Surveillance following angioplasty in April 2019
Enhanced clinical surveillance following stent occlusion in May 2020 and poor communication
Monitoring between July to October 2021
23. Mr Y says following his angioplasty procedure in April 2019, the Trust told him it would monitor him carefully afterwards however this never happened. He says despite his condition continuing to deteriorate after this, the Trust did not take appropriate action. He says lack of surveillance and monitoring led to his bypass surgery in September 2021 failing and eventual leg amputation the month after.
24. On 11 April Mr Y went to his GP complaining of severe ongoing left foot pain and the GP advised him to go to the nearest hospital emergency department. His pain worsened when the leg was lifted and relieved by placing it down. He also developed swelling of the leg. It was noted Mr Y had been on a course of antibiotics for two weeks, and he had wet ulcers on all the toes with some oozing from the first toe. The swelling at the ankle was severe which meant it was not possible to feel either of the two pulses (dorsalis pedis pulse and posterior tibial pulse). These were signs and symptoms of Critical limb-threatening ischaemia (CLTI) and circulation so impaired there is an imminent risk of limb loss.
25. CLTI is an advanced stage of peripheral arterial disease. CLTI has 1-year amputation rates of approximately 12%. Therefore, it is recognised as an urgent condition and requires urgent management, followed by close post-treatment monitoring.
26. Mr Y was admitted to hospital on 11 April and was seen by the vascular surgical team. The team believed the pain and ulceration of the skin on Mr Y’s foot were due to the narrowing of the arterial blood vessels in his leg. On 12 April an ultrasound and a computed tomography (CT – diagnostic imaging procedure) scan confirmed a blockage in the arteries of his leg. A computed tomography angiogram is a type of scan that takes detailed pictures of the inside of the body, which is used to check blood vessels.
27. On 16 April 2019, Mr Y underwent an angioplasty operation to have a stent (metal devices that keep arteries open) inserted into his left leg to increase blood circulation. This is a procedure to treat narrowing and blockages of an artery. This uses either a balloon to stretch the artery (angioplasty) or metal scaffold to hold the artery open (stent). These procedures aim to improve blood flow and relieve symptoms.
28. Mr Y required a stent to keep the blockage open as the artery would recoil shut after the balloon was deflated. Increasing diameter balloons were used, and because the wall of the artery became irregular, it needed to be smoothed over with a stent to prevent blood from creating false passages within the walls.
29. Our consultant adviser says stents are not routinely placed in arteries below the groin because unlike stents placed in the heart, where there is high velocity blood flow to keep the stent open, the blood flow in a stent in the leg is less effective for keeping the stent open, and as a result, they have a high risk of failure.
30. Following the procedure, Mr Y was discharged on 21 April with medication and a plan for an outpatient review with the vascular surgical team the following month to assess his condition.
31. Our consultant adviser says it is well known that after angioplasty has been performed, there is a high risk the same area may become narrowed again because of scar tissue. This is a process called ‘restenosis’ and usually occurs during the first 6 months after the procedure.
32. NICE guidance on chronic limb-threatening ischaemia states that it is good practice to observe patients who have undergone infra-inguinal (below the groin) endovascular interventions for CLTI in a surveillance programme.
33. The NICE guidance says these are the factors to consider in an appointment for surveillance:
• pain in toes on rest • tissue loss • pulse • blood pressure using a doppler scan (this is a blood pressure measurement using a non-invasive technique that uses sound waves to detect the movement of blood through an artery) • ultrasound scan.
34. Global vascular guidelines on the management of chronic limb-threatening ischemia advise surveillance that includes clinical visits, pulse examination, and non-invasive testing (resting ankle pressures and toe pressures). It says the surveillance process is crucial for managing chronic limb-threatening ischemia effectively, as it helps in the early detection and treatment of the condition, which can lead to significant improvements in patient outcomes.
