Surgery 24. Mr B had been considered for AVF surgery for some time. Following the results of the scan taken in June 2020, he was seen at the VA clinic on 25 August 2020. At that appointment, it was decided Mr B should have a left-sided radiocephalic (RC) AVF, or to proceed with left-sided brachiocephalic (BC) AVF if the artery was found to be calcified.
25. With an RC approach, the AVF is created at the patient’s wrist. With a BC approach, the AVF is created in the patient’s upper arm, at or slightly central to the level of the elbow.
26. After Mr B’s repeat scan on 10 May 2021, at the MDT the following day, it was decided he should have a right-sided RCAVF. This is the cause of Ms T’s concern. She complains the Trust made a clinically inappropriate decision to proceed with a different approach, to create the fistula in Mr B’s right wrist, rather than higher in his left arm as had been previously planned. We are aware Ms T understood the original plan was for a left-sided BCAVF. We hope to clarify, the decision was in fact for RCAVF, and only for BCAVF if calcification was found.
27. We hope to assure Ms T the decision to change surgical approach was clinically appropriate. The decision for left-sided RC/BCAVF was made following the June 2020 scan. This did not show any occlusion in Mr B’s left ulnar artery, the artery that would be joined to a vein to create the AVF.
28. When the scan was re-taken, some months later and two days before surgery was to proceed, this showed the clinical circumstances had changed. The 10 May 2021 scan found the left ulnar artery so heavily calcified it was considered occluded. This changed clinical circumstance meant it was no longer appropriate to proceed with a left-sided RC/BCAVF.
29. ESVS guidance explains why proceeding with RCAVF was a clinically appropriate approach. We highlight in particular, the final sentence in the extract below. We understand Ms T’s concern that this approach was inappropriate due to Mr B’s being right-handed and a wheelchair user. As ESVS guidance confirms, the dominant, right side was chosen in Mr B’s case as the vessels in his non-dominant, left arm, were no longer considered suitable:
‘3.3.1. Primary option for vascular access - autogenous arteriovenous fistula. The radiocephalic AVF (RCAVF) at the level of the wrist is the first choice for VA creation. When successfully matured, the RCAVF can function for years with a minimum of complications, revisions and hospital admissions. The RCAVF is preferentially created in the non-dominant arm, but the dominant extremity may be chosen if the vessels in the non-dominant arm are unsuitable.’
30. Our adviser explains the changed approach was also appropriate in attempts to reduce the risk of steal syndrome. Often referred to simply as steal, this can occur for various reasons, and is a known complication of AV surgery. It takes its name from one potential cause, where a newly-created AVF or graft (AVG) can divert too much blood, ‘stealing’ this away from the hand or arm. It therefore describes a condition where the blood supply to the hand is reduced.
31. Ischaemia is a similar medical condition, describing a restriction in blood supply to any tissue or organ of the body, though it is not necessarily related to AV surgery. Steal and ischaemia can cause symptoms including hand numbness, pain, coldness, and weakness. Both conditions can cause tissue death, which may lead to the loss of fingers.
32. Considering the above, the decision to proceed with a right-sided RCAVF is further supported by KDOQI guidance, as follows:
‘2.4 KDOQI considers it reasonable that the choice of AV access (AVF or AVG) be based on the operator’s/clinician’s best clinical judgment that considers the vessel characteristics, patient comorbidities, health circumstances, and patient preference.’
‘As mentioned above, AV access steal occurs less frequently after radial artery–based AV accesses than after brachial based procedures.’
33. As our adviser explains, the nature of medicine is that pathology and physiology evolve. Clinicians can therefore only decide upon the most appropriate way to proceed, based on the most up to date information they have at the point they make their decision. This is what we find the Trust did in Mr B’s case.
34. We recognise the reasons for Ms T’s concern, especially considering a left-sided approach had been decided so many months before surgery proceeded. Yet, at the time that approach was determined, it was done so based on the most up to date information about Mr B’s pathology and physiology at that time. The same can be said for the decision to change the approach, when up to date information gave a different picture, following the scan taken on 10 May 2021.
Consent 35. Ms T complains the surgeon did not appropriately get Mr B’s consent on 12 May, considering the changed approach to his surgery. Ms T says Mr B was told the AVF would be in his right arm, and she accepts that he signed the consent form, but says he was never told it would be in his wrist.
