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Hearing summary

30th November 1999

The Bristol Royal Infirmary Inquiry oral hearings this week centre on the evidence of Mr Janardan Dhasmana, former Consultant Cardiothoracic Surgeon, United Bristol Healthcare NHS Trust (UBHT).

Mr Dhasmana began his evidence this morning by discussing the introduction in Bristol of the arterial switch operation to repair transposition of the great arteries for neo-nates (children aged under 28 days). He commented on results he presented to the medical audit committee about the first arterial neonatal switches he undertook and went on to describe visits he made to Birmingham Children’s Hospital to observe Mr Bill Brawn, paediatric cardiac surgeon, performing the neo-natal correction. Mr Dhasmana explained that he had not been able to identify a reason for his higher mortality figures for early neo-natal arterial switches and was persuaded to resume the procedure in Bristol, whilst keeping it under review. However, he explained that he subsequently took the decision in 1993 to halt the neo-natal programme. Mr Dhasmana and the two members of the expert group then concluded the day’s hearing by discussing three individual cases reviewed as part of the Inquiry’s Clinical Case Note Review. Mr Dhasmana will continue to give evidence tomorrow morning.

Mr Jaroslav Stark, Consultant Paediatric Surgeon, Great Ormond Street Hospital and Dr Eric Silove, Consultant Paediatric Cardiologist, Birmingham Children’s Hospital attended today’s hearing in their capacity as members of the Inquiry’s Expert Group.

FULL TRANSCRIPT

 

   1                Day 85, Tuesday, 30th November 1999
   2   (10.00 am)
   3   THE CHAIRMAN: Good morning, everyone. Good morning,
   4     Mr Langstaff.
   5   MR LANGSTAFF: Sir, I am sorry this morning's start has been
   6     delayed by about half an hour. Matters arose which
   7     necessitated conversations between the legal
   8     representatives and various interested parties and
   9     ourselves and can I once again thank them for their
  10     assistance in resolving a matter which had arisen.
  11          MR JANARDAN DHASMANA (RECALLED):
  12         EXAMINED BY MR LANGSTAFF (CONTINUED):
  13   MR LANGSTAFF: Mr Dhasmana, yesterday we were talking
  14     in the afternoon about the decision that was made to
  15     begin the neonatal arterial switch programme; do you
  16     recall?
  17   A. Yes, sir.
  18   Q. I was suggesting to you that when that decision was made
  19     you had had experience of some 14 operations in the
  20     non-neonates to resolve a condition of transposition and
  21     VSD and of the first 14 operations, 6 of the children
  22     had sadly died. I was pointing out to you that of those
  23     3 appeared to be in the younger age group.
  24        You I think were saying to me yesterday afternoon
  25     that there had been considerable discussion as to
0001
   1     whether or not the neonatal switch programme should be
   2     begun. I think you indicated that discussion took
   3     a year or two before the programme itself started?
   4   A. The last few months of 1991 was what I was really
   5     saying.
   6   Q. That would be a year and a bit because you began the
   7     programme in 1992 -- it would be half a year?
   8   A. It would be about 3 months or 4 really, I would say.
   9   Q. Did you anticipate any technical difficulty in doing the
  10     arterial switch operation on neonates?
  11   A. That was a problem with neonates itself really where
  12     tissue would be friable, coronary arteries may be
  13     smaller and those were -- essentially those tore. The
  14     rest of the technical part I thought it would be the
  15     same as for older switches.
  16   Q. Is it right to regard the neonate as a different
  17     operation because of the size?
  18   A. Yes, sir.
  19   Q. Who was it in particular who supported your starting the
  20     neonatal operation, do you recall?
  21   A. You mean in the hospital?
  22   Q. In the hospital.
  23   A. I thought it was all the members of the group really,
  24     the paediatric cardiac group really, who included
  25     cardiologists as well as surgeons.
0002
   1   Q. When you had done the operation for the best part of
   2     a year, by the end of 1992, you went to Birmingham?
   3   A. Yes, sir.
   4   Q. You went to Birmingham, as you tell us in your
   5     statement, because you felt you needed help with the
   6     operation?
   7   A. That is correct.
   8   Q. Why Birmingham?
   9   A. The last patient I operated on was September 1992 --
  10   Q. No, why Birmingham?
  11   A. It was not Birmingham I went to initially, it was the
  12     BPCA meeting at Birmingham in November 1992, which I was
  13     attending as a member. There I met a lot of my other
  14     colleagues, both cardiologists and paediatric surgeons
  15     and I discussed my problem with them, and one of the
  16     paediatric cardiologists from the Great Ormond Street
  17     Hospital then told me that they had a similar problem at
  18     Great Ormond Street Hospital and Mr Brawn was able to
  19     help really and "It would be a good thing if you talked
  20     to Mr Brawn". It so happened Mr Brawn was also
  21     attending the meeting, so I talked to Mr Brawn and also
  22     Mr Sethia. So it was following that meeting that
  23     I decided to go to Birmingham.
  24   Q. Had you known anything about the abilities of Mr Brawn
  25     and Mr Sethia before the meeting of the BPCA in
0003
   1     November 1992?
   2   A. Mr Brawn was well-known in paediatric cardiac surgical
   3     circles so I knew that his results with arterial
   4     switches are very good.
   5   Q. Did you know that before you began the neonatal series?
   6   A. Yes, I did.
   7   Q. Why then, since you knew that he had a good reputation
   8     in the arterial switch series and since you knew that
   9     the neonatal operation might be rather different because
  10     neonates are very much smaller for the reasons you
  11     described, why is it that you did not go to seek his
  12     help and to watch an operation before you began the
  13     neonatal operation rather than after you had done
  14     a number?
  15   A. Yes. I think now I do ask that question to myself but
  16     at that time I was in a way full of confidence with my
  17     own work, with what I was achieving with arterial
  18     switches in older children and I felt that I was quite
  19     familiar with the neonatal arteries and tissues because
  20     I mean, all right, I had done only, as you found out
  21     yesterday, about 14 or 15 open neonatal or under 90 days
  22     operations. But I had done by that time about 75
  23     neonatal operations at the Children's Hospital and they
  24     were very complex coarctation repair, very minor shunt.
  25     That is again dealing with very fine vessels and you are
0004
   1     joining them together. I was already familiar with
   2     coronary artery -- various patterns which you see in
   3     this condition and I had encountered them during my
   4     switch programme in older children.
   5        So I thought I was well equipped. I knew the
   6     tissue, I knew what I was going to do. I was already
   7     using my magnification and in a way I was familiar with
   8     coronary artery patterns so I did not think at that time
   9     that I needed any further exposure before starting the
  10     neonatal switch programme.
  11   Q. This is despite having waited for 4 years as it were
  12     since starting switch operations in order to move from
  13     the older age group into the younger age group.
  14        You did not feel it necessary to look and see how
  15     others managed, or handled the coronary arteries in the
  16     very young?
  17   A. No, while you are really in a way in this process, not
  18     really waiting, meaning that you sit doing nothing. It
  19     was a type of cautious wait and observation.
  20        You were doing things, you were reading material,
  21     you were attending various meetings where, all right, if
  22     you have not even assisted you were watching it on
  23     videos and other things people were presenting, and by
  24     this time, 1991, I had attended an ATS meeting in
  25     Washington, a whole day symposium was on paediatric
0005
   1     cardiac surgery and two-thirds of it was devoted to
   2     arterial switches.
   3        So in a way I thought I was well equipped to deal
   4     with it. Just to me, or in my mind it was just age
   5     I was changing but not the operation.
   6   Q. You say you thought many times about whether you should
   7     have gone to see someone like Mr Sethia or Mr Brawn
   8     before beginning the neonatal switch. Admittedly that
   9     is with the benefit of hindsight. What answer had you
  10     given yourself?
  11   A. I mean at that time I would have said -- that is again
  12     hypothesis because again I did not go -- if I had gone
  13     I would probably have adjusted it or changed my
  14     technique in the same way as I did after visiting him.
  15   Q. After visiting him you made significant adjustments, do
  16     you think, to your technique?
  17   A. Well, it was more an organisation rather than my
  18     technique because in a way technique was basically the
  19     same. I was still using the trap door method of
  20     coronary transfer which was well documented, well
  21     recognised and that is what Mr Brawn -- I think he is
  22     still using it. I was using the Lecompte manoeuvre
  23     and was familiar with that. In a way the technical part
  24     was no different.
  25        I think it was more organisation because before
0006
   1     I had a setup which was in a way not well rehearsed. If
   2     I was asking for something on the table, that was being
   3     relayed to somebody else to get it and then bring it.
   4     In a way I found that organisation was more important,
   5     how everybody dealt with it during this procedure. That
   6     is what I found very important.
   7        I did after that make sure that the nurses,
   8     perfusionists, anaesthetists also visited the centre and
   9     saw how things were being done.
  10   Q. Admittedly looking back on it you think that had you
  11     visited Birmingham 12 months earlier than you did there
  12     would have been changes to the pattern and organisation
  13     of the work along the lines of the changes that you
  14     introduced after having gone to Birmingham in December
  15     1992.
  16        When Messrs Hunter and de Leval came to write
  17     their report in 1995 you picked up I think on a phrase
  18     they used, talking about "institutional failure" or
  19     "multifactorial" reasons why the switch results might
  20     not be, were not as good as they had been in other
  21     centres.
  22        What do you think, again looking back at the early
  23     period of the neonatal switch, were the many different
  24     factors that went in to the results that you achieved?
  25   A. I think multifactorial is the right term and that
0007
   1     probably explains everything, you know, not just
   2     surgeons, the whole team, everybody has to be geared up
   3     and move in the same way. I do not think I can explain
   4     that any better than the term itself really.
   5   Q. What factors do you now see as having played a part,
   6     factors that might perhaps have been changed had
   7     different views been thought at the time?
   8   A. There were quite a few things really when I looked in my
   9     whole neonatal programme, not just the first 5 really.
  10     I felt or I believed that incidents of coronary
  11     abnormality in my short series of 13 patients was
  12     comparatively higher than what had been reported in the
  13     literature. A lot of people do a lot of cases and then
  14     see one intramural artery and I saw two within the span
  15     of 13/14 cases.
  16        Out of a total experience of 38 switches which
  17     I have done, 17 had coronary abnormality of some sort
  18     which is higher than mentioned in the literature, which
  19     is usually 30 per cent in the literature.
  20        Also, I used to really say, but of course in
  21     scientific terms you should not be using the term,
  22     I felt I was unlucky to have been confronted with so
  23     many problems in the beginning of that experience and
  24     Mr Brawn pointed that out to me when I met him during
  25     work at a paediatric cardiac meeting in Paris and
0008
   1     I talked to him about my problem.
   2   Q. Cutting you short: one factor was the slightly higher,
   3     17 as against say 13 -- a third -- incidents of abnormal
   4     coronary artery patterns in the children that presented
   5     to you.
   6        What were the other factors that you would
   7     identify as playing a part?
   8   A. I think that I noted more in the earlier part of my
   9     experience but some of it continued even later, like
  10     existing coarctation in patients who I was really
  11     operating for simple transposition. Or VSD, even though
  12     it was mentioned that it could be haemodynamically
  13     insignificant, and some of these coronary abnormalities
  14     I found out more on the table rather than described
  15     before. But I do admit that not all coronary
  16     abnormalities can be identified preoperatively.
  17   Q. Are you saying here that although not all coronary
  18     artery abnormalities can be identified preoperatively
  19     you felt that a number appeared for the first time to
  20     you on the table which, as you thought of it at the
  21     time, ought to have been picked up beforehand?
  22   A. That was my belief but I have been told that is not
  23     correct.
  24   Q. Let us explore that for a moment. Your belief would be,
  25     then, would it, that the cardiologist had not carried
0009
   1     out a sufficient or sufficiently thorough investigation
   2     or had not accurately reported what that investigation
   3     showed?
   4   A. I was really commenting on them as a type of helpful
   5     criticism in order to improve further, I was not really
   6     criticising them.
   7   Q. I am not concerned with criticism so much as to
   8     establish the fact that this is what you thought should
   9     have been done.
  10   A. That is correct.
  11   Q. The consequence of a failure by the cardiologist, if it
  12     was, to identify coronary artery abnormalities before
  13     you discovered them on the table was, what, so far as
  14     you were concerned?
  15   A. It took me longer to correct in those cases really, just
  16     once -- I mean as I thought at that time I was probably
  17     taking a bit longer in these abnormal coronary artery
  18     patients trying to work out my programme on the table
  19     rather than having worked it out before.
