still not an easy
  11     operation.
  12   MR LANGSTAFF: Can I explore for a moment the change that
  13     there has been in parental expectations as to
  14     information and the influence that that might have
  15     had -- it is a theoretical question -- if the arterial
  16     switch programme had not developed with Jatene in the
  17     1970s but was proposed today?
  18        Is there a conflict, do you think, between the
  19     development of a new operation, the results of which are
  20     speculative, when there is an operation the results of
  21     which are relatively clear, although far from perfect,
  22     such that if you had said to a parent, if surgeons
  23     generally had said to parents, if Jatene had and the
  24     French surgeon that you quote had said, "The risks of
  25     operative death are very high here; we have not done any
0019
   1     of these operations, or many of these operations
   2     before. Do you want this for your child because I have
   3     an idea that it will be better in the long-term?", the
   4     parent might very well say, "No, I do not want that",
   5     and you would not actually get the development of an
   6     operation which is now thought to be of value generally.
   7   PROFESSOR de LEVAL: This is the big issue of scientific
   8     progress and comparing strategies which can come
   9     subsequently or simultaneously. The only proper
  10     scientific way would be to proceed with a prospective
  11     double-blind study. That is the only scientific way to
  12     compare two techniques. This should apply to the early
  13     and long-term results.
  14        We are talking here about new-born infants whose
  15     life expectancy now, in our civilisation, in this part
  16     of the world, is about 70 years, so normally we should
  17     know what the results at 70 years are of the two
  18     operations before we can decide which one is the best,
  19     which is totally impossible.
  20        The speed with which progress goes on in terms of
  21     science is such that all the time new procedures, new
  22     strategies, new operations are coming out, and this
  23     question comes up all the time. I do not have an answer
  24     for it, but we should realise that this is what happens
  25     in the world, so there will be always patients who will
0020
   1     receive for the first time a new procedure, whatever you
   2     have done before to make sure it was the proper way to
   3     do it, there will always be patients who will be at the
   4     beginning of an experience, and it is unavoidable.
   5        What we have to do is to introduce those new
   6     strategies, new research, to make sure that we minimise
   7     the casualties of this introduction, but I believe that
   8     they are unavoidable.
   9   MR LANGSTAFF: Mr Stark?
  10   MR STARK: I would completely agree with what Marc said.
  11     I think that one thing, when you say "when you discuss
  12     it with the parents", you actually are not asking the
  13     parents to make the decision, because I think, to some
  14     extent, the way you see the benefits, you are willingly
  15     or unwillingly influencing the parents. But the other
  16     way round, the parents sometimes influence you.
  17        I would like to give you an example. One of the
  18     very difficult conditions is pulmonary atresia, with
  19     major collaterals coming from the aorta.
  20        For this condition, although the outlook has
  21     improved, the usual scenario in the 1970s/80s was that
  22     we would do two, three, four palliations in the first
  23     3 years. Eventually there was nothing to offer. So on
  24     those occasions when we told the parents this scenario
  25     and suggested, because the outlook is so bad, that
0021
   1     perhaps we should not treat the child, of course very
   2     often the parents feel anything that could be done
   3     should be tried, and we did, and then the scenario was
   4     followed.
   5        Then, a few years later, the parents would write
   6     to me and say, "We are sorry we did not take your advice
   7     because the misery we have suffered during those three
   8     or four years was immense".
   9        So I think that there is always both sides that
  10     influence each other. I am not sure if I expressed
  11     myself clearly.
  12   MR LANGSTAFF: The problem that I was asking about is that
  13     of scientific progress which inevitably may have a cost,
  14     and the cost may be human.
  15   MR STARK: Yes.
  16   MR LANGSTAFF: It is one thing to see it in the general,
  17     when the cost of progress for all may be reasonable,
  18     possibly, arguably, even though there may initially be
  19     harm to some. If you are looking at it in terms of the
  20     individual patient who represents one of the "some", how
  21     does one reconcile one's duty as a doctor to the
  22     individual with the idea that there may be, but not
  23     necessarily will be, progress for the many?
  24   PROFESSOR de LEVAL: I think that there are ways to minimise
  25     the risks of introducing new strategies, and nowadays,
0022
   1     for example, in terms of education and training, there
   2     are models, there are simulations; some of the
   3     operations can be performed on animals, although the
   4     switch, I think, would have been quite impossible to
   5     do. I am involved personally in some research on
   6     computation of flow dynamics, which is a highly
   7     sophisticated technique of looking at circulation to try
   8     to analyse flow dynamics before we do it on a patient.
   9     There are ways to reduce as much as we can the
  10     casualties, but I think it will be impossible to reach
  11     a stage whereby the risk of an operation is the same
  12     when you do it for the first time than when you do it
  13     for the 100th time, I think.
  14   THE CHAIRMAN: May I ask you a question following on? As
  15     you rightly say, this is a very hard issue but it is one
  16     that has to be confronted. You clearly, in your
  17     professional lives, will have confronted it many times.
  18        It was put to us quite early on in our evidence
  19     that one way of responding to the challenge of
  20     innovation, as you have described it, would be to insist
  21     not only in the kind of measures you have described, the
  22     use of models, whether computerised or whatever, but
  23     also to insist that any proposal for innovation in the
  24     form of surgery be passed before the relevant Ethics
  25     Committee, which will be concerned with looking at
0023
   1     whether the surgeon has had all this other experience,
   2     whether all the opportunities have been exhausted to
   3     acquire technical expertise and whatever else is needed,
   4     as well as whether the balance has been properly weighed
   5     to introduce a programme.
   6        What observations would you have on that?
   7   PROFESSOR de LEVAL: I think that to have a formal proposal
   8     going to an appropriate Ethical Committee is certainly
   9     a good idea, and actually, that exists for a number of
  10     new innovations in medical treatments, new drugs,
  11     et cetera.
  12   THE CHAIRMAN: Certainly, but not traditionally in surgery?
  13   PROFESSOR de LEVAL: No. There was an article in the JAMA
  14     some years ago. The title was "There is no FDA approval
  15     for the surgeons", which is true, and I think that that
  16     could be of some benefit, although we must make sure
  17     that it does not do more harm than good.
  18        For example, the legislation nowadays in the
  19     States is such that the they lag behind in a number of
  20     fields, like orthopaedic surgery, fields where you have
  21     to use prosthetic or artificial materials. It is very
  22     difficult to have an improved prosthetic valve, for
  23     example, accepted in the States and the clinical trials
  24     have to be done outside the country because of those
  25     regulations. So I think that the suggestion of having
0024
   1     an approval for a new procedure is a good one, but we
   2     must make sure it remains well balanced.
   3        The other thing is that there are two types of
   4     progress in science. One is the big new innovation,
   5     very often totally unexpected. Then there is the daily
   6     improvement in what you do. Personally, I have been
   7     involved in the so-called Fontan operation, which is an
   8     operation we do for a patient with a single ventricle.
   9     At the end, I contributed to the design of a new
  10     operation, but it did not start from scratch; it is the
  11     evolution. I did it, and if I had had to put a proposal
  12     for doing the operations I do today, I do not know when
  13     I would have put it, because I was not aware of the end
  14     point.
  15        I think this distinction between the two types of
  16     progress is important.
  17   MR LANGSTAFF: We heard also at an earlier stage of our
  18     evidence the view expressed that, so far as the arterial
  19     switch was concerned, a number of surgeons were, for
  20     reasons of demonstrating their prowess, keen to take up
  21     what seemed to them to be a new operation: because
  22     Jatene had done it, they wanted to do it, was the idea
  23     expressed to us.
  24        To what extent is that a reflection of a number of
  25     surgeons' attitudes in the late 1970s, early 1980s?
0025
   1   PROFESSOR de LEVAL: I have never seen a surgeon who did an
   2     operation because of just wanting to do it, it was
   3     good. I have never come across a surgeon with that
   4     mentality, I must say. Have you, Jaro?
   5   MR STARK: No, it is a new concept to me.
   6   PROFESSOR de LEVAL: Have you, Eric?
   7   DR SILOVE: I do not believe surgeons or cardiologists think
   8     like that at all. I am surprised at the suggestion,
   9     actually.
  10   MR LANGSTAFF: It was one that was made to us.
  11        If I can then ask, before we leave this difficult
  12     area, to what extent would a parent, in the 1980s, in
  13     the late 1980s, in the 1990s and now, looking at those
  14     four different periods, understand that they were one of
  15     the first and so, in a sense, their individual case
  16     might be the sacrifice for the future of others to come?
  17        To what extent might they have appreciated that
  18     that would be the possibility?
  19   PROFESSOR de LEVAL: I think that the parents were informed
  20     that the procedure was new or that there was an
  21     alternative, but we were implying or proposing a new
  22     procedure, but I think all this was done in the context
  23     of a relationship of confidence between the families,
  24     the cardiologist first and the nursing staff, the
  25     surgeon, and I do not think that parents ever considered
0026
   1     that they were probably the "victims" or "guinea pigs"
   2     or whatever you would call that. I think that they
   3     were, you know, as fully informed as we thought they
   4     should be, and we were totally open in what we were
   5     doing. The fact that we were telling them that it was
   6     a new procedure implied, without being necessarily
   7     specific in spelling it, that there was probably
   8     a higher risk in those days than now, because we have
   9     done more.
  10        But I think the relationship and the ambience
  11     where all those things were taking place was such that
  12     there was full confidence between parents and the
  13     institution.
  14   MR STARK: I think this is a very important point, because
  15     I could give you an example of one operation which
  16     I thought could be done and it has not been done before,
  17     and when I talked to that family, I put it to them in
  18     those simple terms: "It has not been done before.
  19     I think it could work". The parents, and many other
  20     parents, in those days usually did not comprehend fully
  21     the anatomy of physiology, because, as I think was
  22     probably explained already yesterday, it is quite
  23     complex. Very often the answer was, "We know that you
  24     will do your best and we trust you". So we went ahead
  25     with the operation, that particular operation went well,
0027
   1     but the feeling that the nurses, cardiologists, surgeons
   2     had the full trust of the parents probably made the
   3     explanation, even under such difficult conditions when
   4     we started new operations or where we knew the risk was
   5     still high, somewhat easier. I think it is much more
   6     difficult today.
   7   MR LANGSTAFF: The cardiologist would probably see the
   8     parents before the surgeon.
   9   DR SILOVE: Yes, the cardiologist would see the parents
  10     first, but the cardiologists and the surgeons will have
  11     discussed all of the ramifications in quite some detail
  12     before the cardiologist ever puts something to the
  13     parents.
  14        I am sure it is the cardiologist who would be the
  15     first to suggest to the parents, "We have discussed this
  16     problem and we feel that the right way to go forward is
  17     to go for the arterial switch operation". It then
  18     becomes a question of how it is dealt with in an
  19     individual institution, whether the parents see the
  20     surgeon or whether the cardiologist and the surgeon see
  21     the parents together, but the communication is terribly
  22     important.
  23   MR LANGSTAFF: One could take the trust point that Mr Stark
  24     has made further, then, could one, and say that it is
  25     a mistake to look at it simply in terms of
0028
   1     a consultation between a parent or patient and
   2     a surgeon, because in effect it is a team consulting
   3     with the patient or parent?
   4   DR SILOVE: That is exactly right. It is a team
   5     consultation, it is a team decision and it is a team
   6     responsibility. I do not think the surgeon should take
   7     the flack for everything that goes wrong. I think the
   8     whole team is responsible for things going right or
   9     wrong.
  10   MR LANGSTAFF: I see Mr Stark is nodding to that.
  11   PROFESSOR de LEVAL: I fully agree with that. As Jaroslav
  12     said, every single patient operated on has been
  13     discussed once, twice or three times in great detail by
  14     at least two consultants, a surgeon and a cardiologist,
  15     but most of them by the junior staff, other consultants.
  16     If it is a difficult problem, we would repeat
  17     investigations. In the beginning we used to go back
  18     with the echocardiograms, repeat an angiogram, to find
  19     out where the coronary arteries were. Because the
  20     coronary artery was so crucial, sometimes we went ahead
  21     with a switch and found different coronary arteries than
  22     expected and we had to back up to a Senning.
  23        So all these decisions were team decisions in
  24     which we all took responsibilities. I think this is
  25     that type of attitude, corporate attitude, that was
0029
   1     communicated to the parents, which I think allowed us to
   2     work in an atmosphere of trust and confidence. I think
   3     it is absolutely vital. I do not think the parents have
   4     ever seen me, as a surgeon, as a single individual
   5     within the hospital. I have been always part of a team,
   6     and they knew when I talked to them that it was after
   7     discussing with others, it was the decision which had
   8     been taking place at the conference.
   9   THE CHAIRMAN: May I ask one particular question in relation
  10     to that? You said at one stage that to say that
  11     something was a new procedure would be understood by
  12     a parent to imply that there was a higher risk.
  13        How do you know that?
  14   PROFESSOR de LEVAL: I do not. Similarly, I do not
  15     understand today whether the patients I speak to
  16     understand, or the parents, what I say. I think that it
  17     happens to me when I speak to people in other fields,
  18     like the legal profession: they think I understand and
  19     I do not, although they try to speak in simple terms.
  20     I think this applies to the parents. Even if you make
  21     a drawing of a switch operation, I cannot be sure that
  22     what I have drawn, you will understand exactly what it
  23     implies.
  24   THE CHAIRMAN: Of course, but if there was, in your mind,
  25     the notion that there were increased risks, why would
0030
   1     that not be said, rather than merely say, a new
   2     procedure would be understood by a parent to imply
   3     greater risk?
   4   PROFESSOR de LEVAL: No, I was specific about this as well.
   5     Each time I see a family, for the last 25 years, I write
   6     a note on the chart or the record of the patients with
   7     the risk I quoted, and if it is 10 per cent or 15 per
   8     cent, and in those areas, I mention the difference of
   9     risks as well, and it is written down in the notes.
  10   THE CHAIRMAN: Do bear in mind many of the questions I ask
  11     you are so as to make sure we are clear on everything
  12     you are telling us.
  13   MR STARK: There is one thing. I think it is very important
  14     to give as accurate information as possible, but I think
  15     the more we learn about the statistics and statistical
  16     evaluation, I personally realise that I have probably
  17     not given very accurate information a number of times.
  18     There has been recently a very nice paper in the BMJ on
  19     the incidence of adverse effects that have not happened
  20     yet.
  21        So can the surgeon who operates 15 switches
  22     without mortality tell the parents that the risk of that
  23     particular operation is zero? No. Actually,
  24     statistically, there is, within 95 per cent confidence
  25     intervals, that he may lose 20 patients out of the next
0031
   1     100 and it could be due to chance.
   2        So that is a sort of new concept for me, because
   3     if I have not lost 15 patients, I would probably quote
   4     the risk of 5 to 10 per cent, but I would probably never
   5     quote the risk of 20 per cent.
   6        So I think that means that we will have to learn
   7     more about these things and perhaps educate the parents
   8     more, because otherwise if we say the risk is very low,
   9     of course if the child dies, for the parents it is
  10     100 per cent risk and it is a tragedy.
  11   MR LANGSTAFF: What you have both indicated is that when you
  12     were dealing with risks with patients, you would quote
  13     a percentage. You have just been indicating, I think,
  14     that the percentage is not worked out on a mathematical
  15     basis because if you are reflecting your own
  16     performance, taking your own series, you would, in the
  17     instance you have quoted, have said 0 per cent. You
  18     modify the mathematics in relation to other factors, so
  19     it becomes a matter of judgment, does it, rather than
  20     a question of mathematics?
  21   MR STARK: It does.
  22   MR LANGSTAFF: To what extent, then, does quoting
  23     a percentage give a spurious impression of scientific
  24     certainty to a patient?
  25   PROFESSOR de LEVAL: I agree with that. I think what I have
0032
   1     done in 25 years lacks of science completely, and
   2     probably misled the patients. I agree with that.
   3   MR STARK: I think very often we would quote the parents
   4     actually very broad idea, like saying the risk is less
   5     than 50:50. Only when the parents insisted, we put
   6     together our own experience, we put together the data
   7     from the literature, but it was not scientific;
   8     I completely agree. Unfortunately, we did not have the
   9     basis for that.
  10   THE CHAIRMAN: Professor Jarman?
  11   PROFESSOR JARMAN: I just wondered: would it be possible to
  12     just give the confidence interval, the percentage, or
  13     would they not understand?
  14   MR STARK: It would, but I would like to know what
  15     percentage of parents would understand "confidence
  16     limits", because I did not understand until a few years
  17     ago myself.
  18   MR LANGSTAFF: Picking up on Professor Jarman's question, it
  19     might be suggested that one way of putting it would be
  20     to say, "I cannot say precisely what the risk is, and of
  21     course no operation is ever successful to a percentage;
  22     it is either successful or it is not, but it is within
  23     the range, 15/25 per cent or 2/15 per cent, and using
  24     the word "range" rather than "confidence interval".
  25        Is that something which is ever done, or not?
0033
   1   PROFESSOR de LEVAL: Nowadays, obviously, we are careful
   2     what we say, what we write and we try to choose our
   3     words, but I think that, frankly, when I was talking to
   4     parents in 1985 about risks, I did not know exactly what
   5     my results were and certainly not what the confidence
   6     interval was, so it was a clinical impression of what
   7     I had done; also a knowledge of what had been published
   8     and what I had heard at meetings. Some of the
   9     conditions, the number of cases I had done, we had done,
  10     was very small, rare conditions, and the risk quoted was
  11     the best I thought I could do in terms of assessing what
  12     the risk was, plus taking into consideration my own
  13     performance from previous cases, which is something you
  14     have alluded to. You tell the parents that three of the
  15     last four patients have died while all the others before
  16     had survived? We did not, but I am sure that when I was
  17     quoting a risk of an operation, having lost one or two
  18     patients from the same condition, I was more
  19     pessimistic. But this is no science. There was no
  20     confidence interval quoted.
  21   MR STARK: I think there may be perhaps another way in
  22     future, if we master adequately data collection, we can
  23     have on our desktop access to our previous data, and
  24     instead of quoting overall numbers, we can say "For this
  25     condition for the last three years I have done [so many]
0034
   1     patients and those were the results". You can then
   2     perhaps discuss around this figure, the percentages,
   3     with the parents, but that means that we have to have
   4     the systems and resources for that, et cetera.
   5   MR LANGSTAFF: Because otherwise your practice of writing
   6     the percentage that you quoted into the clinical notes
   7     is there for the purposes of the record and presumably
   8     it is there because, if anyone were to ask a question
   9     about it, you could say, "That is the percentage
  10     I quoted". But if you were challenged on it, if someone
  11     said "How on earth do you quote 25 per cent when the
  12     last 10 cases you have done have all been successful, or
  13     all been unsuccessful?", you would have to answer. How
  14     easy would that be in any given case?
  15   PROFESSOR de LEVAL: I cannot answer it. I cannot
  16     demonstrate why scientifically; it is just an
  17     impression. I started to do this. I learned that from
  18     my mentor in my clinic, Dwight McGoon who was doing it
  19     in those days, 1973, and I thought it was a good way to
  20     try to introduce the concept of risks and try to give an
  21     idea to the parents, because this is what it is about:
  22     that the parents should be informed that there is
  23     a risk, the risk of death, the risk of morbidity, and to
  24     give them an idea of the magnitude of the risk. It is
  25     no science and we were trying to be as accurate as
0035
   1     possible in terms of our own feeling at the time. But
   2     I cannot demonstrate scientifically that the risks
   3     quoted were the correct ones.
   4   MR LANGSTAFF: There must come a point at which anyone
   5     looking at a figure which has been quoted would be able
   6     to say, "Well, that simply is not a proper professional
   7     figure; we have careful surgeons whose figures may well
   8     be right; we may have cavalier surgeons whose figures
   9     are simply wrong. How does one judge the rightness and
  10     the wrongness of the figures? What are the factors that
  11     go, broadly speaking, to make up this sort of percentage
  12     estimate?"
  13   MR STARK: This is why I mentioned that for a long time
  14     I tried to avoid percentages, because I thought for
  15     a number of parents they were actually meaningless.
  16     I tried to explain to the parents what were the
  17     alternatives; if we did not operate, what sort of life
  18     the child would lead or whether the child would die, and
  19     also mention that even if the risk was 1 per cent, which
  20     is very low risk, if that one child was their child,
  21     therefore it was 100 per cent. I preferred to leave it
  22     at that because I was aware that any percentage I give
  23     them could be challenged. We did not have a better way
  24     to do it.