35. Its recommendations after Femoro-popliteal stent placement as Mr Y had are clinical examination, Ankle Brachial Index (ABI) which is a test that measures blood flow to the legs. Also a Doppler ultrasound scan (DUS) within the first month following Vascular Treatment to provide a post-treatment baseline and to evaluate for residual stenosis. Continued surveillance at 3 months and then every 6 months is indicated after interventions utilizing stents. Our consultant adviser explains this is because of the potential increase in difficulty of treating an occluded (blocked) versus a stenosed (narrowed) stent lesion. This is important for patients undergoing angioplasty for severe limb ischemia, due to increased risk of recurrent critical limb ischemia should the intervention fail.
36. At the time of Mr Y’s discharge following the angioplasty/stent procedure in April 2019, our consultant adviser says clinicians should have recognised he needed close surveillance as per NICE and Global Vascular guidance above. Close surveillance means regularly checking for the presence or absence of symptoms attributable to ischaemia (e.g. foot pain and palpable pulse below the level of the stent).
37. Mr Y had a face to face follow up on 2 May 2019, two weeks after the procedure and it was noted that a foot pulse was present. Although surveillance is mentioned in the consultant letter from this appointment, there is no evidence Mr Y was actually put into a stent surveillance programme as he should have been.
38. Mr Y had further face to face follow up appointments on 9 August 2019, 31 October 2019 and 27 February 2020 and the notes from these appointments do not indicate pulses were examined, which is a surveillance requirement for cases such as Mr Y’s.
39. Mr Y had his first DUS scan on 15 August 2019, 4 months after his stent procedure and a second DUS was performed on 1 May 2020, more than 12 months after the first stent procedure. Our consultant adviser says these two clinically directed DUS scans do not constitute true post procedure surveillance in line with guidance above.
40. The records show Mr Y went to the ED on 14 March 2020 suffering ongoing fluctuating pain in his third left toe. He had seen a podiatrist the day before who advised his GP should prescribe antibiotics to treat infection. The Trust noted ‘no evidence of ischaemia’ in left foot, that his X-ray was normal and observations stable. A duplex ultrasound scan was requested as follow up. Mr Y was discharged and ‘safety netted to return if ongoing concerns or concerns regarding ischaemic foot’.
41. The requested duplex scan that Mr Y underwent on 1 May diagnosed his in-stent stenosis (blockage or narrowing of a blood vessel) and showed 50-75% narrowing. Mr Y’s case was then referred to the vascular surgery MDT for discussion.
42. Global vascular guidelines on the management of chronic limb-threatening ischemia (CLTI) say if the narrowing is at 70% then the patient should have a further procedure. Our consultant adviser says MDT meetings are a weekly event, and this should have been discussed urgently rather than 4/5 weeks later as it was at the MDT meeting of 29 May. Our consultant adviser says stent narrowing can lead to total blockage, with angioplasty narrowing procedures it can be re-opened but once blocked it cannot be re-opened.
43. Mr Y had other follow ups via telephone on 28 May 2020, 20 August 2020 and 3 December 2020. Our consultant adviser says it is not possible that during these telephone appointments, Mr Y’s foot could have been adequately assessed to an acceptable standard. This is because he was not seen in person and could not be examined properly. Following Mr Y’s clinical review on 27 February 2020, he was not seen again face to face by the vascular team until 5 November 2020, by which time his stent was known to be blocked and narrowed as identified on the 1 May 2020 DUS scan.
44. In line with the NICE and Global Vascular guidance above Mr Y should have been followed up by a review at 6 weeks and the clinical review should have confirmed that the findings established at discharge (and at the 2-week review) had remained unchanged. Our consultant adviser says it is recognised that surveillance by clinical follow-up alone may be insufficient to detect restenosis (as patients may remain asymptomatic until the target artery has completely occluded) and a planned surveillance DUS scan should have been performed at 6 weeks to establish baseline flow velocities (to indicate stent patency). Mr Y should then have been entered into a formal stent surveillance programme with regular scheduled, protocol determined recalls to detect problems with the stents before any clinical problem arose.
45. It took 13 months from the point of the ultrasound scan in May 2020 showing blood flow reduction in Mr Y’s stent for the further angioplasty to take place in June 2021.