  20   Q. If you had worked it out before, you would have been
  21     quicker?
  22   A. I would have saved a few minutes, yes.
  23   Q. And is time, as you see it, a matter of importance in
  24     such an operation?
  25   A. Well, I did not realise that at that time but looking
0010
   1     back probably it mattered in the neonatal part of the
   2     switch. Because it did not matter too much to my older
   3     switches really, they were going very well with
   4     a similar percentage of coronary abnormalities in that
   5     group really, I never had any problem.
   6   Q. Looking back on it, you think the additional time you
   7     took because of the abnormalities that were presented to
   8     you on the table, having to think your way round them,
   9     think how to deal with them, may have had an influence?
  10   A. I am sure it did, I admit that.
  11   Q. We have heard in the Inquiry that the surgeon who has
  12     a lot of experience in dealing with a particular type of
  13     case may when he is presented with something unusual,
  14     something which he has not anticipated in advance, may
  15     be able to deal with it more quickly, more speedily
  16     because he has met that sort of problem before?
  17   A. I myself did the same in the last few cases. When I was
  18     presented with an abnormality I corrected them quicker
  19     than I was doing before. That is what I was talking
  20     about with the "learning curve". Everybody goes through
  21     that whether you are an experienced surgeon or not. You
  22     do, with your own experience, learn to really tackle
  23     sometimes these unexpected problems better than if
  24     somebody starts fresh.
  25   Q. We have looked at two of the factors: the slightly
0011
   1     higher number of children presenting to you with
   2     difficult coronary artery patterns, abnormal; and
   3     secondly the failure as you see it of the cardiologists
   4     to tell you beforehand sufficiently in a number of cases
   5     that there were these problems so that your operation
   6     took longer and probably had an impact overall.
   7        What other factors do you think may have played
   8     a part?
   9   A. I feel as a surgeon Mr Brawn managed to have a better
  10     team to help him in the theatre than I managed here in
  11     Bristol.
  12   Q. What was it about his team that was better than your
  13     team?
  14   A. Well, he had a dedicated paediatric cardiac surgical
  15     assistant in a way. My assistant, even though he could
  16     be a Senior Registrar, may not be a dedicated paediatric
  17     cardiac surgical assistant, may not have seen that many
  18     paediatric cardiac surgical cases and I have no other
  19     option but to take his assistance at that time to help
  20     me.
  21        So in a way he would not automatically move in the
  22     same way or anticipate my move as it was being done in
  23     Birmingham. Similarly, nurses in Birmingham, they had
  24     almost everything ready on the table. They knew when he
  25     was going to require a suture, it was almost as if he is
0012
   1     not looking, he is just doing that, he is getting it.
   2     I used to really say in theatre that "we are not running
   3     a relay service here" because that is what I was
   4     noticing. Most of the time I am saying "4 O" then
   5     somebody else is in 4 0 then somebody is getting from
   6     there and obviously by that time I would look at what is
   7     happening and this is all distracting.
   8        That was one of the problems, that sometimes some
   9     of the nurses in theatre were very uncomfortable with me
  10     because I did not like that type of -- it is not service
  11     to me, I thought it is service to the patient, and that
  12     was lacking and I think it was lacking because these
  13     nurses were on the same day dealing with an elderly
  14     gentleman, another person where probably such things do
  15     not matter that much at the time, but here it did.
  16   Q. Again you are picking up I think on two or three factors
  17     there: one is that the consequence of having a "relay"
  18     operation, one person turning to another to another to
  19     another, is a further delay in the time it would take
  20     you to complete your operation?
  21   A. That is correct, sir.
  22   Q. Secondly, it indicates that if you needed something very
  23     quickly you might have to wait for it and that is not
  24     a good thing?
  25   A. That is correct, sir.
0013
   1   Q. Thirdly, it indicates, does it, that you reacted to the
   2     nurses, telling them off for running a relay operation
   3     for the reasons you have explained, which I think you
   4     have told us sometimes affected the atmosphere in the
   5     theatre?
   6   A. I am aware of that.
   7   Q. If you have an atmosphere in an operating theatre
   8     I suppose that the whole team does not function quite so
   9     well; it is inevitable, is it not?
  10   A. By "atmosphere" I do not really mean it should be
  11     pleasant with music going and all these things. I feel
  12     it should be professional and I felt it is not
  13     professional that, you know, things are not there.
  14     I mean the list is already out, you know what we are
  15     going to do. In a way it should be professionally ready
  16     for you and that is where my in a way criticism was.
  17        As far as the pleasantness is concerned, I was
  18     very pleasant outside operating time, but during the
  19     operating time, I did not want chitchat, I wanted things
  20     done and that somehow was not popular with many nurses.
  21   Q. So for the reasons you have given, you could be cross
  22     and irritable in the operating theatre, could you?
  23   A. I never realised that I could be, but yes, it would be
  24     seen that way.
  25   Q. If you were telling nurses off for a relay operation as
0014
   1     you have described it, your need to do that would be
   2     a distraction, would it, of you from focusing upon the
   3     particular job that you had to do with the patient?
   4   A. I think when one uses the word "telling off", it sounds
   5     harsher than what it really was. I do not think I was
   6     "telling off" because when you are telling off that
   7     means you had stopped doing things, what you were really
   8     doing. I was not stopped from doing anything really,
   9     I was just in a way hurrying up, if you like. It could
  10     be seen that way, or it could be interpreted, but I did
  11     not realise I was telling anybody off.
  12   Q. But you said you found it distracting?
  13   A. To me, yes, because I am operating here, looking at
  14     this, and then I ask for a suture and it is not there.
  15     So it is not there. I look this way and you have got
  16     magnification on all those things, all focused. Then
  17     you go back on there, it takes a little time,
  18     a millisecond, but you have gone out from there. To me,
  19     especially when you are doing a very minute vessel,
  20     I think it is a little bit -- you know.
  21        But I did have actually a few nurses who were very
  22     good and mostly they used to work with me and I had no
  23     problem with that.
  24   Q. The assistant you described as not necessarily being
  25     somebody who had an interest in paediatric cardiac
0015
   1     surgery, if you had hit a problem, something that you
   2     had to think your way round on the operating table, if
   3     you had an experienced assistant, is that the sort of
   4     thing you would discuss with such an assistant?
   5   A. I think most of the time you would discuss with your
   6     assistant for two reasons.
   7        One: sometimes, even the person is not
   8     experienced, can give you advice, you know, from his
   9     reading or literature; a lot of younger Senior
  10     Registrars, sometimes they know a lot more about what
  11     you are doing at that time.
  12        Second: when you are discussing you are not really
  13     in a way asking for the person's advice and help to you,
  14     you are also rehearsing in your mind what you are doing
  15     is correct or not, really. That is why I used to do
  16     that.
  17   Q. Was that as helpful with a Registrar who did not have
  18     the interest or the experience as it would be with one
  19     who did have an interest or/and experience?
  20   A. I felt it very helpful really in either case. But on
  21     the two occasions when I visited Birmingham there was
  22     not much chitchat really but probably things were very
  23     straightforward, there was no need for him to ask. So
  24     I did not see him really discussing that with his
  25     assistant or anything like that.
0016
   1        But whenever I was doing it I felt, you know, that
   2     talking with my assistant helped me both ways, in
   3     devising my own plan, what I am really doing and
   4     sometimes getting some very helpful advice, yes.
   5   Q. What else would you say about the team that differed as
   6     between Birmingham and Bristol?
   7   A. I also felt that our anaesthetists did learn when they
   8     visited, even though they kept telling me that they have
   9     not really seen anything different, but I did notice
  10     with the changes which they accepted and they did.
  11        For example, before going to Birmingham we had to
  12     have the patients or neonates, especially younger
  13     children, in a way you could say with very good blood
  14     pressure before the move out from theatre and that
  15     really meant sometimes staying on bypass longer or
  16     adding more inotrope than you could have really done
  17     without.
  18        While at Birmingham -- I watched three operations
  19     on two occasions -- so in a way I saw that blood
  20     pressure was not essentially accepted or regarded as
  21     a very important thing, even 50 or 60 blood pressure was
  22     accepted as all right, if the filling pressure is all
  23     right, this heart is going to improve with the passage
  24     of time. I watched in ITU the first case, say about an
  25     hour, and within the next 40, 50 minutes this patient
0017
   1     got better in ITU.
   2        So you did not really need to stay in theatre to
   3     wait for a patient to improve before transferring, once
   4     you are happy the repair has been done properly, the
   5     filling pressure -- Mr Brawn at that time, I may be
   6     wrong or I think it may have changed by now, but left
   7     atrial pressure was considered most important.
   8        That is all right. He said "Do not worry".
   9     I felt he was using more dilators to keep the body
  10     filled more than the heart. Before going to Birmingham
  11     we were filling the heart more but constricting the rest
  12     of the body really. I thought that was very good in the
  13     post-operative management and it did help us actually
  14     over the next few cases.
  15   Q. Again, the point you were making about keeping the child
  16     in theatre in Bristol when the child might not have been
  17     kept in theatre in Birmingham, would that extend the
  18     time the child would be on bypass for instance?
  19   A. Sometimes I had to keep them on bypass because we were
  20     not happy or not supposed to be happy to come off
  21     bypass, if you understand.
  22   Q. Having seen what they did in Birmingham you appreciated
  23     that with a different, a modified anaesthetic or
  24     post-operative approach you could come off bypass
  25     earlier?
0018
   1   A. Yes.
   2   Q. Was there any other factor apart from the different team
   3     approach that you have described as between Birmingham
   4     and Bristol which you think, looking back on it, may
   5     have affected the surgery in Bristol?
   6   A. I do not remember at the moment, but maybe you will find
   7     out.
   8   Q. I am going to come to how you responded to the start of
   9     your switch operation and what it was that before you
  10     went to the meeting in November you have described of
  11     the BPCA inspired your first visit to Birmingham.
  12        Before I do that, may I ask our experts: here was
  13     a unit beginning a new procedure in some respects. How
  14     often was it that a surgeon who had not done
  15     a particular procedure, introducing it for the first
  16     time would, in the early 1990s, go, watch and observe
  17     another centre before beginning himself to do the work?
  18   MR STARK: I would not have information about that.
  19     I can only speak from personal experience and I think
  20     I would agree with what Mr Dhasmana said, you have
  21     various means, you go to the meetings where the videos
  22     are presented, sometimes you go to the surgeons to see.
  23     What you see sometimes is very good in a positive way
  24     because you think people are doing things better.
  25     Sometimes it is a negative way because you know which
0019
   1     things you should avoid, what the other people do.
   2        So I think everybody would make an effort somehow
   3     to familiarise himself or herself with the procedure
   4     through the various means.
   5        I think as far as the question about the neonatal
   6     as opposed to the older children's programme, I think we
   7     discussed it briefly when we were here with
   8     Mr de Leval. There were basically two schools of
   9     thought. One which we have adopted at Great Ormond
  10     Street, that we would slowly reduce the age of the
  11     patients because there was a myth or feeling that things
  12     are more difficult in neonates. There was another
  13     school which was Dr Castaneda in Boston and subsequently
  14     one of his pupils, Dr Mead in Melbourne, who felt that
  15     perhaps it is easier to correct things in the neonates
  16     because you do not wait for the changes that the defect,
  17     with the passage of time, will inflict upon their heart
  18     or upon their lungs.
  19        Certainly from the technical point of view I think
  20     once we started doing more neonates one can easily say
  21     that the operation on neonates is easier because you use
  22     fewer stitches, the structures are smaller so you have
  23     to be accurate but while you may have to put into aortic
  24     anastomosis 30 stitches in a two-year old, you may put
  25     only 10 in a neonate. I think those were the two
0020
   1     schools of thought, how to go about neonatal vis-a-vis
   2     older operations.
   3   Q. When you began the operations, the first neonatal
   4     arterial switch operation which you did I think you
   5     discovered there was an undiagnosed coarctation?
   6   MR DHASMANA: I found out later, you could say from PM
   7     really, postmortem examination.
   8   Q. So you performed the operation without knowing there had
   9     been an undiagnosed coarctation?
  10   A. On the table I did notice some difference of pressure
  11     because the arterial line was in the femoral monitoring
  12     line. When I was coming off bypass I had my needle in
  13     the aorta which I used to do a number of times just for
  14     the reason that we were using the technique at that time
  15     which you used to keep the periphery cooler but the
  16     heart fuller so you had a better pressure there. And
  17     I noticed some difference. But that I simply thought
  18     was just part as I had seen in a lot of other patients.
