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Daily transcripts
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.
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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)
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5 I N D E X
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7 SEMINAR:
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9 CONGENITAL HEART DEFECTS:
10 SURGICAL OPTIONS, INNOVATIONS and RISKS ........ 1
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12 DR ERIC SILOVE, PROFESSOR MARC de LEVAL
13 and MR JAROSLAV STARK .......................... 2
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Published by the Bristol Royal Infirmary Inquiry, July 2001
© Crown Copyright 2001