TAVI clinic follow-up 24. Mrs L complains despite a diagnosis of severe aortic stenosis and after seeing her father in the TAVI clinic in September 2020, the Trust failed to follow-up with him until an appointment on 10 May 2023. We can best address our decision on this aspect of Mrs L’s complaint by discussing the chronological order of events.
25. When Mr O was first seen in the TAVI clinic on 15 January 2020, the cardiologist noted the radiologist had reported an incidental finding of severe aortic stenosis (AS) and severe aortic regurgitation (AR) from the echocardiogram taken in late 2019. This same echocardiogram clearly showed that Mr O’s heart function was normal in the context of a person with a pacemaker.
26. Our cardiology adviser explains severe AS and AR would reduce heart function. The fact Mr O’s heart function was within the normal range, means it was not clinically appropriate for the finding of AS to have been reported or diagnosed as ‘severe’ at that time.
27. In January 2020 the cardiologist noted Mr O was well and asymptomatic (showing no symptoms). The plan was not to proceed with TAVI and instead to ‘watch and wait’, to review him again in six-months’ time. This was appropriate and in line with NICE IPG 586. This explains the clinical indication to operate, whether via TAVI or by replacing the valve, would only be on presentation of symptoms:
‘2.1 Aortic stenosis causes impaired outflow of blood from the heart and is usually progressive. The increased cardiac workload leads to left ventricular hypertrophy and heart failure. Symptoms of aortic stenosis typically include shortness of breath and chest pain on exertion. Mortality rates are high in symptomatic patients.
2.2 Surgical aortic valve replacement (SAVR) with an artificial (biological or mechanical) prosthesis is the conventional treatment for patients with severe symptomatic aortic stenosis who are well enough for surgery. Optimal medical care has traditionally been the only option for those whose condition is unsuitable for surgery. Aortic balloon valvuloplasty is occasionally used as bridging or palliative treatment. Transcatheter aortic valve implantation (TAVI) is another less invasive alternative treatment.’
28. Our cardiology adviser confirms the decision to arrange to review Mr O on a six-monthly basis in the context of his symptoms, was appropriate. This was in line with ESC guidance, which says:
‘Early intervention may be considered in asymptomatic patients with severe aortic stenosis and one or more of these predictors if procedural risk is low… Otherwise, watchful waiting is a safer and more appropriate strategy.’
29. The next TAVI clinic follow-up in August 2020 went ahead as a teleconsultation. Mr O reported some symptoms, of his physical activity being reduced and some shortness of breath, however reported this was ‘not worrisome at the moment’. Our cardiology adviser confirms the cardiac surgeon’s plan was appropriate, in arranging for MDT discussion, to consider these new symptoms and Mr O’s candidacy for TAVI.
30. The MDT went ahead soon after, documenting this reported decrease in Mr O’s physical activity. It also documents his diagnoses of COPD and PVD which our cardiology adviser confirms from test results, were both already clinically severe at that point in time.
31. Whilst the MDT had been asked to consider Mr O’s candidacy for TAVI, it appropriately concluded that he should be seen in the clinic first. This was in line with NICE IPG 586, as per the extract relayed earlier. This is because, as our cardiology adviser explains, such a procedure would only be indicated by the presence of severe AS and with symptoms, hence the need for face-to-face assessment first.
32. This was the purpose of the appointment in September 2020. Our cardiology adviser explains for TAVI to benefit the patient, the symptoms of breathlessness must be due to the AS and not due to other reason, such as COPD. This is because TAVI is not effective in treating symptoms of breathlessness from other causes. Breathlessness is a primary and common symptom of COPD, particularly when it is severe.
33. In response to Mrs L’s complaint, the Trust acknowledged the letter from the September 2020 TAVI clinic was not typed up and the follow-up appointment was not generated. It said a six-month review was requested. This would indicate Mr O was found to be asymptomatic, or any symptoms he had were not considered related to his AS or so concerning to warrant more than the ‘watch and wait’ approach. We are left without any documentation of what happened at this appointment to support this view.
34. Yet, we do find this outcome aligns with both earlier and later records. Records from the teleconsultation held with Mr O just five weeks earlier noted Mr O reported his symptoms as ‘not worrisome’. This would not suggest anything of significant concern, certainly in the context of his known severe COPD. We also find this outcome aligns with later records, from the heart and lung ICD follow-up appointment Mr O attended on 5 March 2021. This was around the same time his TAVI follow-up should have taken place.
35. Whilst the purpose of this ICD follow-up was to check Mr O’s pacemaker, our cardiology adviser explains these appointments would also check and consider the patient’s wellbeing, general health and any symptoms, particularly from a cardiac perspective. The records of this appointment note a good heart rate spread, normal results, and there are no identified or reported problems or symptoms documented.
