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Hearing summary

14th December 1999

 

The Bristol Royal Infirmary Inquiry this week will hear evidence which covers concerns raised about paediatric cardiac surgery at the Bristol Royal Infirmary between 1984 and 1995 and any failure to take action promptly.

 

Mr James Wisheart, retired Medical Director, United Bristol Healthcare NHS Trust, UBHT, continued to give evidence today.

 

Mr Wisheart and the two members of the expert group began today by discussing four individual cases reviewed as part of the Inquiry’s Clinical Case Note Review. Mr Wisheart, Mr Mankad and Dr Dickinson focussed in detail on the case notes for each patient, commenting on initial diagnosis, timing of surgical intervention, clinical teamwork and post-operative intensive care treatment.

 

Mr Wisheart’s evidence continues tomorrow.

 

Mr Pankaj Mankad, Paediatric Cardiac Surgeon, Royal Hospital for Sick Children and Royal Infirmary, Edinburgh and Dr David Dickinson, Consultant Paediatric Cardiologist, Leeds General Hospital, attended today’s hearing in their capacity as members of the Inquiry’s Expert Group.

 

FULL TRANSCRIPT

 

   1                Day 93, Tuesday, 14th December 1999
   2   (9.40 am)
   3   THE CHAIRMAN: Good morning, everyone. Good morning,
   4     Mr Langstaff. I should say good morning to our experts,
   5     you will introduce us, I am sure.
   6   MR LANGSTAFF: I expect they will introduce themselves,
   7     that is what I shall invite them to do in a moment once
   8     they have taken the oath. We have Mr Mankad and
   9     Dr Dickinson.
  10            MR PANKAJ MANKAD (SWORN):
  11           DR DAVID DICKINSON (SWORN):
  12   MR LANGSTAFF: Mr Mankad, can we begin please with you, this
  13     is your first visit to the Inquiry. Would you like to
  14     tell everyone a little bit about yourself and your claim
  15     to be here sitting in the expert's chair as one of our
  16     consultant surgeons?
  17   MR MANKAD: I am Pankaj Mankad, I am a consultant cardiac
  18     surgeon in the Royal Hospital for Sick Children and
  19     Royal Infirmary in Edinburgh, and also, I am the
  20     Clinical Director of Cardiothoracic Surgery in Lothian
  21     University Hospital's NHS Trust, which is a recent
  22     amalgamation of three hospitals or three previous
  23     Trusts.
  24        My association with paediatric cardiac surgery
  25     goes back to the beginning of 1985 when I started my
0001
   1     training at Harefield Hospital and subsequently
   2     I completed my training at Harefield, Brompton and Great
   3     Ormond Street Hospital in relation to paediatric cardiac
   4     surgery and then I was appointed consultant cardiac
   5     surgeon in Edinburgh just over 6 years ago in
   6     September 1993.
   7        In addition to my clinical role, I am advising the
   8     Scottish Executive through the Scottish Inter-collegiate
   9     Committee on issues surrounding paediatric cardiac
  10     surgery in Scotland.
  11        My qualifications include the Specialty Fellowship
  12     and PhD apart from the general basic qualifications and
  13     my interests remain in overall clinical and academic
  14     area of paediatric cardiac surgery. Thank you.
  15   MR LANGSTAFF: Dr Dickinson?
  16   DR DICKINSON: I am David Dickinson. I qualified at
  17     Manchester in 1968 and trained in paediatrics in
  18     Manchester initially. My interest and expertise in
  19     paediatric cardiology dates from 1971 in Manchester and
  20     I went on then to train in Liverpool and in the Hospital
  21     for Sick Children in Toronto for a year before being
  22     appointed as a consultant paediatric cardiologist in
  23     Leeds in 1982. I have been in Leeds since then. I am
  24     the lead clinician for the paediatric cardiac service in
  25     Leeds and have been so since about 1991 and I am
0002
   1     currently the Secretary to the British Paediatric
   2     Cardiac Association.
   3   MR LANGSTAFF: I think, Mr Mankad, one of the matters you
   4     have been advising the Executive on has been the
   5     question of whether there should be one or two centres
   6     in Scotland to perform paediatric cardiac surgery. We
   7     have already heard I think that the likely result of
   8     that would be a unification of the service in one
   9     centre; has that happened.
  10   MR MANKAD: Yes, that has happened actually. Late
  11     September/beginning of October the Health Minister did
  12     make an announcement that there will be one paediatric
  13     cardiac surgical centre for Scotland. At present we are
  14     in the phase of putting forward the clinical plan for
  15     that and the provisional implementation date for that is
  16     the beginning in April with three months transitional
  17     phase and final implementation at the end of
  18     June/beginning of July next year.
  19   MR LANGSTAFF: What is the plan rationale for this
  20     unification?
  21   MR MANKAD: The rational, number 1, I think we felt that
  22     critical mass is important for not just the paediatric
  23     cardiac surgeon but also for the whole team who is
  24     looking after these children.
  25        Secondly, we felt that also by creating one
0003
   1     centre, not only the clinical care will be improved, but
   2     also it gives us an opportunity to develop academic
   3     expertise in the subspecialty and take forward the
   4     various issues relating to the care of children in
   5     a comprehensive holistic way rather than just providing
   6     a clinical service.
   7   MR LANGSTAFF: Both of you have I think been on a reviewing
   8     panel for cases arising out of the Clinical Case Note
   9     Review, although the cases we shall deal with today are
  10     not necessarily those with which you have personally
  11     been involved save I think in one case.
  12   DR DICKINSON: Correct.
  13           MR JAMES WISHEART (RECALLED):
  14         EXAMINED BY MR LANGSTAFF (CONTINUED):
  15   MR LANGSTAFF: Mr Wisheart, we will this morning, and
  16     I expect into this afternoon, be looking at cases which
  17     arise from the Clinical Case Note Review. You will be
  18     aware because I think you followed the Inquiry's
  19     proceedings fairly closely but others may not be so well
  20     aware, the purpose of examining these cases in this
  21     hearing chamber is as examples from which lessons may be
  22     learned.
  23        It needs I think to be said at the outset that
  24     perhaps because one is likely to learn more from what
  25     might be described as failures or near misses than from
0004
   1     successes. The cases which I will put to you are cases
   2     where there have been criticisms made by the reviewing
   3     panel. It should not however be understood by the wider
   4     audience that this is the typical case so far as your
   5     surgical skills are concerned. Indeed, it needs to be
   6     recognised at the outset that far and away the most
   7     common number that you have been given on the review of
   8     the notes by the reviewing team for surgical performance
   9     as it were, the conduct of surgery has been 4 --
  10   THE CHAIRMAN: You need to explain what 4 is.
  11   MR LANGSTAFF: 4 is, if you like, no criticism, entirely
  12     adequate care and it has also been observed in more than
  13     one case that the conduct of the surgery which you have
  14     performed has been of an exceptional quality. Let that
  15     be said at the outset before we come to the actual cases
  16     we are going to look at.
  17        Can we begin by looking at the case of Gareth
  18     Eccleshare, who was born on 25th July 1975. You have
  19     had a chance, have you, Mr Wisheart, to look at the
  20     details of Gareth's --
  21   A. Yes, I have, thank you.
  22   Q. -- operation. Some of the details I think we can take
  23     probably fairly quickly. He was born on 25th July 1975
  24     and because he was a blue baby was found to have
  25     dextrocardia with single ventricle, probable tricuspid
0005
   1     atresia and pulmonary stenosis, and before the period
   2     with which this Inquiry is concerned was referred to
   3     you; in November 1975 when he was then 4 months of age,
   4     you performed a right Blalock-Taussig shunt?
   5   A. That is correct.
   6   Q. He was then followed up over several years with mild
   7     cyanosis and seen both in Cardiff and in Bristol.
   8     He continued I think to be seen periodically both in
   9     Cardiff and in Bristol and in November 1983 Dr Joffe saw
  10     him in a clinic and commented on having raised the
  11     question of further studies with a view to a Fontan
  12     correction.
  13        At that stage, or about that stage, was it noted
  14     there had been an increase in the filling pressure?
  15   A. That was observed subsequently at cardiac
  16     catheterisation. I think there had been a cardiac
  17     catheterisation in the late 1970s. I do not have it in
  18     my own collection of notes.
  19   Q. November 1979.
  20   A. Yes. The changes then, as I recall, were pretty
  21     modest. The changes in filling pressure were modest in
  22     1979. So I think the changes you are referring to were
  23     observed at the subsequent catheterisation.
  24   Q. That was on 29th April 1984 I think which we can pick up
  25     in the medical reports. May I say before the medical
0006
   1     reports are shown that, as is the case with every case
   2     that we will refer to arising out of the Clinical Case
   3     Note Review, we have full consent from the parents and
   4     relatives of any child that we mention to refer to the
   5     case of the child and the records.
   6        May we have, please, MR 1538/62? Do you have the
   7     medical records themselves?
   8   A. I have the full ones here and I have extracted some key
   9     sheets which I have here.
  10   Q. This is the cardiac catheterisation, is it, for
  11     29th April 1984? We note, do we, if we scroll down,
  12     first of all this child was being considered for
  13     a Fontan-type of operation, was he?
  14   A. I believe that was definitely in mind, yes.
  15   Q. For a Fontan operation it would be essential to have
  16     a measurement or a knowledge of the pulmonary arterial
  17     pressure, would it not?
  18   A. That is desirable, yes, it was regarded as one of the
  19     pieces of information that one should have.
  20   Q. One would go to Fontan's "ten commandments" as they were
  21     called and one of those is that the mean pulmonary
  22     artery pressure should be less than or equal to
  23     15 millimetres of mercury?
  24   A. Yes.
  25   Q. If one is looking at the other features that one might
0007
   1     expect out of those ten commandments, one might mention,
   2     might one, that you would need to demonstrate or have
   3     normal function of the ventricle?
   4   A. That is correct.
   5   Q. A ratio of the diameters of the pulmonary artery and the
   6     aorta greater than or equal to 0.75?
   7   A. That is one of the so-called commandments, but it has
   8     been down the years always a debated criterion.
   9   Q. Certainly the measurements of the vessels are a matter
  10     of consequence?
  11   A. That is what has been a matter of debate down the
  12     years. It is clearly important that they must not be
  13     excessively small and it is important they should not be
  14     distorted as far as possible when there has been
  15     previous surgery as there was in this instance. But the
  16     pure question of size is almost certainly not as
  17     straightforward as the proposal that appeared in the
  18     original "ten commandments".
  19   Q. Finally the features which I would wish to ask you
  20     about, the pulmonary resistance has to be less than
  21     4 units per square metre?
  22   A. That was the recommendation at that time.
  23   Q. If one looks at the catheter report there is no
  24     measurement of the pulmonary arterial pressure, is
  25     there?
0008
   1   A. There is not.
   2   Q. So that desirable element is absent. One can get a view
   3     as to the minimum that the arterial pressure would be by
   4     looking at the left atrial pressure?
   5   A. Regarding the pulmonary artery pressure in isolation you
   6     can, but of course you mention pulmonary vascular
   7     resistance, so these things are related and there are
   8     circumstances, if there is a high pulmonary flow for
   9     example where the pressure may be somewhat elevated but
  10     the resistance may be quite acceptable. These are all
  11     interrelated considerations.
  12   Q. But the arterial pressure cannot be less than the left
  13     atrial pressure?
  14   A. Indeed.
  15   Q. We know that is 18 looking at the catheterisation here,
  16     do we not?
  17   A. We do, yes. 17, I think.
  18   Q. 18, is it not, for the left atrial pressure and 17 for
  19     the right?
  20   A. Yes, I was on the wrong line.
  21   Q. There was not, I think, in the catheterisation and the
  22     report of it -- let us go on to the next page where
  23     there is a report. Go down to "Aortogram" at the
  24     bottom:
  25        "Although there was good flow of contrast medium
0009
   1     into both lungs, the origin of the right subclavian is
   2     very narrow, a small amount of the contrast medium
   3     reflux and the distal part of the main pulmonary trunk.
   4     No abnormality of the peripheral pulmonary vessel is
   5     seen."
   6        There is no measurement as such of the vessels?
   7   A. You mean the calibre of the vessels?
   8   Q. The calibre of the vessels.
   9   A. Yes. No, there is not.
  10   Q. Is there any assistance from the catheterisation of the
  11     degree of pulmonary vascular resistance?
  12   A. Without the measurement of pulmonary artery pressure,
  13     you cannot estimate pulmonary vascular resistance.
  14   MR LANGSTAFF: When the situation of Gareth is discussed
  15     after the catheter has been performed, you I think wrote
  16     a letter of 17th July 1984. We can pick it up on
  17     MR 988/29. It is the second paragraph:
  18        "We saw his angios in the meeting some time ago.
  19     Unfortunately, I have not had a chance to review them
  20     with you again, but would positively like to do so. It
  21     is clear however that he is suitable for a Fontan
  22     operation and I think there can be no doubt that his
  23     pulmonary artery pressure will be low."
  24        What, gentlemen, would you say at this stage about
  25     the suitability for a Fontan operation?
0010
   1   DR DICKINSON: Looking at the catheter data --
   2   MR LANGSTAFF: I think your voice is a little low, can you
   3     pull the microphone closer?
   4   DR DICKINSON: Looking at the catheter data I would say the
   5     mean pulmonary artery pressure cannot possibly be less
   6     than the left atrial pressure obviously and one item of
   7     information which flashed past very quickly on the
   8     screen was that the calculated pulmonary blood flow was
   9     only one-third of the systemic blood flow, so there was
  10     only one-third of the normal volume of blood going
  11     through the pulmonary circulation.
  12        On that basis I would suggest that the pulmonary
  13     resistance probably was elevated and the pulmonary
  14     artery pressure was certainly higher than would be ideal
  15     or acceptable for a Fontan and the end diastolic
  16     pressure in the left ventricle, the change from the
  17     catheter in 1979 to 1984 does suggest that the
  18     ventricular function had deteriorated during that period
  19     of time.
  20   MR LANGSTAFF: Could I pause you there and go back, if
  21     we may, to the catheter report at 1538/62. If we focus
  22     on the third line down where it deals with the left
  23     ventricular pressure. There is a recording there of
  24     96 over 10-25 which is an indication, is it, of a sign
  25     that the left ventricle is failing.
0011
   1   DR DICKINSON: They certainly mean a change from the
   2     previous catheter, the end diastolic pressure has
   3     increased and in these circumstances I think that would
   4     be an indication that the ventricular function had
   5     deteriorated.
   6   MR LANGSTAFF: Can I ask you to stop there because
   7     Mr Wisheart may want to comment on what you have said?
   8   MR WISHEART: I agree with what Dr Dickinson has said.
   9   DR DICKINSON: I think there is evidence of a change in left
  10     ventricular function which would be, as we have said
  11     already, an adverse factor from the point of view of
  12     selection for a Fontan procedure. There is, I think,
  13     evidence that the pulmonary artery resistance or
  14     pulmonary arteriolar resistance is most unlikely to be
  15     at an acceptable level for a Fontan procedure. So
  16     I think they are two factors which, I would have
  17     thought, would make this child unsuitable for a Fontan
  18     in fact.
  19   MR LANGSTAFF: Mr Mankad, you were not of course
  20     a consultant at the time, but it was not long after this
  21     that you became a Senior Registrar. Do you have
  22     a comment from the surgical perspective?
  23   MR MANKAD: If I put the whole thing into perspective
  24     I think there are three or four issues here under
  25     consideration.
0012
   1        The first is the pulmonary artery pressure.
   2        The second one is the pulmonary vascular
   3     resistance.
   4        The third is the possible size of the pulmonary
   5     arteries themselves, both right and left; and probably
   6     the fourth issue is the left ventricular function.
   7        If I take them slightly in the reverse order
   8     I think I concur with what Mr Wisheart said, that the
   9     size of the pulmonary artery pressure is not crucial to
  10     the successful outcome of the Fontan operation. In fact
  11     from the top of my head, if I recall, there was a paper
  12     in circulation from the Boston group in probably 1989
  13     precisely addressing this issue, that their data were
  14     presented to the American Heart Association meeting and
  15     the title of the paper was: 'Does the size of the
  16     pulmonary artery in themselves matter in the Fontan
  17     operation?' and the simple answer to that was "no".
  18        I think I would probably agree that the size of
  19     the pulmonary arteries was not a crucial issue.
  20   MR LANGSTAFF: You said that was 1989?
  21   MR MANKAD: Subsequently, yes.
  22   MR LANGSTAFF: As a matter of biological fact it does
  23     not matter; in terms of decision to carry out the
  24     operation from what was known at the time, are you in
  25     a position to comment or do I have to ask Mr Wisheart
0013
   1     and Dr Dickinson?
   2   MR MANKAD: I would be happy to proceed based on what
   3     I have seen in this particular child. The anatomy of
   4     the pulmonary artery to proceed -- I think I will take
   5     one by one the issues -- that is one issue I think is
   6     probably acceptable.
   7        The second issue, let us come to the most
   8     important issue, the pulmonary artery pressure. The
   9     pulmonary artery pressure, as Mr Wisheart rightly said,
  10     depends upon the pulmonary blood flow and the pulmonary
  11     vascular resistance. This particular child had
  12     pulmonary artery blood flow which was less than a third
  13     of the systemic flow and the left atrial pressure was
  14     18, therefore a very simple extrapolation would say that
  15     the projected mean pulmonary artery pressure would
  16     invariably have to be at least more than 20 millimetres
  17     of mercury.
  18        Secondly, after the Fontan procedure when (in
  19     theory) the ratio of the systemic to pulmonary blood
  20     flow is equal one to one, unless there is a small
  21     fenestration in the Fontan circulation, that would
  22     increase the pulmonary blood flow and that would
  23     translate subsequently after the operation into further
  24     increase in the pulmonary artery pressure, so beyond 20,
  25     we are probably talking about 25 or 30.
0014
   1        The third issue is that cardiopulmonary bypass
   2     itself leads to damaging effects on the pulmonary
   3     vasculature, albeit temporary and reversible, but that
   4     in itself would also increase the pulmonary artery
   5     pressure. So what I am coming from, this projected
   6     pulmonary artery pressure post-Fontan in this child
   7     would probably be too excessive to offer the Fontan
   8     operation.
   9        When you come to the pulmonary vascular
  10     resistance, I again do not have all that problem because
  11     pulmonary vascular resistance is calculated as mean
  12     pulmonary artery pressure minus left atrial pressure or
  13     the pulmonary capillary wedge pressure divided by the
  14     cardiac output. That means the transpulmonary gradient,
  15     the gradient across the pulmonary vascular divided with
  16     the cardiac output gives us the...
  17        The pulmonary vascular resistance is calculated by
  18     the formula: mean pulmonary artery pressure minus either
  19     the left atrial pressure or the pulmonary capillary
  20     wedge pressure divided by the cardiac output.
  21        It is conceivable that this particular baby had
  22     acceptable resistance because the left atrial pressure
  23     is very high, it is 18.
  24        So I think the most important issue on which the
  25     decision not to offer Fontan pre-operatively, I would
0015
   1     rest in this child, is the pulmonary artery projected,
   2     pulmonary artery pressure and projected extrapolated
   3     pulmonary artery pressure after the Fontan circulation.
   4     Both of these would be prohibitively high to consider
   5     this baby as an absolute contraindication for Fontan
   6     circulation even in the area under consideration, that
   7     is the 1980s, because after the ten commandments of
   8     Fontan there was a phase in-between where more and more
   9     surgeons broke more and more commandments, and the more
  10     commandments you break, you get away with it, it was
  11     considered better; that was the phase that in between we
  12     went through and we are back now to square one --
  13   Q. This was macho surgeons, was it?
  14   MR MANKAD: Yes, that was universal across the board for not
  15     just this country but especially in America, that the
  16     more commandments you break you get away with it because
  17     there was no option for these babies except Fontan
  18     operation and the other options were all palliative --
  19   MR LANGSTAFF: I was going to ask about that, if you pause
  20     there. Mr Mankad is making out a strong case perhaps,
  21     I do not know how far you agree with it, for the Fontan
  22     operation being contraindicated in Gareth's case. The
  23     question naturally follows: what else might have been
  24     done for him?
  25        First of all, do you or do you not agree with
0016
   1     Mr Mankad's main thesis which is that the Fontan
   2     operation was, in the light of the probable pulmonary
   3     arterial pressures both before and after the operation,
   4     contraindicated?
   5   A. Yes, I think certainly from my position now in
   6     retrospect I would clearly accept that. The only thing
   7     I can offer to you is some explanation of what our
   8     thinking might have been, or I believe was at the time,
   9     but that is not what you are asking me I do not think.
  10     But that is where I am, broadly.
  11   Q. In that case what -- perhaps you can help with what the
  12     thinking probably was because plainly it was a decision
  13     consciously taken to attempt the Fontan's operation.
  14     The feeling obviously was, given the letter that I have
  15     shown you, that the pulmonary arterial pressure was
  16     critical because you refer to it in the letter and you
  17     had a feeling that the pressure would be low. Can you
  18     help us with how the thinking probably went?
  19     I appreciate it is a long time ago and you may not have
  20     it exactly right.
  21   A. Can I in answering that and by way of introduction first
  22     pick up Mr Mankad's point towards the end of his
  23     remarks, namely, that thinking and practice in relation
  24     to the Fontan operation was very much a changing and
  25     evolving scene; I will not go into that, but let me just
0017
   1     say that that I think is a very important factor behind
   2     understanding the decisions we made in this case.
   3        I think the question you have asked me is
   4     specifically about pulmonary artery pressure and the
   5     issues immediately related to that. Our thinking
   6     I think was as follows: first of all the cardiologists
   7     felt -- and I am not saying whether it was right or
   8     wrong, but it was how they felt and it was not only in
   9     relation to this case at that time -- it was not
  10     appropriate for them to try to pass a catheter through
  11     the shunt which was the only way they could have had
  12     direct access to the pulmonary artery because, although
  13     you said at the beginning that the diagnosis was
  14     pulmonary stenosis it, by this time at any rate, was
  15     pulmonary atresia, that is to say there is no normal
  16     direct route in on. So the only available route was by
  17     the shunt and they felt quite strongly at that stage
  18     that it would have been inappropriate to pass the
  19     catheter through the shunt.
  20        Although that was debated amongst us -- I mean,
  21     this is their territory and we accepted their advice.
  22     So that then leaves us with a dilemma in relation to
  23     a patient like Gareth because in principle therefore we
  24     cannot provide the information to meet the required
  25     series of criteria.
0018
   1        So the second part of the thinking was, we knew
   2     that from the beginning of his life and after the shunt
   3     and in the years subsequently his pulmonary blood flow
   4     had been low, and it is measured here as very low. In
   5     the circumstances where pulmonary blood flow is very low
   6     then the actual pressure in the pulmonary arteries is
   7     unlikely to be high of itself, but clearly it has to be
   8     higher than the left atrial pressure, as you have
   9     pointed out.
  10        But perhaps more importantly it is very unlikely
  11     that the pulmonary vascular resistance will be high. So
  12     at this point our thinking perhaps is not entirely in
  13     accord with how Dr Dickinson has projected his
  14     interpretation of the findings, but that was our
  15     thinking: "Here is a boy who throughout his life has had
  16     a profoundly low pulmonary blood flow, a very low
  17     pulmonary blood flow, and therefore the chances of him
  18     having pulmonary vascular resistance at a level that
  19     would make the operation inappropriate is very very
  20     unlikely"; so that was the thinking on that particular
  21     issue.
