Prevention of Future Deaths reports · 2014
Regulation 28 report to prevent future deaths, reference 2014-0170, written 14 Apr 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 14 Apr 2014 |
|---|---|
| Reference | 2014-0170 |
| Deceased | Paul Ashton |
| Coroner | Alan Walsh |
| Coroner area | Manchester (West) |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
REG ULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) NOTE: This form is to be used after an inquest. 7 _ REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Mr Jeremy Hunt MP, Secretary of State for Health 2. Dr Ian Hudson, Chief Executive, Medicines & Healthcare Products Regulatory Agency (MHRA) CORONER Iam Alan Peter Walsh, Area Coroner for the Coroner Area of Manchester West CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. INVESTIGATION and INQUEST On 7" January 2014 I commenced an investigation into the death of Paul Michael Ashton, 27 years, born 26" March 1986. The investigation concluded at the end of the inquest on 1* April 2014. The medical cause of death was 1a) 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 a 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 Royal Hospital, Eccles Old Road, Salford on the 6" January 2014. 2) On the 25" May 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 the date of his death. Following the transplant surgery in 1987 the deceased was prescribed medication to reduce 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 deceased’s death. 4)_On the 5" November 2013 the deceased was referred to who is a Consultant Orthopaedic Surgeon at the Salford Royal Hospital in Salford, with a loose body, being 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 a right knee arthroscopy, and the procedure was listed for the 6" February 2014 with a general anaesthetic. 5) At no time prior to the procedure did the Anaesthetist nor P| 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. The 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 6” January 2014 for the right knee arthroscopy as a day 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. T 5 | CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. ee Ne The MATTERS OF CONCERN are as follows: 7 (1) During the inquest evidence was heard that The Salford Royal Hospital did not have a protocol or a guideline on the perioperative management of heart transplanted patients undergoing non-cardiac surgery. The Salford Royal Hospital Foundation Trust is now developing Trust wide guidelines for the management of heart transplanted patients undergoing non cardiac surgery and the guidelines should be available and operational in May 2014. However information was given at the inquest that protocols and guidelines do not exist at many other hospitals in the United Kingdom. A Consultant Cardiologist from the cardiac transplant team at Wythenshawe Hospital, Wythenshawe, Manchester confirmed that a member of the team is available 24 hours a day, 7 days a week for the referral of any patient or for guidance in relation to the treatment of heart transplanted patients. The cardiac transplant team at Wythenshawe Hospital would be available to discuss the perioperative management of heart transplanted patients undergoing non cardiac surgery and information has now been given to the Salford Royal Hospital by a cardiac anaesthetist from the Wythenshawe Hospital that the placement of an arterial line might have helped to detect abnormalities earlier during the course of the procedure although it is unclear whether this would have made a difference in relation to the death of the deceased. However the placement of an arterial line may have alerted the anaesthetist earlier of any impending deterioration of the patient’s condition. The deceased became bradycardic in the short period prior to the cardiac arrest and Isoprenaline, which is a direct beta agonist, was not available at the Salford Royal Hospital for use in the course of the resuscitation attempts. Isoprenaline is the most effective anti-bradycardic agent in heart transplanted patients but the evidence at the Inquest was that Isoprenaline is no longer available in the United Kingdom. The evidence was that Isoprenaline was available in the United Kingdom up to approximately 10 years ago and there appears to be no medical reason for its removal from the United Kingdom market. It is understood that it is simply not cost effective for the pharmaceutical companies to make the medication available in the United Kingdom. Evidence was given that Isoprenaline is available from non domestic supplies and international sources. It was understood that supplies of Isoprenaline are available at the Wythenshawe Hospital, Manchester obtained from an international source. The use of Isoprenaline for heart transplanted patients does not increase the resistance of the blood vessels around the body which means that the heart does not have to pump against increased resistance thereby benefitting any attempts at resuscitation particularly in relation to heart transplanted patients. Salford Royal Hospital has now obtained stocks of Isoprenaline which is available in operating theatres together with laminated cards detailing how to prepare and administer the drug. The main root cause of the