- Email: [email protected]
The Bristol Affair: lessons to be learned
Ann Thorac Surg 2001;71:1399 –1404
tion with bacteria and, hence, introduction of infection into the pleural space when performing blood pleurodesis. One potential complication of blood pleurodesis, that everybody should be aware of, is the risk of tension pneumothorax occurring due to blood clotting in the chest drain. In light of the reported success of blood pleurodesis, further randomized control trials are needed to ascertain the true value of this technique, the optimal volume of blood to inject, and the best time to perform blood pleurodesis. Michael Shackcloth, FRCS Mike Poullis, FRCS Richard Page, FRCS (CTh) The Cardiothoracic Centre Thomas Dr Liverpool L14 3PE, United Kingdom e-mail: [email protected].
Reference 1. Rivas de Andre´s JJ, Blanco S, de la Torre M. Postsurgical pleurodesis with autologous blood in patients with persistent air leak. Ann Thorac Surg 2000;70:270–2.
Reply To the Editor: We appreciate the comments and suggestions proposed by Shackcloth and colleagues which will undoubtedly improve the technique described by us of pleurodesis with autologous blood for treating persistent air leak following lung resection surgery [1]. Deciding the timing is complex. Carrying out pleurodesis after 5 days instead of 9 could be beneficial with regard to hospital stay, however, this means that blood patch is done on some patients whose problem could be solved by simply maintaining chest tubes for a further 4 days. On the other hand, we do not know if the rest of the lung parenchyma where there is no air leak would be sufficiently attached to avoid collapse the moment autologous blood patch technique is carried out. Without doubt, further randomized control trials will resolve many of the questions which we have at this moment. Juan J. Rivas de Andre´s, MD Thoracic Surgery Service Hospital “Miguel Servet” Isabel la Cato´lica 1 50009 Zaragoza, Spain e-mail: [email protected]. Sandra Blanco, MD, PhD Mercedes de la Torre, MD Thoracic Surgery Service Hospital “Juan Canalejo” Xubias de Arriba, 84 15006 A Corun˜a, Spain
Reference 1. Rivas de Andre´s JJ, Blanco S, de la Torre M. Postsurgical pleurodesis with autologous blood in patients with persistent air leak. Ann Thorac Surg 2000;70:270–2. © 2001 by The Society of Thoracic Surgeons Published by Elsevier Science Inc
CORRESPONDENCE
1403
The Bristol Affair: Lessons to Be Learned To the Editor: As the two cardiac surgeons found guilty of Serious Professional Misconduct by the General Medical Council (GMC) on June 18, 1998, we welcome the Editorial written by James L. Monro [1]. The profession, and in particular cardiothoracic surgeons, who have had little information other than that available in the press and media, should have access to information that is both detailed and accurate. Our purpose in writing is to clarify further some issues raised by Mr Monro and to draw attention to one or two others. The GMC hearings and verdict focused on the complete atrioventricular septal defect (AVSD) operations performed by Mr Wisheart and the arterial switch procedures carried out by Mr Dhasmana; for each of us this amounted to 3% of our pediatric cardiac surgical practice. There was no criticism of the remainder of our practice. The eventual verdict was based on three AVSD operations, two neonatal arterial switch procedures and one switch operation in an older child [2]. That the results for these two operations were worse than those in other units at the time was known by us and was not in dispute. The question was, “Why were the results worse?” Initially there were charges against each of us that the operations “ . . . were beyond the limits of your clinical competence and technical expertise,” but these were rejected by the GMC. Case-mix and risk stratification were major issues before the GMC. The experts on both sides agreed that there were a disproportionately high number of significant additional risk factors in the small series of patients under consideration, but this did not apparently influence the Professional Conduct Committee in reaching their verdict. Here is another lesson: risk stratification must be given due weight in outcome assessment. Otherwise, not only will some surgeons be wrongly criticized, but more importantly, and as Mr Monro points out so clearly, high-risk patients may suffer by being denied operations. The GMC found that serious concerns had been expressed by colleagues which, it was alleged, were disregarded. The evidence before the GMC on this point was at best contentious. One operation only, the switch operation in January 1995 on an 18-month-old child, followed what could have been regarded as an expression of concern. In