  22   MR LANGSTAFF: Do you want to comment on that,
  23     Dr Dickinson?
  24   DR DICKINSON: I would agree entirely with what Mr Wisheart
  25     has said about the dilemma of measuring the pulmonary
0019
   1     artery pressure directly in these circumstances.
   2     Clearly there is a risk in trying to pass a catheter
   3     through a shunt which is the only source of the child's
   4     pulmonary blood flow, it could result in a very rapid
   5     and possibly irreversible deterioration in the child's
   6     condition, so there clearly is a dilemma and the
   7     cardiologists who were doing the investigation were the
   8     ones best placed to decide whether that was a safe thing
   9     to do or not.
  10        I entirely agree also that from time to time we do
  11     have to make decisions about whether to proceed with a
  12     Fontan operation on the basis of incomplete information,
  13     because this situation of lack of access to the
  14     pulmonary artery to make measurement of pressure is not
  15     that uncommon. So sometimes we do have to make or to
  16     extrapolate, as Mr Wisheart has done, to make an
  17     estimate of what pulmonary artery pressure would be.
  18        I do think in this case, though, with a mean
  19     pressure of 18 in the left atrium we must assume that
  20     the pulmonary artery pressure was significantly elevated
  21     or significantly higher than that, otherwise there would
  22     be no flow through the pulmonary circulation.
  23   MR LANGSTAFF: Is it possible -- as has been suggested to us
  24     earlier, because this is the second time we have looked
  25     in the hearing chamber at Gareth's case -- to measure
0020
   1     the pulmonary arterial pressure in the operation before
   2     the actual process of proceeding to Fontan begins?
   3   MR MANKAD: The simple answer to that is: Yes, it is
   4     advisable, but these practises in paediatric cardiac
   5     surgery have evolved over the years.
   6   MR LANGSTAFF: Let me ask Mr Wisheart: was that something
   7     that was done at this time as a general --
   8   A. Do you mean in the specific context of the Fontan
   9     operation?
  10   Q. Yes.
  11   A. Yes, what I can say is that it definitely was, indeed it
  12     was done in a much wider context and I frequently made
  13     various measurements at the beginning of an operation if
  14     I thought they would be helpful or were necessary.
  15   Q. It was not actually done in this case, at least there is
  16     no record of it?
  17   A. There is no record of it and I have asked myself about
  18     it because doing it -- I mean we can discuss its value
  19     in a moment -- but doing it was very much part of my
  20     practice. So I have asked -- and particularly in this
  21     situation where the information had not been achieved at
  22     catheter, it does seem a very obvious thing to do -- so
  23     I have asked myself about that. I do think it is
  24     definitely probable that I did it. Then the question
  25     is: why did I not say I had done it?
0021
   1   Q. Particularly since your operation notes are, on the
   2     whole, full and detailed?
   3   A. Indeed. The only thing I can offer is that this, as we
   4     no doubt will come to, was an extremely protracted
   5     procedure with an extremely disappointing outcome,
   6     a sequelae that had to be dealt with and therefore the
   7     possibility, when I sat down at the end to dictate the
   8     note, that I overlooked this particular detail exists.
   9     I can only offer it as a probability, there is no
  10     certainty that I did it. It was part of my practice to
  11     do that.
  12   Q. The difficulties that you had really in this case would
  13     have emerged, I think, on the operating table?
  14   A. They did.
  15   Q. There you are faced with a situation in which, am
  16     I right, had you known what you saw on the operating
  17     table and found on the operating table, you would not
  18     have proceeded to a Fontan in the first place?
  19   A. Oh, without any question.
  20   Q. The first aspect that this highlights to us is the
  21     decision-making process at which it was decided to go
  22     ahead to have a Fontan operation. That is a process in
  23     which you are, to an extent, in the hands of the
  24     cardiologist with investigation they can or cannot make
  25     with the difficulties that have been discussed and
0022
   1     accepted between yourself and Dr Dickinson.
   2        The process of the decision-making, what do you
   3     say about that as a process Dr Dickinson?
   4   DR DICKINSON: I think in most units, certainly all the
   5     units I have worked in, the decision-making before an
   6     operation is a joint one between the cardiologists,
   7     usually as a group, not necessarily just the one
   8     cardiologist who has been involved in the patient's care
   9     but the cardiologists as a group and the surgeon or
  10     surgeons as a group. Particularly in difficult cases of
  11     this sort one likes to achieve a situation where the
  12     whole group feels comfortable that you are doing the
  13     right thing for the patient. I think it is very much
  14     a group decision.
  15   MR LANGSTAFF: Given the group decision, the consequence is
  16     that when you come to operation you have the
  17     difficulties that you have to deal with?
  18   MR WISHEART: That is correct.
  19   Q. The operation itself -- we find the note of that at
  20      988/13. If we can scroll down. It describes I think
  21     the length of the procedure. It was in fact a very long
  22     operation, was not it?
  23   A. It was in the end. I mean the initial procedure, the
  24     doing of what we set out to do was not itself unduly
  25     protracted, but by the time we had made adjustments and
0023
   1     then eventually of course taken the whole thing down it
   2     was a very long procedure.
   3   Q. If we go over the page. We see, do we, that when the
   4     Fontan was tried it became obvious that the left atrium
   5     was not filling, suggesting I think that the pulmonary
   6     venous return to the left atrium must have been very
   7     poor?
   8   A. Yes, that is what -- in the middle of page where it says
   9     "the left atrium was virtually empty", suggests there
  10     was very little flow through the lungs which, in the
  11     face of a right atrial pressure that was high suggests
  12     that at that time at any rate, at that instant pulmonary
  13     vascular resistance was high.
  14   Q. It again showed that the conclusion reached
  15     pre-operatively about that was flawed. The conclusion
  16     I think that was made was that the pulmonary arteries
  17     were simply too small?
  18   A. That was a speculation. The only artery that we knew
  19     the size of was the main pulmonary artery which
  20     I commented on at the beginning. It is actually not
  21     necessarily terribly important, it is the size of the
  22     right and the left pulmonary arteries together which are
  23     rather more important. So that, I think, must be
  24     regarded as a possibly correct but essentially
  25     speculative comment.
0024
   1   Q. We can scroll down. You are describing, are you, in the
   2     second last paragraph how you found yourself in
   3     difficulties in the operation because the original
   4     concept of the operation has not succeeded and something
   5     has to be done now given the situation that you are in;
   6     is that the position?
   7   A. That is correct. So I devised something that I thought
   8     might alleviate the situation which, interestingly, in
   9     subsequent years -- not the precise way I did it, but
  10     a manoeuvre based on the same principle -- has actually
  11     become part of the practice. But I tried to offload
  12     some of this pressure from the right atrium so that its
  13     pressure would fall and permit blood to get more easily
  14     to the left atrium which, as you will recall, was
  15     empty.
  16        So, like everything, there is a balance in this
  17     one. What I had hoped to gain was a lower right atrial
  18     pressure, an increased flow into the left atrium. But
  19     the negative side of that is of course that the blood
  20     going into the left atrium is without oxygen and
  21     therefore the blood going around the body will have less
  22     oxygen. So there was a trade-off there that I accepted
  23     and I was trying to find the right balance.
  24   Q. The size of the conduit was what?
  25   A. It was initially 6 and then that did not seem to be
0025
   1     effective so I replaced it with a 10 millimetre conduit.
   2   Q. That is really quite a large conduit, is it not?
   3   A. I thought it was quite large, yes. But, as I say, this
   4     was really a thinking on my feet response to a situation
   5     and I had no good basis in experience or learning on
   6     which to select the size of the conduit. Of course the
   7     length of the conduit is another important factor
   8     because the way I was doing it, it was quite long. So
   9     it was, to some extent, a trial and error situation;
  10     that was the reality.
  11   Q. You described yourself "thinking on your feet" --
  12   A. Yes.
  13   Q. -- in the absence of having experienced this before?
  14   A. Or indeed at that time, it is always hard to put
  15     yourself back 15 years, but I do not think there was
  16     teaching or people describing that they were doing
  17     this. So that is what I was doing, yes.
  18   Q. One way of achieving the same effect would have been to
  19     make a hole to provide a shunt between the two atria?
  20   A. That is correct and that is what later of course became
  21     the manner of implementing this same idea. To do that
  22     of course I would have had to go back inside the heart,
  23     so at this point I was trying to avoid going back on
  24     bypass, going back inside the heart with all the
  25     implications of that.
0026
   1   Q. Because you had already been on bypass for a while?
   2   A. Yes. Yes, and I would have needed to cross-clamp the
   3     aorta and have more ischaemic time. So this appeared to
   4     be a way of doing it without incurring the penalties, if
   5     you like, that were associated with going back on
   6     bypass, cross-clamping the aorta.
   7   Q. That did not work because the right atrial pressure fell
   8     and the oxygen saturation dropped off too much and that
   9     was simply as you say trial and error; this was a shunt
  10     which was too large as it turned out probably, was it?
  11   A. We were not achieving what we needed; we were not
  12     achieving a balance that was favourable to the patient.
  13   Q. What one had to do then was to undo the whole operation
  14     and go back to square one?
  15   A. Yes.
  16   Q. Which, because of the length of time and the fact of
  17     operation, was inevitably really fighting very much
  18     a rear guard action, was it not?
  19   A. Yes, that is correct.
  20        I mean taking down a Fontan is now an established
  21     option in certain circumstances when things are not
  22     working at the end. I am not at all sure that it was an
  23     established option then, but it seemed to be the only
  24     possible way forward because the child was clearly not
  25     going to survive if I left things as they were,
0027
   1     therefore it seemed the correct thing to do.
   2   Q. When you got into difficulties and had to think on your
   3     feet, did you think at all of calling Dr Joffe in to
   4     say: "I have this difficulty, this situation, what do
   5     you think?"
   6   A. Probably not is the answer. I mean I do not know what
   7     the whereabouts of Dr Joffe would have been on that
   8     day. I do not imagine I felt that the expertise that he
   9     could offer was actually going to help us in the
  10     situation we were.
  11        I was just looking to see who was with me. In
  12     fact Mr Dhasmana was with me, who, although still
  13     a Senior Registrar, was a very experienced one and had
  14     spent years in Alabama and Great Ormond Street and so
  15     forth by this time, and also Dr Masey was
  16     anaesthetising.
  17        So I had two colleagues with me with whom I could
  18     share the thinking and who could make a useful
  19     contribution. So I imagine I did not ask Dr Joffe to
  20     come. Of course there was always the problem that he
  21     was at a distance at best so there would have been
  22     delays incurred, whereas I could talk immediately with
  23     my two colleagues here.
  24   Q. I was going to ask you about that particular problem
  25     because bringing a cardiologist into theatre is bound to
0028
   1     be very difficult at this time given the split site?
   2   A. Yes, it was. I mean I actually did do it on occasions.
   3     I could not give you the dates and times, but I did do
   4     it occasionally but in the later days more commonly
   5     I sought the help of Dr Wilde and his echo expertise
   6     because he was on site.
   7   Q. So we would be right in thinking in general terms -- not
   8     necessarily in this case, but in general terms -- the
   9     split of the site made some difference to what you might
  10     otherwise have done?
  11   A. In those circumstances where there were unexpected or
  12     additional findings about which decisions had to be
  13     made.
  14   MR LANGSTAFF: Would you want to say anything further about
  15     the problems that face a surgeon given that an operation
  16     has begun which it turns out should not have been
  17     attempted in the form that it was.
  18   MR MANKAD: I think we need to put the whole discussion
  19     maybe into the context of two things: one thing is that
  20     the area under consideration is 1984 when there are no
  21     precise guidelines or channels available to the surgeon
  22     in the presence of failing Fontan circulation because
  23     all these guidelines have been developed subsequent to
  24     1984, number 1.
  25        Number 2, I think failing Fontan circulation of
0029
   1     this degree on the operation table is a surgical
   2     nightmare and therefore it is not surprising that the
   3     overall time taken for this operation is very prolonged,
   4     it is very stressful to the whole team, it goes on for
   5     a morning, afternoon, evening and probably sometimes
   6     half the night, so we need to put this whole thing into
   7     that context.
   8        That context, number 1, there is no doubt we did
   9     expect that this Fontan circulation is likely to fail
  10     after the operation. Mr Wisheart found that being
  11     confirmed on the table having done the Fontan operation.
  12        Then the problems at that time are what to do, and
  13     no guidelines are available. Now we would make a
  14     fenestration or some other means. I think it is very
  15     ingenious in 1984 for Mr Wisheart and the team to try
  16     and devise the way out of this by considering pulmonary
  17     artery to left atrial conduit with a view to
  18     decompressing the circulation.
  19        It is agreed that the subsequent selection of the
  20     size of the conduit -- 10 millimetres was very large but
  21     that we know now in hindsight because we invariably put
  22     in a 4 millimetre fenestration or maybe at the most
  23     a 5 millimetre fenestration, so we know the is an
  24     adequate size. 10 millimetres was too big, but
  25     unfortunately I do not think at that time there was --
0030
   1     one had to do everything based on logic rather than on
   2     science. So we had to understand that 10 millimetres
   3     was too big, but it was probably considered a relatively
   4     safe bail-out procedure.
   5        When that did not work, again in hindsight in 1999
   6     we would expect --
   7   MR LANGSTAFF: Again can I ask you to slow down, please?
   8   MR MANKAD: When 10 millimetres did not work, in 1999 we can
   9     say safely that, yes, it would not work. The surgeon
  10     then decided to undo the whole thing and put in
  11     a central shunt. So that in itself I think shows the
  12     commitment and dedication on the part of the surgical
  13     team not to give up at an earlier stage and try and do
  14     everything conceivable for the child with a view to
  15     achieving what was expected at that time, a successful
  16     outcome.
  17   MR LANGSTAFF: We have got to 1986, I think there was
  18     a review of Fontan's operations. We can pick that up on
  19     the screen at JDW 7/4. May I say the names are names
  20     which may be left because we have full consent. Was
  21     this case one of the ones which you reviewed which we
  22     may have the names blacked out on?
  23   MR WISHEART: Definitely, yes.
  24   Q. Is it the second in the list?
  25   A. I believe so. I say that because I do not think that
0031
   1     I have in my possession at the moment a document without
   2     the names being deleted, I think you have that document.
   3   Q. Not to hand I am afraid.
   4   A. But that is what I believe, that it is the second
   5     patient on the list, it cannot be any of the others
   6     actually.
   7   Q. Indeed you correctly review this as a selection error
   8     for the Fontan?
   9   A. Yes. I mean we felt it important -- and this is, what,
  10     18 months later -- to review our experience. I think it
  11     reflects the historical evolution to some extent that
  12     has been mentioned because, although we knew the ten
  13     commandments, as Mr Mankad said, there was some
  14     uncertainty as to the importance and absolute necessity
  15     of complying with each individual commandment at
  16     a time. But the conclusion we came to based on our
  17     general knowledge and our own experience in June 1986
  18     was that we must actually adopt a very rigorous policy
  19     in relation to these criteria.
  20        Subsequently of course the importance of different
  21     criteria evolved so that some were seen as terrifically
  22     important and others were seen as actually quite
  23     unimportant. If we just accept that, whatever the
  24     criteria were, we adopted a policy that we must be very
  25     rigorous and I think that was an important basis for our
0032
   1     future improvement as to this procedure.
   2   Q. We can probably see that at the bottom of this page,
   3     what is on the screen at the moment, can we? Underneath
   4     the line it is said, about eight lines down:
   5        "These considerations would seem to suggest that
   6     the selection criteria of patients for surgery are very
   7     critical and should be formally undertaken. Although
   8     I have understood this theoretically for a long time,
   9     I do think we have to be even more rigorous than
  10     before."
  11        This is you saying to yourself and to the team:
  12      "We need to take even more seriously the selection
  13     criteria which I have known as a matter of theory, but
  14     we actually need to put them into practice"?
  15   A. I think that is exactly right, yes, that is where we got
  16     to.
  17   Q. Can we see what is said at the bottom of the page?
  18     Again you emphasise I think in the last sentence of the
  19     penultimate paragraph on the page:
  20        "The question of selection for surgery remains
  21     crucial."
  22   A. Yes.
  23   THE CHAIRMAN: May I ask one question arising from this
  24     document, Mr Wisheart? Taking you to the first full
  25     paragraph, where it says on the screen:
0033
   1        "Further I do not actually know what sort of
   2     proportion of patients are rejected as surgical
   3     candidates at other major centres".
   4        From your experience, then, to what degree was
   5     that sort of information becoming available elsewhere;
   6     to what degree was information like that shared so that
   7     a body of experience could be begun to be built up?
   8   A. It was shared at that time and in the subsequent years,
   9     I think increasingly, probably in three ways that I can
  10     immediately think of. There was an increasing frequency
  11     of people publishing their experience in one shape or
  12     form in the literature and particularly important
  13     contributions came from places like the Mayo Clinic and
  14     Boston Children's Hospital.
  15        Secondly, and really in parallel to that, at
  16     various surgical meetings or cardiological meetings
  17     people would present papers.
  18        The third method of communication was that I can
  19     recall a number of specific symposia or one-day
  20     courses. I can remember one at the Brompton for
  21     example, I think in the late 1980s, but I do not
  22     remember the date, where a day's thinking was focused on
  23     the Fontan operation.
  24   MR LANGSTAFF: I think we have learned the lessons that this
  25     particular case can teach us as an exemplar from the
0034
   1     Case Note Review. What I propose to do is to move on
   2     now to the second of the cases. Given the hour it is
   3     probably convenient if we do that in 15 minutes time
   4     rather than straightaway.
   5   THE CHAIRMAN: Yes. Shall we therefore take a 15-minute
   6     break? That takes us up to 10.55.
   7   (10.40 am)
   8               (A short break)
   9   (10.58 am)
  10   MR LANGSTAFF: Matthew Rundle: Matthew Rundle was born, was
  11     he, on 5th June 1993? He had Down's syndrome, and he
  12     suffered from a complete AVSD.
  13   A. I believe that is correct, yes.
  14   Q. If we look at Medical Report 1633/76, and as before, of
  15     course, we have full consent to refer to the record that
  16     I shall show you, this is a letter dictated by
  17     Dr Jordan --
  18   THE CHAIRMAN: We are just taking an address out,
  19     Mr Langstaff.
  20   MR LANGSTAFF: I am grateful. This is a letter from
  21     Dr Jordan to the GP. The opening words, perhaps, say it
  22     all, do they:
  23        "This baby is struggling."
  24        So at this stage, which is now September, three
  25     months old, he is a struggling baby.
0035
   1        If we go to page 1632/36, there is an address,
   2     again, which we need to take out. It is another three
   3     months later on and we see:
   4        "This baby presents clinically to Truro in heart
   5     failure and has done so on a frequent number of
   6     occasions". The last paragraph:
   7        "It was agreed that he should have total
   8     correction and that his risk was somewhat elevated on
   9     account of the level of pulmonary vascular resistance.
  10     For this reason, it was felt that the operation should
  11     be carried out as quickly as was reasonably possible."
  12        You then say you will make arrangements for
  13     Matthew "to see me as urgently as possible in
  14     outpatients, in any case hopefully not later than the
  15     beginning of January. The child should be scheduled for
  16     surgery if at all possible in January 1994."
  17        So there is a degree of urgency, is there, about
  18     Matthew's case?
  19   A. Yes, there is a degree of urgency.
  20   Q. And the urgency is, is it, that with that condition one
  21     may get pulmonary vascular resistance developing?
  22   A. Yes.
  23   Q. And developing, the risk is, to such a stage as to be
  24     irreversible?
  25   A. Yes, it has been a measure of 4.7 and 4.2 as you have
0036
   1     seen in that document. Whilst it is not going to become
   2     irreversible overnight, clearly as it evolves changes
   3     are only in one direction, and therefore it is a signal
   4     to do it sooner rather than later.
   5   Q. On a clinical basis, you would say, really, you want
   6     this to be done as soon as possible, if possible in
   7     January?
   8   A. That is what we had in mind.
   9   Q. As it happened, Matthew was admitted in February, the
  10     middle of February, not in January, and an operation was
  11     not then possible because he had an upper respiratory
  12     tract infection and a possible urinary tract infection,
  13     so it was put off until March.
  14        Can you help at all as to why there might have
  15     been a difficulty in 1993 in scheduling him earlier
  16     rather than later?
  17   A. We are only talking of a difference between January and
  18     February. I saw him in outpatients in January, as we
  19     had planned, and I imagine that the reality was that
  20     when I saw him in January, the January operating was
  21     already planned so he was scheduled for February. I do
  22     not think that the difference between January and
  23     February can be construed as significant in this regard,
  24     really.
  25   Q. We have a child who, in the child's best interests,
0037
   1     perhaps might have been operated on at an earlier
   2     stage. He comes for surgery at nine months. Ideally,
   3     you would have wanted to operate at what, six months or
   4     less?
   5   A. We were seeking to reduce the age, as you know, because
   6     that was our policy, and I am not quite clear in my own
   7     mind why, following that first letter you showed us, the
   8     next steps were not taken, but as I say, I cannot
   9     comment on that; I am just slightly surprised.
  10   Q. You can comment, and you already have done, by saying
  11     you were surprised?
  12   A. Yes.
  13   Q. Because, given that first letter, you would have thought
  14     that the wheels would have got into motion fairly
  15     quickly, and there must have been some reason, either
  16     individual or systemic, as to why they did not?
  17   A. That is what I really meant when I said I cannot
  18     comment. I do not know if there were other factors
  19     which influenced Dr Jordan at that time.
  20   Q. But in terms of systematical or institutional reasons,
  21     given the middle of 1993 to the end of 1993, what might
  22     they have been?
  23   A. I cannot think of any particular institutional reason.
  24     I cannot believe there would have been. I think that
  25     any circumstances would have had to relate to the child
0038
   1     or the family. If you mean was the catheter lab closed
   2     for renovation or did everybody go on holiday or
   3     something or was there an infection in the hospital,
   4     I do not think there was anything like that.
   5   Q. Waiting lists?
   6   A. I do not have the information about waiting lists for
   7     cardiac catheterisation; I just do not know.
   8   Q. I have been asked to make clear, and I do, that the
   9     first referral to you appears to be December 1993.
  10   A. That is correct, yes.
  11   Q. So whatever the delay was in coming to surgery, it is
  12     not your individual responsibility as such.
  13   A. That is correct.
  14   THE CHAIRMAN: But as you made clear, Mr Langstaff, we
  15     look at these cases to exemplify things much wider than
  16     any particular person's responsibility, as you have said
  17     many times and it is for that reason we are looking at
  18     it now.
