Care on 9 and 10 October 2023
20.Mrs A says the Trust did not consider Mr B’s history of blood clots and undertake investigations to check for a pulmonary thromboembolism when he presented at the Trust’s ED on 9 October. Mrs A also says that when she raised concerns with a doctor that Mr B had the same symptoms as his daughter, who had died the year previously from pulmonary thromboembolism, these were dismissed.
21.Having reviewed Mr B’s medical records, our adviser says the diagnosis of PE was not in the differential diagnosis of any of the three clinicians that reviewed Mr B during this episode of care. Only the diagnosis of infection and cardiac pathology were considered.
22.The NICE guidance regarding when you should suspect PE states:
‘Suspect pulmonary embolism (PE) in a person with any of the following:
-Dyspnoea (shortness of breath) — this is the most common feature and is present in 50% of people with PE.
-Haemoptysis (coughing up blood).
Pleuritic chest pain — present in 39% of people with PE.
Syncope or pre-syncope.
Tachypnoea (fast breathing)— present in 21-39% of people with PE.
Features of deep vein thrombosis (DVT)
Other symptoms that may be present include: -Retrosternal chest pain (due to right ventricular ischaemia).
-Cough — present in approximately 23% of people with PE.
Other signs that may be present include: -Elevated jugular venous pressure.
-Fever.
-Gallop rhythm, a wide split-second heart sound, tricuspid regurgitant murmur.
-Hypotension (systolic blood pressure less than 90 mmHg) and cardiogenic shock — haemodynamic instability is rare and indicates central and/or extensive PE with severely reduced haemodynamic reserve.
-Hypoxia.
Pleural rub.
-Tachycardia (heart rate greater than 100 beats per minute).
-The presence of risk factors, (in Mr B’s case, our adviser says the risk factors were obesity (BMI ≥29 kg/m2), first-degree relative with a history of confirmed PE or DVT), makes the diagnosis of PE more likely’.
23.If clinical suspicion is low, our adviser says that clinicians should consider using the pulmonary embolism rule-out criteria (PERC) to help determine whether any further investigations are needed. Our adviser says Mr B had the signs and symptoms highlighted above. There is no evidence PERC was used by the Trust. If it had been, this would have warranted further tests to rule out PE. We note Mrs A’s recollection that her concerns about Mr B having the same symptoms as his daughter (who had died the previous year from pulmonary thromboembolism) were dismissed, but we were not present at this time. We do not discount Mrs A’s recollection, but we have not seen any documented evidence of this conversation in Mr B’s records that would help us to verify what was said.
24.Mrs A says the Trust misdiagnosed Mr B with a chest infection and discharged him home with antibiotics.
25.We note from Mr B’s records that he was diagnosed with Lower Respiratory Tract Infection/infective exacerbation of Chronic Obstructive Pulmonary Disease (COPD). This is an infection that is a common trigger for the worsening of a patient’s usual COPD symptoms beyond normal variations.
26.The NICE guidance on COPD diagnosis and management states:
‘How should I assess a person with an acute exacerbation of COPD?
If an acute exacerbation is suspected, assess its severity: Features suggestive of an acute exacerbation include: Worsening breathlessness.
Increased sputum volume and purulence.
Cough.
Wheeze.
Fever without an obvious source.
Upper respiratory tract infection in the past 5 days.
Increased respiratory rate or heart rate increase 20% above baseline.
A severe exacerbation may be suggested by: Marked breathlessness and tachypnoea.
Pursed-lip breathing and/or use of accessory muscles at rest.
New-onset cyanosis or peripheral oedema.
Acute confusion or drowsiness.
Marked reduction in activities of daily living.
Carry out a thorough clinical assessment: Check vital signs (including temperature, oxygen saturation [using pulse oximetry], blood pressure, and heart rate).
Assess for confusion or impaired consciousness.
Examine the chest.
Check ability to cope at home.
Consider the need for hospital admission.
Do not send sputum samples for culture routinely.
Consider other causes of symptoms (such as myocardial infarction, worsening heart failure, pulmonary embolus, and pneumonia).
