pISSN 2636-0004eISSN 2636-0012
pISSN 2636-0004Adverse Events during POEM (Selected Large Studies)
| Study | No. of patients/type of study | Adverse events |
GERD (%) |
|---|---|---|---|
| Von Renteln et al (2013)8 | 70/multicenter prospective | Total = 10 (14.3) | At 3 mo |
| Clip dislocation at mucosal closure = 3 (4) | Symptoms = 33 | ||
| Perforation into mediastinum at mucosal entry side = 1 (1) | PPI use = 34 | ||
| Mucosal injury through electrocautery = 3 (4) | Erosive esophagitis = 42 | ||
| Bleeding requiring intervention = 1 (1) | At 6 mo | ||
| Cap detached in submucosal tunnel = 1 (1) | Symptoms = 30 | ||
| Delayed bleeding leading to mediastinal hematoma = 1 (1) | PPI use = 39 | ||
| Inoue et al (2015)9 | 500/prospective | Total = 16 (3.2) | At 2 mo |
| Pneumothorax underwent drainage = 1 (0.2) | Symptoms = 16.8 | ||
| Severe bleeding = 1 (0.2) | Esophagitis = 64.7 | ||
| Mucosal perforation = 8 (1.6) | At 1–2 yr | ||
| Postoperative hematoma = 3 (0.6) | Symptoms = 19.4 | ||
| Inflammation in gastric lesser omentum = 1 (0.2) | Esophagitis = 59.2 | ||
| Pleural effusion = 2 (0.4) | At 3 yr | ||
| Symptoms = 21.3 | |||
| Esophagitis = 56.3 | |||
| Zhang et al (2016)11 | 1,680/retrospective | Major = 55 (3.3) | Not included |
| Delayed mucosal barrier failure = 13 (0.8) | |||
| Delayed bleeding = 3 (0.2) | |||
| Hydrothorax = 8 (0.5) | |||
| Pneumothorax = 25 (1.5) | |||
| Miscellaneous = 6 (0.4) | |||
| Hospital readmission = 3 (0.2) | |||
| ICU admission = 2 (0.1) | |||
| Vital sign instability = 1 (0.1) | |||
| Werner et al (2017)12 | 241/retrospective | Major = 3 (1.2) | Not included |
| Pneumothorax requiring drainage = 1 (0.4) | |||
| Gastric cardia perforation underwent surgery = 1 (0.4) | |||
| Hemothorax underwent surgery = 1 (0.4) | |||
| Minor = 87 (31.1) | |||
| Prolonged intra-procedural bleeding = 23 (9.5) | |||
| Mucosal injury = 20 (8.3) (difficult to repair = 2.9) | |||
| Subcutaneous emphysema = 76 (31.5) | |||
| Capnoperitoneum = 86 (35.7) | |||
| Submucosal hematoma = 2 (0.8) | |||
| Fever = 8 (3.3) | |||
| Readmission = 2 (0.8) | |||
| Haito-Chavez et al (2017)13 | 1,826/multicentre retrospective | Total = 137 (7.5) | Not analysed |
| Mild = 116 (6.4) | |||
| Moderate = 31 (1.7) | |||
| Severe = 9 (0.5) | |||
| Esophageal leak = 2 (0.1) | |||
| Bleeding = 2 (0.1) | |||
| Perforation = 1 (0.05) | |||
| Aspiration pneumonia = 1 (0.05) | |||
| Empyema = 1 (0.05) | |||
| Capnomedaistinum = 1 (0.05) | |||
| Cardiac arrythmia = 1 (0.05) | |||
| Nabi et al (2018)7 | 502/retrospective | Major = 8 (1.6) | At 3 mo |
| Capnopericardium = 2 (0.4) | Symptoms = 46 | ||
| Capnothorax requiring drainage = 2 (0.4) | Erosive esophagitis = 32 | ||
| Enlargement of mucosal incision = 3 (0.6) | High De Meester score = 28.8 | ||
| Readmission = 1 (0.2) | At 1 yr | ||
| Minor = 169 (33.7) | Symptoms = 17 | ||
| Mucosal injury = 19 (3.7) | Erosive esophagitis = 21.5 | ||
| Capnothorax = 3 (0.4) | |||
| Capnoperitoneum = 62 (12.5) | |||
| Retroperitoneal air = 84 (16.7) | |||
| Subcutaneous emphysema = 106 (21.1) | |||
| Pleural effusion = 1 (0.2) | |||
| Li et al (2018)14 | 564/prospective | Major = 36 (6.4) | Symptoms = 36.5 |
| Delayed mucosal barrier failure = 3 (0.5) | Erosive esophagitis = 17 | ||
| Delayed bleeding requiring admission = 3 (0.5) | Clinical reflux = 37.3 (combining symptom + reflux esophagitis) | ||
| Hydrothorax requiring drainage = 6 (1.1) | |||
| Pneumothorax requiring drainage = 21 (3.7) | |||
| Other = 3 (0.5) (1-postoperative epilepsy, 1-pharyngeal edema, 1-transient hypoxia) | |||
| Minor = 5 (0.9) | |||
| Intraoperative bleeding = 3 (0.5) | |||
| Subcutaneous emphysema = 1 (0.2) | |||
| Pneumoperitoneum = 1 (0.2) | |||
| Shiwaku et al (2019)20 | 233/multicenter prospective | Total = 24 (10.3) | At 1 yr |
| Deep mucosal injury (perforation) = 11 (4.7) | Symptoms = 14.7 | ||
| Mucosal injury without perforation = 9 (3.9) | PPI use = 21.1 | ||
| Submucosal hematoma = 3 (1.3) | Erosive esophagitis = 54.2 | ||
| Pleurisy = 1 (0.43) | |||
| Peritonitis = 1 (0.43) | |||
| Shiwaku et al (2020)21 | 1,346/multicentre retrospective | Total = 50 (3.7) | At 6 mo |
| Mucosal perforation = 5 (0.4) | Symptoms = 14.8 | ||
| Mucosal injury without perforation = 24 (1.8) | Erosive esophagitis = 63 | ||
| Submucosal hematoma = 9 (0.7) | |||
| Major bleeding = 2 (0.1) |
POEM, peroral endoscopic myotomy; GERD, gastroesophageal reflux disease; PPI, proton pump inhibitor; ICU, intensive care unit.
*Values are presented as number (%).