  19     The difference I think was probably not more than 15 or
  20     18 millimetres of mercury and I just felt at that time
  21     that that is not relevant.
  22   Q. The second arterial switch you did -- because the first
  23     5 all died, did they not?
  24   A. Unfortunately, yes, sir.
  25   Q. Did you think when you operated on the second that there
0021
   1     might be a technical problem with the way you did the
   2     operation?
   3   A. No, because I looked at the postmortem examination and
   4     that filled me with confidence because both coronary
   5     arteries were widely patent, the patient did not have
   6     any problem attributed to coronary transfer. The
   7     problem here was very tight coarctation.
   8   Q. You told the GMC, I think, that your first reaction to
   9     that operation before you saw the postmortem report was
  10     to think there may have been a technical problem in the
  11     way in which you had conducted the operation?
  12   A. That is what you were talking about yesterday, my
  13     self-critical thing, anything which I had done, and if
  14     it does not go according to plan I questioned myself
  15     first and then look at others. I really kept asking
  16     myself "Did I do anything differently?" and before
  17     I could really see anything I thought "It must be the
  18     coronary artery which had probably caused the problem
  19     because this is a small baby and it is a possibility my
  20     stitches may not have been in the right place". But
  21     when I saw the postmortem examination then you could put
  22     a nice probe in there and the heart did not show any
  23     evidence of ischaemia, it in a way filled me with
  24     confidence.
  25        Until that time, yes, I always was questioning
0022
   1     myself and I may have mentioned to somebody "I hope it
   2     is not the coronary artery", that type of question. But
   3     I thought every surgeon asked that question himself.
   4   Q. The lesson we may take from this is that you were not
   5     confident because this was only the second operation
   6     that you had done?
   7   A. This was the first.
   8   Q. You were not confident that you were necessarily
   9     doing the operation right, that you had to be reassured
  10     by other matters?
  11   A. I think everybody needs reassurance.
  12   Q. When Mr de Leval gave evidence to us he described as
  13     a matter of importance for a cardiac surgeon the feeling
  14     of confidence which such a surgeon has; is he right, do
  15     you think?
  16   A. It is very important when you are going in for surgery
  17     that you feel confident you can do it. I was confident
  18     when I did it. I raised the question in my mind because
  19     the child did not make it and I am asking that question
  20     to myself but when I saw the PM I was quite pleased that
  21     in a way my technique was fine. In a way you could
  22     really say I was back to my own self again.
  23   Q. Did you do the third and the fourth operations before
  24     you saw the PM on the second?
  25   A. No, the PM is usually -- I mean at that time the
0023
   1     practice was that they would do the PM examination at
   2     the next available slot they can really fix it. If
   3     I have time, I am not operating, I would go and watch
   4     them and help him to really find, because a lot of these
   5     operations, the pathologists did not know the exact way,
   6     how things were done. Sometimes if I could not be there
   7     I could see the specimen, at my first available space
   8     really. It was sometimes in the evening, often 5.00 pm
   9     I went to their office and said "You examined that
  10     heart, can I examine with you?"
  11   Q. Let me move on a little: by the time you had done 5
  12     operations and the first 5 had died, what did you think
  13     about continuing with the programme?
  14   A. As I mentioned yesterday, every time a transposition was
  15     being referred we were always asking questions "How are
  16     we going? What we are doing?" All these patients, the
  17     first patient when this has happened I said "You know we
  18     missed coarctation, that is not a nice thing to miss".
  19     Of course an echo was done so in a way I do not know how
  20     we missed it, but sometimes you can and let us hope we
  21     do not.
  22        In a way we are asking questions but here the
  23     question was to improve the diagnosis, not to stop the
  24     programme.
  25        The second one, when I operated -- I am not sure
0024
   1     but probably there was a technical problem on the table
   2     but I managed to in a way correct it. That did actually
   3     prolong the operation, the child took longer to recover
   4     and was recovering in ITU when he got into a septic
   5     state, and that was I would think a week or 10 days
   6     after that.
   7        So in a way in the second case there was another
   8     cause for failure --
   9   Q. Did you then go through each of the five cases and
  10     identify the individual causes and satisfy yourself
  11     about those causes?
  12   A. Yes, sir, I did.
  13   Q. Two questions really follow: you had had an experience
  14     in the first five cases of 100 per cent mortality. In
  15     the papers at the time, what level of mortality was, as
  16     you understood it, to be expected from the neonatal
  17     arterial switch?
  18   A. They were different papers at that time, a lot of papers
  19     coming out. As I mentioned before, I think yesterday,
  20     I was concentrating more on this North American paper
  21     which was really a type of study -- multi-centre study
  22     because, of course you know, papers were coming out from
  23     very good institutions and papers were probably coming
  24     out from not so good institutions.
  25        But this study was really a combination of all
0025
   1     centres together and then analysing the results in a way
   2     that you can get some, what I thought, was sensible
   3     answer. On the basis of that I was expecting that
   4     mortality of 20 to 30 per cent in a centre like ours is
   5     probably expected in this type of operation.
   6   Q. In the middle of 1992, in May -- let us have a look at
   7     UBHT 61/165?
   8   THE CHAIRMAN: Mr Langstaff, as you are going through this
   9     I would like you to explore if you could whether there
  10     was any data which identified the results of the first 5
  11     or 10 as distinct from a longer series at this time.
  12   MR LANGSTAFF: This is a meeting in June 1992. If we look
  13     down at the bottom of the page as it is on the screen:
  14     results of the arterial switch operation by you, because
  15     Mr Wisheart had done three arterial switch operations
  16     I think, three or four, early on in the non-neonates and
  17     he had stopped?
  18   A. Yes, sir.
  19   Q. Why did he stop?
  20   A. I think the main reason was that, in a way centralise
  21     experience in one hand because after a few, or say 2 or
  22     3, he realised that it needed a lot more technical input
  23     from the person and it would be better if it is in one
  24     hand, because our total number, as we were talking
  25     yesterday, of transposition of every type in Bristol was
0026
   1     probably not more than 20 in a year, that is maximum
   2     I would say. So he thought that one person -- it would
   3     be better in the hands of one person rather than both of
   4     us.
   5   Q. And better you than him?
   6   A. That was very kind of him to say that, I did not want to
   7     really put that in.
   8   Q. Because, as you would see it?
   9   A. I thought the word he used was "younger person could
  10     probably put more energy in it".
  11   Q. 61/165, your series: "Findings and observations.
  12     Mortality for TGA and TVSD switch" that is the
  13     non-neonates "similar to reported results particularly
  14     if consider his early experience". A higher mortality
  15     for multiple VSDs. You go on, down the bottom of the
  16     page: "Action taken/clinical changes instituted". There
  17     are these words "persevere with the arterial switch for
  18     the TGA/VSD", so you are going to persevere with the
  19     non-neonatal group. "Continue the programme of switch
  20     for TGA and IVS", that is the neonatal?
  21   A. Intact ventricular septum, yes, neonate.
  22   Q. "Aim for earlier repair when possible", to which group
  23     did that relate?
  24   A. Both.
  25   Q. "A careful search for multiple VSDs and coarctation",
0027
   1     that is emphasising your experience, is it, with the two
   2     cases you have so far told us about where a coarctation
   3     was missed?
   4   A. Sorry, can I just explain further that answer to number
   5     3: "Aim for earlier repair when possible" is really
   6     following the second problem when in hospital. There
   7     was a higher mortality if a person or a child has been
   8     waiting for surgery in the hospital, admitted. That is
   9     why -- he is really saying that if we have got a patient
  10     here please operate on them sooner than what you are
  11     managing at this time.
  12   Q. Is it earlier in terms of the age of the patient or
  13     sooner after admission?
  14   A. I think when he asks us to operate on, that is what he
  15     really means.
  16   Q. When the decision has been made, to operate as soon as
  17     possible?
  18   A. Yes.
  19   Q. What we do not see on this sheet is any reflection of
  20     your telling the meeting about the results that you had
  21     had in the neonatal programme?
  22   A. That is not correct. If you follow, this is a summary
  23     sheet. There were five or six other pages because
  24     I presented data.
  25   Q. So you told them?
0028
   1   A. Yes.
   2   Q. Did you also tell the meeting that in Birmingham on the
   3     neonatal switch hardly any patient died?
   4   A. That was at the end. It was a type of a meeting -- the
   5     meeting had almost finished. In a way we had done this
   6     --
   7   Q. The answer is "yes" you did say that?
   8   A. I did say that, yes.
   9   Q. Did you say to the meeting that Castaneda had reported
  10     results for the neonatal arterial switch of less than
  11     5 per cent mortality?
  12   A. That is correct, I did.
  13   Q. It follows that at this stage you knew that I think all
  14     the switches which had been done in Bristol by the team
  15     had died but elsewhere mortality could be between 0 and
  16     5 per cent?
  17   A. In some centres, yes.
  18   Q. Was there any discussion at the meeting as to whether,
  19     in the light of that, the results you were having
  20     required a review to see if there was anything you were
  21     doing as a team that needed to be changed in order to
  22     improve mortality or even to suggest "we should not be
  23     doing it"?
  24   A. I think there was actually. It was said that we would
  25     continue to deliver this programme and we would see it
0029
   1     again in a few months time in one of these meetings,
   2     yes.
   3   Q. So people were concerned about whether they were doing
   4     the right thing by continuing to carry on the operation?
   5   A. With any programme you have to keep asking yourself that
   6     question, yes.
   7   Q. This was mid 1992. At this stage who was anaesthetising
   8     for the switch operations?
   9   A. By this time I think, we had only -- this is June 1992
  10     -- we started in 1988 when Dr Burton had retired, so
  11     Dr Masey being the main anaesthetist I would say.
  12     Dr Bolsin and Dr Monk, they took their turn when the
  13     rota was like that, but there were probably fewer with
  14     them, and some time in 1991 Dr Underwood came in and she
  15     showed more enthusiasm about paediatrics so I think she
  16     took a greater share of paediatric cases than doctor --
  17   Q. Had you got to the stage by now -- by the middle of 1992
  18      -- when, as it happened, only Dr Masey and Dr Underwood
  19     were actually carrying out the anaesthetic for the
  20     switch operations?
  21   A. I did not know that until December 1992.
  22   Q. By December 1992 you realised, did you, that the
  23     anaesthetists had agreed amongst themselves that only
  24     two would do it?
  25   A. I found out when I talked to Dr Bolsin, because in a way
0030
   1     Dr Masey had gone to Birmingham with me. Dr Underwood
   2     was --
   3   Q. If you forgive missing the details: you spoke to
   4     Dr Bolsin in December 1992?
   5   A. That is correct.
   6   Q. What was he saying to you roughly?
   7   A. I was asking him to go to Birmingham to see the
   8     operation so that we can plan management.
   9   Q. And his response?
  10   A. His response was: that "Janardan, I tell you now Sally
  11     and Sue would really be dealing with these cases because
  12     we thought we would just leave -- we would let them
  13     concentrate on this problem because it is very
  14     technically demanding but of course I am willing to help
  15     if you want and I would make telephone calls", that was
  16     his last word.
  17   Q. Did you understand from what he was saying that he and
  18     Dr Davies were not prepared to anaesthetise for switch
  19     operations?
  20   A. Dr Davies was not even appointed at that time; Dr Davies
  21     was appointed in June 1993 or July 1993.
  22   Q. Did you understand that Dr Bolsin was not prepared to
  23     anaesthetise for switch operations at this stage or not?
  24   A. He did not put it in that way.
  25   Q. You told us that at the meeting there was discussion
0031
   1     about keeping the switch programme under review, about
   2     whether the unit should continue to do it. Do you
   3     remember who it was who was raising those points at the
   4     meeting? Can we scroll back up to the top and see who
   5     was there?
   6   A. You can see it must be myself, Dr Jordan, Dr Joffe and
   7     Martin really. So we were all asking ourselves really.
   8     We did not feel any different from one to another, we
   9     worked as a team. So if there is a problem like that
  10     then they are the cardiologists who are referring, I am
  11     the surgeon who is operating, we are really in a way
  12     deciding that that is how we would really carry on.
  13   Q. How was it that you explained to yourselves at this
  14     meeting the difference in the results which Birmingham
  15     had and Castaneda had on the one hand for the neonatal
  16     switch and you were having in terms of at least the
  17     crude mortality data?