46. In its complaint response, the Trust says ‘it is very likely that the second wave of the pandemic delayed his treatment in the interventional radiology (IR) suite, along with many other patients’.
47. We recognise COVID-19 significantly affected the Trust’s capacity as an organisation and placed an unexpected demand on the organisation as a whole. There were unprecedented delays across the organisation which had a huge impact on patients being seen and cared for as the NHS would usually do.
48. Our consultant adviser says it is unreasonable for the Trust to use the impact of Covid-19 to justify he delays to Mr Y’s angioplasty. By June 2020 guidance on resumption of vascular surgery for managing patients with of chronic limb-threatening ischemia were established in line with other NHS England Covid-19 priority levels for interventions during the Covid pandemic. This included the expected time from diagnosis to treatment for all conditions. Patients like Mr Y, who presented with a stable manifestation of chronic limb-threatening ischemia, were prioritised as priority level 2 (Chronic severe limb ischaemia – no neurology) and treatment for these patients could be deferred for up to 4 weeks from diagnosis. The delay for Mr Y’s treatment of 13 months (from the DUS diagnosis of significant stent narrowing to treatment) is considerably longer than the expected wait time of 4 weeks.
49. We reviewed the medical records with help from our consultant adviser. We asked our consultant advisor whether the Trust appropriately monitored and provided the enhanced clinical surveillance for Mr Y’s symptoms following the results of his ultrasound on 1 May 2020 in line with national guidance. Our consultant adviser says it is possible for clinicians to be able to still feel a foot pulse when there is significant stent stenosis. Because of this, using normal clinical symptoms and signs alone to monitor stents have been shown not to be reliable.
50. Whilst there is documentation at Mr Y’s very first review on 2 May 2019 that a clinical examination for pulses was performed at an in-person review there is no further documentation of pulse examination at any subsequent consultation after this. Our consultant adviser says that because pulse palpation is the only clinical examination that can confirm stent functionality this omission was a serious and repeated failure of the Trust’s duty of care to Mr Y. As a minimum, this basic clinical assessment should have been documented at every clinical review to confirm some level of stent functionality.
51. In line with the Global vascular guidelines on the management of chronic limb-threatening ischemia, if Mr Y had been under the surveillance programme, failure to confirm a pulse would have triggered assessment of the Ankle Brachial Pressure Index (ABPI), a standard bedside test that is performed with an ultrasound probe. Any concerns raised by the ABPI would then have been followed by a request for urgent duplex ultrasound testing to be performed. This standard pathway for assessing blood flow in an artery or stent was never performed for Mr Y at any clinical review after 2 May 2019.
52. We asked our consultant adviser whether the results of the ultrasound scan from 1 May 2020 were appropriately communicated to Mr Y and if not, what the consequences were of this.
53. There is no documentation in the medical records to indicate Mr Y was made aware of the results of the arterial duplex scan he had undergone on 1 May until he was seen by a trainee doctor during a face-to-face appointment on 11 November 2020.
54. NICE guidance on chronic limb-threatening ischaemia says, ‘patients who require revascularisation for treating of chronic limb-threatening ischemia should be offered angioplasty or bypass surgery, taking into account factors including patient preference.
55. The Department of Health’s 2012 ‘Liberating the NHS’ document statement ‘no decisions about me without me’ says patients should be involved in decisions about their care and this applies equally to decisions about their treatment, management and support once a diagnosis has been made.
56. The Global vascular guidelines on the management of chronic limb-threatening guidance states that the Vascular Multidisciplinary Team meeting outcomes should be clearly recorded in the patient’s medical records and should be communicated to the patient
57. As a result of not being told the results of the scan, Mr Y was not given the opportunity to ask questions and make informed decisions about his care, including the opportunity to request a second opinion had he disagreed with the proposed plan.
58. The Trust’s failure in communication in not informing him about the scan results and MDT discussion that took place on 29 May meant he lost the opportunity to push for urgent intervention and treatment of his stent narrowing. This in turn reduced its likelihood of success.
