Benefits and risks

Information for the public

When NICE looked at the evidence, it decided that there was enough evidence to show that percutaneous endoscopic laser balloon pulmonary vein isolation works, although there are some serious, well-recognised complications associated with this procedure. The 9 studies that NICE looked at involved a total of 1,128 patients.

Generally, they showed the following benefits:

About 60% of patients were drug-free and had no symptoms of atrial fibrillation at 12 months.
In patients with persistent (permanent) atrial fibrillation, 75% had no atrial fibrillation at 12 months.
In patients with atrial fibrillation that comes and goes, 75% had no atrial fibrillation at 4 years.

Atrial fibrillation came back within a year of the procedure in up to 28% of patients. Between 6% and 25% of patients needed to have the procedure repeated.

The studies showed that the risks of percutaneous endoscopic laser balloon pulmonary vein isolation included:

lesions in the oesophagus (gullet) caused by heat damage, in 82% of patients
moderate narrowing of the pulmonary vein, in 22% of patients
ulcers in the oesophagus in 10% of patients
diaphragm paralysis lasting more than 90 days, in 4% of patients
phrenic nerve paralysis (the phrenic nerves run from the neck to the diaphragm) or injury in up to 4% of patients
injury to veins or arteries in up to 4% of patients
fluid collecting around the heart preventing it beating properly in up to 3% of patients
stroke or transient ischaemic attack ('mini-stroke') in less than 1% of patients.

In 8% of patients a different procedure was needed to correct the abnormal heart rhythms. One patient died suddenly 6 days after the procedure, but this was not related to the procedure.

NICE was also told about some other possible risks: catheter failure needing a minor surgical procedure to remove it safely from the femoral vein.

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