  19   MR LANGSTAFF: Absolutely. So you were, in general terms,
  20     looking to operate on AVSDs earlier, with, as we saw
  21     yesterday, a meeting in which that had been discussed
  22     earlier than 1993?
  23   A. Indeed. It goes right back to 1990 and 1991.
  24   Q. What I am asking for some assistance on, really from
  25     a general perspective of the time, is in general
0039
   1     terms -- it may not apply necessarily to Matthew's case
   2     but it might have done -- that might not have been
   3     achieved?
   4   A. I think that there was a general agreement and will to
   5     arrange the catheterisation and the discussions and so
   6     forth so that it would be possible to operate on the
   7     child in the first year of life, but I can remember
   8     quite a number of discussions in which we surgeons were
   9     urging the cardiologists to actually take those steps
  10     sooner, really for two reasons, the most important one
  11     so that they could be operated on sooner, earlier in
  12     their life, but also because logistically it gave us
  13     a bit more room for manoeuvre, whereas if the patient
  14     was first brought to our attention later, then it had
  15     become a matter of greater urgency. So it was easier if
  16     it came sooner.
  17   Q. And greater difficulty?
  18   A. As we know, indeed.
  19   Q. We may find subsequently looking with what happened to
  20     Matthew's case, it might have contributed to the
  21     ultimate difficulties?
  22   A. The overall delay, yes. I think it was -- yes, well,
  23     that is true. That and the underlying fact of what had
  24     happened during the months of his life, which was not
  25     fully identified at the investigations. But, yes, that
0040
   1     undoubtedly was a major factor contributing to the
   2     outcome.
   3   Q. We have come upon a number of cases in looking at those
   4     that have been reviewed where there appears to have been
   5     quite a gap between a catheterisation in a case where
   6     the diagnosis was not difficult to establish on echo,
   7     and surgery. I wonder, and therefore ask, whether it
   8     might have been possible to so arrange matters that the
   9     catheterisation and the operation were, if
  10     a catheterisation had to be done, much closer together
  11     in time?
  12   A. The plan for this one was that there was a gap of less
  13     than two months, which I must say I would regard as
  14     quite a short time. But what we surgeons wanted,
  15     really, was earlier referral altogether.
  16   Q. You would have wanted Dr Jordan, in this case, to have
  17     said, "Well, having seen Matthew at three months of age,
  18     he is not thriving; he obviously suffers from a complete
  19     AVSD: put him on your list"?
  20   A. Well, to have referred him to us, we would have
  21     discussed him and whatever steps would then have been
  22     followed, yes.
  23   Q. If that had happened, the chances are you would have
  24     regarded him with something of the same degree of
  25     urgency as you did in December?
0041
   1   A. Perhaps so. I mean, it is speculative, but, yes. We
   2     might well have done.
   3   Q. The operation itself -- if we look at the note at
   4     1633/27, that can now go on the screen. If we scroll
   5     down, there are three matters which one notices from the
   6     perfusion data. It is a bypass time of 3 hours and 16
   7     minutes and a cross-clamp time of 1 hour 59 minutes.
   8     The other matter which I want to pick up at this
   9     stage -- if we go right back up to the top of the
  10     page -- is the weight of the child, 5.2 kilograms.
  11     I will come back to that for reasons which you will
  12     appreciate but the wider audience might not, at this
  13     stage.
  14        Focusing on the time, that is, is it, a relatively
  15     long time for an operation such as this?
  16   A. It is a little bit longer than my average, but not
  17     dramatically longer than my average.
  18   Q. You were, you acknowledge, amongst the slower surgeons?
  19   A. Yes.
  20   MR LANGSTAFF: Do you have any comment about the length of
  21     time?
  22   MR MANKAD: Am I allowed to go back a bit?
  23   MR LANGSTAFF: Yes, please.
  24   MR MANKAD: With due permission of the Chair: we
  25     discussed one issue of the timing of the operation.
0042
   1     It does highlight that in an ideal world, I think, this
   2     child, number 1, may not have required catheter.
   3     Echocardiographic diagnosis was made at three months of
   4     age. In an ideal world, I think it is conceivable that
   5     at that time, when the child was struggling, the
   6     physician should contact the surgeon and say, "I have
   7     a complete AVSD. I am in the process of catheterising,
   8     if at all it is felt that catheter is necessary, but
   9     would you now be in a position to consider him for
  10     surgery within the next three months?"
  11   MR LANGSTAFF: I think that is common ground between
  12     Mr Wisheart and yourself. Dr Dickinson, this relates to
  13     the cardiologist's role as part of the team. What would
  14     you wish to see happen in a case such as this?
  15   DR DICKINSON: I think practice in our unit would be to
  16     refer for surgery at about three to four months of age.
  17     I think I am right in saying that this child was not
  18     actually referred to the cardiologist from the local
  19     hospital until about three months of age, so in that
  20     sense there was a slight delay in the child presenting
  21     to the unit in Bristol in the first instance.
  22        Having got a child of three months of age with
  23     Down's syndrome and complete AV canal, my practice would
  24     have been to refer that child for surgery straightaway
  25     on the basis of ultrasound evidence. I would not at
0043
   1     three months of age have felt it necessary to perform
   2     a cardiac catheterisation.
   3        If surgery is delayed for any reason into the
   4     latter part of the first year of life, then it may be
   5     necessary to do a cardiac catheterisation to be
   6     absolutely sure that the pulmonary resistance is still
   7     acceptable. Ideally, I would have thought that
   8     certainly an operation within the first 6 months of life
   9     would be what we would be aiming for, and ideally 3 to 4
  10     months, sometimes earlier than that if the child is
  11     struggling as this child is described.
  12   MR LANGSTAFF: Can we then move on from that to the length
  13     of the operation? Is it unduly long, or not?
  14   MR MANKAD: I think, as Mr Wisheart stated, there are
  15     tremendous variations in surgical timing of individual
  16     surgeons and although in terms of bypass time it is
  17     considered an incremental risk factor for subsequent
  18     development of morbidity, but considering the ischaemia
  19     time and the cross-clamp time of 1 hour 59 minutes,
  20     I think I can roughly say, from logic rather than any
  21     information, that it is probably within plus or minus 2
  22     standard deviation of a mean time, operative time of
  23     a surgeon.
  24   Q. So in other words, it is not out of step --
  25   A. It is not out of step.
0044
   1   Q. -- with what other surgeons might do, even though it may
   2     be on the slow side?
   3   MR MANKAD: It is on the long side, is it not?
   4   MR LANGSTAFF: Which would correspond with your own
   5     intuition?
   6   MR WISHEART: That was my view of the matter.
   7   MR LANGSTAFF: Again, so that we have the evidence, the
   8     length of time on bypass is, is it, a risk factor which
   9     increases with the length of time that one is on bypass
  10     in terms of morbidity.
  11   MR WISHEART: Yes. I think it would be common ground, I am
  12     sure, that the duration of aorta cross-clamp time is the
  13     more critical time, but that the total period of bypass
  14     is also an important time, but less so, and hopefully,
  15     its influence would chiefly be on morbidity, unless it
  16     was enormously prolonged, in which case it too would
  17     become a factor possibly contributing to mortality.
  18   MR LANGSTAFF: So we have to look at these times critically
  19     in the sense of wishing, if one can, properly to keep
  20     them as low as possible.
  21   MR MANKAD: Yes. It is advisable to keep both ischaemia
  22     time and bypass time as short as possible, but the
  23     difference in terms of the bypass time is the relative
  24     degree, i.e. 3 hours or 4 hours makes relatively small
  25     difference as opposed to 2 hours or 5 hours, so it is
0045
   1     a question of degree rather than an absolute entity.
   2     There is no cut-off point beyond which the bypass time
   3     is extremely dangerous.
   4   MR LANGSTAFF: We have heard, I think, that one should not
   5     put an undue premium on speed, because it is more
   6     important to get the surgery done meticulously.
   7   MR MANKAD: I entirely agree with you.
   8   MR LANGSTAFF: Do you accept that as a proposition?
   9   MR WISHEART: That was always my view, yes. Could I say,
  10     there is one other factor, I think, to be considered in
  11     this, but I am quite sure it is common ground to
  12     everybody, and it is, of course, the care which the
  13     surgeon must take with regard to myocardial protection,
  14     which is the part of the management of the operation
  15     that alleviates, to a degree but not completely, the
  16     effects of aorta cross-clamping.
  17        I would just mention that as I think a very
  18     important component of this discussion.
  19   Q. That is a function not just of the surgeon but of the
  20     anaesthetist?
  21   A. Well, yes. I mean, if the surgeon is engrossed in what
  22     he is doing, as he tends to be, then he may need
  23     a reminder, but it is fundamentally I think the surgeon
  24     who will dictate the policy, if you like, and say to the
  25     anaesthetist, "Please speak to me after 20 minutes" or
0046
   1     30 minutes or whatever, or the perfusionist or somebody,
   2     and will have a method in place, both for being reminded
   3     and for delivering cardioplegia. So it is part of the
   4     team effort.
   5   Q. The operation itself, if we look, please, at the
   6     perfusion data, 1633/4, can we scroll down to where we
   7     see a summary at the bottom, on the bottom right-hand
   8     side.
   9        We can pick up there, can we, the fluid balance?
  10     We will see that Matthew had 635 ml of prime on the
  11     pump. If we add that up, the fluid balance, comparing
  12     fluid in and fluid out, leaves him with a plus of 75 ml
  13     at the end of the operation.
  14        Is that a proper reading of the perfusion record?
  15   A. It seems to be. There is a 5 somewhere I cannot account
  16     for, but in essence it does appear to be.
  17   Q. If we go back, we will come to perhaps the relevance of
  18     that subsequently, but if we go back to 1633/28, the
  19     bottom of the page, so far as the surgery is concerned,
  20     there are some difficulties after coming off bypass.
  21     They are overcome and if we look at the diagnostic
  22     pressures at the bottom of the page, they appear pretty
  23     acceptable, do they not?
  24   A. On the whole they look encouraging. The venous
  25     saturation is a little low but I have not noted the
0047
   1     arterial saturation as a figure so that is the only one
   2     that I would pick out. The significance I cannot tell
   3     you without knowing the arterial saturation at the time.
   4   Q. But there is one feature of the note of that last
   5     paragraph which I do want to ask you a little about.
   6     You deal in the middle of it with the second problem
   7     beginning there:
   8        "The second problem was that the baby's oxygen
   9     saturation appeared to persist in the low 80s after
  10     withdrawal of bypass. This reduction was much greater
  11     than that which would be expected from the diversion of
  12     the coronary sinus flow. In order to eliminate these
  13     two problems, epicardial echocardiography was carried
  14     out by Dr Wilde before closure."
  15        You deal with what that shows: the possibility of
  16     some obstruction, but otherwise reasonably reassuring.
  17        How often was epicardial echocardiography carried
  18     out in the theatre?
  19   A. Not very often at all.
  20   Q. This would involve calling up Dr Wilde from the
  21     basement?
  22   A. That is right.
  23   Q. And Dr Wilde is not a cardiologist but a radiologist,
  24     although very experienced?
  25   A. A cardiac radiologist: totally committed to cardiac
0048
   1     activity. He is a cardiac specialist, it is not
   2     a part-time interest, it is his commitment.
   3   Q. While we deal with the issue of cardiography and its use
   4     intraoperatively, can I just ask you to give me
   5     a moment -- I shall have to come back to it. There is
   6     a letter from Dr Wilde in 1994 I want to ask you about.
   7     I will pick it up subsequently. We will leave that for
   8     the moment.
   9        Matthew then goes into the ICU?
  10   A. Yes.
  11   Q. We pick him up in the ICU at 1633/33. On this page,
  12     at the top of the page, the arterial blood pressure,
  13     68 over 40. That is reasonably good, I think. The
  14     respiratory, the oxygen is 100 per cent saturation, and
  15     on the whole, therefore, appearing to be in reasonably
  16     good state when he goes into intensive care. Is that
  17     a fair reflection?
  18   A. That was what we thought, yes.
  19   Q. So that the surgery has, it would appear, been thus far
  20     successful. It is all now down to the intensive care.
  21        One of the problems, or potential problems, in
  22     intensive care is that the child may suffer from a major
  23     capillary leak syndrome.
  24   A. That is something that one sees from time to time, yes.
  25   Q. It is a known complication?
0049
   1   A. It is, very much so.
   2   Q. And what happens in that syndrome is, is it, that the
   3     capillaries, throughout the body, leak in the sense that
   4     the fluid exudes from them into the surrounding tissues,
   5     so there is an element of oedema, and that in turn sets
   6     up a balance between the tissue and the vessel which may
   7     take some time naturally to resolve and if it is not
   8     dealt with one way or another, may lead to a vicious
   9     cycle?
  10   A. Yes. It has a number of important consequences. It is
  11     almost certainly not just a leak of fluid but also
  12     a leak of plasma proteins to some degree, which
  13     therefore makes it more difficult for the fluid to be
  14     brought back into the capillaries.
  15   Q. The albumen gets out from the vessels into the tissues?
  16   A. Yes.
  17   Q. You do not then have the gradient or whatever it is that
  18     brings the fluid back?
  19   A. That is right; but the more immediate consequence of
  20     course is that this is fluid lost from the circulation,
  21     so that the circulating blood volume becomes reduced and
  22     the cardiac output becomes reduced.
  23   Q. So what one has to do to manage a problem such as this
  24     is either prevent it or treat it when it occurs.
  25     Prevention would involve giving steroids, would it?
0050
   1   A. Prevention in 1994, we did in fact, I believe, as
   2     I recall, use steroids, but I do not think that achieved
   3     a complete prevention. It may have contributed.
   4     I think the techniques that subsequently became widely
   5     used in particular ultrafiltration during bypass, would
   6     now be regarded as a more effective method of
   7     prevention, but we were not using that in 1994.
   8   MR LANGSTAFF: What do you say about the way itself that one
   9     can attempt to prevent this known complication arising?
  10   MR MANKAD: I think my first reaction would be that we
  11     should probably use the term "minimise the incidence" of
  12     capillary leak syndrome rather than complete prevention,
  13     because it is often not possible to completely eliminate
  14     the occurrence of this complication following coronary
  15     pulmonary bypass.
  16        Minimising the incidence of capillary leak
  17     syndrome in babies has a number of avenues and it is the
  18     combination of basic science research as applied to
  19     cardiac surgery which has facilitated our understanding
  20     of this process and the mechanisms to improve the
  21     process or act on this process.
  22        One of those, very rightly as Mr Wisheart has put
  23     it, is ultrafiltration, either on cardiac pulmonary
  24     bypass, or, in addition to on cardiopulmonary bypass, at
  25     the end of coronary pulmonary bypass, which is
0051
   1     a modified form of ultrafiltration.
   2        Before I come to the second issue of minimisation,
   3     I think that would have been important in this child
   4     because if we go back to the perfusion chart, the child
   5     had nearly 1700 ml of clear fluid, crystalloid, during
   6     coronary pulmonary bypass. For a 5 kilogram baby that
   7     is a fairly large quantity of clear fluid. So it is
   8     conceivable that this child would have benefited from
   9     ultrafiltration.
  10   MR LANGSTAFF: But they did not have that on the unit?
  11   MR MANKAD: Yes. The second thing --
  12   MR LANGSTAFF: Can I ask, what is your view as to whether it
  13     was generally available in 1994.
  14   MR MANKAD: Even today, I think that there are a number of
  15     units in the country -- put it this way: I think over
  16     the last five years, there has been an increasing
  17     acceptance and realisation of the importance of
  18     ultrafiltration on and off bypass. An increasing number
  19     of centres have been using that. In 1993/94, it is
  20     conceivable that there were -- from the top of my
  21     head -- maybe 20 or 30 per cent of the units in this
  22     country would be using ultrafiltration in on bypass and,
  23     in the modified way, off bypass.
  24   MR LANGSTAFF: So it was the exception rather than the rule
  25     in 1993/94.
0052
   1   MR MANKAD: Yes.
   2   MR WISHEART: I should say we did have it at that stage, but
   3     it had not become part of our routine procedure. We
   4     used it in circumstances where a big fluid load had been
   5     identified during surgery and we wanted to restore the
   6     balance prior to leaving the operating room, so we had
   7     taken the first step, if you like, but we were not using
   8     it routinely.
   9   MR MANKAD: The second possible way of minimising the
  10     incidence would be the use of, as you alluded to,
  11     steroids. This issue is still very fluid, and whether
  12     to use steroids, when to use steroids, how much to use
  13     steroids what form of steroid, are all still debatable
  14     issues.
  15        Again, I would say that it is not universally
  16     accepted that steroids should be used as one of the
  17     preventive measures for capillary leak, but my own
  18     personal feeling is that methyl prednisolone used in
  19     a particular dosage a few hours before the onset of
  20     cardiopulmonary bypass is beneficial.
  21   MR LANGSTAFF: Is this a controversial view, then.
  22   MR MANKAD: The view in terms of use is not controversial,
  23     but its effectiveness is still under debate.
  24   MR LANGSTAFF: So the theory would be to avoid the risk, try
  25     it, would it?
0053
   1   MR MANKAD: I think more and more evidence is coming forward
   2     now, with proper understanding of the siderokines and
   3     what actually triggers the siderokines at the nuclear
   4     factor level and how this process can be stopped at an
   5     earlier stage. So more understanding is coming through
   6     now about the benefit of steroids than five years ago.
   7     So, yes, I think it is debatable, but more and more
   8     centres now use it.
   9   MR LANGSTAFF: But five years ago it was more debatable.
  10   MR MANKAD: It was much more debatable, that is absolutely
  11     right.
  12   MR LANGSTAFF: Dr Dickinson?
  13   DR DICKINSON: I would just make the point that it is not
  14     a routine measure, even now. So far as I am aware, we
  15     do not use steroids routinely in Leeds pre-operatively
  16     in these circumstances.
  17   MR LANGSTAFF: So much for minimisation, preferring that
  18     word to "prevention".
  19        As for treatment, the principles would be, would
  20     they, to maintain cardiac function, from what you have
  21     said that is vital in this syndrome; to avoid
  22     vasodilation, again, for obvious reasons, and to begin
  23     haemodialysis. Would that be the approach, or not?
  24   MR WISHEART: Well, I would broadly agree with your
  25     early suggestions, but not necessarily with the last
0054
   1     one. The approach which we had in 1994 would have been
   2     first we would recognise that we cannot actually
   3     influence the recovery of the capillaries, so what we
   4     are doing is to hope and expect the capillaries to
   5     recover, and we have to maintain the child's status as
   6     best we can until then. I think that is quite
   7     important.
   8        The second thing I would point out is that this
   9     leak of fluid of course is essentially into all parts of
  10     the body, so it can be into the kidneys and it can
  11     interfere with renal function. It can be into the heart
  12     muscles so can interfere with the cardiac function.
  13     That is just the background.
  14        So the management, therefore, involves the
  15     maintenance of an adequate circulating volume, but then
  16     there is an anxiety if you do that too energetically,
  17     you enhance the process of fluid leakage, so there is an
  18     element of balance and compromise in that.
  19        I have mentioned loss of protein, so there may be
  20     also an element of replacement of proteins to the
  21     circulating volume in an attempt to maintain that
  22     osmotic gradient or that view you referred to a few
  23     moments ago. In the meantime you may have to support
  24     the work of the heart with inotropes or whatever, and
  25     you may have to support the renal function with renal
0055
   1     dialysis, ultrafiltration or some form of renal
   2     support.
   3        Those would be the broad outlines of how I would
   4     approach it. I have to come back to the careful balance
   5     that has to be struck with regard to fluid replacement.
   6     That is, I think, quite a crucial element of the care,
   7     because if one gets that wrong, you can actually enhance
   8     the process of leakage, and I think delay recovery.
   9   Q. Something like 90 to 95 per cent of this condition are
  10     recoverable, are they not?
  11   A. I would not be able to quote a percentage. I just do
  12     not have that information.
  13   Q. It is important, is it, to get on top of it early in
  14     post-operative care?
  15   A. If it is going to happen, it usually becomes evident
  16     within the first 24 to 48 hours. It may not be evident
  17     immediately, and it is in fact usually not evident
  18     immediately; it is something that you see after an
  19     interval. So as soon as you detect this happening, then
  20     it is important that you start thinking and approaching
  21     the problem in the way that I have outlined, or whatever
  22     way you think is best. But I am just outlining how
  23     I personally thought about it and approached it.
  24   Q. So the stages are: detection of the problem and then
  25     having a strategy to deal with it and pursuing that
0056
   1     strategy?
   2   A. Indeed.
   3   MR LANGSTAFF: Are those the two stages?
   4   MR MANKAD: I think I would agree with Mr Wisheart that the
   5     process, once initiated, because of the cardiopulmonary
   6     bypass, is self-limiting and it is very difficult if not
   7     impossible to intervene in that process of capillary
   8     leak.
   9        So the principles of management are to maintain
  10     circulation during that time, but more importantly, to
  11     try not to overdo things, so i.e. to maintain the
  12     pressure at an acceptable level for cerebral and cardiac
  13     perfusion, but at the same time, to institute some form
  14     of dialysis -- and usually in these children it is
  15     peritoneal dialysis rather than haemodialysis or
  16     haemofiltration -- to try and institute at an earlier
  17     stage, thereby, even though there is very little renal
  18     kidney output, the kidneys are supported for the time
  19     being initially and subsequently, when the process is
  20     stopped, say, three, four or five days usually, the leak
  21     invariably stops because there is no more continuing
  22     insult unless there is sepsis or endotoxins in
  23     circulation, then the peritoneal dialysis would slowly,
  24     over a period of time, reabsorb the fluid from the
  25     interstitial compartment of the body and the child will
0057
   1     slowly continue to improve.
   2        The key thing for management is: (1) to anticipate
   3     that this is happening whenever one sees an oedematous
   4     child or a child requiring a disproportionately large
   5     amount of colloid replacement; and (2) to be proactive
   6     in terms of management so as to improve the situation in
   7     due course.
   8   MR LANGSTAFF: Dr Dickinson, do you want to comment?
   9   DR DICKINSON: Really, only to agree with what Mr Mankad has
  10     said: I think it is crucially important from the point
  11     of view of organ functions to restore the fluid balance
  12     to an appropriate situation. I think that removing
  13     fluid is an important part of this, whilst at the same
  14     time one has to support the intervascular volume by
  15     giving a certain amount of fluid as well. As
  16     Mr Wisheart said, there is a balance to be struck
  17     between the two.
  18   MR LANGSTAFF: How does one remove the fluid?
  19   DR DICKINSON: I think in infants, we would always, I think,
  20     use peritoneal dialysis.
  21   MR LANGSTAFF: We see, at page 34, the next page, the
  22     post-operative day 1, the problems that we know to the
  23     top of the page: poor gas exchange, hypoxic despite
  24     100 per cent oxygen, poor cardiac output. If we go down
  25     to the bottom of the page, the word "oedematous" has
0058
   1     been circled, so this note would appear to suggest that
   2     in the first post-operative day one might expect
   3     a capillary leak syndrome to demonstrate itself, but
   4     here Matthew is showing signs of it, is he not?
   5   MR WISHEART: He is showing signs of oedema which could
   6     either be the consequence of the imbalance that you drew
   7     our attention to at the time of the operation or could
   8     be due to a continuing factor, namely the leak that you
   9     have mentioned. I am not sure whether, at this stage,
  10     it would be quite clear which.
  11   Q. Page 36, post-operative day 2, "poor gas exchange", the
