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Benefits and risks

Benefits and risks

When NICE looked at the evidence, it decided that there's not much good evidence about how well transapical transcatheter mitral valve‑in‑valve implantation works in the longer term and that there is a possibility of serious complications. But, it did decide the evidence shows generally good symptom relief in the short term. The 8 studies (including a registry) that NICE looked at involved a total of 406 patients.

A study of 23 patients showed the following benefits:

  • successfully implanted valve in 100% of patients

  • 100% of patients alive 30 days after surgery, and 90% still alive after an average of 753 days

  • improvement in symptoms of heart failure and in heart function.

The 8 studies showed that the risks included:

  • 1 in 10 chance of death within an average of 753 days of surgery

  • fatal pneumonia in 1 patient and the need for prolonged assisted ventilation in 3 patients

  • major stroke in 3–4% of patients and a mini stroke in 1 patient

  • major bleeding in 26% (6 of 23) of patients and late bleeding in 33% (2 of 6) of patients

  • acute kidney injury in 11% (39 of 349) of patients

  • wound infection in 25% (3 of 13) of patients

  • 1 patient needed a permanent pacemaker

  • a blood clot in the valve in 1 patient

  • 1 patient needed a second valve implanted.

NICE was also told about another possible risk: blockage in the lower left chamber of the heart preventing blood flowing from the heart to the body.

If you want to know more about the studies, see the guidance. Ask your health professional to explain anything you don't understand.

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