  18   A. By this meeting I am not sure I had done that many, only
  19     one probably was done, I am not sure. But we were
  20     looking because only one would have been discussed in
  21     this one, the first patient?
  22   Q. In terms of the comment "persevere with"; let us go down
  23     to the bottom of the page. The word "persevere"
  24     suggests there is an element which is less than
  25     enthusiastic to continue the operation. I think that is
0032
   1     something of the reflection you are giving us, given the
   2     necessary concern to see whether the results were
   3     appropriate. Have I read that right?
   4   A. Yes, you have read it right. But if you look at it
   5     further, it says "for TGA and VSD". So what I have done
   6     on this one, I have presented all my experience from
   7     1988 until that time and in a way when we take overall
   8      -- probably by this time I would have operated on, say,
   9     12 cases or 11, I do not know, I have not got in front
  10     of me the paper which you are looking at.
  11   Q. If we go to GMC 8/22, are those the figures you
  12     presented to this meeting?
  13   A. Yes, there was some correction made to that but, yes,
  14     the total number was 16 and out of that -- that was the
  15     mortality as presented. Of course if one looks at it
  16     like that then it does look higher than the reported
  17     series and that is why you can really say that I in
  18     a way go according to year of operation. That was also
  19     a usual way of presentation in scientific papers at that
  20     time and that explains that most of these deaths
  21     occurred in the first 2 years of the programme. After
  22     that there was probably 1 death in the remaining cases.
  23   Q. Can we scroll down, but, sir, you will need to take it
  24     off the public screen. We see there the whole figures
  25     for the non-neonatal series, do we, up to this stage?
0033
   1   A. Yes, sir.
   2   Q. If we turn over the page, page 23, this was the
   3     comparison you were making with the University of
   4     Alabama and Birmingham, was it?
   5   A. That was from the book which was at that time available,
   6     the 1986 edition of a book on cardiac surgery edited by
   7     Kirklin and Barrett-Boyes, yes.
   8   Q. The 1984 figures were unlikely to be very helpful, were
   9     they, looking at matters in 1992?
  10   A. For TGA and VSD this is the 1984 as it was available,
  11     but even in this country TGA and VSD was around 25 to
  12     30 per cent in most of the centres.
  13   Q. Those results for this country you did not show?
  14   A. Because they were not available, we were hardly getting
  15     any information from this country.
  16   Q. Can we scroll down the sheet? "CHSS North America, 1985
  17     to 1st June 1988". Again I do not know, does this
  18     relate to the arterial or the atrial switch, do you
  19     know?
  20   A. You have both there, arterial and atrial, both are
  21     mentioned. This is from 1985 until June 1988.
  22   Q. One can see there the survival rates?
  23   A. Yes.
  24   Q. 21 per cent in the arterial and 15 per cent in the
  25     atrial?
0034
   1   A. You are talking of mid mortality.
   2   Q. You are quite right to correct me, I am sorry.
   3        Again 1988, 4 years earlier, was likely, was it,
   4     to indicate a higher mortality rate than one would
   5     expect in 1992?
   6   A. We know now, yes, but at that time I did not know that.
   7   Q. Was it not the view in 1992 that matters were developing
   8     fast in cardiac surgery?
   9   A. Yes, but as I said before, Britain as a rule is about 3
  10     or 4 years behind America in this type of surgery and
  11     probably Bristol was a few years behind the rest of the
  12     country.
  13   Q. So the papers you were summarising here and conducting
  14     the discussion in respect of the non-neonatal switch
  15     were both American, some at least 4 years old --
  16   A. Can I correct, sir? Even though this says "1985 to
  17     1988", this paper appeared in 1991 and 1992, so this was
  18     the most recent paper available at that time when
  19     I presented the data.
  20   Q. In North America the pattern of cardiac surgery was, was
  21     it, for a large number of units performing a small
  22     number of operations in each unit?
  23   A. No, I think you have another centre in mind. University
  24     hospitals in Northern America combined together to
  25     decide on what they were going to follow in future for
0035
   1     the management of patients with the transposition of
   2     great arteries because here is a new operation come in,
   3     somebody is reporting brilliant results, is it really
   4     safe for everybody else really to take on?
   5        It was with that in mind that these university
   6     hospitals combined together to analyse their results in
   7     a way, what they call Congenital Heart Surgical Society
   8     of North America figures. I think in the beginning it
   9     was only arterial switches, I am not sure whether they
  10     had incorporated other areas or not, the experts may
  11     know more about it.
  12   MR LANGSTAFF: There is an appeal to expertise from
  13     Mr Dhasmana, can you help with the CHSS?
  14   MR STARK: I think a couple of points. Can we perhaps look
  15     at INQ 0070021 because I think that one problem -- and
  16     if we can enlarge the table, please -- this is the study
  17     of the same Congenital Society for the United States,
  18     the follow-up on the study that Mr Dhasmana quoted. The
  19     first author on this paper was Kirklin.
  20        I think the point I would like to make to put
  21     things into context: although the overall mortality for
  22     arterial switches at that time was 17.9 per cent,
  23     Dr Kirklin divided the institutions -- and they were all
  24     university teaching institutions -- into the low risk
  25     which is the first 7, whereas the mortality varied
0036
   1     between 6 and 13 per cent, and then from institution age
   2     we have mortality between 23 and 80 per cent. The last
   3     four institutions were actually taken out of the study
   4     because their numbers were too small and they could not
   5     be taken into statistics.
   6        So I think the point I just wanted to make is:
   7     even at that time there was a variety of results between
   8     the centres.
   9   MR LANGSTAFF: In America?
  10   MR STARK: In America. I would assume purely from hearsay,
  11     and I am not sure if one should quote it, that the same
  12     existed in this country but we did not have hard data.
  13   MR LANGSTAFF: Was it a perception that the high risk
  14     centres (so-called) were those which did lower numbers?
  15   MR STARK: There was some indication. In the earlier
  16     report, not in this one but in the paper published 4
  17     years ago, they did a correlation between the size of
  18     the sample, of the number of patients operated, and
  19     there was a clear indication that institutions that did
  20     less than 10 switches during the study period -- which
  21     I believe was about 3 and a half years -- had
  22     a mortality of over 50 per cent while centres that had
  23     more than 50, and actually there were only two such
  24     centres in the whole study, their mortality was I think
  25     around 10/15 per cent but --
0037
   1   Q. In that study itself there was an indication that not
   2     only experience but --
   3   MR STARK: Volume.
   4   Q. -- volume mattered in terms of producing results?
   5   MR STARK: Can I make one more comment? This is in response
   6     to the question by Professor Kennedy about whether there
   7     is evidence about the differences in early cases, the
   8     learning curve.
   9        Again, the evidence is very very limited but --
  10   THE CHAIRMAN: I interject to say I did not use the word
  11     "learning curve", those two words I would not use.
  12   MR STARK: Sorry. In the beginning of the experience there
  13     is some information, one is from the study by Muller.
  14     It is again North America but different institutions
  15     from the study presented here. He compared the first 10
  16     cases with the subsequent cases in about 15
  17     institutions.
  18        The interesting point was that the first 10 cases,
  19     the risk of infant switches was as high as 30, 50 and
  20     70 per cent in the three institutions. But to me what
  21     was more interesting, that although in the majority of
  22     institutions subsequently the mortality dropped, in some
  23     it remained the same and in others actually went up.
  24     They did not give an explanation for that.
  25        From our own experience at great Ormond Street --
0038
   1     and I briefly mentioned it yesterday -- the transition
   2     period when we changed from the atrial switch to
   3     arterial switch was unfortunately associated with
   4     increased mortality. The mortality for the period of
   5     the atrial switch when we took into consideration even
   6     three operative deaths, as I mentioned yesterday, was 12
   7     to 15 per cent. During the transition it went up to 25
   8     to 30 per cent and that was in the years of, I think,
   9     1986/1991 and after 1992 when it was an entirely switch
  10     programme for all accepted neonates, from 15 per cent
  11     the mortality eventually went to 5.
  12        So this is what I tried to explain yesterday, what
  13     are the difficulties for the surgeon if he believes that
  14     the new operation is better; still during this
  15     transition period we were aware that we had more deaths
  16     than we would have had with the previous programme.
  17        The only other information I have is again from
  18     this study using some statistical evaluation, which is
  19     unfortunately above my head. Dr Kirklin estimated that
  20     the risk of the first switch in high risk units at that
  21     time would be 70 per cent and in low risk 30 per cent.
  22     But I am afraid do not ask me about statistics, this is
  23     a little bit high powered.
  24   MR LANGSTAFF: What I was going to ask you was whether it
  25     was your understanding that the definition of "high risk
0039
   1     centre" was one which was given because of the results,
   2     in which case the argument you have just given may seem
   3     to be circular?
   4   MR STARK: It was given purely on the basis of the results,
   5     yes, because all those institutions had experienced
   6     surgeons. If you look at the end of this paper there is
   7     a list of institutions and surgeons and it basically
   8     reads as to who is who in congenital surgery in America.
   9   MR LANGSTAFF: Was there any attempt to analyse the reasons
  10     why -- apart from the number, the volume of operations
  11     done -- it should be that some centres were high risk
  12     and others low risk.
  13   MR STARK: There were many attempts to find out the
  14     mortality. For example coronary artery pattern was
  15     studied, age was studied, weight was studied but apart
  16     from the fact that it seems to be correlation, and
  17     strong correlation between the volume of cases and
  18     mortality, they did not come up with any conclusive
  19     answers.
  20   MR LANGSTAFF: Sir, perhaps that is a natural moment to have
  21     a break.
  22   THE CHAIRMAN: Thank you, let us say 15 minutes until about
  23     11.35 am.
  24   (11.15 am)
  25               (A short break)
0040
   1   (11.35 am)
   2   MR LANGSTAFF: Mr Brawn had been to Bristol, had he, in
   3     about 1990 and discussed his mortality in the neonatal
   4     switch operation with you?
   5   A. To the meeting. He discussed the arterial switch
   6     experience. I am not sure whether it was very clear
   7     whether they were neonatal or his total experience.
   8     I am not sure, but yes.
   9   Q. And reported to you then that he was achieving
  10     a mortality rate of less than 5 per cent?
  11   A. 5 per cent, I think, was the term he used.
  12   Q. So when, if we go back to UBHT 61/165, we look at the
  13     findings and observations, "mortality for TGA plus VSD
  14     switch similar to reported results", the important word
  15     there is "reported", is it?
  16   A. No, TGA and VSD.
  17   Q. But you did not know, you say, whether what Mr Brawn was
  18     saying was for that operation?
  19   A. That is quite correct, because it was a type of slide
  20     presentation; there was no paper. Just a slide
  21     presentation. It was more a teaching -- I mean, if you
  22     want I can give you the background of that meeting,
  23     but --
  24   Q. No, I do not need that.
  25   A. No, okay. That was just a teaching presentation, and
0041
   1     he was really giving the experience of arterial switch.
   2   Q. Can I ask you to focus on the next words which are
   3     used? Is this your writing or Dr Martin's?
   4   A. It is Dr Martin's writing.
   5   Q. What he has recorded is:
   6        "Similar to reported results, particularly if
   7     consider is early experience."
   8        What he appears to be saying is that it is similar
   9     to reports of early experience elsewhere, the
  10     implication being, it is not as good as reported results
  11     for places where a degree of experience has built up: is
  12     that the sense I should take from it?
  13   A. I do not think I can comment on that. That is somebody
  14     else's summary.
  15   Q. You were at the meeting. Was that the sense of the
  16     meeting?
  17   A. The sense of the meeting was very supportive, and
  18     agreeing with whatever I said at that time, that, you
  19     know, that was the experience in other centres, that is
  20     what I was achieving, and they thought that was
  21     similar. That is the impression I got from the meeting.
  22   Q. Was it raised at the meeting that your results were
  23     early results and therefore one might expect them to be
  24     poorer than results of centres with experience?
  25   A. No. I think, you know, quite clearly at that time there
0042
   1     was no reservation about the word "learning curve"
   2     because that was being mentioned quite commonly in
   3     almost all medical meetings, whether cardiologists,
   4     cardiac surgeons, wherever, and if I recall it
   5     correctly, my initial experience was similar to the
   6     experience elsewhere because I had presented -- I mean,
   7     all right, those were the summaries which you see over
   8     the next few pages, but I would have presented that, we
   9     had had a paper where people had been really saying that
  10     out of this --
  11   Q. Again, I do not want to stop you saying anything that
  12     you particularly want to say, but may I cut you short.
