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Hearing summary14th December 1999
The Bristol Royal Infirmary Inquiry this week will hear evidence which covers concerns raised about paediatric cardiac surgery at the Bristol Royal Infirmary between 1984 and 1995 and any failure to take action promptly.
Mr James Wisheart, retired Medical Director, United Bristol Healthcare NHS Trust, UBHT, continued to give evidence today.
Mr Wisheart and the two members of the expert group began today by discussing four individual cases reviewed as part of the Inquirys Clinical Case Note Review. Mr Wisheart, Mr Mankad and Dr Dickinson focussed in detail on the case notes for each patient, commenting on initial diagnosis, timing of surgical intervention, clinical teamwork and post-operative intensive care treatment.
Mr Wishearts evidence continues tomorrow.
Mr Pankaj Mankad, Paediatric Cardiac Surgeon, Royal Hospital for Sick Children and Royal Infirmary, Edinburgh and Dr David Dickinson, Consultant Paediatric Cardiologist, Leeds General Hospital, attended todays hearing in their capacity as members of the Inquirys Expert Group.
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FULL TRANSCRIPT
1 Day 93, Tuesday, 14th December 1999 2 (9.40 am) 3 THE CHAIRMAN: Good morning, everyone. Good morning, 4 Mr Langstaff. I should say good morning to our experts, 5 you will introduce us, I am sure. 6 MR LANGSTAFF: I expect they will introduce themselves, 7 that is what I shall invite them to do in a moment once 8 they have taken the oath. We have Mr Mankad and 9 Dr Dickinson. 10 MR PANKAJ MANKAD (SWORN): 11 DR DAVID DICKINSON (SWORN): 12 MR LANGSTAFF: Mr Mankad, can we begin please with you, this 13 is your first visit to the Inquiry. Would you like to 14 tell everyone a little bit about yourself and your claim 15 to be here sitting in the expert's chair as one of our 16 consultant surgeons? 17 MR MANKAD: I am Pankaj Mankad, I am a consultant cardiac 18 surgeon in the Royal Hospital for Sick Children and 19 Royal Infirmary in Edinburgh, and also, I am the 20 Clinical Director of Cardiothoracic Surgery in Lothian 21 University Hospital's NHS Trust, which is a recent 22 amalgamation of three hospitals or three previous 23 Trusts. 24 My association with paediatric cardiac surgery 25 goes back to the beginning of 1985 when I started my 0001 1 training at Harefield Hospital and subsequently 2 I completed my training at Harefield, Brompton and Great 3 Ormond Street Hospital in relation to paediatric cardiac 4 surgery and then I was appointed consultant cardiac 5 surgeon in Edinburgh just over 6 years ago in 6 September 1993. 7 In addition to my clinical role, I am advising the 8 Scottish Executive through the Scottish Inter-collegiate 9 Committee on issues surrounding paediatric cardiac 10 surgery in Scotland. 11 My qualifications include the Specialty Fellowship 12 and PhD apart from the general basic qualifications and 13 my interests remain in overall clinical and academic 14 area of paediatric cardiac surgery. Thank you. 15 MR LANGSTAFF: Dr Dickinson? 16 DR DICKINSON: I am David Dickinson. I qualified at 17 Manchester in 1968 and trained in paediatrics in 18 Manchester initially. My interest and expertise in 19 paediatric cardiology dates from 1971 in Manchester and 20 I went on then to train in Liverpool and in the Hospital 21 for Sick Children in Toronto for a year before being 22 appointed as a consultant paediatric cardiologist in 23 Leeds in 1982. I have been in Leeds since then. I am 24 the lead clinician for the paediatric cardiac service in 25 Leeds and have been so since about 1991 and I am 0002 1 currently the Secretary to the British Paediatric 2 Cardiac Association. 3 MR LANGSTAFF: I think, Mr Mankad, one of the matters you 4 have been advising the Executive on has been the 5 question of whether there should be one or two centres 6 in Scotland to perform paediatric cardiac surgery. We 7 have already heard I think that the likely result of 8 that would be a unification of the service in one 9 centre; has that happened. 10 MR MANKAD: Yes, that has happened actually. Late 11 September/beginning of October the Health Minister did 12 make an announcement that there will be one paediatric 13 cardiac surgical centre for Scotland. At present we are 14 in the phase of putting forward the clinical plan for 15 that and the provisional implementation date for that is 16 the beginning in April with three months transitional 17 phase and final implementation at the end of 18 June/beginning of July next year. 19 MR LANGSTAFF: What is the plan rationale for this 20 unification? 21 MR MANKAD: The rational, number 1, I think we felt that 22 critical mass is important for not just the paediatric 23 cardiac surgeon but also for the whole team who is 24 looking after these children. 25 Secondly, we felt that also by creating one 0003 1 centre, not only the clinical care will be improved, but 2 also it gives us an opportunity to develop academic 3 expertise in the subspecialty and take forward the 4 various issues relating to the care of children in 5 a comprehensive holistic way rather than just providing 6 a clinical service. 7 MR LANGSTAFF: Both of you have I think been on a reviewing 8 panel for cases arising out of the Clinical Case Note 9 Review, although the cases we shall deal with today are 10 not necessarily those with which you have personally 11 been involved save I think in one case. 12 DR DICKINSON: Correct. 13 MR JAMES WISHEART (RECALLED): 14 EXAMINED BY MR LANGSTAFF (CONTINUED): 15 MR LANGSTAFF: Mr Wisheart, we will this morning, and 16 I expect into this afternoon, be looking at cases which 17 arise from the Clinical Case Note Review. You will be 18 aware because I think you followed the Inquiry's 19 proceedings fairly closely but others may not be so well 20 aware, the purpose of examining these cases in this 21 hearing chamber is as examples from which lessons may be 22 learned. 23 It needs I think to be said at the outset that 24 perhaps because one is likely to learn more from what 25 might be described as failures or near misses than from 0004 1 successes. The cases which I will put to you are cases 2 where there have been criticisms made by the reviewing 3 panel. It should not however be understood by the wider 4 audience that this is the typical case so far as your 5 surgical skills are concerned. Indeed, it needs to be 6 recognised at the outset that far and away the most 7 common number that you have been given on the review of 8 the notes by the reviewing team for surgical performance 9 as it were, the conduct of surgery has been 4 -- 10 THE CHAIRMAN: You need to explain what 4 is. 11 MR LANGSTAFF: 4 is, if you like, no criticism, entirely 12 adequate care and it has also been observed in more than 13 one case that the conduct of the surgery which you have 14 performed has been of an exceptional quality. Let that 15 be said at the outset before we come to the actual cases 16 we are going to look at. 17 Can we begin by looking at the case of Gareth 18 Eccleshare, who was born on 25th July 1975. You have 19 had a chance, have you, Mr Wisheart, to look at the 20 details of Gareth's -- 21 A. Yes, I have, thank you. 22 Q. -- operation. Some of the details I think we can take 23 probably fairly quickly. He was born on 25th July 1975 24 and because he was a blue baby was found to have 25 dextrocardia with single ventricle, probable tricuspid 0005 1 atresia and pulmonary stenosis, and before the period 2 with which this Inquiry is concerned was referred to 3 you; in November 1975 when he was then 4 months of age, 4 you performed a right Blalock-Taussig shunt? 5 A. That is correct. 6 Q. He was then followed up over several years with mild 7 cyanosis and seen both in Cardiff and in Bristol. 8 He continued I think to be seen periodically both in 9 Cardiff and in Bristol and in November 1983 Dr Joffe saw 10 him in a clinic and commented on having raised the 11 question of further studies with a view to a Fontan 12 correction. 13 At that stage, or about that stage, was it noted 14 there had been an increase in the filling pressure? 15 A. That was observed subsequently at cardiac 16 catheterisation. I think there had been a cardiac 17 catheterisation in the late 1970s. I do not have it in 18 my own collection of notes. 19 Q. November 1979. 20 A. Yes. The changes then, as I recall, were pretty 21 modest. The changes in filling pressure were modest in 22 1979. So I think the changes you are referring to were 23 observed at the subsequent catheterisation. 24 Q. That was on 29th April 1984 I think which we can pick up 25 in the medical reports. May I say before the medical 0006 1 reports are shown that, as is the case with every case 2 that we will refer to arising out of the Clinical Case 3 Note Review, we have full consent from the parents and 4 relatives of any child that we mention to refer to the 5 case of the child and the records. 6 May we have, please, MR 1538/62? Do you have the 7 medical records themselves? 8 A. I have the full ones here and I have extracted some key 9 sheets which I have here. 10 Q. This is the cardiac catheterisation, is it, for 11 29th April 1984? We note, do we, if we scroll down, 12 first of all this child was being considered for 13 a Fontan-type of operation, was he? 14 A. I believe that was definitely in mind, yes. 15 Q. For a Fontan operation it would be essential to have 16 a measurement or a knowledge of the pulmonary arterial 17 pressure, would it not? 18 A. That is desirable, yes, it was regarded as one of the 19 pieces of information that one should have. 20 Q. One would go to Fontan's "ten commandments" as they were 21 called and one of those is that the mean pulmonary 22 artery pressure should be less than or equal to 23 15 millimetres of mercury? 24 A. Yes. 25 Q. If one is looking at the other features that one might 0007 1 expect out of those ten commandments, one might mention, 2 might one, that you would need to demonstrate or have 3 normal function of the ventricle? 4 A. That is correct. 5 Q. A ratio of the diameters of the pulmonary artery and the 6 aorta greater than or equal to 0.75? 7 A. That is one of the so-called commandments, but it has 8 been down the years always a debated criterion. 9 Q. Certainly the measurements of the vessels are a matter 10 of consequence? 11 A. That is what has been a matter of debate down the 12 years. It is clearly important that they must not be 13 excessively small and it is important they should not be 14 distorted as far as possible when there has been 15 previous surgery as there was in this instance. But the 16 pure question of size is almost certainly not as 17 straightforward as the proposal that appeared in the 18 original "ten commandments". 19 Q. Finally the features which I would wish to ask you 20 about, the pulmonary resistance has to be less than 21 4 units per square metre? 22 A. That was the recommendation at that time. 23 Q. If one looks at the catheter report there is no 24 measurement of the pulmonary arterial pressure, is 25 there? 0008 1 A. There is not. 2 Q. So that desirable element is absent. One can get a view 3 as to the minimum that the arterial pressure would be by 4 looking at the left atrial pressure? 5 A. Regarding the pulmonary artery pressure in isolation you 6 can, but of course you mention pulmonary vascular 7 resistance, so these things are related and there are 8 circumstances, if there is a high pulmonary flow for 9 example where the pressure may be somewhat elevated but 10 the resistance may be quite acceptable. These are all 11 interrelated considerations. 12 Q. But the arterial pressure cannot be less than the left 13 atrial pressure? 14 A. Indeed. 15 Q. We know that is 18 looking at the catheterisation here, 16 do we not? 17 A. We do, yes. 17, I think. 18 Q. 18, is it not, for the left atrial pressure and 17 for 19 the right? 20 A. Yes, I was on the wrong line. 21 Q. There was not, I think, in the catheterisation and the 22 report of it -- let us go on to the next page where 23 there is a report. Go down to "Aortogram" at the 24 bottom: 25 "Although there was good flow of contrast medium 0009 1 into both lungs, the origin of the right subclavian is 2 very narrow, a small amount of the contrast medium 3 reflux and the distal part of the main pulmonary trunk. 4 No abnormality of the peripheral pulmonary vessel is 5 seen." 6 There is no measurement as such of the vessels? 7 A. You mean the calibre of the vessels? 8 Q. The calibre of the vessels. 9 A. Yes. No, there is not. 10 Q. Is there any assistance from the catheterisation of the 11 degree of pulmonary vascular resistance? 12 A. Without the measurement of pulmonary artery pressure, 13 you cannot estimate pulmonary vascular resistance. 14 MR LANGSTAFF: When the situation of Gareth is discussed 15 after the catheter has been performed, you I think wrote 16 a letter of 17th July 1984. We can pick it up on 17 MR 988/29. It is the second paragraph: 18 "We saw his angios in the meeting some time ago. 19 Unfortunately, I have not had a chance to review them 20 with you again, but would positively like to do so. It 21 is clear however that he is suitable for a Fontan 22 operation and I think there can be no doubt that his 23 pulmonary artery pressure will be low." 24 What, gentlemen, would you say at this stage about 25 the suitability for a Fontan operation? 0010 1 DR DICKINSON: Looking at the catheter data -- 2 MR LANGSTAFF: I think your voice is a little low, can you 3 pull the microphone closer? 4 DR DICKINSON: Looking at the catheter data I would say the 5 mean pulmonary artery pressure cannot possibly be less 6 than the left atrial pressure obviously and one item of 7 information which flashed past very quickly on the 8 screen was that the calculated pulmonary blood flow was 9 only one-third of the systemic blood flow, so there was 10 only one-third of the normal volume of blood going 11 through the pulmonary circulation. 12 On that basis I would suggest that the pulmonary 13 resistance probably was elevated and the pulmonary 14 artery pressure was certainly higher than would be ideal 15 or acceptable for a Fontan and the end diastolic 16 pressure in the left ventricle, the change from the 17 catheter in 1979 to 1984 does suggest that the 18 ventricular function had deteriorated during that period 19 of time. 20 MR LANGSTAFF: Could I pause you there and go back, if 21 we may, to the catheter report at 1538/62. If we focus 22 on the third line down where it deals with the left 23 ventricular pressure. There is a recording there of 24 96 over 10-25 which is an indication, is it, of a sign 25 that the left ventricle is failing. 0011 1 DR DICKINSON: They certainly mean a change from the 2 previous catheter, the end diastolic pressure has 3 increased and in these circumstances I think that would 4 be an indication that the ventricular function had 5 deteriorated. 6 MR LANGSTAFF: Can I ask you to stop there because 7 Mr Wisheart may want to comment on what you have said? 8 MR WISHEART: I agree with what Dr Dickinson has said. 9 DR DICKINSON: I think there is evidence of a change in left 10 ventricular function which would be, as we have said 11 already, an adverse factor from the point of view of 12 selection for a Fontan procedure. There is, I think, 13 evidence that the pulmonary artery resistance or 14 pulmonary arteriolar resistance is most unlikely to be 15 at an acceptable level for a Fontan procedure. So 16 I think they are two factors which, I would have 17 thought, would make this child unsuitable for a Fontan 18 in fact. 19 MR LANGSTAFF: Mr Mankad, you were not of course 20 a consultant at the time, but it was not long after this 21 that you became a Senior Registrar. Do you have 22 a comment from the surgical perspective? 23 MR MANKAD: If I put the whole thing into perspective 24 I think there are three or four issues here under 25 consideration. 0012 1 The first is the pulmonary artery pressure. 2 The second one is the pulmonary vascular 3 resistance. 4 The third is the possible size of the pulmonary 5 arteries themselves, both right and left; and probably 6 the fourth issue is the left ventricular function. 7 If I take them slightly in the reverse order 8 I think I concur with what Mr Wisheart said, that the 9 size of the pulmonary artery pressure is not crucial to 10 the successful outcome of the Fontan operation. In fact 11 from the top of my head, if I recall, there was a paper 12 in circulation from the Boston group in probably 1989 13 precisely addressing this issue, that their data were 14 presented to the American Heart Association meeting and 15 the title of the paper was: 'Does the size of the 16 pulmonary artery in themselves matter in the Fontan 17 operation?' and the simple answer to that was "no". 18 I think I would probably agree that the size of 19 the pulmonary arteries was not a crucial issue. 20 MR LANGSTAFF: You said that was 1989? 21 MR MANKAD: Subsequently, yes. 22 MR LANGSTAFF: As a matter of biological fact it does 23 not matter; in terms of decision to carry out the 24 operation from what was known at the time, are you in 25 a position to comment or do I have to ask Mr Wisheart 0013 1 and Dr Dickinson? 2 MR MANKAD: I would be happy to proceed based on what 3 I have seen in this particular child. The anatomy of 4 the pulmonary artery to proceed -- I think I will take 5 one by one the issues -- that is one issue I think is 6 probably acceptable. 7 The second issue, let us come to the most 8 important issue, the pulmonary artery pressure. The 9 pulmonary artery pressure, as Mr Wisheart rightly said, 10 depends upon the pulmonary blood flow and the pulmonary 11 vascular resistance. This particular child had 12 pulmonary artery blood flow which was less than a third 13 of the systemic flow and the left atrial pressure was 14 18, therefore a very simple extrapolation would say that 15 the projected mean pulmonary artery pressure would 16 invariably have to be at least more than 20 millimetres 17 of mercury. 18 Secondly, after the Fontan procedure when (in 19 theory) the ratio of the systemic to pulmonary blood 20 flow is equal one to one, unless there is a small 21 fenestration in the Fontan circulation, that would 22 increase the pulmonary blood flow and that would 23 translate subsequently after the operation into further 24 increase in the pulmonary artery pressure, so beyond 20, 25 we are probably talking about 25 or 30. 0014 1 The third issue is that cardiopulmonary bypass 2 itself leads to damaging effects on the pulmonary 3 vasculature, albeit temporary and reversible, but that 4 in itself would also increase the pulmonary artery 5 pressure. So what I am coming from, this projected 6 pulmonary artery pressure post-Fontan in this child 7 would probably be too excessive to offer the Fontan 8 operation. 9 When you come to the pulmonary vascular 10 resistance, I again do not have all that problem because 11 pulmonary vascular resistance is calculated as mean 12 pulmonary artery pressure minus left atrial pressure or 13 the pulmonary capillary wedge pressure divided by the 14 cardiac output. That means the transpulmonary gradient, 15 the gradient across the pulmonary vascular divided with 16 the cardiac output gives us the... 17 The pulmonary vascular resistance is calculated by 18 the formula: mean pulmonary artery pressure minus either 19 the left atrial pressure or the pulmonary capillary 20 wedge pressure divided by the cardiac output. 21 It is conceivable that this particular baby had 22 acceptable resistance because the left atrial pressure 23 is very high, it is 18. 24 So I think the most important issue on which the 25 decision not to offer Fontan pre-operatively, I would 0015 1 rest in this child, is the pulmonary artery projected, 2 pulmonary artery pressure and projected extrapolated 3 pulmonary artery pressure after the Fontan circulation. 4 Both of these would be prohibitively high to consider 5 this baby as an absolute contraindication for Fontan 6 circulation even in the area under consideration, that 7 is the 1980s, because after the ten commandments of 8 Fontan there was a phase in-between where more and more 9 surgeons broke more and more commandments, and the more 10 commandments you break, you get away with it, it was 11 considered better; that was the phase that in between we 12 went through and we are back now to square one -- 13 Q. This was macho surgeons, was it? 14 MR MANKAD: Yes, that was universal across the board for not 15 just this country but especially in America, that the 16 more commandments you break you get away with it because 17 there was no option for these babies except Fontan 18 operation and the other options were all palliative -- 19 MR LANGSTAFF: I was going to ask about that, if you pause 20 there. Mr Mankad is making out a strong case perhaps, 21 I do not know how far you agree with it, for the Fontan 22 operation being contraindicated in Gareth's case. The 23 question naturally follows: what else might have been 24 done for him? 25 First of all, do you or do you not agree with 0016 1 Mr Mankad's main thesis which is that the Fontan 2 operation was, in the light of the probable pulmonary 3 arterial pressures both before and after the operation, 4 contraindicated? 5 A. Yes, I think certainly from my position now in 6 retrospect I would clearly accept that. The only thing 7 I can offer to you is some explanation of what our 8 thinking might have been, or I believe was at the time, 9 but that is not what you are asking me I do not think. 10 But that is where I am, broadly. 11 Q. In that case what -- perhaps you can help with what the 12 thinking probably was because plainly it was a decision 13 consciously taken to attempt the Fontan's operation. 14 The feeling obviously was, given the letter that I have 15 shown you, that the pulmonary arterial pressure was 16 critical because you refer to it in the letter and you 17 had a feeling that the pressure would be low. Can you 18 help us with how the thinking probably went? 19 I appreciate it is a long time ago and you may not have 20 it exactly right. 21 A. Can I in answering that and by way of introduction first 22 pick up Mr Mankad's point towards the end of his 23 remarks, namely, that thinking and practice in relation 24 to the Fontan operation was very much a changing and 25 evolving scene; I will not go into that, but let me just 0017 1 say that that I think is a very important factor behind 2 understanding the decisions we made in this case. 3 I think the question you have asked me is 4 specifically about pulmonary artery pressure and the 5 issues immediately related to that. Our thinking 6 I think was as follows: first of all the cardiologists 7 felt -- and I am not saying whether it was right or 8 wrong, but it was how they felt and it was not only in 9 relation to this case at that time -- it was not 10 appropriate for them to try to pass a catheter through 11 the shunt which was the only way they could have had 12 direct access to the pulmonary artery because, although 13 you said at the beginning that the diagnosis was 14 pulmonary stenosis it, by this time at any rate, was 15 pulmonary atresia, that is to say there is no normal 16 direct route in on. So the only available route was by 17 the shunt and they felt quite strongly at that stage 18 that it would have been inappropriate to pass the 19 catheter through the shunt. 20 Although that was debated amongst us -- I mean, 21 this is their territory and we accepted their advice. 22 So that then leaves us with a dilemma in relation to 23 a patient like Gareth because in principle therefore we 24 cannot provide the information to meet the required 25 series of criteria. 0018 1 So the second part of the thinking was, we knew 2 that from the beginning of his life and after the shunt 3 and in the years subsequently his pulmonary blood flow 4 had been low, and it is measured here as very low. In 5 the circumstances where pulmonary blood flow is very low 6 then the actual pressure in the pulmonary arteries is 7 unlikely to be high of itself, but clearly it has to be 8 higher than the left atrial pressure, as you have 9 pointed out. 10 But perhaps more importantly it is very unlikely 11 that the pulmonary vascular resistance will be high. So 12 at this point our thinking perhaps is not entirely in 13 accord with how Dr Dickinson has projected his 14 interpretation of the findings, but that was our 15 thinking: "Here is a boy who throughout his life has had 16 a profoundly low pulmonary blood flow, a very low 17 pulmonary blood flow, and therefore the chances of him 18 having pulmonary vascular resistance at a level that 19 would make the operation inappropriate is very very 20 unlikely"; so that was the thinking on that particular 21 issue. 