The Royal Wolverhampton NHS Trust

4. Mr R complains about the actions of the Trust, prior to the death of his mother in December 2024.

5. He complains:

• the Trust failed to explain the risks of the surgery, particularly the mortality risk beforehand. Had it done so, his mother would not have consented to the procedure.

• it failed to discuss a DNAR with Mrs R prior to the procedure, despite the mortality risk. He said had it done so, the family would have understood her wishes about resuscitation.

• when completing the TAVI procedure in mid-December 2024, it inserted the valve too far and this ruptured his mother’s aortic artery. Mr R says because the Trust failed to carry out the procedure correctly, his mother died three days later.

6. He explained that he believes that his mother may have lived a lot longer had she not gone through what was described as an everyday procedure. He is now his father’s sole carer, meaning he can only work part-time, which is causing emotional and financial distress.

7. Mr R wants an acknowledgement of failings and a financial remedy.

8. Mrs R was a 90-year-old woman. She had a past medical history of high blood pressure, anaemia (the body lacks enough healthy red blood cells to carry oxygen), fatty liver and a hiatus hernia (part of the stomach moves up into the chest). She was able to walk with a stick, but this became limited as she became increasingly breathless.

9. In September 2024, she was admitted to the Trust after having a two-week history of shortness of breath. During this admission she was diagnosed with critical aortic stenosis, which is where the aortic valve is narrowed, making it difficult for blood to flow out of the heart. The Trust referred Mrs R for a TAVI procedure, which is where an artificial valve made of natural tissues is placed inside the aortic valve using a catheter, allowing the heart to pump blood more effectively.

10. In November 2024, Mrs R attended the TAVI clinic. At this appointment the Trust discussed the procedure with Mrs R. She signed a consent form for the procedure the same day.

11. In mid-December 2024, Mrs R underwent the TAVI procedure. The surgeon deployed the valve into Mrs R’s aorta. Immediately after, Mrs R’s aortic root tore and she became hypotensive (her blood pressure dropped abnormally low), she developed a large pericardial effusion (excess blood in the area between the heart and its protective sac, which can compress the heart) and her heart rate slowed.

12. Surgeons performed cardiopulmonary resuscitation (CPR) and an emergency sternotomy (a procedure which allows surgeons to rapidly access the heart) to fix the aortic tear. A drain was placed in Mrs R’s chest to remove the excess fluid compressing her heart. The Trust also administered medication to stop Mrs R’s blood from clotting.

13. When Mrs R’s condition stabilised, surgeons moved her from the surgical table to a hospital bed. Mrs R’s condition deteriorated for a second time. Her blood pressure dropped and the pericardial effusion increased. The staff provided further CPR and transferred Mrs R to the Intensive Therapy Unit (ITU) where her condition initially stabilised.

14. Two days after surgery, Mrs R’s condition deteriorated. It was the Trust’s cardiologist’s view that Mrs R’s condition at that point meant that ongoing medical care should continue but the treating team would not provide CPR or resuscitation. The cardiologist discussed this with Mrs R’s family and signed a ReSPECT form. This is a form which helps clinicians understand a person’s preferences for their care in an emergency situation where the person may be unable to make or express their wishes.

15. Mrs R sadly died the next day.

The Trust failed to explain the risks of the surgery

19. Mr R explained that in November 2024, he attended the TAVI clinic appointment with Mrs R. The consultant discussed the benefits of the procedure, and discussed some risks with his mother, such as Mrs R may need a pacemaker, there may localised bleeding at the entry point and/or bruising and they may need to administer anti-clotting drugs. Mr R says the Trust did not properly explain the mortality risks or the danger of the procedure to his mother. He said she was under the impression that this was a simple, everyday procedure and, had the Trust properly discussed the mortality risks, Mrs R would not have consented to such a high-risk procedure.

20. The GMC’s professional standards explain how clinicians should record decisions about a person’s care. Point 54 says ‘consent forms can be a helpful prompt to share key information, as well as a standard way to records a decision that can make regular review easer. They can also be used to review decisions made at an earlier stage, and the relevant information they were based on’.

21. Point 55 says ‘but, filling a consent form isn’t a substitute for a meaningful dialogue tailored to the individual person’s needs’.

22. The professional standards make it clear that a signed consent form is a common step of the pre-procedure process, but it is not a substitute for a meaningful conversation in a way that helps the person understand the risks and benefits of the procedure.

23. Point 57 says ‘you should review a person's decision immediately before providing treatment or care and, if treatment is ongoing, make sure there are clear arrangements in place to review decisions regularly, allowing persons opportunity to ask questions and discuss any concerns. You should also consider regularly reviewing a decision to take no action’.

