Paul Ashton
PFD Report
Partially Responded
Ref: 2014-0170
Coroner's Concerns (AI summary)
There was a lack of consultation with the cardiac transplant team and no established protocol for managing heart transplant patients undergoing non-cardiac surgery, leading to insufficient awareness of specific risks.
Responses
Action Planned
NHS England will task its Rare Disease Advisory Group to prepare recommendations within six months for practical steps to improve care for heart transplant patients. NHS England will also ensure, immediately, through Area Medical Directors, that all hospitals are made aware of the ISHLT guidelines for heart transplant patients. (AI summary)
NHS England will task its Rare Disease Advisory Group to prepare recommendations within six months for practical steps to improve care for heart transplant patients. NHS England will also ensure, immediately, through Area Medical Directors, that all hospitals are made aware of the ISHLT guidelines for heart transplant patients. (AI summary)
View full response
From Dr Dan Poulter MP Parliamentary Under Secretary of State for Health Department Richmond House 79 Whitehall of Health London SWIA 2NS POCS 856041 Tel: 020 7210 4850 Mr A Walsh Area Coroner Coroner' s Office 1 0 JUN 2014 First Floor Paderborn House Howell Croft North Bolton BLI 1QY Oea f ^f Wil Thank you for your letter following the inquest into the death of Paul Michael Ashton: In your report you conclude that the medical cause of death was myocardial ischaemia, transplant associated coronary artery disease, heart transplant for cardiomyopathy and anaesthesia for knee arthroscopy. The conclusion of the inquest was that Mr Ashton died as consequence of a recognised complication of anaesthesia. This followed a background of post-transplant coronary artery disease arising from necessary anti-rejection medication following heart surgery_ When Mr Ashton was 14 months old he had had an orthotropic cardiac transplant at Harefield Hospital, Middlesex and had follow up appointments there with the paediatric cardiology department until 2003. Following this surgery he was prescribed medication to reduce the risk of rejection of the transplanted organ: In 1998 he was diagnosed with Non-Hodgkin's Lymphoma and was treated with chemotherapy. During his lifetime, he also had an appendectomy, a laparoscopic cholecystectomy and knee arthroscopy all performed with general anaesthetic. The knee arthroscopy was performed about three before his death: In 2003 his care was transferred to the cardiac transplant department at Wythenshawe Hospital, Manchester where he had follow up appointments until his death. In 2013 he was referred to a surgeon at Salford Royal Hospital for a further knee arthroscopy and had a pre-op assessment. Both the anaesthetist and surgeon were aware ofhis full medical history including the cardiac transplant The procedure was carried out on 6th January 2014 under general anaesthetic. years
Neither the anaesthetist nor consultant at Salford Royal Hospital had consulted the cardiac transplant team at Wythenshawe hospital who were still monitoring Mr Ashton for his cardiac transplant There was no protocol O1 guideline at Salford Royal Hospital regarding perioperative management of heart transplanted patients due to undergo non-cardiac surgery: In addition, it was not known that there is a high incidence of diseased arteries in heart transplanted patients who have survived more than 25 years after cardiac transplant. During the operation Mr Ashton had a cardiac arrest. Although he was given cardiac pulmonary resuscitation with adrenaline and shock treatment; he failed to respond and died. You raisc the following matters of concern: Salford Royal Hospital did not have a protocol or guideline on the perioperative management of heart transplanted patients undergoing non-cardiac surgery: Although the Trust is now developing such guidelines (available 14th May), it was evident that protocols and guidelines do not exist at many other hospitals in the UK , You are concerned about the absence of such guidelines nationally and you suggest the type of information you would like to see included in guidance to be available in all hospitals. The deceased became bradycardic prior to cardiac arrest and isoprenaline (a direct beta agonist and most effective agent for heart transplanted patients) was not available at Salford Royal Hospital for use in resuscitation. You state that this is no longer available in the UK although it was available until 10 years ago. You consider that there is no medical reason for its removal from the UK market; and note that the is available from non- domestic supplies and international sources and is available at Wythenshaw Hospital: You ask that the source of supply and the important use of Isoprenaline for resuscitation of heart transplanted patients be brought to the attention of all hospitals and health professionals in the UK. Officials have consulted colleagues in NHS England about your concern that guidelines on the perioperative management of heart transplanted patients undergoing non-cardiac surgery should be available in all hospitals. NHS England has advised us that the International Society for Heart and Lung Transplantation (ISHLT) has published guidelines for the care ofheart transplant recipients. Section 12 of these guidelines gives specific advice about non-cardiac surgical procedures carried out in hospitals away from the transplant centre. This includes the importance of a discussion with the centre, and a specific set of recommendations for anaesthesia: drug drug