22 MR LANGSTAFF: Do you want to comment on that, 23 Dr Dickinson? 24 DR DICKINSON: I would agree entirely with what Mr Wisheart 25 has said about the dilemma of measuring the pulmonary 0019 1 artery pressure directly in these circumstances. 2 Clearly there is a risk in trying to pass a catheter 3 through a shunt which is the only source of the child's 4 pulmonary blood flow, it could result in a very rapid 5 and possibly irreversible deterioration in the child's 6 condition, so there clearly is a dilemma and the 7 cardiologists who were doing the investigation were the 8 ones best placed to decide whether that was a safe thing 9 to do or not. 10 I entirely agree also that from time to time we do 11 have to make decisions about whether to proceed with a 12 Fontan operation on the basis of incomplete information, 13 because this situation of lack of access to the 14 pulmonary artery to make measurement of pressure is not 15 that uncommon. So sometimes we do have to make or to 16 extrapolate, as Mr Wisheart has done, to make an 17 estimate of what pulmonary artery pressure would be. 18 I do think in this case, though, with a mean 19 pressure of 18 in the left atrium we must assume that 20 the pulmonary artery pressure was significantly elevated 21 or significantly higher than that, otherwise there would 22 be no flow through the pulmonary circulation. 23 MR LANGSTAFF: Is it possible -- as has been suggested to us 24 earlier, because this is the second time we have looked 25 in the hearing chamber at Gareth's case -- to measure 0020 1 the pulmonary arterial pressure in the operation before 2 the actual process of proceeding to Fontan begins? 3 MR MANKAD: The simple answer to that is: Yes, it is 4 advisable, but these practises in paediatric cardiac 5 surgery have evolved over the years. 6 MR LANGSTAFF: Let me ask Mr Wisheart: was that something 7 that was done at this time as a general -- 8 A. Do you mean in the specific context of the Fontan 9 operation? 10 Q. Yes. 11 A. Yes, what I can say is that it definitely was, indeed it 12 was done in a much wider context and I frequently made 13 various measurements at the beginning of an operation if 14 I thought they would be helpful or were necessary. 15 Q. It was not actually done in this case, at least there is 16 no record of it? 17 A. There is no record of it and I have asked myself about 18 it because doing it -- I mean we can discuss its value 19 in a moment -- but doing it was very much part of my 20 practice. So I have asked -- and particularly in this 21 situation where the information had not been achieved at 22 catheter, it does seem a very obvious thing to do -- so 23 I have asked myself about that. I do think it is 24 definitely probable that I did it. Then the question 25 is: why did I not say I had done it? 0021 1 Q. Particularly since your operation notes are, on the 2 whole, full and detailed? 3 A. Indeed. The only thing I can offer is that this, as we 4 no doubt will come to, was an extremely protracted 5 procedure with an extremely disappointing outcome, 6 a sequelae that had to be dealt with and therefore the 7 possibility, when I sat down at the end to dictate the 8 note, that I overlooked this particular detail exists. 9 I can only offer it as a probability, there is no 10 certainty that I did it. It was part of my practice to 11 do that. 12 Q. The difficulties that you had really in this case would 13 have emerged, I think, on the operating table? 14 A. They did. 15 Q. There you are faced with a situation in which, am 16 I right, had you known what you saw on the operating 17 table and found on the operating table, you would not 18 have proceeded to a Fontan in the first place? 19 A. Oh, without any question. 20 Q. The first aspect that this highlights to us is the 21 decision-making process at which it was decided to go 22 ahead to have a Fontan operation. That is a process in 23 which you are, to an extent, in the hands of the 24 cardiologist with investigation they can or cannot make 25 with the difficulties that have been discussed and 0022 1 accepted between yourself and Dr Dickinson. 2 The process of the decision-making, what do you 3 say about that as a process Dr Dickinson? 4 DR DICKINSON: I think in most units, certainly all the 5 units I have worked in, the decision-making before an 6 operation is a joint one between the cardiologists, 7 usually as a group, not necessarily just the one 8 cardiologist who has been involved in the patient's care 9 but the cardiologists as a group and the surgeon or 10 surgeons as a group. Particularly in difficult cases of 11 this sort one likes to achieve a situation where the 12 whole group feels comfortable that you are doing the 13 right thing for the patient. I think it is very much 14 a group decision. 15 MR LANGSTAFF: Given the group decision, the consequence is 16 that when you come to operation you have the 17 difficulties that you have to deal with? 18 MR WISHEART: That is correct. 19 Q. The operation itself -- we find the note of that at 20 988/13. If we can scroll down. It describes I think 21 the length of the procedure. It was in fact a very long 22 operation, was not it? 23 A. It was in the end. I mean the initial procedure, the 24 doing of what we set out to do was not itself unduly 25 protracted, but by the time we had made adjustments and 0023 1 then eventually of course taken the whole thing down it 2 was a very long procedure. 3 Q. If we go over the page. We see, do we, that when the 4 Fontan was tried it became obvious that the left atrium 5 was not filling, suggesting I think that the pulmonary 6 venous return to the left atrium must have been very 7 poor? 8 A. Yes, that is what -- in the middle of page where it says 9 "the left atrium was virtually empty", suggests there 10 was very little flow through the lungs which, in the 11 face of a right atrial pressure that was high suggests 12 that at that time at any rate, at that instant pulmonary 13 vascular resistance was high. 14 Q. It again showed that the conclusion reached 15 pre-operatively about that was flawed. The conclusion 16 I think that was made was that the pulmonary arteries 17 were simply too small? 18 A. That was a speculation. The only artery that we knew 19 the size of was the main pulmonary artery which 20 I commented on at the beginning. It is actually not 21 necessarily terribly important, it is the size of the 22 right and the left pulmonary arteries together which are 23 rather more important. So that, I think, must be 24 regarded as a possibly correct but essentially 25 speculative comment. 0024 1 Q. We can scroll down. You are describing, are you, in the 2 second last paragraph how you found yourself in 3 difficulties in the operation because the original 4 concept of the operation has not succeeded and something 5 has to be done now given the situation that you are in; 6 is that the position? 7 A. That is correct. So I devised something that I thought 8 might alleviate the situation which, interestingly, in 9 subsequent years -- not the precise way I did it, but 10 a manoeuvre based on the same principle -- has actually 11 become part of the practice. But I tried to offload 12 some of this pressure from the right atrium so that its 13 pressure would fall and permit blood to get more easily 14 to the left atrium which, as you will recall, was 15 empty. 16 So, like everything, there is a balance in this 17 one. What I had hoped to gain was a lower right atrial 18 pressure, an increased flow into the left atrium. But 19 the negative side of that is of course that the blood 20 going into the left atrium is without oxygen and 21 therefore the blood going around the body will have less 22 oxygen. So there was a trade-off there that I accepted 23 and I was trying to find the right balance. 24 Q. The size of the conduit was what? 25 A. It was initially 6 and then that did not seem to be 0025 1 effective so I replaced it with a 10 millimetre conduit. 2 Q. That is really quite a large conduit, is it not? 3 A. I thought it was quite large, yes. But, as I say, this 4 was really a thinking on my feet response to a situation 5 and I had no good basis in experience or learning on 6 which to select the size of the conduit. Of course the 7 length of the conduit is another important factor 8 because the way I was doing it, it was quite long. So 9 it was, to some extent, a trial and error situation; 10 that was the reality. 11 Q. You described yourself "thinking on your feet" -- 12 A. Yes. 13 Q. -- in the absence of having experienced this before? 14 A. Or indeed at that time, it is always hard to put 15 yourself back 15 years, but I do not think there was 16 teaching or people describing that they were doing 17 this. So that is what I was doing, yes. 18 Q. One way of achieving the same effect would have been to 19 make a hole to provide a shunt between the two atria? 20 A. That is correct and that is what later of course became 21 the manner of implementing this same idea. To do that 22 of course I would have had to go back inside the heart, 23 so at this point I was trying to avoid going back on 24 bypass, going back inside the heart with all the 25 implications of that. 0026 1 Q. Because you had already been on bypass for a while? 2 A. Yes. Yes, and I would have needed to cross-clamp the 3 aorta and have more ischaemic time. So this appeared to 4 be a way of doing it without incurring the penalties, if 5 you like, that were associated with going back on 6 bypass, cross-clamping the aorta. 7 Q. That did not work because the right atrial pressure fell 8 and the oxygen saturation dropped off too much and that 9 was simply as you say trial and error; this was a shunt 10 which was too large as it turned out probably, was it? 11 A. We were not achieving what we needed; we were not 12 achieving a balance that was favourable to the patient. 13 Q. What one had to do then was to undo the whole operation 14 and go back to square one? 15 A. Yes. 16 Q. Which, because of the length of time and the fact of 17 operation, was inevitably really fighting very much 18 a rear guard action, was it not? 19 A. Yes, that is correct. 20 I mean taking down a Fontan is now an established 21 option in certain circumstances when things are not 22 working at the end. I am not at all sure that it was an 23 established option then, but it seemed to be the only 24 possible way forward because the child was clearly not 25 going to survive if I left things as they were, 0027 1 therefore it seemed the correct thing to do. 2 Q. When you got into difficulties and had to think on your 3 feet, did you think at all of calling Dr Joffe in to 4 say: "I have this difficulty, this situation, what do 5 you think?" 6 A. Probably not is the answer. I mean I do not know what 7 the whereabouts of Dr Joffe would have been on that 8 day. I do not imagine I felt that the expertise that he 9 could offer was actually going to help us in the 10 situation we were. 11 I was just looking to see who was with me. In 12 fact Mr Dhasmana was with me, who, although still 13 a Senior Registrar, was a very experienced one and had 14 spent years in Alabama and Great Ormond Street and so 15 forth by this time, and also Dr Masey was 16 anaesthetising. 17 So I had two colleagues with me with whom I could 18 share the thinking and who could make a useful 19 contribution. So I imagine I did not ask Dr Joffe to 20 come. Of course there was always the problem that he 21 was at a distance at best so there would have been 22 delays incurred, whereas I could talk immediately with 23 my two colleagues here. 24 Q. I was going to ask you about that particular problem 25 because bringing a cardiologist into theatre is bound to 0028 1 be very difficult at this time given the split site? 2 A. Yes, it was. I mean I actually did do it on occasions. 3 I could not give you the dates and times, but I did do 4 it occasionally but in the later days more commonly 5 I sought the help of Dr Wilde and his echo expertise 6 because he was on site. 7 Q. So we would be right in thinking in general terms -- not 8 necessarily in this case, but in general terms -- the 9 split of the site made some difference to what you might 10 otherwise have done? 11 A. In those circumstances where there were unexpected or 12 additional findings about which decisions had to be 13 made. 14 MR LANGSTAFF: Would you want to say anything further about 15 the problems that face a surgeon given that an operation 16 has begun which it turns out should not have been 17 attempted in the form that it was. 18 MR MANKAD: I think we need to put the whole discussion 19 maybe into the context of two things: one thing is that 20 the area under consideration is 1984 when there are no 21 precise guidelines or channels available to the surgeon 22 in the presence of failing Fontan circulation because 23 all these guidelines have been developed subsequent to 24 1984, number 1. 25 Number 2, I think failing Fontan circulation of 0029 1 this degree on the operation table is a surgical 2 nightmare and therefore it is not surprising that the 3 overall time taken for this operation is very prolonged, 4 it is very stressful to the whole team, it goes on for 5 a morning, afternoon, evening and probably sometimes 6 half the night, so we need to put this whole thing into 7 that context. 8 That context, number 1, there is no doubt we did 9 expect that this Fontan circulation is likely to fail 10 after the operation. Mr Wisheart found that being 11 confirmed on the table having done the Fontan operation. 12 Then the problems at that time are what to do, and 13 no guidelines are available. Now we would make a 14 fenestration or some other means. I think it is very 15 ingenious in 1984 for Mr Wisheart and the team to try 16 and devise the way out of this by considering pulmonary 17 artery to left atrial conduit with a view to 18 decompressing the circulation. 19 It is agreed that the subsequent selection of the 20 size of the conduit -- 10 millimetres was very large but 21 that we know now in hindsight because we invariably put 22 in a 4 millimetre fenestration or maybe at the most 23 a 5 millimetre fenestration, so we know the is an 24 adequate size. 10 millimetres was too big, but 25 unfortunately I do not think at that time there was -- 0030 1 one had to do everything based on logic rather than on 2 science. So we had to understand that 10 millimetres 3 was too big, but it was probably considered a relatively 4 safe bail-out procedure. 5 When that did not work, again in hindsight in 1999 6 we would expect -- 7 MR LANGSTAFF: Again can I ask you to slow down, please? 8 MR MANKAD: When 10 millimetres did not work, in 1999 we can 9 say safely that, yes, it would not work. The surgeon 10 then decided to undo the whole thing and put in 11 a central shunt. So that in itself I think shows the 12 commitment and dedication on the part of the surgical 13 team not to give up at an earlier stage and try and do 14 everything conceivable for the child with a view to 15 achieving what was expected at that time, a successful 16 outcome. 17 MR LANGSTAFF: We have got to 1986, I think there was 18 a review of Fontan's operations. We can pick that up on 19 the screen at JDW 7/4. May I say the names are names 20 which may be left because we have full consent. Was 21 this case one of the ones which you reviewed which we 22 may have the names blacked out on? 23 MR WISHEART: Definitely, yes. 24 Q. Is it the second in the list? 25 A. I believe so. I say that because I do not think that 0031 1 I have in my possession at the moment a document without 2 the names being deleted, I think you have that document. 3 Q. Not to hand I am afraid. 4 A. But that is what I believe, that it is the second 5 patient on the list, it cannot be any of the others 6 actually. 7 Q. Indeed you correctly review this as a selection error 8 for the Fontan? 9 A. Yes. I mean we felt it important -- and this is, what, 10 18 months later -- to review our experience. I think it 11 reflects the historical evolution to some extent that 12 has been mentioned because, although we knew the ten 13 commandments, as Mr Mankad said, there was some 14 uncertainty as to the importance and absolute necessity 15 of complying with each individual commandment at 16 a time. But the conclusion we came to based on our 17 general knowledge and our own experience in June 1986 18 was that we must actually adopt a very rigorous policy 19 in relation to these criteria. 20 Subsequently of course the importance of different 21 criteria evolved so that some were seen as terrifically 22 important and others were seen as actually quite 23 unimportant. If we just accept that, whatever the 24 criteria were, we adopted a policy that we must be very 25 rigorous and I think that was an important basis for our 0032 1 future improvement as to this procedure. 2 Q. We can probably see that at the bottom of this page, 3 what is on the screen at the moment, can we? Underneath 4 the line it is said, about eight lines down: 5 "These considerations would seem to suggest that 6 the selection criteria of patients for surgery are very 7 critical and should be formally undertaken. Although 8 I have understood this theoretically for a long time, 9 I do think we have to be even more rigorous than 10 before." 11 This is you saying to yourself and to the team: 12 "We need to take even more seriously the selection 13 criteria which I have known as a matter of theory, but 14 we actually need to put them into practice"? 15 A. I think that is exactly right, yes, that is where we got 16 to. 17 Q. Can we see what is said at the bottom of the page? 18 Again you emphasise I think in the last sentence of the 19 penultimate paragraph on the page: 20 "The question of selection for surgery remains 21 crucial." 22 A. Yes. 23 THE CHAIRMAN: May I ask one question arising from this 24 document, Mr Wisheart? Taking you to the first full 25 paragraph, where it says on the screen: 0033 1 "Further I do not actually know what sort of 2 proportion of patients are rejected as surgical 3 candidates at other major centres". 4 From your experience, then, to what degree was 5 that sort of information becoming available elsewhere; 6 to what degree was information like that shared so that 7 a body of experience could be begun to be built up? 8 A. It was shared at that time and in the subsequent years, 9 I think increasingly, probably in three ways that I can 10 immediately think of. There was an increasing frequency 11 of people publishing their experience in one shape or 12 form in the literature and particularly important 13 contributions came from places like the Mayo Clinic and 14 Boston Children's Hospital. 15 Secondly, and really in parallel to that, at 16 various surgical meetings or cardiological meetings 17 people would present papers. 18 The third method of communication was that I can 19 recall a number of specific symposia or one-day 20 courses. I can remember one at the Brompton for 21 example, I think in the late 1980s, but I do not 22 remember the date, where a day's thinking was focused on 23 the Fontan operation. 24 MR LANGSTAFF: I think we have learned the lessons that this 25 particular case can teach us as an exemplar from the 0034 1 Case Note Review. What I propose to do is to move on 2 now to the second of the cases. Given the hour it is 3 probably convenient if we do that in 15 minutes time 4 rather than straightaway. 5 THE CHAIRMAN: Yes. Shall we therefore take a 15-minute 6 break? That takes us up to 10.55. 7 (10.40 am) 8 (A short break) 9 (10.58 am) 10 MR LANGSTAFF: Matthew Rundle: Matthew Rundle was born, was 11 he, on 5th June 1993? He had Down's syndrome, and he 12 suffered from a complete AVSD. 13 A. I believe that is correct, yes. 14 Q. If we look at Medical Report 1633/76, and as before, of 15 course, we have full consent to refer to the record that 16 I shall show you, this is a letter dictated by 17 Dr Jordan -- 18 THE CHAIRMAN: We are just taking an address out, 19 Mr Langstaff. 20 MR LANGSTAFF: I am grateful. This is a letter from 21 Dr Jordan to the GP. The opening words, perhaps, say it 22 all, do they: 23 "This baby is struggling." 24 So at this stage, which is now September, three 25 months old, he is a struggling baby. 0035 1 If we go to page 1632/36, there is an address, 2 again, which we need to take out. It is another three 3 months later on and we see: 4 "This baby presents clinically to Truro in heart 5 failure and has done so on a frequent number of 6 occasions". The last paragraph: 7 "It was agreed that he should have total 8 correction and that his risk was somewhat elevated on 9 account of the level of pulmonary vascular resistance. 10 For this reason, it was felt that the operation should 11 be carried out as quickly as was reasonably possible." 12 You then say you will make arrangements for 13 Matthew "to see me as urgently as possible in 14 outpatients, in any case hopefully not later than the 15 beginning of January. The child should be scheduled for 16 surgery if at all possible in January 1994." 17 So there is a degree of urgency, is there, about 18 Matthew's case? 19 A. Yes, there is a degree of urgency. 20 Q. And the urgency is, is it, that with that condition one 21 may get pulmonary vascular resistance developing? 22 A. Yes. 23 Q. And developing, the risk is, to such a stage as to be 24 irreversible? 25 A. Yes, it has been a measure of 4.7 and 4.2 as you have 0036 1 seen in that document. Whilst it is not going to become 2 irreversible overnight, clearly as it evolves changes 3 are only in one direction, and therefore it is a signal 4 to do it sooner rather than later. 5 Q. On a clinical basis, you would say, really, you want 6 this to be done as soon as possible, if possible in 7 January? 8 A. That is what we had in mind. 9 Q. As it happened, Matthew was admitted in February, the 10 middle of February, not in January, and an operation was 11 not then possible because he had an upper respiratory 12 tract infection and a possible urinary tract infection, 13 so it was put off until March. 14 Can you help at all as to why there might have 15 been a difficulty in 1993 in scheduling him earlier 16 rather than later? 17 A. We are only talking of a difference between January and 18 February. I saw him in outpatients in January, as we 19 had planned, and I imagine that the reality was that 20 when I saw him in January, the January operating was 21 already planned so he was scheduled for February. I do 22 not think that the difference between January and 23 February can be construed as significant in this regard, 24 really. 25 Q. We have a child who, in the child's best interests, 0037 1 perhaps might have been operated on at an earlier 2 stage. He comes for surgery at nine months. Ideally, 3 you would have wanted to operate at what, six months or 4 less? 5 A. We were seeking to reduce the age, as you know, because 6 that was our policy, and I am not quite clear in my own 7 mind why, following that first letter you showed us, the 8 next steps were not taken, but as I say, I cannot 9 comment on that; I am just slightly surprised. 10 Q. You can comment, and you already have done, by saying 11 you were surprised? 12 A. Yes. 13 Q. Because, given that first letter, you would have thought 14 that the wheels would have got into motion fairly 15 quickly, and there must have been some reason, either 16 individual or systemic, as to why they did not? 17 A. That is what I really meant when I said I cannot 18 comment. I do not know if there were other factors 19 which influenced Dr Jordan at that time. 20 Q. But in terms of systematical or institutional reasons, 21 given the middle of 1993 to the end of 1993, what might 22 they have been? 23 A. I cannot think of any particular institutional reason. 24 I cannot believe there would have been. I think that 25 any circumstances would have had to relate to the child 0038 1 or the family. If you mean was the catheter lab closed 2 for renovation or did everybody go on holiday or 3 something or was there an infection in the hospital, 4 I do not think there was anything like that. 5 Q. Waiting lists? 6 A. I do not have the information about waiting lists for 7 cardiac catheterisation; I just do not know. 8 Q. I have been asked to make clear, and I do, that the 9 first referral to you appears to be December 1993. 10 A. That is correct, yes. 11 Q. So whatever the delay was in coming to surgery, it is 12 not your individual responsibility as such. 13 A. That is correct. 