23. We have split findings into two parts. First, whether the angiogram and angioplasty should have been done. Second, whether the procedure was rushed and the complication that occurred was not dealt with properly.
The angiogram and angioplasty should not have been done
24. Mr R told us his father was not unwell and had not had any significant symptoms of angina or shortness of breath at the time he saw the consultant. He said Mr F had serviced his own car the day before the angiogram. Mr R also said his father had walked unaided through the hospital to the appointment without any shortness of breath.
25. Mr R told us his father always told him about his hospital appointments. He said his father did not know the angiogram was being done to diagnose a problem. He thought it was only for treatment of a known problem. He said he did not think his father would have had the procedure if it was just for diagnosis or if the angioplasty was not urgent.
26. Decisions about when to use an angiogram and angioplasty for patients with stable angina/stable coronary artery disease (patients who are experiencing transient and predictable angina on exertion or stress) are set out in NICE guidance and ESC guidance.
27. In summary, the guidance says that angiograms should generally only be used for diagnosis when indicated by severe or uncontrolled symptoms of angina, or other evidence that build-up of plaque within a blood vessel is causing restricted blood flow to the heart. To gather that evidence, the guidance suggests non-invasive testing.
28. The guidance says that an angioplasty is indicated on similar lines to an angiogram. The guidance says angioplasty is indicated for relief of symptoms, improvement in quality of life, or for prognostic benefit.
29. The clinical advice we received said decisions to proceed to angiogram and angioplasty would normally be based on the severity of symptoms (or other evidence of ischemia) the patient was having.
30. Our advisers explained that there may be situations where guidance does not apply to a patient. They explained this may particularly be in the case of a patient with a complex history. Both advisers said there could be justification for not following the guidance where the doctor, as a result of their knowledge and assessment of the patient, is aware of reasons why it was clinically appropriate to act differently to the guidance.
31. The Trust and the consultant told us they thought the parts of the NICE guidance which refer to testing did not fully apply in Mr F’s case given his complex history.
32. The explanations we received from the Trust and the consultant about why Mr F should be treated outside of the guidance have varied in emphasis throughout this investigation. Initially the consultant placed more emphasis on the CT angiogram not having been done, and the possibility of aggressive early restenosis as a result of competitive blood flow. They told us:
• they had always intended to follow up Mr F with CT angiogram because they had a suspicion that Mr F’s LAD may develop early restenosis as a result of competitive flow (paragraph 15) • they thought it was likely the vein graft would fail again or become blocked because it had done several times before July 2017. They said if that happened at the same time the LAD developed restenosis this would leave no route for blood flow and could cause an acute cardiac event • the openness of the LAD could only be checked by CT angiogram or invasive angiogram • by August 2018 the consultant was concerned a CT angiogram would not be clear enough and not worth waiting for • they thought other non-invasive tests that might show whether blood was reaching the heart muscle would not show whether the LAD had restenosis. This was because there might be dual blood flow to the heart muscle through the vein graft. The consultant therefore thought Mr F may not show any evidence of ischaemia even if there was significant blocking of the LAD • they were very concerned by the development of a new breathlessness symptom and thought the situation had therefore become more urgent. Although the consultant said the breathlessness was very mild, they were concerned because the more severe symptoms usually expected as a result of restenosis could have been masked in Mr F’s case because of blood flow through the vein graft. This means they symptoms would become much more severe if the vein graft failed again.
33. Our advisers explained that concerns connected to competitive flow was not a sufficient justification to proceed to angiogram. They explained that by the time Mr F saw the consultant in August 2018, problems associated with competitive flow would have been evident. As symptoms generally occur within several months of surgery and, in any event, could no longer be prevented by angioplasty. They did not consider the situation to be urgent or different to a patient without dual flow. They re-stated that decisions to proceed to angiogram would normally be based on symptoms of angina.
34. In later explanations to us, the Trust placed more emphasis on the fact Mr F had developed a new symptom of mild breathlessness, which it told us the consultant thought was an angina equivalent. We now understand the consultant’s comments about competitive and dual blood flow were therefore part of their justification for acting on a mild symptom, without further testing or evidence of ischemia, (i.e. acting outside of the guidance) rather than their sole rationale for doing an angiogram.
35. Our consultant interventional cardiologist agreed testing for ischemia might not be useful for Mr F, although not for the same reasons as the consultant. They did not agree with the consultant’s reliance on the issues of dual flow through LAD and the vein graft and the potential problems that may arise from those. They also said the situation was not urgent and other testing would not have caused an unnecessary delay. However, they said ischemic testing may not be useful in the context of Mr F’s complex cardiac history.
36. Our consultant interventionist adviser said a small amount of breathlessness would not normally be a reason to proceed to angiogram. However, they said it was possible there was justification for thinking the breathlessness was an angina equivalent and so the consultant may have been justified in their thinking. In that case, they said it would be reasonable to do an angiogram.