36. On the balance of probabilities, considering the evidence we have, we think it reasonable to consider Mr O was either asymptomatic or not concerningly symptomatic due to AS at the TAVI clinic appointment in September 2020. The Trust’s determination that a six-month review was requested was the appropriate approach at that time.
37. Just as the Trust has already acknowledged this error, we identify the lack of follow-up a failing here. Mr O should have been seen in the TAVI clinic again in March 2021 and he was not. Yet, he was seen in the heart and lung ICD clinic in March 2021 with records of this attendance noting he was asymptomatic. On this basis, continued six-monthly reviews with the TAVI clinic would have been appropriate in line with guidance.
38. He should therefore have been seen again in September 2021, then in March 2022. We recognise that as these appointments did not go ahead, we do not have evidence at these times to know whether Mr O would have been asymptomatic or found to have symptoms that warranted any alternative approach. Yet, we do have evidence from the next heart and lung ICD attendance in April 2022 to give an important insight.
39. The record of the ICD appointment in April 2022 reports normal heart findings. It documents that Mr O was taking two medications, aspirin (a blood thinner) which is used in the management of AS, and furosemide (a diuretic to help fluid retention), which is appropriate in treating heart failure. Most importantly, the record of this appointment clearly documents Mr O had no symptoms.
40. From this evidence, our cardiology adviser is assured that TAVI was not clinically indicated up to April 2022, nor had it been in the intervening period, even in the absence of the TAVI clinic checks he should have had.
41. Importantly, the record from April 2022 further confirms there was no clinical indication to support the view that Mr O’s AS was severe. This is because it would have shown more debilitating symptoms by this time, had it been severe since the echocardiogram scan in late 2019.
42. Even in the absence of the TAVI follow-ups he should have had, from his attendances elsewhere, we can say Mr O should have been continued on six-monthly checks. Our cardiology adviser says it would have been appropriate to have kept Mr O on these six-monthly checks, even over the course of years, until symptoms due to his AS presented. We are of the view this would have been the appropriate outcome had the TAVI clinic follow-up gone ahead as we think it should in March 2022, meaning he should have next been seen in September 2022.
43. The next entry we have is of the TAVI clinic Mr O attended on 10 May 2023. At this time, the clinical situation had changed. The records note Mr O was breathless on very minimal exertion and getting chest pain on exertion. Our cardiology adviser says these are the typical symptoms of AS that would indicate a need for more than six-monthly checks.
44. Records show the cardiologist acted accordingly, reaching the appropriate conclusion that with this symptom presentation, Mr O’s AS was now considered severe and there was a: ‘solid indication for intervention on his aortic valve’.
45. The cardiologist appropriately requested an urgent outpatient echocardiogram as the next step and arranged to speak with colleagues soon after. Our cardiology adviser explains the updated echocardiogram was needed before anything else, to view any changes with the heart’s function. This would then determine the decision about best next steps.
46. Very sadly, the subsequent events took place before the echocardiogram took place. We are assured the consultant took the appropriate action on 10 May 2023. There was no indication Mr O required immediate care or admission, and our cardiology adviser confirms that sadly, the subsequent event was not in any way predictable even from the reported symptoms on 10 May.
47. Whilst we find the symptoms Mr O reported were typical symptoms of AS, we do not know what the repeat echocardiogram would have shown. It is possible it would have shown stability in the heart’s function, even in the context of a narrowing from the AS causing symptoms. It is also possible it could have shown a reduction in heart function.
48. On the balance of probabilities, considering the symptoms that were found, we think it is likely the recommended outcome would have been for aortic valve intervention. That said, we do not know whether intervention such as TAVI would have gone ahead, as this decision would have been dependent on further assessment of Mr O at that time.
49. We can see that the echocardiogram was appropriately requested on an urgent basis. Sadly, Mr O deteriorated and died before this could take place. Considering these subsequent events, any further consideration of or assessment for aortic intervention would not have taken place prior to Mr O’s death.
50. From the records we have, we know Mr O was asymptomatic on 26 April 2022, and symptomatic on 10 May 2023. We are left not knowing when Mr O became symptomatic from his AS in that period. If not for the Trust’s earlier failing in September 2020, we think Mr O would have been reviewed in the TAVI clinic in September 2022 then March 2023.
51. We cannot know whether he would have been symptomatic or not on those earlier occasions. We therefore cannot say that the action taken in May 2023 should have been taken any sooner. Yet, we are, and most importantly Mrs L is, left not knowing.
52. We know this will leave her deeply concerned about whether a different action should have happened sooner and what impact, if any, this may have had. We asked our cardiology adviser to consider the events on 20 May 2023. They explain that whilst it is possible Mr O’s symptoms at that time could have been due to AS, they could have been symptoms of his known severe COPD and later identified respiratory failure. Notably, Mr O died due to respiratory failure, and not heart failure.