  12     third line down, "gross oedema, colloid sequestration".
  13        "Colloid sequestration": what does that suggest?
  14   A. Well, the words suggest that there is fluid in the
  15     tissues and that there is some plasma proteins with
  16     them, but I think one would have to say that this is an
  17     expression of clinical judgment. I am not quite sure
  18     whether this is a precise scientific statement.
  19   Q. If we have gross swelling, together with a degree of
  20     proteins in the tissues rather than --
  21   A. But he does not actually know that. He just knows there
  22     is oedema. The word "colloid" I am a little uneasy
  23     with.
  24   Q. So what do you think the recording clinician here has
  25     concluded? He has concluded, has he, that there is
0059
   1     a capillary leak syndrome?
   2   A. Yes, so I think if he had said "gross oedema query
   3     colloid sequestration" or whatever, but I think it is
   4     important to note that gross oedema is an actual
   5     observation. Colloid sequestration is a conclusion that
   6     may be drawn from that.
   7        That is the point I wish to make.
   8   Q. Having decided that there is a capillary leak syndrome,
   9     as the clinician here appears to have done, if we go
  10     down the page, we have an idea of the balance, plus 64
  11     and plus 150 is crystalloid and colloid. And
  12     clinically, obviously, oedematous. Can we go on to the
  13      next page? The plan is "Continue to cool. Full
  14     inotropic support". I am not sure I can decipher the
  15     next few words.
  16   A. The word following the upward arrow is Enoximone, which
  17     is, let us say an inotropic drug, a drug to support the
  18     work of the heart.
  19   Q. Then "Keep positive on colloid"?
  20   A. Yes.
  21   Q. Then the next one you will have to interpret for me.
  22   A. I am having difficulty. It may be short for Fentanil.
  23     I am really not sure; I should not speculate. I do not
  24     know, is the answer.
  25   MR MANKAD: It is "Reduce Fentanil Vancuronium to 1 ml per
0060
   1     hour". That is a paralysing agent.
   2   MR WISHEART: That is correct.
   3   THE CHAIRMAN: They are referred to higher up, under the
   4     heading, "Sedation".
   5   MR WISHEART: That is right, yes, the Fantanil is.
   6   MR LANGSTAFF: Can we go to the comments at the bottom
   7     of the page? What comment would you make about what is
   8     said there, Mr Mankad?
   9   MR MANKAD: I think that is the first time that a plan is
  10     made to insert a peritoneal dialysis catheter, but it
  11     seems from that that, not with a view to dialysing the
  12     baby but with a view to slowly -- and I stress the word
  13     "slowly" -- decompressing the abdominal fluid. The
  14     final line, 1700 hours, "20 ml per hour of ascitis
  15     drained off", so the plan has been to do extremely
  16     gradual draining of the abdominal fluid.
  17   MR LANGSTAFF: We can tell that there was not actually
  18     dialysis at this stage because we can actually check the
  19     charts, can we not, if we go to page 259?
  20   MR WISHEART: Dialysis did not begin until the sixth
  21     post-operative day.
  22   MR LANGSTAFF: I am grateful. If we go, then, to the
  23     third day, page 38, the top of the page is the last item
  24     under "Problems", "Very oedematous". We can go to
  25     page 40 for the fifth day. Again, oedema. Not until
0061
   1     the sixth day was, as you say, dialysis begun, and it
   2     was not long after that that Matthew failed to survive,
   3     was it?
   4        What do you say about the plan here and approach,
   5     Dr Dickinson?
   6   DR DICKINSON: I think that the initial assessment
   7     following the surgery seems to me that this child had
   8     a very good anatomical result from the operation.
   9     I think Dr Wilde's intraoperative echocardiogram can be
  10     relied upon as showing a good anatomical result, and the
  11     right heart and pulmonary pressures recorded on the
  12     first day show that they were substantially less than
  13     the systemic pressure, which I think indicates fairly
  14     clearly that the pulmonary resistance, which we talked
  15     about earlier as potentially being a problem really
  16     probably was not a problem, even with a relatively late
  17     operation.
  18        So I think, from all those points of view, things
  19     really looked very good. In fact, from that starting
  20     point I think you would expect the child to have
  21     survived. The fact that he was oedematous I think on
  22     the second post-operative day and active dialysis to
  23     bring the fluid balance under control was not started on
  24     the sixth post-operative day does concern me. In our
  25     unit, we would certainly be more proactive about that,
0062
   1     and it is not unusual for dialysis to be started
   2     immediately on coming back from theatre if we are
   3     concerned about the fluid balance.
   4        Certainly, in a child who is described as "grossly
   5     oedematous", I think on the third post-operative day,
   6     I would certainly be feeling very strongly that dialysis
   7     ought to be -- it is an important aspect of management
   8     at that stage.
   9   MR LANGSTAFF: Were you a member of the review team of
  10     this particular case?
  11   DR DICKINSON: No, I do not think so.
  12   MR LANGSTAFF: Nor you, Mr Mankad?
  13   MR MANKAD: No.
  14   MR LANGSTAFF: That corresponds, I think, with their
  15     observation that earlier dialysis should have been
  16     performed. That is what they are saying. Can you help
  17     us as to whether you agree or not, why it was not?
  18   MR WISHEART: I can try to explain what we were thinking,
  19     and I have jotted a few numbers and notes from these
  20     notes, because it is quite difficult to bring things
  21     together, as I am sure -- you know, for the different
  22     fluid charts and dialysis charts.
  23   Q. We will do the best we can.
  24   A. What I have here, I have just made a note of some
  25     figures day-by-day. For crystalloid fluids in and out,
0063
   1     colloid fluids in and out, urine output, blood test
   2     results and so forth.
   3        It is quite clear, and I do not think there is any
   4     disagreement about the fact that the child was
   5     oedematous and became more oedematous. The question
   6     really is at what point did we think or conclude that
   7     this was an active or a major sequestration process that
   8     we were observing, as opposed to the alternative that
   9     I mentioned.
  10        If a sequestration process is gross, you know,
  11     a really severe one, the amount of fluids, colloid
  12     fluids which can be going in and out through peritoneal
  13     drains, chest drains and so forth, can measure many
  14     litres a day, even in a small child. The amounts in
  15     this child on the first day were just over half a litre,
  16     and on the second day, under one litre and on the third
  17     day, slightly less than on the second day.
  18        So I give you that information just as background
  19     information.
  20        The crystalloid balance and the urine output were
  21     acceptable through this period. The urine output was
  22     sufficient. The blood tests, which might reflect an
  23     inadequacy of kidney function -- they were really not
  24     rising at all. It is not that they were rising but not
  25     significantly, they were not rising at all. So I think
0064
   1     that our thinking was that if this was a sequestration
   2     process, it did not at that point appear to be of itself
   3     one of the more severe ones and therefore we were taking
   4     the steps we would normally take, but there was oedema,
   5     which was influencing organ function and the fluid
   6     collected in the abdomen was probably splinting the
   7     diaphragm and interfering with pulmonary function, and
   8     then, whatever fluid was in the lungs was also
   9     interfering with pulmonary function, contributing to the
  10     hypoxia that has been noted.
  11        So we tried, therefore, to deal with that in
  12     a controlled way by draining the fluid from the abdomen,
  13     so that hopefully pulmonary function would improve and
  14     by dealing with it in the other ways that we have
  15     already agreed are appropriate, but not yet proceeding
  16     to the step of dialysis.
  17        I think that we did take the view -- I am not sure
  18     I would not still take it -- that there was not a clear
  19     indication to institute dialysis at that time. I do not
  20     remember there being any debate, for example, amongst
  21     the different members of the team. Most of these notes
  22     that you have referred to are, I think, the notes of
  23     Dr Pryn, but I am not 100 per cent certain. I think
  24     they are.
  25        So we would have been discussing and debating
0065
   1     these matters and there is certainly no suggestion here
   2     that there was a tension between us as to what direction
   3     we should go in.
   4        I hope, therefore, I am reflecting the view of
   5     myself and the team. Those were our thoughts.
   6   Q. Was there a reason why one would not wish to begin
   7     dialysis? You told us that there was not, perhaps, as
   8     you saw it, the strongest of reasons to do so, but was
   9     there a reason not to do so?
  10   A. Yes. I think there are a number of reasons. I mean,
  11     I think you always have to have a reason to institute
  12     any intervention, because in fact any intervention
  13     carries its own risks and complications and therefore
  14     there has to be a clear reason to justify taking on
  15     board those risks.
  16        One of the risks, of course, is that by putting
  17     a tube, a foreign body, into the abdomen of a child, or
  18     indeed any patient, you are creating another route
  19     whereby infection may be introduced. You will say, of
  20     course, that that risk was taken on whichever day it
  21     was, the second or third day, and that is absolutely
  22     correct --
  23   Q. The dialysis was not started until the sixth.
  24   A. But that is nevertheless one factor. Another factor
  25     brings us back to the management of sequestration and
0066
   1     the need to strike the right balance.
   2        Mr Mankad picked up the point which is in the
   3     notes that it was important to drain the fluid slowly
   4     from the abdomen, because if you drain it quickly, then
   5     you could quickly induce a serious imbalance, the effect
   6     of which would be to reduce the cardiac output in the
   7     end result.
   8        So the introduction of dialysis, although you hope
   9     it is controlled, and that is what you are aiming for,
  10     nevertheless, you recognise the possibility that from
  11     hour to hour there may be fluctuations, and you are
  12     therefore introducing another element whereby an
  13     imbalance of fluid can actually be created.
  14        You may feel that is a bit cautious, even
  15     defensive, but it is a factor entering into this, and as
  16     I say, the urine output for this size of child was
  17     continuing to be sufficient and the biochemical markers,
  18     if you like, the blood tests that would indicate
  19     a problem with renal function, were not doing so.
  20     So those were our reasons. I am sure there are others,
  21     but I cannot just marshal them at the moment.
  22   Q. Was there a paediatric nephrologist available?
  23   A. Yes. We worked closely with paediatric nephrologists.
  24     There were a team of three. They were based inevitably
  25     at another hospital, not even at the Children's
0067
   1     Hospital, but we had an excellent working relationship
   2     with them and they came very quickly and responsively to
   3     advise us when we asked them to do so.
   4   Q. Do you know whether any advice was taken in this case?
   5   A. I would not have thought there was, prior to the
   6     institution of dialysis. There may well have been then,
   7     but I doubt if there would have been beforehand.
   8   MR LANGSTAFF: There is a difference of approach which has
   9     become apparent in the process Mr Wisheart has described
  10     and the approach the reviewing team felt ought to have
  11     been the position with regard to dialysis.
  12        The sense in which the debate is going to help us
  13     may be limited, but do you want to say anything about
  14     that before I move to some of the other issues that may
  15     be highlighted?
  16   DR DICKINSON: I was going to make the observation that
  17     clearly there are differences in practice from one unit
  18     to another. I do not feel confident about saying what
  19     the practice in my --
  20   THE CHAIRMAN: I cannot hear very well. It is my fault, but
  21     I simply cannot.
  22   DR DICKINSON: I can only speak for the practice in my own
  23     unit in Leeds. I know my current surgical colleague
  24     feels very strongly that fluid balance in the critical
  25     period immediately after an operation of this sort is
0068
   1     indeed really vitally important to the extent that he
   2     leaves a peritoneal dialysis catheter in the peritoneum
   3     at the end of every operation, irrespective of whether
   4     there have been problems during the surgery or not, so
   5     every patient in Leeds comes back with a peritoneal
   6     catheter in place. Whether we use it or not is
   7     immaterial.
   8   MR LANGSTAFF: That is something we had suggested to
   9     us by another one of the consultant experts who sat
  10     where you are sitting now in relation to a case of
  11     Mr Dhasmana's. I will ask Mr Dhasmana to comment in
  12     a moment on that.
  13   DR DICKINSON: I entirely agree with what Mr Wisheart is
  14     saying about the risk of infection and the good reason
  15     for doing it, but we do feel there is a good reason for
  16     being proactive about fluid balance in the immediate
  17     postoperative period.
  18   MR LANGSTAFF: Mr Mankad?
  19   MR MANKAD: I think I agree that there are going to be
  20     different lines of management practices in the Intensive
  21     Care Unit. Whichever way we look at it, I think the
  22     fundamental issue here is, was this child considered to
  23     have capillary leak syndrome from Day 1/Day 2, or was it
  24     felt until very late that this child did not have
  25     capillary leak syndrome and just normal oedema?
0069
   1        Whichever way one looks at it -- in fact, let us
   2     take an example of what Mr Wisheart says: that it was
   3     felt that this child did not have capillary leak,
   4     because he was only leaking very small quantities, fluid
   5     balance was not grossly positive, and he was just
   6     oedematous. If so, I would actually make an even
   7     stronger case for earlier dialysis, because if there was
   8     no leak, then there was no albumen in the interstitial
   9     fluid and by dialysing the child earlier, we could have
  10     shifted the fluid at an earlier stage and thereby taking
  11     best advantage of the dialysis.
  12        However, I personally feel that the child, from
  13     24/48 hours, even 24 hours down the road, experienced
  14     clinicians would usually know whether it was a capillary
  15     leak or not. It did look and sound like capillary leak,
  16     in which case, weighing the pros and cons of risk of
  17     dialysis against the benefits, I think one would err on
  18     the side of earlier dialysis.
  19        So my feeling here is that it is an approach to
  20     postoperative management which is different in different
  21     centres which is probably under consideration.
  22   MR LANGSTAFF: Do you want to comment on the suggestion
  23     that in other surgeons' practices, a catheter is left in
  24     situ?
  25   MR WISHEART: Yes. I would just like to comment that
0070
   1     Dr Dickinson's surgical colleague was my trainee.
   2   Q. So he learned it from you, did he?
   3   A. No. My next point is that he actually learned it from
   4     Melbourne, he said. I think you may have heard that in
   5     previous evidence as well. There was a time when
   6     I think people quite widely practised that and we did
   7     for a time, but we did not continue it because our
   8     experience was that we did not always use it and we
   9     thought it preferable, therefore, to put in a peritoneal
  10     dialysis cannula when we thought we needed to do so.
  11     That is something we had tried but we did not persevere
  12     with.
  13        I think we are probably talking of differences of
  14     approach here. I think that there is a lot of common
  15     ground. I think the common ground is that by the second
  16     day, I am sure it was our view that there was
  17     a capillary leak. I think it was our view that it was
  18     a relatively modest capillary leak, and I think,
  19     therefore, we had an expectation that it would resolve.
  20     Which in a sense brings us back to the very initial
  21     point that has been made, namely, that the management of
  22     the patient is in the expectation that this underlying
  23     problem with the capillary leak will get better.
  24   Q. It also brings us back, perhaps, to the very first point
  25     that we dealt with and agreed upon, in dealing with this
0071
   1     sort of position, that one has to recognise the problem
   2     first, and secondly, then, attempt to approach it.
   3        I think what you are saying to me is that what may
   4     not have happened here is that the full extent, the
   5     degree of the problem, may not have been recognised, as
   6     it happens, quite soon enough?
   7   A. No, I think I would say that our assessment of the
   8     problem was that it was not one of the more severe
   9     episodes and that the divergence, then, I think is what
  10     follows after that. Because it did not appear to be one
  11     of the more severe episodes we had an expectation that
  12     it would recover, and we took the steps which were our
  13     normal practice to take in those circumstances, and
  14     which did not include dialysis unless there was a reason
  15     to dialyse over and above, but things then progressed
  16     from there.
  17   Q. You would have the overview of intensive care as having
  18     been the surgeon who had conducted the operation. At
  19     this stage, in 1994, there was not a consistent
  20     intensivist presence on the unit, was there?
  21   A. Not round the clock, not every day of the week.
  22   Q. The anaesthetists had some sessions which they devoted
  23     to intensive care?
  24   A. When I mentioned that these are possibly the notes of
  25     Dr Pryn, and it is only "possibly", I think -- the notes
0072
   1     of either Dr Pryn or Dr Davies, but I think it is
   2     Dr Pryn. That means he was acting in his intensivist
   3     capacity, which meant that he was there in the mornings,
   4     advising and so forth and participating fully.
   5        So that was his intensivist input into the
   6     discussions, yes.
   7   Q. But in terms of someone keeping a careful eye to see if
   8     the expectation was justified, in the event, one would
   9     need ideally a regular presence about a regular review
  10     by someone who knew the details and the facts?
  11   A. Yes, and that is essentially me. Well, my team and
  12     myself.
  13   Q. Except that you are only able to get to the Intensive
  14     Care Unit when surgical commitments permit?
  15   A. You said a regular review and I was able to undertake
  16     a regular review. I was not able to maintain a constant
  17     presence, rather a repetitive presence. I was not there
  18     all the time, but I was there regularly, keeping the
  19     review in mind, but then, you see, Dr Pryn was also
  20     there each day and in a sense, the fact that he was not
  21     there for a period gave him a slight distance that would
  22     enable him to see changes possibly more clearly than
  23     I would have seen them.
  24        So it is a team effort, but I absolutely agree, it
  25     was part of my fundamental attitude, that I was
0073
   1     maintaining the continuity and the overview.
   2   Q. The development to having an intensivist in the ICUs was
   3     something which I think initially you were not so
   4     convinced about, as you later became. Is that fair?
   5   A. I think it is like all major changes, and this
   6     represented quite an important change. We debated it
   7     and part of the difficulty, I think, in it was that
   8     there was a rather long and difficult transitional
   9     period. My view to intensive care was very much that
  10     people needed to be committed to it, and it was very
  11     hard to function in intensive care if you just came in
  12     and went out again, so to speak and did not pick up the
  13     consequences of what you had advised or instituted or
  14     done, so there had to be an element of continuity.
  15        The difficulty with the transitional period, when
  16     we first had intensivists, was, of course, that we only
  17     had them part of the time and therefore, it was still
  18     necessary for the surgeon, and I think Mr Dhasmana --
  19     I do not know what he said on this point, but I do not
  20     think there was a great deal of distance between us --
  21     so we continued to feel that in fact the continuing
  22     responsibility lay with us.
  23   Q. In fact, I think at one stage in your statements you
  24     make the point that both you and Mr Dhasmana attempted
  25     to remedy some of the less attractive aspects of the
0074
   1     split site by spending rather longer in the Intensive
   2     Care Unit than you might otherwise have done?
   3   A. I think that is correct, because we represented the
   4     regular cardiological input, if I may say that, but we
   5     were the cardiac specialists who were regularly there,
   6     yes.
   7   Q. Again, in this question of organisation, appreciating
   8     that it was developing over a period, what Dr Macrae
   9     told us, in terms of reviewing the Case Note Review, was
  10     that it was not entirely clear to him what precise role
  11     or what tasks evolved to the anaesthetists in the
  12     Intensive Care Unit. He was looking at the anaesthetist
  13     here. It was not clear to him how the various elements
  14     worked as a team, or if they really did see intensive
  15     care as a team issue or whether it was just seen as
  16     a surgical environment into which other people were
  17     invited to contribute in a sort of "We need this doing,
  18     he should come and do it" basis.
  19   A. I would like to comment on that, if I may?
  20   Q. Please.
  21   A. Two comments just straightaway:
  22        I think that it is difficult, looking at the
  23     notes, to answer the questions that Dr Macrae was asking
  24     and it is certainly my view that there was by and large
  25     a very good co-operation between the members of the team
0075
   1     in intensive care. There were areas that the
   2     anaesthetists certainly had the predominant interest.
   3     There were areas where the surgeon had the predominant
   4     interest, and there were also overlapping areas, but no
   5     aspect of the care of the child was outside the
   6     interests and comment and suggestion of any member of
   7     the team. If the anaesthetists suggested to me
   8     something that I would have regarded as predominantly my
   9     territory, then that would have been helpful and
  10     hopefully would have been properly considered. With all
  11     due sensitivity, of course, the surgeon from time to
  12     time might have suggested things to the anaesthetist and
  13     by and large, that was properly received and it was just
  14     debated and common ground established.
  15        So my own view is that there was a good
  16     understanding mostly, in intensive care, and good
  17     co-operation, and I do not actually agree with
  18     Dr Macrae's comments.
  19        I have now forgotten what the second point was
  20     that I wanted to respond to.
  21   Q. Shall I read you the comments again:
  22        "It is not entirely clear to me what precise role
  23     or what tasks devolved to the anaesthetists in the
  24     Intensive Care Unit."
  25   A. I have responded to that.
0076
   1   Q. "It was not clear to me how the various elements worked
   2     as a team or if they did really see intensive care as
   3     a team issue, or whether it was just seen as a surgical
   4     environment into which other people could be invited
   5     to contribute."
   6   A. Yes, thank you; that was it. It was that final comment
   7     about the suggestion that it was run by the surgeons and
   8     they said, "Please come and do this". Never, in my time
   9     in Bristol from 1975, was it like that, never at all.
  10     As far as I am concerned, we were a team; we were
  11     colleagues. Whether they were anaesthetists, paediatric
  12     nephrologists, cardiologists, nurses, physiotherapists,
  13     whatever, we were a team, each with input, each with
  14     a freedom to make any comment they wished to make and
  15     contribute to the debate. It was never a question of
  16     "Please step up and do X". Absolutely not.
  17   Q. But you were not a team that found it very easy to talk
  18     to each other though, were you, because you would do
  19     your ward round at a time when you could go to theatre
  20     thereafter; the anaesthetist, if he was doing a ward
  21     round, would be later?
  22   A. There were some practical difficulties, but if somebody
  23     wanted to talk to somebody, a way would usually be
  24     found, and for the great majority of the people, it was
  25     found.
0077
   1   Q. If we look at UBHT 52/263, the foot of it, this is the
   2     Hunter/de Leval report. It is the first of the two
   3     versions.  Both versions make the same point. It says
   4     here:
   5        "The paediatric cardiologists", it deals with
   6     intensive care at the bottom of the page, postoperative
   7     care in the Children's Hospital, it deals with that. At
   8     the Royal Infirmary the postoperative management was
   9     done by the cardiac surgical team and the anaesthetic
  10     team, as you describe:
  11        "The person on site on a 24-hour basis is
  12     a surgical SHO. During the daytime there are currently
  13     two or three anaesthetic sessions which are dedicated to
  14     postoperative care", looking at 1995.
  15   A. Yes.
  16   Q. "The paediatric cardiologists help with the
  17     postoperative management of the children at the Royal
  18     Infirmary. The overall postoperative management at the
  19     Royal Infirmary appears to be highly disorganised with
  20     conflicting decisions between the surgical Senior
  21     Registrar and the SHO, who do rounds at 8.00 am, the
  22     anaesthetists who see the patients at 9.00 am and the