  13     Are you saying that your experience that you presented
  14     was that of a, using the words at the time, "learning
  15     curve" and the results were appropriate for a learning
  16     curve?
  17   A. That is what I am saying, yes.
  18   Q. It follows that the results which you were reporting
  19     were appreciated to be higher mortality than those
  20     centres where the learning curve had been passed,
  21     because, as you have explained, you were in the process
  22     of the learning curve. That was the discussion, was it?
  23   A. I am very sorry, I cannot explain if I am not allowed
  24     to say the way I want.
  25   Q. I am not going to stop you, I am trying to help.
0043
   1   A. Okay.
   2   Q. Please explain as you would wish.
   3   A. Thank you, sir. Here I was presenting my experience and
   4     I gave them my experience of 16 cases, as you have
   5     already seen. I am really telling them how the case
   6     progressed and what had happened in previous years, and
   7     while I am doing that, I am also telling them that
   8     similar things had happened in other people's
   9     experience. That is how I think, you know, everybody
  10     else is taking it. I cannot really explain any further
  11     why he has used a term, particularly considering --
  12     I mean, whether it is his early experience, whether he
  13     is calling up our early experience or early experience
  14     anywhere else, I cannot explain further on that.
  15   Q. Do you accept now what you accepted before the GMC, that
  16     you never really got beyond the learning curve so far as
  17     the arterial switch operation is concerned?
  18   A. I did not accept that to the GMC also. I accepted that
  19     it was in the neonatal programme. I was not able to
  20     transfer my experience from older switches to the
  21     neonatal switches. That is what I accepted.
  22   Q. Let me move on from here to the end of the year, to
  23     December. You kept the programme under review. You had
  24     had the experience you had at the neonatal switch
  25     deaths, and you recognised that you had a problem
0044
   1     transferring the technique, or you think you had
   2     a problem transferring the technique, amongst the other
   3     difficulties you have mentioned, from the non-neonates
   4     to the neonates.
   5   A. I realised at the last operation, when I saw that the
   6     wound of the coronary artery anastomosis was not as it
   7     should have been.
   8   Q. That then caused you to raise the matter at the meetings
   9     as you told us in November, and to go to Birmingham in
  10     December. When you chose to go to Birmingham, did you
  11     think of asking either Mr Sethia or Mr Brawn to come
  12     down to Bristol and to assist you with an operation?
  13   A. I very clearly asked Mr Brawn if he would like to come
  14     to Bristol and help me with the programme here, yes,
  15     I did.
  16   Q. Was he willing to do so?
  17   A. No.
  18   Q. Did you ask Mr Sethia?
  19   A. Mr Sethia, when I talked to him later, he offered, but
  20     because I was already now connected with Mr Brawn, I was
  21     in a way happy to go along with Mr Brawn and in a way,
  22     did not go back to Mr Sethia.
  23   Q. At this stage, did you think of taking the advice of any
  24     other person with whom you had trained? I think you had
  25     trained with Mr Stark, had you not, at one stage?
0045
   1   A. Yes, but I knew that Mr Stark is not doing neonatal
   2     switch at that time. I now have come to know, at the
   3     BPCA meeting, that Mr Brawn was helping people not just
   4     at the GOS, he has been to other places. So I thought
   5     here is a man who comes from the centre, which really in
   6     a way you could say his technique in the neonatal
   7     switch, that is from the Royal London Hospital, Dr Mee's
   8     clinic, well-known, and now I know that he has been to
   9     GOS, he has been to centres like Liverpool and
  10     Newcastle. So in a way, I felt quite happy to stay with
  11     him, really, and I did not really ask anybody else.
  12   Q. How many operations did you see him do in Birmingham?
  13   A. One.
  14   Q. You then came back to Bristol and put the lessons into
  15     effect?
  16   A. Yes.
  17   Q. You have told us about the lessons you learned having
  18     seen, I think, three operations, because that no doubt
  19     includes the operations you were later on to see in
  20     July 1993?
  21   A. Yes, but those lessons were learned after the first
  22     one. The second one, I did not basically see anything
  23     new, if you understand what I mean.
  24   Q. You have told us how you thought those lessons were to
  25     an extent effective?
0046
   1   A. Yes, and also in the technique of my own work, if you
   2     understand. I think I mentioned a few in the
   3     beginning. Or not. I am not sure.
   4   Q. So you gained, yourself, in your technique. You gained
   5     in the manner of the matters we discussed this morning
   6     and tried to put those lessons into effect in Bristol?
   7   A. Yes. When I was leaving the unit, Mr Brawn also handed
   8     me over a video of the operation we watched at that time
   9     and advised me to study that at my leisure, at home, and
  10     then, when I am doing the next case, really. So in
  11     a way, here I have guidance with me for all the time, if
  12     you understand what I mean.
  13   Q. After that visit to Birmingham, what was the success
  14     like with the neonatal arterial switch?
  15   A. I think we had success with the first two.
  16   Q. What about after that?
  17   A. The third had an abnormal coronary arterial pattern
  18     which was not identified before. I tried to correct it
  19     but I was unsuccessful. Literature puts it very high
  20     risk probably at any centre.
  21   Q. So once again, you had a problem, did you, with the --
  22   A. Coronary artery.
  23   Q. -- not being identified to you beforehand?
  24   A. Not in that one, no.
  25   Q. What was it that made you go back to Birmingham for the
0047
   1     second visit in July 1993?
   2   A. I lost two patients in succession and both of these
   3     patients had normal coronary arteries, so in a way, that
   4     raised doubt again in my mind that here I was, I did two
   5     successful operations, the third did not make it, but it
   6     was a highly abnormal coronary artery and probably could
   7     be explained in any centre. But the next one survived
   8     so I am still happy, I have got, you know, out of four,
   9     three survivals. And the next two did not, although of
  10     course, with one of them we did have evidence of
  11     myocardial infarction, but nevertheless, these two did
  12     not and they had a normal coronary artery.
  13        After the second of those two, I immediately rang
  14     the cardiologist concerned and said, "I am not doing any
  15     more now because there is something which it is obvious
  16     that if I still have not got it --", during this period,
  17     between 1992 and this time, July 1993, I had operated on
  18     about 7 or 8 older switches and they all survived. So
  19     that is why, really, I was very concerned that something
  20     is probably a little different in neonates which I have
  21     not still been able to transfer. That is what was quite
  22     worrying me.
  23        I told Dr Joffe that, "I am very sorry, it appears
  24     that I will not do any more neonatal switches".
  25        Do you want me to continue further?
0048
   1   Q. Yes, please.
   2   A. He said, "Well, it so happens that I was going to get in
   3     touch with you". I said "What for?" He said "I have
   4     got another patient admitted with a similar problem".
   5        Then I narrated again what happened during the day
   6     in theatre and he I think tried to probably comfort me,
   7     saying "Let us just wait for the postmortem examination
   8     and then we can really --". I said, "Well, I am not
   9     taking that next case on".
  10   Q. So he was trying to persuade you to go on with the
  11     operation and you were unwilling to do so because you
  12     thought that your technique was not good enough?
  13   A. Well, you know, when you work with people for some
  14     years, sometimes you know a little bit more about them
  15     than they themselves know. I thought that probably he
  16     was thinking that "This man is again criticising
  17     himself, and probably at this time of night he should
  18     not be making this decision, he should be making it the
  19     next day after considering everything". But I was quite
  20     firm that I am not really taking that patient on.
  21   Q. What happened with that patient?
  22   A. He said "Well, what should we do?" I said "I tell you
  23     why not. We talk to Birmingham". He said "Well, why do
  24     you not do that?" So the next day I ring Birmingham,
  25     I ask for Mr Brawn. It so happened he was nearby, the
0049
   1     secretary connected me to him, and I said -- he said "No
   2     problem, you know, bring the patient and I will operate
   3     here, and I tell you, I have got another patient here,
   4     so you will see two patients operated on the same day".
   5        So I arranged for that patient to be transferred
   6     to Birmingham Children's Hospital. Of course, when
   7     I say "I arranged", I am sure Dr Joffe did the rest.
   8     I told him that is what had happened. By this time,
   9     I talked to my anaesthetic colleague, I am not sure who
  10     helped me with the last operation but it must be the
  11     same one, or maybe Dr Underwood, and she was free, so
  12     I said "Let us go together and just see again. Maybe
  13     I may not be able to pick it up but you have watched me
  14     a number of times ..."
  15   Q. So you go?
  16   A. Yes.
  17   Q. Can I ask what you expected you might discover that you
  18     had not picked up on the first visit?
  19   A. What I noticed over these cases is that somehow, from
  20     outside and even when I have gone back in, the coronary
  21     artery looked in the right place. There was no obvious
  22     kink from outside. So I started asking myself whether
  23     what I called at that time the "lie", the way they are
  24     lying over the heart, have I got the angulation right,
  25     and maybe, technically anastomosis fine, and when you
0050
   1     are looking at the postmortem, it looks fine, no
   2     problem, but the heart did not work. One of the things
   3     with anastomosis I think is the coronary artery, which
   4     I think is very important.
   5        Because that is focused in my mind, maybe the
   6     angulation, maybe the lie is important, I would say
   7     that. And of course, you know, it may be that I missed
   8     something in the technique, but mind you, as I said
   9     before, I had the video. Every time I would do the
  10     switch, whether older or on the younger, I watched that
  11     video. That video became part of my family, really.
  12     It was there.
  13   Q. Did you at that second visit to Birmingham discover
  14     anything you had not been doing technically beforehand?
  15   A. I mean, that is a very difficult question to answer,
  16     because frankly, I did, so in a way, I felt quite
  17     reassured in one way that I was not doing anything
  18     different causing a problem, but at the same time, I was
  19     not satisfied in my own self, so I asked Mr Brawn.
  20     I said, you know, I have been --
  21   Q. Can I stop you there? It may be that the answer you are
  22     about to give is an answer to my next question, but here
  23     you had been, before you went to Birmingham, just on the
  24     point of giving up the neonatal switch operation. You
  25     were going to give up because you thought for some
0051
   1     reason or other, you could not do it, you could not
   2     translate the techniques you were using in the
   3     non-neonates to the neonates, and you wanted to avoid
   4     risk to patients and therefore you wanted, I take it, to
   5     give up operating on neonates with this particular
   6     operation.
   7        When you go to Birmingham and you discover, having
   8     watched two operations, that so far as you can see you
   9     cannot identify what it is, if anything, in your
  10     technique that may not be appropriate, are you not in
  11     the same position of saying, "Well, I must be doing
  12     something wrong but I do not know what it is?" Why then
  13     continue to operate after that?
  14   A. I think retrospectoscope is a very good thing. What we
  15     are talking about here, many things after and in a very
  16     cool environment, is different than what I was thinking
  17     on that day at that time. You know, in-between, I have
  18     also met Mr Brawn, in Paris, when we had another
  19     discussion and watched a number of operations there on
  20     video by different surgeons, so I also knew a few other
  21     techniques you do. So all these things were now at the
  22     back of my mind, and when I talked to Mr Brawn, I felt
  23     that this is something which really just takes a long --
  24     you keep on -- in a word, it comes on. But that was
  25     exactly what was in my mind and that is how
0052
   1     I interpreted what Mr Brawn said to me: that this thing
   2     comes with experience and there would be no problem.
   3   Q. So you decided -- I want to see that this is right -- to
   4     have further operations on neonates after your second
   5     visit to Birmingham without having identified anything
   6     that you were doing wrong as a result of that visit?
   7   A. There was another factor in the middle, really. This is
   8     now July 1992 when I went to Mr Brawn --
   9   Q. 1993?
  10   A. Forgive me, you are quite right: July 1993, when I went
  11     to Mr Brawn again. Following that, I had in a way an
  12     older patient -- only three months older, really -- with
  13     transposition and VSD, who had a highly abnormal
  14     coronary artery, and I managed to repair it
  15     satisfactorily to its intramural coronary artery and we
  16     had the patient survive the operation, and quite well.
  17        So that also filled me with confidence, that here
  18     is very highly abnormal coronary artery pattern, which
  19     is known to be very high risk anywhere, so it brought my
  20     confidence back in, and then I go on summer holiday.
  21     The next patient was really, in a way, lined up for me,
  22     you could say, waiting in the unit on my return, and
  23     maybe in that environment, having gone on holiday after
  24     doing a very highly abnormal coronary artery operation
  25     successfully, having visited Mr Brawn again and seen
0053
   1     that there was nothing wrong with my technique before,
   2     having seen other operations in Paris, I did not
   3     question other people, you know, putting the patient on
   4     my list on my first day return in a way.