59. The records show the recommendation discussed at the MDT meeting on 29 May was for another non-urgent or elective angioplasty procedure with the interventional radiology (medical speciality which performs various minimally invasive procedures) team. It is noted the procedure was scheduled to be performed within four to eight weeks. This decision was not discussed with Mr Y.
60. Based on Mr Y’s recent clinic review, the procedure was not considered urgent as priority was being given to lifesaving procedures. Our consultant adviser says this was a critical and urgent situation where the angioplasty request should have been done much sooner as Mr Y’s limb was clearly at risk. It was an emergency situation from early May 2020 and should have been treated as such.
61. There was a significant delay of several months in Mr Y receiving an appointment for his stent surgery which the Trust has said was due to COVID-19. During this period, priority was given to patients having treatment for cancer or unwell patients who required inpatient care in hospital.
62. On 20 August, Mr Y had a telephone consultation with the consultant vascular surgeon. It was noted his symptoms had not changed, and no appointment had been given for the angioplasty. The consultant considered he was stable from a vascular point of view, and angioplasty was not considered as an emergency intervention.
63. Mr Y requested a surgical review before agreeing to the angioplasty procedure, as his toe tip had auto amputated, and he had new pains in his first toe. The scheduling of his angioplasty procedure was put on hold until he was reviewed by a consultant.
64. Within a week, Mr Y attended a pre-operative appointment on 18 September to have the required tests and preparations to confirm it was safe for him to have the planned angioplasty procedure.
65. A face-to-face appointment was scheduled on 5 November 2020. During this appointment, Mr Y informed the consultant of his night pain, and calf cramps upon walking.
66. Mr Y underwent an ultrasound scan on 6 November, which showed the stent had become narrower since April 2019 when it was inserted and then also narrowed further since the scan he had in May 2020. A review was scheduled in four weeks, and Mr Y was seen in a virtual clinic on 3 December. He was advised to proceed with the angioplasty.
67. our consultant adviser said the lack of adequate surveillance and delay in treatment allowed the stenosis to progress to complete occlusion by 6 November 2020. The delay of angioplasty for 6 months after the stent occlusion was first diagnosed on the DUS also allowed the blockage to become more chronically scarred and further reduced the likelihood of angioplasty success.
68. As the scan from 1 May 2020 showed narrowing and the scan from November 2020 showed the blockage, we know that at some point during this period the full blockage occurred. Lack of surveillance meant there was a missed opportunity to identify the narrowing before it had progressed to the blockage by November.
69. The scan Mr Y had in November 2020 showed the stent was completely blocked and our consultant adviser says because of this, at this time the chances of saving Mr Y’s leg using angioplasty were less than 10%.
70. Our consultant adviser says Mr Y’s scan from 6 November showing the blockage should have been alerted to the vascular team immediately and it should have seen and admitted him to hospital. The team could have then tried to decide if the blockage had just happened, and if so, give an anticoagulant (blood thinner) if not they could have tried intervention at that point to save the foot.
71. Following Mr Y’s scan on 6 November, a review was scheduled for four weeks later, and he was seen in a virtual clinic on 3 December. He was advised to proceed with the angioplasty. This was the last time Mr Y was reviewed prior to the procedure.
72. Mr Y’s angioplasty procedure was significantly delayed, which the Trust says was due to the second wave of COVID-19 and this was scheduled for 26 April 2021.
73. The angioplasty procedure was delayed further due to COVID-19 and eventually went ahead on 9 June 2021. During the procedure, the interventional radiology team contacted his consultant to inform him the stent blockage could not be treated with angioplasty.
74. Following the failed angioplasty procedure in June 2021, the MDT decided a surgical bypass operation may be the best option following the findings by the interventional radiology team. The team arranged for an ultrasound of the leg and vein to assess the suitability of a surgical bypass.
75. The MDT met on 11 June 2021, where Mr Y’s case was discussed with radiology specialists and vascular surgeons. The team decided there was an option to improve the blood flow within radiology as opposed to undertaking a surgical bypass. This plan was to be discussed with Mr Y at an outpatient appointment.