  23     intensivists who work three days a week."
  24        That was their view expressed in both versions,
  25     a similar view expressed in the other version of the
0078
   1     Hunter/de Leval report. Are you saying it was not
   2     justified?
   3   A. I am grateful for an opportunity to comment on this.
   4     I have to say that I was shocked when I read this, and
   5     I did not recognise the Intensive Care Unit that
   6     I worked in, and have done for many years. I recognise
   7     that everybody did not always, at the first word, agree
   8     with everybody else, but nearly always, after proper
   9     discussion, agreement would be reached.
  10        I actually refrained from any comment -- well,
  11     pretty well any comment -- to anybody on this, until
  12     very recently, when I read in the transcripts of these
  13     proceedings that this remark was based on the evidence
  14     of one person only to Mr de Leval and Dr Hunter. That
  15     is the evidence of Fiona Thomas.
  16        In fact -- I am not really wishing to criticise
  17     Mr de Leval or Dr Hunter, because they had a very
  18     limited time to carry out their inquiry, but they did
  19     state quite clearly that they did not take evidence on
  20     this point from anybody else. All I knew was that they
  21     had not taken evidence from me on this point, but I did
  22     not know who else.
  23        So I would simply draw your attention to that.
  24     I think that, therefore, this conclusion is not based on
  25     canvassing a broad spectrum of opinion.
0079
   1   Q. It appears, I think, to be based in part upon what one
   2     might describe as "acknowledged fact", the different
   3     ward rounds that there were?
   4   A. Yes.
   5   Q. The identity of the consistent presence and the
   6     difficulties which we have had expressed to us from
   7     a number of different sources, the difficulties of the
   8     surgeon on the one part, the anaesthetist for the other
   9     being at the Intensive Care Unit and being in a position
  10     to make decisions in respect of a particular child of
  11     the unit.
  12        That is, I think, a general flavour of much of the
  13     material which, as you know, we have heard.
  14        Is it the case that it was not easy to co-ordinate
  15     the care in the Intensive Care Unit?
  16   A. In terms of what is happening in Bristol today, then one
  17     can clearly see that this was not an ideal arrangement.
  18     The facts that you have described are largely correct
  19     but I think there are other facts that could also be
  20     added to it that are necessary to have a complete view.
  21        I would be grateful if I could see the bottom of
  22     the previous page again, please, so that I do not make
  23     an error here.
  24        You see, what it does not say is that there is an
  25     anaesthetic Senior Registrar or Registrar; there is
0080
   1     a cardiac surgical Senior Registrar, or Registrar, who
   2     are available at all times to intensive care. It rather
   3     sets up the notion that the cardiac SHO is sort of the
   4     "kingpin", but in fact, the cardiac SHO was not, he was
   5     just the person who was there, and indeed, one of his
   6     functions stated explicitly in the "red book" that has
   7     been referred to was to ensure that if somebody came at
   8     one time and somebody else came at another time, they
   9     would be aware of each other's suggestion and advice in
  10     the event that it was not written down. So he was very
  11     much a co-ordinator, a person who did things that people
  12     more experienced than himself advised him to do, or he
  13     helped the more experienced person to do it.
  14        Then, of course, the consultants involved were
  15     actually frequently in intensive care, as operations,
  16     outpatients, whatever commitments, permitted. They
  17     would be in and out. They were keeping a careful eye
  18     and offering their advice, because things change and
  19     evolve and it is necessary to do so.
  20        So I would regard this as an incomplete picture.
  21     I would not claim it was ideal, and the basic reason it
  22     was not ideal is that not all of the members of the team
  23     were totally committed to either cardiac surgery or
  24     paediatric cardiac surgery. Some members of the team
  25     had commitments elsewhere, and that was quite a major
0081
   1     difficulty, and one of the things we had been seeking to
   2     overcome.
   3        So I think it is an incomplete view of what was
   4     going on.
   5   Q. In that answer to me, you mentioned two positive
   6     factors, one negative factor, the negative factor being
   7     the nature of the interests of the junior doctor
   8     concerned?
   9   A. No, I am sorry, I beg your pardon, I did not make it
  10     clear. At that point I was referring to the nature of
  11     the commitments, the proper contractual commitments of
  12     the consultants and in particular, the consultant
  13     anaesthetists.
  14   Q. I am grateful. There is a further point, then, in
  15     respect of the natural interests of the surgical SHO,
  16     who is in the unit. He may not, we have been told, have
  17     a particular long-term interest in paediatric cardiac
  18     surgery, and indeed, may not have a particular interest
  19     in cardiac surgery. So to that extent, he is less able
  20     than somebody with a greater interest and experience to
  21     identify the sorts of problems that one might anticipate
  22     in a child, and in particular a child who has undergone
  23     cardiac surgery.
  24   A. That is not a criticism, if I might say so, sir. Part
  25     of the training of all junior doctors is that before
0082
   1     they specialise in a narrow field, they have a broad
   2     experience through a whole series of specialties. So in
   3     all the clinical departments, you will find junior
   4     doctors at an early stage of their training who are
   5     gaining their early experience in a broad range of
   6     activity. It is only on the basis of that experience
   7     they can then choose what direction they want to go in.
   8        It is for that reason that the Registrars, who
   9     were experienced and committed, had a 24-hour commitment
  10     to intensive care.
  11   Q. Whether it is properly classed as a criticism or not, it
  12     is a deficiency in the level of care, is it not?
  13   A. No, it is not a deficiency, sir. It is part of the way
  14     that all clinical care in our hospitals is structured.
  15     You cannot have specialists in the most junior people.
  16     You have specialists in the more senior people. You
  17     cannot have a House Officer who is a specialist in
  18     dermatology or in oncology. That is not part of the
  19     system. You may have a Senior House Officer who has
  20     identified his interests as being in surgery or
  21     paediatrics or medicine, but they will not have
  22     a commitment to any specific subspecialty within that.
  23     So they are at an early part of their experience and the
  24     specialist informed input comes from those who are more
  25     senior to them.
0083
   1   Q. And he, the junior doctor, has to know when to bring in
   2     the more senior?
   3   A. The one instruction they are given is that the telephone
   4     or the bleeper or whatever is always there and is always
   5     available and always there to be used.
   6   Q. Which is why I come back to one of the two points you
   7     mentioned in your longish answer to me --
   8   A. Apologies.
   9   Q. Not at all, it is to identify it. You used the phrase,
  10     "when circumstances permit"?
  11   A. In what context?
  12   Q. The consultant coming in.
  13   A. Yes.
  14   Q. That is the weakness, is it not, in a system which
  15     relies upon the junior doctor calling in more senior
  16     expertise? The Senior Registrar, you say, the
  17     anaesthetist is on call on a regular basis, but the
  18     consultant, take yourself, you would be able to get to
  19     the Intensive Care Unit, as I understand it, when
  20     circumstances permit it?
  21   A. But that is why the Registrar or the Senior Registrar is
  22     available. I mean, if I were to make the requirement
  23     that you are setting out, I would never do an
  24     operation. I would never see an outpatient.
  25   Q. What is required, ideally, is that there be a senior
0084
   1     medical, clinical, presence with a regular overview of
   2     the particular patient, rather than, if I use the
   3     expression, someone who pops in and out, I do not mean
   4     it pejoratively. But that must be the better system,
   5     must it not?
   6   A. I think there are two different situations that need to
   7     be catered for. What the regular "pop in and out"
   8     achieves is a frequent supervision of a patient whose
   9     condition may be evolving in whatever direction.
  10        What is also necessary is to have sufficiently
  11     senior expertise immediately available when something
  12     unexpected or quickly develops, so that by popping in
  13     and out you can deal with the first of those, but you
  14     will also need to have a provision to deal with the
  15     second, and that is the one that I cannot do in the
  16     middle of an operation.
  17        So that is why the Senior Registrar, or Registrar,
  18     is available and that is another reason why you need to
  19     have two surgeons instead of one surgeon, because if one
  20     is operating, the other may not be, and so by
  21     co-operating with each other, as Mr Dhasmana and I did,
  22     we are able to contribute to that. But of course, you
  23     could say that the ideal way -- because if I am
  24     operating Mr Dhasmana might be in outpatients or up in
  25     the Children's Hospital, the ideal way, although that
0085
   1     was not clear to us I think in the early days, is to
   2     have somebody who actually specialises in the area.
   3     That is the service that is now provided in the
   4     Children's Hospital.
   5        You may say, why did not it occur to us? I think
   6     that is a very good question. I think it did not occur
   7     to us because it did not appear to be within the realm
   8     of possibility, until towards the end of the period in
   9     question.
  10   Q. The system that we have been discussing must be made all
  11     the more difficult if the popping in and out, as I have
  12     described it, is irregular rather than regular, which it
  13     must necessarily be, given the commitments of a surgeon?
  14   A. It increases the possibility that people will be able to
  15     discuss things together and that is what often happened.
  16   Q. If you have two surgeons, that necessitates the
  17     hypothesis that one surgeon will give instructions, deal
  18     with the case that the other surgeon has operated upon
  19     and therefore knows much more intimately. One may ask,
  20     who, overall, is in control, may one not?
  21   A. No. I think you are carrying the thing to a degree that
  22     is not quite reflected in reality. First of all,
  23     Mr Dhasmana and I had a very similar approach -- not
  24     identical, because he absolutely had his own views in
  25     a number of areas, but a broadly similar approach -- and
0086
   1     had fundamentally complete confidence in each other to
   2     deal with things.
   3        The issue of people coming with conflicting advice
   4     is an important one, but not between Mr Dhasmana and
   5     myself.
   6        The overall care of his patient resided with
   7     Mr Dhasmana and I would only contribute to it -- I will
   8     not use the word "interfere" -- if an emergency arose
   9     when he was not available, or if he was away for the
  10     weekend and I was in town or if he was on holiday or
  11     whatever, in which case he would ask me and I would care
  12     for the child.
  13        I think the possibility of conflicting advice is
  14     a very real one and a very important one, but that is
  15     more likely between different specialties, people coming
  16     in and out, and that again is why it was important to
  17     have an SHO and to have Registrars who are continually
  18     available, so that they can ensure that there is actual
  19     co-ordination of advice from different people.
  20     Sometimes that may mean resolving an apparent
  21     contradiction.
  22   Q. Two more questions, and I think I think it may be time
  23     for a longer break.
  24        The first is this: in the system as you describe
  25     it before the intensivist, the clinician on the
0087
   1     intensive care, the health professional on the intensive
   2     care, the nurse, for instance, the junior doctor, would
   3     understand that his or her role would be subject to the
   4     advice and decision of the surgeon or, I suppose, the
   5     consultant anaesthetist, whenever he or she came to
   6     visit the patient.
   7   A. I can speak for the junior doctor and that would
   8     certainly be his position, but more than that, it is not
   9     a question of just passively receiving advice when
  10     whoever comes. If at any point they felt in need of
  11     advice, then they could press buttons and get that
  12     advice.
  13   Q. But it might not come from the consultant who may then
  14     come in later, and you have the problem with the
  15     conflicting advice which you have referred to?
  16   A. There is the experienced Registrar who is an experienced
  17     person and who is there and available.
  18   Q. The last matter I want to canvass with you before the
  19     break is the letter which I promised you earlier I would
  20     come back to in respect of the echocardiography
  21     service. It is Dr Wilde's letter at UBHT 146/50. It is
  22     3rd March 1994. It is addressed to you, amongst others,
  23     from Dr Peter Wilde. Can we scroll down?
  24        "I am circulating this document to generate some
  25     discussion on the subject of echocardiography on the
0088
   1     cardiac surgery unit. The system is certainly
   2     unsatisfactory at present and could potentially be very
   3     much better if we had an organised strategy. I feel
   4     sure that a high quality supporting echo service would
   5     undoubtedly lead to improvements in cardiac surgical
   6     outcomes."
   7        He encloses a document.
   8        The view expressed there: was it a view that you
   9     shared that the system in use for echocardiography on
  10     the cardiac surgery unit was, before March 1994 at any
  11     rate, unsatisfactory?
  12   A. I may say, I have not seen this letter until this
  13     instant.
  14   Q. You might want to take the lunch break to think about
  15     it.
  16   A. I am not sure what is set out on page 2, but I could
  17     make a general comment, certainly, and it is this: that
  18     the provision of echo services in cardiac surgery with
  19     intensive care is something that was evolving over
  20     a period of time. I think you have already heard
  21     evidence of how we made some efforts to acquire the
  22     equipment and to have an echo machine on the unit, so
  23     when Dr Wilde or the cardiologist came to the unit, they
  24     would use that machinery.
  25        Further, we, that is myself certainly, encouraged
0089
   1     two of my surgical trainees to be instructed by Dr Wilde
   2     so that they themselves became proficient in performing
   3     echocardiography on the ward.
   4        So we are seeing something evolve. It was not as
   5     cohesive, as regular, as consistent as one would have
   6     wished, recognising the potential importance of the
   7     contribution it could make, and I think that is what
   8     Dr Wilde is addressing: that we now need to take a step
   9     forward to make this a better and more important service
  10     within intensive care.
  11   Q. Well, he is talking about "an organised strategy".
  12   A. Yes.
  13   Q. Which suggests that someone needs to take control and
  14     organise it?
  15   A. I think that is right.
  16   Q. Who would that be?
  17   A. Well, it would be essentially Dr Wilde, as the lead
  18     person in this area, within the team.
  19   MR LANGSTAFF: Thank you. Sir, as I have indicated, it may
  20     perhaps --
  21   THE CHAIRMAN: Before we do take a break, I noticed
  22     Mr Mankad wanted to come in on the discussion on
  23     intensive care. It may well be helpful to tidy up
  24     observations in that area before we move on after lunch.
  25   MR LANGSTAFF: Yes, please.
0090
   1   MR MANKAD: I think this case highlights two very important
   2     areas of team working in paediatric cardiac surgery.
   3     One had a positive influence on the outcome and the
   4     second one had a relatively negative influence.
   5        The positive influence was the intraoperative
   6     echocardiography, which very clearly outlined that the
   7     anatomical and physiological result of the operation was
   8     very good indeed. That is a positive influence on this,
   9     and I think that is noteworthy, that we ought to have
  10     that system for the future.
  11        The negative influence is the overall
  12     postoperative management and organisation of the
  13     Intensive Care Unit.
  14        The key issues in intensive care management which
  15     come out are: (1) communication; (2) continuity of care
  16     between juniors and seniors and around the clock;
  17     (3) and most importantly, I think, is leadership.
  18     Leadership is important. A leader is able and willing
  19     to take decisions with the overall team -- whether it is
  20     a surgeon, intensivist or anaesthetist I think is
  21     immaterial -- and be responsible and accountable for
  22     those decisions. That leader has an ability to take the
  23     team, communicate with the team and provide and maintain
  24     continuity of care. It is conceivable that if there was
  25     no error of judgment in this particular case in the
0091
   1     management of post-operative care in this child, then
   2     probably what fell down was some sort of organisational
   3     aspect of the care structure.
   4   THE CHAIRMAN: Perhaps before you respond to that,
   5     Mr Wisheart, I can make it a more concrete question.
   6        We have heard from you, and from others, about the
   7     difficulties of having ward rounds and the possibility
   8     of advice being given at 8 o'clock that might be changed
   9     at 9 o'clock, or countermanded. Of course, if that has
  10     then to be communicated to a nurse who then has to speak
  11     to a parent who may have been up all night, that X is
  12     going to take place soon, that is the advice given at
  13     8 o'clock, but then at 9 o'clock that decision is
  14     changed, you can see that the, as it were, rollercoaster
  15     of emotion which is already there in a parent might be
  16     even more exacerbated, if you can exacerbate
  17     a rollercoaster. Is that not a problem in a very real
  18     and personal sense, as well as the organisational sense
  19     of managing the care of the child?
  20   MR WISHEART: Thank you. Responding to your point first,
  21     I think that, taking the point of the consultant coming
  22     in at 9 o'clock, the junior having seen the patient at
  23     8 o'clock or 8.30, or whatever --
  24   THE CHAIRMAN: Or the different specialty, indeed, the
  25     anaesthetist and then the cardiac --
0092
   1   MR WISHEART:  The junior surgeons and the junior
   2     anaesthetists were both present at 8 o'clock, so there
   3     is absolutely no reason why their views should not have
   4     been co-ordinated, or if they were not unanimous, some
   5     way found to resolve it.
   6        I think the question of coming in at 9 o'clock and
   7     changing the orders is one that has received some
   8     prominence in evidence, and of course I can only speak
   9     from my own perspective; I cannot speak for the other
  10     four cardiac surgeons, because I think that comment
  11     actually picked up adult and paediatric cardiac
  12     surgery.
  13        I would say that occasionally that happened, but
  14     the notion that it was the general rule I think lacks
  15     perspective.
  16        Of the occasions when it happened, it would only
  17     rarely, I think, have had consequences of the type that
  18     you have described. Usually it would be some adjustment
  19     of what was happening, which would not necessarily
  20     impinge in any dramatic way upon the parents. Of
  21     course, it would have to be communicated and discussed
  22     with the nurse, naturally, and if it were important, it
  23     would need to be discussed with whoever else had been
  24     involved in the earlier decision, so that everybody was
  25     working to the same plan.
0093
   1        So I think that occasionally it may have happened
   2     the way you mentioned, but I think quite rarely.
   3     I think there is a perspective which needs to be applied
   4     to that. That would be my view.
   5   THE CHAIRMAN: Thank you. If I could pursue it just
   6     a little more, Mr Mankad has rightly pointed to what we
   7     have heard a lot of evidence about, the need for
   8     teamwork, whereas you paint a particular picture of the
   9     teamwork as you have seen it.
  10        Could there not be another view -- you will
  11     forgive me if I use a metaphor which I hope is not out
  12     of place -- that here we have a team where some are not
  13     always "on the pitch", or even available, where
  14     sometimes the goalposts move from time to time because
  15     advice has changed, and also, a sense of whether you are
  16     belonging to the team is not always internalised in all
  17     the staff?
  18        In those contexts, and we have heard evidence
  19     along all of those particular scenes, the concept of
  20     a team becomes less of a description of what was
  21     happening than as you have described it.
  22   MR WISHEART: It is difficult to respond to how other people
  23     genuinely perceive the situation to be, because I would
  24     wish to respect their judgment and view. At the same
  25     time, I am not quite in the position of saying that this
0094
   1     is my view and if others think differently, so be it.
   2        I think that there is a lot to be teased out in
   3     this area and it is probably part of the evolution of
   4     the unit. I believe that historically there was close
   5     teamwork, and if we went right back to the beginning of
   6     the period of this review, in 1984, there were just two
   7     anaesthetists working in paediatric cardiac anaesthesia
   8     and they, of course, were unable to have the continual
   9     presence that the five or six or whatever number of
  10     anaesthetists provided in the 1990s. Interestingly, by
  11     their personal commitment and a feeling of being
  12     a member of the team, it was actually quite easy to
  13     co-operate with them, to get their advice, and there was
  14     always a clear knowledge of who to go to.
  15        It may be that some of what has been reflected to
  16     you is a consequence of the team increasing in numbers
  17     and the fact that in some areas of work somebody was
  18     responsible on Wednesday, but it was somebody else on
  19     Thursday and somebody else again on Friday.
  20        It is against that background that the surgeons
  21     I think felt not less but more of a pressure to maintain
  22     a continual interest, and they had to deal with the
  23     differing notions that people might have had on
  24     Wednesday, Thursday and Friday, and tried to work that
  25     into the system. But I do actually still feel -- and
0095
   1     I do not want any misunderstanding to come from my
   2     remarks -- that the commitment of the people who
   3     provided that service in the 1990s, I mean, by and large
   4     was terrific. I did not, myself, sense that there was
   5     any lack of a feeling of being on the same team with
   6     them in this area in theatre and so forth.
   7        Those would be my remarks.
   8   THE CHAIRMAN: Why do we not now break for lunch until
   9     1.30?
  10   MR WISHEART:  May I say one thing more? It could lead to
  11     a longer discussion; if that is so, it would be better
  12     after lunch, but I do not think -- two things, really.
  13     I do not think I need to respond in detail to what
  14     Mr Mankad has said, although I personally - it is my
  15     personal view that there was leadership and there was
  16     co-ordination, and I think most of the leadership came
  17     from the surgeons, but when the intensivists began to
  18     have a significant time there, clearly from them as
  19     well.
  20        The more important fact that I want to draw your
  21     attention to, before we depart from Matthew Rundle, is
  22     what I think may have been a factor underlying what we
  23     have been discussing at such great length for the last
  24     while, and that is the fact that he did have
  25     a significant level of pulmonary vascular disease. To
0096
   1     be very brief, the estimate that Dr Hayes made following
   2     the catheterisation in November 1993 was revised
   3     subsequently in 1997 to a much higher level of pulmonary
   4     vascular resistance, and because the case of Matthew
   5     Rundle has been considered elsewhere, the pathology of
   6     his lungs has been considered by the national and
   7     probably world expert in the field, whose opinion was
   8     that the level of pulmonary vascular disease was very
   9     severe and that it was so severe as to make this a very
  10     high risk operation.
  11        Be that as it may, the fact that it was there
  12     I think was a significant factor underlying the low
  13     cardiac output, which in a sense was or may have been --
  14     may have been -- the basic problem that underlay all
  15     these other problems that we have been discussing.
  16        I will stop there, but I just want to draw your
  17     attention to that, so that if there is any desire to
  18     explore that further, it can be done.
  19   MR LANGSTAFF: What you are saying is that in placing the
  20     emphasis in the questions as we have done, more on the
  21     postoperative phase than the pre-operative question of
  22     when should the operation have been done, you would say,
  23     the emphasis should be the other way round?
  24   MR WISHEART:  What I am drawing your attention to certainly
  25     brings us back to when the operation should have been
0097
   1     done, but it also brings us to the point that, given
   2     that the operation was done when it was done, here is
   3     what appears to be a fact which, however you judge it,
   4     was a very major factor in what happened following the
   5     operation and the outcome.
   6   MR LANGSTAFF: Until half past 1.
   7   MR WISHEART:  Thank you. I am sorry for the delay.
