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

Ms Rachel Galloway HM Assistant Coroner H.M. Coroner’s Office Manchester City Area Exchange Floor The Royal Exchange Cross Street Manchester M2 7EF

Professor Stephen Powis National Medical Director Skipton House 80 London Road SE1 6LH

10th February 2020

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.

From Edward Argar MP Minister of State for Health Department 9 MAR 2020 of Health & 39 Victoria Street London Social Care Pc SWIH OEU 020 7210 4850 Our Reference: PFD-1196556 Rachel Galloway HM Assistant Coroner; Manchester HM Coroner's Office Exchange Floor; The Royal Exchange Cross Street Manchester M2 7EF 1 S March 2020 2 Ma 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 s0. Firstly, would like to extend deepest sympathies to Mr Clarke's family and loved ones_ understand how distressing it is to lose 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 f 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 https Iwwwnce org uklquidancelng106 Receuve Ms City Gawv7" my

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: ~o EDWARD ARGAR MP

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 andlor from secondary care to tertiary care for patients with known valve disease Based on the clinical detall 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 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 ngllitre (236 pmolllitre) urgently, to have specialist assessment and transthoracic echocardiography within 2 weeks [2018] 2 4 Refer people with suspected heart failure and an NT-proBNP level between 400 and 2,000 ngllitre (47 to 236 pmol/litre) to have specialist assessment and transthoracic echocardiography within 6 weeks. [2018] Where chronic heart failure IS 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 WWWniceorg:uk nice@niceorg.uk Qsls E C E IV E C 2019 2014 Jlel

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 IS 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 responsibility of the Trust, with oversight from the specialist commissioner (NHS England): NICE Is 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 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"

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

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