  25   PROFESSOR de LEVAL: I think we should also look at this in
0036
   1     the context of what the mortality was 25 years ago for
   2     open-heart surgery in children. 25 years ago, I think
   3     the overall mortality for infant cardiac surgery was
   4     poor, 25 per cent? Now we are --
   5   MR STARK: I am sorry, I have these figures because I looked
   6     it up in one of the early articles. In 1965 to 1970,
   7     mortality for infants under 1 year done on bypass was
   8     70 per cent.
   9   PROFESSOR de LEVAL: Now we are at a mortality of probably
  10     5 per cent overall, I suppose, so the concept of death
  11     following surgery, in those days, was different from
  12     what it is now. That has to be taken into consideration
  13     in this discussion, because we are discussing events,
  14     procedures and practices of 20 years ago, with our
  15     today's mentality, which is a bit difficult, I think.
  16   MR LANGSTAFF: Can I ask you to think perhaps over the
  17     break -- because we have come, sir, I think to a time
  18     when we perhaps ought to have a coffee break, but if
  19     I can return after the break to the question of what, if
  20     any, factors that would go to a percentage can be
  21     identified, how one would set about, as it were, telling
  22     the good and proper percentage figure from the
  23     inadequate, wrong, cavalier figure?
  24        That is what I would welcome your views on, as to
  25     whether there is any touchstone or any factors which one
0037
   1     can identify which would go to distinguish the one from
   2     the other.
   3   THE CHAIRMAN: That will start the discussion, but there
   4     will be many other matters which will subsequently be
   5     raised. We will now take a break for 15 minutes and
   6     reconvene, therefore, at 11 o'clock.
   7   (10.45 am)
   8               (A short break)
   9   (11.05 am)
  10   MR LANGSTAFF: Returning to the question I left you puzzling
  11     over at the start of the coffee break, what factors
  12     would one consider in distinguishing a good percentage
  13     judgment from a bad percentage judgment?
  14   MR STARK: It is a professorial question.
  15   PROFESSOR de LEVAL: I suspect that what you would like to
  16     ask is how do I identify a surgeon who is
  17     over-optimistic from a surgeon who is over-pessimistic?
  18     I suspect you want to tell us that some surgeons are
  19     over-confident and when they speak to parents they quote
  20     risks which are lower than they actually are. I suspect
  21     that is what you want to discuss now?
  22   MR LANGSTAFF: Yes.
  23   PROFESSOR de LEVAL: The only way to be sure that the risks
  24     quoted are correct is the scientific way. I do not
  25     think we can do it. I think that it is impossible, with
0038
   1     small numbers, et cetera, to give you a risk for
   2     conditions which you see once, twice, three or four
   3     times a year. I think it is very difficult.
   4   MR LANGSTAFF: What you were telling me, I think, before the
   5     break was that if you ask the question, how do you tell
   6     a surgeon who quotes risks which are lower or higher
   7     than they actually are, is that that implies a starting
   8     point that you are able, actually, to say what the risk
   9     is. You were telling me you cannot, because --
  10   PROFESSOR de LEVAL: That is right.
  11   MR LANGSTAFF: -- the individual surgeon has individual risk
  12     and may not do a sufficient number of operations to
  13     identify his particular risk. Even if he does, his own
  14     performance in that operation may vary from time to
  15     time -- and this I think we will touch on in your CUSUM
  16     analysis in a moment -- so that it is going to be
  17     variable. Thirdly, there may be particular factors in
  18     relation to recent history which may or may not indicate
  19     a proper assessment of risk. Fourthly, one has to put
  20     that in the context of a generally changing risk
  21     elsewhere, because there are undoubtedly going to be
  22     improvements in surgery, surgical techniques, the
  23     abilities of the team to provide the result, and you are
  24     also looking at not only your own surgical results, but
  25     the results of the team around you who may vary in the
0039
   1     same way.
   2        Those are all the features that one might quickly
   3     identify as being matters which would make it difficult
   4     to quote a particular risk, as Mr Stark has indicated,
   5     but it still leaves the question: can one, even despite
   6     that, say of a particular estimate, "That is obviously
   7     wrong" because it is too high or too low?
   8   MR STARK: I have been discussing recently this aspect with
   9     the statisticians, with Professor Gallivan from UCL (who
  10     I think is actually on your panel) with regards to the
  11     paper I mentioned when we analysed the results from the
  12     five UK centres.
  13        We find this question very difficult because in
  14     that study we had 11 surgeons and the mortality, say,
  15     for open-heart under 1 year varied widely between,
  16     I think, 2 and 10 per cent, yet with the statistical
  17     analysis, we found that all these results were within 95
  18     performance confidence intervals; therefore they could
  19     be due to chance; therefore it would be probably
  20     inappropriate for the surgeon with the risk -- and again
  21     we are talking about very small numbers -- based on the
  22     results of say 10 per cent mortality, to say that his
  23     mortality is any different from the surgeon who had
  24     2 per cent mortality.
  25        I know that you desperately want the answer, but
0040
   1     I think that I personally find it very difficult to
   2     answer it in any scientific way.
   3   DR SILOVE: I think there are very few operations actually
   4     which a surgeon does sufficiently frequently to be able
   5     to build up adequate statistics. If you are talking
   6     about, say, ventricular septal defect, he might have
   7     done enough VSDs to be able to give you reasonable
   8     statistics, but if you are talking about one of the less
   9     frequently seen conditions, such as truncus arteriosus
  10     or total anomalous pulmonary venous drainage, no surgeon
  11     will have done enough to be able to quote accurate
  12     statistics, and certainly not any confidence limits that
  13     can be relied upon.
  14   MR LANGSTAFF: Can I take an example and ask what you might
  15     think it appropriate to say in a case such as this?
  16     Suppose you have a surgeon who, in terms of repairing
  17     VSDs, AVSDs, Fallot's, has near perfect results, but of
  18     the last three operations for truncus arteriosus which
  19     he has done -- he has just done three -- two have died;
  20     one, let us suppose, dies not even reaching the surgeon
  21     on the table because he dies in the anaesthetic room.
  22        In such a case, a fourth child suffering from
  23     truncus arteriosus comes to him. What risks does he
  24     quote?
  25   MR STARK: I think it would be in my view inappropriate to
0041
   1     quote any figures because he would not be in a position
   2     to quote figures of, say, other surgeons in the UK
   3     because he would not know them; he would know perhaps
   4     figures from literature and, as I mentioned during the
   5     coffee break, results in peer review journals are only
   6     the best results; the editor would not accept anything
   7     else.
   8        I think in the example you mentioned, that surgeon
   9     obviously is an outstanding surgeon if, for the five
  10     conditions he has not lost a patient, and here he lost
  11     two out of three, to tell the parents that in his view
  12     the risk would be 60 per cent would be inappropriate.
  13     But I would not know. I think I would advise such
  14     a surgeon not to quote any figures and just say the
  15     results of the operation, this child's chances of
  16     surviving without operation is nil, and it is a high 
  17     risk procedure, and I think I would leave it at that.
  18        I do not know if you have something else on that,
  19     Marc?
  20   PROFESSOR de LEVAL: No. I think prospectively, the use of
  21     CUSUM is another simple way to try to assess your own
  22     performance, or the institution's performance, is that
  23     you may have an alert, an alarm, indicating that the
  24     performance is deteriorating. But if you do that, I do
  25     not think that to base your analysis purely on mortality
0042
   1     is sufficient. I think that, again, you are talking
   2     about a period of cardiac surgery where mortalities were
   3     high in all centres, and we extrapolate this to
   4     a discussion where the mortality currently is much
   5     lower.
   6        I think that if your performance, for example, in
   7     repairing ventricle septal defects, and look at the
   8     mortality nowadays, it is an exercise which will be
   9     meaningless, to some extent. You have to look at other
  10     indicators of performance which are more subtle, such as
  11     the length of intubations post-operatively, et cetera.
  12     But I think that the difficulty I have here is that you
  13     are asking current questions for past history. It is
  14     very difficult to know if you want us to answer as being
  15     in the past or as being today. I think it is different.
  16   THE CHAIRMAN: Before you go on Mr Langstaff, you said,
  17     Mr de Leval, that you must look at other indications and
  18     you gave one example. Could you spell that out a little
  19     bit more? What other relevant indications?
  20   PROFESSOR de LEVAL: I think that, again, if you look at
  21     analysis of results, what we normally do is to go to
  22     a statistician. You have two extremes: one who is going
  23     to look at 500 variables and parameters, and someone
  24     else who will look at 2.
  25        If you were asking me to have one indicator of
0043
   1     performance of cardiac surgery outside the operating
   2     room, or even including the operating room, I would tell
   3     you the times of intubation post-operatively because
   4     that reflects more or less the haemodynamic conditions
   5     coming out from the operating theatre, the condition of
   6     the body, therefore the way the body was perfused, the
   7     lungs were perfused; the patient is able to breathe,
   8     therefore, neurologically intact. You can remove all
   9     the interlinked catheters in the lungs, the neck, the
  10     arteries; you reduce the risk of infection.
  11        So, as a simple surgeon, I would tell you that
  12     that would be my indicator because it means a lot of
  13     things. But I am sure statisticians would be totally
  14     disappointed with that and disagree and say "You have
  15     much much more to know", but this is what I would say.
  16   DR SILOVE: Could I come in on the question you posed about
  17     the surgeon with very good results in one regard but who
  18     has lost some patients with truncus?
  19        Another approach that that surgeon could use in
  20     discussing it with the parents, I think, is he could
  21     say, "Well, the actual technical approach to correcting
  22     truncus arteriosus has many similarities and uses many
  23     of the same strategies and techniques that we use for
  24     other conditions which we see more commonly". I mean
  25     the Rastelli operation, for example, is done in a number
0044
   1     of situations. "The difference with your child, because
   2     he has truncus arteriosus, is that he is very, very ill
   3     at this moment and there are other complicating
   4     factors." I just wonder whether that approach could not
   5     be used. I do not know what the surgeons feel about
   6     that.
   7   MR STARK: I think it certainly could be used, but it still
   8     does not get us away from your question.
   9   MR LANGSTAFF: The question is complicated by what Professor
  10     de Leval said about looking at it through present day
  11     eyes. If one steps back ten years, how would it have
  12     been approached then? Would people then have seen the
  13     shortcomings of the percentage approach, or not?
  14   PROFESSOR de LEVAL: If you go back another 10/20 years,
  15     where 25 per cent of the patients were dying, it was
  16     very difficult in those days first of all to understand
  17     exactly what the mortality was. The distinction between
  18     human performance and medical problems was very
  19     difficult; it still is now. Now we reach a point where
  20     the technicality of the operation, the medical aspect of
  21     it, is resolved for many conditions, and this emphasises
  22     the importance of performance and human factors, which
  23     is what we like to discuss here. But we should realise
  24     that in those days the medical component of the outcome
  25     was much greater than now and we are quoting risks
0045
   1     giving outcomes having not dissociated the two
   2     components which lead to a good or bad outcome. Again,
   3     there was lack of science, lack of knowledge, lack of
   4     understanding, but this is the way it was. I think it
   5     is difficult to be more scientific.
   6   MR LANGSTAFF: If you take a 10-year snapshot, how was it
   7     then?
   8   PROFESSOR de LEVAL: This is, as usual, a progression.
   9     I think that the results were better and therefore there
  10     was more room to assess performance, and then we
  11     probably started to see differences between individuals
  12     or institutions where human factors play proportionately
  13     a more important role in the outcomes.
  14   MR LANGSTAFF (to Mr Stark): So I get it on the transcript,
  15     you were nodding at that?
  16   MR STARK: Yes, I agree with that.
  17   MR LANGSTAFF: Can I come back to where we began this
  18     discussion? We will come back to human factors in
  19     a moment or two. We still have on the screen a simple
  20     diagram showing the coronary artery transfer which is
  21     necessary for the arterial switch to take effect.
  22        You were saying that the biggest variable in
  23     making an operation successful or not was the coronary
  24     arteries.
  25   PROFESSOR de LEVAL: It is not exactly what I said, or meant
0046
   1     to say.
   2   MR LANGSTAFF: It is my inadequate reflection of it, I am
   3     quite sure.
   4   PROFESSOR de LEVAL: I think that in a statistical analysis,
   5     the most important risk factor of success or failure is
   6     the pattern of the coronary arteries. In other words,
   7     we had identified a number of distributions of coronary
   8     arteries which were carrying a much higher risk than
   9     others. This is what I said.
  10   MR LANGSTAFF: Can you tell us a bit more about that?
  11     I think this may relate to recent work which you have
  12     completed and is about to be published?
  13   PROFESSOR de LEVAL: I think the work we have recently done
  14     confirmed that the distribution of the coronary arteries
  15     was a key issue in terms of risks of a switch operation,
  16     but that was known. We confirmed that. We confirmed
  17     that the type of coronary arteries which carries the
  18     higher risk is the so-called intramural coronary artery,
  19     where one of the arteries is actually inside the wall of
  20     the aorta before it comes out of it to be distributed
  21     over the surface of the heart. We have confirmed that.
  22        What this paper said is that -- does it explain
  23     all? We try to say that it does not; we try to say that
  24     human factors play a major role in the outcome of those
  25     patients; and more importantly, in those with the higher
0047
   1     risk, I think.
   2   MR LANGSTAFF: We can have a look at your paper; it has been
   3     scanned in if you want to look at any table or any part
   4     of it. Looking at it first of all generally and then
   5     focusing in, what human factors do you identify as being
   6     of importance?
   7   PROFESSOR de LEVAL: The word "human factors" has been
   8     brought from the high-technology industry, aviation,
   9     nuclear power plants, where human factors include
  10     institutional factors, organisational factors; it is not
  11     only just what the human performance is.
  12        What the study has confirmed is that even if you
  13     allow for the risk for coronary arteries, for example,
  14     success or failure can be related to the presence of
  15     human factors.
  16   MR LANGSTAFF: Those human factors, as you have indicated,
  17     are not simply a question of focusing on the surgeon's
  18     hands.
  19   PROFESSOR de LEVAL: Absolutely not, no.
  20   MR LANGSTAFF: But they are looking at, if you like, the
  21     team aspects, the organisation, finance, equipment,
  22     those sort of things, are they?
  23   PROFESSOR de LEVAL: That is right, yes.
  24   MR LANGSTAFF: In your study (which is about to be
  25     published) you looked at a series, I think, of 230
0048
   1     arterial switches, but for statistical reasons, I think
   2     you considered 165 of those?
   3   PROFESSOR de LEVAL: First of all, I would like to confirm
   4     that this paper is not published yet. I spoke to the
   5     editorial office last night and they have allowed me to
   6     discuss it today.
   7        The intention was to look at all the arterial
   8     switches done in the UK for an 18 months period. All
   9     the cardiac surgeons doing the switch came to Great
  10     Ormond Street for one day with cardiologists,
  11     anaesthetists, and they all agreed to take part in the
  12     study.
  13        I had a grant from the British Heart Foundation
  14     for the salary of two human factor researchers. The
  15     most senior one is a person who has a PhD in a nuclear
  16     power plant. We started the work by looking at a death
  17     after a switch as being, let us say, a crash in
  18     aviation. So we used the same type of technology that
  19     had been used in the so-called organisational accident
  20     to look at this.
  21        We had three sets of data. We looked at the
  22     classical procedural and patient variability data,
  23     so we did a conventional analysis of the coronary
  24     distribution, the age of the patient, et cetera.
  25     This is listed in Appendix A -- can we show that? It is
0049
   1     page 22.
   2   MR LANGSTAFF: If we can have it on the screen, is INQ 6/58.
   3   PROFESSOR de LEVAL: So this would be what a detailed
   4     scientific paper on the switch would include in terms of
   5     procedures, patient specific, and the post-operative
   6     variables. This was filled in by the surgeons at the
   7     end of each operation.
   8        Then we used a questionnaire, again that was based
   9     on --
  10   MR LANGSTAFF: Let me stop you for a moment and let us
  11     scroll down the screen so we have those.
  12   PROFESSOR de LEVAL: In the patients you have the coronary
  13     arterial pattern which, as has been indicated, is the
  14     most important factor related to patients.
  15        The procedures: we have all the technology, the
  16     procedural aspect, the technical aspect of the
  17     operation, the way the heart was protected with
  18     cardioplegia, the type of cardioplegia, the technique
  19     used to implant the coronary arteries, the presence or
  20     absence of an additional ventricular septal defect, the
  21     drugs used after the operation, whether the patients
  22     required assistance or not, and then the post-operative
  23     variables: the bleeding, major renal failure,
  24     neurological complications and time of discharge from
  25     the intensive care unit. Then you can see I have also
0050
   1     the time of extubation, which I am so keen to include.
   2        Then we had a questionnaire, which is again
   3     a methodology used by human factor experts --
   4   MR LANGSTAFF: Page 59(INQ 06/59), please.
   5   PROFESSOR de LEVAL: We were guided in this by Professor Jim
   6     Reason, Professor of Psychology in Manchester, who, as
   7     you probably know, has written a book on human error.
   8     He is the father of the theory of organisational
   9     accident. He had designed a questionnaire; we call it
  10     the STAR Questionnaire, where we had investigated
  11     organisational factors.
  12        Can you put up page 23 now?
  13   MR LANGSTAFF: It is on the screen.
  14   PROFESSOR de LEVAL: Thank you. We looked at
  15     organisational, situational, team and personnel factors,
  16     what I call human factors (not only the individuals) and
  17     you can see that organisational factor, the personnel
  18     availability, equipment, bed space in the ITU,
  19     scheduling of the operation, situational factors: free
  20     to concentrate, distractions and interruptions during
  21     the operation, physical conditions in the theatres,
  22     atmosphere, equipment design or reliability, monitoring
  23     of displays or equipment, team factors, pre-operative
  24     briefing of the team, confidence in the team members,
  25     team's ability.
0051
   1        On the confidence of team members, it is
   2     important, for example when you have a new first
   3     assistant, a new scrub nurse or an anaesthetist you are
   4     not familiar at working with, personnel factors related
   5     to those who fill the forms. Those forms are filled in
   6     after the operation by all the members of the team, so
   7     the surgeon, the two assistants, if there were two, the
   8     scrub nurse, the perfusionists, the anaesthetists. So
   9     we were actually very hopeful that this type of
  10     questionnaire would give us a large amount of useful
  11     information for our analysis.
  12   MR LANGSTAFF: The research you did was, I think, unusual in
  13     that it actually had a researcher in the operating
  14     theatre for virtually all the operations.
  15   PROFESSOR de LEVAL: I am coming to that, yes. The third
  16     component of the material we had --
  17   MR LANGSTAFF: The next page, please.
  18   PROFESSOR de LEVAL: -- was page 24. The human factor
  19     researcher was observing the operation and those human
  20     factor researchers depict themselves as a fly who is on
  21     the wall. The fly can see everything and nobody can see
  22     the fly. It is not really true. The switch operation
  23     in the UK was better in those 18 months because she was
  24     on site; but no way they should not be seen.
  25        So they wrote a detailed report of the operation
0052
   1     as the operation took place, having some information of
   2     what happened pre-operatively and following the patient
   3     until the handover in the intensive care unit.
   4        When we analysed the data we had collected,
   5     obviously we did the usual statistical analysis --
   6     I must say, I am not a statistician so I am not able to
   7     tell you the details of this analysis, they have been
   8     done by two professional statisticians.
   9   MR LANGSTAFF: Can I ask you to pause there, because we
  10     ought to let those who are looking at this see the full
  11     list of major events.
  12   PROFESSOR de LEVAL: We will come back to this, if you do
  13     not mind.
  14   MR LANGSTAFF: Certainly.
  15   PROFESSOR de LEVAL: The procedural factors, again, the
  16     coronary arteries came up as the most important risk
  17     factor, and this is on Table I, I think.
  18   MR LANGSTAFF: Table I is INQ 6/63.
  19   PROFESSOR de LEVAL: What they did was to look at the odds
  20     ratios, which means that you compare two types of
  21     coronary arteries and you can see here that if you
  22     compare -- I am sorry, Table I shows you the mortality
  23     related to the pattern of the coronary arteries, so
  24     before I go further, I should say that we divided the
  25     outcomes into four categories: outcome 1 is survival
0053
   1     with extubation within 72 hours; outcome 2 is survival
   2     with no sequelae, but intubation for more than 72 hours
   3     and minor reversible problems. Outcome 3, which is near
   4     miss, is the need for mechanical support after the
   5     operation, such as ECMO or major complications such as
   6     neurological problems, deep-seated infections,
   7     et cetera. Type 4 is death.