Heart transplant centres in England do ask patients to inform them when patients are having any medical 0 surgical procedure; and advise that the relevant medical staff should contact the transplant centre. The transplant centre is then able to send advice based on the ISHLT guidelines. However; it is not possible to ensure beyond doubt this method that heart transplant centres are made aware of every procedure on every heart transplant patient: NHS England is therefore considering a strategy that would empower patients to insist that the responsible medical staff take appropriate advice from the expert centre. Patients do not always feel able to voice their needs and concerns, as this tragic case may illustrate The problem is not simple and NHS England intend to consider in more detail what the obstacles are to empowering patients in this way, and what can be done to make the process effective. NHS England is also aware that the problem goes wider than heart transplant patients, though fatal outcomes are mercifully rare. NHS England will therefore task its Rare Disease Advisory Group to prepare recommendations, within six months; for practical steps to make improvements: NHS England will also ensure, immediately, through Area Medical Directors, that all hospitals are made aware of the ISHLT guidelines for heart transplant patients. NHS England also believes that it is likely that isoprenaline is used by all cardiac surgical centres, both adult and paediatric, and that it is also available in private hospitals performing cardiac surgery. It is therefore unlikely to be stocked by hospitals that do not perform cardiac surgery or tertiary cardiology. Good communication between the cardiac centre and the hospital operating on the heart transplant patient should enable supplies to be made available to cover specific procedures in high risk patients. However; the Department of Health is aware that there have been problems with the availability of isoprenaline and I can confirm that as a result of the current problems; the Department of Health asked the NHS UK Medicines Information service (UKMI) to produce a "Shortage Memo' which summarises the situation and advises on alternatives This was sent out to hospitals and uploaded to the UKMI website, at the following address, on 24"h April 2014: Iwww medicinesresources nhsuklen/CommunitiesNNHSISPS_E-and-SE England Medicines-Information Discontinuation-Supply-Shortage-Memos/Shortage_ of-isoprenaline_injectionl The memo is also attached at Annex A for your information. using http:
Ihope that this response is helpful and I am grateful to you for bringing the circumstances of Mr Ashton 's death to my attention: WF Vk Wxa , DR DAN POULTER
Neither the anaesthetist nor consultant at Salford Royal Hospital had consulted the cardiac transplant team at Wythenshawe hospital who were still monitoring Mr Ashton for his cardiac transplant There was no protocol O1 guideline at Salford Royal Hospital regarding perioperative management of heart transplanted patients due to undergo non-cardiac surgery: In addition, it was not known that there is a high incidence of diseased arteries in heart transplanted patients who have survived more than 25 years after cardiac transplant. During the operation Mr Ashton had a cardiac arrest. Although he was given cardiac pulmonary resuscitation with adrenaline and shock treatment; he failed to respond and died. You raisc the following matters of concern: Salford Royal Hospital did not have a protocol or guideline on the perioperative management of heart transplanted patients undergoing non-cardiac surgery: Although the Trust is now developing such guidelines (available 14th May), it was evident that protocols and guidelines do not exist at many other hospitals in the UK , You are concerned about the absence of such guidelines nationally and you suggest the type of information you would like to see included in guidance to be available in all hospitals. The deceased became bradycardic prior to cardiac arrest and isoprenaline (a direct beta agonist and most effective agent for heart transplanted patients) was not available at Salford Royal Hospital for use in resuscitation. You state that