cardiac arrest suffered by the deceased and his subsequent failure to respond to all the resuscitative measures was identified as his past medical history of heart transplant more than 25 years ago. It has become clear that the predominant cause of death once the first 5 years after heart transplantation has passed is cardiac allograft vasculopathy, which is a form of coronary artery disease that is not amenable to surgical treatment such as angioplasty, stenting or even bypass graft surgery. Symptoms of myocardial ischaemia that occurs as a consequence of coronary artery narrowing e.g. chest pain, are frequently absent due to the denervated state of the transplanted heart. The knowledge of conditions special to heart transplanted patients is with Cardiac Consultants in cardiac transplant teams at regional centres around the United Kingdom who should be consulted to give guidance regarding the perioperative management of heart transplanted patients undergoing non cardiac surgery and such guidance could be embodied in protocols and guidelines at each hospital in the United Kingdom. The supply of Isoprenaline is not available in the United Kingdom and the source of the supply and the importance of the use of Isoprenaline in the resuscitation of heart transplanted patients should be brought to the attention of all hospitals and health professionals in the United Kingdom. (2) I have concerns with regard to the following:- The absence of protocols and guidelines in Hospitals dealing with the perioperative management of heart transplanted patients due to undergo or undergoing non cardiac surgery. Such a protocol or guidelines could summarise issues that need to be considered when assessing and caring for a patient with a transplanted heart and the elements of such protocol or guidelines could include the following: a) Pre-operative assessment b) Liaising with the transplant unit the patient is under for follow up. c) Guidance on risk d) Benefit discussions with the patient and consent process ACTION SHOULD BE TAKEN e) Perioperative management (anaesthetic technique(s), monitoring, drugs and their doses and fluid balance etc.) f} Postoperative care g) Strategies for perioperative complications including resuscitation procedures and the use of Isoprenaline. ii, The source, availability and the use of Isoprenaline in Hospitals and by health professionals in relation to the resuscitation of heart transplanted patients. Isoprenaline is a drug that is considered to be the best anti-bradycardic agent in denervated or transplanted patients and disappeared from the United Kingdom formulary about 10 years ago. It is therefore assumed that it is not available anymore and that Adrenaline is the only drug effective in bradycardia in denervated hearts. iii. Trequest the Ministry of State and the Medicines and Healthcare Products Regulatory Agency to consider the above concerns. In my opinion urgent action should be taken to prevent future deaths and 1 believe you and/or your organisation have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this | report, namely by 9" June 2014. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. COPIES and PUBLICATION of your response by the Chief Coroner. I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: 1) father of Paul Michael Ashton 2) Sir David Dalton, Chief Executive, Salford Royal Hospital, Salford I am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication Dated 14" April 2014 Alan Peter Walsh
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
; 2 » From Dr Dan Poulter MP NSD Parliamentary Under Secretary of State for Health Department Richmond House of Health ila SWIA 2NS POCS5 856041 Tel: 020 7210 4850 Mr A Walsh Area Coroner Coroner’s Office First Floor 10 JUN 2014 Paderborn House Howell Croft North Bolton BL1 1QY Deny DN Wobde 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 a 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 years 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 of his full medical history including the cardiac transplant. The procedure was carried out on 6" January 2014 under general anaesthetic. 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 or 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 raise 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 14 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. e 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 drug 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 drug 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 of heart 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. Heart transplant centres in England do ask patients to inform them when patients are having any medical or 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 using 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" April 2014: http://www.medicinesresources.nhs.uk/en/Communities/NHS/SPS-E-and-SE- England/Medicines-Information/Discontinuation-Supply-Shortage-Memos/Shortage- of-isoprenaline-injection/ The memo is also attached at Annex A for your information. I hope that this response is helpful and I am grateful to you for bringing the circumstances of Mr Ashton’s death to my attention. jy DR DAN POULTER
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