36. Ms T says Mr B arrived late for his surgery so there was no time for the in-depth discussion the surgeon says took place. Ms T says Mr B was already prepped for surgery when asked to sign the consent form. She says he felt pressured to do so, and unable to look at the form properly as he was rushed and had an eyesight problem.
37. We have looked at what is documented in the clinical records. The discharge summary notes the scan findings of the left-side occlusion corresponded to findings when Mr B was examined before his surgery. It is noted that on examination, both radial and ulnar pulses were present on the right side, and an Allen’s test on this side was satisfactory.
38. An Allen’s test is performed to check blood flow. The patient is asked to clench their hand into a fist. The clinician then uses their fingers to put pressure on the arteries at two points on the wrist, obstructing blood flow to the hand. The patient then relaxes their hand, the clinician removes their fingers, and signs of how long it takes the hand to flush indicates the extent of blood flow through those vessels.
39. After these examinations, the discharge summary notes: ‘Explained to patient that there was a higher risk of thrombosis and failure due to nature of vessels, but having a wrist AVF would reduce the risk of steal and vascular compromise’. Thrombosis is a condition where blood clots block blood vessels.
40. We find a separate entry of the surgeon’s discussion with Mr B on the morning before his surgery. This entry notes after MDT discussion Mr B was determined for right RCAVF. It says on examination he had a normal Allen’s test on the right. It also notes: ‘Patient is aware that his vessels are calcified and this increases the risk of failure, but doing wrist fistula drastically reduces the risk of steal syndrome’.
41. We also find the surgical consent form noting the proposed procedure as: ‘Right RC AVF under LA’ (local anaesthetic). Under the heading: Serious or frequently occurring risks’, we find the following written: ‘bleeding, pain, infection, thrombosis and failure rate 25%, damage to surrounding structures, neuropathy, aneurysm formation and steal syndrome’. Aneurysm is an abnormal bulge or ballooning in the wall of a blood vessel. Mr B signed this form, against his name and the date of 12 May 2021.
42. Our adviser explains that general guidance on surgical consent applies, as set out in GMC 2008 guidance and GMC 2020 guidance. This says the patient must be informed of the risks, benefits and the alternatives and they must have the capacity to make a decision, which must be voluntary. GMC 2020 guidance specifically sets out ‘the seven principles of decision making and consent’.
43. We know the signing of the consent form is not in contention, as Ms T accepts it was signed by Mr B. We recognise her concerns about any pressure Mr B felt, the time for the discussion to take place and whether it was made clear the attempt would be in the right wrist.
44. We were not present to have independently witnessed what happened. Ms T was also not present, yet we acknowledge she spoke with Mr B after the procedure to learn of his views afterwards. We also acknowledge the surgeon was present. She said she remembered the conversation with Mr B very well, recalling the risks were outlined clearly and said Mr B was: ‘very keen on going ahead’.
45. We have considered the evidence made available to us carefully. We are satisfied this shows Mr B was consented properly, and he gave his consent freely. We are sorry to learn that he felt otherwise. We are satisfied to see sufficient evidence that appropriate consent was obtained from Mr B for the procedure that took place, before it took place, in line with GMC 2008 and 2020 guidance.
Treatment 46. Ms T complains the Trust failed to appropriately manage Mr B’s finger deterioration and pain in the seven months following surgery, with a consultant delaying referring him to the hand clinic until 27 September. She says through sheer desperation, Ms D emailed the Trust’s CE on 6 December 2021, and via her intervention, action was finally taken. Ms T says in all the time between the surgery and this email, Mr B’s pain was ignored, and nothing was done to even try to remedy the deterioration and necrosis in his fingers.
47. Our adviser says it is clear Mr B suffered with hand ischaemia following his RCAVF surgery. His symptoms were consistent with ischaemia which, as we have explained, can share similarities with signs of steal. To consider the complaint raised here, the relevant KDOQI guidance is as follows: ‘18.3 KDOQI considers it reasonable that patients with signs and symptoms consistent with AV access steal should be referred urgently to a surgeon/interventionist familiar with the diagnosis and options for the definitive treatment of AV access complications, particularly AV access steal.’
18.4 KDOQI considers it reasonable that the optimal treatment of AV access steal should be determined based on the patient’s clinical presentation, local expertise, and resources.’
