5 Safety

Guidance

This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1

Gastrointestinal haemorrhage was reported in 1 patient being treated by antiplatelet therapy for heart disease in the radiofrequency ablation group in a randomised controlled trial of 127 patients. This was treated endoscopically.

5.2

Perforation of the oesophagus (measuring 1.5 cm) within the proximal radiofrequency ablation field (noted 6 weeks postoperatively because of a report of 'a food impaction') was reported in 1 patient in a case series of 10 patients. Further details were not reported.

5.3

Oesophageal strictures were reported in 12% (8 of 68) of patients treated by radiofrequency ablation (time of occurrence not reported) in a randomised controlled trial of 136 patients: these were all successfully treated by endoscopic dilatation (in median of 1 session).

5.4

Erosive oesophagitis (transient and resolved completely) was reported in 6% (3 of 50) of patients at 5‑year follow‑up in a case series of 70 patients.

5.5

Overnight hospitalisation for new chest pain was reported in 1 patient (8 days after radiofrequency ablation) in the radiofrequency ablation group in the randomised controlled trial of 127 patients (outcome not reported). Chest pain (transient and resolved spontaneously) was reported in 8% (9 of 106) of procedures in the case series of 70 patients.

5.6

Fever (transient and resolved completely) was reported in 2% (2 of 106) of procedures undertaken in the case series of 70 patients.

5.7

The specialist advisers listed additional adverse events as dysphagia and oesophageal laceration.