14 THE CHAIRMAN: But as you made clear, Mr Langstaff, we 15 look at these cases to exemplify things much wider than 16 any particular person's responsibility, as you have said 17 many times and it is for that reason we are looking at 18 it now. 19 MR LANGSTAFF: Absolutely. So you were, in general terms, 20 looking to operate on AVSDs earlier, with, as we saw 21 yesterday, a meeting in which that had been discussed 22 earlier than 1993? 23 A. Indeed. It goes right back to 1990 and 1991. 24 Q. What I am asking for some assistance on, really from 25 a general perspective of the time, is in general 0039 1 terms -- it may not apply necessarily to Matthew's case 2 but it might have done -- that might not have been 3 achieved? 4 A. I think that there was a general agreement and will to 5 arrange the catheterisation and the discussions and so 6 forth so that it would be possible to operate on the 7 child in the first year of life, but I can remember 8 quite a number of discussions in which we surgeons were 9 urging the cardiologists to actually take those steps 10 sooner, really for two reasons, the most important one 11 so that they could be operated on sooner, earlier in 12 their life, but also because logistically it gave us 13 a bit more room for manoeuvre, whereas if the patient 14 was first brought to our attention later, then it had 15 become a matter of greater urgency. So it was easier if 16 it came sooner. 17 Q. And greater difficulty? 18 A. As we know, indeed. 19 Q. We may find subsequently looking with what happened to 20 Matthew's case, it might have contributed to the 21 ultimate difficulties? 22 A. The overall delay, yes. I think it was -- yes, well, 23 that is true. That and the underlying fact of what had 24 happened during the months of his life, which was not 25 fully identified at the investigations. But, yes, that 0040 1 undoubtedly was a major factor contributing to the 2 outcome. 3 Q. We have come upon a number of cases in looking at those 4 that have been reviewed where there appears to have been 5 quite a gap between a catheterisation in a case where 6 the diagnosis was not difficult to establish on echo, 7 and surgery. I wonder, and therefore ask, whether it 8 might have been possible to so arrange matters that the 9 catheterisation and the operation were, if 10 a catheterisation had to be done, much closer together 11 in time? 12 A. The plan for this one was that there was a gap of less 13 than two months, which I must say I would regard as 14 quite a short time. But what we surgeons wanted, 15 really, was earlier referral altogether. 16 Q. You would have wanted Dr Jordan, in this case, to have 17 said, "Well, having seen Matthew at three months of age, 18 he is not thriving; he obviously suffers from a complete 19 AVSD: put him on your list"? 20 A. Well, to have referred him to us, we would have 21 discussed him and whatever steps would then have been 22 followed, yes. 23 Q. If that had happened, the chances are you would have 24 regarded him with something of the same degree of 25 urgency as you did in December? 0041 1 A. Perhaps so. I mean, it is speculative, but, yes. We 2 might well have done. 3 Q. The operation itself -- if we look at the note at 4 1633/27, that can now go on the screen. If we scroll 5 down, there are three matters which one notices from the 6 perfusion data. It is a bypass time of 3 hours and 16 7 minutes and a cross-clamp time of 1 hour 59 minutes. 8 The other matter which I want to pick up at this 9 stage -- if we go right back up to the top of the 10 page -- is the weight of the child, 5.2 kilograms. 11 I will come back to that for reasons which you will 12 appreciate but the wider audience might not, at this 13 stage. 14 Focusing on the time, that is, is it, a relatively 15 long time for an operation such as this? 16 A. It is a little bit longer than my average, but not 17 dramatically longer than my average. 18 Q. You were, you acknowledge, amongst the slower surgeons? 19 A. Yes. 20 MR LANGSTAFF: Do you have any comment about the length of 21 time? 22 MR MANKAD: Am I allowed to go back a bit? 23 MR LANGSTAFF: Yes, please. 24 MR MANKAD: With due permission of the Chair: we 25 discussed one issue of the timing of the operation. 0042 1 It does highlight that in an ideal world, I think, this 2 child, number 1, may not have required catheter. 3 Echocardiographic diagnosis was made at three months of 4 age. In an ideal world, I think it is conceivable that 5 at that time, when the child was struggling, the 6 physician should contact the surgeon and say, "I have 7 a complete AVSD. I am in the process of catheterising, 8 if at all it is felt that catheter is necessary, but 9 would you now be in a position to consider him for 10 surgery within the next three months?" 11 MR LANGSTAFF: I think that is common ground between 12 Mr Wisheart and yourself. Dr Dickinson, this relates to 13 the cardiologist's role as part of the team. What would 14 you wish to see happen in a case such as this? 15 DR DICKINSON: I think practice in our unit would be to 16 refer for surgery at about three to four months of age. 17 I think I am right in saying that this child was not 18 actually referred to the cardiologist from the local 19 hospital until about three months of age, so in that 20 sense there was a slight delay in the child presenting 21 to the unit in Bristol in the first instance. 22 Having got a child of three months of age with 23 Down's syndrome and complete AV canal, my practice would 24 have been to refer that child for surgery straightaway 25 on the basis of ultrasound evidence. I would not at 0043 1 three months of age have felt it necessary to perform 2 a cardiac catheterisation. 3 If surgery is delayed for any reason into the 4 latter part of the first year of life, then it may be 5 necessary to do a cardiac catheterisation to be 6 absolutely sure that the pulmonary resistance is still 7 acceptable. Ideally, I would have thought that 8 certainly an operation within the first 6 months of life 9 would be what we would be aiming for, and ideally 3 to 4 10 months, sometimes earlier than that if the child is 11 struggling as this child is described. 12 MR LANGSTAFF: Can we then move on from that to the length 13 of the operation? Is it unduly long, or not? 14 MR MANKAD: I think, as Mr Wisheart stated, there are 15 tremendous variations in surgical timing of individual 16 surgeons and although in terms of bypass time it is 17 considered an incremental risk factor for subsequent 18 development of morbidity, but considering the ischaemia 19 time and the cross-clamp time of 1 hour 59 minutes, 20 I think I can roughly say, from logic rather than any 21 information, that it is probably within plus or minus 2 22 standard deviation of a mean time, operative time of 23 a surgeon. 24 Q. So in other words, it is not out of step -- 25 A. It is not out of step. 0044 1 Q. -- with what other surgeons might do, even though it may 2 be on the slow side? 3 MR MANKAD: It is on the long side, is it not? 4 MR LANGSTAFF: Which would correspond with your own 5 intuition? 6 MR WISHEART: That was my view of the matter. 7 MR LANGSTAFF: Again, so that we have the evidence, the 8 length of time on bypass is, is it, a risk factor which 9 increases with the length of time that one is on bypass 10 in terms of morbidity. 11 MR WISHEART: Yes. I think it would be common ground, I am 12 sure, that the duration of aorta cross-clamp time is the 13 more critical time, but that the total period of bypass 14 is also an important time, but less so, and hopefully, 15 its influence would chiefly be on morbidity, unless it 16 was enormously prolonged, in which case it too would 17 become a factor possibly contributing to mortality. 18 MR LANGSTAFF: So we have to look at these times critically 19 in the sense of wishing, if one can, properly to keep 20 them as low as possible. 21 MR MANKAD: Yes. It is advisable to keep both ischaemia 22 time and bypass time as short as possible, but the 23 difference in terms of the bypass time is the relative 24 degree, i.e. 3 hours or 4 hours makes relatively small 25 difference as opposed to 2 hours or 5 hours, so it is 0045 1 a question of degree rather than an absolute entity. 2 There is no cut-off point beyond which the bypass time 3 is extremely dangerous. 4 MR LANGSTAFF: We have heard, I think, that one should not 5 put an undue premium on speed, because it is more 6 important to get the surgery done meticulously. 7 MR MANKAD: I entirely agree with you. 8 MR LANGSTAFF: Do you accept that as a proposition? 9 MR WISHEART: That was always my view, yes. Could I say, 10 there is one other factor, I think, to be considered in 11 this, but I am quite sure it is common ground to 12 everybody, and it is, of course, the care which the 13 surgeon must take with regard to myocardial protection, 14 which is the part of the management of the operation 15 that alleviates, to a degree but not completely, the 16 effects of aorta cross-clamping. 17 I would just mention that as I think a very 18 important component of this discussion. 19 Q. That is a function not just of the surgeon but of the 20 anaesthetist? 21 A. Well, yes. I mean, if the surgeon is engrossed in what 22 he is doing, as he tends to be, then he may need 23 a reminder, but it is fundamentally I think the surgeon 24 who will dictate the policy, if you like, and say to the 25 anaesthetist, "Please speak to me after 20 minutes" or 0046 1 30 minutes or whatever, or the perfusionist or somebody, 2 and will have a method in place, both for being reminded 3 and for delivering cardioplegia. So it is part of the 4 team effort. 5 Q. The operation itself, if we look, please, at the 6 perfusion data, 1633/4, can we scroll down to where we 7 see a summary at the bottom, on the bottom right-hand 8 side. 9 We can pick up there, can we, the fluid balance? 10 We will see that Matthew had 635 ml of prime on the 11 pump. If we add that up, the fluid balance, comparing 12 fluid in and fluid out, leaves him with a plus of 75 ml 13 at the end of the operation. 14 Is that a proper reading of the perfusion record? 15 A. It seems to be. There is a 5 somewhere I cannot account 16 for, but in essence it does appear to be. 17 Q. If we go back, we will come to perhaps the relevance of 18 that subsequently, but if we go back to 1633/28, the 19 bottom of the page, so far as the surgery is concerned, 20 there are some difficulties after coming off bypass. 21 They are overcome and if we look at the diagnostic 22 pressures at the bottom of the page, they appear pretty 23 acceptable, do they not? 24 A. On the whole they look encouraging. The venous 25 saturation is a little low but I have not noted the 0047 1 arterial saturation as a figure so that is the only one 2 that I would pick out. The significance I cannot tell 3 you without knowing the arterial saturation at the time. 4 Q. But there is one feature of the note of that last 5 paragraph which I do want to ask you a little about. 6 You deal in the middle of it with the second problem 7 beginning there: 8 "The second problem was that the baby's oxygen 9 saturation appeared to persist in the low 80s after 10 withdrawal of bypass. This reduction was much greater 11 than that which would be expected from the diversion of 12 the coronary sinus flow. In order to eliminate these 13 two problems, epicardial echocardiography was carried 14 out by Dr Wilde before closure." 15 You deal with what that shows: the possibility of 16 some obstruction, but otherwise reasonably reassuring. 17 How often was epicardial echocardiography carried 18 out in the theatre? 19 A. Not very often at all. 20 Q. This would involve calling up Dr Wilde from the 21 basement? 22 A. That is right. 23 Q. And Dr Wilde is not a cardiologist but a radiologist, 24 although very experienced? 25 A. A cardiac radiologist: totally committed to cardiac 0048 1 activity. He is a cardiac specialist, it is not 2 a part-time interest, it is his commitment. 3 Q. While we deal with the issue of cardiography and its use 4 intraoperatively, can I just ask you to give me 5 a moment -- I shall have to come back to it. There is 6 a letter from Dr Wilde in 1994 I want to ask you about. 7 I will pick it up subsequently. We will leave that for 8 the moment. 9 Matthew then goes into the ICU? 10 A. Yes. 11 Q. We pick him up in the ICU at 1633/33. On this page, 12 at the top of the page, the arterial blood pressure, 13 68 over 40. That is reasonably good, I think. The 14 respiratory, the oxygen is 100 per cent saturation, and 15 on the whole, therefore, appearing to be in reasonably 16 good state when he goes into intensive care. Is that 17 a fair reflection? 18 A. That was what we thought, yes. 19 Q. So that the surgery has, it would appear, been thus far 20 successful. It is all now down to the intensive care. 21 One of the problems, or potential problems, in 22 intensive care is that the child may suffer from a major 23 capillary leak syndrome. 24 A. That is something that one sees from time to time, yes. 25 Q. It is a known complication? 0049 1 A. It is, very much so. 2 Q. And what happens in that syndrome is, is it, that the 3 capillaries, throughout the body, leak in the sense that 4 the fluid exudes from them into the surrounding tissues, 5 so there is an element of oedema, and that in turn sets 6 up a balance between the tissue and the vessel which may 7 take some time naturally to resolve and if it is not 8 dealt with one way or another, may lead to a vicious 9 cycle? 10 A. Yes. It has a number of important consequences. It is 11 almost certainly not just a leak of fluid but also 12 a leak of plasma proteins to some degree, which 13 therefore makes it more difficult for the fluid to be 14 brought back into the capillaries. 15 Q. The albumen gets out from the vessels into the tissues? 16 A. Yes. 17 Q. You do not then have the gradient or whatever it is that 18 brings the fluid back? 19 A. That is right; but the more immediate consequence of 20 course is that this is fluid lost from the circulation, 21 so that the circulating blood volume becomes reduced and 22 the cardiac output becomes reduced. 23 Q. So what one has to do to manage a problem such as this 24 is either prevent it or treat it when it occurs. 25 Prevention would involve giving steroids, would it? 0050 1 A. Prevention in 1994, we did in fact, I believe, as 2 I recall, use steroids, but I do not think that achieved 3 a complete prevention. It may have contributed. 4 I think the techniques that subsequently became widely 5 used in particular ultrafiltration during bypass, would 6 now be regarded as a more effective method of 7 prevention, but we were not using that in 1994. 8 MR LANGSTAFF: What do you say about the way itself that one 9 can attempt to prevent this known complication arising? 10 MR MANKAD: I think my first reaction would be that we 11 should probably use the term "minimise the incidence" of 12 capillary leak syndrome rather than complete prevention, 13 because it is often not possible to completely eliminate 14 the occurrence of this complication following coronary 15 pulmonary bypass. 16 Minimising the incidence of capillary leak 17 syndrome in babies has a number of avenues and it is the 18 combination of basic science research as applied to 19 cardiac surgery which has facilitated our understanding 20 of this process and the mechanisms to improve the 21 process or act on this process. 22 One of those, very rightly as Mr Wisheart has put 23 it, is ultrafiltration, either on cardiac pulmonary 24 bypass, or, in addition to on cardiopulmonary bypass, at 25 the end of coronary pulmonary bypass, which is 0051 1 a modified form of ultrafiltration. 2 Before I come to the second issue of minimisation, 3 I think that would have been important in this child 4 because if we go back to the perfusion chart, the child 5 had nearly 1700 ml of clear fluid, crystalloid, during 6 coronary pulmonary bypass. For a 5 kilogram baby that 7 is a fairly large quantity of clear fluid. So it is 8 conceivable that this child would have benefited from 9 ultrafiltration. 10 MR LANGSTAFF: But they did not have that on the unit? 11 MR MANKAD: Yes. The second thing -- 12 MR LANGSTAFF: Can I ask, what is your view as to whether it 13 was generally available in 1994. 14 MR MANKAD: Even today, I think that there are a number of 15 units in the country -- put it this way: I think over 16 the last five years, there has been an increasing 17 acceptance and realisation of the importance of 18 ultrafiltration on and off bypass. An increasing number 19 of centres have been using that. In 1993/94, it is 20 conceivable that there were -- from the top of my 21 head -- maybe 20 or 30 per cent of the units in this 22 country would be using ultrafiltration in on bypass and, 23 in the modified way, off bypass. 24 MR LANGSTAFF: So it was the exception rather than the rule 25 in 1993/94. 0052 1 MR MANKAD: Yes. 2 MR WISHEART: I should say we did have it at that stage, but 3 it had not become part of our routine procedure. We 4 used it in circumstances where a big fluid load had been 5 identified during surgery and we wanted to restore the 6 balance prior to leaving the operating room, so we had 7 taken the first step, if you like, but we were not using 8 it routinely. 9 MR MANKAD: The second possible way of minimising the 10 incidence would be the use of, as you alluded to, 11 steroids. This issue is still very fluid, and whether 12 to use steroids, when to use steroids, how much to use 13 steroids what form of steroid, are all still debatable 14 issues. 15 Again, I would say that it is not universally 16 accepted that steroids should be used as one of the 17 preventive measures for capillary leak, but my own 18 personal feeling is that methyl prednisolone used in 19 a particular dosage a few hours before the onset of 20 cardiopulmonary bypass is beneficial. 21 MR LANGSTAFF: Is this a controversial view, then. 22 MR MANKAD: The view in terms of use is not controversial, 23 but its effectiveness is still under debate. 24 MR LANGSTAFF: So the theory would be to avoid the risk, try 25 it, would it? 0053 1 MR MANKAD: I think more and more evidence is coming forward 2 now, with proper understanding of the siderokines and 3 what actually triggers the siderokines at the nuclear 4 factor level and how this process can be stopped at an 5 earlier stage. So more understanding is coming through 6 now about the benefit of steroids than five years ago. 7 So, yes, I think it is debatable, but more and more 8 centres now use it. 9 MR LANGSTAFF: But five years ago it was more debatable. 10 MR MANKAD: It was much more debatable, that is absolutely 11 right. 12 MR LANGSTAFF: Dr Dickinson? 13 DR DICKINSON: I would just make the point that it is not 14 a routine measure, even now. So far as I am aware, we 15 do not use steroids routinely in Leeds pre-operatively 16 in these circumstances. 17 MR LANGSTAFF: So much for minimisation, preferring that 18 word to "prevention". 19 As for treatment, the principles would be, would 20 they, to maintain cardiac function, from what you have 21 said that is vital in this syndrome; to avoid 22 vasodilation, again, for obvious reasons, and to begin 23 haemodialysis. Would that be the approach, or not? 24 MR WISHEART: Well, I would broadly agree with your 25 early suggestions, but not necessarily with the last 0054 1 one. The approach which we had in 1994 would have been 2 first we would recognise that we cannot actually 3 influence the recovery of the capillaries, so what we 4 are doing is to hope and expect the capillaries to 5 recover, and we have to maintain the child's status as 6 best we can until then. I think that is quite 7 important. 8 The second thing I would point out is that this 9 leak of fluid of course is essentially into all parts of 10 the body, so it can be into the kidneys and it can 11 interfere with renal function. It can be into the heart 12 muscles so can interfere with the cardiac function. 13 That is just the background. 14 So the management, therefore, involves the 15 maintenance of an adequate circulating volume, but then 16 there is an anxiety if you do that too energetically, 17 you enhance the process of fluid leakage, so there is an 18 element of balance and compromise in that. 19 I have mentioned loss of protein, so there may be 20 also an element of replacement of proteins to the 21 circulating volume in an attempt to maintain that 22 osmotic gradient or that view you referred to a few 23 moments ago. In the meantime you may have to support 24 the work of the heart with inotropes or whatever, and 25 you may have to support the renal function with renal 0055 1 dialysis, ultrafiltration or some form of renal 2 support. 3 Those would be the broad outlines of how I would 4 approach it. I have to come back to the careful balance 5 that has to be struck with regard to fluid replacement. 6 That is, I think, quite a crucial element of the care, 7 because if one gets that wrong, you can actually enhance 8 the process of leakage, and I think delay recovery. 9 Q. Something like 90 to 95 per cent of this condition are 10 recoverable, are they not? 11 A. I would not be able to quote a percentage. I just do 12 not have that information. 13 Q. It is important, is it, to get on top of it early in 14 post-operative care? 15 A. If it is going to happen, it usually becomes evident 16 within the first 24 to 48 hours. It may not be evident 17 immediately, and it is in fact usually not evident 18 immediately; it is something that you see after an 19 interval. So as soon as you detect this happening, then 20 it is important that you start thinking and approaching 21 the problem in the way that I have outlined, or whatever 22 way you think is best. But I am just outlining how 23 I personally thought about it and approached it. 24 Q. So the stages are: detection of the problem and then 25 having a strategy to deal with it and pursuing that 0056 1 strategy? 2 A. Indeed. 3 MR LANGSTAFF: Are those the two stages? 4 MR MANKAD: I think I would agree with Mr Wisheart that the 5 process, once initiated, because of the cardiopulmonary 6 bypass, is self-limiting and it is very difficult if not 7 impossible to intervene in that process of capillary 8 leak. 9 So the principles of management are to maintain 10 circulation during that time, but more importantly, to 11 try not to overdo things, so i.e. to maintain the 12 pressure at an acceptable level for cerebral and cardiac 13 perfusion, but at the same time, to institute some form 14 of dialysis -- and usually in these children it is 15 peritoneal dialysis rather than haemodialysis or 16 haemofiltration -- to try and institute at an earlier 17 stage, thereby, even though there is very little renal 18 kidney output, the kidneys are supported for the time 19 being initially and subsequently, when the process is 20 stopped, say, three, four or five days usually, the leak 21 invariably stops because there is no more continuing 22 insult unless there is sepsis or endotoxins in 23 circulation, then the peritoneal dialysis would slowly, 24 over a period of time, reabsorb the fluid from the 25 interstitial compartment of the body and the child will 0057 1 slowly continue to improve. 2 The key thing for management is: (1) to anticipate 3 that this is happening whenever one sees an oedematous 4 child or a child requiring a disproportionately large 5 amount of colloid replacement; and (2) to be proactive 6 in terms of management so as to improve the situation in 7 due course. 8 MR LANGSTAFF: Dr Dickinson, do you want to comment? 9 DR DICKINSON: Really, only to agree with what Mr Mankad has 10 said: I think it is crucially important from the point 11 of view of organ functions to restore the fluid balance 12 to an appropriate situation. I think that removing 13 fluid is an important part of this, whilst at the same 14 time one has to support the intervascular volume by 15 giving a certain amount of fluid as well. As 16 Mr Wisheart said, there is a balance to be struck 17 between the two. 18 MR LANGSTAFF: How does one remove the fluid? 19 DR DICKINSON: I think in infants, we would always, I think, 20 use peritoneal dialysis. 21 MR LANGSTAFF: We see, at page 34, the next page, the 22 post-operative day 1, the problems that we know to the 23 top of the page: poor gas exchange, hypoxic despite 24 100 per cent oxygen, poor cardiac output. If we go down 25 to the bottom of the page, the word "oedematous" has 0058 1 been circled, so this note would appear to suggest that 2 in the first post-operative day one might expect 3 a capillary leak syndrome to demonstrate itself, but 4 here Matthew is showing signs of it, is he not? 5 MR WISHEART: He is showing signs of oedema which could 6 either be the consequence of the imbalance that you drew 7 our attention to at the time of the operation or could 8 be due to a continuing factor, namely the leak that you 9 have mentioned. I am not sure whether, at this stage, 10 it would be quite clear which. 