48. Urgent referral is expressed within the above KDOQI guidance. Our adviser explains the definition of ‘urgent’ in the context of an NHS referral can involve differing expectations of time, depending upon the area of care involved. An urgent primary (GP) care referral into secondary (specialist, hospital) care is nationally considered to be within two weeks, the ‘two-week-wait’.
49. This does not apply here, as Mr B was already under secondary care services. We explain it however, because the only period we find Mr B waited for any significant period of over two weeks without clinical input, during the seven-month period in question, was the time from the nephrologist’s referral to the hand clinic appointment proceeding.
50. Four days after surgery, Mr B’s case was discussed at the VA MDT. It noted the RCAVF failure, his severely calcified vessels and increased risk of steal. The MDT concluded he was unfortunately not suitable for further VA surgery.
51. The nephrologist held a haemodialysis review just one week after this VA MDT, on 1 June. ‘Steal-like symptoms’ were noted in the clinic letter however, our adviser explains there was nothing to suggest this was so severe to require further input or onward referral at that point in time.
52. Mr B attended a diabetic foot clinic appointment on 17 June, with notes recording he reported his significant right-hand pain. He was seen and examined by a consultant vascular surgeon. Where KDOQI guidance says any symptoms consistent with steal should be referred urgently to a surgeon, Mr B was in fact already being seen by the relevant clinician with the appropriate expertise at that appointment. Despite this, the consultant made an onward referral, acting in line with KDOQI guidance by referring Mr B back to the VA MDT.
53. The VA MDT met to discuss Mr B’s case again on 22 June, identifying his worsening ischaemia. It requested a repeat Duplex before re-discussion at MDT. The Duplex was taken promptly, on 29 June. The VA MDT met again that same day, and requested a CT angiogram (CTA, a type of X-ray scan to look at the blood vessels). Further investigation was appropriate, to ensure the MDT had the clearest picture to determine the next best course of action.
54. The CTA had been arranged for 22 July however was appropriately postponed due to Mr B’s admission from 13 July following his heart attack and for pacemaker insertion. The CTA was re-requested on 5 August, after Mr B had been discharged from his inpatient stay.
55. Mr B had another haemodialysis review with the nephrologist on 10 August. This clinic letter noted the various recent medical problems Mr B had, including his heart attack as well as other issues with his left heel skin, gastrointestinal and urological concerns and more. This noted his ongoing treatment and upcoming plans for care with all these matters, including the upcoming CTA for his hand pain.
56. The CTA was taken on 7 September. When the nephrologist next saw Mr B just ten days later, on 17 September, with the results from both the Duplex and CTA, he determined to make a referral to the hand clinic. The referral letter was dictated on 17 September.
57. The same day, the nephrologist also wrote to Mr B’s GP. The nephrologist informed the GP of the current clinical circumstances and onward referral, whilst stating the major symptom for Mr B at that point was his pain. The nephrologist asked the GP to increase the current prescription of painkillers, recommending discussion to explore the possibility of an analgesic patch.
58. The Trust said the referral was entered onto the system on 27 September. The time between the referral being entered and the hand clinic appointment taking place was just over four weeks. Our adviser explains there is no definition for what constitutes the relevant period, for referrals in secondary and tertiary (more highly specialised) care. Records show the appointment booking service noted the appointment should take place within four weeks of referral, which our adviser considers reasonable. During the four-week period Mr B waited, records show the booking team made comments and changes to ensure the appointment was generated as soon as possible. This included efforts to explore whether Mr B could be seen sooner elsewhere.
59. Our adviser also highlights that during this four-week period, Mr B remained under secondary care services. He had not been discharged and so remained under the appropriate level of care, with records showing the Trust took active steps in attempts to best help his pain, by the nephrologist contacting his GP to ask for increased analgesia.
60. Considering the noted expected four-week wait, and the appointment taking place exactly four weeks later, we do not identify any delay. We acknowledge there was a delay between the referral’s dictation on 17 September and this being entered on the Trust’s system on 27 September. We hope to assure Ms T that even had the referral been entered without delay, our adviser said Mr B’s wait between 17 September and the appointment taking place on 25 October was not so significant to represent any considerable delay.
61. The surgeon saw Mr B at the hand clinic on 25 October, performing an examination and requesting further information. The nephrologist saw Mr B three days later, in the meantime, having been in email correspondence with him and Ms T about their concerns regarding the right hand. The nephrologist noted a clear examination of the hand and management plan going forward including prescribing antibiotics, noting further angiogram, and contacting the diabetic foot clinic with a view this was likely interlinked with similar narrowing of the vessels as seen in the feet.