   8   (12.50 pm)
   9            (Adjourned until 1.30 pm)
  10   (1.40 pm)
  11   MR LANGSTAFF: Mr Wisheart, I am told that you want to add
  12     something about Matthew Rundle?
  13   A. Thank you. It is just in case I did not make myself
  14     quite clear in the remarks before lunch: I believe that
  15     Dr Pryn and I did have a clear strategy as to how to
  16     deal with fluid balance which is set out in either the
  17     second or third day when the PD cannula was put in,
  18     namely while urine output was adequate, then our
  19     strategy was based on that continuing urine output while
  20     it continued together with management by drainage
  21     through the PD cannula. That is really all I would wish
  22     to say, thank you.
  23   Q. Can we move on to Bridie Kinsman. Again, summarising
  24     the circumstances in which Bridie came to surgery, she
  25     was born, was she, on 22nd September 1983?
0098
   1   A. She was.
   2   Q. A cardiac catheterisation in 1983 showed a coarctation
   3     of the aorta which was responsible for her being in
   4     cardiac failure and later in November 1983 you repaired
   5     that coarctation successfully?
   6   A. That is correct.
   7   Q. In 1984 she was seen by Dr Joffe at a clinic. He found
   8     signs which I think suggested mitral stenosis as well as
   9     aortic or some aortic stenosis?
  10   A. I actually thought that he had detected mitral stenosis
  11     at his first consultation with the baby prior to the
  12     coarctation surgery, but ...
  13   Q. I do not think it is material when quite, because there
  14     is no doubt, is there --
  15   A. No.
  16   Q. -- that by the time of the third cardiac catheterisation
  17     which, because they repeated catheters, the last of
  18     which was 24th September 1985. It was clear, was it,
  19     that what Bridie suffered from was a severe obstruction
  20     at mitral valve or supravalvar level?
  21   A. Indeed.
  22   Q. And the angiography suggested there might be
  23     a supravalvar stenosing ring?
  24   A. Correct.
  25   Q. There were effectively two problems: one was the mitral
0099
   1     valve problem, the other I think was a subaortic
   2     stenosis which was moderately severe?
   3   A. Yes, I think it was valvar and subvalvar, the aortic
   4     stenosis.
   5   Q. This was always going to be a difficult case to operate
   6     on at that time, was it not?
   7   A. It depended on exactly what anatomy was found and while
   8     we did expect there to be a supravalvar ring, we were
   9     not certain that is what we would find. But
  10     a combination of these abnormalities in a child of this
  11     age would always be a fairly significant operation, yes.
  12   MR LANGSTAFF: If I may just ask, Mr Mankad, in the best of
  13     hands in 1985 what would one anticipate in terms of the
  14     risks for a girl with the condition that Bridie had.
  15   MR MANKAD: If we are dealing with just over a 2 year old
  16     baby with what we call a "Shone" complex, a Shone
  17     syndrome, which is the whole of the left-sided
  18     structures from inflow to the left ventricle above the
  19     mitral valve, at the mitral valve level, outflow of the
  20     left ventricle below the valve, at the valve and also
  21     distally coarctation, everything is obstructed albeit
  22     coarctation was very satisfactorily relieved in this
  23     baby and I think no doubt that in November 1985 when
  24     this girl was operated, my feeling is that the overall
  25     results of this particular operation, the risk would be
0100
   1     in the region of 50 per cent, average risk.
   2        The risk may vary from the best surgeon in North
   3     America with tremendous experience of these operations
   4     maybe 20 per cent, and if you do not see those number of
   5     cases so often anything between 60 to 70 per cent. But
   6     the average risk would be in the region of 50 per cent.
   7   MR LANGSTAFF: Would you seek to agree or disagree with
   8     that?
   9   MR WISHEART: Broadly. I think if I had been asked I would
  10     probably have said something slightly smaller but it is
  11     a big risk whichever way you look at it, it is a very
  12     significant undertaking.
  13   Q. Had you yourself come across many such cases in your
  14     practice?
  15   A. Not many because it is quite uncommon, but I had come
  16     across a number. I am not in a position to say exactly
  17     what the number was prior to this operation but through
  18     the 1980s I think I saw six.
  19   Q. You subsequently I think reviewed those cases in a paper
  20     which you provided to the Inquiry and which, if you want
  21     to make reference to it, we have at WIT 120/459. In
  22     that you tell us that -- it is the second line down:
  23     "Between 1975 and 1987 10 patients aged between 4
  24     months and 14 years underwent surgical treatment for
  25     congenital abnormalities of the mitral valve". You go
0101
   1     on to say "7 had mitral stenosis, 6 had supravalvar
   2     rings". The supravalvar ring is part of the Shone
   3     syndrome, is it not?
   4   A. It is.
   5   Q. Bridie would be one of the 6, would she?
   6   A. She was one of the 6.
   7   Q. Can we have a look at the operation note which we find
   8     at MR 2321/24. Can we remove the address? May I say of
   9     course that although we have removed the address, we
  10     have full consent for her case, as for all those that we
  11     refer to in connection with the Congenital Case Note
  12     Review.
  13        Indeed the diagnosis set out there, a result of
  14     the number of preoperative investigations which Dr Joffe
  15     had conducted.
  16   THE CHAIRMAN: Mr Langstaff, that paper you referred to,
  17     I do not think it is yet scanned. Where did it appear?
  18   MR LANGSTAFF: That was in a book called "Cardiac
  19     Reconstructions", published in Heidelberg 1989 and it is
  20     a paper, the first nominal author of which is
  21     Mr Bhatnagar and Mr Wisheart. It is in fact, as I say,
  22     scanned in starting at 120/459.
  23   THE CHAIRMAN: To avoid confusion, we do not yet have it, so
  24     I am grateful to you.
  25   MR LANGSTAFF: We do not want to go back to it. This was
0102
   1     a long operation, 5 hours 43 minutes, on bypass. Is
   2     that a reflection of the difficulty of the surgery that
   3     had to be done?
   4   A. Very much so because what had initially been anticipated
   5     as what had to be done was really magnified many times
   6     subsequently.
   7   Q. So there is no secret as it were about what ultimately
   8     happened, what happened was that during the course of
   9     the operation the mitral valve, the natural mitral valve
  10     was damaged, damaged surgically?
  11   A. By me, yes.
  12   Q. That because damage was there, you then had to seek to
  13     replace the mitral valve and sought to do so?
  14   A. Actually initially I sought to repair the valve because
  15     as far as I was concerned one always sought to conserve
  16     the valve, particularly in a small child and it was only
  17     when that failed that I then replaced it. So in fact,
  18     therefore, we are describing two very major steps beyond
  19     what we had originally anticipated in this operation.
  20   Q. That is reflected I think, is it, in the length of time
  21     on bypass ultimately?
  22   A. Yes.
  23   Q. If we can scroll down. You describe the approach to the
  24     mitral valve through an incision in the left atrium.
  25     You describe that access was difficult and the view of
0103
   1     the valve also difficult.
   2        What you were going to do, what you proposed to do
   3     so far as the mitral valve was concerned would be to
   4     remove or excise the ring of tissue above the valve
   5     which was in effect causing an obstruction to flow
   6     through the valve?
   7   A. That is correct. That sheet of tissue basically lies
   8     between the valve and myself, so to speak, as I look at
   9     the valve and the intention was simply to excise that,
  10     and had that been possible in the way that in my
  11     experience it was usually possible, that would actually
  12     have been quite quick and straightforward.
  13   Q. Then you would have proceeded beyond that, you would
  14     have relieved the inflow obstruction above the valve,
  15     you would then proceed, would you, to deal with the
  16     outflow obstruction?
  17   A. Yes.
  18   Q. One would expect that to involve, would it, perhaps some
  19     element of septal myectomy?
  20   A. Sometimes but not always. At that time in the
  21     mid-1980s, it would have been an occasional or some time
  22     addition to the operation, but certainly in my practice
  23     it was not a routine part of the operation.
  24   Q. It would depend upon whether there was a muscular septum
  25     which was contributing to the obstruction, to the
0104
   1     outflow, presumably?
   2   A. Yes. The aortic valvar stenosis can be purely at the
   3     valve or it can be below the valve and if it is below
   4     the valve, there may be a ring of tissue narrowing the
   5     pathway and excision of that ring may be sufficient to
   6     relieve the obstruction. But in other cases, if the
   7     muscle is thickened then it may also be necessary to
   8     excise a wedge of muscle to enlarge the pathway to
   9     relieve the obstruction.
  10   Q. You go on in the operation note: "difficult to find the
  11     relationship of this tissue to the mitral valve." What
  12     is essential, I suppose, is getting as good
  13     a visualisation as you can of the relationship of the
  14     supravalvar piece of tissue to the valve itself?
  15   A. Yes. In my experience, before that the two have been
  16     clearly -- they had been distinct one from the other.
  17     Although the sheet is attached to the valve or had been
  18     in my experience up until then at one point, but because
  19     they were otherwise distinct, that could be identified
  20     and the whole thing could be done safely and really
  21     relatively easily.
  22        In Bridie's case the anatomy, if you like, of this
  23     sheet of tissue and its relationship to the mitral valve
  24     was importantly different because it seemed to be
  25     attached to the valve more or less all the way around
0105
   1     and it was extremely difficult to distinguish what was
   2     sheet and what was valve and in my attempts to excise
   3     the sheet then the valve itself was injured and it was
   4     because of this close identity of the two.
   5   MR LANGSTAFF: This process that Mr Wisheart is describing,
   6     Mr Mankad, is something which is a risk, is it, of
   7     surgery such as this?
   8   MR MANKAD: The important thing to understand is the damage
   9     to the mitral valve intraoperatively, was it inadvertent
  10     or accidental or was it the supravalvar tissue, as you
  11     outlined, was it so densely adhering, stuck to the
  12     mitral valve itself that it was not possible to separate
  13     from the mitral valve and as a result the damage to the
  14     mitral valve was part and parcel of excising the ring or
  15     was it accidental?
  16        From what I think Mr Wisheart is describing,
  17     number 1, and having tabled this particular paper is
  18     also useful because here is a surgeon who is not dealing
  19     with this particular morphology for the first time, has
  20     obviously experience and knowledge of that particular
  21     type of operation and because of that it seems more
  22     likely that the damage to the mitral valve was
  23     unavoidable.
  24        Although it is rare I personally have not come
  25     across a mitral valve ring in my small series which is
0106
   1     densely stuck to the mitral, but every case is different
   2     and I think it is conceivable that that was the scenario
   3     and it was unavoidable.
   4   MR LANGSTAFF: The way in which the note reads on, shall we
   5     turn over the page, is that the initial part:
   6        "Subsequently I gained the misleading impression
   7     through the small orifice that the valve was at some
   8     distance from this tissue and I, therefore, made
   9     a tentative start to excising this tissue and removed
  10     that which I believed I could clearly define. The
  11     initial part of the excision was anteriorly and was
  12     satisfactory. Unfortunately the further removal of this
  13     tissue involved severe damage to the posterior leaflet
  14     of the mitral valve in its superior part. At this point
  15     it was abundantly clear that the stenosing tissue and
  16     the mitral valve were integral and were in fact one and
  17     the same structure."
  18        That is the point you are making, is it?
  19   MR MANKAD: Yes, that is it, because if it is accidental
  20     then it is a completely different ball game, because if
  21     it is an accidental damage then the question is: was it
  22     avoidable or was it as a result of poor exposure of the
  23     mitral valve, an inability to see the two structures
  24     distinctly and then it would raise a question of
  25     alternative exposure to the mitral valve.
0107
   1   MR LANGSTAFF: How differently might one have exposed the
   2     mitral valve in a case such as this?
   3   MR MANKAD: The alternative approach to exposing the mitral
   4     valve or supramitral ring would be by opening the right
   5     atrium, going through, across the intra-atrial septum
   6     and exposing the mitral ring and the mitral valve
   7     through that route which would give probably better and
   8     direct exposure to the supravalvar and mitral apparatus
   9     and the mitral valve itself.
  10        But the question is whether it was accidental
  11     damage or an integral part, I think that is the key
  12     debate in this case. If it was an integral part,
  13     irrespective of what approach the surgeon took, the
  14     surgeon had to excise the mitral valve together with the
  15     ring.
  16   MR LANGSTAFF: You are saying it would have made no
  17     difference. Do I take it from what you have said that
  18     if you, although you were not at this stage
  19     a consultant, had been a consultant performing an
  20     operation such as this, you might have sought to
  21     visualise the stenosing ring and the mitral valve from
  22     the different aspect, not being able to see it easily
  23     through the access which Mr Wisheart had chosen.
  24   MR MANKAD: Yes, I think if I am doing a case and if I found
  25     the exposure to the mitral ring is not sufficient, then
0108
   1     I would not hesitate to have an alternative exposure to
   2     the mitral valve through the septum and thereby
   3     facilitating the dissection of the mitral ring.
   4   MR LANGSTAFF: Mr Wisheart, would you like to comment on
   5     that as an alternative approach? You had had difficulty
   6     as it happens in this operation in seeing the
   7     relationship of the ring which you were excising to the
   8     valve. On reflection, would it in fact have been better
   9     to take a transeptal approach and visualise it that
  10     way?
  11   MR WISHEART: I was of course aware of a variety of
  12     approaches to the mitral valve and from time to time
  13     used them. I think what I am saying here is that it did
  14     not immediately present itself to me when I opened the
  15     left atrium and there was some difficulty. But I think
  16     having then adjusted the retraction and the way I was
  17     set up, I proceeded with it and so that means I had
  18     a sufficiently good view for me to feel that I could see
  19     and do whatever had to be seen and done. Had that not
  20     been the case, then I would certainly have used some
  21     alternative approach.
  22   MR LANGSTAFF: Dr Dickinson, are you able to comment at all
  23     as to what one might have anticipated in advance in this
  24     case from the catheterisations?
  25   DR DICKINSON: Yes, I would simply say when you have
0109
   1     multiple levels of obstruction in the left side of the
   2     heart, the assessment of the severity of various levels
   3     of obstruction really is extremely difficult.
   4        The distinction of congenital mitral valve
   5     stenosis from supravalvar mitral stenosing ring can also
   6     be very difficult even now. I think with the quality of
   7     ultrasound that was available in 1985 it would have been
   8     even more difficult and clearly this is a very unusual
   9     form of supravalvar stenosis with a very close
  10     application of the supravalvar ring to the valve.
  11     I cannot recollect ever having seen one quite like this
  12     where the ring is inseparable from the valve so I think
  13     --
  14   Q. And the valve is still able to function as such
  15     because --
  16   DR DICKINSON: I suspect the valve probably did not function
  17     in any way normally, the obstruction caused by the
  18     stenosing ring I think would clearly have impaired the
  19     valve function, so the two would be taken together.
  20     I think distinguishing those two things preoperatively
  21     would have been very difficult indeed.
  22   MR LANGSTAFF: I have had it suggested to me from another
  23     source that the mitral valve opened reasonably well
  24     apparently on echo. You have not had a chance to review
  25     the echo?
0110
   1   DR DICKINSON: I have not seen the echos on this case.
   2     Normally if you have a supravalvar stenosis which is
   3     nicely separated from the mitral valve, then the mitral
   4     valve may well function entirely normally and the
   5     problem is cured, as Mr Wisheart has said, by removing
   6     the stenosing tissue probably fairly easily. But in
   7     this case -- I have not seen the echocardiography so
   8     I cannot really comment, but the description of how
   9     closely the stenosing tissue is applied to the mitral
  10     valve makes me feel I cannot quite see how the mitral
  11     valve would open fully because it would be held back by
  12     the stenosing tissue connected within the left atrium.
  13   MR LANGSTAFF: Is that something you would expect to have
  14     identified before the operation?
  15   DR DICKINSON: No, I think it would be extremely difficult
  16     to identify it before, to delineate two levels of
  17     obstruction when they are so close together, I think it
  18     would be extremely difficult indeed.
  19   MR LANGSTAFF: Mr Mankad, you were going to comment?
  20   MR MANKAD: I think the alternative source that you are
  21     referring to, suggesting that mitral valve opening was
  22     acceptable, this is the only point maybe that to some
  23     extent I tend to slightly defer and say that it is
  24     conceivable that supravalvar ring adhering to the atrial
  25     aspect of the posterior mitral leaflet would still make
0111
   1     functioning, the opening and closing mechanics of the
   2     mitral valve normal.
   3        I think that is possible, it depends upon how,
   4     where and how from it is adherent but it is adherent to
   5     the atrial aspect and not to the ventricular aspect.
   6     Therefore I think it is possible that the mitral valve
   7     opening and closing before operation would not be
   8     significantly jeopardised or would not be jeopardised at
   9     all.
  10   MR LANGSTAFF: One can learn nothing, if you like, from
  11     a retrospective review of the echos in this case?
  12   MR MANKAD: No.
  13   MR LANGSTAFF: Given the problems that Mr Wisheart has
  14     explained in dealing with his operation note, is this
  15     a case which in fact merits the grading which the
  16     surgical procedure was given, do you think, by the
  17     review team?
  18   MR MANKAD: It is interesting because I reviewed the cases
  19     tabled, 5 or 6 cases, without looking at the review
  20     clinical record forms. I came to my own judgment of
  21     different aspects of care and my own feeling, which was
  22     echoed by Dr Dickinson, that the grading that was given
  23     for the surgical aspect by the review of the clinical
  24     record team was proverbially extreme and we rated it as
  25     3 rather than 1.
0112
   1        3 refers to "less than adequate care but different
   2     management would have made no difference to outcome" as
   3     opposed to 1 which implies "less than adequate care in
   4     which different management would reasonably be expected
   5     to have made a difference to the outcome".
   6   MR LANGSTAFF: I think you would still need to explain to us
   7     in the light of your observations about the case having
   8     heard what Mr Wisheart has to say, why you would say in
   9     this case, looking at the surgical aspects, it is less
  10     than adequate?
  11   MR MANKAD: I am saying "less than adequate" for two
  12     reasons. One is we already discussed the mitral valve
  13     itself and then, now for the time being if we go away
  14     from the inflow of the mitral valve to the outflow of
  15     the left ventricle -- inflow of the left ventricle to
  16     the outflow of the left ventricle, and once again
  17     I think we say "slightly less than adequate" is because,
  18     as Mr Wisheart has alluded to earlier on, in some cases
  19     relieving left ventricle outflow tract obstruction, i.e.
  20     septal myomectomy, in relation to resection or
  21     enucleation of the subvalvar ring is done.
  22        Sometimes I think the left ventricle outflow
  23     obstruction is quite a fascinating entity and often in
  24     the immediate postoperative period when the inotropes
  25     are used, that is drugs to improve the contractility of
0113
   1     the heart, despite the fact there is no organic or
   2     morphological obstruction the inotropes would give
   3     a dynamic functional obstruction because of the nature
   4     of the hypertrophy outlet septum and it is very likely
   5     that a child of this type with long bypass may require
   6     inotropes in the postoperative period which would unmask
   7     or unfold the dynamic component of the obstruction and
   8     therefore it may be advisable to add septum myomectomy
   9     as an adjunct to morality to resection or enucleation of
  10     the ring.
  11        So we took all these areas into consideration,
  12     inflow to the mitral valve, adherence of the ring,
  13     subsequent requirement of the mitral valve replacement,
  14     which in itself was an oversizing because the mitral
  15     annulus was smaller than the wall itself, 17 which is
  16     the smallest wall available at the time; that in itself
  17     will push the mitral valve further towards the outlet
  18     septum and aggravate the dynamic component of the
  19     obstruction.
  20        Taking all that into account we felt that 3 was
  21     more appropriate rather than 4.
  22   MR LANGSTAFF: Are you saying that had the operation gone as
  23     originally intended, there would have been no need to
  24     cut away any of the septal musculature underneath the
  25     outflow tract because of the insertion of the valve to
0114
   1     replace the damaged mitral valve, that became something
   2     which you would regard as highly desirable?
   3   MR MANKAD: I would slightly rephrase it and say, yes, it
   4     was advisable in the first instance but it was probably
   5     more advisable and necessary in the second instance.
   6   MR LANGSTAFF: Again, pressing you on this: is it not
   7     a matter of choice for the surgeon in the first place
   8     faced with the degree of obstruction that he happens to
   9     see.
  10   MR MANKAD: Yes.
  11   MR LANGSTAFF: One could not, could one, say the care was
  12     less than adequate if the surgeon chose to leave the
  13     original outflow without conducting any taking away,
  14     cutting away of the musculature?
  15   MR MANKAD: I would then go back to the preoperative issue
  16     and say that if the case is coming for discussion in
  17     1999 then one would very much like to know from the
  18     physicians how thick is the outlet septum in the
  19     particular case. If the septum is 2 or 3 or 4
  20     centimetres thick then, even though it is potentially
  21     non-obstructive, one would wish to excise in the first
  22     instance.
  23   MR LANGSTAFF: That is 1999, we are looking here at 1985.
  24   MR MANKAD: I would turn to my colleague.
  25   DR DICKINSON: I think if we had been asked that question in
0115
   1     1985 we certainly would have been able to answer it with
   2     the ultrasound equipment that was available, measuring
   3     the thickness of the septum would be a relatively
   4     straightforward measurement to make. I think if we had
   5     been asked the question we could have answered it;
   6     whether we would have been asked the question I am less
   7     sure.
   8   MR LANGSTAFF: Would that have to be done intraoperatively?
   9   MR DICKINSON: No, preoperatively.
  10   MR LANGSTAFF: Mr Wisheart, you have been a passive
  11     spectator in the conversation I have been conducting
  12     with Mr Mankad and putting, I imagine, points that you
  13     may be able to put better to him, but along a line
  14     I suspect you might have taken. What do you say about
  15     what Mr Mankad has said?
  16   MR WISHEART: Thank you. As I indicated at the beginning,
  17     our policy was not always to do an excision of muscle.
  18     We did it where we thought it was necessary. I would
  19     not be quite sure at what stage we began to use echo
  20     information in order to help with that decision, I just
  21     cannot remember, but I do not think we were at this
  22     stage. We do know echos were done here, so I do not
  23     think anybody would have had to ask the
  24     echocardiographer, I think measurement of the septum
  25     could have been done and would have been there and had
0116
   1     been recognised that as information it would be helpful
   2     and we would have used it. But I do not think we were
   3     doing that at that time; that is number 1.
   4        I take (and appreciate) Mr Mankad's point, that in
   5     the event that inotropes were going to be needed and of
   6     course by the time we were doing this bit of the
   7     operation it was highly likely they would be, then their
   8     use would exacerbate or enhance the muscular component
   9     of an obstruction, and I cannot remember that that was
  10     part of our thinking at the time.
  11        The final point I think that he made was to draw
  12     attention to the fact that the insertion of the
  13     artificial mitral valve would itself or could itself
  14     contribute to some restriction of that pathway below the
  15     aortic valve. That I absolutely agree with and we were
  16     certainly very conscious of, although it would be wrong
  17     to say that I remember clearly. I think we did look at
  18     postmortem to see if in fact it had impinged upon or
  19     restricted the pathway below the aortic valve and I know