11 Q. Page 36, post-operative day 2, "poor gas exchange", the 12 third line down, "gross oedema, colloid sequestration". 13 "Colloid sequestration": what does that suggest? 14 A. Well, the words suggest that there is fluid in the 15 tissues and that there is some plasma proteins with 16 them, but I think one would have to say that this is an 17 expression of clinical judgment. I am not quite sure 18 whether this is a precise scientific statement. 19 Q. If we have gross swelling, together with a degree of 20 proteins in the tissues rather than -- 21 A. But he does not actually know that. He just knows there 22 is oedema. The word "colloid" I am a little uneasy 23 with. 24 Q. So what do you think the recording clinician here has 25 concluded? He has concluded, has he, that there is 0059 1 a capillary leak syndrome? 2 A. Yes, so I think if he had said "gross oedema query 3 colloid sequestration" or whatever, but I think it is 4 important to note that gross oedema is an actual 5 observation. Colloid sequestration is a conclusion that 6 may be drawn from that. 7 That is the point I wish to make. 8 Q. Having decided that there is a capillary leak syndrome, 9 as the clinician here appears to have done, if we go 10 down the page, we have an idea of the balance, plus 64 11 and plus 150 is crystalloid and colloid. And 12 clinically, obviously, oedematous. Can we go on to the 13 next page? The plan is "Continue to cool. Full 14 inotropic support". I am not sure I can decipher the 15 next few words. 16 A. The word following the upward arrow is Enoximone, which 17 is, let us say an inotropic drug, a drug to support the 18 work of the heart. 19 Q. Then "Keep positive on colloid"? 20 A. Yes. 21 Q. Then the next one you will have to interpret for me. 22 A. I am having difficulty. It may be short for Fentanil. 23 I am really not sure; I should not speculate. I do not 24 know, is the answer. 25 MR MANKAD: It is "Reduce Fentanil Vancuronium to 1 ml per 0060 1 hour". That is a paralysing agent. 2 MR WISHEART: That is correct. 3 THE CHAIRMAN: They are referred to higher up, under the 4 heading, "Sedation". 5 MR WISHEART: That is right, yes, the Fantanil is. 6 MR LANGSTAFF: Can we go to the comments at the bottom 7 of the page? What comment would you make about what is 8 said there, Mr Mankad? 9 MR MANKAD: I think that is the first time that a plan is 10 made to insert a peritoneal dialysis catheter, but it 11 seems from that that, not with a view to dialysing the 12 baby but with a view to slowly -- and I stress the word 13 "slowly" -- decompressing the abdominal fluid. The 14 final line, 1700 hours, "20 ml per hour of ascitis 15 drained off", so the plan has been to do extremely 16 gradual draining of the abdominal fluid. 17 MR LANGSTAFF: We can tell that there was not actually 18 dialysis at this stage because we can actually check the 19 charts, can we not, if we go to page 259? 20 MR WISHEART: Dialysis did not begin until the sixth 21 post-operative day. 22 MR LANGSTAFF: I am grateful. If we go, then, to the 23 third day, page 38, the top of the page is the last item 24 under "Problems", "Very oedematous". We can go to 25 page 40 for the fifth day. Again, oedema. Not until 0061 1 the sixth day was, as you say, dialysis begun, and it 2 was not long after that that Matthew failed to survive, 3 was it? 4 What do you say about the plan here and approach, 5 Dr Dickinson? 6 DR DICKINSON: I think that the initial assessment 7 following the surgery seems to me that this child had 8 a very good anatomical result from the operation. 9 I think Dr Wilde's intraoperative echocardiogram can be 10 relied upon as showing a good anatomical result, and the 11 right heart and pulmonary pressures recorded on the 12 first day show that they were substantially less than 13 the systemic pressure, which I think indicates fairly 14 clearly that the pulmonary resistance, which we talked 15 about earlier as potentially being a problem really 16 probably was not a problem, even with a relatively late 17 operation. 18 So I think, from all those points of view, things 19 really looked very good. In fact, from that starting 20 point I think you would expect the child to have 21 survived. The fact that he was oedematous I think on 22 the second post-operative day and active dialysis to 23 bring the fluid balance under control was not started on 24 the sixth post-operative day does concern me. In our 25 unit, we would certainly be more proactive about that, 0062 1 and it is not unusual for dialysis to be started 2 immediately on coming back from theatre if we are 3 concerned about the fluid balance. 4 Certainly, in a child who is described as "grossly 5 oedematous", I think on the third post-operative day, 6 I would certainly be feeling very strongly that dialysis 7 ought to be -- it is an important aspect of management 8 at that stage. 9 MR LANGSTAFF: Were you a member of the review team of 10 this particular case? 11 DR DICKINSON: No, I do not think so. 12 MR LANGSTAFF: Nor you, Mr Mankad? 13 MR MANKAD: No. 14 MR LANGSTAFF: That corresponds, I think, with their 15 observation that earlier dialysis should have been 16 performed. That is what they are saying. Can you help 17 us as to whether you agree or not, why it was not? 18 MR WISHEART: I can try to explain what we were thinking, 19 and I have jotted a few numbers and notes from these 20 notes, because it is quite difficult to bring things 21 together, as I am sure -- you know, for the different 22 fluid charts and dialysis charts. 23 Q. We will do the best we can. 24 A. What I have here, I have just made a note of some 25 figures day-by-day. For crystalloid fluids in and out, 0063 1 colloid fluids in and out, urine output, blood test 2 results and so forth. 3 It is quite clear, and I do not think there is any 4 disagreement about the fact that the child was 5 oedematous and became more oedematous. The question 6 really is at what point did we think or conclude that 7 this was an active or a major sequestration process that 8 we were observing, as opposed to the alternative that 9 I mentioned. 10 If a sequestration process is gross, you know, 11 a really severe one, the amount of fluids, colloid 12 fluids which can be going in and out through peritoneal 13 drains, chest drains and so forth, can measure many 14 litres a day, even in a small child. The amounts in 15 this child on the first day were just over half a litre, 16 and on the second day, under one litre and on the third 17 day, slightly less than on the second day. 18 So I give you that information just as background 19 information. 20 The crystalloid balance and the urine output were 21 acceptable through this period. The urine output was 22 sufficient. The blood tests, which might reflect an 23 inadequacy of kidney function -- they were really not 24 rising at all. It is not that they were rising but not 25 significantly, they were not rising at all. So I think 0064 1 that our thinking was that if this was a sequestration 2 process, it did not at that point appear to be of itself 3 one of the more severe ones and therefore we were taking 4 the steps we would normally take, but there was oedema, 5 which was influencing organ function and the fluid 6 collected in the abdomen was probably splinting the 7 diaphragm and interfering with pulmonary function, and 8 then, whatever fluid was in the lungs was also 9 interfering with pulmonary function, contributing to the 10 hypoxia that has been noted. 11 So we tried, therefore, to deal with that in 12 a controlled way by draining the fluid from the abdomen, 13 so that hopefully pulmonary function would improve and 14 by dealing with it in the other ways that we have 15 already agreed are appropriate, but not yet proceeding 16 to the step of dialysis. 17 I think that we did take the view -- I am not sure 18 I would not still take it -- that there was not a clear 19 indication to institute dialysis at that time. I do not 20 remember there being any debate, for example, amongst 21 the different members of the team. Most of these notes 22 that you have referred to are, I think, the notes of 23 Dr Pryn, but I am not 100 per cent certain. I think 24 they are. 25 So we would have been discussing and debating 0065 1 these matters and there is certainly no suggestion here 2 that there was a tension between us as to what direction 3 we should go in. 4 I hope, therefore, I am reflecting the view of 5 myself and the team. Those were our thoughts. 6 Q. Was there a reason why one would not wish to begin 7 dialysis? You told us that there was not, perhaps, as 8 you saw it, the strongest of reasons to do so, but was 9 there a reason not to do so? 10 A. Yes. I think there are a number of reasons. I mean, 11 I think you always have to have a reason to institute 12 any intervention, because in fact any intervention 13 carries its own risks and complications and therefore 14 there has to be a clear reason to justify taking on 15 board those risks. 16 One of the risks, of course, is that by putting 17 a tube, a foreign body, into the abdomen of a child, or 18 indeed any patient, you are creating another route 19 whereby infection may be introduced. You will say, of 20 course, that that risk was taken on whichever day it 21 was, the second or third day, and that is absolutely 22 correct -- 23 Q. The dialysis was not started until the sixth. 24 A. But that is nevertheless one factor. Another factor 25 brings us back to the management of sequestration and 0066 1 the need to strike the right balance. 2 Mr Mankad picked up the point which is in the 3 notes that it was important to drain the fluid slowly 4 from the abdomen, because if you drain it quickly, then 5 you could quickly induce a serious imbalance, the effect 6 of which would be to reduce the cardiac output in the 7 end result. 8 So the introduction of dialysis, although you hope 9 it is controlled, and that is what you are aiming for, 10 nevertheless, you recognise the possibility that from 11 hour to hour there may be fluctuations, and you are 12 therefore introducing another element whereby an 13 imbalance of fluid can actually be created. 14 You may feel that is a bit cautious, even 15 defensive, but it is a factor entering into this, and as 16 I say, the urine output for this size of child was 17 continuing to be sufficient and the biochemical markers, 18 if you like, the blood tests that would indicate 19 a problem with renal function, were not doing so. 20 So those were our reasons. I am sure there are others, 21 but I cannot just marshal them at the moment. 22 Q. Was there a paediatric nephrologist available? 23 A. Yes. We worked closely with paediatric nephrologists. 24 There were a team of three. They were based inevitably 25 at another hospital, not even at the Children's 0067 1 Hospital, but we had an excellent working relationship 2 with them and they came very quickly and responsively to 3 advise us when we asked them to do so. 4 Q. Do you know whether any advice was taken in this case? 5 A. I would not have thought there was, prior to the 6 institution of dialysis. There may well have been then, 7 but I doubt if there would have been beforehand. 8 MR LANGSTAFF: There is a difference of approach which has 9 become apparent in the process Mr Wisheart has described 10 and the approach the reviewing team felt ought to have 11 been the position with regard to dialysis. 12 The sense in which the debate is going to help us 13 may be limited, but do you want to say anything about 14 that before I move to some of the other issues that may 15 be highlighted? 16 DR DICKINSON: I was going to make the observation that 17 clearly there are differences in practice from one unit 18 to another. I do not feel confident about saying what 19 the practice in my -- 20 THE CHAIRMAN: I cannot hear very well. It is my fault, but 21 I simply cannot. 22 DR DICKINSON: I can only speak for the practice in my own 23 unit in Leeds. I know my current surgical colleague 24 feels very strongly that fluid balance in the critical 25 period immediately after an operation of this sort is 0068 1 indeed really vitally important to the extent that he 2 leaves a peritoneal dialysis catheter in the peritoneum 3 at the end of every operation, irrespective of whether 4 there have been problems during the surgery or not, so 5 every patient in Leeds comes back with a peritoneal 6 catheter in place. Whether we use it or not is 7 immaterial. 8 MR LANGSTAFF: That is something we had suggested to 9 us by another one of the consultant experts who sat 10 where you are sitting now in relation to a case of 11 Mr Dhasmana's. I will ask Mr Dhasmana to comment in 12 a moment on that. 13 DR DICKINSON: I entirely agree with what Mr Wisheart is 14 saying about the risk of infection and the good reason 15 for doing it, but we do feel there is a good reason for 16 being proactive about fluid balance in the immediate 17 postoperative period. 18 MR LANGSTAFF: Mr Mankad? 19 MR MANKAD: I think I agree that there are going to be 20 different lines of management practices in the Intensive 21 Care Unit. Whichever way we look at it, I think the 22 fundamental issue here is, was this child considered to 23 have capillary leak syndrome from Day 1/Day 2, or was it 24 felt until very late that this child did not have 25 capillary leak syndrome and just normal oedema? 0069 1 Whichever way one looks at it -- in fact, let us 2 take an example of what Mr Wisheart says: that it was 3 felt that this child did not have capillary leak, 4 because he was only leaking very small quantities, fluid 5 balance was not grossly positive, and he was just 6 oedematous. If so, I would actually make an even 7 stronger case for earlier dialysis, because if there was 8 no leak, then there was no albumen in the interstitial 9 fluid and by dialysing the child earlier, we could have 10 shifted the fluid at an earlier stage and thereby taking 11 best advantage of the dialysis. 12 However, I personally feel that the child, from 13 24/48 hours, even 24 hours down the road, experienced 14 clinicians would usually know whether it was a capillary 15 leak or not. It did look and sound like capillary leak, 16 in which case, weighing the pros and cons of risk of 17 dialysis against the benefits, I think one would err on 18 the side of earlier dialysis. 19 So my feeling here is that it is an approach to 20 postoperative management which is different in different 21 centres which is probably under consideration. 22 MR LANGSTAFF: Do you want to comment on the suggestion 23 that in other surgeons' practices, a catheter is left in 24 situ? 25 MR WISHEART: Yes. I would just like to comment that 0070 1 Dr Dickinson's surgical colleague was my trainee. 2 Q. So he learned it from you, did he? 3 A. No. My next point is that he actually learned it from 4 Melbourne, he said. I think you may have heard that in 5 previous evidence as well. There was a time when 6 I think people quite widely practised that and we did 7 for a time, but we did not continue it because our 8 experience was that we did not always use it and we 9 thought it preferable, therefore, to put in a peritoneal 10 dialysis cannula when we thought we needed to do so. 11 That is something we had tried but we did not persevere 12 with. 13 I think we are probably talking of differences of 14 approach here. I think that there is a lot of common 15 ground. I think the common ground is that by the second 16 day, I am sure it was our view that there was 17 a capillary leak. I think it was our view that it was 18 a relatively modest capillary leak, and I think, 19 therefore, we had an expectation that it would resolve. 20 Which in a sense brings us back to the very initial 21 point that has been made, namely, that the management of 22 the patient is in the expectation that this underlying 23 problem with the capillary leak will get better. 24 Q. It also brings us back, perhaps, to the very first point 25 that we dealt with and agreed upon, in dealing with this 0071 1 sort of position, that one has to recognise the problem 2 first, and secondly, then, attempt to approach it. 3 I think what you are saying to me is that what may 4 not have happened here is that the full extent, the 5 degree of the problem, may not have been recognised, as 6 it happens, quite soon enough? 7 A. No, I think I would say that our assessment of the 8 problem was that it was not one of the more severe 9 episodes and that the divergence, then, I think is what 10 follows after that. Because it did not appear to be one 11 of the more severe episodes we had an expectation that 12 it would recover, and we took the steps which were our 13 normal practice to take in those circumstances, and 14 which did not include dialysis unless there was a reason 15 to dialyse over and above, but things then progressed 16 from there. 17 Q. You would have the overview of intensive care as having 18 been the surgeon who had conducted the operation. At 19 this stage, in 1994, there was not a consistent 20 intensivist presence on the unit, was there? 21 A. Not round the clock, not every day of the week. 22 Q. The anaesthetists had some sessions which they devoted 23 to intensive care? 24 A. When I mentioned that these are possibly the notes of 25 Dr Pryn, and it is only "possibly", I think -- the notes 0072 1 of either Dr Pryn or Dr Davies, but I think it is 2 Dr Pryn. That means he was acting in his intensivist 3 capacity, which meant that he was there in the mornings, 4 advising and so forth and participating fully. 5 So that was his intensivist input into the 6 discussions, yes. 7 Q. But in terms of someone keeping a careful eye to see if 8 the expectation was justified, in the event, one would 9 need ideally a regular presence about a regular review 10 by someone who knew the details and the facts? 11 A. Yes, and that is essentially me. Well, my team and 12 myself. 13 Q. Except that you are only able to get to the Intensive 14 Care Unit when surgical commitments permit? 15 A. You said a regular review and I was able to undertake 16 a regular review. I was not able to maintain a constant 17 presence, rather a repetitive presence. I was not there 18 all the time, but I was there regularly, keeping the 19 review in mind, but then, you see, Dr Pryn was also 20 there each day and in a sense, the fact that he was not 21 there for a period gave him a slight distance that would 22 enable him to see changes possibly more clearly than 23 I would have seen them. 24 So it is a team effort, but I absolutely agree, it 25 was part of my fundamental attitude, that I was 0073 1 maintaining the continuity and the overview. 2 Q. The development to having an intensivist in the ICUs was 3 something which I think initially you were not so 4 convinced about, as you later became. Is that fair? 5 A. I think it is like all major changes, and this 6 represented quite an important change. We debated it 7 and part of the difficulty, I think, in it was that 8 there was a rather long and difficult transitional 9 period. My view to intensive care was very much that 10 people needed to be committed to it, and it was very 11 hard to function in intensive care if you just came in 12 and went out again, so to speak and did not pick up the 13 consequences of what you had advised or instituted or 14 done, so there had to be an element of continuity. 15 The difficulty with the transitional period, when 16 we first had intensivists, was, of course, that we only 17 had them part of the time and therefore, it was still 18 necessary for the surgeon, and I think Mr Dhasmana -- 19 I do not know what he said on this point, but I do not 20 think there was a great deal of distance between us -- 21 so we continued to feel that in fact the continuing 22 responsibility lay with us. 23 Q. In fact, I think at one stage in your statements you 24 make the point that both you and Mr Dhasmana attempted 25 to remedy some of the less attractive aspects of the 0074 1 split site by spending rather longer in the Intensive 2 Care Unit than you might otherwise have done? 3 A. I think that is correct, because we represented the 4 regular cardiological input, if I may say that, but we 5 were the cardiac specialists who were regularly there, 6 yes. 7 Q. Again, in this question of organisation, appreciating 8 that it was developing over a period, what Dr Macrae 9 told us, in terms of reviewing the Case Note Review, was 10 that it was not entirely clear to him what precise role 11 or what tasks evolved to the anaesthetists in the 12 Intensive Care Unit. He was looking at the anaesthetist 13 here. It was not clear to him how the various elements 14 worked as a team, or if they really did see intensive 15 care as a team issue or whether it was just seen as 16 a surgical environment into which other people were 17 invited to contribute in a sort of "We need this doing, 18 he should come and do it" basis. 19 A. I would like to comment on that, if I may? 20 Q. Please. 21 A. Two comments just straightaway: 22 I think that it is difficult, looking at the 23 notes, to answer the questions that Dr Macrae was asking 24 and it is certainly my view that there was by and large 25 a very good co-operation between the members of the team 0075 1 in intensive care. There were areas that the 2 anaesthetists certainly had the predominant interest. 3 There were areas where the surgeon had the predominant 4 interest, and there were also overlapping areas, but no 5 aspect of the care of the child was outside the 6 interests and comment and suggestion of any member of 7 the team. If the anaesthetists suggested to me 8 something that I would have regarded as predominantly my 9 territory, then that would have been helpful and 10 hopefully would have been properly considered. With all 11 due sensitivity, of course, the surgeon from time to 12 time might have suggested things to the anaesthetist and 13 by and large, that was properly received and it was just 14 debated and common ground established. 15 So my own view is that there was a good 16 understanding mostly, in intensive care, and good 17 co-operation, and I do not actually agree with 18 Dr Macrae's comments. 19 I have now forgotten what the second point was 20 that I wanted to respond to. 21 Q. Shall I read you the comments again: 22 "It is not entirely clear to me what precise role 23 or what tasks devolved to the anaesthetists in the 24 Intensive Care Unit." 25 A. I have responded to that. 0076 1 Q. "It was not clear to me how the various elements worked 2 as a team or if they did really see intensive care as 3 a team issue, or whether it was just seen as a surgical 4 environment into which other people could be invited 5 to contribute." 6 A. Yes, thank you; that was it. It was that final comment 7 about the suggestion that it was run by the surgeons and 8 they said, "Please come and do this". Never, in my time 9 in Bristol from 1975, was it like that, never at all. 10 As far as I am concerned, we were a team; we were 11 colleagues. Whether they were anaesthetists, paediatric 12 nephrologists, cardiologists, nurses, physiotherapists, 13 whatever, we were a team, each with input, each with 14 a freedom to make any comment they wished to make and 15 contribute to the debate. It was never a question of 16 "Please step up and do X". Absolutely not. 17 Q. But you were not a team that found it very easy to talk 18 to each other though, were you, because you would do 19 your ward round at a time when you could go to theatre 20 thereafter; the anaesthetist, if he was doing a ward 21 round, would be later? 22 A. There were some practical difficulties, but if somebody 23 wanted to talk to somebody, a way would usually be 24 found, and for the great majority of the people, it was 25 found. 0077 1 Q. If we look at UBHT 52/263, the foot of it, this is the 2 Hunter/de Leval report. It is the first of the two 3 versions. Both versions make the same point. It says 4 here: 5 "The paediatric cardiologists", it deals with 6 intensive care at the bottom of the page, postoperative 7 care in the Children's Hospital, it deals with that. At 8 the Royal Infirmary the postoperative management was 9 done by the cardiac surgical team and the anaesthetic 10 team, as you describe: 11 "The person on site on a 24-hour basis is 12 a surgical SHO. During the daytime there are currently 13 two or three anaesthetic sessions which are dedicated to 14 postoperative care", looking at 1995. 