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    Safety summary

    All events

    In the systematic review and meta-analysis of 1,475 people, the overall rate of serious adverse events was 2% (95% CI 1% to 3%; 29 studies; p<0.001; I2=54.1%; McCarty 2018), with follow up from studies included in this measure ranging from 1.5 to 59 months (McCarty 2018).

    In the evidence synthesis of 580 people, 1 study reported a greater percentage of people experiencing from moderate to severe adverse events in the intervention group than the control group with a follow up range of 3 to 12 months (Grössmann 2021).

    Death

    In a HTA of 580 people, death was reported in 1 study in 1 person in 11 months after the procedure (Grössmann 2021).

    Perforation

    In a case report outlining a case of oesophageal perforation after the procedure, the person subsequently developed mediastinitis, left sided pneumothorax, bilateral pleural effusions, and empyema. The person needed mechanical ventilation for 12 days and also developed acute renal injury; at the most recent follow up (time not reported) the patient had been hospitalised for 2 weeks because of the non-resolving right-sided empyema (Edriss 2014).

    In a case report outlining a case of oesophageal perforation and oesophagopulmonary fistula after the procedure, the person was admitted to hospital multiple times over several weeks and went into early septic shock. After surgical treatment and drainage of a large parenchymal abscess cavity, the person was discharged with oral antibiotics and had no further complaints of reflux at 1 month follow up (Titus 2013).

    In the case series of 151 people, oesophageal perforation was reported in 1% (2/151) of people, with 1 of the 2 people presenting with a mediastinal abscess. Both patients had laparoscopic surgery and recovered without further complications (Bell 2021).

    In a case series of 46 people, 1 person reported oesophageal perforation and 1 person reported gastric fundus perforation (Testoni 2022).

    Pneumothorax

    In a case series of 50 people, pneumothorax happened in 4% (2/51) of procedures which was confirmed by X-ray immediately after the procedure and managed by immediate transthoracic drainage. Both people were discharged from hospital within 3 days (Testoni 2019).

    Pleural effusion

    Pain

    In the evidence synthesis of 580 people, 1 study reported readmission of 1 person because of immediate postoperative pain (Grössmann 2021).

    In the case series of 46 people, 7% (3/45) reported epigastric pain which presented 6 hours after initial procedure and needed major analgesics (Testoni 2022).

    Bleeding

    Other

    In 1 included study in the evidence synthesis of 580 people for a HTA, 13% of people reported an extra hospital day because of pain, anxiety, nausea, or postoperative urinary retention (Grössmann 2021).

    In a case series of 151 people, 1 person reported vomiting and was treated with antibiotics, 1 person with existing interstitial lung disease had hypoxaemia and was hospitalised for 5 days, and 1 person had a prolonged ileus and needed 3 days hospitalisation (Bell 2021).

    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: oesophageal and pharyngeal perforation.