Prevention of Future Deaths reports · 2019
Regulation 28 report to prevent future deaths, reference 2019-0366, written 6 Nov 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 6 Nov 2019 |
|---|---|
| Reference | 2019-0366 |
| Deceased | Stuart Clarke |
| Coroner | Rachel Galloway |
| Coroner area | Manchester City |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Manchester University NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 4 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: (1) NHS England and NHS Improvement (2) National Institute for Health and Care Excellence (NICE) (3) Department of Health and Social Care (4) British Cardiovascular Intervention Society 1 CORONER I am, Rachel Galloway, Assistant Coroner for the Coroner Area of Manchester City. 2 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 3 INVESTIGATION and INQUEST On the 2nd July 2019 an investigation was commenced into the death of Stuart Clarke, aged 82 years, born on the 15th October 1936. The investigation concluded following the inquest on the 22nd October 2019. The Medical Cause of Death was: 1a Pulmonary Oedema 1b Left Ventricular Dysfunction II Complications of Aortic Valve Procedure, Coronary Artery Disease and Hypertension. The conclusion at the inquest was: Narrative Conclusion: Stuart Clarke died as a consequence of naturally occurring disease, exacerbated by complications arising out of an aortic valve procedure. 4 CIRCUMSTANCES OF THE DEATH 1. In February 2018, Stuart Clarke presented at his GP with symptoms of breathlessness. However, it was not until the 25th June 2019 (16 months later) that Mr Clarke finally underwent necessary Transcatheter Aortic Valve Implantation (TAVI) at Wythenshawe Hospital. 2. Evidence was heard from the Consultant Cardiologist at Wythenshawe Hospital, who carried out the TAVI procedure on the 25th June 2019. She confirmed that this overall pathway from onset of symptoms to treatment in Mr Clarke’s case was unacceptably long. In the event, Mr Clarke did not recover following the procedure on the 25th June 2019 and his condition declined, leading to his death at Wythenshawe Hospital on the 27th June 2019. 1 In evidence, the Consultant Cardiology expressed the view that – had the procedure been carried out in a timelier manner – the outcome might have been different for Mr Clarke. She could not say if the outcome would have been different on the balance of probabilities. 3. The Consultant Cardiologist explained that the normal patient journey would involve referral by the GP to the local hospital. In the present case, Mr Clarke was referred to Cardiology at Royal Oldham Hospital. It is then for the local hospital (in this instance, Royal Oldham Hospital) to refer to the tertiary centre (in this case, Wythenshawe Hospital) for specialist assessment. Mr Clarke was not seen at Wythenshawe Hospital until January 2019. It then took a further 5 months for his suitability for TAVI to be confirmed and then for the procedure to take place. 5 CORONER’S CONCERNS During 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. During the inquest, evidence was heard that: By the time that Mr Clarke underwent the TAVI procedure on the 25th June 2019 he had deteriorated and was significantly less well than he had been in the months following his initial presentation to his GP in February 2018. During the course of the inquest, I heard that steps are being taken at local level to ensure more timely intervention in similar cases. However, I was concerned that there remain no national guidelines for referral from primary care to secondary care and/or from secondary care to tertiary care for patients with known valve disease. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by Monday 6th January 2020. I, the assistant 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. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and the following Persons: – Wife of Mr Clarke (1) (2) (3) Medical Director - Manchester University NHS Foundation Trust (4) Medical Director – The Pennine Acute Hospitals NHS Foundation Trust (5) MFT Heart and Lung Clinical Standards Group – Daughter of Mr Clarke 2 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 assistant coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. 9 Dated 6th November 2019 Signed: Rachel Galloway HM Assistant Coroner 3
4 responses 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.