   8        The mortality was 6.5 per cent and the incidence
   9     of what I have called "near misses" was about 18.5 per
  10     cent. If you put the near misses and deaths together,
  11     you have a failure rate, if I consider type 3 a failure,
  12     of 25 per cent. So we did this in order to have more
  13     negative events, to be able to analyse them. All the
  14     analyses have been done for deaths or near misses as
  15     a negative event.
  16        You can see here that the pattern of the coronary
  17     arteries, number 6, Table I, which is an internal
  18     coronary artery, had a mortality of 25 per cent and
  19     a risk of death and/or near miss of 69 per cent.
  20   MR LANGSTAFF: There would only be one in the series of 16
  21     which was either a category 1 or category 2? One actual
  22     case? No, I am sorry, I am wrong on that; there would
  23     be 5.
  24   PROFESSOR de LEVAL: No, there were 16.
  25   MR LANGSTAFF: You are absolutely right.
0054
   1   PROFESSOR de LEVAL: If you take Table II now --
   2   MR LANGSTAFF: That is page 64(INQ 6/64).
   3   PROFESSOR de LEVAL: -- here we have the odds ratios. If
   4     you take, for example, the pattern of coronary arteries
   5     4, 5 or 6 compared to 1, which is here, you have a risk
   6     of death which is 7.5 higher for 4, 5 and 6 than it is
   7     for 1.
   8   THE CHAIRMAN: It may help to have a blank screen again and
   9     do that line again -- it is not a comment on you.
  10     Dr Silove found that the pen --
  11   PROFESSOR de LEVAL: I hope my surgery is better than this!
  12   THE CHAIRMAN: I think we all do!
  13   PROFESSOR de LEVAL: The next one, please, the following
  14     one.
  15   MR LANGSTAFF: The fourth line down. Can we highlight
  16     that?
  17   PROFESSOR de LEVAL: The odds ratio is 7.5, and I think that
  18     if you look at the risk, if you could take the next
  19     table, Table III now, the next page(INQ 06/65), it is the same type
  20     of table which shows you the odds ratios for deaths or
  21     deaths and near miss. Similarly, you can see that 4, 5
  22     and 6, which is here, versus the type 1, have an odds
  23     ratio of negative event of 5.1.
  24   MR LANGSTAFF: Can we highlight the fourth line, please?
  25   PROFESSOR de LEVAL: Maybe I could come back later to the
0055
   1     timings, because it is a difficult issue.
   2        What we did then is to add on to this the human
   3     factors, to take into consideration the risk and see if
   4     the human factors would influence the risk negatively or
   5     positively.
   6        Again, we were hoping that the STAR Questionnaire
   7     would give us a great deal of information.
   8     Unfortunately, we essentially did not find any of those
   9     factors as influencing, in a strong statistical way, the
  10     outcomes.
  11        I do not think there is much point in discussing
  12     the reason for that. I think that one of the
  13     deficiencies was that those questionnaires were filled
  14     in after the event. I think that with hindsight, be it
  15     biassed, if you ask a surgeon how he felt before, if
  16     everything went fine he felt great; if things did not go
  17     very well, he said he felt terrible. So I think that it
  18     is not very good to do it that way.
  19        Also, you could say that we did not target the
  20     proper factors, so those questionnaires may have to be
  21     revised. If I had to revise them, I certainly would ask
  22     a number of questions to each member of the team before
  23     the operation rather than afterwards.
  24        But what becomes much more useful is to go through
  25     this very detailed report from the human factor
0056
   1     researchers. We have only 165 reports because, for 40
   2     cases, there were switches taking place in two or three
   3     units at the same time in the UK. Also, we dropped
   4     5 switches from each researcher as being a learning
   5     curve. And one of the youngest of the three researchers
   6     was a student who had seen 10 switches and when we read
   7     his observations, we really felt that they were not as
   8     professional as the other ones. So we have only 165
   9     reports.
  10        When we looked at those reports, we extracted what
  11     we have called a number of minor and major negative
  12     events. Those events were listed. We also looked at
  13     whether they were compensated or not. The compensation
  14     is a mechanism or actions which either rectify the
  15     problem or allow people to cope with it but to prevent
  16     the effects of a major event.
  17        Those events were found to be closely related with
  18     outcomes. Before I go to the outcomes, maybe I could
  19     now go to the list of those events --
  20   MR LANGSTAFF: Page 60(INQ 06/60), Appendix C.
  21   PROFESSOR de LEVAL: I think it is probably important to go
  22     into some details here. We looked at a number of
  23     pre-operative events. The pre-operative events started
  24     at the time of induction of anaesthesia -- no, even if
  25     there had been a problem before that, they would be
0057
   1     included, like a cardiac perforation doing balloon
   2     atrial septostomy, or a serious error prior to the
   3     induction of anaesthesia. An error in the diagnosis of
   4     coronary arteries would not be a major event because it
   5     is a minor event, but a cardiac arrest or major sepsis
   6     would be a major event before surgery.
   7        Anaesthesia, failure to gain sufficient vascular
   8     access: one of the key parts of a switch operation is
   9     the induction of anaesthesia. Those patients can be
  10     very unstable. The circulation of a transposition is
  11     very critical because in transposition -- could I have
  12     the diagram of the transposition again?
  13   MR LANGSTAFF: Certainly. It is ES 1/11 -- I think it is
  14     11; it may be 12.
  15   PROFESSOR de LEVAL: In the transposition, the blood from
  16     the cavae, the blue blood, goes to the right ventricle
  17     and then the aorta, and comes back to the right
  18     ventricle. The pink blood from the pulmonary veins goes
  19     to the left ventricle, to the pulmonary artery.
  20        The two circulations are in parallel so the blue
  21     blood goes around the body; the pink blood goes round
  22     the pulmonary circulations. This is incompatible with
  23     life, so those patients should die immediately as soon
  24     as they are born, unless there is, some way in the
  25     circulation, a communication between the blue blood and
0058
   1     the red blood. This takes place usually here at the
   2     atrial level. The cardiologist, before the operation,
   3     usually does what we call an atrial balloon septostomy,
   4     so they make that hole bigger. But yet, the only part
   5     of the blood which circulates in the body which is
   6     efficient in those patients is the amount of blood which
   7     goes through that hole. They live on that amount of
   8     blood which goes in both directions at atrial level,
   9     so they have a very critical situation.
  10        Before the operation they come to the anaesthetic
  11     room. They become cold. If you are cold you have
  12     a vasal constriction so the resistance in your systemic
  13     circulation increases. That can change the way the
  14     blood mixes at atrial level.
  15        More importantly, we need some monitoring lines,
  16     we need an artery, at least two veins. This can take
  17     quite a long time and you need expert anaesthetists.
  18        So the quality of the patient coming to the
  19     operating theatre depends greatly on the expertise and
  20     the quality of the induction of anaesthesia.
  21        If I can come back now to the major events, which
  22     is page 24 --
  23   MR LANGSTAFF: That is 60(INQ 6/60), yes.
  24   PROFESSOR de LEVAL: Anaesthesia: you have failure to gain
  25     sufficient vascular access. Some of those patients went
0059
   1     to the operating theatre actually with a peripheral line
   2     instead of having proper lines inserted. I quite like
   3     the word my researcher has used here: "pincushioning
   4     during lines insertion leading to serious cardiac
   5     events", which is an attempt to put in needles to try to
   6     get access to the arteries.
   7        "Delayed diagnosis of major deterioration in the
   8     patient's condition": those patients may or may not be
   9     monitored, because traditionally the monitors are in the
  10     operating theatre and the monitoring of those patients
  11     is not as close during the induction of anaesthesia.
  12     Sometimes it is absent. Nowadays we would have
  13     a saturation monitor and a percutaneous oximeter which
  14     will indicate if the patient becomes desaturated, or, as
  15     soon as you have vascular access, you should send blood
  16     to make sure that the pH is correct, et cetera, but if
  17     you spend an hour in the induction of anaesthesia, you
  18     may have a patient whose haemodynamic condition has
  19     deteriorated greatly between the time of leaving the
  20     bed in the ward and the time of being in the theatre.
  21        So a lack of monitoring, delaying diagnosis of
  22     a serious event: you can see that it happened on
  23     8 occasions amongst those 165 patients.
  24        The pre-bypass: there were 27 major events.
  25        Haemodynamic instability of the patient due to
0060
   1     rough surgical manipulations: this is very common if you
   2     have -- we see that at Great Ormond Street usually the
   3     first two weeks of July because it is when the new
   4     residents come. They come from a programme of other
   5     cardiac surgery and they manipulate the tissues in a way
   6     which is not appropriate for small babies.
   7        So the problem here is one of supervision. The
   8     staff surgeon should be present at the beginning of the
   9     operation. Again there was a great variety of this
  10     practice within the UK during the 18 months here.
  11        You can have an error, of course, in the
  12     laceration that the doctors have to use in performing
  13     bypass. A careful surgeon will do it on bypass or if it
  14     is difficult, will not pursue a dissection before having
  15     established a bypass.
  16        Recognising a deterioration in the patient's
  17     condition, low blood pressure, acidosis before the
  18     bypass: again, this is the jargon of the human factor
  19     researcher, which is "the cognitive tunnel vision",
  20     which is very very common, is what we do. You
  21     concentrate on a small problem disregarding what goes on
  22     around yourself. This is a fairly common problem.
  23        Delayed administration of heparin: heparin is the
  24     drug you use before connecting the patient to the
  25     heart/lung machine to make sure the blood does not clot
0061
   1     into the extracorporeal circuit. I think it was never
   2     forgotten, but there was some delay at least in one
   3     case.
   4        During bypass obviously there are a number of
   5     errors. Quite a few were related to the implantation of
   6     the coronary arteries, or technical errors. Obviously
   7     if you make a hole in the aorta it is not a very good
   8     start and it is a major error. But we had perforation
   9     of the aorta when the cardioplegia was given. The
  10     cardioplegia is a solution of potassium which is
  11     arresting the heart before the operation.
  12        Major perfusion problems, such as air in the
  13     arterial circuit would be a major problem.
  14        Anaesthetic problem: failure to cool the
  15     cardioplegia. The cardioplegia should be cold to have
  16     a proper effect.
  17        Failure to flush the cardioplagia.
  18        Post bypass, there were quite a number of events.
  19     Again, it is very often due to a lack of supervision,
  20     that the surgeon would leave the operating theatre
  21     instead of doing the haemostasis himself or herself, or
  22     surgical omissions, lack of a pacing wire, serious
  23     deterioration of a patient when you close the sternum.
  24     Quite frequently the heart is oedematous and has
  25     increased in volume at the end of the procedure. If you
0062
   1     approximate the sternum, the blood pressure goes down.
   2     Quite frequently we leave the sternum open and again,
   3     this is often not seen or not observed properly by
   4     surgeons and more often, when the closure is done by
   5     a junior doctor, he does not have sufficient experience.
   6        So this is a list --
   7   THE CHAIRMAN: Mrs Howard has one question, interrupting you
   8     for a moment.
   9   MRS HOWARD: I am sorry to interrupt your flow. In the
  10     section headed "During Bypass" you refer to the LeCompte
  11     manoeuvre. I have read other details about the LeCompte
  12     manoeuvre. Could you explain a little about why that
  13     clearly is seen as a technical error in terms of
  14     twisting the artery? Why is that particular manoeuvre
  15     seen as a problem?
  16   PROFESSOR de LEVAL: Can I have the drawing of the switch?
  17   MR LANGSTAFF: ES 1/12, please.
  18   PROFESSOR de LEVAL: No, the drawing from my paper on the
  19     cluster, the switch operation.
  20   MR LANGSTAFF: That is INQ 6/3.
  21   PROFESSOR de LEVAL: In transposition, the pulmonary artery
  22     is behind and the aorta is in the front. You transect
  23     the pulmonary artery just above the pulmonary valve.
  24     Then you bring the distal pulmonary arteries forward in
  25     front of the aorta to be anastomosed to the neoaorta
0063
   1     here. That is called the LeCompte manoeuvre, or French
   2     manoeuvre because LeCompte is French. When you do that,
   3     you can obviously twist the pulmonary artery. I think
   4     on one occasion the surgeon managed to rotate it
   5     180 degrees and bring it to the neoaorta. Obviously the
   6     blood has some difficulty to find its way out and that
   7     had to be rectified.
   8   MRS HOWARD: So the issue is how the arteries are
   9     manipulated, not the use of the manoeuvre?
  10   PROFESSOR de LEVAL: That is right. This is an error in
  11     doing the manoeuvre, but the manoeuvre is a good
  12     manoeuvre. Can we go back?
  13   MR LANGSTAFF: Can we go back, please, to 6/60?(INQ6/60)
  14   PROFESSOR de LEVAL: If I take those major errors and see
  15     their impact, again, we have looked at those errors,
  16     taking into consideration the risks of the coronary
  17     arteries. So we try to analyse this taking into
  18     consideration the type of coronary arteries we have.
  19   THE CHAIRMAN: May I ask a question? You stop at the point
  20     of transfer to the intensive care unit. Does the
  21     analysis follow while the patient remains in intensive
  22     care?
  23   PROFESSOR de LEVAL: No. Those reports ended after the
  24     handover. What follows the handover is part of an
  25     on-going study, but I can tell you already now that one
0064
   1     of the most crucial parts of the treatment of those
   2     patients is particularly that handover, when the patient
   3     has to be transferred from one team to another team.
   4        To give you an example, I would do a difficult
   5     switch operation with an anaesthetist with whom I have
   6     been working for 25 years. A switch operation like this
   7     may last 6/7 hours, and both of us, having together 50
   8     years of experience of paediatric surgery, would watch
   9     that heart on an electrocardiogram beat by beat for
  10     5 hours.
  11        The patient is transferred to the intensive care
  12     unit. The patient has lots of lines, electrocardiograms
  13     and so forth. There are four or five nurses trying to
  14     connect the patient to a new monitor, so the patient is
  15     not monitored for that period of time because we have to
  16     reconnect it. Then you may or may not find a system
  17     where your level of expertise will be matched in the
  18     intensive care unit.
  19        This is the big problem of a multiple team dealing
  20     with a patient. Ideally, what you have to do is to make
  21     sure that the knowledge of that particular patient at
  22     the time of leaving one team must be acquired by the
  23     other team to make sure you keep the same level of
  24     expertise. The only way to achieve that is to have
  25     either people who overlap that part of the treatment, or
0065
   1     having the two teams overlapping at one period of
   2     treatment, which is either at the end of the operation
   3     or when you come to the intensive care unit. It is not
   4     uncommon that the person who takes that patient in
   5     charge would be a junior doctor who is in the intensive
   6     care unit for the first week, who hardly knows what
   7     a switch is, and then you have the whole expertise of
   8     two people, 50 years which goes down to nothing. It is
   9     the ups and downs of the expertise which is causing
  10     major problems in the handover. But again, this is
  11     being investigated now and I do not have any hard data
  12     to discuss this here.
  13   THE CHAIRMAN: When do you expect that study to be
  14     completed?
  15   PROFESSOR de LEVAL: It depends on funding.
  16   THE CHAIRMAN: Mrs Howard has a question.
  17   MRS HOWARD: Directly for the point about the ups and downs
  18     of expertise, I note in your lecture that you very
  19     graciously passed on to us that you talked about the
  20     difference between the junior doctor and the very
  21     experienced intensive care nurse. I wonder whether
  22     there is any comment you would want to make about
  23     handover at that point and where perhaps the skilled
  24     nurse could come into it.
  25   PROFESSOR de LEVAL: This is a slightly different issue.
0066
   1     I think that in that lecture I summarised my views on
   2     how high-technology medicine should be practised.
   3     I think the care should be provided by specialists, and
   4     it is a mistake to believe that the specialists are the
   5     doctors, basically.
   6        If you look at the analysis of those major events,
   7     this is Table VII.
   8   MR LANGSTAFF: Page 69(INQ 6/69).
   9   PROFESSOR de LEVAL: This table shows you that the number of
  10     major events per case has a very, very high risk of
  11     deaths or near misses with a p-value of less than 0.001
  12     for both negative outcomes.
  13        Obviously this is not surprising. If you transect
  14     the aorta, the patient will not survive unless you do
  15     something, so it is a bit of common sense. I do not
  16     want to say that it is a highly scientific discovery
  17     here. Obviously if you have a major problem, it can
  18     lead to a bad outcome.
  19        What is more important is number 2, which tries to
  20     look at the effect of compensation. If you have
  21     a compensation, you can reduce very significantly your
  22     risk of death or near misses. A compensated major event
  23     will not lead to death if it is compensated.
  24        This is, I think, an important message of this
  25     study which goes along very well with what is done now
0067
   1     in high-technology areas such as the aviation industry.
   2     People realise that errors are unavoidable and there are
   3     always failures. Rather than concentrating on
   4     abolishing errors and failures, what the human factor
   5     experts do today is to educate people to compensate.
   6         The way I see what I do today, or the switch
   7     operation, we should look at this as an eventful
   8     procedure. It would be impossible to remove the fact
   9     that it is eventful. What you have to train people to
  10     do is to compensate for those negative events. It will
  11     be impossible to avoid a major problem, but you have to
  12     tell people to compensate to make sure that you can
  13     reach a good outcome.
  14        The study shows that a good compensation will
  15     provide a good outcome, even with difficult coronary
  16     arteries.
  17        We had a patient who had an intramural coronary
  18     artery. The coronary was implanted 7 times, so you have
  19     the resilience of a surgeon who never gives up, who
  20     carries on, who is meticulous from the first minute to
  21     the last minute, even after 10 hours, and this can still
  22     lead to a good outcome. So that was an important
  23     message of this today.
  24        The minor events: if you now go back to the
  25     Appendix --
0068
   1   MR LANGSTAFF: It is page 61(INQ 6/61).
   2   PROFESSOR de LEVAL: Again, I think it is interesting, but
   3     I do not think we should give it too much value. It is
   4     the first time we do this study; it is the first time we
   5     do an analysis like this. I am sure next time we
   6     probably would do it more prospectively, but I think
   7     that the results of this analysis gives some indication
   8     of what human factors can play in terms of the role they
   9     can play in terms of outcomes.
  10        If you look at the pre-operative events,
  11     a co-ordination problem with the bloodbank, problems
  12     with the availability of a bed ITU -- I hate to say it,
  13     but you would not believe the number of times -- it
  14     happens at Great Ormond Street -- that a patient is fed
  15     one hour before going to the operating room. It is just
  16     unbelievable; it happens all the time. I do not know
  17     how to prevent that. We put big signs in red, in blue,
  18     in green, but despite that it happens all the time.
  19     I do not know what to do.
  20        Problems with the scheduling of operations of
  21     course happens also very frequently. You can try to
  22     have any protocol, the patient will be booked in the
  23     wrong theatre at the wrong time.
  24        These are all small things but which at the end of
  25     the day count for the result.
0069
   1        Anaesthesia, cognitive tunnel vision on lines of
   2     insertion, to neglect monitoring of the patient on the
   3     electrocardiogram.
   4        Inappropriate delegation of tasks is one of the
   5     features we have noticed on many occasions as well.
   6        Equipment problems: the alarm systems are
   7     a nightmare as they do not alarm when they should.
   8     That happens all the time. Incorrect ECG readings,
   9     human resource problems, no general anaesthetic
  10     assistant is available, no technical assistance.
  11     Pre-bypass and bypass, positioning and tension errors by
  12     the surgical assistants. Very often the surgeons try to
  13     have an assistant who is familiar with the operation,
  14     but it is sometimes impossible in some institutions,
  15     doing for example adult and paediatric cardiac surgery,
  16     you have junior doctors who rotate between different
  17     services and you may end up one morning by having
  18     a junior surgeon to help you do your switch operation,
  19     which is important. It is a minor event, but as you
  20     will see, it probably counts at the end of the day.
  21        Inappropriate task delegation at every level,
  22     surgical, anaesthetic, perfusion, an inexperienced
  23     assistant, problems with equipment, communication
  24     errors, for example, the indication that the heparin has
  25     been given or that some drugs are started by the
0070
   1     anaesthetist without having checked with the surgeon
   2     that they were happy to go ahead with the introduction
   3     of a new drug.
