14. Mr A complains about the TAVI procedure his wife had on 1 April. He says the failure of the device, used to close the artery in her left leg, led to complications and her eventual death on 5 April.
15. In the minutes of the meeting the Trust held with Mr A on 17 August 2020, it said:
‘[Consultant A] explained that they had reviewed Mrs A’s documentation and confirmed that access to the site was made through her right groin where a large hole was made to insert the TAVI device. A smaller hole was made in her left groin which was used during the TAVI procedure for lines to monitor Mrs A and to perform angiograms to assess the vessel.
A closure device was used to close the puncture sites to reduce the risk of bleeding. The
right groin was closed with a suture device called Proglide and for the smaller site on the left groin a device called Angio-Seal was used, which is a collagen plug that seals the site and dissolves after three months.
Following the procedure Mrs A was stable and there were no signs of any bleeding.
It was on 3 April when Mrs A began to develop complications. She got up to use the bathroom and experienced dizziness associated with a fall in blood pressure and a sudden pain in her left groin. It was at this point that [the consultant vascular surgeon] was contacted and confirmed localised bleeding around the puncture site. Mrs A underwent emergency surgery on her left groin by [the consultant vascular surgeon] to repair the hole in the artery who also remarked there had been a haematoma (collection of blood) accumulate prior to this. No sign of the Angio-Seal could be seen and therefore it appears that the closure plug had become displaced when Mrs A had been mobilising around the ward, which can sometimes happen although rare. Mrs A was reviewed the next day on the Critical Care Unit and there appeared to be no further haemorrhage’.
16. To determine whether the Trust did anything wrong, we looked at what the relevant guidance says should have happened. NICE guidance ‘Transcatheter Aortic Valve Implantation for aortic stenosis’ says:
‘Aortic stenosis causes impaired outflow of blood from the heart and is usually progressive. The increased cardia 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.
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. TAVI is another less invasive alternative treatment’.
17. We can see from the records that Mrs A was reviewed in the TAVI clinic on 27 March, the clinic letter from this review says:
‘I have discussed the nature of the aortic stenosis and the risks and benefits of open surgery verses TAVI with her and her husband today. She has been reviewed by [named consultants] and they agree that early TAVI treatment is warranted and once again I ran through all of the complications of this procedure with family. She understands that there is a mortality rate of 2-3%, a stroke risk of 2-3%, major vascular injury of 5% and pacemaker of 12-15%’
18. The consent form which Mrs A signed prior to the surgery also lists the risks and says, ‘death 2-3%, vascular injury, bleeding, pacemaker 10-15%’. We also looked at the Angio-Seal manufacturer’s website which says, ‘possible adverse side effects for vascular closure devices include, but are not limited to bleeding or hematoma, AV fistula pseudoaneurysm, allergic reaction, foreign body reaction, inflammation or edema’.
19. We also asked our adviser for their view on whether anything went wrong during the procedure which could have caused the complications Mrs A suffered. Our adviser told us that Mrs A met the criteria for the TAVI procedure as outlined in the NICE guidance quoted above, and that the performance of the TAVI has been described in detail in the medical notes and was carried out in the standard way.
20. We can see from the medical records that after the procedure on 1 April it is recorded at ‘patient has had a successful TAVI’. That evening it says, ‘patient’s groins checked small stroke through to right groin dressing intact’. In the afternoon of 2 April, it is recorded ‘groins both looking good small amount of bruising’. The medical records also show that Mrs A was reviewed by a consultant on the morning of 2 April, and it is recorded that there were no concerns, and it was intended for Mrs A to be discharged the following day.
21. However, on the morning of 3 April when she was reviewed by the consultant it is noted ‘was feeling well till morning after having wash had pain in L groin’. The notes also say that on examination ‘haematoma L groin’. Mrs A was then taken back to theatre for surgery on her left groin.
22. Our adviser told us that Mrs A had severe aortic stenosis, which is a serious condition which shortens life. Mrs A’s life expectancy with it was about one year and she underwent TAVI treatment for this. However, she suffered vascular damage with severe bleeding, which is a recognised complication of a complex procedure usually undertaken in the frail and elderly.
23. From the evidence we have seen we do not consider that that, prior to 3 April, there were any indications that the Angio-Seal had failed. The medical notes show that the operation was carried out in the standard way and there is nothing in the notes to suggest anything unexpected happened during the surgery. Mrs A was being monitored after the operation and there is no evidence, prior to 3 April, that the Trust had any concerns about her recovery from the procedure. However, the complications Mrs A then suffered are known complications, and we are satisfied that the risk of these were clearly explained to her both in the clinic on 27 March and prior to the procedure on 2 April. While the chance of these complications occurring was relatively low, there is no suggestion that these occurred due to anything the Trust did wrong. It is for this reason that we do not uphold this complaint.
24. We are in no doubt that this has been a difficult and traumatic time for Mr A especially as his wife died so suddenly, and we appreciate why he wants to understand what happened. We hope he is reassured that her care has been looked at independently and that there are no indications the Trust did anything wrong.