Safety summary

Overall rate of adverse events

In the RCT of 162 people (87 on active treatment) with post-stroke dysphagia, there was no statistically significant difference in the rate of serious adverse events (SAEs) at the end of follow up: PES n=22 (25.9%), sham n=18 (26.9%); p=1.00; (Bath 2016).

In the RCT of 69 people (35 on active treatment) with post-stroke dysphagia and tracheotomy, there was no statistically significant difference between the number of people with at least 1 SAE between the PES and sham groups: PES n=12 (10 people, 29%), sham n=9 (8 people, 24%; Dziewas 2018).

In the analysis of a prospective registry of 252 people with dysphagia from various neurological causes, there were 74 SAEs in 60 people (24.5%; Bath 2020).

Device- and treatment-related adverse events

In the RCT of 69 people (35 on active treatment) with post-stroke dysphagia and tracheostomy, there were 8 non-serious device-related adverse events in 5 people in the PES group (14%) and 4 non-serious device-related adverse events in 3 people (9%). The most common device-related adverse event in both the PES and sham groups was medical device complication (Dziewas 2018).

In the analysis of a prospective registry of 252 people with dysphagia from various neurological causes, there was 1 SAE (0.4%) that was considered possibly related to PES: pneumonia related to catheter insertion leading to sepsis (Bath 2020).

Device- and treatment-unrelated adverse events

In the RCT of 162 people (87 on active treatment) with post-stroke dysphagia, there were 22 SAEs in the PES group that were deemed unrelated to the device. These included SAEs in the following categories: cardiac n=6 (7.1%), gastrointestinal n=2 (2.4%), hepatobiliary n=1 (1.2%), infections n=6 (7.1%), investigations n=1 (1.2%), neoplasms n=1 (1.2%), nervous system n=4 (4.7%), renal and urinary n=1 (1.2%), respiratory n=5 (5.9%), and surgical or medical n=2 (2.4%; Bath 2016).

In the RCT of 69 people (35 on active treatment) with post-stroke dysphagia and tracheotomy, there were 12 SAEs in the PES group that were deemed unrelated to the device. The most common SAEs were pneumonia n=2 (2 people, 6%), cardiac arrest n=2 (2 people, 6%), sepsis n=3 (3 people, 9%), hydrocephalus n=2 (2 people, 6%), and death n=7 (7 people, 20%; Dziewas 2018).

In the analysis of a prospective registry of 252 people with dysphagia from various neurological causes, there were 73 SAEs considered unrelated to treatment. The most common SAEs were pneumonia n=26 (10.6%), cardiac arrest n=5 (2.0%), respiratory failure n=4 (1.6%), stroke n=3 (1.2%), and infection including sepsis. 'Other' SAEs accounted for n=3 (1.2%; Bath 2020).

In the pilot RCT of 20 people (10 people on PES plus SLT) with dysphagia related to ALS, there were 2 adverse events reported: uncomfortable feeling in the pharynx while using non-invasive ventilation after PES, n=1 (10%), mild burning pain in the nasopharynx after PES caused by an erythema, n=1 (10%; Herrmann 2022).

Death

In the RCT of 162 people (87 on active treatment) with post-stroke dysphagia, there was no statistically significant difference in the cumulative risk of all-cause death between the PES and sham groups (Bath 2016): the time to event hazard ratio was 1.11; 95% CI 0.34 to 3.59; p=0.86.

In the RCT of 69 people (35 on active treatment) with post-stroke dysphagia and tracheotomy, 7 people in the PES group, 3 people in the sham group and 1 person before randomisation died during the study. None of the deaths were judged to be PES treatment or investigational device (base station and catheter) related (Dziewas 2018).

In the analysis of a prospective registry of 252 people with dysphagia from various neurological causes, there were 29 SAEs that were fatal (Bath 2020).

Anecdotal and theoretical adverse events

In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).

For this procedure, professional experts listed the following anecdotal adverse events: discomfort, hypersalivation, reddening of mucosa, pain in the ear and eye, local oedema.