37. Our consultant cardiologist adviser did not completely agree with our consultant interventional cardiologist. They explained they thought testing would still be helpful in Mr F’s case. However, they agreed a small amount of breathlessness would not on its own be an indication of angina. They said it would not be a ‘severe’ or uncontrolled symptom in the meaning of the NICE or ESC guidance about when to proceed to invasive angiogram and angioplasty.
38. Our consultant cardiology adviser referred to NICE Guidance CG 126 (paragraph 1.5.2) which says that doctors should ‘Offer coronary angiography to guide treatment strategy for people with stable angina whose symptoms are not satisfactorily controlled with optimal medical treatment’. Our consultant cardiology adviser explained that Mr F’s symptoms were not ‘uncontrolled’ in the meaning of this guidance. Our consultant cardiology adviser said they would expect to see evidence of an assessment of the type and nature of Mr F’s breathlessness.
39. The consultant said they relied on 2019 ESC guidance, section 5 (NB: we note the 2019 guidelines post-date the events we are considering but the 2013 (section 6) guidelines for the diagnosis and management of chronic coronary syndromes are similar). That recommends invasive coronary angiography without other testing for the diagnosis and management of patients who have severe angina and who are high risk.
40. Our advisers said that Mr F was high risk. However, they both explained mild breathlessness would not on its own be considered obviously indicative of severe angina. Both advisers have told us they would expect the consultant to have had some other reasons for thinking an angiogram was needed in response to Mr F’s breathlessness.
41. We considered whether there is evidence from the same time in Mr F’s medical record, or clinic letters, that explains why the consultant thought Mr F’s mild breathlessness was angina, outside of his concerns about competitive flow. We have considered whether their actions were in line with GMC Good Medical Practice paragraph 15, that says doctors should adequately assess patients taking account of their history and examining the patient where necessary.
42. There is no assessment of Mr F’s breathlessness in the medical record. The medical record and clinic letter only says Mr F was breathless ‘as before’.
43. When we asked the consultant about their knowledge of Mr F’s breathlessness and symptoms, they told us they just recorded Mr F’s self-report that his breathlessness was the same ‘as before’. The consultant did not clarify in the medical record the nature of that breathlessness. During the investigation they only told us the breathlessness was mild, and that Mr F’s family may not have noticed it.
44. It is not clear what Mr F may have meant by telling the consultant he was breathless ‘as before’. We have seen no evidence that Mr F had breathlessness as a symptom of angina before.
45. Our consultant cardiologist adviser said the breathlessness may have been a symptom of increasing heart failure. Our consultant interventionist cardiologist adviser agreed, but thought it was unlikely.
46. Our advisers said an echocardiogram would have been a useful investigation to help with the assessment of Mr F’s breathlessness. Our consultant interventional cardiologist adviser noted that would not have been necessary if there were no clinical indications of heart failure (waking at night, leg swelling). However, there is no recorded assessment of Mr F’s breathlessness or any other symptoms in the medical record and so it is not apparent those factors were assessed.
47. Mr R has told us that his father had asthma. He has questioned whether this is what caused breathlessness the consultant observed.
48. Without any assessment of Mr F’s breathlessness, it is not possible to say what caused it at the time the consultant saw him in August 2018. The Trust and our advisers recognised it was possible that breathlessness was a symptom of angina, given the findings of the angiogram. A later echocardiogram was also done but this was when Mr F was having the acute cardiac event and was not a full diagnostic test. This showed Mr F probably had moderate heart failure. However, that would not have been known to the consultant at the time he decided to do an angiogram.
49. We have no evidence that the consultant did an appropriate assessment of Mr F’s shortness of breath in order to adequately justify proceeding to angiogram at the time they did.
50. Finally, both NICE guidance and ESC guidance recommend that decisions to proceed to angiogram should only be made if the patient is suitable for angioplasty. That is, would benefit from diagnosis and quality of life from angioplasty.
51. During our investigation the consultant told us they thought that doing the angioplasty may prevent Mr F from having an acute cardiac event. However, the medical record from the time says the procedure was done for ‘relief of symptoms’ and ‘diagnosis and optimisation of stents’. There is no evidence in the medical record that at the time of their decision the consultant considered and discussed with Mr F the specific prognostic benefit or quality of life benefits of angioplasty. This would have helped them determine if Mr F was suitable for angioplasty and therefore angiogram.
52. The consultant’s actions were a failure to adhere to the following standards:
• GMC Good Medical Practice, paragraph 15 says doctors should adequately assess patients taking account of their history and examining the patient where necessary.
• The Parliamentary and Health Service Ombudsman’s Principles of Good Administration say that when reaching decisions, public bodies should take all relevant considerations into account.
Injustice
53. The Trust did not take all relevant considerations into account before offering Mr F an angiogram. Had that failing not occurred, the consultant may have done a more comprehensive assessment. They may have done an echocardiogram, or given more consideration (and therefore had a more detailed discussion with Mr F) to the benefit of diagnosis and Mr F’s quality of life.
54. We do not know the cause of Mr F’s mild breathlessness on the day of the consultation. However, given the findings of the later angiogram and echocardiogram (which showed Mr F to have narrowing of his LAD), it seems more likely than not the outcome of any further clinical assessment or echocardiogram would still have been that Mr F was offered an angiogram and angioplasty.
