Information for the public

Benefits and risks

Benefits and risks

When NICE looked at the evidence, it decided that there was some evidence that the procedure worked but the evidence did not clearly show which babies benefit from having this procedure. It also decided that there was not enough evidence to know whether the procedure is safe enough. The procedure should therefore only be used when extra steps are put in place. The 8 studies that NICE looked at involved a total of 64 babies.

Generally, they showed the following benefits:

  • a study of 40 babies showed that, compared to standard pulmonary artery banding, babies who had a remote‑controlled adjustable band spent a shorter time on a ventilator after the operation, needed a shorter period in intensive care and left hospital quicker. But another study of 19 babies showed no difference in these outcomes

  • in a study of 20 babies, open heart surgery to fix a large hole in the middle of the heart was not delayed in 7 babies who had an adjustable band. But of 13 babies who had a standard band, 6 had to wait longer for open heart surgery

  • in a study of 20 babies with a leaky heart valve, the flow of blood through the heart improved in 2 babies who had an adjustable band but became worse in 2 babies who had a standard band

  • in a study of 10 babies who had pulmonary artery banding to retrain the left ventricle of the heart, improvements in pulmonary blood pressure at 20‑month follow‑up were similar in babies who had a standard band and in babies who had an adjustable band.

The studies showed that the risks of the procedure included:

  • in a study of 40 babies, 2 babies who had an adjustable band died 30 days after having the procedure. Five babies who had a standard band died (3 within 30 days and 2 after 30 days)

  • in 1 baby the band cut through the pulmonary artery and caused a blood clot. The baby needed further surgery to remove the clot and reconstruct the pulmonary artery, and then recovered

  • in 2 babies who had an adjustable band,1 baby needed more surgery to drain excess fluid from around the heart and 1 baby needed more surgery to remove the band because it was too big

  • in a study of 19 babies, at the time of open heart surgery to fix the defect, a patch to strengthen the pulmonary artery was needed in 4 babies who had an adjustable band and in 1 baby who had a standard band

  • 3 babies who had an adjustable band developed blood poisoning, which was successfully treated with antibiotics.

NICE was also told about some other possible risks. The band may move from its correct position or have to be taken out because of complications; the band may lose the wireless connection with the remote control so that it cannot be adjusted; the remote control may stop working; the band may not adjust properly; it may cause a leak in the pulmonary valve in the heart; or put pressure on the heart.

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

  • Information Standard