76. Mr Y was reviewed virtually on 15 July after a discussion with three other vascular consultants. The consultant outlined the concerns relating to the complexity of Mr Y’s case, and the potential of losing his limb as well as complications such as a heart attack or blood clot.
77. A high-risk anaesthetic review was arranged for 27 July to assess whether Mr Y had the fitness to undergo the bypass procedure under general anaesthetic.
78. The review made several recommendations which included optimisations of his blood thinners, diabetes control, and a lung specialists’ opinion on his smoking history.
79. Mr Y was reviewed on 17 August and the specifics of the operation were noted. This included the need to use veins harvested from his arm and leg, possibilities of infection, and complication due to his diabetes. It also included the potential risk of the procedure failing, with a five to ten percent risk of limb loss.
80. Given the complexity of Mr Y’s case, his surgical bypass surgery was performed on 22 September 2021 by three consultants. A bypass was made with good flow to his foot in terms of a pulse.
81. Six days after his procedure on 26 September, Mr Y complained of severe pain comparable to his pre-procedure levels. The scan results and the symptoms showed his bypass operation was failing, without any further options to try and save the limb. Pain relief was increased by the surgical team with the hopes of his condition improving. He underwent a duplex ultrasound scan on this date which confirmed graft occlusion (complete blockage of the graft).
82. Mr Y’s pain increased over the days following, with difficulties to manage it, and he agreed to an above-knee amputation which took place on 12 October 2021.
83. As the scan from November 2020 diagnosed stenosis (narrowing), Mr Y’s further monitoring and treatment should have been prioritised as level 2 as per the previously mentioned guidance on resumption of vascular surgery for managing patients with of chronic limb-threatening ischemia. He should not have been left waiting a further 7 months for intervention.
84. As per guidance and our clinical advice, Mr Y should have had an in-person MDT review in November 2020 which would have identified there was little chance of saving the limb. As the blockage had already occurred in November 2020, our consultant adviser says the further angioplasty procedure in June 2021 was never going to be successful in saving his leg. Had this been established earlier, the option of amputation could have been discussed with Mr Y and planned sooner. This could have spared Mr Y months of unnecessary pain and distress.
85. We have found the lack of surveillance and delay in treating Mr Y had the impact of reducing opportunity for intervention to save the limb, accelerating the need for the bypass procedure in September 2021 and ultimately increased the risk of amputation which was the end result in October 2021. We have also found the failings in communication meant Mr Y lost the opportunity to push for urgent intervention and treatment of his stent narrowing. This in turn reduced its likelihood of success. We will consider the impact of these failings together later in our report.
Rehabilitation in hospital setting
86. Mr Y says following his amputation on 12 October 2021, he spent four months in 3 different hospitals waiting to be transferred to a specialist rehabilitation unit. He says during this time he was not allowed visitors, and this impacted his mental health significantly.
87. He says his mental health was adversely affected by just waiting on the wards for many weeks to be transferred out. Mr Y tells us he was frightened about the thought of how he would cope at home alone using a wheelchair. He says his family and friends became concerned for him. Mr Y explains he spent his birthday on the ward when he should have been celebrating with friends. He says he felt very low at this time waiting for a bed at the rehabilitation unit. Mr Y says after several months in rehabilitation he was told that he could return home with his prosthetic leg but using a wheelchair because he was still immobile.
88. We requested the relevant records from the Trust for Mr Y’s rehabilitation period between October 2021 and March 2022. The Trust failed to provide these. Based on the missing records, we cannot take a view on the rehabilitation care the Trust gave Mr Y between October 2021 and March 2022 and in turn cannot consider any failing and any possible linked impact on his mental health.
89. The Trust’s response acknowledges at the time it did not have a formally funded physiotherapy amputee rehabilitation service but has not explained the care and treatment it provided in this respect.
90. The NHS complaint standards outline that organisations must provide ‘open and honest’ answers. They also say organisations should give a clear, balanced account of what happened based on established facts.