27.Our adviser says that Mr B had the features highlighted above, some of which occur in both PE and chest infection. Therefore, it was not unreasonable for the Trust to diagnose a Lower Respiratory Tract Infection/infective exacerbation of COPD, or in other words, a chest infection. This is common in COPD patients like Mr B.
28.As above, our adviser says the Trust should not have ruled out PE without further investigation, given Mr B’s risk factors for PE. Instead, Mr B was discharged home with antibiotics. Only worsening heart failure was considered as a possible alternative diagnosis.
29.In summary, we consider there were failings by the Trust in that it did not sufficiently explore and investigate Mr B’s symptoms when he was in hospital to rule out the possibility of PE, contrary to the relevant NICE guidance and the PERC. We have made recommendations about this.
30.Mrs A says the Trust failed to consider Mr B’s social care needs prior to his discharge, which he needed as his mobility had significantly reduced due to his symptoms.
31.We have noted an entry in Mr B’s records by the community discharge assessment team at the Trust timed at 10.34am on 10 October 2023. It states:
‘COMMUNITY: POD: Podiatry Service
PC: Breathlessness + Low blood pressure
PMH: MI Pacemaker COPD Spondylosis Dilated cardiomyopathy - HF LVEF 20%
NOK: Mrs A (wife)
SOCIAL: Met Mr B on his bedside, introduced myself and role. Mr B lives in a house with his wife. House stairs has banister in placed. He mobilises independently unaided and actively engages with his ADL's. He states that his wife is self-caring as well. No anticipated CDAT input on discharge.
Kindly refer if the need arise. Ma. Discharge Facilitator RN (Community Discharge Assessment Team’).
32.Given this, our adviser says it is documented that Mr B was mobilising independently prior to his discharge on 10 October 2023, and he was independent in performing activities of daily living like washing, dressing, and eating. On Mr B’s discharge summary, it states: ‘patient is feeling well, no longer dizzy and is medically optimised for discharge.’
33.While we note Mrs A’s view that her husband’s mobility had significantly reduced whilst he was in hospital due to his symptoms and therefore, he needed social care after his discharge, the records from 10 October 2023 do not support this view. They demonstrate that Mr B’s needs on discharge were considered, and the Trust’s assessment concluded that he did not require any support.
34.As such, there is conflicting evidence about Mr B’s social care needs prior to his discharge. Unfortunately, we were not present at the time, so we cannot verify with any certainty if Mr B needed social care on discharge, as his wife suggests. What we can say is that Mr B’s other clinical issues, discussed elsewhere in this report, override any concerns about his social care needs on discharge.
35.Mrs A says the Trust failed to give her and Mr B safety netting advice as to what to do if he deteriorated and when to approach the ED.
36.Our adviser says that as PE was not considered in the Trust’s differential diagnosis, no safety netting advice regarding PE was given. The advice on Mr B’s discharge summary stated: ‘If not passing urine, not eating or drinking, feeling more unwell please re-present for urgent blood tests.’
37.Therefore, there is some evidence of safety netting advice in Mr B’s records, but our adviser says this advice was mainly due to his diagnosis of Acute Kidney Injury from his blood tests on admission. These showed an acute drop in Mr B’s kidney function which was attributed to his cardiac medications and dehydration.
38.Furthermore, it is noted from Mr B’s records on 9 October 2023 and a letter from the cardiology department dated 11 October 2023 that he had developed atrial fibrillation. This meant he was at high risk of having a stroke, but his condition could have been treated with anticoagulation which he had been on before. Our adviser says Mr B’s atrial fibrillation was confirmed by an ECG, but no action was taken by the Trust when he was in hospital or on discharge including safety netting information.
39.The NICE guidance on atrial fibrillation states:
1.2 Assessment of stroke and bleeding risks:
Stroke risk
1.2.1 Use the CHA2DS2-VASc stroke risk score to assess stroke risk in people with any of the following:
-symptomatic or asymptomatic paroxysmal, persistent, or permanent atrial fibrillation
Discussing the results of the risk assessment:
1.2.4 Discuss the results of the assessments of stroke and bleeding risk with the person taking into account their specific characteristics, for example comorbidities, and their individual preferences.