   5        So going back into a neonatal switch, you could
   6     really say was somehow -- I just moved in again, but
   7     I do not think I can honestly say that we discussed in
   8     the same way as we discussed after the first stoppage.
   9   Q. What you have described is a process of getting your
  10     confidence back in order to go again with a neonatal
  11     arterial switch. I am interested in your logic, which
  12     was that watching Mr Brawn had not identified any flaw
  13     in your technique, and your worry had been that there
  14     was a flaw which you could not identify. Why did
  15     a continued failure, albeit watching Mr Brawn, to
  16     identify what the flaw might be, give you back
  17     confidence?
  18   A. I think it is the biggest confidence if you can very
  19     successfully repair a highly abnormal, which is almost
  20     considered universally a fatal abnormality.
  21   Q. What Mr Brawn said at the GMC was that if a surgeon can
  22     do a switch operation, he should be able to deal with
  23     coronary arteries, the two go together. Is he right?
  24   A. Well, that is accepted, really, yes. I mean, that was
  25     probably also at the back of my mind, really, having
0054
   1     dealt with such highly abnormal coronary arteries.
   2   Q. And the problem you had had with the neonatal switch
   3     which made you go to Birmingham was not the abnormal
   4     coronary arteries, it was two neonates with normal
   5     arteries?
   6   A. That is right.
   7   Q. But you had nonetheless had your confidence restored for
   8     any neonatal switch?
   9   A. I had my confidence back then, yes.
  10   Q. Looking back on it, using the retrospectoscope, do you
  11     think you were justified in so doing?
  12   A. When, in 1999, I am looking back, probably not, but at
  13     that time, that is how I thought, and I had the full
  14     support of my team. I think that is probably then
  15     another factor, really, because that next case, the next
  16     neonatal switch, was all ready in the unit.
  17   Q. So you did it. When did you take the decision to stop
  18     doing neonatal switches?
  19   A. This patient survived, so in a way, I am feeling happy,
  20     you know, that I am back on the road. The next one
  21     comes and this was the same highly abnormal coronary
  22     arterial pattern, which I had repaired in a three month
  23     old child just a few months ago. So unfortunately,
  24     suspicion was raised but not confirmed pre-operatively.
  25     So when I see on the table and I look at this and I say
0055
   1     no, not in that quick succession -- it was not a quick
   2     succession, but it was so soon after. Of course, this
   3     time my manoeuvre did not work out on this patient, and
   4     unfortunately, I lost that patient on the table.
   5        That was enough. I felt that I could not really
   6     now carry on whatever support I have here, because there
   7     is something which is not right with the neonatal
   8     switches, that at the moment I am not able to transfer
   9     my knowledge from older switches to neonates.
  10   Q. Whose decision was it that you should stop?
  11   A. It started from me, and I think it was stronger or -- it
  12     was I who refused, and after that a similar conversation
  13     took place and by this time, I think Dr Jordan was now
  14     retired so it would be Dr Joffe, and Dr Hayes had just
  15     joined the unit, so Dr Joffe really said almost the same
  16     thing again, "Janardan, you know, again, you are now
  17     too involved in this thing. Let somebody else review
  18     the whole experience and in a way, come out with some
  19     advice what to do for the future".
  20        I said, "Well, I am not going to do it. I am not
  21     going to take these patients on, but, yes, I agree with
  22     you, somebody else really should", and Dr Hayes in a way
  23     took it on herself to review the neonatal switch
  24     experience.
  25   Q. And as a result of that review by Dr Hayes, did that
0056
   1     confirm your decision to stop?
   2   A. I had already stopped, really, because Dr Hayes wanted
   3     me to do a switch operation some time in late October,
   4     which I --
   5   Q. So it was Dr Hayes whom you referred to in your
   6     statement as being the cardiologist who wanted you to do
   7     another one?
   8   A. Yes.
   9   Q. And you refused?
  10   A. Yes.
  11   Q. Who knew of your decision to stop doing neonatal
  12     switches?
  13   A. Forgive me for mentioning, sir, here, but I have been
  14     reading the Internet and various things. I am quite
  15     surprised what I have heard. I thought people very
  16     close to me, both anaesthetic colleagues, they should
  17     have known because I had talked to them, and I am
  18     mentioning Dr Masey and Dr Underwood, that the neonatal
  19     switch programme was stopped.
  20   Q. None of the anaesthetists who have given evidence to us
  21     seem to have known that the programme was stopped,
  22     although they appreciate they were no longer
  23     anaesthetising for such operations.
  24        Did the cardiologists know you had stopped?
  25   A. Yes, obviously.
0057
   1   Q. Because presumably they had to refer their children
   2     on, if they had a transposition case, to Birmingham?
   3   A. Yes, and they were still referring older switches to me.
   4   Q. Can you explain at all why it should be that the
   5     anaesthetists did not know or appreciate that you had
   6     taken this decision?
   7   A. I am quite surprised myself. I mean, I cannot really,
   8     in a way, explain why they are saying whether -- I mean,
   9     of course I did not put it on the notice board in a way
  10     for everybody to know that the neonatal switch programme
  11     had stopped in Bristol, but I thought everybody closely
  12     connected with me, especially with this programme, would
  13     have known my desire.
  14   Q. Did you mention that you were stopping to Mr Wisheart?
  15   A. Mr Wisheart had been very closely involved with --
  16   Q. It is a "Yes" or a "No", really. Did you mention it
  17     to Mr Wisheart?
  18   A. Yes, I did.
  19   Q. He was the Associate Director of Cardiac Surgery.
  20   A. No, at that time I was the Associate Director.
  21   Q. Of course, you began in January 1993, I am sorry. So
  22     you were the Associate Director. As such, did you have
  23     any responsibility to tell the team of decisions that
  24     had been made which might affect the team?
  25   A. I thought I did tell everybody in the team, really,
0058
   1     including theatre nurses, that we are not doing neonatal
   2     switches any more.
   3   Q. How did you tell them?
   4   A. In a personal, informal manner, really. No written
   5     notice or anything like that.
   6   Q. So one by one in conversations?
   7   A. Yes. Because the last case, if I could find out who
   8     the anaesthetist was, I do remember, when we talked
   9     about it, the anaesthetist and the nurse, we all said it
  10     is not really -- I think the anaesthetist's words
  11     were ,"Back to the drawing board, Janardan".
  12   Q. Having given up the neonatal switch, you continued with
  13     the non-neonatal switch?
  14   A. Yes, sir.
  15   Q. If it is the case that anyone who does a switch
  16     operation should be able to cope with the coronary
  17     arteries, if that is true of both neonatal and
  18     non-neonatal switch operations, did your stopping the
  19     neonatal switch operations cause you to think at all as
  20     to whether you should have continued to do the
  21     non-neonatal operations?
  22   A. This question has always puzzled me because while I was
  23     having problems with the neonatal, I was carrying on
  24     doing successful older switches. During 1992/1993, or
  25     by the end of 1993, I would have done probably 12 or 13
0059
   1     with only one death in that group, so it did surprise me
   2     and I did not have any real answer, but somehow I could
   3     not explain how I had a successful programme in the
   4     older age group but not in the neonatal group.
   5   Q. Did you at any stage take a decision to stop doing the
   6     non-neonatal switches?
   7   A. No.
   8   Q. Not at all?
   9   A. No.
  10   Q. Was a decision taken within the unit before the end of
  11     1995 to cease doing the non-neonatal switch?
  12   A. I am sorry, but you would have to explain a bit more --
  13   Q. I am sorry, can I repeat the question, because it is my
  14     fault. Was a decision taken within the unit before the
  15     end of 1994, to stop doing the non-neonatal switch?
  16   A. No.
  17   Q. I will come at a later stage in the questioning to ask
  18     you about the events that led up to the operation which
  19     you performed on Joshua Loveday in 1995, and that would
  20     involve looking at this later part of the non-neonatal
  21     switch programme. But before we leave this topic and
  22     go, bearing in mind the questions I have asked, to some
  23     of the cases that I particularly want to ask you about,
  24     were you aware during 1994 of concern being expressed by
  25     others, amongst them anaesthetists, about the switch
0060
   1     programme you were then carrying on?
   2   A. Not in the first half.
   3   Q. Did you become aware, then, in the middle or later part
   4     of 1994 of such a concern?
   5   A. Dr Monk came to talk to me during the first week of
   6     July 1994.
   7   Q. Was he, as you saw it, expressing a view on behalf of
   8     all the anaesthetists?
   9   A. That is what he was doing, yes.
  10   Q. Did you work regularly, both as adult and paediatric
  11     surgeon, throughout 1993 and 1994, with all those
  12     anaesthetists?
  13   A. The two anaesthetists really joined only in July or
  14     August 1993. Dr Davies and Dr Pryn. Dr Davies was not
  15     primarily a paediatric anaesthetist; he had some
  16     experience during training and he was willing to help in
  17     the training --
  18   Q. Did you work with him?
  19   A. Dr Davies? Yes, at times.
  20   Q. And you worked with Dr Pryn?
  21   A. Quite often, yes.
  22   Q. And you worked with Dr Bolsin?
  23   A. Yes.
  24   Q. And Dr Masey?
  25   A. Yes.
0061
   1   Q. And Dr Underwood?
   2   A. Yes.
   3   Q. And Dr Monk?
   4   A. Yes.
   5   Q. It would follow, from what you said, that none of them
   6     had expressed any concern to you that you understood at
   7     any rate as being concern about the switch programme
   8     until Dr Monk spoke to you at the beginning of July
   9     1994?
  10   A. That is correct, sir.
  11   Q. Do you find it surprising that you could work in the
  12     same theatre day in, day out with anaesthetists and not
  13     appreciate that they had concerns about a particular
  14     part of the work that you were doing?
  15   A. When I heard from Dr Monk, I could not believe it.
  16   Q. To what do you attribute, looking back on it, the
  17     absence of communication between the anaesthetists on
  18     the one hand and yourself on the other, so that you
  19     might become aware of that concern?
  20   A. That is what I am wondering even until now, really,
  21     because if I was not talking to anybody, then I could
  22     not really understand that, but I was talking to these
  23     gentlemen, and ladies, almost, if not every day, a few
  24     times a week. So I was in communication with them;
  25     I did not know of any reason not to talk to anybody.
0062
   1     And I felt if there was any concern, they should have
   2     expressed to me before, in a way, going to their
   3     Director in a way which I thought probably is not right
   4     when we are so closely working together. So that is why
   5     I was surprised.
   6   Q. Again, that is a topic I will come back to. Since we
   7     have Mr Stark and Dr Silove here, can I turn from the
   8     questions I have asked thus far in relation to the
   9     switch operation in particular, and look at some of the
  10     cases which the Clinical Case Note Review have thrown up
  11     for our examination?
  12        May I begin -- I think you have the notes there --
  13     with the case of Ellie Brain. Sir, I should say, it is
  14     obvious from the fact I have used the name, that we have
  15     full consent.
  16   A. Thank you. Could I ask for your permission to use this
  17     file, because it has my quick reference and I can
  18     quickly turn the pages?
  19   Q. Please have anything you wish there. Ellie Brain was
  20     born, was she, on 3rd July 1988.
  21   THE CHAIRMAN: You need a bit of time to find your page?
  22   A. Yes, I am sorry.
  23   THE CHAIRMAN: Take whatever time you need.
  24   MR LANGSTAFF: While Mr Dhasmana is doing that, the
  25     particular interest which the Panel may have when the
0063
   1     evidence is complete in respect of these cases should,
   2     I hope, exemplify aspects in the Brain case of
   3     pre-operative care and decision-making; in the second
   4     case to which I shall turn, the operation itself, in
   5     particular; and in the third, post-operative care. The
   6     fourth to which I shall pay regard will be the case of
   7     Joshua Loveday himself.
   8   THE CHAIRMAN: Thank you, Mr Langstaff.
   9   MR LANGSTAFF: So, Ellie Brain: was she born on 3rd July
  10     1988?
  11   A. Yes, sir.
  12   Q. Did she have a catheterisation at the age of 11 days?
  13   A. On 14th July 1988, yes.
  14   Q. She was suffering, was she, from a transposition of the
  15     great arteries?
  16   A. That is correct, sir.
  17   Q. So the question was whether or not she would be
  18     a candidate for the switch operation?
  19   A. Yes. This was in 1988, July 1988, and on the catheter,
  20     the patient was found to have a transposition of the
  21     great arteries and VSD.