   4        Absence of a senior team member in the theatre:
   5     this is also very interesting. If you look at the
   6     seniority level in the theatre and the atmosphere in the
   7     theatre, you can see that you have a high level. If the
   8     surgeon leaves the theatre, a number of things can
   9     happen. Usually it continues to be all right, but
  10     someone turns the music on, for example, or the senior
  11     anaesthetist will also leave to have a break. You end
  12     up, again, by a very high level of experience and
  13     expertise down to a very low one in a very short period
  14     of time, which can also be important.
  15        Perfusion problems, airlocks, poor visibility
  16     because of unsatisfactory blood aspiration.
  17        Post-bypass, the same error of positioning,
  18     tension and instrument handling errors, communications,
  19     anaesthetic problems, communication problems during the
  20     handover in the ITU. I have already mentioned that
  21     before. Lack of seniority during transfer in the team
  22     admitting the patient to the ITU.
  23        This is very, very important. I think that this
  24     part of the operation has to be supervised by the
  25     presence of the most senior people. It is one of the
0071
   1     most difficult parts of the operation.
   2        Absence of monitoring.
   3        When we look at those minor events, there may be
   4     many more, we missed some or some should not be counted,
   5     but if we assume that those events have some values, if
   6     you put them in a statistical analysis.
   7   MR LANGSTAFF: Back to page INQ 6/69, Table VII.
   8   PROFESSOR de LEVAL: You have here the number of minor
   9     events per case is 3; p-value for both deaths and near
  10     misses of less than 0.001, which to me is the most
  11     important message of this analysis: that those minor
  12     events which actually are often not even noticed by
  13     those who perform the operation, they have a cumulative
  14     effect. You add them on. When in isolation there is no
  15     influence, but at the end of the day they have a major
  16     impact on outcome, having again taken into consideration
  17     the stratification of the patient in terms of risk for
  18     coronary arteries.
  19   MR LANGSTAFF: Can we just highlight them?
  20   PROFESSOR de LEVAL: It is number 3 there (indicating).
  21     I think this is probably the most important message of
  22     this research, besides the importance of compensation.
  23        To try to go a bit further in the understanding of
  24     those minor events, we looked at those having accounted
  25     for the major event and the major compensated event to
0072
   1     see if it is still important. This is Table VII.
   2   MR LANGSTAFF: Page 70(INQ 6/70).
   3   PROFESSOR de LEVAL: I forgot to say, there is no
   4     compensation for those events, very little effective
   5     compensation. Precisely because they are not noticed,
   6     there is no attempt to compensate them.
   7        If you have Table VIII, you a number of minor
   8     events are still of significance, the last line of this
   9     table here, for the deaths; certainly for the near
  10     miss. In the near miss, you still have a p-value of
  11     0.001, having taken into consideration both the major
  12     event and the number of uncompensated major events.
  13        My interest now is to try to understand the
  14     dynamics of those events. We understand a lot of this
  15     is common sense, although we think we have demonstrated
  16     that. The last figure which I will show here is, as we
  17     began this research by saying that we could look at the
  18     deaths after the switch as an organisational accident,
  19     I have taken Jim Reason's diagram of an organisational
  20     accident, which is figure 3, I believe.
  21   MR LANGSTAFF: It is 78(INQ 6/78).
  22   PROFESSOR de LEVAL: Jim Reason's theory of accident is the
  23     'Swiss cheese' model, where in theory it says that an
  24     accident is the result of the concatenation between
  25     active and latent failures. The active failures are the
0073
   1     errors or failures made at the sharp end of a system:
   2     the surgeon, the pilot, the nurse, the engineer. Then
   3     you have latent failures.
   4        According to this theory, those casts are the
   5     different mechanisms. The perforations are the failures
   6     or the errors. He said that for an accident to happen,
   7     you need all those errors to be aligned so that an arrow
   8     can penetrate them to produce the accident.
   9        I think this is probably applicable to the minor
  10     events. If you align them, they have a cumulative
  11     effect and they can lead to death. I wanted to show
  12     there you have a high hazard procedure, let us say an
  13     intramural coronary artery. For this we know it is
  14     a high risk procedure, but for this to lead to death you
  15     have the human component. Many of the minor events,
  16     although they take place at the sharp end of the system
  17     and the operation, have their origin much further away
  18     from the operating theatre: there is the teaching
  19     system, you have an institution which is dealing with
  20     other than cardiac surgery, an intensive care unit
  21     dealing with meningitis and switches, et cetera. But
  22     all these minor errors, or many of them, actually have
  23     their origin not on site but further remote from them.
  24     I think this is the essence of this paper.
  25   MR LANGSTAFF: We have come to a time when we would
0074
   1     naturally, sir, have a break. I am conscious that we
   2     still have a number of questions to ask Professor
   3     de Leval, and much that he can tell us not only by
   4     further exploration of his recent paper but by his work
   5     on the CUSUM analysis, looking at the individual surgeon
   6     and his own performance.
   7        But we have the advantage that Mr Stark brought
   8     with him some slides which will be shown by making
   9     arrangements over the luncheon break. For that reason,
  10     we will need something of an hour rather than our more
  11     usual 45 minutes. I shall invite him to present his
  12     slides to us immediately after the lunch break. It may
  13     be that we may then need to dismantle that before we
  14     begin in the format that we have at the moment.
  15   THE CHAIRMAN: What you are saying is that the time needed
  16     to continue with Professor de Leval will probably be too
  17     long from now for us to carry on?
  18   MR LANGSTAFF: I think that is right.
  19   THE CHAIRMAN: I take your advice, and thank you.
  20     Therefore, yes, we will adjourn for an hour because
  21     there is this need to set up some equipment. I express
  22     my thanks to all three of our experts. We will continue
  23     what is a very important dialogue after a break of about
  24     an hour, therefore reconvening at almost 1.15.
  25   (12.15 pm)
0075
   1            (Adjourned until 1.15 pm)
   2   (1.15 pm)
   3   MR LANGSTAFF: I am going to invite Mr Jaroslav Stark to
   4     talk us through the slides which he has brought with
   5     him. May I say he will be happy after each slide to
   6     take any questions that there are -- he will not
   7     necessarily invite them -- but if there are any if the
   8     Panel would wish to ask them in addition to any that
   9     I might ask or either Professor de Leval or Dr Silove
  10     might ask.
  11   MR STARK: I was asked if I can briefly illustrate the
  12     complexity of the work we do. I think the first slide,
  13     as you see here, is exactly how the slide should not
  14     look. It is far too much, but I just am putting it up
  15     to show you the spectrum of various procedures that
  16     we have to do, and I think one has to realise that in
  17     some patients we do several operations at the same time.
  18        In essence, when you look at the work of
  19     paediatric cardiac surgeons (Slide), you can say that we are
  20     closing defects but also creating defects. We are
  21     opening valves, we are repairing or replacing valves,
  22     removing or bypassing obstructions, and you have all the
  23     combinations between them. So, unless the surgeon has
  24     full understanding of the diagnosis and all the
  25     procedures, it is quite clear that at any stage one can
0076
   1     fail.
   2        Now, the procedures that we do vary (Slide) from a very
   3     simple one where you just ligate this structure which is
   4     patent ductus arteriosus connection between aorta and
   5     pulmonary artery, and, as probably Dr Silove explained
   6     yesterday, nowadays that can be done during cardiac
   7     catheterisation by placing a little umbrella or coil, or
   8     what is called a Blalock-Taussig shunt, when there is an
   9     obstruction to flow from the right ventricle to the
  10     pulmonary artery, you bypass that obstruction by either
  11     turning down the artery or interposing a small segment
  12     of prosthetic material.(Slide)
  13        But the majority nowadays, the majority of
  14     operations are done on heart/lung machines (Slide) , on so-called
  15     open heart procedures. Again just to familiarise you
  16     briefly with what it involves, the blood from the
  17     superior and inferior vena cava, that is the blue blood
  18     which normally returns to heart, is syphoned off from
  19     the body, from the heart to the oxygenator, which
  20     provides the exchange of gases, to the pump, to the heat
  21     exchanger, because we may have to cool and then re-warm
  22     the patient, and then it is pumped back to the patient.
  23        Now, the technology of this has improved really
  24     tremendously. This is early 1970s, (Slide) when we were using
  25     this monstrous machine which was used even for small
0077
   1     children and infants. The volume of fluid which we had
   2     to put in was something like 5 litres. Now, if you can
   3     imagine that the volume of a 3 kilo baby is only 240
   4     mls, you could imagine what biochemical and fluid
   5     changes it can cause, so then we come to the further
   6     development, and nowadays you can see a tiny machine
   7     that squeezes under the table next to the surgeon.(Slide)
   8     It is much kinder to the organs of the child but also
   9     it has some dangers because the time that elapses
  10     between the alarm sounding that the level of the blood
  11     is too low, and that means that you can start sucking in
  12     some air and pumping to the patient, may be as short as
  13     five or six seconds. So you realise that that means the
  14     perfusionist has to be on alert all the time.
  15        It also shows you that the operation, what we
  16     already heard so elegantly from Marc, where you have
  17     possibility of errors, it is errors of all members of
  18     the team. You have here usually two anaesthetist
  19     surgeons, two assistants, one or two scrub nurses, two
  20     perfusionists, and that has to be co-ordinated and all
  21     in their individual field have to be very professional.
  22        Then I just thought I would illustrate one
  23     operation to you which probably will show many of these
  24     points. I also brought a video of the AV septal defect
  25     repair, but unfortunately we do not have the facilities
0078
   1     to show that.
   2        This is the repair of truncus arteriosus which is
   3     a condition which usually presents in the first few days
   4     or weeks of life and it consists of, instead of two
   5     arteries, aorta and pulmonary artery coming out of the
   6     heart, there is just one common trunk, and, from that,
   7     the aorta and the pulmonary artery arises.
   8        So here you can see the arterial cannular for
   9     bypass; aorta is cross clamped and the pulmonary artery
  10     has to be detached first (slide). Then the defect in the aorta
  11     has to be closed. The right ventricle is opened and
  12     here you can visualise the hole between the two pumping
  13     chambers, right and left ventricle, and that is closed
  14     with a piece of prosthetic material. (Slide) In the next step,
  15     the hole is closed but then you have to --
  16   MR LANGSTAFF: Can I just stop you there? Is the prosthetic
  17     material Goretex or is it likely to actually be tissue?
  18   MR STARK: That can be more or less anything, depending on
  19     your preference and the time when it was done.
  20     Originally this was a piece of Dacron, then it was
  21     Goretex. Some surgeons would nowadays use bovine
  22     pericardium, so it may be a different material but the
  23     important thing is it has to close the hole. It will
  24     not grow and it will be covered by the heart's own
  25     tissue probably in three to six weeks, so it will just
0079
   1     form the substrate of the closure and on both sides this
   2     will be covered by the heart's own tissue.
   3        Then, the last step of the operation is to bridge
   4     the gap between the pulmonary artery and the right
   5     ventricle. On this slide, this is a piece of Dacron
   6     tube with the porcine valve inside, but nowadays most
   7     probably this will be done with a human valve, either
   8     aortic or pulmonary, which is usually harvested from
   9     cadavers.
  10   MR LANGSTAFF: So this slide would illustrate the procedure
  11     at what period of time?
  12   MR STARK: This is almost at -- you mean period of time --
  13   MR LANGSTAFF: Chronologically.
  14   MR STARK: Chronologically. It would be probably up to
  15     mid-1970s. After the mid-1970s most of us use the
  16     homograft.
  17        Here, you can see (Slide) more or less the completed
  18     operation when the blood from the left ventricle will go
  19     to the aorta and from the right ventricle through this
  20     conduit to the pulmonary arteries. I think it
  21     illustrates one more point, that if you do this
  22     operation on a small infant, as the infant grows,
  23     whatever you put here will not grow, and one or two
  24     replacements of this tube will be required after
  25     10 years, 15 years or so.
0080
   1   THE CHAIRMAN: Mrs Maclean has a question.
   2   MRS MACLEAN: Just a small point. I was interested in the
   3     use of valves harvested from cadavers. Presumably these
   4     must be the proper size. Is the supply of such valves
   5     problematic?
   6   MR STARK: Supply is always a problem but the size of the
   7     valve -- we usually try to put a size bigger than would
   8     be appropriate for the child so that the child will, so
   9     to speak, grow into it, but for some very small babies
  10     we need very small valves and supply of those small
  11     valves is really a major problem.
  12        Here, the operation is completed (Slide). As I say, it is
  13     only one of the operations which we do but I thought
  14     perhaps it would illustrate some of the most technical
  15     difficulties, the problems that the child will grow, so
  16     that we have to keep that in mind, and, although we
  17     cannot in this instance avoid re-operation for
  18     replacement of the conduit, we should at least try to
  19     make the number of replacements as few as possible.
  20   MR LANGSTAFF: Roughly how long would an operation such as
  21     that shown on the screen take today?
  22   MR STARK: I would think that it would not take less than
  23     five and hopefully not more than eight or nine hours.
  24     I have not been operating for two years. Marc, what do
  25     you think?
0081
   1   MR LANGSTAFF: That is today. Looking back let us say
   2     10 years to 1989, would it take longer or the same time
   3     then for this operation?
   4   MR STARK: In general, longer, because we did not have some
   5     of the new developments we have now; for example, to use
   6     special material for suturing that does not cause much
   7     breathing. In the past we were using silk and each
   8     stitch, each stitch hole, tended to bleed. It still
   9     bleeds nowadays, but it is much less because we have
  10     better automatic needles. We have also so-called
  11     biological glue which we can apply to our suture lines
  12     to minimise the bleeding. We have other tools like
  13     magnifying glasses, we have better lights, so in
  14     general, 10, 20 years ago it would take longer.
  15   MR LANGSTAFF: The advances that you are mentioning, they
  16     are general to all cardiac surgery, rather than this
  17     specific operation?
  18   MR STARK: Yes.
  19   MR LANGSTAFF: What other advances or changes have there
  20     been in terms of the equipment or the techniques, other
  21     materials available, that might make surgery today more
  22     successful than it might have been 10 years ago?
  23   MR STARK: I think there are many and I think that one of
  24     the difficulties which we discussed earlier today about
  25     giving advice to parents when seeking consent, about
0082
   1     evaluating results -- that with the small groups you
   2     need a longer period of time to accumulate results or
   3     numbers that would allow you statistical evaluation, yet
   4     if you wait five years the scenario has shifted and what
   5     was the risk in 1990 is probably different now. But
   6     I can run through, if you like, some of the innovations
   7     which I --
   8   MR LANGSTAFF: Yes, please.
   9   MR STARK: Well, this is just to reiterate that when we talk
  10     about -- whether it is treatment or improvements, it
  11     really involves areas of all those people who are
  12     involved in the diagnosis and treatment.(Slide)
  13   MR LANGSTAFF: Could you go back to that slide? The
  14     intensivist is a relatively recent development, is it
  15     not?
  16   MR STARK: It depends on the hospitals. In some hospitals
  17     the intensive care is still done by surgeons, as was
  18     traditionally done in the past, or by surgeons and
  19     cardiologists, or surgeons and anaesthetists, but the
  20     term "intensivist" is probably the term of the past
  21     10 years.
  22   MR LANGSTAFF: Before then, your team -- the peak of the
  23     pyramid which you are showing there would just be
  24     cardiologist, surgeon and anaesthetist, would it?
  25   MR STARK: I did not want to be boastful but in general
0083
   1     post-operative care was generally led by surgeons. In
   2     some places, cardiologists; in best places, by both of
   3     them.
   4   MR LANGSTAFF: Did that not lead to a difficulty in that the
   5     surgeon by definition is going to be operating and, if
   6     he is operating in conditions such as this, he will be
   7     operating for five, eight, ten hours perhaps during
   8     a day and during those hours will not be available in
   9     the intensive care unit to look after his patients of
  10     the day before?
  11   MR STARK: This is exactly why we introduced intensivists at
  12     Great Ormond Street because we felt that, but you have
  13     some sort of trade-off. I think Mr de Leval already
  14     pointed out that, if you spend with the anaesthetists in
  15     the operating room six, eight hours and observe the
  16     heart, you know how the heart reacts to various stimuli,
  17     to various drugs, much better than the intensivist who
  18     meets the child when it is handed over at the end of the
  19     procedure. So I think both systems have some
  20     advantages.
  21        For the long-term difficult intensive care I think
  22     intensivist is the better option, but with the heavy
  23     presence of cardiologist and surgeon, but you have to
  24     accept that, if the surgeon operates every day, there
  25     are long periods when he is not available for intensive
0084
   1     care.
   2   MR LANGSTAFF: Again just concentrating on the intensive
   3     care for a moment, in those units where the surgeon
   4     cannot be available because of his operative
   5     commitments, to what extent would you expect the
   6     cardiologist to be there in the intensive care unit
   7     after operation?
   8   MR STARK: There are various aspects to intensive care.
   9     Some of that is surgical, so for that I would expect
  10     a fairly experienced surgical resident to look after the
  11     aspects that the consultant surgeon cannot do because
  12     he is in theatre, but the cardiologist should be
  13     present, if not all the time -- but be available all the
  14     time. Maybe Dr Silove can comment on that, but if the
  15     child comes back from the operating room, certainly if
  16     you are not entirely happy with some aspects of the
  17     progress, the first thing is that you would ask the
  18     cardiologist to perform the echocardiogram to see
  19     whether our repair was adequate.
  20   MR LANGSTAFF: Dr Silove?
  21   DR SILOVE: I think things are very much as Mr Stark has
  22     outlined, the relationship with the surgeons and the
  23     cardiologist. The cardiologist would not spend hours
  24     and hours in the intensive care unit looking after the
  25     patient. He also has things to do outside the intensive
0085
   1     care unit and it really has been in the past, in those
   2     days, probably the surgical senior registrar who would
   3     take charge and would call people in as necessary.
   4     I also agree with what Mr Stark is saying about the
   5     introduction of the intensivist. It has tended to break
   6     down communications a little, I think, in the way the
   7     patient is managed, and, as he says, it is a trade-off.
   8   THE CHAIRMAN: Professor Jarman has a question.
   9   PROFESSOR JARMAN: Could I just ask Mr de Leval if he would
  10     also agree with Mr Stark that that is the best way to do
  11     it, and would it be with this overlap period which you
  12     suggested might be necessary just before the handover or
  13     just after, which I think you mentioned earlier this
  14     morning?
  15   PROFESSOR de LEVAL: I think I agree with Jaro that you have
  16     to find a system whereby the level of expertise,
  17     knowledge and performance remains the same throughout
  18     the treatment, and I think that there are a number of
  19     ways to achieve that. In the system that Jaro is
  20     alluding to, the intensivist is there waiting for the
  21     patient to come back from the operating theatre, and the
  22     presence of the surgeons makes that link between the
  23     operating theatre and the intensive care; but you can
  24     have another scenario, for example, where the
  25     intensivist comes to the operating theatre and stays
0086
   1     there for the end of the procedure and, at the end of
   2     it, goes back to the intensive care unit and has
   3     acquired that knowledge of that particular patient which
   4     allows him to prevent a dip in the lack of expertise.
   5        So I think that there are a number of systems.
   6     The cardiologists sometimes are available but they have
   7     a number of commitments such as out-patients, et cetera,
   8     which does not allow them to be present when there is
   9     a crisis, so the key is to have on-site experts, whoever
  10     they are, who know the patients, and that expertise
  11     available at all times.
  12   PROFESSOR JARMAN: Thank you.
  13   THE CHAIRMAN: Mrs Maclean has a question.
  14   MRS MACLEAN: I think what Professor de Leval is describing
  15     is his preferred method of operation, as it were, best
  16     practice. Can you tell us how far and how widespread
  17     such a handover practice is now and might have been
  18     ten years ago?
  19   PROFESSOR de LEVAL: I think that it is a difficult question
  20     because -- we were discussing this over lunch. It is
  21     very, very difficult in all honesty to go back ten years
  22     ago without any hindsight bias. I think that it is
  23     very, very difficult to know what was the situation
  24     ten years ago. I believe that even 25 years ago, when
  25     I started at Great Ormond Street, by and large all the
0087
   1     patients had that expertise on site because it was due
   2     to a complete dedication, and probably craziness, of
   3     both of us being there all the time, day and night,
   4     which is no longer acceptable today. But I think that
   5     was a system where you can provide also continuity of
   6     care. Obviously today we could question our fatigue,
   7     our lack of judgment after so many hours, but that is
   8     the way it was at the time.