40.Our adviser says that anticoagulation should be started in patients with a CHA₂DS₂-VASc score of ≥2 if male or ≥3 if female. Mr B’s score was 2 due to him being over 65 years old and the presence of heart failure.
41.Therefore, we consider there was a failing by the Trust to manage Mr B’s atrial fibrillation appropriately when he was in hospital and on discharge, contrary to the NICE guidance and the score chart for atrial fibrillation stroke risk. We have made recommendations about this.
Impact
42.We have considered the impact of these failings with support from our adviser. Firstly, If the Trust had carried out further investigations of Mr B’s symptoms, diagnosed pulmonary embolism, and then initiated anti-coagulation therapy.
43.Our adviser says the risk of death from PE after diagnosis and initiation of treatment varies based on several factors, including the severity of the PE (the size and the distribution of the clot), the patient’s overall health, and the promptness and appropriateness of treatment.
44.Massive or sub massive PE (causing significant strain on the heart) carries a higher mortality risk compared to smaller, distal emboli. In Mr B’s case, his age (67) was a risk factor as incidence increases with age (approximately 1–2% annual risk in those over 65). He had a Body Mass Index (BMI) of 29 which is considered overweight. He also had ischemic heart disease, heart failure, and COPD, all of which are significant risk factors for PE. Our adviser says heart failure increases venous stasis, and COPD contributes to hypoxia and inflammation, both promoting clot formation.
45.Mr B had a family history of PE as his daughter had sadly died from the condition. Our adviser says this suggests a possible hereditary thrombophilia, increasing Mr B’s predisposition to PE. In terms of symptoms, it is noted that Mr B had shortness of breath, tachycardia, and dizziness, all of which are signs of PE.
46.For bilateral PE (as was discovered on Mr B’s post-mortem examination), our adviser says untreated mortality may approach 50% or higher, given his comorbidities and hemodynamic instability (fast heart rate, dizziness), as supported by the JSCAI and AHA Flame Study articles.
47.The PESI Predicts 30-day outcome of patients with treated pulmonary embolism. Our adviser says Mr B would have scored 147 points due to his age, male sex, comorbidities (heart failure and COPD), the presence of fast heart rate and low blood pressure. A score of over 125 points is Class V, Very High Risk: mortality risk of 10.0-24.5% in the first 30-days.
48.Therefore, if the Trust had carried out further investigations of Mr B’s symptoms, diagnosed pulmonary embolism, and then initiated anti-coagulation therapy, we consider on the balance of probabilities that Mr B’s risk of death could have been reduced from around 50% to 10-24.5% which is a significant potential reduction.
49.Secondly, we have considered if the Trust had initiated anticoagulation treatment for Mr B’s Atrial fibrillation that was diagnosed on admission without having diagnosed PE.
50.Our adviser says Apixaban (a direct oral anticoagulant that was suggested by the Arrhythmia specialist nurse to be prescribed to reduce Mr B’s risk of stroke from atrial fibrillation), is a standard treatment for acute PE, reducing clot progression and recurrence risk but, for PE, the practice is to give a loading dose of Apixaban at 10mg twice a day for 7 days then reduce it to the maintenance dose of 5mg twice a day long term. While for Atrial fibrillation, patients start directly on 5mg twice a day without the loading dose.
51.The standard regimen for acute PE, in accordance with the AMPLIFY trial highlighted in the NEJM article, is Apixaban 10 mg twice daily for 7 days (loading dose) followed by 5 mg twice daily. The loading dose achieves rapid therapeutic anticoagulation to prevent clot progression and recurrence, critical in the early phase of PE treatment. Without the loading dose, Apixaban 5 mg twice daily may take longer to reach therapeutic levels, potentially reducing its early efficacy in stabilizing the clot and preventing further embolization.