15 A. Yes. 16 Q. "The paediatric cardiologists help with the 17 postoperative management of the children at the Royal 18 Infirmary. The overall postoperative management at the 19 Royal Infirmary appears to be highly disorganised with 20 conflicting decisions between the surgical Senior 21 Registrar and the SHO, who do rounds at 8.00 am, the 22 anaesthetists who see the patients at 9.00 am and the 23 intensivists who work three days a week." 24 That was their view expressed in both versions, 25 a similar view expressed in the other version of the 0078 1 Hunter/de Leval report. Are you saying it was not 2 justified? 3 A. I am grateful for an opportunity to comment on this. 4 I have to say that I was shocked when I read this, and 5 I did not recognise the Intensive Care Unit that 6 I worked in, and have done for many years. I recognise 7 that everybody did not always, at the first word, agree 8 with everybody else, but nearly always, after proper 9 discussion, agreement would be reached. 10 I actually refrained from any comment -- well, 11 pretty well any comment -- to anybody on this, until 12 very recently, when I read in the transcripts of these 13 proceedings that this remark was based on the evidence 14 of one person only to Mr de Leval and Dr Hunter. That 15 is the evidence of Fiona Thomas. 16 In fact -- I am not really wishing to criticise 17 Mr de Leval or Dr Hunter, because they had a very 18 limited time to carry out their inquiry, but they did 19 state quite clearly that they did not take evidence on 20 this point from anybody else. All I knew was that they 21 had not taken evidence from me on this point, but I did 22 not know who else. 23 So I would simply draw your attention to that. 24 I think that, therefore, this conclusion is not based on 25 canvassing a broad spectrum of opinion. 0079 1 Q. It appears, I think, to be based in part upon what one 2 might describe as "acknowledged fact", the different 3 ward rounds that there were? 4 A. Yes. 5 Q. The identity of the consistent presence and the 6 difficulties which we have had expressed to us from 7 a number of different sources, the difficulties of the 8 surgeon on the one part, the anaesthetist for the other 9 being at the Intensive Care Unit and being in a position 10 to make decisions in respect of a particular child of 11 the unit. 12 That is, I think, a general flavour of much of the 13 material which, as you know, we have heard. 14 Is it the case that it was not easy to co-ordinate 15 the care in the Intensive Care Unit? 16 A. In terms of what is happening in Bristol today, then one 17 can clearly see that this was not an ideal arrangement. 18 The facts that you have described are largely correct 19 but I think there are other facts that could also be 20 added to it that are necessary to have a complete view. 21 I would be grateful if I could see the bottom of 22 the previous page again, please, so that I do not make 23 an error here. 24 You see, what it does not say is that there is an 25 anaesthetic Senior Registrar or Registrar; there is 0080 1 a cardiac surgical Senior Registrar, or Registrar, who 2 are available at all times to intensive care. It rather 3 sets up the notion that the cardiac SHO is sort of the 4 "kingpin", but in fact, the cardiac SHO was not, he was 5 just the person who was there, and indeed, one of his 6 functions stated explicitly in the "red book" that has 7 been referred to was to ensure that if somebody came at 8 one time and somebody else came at another time, they 9 would be aware of each other's suggestion and advice in 10 the event that it was not written down. So he was very 11 much a co-ordinator, a person who did things that people 12 more experienced than himself advised him to do, or he 13 helped the more experienced person to do it. 14 Then, of course, the consultants involved were 15 actually frequently in intensive care, as operations, 16 outpatients, whatever commitments, permitted. They 17 would be in and out. They were keeping a careful eye 18 and offering their advice, because things change and 19 evolve and it is necessary to do so. 20 So I would regard this as an incomplete picture. 21 I would not claim it was ideal, and the basic reason it 22 was not ideal is that not all of the members of the team 23 were totally committed to either cardiac surgery or 24 paediatric cardiac surgery. Some members of the team 25 had commitments elsewhere, and that was quite a major 0081 1 difficulty, and one of the things we had been seeking to 2 overcome. 3 So I think it is an incomplete view of what was 4 going on. 5 Q. In that answer to me, you mentioned two positive 6 factors, one negative factor, the negative factor being 7 the nature of the interests of the junior doctor 8 concerned? 9 A. No, I am sorry, I beg your pardon, I did not make it 10 clear. At that point I was referring to the nature of 11 the commitments, the proper contractual commitments of 12 the consultants and in particular, the consultant 13 anaesthetists. 14 Q. I am grateful. There is a further point, then, in 15 respect of the natural interests of the surgical SHO, 16 who is in the unit. He may not, we have been told, have 17 a particular long-term interest in paediatric cardiac 18 surgery, and indeed, may not have a particular interest 19 in cardiac surgery. So to that extent, he is less able 20 than somebody with a greater interest and experience to 21 identify the sorts of problems that one might anticipate 22 in a child, and in particular a child who has undergone 23 cardiac surgery. 24 A. That is not a criticism, if I might say so, sir. Part 25 of the training of all junior doctors is that before 0082 1 they specialise in a narrow field, they have a broad 2 experience through a whole series of specialties. So in 3 all the clinical departments, you will find junior 4 doctors at an early stage of their training who are 5 gaining their early experience in a broad range of 6 activity. It is only on the basis of that experience 7 they can then choose what direction they want to go in. 8 It is for that reason that the Registrars, who 9 were experienced and committed, had a 24-hour commitment 10 to intensive care. 11 Q. Whether it is properly classed as a criticism or not, it 12 is a deficiency in the level of care, is it not? 13 A. No, it is not a deficiency, sir. It is part of the way 14 that all clinical care in our hospitals is structured. 15 You cannot have specialists in the most junior people. 16 You have specialists in the more senior people. You 17 cannot have a House Officer who is a specialist in 18 dermatology or in oncology. That is not part of the 19 system. You may have a Senior House Officer who has 20 identified his interests as being in surgery or 21 paediatrics or medicine, but they will not have 22 a commitment to any specific subspecialty within that. 23 So they are at an early part of their experience and the 24 specialist informed input comes from those who are more 25 senior to them. 0083 1 Q. And he, the junior doctor, has to know when to bring in 2 the more senior? 3 A. The one instruction they are given is that the telephone 4 or the bleeper or whatever is always there and is always 5 available and always there to be used. 6 Q. Which is why I come back to one of the two points you 7 mentioned in your longish answer to me -- 8 A. Apologies. 9 Q. Not at all, it is to identify it. You used the phrase, 10 "when circumstances permit"? 11 A. In what context? 12 Q. The consultant coming in. 13 A. Yes. 14 Q. That is the weakness, is it not, in a system which 15 relies upon the junior doctor calling in more senior 16 expertise? The Senior Registrar, you say, the 17 anaesthetist is on call on a regular basis, but the 18 consultant, take yourself, you would be able to get to 19 the Intensive Care Unit, as I understand it, when 20 circumstances permit it? 21 A. But that is why the Registrar or the Senior Registrar is 22 available. I mean, if I were to make the requirement 23 that you are setting out, I would never do an 24 operation. I would never see an outpatient. 25 Q. What is required, ideally, is that there be a senior 0084 1 medical, clinical, presence with a regular overview of 2 the particular patient, rather than, if I use the 3 expression, someone who pops in and out, I do not mean 4 it pejoratively. But that must be the better system, 5 must it not? 6 A. I think there are two different situations that need to 7 be catered for. What the regular "pop in and out" 8 achieves is a frequent supervision of a patient whose 9 condition may be evolving in whatever direction. 10 What is also necessary is to have sufficiently 11 senior expertise immediately available when something 12 unexpected or quickly develops, so that by popping in 13 and out you can deal with the first of those, but you 14 will also need to have a provision to deal with the 15 second, and that is the one that I cannot do in the 16 middle of an operation. 17 So that is why the Senior Registrar, or Registrar, 18 is available and that is another reason why you need to 19 have two surgeons instead of one surgeon, because if one 20 is operating, the other may not be, and so by 21 co-operating with each other, as Mr Dhasmana and I did, 22 we are able to contribute to that. But of course, you 23 could say that the ideal way -- because if I am 24 operating Mr Dhasmana might be in outpatients or up in 25 the Children's Hospital, the ideal way, although that 0085 1 was not clear to us I think in the early days, is to 2 have somebody who actually specialises in the area. 3 That is the service that is now provided in the 4 Children's Hospital. 5 You may say, why did not it occur to us? I think 6 that is a very good question. I think it did not occur 7 to us because it did not appear to be within the realm 8 of possibility, until towards the end of the period in 9 question. 10 Q. The system that we have been discussing must be made all 11 the more difficult if the popping in and out, as I have 12 described it, is irregular rather than regular, which it 13 must necessarily be, given the commitments of a surgeon? 14 A. It increases the possibility that people will be able to 15 discuss things together and that is what often happened. 16 Q. If you have two surgeons, that necessitates the 17 hypothesis that one surgeon will give instructions, deal 18 with the case that the other surgeon has operated upon 19 and therefore knows much more intimately. One may ask, 20 who, overall, is in control, may one not? 21 A. No. I think you are carrying the thing to a degree that 22 is not quite reflected in reality. First of all, 23 Mr Dhasmana and I had a very similar approach -- not 24 identical, because he absolutely had his own views in 25 a number of areas, but a broadly similar approach -- and 0086 1 had fundamentally complete confidence in each other to 2 deal with things. 3 The issue of people coming with conflicting advice 4 is an important one, but not between Mr Dhasmana and 5 myself. 6 The overall care of his patient resided with 7 Mr Dhasmana and I would only contribute to it -- I will 8 not use the word "interfere" -- if an emergency arose 9 when he was not available, or if he was away for the 10 weekend and I was in town or if he was on holiday or 11 whatever, in which case he would ask me and I would care 12 for the child. 13 I think the possibility of conflicting advice is 14 a very real one and a very important one, but that is 15 more likely between different specialties, people coming 16 in and out, and that again is why it was important to 17 have an SHO and to have Registrars who are continually 18 available, so that they can ensure that there is actual 19 co-ordination of advice from different people. 20 Sometimes that may mean resolving an apparent 21 contradiction. 22 Q. Two more questions, and I think I think it may be time 23 for a longer break. 24 The first is this: in the system as you describe 25 it before the intensivist, the clinician on the 0087 1 intensive care, the health professional on the intensive 2 care, the nurse, for instance, the junior doctor, would 3 understand that his or her role would be subject to the 4 advice and decision of the surgeon or, I suppose, the 5 consultant anaesthetist, whenever he or she came to 6 visit the patient. 7 A. I can speak for the junior doctor and that would 8 certainly be his position, but more than that, it is not 9 a question of just passively receiving advice when 10 whoever comes. If at any point they felt in need of 11 advice, then they could press buttons and get that 12 advice. 13 Q. But it might not come from the consultant who may then 14 come in later, and you have the problem with the 15 conflicting advice which you have referred to? 16 A. There is the experienced Registrar who is an experienced 17 person and who is there and available. 18 Q. The last matter I want to canvass with you before the 19 break is the letter which I promised you earlier I would 20 come back to in respect of the echocardiography 21 service. It is Dr Wilde's letter at UBHT 146/50. It is 22 3rd March 1994. It is addressed to you, amongst others, 23 from Dr Peter Wilde. Can we scroll down? 24 "I am circulating this document to generate some 25 discussion on the subject of echocardiography on the 0088 1 cardiac surgery unit. The system is certainly 2 unsatisfactory at present and could potentially be very 3 much better if we had an organised strategy. I feel 4 sure that a high quality supporting echo service would 5 undoubtedly lead to improvements in cardiac surgical 6 outcomes." 7 He encloses a document. 8 The view expressed there: was it a view that you 9 shared that the system in use for echocardiography on 10 the cardiac surgery unit was, before March 1994 at any 11 rate, unsatisfactory? 12 A. I may say, I have not seen this letter until this 13 instant. 14 Q. You might want to take the lunch break to think about 15 it. 16 A. I am not sure what is set out on page 2, but I could 17 make a general comment, certainly, and it is this: that 18 the provision of echo services in cardiac surgery with 19 intensive care is something that was evolving over 20 a period of time. I think you have already heard 21 evidence of how we made some efforts to acquire the 22 equipment and to have an echo machine on the unit, so 23 when Dr Wilde or the cardiologist came to the unit, they 24 would use that machinery. 25 Further, we, that is myself certainly, encouraged 0089 1 two of my surgical trainees to be instructed by Dr Wilde 2 so that they themselves became proficient in performing 3 echocardiography on the ward. 4 So we are seeing something evolve. It was not as 5 cohesive, as regular, as consistent as one would have 6 wished, recognising the potential importance of the 7 contribution it could make, and I think that is what 8 Dr Wilde is addressing: that we now need to take a step 9 forward to make this a better and more important service 10 within intensive care. 11 Q. Well, he is talking about "an organised strategy". 12 A. Yes. 13 Q. Which suggests that someone needs to take control and 14 organise it? 15 A. I think that is right. 16 Q. Who would that be? 17 A. Well, it would be essentially Dr Wilde, as the lead 18 person in this area, within the team. 19 MR LANGSTAFF: Thank you. Sir, as I have indicated, it may 20 perhaps -- 21 THE CHAIRMAN: Before we do take a break, I noticed 22 Mr Mankad wanted to come in on the discussion on 23 intensive care. It may well be helpful to tidy up 24 observations in that area before we move on after lunch. 25 MR LANGSTAFF: Yes, please. 0090 1 MR MANKAD: I think this case highlights two very important 2 areas of team working in paediatric cardiac surgery. 3 One had a positive influence on the outcome and the 4 second one had a relatively negative influence. 5 The positive influence was the intraoperative 6 echocardiography, which very clearly outlined that the 7 anatomical and physiological result of the operation was 8 very good indeed. That is a positive influence on this, 9 and I think that is noteworthy, that we ought to have 10 that system for the future. 11 The negative influence is the overall 12 postoperative management and organisation of the 13 Intensive Care Unit. 14 The key issues in intensive care management which 15 come out are: (1) communication; (2) continuity of care 16 between juniors and seniors and around the clock; 17 (3) and most importantly, I think, is leadership. 18 Leadership is important. A leader is able and willing 19 to take decisions with the overall team -- whether it is 20 a surgeon, intensivist or anaesthetist I think is 21 immaterial -- and be responsible and accountable for 22 those decisions. That leader has an ability to take the 23 team, communicate with the team and provide and maintain 24 continuity of care. It is conceivable that if there was 25 no error of judgment in this particular case in the 0091 1 management of post-operative care in this child, then 2 probably what fell down was some sort of organisational 3 aspect of the care structure. 4 THE CHAIRMAN: Perhaps before you respond to that, 5 Mr Wisheart, I can make it a more concrete question. 6 We have heard from you, and from others, about the 7 difficulties of having ward rounds and the possibility 8 of advice being given at 8 o'clock that might be changed 9 at 9 o'clock, or countermanded. Of course, if that has 10 then to be communicated to a nurse who then has to speak 11 to a parent who may have been up all night, that X is 12 going to take place soon, that is the advice given at 13 8 o'clock, but then at 9 o'clock that decision is 14 changed, you can see that the, as it were, rollercoaster 15 of emotion which is already there in a parent might be 16 even more exacerbated, if you can exacerbate 17 a rollercoaster. Is that not a problem in a very real 18 and personal sense, as well as the organisational sense 19 of managing the care of the child? 20 MR WISHEART: Thank you. Responding to your point first, 21 I think that, taking the point of the consultant coming 22 in at 9 o'clock, the junior having seen the patient at 23 8 o'clock or 8.30, or whatever -- 24 THE CHAIRMAN: Or the different specialty, indeed, the 25 anaesthetist and then the cardiac -- 0092 1 MR WISHEART: The junior surgeons and the junior 2 anaesthetists were both present at 8 o'clock, so there 3 is absolutely no reason why their views should not have 4 been co-ordinated, or if they were not unanimous, some 5 way found to resolve it. 6 I think the question of coming in at 9 o'clock and 7 changing the orders is one that has received some 8 prominence in evidence, and of course I can only speak 9 from my own perspective; I cannot speak for the other 10 four cardiac surgeons, because I think that comment 11 actually picked up adult and paediatric cardiac 12 surgery. 13 I would say that occasionally that happened, but 14 the notion that it was the general rule I think lacks 15 perspective. 16 Of the occasions when it happened, it would only 17 rarely, I think, have had consequences of the type that 18 you have described. Usually it would be some adjustment 19 of what was happening, which would not necessarily 20 impinge in any dramatic way upon the parents. Of 21 course, it would have to be communicated and discussed 22 with the nurse, naturally, and if it were important, it 23 would need to be discussed with whoever else had been 24 involved in the earlier decision, so that everybody was 25 working to the same plan. 0093 1 So I think that occasionally it may have happened 2 the way you mentioned, but I think quite rarely. 3 I think there is a perspective which needs to be applied 4 to that. That would be my view. 5 THE CHAIRMAN: Thank you. If I could pursue it just 6 a little more, Mr Mankad has rightly pointed to what we 7 have heard a lot of evidence about, the need for 8 teamwork, whereas you paint a particular picture of the 9 teamwork as you have seen it. 10 Could there not be another view -- you will 11 forgive me if I use a metaphor which I hope is not out 12 of place -- that here we have a team where some are not 13 always "on the pitch", or even available, where 14 sometimes the goalposts move from time to time because 15 advice has changed, and also, a sense of whether you are 16 belonging to the team is not always internalised in all 17 the staff? 18 In those contexts, and we have heard evidence 19 along all of those particular scenes, the concept of 20 a team becomes less of a description of what was 21 happening than as you have described it. 22 MR WISHEART: It is difficult to respond to how other people 23 genuinely perceive the situation to be, because I would 24 wish to respect their judgment and view. At the same 25 time, I am not quite in the position of saying that this 0094 1 is my view and if others think differently, so be it. 2 I think that there is a lot to be teased out in 3 this area and it is probably part of the evolution of 4 the unit. I believe that historically there was close 5 teamwork, and if we went right back to the beginning of 6 the period of this review, in 1984, there were just two 7 anaesthetists working in paediatric cardiac anaesthesia 8 and they, of course, were unable to have the continual 9 presence that the five or six or whatever number of 10 anaesthetists provided in the 1990s. Interestingly, by 11 their personal commitment and a feeling of being 12 a member of the team, it was actually quite easy to 13 co-operate with them, to get their advice, and there was 14 always a clear knowledge of who to go to. 15 It may be that some of what has been reflected to 16 you is a consequence of the team increasing in numbers 17 and the fact that in some areas of work somebody was 18 responsible on Wednesday, but it was somebody else on 19 Thursday and somebody else again on Friday. 20 It is against that background that the surgeons 21 I think felt not less but more of a pressure to maintain 22 a continual interest, and they had to deal with the 23 differing notions that people might have had on 24 Wednesday, Thursday and Friday, and tried to work that 25 into the system. But I do actually still feel -- and 0095 1 I do not want any misunderstanding to come from my 2 remarks -- that the commitment of the people who 3 provided that service in the 1990s, I mean, by and large 4 was terrific. I did not, myself, sense that there was 5 any lack of a feeling of being on the same team with 6 them in this area in theatre and so forth. 7 Those would be my remarks. 8 THE CHAIRMAN: Why do we not now break for lunch until 9 1.30? 10 MR WISHEART: May I say one thing more? It could lead to 11 a longer discussion; if that is so, it would be better 12 after lunch, but I do not think -- two things, really. 13 I do not think I need to respond in detail to what 14 Mr Mankad has said, although I personally - it is my 15 personal view that there was leadership and there was 16 co-ordination, and I think most of the leadership came 17 from the surgeons, but when the intensivists began to 18 have a significant time there, clearly from them as 19 well. 20 The more important fact that I want to draw your 21 attention to, before we depart from Matthew Rundle, is 22 what I think may have been a factor underlying what we 23 have been discussing at such great length for the last 24 while, and that is the fact that he did have 25 a significant level of pulmonary vascular disease. To 0096 1 be very brief, the estimate that Dr Hayes made following 2 the catheterisation in November 1993 was revised 3 subsequently in 1997 to a much higher level of pulmonary 4 vascular resistance, and because the case of Matthew 5 Rundle has been considered elsewhere, the pathology of 6 his lungs has been considered by the national and 7 probably world expert in the field, whose opinion was 8 that the level of pulmonary vascular disease was very 9 severe and that it was so severe as to make this a very 10 high risk operation. 11 Be that as it may, the fact that it was there 12 I think was a significant factor underlying the low 13 cardiac output, which in a sense was or may have been -- 14 may have been -- the basic problem that underlay all 15 these other problems that we have been discussing. 16 I will stop there, but I just want to draw your 17 attention to that, so that if there is any desire to 18 explore that further, it can be done. 19 MR LANGSTAFF: What you are saying is that in placing the 20 emphasis in the questions as we have done, more on the 21 postoperative phase than the pre-operative question of 22 when should the operation have been done, you would say, 23 the emphasis should be the other way round? 24 MR WISHEART: What I am drawing your attention to certainly 25 brings us back to when the operation should have been 0097 1 done, but it also brings us to the point that, given 2 that the operation was done when it was done, here is 3 what appears to be a fact which, however you judge it, 4 was a very major factor in what happened following the 5 operation and the outcome. 6 MR LANGSTAFF: Until half past 1. 