Dear Mr Crooks Thank you for your letter of 10 September 2025 following the conclusion of the inquest into the death of Mr Keith Reynolds on 10 September 2025, in which you sent the Trust a Regulation 28 Report to Prevent Future Deaths. The matter of concern you identified was: A mechanical thrombectomy service is not available in the region outside of 9.00am to
5.00pm due to insufficient neuroradiologists being available to run such a service. I am told that this issue is listed on the Newcastle Upon Tyne Hospitals NHS Foundation Trust’s 'Risk Register' and that a business plan has been submitted to NHS England in relation to funding for additional clinicians. However, at the present time, should patients currently require a mechanical thrombectomy outside of the hours of 9.00am to
5.00pm, such a service would not be available to them and this could result in their death despite this potentially being preventable were such a service available. Background and context In the North East and North Cumbria (NENC), approximately 6000 people per year will suffer a stroke. Many of the most devastating strokes occur when there is acute thrombotic occlusion of large vessel, typically the internal carotid artery or middle cerebral artery. Whilst thrombolysis to dissolve the thrombus is of some benefit, the most effective treatment for such patients is the use of mechanical thrombectomy (MT).

2 This involves the use of an intra-arterial catheter to physically remove the thrombus and restore blood flow to the brain. This a time critical procedure and is most effective when undertaken within 6 hours of the onset of symptoms, although even short delays during this period reduce the effectiveness of the intervention. We acknowledge that whilst in this case, the absence of 24/7 MT service was not felt to have contributed to the patient's death, meta-analysis data suggests that MT can reduce the mortality rate from around 20% to 16% following these large strokes. However by far the most important impact of MT is its ability to reduce long-term disability, which it does in 2 out of 5 patients treated, making it one of the most effective evidence-based treatments in medical practice today. MT is usually conducted under general anaesthesia. It requires the input of the specialist stroke team to identify a patient’s eligibility and manage their overall care, and a team to perform the procedure which includes a consultant interventional neuroradiologist (INR), neuroradiographer, neuroradiology nurse, senior anaesthetist and anaesthetic nurse/Operating Department Practitioner. At present, the Trust is able to offer MT between 8am and 6pm, 7 days per week. The procedure typically takes 11/2
- 2 hours, hence a patient must be ready in neuroradiology by 4 pm at the latest. Mathematical modelling estimates that around 10% of patients suffering a stroke would be eligible for MT. The 2022 Getting It Right First Time report on Stroke however indicated that only about 1.8% of patients nationally were benefitting from the intervention, and they recommended a target of 8% to be achieved by 2025. The latest data from the Sentinal Stroke National Audit Programme indicates that very few centres have been able to achieve this, and the current national average is 4.5%. For patients presenting to hospitals within NENC, the rate is 2.7%. Commissioning arrangements for Mechanical Thrombectomy In January 2018, NHS England published its Clinical Commissioning Policy on the use of MT as treatment for adult acute ischaemic stroke (all ages). The aim was to improve outcomes for adults with stroke, and to improve access to MT as soon as possible after the onset of stroke symptoms. In February 2018 MT was commissioned from the Trust; initially this was for a 9am to 5pm service with the last patient referral accepted at 4pm. In October 2020, funding was received recurrently to provide a permanent service with an indicative level of 100 patients and requirement to start to look at extended hours (till 8pm). The original intention had been that an extension in hours would be funded by paying for the additional activity incurred (at tariff) but, due to the COVID pandemic, the funding for this service became “block funded” and so any funding required to expand the service would now require a separate business case to be sent to NHSE for approval prior to expansion. As a result of this, and COVID, the expansion of the service was paused.

3 In 2023/24 an additional £400k funding was received to carry out an additional 40 procedures per year. This gave a position that the Trust received approximately £1,8M income for 140 cases. This was to fund the increasing activity and not for an expansion of service hours. This approximately covers the activity that the Trust delivers within the current service hours. In February 2024 the Trust submitted a new business case to expand the service in 2 stages, first to move to an 8am to 8pm service and then to a 24/7 service. In July 2024, the Trust received a response from NHSE offering £1.8M additional funding. The Trust rejected this as the funding gap was too large to enable the provision of a 24/7 service and the funding offered did not cover that gap. Following this the commissioners requested that the Trust review their clinical model (working with Salford on this to look at their model) and to review the cost of service provision. In February 2025 the Trust submitted a revised model and costing to NHSE. This reduced the required increase in costs to £3.1M and increased the proposed activity to 258 cases per annum for a 24/7 service. We received no response to this revised proposal. At a meeting with NHS England and commissioners in May 2025, the Trust further outlined its plan for delivering a 24/7 service, including an indicative timeline to be put in place once funding was agreed. Had we received approval of our proposal at that time, we would have been preparing to commence our 24/7 MT service in December 2025. Current Position The Trust has an established MT Steering Group which includes senior representation from clinicians and operational managers within the neuroradiology, stroke medicine, and perioperative departments. The group meets monthly and has agreed a plan for achieving a 24/7 MT service at the RVI which would serve all patients in NENC. As we have agreed to implement a joint INR rota with colleagues at James Cook University Hospital, we currently have enough INRs in place to deliver this 24/7 service. As we would be more than doubling our operational hours and accepting additional stroke patients from other hospitals, we would need to recruit other clinical staff to support service expansion. The limiting factor to expansion is solely the approval of funding to support this recruitment. The lack of 24/7 MT in the neighbouring areas of Yorkshire and Cumbria, together with the time-sensitive nature of the procedure, means that there is no viable alternative option for treatment of stroke patients requiring MT in Newcastle- upon-Tyne and the wider NENC. NHS England has emphasised that Trusts must operate within their allocated budget, such that additional services must be adequately funded by commissioners prior to approval. As of October 2025 we continue to await a response from the commissioners to our proposal for the funding to expand to a 24/7 service. If we were to receive approval, we would envisage being able to implement an 8am to 8pm service within 6 weeks, with progression to a 24/7 service in the following 6 months.

4 This issue remains on the Trust’s Risk Register and is subject to regular review by the Executive Team. I trust this response provides reassurance that the Trust remains committed to improving access to MT for patients across NENC.