this is no longer available in the UK although it was available until 10 years ago. You consider that there is no medical reason for its removal from the UK market; and note that the is available from non- domestic supplies and international sources and is available at Wythenshaw Hospital: You ask that the source of supply and the important use of Isoprenaline for resuscitation of heart transplanted patients be brought to the attention of all hospitals and health professionals in the UK. Officials have consulted colleagues in NHS England about your concern that guidelines on the perioperative management of heart transplanted patients undergoing non-cardiac surgery should be available in all hospitals. NHS England has advised us that the International Society for Heart and Lung Transplantation (ISHLT) has published guidelines for the care ofheart transplant recipients. Section 12 of these guidelines gives specific advice about non-cardiac surgical procedures carried out in hospitals away from the transplant centre. This includes the importance of a discussion with the centre, and a specific set of recommendations for anaesthesia: drug drug
Heart transplant centres in England do ask patients to inform them when patients are having any medical 0 surgical procedure; and advise that the relevant medical staff should contact the transplant centre. The transplant centre is then able to send advice based on the ISHLT guidelines. However; it is not possible to ensure beyond doubt this method that heart transplant centres are made aware of every procedure on every heart transplant patient: NHS England is therefore considering a strategy that would empower patients to insist that the responsible medical staff take appropriate advice from the expert centre. Patients do not always feel able to voice their needs and concerns, as this tragic case may illustrate The problem is not simple and NHS England intend to consider in more detail what the obstacles are to empowering patients in this way, and what can be done to make the process effective. NHS England is also aware that the problem goes wider than heart transplant patients, though fatal outcomes are mercifully rare. NHS England will therefore task its Rare Disease Advisory Group to prepare recommendations, within six months; for practical steps to make improvements: NHS England will also ensure, immediately, through Area Medical Directors, that all hospitals are made aware of the ISHLT guidelines for heart transplant patients. NHS England also believes that it is likely that isoprenaline is used by all cardiac surgical centres, both adult and paediatric, and that it is also available in private hospitals performing cardiac surgery. It is therefore unlikely to be stocked by hospitals that do not perform cardiac surgery or tertiary cardiology. Good communication between the cardiac centre and the hospital operating on the heart transplant patient should enable supplies to be made available to cover specific procedures in high risk patients. However; the Department of Health is aware that there have been problems with the availability of isoprenaline and I can confirm that as a result of the current problems; the Department of Health asked the NHS UK Medicines Information service (UKMI) to produce a "Shortage Memo' which summarises the situation and advises on alternatives This was sent out to hospitals and uploaded to the UKMI website, at the following address, on 24"h April 2014: Iwww medicinesresources nhsuklen/CommunitiesNNHSISPS_E-and-SE England Medicines-Information Discontinuation-Supply-Shortage-Memos/Shortage_ of-isoprenaline_injectionl The memo is also attached at Annex A for your information. using http:
Ihope that this response is helpful and I am grateful to you for bringing the circumstances of Mr Ashton 's death to my attention: WF Vk Wxa , DR DAN POULTER
Sent To
- Department of Health and Social Care
- Medicines and Healthcare Products Regulatory Agency
Response Status
Linked responses
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56-Day Deadline
9 Jun 2014
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 7th January 2014 I commenced an investigation into the death of Paul Michael Ashton, 27 years, born 26th March 1986, The investigation concluded at the end of the inquest on 1st April 2014. The medical cause of death was la) Myocardial Ischaemia, 1b) Transplant: Associated Coronary Artery Disease, 1c) Heart Transplant for Cardiomyopathy 2) Anaesthesia for Knee Arthroscopy: The conclusion of the Inquest was Paul Michael Ashton died as a consequence of a recognised complication of anaesthesia on background of post-transplant coronary artery disease arising from necessary anti-rejection medication following heart transplant surgery:
Circumstances of the Death
1) Paul Michael Ashton died at the Salford Roval Hospital, Eccles Old Road, Salford on the 6th January 2014.