response to those concerns, two meetings of the full clinical team, in December 1994 and in January 1995, considered whether proceeding with the operation was in the child’s best interest; only then was it scheduled and carried out. The results of switch operations in nonneonates in our unit were presented and found to be within the range of published outcomes and were accepted by all as satisfactory. Without presuming to anticipate the findings of the Bristol Royal Infirmary Inquiry (BRII), it is clear from the evidence given to it, and available on the Internet [3], that these concerns were not articulated to us or to our pediatric cardiological colleagues before the final stages of this affair. The editorial states, “The operations had continued until, following the death of a child in January 1995, they were stopped and another surgeon appointed.” This is not correct. Mr Dhasmana made his own decision to stop doing the neonatal switch operation in October 1993, and Mr Wisheart stopped correcting complete AVSDs in the autumn of 1994. The circumstances of the operation in January 1995 have been described in the preceding paragraph. Bristol’s first full-time pediatric cardiac surgeon was appointed in September 1994 in recognition of the need to improve the pediatric cardiac surgical service for the future. 0003-4975/01/$20.00
1404
CORRESPONDENCE
The United Kingdom Cardiac Surgical Register (UKCSR) is one of the prized achievements of the specialty in the United Kingdom. Sadly, it has been criticized for lack of validation and potentially significant inaccuracies [4, 5]. The importance of this is that information from the UKCSR has been the comparator against which our results have been judged. If the comparator is unreliable to a significant extent, how valid are the comparisons? Mr Monro points to the need for a “whistle-blower” to be able to act without fear. We agree absolutely that any colleague should be able to raise issues openly and fully in a constructive forum, with the goal of improving patient care. In Bristol we had a multidisciplinary audit process that was evolving, thorough, openly undertaken, and provided such opportunities regularly. Rhetorically, Mr Monro asks why the pediatricians continued to refer patients to the Bristol surgeons. The answer lies in their knowledge of the results and the patients. The cardiologists joined with the surgeons in regular audits of the results and in a detailed review of each patient who died; thus they were familiar not only with the figures but also with the individual cases making up those figures. For example, the arterial switch data were formally presented on at least three occasions between June 1992 and January 1995. The Hospital Trust published the pediatric cardiac surgical results for 1990 to 1995 in January 1996 [6]. In commenting on them, Mr Marc de Leval stated that “the Bristol performance over the last 3 years in terms of mortality matches with the average U.K. results as published by the U.K. Cardiac Surgical Register, including open heart surgery in infants, with the exception of the results of AVSD and arterial switch procedures” [6]. Not everything was right at Bristol and there are lessons to be learned, but the reporting of what happened has been inaccurate and distorted to an alarming degree. Finally, we would like to draw your attention to the remarks of the Legal Assessor to the committee of the GMC before it retired to reach its verdict. He said, “You have heard evidence that all the practitioners before you are of unimpeachable character. Their integrity and their commitment to the interests of patients have not been questioned. Their honesty in giving evidence has not been challenged” [7]. James D. Wisheart, MCh Janardan P. Dhasmana, FRCS Gorsehill 3a Southfield Rd
Ann Thorac Surg 2001;71:1399 –1404
Westbury-on-Trym Bristol BS9 3BG, United Kingdom
References 1. Monro JL. Lessons to be learnt from the Bristol Affair [Editorial]. Ann Thorac Surg 2000;69:674–5. 2. President of the General Medical Council. Announcement of determination. The Bristol Hearing, London, June 18, 1998. 3. The Internet address of the Bristol Royal Infirmary Inquiry is: http://www.bristol-inquiry.org.uk. 4. Stark J. Evidence to the Bristol Royal Infirmary Inquiry, transcript day 84, page 36, line 15, to page 37, line 4, November 29, 1999 (as on the Internet). 5. Murray G. Evidence to the Bristol Royal Infirmary Inquiry, transcript day 70, page 125, line 20, to page 127, line 1, November 3, 1999 (as on the Internet). 6. Bristol Paediatric Cardiac Surgery 1990 –1995. United Bristol Healthcare Trust, January 1996. 7. The Legal Assessor. Advice to the Professional Conduct Committee, General Medical Council, London.