  20     there is no comment in the postmortem report to help us.
  21        My recollection is that it did not, but that is
  22     hazy and could not be relied upon.
  23   Q. Again we are faced, are we here, with decisions which as
  24     it were have to be made in the heat of the moment?
  25   A. That was certainly our policy at the time, although
0117
   1     clearly from -- I mean my own impressions and from what
   2     Mr Mankad says, that today I think a more active,
   3     aggressive even, approach to undertaking an excision of
   4     muscle would be usual. I absolutely agree with that,
   5     but not at this time.
   6   Q. Would you, in the event, agree or disagree with the
   7     score of 3 which Mr Mankad would attribute?
   8   A. I would be very pleased. I do not think one could
   9     conceivably score this operation as 4, as you have
  10     challenged him because -- I just do not think you
  11     could. But I would be very pleased with a 3 because it
  12     would remove the only 1 that I had; it would remove the
  13     only score of 1 that I had, yes.
  14   Q. Shall we then leave Bridie Kinsman there and look at
  15     another surgical procedure where we may find perhaps
  16     illustrations of the team that operates. It is the case
  17     of Sean Naughton. You are happy to go straight on
  18     without a break, have you, because we have not been very
  19     long on Bridie Kinsman?
  20   A. Yes, I am happy, thank you.
  21   Q. Sean Naughton, born on 12th March 1984, suffering from
  22     a supracardiac total anomalous pulmonary venous
  23     drainage. A catheter conducted on 20th March, showing
  24     that the pulmonary artery pressure was reasonable. The
  25     TAPVD appeared to be unobstructed; is that right?
0118
   1   A. That is correct.
   2   Q. We have the operation. To have the operation note we
   3     need to go to MR 864/21. Here we see, do we, the nature
   4     of the operation? Conducted at a fairly young age, as
   5     it would have to be, would it not, for this condition?
   6     You are nodding the reason I say that --
   7   A. I am sorry. Yes, I was just looking to see exactly how
   8     old he was; he was in his third week, I think.
   9   Q. There are three particular aspects of this operation
  10     that I want to examine with you. The first is the
  11     anaesthesia. If we go from this operation note. We
  12     will come back to it in a moment or two, if we go to
  13     864/60, we have I think the anaesthetic record sheet.
  14   THE CHAIRMAN: Just taking the address out.
  15   MR LANGSTAFF: Perhaps if I turn here to Dr Dickinson, do we
  16     find on this sheet documented some severe acidosis?
  17   DR DICKINSON: Yes, I think if we scroll down to the bottom,
  18     this is a case which -- I was a member of the team which
  19     reviewed this case and it was a point which was drawn to
  20     my attention by the intensivist or anaesthetists on that
  21     team. Obviously anaesthesia is not my specialty so I am
  22     commenting slightly at second-hand, but there are
  23     a column of figures at the top right-hand corner of the
  24     graphed area which are blood gases prior to the
  25     commencement of the operation. We have a base deficit
0119
   1     of minus 8 and subsequently minus 12, I think, before
   2     the operation commenced --
   3   MR LANGSTAFF: That is under the line we see marked at "200"
   4     on the screen?
   5   DR DICKINSON: Yes.
   6   MR LANGSTAFF: Can we draw a yellow line across there?
   7     Thank you.
   8   DR DICKINSON: -- and the interpretation of my anaesthetic
   9     colleague of these figures was that the child during the
  10     course of induction of anaesthesia had, for whatever
  11     reason, become quite significantly acidotic and he also
  12     drew attention to the high valves for the blood carbon
  13     dioxide level directly opposite the number 200.
  14   MR LANGSTAFF: That is the line above the base?
  15   DR DICKINSON: That is right. So those were the two
  16     criticisms which he had.
  17        Those, I think, were the two criticisms which he
  18     drew our attention to and reservations he had about the
  19     period, presumably in the anaesthetic induction room
  20     prior to the onset of the operation. The implications
  21     of that would --
  22   MR LANGSTAFF: Why do you say "presumably in the anaesthetic
  23     room"; why not before?
  24   DR DICKINSON: My recollection is that the child's cardiac
  25     catheterisation was entirely uneventful, he did not
0120
   1     deteriorate during the course of the cardiac
   2     catheterisation and I think the procedure, the date of
   3     the operation was a few days after the cardiac
   4     catheterisation --
   5   MR LANGSTAFF: 9 days.
   6   DR DICKINSON: -- with no suggestion whatever that he had
   7     deteriorated or become acutely unwell in the written
   8     record of his care in hospital.
   9        So I think the implication, the inference we drew
  10     from these figures was that this child, for whatever
  11     reason, had deteriorated during the period of induction
  12     of anaesthesia prior to the operation commencing.
  13   MR LANGSTAFF: Mr Wisheart, having looked at and reviewed
  14     that point, it is not directly your specialty but does
  15     it seem to you to be right as a conclusion to be reached
  16     from the records?
  17   A. Yes. I think it is first highly unlikely that his
  18     metabolic state would be as described here over a number
  19     of days prior to the operation; I do not think that is
  20     really a possibility.
  21        Secondly, anaesthesia was commenced at 9.00 but
  22     the operation did not begin until 11.15. We see that in
  23     the left-hand column just to the left of the numbers we
  24     have been looking at and, therefore, it does seem
  25     inescapable that what we see here is something that
0121
   1     developed over that period.
   2        I am not able to say exactly what the timing of
   3     those first set of blood gases are. The numbers are
   4     below 11.00, but the other writing occupies space and
   5     I think it would be difficult to be sure. But the
   6     second set seems to be at quite a precise time and that
   7     is clearly when we were well into the operation.
   8        So it does look as if these disturbed blood gases
   9     were present throughout the whole of the initial part of
  10     the operation, and I cannot say beyond that because
  11     I have not myself seen the perfusion record, I do not
  12     think it was in the set of notes sent to me, but I think
  13     the implication of the comment from the reviewers is
  14     that it may well have persisted beyond the time that we
  15     see here.
  16   DR DICKINSON: Could I go on from there? The comment that
  17     was made by the reviewers was that there was
  18     a persistent uncorrected acidosis during the course of
  19     the, so I think the perfusion notes were available to
  20     the review team. But I think the implication that was
  21     drawn from these figures was that the acidosis preceded
  22     the commencement of the operation.
  23   MR LANGSTAFF: If it happened in the anaesthetic room
  24     preoperatively and going on into the operation, can
  25     I ask a simple question: should it have done so?
0122
   1   MR WISHEART: Ideally certainly not.
   2   Q. Does it indicate some defect of anaesthesia, whatever
   3     that defect might be?
   4   A. Like Dr Dickinson I am not an anaesthetist and I would
   5     hesitate to say, because clearly ideally that is not the
   6     way a patient should come into the operating room.
   7   Q. It makes life more difficult, does it?
   8   A. I believe it is more than that, I believe it actually
   9     makes a major contribution to the risks involved in the
  10     operation because I think it impinges on how the heart
  11     will work afterwards, bearing in mind that it persisted
  12     through the whole operation.
  13        So where I am not able really to say and would not
  14     say is -- to comment on the standards and expectations
  15     of the conduct of anaesthesia in 1985 I would find
  16     difficult, but I think everybody would agree that this
  17     is not the way (even in 1985) that an anaesthetist would
  18     have wished to deliver the patient to the operating
  19     room.
  20   Q. Can you help with what seems to be a surprising time
  21     between the induction and the operation, 2 and a half
  22     hours?
  23   A. It was not uncommon in my experience at that time.
  24     I think the reason is of course that the anaesthetist is
  25     having to put in little plastic tubes into arteries and
0123
   1     veins that are ever so small and I think it is a very
   2     difficult task, it amazes me that they can do it at all.
   3   Q. Saying it is "not uncommon" does not necessarily give me
   4     a reason for it?
   5   A. No.
   6   Q. You are then volunteering the possibility that one of
   7     the reasons may be they need to cannulate or put lines
   8     into vessels. That has always been, I suspect,
   9     a difficulty with operating upon very small children
  10     but, from what you are saying today, it takes place much
  11     more quickly?
  12   A. Yes, it does. Of course if you go back further in
  13     history people were not doing this in little tiny
  14     children very much. So it is a skill that I think has
  15     developed.
  16        Certainly it is the case today in my personal
  17     experience that it would be done much more quickly --
  18     when I say "today" I mean a little while ago -- but
  19     I know there are places where people still take a very
  20     long time to do this and in those circumstances they pay
  21     great attention to the details so that the patient does
  22     not get into the state which is described here by these
  23     blood gases.
  24        So you can either be quick or if you are slow then
  25     you have to take care to prevent this sort of thing
0124
   1     developing.
   2   THE CHAIRMAN: I think Mr Mankad wants to come in on that.
   3   MR MANKAD: I think, with due respect to my anaesthetic
   4     colleagues, I would like to point out that these
   5     scenarios even occur in 1999. This morning I raised the
   6     issue of the importance critical mass not just for the
   7     surgeons but for the whole team, and I think this case
   8     very clearly highlights that a critical mass is vital
   9     for the whole team including the anaesthetic colleagues,
  10     and if one is doing very very few numbers of open heart
  11     operations especially in infants and neonates, then it
  12     is very difficult to maintain the skills required for
  13     neonatal anaesthesia for cardiac surgery and I would
  14     strongly make a plea that the critical mass is important
  15     for the whole team including anaesthetists and we
  16     had debates on several occasions in-house, especially
  17     when the numbers of the unit are relatively small, one
  18     or two surgeons doing the operations but anything
  19     between 4 to 8 anaesthetists giving an input into those
  20     operations. I think we need to ensure the importance of
  21     critical mass for the whole team.
  22   MR LANGSTAFF: Can I explore one suggestion that has been
  23     made in the course of evidence to us, that there were
  24     occasions when one or other of the surgeons was late in
  25     arriving in theatre. First of all did that happen?
0125
   1   MR WISHEART: It sometimes happens, yes.
   2   Q. Secondly, what sort of event was likely to make it
   3     happen?
   4   A. I think what we are discussing is actually what I wanted
   5     to say. I think what you are referring to, if I may be
   6     quite clear, is the comment that I was sometimes late.
   7        What we see here is an operation which began at
   8     11.15. So I came into the hospital at 8.00 or just
   9     after it each morning and the question is: do I sit in
  10     the operating theatre waiting for this, or do I try to
  11     use the time in some other way. So I sought to use the
  12     time, not knowing how long this would take. so I, in
  13     general, sought to use the time some other way and asked
  14     the theatre to inform me in good time so I could stop
  15     what I was doing, change, scrub and join the operation.
  16        The problem that seemed to arise is that when they
  17     informed me they really wanted me in 10 minutes rather
  18     than in 20, if I may put it that way. I am not saying
  19     I was never at fault myself in any other way, but that
  20     was a common issue and it arises directly out of this
  21     sort of background; how long does it take to get going,
  22     and one never knew.
  23   Q. You are quite right that a comment was made about you,
  24     I think my recollection is that it may have been made
  25     about both you and Mr Dhasmana, but I think more in
0126
   1     respect of you than Mr Dhasmana hence my next question,
   2     which is: if it is the case that it was a late call by
   3     the theatre to you when you were quite appropriately
   4     doing something else, can you help with why the comment
   5     should be directed more at you than at him because one
   6     would have thought that it ought to have been equal?
   7   A. I cannot comment. I mean I cannot contribute anything
   8     to that, I am sorry.
   9   Q. The problems caused by the anaesthetist, who is an
  10     essential part of the team, may be demonstrated by this
  11     chart. We will come to the perfusionists' charts in
  12     a moment because we do have them and scanned them in.
  13     They have had to be reduced somewhat, as you will
  14     appreciate.
  15        Any operation is a team operation, not only in the
  16     planning in the postoperative phase but also during the
  17     operation, is it not?
  18   A. Very much so.
  19   Q. As a surgeon you coordinate the team, do you?
  20   A. You could say that. Seeing one is doing this repeatedly
  21     day after day, week after week, year after year the team
  22     largely knows what it has to do so you do not have to
  23     reinvent the wheel every time, you need to provide the
  24     information that the members of the team know and, by
  25     and large, they then do what is required of them and if
0127
   1     there is something out of the ordinary then you talk to
   2     them about it or make sure that they know.
   3   Q. Although you accept that your role is to coordinate the
   4     team you have to, do you, rely upon other members of the
   5     team doing their particular job as they, if I use the
   6     word 'should' I do not mean to imply anything other than
   7     as you might expect?
   8   A. All the members of the team have to make their
   9     contribution.
  10   Q. Can we go back to the operation note here? If we look
  11     at the operation which was then to be performed, what
  12     you would expect I think as soon as you were on bypass,
  13     it would be advisable, would it, to vent the common
  14     chamber to let any blood that is returning drain out?
  15   A. As soon as you go on bypass?
  16   Q. Once you are on bypass, yes.
  17   A. It is not the first thing you would do, no.
  18   Q. Would you do that fairly soon after going on bypass?
  19   A. I would not normally have done. I am considering the
  20     differing ways I did this. There were times when
  21     I earlier on, indeed continued it quite a long time,
  22     I would have routinely put a vent into the left
  23     ventricle, but that would not of course have vented the
  24     chamber that you are referring to prior to doing the
  25     operation. But the diversion of blood from the heart to
0128
   1     the bypass machine would usually tend to decompress that
   2     chamber by itself, particularly when the whole setup is
   3     non-obstructed and this was a non-obstructed total
   4     anomalous pulmonary venous drainage.
   5        The other possible factor that might delay its
   6     emptying would be if there was a patent ductus
   7     arteriosus which was continuing to put blood into that
   8     circulation, and we dealt with that at an early stage.
   9        So when I go on bypass in this condition the first
  10     thing I seek to do usually is to control the ductus,
  11     regardless of what information I have been given
  12     beforehand, I would do that because often it may be
  13     patent to a small degree even if we have not been told
  14     that, but that is everybody's practice I think. So that
  15     would have been the first move.
  16        As I said it was for a very long time my custom to
  17     use a left ventricular vent, and I would have done that
  18     and I would not usually have opened or emptied the
  19     common chamber until I had arrested the circulation and
  20     given myocardial protection and so forth.
  21   MR LANGSTAFF: Would you like to comment on that,
  22     Mr Mankad?
  23   MR MANKAD: I think it is a fair point that in the
  24     cardiopulmonary bypass the right side of the heart is in
  25     theory empty and therefore there is not any blood in
0129
   1     theory into the pulmonary venous circuit.
   2        Number 2, if the total anomalous pulmonary venous
   3     connection to whatever chamber, supra or intracardiac,
   4     if it is unobstructed -- and I use the word
   5     "unobstructed" specifically -- it is not vital that the
   6     common chamber is vented, but either the common chamber
   7     is obstructed by nature or heterogenetically then it
   8     becomes important despite the fact that there is no
   9     blood in the pulmonary venous circuit in theory.
  10        In practice we find there is invariably
  11     a significant quantity of blood in the pulmonary venous
  12     circuit and one of the first things I was told during my
  13     training sessions was to try and vent the common chamber
  14     soon after going on bypass, it is a good clinical
  15     practice to take the ductus in the first instance
  16     definitely but even, having included the duct, to open
  17     the common chamber. In practice I do find, having done
  18     that on every case, that despite the fact the right
  19     heart is in theory empty, there is a significant
  20     quantity of blood coming back through the common chamber
  21     into the pericardial cavity which we suck.
  22   MR LANGSTAFF: During the cooling time if there is not
  23     a vent can one get pressure building up?
  24   MR MANKAD: The logic of opening the common chamber is that
  25     if the pulmonary venous region is obstructed by nature
0130
   1     or heterogenetically then the back pressure, the amount
   2     of blood would tend to bring, generate more pulmonary
   3     capillary pressure which in theory -- I am using the
   4     word "theory" because I have never seen that and I am
   5     extrapolating that theory into this particular scenario
   6     (we will come back to the scoring and everything later
   7     on) -- in theory the pressure would build up.
   8        In turn that would lead to rupture of pulmonary
   9     capillaries at the annular capillary level resulting in
  10     hemorrhaging, interstitial pulmonary oedema, and
  11     resulting in a vicious cycle and when you are trying to
  12     come off bypass that could contribute to intractable
  13     pulmonary hypertension. These are theoretical
  14     possibilities of an obstructed return on bypass despite
  15     the fact that the right heart is empty.
  16   MR LANGSTAFF: If we have a look at the note -- I will
  17     invite you to comment on that in a moment. Can we
  18     scroll down the operation note? We see in the first
  19     paragraph, after you talk about establishing
  20     cardiopulmonary bypass with a single or atrial line and
  21     the temperature being reduced, approximately 70 ccs of
  22     cardioplegic solution given.
  23        "During the period of cooling the ascending vein
  24     was identified outside the pericardium. It was
  25     separated from the phrenic nerve and snared. The ductus
0131
   1     was also dissected and carefully defined and ligated."
   2        What was the purpose of snaring the ascending
   3     vein?
   4   MR WISHEART: Because at a later stage in the operation when
   5     you actually open the common pulmonary chamber, then air
   6     would be able to pass through that vein into other parts
   7     of the circulation. Normally the bypass would be
   8     arrested at that time but it simply isolates the
   9     ordinary main veins with which the venous cannula would
  10     be in communication if it were being used from that part
  11     of the heart where you are working and prevents the
  12     entry of air into it.
  13   MR LANGSTAFF: Would you like to comment?
  14   MR MANKAD: In my practice when the circulation -- two
  15     things I think. Number 1, I never include the ascending
  16     or descending vein and I do not think the air is
  17     a problem.
  18        The second thing, even if in theory it is
  19     anticipated that there will be a problem, that is not
  20     a problem on bypass it is only at the end. Again
  21     I still slightly fail to understand the logic of snaring
  22     the vein on bypass.
  23   MR LANGSTAFF: You were nodding Dr Dickinson?
  24   DR DICKINSON: No, I was not nodding. I think this is
  25     a fine matter of surgical technique and I am not going
0132
   1     to comment.
   2   MR LANGSTAFF: I saw what I thought was a nod, I am sorry
   3     for misinterpreting. There is a difference of surgical
   4     technique, is there?
   5   MR WISHEART: There would appear to be. I would add one
   6     thing: it would normally be my practice having completed
   7     the repair to actually ligate the ascending vein. So
   8     the snaring is part of the preparation for that as well
   9     and so it means when that time comes I am immediately
  10     ready to do so.
  11   Q. What I am going to do now is to take you on to look at
  12     the perfusion charts and the bypass charts, some of
  13     which are in the original, in colour. The benefit
  14     I think from seeing the original which you may not have
  15     had an opportunity to see. What I am going to suggest
  16     therefore is, given the time, we have a short break now,
  17     allow Mr Wisheart to have a look at the original so that
  18     he will be better able to assist in the discussion that
  19     will follow, if that is a convenient course?
  20   THE CHAIRMAN: Mr Langstaff, shall we say until 2.55?
  21   (2.45 pm)
  22               (A short break)
  23   (3.15 pm)
  24   MR LANGSTAFF: Mr Wisheart, we have dealt, before the break,
  25     with the anaesthetic problems, if I can call them that,
0133
   1     in this case. I think it is common ground, is it, that
   2     no-one has yet been able to identify clearly why it
   3     should be that Sean died, given that there was an
   4     unobstructed pulmonary venous drainage and given the
   5     apparent progress of the operation?
   6   A. Certainly on the first point, it puts him into a group
   7     of lower risk, not zero risk but lower risk, and the
   8     apparent progress of the operation from a technical
   9     standpoint, and the information we have subsequently
  10     confirms that as far as I can see. It does not suggest
  11     any particular problem or difficulty, I agree.
  12   Q. Mr Mankad, what is your approach to the detective work
  13     here? We will see if we can learn any lessons from it.
  14   MR MANKAD: I do not know whether it is appropriate to call
  15     it detective work, but I was fascinated by this
  16     mortality, and I also noted that in the group
  17     discussion, by the review group, it remained elusive
  18     because of that.
  19        A few things struck me. Here is a baby who, as
  20     Mr Wisheart says, was relatively low risk. Because of
  21     that, number 1 could be, the ill-effects of
  22     cardiopulmonary bypass in a neonate, giving rise to
  23     intractable pulmonary hypertension in the early
  24     post-bypass period, resulting in death. It is not
  25     a very valid explanation, because the child had
0134
   1     a reasonable bypass time, shortish bypass time;
   2     myocardial protection was adequate; the autopsy
   3     confirmed that the anastomosis was wide open. There was
   4     no organic obstruction of the anastomotic site; the left
   5     atrium was small, but it is always small, the left-sided
   6     structures in this condition are always small, so it is
   7     difficult to say that contributed.
   8        Before I went into this, it struck me, the snaring
   9     of the common vein, as I referred to earlier on, what it
  10     in theory could lead to. Then I started to do more and
  11     more work that the hypothesis I had put forward of
  12     snaring the common vein resulting into retention of
  13     blood into the whole pulmonary venous vascular tree,
  14     increasing pressure, resulting into rupture of
  15     capillaries, and haemorrhaging interstitial pulmonary
  16     oedema, giving rise to --
  17   MR LANGSTAFF: Take it slowly.
  18   MR MANKAD: -- giving rise to increased pulmonary vascular
  19     resistance in the early post-bypass period, and
  20     contributing to mortality.
  21        What is the evidence to this? There are three or
  22     four things that have been baffling, including to the
  23     surgeon on the table. Let me go to the first thing, and
  24     what struck me was that normally on bypass, when the
  25     right-sided structures are emptied, the central venous
0135
   1     pressure is almost zero, so when I looked at the chart
   2     of the recording on bypass, it is not a perfusion chart,
   3     the chart which shows the temperature, arterial pressure
   4     and the central venous pressure throughout the course of
   5     the operation --
   6   Q. Do we have that, please, at MR 864/66? Do we need to
   7     rotate that?
   8   MR MANKAD: Yes, please.
   9   MR LANGSTAFF: The top line is what?
  10   THE CHAIRMAN: We are just taking an address out again.
  11   MR MANKAD: The top short bars are arterial pressure. The
  12     middle one, long horizontal, is central venous pressure;
  13     the bottom line is the temperature. In fact, it is
  14     difficult to see, but the point of bypass is clearly
  15     delineated. The speed is delineated on the paper, on
  16     the tracer, and the scale. The scale is 0 to 200 ml of
  17     mercury on the arterial side, 0 to 20 ml of mercury on
  18     the venous circuit and the temperature reference point,
  19     I presume, is 37 degrees, going down, as the child is
  20     being cooled on coronary pulmonary bypass.
  21        What struck me was the persistently high central
  22     venous pressure on bypass, and until the circulation is
  23     arrested, and in fact, even for a few minutes after the
  24     circulation is arrested, the venous pressure remains
  25     anything between 10 to 12 ml of mercury mean; that is
0136
   1     all.
   2   MR LANGSTAFF: Can I stop you there? What would you expect
   3     to happen to the venous pressure once you go on bypass?