2) On the 25th 1987 the deceased, who was 14 months old at the time, underwent orthotropic cardiac transplant at Harefield Hospital, Middlesex after a diagnosis of Dilated Cardiomyopathy and subsequently he had follow up appointments at Harefield Hospital with the Paediatric Cardiology Department until 2003 when his care was transferred to the Cardiac Transplant Department at Wythenshawe Hospital, Wythenshawe, Manchester where he continued to have follow up appointments until date of his death: Following the transplant surgery in 1987 the deceased was prescribed medication to reduce the the May the risk of rejection of the transplanted organ_
3) In 1998 the deceased was diagnosed with Non-Hodgkin's Lymphoma which was treated with chemotherapy: The deceased also had an appendectomy, a laparoscopic cholecystectomy and a knee arthroscopy which were all performed with general anaesthetics and both the procedures and the anaesthetics were uneventful; The knee arthroscopy was performed approximately 3 years before the deceaseds death. On the 5th November 2013 the deceased was referred tol who is a Consultant Orthopaedic Surgeon at the Salford Roval Hospital in Salford, with a loose body, a small piece of bone in his right knee which was giving him mechanical symptoms and required surgical treatment by way of a right knee arthroscopy: The deceased had a pre-operative assessment and both the anaesthetist and were aware of the deceased's full medical history including the cardiac transplant: The deceased consented to the procedure, namely right knee arthroscopy; and the procedure was listed for the 6th February 2014 with general anaesthetic:
5) At no time prior to the procedure did the Anaesthetist nor consult with the cardiac transplant team at Wythenshawe Hospital who were continuing to monitor the deceased with regard to his cardiac transplant and there was no protocol or guideline at the Salford Royal Hospital relating to the perioperative management of heart-transplanted patients due to undergo or undergoing non-cardiac surgery: It was also not known that there is a high incidence of allograft vasculopathy, meaning the patients coronary arteries are in a diseased state, in heart transplanted patients particularly in patients with long term survival after cardiac transplant beyond 25 years, which is rare: deceased had survived beyond 25 years from the date of his cardic transplant:
6) The deceased was admitted to the Salford Royal Hospital on the 6th January 2014 for the right knee arthroscopy as a patient and the anaesthetic was commenced at 13.39 hours on that date: The deceased was transferred into the operating theatre at 13.58 hours and the procedure was commenced, During the procedure at 14.17 hours the deceased had a cardiac arrest and cardiac pulmonary resuscitation was commenced The deceased was given cardiac pulmonary resuscitation with Adrenaline and shock treatment but in spite of the return of a weak pulse, the deceased failed to respond and his death was certified at 15.55 hours:
2) On the 25th 1987 the deceased, who was 14 months old at the time, underwent orthotropic cardiac transplant at Harefield Hospital, Middlesex after a diagnosis of Dilated Cardiomyopathy and subsequently he had follow up appointments at Harefield Hospital with the Paediatric Cardiology Department until 2003 when his care was transferred to the Cardiac Transplant Department at Wythenshawe Hospital, Wythenshawe, Manchester where he continued to have follow up appointments until date of his death: Following the transplant surgery in 1987 the deceased was prescribed medication to reduce the the May the risk of rejection of the transplanted organ_
3) In 1998 the deceased was diagnosed with Non-Hodgkin's Lymphoma which was treated with chemotherapy: The deceased also had an appendectomy, a laparoscopic cholecystectomy and a knee arthroscopy which were all performed with general anaesthetics and both the procedures and the anaesthetics were uneventful; The knee arthroscopy was performed approximately 3 years before the deceaseds death. On the 5th November 2013 the deceased was referred tol who is a Consultant Orthopaedic Surgeon at the Salford Roval Hospital in Salford, with a loose body, a small piece of bone in his right knee which was giving him mechanical symptoms and required surgical treatment by way of a right knee arthroscopy: The deceased had a pre-operative assessment and both the anaesthetist and were aware of the deceased's full medical history including the cardiac transplant: The deceased consented to the procedure, namely right knee arthroscopy; and the procedure was listed for the 6th February 2014 with general anaesthetic:
5) At no time prior to the procedure did the Anaesthetist nor consult with the cardiac transplant team at Wythenshawe Hospital who were continuing to monitor the deceased with regard to his cardiac transplant and there was no protocol or guideline at the Salford Royal Hospital relating to the perioperative management of heart-transplanted patients due to undergo or undergoing non-cardiac surgery: It was also not known that there is a high incidence of allograft vasculopathy, meaning the patients coronary arteries are in a diseased state, in heart transplanted patients particularly in patients with long term survival after cardiac transplant beyond 25 years, which is rare: deceased had survived beyond 25 years from the date of his cardic transplant:
6) The deceased was admitted to the Salford Royal Hospital on the 6th January 2014 for the right knee arthroscopy as a patient and the anaesthetic was commenced at 13.39 hours on that date: The deceased was transferred into the operating theatre at 13.58 hours and the procedure was commenced, During the procedure at 14.17 hours the deceased had a cardiac arrest and cardiac pulmonary resuscitation was commenced The deceased was given cardiac pulmonary resuscitation with Adrenaline and shock treatment but in spite of the return of a weak pulse, the deceased failed to respond and his death was certified at 15.55 hours:
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.