24. The professional standards make it clear that at each stage of the pre-procedure process, whether that be the clinic appointment or on the day of the procedure, the Trust must make sure a person understands what the procedure involves, the risks, the benefits and ensure that the person still consents.

25. The records show that at the TAVI clinic appointment in November 2024, the clinician discussed the aortic stenosis and TAVI procedure with Mrs R. The clinician discussed the risks of the procedure, took a blood sample and arranged for a chest X-ray to be taken when she attended for the TAVI procedure.

26. Mrs R provided her consent for the procedure and signed the consent form at the clinic appointment. This form listed the risks of the procedure as:

• Death – in 1% of cases • Stroke – in 2% of cases • Pacemaker – fitted in 5-10% of cases • Vascular injury • Emergency surgery • Renal injury 27. The Trust gave Mrs R a copy of its TAVI booklet that she could take home. This booklet explained the procedure, risks and benefits again and described what Mrs R could expect during her hospital stay.

28. The booklet explains:

• The risk of serious complications during the procedure is 2-3% (2 or 3 in every 100). These risks include heart attack, stroke, bleeding, kidney failure, complications related to the valve insertion site and leaking around the new aortic valve.

• 1 in 20 persons will need an operation to fix the insertion site in the leg (where the catheter enters the body).

• The aortic valve is near the natural pacemaker of your heart. Sometimes the procedure can affect your heart rhythm and 10-15% of patients require a permanent pacemaker after valve implantation.

• The overall risk of death within a month of the procedure is 2-3%. In rare cases (1 in 400) it may be necessary to carry out immediate surgery to replace the aortic valve. The surgical team and all emergency equipment are always available.

29. Our adviser told us that Mrs R’s medical records show the Trust discussed the specific risks of the procedure with Mrs R before she provided her consent. While Mrs R’s records do not confirm if she understood the risks as explained at the clinic appointment, there is also no evidence in her medical records to suggest that she did not understand the risks. Before the procedure, the consultant re-confirmed Mrs R’s consent to undergo the TAVI procedure.

30. We acknowledge that Mr R’s recollection of the clinic appointment is different from what Mrs R’s medical records show. We can see that Mrs R had a pre-operative assessment with the consultant and the consent form details the risks involved, including the mortality risk. The Trust’s TAVI booklet further sets out the risks of the procedure.

31. In the absence of any further evidence that might allow us to reach an independent view on the balance of probabilities as to what was said and how, we cannot comment on the quality or the clarity of the information that was provided to Mrs R, nor can we comment on her understanding of the information.

32. From our work and the advice we received, we have not seen anything to indicate that the Trust failed to discuss all the risks involved with Mrs R, in line with the GMC’s professional standards.

During the TAVI procedure the Trust ruptured Mrs R’s aortic artery

33. Mr R explained his view that the Trust performed a sub-standard operation in December 2024. He said it inserted the valve too far into Mrs R’s aorta and it ruptured. Because of this, his mother sadly died three days later.

34. Before carrying out a TAVI procedure, clinicians take CT imaging of the person. This helps to identify the size of transcatheter heart valve needed. The Trust said that two operators independently sized the valve required for Mrs R’s procedure. After reviewing the CT imaging and CT report, our adviser confirmed the valve used was appropriately sized, as set out in the manufacturer booklet.

35. It is important that the right sized valve is used in the procedure. Proper sizing is crucial for the valve’s efficiency and for the patient’s overall health and quality of life post-procedure.

36. During the procedure, clinicians use a fluoroscopy to help guide the catheter through a person’s body. The fluoroscopy helps clinicians ensure the catheter is in the right place before deploying the valve. Our adviser reviewed the fluoroscopy images taken in Mrs R’s procedure and confirmed that these images show that the valve was deployed in the correct place, and as per the manufacturer advice in its booklet.

37. From the Trust records, we can see that the manufacturer reviewed Mrs R’s case. The manufacturer confirmed that the Trust used the correct sized valve and deployed the valve as per recommended techniques.

38. Despite the valve being appropriately sized and deployed in the correct place, Mrs R suffered a vascular injury and her aortic root tore. The tear caused the pericardial effusion and resulted in emergency surgery and two rounds of CPR to stabilise her condition. The tear is a recognised risk of the TAVI procedure. NICOR’s Annual Report set out that in the year 2024/25, TAVI procedures had 1-2% complication rate, with major bleeding occurring nationally in 0.7% of procedures. This is in line with the risk likelihood percentages as set out in the consent form and the TAVI booklet.