   4   MR MANKAD: You would expect the venous pressure to be 0, or
   5     at the most, minimum 1 or 2, maybe, but with a single
   6     venous cannula in the right atrium, draining the
   7     superior vena cava and inferior vena cava adequately the
   8     venous pressure theoretically is 0.
   9   MR LANGSTAFF: You are agreeing?
  10   MR WISHEART: I agree that that is what would normally
  11     happen, yes.
  12   MR LANGSTAFF: What we see here is that it did not happen
  13     in this particular case, for whatever reason.
  14   MR MANKAD: It remained elevated. I will come back to
  15     that. The second thing is that when the circulation is
  16     arrested, usually no blood is coming back, either from
  17     the right or left-sided structures. Mr Wisheart has
  18     commented in the operation note -- I am not sure whether
  19     we wish to go back to the operation note --
  20   MR LANGSTAFF: Let us go back and have a look at that. That
  21     is at page 21. The address needs to come out.
  22   MR MANKAD: It is the second paragraph under "Procedure".
  23   MR LANGSTAFF: The opening words, "When the circulation
  24     had been arrested there continued to be a troublesome
  25     slow return of blood".
0137
   1   MR MANKAD: Yes, through the SVC in the left side of the
   2     heart, which obscured the surgical field, so much so
   3     that an additional left ventricular vent was required.
   4   MR LANGSTAFF: Can you just stop there for a moment? This
   5     would be a vent inserted after circulatory arrest?
   6   MR WISHEART: Yes.
   7   MR LANGSTAFF: The process of venting you described earlier:
   8     was that one you would do before bypass or arrest,
   9     normally?
  10   MR WISHEART: Frequently, but I had not done in this
  11     instance, but I did do subsequently, because I was being
  12     held up for longer than I was comfortable with in
  13     getting on with operation, because of the return of
  14     blood.
  15   MR MANKAD: This return of blood, when we superimpose that
  16     with the perfusion chart of venous pressure, it shows
  17     clearly that for the first few minutes, until the vent
  18     was inserted, the central venous pressure is slowly
  19     coming down, implying, coming back to that hypothesis
  20     that this blood is coming back which has been
  21     accumulated into the pulmonary vascular tree. There are
  22     always naturally occurring systemic pulmonary
  23     collaterals, and these collaterals then would then open
  24     up and blood would then drain back, because either it
  25     can drain back into the pulmonary artery, retrovertly,
0138
   1     or it can drain back into the superior vena cava or the
   2     systemic circulation through naturally occurring
   3     systemic pulmonary collaterals.
   4        The hypothesis which I put forward was that that
   5     later thing was occurring, as we see in these two
   6     things, implying that snaring of the pulmonary vein
   7     contributed to subsequent events and that led to the
   8     increased pulmonary vascular resistance and haemorrhagic
   9     pulmonary oedema. That is another key feature which
  10     I noted in one of the charts off bypass: there was
  11     evidence of haemorrhagic pulmonary oedema, which is
  12     again very unusual, or haemorrhagic fluid from the
  13     endotracheal tube.
  14        Putting all this together with no adequate
  15     explanation, I put forward the hypothesis, which remains
  16     to be tested, that probably contributed to mortality and
  17     compounded obviously by the pre-operative anaesthetic
  18     problem and the persistent acidosis on bypass,
  19     et cetera.
  20   MR LANGSTAFF: In the scenario you painted, what part
  21     does the persistent acidosis play?
  22   MR MANKAD: Minor.
  23   MR LANGSTAFF: Because one of the factors, I think, that one
  24     can identify in this case is that the perfusionist does
  25     not appear to have remedied the acidosis. Would you
0139
   1     normally expect, on bypass, that the acidosis would be
   2     monitored and regulated?
   3   MR MANKAD: One would normally expect acid-based balance
   4     occasionally to be more acid than minus 6, base excess.
   5     That would usually either be compensated by giving
   6     sodium bicarbonate temporarily, but more importantly, by
   7     increasing the bypass flow, because that invariably
   8     reflects that the bypass flow is not adequate for the
   9     temperature and the surface area of the child, so it is
  10     usually remedied by increasing the flow.
  11   MR LANGSTAFF: So the hypothesis I would put to you, you
  12     would answer "Yes", that if the degree of acidosis
  13     should be both monitored and regulated --
  14   MR MANKAD: Yes.
  15   MR LANGSTAFF: -- by the perfusionist --
  16   MR MANKAD: Yes.
  17   MR LANGSTAFF: -- you would expect that to be his task as
  18     part of the team contributing to the surgery?
  19   MR MANKAD: Absolutely right. Usually he is led by the
  20     anaesthetist in terms of regulating the flow.
  21   MR LANGSTAFF: Before I invite Mr Wisheart to respond if he
  22     wishes to do so, at this stage, the thesis that you have
  23     put forward you have put forward as a hypothesis and it
  24     must follow that it would not necessarily be obvious to
  25     any surgeon at the time as being a likely event nor
0140
   1     indeed does it appear to have occurred to the surgical
   2     team after this particular operation, nor, I think, the
   3     reviewing surgeon when the Case Note Review occurred.
   4   MR MANKAD: That is correct.
   5   MR LANGSTAFF: Although there is the query in the Case Note
   6     Review as to why it was that a vent was needed after
   7     bypass had commenced.
   8   MR MANKAD: Yes.
   9   MR LANGSTAFF: Mr Wisheart, I think we are probably
  10     going to learn lessons for the Inquiry here in respect
  11     of the anaesthetic and the perfusion, but Mr Mankad is
  12     putting forward a possible explanation as to why it
  13     should be that the outcome in this case was as it
  14     tragically was.
  15        Have you had a sufficient opportunity, do you
  16     think, to be in a position to respond to that
  17     hypothesis, or would you wish further time to consider
  18     it and do so?
  19   MR WISHEART: I think I am in a position to make
  20     a response, although I would be grateful if I could make
  21     a further response if I wished to, tomorrow morning,
  22     after I have given it some thought.
  23   MR LANGSTAFF: Absolutely.
  24   THE CHAIRMAN: You may respond now if you wish, and you
  25     may also -- whether tomorrow or in writing, it is
0141
   1     a matter entirely for you and those who advise you.
   2   MR WISHEART: Thank you. I do not know what Mr Mankad is
   3     doing tomorrow, but I would like to respond today so
   4     that we can continue the discussion.
   5        The first thing I would like to say is that I find
   6     the general hypothesis put forward -- I am not now
   7     speaking of this operation -- as a very attractive one.
   8     I think if I were doing this operation tomorrow, I would
   9     incorporate that into my conduct of the operation.
  10        That would be my first comment.
  11        My second comment would be, I think, one of
  12     clarification, which I think is actually quite important
  13     and it is, of course, that the snare would have been
  14     applied to the ascending vein, not immediately after
  15     going on bypass, but immediately before arresting the
  16     circulation, so there would not have been a substantial
  17     time when that vein was snared prior to circulatory
  18     arrest.
  19        I would just like to say in passing that many
  20     years ago that is basically the way I was taught to do
  21     the operation, I believe, I think, I cannot remember
  22     with crystal clarity, by Mr Stark and his colleagues in
  23     Great Ormond Street when I was Senior Registrar there.
  24        So what I think I would now like to do, if I may,
  25     is to make some precise comments about the operation and
0142
   1     the hypothesis, and then maybe briefly return to the
   2     question of acidosis and allied topics afterwards?
   3   MR LANGSTAFF: Please.
   4   A. You have put forward a hypothesis and some of my
   5     comments will be equally hypothetical, but based on
   6     knowledge of what sometimes happened in Bristol.
   7        The venous line which was used to monitor this
   8     pressure was a tunnelled left subclavian line, according
   9     to the anaesthetic note. Dr Burton who put it in was
  10     notorious for passing his venous lines into any vein
  11     from the neck up, tying it in knots. We used to look at
  12     the x-ray afterwards with great interest to see exactly
  13     what tortuous pathway it had followed. That is not by
  14     way of criticism of Dr Burton, but the point is that
  15     sometimes these lines, although put in centrally, did
  16     not end up in a central position. Therefore, that would
  17     be important, critically important, in terms of the
  18     relevance of this observation of pressure.
  19        The second thing is that if we, having said that,
  20     made the assumption that it is where we would want it to
  21     be, then I agree with you that the pressure observed
  22     here is certainly higher than one would expect on
  23     bypass, definitely.
  24        The next comment I would make is that -- and you
  25     may advise me on this, but I would have thought that
0143
   1     a level of 10 or 12, if that is correct, is unlikely to
   2     lead to the sequence of pathological changes in the
   3     lungs that you have outlined, and that one would really
   4     be thinking in terms of a rather higher pressure to
   5     cause that, but you may disagree with that.
   6        Finally, you commented, I think the words you used
   7     were "haemorrhagic pulmonary oedema"; is that right?
   8        I have had a quick look through the notes I have
   9     extracted into my own file. I think I have read that as
  10     well but I could not find it. I wonder therefore if you
  11     could identify it for me.
  12        Finally, the findings at postmortem I think you
  13     may take the view they do not really help us too much.
  14     They certainly, I do not think, help us positively.
  15     They say the lungs are congested, heavy and oedematous,
  16     but at the end of totally anomalous venous drainage,
  17     a period of bypass, et cetera, and then of failing
  18     circulation, that is not a very specifically helpful
  19     finding.
  20        So I think those would be the points I would wish
  21     to make at this stage in relation to the hypothesis.
  22        Finally, and very briefly, with regard to the
  23     acidosis, I may say I have no recollection of being
  24     aware of the severity of this at the time. It is very
  25     impressive looking at the perfusionist's chart, not only
0144
   1     to observe the acidosis, which may be seen under the
   2     horizontal lines labelled "pH" on the left, or base
   3     excess on the left, but also the level of CO2 in the
   4     arterial blood, really right up until the reinstitution
   5     of bypass after the period of circulatory arrest and we
   6     see a figure up to 99 which is really extraordinarily
   7     high.
   8        What influence these metabolic disturbances, let
   9     me call them that, would have had on the subsequent
  10     performance of the myocardium I think is a matter one
  11     could debate.
  12        That is what I wish to say at this stage, thank
  13     you.
  14   MR LANGSTAFF: Mr Mankad, in terms of the pressure of
  15     10 or 12, is that sufficient to cause the sort of
  16     changes which your hypothesis would involve?
  17   MR MANKAD: That is the third point that I was planning to
  18     respond to in relation to point by point response to
  19     Mr Wisheart.
  20   MR LANGSTAFF: Do not let me take you out of your way.
  21   MR MANKAD: No, it is perfectly all right, I will take
  22     that first.
  23        Yes, I think it would concur, because the 10 or 12
  24     pressure is not a direct reflection of intracapillary
  25     pressure into the pulmonary capillaries, because the
0145
   1     very small amount of that blood which is in the lungs
   2     would go back into the systemic venous circuit through
   3     the naturally occurring collaterals, i.e. if the
   4     naturally occurring collaterals are absolutely vast,
   5     then the pressure will fluctuate, but it is conceivable
   6     that the pressure required to rupture these capillaries,
   7     whatever the threshold pressure is, let us say 20 or 25,
   8     once that pressure is there, the amount of central
   9     venous pressure is only the amount of blood that is
  10     going back into the veins, and that could still be
  11     10 or 12.
  12   MR LANGSTAFF: So the theoretical point Mr Wisheart makes
  13     that pressure is not enough is right, but you are saying
  14     that the measurement of pressure is not being taken at
  15     the point where the pressure is being exerted?
  16   MR MANKAD: Yes. My first point is Mr Wisheart is
  17     absolutely right. The crucial hypothesis this underpins
  18     is the timing of snaring the vein. If the common vein
  19     was snared just before circulatory arrest, then the
  20     hypothesis is null and void. The reason why I put
  21     forward this hypothesis is because it is not clear, and
  22     it is like the beginning if you say that the vein was
  23     snared, so I presume that it was snared at the same time
  24     as the duct was occluded, but if the common vein was
  25     snared just before circulatory arrest, then this is not
0146
   1     a proper explanation, number 1. So the timing of that
   2     is crucial.
   3        Secondly, the point that you raised about the
   4     central venous pressure lying in anywhere else from head
   5     to toe, it can rightly affect the reading on the table,
   6     but the difference would be that that reading usually
   7     would be non-pulsatile and we have no means to judge
   8     whether this particular reading on this occasion was
   9     pulsatile or non-pulsatile, but it would surely affect
  10     the recording.
  11        The third one you already alluded to. The fourth
  12     is the haemorrhagic pulmonary oedema. I do not have
  13     a note in front of me here, but it was haemorrhaging
  14     fluid into the ET tube. This is what I refer to.
  15     I will go back to that if I can find it.
  16        The last point which you made was the PCO2 and
  17     metabolic acid, the metabolic factors affecting the
  18     organ function. Yes, it is possible that would have an
  19     adverse effect on the overall organ function, and if we
  20     for the time being -- if, on this hypothesis,
  21     considering the fact that the vein was snared at the
  22     last minute, then that probably is the only explanation
  23     of metabolic insult to the multi-organ of persistent
  24     problems on cardiopulmonary bypass affecting the
  25     myocardial and pulmonary function.
0147
   1   MR LANGSTAFF: So the earlier the snaring is, the more
   2     likely your thesis is, you think?
   3   MR MANKAD: Yes.
   4   MR LANGSTAFF: The later, the less likely and the more
   5     likely the submetabolic insult as demonstrated by the
   6     degree of acidosis.
   7        Can you help, Mr Wisheart, looking back to the
   8     perfusionist and going back to the charts, which we have
   9     at page 66 and which you have in glorious technicolour
  10     in front of you --
  11   THE CHAIRMAN: We need to take an address out.
  12   MR LANGSTAFF: Yes, thank you. This is not, I think it is
  13     agreed between you and Mr Mankad, not as you would
  14     expect it to be? You are agreeing with that?
  15   MR WISHEART: Yes, I do.
  16   Q. At the time of the operation, is this something that
  17     you, as the surgeon, would expect to be drawn to your
  18     attention by the perfusionist?
  19   A. It would be drawn to my attention by my own
  20     observations, because the right atrium would be full
  21     instead of empty.
  22   Q. And you had to vent the --
  23   A. That was later. At this stage, unlike the ventricle,
  24     the atrium is a thin-walled organ and when it is emptied
  25     it collapses so it is easily visible to the naked eye
0148
   1     and there is a usual emptying, quite quickly, once you
   2     drain the venous blood off, so that would have been
   3     evident. All I can say is that I have not made a note
   4     about it, but that is not conclusive evidence one way or
   5     the other.
   6   Q. And the persistent acidosis in the operation, again that
   7     is not something that you would notice with your naked
   8     eye?
   9   A. Not at all. Not at all.
  10   Q. You had to rely on being told by the perfusionist?
  11   A. Yes, or the anaesthetist, totally.
  12   Q. Had you known that the readings were as they were,
  13     which, as you say when you look back on them look fairly
  14     stark, would you have done something about it, do you
  15     think, at the time?
  16   A. That is a very difficult question. I mean, you would
  17     have encouraged people to take action, but I think you
  18     would have had no option but to continue with the
  19     operation. I think that probably -- I will be
  20     interested to know what Mr Mankad says, but I think that
  21     probably the best course of action would have been to
  22     get the patient on to bypass as expeditiously as
  23     possible, and then take whatever time is needed on
  24     bypass to stabilise the metabolic state prior to the
  25     period of circulatory arrest. I think that is probably
0149
   1     the approach I would have had, if the matters had been
   2     drawn to my attention.
   3   MR MANKAD: Something has occurred to me: is it not odd that
   4     while we are cooling the child, usually the oxygen
   5     requirement is going down and it is actually more
   6     unusual to have persistent acidosis, because the cardiac
   7     output, the bypass flow required to sustain tissue
   8     oxygenation is much lower than at normal thermia. In
   9     that scenario, is it likely that this acid base that we
  10     are seeing on the chart is not corrected for
  11     temperature, and it is actually a misnomer? This is
  12     just a --
  13   MR LANGSTAFF: It is a question of record-keeping?
  14   MR MANKAD: Yes, because normally it is corrected for
  15     temperature, especially when you cool down to 18 or
  16     20 degrees Celsius.
  17   MR WISHEART: I would not be able to comment on this so many
  18     years afterwards, I am afraid, but in fact the last
  19     observation, where there is severe acidosis and severe
  20     elevation of CO2 is actually immediately prior to going
  21     on bypass. There is no record here after that until
  22     14.40 which is after the period of circulatory arrest
  23     and bypass has been resumed. Unless I have got my
  24     timings wrong. I think that is what it says.
  25   MR MANKAD: It was genuine.
0150
   1   MR LANGSTAFF: It looks as though it was genuine. This case
   2     would demonstrate, then, would it, the need for there to
   3     be, as it were, constant communication within the
   4     operating theatre between the anaesthetist, the
   5     perfusionist and the surgeon, because that is how one
   6     gets the collaborative effort which is the surgical
   7     result one hopes for?
   8   MR WISHEART: Yes, although of course you expect that the
   9     anaesthetist or the perfusionist will be doing the
  10     things that are necessary and they will take the view,
  11     "The surgeon has enough to cope with so let us not
  12     trouble him with all the details when he himself cannot
  13     actually do anything about them". So it works in
  14     a variety of ways.
  15   MR LANGSTAFF: The point Mr Mankad made earlier, some time
  16     before the break, about the need in surgery on very
  17     small children such as Sean was, was to emphasise the
  18     importance of regular experience of it. Do we, do you
  19     think, learn anything from this case to emphasise the
  20     importance of that, that experience counts and helps to
  21     ensure that everyone within the team knows what has to
  22     happen and how best to do it?
  23   A. I think it is fair to point out that Dr Burton was
  24     a most experienced paediatric anaesthetist. That is not
  25     to say he did not do anything else, but he was most
0151
   1     experienced, both in open-heart surgery and in
   2     paediatric intensive care, and spent -- in fact, he
   3     really instituted it in Bristol, so this is a most
   4     experienced and very careful anaesthetist.
   5   Q. Can you help with the perfusionist?
   6   A. Yes. The names here are that the perfusionist was
   7     Mr Allen, assisted by Mr Caddy. Mr Allen was relatively
   8     junior, but Mr Caddy was one of the "grandfathers" of
   9     perfusion, if I can say that. He was most experienced,
  10     and I think we can safely conclude that everything
  11     Mr Allen did would have been directed and supervised by
  12     Mr Caddy and would have been according to the book.
  13     I would have complete confidence in that.
  14   Q. Do we know from the records whether the anaesthetist,
  15     Dr Burton, would have been present in theatre
  16     throughout?
  17   A. It is very highly likely. I mean, I clearly do not
  18     remember, but with Dr Burton, it would have been highly
  19     likely. If he had popped out, it would have been for
  20     a few minutes and back in again.
  21   Q. If one looks at the general pattern of an operation,
  22     once bypass is established, is it the case that the
  23     consultant anaesthetist may often absent him or herself
  24     from the theatre and leave a junior anaesthetic
  25     colleague to supervise and call him or her back in, if
0152
   1     need be?
   2   A. That is not uncommon, although, as you would imagine, it
   3     does vary from anaesthetist to anaesthetist, and some --
   4     let me put it this way -- do not find it easier to take
   5     themselves away from the operating theatre for long
   6     periods of time. So, if they go out for a cup of
   7     coffee, which I think is perfectly appropriate, they
   8     will be popping back in just to see what is happening.
   9     I would definitely put Dr Burton in that group.
  10   MR LANGSTAFF: Mr Mankad, Dr Dickinson, are there any
  11     further general lessons which we may derive, do you
  12     think, from this case?
  13   MR MANKAD: I think, taking fully into account what
  14     Mr Wisheart is saying, that here we do not have
  15     relatively inexperienced but in fact dedicated
  16     anaesthetists and senior perfusionists. It does
  17     highlight that due vigilance is required on the part of
  18     both anaesthetists and perfusionists in overall
  19     intraoperative management, and it also highlights the
  20     importance of tripartite communication between
  21     anaesthetist, surgeon and perfusionist of everything
  22     that is going around the surgical field, because as
  23     Mr Wisheart rightly said, the surgeon is concentrating
  24     on the technical aspects of the operation and he will be
  25     guided by the next in command, the anaesthetist, to
0153
   1     inform him and communicate that these aspects are not
   2     right and "This is the way to sort it out, could you
   3     please do that". It highlights vigilance and
   4     communication.
   5   DR DICKINSON: I concur. I do not have any additional
   6     comments to make.
   7   MR LANGSTAFF: Mr Wisheart, today we have looked at
   8     different aspects of care; we have looked at the
   9     pre-operative; the decision-making; we have looked in
  10     the context of at least one of the cases, that of
  11     Matthew Rundle, at the question of delay in coming to
  12     surgery and the timing of surgery. We have looked at
  13     the surgical procedures themselves and, unusually,
  14     perhaps, this last case demonstrates the role that each
  15     of the individual main components of the team in theatre
  16     may play. I have not added to that the roles that
  17     others in the theatre such as your assistant or the
  18     nurses may play, but they do not emerge, I think, from
  19     this particular case.
  20        Those, I think, may be the lessons that we will
  21     draw from these cases, subject of course to anything
  22     that you may want to add in respect of this last case,
  23     having had a longer opportunity to think about the
  24     thesis that Mr Mankad has put forward, overnight.
  25        May I say that I do not expect that Mr Mankad will
0154
   1     be here tomorrow, but we can, of course, obtain in due
   2     course his input if there is anything which requires it
   3     in anything further you want to say.
   4        Sir, it is probably too late in the day to make it
   5     convenient to begin as it were where we left off in
   6     dealing with more general matters, not specifically
   7     related to individual cases, and subject to one matter,
   8     I am going to propose that we may finish for the
   9     afternoon.
  10        Would you just give me a moment? (Counsel confer)
  11        Thank you sir, for that opportunity to review
  12     matters with Mr Moon and with the assistance of
  13     Mr Maclean. I am sorry for taking up the few extra
  14     minutes -- I am not sorry actually for taking the few
  15     extra minutes we did, but we have done.
  16        We are now nearly at 4 o'clock, and it may seem an
  17     appropriate time to call it a day for today, bearing in
  18     mind that we begin tomorrow at 9 o'clock with the
  19     evidence of Professor Prys Roberts. I would anticipate
  20     that his evidence will take something in the region of
  21     a first session in the morning, and so it may well be
  22     somewhere round about half past 10, thereabouts, that we
  23     will be beginning to hear from Mr Wisheart again.
  24   THE CHAIRMAN: That last guidance is helpful, I think,
  25     to all. Then we adjourn for this afternoon, until
0155
   1     9 o'clock tomorrow morning. I say good afternoon to
   2     everyone.
   3   MR LANGSTAFF: Sir, may I thank Dr Dickinson and Mr Mankad
   4     for their presence.
   5   THE CHAIRMAN: You are right to remind me in that
   6     indirect manner of my bad manners! I omitted to do
   7     that. We, the Panel, are as ever greatly indebted to
   8     the help you have given us, today and before, and
   9     I thank you very much for coming and being with us.
  10   MR MANKAD: It has been a pleasure to be here.
  11   (4.00 pm)
  12     (Adjourned until 9.00 am on Wednesday, 15th December,
  13     1999)
  14
  15
  16                I N D E X
  17
  18
  19     JAMES WISHEART (RECALLED):
  20        Examined by MR LANGSTAFF (continued) ....... 4
  21
  22
  23        [Mr Pankaj Mankad and Dr David Dickinson
  24               sworn, page 1]
  25
0156

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