52.The 10 mg twice-daily loading dose ensures rapid inhibition of factor Xa (clotting factor in the blood), achieving steady-state anticoagulation within 2–3 days. With only 5 mg twice daily, the time to therapeutic anticoagulation is extended (potentially 5–7 days), increasing the risk of clot progression or recurrence in the critical first week. Studies such as the article in CHEST journal suggest that sub-therapeutic anticoagulation in the initial phase of PE treatment increases the risk of recurrent venous thromboembolism (VTE) by 2–3% in the first 7–14 days. For high-risk PE, this could translate to a higher mortality risk compared to standard dosing.
53.Our adviser says no specific trials directly compare Apixaban 5 mg twice daily without a loading dose to the standard regime for PE. However, pharmacokinetic data, as outlined in the JCP article, indicate that 5 mg twice daily achieves ~50–60% of the factor Xa inhibition of the 10 mg dose in the first few days, suggesting reduced early efficacy.
54.Overall, if the Trust had initiated anti-coagulation therapy for Mr B’s atrial fibrillation, our adviser says it would have still provided some risk reduction but there are no studies to compare it to the standard PE treatment.
55.In summary, we cannot say for certain that Mr B would have survived or how long he would have survived if his PE had been diagnosed and treated from when he was in hospital. His clinical profile shows that he had multiple comorbidities, some of which were risk factors for PE. Therefore, Mr B was a patient at heightened risk of suffering a PE. Nevertheless, we can say that if Mr B’s PE had been diagnosed and treated at this time, on the balance of probabilities, there is evidence that his chances of survival would have been significantly improved.
56.This will be distressing news for Mrs A to hear. She has struggled with a complex bereavement which has adversely affected her own health, and now in the knowledge that more could have been done by the Trust to investigate and manage her husband’s condition. As we have indicated above, this may not have changed the sad outcome for Mr B, but we consider it was a missed opportunity by the Trust which has resulted in an unremedied injustice for Mrs A.
Complaint handling
57.Mrs A says the Trust communicated poorly with her after she raised her complaint. It delayed in providing a full response to her concerns, meaning she had to approach the Trust multiple times for an answer. Also, Mrs A says the Trust did not acknowledge what went wrong in its responses.
58.Having considered the complaint correspondence, we note that Mrs A originally submitted her complaint to the Trust on 26 November 2023. It acknowledged her complaint promptly (on 30 November 2023) and said it would provide a full response by 25 January 2024. Unfortunately, the response was delayed, but only by a few days until 1 February 2024. In our view, the Trust’s initial response addresses Mrs A’s concerns about unsafe discharge, DVT/PE, and referrals.
59.Mrs A was unhappy with some of the Trust’s initial response, so she wrote to the Trust again with her outstanding concerns on 17 February 2024. The Trust provided a second response on 16 April 2024. In our view, this response also addresses Mrs A’s outstanding concerns about blood clots, scans, and her daughter’s sad death.
60.Unfortunately, Mrs A was still unhappy, so she wrote to the Trust again on 16 May 2024. The Trust offered Mrs A a meeting as a next step in its letter of 7 June 2024. Mrs A tried to call the Trust on three occasions on 13 and 14 June 2024 and left voicemail messages but says she did not get any call back. Therefore, she wrote to the Trust again on 17 June 2024 declining its offer of a meeting and asking why her husband had not been scanned when he was in hospital. The Trust provided a final response on 4 July 2024 confirming why it could not offer any further local resolution and suggesting the Ombudsman as a potential next step.
61.In summary, it is unfortunate that the Trust missed its own deadline by a few days in providing an initial response to Mrs A’s complaint, but all other written correspondence was replied to promptly by the Trust. After two written responses, it offered a meeting, but Mrs A declined this. It is unfortunate that Mrs A could not get through on the telephone, but we cannot say this unduly delayed the complaints process. In our view, the Trust’s complaint responses demonstrate that it tried to address Mrs A’s concerns, and local resolution was complete within 8 months which is not an unreasonable period when several replies are required. Given our findings, we can understand Mrs A’s concerns that the Trust did not acknowledge what went wrong in its complaint response. Nevertheless, we consider the Trust addressed Mrs A’s concerns adequately and gave its view in the complaint response. Overall, we have not seen any failings in how the Trust handled Mrs A’s complaint.