   9   MR LANGSTAFF: You mention on the screen there, Mr Stark,
  10     a number of other disciplines, the input from which may
  11     not be entirely obvious to the wider public. I just
  12     wonder if you would like to comment on one or two of
  13     them. The microbiologist?
  14   MR STARK: Obviously you have the child, and it has been
  15     alluded to, who does have many in-dwelling catheters,
  16     that is, lines inside the venous or arterial system.
  17     That is rather dangerous for infection, so once you have
  18     suspicion of infection, and that is very difficult in
  19     the post-operative period because in the first two or
  20     three days the child is febrile as a result of injury of
  21     surgery, if you have very good microbiologists they will
  22     advise you what tests, what cultures to take, process
  23     them quickly, and then advise you as far as the best
  24     antibiotics are concerned. Now, the cardiologist or
  25     surgeon can do that himself but, if you have that little
0088
   1     bit of extra, that may play an important role.
   2        The same with physiotherapists. I can tell you
   3     that every year over the past 20 years we usually had
   4     two senior registrars from the United States, and the
   5     first thing that happened was conflict with our
   6     physiotherapists because they said, "You will break this
   7     child's wound", because their physio was very vigorous,
   8     but, as a consequence, the airways were clear and we did
   9     not have to do, for example, bronchoscopies, that is
  10     passing the instrument into the trachea and bronchi to
  11     clear the airway, because the physios would do it.
  12        I think it is the professionalism of that whole
  13     team. Some of them, like cardiologists, surgeons,
  14     anaesthetists, bring a big chunk; the others may be
  15     smaller but nevertheless very important.
  16   MR LANGSTAFF: Would you just comment for our general
  17     information on the role of the nephrologist and then the
  18     role that the neurologists play?
  19   MR STARK: Well, the neurological injury after open heart
  20     surgery is well-known and documented and it happens in a
  21     number of children, sometimes for known, sometimes
  22     unfortunately for unknown reasons, and, the same,
  23     kidneys can be influenced in a deleterious way by our
  24     procedure. Some children develop what you call
  25     oliguria, they do not pass enough urine; some become
0089
   1     anuric, that is, do not pass any urine; and unless
   2     we have an expert help there, for example peritoneal
   3     dialysis, which will deal with the situation of
   4     metabolic disorder until the kidneys recover, we may be
   5     in trouble.
   6        This is, for example, one of the arguments used in
   7     the past against the specialist hospitals, one-organ
   8     hospitals, where you would deal with all aspects of
   9     heart but would not have the paediatric specialist for
  10     nephrology, neurology and others. So it has been
  11     accepted that the best environment for this type of
  12     surgery is within the children's hospital where you have
  13     all these facilities available.
  14   THE CHAIRMAN: Mrs Howard has a question.
  15   MRS HOWARD: For some clarity please, just on that last
  16     statement, for all of these roles would you see the word
  17     "paediatric" in front of them?
  18   MR STARK: Yes.
  19   MR LANGSTAFF: Going back to the neurologist, you were
  20     saying that it has been for a long time an accepted risk
  21     of this sort of surgery; is that because it is an
  22     inevitable consequence, possibly, of having a child on
  23     cardiopulmonary bypass?
  24   MR STARK: I did not say, or did not want to say, it was
  25     accepted. I wanted to say that it was well-known.
0090
   1   MR LANGSTAFF: I was using "accepted" in that sense.
   2   MR STARK: Obviously nobody wants to accept the neurological
   3     damage to the child but, depending which textbook or
   4     which paper you read, the incidence varies between about
   5     7 and 20 per cent in several series. There is a book
   6     published on the subject by Dr Janus from Boston and
   7     it is multifactorial. It is the fact that bypass can
   8     cause some microemboli, either of air or particulate
   9     matter. It is the fact that sometimes you introduce
  10     circulatory arrest. Obviously low temperature would
  11     protect the brain, but under certain circumstances in
  12     some children it protects better than in others. One
  13     can enumerate a number of things but the unfortunate
  14     fact is that some children do develop neurological
  15     consequences.
  16   MR LANGSTAFF: If one is dealing with a neonate where it may
  17     be very difficult to know what the neurological state is
  18     before operation, how does one detect or understand
  19     the degree of deterioration?
  20   MR STARK: Well, it is difficult because some children have
  21     major trauma from birth. They may have haematomas and
  22     they have neurological injury, but if the operation has
  23     to be done, say within 24 hours of birth, you sometimes
  24     cannot really assess the situation as fully as you would
  25     wish if the child was one month old or one year old.
0091
   1   THE CHAIRMAN: May I just interrupt for a moment and take
   2     you back to your response to Mrs Howard? You would
   3     expect to see the word "paediatric" before all of these
   4     professions now, but would that also have been your view
   5     in the period we are considering, mid-1980s to
   6     mid-1990s?
   7   MR STARK: I think it depends what you mean by "expecting".
   8     If you ask if I thought that was ideal, the answer was
   9     yes. On the other hand, the majority of departments
  10     doing congenital heart surgery was a mixed practice, and
  11     indeed the first pioneers of congenital heart surgery,
  12     like -- Mr de Leval mentioned Dr McGoon, Dr Kirklin,
  13     Dr Lilleyhigh -- they did the whole spectrum of
  14     cardiothoracic surgery in adults and children.
  15        I think the way how the speciality developed -- if
  16     you want to cope with the fine points of coronary
  17     transfer in arterial switch you can be helped by doing
  18     coronary artery surgery in adults, but for the majority
  19     of problems I think you are better equipped if you have
  20     good training in all aspects of paediatrics and
  21     paediatric cardiac surgery.
  22   MRS HOWARD: Could I just press you a little on that? Given
  23     you used the word "ideal", would there be any roles as
  24     described there that you would have said were critical
  25     that they were paediatric during the time that Professor
0092
   1     Kennedy has just referred to?
   2   MR STARK: Well, I would say perhaps -- Marc, do you want to
   3     answer this one for a change?
   4        I would think that probably the microbiologist,
   5     haematologist may be not so critical. Anaesthetist: in
   6     my view absolutely critical. Cardiologist: critical.
   7     Pathologist: sometimes, when you read the reports of
   8     postmortem from adult pathologists about children hearts
   9     postmortems, you realise that they do not understand it.
  10        Nurses: I mean, example par excellence, it has to
  11     be a nurse who not only understands the child, the
  12     physiology, the mentality, the parents, so I think most
  13     of those I would say "paediatric" would be appropriate.
  14   MRS HOWARD: Thank you.
  15   MR LANGSTAFF: We have stuck on this one for quite a time
  16     now but before we leave the slide, going back to the
  17     neurologist and the answer you gave me a moment or two
  18     ago about whether you can detect neurological deficit as
  19     a consequence of operation as opposed to a consequence
  20     of birth, or any congenital condition, you mentioned the
  21     case of the child operated on within 24 hours of birth.
  22     Was it and is it usual for some degree of neurological
  23     assessment to be made of the child before operation, or
  24     not?
  25   MR STARK: I think in those critical situations, and maybe
0093
   1     Eric can comment on that, it was basically the
   2     assessment of the paediatrician or the paediatric
   3     cardiologist rather than a specialised neurologist,
   4     unless there was a suspicion. If there was a suspicion
   5     that the child may have been damaged, the neurological
   6     opinion would have been sought, but I do not think
   7     routinely.
   8   DR SILOVE: Yes, I agree. It would not be practical to get
   9     a paediatric neurologist to see every baby and it is
  10     really terribly difficult to assess a neurological
  11     deficit in a new born baby, say 24 hours old, or even
  12     three or four days old, unless it is something quite
  13     gross.
  14        What we very often do, and have done, if one has
  15     a very sick baby in whom one suspects there would be
  16     a predilection for a neurological problem, one might do
  17     a cerebral ultrasound scan in order to see whether there
  18     are any major changes in the brain, but again one would
  19     not get a paediatric neurologist to see the baby unless
  20     one suspected a problem clinically.
  21   MR LANGSTAFF: In the paper whose results were quoted then
  22     by Mr Stark as ranging between 7 per cent and
  23     20 per cent of damage, I think were the figures, what
  24     validity do those figures have if the reality is that it
  25     really is very difficult to know what the starting point
0094
   1     is and how far it is surgery as opposed to some other
   2     factor, or care as opposed to some other factor, that
   3     has caused the deficit?
   4   DR SILOVE: Well, very difficult indeed, in fact
   5     impossible. I wanted to ask Mr Stark, if I may: 7 to
   6     20 per cent sounds awfully high. That presumably
   7     includes temporary neurological changes and not
   8     permanent ones?
   9   MR STARK: I think it is very important, and in that book
  10     it is made abundantly clear, that the percentage varies
  11     very much, whether the assessment is done by a surgeon
  12     or by the paediatric neurologist, because the surgeon
  13     would see only the really gross changes while the
  14     neurologist will assess even the smaller ones.
  15        I cannot remember offhand -- I can provide you
  16     with the reference for that book -- what was the
  17     percentage of relatively small injuries or small
  18     impairments and what were the major ones, but the fact
  19     is that we found it difficult to believe this high
  20     number. My colleague, Martin Elliot, with one of the
  21     neurologists did a study. He found, I think I am
  22     correct in quoting rightly, that in our experience
  23     it was about 7 or 8 per cent, so it is not something
  24     that is irrelevant.
  25   THE CHAIRMAN: Can I ask whether entailed in the word
0095
   1     "damage" is permanence, or could it include damage
   2     which, as Dr Silove was suggesting, might be temporary?
   3   MR STARK: It can be temporary because children fortunately
   4     have, in general, a very good possibility to recover
   5     long-term. Sometimes you have what looks like a major
   6     damage and when you see this child ten years later the
   7     child performs well at school, so I think this is the
   8     whole spectrum.
   9   MR LANGSTAFF: We would be grateful if at some stage
  10     you could give us the reference to the paper, please.
  11        I have taken long enough on this slide. Do you
  12     want to go on to the next one?
  13   MR STARK: That could be quicker. I just thought that
  14     I would enumerate some of the developments or advances
  15     during the last 10, 15 years.(Slide) I think that many have
  16     been done in diagnosis because, first of all, the
  17     cardiologists can now diagnose some defects prenatally,
  18     which leads both to the more efficient and earlier
  19     treatment, and, with some difficult or so-called
  20     inoperable conditions, the parents may opt for
  21     termination. Then, some of the postnatal diagnoses,
  22     which there is now more work done -- one of my
  23     colleagues, Dr Bull, has done quite a lot of work on the
  24     telephone diagnosis -- and the diagnosis postnatal
  25     pre-operative also can be both invasive but
0096
   1     non-invasive.
   2        In the early 1980s we started operating on many
   3     conditions without cardiac catheterisation, only on the
   4     basis of good echo. Then we have the possibility to
   5     diagnose some residual defects, both during the
   6     operation, by either epicardial or transoesophagory
   7     echo, and the same in IDU. So what I am trying to
   8     stress here is that one has to have the modalities, how
   9     to find out what is wrong in the first instance, but
  10     also check to what extent our surgery was able to repair
  11     it and, if it was not perfect, to tell us; then we have
  12     to go back and make it better.
  13   MR LANGSTAFF: How shortly before operation would you expect
  14     the cardiologist to have done and completed an
  15     echocardiogram?
  16   MR STARK: I think it depends very much on the unit, on the
  17     department, what is their modus operandi, because, for
  18     example at Great Ormond Street, the child would be
  19     investigated and the data will be seen, including echo,
  20     by the surgeon and cardiologist, and then, one week
  21     before the operation, this exercise would be repeated.
  22     Then we could decide whether the investigation we have
  23     is adequate or whether, when the child is admitted,
  24     we have to repeat echo. So not necessarily every child
  25     will have echo immediately pre-operatively, providing
0097
   1     both cardiologists and surgeons were happy with the data
   2     that was presented. Eric, do you have any --
   3   DR SILOVE: Yes, that is exactly what our practice is as
   4     well.
   5   MR STARK: Now, this is just to show that it is not only
   6     surgical improvements but that the cardiologists did
   7     improve a few things as well. You can see (Slide) the great
   8     number of defects that nowadays a cardiologist can treat
   9     without surgery during cardiac catheterisation. Here,
  10     we are probably back to what we discussed before lunch:
  11     how do you decide which procedure you perform?
  12        I think to enlarge the stenopulmonary valve is
  13     well accepted, but with the aortic valve, if the split
  14     caused by balloon is not exactly in the commissure,
  15     you can cause incompetence. There is still continuing
  16     dialogue between surgeons and cardiologists: what is the
  17     better technique? What Marc mentioned earlier, that
  18     you have to put yourself to the time, say, ten years
  19     earlier. What is happening now, sometimes the
  20     cardiologists argue, "Our technique is better", but they
  21     compare their current results with the surgical results
  22     achieved 15 years ago. It is not very easy, but on the
  23     whole it has been a tremendous improvement and some of
  24     the operations -- we had to take the child to the
  25     operating room -- can be now done in the catheterisation
0098
   1     laboratory.
   2   THE CHAIRMAN: We have heard evidence about Guy's Hospital
   3     moving quite early towards more cardiological
   4     intervention rather than surgery. Would that be in
   5     keeping with what you are describing over the period, or
   6     would they have been regarded as being at the forefront,
   7     whatever implication that may have?
   8   MR STARK: Well, somebody may regard it as forefront but you
   9     may also use the words that you have used earlier: they
  10     may have been a bit experimental. Certainly some of the
  11     procedures I think myself and my colleagues would
  12     consider safer in surgeons' hands than in the
  13     cardiological way and vice versa, so certainly the way
  14     to be in the forefront is appropriate, with certain
  15     hesitation. Does that answer your question?
  16   THE CHAIRMAN: Absolutely. I gave no value to the word
  17     "forefront". It was merely a descriptive term.
  18   MR STARK: What do you think about this aspect, Eric?
  19   DR SILOVE: Well, I agree with you again. It is amazing
  20     how -- I am beginning to get a little worried about
  21     this. I do not mean to become more surgical, but there
  22     are certain problems, for example the aortic valvotomy,
  23     using a balloon.
  24        I think the cardiologists need to choose their
  25     cases very carefully and they are usually the cases
0099
   1     which would be absolutely ideal and would have
   2     a marvellous surgical result, and usually have a good
   3     cardiological result, but the bad aortic valve, the
   4     valve which the surgeons are going to find very
   5     difficult, the cardiologists will destroy. The
   6     cardiologists should not be doing those very bad valves,
   7     and that is a very big problem. So it does become
   8     a matter of very careful selection and very careful
   9     decision-making, and I think the decision-making should
  10     really involve both the cardiologist and the surgeon and
  11     should not simply be the decision of the cardiologist.
  12   THE CHAIRMAN: You are describing again what Professor
  13     de Leval talked about this morning, as I understood it,
  14     the need for collaborative decision-making between
  15     cardiologists and surgeons. Would that be the case?
  16   DR SILOVE: Yes.
  17   MR STARK: Then we come to surgery and I already mentioned
  18     that the suture materials, magnification, lighting, has
  19     improved. When I showed you the picture of ligation (Slide) of
  20     patent ductus arteriosus, that is one of the simplest
  21     procedures, but, if you do that operation on the
  22     premature baby that is only 600 grams, it presents a lot
  23     of problems for the surgeon, for the anaesthetist, for
  24     the intensivist. The conduits and valves are getting
  25     better. I mentioned the biological glue. I will come
0100
   1     to the new surgical techniques.
   2        With the improving results which reach almost zero
   3     in some conditions, I think it became also important to
   4     think about the cosmetic incisions, although
   5     I personally always felt that good exposure is important
   6     and one should not possibly compromise the result by
   7     putting too much emphasis on that.
   8        Now, in perfusion I have already shown you the
   9     advances in oxygenators. (Slide) Also, the cannulae. If
  10     you are to cannulate the vessels which are only 3 mm or
  11     4 mm then the technology is very important. I mentioned
  12     that from the 5 litres originally we are down to, say,
  13     400 mls or 500 mls to put into the machine.
  14        The cardioplegia, or any form of myocardial
  15     protection, has also improved considerably over the past
  16     10, 15 years.
  17        Twenty years ago, if one had to cross clamp
  18     the aorta for one hour, one was worried. Nowadays some
  19     of the complex operations, like the so-called double
  20     switch operation for corrected transposition, I have
  21     done only three of those but in all three the cross
  22     clamping time was over three hours and they all did
  23     well.
  24        Aprotinin, I will not go into this.
  25     Ultrafiltration: at the end of the operation the patient
0101
   1     usually gains from the heart/lung machine quite a lot of
   2     water, so it is very important that that water can be
   3     somehow removed because otherwise the lungs would not
   4     function well.
   5   THE CHAIRMAN: Mrs Howard.
   6   MRS HOWARD: Sorry, it is clarity again. You talked about
   7     the improvement in the protection of the heart.
   8   MR STARK: Yes.
   9   MRS HOWARD: You said that now, three hours, you would not
  10     be so concerned. Do you have a point in time where it
  11     shifted from your concern for over one hour to a longer
  12     period?
  13   MR STARK: I am sorry, I do not think I said I would not be
  14     concerned. I would be very concerned --
  15   MRS HOWARD: Right.
  16   MR STARK: -- if I have to cross clamp for three hours, but
  17     what I am saying is that we can do it and get good
  18     results. For example, I think a good example is, again,
  19     what Marc de Leval showed you, that one surgeon had to
  20     go back and bypass seven times to re-do the coronaries.
  21     Now, the time is important but what is perhaps slightly
  22     more important is that you get it right at the end.
  23   MR LANGSTAFF: Just pausing for a moment on cross clamp
  24     times, what is the perceived risk from length of time on
  25     cross clamp?
0102
   1   MR STARK: There is not really, to my knowledge, hard data.
   2     We all feel that with increased cross clamp time the
   3     risk increases, but if there is the cut-off point, I do
   4     not know. What do you say, Marc?
   5   PROFESSOR de LEVAL: It is a very difficult question
   6     because, again, you have to look at risk stratification
   7     on this. You may have a long clamping time because
   8     there is a lot to do, or because you are a slow
   9     surgeon. At the end of the day, when you have the data,
  10     it is very difficult to decide what is the cause of it,
  11     so therefore you should compare the same type of, let us
  12     say, corollary anatomies, the same type of anatomy, and
  13     look at clamping times, which we have done. I think
  14     that that analysis did not demonstrate major
  15     differences. The bypass time is important but cross
  16     clamping time was more difficult to analyse and give
  17     an interpretation of the results.
  18   MR LANGSTAFF: I know you are going to go back to timings
  19     later on, you told us that this morning, but just so
  20     that I understand and the Panel is helped perhaps, the
  21     theoretical problem of having a long cross clamp time is
  22     what?
  23   PROFESSOR de LEVAL: Just the cross clamping time, let us
  24     say if you take a normal heart, if you clamp the aorta,
  25     the longer you clamp the more likely you are to have
0103
   1     some damage to the heart, but in addition here we have
   2     a defect to repair, so we have to take the two points
   3     into consideration. If a repair takes longer, maybe it
   4     also indicates that it is not done as well as it could
   5     have been done, so the quality of the repair is also
   6     important. It is difficult to dissociate the effect of
   7     just a time on myocardial damage and the quality of the
   8     repair.
   9   MR LANGSTAFF: But are you saying then nothing more than
  10     what is needed is best quality of repair --
  11   PROFESSOR de LEVAL: In the shortest period of time, yes.
  12     This is my view, but others would argue that nowadays
  13     you can spend as long as you want and that the heart can
  14     recover. It depends on the type of protection and your
  15     own fears of cardiac surgery. Personally, I believe
  16     that nature decided that the heart should be perfused
  17     with blood, and I believe it was right. It took
  18     thousands of years to discover that and I think it is
  19     the best thing to have.
  20   MR STARK: I think the danger, as you asked, is the death of
  21     the cells, and then it depends how well you --
  22   MR LANGSTAFF: That is the death of the heart muscle?
  23   MR STARK: The heart muscle, and then obviously it depends
  24     how well you can protect the heart. For example, the
  25     heart for transplantation that you get and transport, it
0104
   1     sometimes takes a longer time than we would use for
   2     cross clamping the aorta when we do the repairs, and
   3     yet, when well preserved, such hearts function well.
   4        It is give and take between good repair and
   5     reasonable time, but exactly where the cut-off point is
   6     I would find difficult to answer.
   7   PROFESSOR de LEVAL: I would just like to emphasise this.
   8     I think it is a very important point that Jaro is making
   9     because the hearts for transplantation are precisely
  10     normal hearts, so the only insult you do to those hearts
  11     is the clamping. Yet you can go to four, five hours
  12     sometimes.
