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Hearing summary30th 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 Childrens 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 days hearing by discussing three individual cases reviewed as part of the Inquirys 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 Childrens Hospital attended todays hearing in their capacity as members of the Inquirys Expert Group. |
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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 0082 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 0083 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