President Prof Adrian Banning Department of Cardiology John Radcliffe Hospital Headington Oxford OX3 9DU Honorary Secretary Treasurer Department of Cardiology Leeds General Infirmary Great George Street Leeds LS1 3EX Manchester Heart Centre Manchester Royal Infirmary Oxford Road Manchester M13 9WL Ms Rachel Galloway H.M Assistant Coroner H.M Coroner’s Office Manchester City Area Exchange Floor The Royal Exchange Cross Street Manchester, M2 7EF 12 December 2019 Dear Ms Galloway Regulation 28 report (re: Stuart Clarke, deceased) Thank you for contacting the British Cardiovascular Intervention Society (BCIS) about the outcome of this recent inquest. We note that the patient presented with symptoms of breathlessness in Feb 2018 and sadly died two days after a TAVI procedure in June 2019. We agree that this represents a clinically unacceptable delay (18 months) before the TAVI procedure was performed. Transcatheter Aortic Valve Intervention (TAVI) is a transformative technology which is much less invasive than conventional open heart surgery. Large international clinical trials have shown that patient outcomes are better than conventional surgery for patients who are ‘high risk’ (Euroscore II >8%) or ‘intermediate risk’ (Euroscore II >4%) surgical candidates. As the evidence base increases it is likely that the use of TAVI internationally will grow. Our professional society has published an updated service specification for TAVI this year (enclosed). In this document we outline the essential criteria for hospitals to provide a high quality TAVI service. These include detailed recommendations about training, hospital volumes, length of stay and national data collection. In particular we recommend a maximum waiting time of 18 weeks between initial referral and treatment and local audit of waiting times. BCIS would support the Department of Health and NHS England in moves to ensure that there is adequate capacity for TAVI candidates to be seen, investigated and treated without undue delay. In addition, we will contact our members to ask them to review local referral pathways to expedite treatment and prevent delays. c/o BCS, 9 Fitzroy Square, London W1T 5HW / Tel: +44 (0)20 7380 1918 / Email bcis@bcs.com / Web: www.bcis.org.uk Company limited by guarantee, registered no 07326046. Registered charity no 1138385 Yours sincerely Dr Gerald Clesham Chairman, Clinical Standards Group, British Cardiovascular Intervention Society c/o BCS, 9 Fitzroy Square, London W1T 5HW / Tel: +44 (0)20 7380 1918 / Email bcis@bcs.com / Web: www.bcis.org.uk Company limited by guarantee, registered no 07326046. Registered charity no 1138385
a6} F le G FE I V E From Edward Argar MP Departm ent Minister of State for Health ~ 9 MAR 2028 ero of Health & 39 Victoria Street SocialCare __uut Pe. SW1H EU 020 7210 4850 Our Reference: PFD-1196556 Ms Rachel Galloway HM Assistant Coroner, Manchester City HM Coroner's Office Exchange Floor, The Royal Exchange Cross Street Manchester M2 7EF nt 5” March 2020 Den Me Gatien, Thank you for your letter of 5 November 2019 to Matt Hancock about the death of Mr Stuart Clarke. | am replying as Minister with responsibility for elective care and | am grateful for the additional time in which to do so. Firstly, | would like to extend my deepest sympathies to Mr Clarke’s family and loved ones. | understand how distressing it is to lose a loved one and concerns about the timeliness of the medical treatment Mr Clarke received must be particularly upsetting. We must do all we can to learn from Mr Clarke’s death to make improvements and prevent future deaths. You issued your report to NHS England and NHS Improvement and the National Institute for Health and Care Excellence (NICE). You will therefore be aware from their responses that existing NICE guidance on chronic heart failure’, issued in 2018, does not specify a time in which patients with chronic heart failure thought to be caused by heart valve disease should be seen by a specialist. The timing of any intervention is a matter of clinical judgement and services should be arranged to support the provision of timely and appropriate clinical care. | note that NICE is currently developing a clinical guideline on heart valve disease in adults and the guideline is expected to cover investigation and management of the condition, as well as indications for the referral of patients from primary to specialist care. | understand that the matters of concern in your report about the circumstances of Mr Clarke’s treatment journey will be made known to those developing the guideline. The provision of Transcatheter Aortic Valve Implantation (TAVI) services in Greater Manchester is a matter for the relevant NHS acute trust, with oversight from NHS England as the commissioner of specialised services. It is for the NHS in Greater Manchester to 1 https:/Awww.nice org.uk/guidance/ng106 work with NHS England to ensure that services meet the healthcare needs of patients with heart valve disease. | am advised that the Manchester University NHS Foundation Trust, which is the only NHS trust in Greater Manchester to provide TAVI, is looking at how it can improve processes to support quicker diagnosis and treatment for patients with suspected heart valve disease. In addition, the Greater Manchester Cardiac Network is looking at what more can be done to support GPs across Greater Manchester to identify and refer patients with heart problems in good time to the right heart specialist centre. | hope this response is helpful. Thank you for bringing these concerns to my attention. EDWARD ARGAR MP
Professor Stephen Powis
National Medical Director
Skipton House
80 London Road
SE1 6LH
10th February 2020
Ms Rachel Galloway
HM Assistant Coroner
H.M. Coroner’s Office
Manchester City Area
Exchange Floor
The Royal Exchange
Cross Street
Manchester
M2 7EF
Dear Ms Galloway
Re: Regulation 28 Report to Prevent Future Deaths – Stuart Clarke, 27 June
2019
Thank you for your Regulation 28 Report (hereinafter the ‘report’) dated 05
November 2019 concerning the death of Mr Stuart Clarke on 27 June 2019. Firstly,
I would like to express my deep condolences to Mr Clarke’s family.
The report notes that the recent inquest concluded that Mr Clarke’s death was a
consequence of naturally occurring disease, exacerbated by complications arising
out of an aortic valve procedure.