  13   MR LANGSTAFF: Again, just for clarification, I suggested to
  14     you that it was the heart muscle that might suffer from
  15     the lack of normal perfusion. Does the same apply to
  16     the nerves, the electronic pathways, for instance, other
  17     tissues which are part and parcel of the heart?
  18   MR STARK: Not to my knowledge.
  19   DR SILOVE: I do not know of any such problem, no.
  20   MR STARK: (Slide), (Slide), (Slide) Now, the new surgical techniques,
  21     for example for treatment of patients with a single ventricle or
  22     univentricle heart, we used to have the Fontan operation
  23     and now we do this total cavopulmonary connection which
  24     Marc was very much involved in developing. That can be
  25     coupled together with either fenestrating or creating
0105
   1     adjustable ASD, atrioseptal defect, and I do not want to
   2     trouble you with the details of why we do it but all
   3     these things improve the prognosis of children with a
   4     single ventricle. Arterial switch. The double switch
   5     operation for patients with corrected transposition
   6     I just mentioned a little time ago. Finally,
   7     transplantation, which is almost a discipline on its
   8     own, which during the past 15 years in children has
   9     made tremendous progress.
  10   MR LANGSTAFF: Just sticking with transplantation for
  11     a moment, how many centres in the UK currently undertake
  12     transplantation in children?
  13   PROFESSOR de LEVAL: Three. Newcastle, Harefield and
  14     ourselves.
  15   MR LANGSTAFF: Is there a technical or philosophical reason
  16     why it should be restricted to three rather than be as
  17     widespread as other forms of correction of congenital
  18     heart disease?
  19   PROFESSOR de LEVAL: I think there are two reasons. One is
  20     the use and the optimisation of use of limited
  21     resources; and two is to have the expertise to deal
  22     efficiently with those specialists. The resources --
  23     the limiting factor is of course the pool of donors and
  24     the distribution of donors is organised at a national
  25     level, or even international level, and the distribution
0106
   1     and organisation of those donor organs will be quite
   2     impossible if any centre was entitled to do
   3     transplantation. I think this is one of the main
   4     reasons.
   5        In addition to that, transplantation requires the
   6     presence on site of experts, a multi-disciplinary team
   7     of immunologists, transplantation physicians,
   8     paediatricians. It is much, much more than a cardiac
   9     surgeon and a cardiologist. It is much more than that,
  10     and that is another reason.
  11   MR LANGSTAFF: Does the expertise extend further to the
  12     expertise in the team doing the surgery so that it is
  13     necessary, in order to do transplantation well, to do
  14     transplantation reasonably often?
  15   PROFESSOR de LEVAL: Again, it is a bit like the intensive
  16     care. You can look at transplantation as a modality of
  17     treatment and have an institution doing nothing but
  18     transplantation, and that has the advantage of providing
  19     the science, the basic requirement of -- or clinical
  20     applications, so for injections, et cetera; but I think
  21     the differences between a renal transplant, a liver
  22     transplant, a lung transplant, are such that they are
  23     better treated in specialised units dealing with the
  24     organ they are transplanted for.
  25   MR LANGSTAFF: Finally on this, does any of the logic that
0107
   1     might suggest that a limited number of centres do
   2     transplantation equally apply to a logic that would
   3     suggest, and we have heard underpinned the
   4     supra-regional status of paediatric cardiac surgery for
   5     a while, so far as other forms of cardiac surgery are
   6     concerned?
   7   MR STARK: I would certainly feel that way because I myself
   8     was somewhat associated with the creation of the
   9     supra-regional centres, and I must say that both myself
  10     and a number of my colleagues felt very badly when
  11     it was decided to dismantle the system of supra-regional
  12     centres because I think it was shown that the results
  13     have improved and a number of other European countries
  14     followed our example, so I think the principle you are
  15     talking about in transplantation should equally apply to
  16     the treatment of congenital heart defects, particularly
  17     some of the rare defects.
  18   MR LANGSTAFF: Again pushing on this particular topic,
  19     I think you, Professor de Leval, have recommended, or
  20     written suggesting that a unit doing congenital heart
  21     disease or operations to relieve congenital heart
  22     disease in children should have a minimum number of
  23     surgeons?
  24   PROFESSOR de LEVAL: I have, but this is a totally personal
  25     opinion. I believe that to maintain your skill you need
0108
   1     to do a minimum of operations per year. I also believe
   2     that nowadays a single-handed unit is not acceptable.
   3     Therefore, I think that two people at least should be on
   4     site all the time to share the on-call duties,
   5     et cetera.
   6        If you take into consideration the study leaves,
   7     holidays, et cetera, with two surgeons, for about
   8     a third of the year there will be only one on site, so
   9     for a third of the year it is a single-handed unit.
  10     Therefore, to prevent that, you should have three
  11     surgeons. If you think that each surgeon should do at
  12     least 200 cases per year to maintain his skills, and if
  13     you think it is better for them to do only congenital
  14     cardiac surgery, I would recommend units with 600 cases
  15     per year, but this is my own opinion and it is not based
  16     on any science. It is just what I think.
  17   MR LANGSTAFF: If not on science, at least on experience?
  18   PROFESSOR de LEVAL: And common sense perhaps.
  19   MR STARK: We have not discussed this point actually before,
  20     with Marc, and I would say exactly the same because, in
  21     addition to what he already explained, I think you would
  22     expect a good unit of congenital cardiology and cardiac
  23     surgery to also engage in research; otherwise, that unit
  24     will become stale after a while.
  25        If you have three surgeons, you actually would be
0109
   1     surprised, with teaching and all the things that are now
   2     required from paediatric cardiac surgeons, how often
   3     there will be only one of the three in the operating
   4     room. So I think the minimum, three, and something like
   5     600 cases because 200 cases per year, it is only four
   6     a week, and to gain experience and to maintain
   7     experience it is not a very large number.
   8   MR LANGSTAFF: Being devil's advocate, as it were, for
   9     a moment, that would pre-suppose that there could be
  10     a large number of congenital heart cases in infants or
  11     youngsters, children, dealt with in what would have then
  12     to be a very limited number of centres.
  13   MR STARK: Yes.
  14   MR LANGSTAFF: What about the desirability, for reasons of
  15     parental access, parental involvement, emergency,
  16     convenience, and to some extent local aspirations, of
  17     having a local centre? How does one balance the two?
  18   MR STARK: I think always you have to balance these
  19     factors. It is no question that they have to be taken
  20     into consideration.
  21        Perhaps I can give you two examples. I was
  22     involved at the end of the last year in the
  23     deliberations of the Scottish Office because, as you
  24     know, there are two departments in Scotland doing
  25     congenital heart surgery, Edinburgh and Glasgow, each
0110
   1     doing a relatively small number of patients. They
   2     wanted to merge it into one. I think very rightly so
   3     they asked the opinion of both these units, they asked
   4     the opinions of the administrators and of the parents,
   5     and the parents came with the unanimous recommendation:
   6     "We do not mind where the unit is sited providing it is
   7     an excellent unit".
   8        In Sweden, about four or five years ago, they had
   9     four departments doing congenital heart surgery and
  10     there was some disquiet about the results, so they
  11     looked at the results over the previous three years and
  12     they found that the two departments of the four produced
  13     better results than the other two, so they did not
  14     administratively stop the other two departments but they
  15     just made recommendations that children with congenital
  16     heart defects should be sent to those two centres. It
  17     so happened that the two centres were both on the west
  18     coast and none was left on the east coast, but over the
  19     subsequent few years the results, by concentrating in
  20     the two, improved dramatically. So I think it is
  21     a trade-off. It is obviously much more convenient for
  22     the family to be close by, but I think it cannot
  23     compensate if you can get much lower risk of operating.
  24   MR LANGSTAFF: In Glasgow and Edinburgh there is 40 miles
  25     roughly between the two.
0111
   1   MR STARK: But Gothenburg and Stockholm, it is across the
   2     whole country.
   3   MR LANGSTAFF: What about places like Australia?
   4   MR STARK: There, you are talking about 1,000 miles, not 100
   5     miles, and it is again the same. They have a few
   6     centres in Australia, so transport of some patients
   7     involves transport of a few thousand miles.
   8   MR LANGSTAFF: Is there any evidence that that operates to
   9     the detriment of the patient?
  10   MR STARK: I do not know of any. We have certain examples
  11     from our own practice at Great Ormond Street where
  12     some years ago we operated on quite a few patients from
  13     Norway, from Bergen, because at that time they did not
  14     have the unit, and because they organised the transport
  15     in the appropriate way -- the child was intubated with
  16     the lines, with the cardiologist or paediatrician and
  17     the nurse -- we sometimes got patients in a better
  18     condition from Bergen than we had them from Newcastle or
  19     from Luton. So I think the transport nowadays can be
  20     organised at a very low risk.
  21   THE CHAIRMAN: May I ask you a question. Of course, in
  22     giving your answer to that, you were speaking about now
  23     and drawing upon what we know now. If you had been
  24     advising policy makers 15 years ago, imagining you are
  25     not talking about Scotland but talking about another
0112
   1     situation, and the choice was between putting a place
   2     close to parents, as it were, favouring parental access,
   3     or it being a centre of excellence, how would you have
   4     advised then?
   5   MR STARK: We actually were asked for advice and we have
   6     given the advice when the supra-regional centres were
   7     established. I think it was consensus among the
   8     paediatric cardiologists and cardiac surgeons that there
   9     should be about six centres in England and Wales,
  10     because Scotland was left out of it, and then of course
  11     various local pressures made it nine centres. Then,
  12     when the supra-regional centres were established,
  13     I believe it went up to 11. That is probably not
  14     an ideal situation.
  15   MR LANGSTAFF: Would there be anything that you think could
  16     be done in a situation where there are, let us say, 11
  17     centres funded, supra-regional centres, and another two
  18     centres doing a moderate quantity of operations, 40 or
  19     50 per year -- what could have been done, in your view,
  20     in the early 1990s, to concentrate congenital heart
  21     operations in a handful, a few centres, so that all
  22     might benefit from the greater success rate that would
  23     intuitively bring?
  24   MR STARK: I think exactly what has been done: that the
  25     number of centres received protected funding; that they
0113
   1     did not have to fight within their own hospital; and
   2     that immediately led to the cardiologists sending them
   3     to those centres. I think it has to be accepted as
   4     a gradual process. You cannot just suddenly close the
   5     unit. But also in those days, probably even today, most
   6     of the departments have mixed practice, so if they stop
   7     doing children you do not deprive them of their jobs;
   8     they still can continue doing adults. But it may
   9     involve some very painful decisions. I accept that.
  10   MR LANGSTAFF: Just pushing the analogy a little bit
  11     further, suppose one has a unit in which there is a new
  12     procedure which is done elsewhere with success. Let us
  13     take the arterial switch. Suppose there is a unit which
  14     has never done the arterial switch and it is being done
  15     with success elsewhere. Is there an analogy with what
  16     happens with transplants nowadays -- if a baby needs
  17     a transplant it will go to one of the three centres that
  18     does it, it will not stay in one of the other centres
  19     that does not -- should such a centre in the late 1980s,
  20     early 1990s, have at least considered not doing that
  21     particular operation because other centres were
  22     repositories of excellence and success at it?
  23   MR STARK: When you talk about the 1980s and 1990s, we had
  24     in the 1980s the largest series of Mustard operations
  25     from German patients because many German units were
0114
   1     sending us the patients because our results were good.
   2     So I think that is the answer.
   3   THE CHAIRMAN: I hear that answer. May I ask the question
   4     in a slightly different way from the way in which
   5     Mr Langstaff put it. Would you think there is a choice
   6     to be made between sending the child to the other centre
   7     in that kind of context, or sending the surgeons to the
   8     other centre for a while? Are they both options, or
   9     would the latter not be the right way?
  10   PROFESSOR de LEVAL: Well, I alluded to this problem
  11     slightly this morning. To take the case of the switch
  12     operation, transposition of arteries is one of the
  13     commonest conditions we are treating, so on a purely
  14     theoretical basis I believe that there should be
  15     a number of highly specialised centres in each country
  16     dealing with paediatric cardiac surgery, and all should
  17     be able to offer the whole spectrum of treatments to
  18     those patients, with the exception of a few treatments
  19     which have specific needs such as transplantation, for
  20     example, because of, as I explained before, mainly the
  21     problem of the donors.
  22        Having, let us say, agreed that there should be a
  23     limited number of centres able to deal with the whole
  24     spectrum of treatments, there would be always centres
  25     which would initiate or start new treatments, and the
0115
   1     question is: how is it best for the patients to
   2     communicate the knowledge, the skill, preventing or
   3     avoiding the casualties of learning new treatments?
   4        I believe that those who have gone through the
   5     learning curves should make themselves available to
   6     communicate their knowledge to others. That can be done
   7     in different ways. You can have people from outside
   8     coming to you or you can go outside; I think that is
   9     a detail. But this is the principle of what I would
  10     suggest.
  11        Again, this is my view now. It is very difficult
  12     to tell you now what I would have answered ten years
  13     ago. This is what I think now.
  14   MR LANGSTAFF: Your views really on this have two
  15     components: one is that whatever centre does work should
  16     do the full range of work except for those treatments
  17     which require the specialist facilities such as
  18     transplantation, but that the centre should have
  19     a sufficient throughput and a sufficient number of
  20     paediatric cardiac surgeons to maintain a level of
  21     expertise or practice or familiarity with the operation,
  22     four a week not being enough. That on the one hand and,
  23     on the other hand, you are saying that, when a unit
  24     somewhere develops a new procedure, other units doing
  25     the work should learn from the surgeons doing the
0116
   1     procedure at the unit which does the work so that they
   2     reduce the effects of the learning curve on them? It is
   3     a two-pronged -- two aspects to it?
   4   PROFESSOR de LEVAL: Two aspects in my answer, yes.
   5   MR STARK: I think I would agree about the point that it is
   6     probably better to have a smaller number of units doing
   7     the whole gamut of operations. I think your example to
   8     have a unit doing 40 or 50 operations a year, in my
   9     personal view, is not viable. If you would like to have
  10     a look, I provided you with a paper on the subject by
  11     Hannan. This is the document 9. Sorry, I have the
  12     numbering here.
  13   THE CHAIRMAN: While Mr Langstaff finds that document, you
  14     may like to perhaps dilate a little bit on what you mean
  15     by "not viable"?
  16   MR STARK: Okay, I should rephrase it. I do not think that
  17     it should be done. 40 operations a year means less than
  18     one operation per week and I do not think that in most
  19     specialities, and particularly in -- if you remember the
  20     first slide, when I showed the number of operations
  21     we have to do, I do not think it should be done.
  22   THE CHAIRMAN: There may be more than one person or one
  23     group of persons, but on whom should that responsibility
  24     and recognition that it should not be done rest?
  25   MR STARK: I think it could only rest on people who hold the
0117
   1     purse, that is, the administration, or in other words
   2     the Department of Health, because the profession can
   3     make recommendations, as we have done in 1992 about the
   4     supra-regional centres, but we cannot enforce that. We
   5     cannot tell our colleagues in place A or B, "You should
   6     stop it". That, I think, is something which should be
   7     done by the authorities.
   8   THE CHAIRMAN: My question was clearly too opaque. If
   9     it was a view that 40 or 50 was not enough, and let us
  10     imagine there is a centre that is doing that, on whom,
  11     if anyone, should the responsibility and recognition
  12     rest to realise that that should not continue?
  13   MR STARK: As I said, you would have to look in more
  14     aspects, not only at the numbers, because in the
  15     unlikely event that that centre is doing 40 patients
  16     a year with no mortality then I think that is something
  17     different, but I believe that the recommendations of the
  18     number that should be done, or below which one should
  19     not go, should rest with the professional organisations
  20     like the Society of Cardiothoracic Surgeons, or the
  21     College; but for the implementation I cannot see anybody
  22     else except the Department of Health. What do
  23     you think, Marc?
  24   PROFESSOR de LEVAL: This is a difficult question. One of
  25     the problems is that the medical profession has behaved
0118
   1     as a very independent body and, furthermore, the English
   2     system is such that through the consultant system, which
   3     is a parallel system, each consultant more or less has
   4     his or her own freedom and independence on judgment.
   5     I believe that there has been, in the past, a lack of
   6     co-ordination and organisation within units, partly
   7     because of that independence between surgeons or
   8     cardiologists or physicians, and there has been a lack
   9     of co-operation between the professional body and the
  10     Department of Health.
  11        I think there has been a lack of auditing to find
  12     out what was going on and I think that the recent
  13     reforms of the Health Service, the Trust system, has
  14     been such that, health care having become a commodity
  15     and patients a source of income, there has been
  16     a pressure made on the profession to prevent that
  17     sending away of patients, and so forth, so I think that
  18     the problem we are in, or will be in, is the result of
  19     a professional issue, the Governmental issue, a lack of
  20     communication between the two, and I think the recent
  21     reforms have made things perhaps worse than they were.
  22   DR SILOVE: May I? I think that in the slightly longer term
  23     clinical governance is going to sort all of this out,
  24     but it is going to take a long time. I think that it
  25     really boils down to the original problem of the
0119
   1     Department of Health not having insisted on protected
   2     funding for a small number of supra-regional centres.
   3   MR LANGSTAFF: We were directed by you, Mr Stark, to the
   4     Hannan paper which we have at INQ 7/22.
   5   MR STARK: I only wanted to mention page INQ 7/0027.
   6   MR LANGSTAFF: Before you go there, let me just ask you so
   7     that we can see what we are dealing with. We are
   8     dealing with a paper by Hannan and others.
   9   THE CHAIRMAN: Do you want it to be brought up on the
  10     screen?
  11   MR LANGSTAFF: Yes, please. If one looks down the abstract
  12     to the conclusions of the paper, the conclusions of the
  13     authors were that both hospital volume and surgeon
  14     volume are significantly associated within hospital
  15     mortality, and I suspect that you will tell us that what
  16     that means is that the more the hospital does, and the
  17     more the surgeon does, the better the results are?
  18   MR STARK: Yes, this is what I wanted to bring your
  19     attention to, although even that is not 100 per cent and
  20     one has to look at these results very carefully because
  21     in the United States, where you have many more
  22     departments dealing with the problem than in the UK,
  23     they set the cut-off point, I think, for the departments
  24     at 100 and for surgeons it is 75.
  25   MR LANGSTAFF: That is page 27 that you want to look at.
0120
   1   MR STARK: Page 27.
   2   MR LANGSTAFF: Tables 3 and 4, is it?
   3   MR STARK: Tables 3 and 4. The cut-off point is hospital
   4     volume 100 and surgeons volume 75, where they show
   5     clearly statistical difference. I mentioned earlier
   6     that we are just completing the paper looking at the
   7     results of five UK departments, but the smallest number
   8     in those five UK departments was -- I think 170 was the
   9     smallest and 600 was the largest. In these five
  10     departments we actually did not find statistical
  11     difference, neither between surgeons nor the
  12     departments, so I think it applies probably mainly to
  13     the great differences in numbers as presented in this
  14     paper, but, you know, back to your suggestion that
  15     perhaps 40 or 50 is something viable, I think it
  16     probably is not.
  17   DR SILOVE: I just wonder if I could ask Mr Stark, is it
  18     possible that those centres with the largest volumes of
  19     patients were also centres to which the most difficult
  20     cases were being sent by some of the smaller centres, or
  21     was that not actually looked at?
  22   MR STARK: We do not have evidence for that but they tried
  23     to do some risk stratification and risk stratification
  24     in congenital heart operations basically has not been
  25     done and developed because of the complexities, but when
0121
   1     I looked at it with the statisticians, we questioned
   2     their categories because, just as an example, they put
   3     into the most difficult category -- this is page 25 (INQ 7/025)--
   4     they have put patent ductus arteriosus under 1,500
   5     grams; bending of pulmonary artery or central shunt.
   6     That, to them, is a higher category than switch, which
   7     is in category 3, or Rastelli procedure which is in
   8     category 2. I think any paediatric cardiac surgeon
   9     would tell you that this is really not how it should be
  10     done.
  11        The possible explanation is -- in the State of
  12     New York you have one department that performs about 400
  13     operations a year. Therefore, I would assume that the
  14     difficult operations like switch and Rastelli are done
  15     in that department with slow mortality while the other
  16     operations I mentioned are done by almost anybody, with
  17     high mortality. As these categories were based purely
  18     on mortality in their series, you can get such a skewed
  19     result. So it just illustrates that the risk
  20     stratification is not all that easy.