  22   Q. Yes.
  23   A. Therefore, a decision was to be made, what we are going
  24     to do about it? That is what that meeting was about.
  25   Q. Yes. The decision which was taken, was it, following
0064
   1     that catheterisation, was to list her for the switch
   2     operation?
   3   A. Yes. It is the Joint Cardiology Meeting. Can I refer
   4     to a page?
   5   Q. Yes, please.
   6   A. It is on page 67 on Medical Record No. 2420.
   7   THE CHAIRMAN: Mr Langstaff, you will help us while this is
   8     being found. Is this patient classed as a neonate, or
   9     not, because in 1988 --
  10   MR LANGSTAFF: No, she was not operated as a neonate; she
  11     was, of course, a neonate when the catheterisation was
  12     performed, and something may turn on that.
  13   THE CHAIRMAN: Thank you very much.
  14   MR LANGSTAFF: You are taking me to MR 2420/67, and we see
  15     there the --
  16   A. This is a Joint Paediatric Cardiac Surgical and
  17     Radiology Meeting, and there it lists "Dr Jordan,
  18     Dr Joffe, Dr Benatar, Dr Cormack ... and team."
  19        What we have done in these meetings,
  20     a cardiologist would present the clinical data, would
  21     present the echo picture, discuss the catheter finding,
  22     and the radiologist would help us to look at the
  23     cineangio.
  24        On the basis of that, we are really now writing
  25     here that the diagnosis of transposition of the great
0065
   1     arteries and ventricular septal defect was confirmed.
   2        What we have noted is that this patient has
   3     pulmonary hypertension and if one looks in the -- let me
   4     finish the letter first: "... and pulmonary vascular
   5     resistance over systemic vascular resistance ratio 0.7.
   6     Angiography shows a single large very [peri]membranous
   7     VSD, and there was suspicion of tiny muscular VSD
   8     beneath it".
   9        With that, we were going to discuss, we were going
  10     to plan for this one --
  11   Q. Can I just stop you there? The position in general
  12     would be this, would it: that if there were pulmonary
  13     hypertension, then that might lead to reversible changes
  14     in the lungs, so one would need to operate sooner rather
  15     than later?
  16   A. That is correct, sir.
  17   Q. If there were no pulmonary hypertension in the lungs,
  18     a case of transposition with a VSD would normally wait,
  19     would it, and the first step would be a banding of the
  20     pulmonary artery, because otherwise the left ventricle
  21     would not develop the thick muscle it would need to pump
  22     the blood around the body when it became the systemic
  23     ventricle.
  24   A. I beg to differ there. I think it is a little bit
  25     different. When you have transposition with VSD, you
0066
   1     already have pulmonary hypertension. These patients
   2     would normally have pulmonary hypertension. Either you
   3     repair it in a primary state at that time or you
   4     palliate -- and for palliation you are banding it -- and
   5     then you wait for child to grow to an age when you think
   6     you can repair it and then do the repair which you want
   7     to do, whether you do arterial switch or you do
   8     a Senning with VSD.
   9   MR LANGSTAFF: If I can ask you to pause there, Dr Silove,
  10     is there a problem if in fact the level of pulmonary
  11     resistance or hypertension is low, with the development
  12     of the left ventricle?
  13   DR SILOVE: Yes. I think -- may I answer that in a little
  14     more detail?
  15   MR LANGSTAFF: Yes, please.
  16   DR SILOVE: When there is a ventricular septal defect,
  17     Mr Dhasmana is quite right that it is usual that the
  18     pressure in the pulmonary artery and in the left
  19     ventricle will be high and will very often be at the
  20     same level as the pressure in the right ventricle, in
  21     transposition of course, which is the systemic
  22     ventricle.
  23        What happens if there is no VSD in the early
  24     neonatal period is that the pressure in the pulmonary
  25     artery falls quite rapidly. If there is a VSD, the
0067
   1     pressure in the pulmonary artery tends to stay raised
   2     for a longer period.
   3        It is unpredictable, really, whether the pressure
   4     will fall for certain or not. What can happen is that
   5     the pressure can stay high, and it can stay high for
   6     many months, and that patient is then at risk of
   7     developing pulmonary vascular disease; the pulmonary
   8     vessels themselves can become diseased.
   9        On the other hand, the pressure or the pulmonary
  10     vascular resistance can fall, very often round about
  11     4 to 6 weeks of age, and you would then expect the left
  12     ventricular pressure and the pulmonary artery pressure
  13     to be higher than if there was no VSD, but it might not
  14     remain quite as high as the systemic pressure.
  15        If the pressure has fallen, reflecting a fall in
  16     the pulmonary vascular resistance, then the left
  17     ventricle is not having to work quite as hard as it
  18     would have to work if it was pumping against a greater
  19     resistance, and so it might not be quite so suitable for
  20     doing an arterial switch because it will lose some of
  21     the thickness of the left ventricular muscle.
  22   MR LANGSTAFF: In such a case, what is the appropriate
  23     surgical step? Is it to go straight to a switch, or
  24     not?
  25   DR SILOVE: Well, I think the conventional approach would be
0068
   1     to do a relatively early arterial switch with closure of
   2     the ventricular septal defect. One can take the option
   3     of waiting, but if one waits, one has to consider
   4     whether one is going to band the pulmonary artery so as
   5     to protect the lungs from developing pulmonary vascular
   6     disease, and go for an arterial switch with closure of
   7     the VSD later, at which time you would then have to
   8     deband the pulmonary artery.
   9        The alternative strategy might be to leave the
  10     baby for a period of, say, two or three months, and it
  11     might be reasonable, say, to leave it for two months in
  12     the belief that the pulmonary vascular resistance will
  13     have remained high, and then do the arterial switch and
  14     close the VSD at that stage, but one has to be fairly
  15     certain that the pulmonary vascular resistance has
  16     remained high and that the left ventricular pressure has
  17     remained high in order for the left ventricle to be able
  18     to take over as the systemic ventricle.
  19   MR LANGSTAFF: In order to be certain, one needs to carry
  20     out what sort of investigation?
  21   DR SILOVE: One can very often get by with good
  22     echocardiography. One can look at the thickness of the
  23     left ventricle and the shape of the left ventricle, and
  24     if one has colour flow Doppler facility, one can get
  25     some estimate of whether there is purely shunting from
0069
   1     the right ventricle through the VSD into the pulmonary
   2     artery, or whether there might be some bidirectional
   3     shunting. If one does not have echocardiography
   4     available, or if it is uncertain, then one probably
   5     needs to do a cardiac catheterisation nearer the time of
   6     the operation in order to be certain about the pulmonary
   7     artery pressure and the left ventricular pressure.
   8   MR LANGSTAFF: So what you are saying is that the critical
   9     aspect is the ability of the left ventricle to take over
  10     the systemic circulation, and that in order to satisfy
  11     oneself of that, one needs to have investigations nearer
  12     or at about the time of the operation, does one?
  13   DR SILOVE: I believe that is right. I think if you are
  14     going to do the arterial switch at the age of six weeks,
  15     there is probably no need to do further investigations,
  16     but beyond that time, you have to be fairly certain that
  17     you can expect there will still be a high left
  18     ventricular pressure.
  19   MR LANGSTAFF: Mr Dhasmana, do you want to comment on what
  20     Dr Silove has said? Please comment if you take
  21     exception to any of the points that he has made.
  22   A. No, I think Dr Silove has really described adequately
  23     the discussion on that day. It was exactly along those
  24     lines that we were talking that day, because this is the
  25     time, July 1988, when I had just started the arterial
0070
   1     switch programme in older children. Though the
   2     pathology is the same, TGA with VSD, I was not very
   3     happy nor felt comfortable to transfer it to such
   4     a small child at that time.
   5        If I was not doing an arterial switch, conforming
   6     to my usual practice beforehand, I would have really
   7     gone for a PA band in this patient, but we had some
   8     problem with the PA band because by the time they
   9     waited, there was some further problem in the muscle,
  10     which did not help me when I tried to do a repair at the
  11     time. So I was not very happy on that.
  12        At the same time, I did not feel very comfortable
  13     in proceeding with arterial switch. Therefore, we were
  14     looking at some type of compromise for this child to
  15     reach -- I mean, there is no magic figure about it, but
  16     maybe at the back of my mind was that if three months
  17     had gone, probably the high risk period would be gone
  18     and we could do better with the arterial switch itself,
  19     really.
  20        That is how the discussion proceeded.
  21        What it did not go on was the mechanism of
  22     checking it, and of course, in pre-operative states I am
  23     very much guided by my cardiac colleagues, really. I do
  24     not think we made up our mind whether we would check
  25     anything at that time; we just simply took it on the day
0071
   1     that I would do the arterial switch, but not now when
   2     this child is about three months of age.
   3   Q. One of the difficulties of taking pulmonary artery
   4     pressures of child who is 11 days old, as Ellie was at
   5     the date of her catheterisation, is that inevitably
   6     post-birth the lungs do have a hypertension which
   7     reduces over a period of time.
   8   A. That is physiological, yes.
   9   Q. So one would expect a catheter taken after 11 days to
  10     show relatively high pulmonary artery pressures, and one
  11     would anticipate, would one, taking your point,
  12     Dr Silove, that after a period of time that might -- one
  13     does not know -- reduce?
  14   DR SILOVE: Yes, that is right, it might. And it might
  15     not. But one has to find out.
  16   MR LANGSTAFF: It is common ground, I think, from what you
  17     were just saying, that in Ellie's case there was no
  18     further investigation?
  19   MR DHASMANA: Yes. I can see from the notes and, yes, there
  20     was none.
  21   Q. And I think we are agreed that there should have been?
  22   A. Well, now, looking back, yes, I do.
  23   Q. The reason why there was not, you say: this is something
  24     that we might have discussed in reaching the compromise
  25     that we did at the discussion, bearing in mind that she
0072
   1     was a child who was young; we did not operate on
   2     neonates because they were too young at that stage, and
   3     it might have been suggested at that meeting that
   4     a further investigation was carried out and it was not,
   5     so that is part of the story why one was not?
   6   A. Looking back, yes.
   7   Q. Is it also part of the story as to why the further
   8     investigation that should have been carried out was not
   9     that the child was admitted for operation to the Royal
  10     Infirmary. The operation took place on 4th October
  11     1988. Is it part of the fact that the child went into
  12     the Royal Infirmary rather than to the place where --
  13   A. No, if people have made a decision on that day which
  14     child is to have a pre-operative catheter -- now with
  15     echo I do not have control because cardiologists, when
  16     they see these children in outpatients, they normally
  17     echo them. So I would not have questioned that one.
  18     But if there was a catheterisation to be done, then it
  19     would have been mentioned, "Admit to the Children's
  20     Hospital, catheter, transfer to BRI". That is how it
  21     would have been mentioned.
  22   Q. And because that was not done, she went straight into
  23     the BRI and straight into operation?
  24   A. That is correct.
  25   Q. So when you came to do the operation, you had no means
0073
   1     of knowing, before you began, quite what the level of
   2     hypertension was, and therefore quite how able the left
   3     ventricle would be to take over the systemic flow?
   4     Is that right?
   5   A. I had relied on a patient who had a large perimembranous
   6     VSD and also a small muscular VSD underneath probably
   7     would have pulmonary hypertension, even at this time.
   8     My worry would have been more if the damage to the lung
   9     would not have become irreversible. Probably, when I am
  10     talking of the catheter, I am really talking of looking
  11     at that area rather than the suitability of this child
  12     for switch. I do not know what the experts would say.
  13   DR SILOVE: I think it is unusual for a baby to develop
  14     pulmonary vascular disease as early as three months of
  15     transposition, and I think it would be reasonable to
  16     proceed on the basis that there probably was no
  17     pulmonary vascular disease, but having said that, we do
  18     sometimes see pulmonary vascular disease very early in
  19     transposition with VSDs. It is an unknown, but I think
  20     the main reason for doing a cardiac catheter or some
  21     investigation -- a very good echo would probably have
  22     been a good substitute -- would be to try to get some
  23     confirmation that that left ventricle is likely to have
  24     a high enough pressure and be sufficiently thick-walled
  25     to take over the systemic circulation.
0074
   1   MR STARK: I would agree completely with what Dr Silove
   2     said. Irreversible pulmonary vascular disease is very
   3     rare. I have seen it as early as six weeks, but it is
   4     very rare, so I think at three months I would feel very
   5     comfortable to operate. I think it is also very rare
   6     that the pressure with a large VSD would drop, but
   7     nevertheless, if one wants to be absolutely sure,
   8     I think one form of investigation or the other, echo
   9     certainly, should answer that perfectly well, or
  10     otherwise catheterisation. So I completely agree.