Reply To the Editor: Thank you for the opportunity of replying to the letter from Mr Wisheart and Mr Dhasmana. I am grateful to them for clarifying and expanding on the brief comment on the events related to the Bristol Affair in my editorial. The current inquiry under the chairmanship of Professor Ian Kennedy has gone rather quiet lately. This is possibly the lull before the storm that we can expect with the report due out later this year. Hopefully all units undertaking pediatric cardiac operations will have established a database of all pediatric operations performed and have in place a system of audit for mortality and morbidity. James L Monro, FRCS Department of Cardiac Surgery The General Hospital Tremona Rd, Mailpoint 46 Southampton SO16 6YD, United Kingdom e-mail: monro1711aol.com.
tion with bacteria and, hence, introduction of infection into the pleural space when performing blood pleurodesis. One potential complication of blood pleurodesis, that everybody should be aware of, is the risk of tension pneumothorax occurring due to blood clotting in the chest drain. In light of the reported success of blood pleurodesis, further randomized control trials are needed to ascertain the true value of this technique, the optimal volume of blood to inject, and the best time to perform blood pleurodesis. Michael Shackcloth, FRCS Mike Poullis, FRCS Richard Page, FRCS (CTh) The Cardiothoracic Centre Thomas Dr Liverpool L14 3PE, United Kingdom e-mail: [email protected].
Reference 1. Rivas de Andre´s JJ, Blanco S, de la Torre M. Postsurgical pleurodesis with autologous blood in patients with persistent air leak. Ann Thorac Surg 2000;70:270–2.
Reply To the Editor: We appreciate the comments and suggestions proposed by Shackcloth and colleagues which will undoubtedly improve the technique described by us of pleurodesis with autologous blood for treating persistent air leak following lung resection surgery [1]. Deciding the timing is complex. Carrying out pleurodesis after 5 days instead of 9 could be beneficial with regard to hospital stay, however, this means that blood patch is done on some patients whose problem could be solved by simply maintaining chest tubes for a further 4 days. On the other hand, we do not know if the rest of the lung parenchyma where there is no air leak would be sufficiently attached to avoid collapse the moment autologous blood patch technique is carried out. Without doubt, further randomized control trials will resolve many of the questions which we have at this moment. Juan J. Rivas de Andre´s, MD Thoracic Surgery Service Hospital “Miguel Servet” Isabel la Cato´lica 1 50009 Zaragoza, Spain e-mail: [email protected]. Sandra Blanco, MD, PhD Mercedes de la Torre, MD Thoracic Surgery Service Hospital “Juan Canalejo” Xubias de Arriba, 84 15006 A Corun˜a, Spain
Reference 1. Rivas de Andre´s JJ, Blanco S, de la Torre M. Postsurgical pleurodesis with autologous blood in patients with persistent air leak. Ann Thorac Surg 2000;70:270–2. © 2001 by The Society of Thoracic Surgeons Published by Elsevier Science Inc
CORRESPONDENCE
1403
The Bristol Affair: Lessons to Be Learned To the Editor: As the two cardiac surgeons found guilty of Serious Professional Misconduct by the General Medical Council (GMC) on June 18, 1998, we welcome the Editorial written by James L. Monro [1]. The profession, and in particular cardiothoracic surgeons, who have had little information other than that available in the press and media, should have access to information that is both detailed and accurate. Our purpose in writing is to clarify further some issues raised by Mr Monro and to draw attention to one or two others. The GMC hearings and verdict focused on the complete atrioventricular septal defect (AVSD) operations performed by Mr Wisheart and the arterial switch procedures carried out by Mr Dhasmana; for each of us this amounted to 3% of our pediatric cardiac surgical practice. There was no criticism of the remainder of our practice. The eventual verdict was based on three AVSD operations, two neonatal arterial switch procedures and one switch operation in an older child [2]. That the results for these two operations were worse than those in other units at the time was known by us and was not in dispute. The question was, “Why were the results worse?” Initially there were charges against each of us that the operations “ . . . were beyond the limits of your clinical competence and technical expertise,” but these were rejected by the GMC. Case-mix and risk stratification were major issues before the GMC. The experts on both sides agreed that there were a disproportionately high number of significant additional risk factors in the small series of patients under consideration, but this did not apparently influence the Professional Conduct Committee in reaching their verdict. Here is another lesson: risk stratification must be given due weight in outcome assessment. Otherwise, not only will some surgeons be wrongly criticized, but more importantly, and as Mr Monro points out so clearly, high-risk patients may suffer by being denied operations. The GMC found that serious concerns had been expressed by colleagues which, it was alleged, were disregarded. The evidence before the GMC on this point was at best contentious. One operation only, the switch operation in January 1995 on an 18-month-old child, followed what could have been regarded as an expression of concern. In response to those concerns, two meetings of the