  21   THE CHAIRMAN: I think perhaps, Mr Langstaff, this is
  22     a proper time to take a --
  23   MR LANGSTAFF: I was wondering about that on my feet, sir,
  24     and perhaps because of the time that we will need to
  25     take down the screen, if we can let Mr Stark complete
0122
   1     his slides, we can then have a break during which the
   2     screen can be dismantled.
   3   THE CHAIRMAN: Of course.
   4   MR STARK: I think it is only probably two or three I can go
   5     through them very quickly. This is just some advances
   6     in the post-operative care. Nowadays, when the patient
   7     is not doing well after open-heart procedure, we can use
   8     assist devices or ECMO. For treatment of pulmonary
   9     hypertensive crises we have nitric oxide, which is a
  10     very powerful agent. We can do now safely long-term
  11     parental nutrition, peritoneal dialysis, and of course
  12     I do not specify all the numerous improvements in
  13     nursing care.
  14        This is just the final slide, that the way how
  15     I see the future trends we probably will get even more
  16     accurate diagnosis even earlier. We have already
  17     discussed quite a bit organisation, which -- not only
  18     regional but probably at the national level. We will
  19     certainly see some more operation and perfusion
  20     techniques improvements, post-operative care, and in
  21     order to analyse it and to come to some conclusion we
  22     obviously need collection and evaluation of good data.
  23     So I think that is about all I wanted to show you.
  24   MR LANGSTAFF: There is just one question which I cannot
  25     resist before we close. You indicated to me just before
0123
   1     we began this afternoon some of the problems that there
   2     are presently in dealing with data, even data about
   3     matters which should be obvious, such as mortality.
   4     Would you like to just expand on that for a moment?
   5     I think you have a particular example in mind.
   6   MR STARK: I do, but I think that it is actually difficult
   7     to comment on various data collections because
   8     I understand you commissioned a group of statisticians
   9     to look into the collection of data by the Department of
  10     Health --
  11   MR LANGSTAFF: Yes.
  12   MR STARK: -- and another group who asked my opinion, and we
  13     discussed that with Mr Murray in Glasgow, about the
  14     cardiac register. The reason why I personally, and
  15     I think most of my colleagues, have great doubts about
  16     some of these data collections is that they were never
  17     validated and they were, like the data from the
  18     Department of Health, never shown to the surgeons. So
  19     when you look at the data and you find that in the
  20     five-year period, or whatever it was, that there were
  21     about 60 or 90 patients who had coronary artery bypass
  22     under the age of 16, well, you do not have to think too
  23     much to know that this is not on.
  24        The same with the national register, which I think
  25     for a number of things, to look at the trends,
0124
   1     et cetera, was very important, but, as far as mortality
   2     is concerned, I believe mortality was very much
   3     underreported because, when you look at other data, for
   4     example, data published in literature, or we have data
   5     collected by Professor Hamilton for the working party of
   6     the College in 1992, and then you find that overall
   7     mortality, for example for open heart over one year, was
   8     about 6.7 per cent in the register, and Great Ormond
   9     Street that year had 9 per cent, Birmingham had
  10     9 per cent and several other units had 20, 30 per cent,
  11     you feel that that data collection was very
  12     questionable.
  13   MR LANGSTAFF: That, I think, concludes your slides.
  14   MR STARK: Yes.
  15   MR LANGSTAFF: Would now be a convenient moment to have
  16     a break?
  17   THE CHAIRMAN: A break of 15 minutes would allow for the
  18     transfer of machinery, and so on?
  19   MR LANGSTAFF: Yes, it would.
  20   THE CHAIRMAN: Thank you. Shall we adjourn then for 15
  21     minutes.
  22   (2.40 pm)
  23             (Short adjournment)
  24   (3.00 pm)
  25   MR LANGSTAFF: May I start the last session of the afternoon
0125
   1     by inviting Dr Silove to comment on aspects of the
   2     presentation we have just had?
   3   DR SILOVE: I would like to say I thought it was an
   4     excellent presentation by Mr Stark, which highlighted
   5     how improvements right across the board have resulted in
   6     so much better results in the management of these babies
   7     in particular.
   8        The one thing I wanted to emphasise, though, was
   9     the pre-operative management of these babies has also
  10     improved a great deal, and I think that this has
  11     contributed towards their improved results: the way the
  12     babies are brought into the tertiary centres these days
  13     usually, if it is properly arranged by our intensive
  14     care unit sending out a team to collect the baby, they
  15     resuscitate the baby at the peripheral hospital and the
  16     baby arrives at our tertiary centre in really good
  17     condition, whereas they used to arrive moribund and
  18     required an enormous amount of resuscitation before we
  19     could get started.
  20        Then the acquiescence of the intensive care unit
  21     in allowing babies to be placed on the intensive care
  22     unit pre-operatively in order to get them into the best
  23     possible physical shape before going through to
  24     surgery. Those are important developments.
  25        There is just one other comment I want to make,
0126
   1     totally unrelated to that. Those diagrams I showed
   2     yesterday were taken from a book, the copyright of which
   3     belongs to Heartline Association, a book called "Heart
   4     Children". They kindly gave us permission to use those
   5     diagrams, and I am very grateful to them for that.
   6   MR LANGSTAFF: I am sorry they did not get the
   7     acknowledgment yesterday, but they have it today,
   8     flagged up by what has just been said.
   9        Professor de Leval, you have comments, I think,
  10     springing out of the presentation?
  11   PROFESSOR de LEVAL: I think it is perhaps more like
  12     a philosophical comment on scientific progress, trying
  13     to understand what has happened in those years in
  14     paediatric cardiac surgery, and I think that progress
  15     has evolved in two different ways, and the most common
  16     way, which is the way we follow and the most traditional
  17     way, was that we had the perception that one of the main
  18     risk factors in what we were doing was young age and low
  19     weight, and therefore, what we had done was to try to
  20     reduce the age and weight of the patients at which the
  21     operation took place.
  22        So more or less, we considered that older age and
  23     bigger patients were better candidates for surgery.
  24        The other school which was introduced by Aldo
  25     Castaneda in the early 1970s in Boston was that he
0127
   1     decided that patients born with heart defects should be
   2     operated at birth or soon after birth, and he built up
   3     a system allowing them to do that successfully.
   4     Consequently, they operated on a large number of very
   5     small babies.
   6        In this country, at I think most institutions, but
   7     at Birmingham, had followed the first traditional
   8     pattern. Birmingham was following a different pattern
   9     following the arrival of Bill Brawn, who was from the
  10     Aldo Castaneda school. In 1994 we had a meeting --
  11   DR HOUSTON: 1991.
  12   PROFESSOR de LEVAL: -- attended by most cardiac surgeons of
  13     this country. We discussed the results of the
  14     atrioventricular septal defects. Jaro has given the
  15     data I think earlier today or yesterday. Our own
  16     mortality from 1984 to 1991 was I believe 23 per cent,
  17     which was the case for most units in the UK, but
  18     Birmingham: Birmingham had a low mortality. We did
  19     a statistical analysis of all results, the only
  20     significant difference was the age at which the patient
  21     was operated.
  22        So we actually made a gross error by considering
  23     that all the patients were lower risk, and I think it is
  24     important in the context of this Inquiry where I believe
  25     for a number of reasons, the system was not good enough
0128
   1     to go to the low weight gain, and consequently, we are
   2     offering treatment to patients which were often higher
   3     risks because of greater age, because they are older.
   4   MR STARK: It is 7/14.
   5   PROFESSOR de LEVAL: I think this applies to other
   6     conditions, such as the truncus arteriosus Mr Stark has
   7     elegantly demonstrated this afternoon. One of the major
   8     problems with those patients were the so-called
   9     pulmonary hypertensive crisis, the pressure of the
  10     pulmonary artery goes up after the operation, and since
  11     we have lowered the age of repairing the truncus to the
  12     first few weeks of life, those crises have disappeared.
  13        So we had a misconception of where the risks were
  14     in those days, but to achieve what Aldo Castaneda was
  15     doing, you needed in place a system which allowed you to
  16     do heart surgery on very small children.
  17        Jaro, you can go through that; it is your data?
  18   MR STARK: It basically shows that our mortality rate for AV
  19     septal defect was quite high, although, when you compare
  20     it to the data from Molesbourg, which shows 10 years
  21     from about 35 units in the United States, it is in
  22     keeping with those results, and then following the
  23     meeting where we discussed it and we analysed and found
  24     that the age was a major risk factor, we changed into
  25     earlier age and you see in the subsequent three years we
0129
   1     had only one death out of 68, 1.5 per cent, from the
   2     previously reported 23 per cent.
   3        So I think that is a very, very important
   4     argument.
   5   MR LANGSTAFF: If you turn over to 7/16 --
   6   MR STARK: 15(INQ 7/15), I think, is better: Table VI, which shows the
   7     mortality between 1984 to 1993 in those centres in North
   8     America. You can see that the deaths there are in the
   9     region of 15, 20 per cent, and presumably they did not
  10     follow what we have done in this country, of changing
  11     suddenly the age down, because there, overall, the last
  12     year of the study, 1993, it still remains 11.6 per cent.
  13   MR LANGSTAFF: If one looks across at deaths in infants, you
  14     are assuming that the infants are operated in late
  15     infancy rather than early infancy?
  16   MR STARK: Yes.
  17   THE CHAIRMAN: May I just ask Professor de Leval to clarify
  18     a little bit what he was saying earlier, namely, as
  19     I understood it, you were saying that the difficulty in
  20     the previous time, 1984 to early 1990s, was that those
  21     who were operating were doing so within a system which
  22     did not allow for operations on younger babies. That is
  23     I think your words.
  24        What did you mean by "operating within a system"?
  25   PROFESSOR de LEVAL: I suppose it is more an assumption than
0130
   1     anything else, although, having followed the traditional
   2     pattern, and it is what Jaro has demonstrated, we were
   3     able to operate on smaller and smaller children by using
   4     equipment which is more and more able to cope with the
   5     difference in volumes. We introduced a number of
   6     experts on site such as physiotherapists et cetera,
   7     allowing us to lower the age group and do with more
   8     confidence surgery on new-born infants.
   9        I talk about the "system" because it is all the
  10     people and the technology that we introduced in the late
  11     1970s and early 1980s which have, I believe, allowed us
  12     to operate on those small children.
  13        Subsequently we realised that those patients were
  14     actually lower risks than the others.
  15   THE CHAIRMAN: So it was a system which did not have the
  16     material and human resources to allow you to operate on
  17     the young ones. Was that because they were not made
  18     available, or not deemed to be appropriate to be
  19     available?
  20   PROFESSOR de LEVAL: I have not investigated the reasons for
  21     that, and I think that the traditional way originated
  22     from centres dealing with adults and children, and
  23     paediatric cardiac surgery became a field of
  24     extrapolating what we do on the big patients to the
  25     smaller patients, and the schools, mainly Kirklin and
0131
   1     McGoon in the early 60s at the Mayo Clinic, or
   2     Lilleyhigh et cetera, and I think the revolution has
   3     been Aldo Castaneda in Boston, who changed the
   4     philosophy completely and decided that by definition
   5     those patients should be operated very soon, and all his
   6     pupils have produced immediately better results than
   7     anybody else.
   8   MR STARK: I would like to add to it just that in the places
   9     where you had the technology and had the paediatric
  10     components to all the professions, once we realised it
  11     was important, we could switch. In the places for
  12     example where you had a split site, where the children
  13     on bypass were operated in an adult hospital, then
  14     I think that was out of the question, because they were
  15     looked after basically after operation by people who
  16     were adult trained and adult orientated.
  17   MR LANGSTAFF: Does what you were saying about the age of
  18     operation, the advantages, the lower risk being the
  19     younger and smaller patient, apply to more than AVSD and
  20     arterial switch?
  21   PROFESSOR de LEVAL: I believe so, but again I would like to
  22     have more scientific data for that. But I believe that
  23     there is a window of opportunity, an ideal age at which
  24     the side effects of open-heart surgery, extracorporeal
  25     perfusion, circulatory arrest, hypothermia, is better
0132
   1     tolerated. The truncus arteriosus is another good
   2     example, because it is following this we started to
   3     lower the age of truncus arteriosus, and nowadays we
   4     would electively operate on those patients during the
   5     first months of life. The same applies for
   6     transposition of ventricular septal defects, you could
   7     wait for those patients for a month or so. We believe
   8     that the post-operative complication management is
   9     actually easier on the smaller ones, the younger
  10     infants. I do not know how far we should go into the
  11     age; I do not think that the premature infants are in
  12     the same category, but my impression is that there is
  13     probably a window, a golden period which might be around
  14     three weeks of age. But the changes which take place
  15     soon after birth are so rapid and complex, I do not have
  16     any science except my clinical feeling about this.
  17   MR LANGSTAFF: Would you agree or not?
  18   MR STARK: Yes, I would completely agree, because if you
  19     take a simple example of ventricular septal defect,
  20     a hole in the heart, if such child can be operated at
  21     the age of one month, why wait until one year when some
  22     patients will develop changes in lungs and other
  23     patients will by that time would have four or five
  24     pneumonias, therefore then the chances of the child then
  25     to survive are much less?
0133
   1   MR LANGSTAFF: It may be said in the case of a VSD that
   2     a number of such defects close or begin to close
   3     naturally?
   4   MR STARK: This is correct, but there are certain defects
   5     that are so large that although you cannot exclude
   6     100 per cent that such defects will not close, I think
   7     on balance to submit this child to the waiting period,
   8     to the infections and everything, on balance it might be
   9     better to close the defect even if, in few of them, it
  10     would close spontaneously.
  11   MR LANGSTAFF: In 1991 the view changed at least so far as
  12     AVSD was concerned at the conference you told us of.
  13        To what extent is there still any disagreement
  14     about there being such a "window of opportunity", as
  15     you have described, in very early life?
  16   PROFESSOR de LEVAL: I think most centres nowadays would
  17     electively operate on an atrial septal defect within the
  18     first few months of age.
  19   DR SILOVE: Yes, certainly before they are three months old,
  20     round about two months would be a good time.
  21   PROFESSOR de LEVAL: The truncus within the first month;
  22     transposition of VSD the first month. That would be the
  23     current policy, I think. It was not ten years ago.
  24   MR STARK: I think if you look at it, though, you will find
  25     that although this is the policy of the departments,
0134
   1     very often, for a number of reasons, it does not
   2     happen. Certainly the first year, when we changed the
   3     policy, the change in bringing the age down was much
   4     slower than Marc and I wanted, again for multi-factorial
   5     things.
   6        If you look at the policy in other countries,
   7     apart from the UK, you still find many places where,
   8     even nowadays, they would still hold this view that if
   9     you operate on an older child, it is safer.
  10   MR LANGSTAFF: We dealt with timing in terms of the timing
  11     of the operation in the child's life. You were going to
  12     come back to questions of timing in terms of operative
  13     timing, I think time on bypass, time on cross-clamp, and
  14     the significance of timings in post-operative care of
  15     intubation.
  16        Do you want to comment on that now?
  17   PROFESSOR de LEVAL: I can, although I am not terribly
  18     excited about this, because I think the data is quite
  19     weak, but I can try to go through this with you.
  20        If you take the results of univariate analysis,
  21     which is Table II on the paper --
  22   MR LANGSTAFF: Can we just find that? It is INQ 6/64. So
  23     that the wider audience understand, we are going back to
  24     your recent research.
  25   PROFESSOR de LEVAL: This is a table which looks at the
0135
   1     univariate logistic regression analyses of procedural
   2     factors and deaths as an outcome variable.
   3        You can see that the length of bypass here is very
   4     closely related to death, with a p-value of less than
   5     0.001. Then, if you could do the cross-clamping time,
   6     perhaps (lines highlighted).
   7        In univariate analysis, we have to be very careful
   8     about the interpretation of those data. That does not
   9     take into consideration the type of anomalies you are
  10     dealing with. Obviously, if you have an intermural
  11     coronary artery it takes longer to repair it and we know
  12     it is a higher risk factor, so it is very difficult to
  13     give a lot of weight to a univariate analysis of this
  14     type.
  15   THE CHAIRMAN: I think Professor de Leval wanted the
  16     cross-clamping, the one below.
  17   PROFESSOR de LEVAL: That is right, yes.
  18   MR LANGSTAFF: So the point you are making is that it is
  19     artificial, really, to look at this in isolation?
  20   PROFESSOR de LEVAL: Interpretation in isolation is
  21     difficult.
  22   MR LANGSTAFF: The point for the general public might be
  23     this: if one were ever to do an analysis of smokers, you
  24     could perhaps associate the fact that people who drank
  25     gin or beer were much more likely to suffer from lung
0136
   1     cancer, and that in itself would indicate it was a risk
   2     factor, but the truth would be that they happened to
   3     smoke while they are drinking. Is that the same sort of
   4     point? It is a confusing factor.
   5   PROFESSOR de LEVAL: Yes. The length of anaesthesia has
   6     perhaps some interest, because obviously the length of
   7     anaesthesia, which is the line above length of time on
   8     bypass, there is some correlation, not as powerful,
   9     between length of anaesthesia and death as an outcome.
  10        This is interesting because the length of
  11     anaesthesia obviously does not relate to the coronary
  12     arteries, it does not take more time to put a baby to
  13     sleep with an intramural coronary artery than the other
  14     one.
  15        This is why we tried to look at timings, surrogate
  16     outcome, and then look at volumes and surrogate
  17     outcomes. But this is becoming statistical
  18     manipulations and I think it is very, very dangerous to
  19     take those data and use them in a very powerful way.
  20     But if we do that, the high volume surgeons have
  21     a shorter bypass time and have a shorter, within
  22     brackets, anaesthetic time, which indicates that the
  23     surgeons who have a low volume necessarily, or by
  24     definition, have also low volume anaesthetists.
  25        So those anaesthetists take more time. In
0137
   1     univariate analysis there is some correlation between
   2     negative outcome and timings. I do not want to draw
   3     more conclusions than this. I would just like to leave
   4     it as an observation, rather than taking conclusions.
   5        So far as volume is concerned, I think the volumes
   6     were too small. We differentiated the high and low
   7     volume surgeons by considering those who were doing less
   8     than 15 switches, a low volume, and more than 15, a high
   9     volume, and there were no statistical differences in
  10     negative outcomes for the two groups.
  11        The problem is that it is probably a mistake to
  12     use statistics only to demonstrate the effect of an
  13     event, and, for example, there is in that series of
  14     switches, surgeons who I believe had three deaths out of
  15     four cases. Because of the risk stratification there
  16     are no statistical differences, but you ask the human
  17     factor researcher if she would like to have a switch
  18     done by that particular surgeon, and she will say,
  19     "Obviously not". This is the difficulty of using
  20     statistics only to give evidence. In the forensic world
  21     they never use statistics to give evidence, but it is
  22     very difficult in medicine to decide what should be used
  23     to give statistics. Ideally, we should have other ways,
  24     scientifically acceptable, to prove the effect of the
  25     variables without having to demonstrate necessarily
0138
   1     a robust statistical significance. That becomes
   2     philosophical as well, I think.
   3   MR STARK: I would like to add just one observation again.
   4     It is not scientific, but I think it may help to some
   5     extent the understanding about the length of bypass. In
   6     the late 1960s/early 1970s, my predecessor, Mr Aberdeen
   7     at Great Ormond Street had what I think was considered
   8     one of the longest bypass times in the world, and yet he
   9     organised a whole team and all the sections in such
  10     a way that our results of Mustard operation, which was
  11     the one for transposition at that time, were amongst the
  12     best, if not the best in the world.
  13        So it is not a very straightforward correlation,
  14     although I think, myself and Professor de Leval, most
  15     surgeons believe that if you can do the operation
  16     quicker, it is important. But you can get good outcome
  17     even with the long operation.
  18   MR LANGSTAFF: Can I sum up by saying that you both
  19     intuitively feel or judge that the shorter the time on
  20     bypass, the better, but one has to look at factors other
  21     than that in order to determine the success of or
  22     failure of cardiac surgery?
  23   MR STARK: Shorter within certain limits. It is not in
  24     actual terms.
  25   MR LANGSTAFF: The example you use of Ian Aberdeen, is that
0139
   1     really an example because it is contrary to one's
   2     expectations and contrary to general experience, which
   3     is why you mention it, the exception that proves the
   4     rule?