91. In relation to keeping reliable records, Our Principles of Good Administration say;
‘Public bodies should create and maintain reliable and usable records as evidence of their activities. They should manage records in line with recognised standards to ensure that they can be retrieved and that they are kept for as long as there is a statutory duty or business need.’
92. In not providing the relevant records to assist with our detailed investigation, the Trust has not acted in line with Our Principles of Good Administration. Due to this, we cannot say the Trusts response is in line with the NHS complaint standards or investigate this part of Mr Y’s complaint. This is because there appears to be no evidence to support whether its actions were appropriate for the rehabilitation period between November 2021 and March 2022. This is a further failing. We recognise that not being able to give a view on this will add to Mr Y’s frustration and distress and do not underestimate this.
Impact
93. Next, we considered the impact of the failings we have identified.
94. The Trust did not provide Mr Y with urgent management as it should have following his initial presentation in April 2019. This was when he first reported typical symptoms and signs of chronic limb-threatening ischemia. Following Mr Y’s Angioplasty procedure in April 2019, the Trust did not provide adequate surveillance to detect problems arising in the stent, and did not intervene as it should have done, to maintain the stent’s functionality.
95. The urgency for Mr Y to undergo repeat intervention to save the stent should have been realised by the Trust after his scan on 1 May 2020, which showed significant stenosis (narrowing). As the stenosis was not resolved with urgent angioplasty it was then allowed to progress to the complete occlusion (full blockage) that was diagnosed by the scan he had on 6 November 2020.
96. Once the complete occlusion was identified the surgeons should have discussed the case at MDT (and included Mr Y in this discussion) and then proceeded to attempt operative bypass surgery. If bypass surgery was considered not to have a realistic chance of success, then the consultants should have discussed the situation with Mr Y and he should have been offered planned urgent amputation to relieve his ischaemic pain. This discussion should have taken place between the vascular consultant and Mr Y in a face-to-face meeting.
97. Mr Y was made to wait from May to November 2020 for the angioplasty that was never performed, and then from November 2020 until June 2021 for the failed attempted angioplasty and then the failed bypass surgery in September of 2021, when amputation became inevitable. We consider this prolongation of Mr Y’s suffering with ischaemic pain could have been avoided or reduced if he had been given the right surveillance and treatment.
98. The Trust’s actions meant Mr Y did not receive the appropriate surveillance he should have after he presented to A&E in April 2019. He was then denied timely intervention to save the stent and bypass surgery when the stent failed. This resulted in Mr Y being left in significant pain and distress for longer than might otherwise have been the case.
99. It is not possible for us to say Mr Y would not have lost his leg even if timely intervention had been undertaken. This is because amputation is the end result for many patients with of chronic limb-threatening ischemia, especially for patients with diabetes. Had Mr Y been given timely intervention and treatment to try to save the leg, this could have made him more comfortable and avoided the amputation for longer. As our consultant adviser says, studies on the natural history of untreated severe or critical limb ischemia report 15%-30% of patients with of chronic limb-threatening ischemia (e.g. ischaemic rest pain and tissue loss such as ulceration or gangrene of the toes) will lose their limb within a year if they do not receive appropriate and timely treatment. We recognise and do not underestimate the upset, distress and pain caused to Mr Y by the prolonged delays in his care and treatment.
100. We recognise the impact COVID-19 had at the time of events complained about on the provision of services across the NHS and have taken this into consideration. However, this does not detract from the fact Mr Y should have received the appropriate surveillance and timely treatment, given the urgency of his condition.
101. The Trust’s failings in communicating the scan results from May 2020 meant Mr Y lost the opportunity to seek urgent intervention and treatment of his stent narrowing. He lost the opportunity to discuss and be involved in making informed decisions about his care and treatment at this point. This further reduced the angioplasty procedure’s likelihood of success.
102. In addition to this, we recognise the upset, distress and disappointment Mr Y will likely feel as a result of us being unable to investigate his rehabilitation period, due to lack of records from the Trust.