5 Safety
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
Oesophageal perforations were reported in 5% (2 of 44) of patients in a case series of 44 patients. Both perforations were drained externally, and the patients were given systemic antibiotics, leading to full recovery and improved swallowing. A hypopharyngeal perforation that resulted in infection and prolonged hospitalisation as a result of pharyngocutaneous fistula, and a complete pharyngeal wall perforation, were reported in 1 patient each in the CO2 laser assisted cricopharyngeal myotomy group in a retrospective comparative case series of 153 patients who had endoscopic myotomy either by CO2 laser (n=123) or by stapler (n=23). Further details were not reported.
5.2
Fistula (without mediastinitis) was reported in 1 patient immediately after the procedure in a case series of 65 patients. Further details were not reported.
5.3
Mucosal tears occurred during cricopharyngeal myotomy (as the endoscope or the stapler were introduced) in 5% (6 of 123) of patients in the CO2 laser group and 1 patient in the stapler group, in the retrospective comparative case series of 153 patients. Further details were not reported.
5.4
Left vocal fold paralysis was reported in 1 patient in a case series of 87 patients.
5.5
Severe bleeding (controlled during the procedure) was reported in 1 patient in the case series of 65 patients.
5.6
Aspiration pneumonia (needing further hospitalisation) was reported in 2% (2 of 123) of patients in the CO2 laser group in the retrospective comparative case series of 153 patients. Both patients were managed conservatively.
5.7
Progressive fibrosis was reported in 36% (4 of 11) of patients in a case series of 11 patients. They presented with multiple problems with bolus propulsion and poor cricopharyngeal opening. All had worse swallowing outcomes following the procedure and 1 patient eventually had a pharyngolaryngectomy due to dysfunctional larynx.
5.8
Restenosis was reported in 10% (4 of 44) of patients with stage IV dysfunction in the case series of 44 patients. Two patients had revision surgery after 6 to 12 months, but the other 2 patients died of coronary heart disease before a further myotomy could be done.
5.9
Pulmonary infection immediately after the procedure was reported in 1 patient in the case series of 65 patients. Further details were not reported.
5.10
Chest pain (self-limited) was reported in 1 patient in the CO2 laser group in a retrospective comparative case series of 22 patients who had either endoscopic CO2 laser CP myotomy (n=14) or transcervical CP myotomy (n=8). No further details were reported.
5.11
In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: mediastinitis, dental damage, scarring and stenosis in patients who have had radiotherapy. They considered that the following were theoretical adverse events: recurrent laryngeal nerve injury, voice problems, airway fire caused by laser use and stricture of the upper oesophagus.