   5   MR STARK: No, I think it is a pure observation and the fact
   6     that in those days a lot of surgeons from all parts of
   7     the world were coming to us to learn the procedure, and
   8     they were all amazed that the length of bypass was such
   9     and that the results were so good. So it may go
  10     a little bit your way, that it was something that people
  11     would not expect to happen.
  12   MR LANGSTAFF: Can I turn from this area? There are two
  13     other areas I want to explore in particular, besides
  14     anything that the Panel may wish to explore before we
  15     finish. We are aiming to finish just before 4 o'clock,
  16     if that is, I hope, not unacceptable.
  17        Can we look at the paper which you produced,
  18     Professor de Leval, in 1994? We have it at INQ 6/02.
  19        Can you tell me how it came about that you began
  20     to research into the risks of surgery?
  21   PROFESSOR de LEVAL: I think as any surgeon dealing with
  22     high risk surgery, one has to face early in your
  23     training the problem of operative or surgical deaths,
  24     which I think in itself is a very important problem,
  25     because those are deaths which follow a physical act.
0140
   1     It is a death which follows a manipulation, which is
   2     quite unique in medicine. A physician has a patient who
   3     dies, but it may be related to the disease or a drug.
   4     Here it is a death which follows a manipulation, and
   5     that in itself is important to take into consideration
   6     in the life, the training and the behaviour of the
   7     surgeons.
   8        A friend was telling me once that the difference
   9     between the knife of the surgeon and the criminal is the
  10     intention, but it is still the knife. I could see that
  11     process becoming applicable to the cardiologist when
  12     they started to do interventional catheters, and they
  13     were used to this, but when they lost patients following
  14     a procedure, they behaved totally differently between
  15     that death and they became like surgeons. It is the
  16     fact that it is a death which follows a manipulation
  17     which I think is very important.
  18        I think a surgeon going to high risk surgery, when
  19     I started the mortality in my field was more than 20 per
  20     cent, so most weeks I had to cope with a death.
  21     I obviously became interested and concerned about this,
  22     and as a junior surgeon, my first death, which I am
  23     alluding to in a paper on excellence, was the first time
  24     I was doing an operation unsupervised, and obviously
  25     I felt guilty, but since then, I always feel that
0141
   1     whatever the condition was, that that patient could have
   2     survived in other hands. This is a dilemma that faces
   3     the surgeon all the time. I believe that the cartoonist
   4     depicting surgeons depicts behaviours which I think are
   5     quite frequently related to that particular problem of
   6     the way that they have educated themselves to react with
   7     the fact that they are facing death quite frequently in
   8     high risk operations.
   9        That was the background. Obviously, when, being
  10     an established surgeon, I had to face not only one death
  11     but a succession of deaths in a short period of time for
  12     an operation which I had performed successfully on
  13     numerous occasions, I became intrigued and started to
  14     investigate it, and actually, I had decided that if
  15     I could not solve the problem of those patients, I was
  16     going to quit cardiac surgery.
  17        So that became an important part of my activities,
  18     and trying to research this, I became more and more
  19     interested in understanding outcomes which led to the
  20     study I have alluded to earlier today.
  21        So this is the reason for my interest in this.
  22   MR LANGSTAFF: You describe the questions you asked at the
  23     bottom of this page, the cluster of failures in
  24     a surgeon's performance. This was looking at your own,
  25     was it?
0142
   1   PROFESSOR de LEVAL: Yes.
   2   MR LANGSTAFF: Could that be due to chance? Could it be due
   3     to procedural risks and their variation across time?
   4     Could human error account for it? Could there be
   5     appropriate monitoring techniques which in effect would
   6     prevent it by detecting trends early? Could there be
   7     other outcome measures, and how do you best express the
   8     surgeon's performance across time?
   9        Essentially, what answers to those questions did
  10     you come to?
  11   PROFESSOR de LEVAL: They were very good questions, and very
  12     ambitious, when I look at it today. I do not think
  13     I have answered many of them. For example, in that
  14     paper I used the word "retrained", but I decided that
  15     the analysis of the procedural risk factors did not help
  16     me to understand the deaths and I therefore included
  17     myself and decided I was not doing the operation
  18     properly, and that I had to retrain.
  19        Nowadays, looking back at that series of patients,
  20     and the techniques I am using today, I realised that my
  21     retraining was not to learn a surgical technique,
  22     although this paper seems to indicate it was, because
  23     the switch I am doing today is the switch I was doing
  24     before the cluster. I am convinced that the only thing
  25     the retraining did was to help me find my confidence,
0143
   1     which I had lost.
   2        So I think that a cluster like this, first of all,
   3     clustering happens everywhere all the time. It is not
   4     a unique phenomenon; maybe it was just the same
   5     situation here, I still do not know. But whatever the
   6     cause of the cluster was, I had reached a point where
   7     I had lost confidence. I think that in terms of human
   8     factors, the quality of your performance depends for
   9     a great deal on mental readiness, of which confidence is
  10     part. I think again, when a surgeon or anybody faces
  11     a similar situation, the message is that one has to
  12     explore ways to recover the mental readiness and the
  13     confidence that you inevitably lose afterwards.
  14        I think that when you are in a situation of
  15     failures like this, you may be still able to cope with
  16     the straightforward case, but your spare capacity to
  17     deal with a major event, for example, I am pretty sure
  18     is lost, and then there is a vicious circle of going to
  19     more and more failures.
  20   MR LANGSTAFF: In order to identify trends in surgeons
  21     generally, and moving it away from the personal and the
  22     particular to the general, you demonstrate at page 7
  23     [INQ 6/7] a graph which shows in graphical form the
  24     results of the CUSUM analysis.
  25        I wonder if you would just say something about the
0144
   1     way in which this form of analysis, used in industry,
   2     I think, may possibly be applicable to detect trends in
   3     surgical performance?
   4   PROFESSOR de LEVAL: First of all, I am not a statistician,
   5     and this work was done by David Spiegelhalter and Kate
   6     Bull who did the statistical analysis. It is David who
   7     introduced the concept of CUSUM to medicine. Actually,
   8     CUSUM was a very well known method of monitoring quality
   9     in production lines, and it is a simple way in which
  10     graphically you add each event or each new case on
  11     a diagram. For example, if you look at the lower part
  12     of my diagram, you have my experience here, my
  13     experience of 52 cases, going up to here, with only one
  14     death, so that death is here, and then you have
  15     a cluster of failure.
  16        So just looking simply at this diagram, you
  17     realise that there was a problem in my cluster of
  18     failure.
  19        Then I retrained and there was another death here,
  20     after 30 or 40 patients.
  21   MR LANGSTAFF: Is the idea, for simplicity of explanation,
  22     that each and every time there is a success, as it were,
  23     the line plotting --
  24   PROFESSOR de LEVAL: It is a horizontal line. It is
  25     a vertical line when you have a failure. This obviously
0145
   1     was telling us about performance using as an outcome
   2     event death. What we tried to do in that paper was to
   3     find out whether premonitoring signs or warning signs
   4     could have been detected and this is why we introduced
   5     the concept again, borrowed from aviation, of "near
   6     miss". We took as a near miss the need to go back on
   7     the cardiopulmonary bypass, or the need to be on ECMO or
   8     major ECG changes at the end of the operation.
   9        In doing so, we realised that my performance of
  10     one death amongst the first 52 patients was perhaps not
  11     as good as I thought.
  12        Following this paper, I have continued to look at
  13     my performance up to I think 220 cases, and the
  14     mortality for more than 100 cases after the last patient
  15     who died in the cluster here has been, I think, 2.3 per
  16     cent, or 2.5: I think 3 patients in 220 cases.
  17        But if I looked at the near misses in that series
  18     after the training, the number of near misses, their
  19     incidence has remained the same.
  20        I do not have a clear explanation for that. You
  21     could say I still do not know how to do the switch,
  22     which is possible, but I have a feeling that it
  23     indicates that I have managed to cope with the major
  24     failures and the events.
  25        So I think that what happened there is that I have
0146
   1     the capacity to deal with problems: when I have a near
   2     miss I manage to have a success, whereas before that,
   3     that near miss was probably more likely to lead to
   4     failure.
   5        I think, again, what makes you able to cope with
   6     those near misses is probably your mental readiness.
   7     Obviously there are some technical skills, experience,
   8     but it is the confidence that you are going to be able
   9     to sort out the problem which is a major issue in this.
  10   MR LANGSTAFF: You have described from your own personal
  11     experience how you dealt with the possibility of, if
  12     I use the word "error", I mean the failure to achieve
  13     the outcome which was desirable.
  14        In one of your papers, you tell us -- this is
  15     INQ 6/19 -- this was the Edgar Mannheimer lecture for
  16     1996 which you were invited to deliver in Goteborg. At
  17     the bottom of the page, page 7 which is on the screen,
  18     you look at some of the corollaries of applying accident
  19     theories to surgical outcomes. The first thing you say
  20     is that you must develop a "culture of error" and you
  21     say:
  22        "The medical world has had great difficulty in
  23     dealing with errors. The traditional teaching is that
  24     medical doctors are expected to function without error.
  25     This need to perform faultlessly has created a strong
0147
   1     pressure to intellectual dishonesty to cover up mistakes
   2     rather than admit them and to overlook opportunities for
   3     improvement. In addition, the realities of the
   4     malpractice threat provide strong incentives against
   5     disclosure, or investigation of mistakes."
   6        Leave aside people in this room, but are you
   7     saying there that you are aware that other people in the
   8     medical profession cover up mistakes rather than admit
   9     them?
  10   PROFESSOR de LEVAL: I think that doctors are human beings
  11     and I do not think they are different from other human
  12     beings. I think the question you are asking me applies
  13     to all of us here, whatever we are, and I do not think
  14     we are different. I think that if being open about your
  15     failures is at the risk of jeopardising your own life,
  16     your own profession, there is an obvious tendency to be
  17     careful about being open.
  18   MR LANGSTAFF: And being careful about being open amounts to
  19     hiding the truth, does it?
  20   PROFESSOR de LEVAL: Not necessarily.
  21   MR LANGSTAFF: But it may do?
  22   PROFESSOR de LEVAL: I suppose it may.
  23   MR LANGSTAFF: What you are describing here, has this been,
  24     however professional doctors may have tried to be,
  25     nonetheless part of the culture of the medical world as
0148
   1     it is in other areas?
   2   PROFESSOR de LEVAL: I am sorry?
   3   MR LANGSTAFF: You say you are not describing doctors in
   4     particular, you are describing people?
   5   PROFESSOR de LEVAL: That is right. This lecture is trying
   6     to understand the problems and reactions to failures in
   7     my own profession, but I believe that they are unlikely
   8     to be different from other professions.
   9   MR LANGSTAFF: Would you wish to comment, Mr Stark, on
  10     this?
  11   MR STARK: No, I would agree entirely.
  12   MR LANGSTAFF: Dr Silove?
  13   DR SILOVE: I think he has worded this very eloquently.
  14     I agree with him.
  15   MR LANGSTAFF: You ask, in the next paragraph, that
  16     physicians become more open and comfortable with their
  17     fallibility and that patients must accept their own
  18     vulnerability. So this is a plea for the recognition,
  19     is it, that mistakes can be made, may be made, and that
  20     when you say "patients must accept their own
  21     vulnerability", patients have to accept that a doctor
  22     doing his best may nonetheless make a mistake?
  23   PROFESSOR de LEVAL: I would like to make two comments about
  24     this. The first one -- maybe it is a mistake to have
  25     given a lecture about this without proper references,
0149
   1     not because I am worried about your questions, but
   2     I think that obviously a lot of this lecture has been
   3     taken from my readings, and if it was a proper paper it
   4     should have references. Many of the sentences you read
   5     are sentences taken from articles. So I would like to
   6     make the point here, because it is important. This is
   7     now public knowledge that I have not put the references,
   8     because it is not a paper to be published, but many of
   9     those sentences have been taken there.
  10   THE CHAIRMAN: If it will put you at rest, Professor
  11     de Leval, the lecture speaks for itself and is very
  12     clear. It does not call for references. I think it
  13     sets out a set of views which we on the Panel can quite
  14     understand. You set out the views you have and we
  15     clearly understand them. I do not think it calls for
  16     you either to make apology or further elucidation.
  17   PROFESSOR de LEVAL: No, I do not apologise, I just want to
  18     give credit to those who have written part of those
  19     sentences. And to answer the other part of the
  20     questions: doctors are fallible as all human beings.
  21     Whatever you do, if you see a doctor, that doctor is
  22     fallible; he can make mistakes. So we have to have
  23     a system which is built with human beings who make
  24     errors. What we have to do is to build systems which
  25     are error tolerant. Failures will not be avoided,
0150
   1     doctors will remain human beings -- not necessarily,
   2     maybe robots soon, but for the time being, human beings.
   3   MR LANGSTAFF: The idea of having a system which accepts
   4     that there are risks goes back, does it, to what you
   5     were telling us before the lunch break of the need, as
   6     it were, to design a system which minimises the chances
   7     of those risks producing an event --
   8   PROFESSOR de LEVAL: A system where we know they are made of
   9     human beings who make errors. This is not just
  10     a problem in medicine. In aviation what they are facing
  11     now, they have to decide between fallible individuals or
  12     getting rid of them to use pure technology or computers
  13     to fly. They are now in a crisis because they have
  14     removed too much human component in it, and they have to
  15     decide to withdraw it completely or to put more into it,
  16     and if they do, they have to deal with the fallibility
  17     of the human beings. I think that the system you have
  18     to create in medicine is to realise that we will make
  19     errors and mistakes.
  20   MR LANGSTAFF: I think in part of your writings you mention
  21     not only the doctor who may make a mistake, or the
  22     system which may make mistakes because of, as it were,
  23     not trying hard enough, but the risk that there may be
  24     mistakes made by a person or system who in effect is
  25     trying too hard?
0151
   1   PROFESSOR de LEVAL: By an individual who is trying too
   2     hard?
   3   MR LANGSTAFF: Yes.
   4   PROFESSOR de LEVAL: Certainly. Again, if I take my
   5     example, following those clusters, I was so concerned
   6     about my patients that I used to stay in the intensive
   7     care unit for hours, for the whole night, because I was
   8     too concerned about the patient and something
   9     happening. It is all a problem of behaviour influenced
  10     by a failure which is such that that person, the
  11     person's performance, can actually suffer from what he
  12     or she does to do better for the patient.
  13   MR LANGSTAFF: Would you, gentlemen, like to comment on the
  14     dangers of trying too hard?
  15   MR STARK: I think it certainly does exist, because if you
  16     are in the operating room with the patient 7 or 8 hours
  17     and you are in that state of mind as Professor de Leval
  18     explained, instead of perhaps looking at your patient in
  19     the intensive care unit at midnight, you may stay for 4,
  20     5 hours, and I think your performance the next morning
  21     for the operation, even if the outcome is successful, it
  22     cannot be as perfect as if you had a decent sleep.
  23        That is obviously a cumulative effect, and I think
  24     in the units where you do not have relief, and I think
  25     also importantly, you do not have a chance to discuss it
0152
   1     with your colleague because, you know, having been
   2     consultants for 20 years, we still found occasional
   3     difficult patients where it was very useful to discuss
   4     it, or even call each other to the operating room, and
   5     I think that is part of it.
   6        So I certainly think that there are circumstances
   7     when you can perhaps try too hard.
   8   DR SILOVE: I agree. It also highlights the need for
   9     professionals such as us to be given support and, if
  10     necessary, counselling when a problem like this arises.
  11   MR STARK: I would like to add just one more thing, if
  12     I may. You asked if the doctors or surgeons do not
  13     reveal some of the mistakes or problems, whether they
  14     are hiding the truth. I think that sometimes this is
  15     actually not hiding the truth but simply because of the
  16     outside pressures, you find that some of the doctors or
  17     some of the surgeons would not report their results, for
  18     example, to the national or international registries.
  19     I give you an example: when the results of coronary
  20     artery surgery became public domain in the State of New
  21     York, this was done on crude results without any risk
  22     stratification, and the surgeons who found themselves at
  23     the bottom of the league table, they found themselves
  24     suddenly without patients. Yet, next year, when the
  25     risk stratification was done, it was suddenly found
0153
   1     those surgeons were actually good surgeons because they
   2     received a great number of very high risk patients.
   3        So I think the problem we have discussed earlier,
   4     the confidence of your patients and the parents of your
   5     patients is very important in this setting. If you lose
   6     it, you start practising perhaps the medicine which is
   7     defensive medicine, which may not be to the best
   8     advantage of your patients.
   9   MR LANGSTAFF: Can I, for my part, thank you both enormously
  10     for the contribution and discussions? Can I thank
  11     Dr Silove in particular, for having been here not just
  12     to endure one day, but to endure the whole week.
  13        Sir, there may be questions that the Panel would
  14     have to ask?
  15   THE CHAIRMAN: Thank you. Mrs Maclean?
  16   MRS MACLEAN: I am interested in the consultation between
  17     cardiologists and surgeons in the post-operative
  18     period. I am beginning I think to get a picture of how
  19     the discussions take place as you are leading up to the
  20     surgery. After surgery, is it imperative for
  21     cardiologist and surgeon to meet face-to-face in
  22     intensive care to discuss a patient, or is it possible
  23     to communicate in other ways?
  24   MR STARK: I think there are many ways. The important
  25     factor for me would be the availability. If we are in
0154
   1     the same building on the same floor, if I find that my
   2     patient is not doing as expected, then all I need is to
   3     call my colleague and say, "Could you kindly do the
   4     echo?" and half an hour later, he would either come and
   5     see me or call me and say "We found this and that, and
   6     such-and-such an action has to be taken".
   7        So I am not sure whether face-to-face is
   8     mandatory, although sometimes it is useful, but the
   9     availability to respond one to another, I think, is
  10     crucial.
  11   DR SILOVE: Could I add that in Birmingham, for many years
  12     now, we have done a ward round every single morning on
  13     the intensive care unit -- surgeon, cardiologist,
  14     anaesthetist, junior staff -- and all the patients are
  15     carefully reviewed and discussed as to what the plan
  16     will be for the rest of the day.
  17        There will always be somebody on the intensive
  18     care unit who is responsible for the immediate
  19     management of that patient who will know, or should
  20     know, when to call a cardiologist because there is
  21     a problem developed, or whether to call somebody else
  22     because there is a problem developed. But I think the
  23     team approach is a very important one and it is
  24     essential, really, for proper patient management.
  25   THE CHAIRMAN: Thank you. Gentlemen, I echo the thanks of
0155
   1     Mr Langstaff on behalf of the Panel. It has been an
   2     extremely instructive day. We are very greatly in your
   3     debt. Yesterday, Dr Silove with Dr Houston helped us.
   4     Today he has stayed with us and you have helped us,
   5     Professor de Leval and Mr Stark. This is with a view to
   6     laying, as I said yesterday, the factual basis, so that
   7     we and others can understand the background against
   8     which we will take our considerations forward.
   9        We could not have been helped in a more
  10     perceptive, incisive and thoughtful way, I venture to
  11     suggest, and we are very grateful to all three of you.
  12     Thank you very much indeed.
  13   MR LANGSTAFF: Sir, quickly, because the taxi is probably
  14     downstairs for our experts to take them back to London:
  15     tomorrow is post-operative care. We will hear at 9.30
  16     from a panel of independent experts consisting of
  17     a paediatric cardiac surgeon, Mr Leslie Hamilton;
  18     a paediatric intensivist, Dr Duncan MacCrae;
  19     a paediatric cardiologist, Dr Barry Keeton; and
  20     a cardiac nurse clinician, Mr Andrew Darbyshire.
  21   THE CHAIRMAN: Then we adjourn now and reconvene at 9.30
  22     tomorrow morning. Thank you, Mr Langstaff. Good
  23     afternoon, everyone.
  24   (3.55 pm)
  25     (Adjourned until 9.30 on Thursday, 16th September, 1999)
0156
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   5                I N D E X
   6
   7     SEMINAR:
   8
   9        CONGENITAL HEART DEFECTS:
  10        SURGICAL OPTIONS, INNOVATIONS and RISKS ........ 1
  11
  12        DR ERIC SILOVE, PROFESSOR MARC de LEVAL
  13        and MR JAROSLAV STARK .......................... 2
  14
  15
  16
  17
  18
  19
  20
  21
  22
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0157

Published by the Bristol Royal Infirmary Inquiry, July 2001
© Crown Copyright 2001