7 MR WISHEART: Thank you. I am sorry for the delay. 8 (12.50 pm) 9 (Adjourned until 1.30 pm) 10 (1.40 pm) 11 MR LANGSTAFF: Mr Wisheart, I am told that you want to add 12 something about Matthew Rundle? 13 A. Thank you. It is just in case I did not make myself 14 quite clear in the remarks before lunch: I believe that 15 Dr Pryn and I did have a clear strategy as to how to 16 deal with fluid balance which is set out in either the 17 second or third day when the PD cannula was put in, 18 namely while urine output was adequate, then our 19 strategy was based on that continuing urine output while 20 it continued together with management by drainage 21 through the PD cannula. That is really all I would wish 22 to say, thank you. 23 Q. Can we move on to Bridie Kinsman. Again, summarising 24 the circumstances in which Bridie came to surgery, she 25 was born, was she, on 22nd September 1983? 0098 1 A. She was. 2 Q. A cardiac catheterisation in 1983 showed a coarctation 3 of the aorta which was responsible for her being in 4 cardiac failure and later in November 1983 you repaired 5 that coarctation successfully? 6 A. That is correct. 7 Q. In 1984 she was seen by Dr Joffe at a clinic. He found 8 signs which I think suggested mitral stenosis as well as 9 aortic or some aortic stenosis? 10 A. I actually thought that he had detected mitral stenosis 11 at his first consultation with the baby prior to the 12 coarctation surgery, but ... 13 Q. I do not think it is material when quite, because there 14 is no doubt, is there -- 15 A. No. 16 Q. -- that by the time of the third cardiac catheterisation 17 which, because they repeated catheters, the last of 18 which was 24th September 1985. It was clear, was it, 19 that what Bridie suffered from was a severe obstruction 20 at mitral valve or supravalvar level? 21 A. Indeed. 22 Q. And the angiography suggested there might be 23 a supravalvar stenosing ring? 24 A. Correct. 25 Q. There were effectively two problems: one was the mitral 0099 1 valve problem, the other I think was a subaortic 2 stenosis which was moderately severe? 3 A. Yes, I think it was valvar and subvalvar, the aortic 4 stenosis. 5 Q. This was always going to be a difficult case to operate 6 on at that time, was it not? 7 A. It depended on exactly what anatomy was found and while 8 we did expect there to be a supravalvar ring, we were 9 not certain that is what we would find. But 10 a combination of these abnormalities in a child of this 11 age would always be a fairly significant operation, yes. 12 MR LANGSTAFF: If I may just ask, Mr Mankad, in the best of 13 hands in 1985 what would one anticipate in terms of the 14 risks for a girl with the condition that Bridie had. 15 MR MANKAD: If we are dealing with just over a 2 year old 16 baby with what we call a "Shone" complex, a Shone 17 syndrome, which is the whole of the left-sided 18 structures from inflow to the left ventricle above the 19 mitral valve, at the mitral valve level, outflow of the 20 left ventricle below the valve, at the valve and also 21 distally coarctation, everything is obstructed albeit 22 coarctation was very satisfactorily relieved in this 23 baby and I think no doubt that in November 1985 when 24 this girl was operated, my feeling is that the overall 25 results of this particular operation, the risk would be 0100 1 in the region of 50 per cent, average risk. 2 The risk may vary from the best surgeon in North 3 America with tremendous experience of these operations 4 maybe 20 per cent, and if you do not see those number of 5 cases so often anything between 60 to 70 per cent. But 6 the average risk would be in the region of 50 per cent. 7 MR LANGSTAFF: Would you seek to agree or disagree with 8 that? 9 MR WISHEART: Broadly. I think if I had been asked I would 10 probably have said something slightly smaller but it is 11 a big risk whichever way you look at it, it is a very 12 significant undertaking. 13 Q. Had you yourself come across many such cases in your 14 practice? 15 A. Not many because it is quite uncommon, but I had come 16 across a number. I am not in a position to say exactly 17 what the number was prior to this operation but through 18 the 1980s I think I saw six. 19 Q. You subsequently I think reviewed those cases in a paper 20 which you provided to the Inquiry and which, if you want 21 to make reference to it, we have at WIT 120/459. In 22 that you tell us that -- it is the second line down: 23 "Between 1975 and 1987 10 patients aged between 4 24 months and 14 years underwent surgical treatment for 25 congenital abnormalities of the mitral valve". You go 0101 1 on to say "7 had mitral stenosis, 6 had supravalvar 2 rings". The supravalvar ring is part of the Shone 3 syndrome, is it not? 4 A. It is. 5 Q. Bridie would be one of the 6, would she? 6 A. She was one of the 6. 7 Q. Can we have a look at the operation note which we find 8 at MR 2321/24. Can we remove the address? May I say of 9 course that although we have removed the address, we 10 have full consent for her case, as for all those that we 11 refer to in connection with the Congenital Case Note 12 Review. 13 Indeed the diagnosis set out there, a result of 14 the number of preoperative investigations which Dr Joffe 15 had conducted. 16 THE CHAIRMAN: Mr Langstaff, that paper you referred to, 17 I do not think it is yet scanned. Where did it appear? 18 MR LANGSTAFF: That was in a book called "Cardiac 19 Reconstructions", published in Heidelberg 1989 and it is 20 a paper, the first nominal author of which is 21 Mr Bhatnagar and Mr Wisheart. It is in fact, as I say, 22 scanned in starting at 120/459. 23 THE CHAIRMAN: To avoid confusion, we do not yet have it, so 24 I am grateful to you. 25 MR LANGSTAFF: We do not want to go back to it. This was 0102 1 a long operation, 5 hours 43 minutes, on bypass. Is 2 that a reflection of the difficulty of the surgery that 3 had to be done? 4 A. Very much so because what had initially been anticipated 5 as what had to be done was really magnified many times 6 subsequently. 7 Q. So there is no secret as it were about what ultimately 8 happened, what happened was that during the course of 9 the operation the mitral valve, the natural mitral valve 10 was damaged, damaged surgically? 11 A. By me, yes. 12 Q. That because damage was there, you then had to seek to 13 replace the mitral valve and sought to do so? 14 A. Actually initially I sought to repair the valve because 15 as far as I was concerned one always sought to conserve 16 the valve, particularly in a small child and it was only 17 when that failed that I then replaced it. So in fact, 18 therefore, we are describing two very major steps beyond 19 what we had originally anticipated in this operation. 20 Q. That is reflected I think, is it, in the length of time 21 on bypass ultimately? 22 A. Yes. 23 Q. If we can scroll down. You describe the approach to the 24 mitral valve through an incision in the left atrium. 25 You describe that access was difficult and the view of 0103 1 the valve also difficult. 2 What you were going to do, what you proposed to do 3 so far as the mitral valve was concerned would be to 4 remove or excise the ring of tissue above the valve 5 which was in effect causing an obstruction to flow 6 through the valve? 7 A. That is correct. That sheet of tissue basically lies 8 between the valve and myself, so to speak, as I look at 9 the valve and the intention was simply to excise that, 10 and had that been possible in the way that in my 11 experience it was usually possible, that would actually 12 have been quite quick and straightforward. 13 Q. Then you would have proceeded beyond that, you would 14 have relieved the inflow obstruction above the valve, 15 you would then proceed, would you, to deal with the 16 outflow obstruction? 17 A. Yes. 18 Q. One would expect that to involve, would it, perhaps some 19 element of septal myectomy? 20 A. Sometimes but not always. At that time in the 21 mid-1980s, it would have been an occasional or some time 22 addition to the operation, but certainly in my practice 23 it was not a routine part of the operation. 24 Q. It would depend upon whether there was a muscular septum 25 which was contributing to the obstruction, to the 0104 1 outflow, presumably? 2 A. Yes. The aortic valvar stenosis can be purely at the 3 valve or it can be below the valve and if it is below 4 the valve, there may be a ring of tissue narrowing the 5 pathway and excision of that ring may be sufficient to 6 relieve the obstruction. But in other cases, if the 7 muscle is thickened then it may also be necessary to 8 excise a wedge of muscle to enlarge the pathway to 9 relieve the obstruction. 10 Q. You go on in the operation note: "difficult to find the 11 relationship of this tissue to the mitral valve." What 12 is essential, I suppose, is getting as good 13 a visualisation as you can of the relationship of the 14 supravalvar piece of tissue to the valve itself? 15 A. Yes. In my experience, before that the two have been 16 clearly -- they had been distinct one from the other. 17 Although the sheet is attached to the valve or had been 18 in my experience up until then at one point, but because 19 they were otherwise distinct, that could be identified 20 and the whole thing could be done safely and really 21 relatively easily. 22 In Bridie's case the anatomy, if you like, of this 23 sheet of tissue and its relationship to the mitral valve 24 was importantly different because it seemed to be 25 attached to the valve more or less all the way around 0105 1 and it was extremely difficult to distinguish what was 2 sheet and what was valve and in my attempts to excise 3 the sheet then the valve itself was injured and it was 4 because of this close identity of the two. 5 MR LANGSTAFF: This process that Mr Wisheart is describing, 6 Mr Mankad, is something which is a risk, is it, of 7 surgery such as this? 8 MR MANKAD: The important thing to understand is the damage 9 to the mitral valve intraoperatively, was it inadvertent 10 or accidental or was it the supravalvar tissue, as you 11 outlined, was it so densely adhering, stuck to the 12 mitral valve itself that it was not possible to separate 13 from the mitral valve and as a result the damage to the 14 mitral valve was part and parcel of excising the ring or 15 was it accidental? 16 From what I think Mr Wisheart is describing, 17 number 1, and having tabled this particular paper is 18 also useful because here is a surgeon who is not dealing 19 with this particular morphology for the first time, has 20 obviously experience and knowledge of that particular 21 type of operation and because of that it seems more 22 likely that the damage to the mitral valve was 23 unavoidable. 24 Although it is rare I personally have not come 25 across a mitral valve ring in my small series which is 0106 1 densely stuck to the mitral, but every case is different 2 and I think it is conceivable that that was the scenario 3 and it was unavoidable. 4 MR LANGSTAFF: The way in which the note reads on, shall we 5 turn over the page, is that the initial part: 6 "Subsequently I gained the misleading impression 7 through the small orifice that the valve was at some 8 distance from this tissue and I, therefore, made 9 a tentative start to excising this tissue and removed 10 that which I believed I could clearly define. The 11 initial part of the excision was anteriorly and was 12 satisfactory. Unfortunately the further removal of this 13 tissue involved severe damage to the posterior leaflet 14 of the mitral valve in its superior part. At this point 15 it was abundantly clear that the stenosing tissue and 16 the mitral valve were integral and were in fact one and 17 the same structure." 18 That is the point you are making, is it? 19 MR MANKAD: Yes, that is it, because if it is accidental 20 then it is a completely different ball game, because if 21 it is an accidental damage then the question is: was it 22 avoidable or was it as a result of poor exposure of the 23 mitral valve, an inability to see the two structures 24 distinctly and then it would raise a question of 25 alternative exposure to the mitral valve. 0107 1 MR LANGSTAFF: How differently might one have exposed the 2 mitral valve in a case such as this? 3 MR MANKAD: The alternative approach to exposing the mitral 4 valve or supramitral ring would be by opening the right 5 atrium, going through, across the intra-atrial septum 6 and exposing the mitral ring and the mitral valve 7 through that route which would give probably better and 8 direct exposure to the supravalvar and mitral apparatus 9 and the mitral valve itself. 10 But the question is whether it was accidental 11 damage or an integral part, I think that is the key 12 debate in this case. If it was an integral part, 13 irrespective of what approach the surgeon took, the 14 surgeon had to excise the mitral valve together with the 15 ring. 16 MR LANGSTAFF: You are saying it would have made no 17 difference. Do I take it from what you have said that 18 if you, although you were not at this stage 19 a consultant, had been a consultant performing an 20 operation such as this, you might have sought to 21 visualise the stenosing ring and the mitral valve from 22 the different aspect, not being able to see it easily 23 through the access which Mr Wisheart had chosen. 24 MR MANKAD: Yes, I think if I am doing a case and if I found 25 the exposure to the mitral ring is not sufficient, then 0108 1 I would not hesitate to have an alternative exposure to 2 the mitral valve through the septum and thereby 3 facilitating the dissection of the mitral ring. 4 MR LANGSTAFF: Mr Wisheart, would you like to comment on 5 that as an alternative approach? You had had difficulty 6 as it happens in this operation in seeing the 7 relationship of the ring which you were excising to the 8 valve. On reflection, would it in fact have been better 9 to take a transeptal approach and visualise it that 10 way? 11 MR WISHEART: I was of course aware of a variety of 12 approaches to the mitral valve and from time to time 13 used them. I think what I am saying here is that it did 14 not immediately present itself to me when I opened the 15 left atrium and there was some difficulty. But I think 16 having then adjusted the retraction and the way I was 17 set up, I proceeded with it and so that means I had 18 a sufficiently good view for me to feel that I could see 19 and do whatever had to be seen and done. Had that not 20 been the case, then I would certainly have used some 21 alternative approach. 22 MR LANGSTAFF: Dr Dickinson, are you able to comment at all 23 as to what one might have anticipated in advance in this 24 case from the catheterisations? 25 DR DICKINSON: Yes, I would simply say when you have 0109 1 multiple levels of obstruction in the left side of the 2 heart, the assessment of the severity of various levels 3 of obstruction really is extremely difficult. 4 The distinction of congenital mitral valve 5 stenosis from supravalvar mitral stenosing ring can also 6 be very difficult even now. I think with the quality of 7 ultrasound that was available in 1985 it would have been 8 even more difficult and clearly this is a very unusual 9 form of supravalvar stenosis with a very close 10 application of the supravalvar ring to the valve. 11 I cannot recollect ever having seen one quite like this 12 where the ring is inseparable from the valve so I think 13 -- 14 Q. And the valve is still able to function as such 15 because -- 16 DR DICKINSON: I suspect the valve probably did not function 17 in any way normally, the obstruction caused by the 18 stenosing ring I think would clearly have impaired the 19 valve function, so the two would be taken together. 20 I think distinguishing those two things preoperatively 21 would have been very difficult indeed. 22 MR LANGSTAFF: I have had it suggested to me from another 23 source that the mitral valve opened reasonably well 24 apparently on echo. You have not had a chance to review 25 the echo? 0110 1 DR DICKINSON: I have not seen the echos on this case. 2 Normally if you have a supravalvar stenosis which is 3 nicely separated from the mitral valve, then the mitral 4 valve may well function entirely normally and the 5 problem is cured, as Mr Wisheart has said, by removing 6 the stenosing tissue probably fairly easily. But in 7 this case -- I have not seen the echocardiography so 8 I cannot really comment, but the description of how 9 closely the stenosing tissue is applied to the mitral 10 valve makes me feel I cannot quite see how the mitral 11 valve would open fully because it would be held back by 12 the stenosing tissue connected within the left atrium. 13 MR LANGSTAFF: Is that something you would expect to have 14 identified before the operation? 15 DR DICKINSON: No, I think it would be extremely difficult 16 to identify it before, to delineate two levels of 17 obstruction when they are so close together, I think it 18 would be extremely difficult indeed. 19 MR LANGSTAFF: Mr Mankad, you were going to comment? 20 MR MANKAD: I think the alternative source that you are 21 referring to, suggesting that mitral valve opening was 22 acceptable, this is the only point maybe that to some 23 extent I tend to slightly defer and say that it is 24 conceivable that supravalvar ring adhering to the atrial 25 aspect of the posterior mitral leaflet would still make 0111 1 functioning, the opening and closing mechanics of the 2 mitral valve normal. 3 I think that is possible, it depends upon how, 4 where and how from it is adherent but it is adherent to 5 the atrial aspect and not to the ventricular aspect. 6 Therefore I think it is possible that the mitral valve 7 opening and closing before operation would not be 8 significantly jeopardised or would not be jeopardised at 9 all. 10 MR LANGSTAFF: One can learn nothing, if you like, from 11 a retrospective review of the echos in this case? 12 MR MANKAD: No. 13 MR LANGSTAFF: Given the problems that Mr Wisheart has 14 explained in dealing with his operation note, is this 15 a case which in fact merits the grading which the 16 surgical procedure was given, do you think, by the 17 review team? 18 MR MANKAD: It is interesting because I reviewed the cases 19 tabled, 5 or 6 cases, without looking at the review 20 clinical record forms. I came to my own judgment of 21 different aspects of care and my own feeling, which was 22 echoed by Dr Dickinson, that the grading that was given 23 for the surgical aspect by the review of the clinical 24 record team was proverbially extreme and we rated it as 25 3 rather than 1. 0112 1 3 refers to "less than adequate care but different 2 management would have made no difference to outcome" as 3 opposed to 1 which implies "less than adequate care in 4 which different management would reasonably be expected 5 to have made a difference to the outcome". 6 MR LANGSTAFF: I think you would still need to explain to us 7 in the light of your observations about the case having 8 heard what Mr Wisheart has to say, why you would say in 9 this case, looking at the surgical aspects, it is less 10 than adequate? 11 MR MANKAD: I am saying "less than adequate" for two 12 reasons. One is we already discussed the mitral valve 13 itself and then, now for the time being if we go away 14 from the inflow of the mitral valve to the outflow of 15 the left ventricle -- inflow of the left ventricle to 16 the outflow of the left ventricle, and once again 17 I think we say "slightly less than adequate" is because, 18 as Mr Wisheart has alluded to earlier on, in some cases 19 relieving left ventricle outflow tract obstruction, i.e. 20 septal myomectomy, in relation to resection or 21 enucleation of the subvalvar ring is done. 22 Sometimes I think the left ventricle outflow 23 obstruction is quite a fascinating entity and often in 24 the immediate postoperative period when the inotropes 25 are used, that is drugs to improve the contractility of 0113 1 the heart, despite the fact there is no organic or 2 morphological obstruction the inotropes would give 3 a dynamic functional obstruction because of the nature 4 of the hypertrophy outlet septum and it is very likely 5 that a child of this type with long bypass may require 6 inotropes in the postoperative period which would unmask 7 or unfold the dynamic component of the obstruction and 8 therefore it may be advisable to add septum myomectomy 9 as an adjunct to morality to resection or enucleation of 10 the ring. 11 So we took all these areas into consideration, 12 inflow to the mitral valve, adherence of the ring, 13 subsequent requirement of the mitral valve replacement, 14 which in itself was an oversizing because the mitral 15 annulus was smaller than the wall itself, 17 which is 16 the smallest wall available at the time; that in itself 17 will push the mitral valve further towards the outlet 18 septum and aggravate the dynamic component of the 19 obstruction. 20 Taking all that into account we felt that 3 was 21 more appropriate rather than 4. 22 MR LANGSTAFF: Are you saying that had the operation gone as 23 originally intended, there would have been no need to 24 cut away any of the septal musculature underneath the 25 outflow tract because of the insertion of the valve to 0114 1 replace the damaged mitral valve, that became something 2 which you would regard as highly desirable? 3 MR MANKAD: I would slightly rephrase it and say, yes, it 4 was advisable in the first instance but it was probably 5 more advisable and necessary in the second instance. 6 MR LANGSTAFF: Again, pressing you on this: is it not 7 a matter of choice for the surgeon in the first place 8 faced with the degree of obstruction that he happens to 9 see. 10 MR MANKAD: Yes. 11 MR LANGSTAFF: One could not, could one, say the care was 12 less than adequate if the surgeon chose to leave the 13 original outflow without conducting any taking away, 14 cutting away of the musculature? 15 MR MANKAD: I would then go back to the preoperative issue 16 and say that if the case is coming for discussion in 17 1999 then one would very much like to know from the 18 physicians how thick is the outlet septum in the 19 particular case. If the septum is 2 or 3 or 4 20 centimetres thick then, even though it is potentially 21 non-obstructive, one would wish to excise in the first 22 instance. 23 MR LANGSTAFF: That is 1999, we are looking here at 1985. 24 MR MANKAD: I would turn to my colleague. 25 DR DICKINSON: I think if we had been asked that question in 0115 1 1985 we certainly would have been able to answer it with 2 the ultrasound equipment that was available, measuring 3 the thickness of the septum would be a relatively 4 straightforward measurement to make. I think if we had 5 been asked the question we could have answered it; 6 whether we would have been asked the question I am less 7 sure. 8 MR LANGSTAFF: Would that have to be done intraoperatively? 9 MR DICKINSON: No, preoperatively. 10 MR LANGSTAFF: Mr Wisheart, you have been a passive 11 spectator in the conversation I have been conducting 12 with Mr Mankad and putting, I imagine, points that you 13 may be able to put better to him, but along a line 14 I suspect you might have taken. What do you say about 15 what Mr Mankad has said? 16 MR WISHEART: Thank you. As I indicated at the beginning, 17 our policy was not always to do an excision of muscle. 18 We did it where we thought it was necessary. I would 19 not be quite sure at what stage we began to use echo 20 information in order to help with that decision, I just 21 cannot remember, but I do not think we were at this 22 stage. We do know echos were done here, so I do not 23 think anybody would have had to ask the 24 echocardiographer, I think measurement of the septum 25 could have been done and would have been there and had 0116 1 been recognised that as information it would be helpful 2 and we would have used it. But I do not think we were 3 doing that at that time; that is number 1. 4 I take (and appreciate) Mr Mankad's point, that in 5 the event that inotropes were going to be needed and of 6 course by the time we were doing this bit of the 7 operation it was highly likely they would be, then their 8 use would exacerbate or enhance the muscular component 9 of an obstruction, and I cannot remember that that was 10 part of our thinking at the time. 11 The final point I think that he made was to draw 12 attention to the fact that the insertion of the 13 artificial mitral valve would itself or could itself 14 contribute to some restriction of that pathway below the 15 aortic valve. That I absolutely agree with and we were 16 certainly very conscious of, although it would be wrong 17 to say that I remember clearly. I think we did look at 18 postmortem to see if in fact it had impinged upon or 19 restricted the pathway below the aortic valve and I know 20 there is no comment in the postmortem report to help us. 21 My recollection is that it did not, but that is 22 hazy and could not be relied upon. 23 Q. Again we are faced, are we here, with decisions which as 24 it were have to be made in the heat of the moment? 