55. We found that there were additional steps the consultant should have taken before making the offer of an angiogram. We cannot say that offer would have been significantly delayed if a more robust clinical assessment and a more detailed discussion had happened at the consultation.
56. In saying this we note our consultant interventional cardiologist adviser told us that Mr F could have reasonably been offered an angiogram at the consultation in August 2018, given his history and presenting symptoms. His presentation was one which our adviser says can be shown to be justifiably investigated by angiogram.
57. The angiogram and angioplasty were therefore likely to have been offered in a similar timeframe regardless of the failings we have found.
58. Mr R has told us he thinks it is very unlikely that his father would have agreed to an angiogram and angioplasty had he known more relevant facts about prognostic benefit or if he had understood that a firm diagnosis had not been reached. Mr R explained that his father’s sister had been told that she needed heart surgery in similar circumstances, had declined it, and was quite fit and well.
59. We acknowledge it would have been open to Mr F to refuse an angiogram. We also acknowledge Mr R knows his father’s likely choices. We accept that Mr F may have decided not to have the angiogram if relevant steps had been taken by the consultant (more assessment, a test, a consideration of prognosis) because in taking those steps they may have given Mr F different information.
60. We also recognise that Mr F had acted on medical advice and agreed to what was offered, including angioplasty, at this appointment and previous ones.
61. We therefore cannot say, even on the balance of probabilities, that events would have unfolded differently. We are not able to say that Mr F would have made a different choice or that the procedure would have been delayed significantly. However, there is a small chance Mr F would have decided not to have an angiogram and angioplasty at that time. If he had decided that our adviser explained, we cannot say how long he may have lived.
62. Mr R has also given us a compelling account that his doubts over whether things could have been different have been heightened by the fact that his father was well before the procedure, had a good quality of life, and had no significant symptoms. That has made him feel even more deeply his father’s life was cut short and he would have lived for some time longer if he had not had the angiogram and angioplasty. He has told us his distress has been with him since his father’s death in 2018 and continues even now.
63. There was a very small chance Mr F may have chosen not to have the angiogram and angioplasty. Mr R believes that chance was much more significant than we do. Given the failings we have found, we are not able to assure him otherwise. Mr R’s bereavement is exacerbated by the doubt that things may have been different. That is a significant injustice to him.
The procedure was rushed, and the surgeon did not take appropriate action when a complication occurred
64. Our consultant interventional cardiologist adviser looked at the images of the angiogram performed in October 2018. They explained there are no specific guidelines that apply to how an angiogram is carried out. They said the only guidance is given in student textbooks.
65. We have therefore considered the conduct of the angiogram against GMC Good Medical Practice guidance, Domain 1, paragraph 15, which says that doctors should provide a good standard of practice and care. In doing this we have considered the records of the procedure.
66. Our adviser explained the angiogram images show Trust staff carried out the procedure in accordance with usual practice. They said the procedure was difficult, which the consultant has acknowledged. Our adviser said this is not unusual in patients with extensive coronary artery disease. They said the result of the angiogram was as expected, and they had no concerns.
67. Our adviser said the procedure note says Mr F had a drop in blood pressure. Our advisers both explained that a drop in blood pressure is a complication that can occur during an angiogram. It does not indicate Trust staff did something incorrectly.
68. Our advisers explained a drop in blood pressure is normally caused when a catheter (a small tube used to do the angiogram) is put into a blood vessel. The catheter blocks blood flow to the heart and causes the heart to not function properly. This causes low blood pressure. In turn, the low blood pressure causes fluid to build up in the lungs. This is called pulmonary oedema and is what Mr F had.
69. Our adviser said the procedure note does not say anything about Mr F’s low blood pressure other than recording the drug treatment he received for it. However, both our advisers explained that Trust staff gave Mr F appropriate drug treatment during the procedure for his low blood pressure. This is in accordance with Good Medical Practice, paragraph 15.
70. Our advisers also explained that after the procedure, Trust staff gave Mr F intravenous furosemide (a diuretic), nitrates and oxygen. He was moved from the recovery room to the cardiac care unit after he had a slowing of his heart rate after the procedure. Our advisers explained that it may have been better, given the complication, to have moved Mr F to the cardiac care unit immediately following the procedure. However, they noted that Mr F was attended to immediately when his heart rate slowed.
71. Our advisers explained pulmonary oedema makes cardiac arrest more likely. They explained the treatment Mr F had, and his move to a cardiac care unit, would have helped to prevent a further cardiac arrest as far as possible.
72. We do not think that there were any failings in the way Trust staff did the angiogram. We have seen evidence to show that the procedure was carried out appropriately and there is no evidence it was rushed. We have not seen evidence the Trust could have prevented the complication that occurred. The evidence suggests the complication was treated appropriately and in accordance with the standard in Good Medical Practice, paragraph 15. There was a shortcoming in the failure to immediately transfer Mr F to the cardiac care unit.