In summary 53. The failure in the lack of TAVI clinic follow-up is already agreed by the Trust. We consider Mr O should have been seen again in March 2021. We are assured by the other evidence we have, that Mr O remained asymptomatic and as such did not warrant aortic intervention but should have had continued TAVI clinic follow-ups every six months, up to September 2022.
54. We are left without any evidence to know whether Mr O would have been asymptomatic or not, had he been seen in September 2022. If remaining asymptomatic he should have been seen again in March 2023, and yet again, we are without evidence to know what that check would have found.
55. He was seen in May 2023 with concerning symptoms. The Trust’s response to this at that time was appropriate, simply the subsequent events sadly overtook the situation.
56. As we cannot know what would have been found had Mr O been seen at TAVI clinic reviews in September 2022 or March 2023, we cannot say consideration for aortic intervention was indicated or should have gone ahead on either of those earlier times. Even then, we now know Mr O had and sadly died of a respiratory failure.
57. We know Mrs L is concerned her father was left without any care for his severe AS for two and a half years. We hope to assure her we do not find clinical indication that it was severe when first identified. Furthermore, we can see Mr O was being assessed and checked, and confirmed to be on medication for AS, albeit via an ICD clinic and not the TAVI clinic.
58. In response to Mrs L’s complaint, the Trust said it was unclear why the clinic letter and follow-up appointment was not generated. In comments sent to us during our investigation, the Trust said all patient clinic attendances for 16 September 2020 were dictated and typed up, with the sole exception of Mr O’s. It said this was an administrative error that was unfortunately not picked up by the secretary at the time.
59. The Trust said the TAVI coordinator emailed the team in November 2022 and January 2023 with information about capacity issues and subsequently Mr O was seen on 10 May 2023.
60. The Trust told us it accepts this as a clear failure in its processes alongside capacity constraints, which it acknowledged to have impacted Mr O’s care. It provided apologies and set out the actions it has since taken to prevent a recurrence. We find the Trust’s comments to us reassuring, that it has completed further work to both explain the reasons for the failing and set out what it has since done as a remedy.
61. It is disappointing this information was not available at the time the Trust responded to Mrs L’s complaint. The Trust’s complaint response to her did not recognise what led to the failing or make any substantive comment on the impact. We consider she has been left uncertain about the impact, and she remains with a short period where we cannot say whether anything different should have happened.
62. We consider her injustice unremedied. We have set recommendations at the end of this report, for the Trust to address this.
Emergency department attendance 63. Mrs L complains the Trust failed to act on the ambulance pre-alert and it was not prepared for her father’s imminent arrival and deteriorating condition on 20 May 2023.
64. We hope to assure Mrs L that evidence shows the Trust was appropriately prepared for her father’s arrival and it provided timely treatment to him. The records show it received the ambulance pre-alert, and there is nothing to suggest it failed to act on it or was unprepared for Mr O’s arrival.
65. Mr O sadly had a cardiac arrest within 19 minutes of arriving at the Trust. In that short period, records show the Trust had already received him, taken him straight into the resus area and performed a blood gas test which showed Mr O was very unwell with respiratory acidosis (an accumulation of carbon dioxide in the body due to decreased ventilation, with causes including COPD). Our emergency medicine adviser says the Trust responded promptly by starting Mr O on the appropriate treatment, giving magnesium, steroids and oxygen.
66. In that same short period Mr O was also was seen and thoroughly assessed by advanced clinical practitioners, his blood was taken and sent for testing, and he was placed onto a machine to continually monitor his condition. A plan was in place to take a chest X-ray and assess Mr O’s suitability for intensive care, when he had his cardiac arrest.
67. We are assured by the evidence, that Mr O was seen with appropriate urgency as soon as he arrived. Our emergency medicine adviser says whilst there is no specific guidance that sets out the required timing of actions in this context, GMC guidance applies. This says clinicians must adequately assess the patient’s conditions, promptly provide or arrange suitable advice, investigations or treatment where necessary and refer a patient to another practitioner when it serves a patient’s needs. Evidence shows GMC guidance was followed in this regard.
68. We know Mrs L is concerned in part because of an entry in ambulance records, which notes: ‘o/a [on arrival] staff in resus not aware’. Considering the Trust’s records of what happened once Mr O arrived, we do not find evidence from these comprehensive records to show there was any unawareness or delay in the necessary actions taken by the Trust.
69. The evidence shows Mr O was extremely unwell on his arrival, as identified by the blood gas test, and he very sadly died despite appropriate and immediate management including resuscitation efforts. We do not find anything to show any unpreparedness or delay in the actions taken by the Trust, nor delay in any specific treatment as Mrs L has raised as a concern. We hope to assure her in this regard.