25 A. That was certainly our policy at the time, although 0117 1 clearly from -- I mean my own impressions and from what 2 Mr Mankad says, that today I think a more active, 3 aggressive even, approach to undertaking an excision of 4 muscle would be usual. I absolutely agree with that, 5 but not at this time. 6 Q. Would you, in the event, agree or disagree with the 7 score of 3 which Mr Mankad would attribute? 8 A. I would be very pleased. I do not think one could 9 conceivably score this operation as 4, as you have 10 challenged him because -- I just do not think you 11 could. But I would be very pleased with a 3 because it 12 would remove the only 1 that I had; it would remove the 13 only score of 1 that I had, yes. 14 Q. Shall we then leave Bridie Kinsman there and look at 15 another surgical procedure where we may find perhaps 16 illustrations of the team that operates. It is the case 17 of Sean Naughton. You are happy to go straight on 18 without a break, have you, because we have not been very 19 long on Bridie Kinsman? 20 A. Yes, I am happy, thank you. 21 Q. Sean Naughton, born on 12th March 1984, suffering from 22 a supracardiac total anomalous pulmonary venous 23 drainage. A catheter conducted on 20th March, showing 24 that the pulmonary artery pressure was reasonable. The 25 TAPVD appeared to be unobstructed; is that right? 0118 1 A. That is correct. 2 Q. We have the operation. To have the operation note we 3 need to go to MR 864/21. Here we see, do we, the nature 4 of the operation? Conducted at a fairly young age, as 5 it would have to be, would it not, for this condition? 6 You are nodding the reason I say that -- 7 A. I am sorry. Yes, I was just looking to see exactly how 8 old he was; he was in his third week, I think. 9 Q. There are three particular aspects of this operation 10 that I want to examine with you. The first is the 11 anaesthesia. If we go from this operation note. We 12 will come back to it in a moment or two, if we go to 13 864/60, we have I think the anaesthetic record sheet. 14 THE CHAIRMAN: Just taking the address out. 15 MR LANGSTAFF: Perhaps if I turn here to Dr Dickinson, do we 16 find on this sheet documented some severe acidosis? 17 DR DICKINSON: Yes, I think if we scroll down to the bottom, 18 this is a case which -- I was a member of the team which 19 reviewed this case and it was a point which was drawn to 20 my attention by the intensivist or anaesthetists on that 21 team. Obviously anaesthesia is not my specialty so I am 22 commenting slightly at second-hand, but there are 23 a column of figures at the top right-hand corner of the 24 graphed area which are blood gases prior to the 25 commencement of the operation. We have a base deficit 0119 1 of minus 8 and subsequently minus 12, I think, before 2 the operation commenced -- 3 MR LANGSTAFF: That is under the line we see marked at "200" 4 on the screen? 5 DR DICKINSON: Yes. 6 MR LANGSTAFF: Can we draw a yellow line across there? 7 Thank you. 8 DR DICKINSON: -- and the interpretation of my anaesthetic 9 colleague of these figures was that the child during the 10 course of induction of anaesthesia had, for whatever 11 reason, become quite significantly acidotic and he also 12 drew attention to the high valves for the blood carbon 13 dioxide level directly opposite the number 200. 14 MR LANGSTAFF: That is the line above the base? 15 DR DICKINSON: That is right. So those were the two 16 criticisms which he had. 17 Those, I think, were the two criticisms which he 18 drew our attention to and reservations he had about the 19 period, presumably in the anaesthetic induction room 20 prior to the onset of the operation. The implications 21 of that would -- 22 MR LANGSTAFF: Why do you say "presumably in the anaesthetic 23 room"; why not before? 24 DR DICKINSON: My recollection is that the child's cardiac 25 catheterisation was entirely uneventful, he did not 0120 1 deteriorate during the course of the cardiac 2 catheterisation and I think the procedure, the date of 3 the operation was a few days after the cardiac 4 catheterisation -- 5 MR LANGSTAFF: 9 days. 6 DR DICKINSON: -- with no suggestion whatever that he had 7 deteriorated or become acutely unwell in the written 8 record of his care in hospital. 9 So I think the implication, the inference we drew 10 from these figures was that this child, for whatever 11 reason, had deteriorated during the period of induction 12 of anaesthesia prior to the operation commencing. 13 MR LANGSTAFF: Mr Wisheart, having looked at and reviewed 14 that point, it is not directly your specialty but does 15 it seem to you to be right as a conclusion to be reached 16 from the records? 17 A. Yes. I think it is first highly unlikely that his 18 metabolic state would be as described here over a number 19 of days prior to the operation; I do not think that is 20 really a possibility. 21 Secondly, anaesthesia was commenced at 9.00 but 22 the operation did not begin until 11.15. We see that in 23 the left-hand column just to the left of the numbers we 24 have been looking at and, therefore, it does seem 25 inescapable that what we see here is something that 0121 1 developed over that period. 2 I am not able to say exactly what the timing of 3 those first set of blood gases are. The numbers are 4 below 11.00, but the other writing occupies space and 5 I think it would be difficult to be sure. But the 6 second set seems to be at quite a precise time and that 7 is clearly when we were well into the operation. 8 So it does look as if these disturbed blood gases 9 were present throughout the whole of the initial part of 10 the operation, and I cannot say beyond that because 11 I have not myself seen the perfusion record, I do not 12 think it was in the set of notes sent to me, but I think 13 the implication of the comment from the reviewers is 14 that it may well have persisted beyond the time that we 15 see here. 16 DR DICKINSON: Could I go on from there? The comment that 17 was made by the reviewers was that there was 18 a persistent uncorrected acidosis during the course of 19 the, so I think the perfusion notes were available to 20 the review team. But I think the implication that was 21 drawn from these figures was that the acidosis preceded 22 the commencement of the operation. 23 MR LANGSTAFF: If it happened in the anaesthetic room 24 preoperatively and going on into the operation, can 25 I ask a simple question: should it have done so? 0122 1 MR WISHEART: Ideally certainly not. 2 Q. Does it indicate some defect of anaesthesia, whatever 3 that defect might be? 4 A. Like Dr Dickinson I am not an anaesthetist and I would 5 hesitate to say, because clearly ideally that is not the 6 way a patient should come into the operating room. 7 Q. It makes life more difficult, does it? 8 A. I believe it is more than that, I believe it actually 9 makes a major contribution to the risks involved in the 10 operation because I think it impinges on how the heart 11 will work afterwards, bearing in mind that it persisted 12 through the whole operation. 13 So where I am not able really to say and would not 14 say is -- to comment on the standards and expectations 15 of the conduct of anaesthesia in 1985 I would find 16 difficult, but I think everybody would agree that this 17 is not the way (even in 1985) that an anaesthetist would 18 have wished to deliver the patient to the operating 19 room. 20 Q. Can you help with what seems to be a surprising time 21 between the induction and the operation, 2 and a half 22 hours? 23 A. It was not uncommon in my experience at that time. 24 I think the reason is of course that the anaesthetist is 25 having to put in little plastic tubes into arteries and 0123 1 veins that are ever so small and I think it is a very 2 difficult task, it amazes me that they can do it at all. 3 Q. Saying it is "not uncommon" does not necessarily give me 4 a reason for it? 5 A. No. 6 Q. You are then volunteering the possibility that one of 7 the reasons may be they need to cannulate or put lines 8 into vessels. That has always been, I suspect, 9 a difficulty with operating upon very small children 10 but, from what you are saying today, it takes place much 11 more quickly? 12 A. Yes, it does. Of course if you go back further in 13 history people were not doing this in little tiny 14 children very much. So it is a skill that I think has 15 developed. 16 Certainly it is the case today in my personal 17 experience that it would be done much more quickly -- 18 when I say "today" I mean a little while ago -- but 19 I know there are places where people still take a very 20 long time to do this and in those circumstances they pay 21 great attention to the details so that the patient does 22 not get into the state which is described here by these 23 blood gases. 24 So you can either be quick or if you are slow then 25 you have to take care to prevent this sort of thing 0124 1 developing. 2 THE CHAIRMAN: I think Mr Mankad wants to come in on that. 3 MR MANKAD: I think, with due respect to my anaesthetic 4 colleagues, I would like to point out that these 5 scenarios even occur in 1999. This morning I raised the 6 issue of the importance critical mass not just for the 7 surgeons but for the whole team, and I think this case 8 very clearly highlights that a critical mass is vital 9 for the whole team including the anaesthetic colleagues, 10 and if one is doing very very few numbers of open heart 11 operations especially in infants and neonates, then it 12 is very difficult to maintain the skills required for 13 neonatal anaesthesia for cardiac surgery and I would 14 strongly make a plea that the critical mass is important 15 for the whole team including anaesthetists and we 16 had debates on several occasions in-house, especially 17 when the numbers of the unit are relatively small, one 18 or two surgeons doing the operations but anything 19 between 4 to 8 anaesthetists giving an input into those 20 operations. I think we need to ensure the importance of 21 critical mass for the whole team. 22 MR LANGSTAFF: Can I explore one suggestion that has been 23 made in the course of evidence to us, that there were 24 occasions when one or other of the surgeons was late in 25 arriving in theatre. First of all did that happen? 0125 1 MR WISHEART: It sometimes happens, yes. 2 Q. Secondly, what sort of event was likely to make it 3 happen? 4 A. I think what we are discussing is actually what I wanted 5 to say. I think what you are referring to, if I may be 6 quite clear, is the comment that I was sometimes late. 7 What we see here is an operation which began at 8 11.15. So I came into the hospital at 8.00 or just 9 after it each morning and the question is: do I sit in 10 the operating theatre waiting for this, or do I try to 11 use the time in some other way. So I sought to use the 12 time, not knowing how long this would take. so I, in 13 general, sought to use the time some other way and asked 14 the theatre to inform me in good time so I could stop 15 what I was doing, change, scrub and join the operation. 16 The problem that seemed to arise is that when they 17 informed me they really wanted me in 10 minutes rather 18 than in 20, if I may put it that way. I am not saying 19 I was never at fault myself in any other way, but that 20 was a common issue and it arises directly out of this 21 sort of background; how long does it take to get going, 22 and one never knew. 23 Q. You are quite right that a comment was made about you, 24 I think my recollection is that it may have been made 25 about both you and Mr Dhasmana, but I think more in 0126 1 respect of you than Mr Dhasmana hence my next question, 2 which is: if it is the case that it was a late call by 3 the theatre to you when you were quite appropriately 4 doing something else, can you help with why the comment 5 should be directed more at you than at him because one 6 would have thought that it ought to have been equal? 7 A. I cannot comment. I mean I cannot contribute anything 8 to that, I am sorry. 9 Q. The problems caused by the anaesthetist, who is an 10 essential part of the team, may be demonstrated by this 11 chart. We will come to the perfusionists' charts in 12 a moment because we do have them and scanned them in. 13 They have had to be reduced somewhat, as you will 14 appreciate. 15 Any operation is a team operation, not only in the 16 planning in the postoperative phase but also during the 17 operation, is it not? 18 A. Very much so. 19 Q. As a surgeon you coordinate the team, do you? 20 A. You could say that. Seeing one is doing this repeatedly 21 day after day, week after week, year after year the team 22 largely knows what it has to do so you do not have to 23 reinvent the wheel every time, you need to provide the 24 information that the members of the team know and, by 25 and large, they then do what is required of them and if 0127 1 there is something out of the ordinary then you talk to 2 them about it or make sure that they know. 3 Q. Although you accept that your role is to coordinate the 4 team you have to, do you, rely upon other members of the 5 team doing their particular job as they, if I use the 6 word 'should' I do not mean to imply anything other than 7 as you might expect? 8 A. All the members of the team have to make their 9 contribution. 10 Q. Can we go back to the operation note here? If we look 11 at the operation which was then to be performed, what 12 you would expect I think as soon as you were on bypass, 13 it would be advisable, would it, to vent the common 14 chamber to let any blood that is returning drain out? 15 A. As soon as you go on bypass? 16 Q. Once you are on bypass, yes. 17 A. It is not the first thing you would do, no. 18 Q. Would you do that fairly soon after going on bypass? 19 A. I would not normally have done. I am considering the 20 differing ways I did this. There were times when 21 I earlier on, indeed continued it quite a long time, 22 I would have routinely put a vent into the left 23 ventricle, but that would not of course have vented the 24 chamber that you are referring to prior to doing the 25 operation. But the diversion of blood from the heart to 0128 1 the bypass machine would usually tend to decompress that 2 chamber by itself, particularly when the whole setup is 3 non-obstructed and this was a non-obstructed total 4 anomalous pulmonary venous drainage. 5 The other possible factor that might delay its 6 emptying would be if there was a patent ductus 7 arteriosus which was continuing to put blood into that 8 circulation, and we dealt with that at an early stage. 9 So when I go on bypass in this condition the first 10 thing I seek to do usually is to control the ductus, 11 regardless of what information I have been given 12 beforehand, I would do that because often it may be 13 patent to a small degree even if we have not been told 14 that, but that is everybody's practice I think. So that 15 would have been the first move. 16 As I said it was for a very long time my custom to 17 use a left ventricular vent, and I would have done that 18 and I would not usually have opened or emptied the 19 common chamber until I had arrested the circulation and 20 given myocardial protection and so forth. 21 MR LANGSTAFF: Would you like to comment on that, 22 Mr Mankad? 23 MR MANKAD: I think it is a fair point that in the 24 cardiopulmonary bypass the right side of the heart is in 25 theory empty and therefore there is not any blood in 0129 1 theory into the pulmonary venous circuit. 2 Number 2, if the total anomalous pulmonary venous 3 connection to whatever chamber, supra or intracardiac, 4 if it is unobstructed -- and I use the word 5 "unobstructed" specifically -- it is not vital that the 6 common chamber is vented, but either the common chamber 7 is obstructed by nature or heterogenetically then it 8 becomes important despite the fact that there is no 9 blood in the pulmonary venous circuit in theory. 10 In practice we find there is invariably 11 a significant quantity of blood in the pulmonary venous 12 circuit and one of the first things I was told during my 13 training sessions was to try and vent the common chamber 14 soon after going on bypass, it is a good clinical 15 practice to take the ductus in the first instance 16 definitely but even, having included the duct, to open 17 the common chamber. In practice I do find, having done 18 that on every case, that despite the fact the right 19 heart is in theory empty, there is a significant 20 quantity of blood coming back through the common chamber 21 into the pericardial cavity which we suck. 22 MR LANGSTAFF: During the cooling time if there is not 23 a vent can one get pressure building up? 24 MR MANKAD: The logic of opening the common chamber is that 25 if the pulmonary venous region is obstructed by nature 0130 1 or heterogenetically then the back pressure, the amount 2 of blood would tend to bring, generate more pulmonary 3 capillary pressure which in theory -- I am using the 4 word "theory" because I have never seen that and I am 5 extrapolating that theory into this particular scenario 6 (we will come back to the scoring and everything later 7 on) -- in theory the pressure would build up. 8 In turn that would lead to rupture of pulmonary 9 capillaries at the annular capillary level resulting in 10 hemorrhaging, interstitial pulmonary oedema, and 11 resulting in a vicious cycle and when you are trying to 12 come off bypass that could contribute to intractable 13 pulmonary hypertension. These are theoretical 14 possibilities of an obstructed return on bypass despite 15 the fact that the right heart is empty. 16 MR LANGSTAFF: If we have a look at the note -- I will 17 invite you to comment on that in a moment. Can we 18 scroll down the operation note? We see in the first 19 paragraph, after you talk about establishing 20 cardiopulmonary bypass with a single or atrial line and 21 the temperature being reduced, approximately 70 ccs of 22 cardioplegic solution given. 23 "During the period of cooling the ascending vein 24 was identified outside the pericardium. It was 25 separated from the phrenic nerve and snared. The ductus 0131 1 was also dissected and carefully defined and ligated." 2 What was the purpose of snaring the ascending 3 vein? 4 MR WISHEART: Because at a later stage in the operation when 5 you actually open the common pulmonary chamber, then air 6 would be able to pass through that vein into other parts 7 of the circulation. Normally the bypass would be 8 arrested at that time but it simply isolates the 9 ordinary main veins with which the venous cannula would 10 be in communication if it were being used from that part 11 of the heart where you are working and prevents the 12 entry of air into it. 13 MR LANGSTAFF: Would you like to comment? 14 MR MANKAD: In my practice when the circulation -- two 15 things I think. Number 1, I never include the ascending 16 or descending vein and I do not think the air is 17 a problem. 18 The second thing, even if in theory it is 19 anticipated that there will be a problem, that is not 20 a problem on bypass it is only at the end. Again 21 I still slightly fail to understand the logic of snaring 22 the vein on bypass. 23 MR LANGSTAFF: You were nodding Dr Dickinson? 24 DR DICKINSON: No, I was not nodding. I think this is 25 a fine matter of surgical technique and I am not going 0132 1 to comment. 2 MR LANGSTAFF: I saw what I thought was a nod, I am sorry 3 for misinterpreting. There is a difference of surgical 4 technique, is there? 5 MR WISHEART: There would appear to be. I would add one 6 thing: it would normally be my practice having completed 7 the repair to actually ligate the ascending vein. So 8 the snaring is part of the preparation for that as well 9 and so it means when that time comes I am immediately 10 ready to do so. 11 Q. What I am going to do now is to take you on to look at 12 the perfusion charts and the bypass charts, some of 13 which are in the original, in colour. The benefit 14 I think from seeing the original which you may not have 15 had an opportunity to see. What I am going to suggest 16 therefore is, given the time, we have a short break now, 17 allow Mr Wisheart to have a look at the original so that 18 he will be better able to assist in the discussion that 19 will follow, if that is a convenient course? 20 THE CHAIRMAN: Mr Langstaff, shall we say until 2.55? 21 (2.45 pm) 22 (A short break) 23 (3.15 pm) 24 MR LANGSTAFF: Mr Wisheart, we have dealt, before the break, 25 with the anaesthetic problems, if I can call them that, 0133 1 in this case. I think it is common ground, is it, that 2 no-one has yet been able to identify clearly why it 3 should be that Sean died, given that there was an 4 unobstructed pulmonary venous drainage and given the 5 apparent progress of the operation? 6 A. Certainly on the first point, it puts him into a group 7 of lower risk, not zero risk but lower risk, and the 8 apparent progress of the operation from a technical 9 standpoint, and the information we have subsequently 10 confirms that as far as I can see. It does not suggest 11 any particular problem or difficulty, I agree. 12 Q. Mr Mankad, what is your approach to the detective work 13 here? We will see if we can learn any lessons from it. 14 MR MANKAD: I do not know whether it is appropriate to call 15 it detective work, but I was fascinated by this 16 mortality, and I also noted that in the group 17 discussion, by the review group, it remained elusive 18 because of that. 19 A few things struck me. Here is a baby who, as 20 Mr Wisheart says, was relatively low risk. Because of 21 that, number 1 could be, the ill-effects of 22 cardiopulmonary bypass in a neonate, giving rise to 23 intractable pulmonary hypertension in the early 24 post-bypass period, resulting in death. It is not 25 a very valid explanation, because the child had 0134 1 a reasonable bypass time, shortish bypass time; 2 myocardial protection was adequate; the autopsy 3 confirmed that the anastomosis was wide open. There was 4 no organic obstruction of the anastomotic site; the left 5 atrium was small, but it is always small, the left-sided 6 structures in this condition are always small, so it is 7 difficult to say that contributed. 8 Before I went into this, it struck me, the snaring 9 of the common vein, as I referred to earlier on, what it 10 in theory could lead to. Then I started to do more and 11 more work that the hypothesis I had put forward of 12 snaring the common vein resulting into retention of 13 blood into the whole pulmonary venous vascular tree, 14 increasing pressure, resulting into rupture of 15 capillaries, and haemorrhaging interstitial pulmonary 16 oedema, giving rise to -- 17 MR LANGSTAFF: Take it slowly. 18 MR MANKAD: -- giving rise to increased pulmonary vascular 19 resistance in the early post-bypass period, and 20 contributing to mortality. 21 What is the evidence to this? There are three or 22 four things that have been baffling, including to the 23 surgeon on the table. Let me go to the first thing, and 24 what struck me was that normally on bypass, when the 25 right-sided structures are emptied, the central venous 0135 1 pressure is almost zero, so when I looked at the chart 2 of the recording on bypass, it is not a perfusion chart, 3 the chart which shows the temperature, arterial pressure 4 and the central venous pressure throughout the course of 5 the operation -- 6 Q. Do we have that, please, at MR 864/66? Do we need to 7 rotate that? 8 MR MANKAD: Yes, please. 9 MR LANGSTAFF: The top line is what? 10 THE CHAIRMAN: We are just taking an address out again. 11 MR MANKAD: The top short bars are arterial pressure. The 12 middle one, long horizontal, is central venous pressure; 13 the bottom line is the temperature. In fact, it is 14 difficult to see, but the point of bypass is clearly 15 delineated. The speed is delineated on the paper, on 16 the tracer, and the scale. The scale is 0 to 200 ml of 17 mercury on the arterial side, 0 to 20 ml of mercury on 18 the venous circuit and the temperature reference point, 19 I presume, is 37 degrees, going down, as the child is 20 being cooled on coronary pulmonary bypass. 21 What struck me was the persistently high central 22 venous pressure on bypass, and until the circulation is 23 arrested, and in fact, even for a few minutes after the 24 circulation is arrested, the venous pressure remains 25 anything between 10 to 12 ml of mercury mean; that is 0136 1 all. 2 MR LANGSTAFF: Can I stop you there? What would you expect 3 to happen to the venous pressure once you go on bypass? 