full clinical team, in December 1994 and in January 1995, considered whether proceeding with the operation was in the child’s best interest; only then was it scheduled and carried out. The results of switch operations in nonneonates in our unit were presented and found to be within the range of published outcomes and were accepted by all as satisfactory. Without presuming to anticipate the findings of the Bristol Royal Infirmary Inquiry (BRII), it is clear from the evidence given to it, and available on the Internet [3], that these concerns were not articulated to us or to our pediatric cardiological colleagues before the final stages of this affair. The editorial states, “The operations had continued until, following the death of a child in January 1995, they were stopped and another surgeon appointed.” This is not correct. Mr Dhasmana made his own decision to stop doing the neonatal switch operation in October 1993, and Mr Wisheart stopped correcting complete AVSDs in the autumn of 1994. The circumstances of the operation in January 1995 have been described in the preceding paragraph. Bristol’s first full-time pediatric cardiac surgeon was appointed in September 1994 in recognition of the need to improve the pediatric cardiac surgical service for the future. 0003-4975/01/$20.00
1404
CORRESPONDENCE
The United Kingdom Cardiac Surgical Register (UKCSR) is one of the prized achievements of the specialty in the United Kingdom. Sadly, it has been criticized for lack of validation and potentially significant inaccuracies [4, 5]. The importance of this is that information from the UKCSR has been the comparator against which our results have been judged. If the comparator is unreliable to a significant extent, how valid are the comparisons? Mr Monro points to the need for a “whistle-blower” to be able to act without fear. We agree absolutely that any colleague should be able to raise issues openly and fully in a constructive forum, with the goal of improving patient care. In Bristol we had a multidisciplinary audit process that was evolving, thorough, openly undertaken, and provided such opportunities regularly. Rhetorically, Mr Monro asks why the pediatricians continued to refer patients to the Bristol surgeons. The answer lies in their knowledge of the results and the patients. The cardiologists joined with the surgeons in regular audits of the results and in a detailed review of each patient who died; thus they were familiar not only with the figures but also with the individual cases making up those figures. For example, the arterial switch data were formally presented on at least three occasions between June 1992 and January 1995. The Hospital Trust published the pediatric cardiac surgical results for 1990 to 1995 in January 1996 [6]. In commenting on them, Mr Marc de Leval stated that “the Bristol performance over the last 3 years in terms of mortality matches with the average U.K. results as published by the U.K. Cardiac Surgical Register, including open heart surgery in infants, with the exception of the results of AVSD and arterial switch procedures” [6]. Not everything was right at Bristol and there are lessons to be learned, but the reporting of what happened has been inaccurate and distorted to an alarming degree. Finally, we would like to draw your attention to the remarks of the Legal Assessor to the committee of the GMC before it retired to reach its verdict. He said, “You have heard evidence that all the practitioners before you are of unimpeachable character. Their integrity and their commitment to the interests of patients have not been questioned. Their honesty in giving evidence has not been challenged” [7]. James D. Wisheart, MCh Janardan P. Dhasmana, FRCS Gorsehill 3a Southfield Rd
Ann Thorac Surg 2001;71:1399 –1404
Westbury-on-Trym Bristol BS9 3BG, United Kingdom
References 1. Monro JL. Lessons to be learnt from the Bristol Affair [Editorial]. Ann Thorac Surg 2000;69:674–5. 2. President of the General Medical Council. Announcement of determination. The Bristol Hearing, London, June 18, 1998. 3. The Internet address of the Bristol Royal Infirmary Inquiry is: http://www.bristol-inquiry.org.uk. 4. Stark J. Evidence to the Bristol Royal Infirmary Inquiry, transcript day 84, page 36, line 15, to page 37, line 4, November 29, 1999 (as on the Internet). 5. Murray G. Evidence to the Bristol Royal Infirmary Inquiry, transcript day 70, page 125, line 20, to page 127, line 1, November 3, 1999 (as on the Internet). 6. Bristol Paediatric Cardiac Surgery 1990 –1995. United Bristol Healthcare Trust, January 1996. 7. The Legal Assessor. Advice to the Professional Conduct Committee, General Medical Council, London.
Reply To the Editor: Thank you for the opportunity of replying to the letter from Mr Wisheart and Mr Dhasmana. I am grateful to them for clarifying and expanding on the brief comment on the events related to the Bristol Affair in my editorial. The current inquiry under the chairmanship of Professor Ian Kennedy has gone rather quiet lately. This is possibly the lull before the storm that we can expect with the report due out later this year. Hopefully all units undertaking pediatric cardiac operations will have established a database of all pediatric operations performed and have in place a system of audit for mortality and morbidity. James L Monro, FRCS Department of Cardiac Surgery The General Hospital Tremona Rd, Mailpoint 46 Southampton SO16 6YD, United Kingdom e-mail: monro1711aol.com.