39. Based on the evidence we have seen and the advice received, we have seen no indications of failings in the way the Trust performed the TAVI procedure.

40. We understand that it will be difficult for Mr R to read that there can be times when there is a recognised risk that can sadly lead to death. All TAVI procedures carry the risk of vascular injuries, emergency surgery and sadly, the death of the patient.

41. We recognise that Mrs R sadly died three days after the procedure and this clearly left Mr R with concerns about the treatment she received. The evidence does not indicate that her death was caused by the way the Trust performed the procedure; rather, her death was combination of different elements, one of which was a recognised risk of the procedure.

The Trust failed to discuss a Do Not Resuscitate Order (DNAR) with Mrs R prior to the procedure.

42. Mr R said that prior to the procedure the Trust failed to discuss a DNAR with Mrs R. He said considering the mortality risks associated with the procedure and the outcome of the procedure, the lack of prior conversations about the DNAR left Mrs R with no options, no choice about her care and no chance to prepare for the worst outcome.

43. The DNAR process involves making a formal decision not to perform CPR in the event of a cardiac or respiratory arrest. These decisions can be made in advance by a person and/or a doctor in cases where CPR would not help a person live longer or would cause harm and suffering. A DNAR decision is also made when a person approaches the end of their life.

44. In Mrs R’s case, she did not sign a DNAR prior to the TAVI procedure. We understand why Mr R is concerned that this was the case, when the risks involved could have serious consequences.

45. Our adviser said it would not be usual or expected to discuss, or for a person to sign, a DNAR before a procedure such as a TAVI as the need for CPR during the procedure regularly occurs. Mrs R was expected to survive the TAVI procedure and any complication that arose. There was no need for Mrs R to sign a DNAR at that point, as this would not have benefitted her at the time.

46. In paragraphs 23 to 25, we have explained the risks involved in the TAVI procedure as explained to Mrs R during the consent process and in the TAVI booklet. A vascular injury, such as an aortic tear, can be fatal, and emergency surgery is usually required for the patient to survive. Had Mrs R signed the DNAR before the procedure, this would have prevented clinicians from performing the emergency surgery to treat the complication, and she may have died while in the operating theatre.

47. Most complications in the TAVI procedure can be treated without major surgery. In the case of bleeding, which is also what happened in Mrs R’s case, clinicians may be required to conduct CPR while the problem is fixed. As we have said in paragraph 42, if Mrs R had signed a DNAR before the procedure, this would have prevented the clinicians from acting to fix the complication.

48. Point 6 of GMC’s Good Medical Practice says ‘if you assess, diagnose or treat patients, you must work in partnership with them to assess their needs and priorities. The investigation or treatment you propose, provide or arrange must be based on this assessment, and on your clinical judgment about the likely effectiveness of the treatment options’.

49. We have set out in paragraphs 18 to 29 the evidence shows the Trust acted in line with the relevant guidance when discussing the risks of the TAVI procedure. The consent form and its TAVI booklet set out that vascular injuries and emergency surgery may occur. The TAVI booklet says, ‘the cardiologist or cardiac surgeon will discuss these (the risks) with you and only proceed if the feel the benefit outweighs the risk’. The evidence indicates that Mrs R had all the information she needed to consent to the procedure, including resuscitation being a required treatment option.

50. With this in mind, we have not seen an indication of a failing in the Trust’s decision not to discuss a DNAR prior to the TAVI procedure. We can see that the Trust used its clinical judgement about the likely effectiveness of the treatment options and this was in line with GMC’s Good Medical Practice.

51. We understand this complaint is very important to Mr R and his mother’s sad death continues to cause him distress. We hope our statement provides Mr R with the reassurance that, in our independent view, the Trust acted in line with the guidance, and that our statement clearly explains how we have reached this decision.

1. We have carefully considered Mr R’s complaint about the actions of the Trust. Having done, so we have not seen any indications of failings in the way the Trust discussed the risks of the Transcatheter Aortic Valve Implantation (TAVI) procedure with his mother, Mrs R.

2. We have not found any indications of failings in the way that the Trust performed the TAVI procedure, nor have we found any indication of failings in relation to whether the Trust discussed a Do No Attempt Resuscitation (DNAR) order with Mrs R prior to the procedure.

3. We were very sorry to hear of Mrs R’s death. We understand that this continues to be an upsetting time for Mr R and his father and we extend our condolences to them both. We hope that he will be reassured by the information in this statement that there is no further action we need to take.