4 MR MANKAD: You would expect the venous pressure to be 0, or 5 at the most, minimum 1 or 2, maybe, but with a single 6 venous cannula in the right atrium, draining the 7 superior vena cava and inferior vena cava adequately the 8 venous pressure theoretically is 0. 9 MR LANGSTAFF: You are agreeing? 10 MR WISHEART: I agree that that is what would normally 11 happen, yes. 12 MR LANGSTAFF: What we see here is that it did not happen 13 in this particular case, for whatever reason. 14 MR MANKAD: It remained elevated. I will come back to 15 that. The second thing is that when the circulation is 16 arrested, usually no blood is coming back, either from 17 the right or left-sided structures. Mr Wisheart has 18 commented in the operation note -- I am not sure whether 19 we wish to go back to the operation note -- 20 MR LANGSTAFF: Let us go back and have a look at that. That 21 is at page 21. The address needs to come out. 22 MR MANKAD: It is the second paragraph under "Procedure". 23 MR LANGSTAFF: The opening words, "When the circulation 24 had been arrested there continued to be a troublesome 25 slow return of blood". 0137 1 MR MANKAD: Yes, through the SVC in the left side of the 2 heart, which obscured the surgical field, so much so 3 that an additional left ventricular vent was required. 4 MR LANGSTAFF: Can you just stop there for a moment? This 5 would be a vent inserted after circulatory arrest? 6 MR WISHEART: Yes. 7 MR LANGSTAFF: The process of venting you described earlier: 8 was that one you would do before bypass or arrest, 9 normally? 10 MR WISHEART: Frequently, but I had not done in this 11 instance, but I did do subsequently, because I was being 12 held up for longer than I was comfortable with in 13 getting on with operation, because of the return of 14 blood. 15 MR MANKAD: This return of blood, when we superimpose that 16 with the perfusion chart of venous pressure, it shows 17 clearly that for the first few minutes, until the vent 18 was inserted, the central venous pressure is slowly 19 coming down, implying, coming back to that hypothesis 20 that this blood is coming back which has been 21 accumulated into the pulmonary vascular tree. There are 22 always naturally occurring systemic pulmonary 23 collaterals, and these collaterals then would then open 24 up and blood would then drain back, because either it 25 can drain back into the pulmonary artery, retrovertly, 0138 1 or it can drain back into the superior vena cava or the 2 systemic circulation through naturally occurring 3 systemic pulmonary collaterals. 4 The hypothesis which I put forward was that that 5 later thing was occurring, as we see in these two 6 things, implying that snaring of the pulmonary vein 7 contributed to subsequent events and that led to the 8 increased pulmonary vascular resistance and haemorrhagic 9 pulmonary oedema. That is another key feature which 10 I noted in one of the charts off bypass: there was 11 evidence of haemorrhagic pulmonary oedema, which is 12 again very unusual, or haemorrhagic fluid from the 13 endotracheal tube. 14 Putting all this together with no adequate 15 explanation, I put forward the hypothesis, which remains 16 to be tested, that probably contributed to mortality and 17 compounded obviously by the pre-operative anaesthetic 18 problem and the persistent acidosis on bypass, 19 et cetera. 20 MR LANGSTAFF: In the scenario you painted, what part 21 does the persistent acidosis play? 22 MR MANKAD: Minor. 23 MR LANGSTAFF: Because one of the factors, I think, that one 24 can identify in this case is that the perfusionist does 25 not appear to have remedied the acidosis. Would you 0139 1 normally expect, on bypass, that the acidosis would be 2 monitored and regulated? 3 MR MANKAD: One would normally expect acid-based balance 4 occasionally to be more acid than minus 6, base excess. 5 That would usually either be compensated by giving 6 sodium bicarbonate temporarily, but more importantly, by 7 increasing the bypass flow, because that invariably 8 reflects that the bypass flow is not adequate for the 9 temperature and the surface area of the child, so it is 10 usually remedied by increasing the flow. 11 MR LANGSTAFF: So the hypothesis I would put to you, you 12 would answer "Yes", that if the degree of acidosis 13 should be both monitored and regulated -- 14 MR MANKAD: Yes. 15 MR LANGSTAFF: -- by the perfusionist -- 16 MR MANKAD: Yes. 17 MR LANGSTAFF: -- you would expect that to be his task as 18 part of the team contributing to the surgery? 19 MR MANKAD: Absolutely right. Usually he is led by the 20 anaesthetist in terms of regulating the flow. 21 MR LANGSTAFF: Before I invite Mr Wisheart to respond if he 22 wishes to do so, at this stage, the thesis that you have 23 put forward you have put forward as a hypothesis and it 24 must follow that it would not necessarily be obvious to 25 any surgeon at the time as being a likely event nor 0140 1 indeed does it appear to have occurred to the surgical 2 team after this particular operation, nor, I think, the 3 reviewing surgeon when the Case Note Review occurred. 4 MR MANKAD: That is correct. 5 MR LANGSTAFF: Although there is the query in the Case Note 6 Review as to why it was that a vent was needed after 7 bypass had commenced. 8 MR MANKAD: Yes. 9 MR LANGSTAFF: Mr Wisheart, I think we are probably 10 going to learn lessons for the Inquiry here in respect 11 of the anaesthetic and the perfusion, but Mr Mankad is 12 putting forward a possible explanation as to why it 13 should be that the outcome in this case was as it 14 tragically was. 15 Have you had a sufficient opportunity, do you 16 think, to be in a position to respond to that 17 hypothesis, or would you wish further time to consider 18 it and do so? 19 MR WISHEART: I think I am in a position to make 20 a response, although I would be grateful if I could make 21 a further response if I wished to, tomorrow morning, 22 after I have given it some thought. 23 MR LANGSTAFF: Absolutely. 24 THE CHAIRMAN: You may respond now if you wish, and you 25 may also -- whether tomorrow or in writing, it is 0141 1 a matter entirely for you and those who advise you. 2 MR WISHEART: Thank you. I do not know what Mr Mankad is 3 doing tomorrow, but I would like to respond today so 4 that we can continue the discussion. 5 The first thing I would like to say is that I find 6 the general hypothesis put forward -- I am not now 7 speaking of this operation -- as a very attractive one. 8 I think if I were doing this operation tomorrow, I would 9 incorporate that into my conduct of the operation. 10 That would be my first comment. 11 My second comment would be, I think, one of 12 clarification, which I think is actually quite important 13 and it is, of course, that the snare would have been 14 applied to the ascending vein, not immediately after 15 going on bypass, but immediately before arresting the 16 circulation, so there would not have been a substantial 17 time when that vein was snared prior to circulatory 18 arrest. 19 I would just like to say in passing that many 20 years ago that is basically the way I was taught to do 21 the operation, I believe, I think, I cannot remember 22 with crystal clarity, by Mr Stark and his colleagues in 23 Great Ormond Street when I was Senior Registrar there. 24 So what I think I would now like to do, if I may, 25 is to make some precise comments about the operation and 0142 1 the hypothesis, and then maybe briefly return to the 2 question of acidosis and allied topics afterwards? 3 MR LANGSTAFF: Please. 4 A. You have put forward a hypothesis and some of my 5 comments will be equally hypothetical, but based on 6 knowledge of what sometimes happened in Bristol. 7 The venous line which was used to monitor this 8 pressure was a tunnelled left subclavian line, according 9 to the anaesthetic note. Dr Burton who put it in was 10 notorious for passing his venous lines into any vein 11 from the neck up, tying it in knots. We used to look at 12 the x-ray afterwards with great interest to see exactly 13 what tortuous pathway it had followed. That is not by 14 way of criticism of Dr Burton, but the point is that 15 sometimes these lines, although put in centrally, did 16 not end up in a central position. Therefore, that would 17 be important, critically important, in terms of the 18 relevance of this observation of pressure. 19 The second thing is that if we, having said that, 20 made the assumption that it is where we would want it to 21 be, then I agree with you that the pressure observed 22 here is certainly higher than one would expect on 23 bypass, definitely. 24 The next comment I would make is that -- and you 25 may advise me on this, but I would have thought that 0143 1 a level of 10 or 12, if that is correct, is unlikely to 2 lead to the sequence of pathological changes in the 3 lungs that you have outlined, and that one would really 4 be thinking in terms of a rather higher pressure to 5 cause that, but you may disagree with that. 6 Finally, you commented, I think the words you used 7 were "haemorrhagic pulmonary oedema"; is that right? 8 I have had a quick look through the notes I have 9 extracted into my own file. I think I have read that as 10 well but I could not find it. I wonder therefore if you 11 could identify it for me. 12 Finally, the findings at postmortem I think you 13 may take the view they do not really help us too much. 14 They certainly, I do not think, help us positively. 15 They say the lungs are congested, heavy and oedematous, 16 but at the end of totally anomalous venous drainage, 17 a period of bypass, et cetera, and then of failing 18 circulation, that is not a very specifically helpful 19 finding. 20 So I think those would be the points I would wish 21 to make at this stage in relation to the hypothesis. 22 Finally, and very briefly, with regard to the 23 acidosis, I may say I have no recollection of being 24 aware of the severity of this at the time. It is very 25 impressive looking at the perfusionist's chart, not only 0144 1 to observe the acidosis, which may be seen under the 2 horizontal lines labelled "pH" on the left, or base 3 excess on the left, but also the level of CO2 in the 4 arterial blood, really right up until the reinstitution 5 of bypass after the period of circulatory arrest and we 6 see a figure up to 99 which is really extraordinarily 7 high. 8 What influence these metabolic disturbances, let 9 me call them that, would have had on the subsequent 10 performance of the myocardium I think is a matter one 11 could debate. 12 That is what I wish to say at this stage, thank 13 you. 14 MR LANGSTAFF: Mr Mankad, in terms of the pressure of 15 10 or 12, is that sufficient to cause the sort of 16 changes which your hypothesis would involve? 17 MR MANKAD: That is the third point that I was planning to 18 respond to in relation to point by point response to 19 Mr Wisheart. 20 MR LANGSTAFF: Do not let me take you out of your way. 21 MR MANKAD: No, it is perfectly all right, I will take 22 that first. 23 Yes, I think it would concur, because the 10 or 12 24 pressure is not a direct reflection of intracapillary 25 pressure into the pulmonary capillaries, because the 0145 1 very small amount of that blood which is in the lungs 2 would go back into the systemic venous circuit through 3 the naturally occurring collaterals, i.e. if the 4 naturally occurring collaterals are absolutely vast, 5 then the pressure will fluctuate, but it is conceivable 6 that the pressure required to rupture these capillaries, 7 whatever the threshold pressure is, let us say 20 or 25, 8 once that pressure is there, the amount of central 9 venous pressure is only the amount of blood that is 10 going back into the veins, and that could still be 11 10 or 12. 12 MR LANGSTAFF: So the theoretical point Mr Wisheart makes 13 that pressure is not enough is right, but you are saying 14 that the measurement of pressure is not being taken at 15 the point where the pressure is being exerted? 16 MR MANKAD: Yes. My first point is Mr Wisheart is 17 absolutely right. The crucial hypothesis this underpins 18 is the timing of snaring the vein. If the common vein 19 was snared just before circulatory arrest, then the 20 hypothesis is null and void. The reason why I put 21 forward this hypothesis is because it is not clear, and 22 it is like the beginning if you say that the vein was 23 snared, so I presume that it was snared at the same time 24 as the duct was occluded, but if the common vein was 25 snared just before circulatory arrest, then this is not 0146 1 a proper explanation, number 1. So the timing of that 2 is crucial. 3 Secondly, the point that you raised about the 4 central venous pressure lying in anywhere else from head 5 to toe, it can rightly affect the reading on the table, 6 but the difference would be that that reading usually 7 would be non-pulsatile and we have no means to judge 8 whether this particular reading on this occasion was 9 pulsatile or non-pulsatile, but it would surely affect 10 the recording. 11 The third one you already alluded to. The fourth 12 is the haemorrhagic pulmonary oedema. I do not have 13 a note in front of me here, but it was haemorrhaging 14 fluid into the ET tube. This is what I refer to. 15 I will go back to that if I can find it. 16 The last point which you made was the PCO2 and 17 metabolic acid, the metabolic factors affecting the 18 organ function. Yes, it is possible that would have an 19 adverse effect on the overall organ function, and if we 20 for the time being -- if, on this hypothesis, 21 considering the fact that the vein was snared at the 22 last minute, then that probably is the only explanation 23 of metabolic insult to the multi-organ of persistent 24 problems on cardiopulmonary bypass affecting the 25 myocardial and pulmonary function. 0147 1 MR LANGSTAFF: So the earlier the snaring is, the more 2 likely your thesis is, you think? 3 MR MANKAD: Yes. 4 MR LANGSTAFF: The later, the less likely and the more 5 likely the submetabolic insult as demonstrated by the 6 degree of acidosis. 7 Can you help, Mr Wisheart, looking back to the 8 perfusionist and going back to the charts, which we have 9 at page 66 and which you have in glorious technicolour 10 in front of you -- 11 THE CHAIRMAN: We need to take an address out. 12 MR LANGSTAFF: Yes, thank you. This is not, I think it is 13 agreed between you and Mr Mankad, not as you would 14 expect it to be? You are agreeing with that? 15 MR WISHEART: Yes, I do. 16 Q. At the time of the operation, is this something that 17 you, as the surgeon, would expect to be drawn to your 18 attention by the perfusionist? 19 A. It would be drawn to my attention by my own 20 observations, because the right atrium would be full 21 instead of empty. 22 Q. And you had to vent the -- 23 A. That was later. At this stage, unlike the ventricle, 24 the atrium is a thin-walled organ and when it is emptied 25 it collapses so it is easily visible to the naked eye 0148 1 and there is a usual emptying, quite quickly, once you 2 drain the venous blood off, so that would have been 3 evident. All I can say is that I have not made a note 4 about it, but that is not conclusive evidence one way or 5 the other. 6 Q. And the persistent acidosis in the operation, again that 7 is not something that you would notice with your naked 8 eye? 9 A. Not at all. Not at all. 10 Q. You had to rely on being told by the perfusionist? 11 A. Yes, or the anaesthetist, totally. 12 Q. Had you known that the readings were as they were, 13 which, as you say when you look back on them look fairly 14 stark, would you have done something about it, do you 15 think, at the time? 16 A. That is a very difficult question. I mean, you would 17 have encouraged people to take action, but I think you 18 would have had no option but to continue with the 19 operation. I think that probably -- I will be 20 interested to know what Mr Mankad says, but I think that 21 probably the best course of action would have been to 22 get the patient on to bypass as expeditiously as 23 possible, and then take whatever time is needed on 24 bypass to stabilise the metabolic state prior to the 25 period of circulatory arrest. I think that is probably 0149 1 the approach I would have had, if the matters had been 2 drawn to my attention. 3 MR MANKAD: Something has occurred to me: is it not odd that 4 while we are cooling the child, usually the oxygen 5 requirement is going down and it is actually more 6 unusual to have persistent acidosis, because the cardiac 7 output, the bypass flow required to sustain tissue 8 oxygenation is much lower than at normal thermia. In 9 that scenario, is it likely that this acid base that we 10 are seeing on the chart is not corrected for 11 temperature, and it is actually a misnomer? This is 12 just a -- 13 MR LANGSTAFF: It is a question of record-keeping? 14 MR MANKAD: Yes, because normally it is corrected for 15 temperature, especially when you cool down to 18 or 16 20 degrees Celsius. 17 MR WISHEART: I would not be able to comment on this so many 18 years afterwards, I am afraid, but in fact the last 19 observation, where there is severe acidosis and severe 20 elevation of CO2 is actually immediately prior to going 21 on bypass. There is no record here after that until 22 14.40 which is after the period of circulatory arrest 23 and bypass has been resumed. Unless I have got my 24 timings wrong. I think that is what it says. 25 MR MANKAD: It was genuine. 0150 1 MR LANGSTAFF: It looks as though it was genuine. This case 2 would demonstrate, then, would it, the need for there to 3 be, as it were, constant communication within the 4 operating theatre between the anaesthetist, the 5 perfusionist and the surgeon, because that is how one 6 gets the collaborative effort which is the surgical 7 result one hopes for? 8 MR WISHEART: Yes, although of course you expect that the 9 anaesthetist or the perfusionist will be doing the 10 things that are necessary and they will take the view, 11 "The surgeon has enough to cope with so let us not 12 trouble him with all the details when he himself cannot 13 actually do anything about them". So it works in 14 a variety of ways. 15 MR LANGSTAFF: The point Mr Mankad made earlier, some time 16 before the break, about the need in surgery on very 17 small children such as Sean was, was to emphasise the 18 importance of regular experience of it. Do we, do you 19 think, learn anything from this case to emphasise the 20 importance of that, that experience counts and helps to 21 ensure that everyone within the team knows what has to 22 happen and how best to do it? 23 A. I think it is fair to point out that Dr Burton was 24 a most experienced paediatric anaesthetist. That is not 25 to say he did not do anything else, but he was most 0151 1 experienced, both in open-heart surgery and in 2 paediatric intensive care, and spent -- in fact, he 3 really instituted it in Bristol, so this is a most 4 experienced and very careful anaesthetist. 5 Q. Can you help with the perfusionist? 6 A. Yes. The names here are that the perfusionist was 7 Mr Allen, assisted by Mr Caddy. Mr Allen was relatively 8 junior, but Mr Caddy was one of the "grandfathers" of 9 perfusion, if I can say that. He was most experienced, 10 and I think we can safely conclude that everything 11 Mr Allen did would have been directed and supervised by 12 Mr Caddy and would have been according to the book. 13 I would have complete confidence in that. 14 Q. Do we know from the records whether the anaesthetist, 15 Dr Burton, would have been present in theatre 16 throughout? 17 A. It is very highly likely. I mean, I clearly do not 18 remember, but with Dr Burton, it would have been highly 19 likely. If he had popped out, it would have been for 20 a few minutes and back in again. 21 Q. If one looks at the general pattern of an operation, 22 once bypass is established, is it the case that the 23 consultant anaesthetist may often absent him or herself 24 from the theatre and leave a junior anaesthetic 25 colleague to supervise and call him or her back in, if 0152 1 need be? 2 A. That is not uncommon, although, as you would imagine, it 3 does vary from anaesthetist to anaesthetist, and some -- 4 let me put it this way -- do not find it easier to take 5 themselves away from the operating theatre for long 6 periods of time. So, if they go out for a cup of 7 coffee, which I think is perfectly appropriate, they 8 will be popping back in just to see what is happening. 9 I would definitely put Dr Burton in that group. 10 MR LANGSTAFF: Mr Mankad, Dr Dickinson, are there any 11 further general lessons which we may derive, do you 12 think, from this case? 13 MR MANKAD: I think, taking fully into account what 14 Mr Wisheart is saying, that here we do not have 15 relatively inexperienced but in fact dedicated 16 anaesthetists and senior perfusionists. It does 17 highlight that due vigilance is required on the part of 18 both anaesthetists and perfusionists in overall 19 intraoperative management, and it also highlights the 20 importance of tripartite communication between 21 anaesthetist, surgeon and perfusionist of everything 22 that is going around the surgical field, because as 23 Mr Wisheart rightly said, the surgeon is concentrating 24 on the technical aspects of the operation and he will be 25 guided by the next in command, the anaesthetist, to 0153 1 inform him and communicate that these aspects are not 2 right and "This is the way to sort it out, could you 3 please do that". It highlights vigilance and 4 communication. 5 DR DICKINSON: I concur. I do not have any additional 6 comments to make. 7 MR LANGSTAFF: Mr Wisheart, today we have looked at 8 different aspects of care; we have looked at the 9 pre-operative; the decision-making; we have looked in 10 the context of at least one of the cases, that of 11 Matthew Rundle, at the question of delay in coming to 12 surgery and the timing of surgery. We have looked at 13 the surgical procedures themselves and, unusually, 14 perhaps, this last case demonstrates the role that each 15 of the individual main components of the team in theatre 16 may play. I have not added to that the roles that 17 others in the theatre such as your assistant or the 18 nurses may play, but they do not emerge, I think, from 19 this particular case. 20 Those, I think, may be the lessons that we will 21 draw from these cases, subject of course to anything 22 that you may want to add in respect of this last case, 23 having had a longer opportunity to think about the 24 thesis that Mr Mankad has put forward, overnight. 25 May I say that I do not expect that Mr Mankad will 0154 1 be here tomorrow, but we can, of course, obtain in due 2 course his input if there is anything which requires it 3 in anything further you want to say. 4 Sir, it is probably too late in the day to make it 5 convenient to begin as it were where we left off in 6 dealing with more general matters, not specifically 7 related to individual cases, and subject to one matter, 8 I am going to propose that we may finish for the 9 afternoon. 10 Would you just give me a moment? (Counsel confer) 11 Thank you sir, for that opportunity to review 12 matters with Mr Moon and with the assistance of 13 Mr Maclean. I am sorry for taking up the few extra 14 minutes -- I am not sorry actually for taking the few 15 extra minutes we did, but we have done. 16 We are now nearly at 4 o'clock, and it may seem an 17 appropriate time to call it a day for today, bearing in 18 mind that we begin tomorrow at 9 o'clock with the 19 evidence of Professor Prys Roberts. I would anticipate 20 that his evidence will take something in the region of 21 a first session in the morning, and so it may well be 22 somewhere round about half past 10, thereabouts, that we 23 will be beginning to hear from Mr Wisheart again. 24 THE CHAIRMAN: That last guidance is helpful, I think, 25 to all. Then we adjourn for this afternoon, until 0155 1 9 o'clock tomorrow morning. I say good afternoon to 2 everyone. 3 MR LANGSTAFF: Sir, may I thank Dr Dickinson and Mr Mankad 4 for their presence. 5 THE CHAIRMAN: You are right to remind me in that 6 indirect manner of my bad manners! I omitted to do 7 that. We, the Panel, are as ever greatly indebted to 8 the help you have given us, today and before, and 9 I thank you very much for coming and being with us. 10 MR MANKAD: It has been a pleasure to be here. 11 (4.00 pm) 12 (Adjourned until 9.00 am on Wednesday, 15th December, 13 1999) 14 15 16 I N D E X 17 18 19 JAMES WISHEART (RECALLED): 20 Examined by MR LANGSTAFF (continued) ....... 4 21 22 23 [Mr Pankaj Mankad and Dr David Dickinson 24 sworn, page 1] 25 0156