62. On 4 November Mr B was seen again by the consultant vascular surgeon in the diabetes foot clinic, where his foot as well as his ischaemic right arm were noted. The consultant noted the plan for angioplasty (a procedure to widen the vessels). The VA MDT met to discuss Mr B again on 9 November, noting there were sadly no further VA interventions for him. The MDT did note he had undergone the upper limb angioplasty that week and that Mr B’s care remained under plastics.
63. Our adviser considered the timeline of events both before and following Mr B’s hand clinic referral and that appointment taking place. The evidence we have seen does not show the Trust was ignoring or failing to appropriately manage Mr B’s pain or the symptoms he was reporting with his right hand. The timeline shows Mr B was being seen regularly by various relevant clinical specialists.
64. He had regular input from VA and vascular surgeons who are experts in managing hand ischaemia. There were multiple MDT discussions, investigations and clinic appointments during this period, throughout which Mr B he was receiving morphine-based analgesia.
65. Action was taken in referring Mr B to vascular surgeons, in line with KDOQI guidance. Our adviser says the earlier VA referrals, discussions, clinic appointments and investigations were appropriate before deciding to refer Mr B to the hand clinic. We do not find evidence to suggest the timing of the hand clinic referral constituted a delay. Our adviser says there is nothing to suggest earlier review by the hand surgeon would have resulted in any change in Mr B’s management at that time, with nothing to suggest a different outcome.
Complaint handling 66. Ms T complains about the time taken by the Trust to respond. Ms D first emailed these concerns to the Trust’s CE on 6 December 2021. The CE replied, confirming she had asked this to be investigated. The Trust sent its first complaint response eight weeks later, in a letter dated 31 January 2022.
67. NHS complaint regulations say the organisation investigating should send the complaint response ‘within the relevant period’, which it defines as: ‘the period of 6 months commencing on the day on which the complaint was received’. The time between the Trust receiving the complaint and sending its response was prompt and well within the regulations.
68. Four weeks later, on 28 February, Ms D replied raising outstanding concerns. On 1 March, the renal consultant replied and asked the complaints department to re-open their case. The Trust sent its second complaint response over nine months later, in a letter dated 12 December 2022.
69. Within that second response, the Trust apologised to Ms D for what it described as an ‘unacceptable delay’. It explained the NHS, the Trust and the renal surgery service had experienced an unprecedented level of operational pressure and challenges over the previous few months, coupled with high staff absence rates. It said this meant it had not been possible for the investigation lead to complete their work and reply sooner.
70. The Trust provided sincere and unreserved apologies for the impact this has caused. It conveyed its deepest condolences to Ms D, Ms T and Mr B’s wider friends and family for their loss, appreciating this remained a very difficult and distressing time.
71. Whilst NHS complaint regulations give a timeframe to respond, they do not set a timeframe for any ongoing issues raised. We recognise the time taken to investigate and respond to the ongoing concerns was not ideal. We are satisfied the Trust met requirements within the regulations by its prompt first response. We are satisfied it provided a reasonable explanation, acknowledgement and sincere apologies for the lengthy period subsequently taken. Whilst we do not identify this as a service failure, in any event we are satisfied the actions taken put right the impact caused by the time taken.
72. Ms T also complains about the adequacy of the action plans in the Trust’s responses. We would expect any action plan to be SMART: Specific, Measurable, Achievable, Relevant and Time-bound. We are satisfied the action plans in both responses are SMART. We note the blank box in the second letter’s action plan and consider this may be the cause of Ms T’s concern. Yet, the ‘action required’ blank box, we find is addressed by the ‘area for development’ box to its left. The area, and action, are fulfilled in the Trust stating it would investigate the complaint process.
73. We have not identified any systemic failing with the Trust’s handling of the complaint, and as such we would not expect nor require any systemic action plans. We recognise the Trust chose to take further action, and we have explained we consider those stated actions reasonable.
74. We acknowledge Ms T feels otherwise and has said she would like to know more about the outcome of those actions. We note that at the close of both letters, the Trust offered Ms T could return, should she wish for more information. We consider this offer extended to any further information Ms T could have requested about the stated actions the Trust said it had already taken and would take in future.