11. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this, and, it appears that surgeons carried out the appropriate checks on the size of the band needed and of her valve function during the procedure. This means we have seen no indication that anything went wrong.
12. Miss R told us that after her second heart surgery in 2022, her surgeon told her that the annuloplasty band used in the first surgery had shrunk or was too small, and this caused the fibrotic reaction and led to her increasing symptoms. She noted that the surgeon said the valve (we assume band) had become embedded and it was ‘a mess’.
13. Surgeons used a 28mm Cosgrove Edwards band to repair Miss R’s mitral valve. Miss R said she was told this is a size normally used in children, not adults.
14. The Trust said that the size of the band was determined by taking measurements of the valve. After the repair was completed, it said Miss R was weaned off the heart and lung machine, and a transoesophageal echocardiogram (TOE) was carried out (an ultrasound probe passed down the throat). It said the TOE showed that the mitral valve was opening and closing well and there was no evidence of any narrowing or restriction of the valve.
15. Our adviser explained that this band goes part of the way round the posterior of the valve to bring the leaflets together. The leaflets are flaps which open and close as the blood is pumped through the valve. Miss R’s valve was leaking because the leaflets did not meet as they should when they closed.
16. Surgeons could also have considered using a ring, which circles the whole valve, to affect the repair, or replacing the valve with a mechanical valve (as happened in the second surgery). Our adviser explained that surgeons should act in line with the European Society of Cardiology/European Association of Cardiothoracic Surgery guidelines for the management of valvular heart disease, 2017 (the Guidelines). Guideline 6.1 explains that surgeons should aim to repair, rather than replace, a mitral valve where possible. They said that in Miss R’s case, this conversative approach was the appropriate one and in line with the Guidelines.
17. Our adviser said that it is not possible to accurately determine the size of band needed until surgery has started. This is because surgeons use ‘sizers’ – models of parts of the valve – which they compare to the actual valve. In line with Guideline 6.1.1, they also carry out a TOE, to visualise and measure the nature of the leak, the pathology of the valves of the heart, and also assess the immediate result of a valve repair. The records confirm that the size of the band was checked.
18. We also asked our adviser what they would expect to see if a band which was too small was used. They explained there would be a degree of mitral stenosis (narrowing of the mitral valve). Mitral stenosis causes a reduction in the flow of blood through the valve and this would have been apparent on the TOE when Miss R was taken off the heart and lung machine during surgery. Our adviser considered the surgical records and concluded there no indication of narrowing of the mitral valve at this time.
19. The manufacturer’s manual for the Cosgrove Edwards band also explains that sizers should be used to decide which length of band should be chosen and that intraoperative echo (in other words, a TOE) can be used to assess the quality of the repair. It additionally says that the most commonly used sizes for women undergoing a repair are 30mm and 32mm. Available sizes range from 26 mm to 34mm, and Miss R received a 28mm band, so we can see this is smaller than the commonly used sizes for a woman. This does not necessarily imply that the band was too small; it can also mean that the structures of Miss R’s heart are smaller than for the average woman.
20. We recognise there are limitations to the records and the only way to know exactly how the band size was selected would be to have seen the surgeons using the sizers. All we can do, after the fact, is look at whether the appropriate steps were followed. The records indicate that they were. Coupled with the intraoperative TOE results ,we think that, on balance, there is no indication that the band used was too small. Therefore, we have decided not to take any further action on Miss R’s complaint.
21. Miss R was - and remains - considerably impacted by the symptoms from the mitral stenosis and her subsequent heart surgery. We recognise she was distressed to be told the band was too small and suitable for a child, as this suggested that some of her symptoms and perhaps the second operation were avoidable. We hope that she finds the explanation for our decision helpful and reassuring.