Following the inquest, you raised concerns in the report for the consideration of
NHS England regarding a risk that future deaths will occur unless action is taken. In
particular you were concerned that there is no national guideline for referral from
primary care to secondary care, and/or from secondary care to tertiary care, for
patients with known valve disease.
In response please note following the very sad death of Mr Clarke, the cardiac
doctors of the Greater Manchester Cardiac Network have reviewed the case and
believe that the main issue in Mr Clarke’s care was the delay in his specialised
treatment. Currently there are no national targets or guidelines on how quickly a
patient with a heart condition similar to Mr Clarke’s should be diagnosed and then
receive the corrective treatment. However if on the first presentation of symptoms
Mr Clarke was clinically suitable and eligible for a Transcatheter aortic value
implantation (TAVI) procedure, the clinicians believe the length of wait was and is
unacceptable.
The procedure that Mr Clarke had (TAVI) is only performed at one specialist heart
centre in Greater Manchester at Manchester Foundation Trust (MFT). Patients
who need this procedure are referred into the service through hospital cardiology
departments.
MFT has already started looking at how to improve systems between the two
NHS England and NHS Improvement
cardiac centres (Manchester Royal Infirmary and Wythenshawe Hospital) so that
patients with this heart condition are able to receive a much quicker service.
The Greater Manchester Cardiac Network, which includes cardiac doctors, nurses
and other health professionals will now look at how they could support and extend
the work being done at MFT to improve this heart care pathway so that people
across GM are better identified by General Practitioners (GPs) and then sent to the
right heart specialist centre to have the procedure done much quicker than is
currently the case.
Thank you for bringing this important patient safety issue to my attention and
please do not hesitate to contact me should you need any further information.
Yours sincerely,
Professor Stephen Powis
National Medical Director
NHS England and NHS Improvement
NHS England and NHS Improvement
Roo) 25 — Fufs, MICE. N | C National Institute for 10 Spring Gardens Health and Care Excellence London SW1A 2BU United Kingdom 11 December 2019 +44 (0)300 323 0140 Rachel Galloway iy HM Assistant Coroner iy G giv HM Coroner's Office C nid Manchester City Area 46 dE o> Exchange floor ones (<1 The Royal Exchange \- 202+ - Cross Street \\oNe <= Manchester M2 7EF Our ref. EH-302753 Dear Ms Galloway, | write in response to your letter of 5 November 2019, regarding the death of Mr Stuart Clarke. We have considered the circumstances surrounding Mr Clarke’s death, and the concern raised in your report, that there are no national guidelines for referral from primary care to secondary care and/or from secondary care to tertiary care for patients with known valve disease Based on the clinical detail provided, it’s not clear how severe Mr Clarke’s symptoms were or if any other symptoms were present However, It appears likely that the NICE guideline on chronic heart failure in adults (NG106) is relevant This guideline contains the following recommendations regarding the speed of specialist assessment 1 2 3 Because very high levels of NT-proBNP carry a poor prognosis, refer people with suspected heart failure and an NT-proBNP level above 2,000 ng/litre (236 pmol/litre) urgently, to have specialist assessment and transthoracic echocardiography within 2 weeks, [2018] 1 2 4 Refer people with suspected heart failure and an NT-proBNP level between 400 and 2,000 ng/itre (47 to 236 pmol/itre) to have specialist assessment and transthoracic echocardiography within 6 weeks. [2018] Where chronic heart failure 1s thought to be due to heart valve disease, we make this recommendation, but we do not specify a referral time since this would depend on the severity of the symptoms www.nice.org.uk | nice@nice.org.uk 1.2 15 Refer people with heart failure caused by valve disease for specialist assessment and advice regarding follow-up [2003] Ultimately, we consider the degree of urgency would be a matter for clinical judgement and will depend on the individual clinical scenario It 1s important that services are organised in such a way to respond appropriately to clinical scenarios to allow progression through the pathway in an appropriate and timely way. The organisation of such services would be the responsiblity of the Trust, with oversight from the specialist commissioner (NHS England). NICE ts at the early stages of developing a clinical guideline on heart valve disease presenting in adults: investigation and management One of the issues to be covered by this guideline are the indications for patient referral from primary care to a specialist The draft guidance is expected to go out for consultation with stakeholders in November 2020, and we expect to publish our final guideline to the NHS on 20 May 2021 Details of the concerns you have raised have been highlighted to the guideline developers, so they can consider indicating which factors merit more and less urgent referral, where the evidence is available This guideline will also be considering the indications for TAVI, and its clinical effectiveness and cost effectiveness However, we are unlikely to cover issues relating to the patient pathway from secondary to tertiary care, as TAVI is commissioned by NHS England (as outlined within their publication titled ‘Clinical Commissioning Policy Transcatheter Aortic Valve Implantation (TAVI) For Aortic Stenosis’ Yours sincerely, Sir Andrew Dillon Chief Executive
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