  11   MR LANGSTAFF: Would you normally expect, as a surgeon, to
  12     have a pre-operative echo or angiography?
  13   MR STARK: I personally would, but there are differences
  14     between surgeons. Some surgeons are happy to operate on
  15     the basis of echo only; some others require
  16     catheterisation. Some others may perhaps say that the
  17     previous one was all right, but I personally think one
  18     form or other of confirmation of this pulmonary arterial
  19     pressure is safer.
  20   DR SILOVE: I am sure we would have been happy with a good
  21     echocardiogram in this case, in Birmingham, but we
  22     certainly would have done an investigation.
  23   MR LANGSTAFF: Does this go so far as to say that in most
  24     cases where there is going to be a complex open-heart
  25     operation, one would expect to see some form of
0075
   1     investigation appropriate to the operation at a time
   2     pretty close before the operation itself takes place?
   3   DR SILOVE: Yes, that is right.
   4   MR STARK: I think our cardiologists would perhaps routinely
   5     perform the echo the night before the surgery and
   6     discuss it with us, but, you know, our cardiologists are
   7     present on the premises, so that makes life a bit
   8     easier.
   9   MR LANGSTAFF: Do I take it that there was no routine
  10     practice of pre-operative echo or angiogram before
  11     complex coronary heart surgery?
  12   MR DHASMANA: That is correct.
  13   Q. And is part of the reason for that the split site, that
  14     the cardiologists were at one place and the operating
  15     theatre at another?
  16   A. That is also correct.
  17   Q. So one would not have the presence that Mr Stark has
  18     referred to on the ward the night before the operation
  19     as a matter of routine; it would have to be a matter of
  20     special request?
  21   A. Please correct me if I am wrong, but having worked in
  22     one hospital and visited the other, in both these places
  23     most of the patients are really admitted first under the
  24     paediatric cardiologist. They are almost worked out,
  25     so --
0076
   1   Q. This is a question of looking at the team and not
   2     looking at individual responsibility?
   3   A. Exactly, so I am just saying that something comes
   4     naturally and routinely there which becomes a little bit
   5     more an "on demand" service in a centre like Bristol
   6     where you have a facility at two different places.
   7     Unless it has really been marked out right in the
   8     beginning, you do not get it unless you ask for it.
   9   Q. Thank you, Mr Dhasmana. Let us leave the case of Ellie
  10     Brain, unless -- perhaps it is convenient, as I deal
  11     with each these cases, if there are questions which the
  12     Panel may wish to address in respect of it --
  13   DR SILOVE: May I interject, please, sir? I think we should
  14     finish the story, if I may, about this particular
  15     patient. As it turns out, the left ventricle was able
  16     to take over the systemic circulation, as the evidence
  17     for that is that there was a blood pressure in the
  18     Intensive Care Unit post-operatively which was a very
  19     satisfactory blood pressure, and it showed that the left
  20     ventricle was performing as it should do. So although
  21     I am saying that measurements should have been done
  22     pre-operatively, fortunately the left ventricle was
  23     suitable for an arterial switch.
  24   MR LANGSTAFF: I think, if I can take, as it were, other
  25     questions that might arise on this, we can see from the
0077
   1     medical notes that you quoted a risk for the operation
   2     of about 20 per cent?
   3   MR DHASMANA: I think in the notes it is a little bit
   4     different. In my hand it is written "15 per cent".
   5   MR LANGSTAFF: I am sorry, 15 per cent. What do you say
   6     about that as an estimate of risk, bearing in mind what
   7     one would have known about the 1988s?
   8   MR STARK: I think that every surgeon in every department
   9     has to have this a little bit on their own. I think at
  10     Great Ormond Street from the figures I quoted earlier,
  11     with transposition with VSD, at that stage we would have
  12     quoted high risk. I think in our hands the risk would
  13     be higher.
  14   MR LANGSTAFF: This is one of the very first operations that
  15     you were doing, was it not?
  16   MR DHASMANA: Yes.
  17   Q. And you would be appreciative that you had the learning
  18     curve anyway, to cope with. Do you think perhaps the
  19     15 per cent was overoptimistic?
  20   A. I now totally agree with you.
  21   MR LANGSTAFF: Sir, I am now going to go on to the second of
  22     our cases. I am in your hands as to whether it would be
  23     appropriate now we have gone, I think, about an hour and
  24     a quarter since the last break, whether it would be
  25     appropriate to break now or after the next case.
0078
   1   THE CHAIRMAN: Why don't we break now until 1.30,
   2     Mr Langstaff?
   3   (12.50 pm)
   4            (Adjourned until 1.30 pm)
   5   (1.30 pm)
   6   MR LANGSTAFF: Mr Dhasmana, our next case is that of Ben
   7     Elliott. Ben Elliott, a little boy born on 8th October
   8     1989.
   9   A. Yes, sir.
  10   Q. And diagnosed fairly early on, no problem with that, as
  11     suffering from pulmonary atresia and VSD?
  12   A. That is correct, sir.
  13   Q. There is a catheterisation which takes place under
  14     Dr Martin on 13th October 1989, which showed
  15     I understand that the pulmonary arterial structures were
  16     hypoplastic with narrowing of the right pulmonary
  17     artery, separating its origin from the main pulmonary
  18     artery and the left pulmonary artery not being well
  19     seen.
  20   A. You are talking about Ben Elliott?
  21   Q. Ben Elliott. We pick that catheterisation up at
  22     MR 401/70 to 72.
  23   A. My fault because I was looking at the other catheter
  24     report.
  25   THE CHAIRMAN: Can we take the date of birth off?
0079
   1   MR LANGSTAFF: We have full consent, of course. If we look
   2     at page 72 on the screen, the top of the page, that was
   3     the bit I was reading out to you:
   4        "the right pulmonary artery, separating its
   5     origin from the main pulmonary artery. The left
   6     pulmonary artery is not well seen probably due to some
   7     forward flow into the main pulmonary artery from the
   8     ventricular direction. This cannot be stated with
   9     absolute certainty but seems likely in the absence of
  10     alternative collateral supply into the left lung being
  11     shown."
  12        Measurements I think are attempted then and they
  13     showed that the pulmonary arteries were very small?
  14   A. That is correct.
  15   Q. Accordingly you saw Ben Elliott and made the decision,
  16     entirely appropriate, that there should be a left-sided
  17     shunt. That was performed on 14th October 1989.
  18     Thereafter the lad goes on fairly successfully into 1990
  19     until, at the age of 11 months there is a second
  20     catheterisation. That is what I think you must have
  21     been looking at before?
  22   A. Yes, page 30 I think.
  23   Q. If we can pick up that at page 49, that is where the
  24     catheterisation starts. We go over to page 50, can we
  25     scroll down, four lines underneath where it says "Right
0080
   1     ventricle" we read:
   2        "The main pulmonary artery appears to have grown
   3     somewhat to a substantial size compared with the
   4     previous examination. The region of the proximal right
   5     pulmonary artery is not well seen and may well have
   6     increased in size but this cannot be stated with
   7     complete confidence."
   8        Underneath "Aorta": "The previous communication to
   9     the left pulmonary artery is better seen on this
  10     examination as is the opacification of the pulmonary
  11     artery itself. Again, the origin of the right pulmonary
  12     artery cannot be assessed adequately."
  13        What is apparent on the catheterisation is that
  14     there is an absence of information about the right
  15     pulmonary artery; that appears to be what it is saying?
  16   A. That is what it reads, yes.
  17   Q. Was there, at this stage, a choice of how one would deal
  18     with Ben's case?
  19   A. Ben was originally diagnosed to have pulmonary atresia
  20     with VSD and at that time we formed the view that the
  21     main pulmonary artery was either very tiny or
  22     hypoplastic. So the plan was to put a shunt in now, see
  23     him later and then decide for the future. That is why
  24     this catheter was done. On this catheter we really saw
  25     that a window -- I mean diagnosis is not exactly
0081
   1     pulmonary atresia now because there is some
   2     communication between the right ventricle and the main
   3     pulmonary artery though it is very tiny.
   4   Q. Stop there for a moment: the main pulmonary artery would
   5     not have grown unless it was getting some blood in?
   6   A. From the shunt.
   7   Q. From the ventricle or from the shunt?
   8   A. Not exactly. From both really, from the ventricle as
   9     well as from the shunt but if it is true pulmonary
  10     atresia then it is from the shunt.
  11   Q. But there appeared to be some communication?
  12   A. Tiny communication, as it says here. I thought I saw
  13     somewhere "tiny communication".
  14   Q. I think it is there somewhere but --
  15   THE CHAIRMAN: Fourth line of the paragraph beginning "Right
  16     ventricle": "Tiny pulmonary artery communication...".
  17   A. So once we have that picture, of course what is
  18     described here is not exactly the same as you see on the
  19     Senning. When you look at the Senning film you are
  20     seeing the pulmonary arteries on either side and you
  21     then have a little better idea about the size than what
  22     is described because size has not been described
  23     anywhere in this report. So we would have actually, we
  24     used to have a ruler there in the same room and of
  25     course magnification, how much magnification as compared
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   1     on the X-ray film.
   2        We would then have measured the pulmonary artery
   3     on either side and decided what we are going to do and
   4     we would have done that, it just somehow was not
   5     mentioned in any letter or even in our joint cardiology
   6     meeting except saying "It appears suitable for repair".
   7   Q. There is no record of that having been done, you are
   8     right. The choice in a case such as this would be,
   9     what, to go for repair?
  10   A. To go for one stage repair now.
  11   Q. Or?
  12   A. Or do another shunt, you know, to make it grow any
  13     bigger and then decide whether we can do a repair in
  14     a conventional manner, that is establishing direct
  15     communication between right ventricle and pulmonary
  16     artery or if it is true pulmonary atresia, fixing with
  17     a conduit outside.
  18   Q. Critical to the decision might be an idea of the size of
  19     the pulmonary arteries?
  20   A. Yes.
  21   Q. This picks up a point which you may have seen in the
  22     transcript where Ben Elliott's case was discussed
  23     earlier.
  24   A. I have seen that.
  25   Q. Dr Silove was making the point that size is important
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   1     and there appeared here to be a difficulty with
   2     identifying the right pulmonary artery and he was
   3     suggesting various cardiological techniques that might
   4     have been adopted.
   5   DR SILOVE: Yes, I mean the original angiogram had not been
   6     made available to me and I was just going by the report
   7     I had read and, as you have said, there is nothing in
   8     the report to say that the pulmonary arteries had
   9     actually been measured. It seems to me as if you are
  10     agreeing with my own sentiments, that it is very
  11     important to measure the size of the pulmonary arteries
  12     in order to assess whether they would be suitable for
  13     a complete repair.
  14   A. That is what I was trying to explain, sir.
  15   MR LANGSTAFF: In any event, the decision is made because of
  16     the review that takes place that Ben is suitable for
  17     a one-stage repair?
  18   A. That is what I considered, yes.
  19   Q. The parents, Mrs Elliott, you have read her statement
  20     and you have responded to it on an earlier occasion.
  21     She recollects being in some uncertainty about what
  22     operation was proposed and at one stage thought there
  23     was to be a shunt until the night before the operation
  24     when the consent form was signed when you explained to
  25     her that it was a repair rather than a shunt.
0084
   1        I do not know whether you recollect dealing with
   2     Mrs Elliott at all, do you?
   3   A. I cannot recollect in certain terms but all my patients,
   4     I would not have listed them for surgery unless I have
   5     talked with them in outpatients and I had talked to
   6     Mrs Elliott in outpatients.
   7        I think Mrs Elliott got confused between what she
   8     had heard from Mr Wisheart when she came to the clinic
   9     earlier when somehow she saw Mr Wisheart. That was very
  10     soon after the first shunt when the diagnosis was still
  11     pulmonary atresia. So Mr Wisheart explained to her how
  12     this would be managed in future and exactly that is what
  13     he said, as you have mentioned, that the next operation
  14     could be the shunt, and then when he grows further
  15     because he is thinking of pulmonary atresia, he is
  16     really thinking that this patient is going to need
  17     a conduit and probably a shunt on one side would not be
  18     big enough to really take it any further because they
  19     tend to get narrow or the artery gets bigger and they
  20     become less efficient and you have to provide another