Table 6.
Pooled analysis of adverse events in patients with benign esophageal leaks, perforations and fistulae
| Total number of patients analyzed: n = 599 | No. of patients (n = 599) | No. of FC SEMS (n = 295) | No. of PC SEMS (n = 302) | No. of SEPS (n = 75)1 | Stent type unknown (n = 162)2 |
| Overall complications | 803 (13.4) | 26 (8.8) | 38 (12.6) | 1 (1.3) | 17 (10.5) |
| Overall major complications | 473 (7.8) | 11 (3.7) | 28 (9.3) | 1 (1.3) | 8 (4.9) |
| Hyperplasia-induced stenosis | 16 (2.7) | 0 | 16 | 0 | 0 |
| Hemorrhage4 | 8 (1.3) | 24 | 6 | 0 | 0 |
| Stent-related perforation | 6 (1.0) | 4 | 1 | 0 | 1 |
| Aspiration pneumonia | 4 (0.7) | 2 | 0 | 0 | 2 |
| Respiratory compromise/ tracheal compression | 2 (0.3) | 1 | 1 | 0 | 0 |
| Severe retrosternal pain | 2 (0.3) | 0 | 2 | 0 | 0 |
| Bowel obstruction | 2 (0.3) | 0 | 0 | 0 | 2 |
| Erosion4 | 2 (0.3) | 0 | 14 | 0 | 1 |
| Hemorrhage from aorta-esophageal fistula | 1 (0.2) | 1 | 0 | 0 | 0 |
| Stricture formation | 1 (0.2) | 0 | 0 | 0 | 1 |
| Stent-related fistula | 1 (0.2) | 0 | 1 | 0 | 0 |
| Stent dislocation and inability to place new stent requiring rethoracotomy | 1 (0.2) | 0 | 0 | 1 | 0 |
| Left atrial compression | 1 (0.2) | 0 | 0 | 0 | 1 |
| Death due to esophageal necrosis at proximal stent end | 1 (0.2) | 1 | 0 | 0 | 0 |
| Overall minor complications | 333 (5.5) | 15 (5.1) | 10 (3.3) | 0 (0) | 9 (5.6) |
| Transient stent-related dysphagia | 11 (1.8) | 1 | 10 | 0 | 0 |
| Stent-related ulcers | 5 (0.8) | 5 | 0 | 0 | 0 |
| Reflux/esophagitis | 3 (0.5) | 0 | 0 | 0 | 3 |
| Chest pain | 3 (0.5) | 1 | 0 | 0 | 2 |
| Stent disintegration | 3 (0.5) | 3 | 0 | 0 | 0 |
| Stent collapse/invagination | 2 (0.3) | 1 | 0 | 0 | 1 |
| Pneumoperitoneum during endoscopy secondary to air insufflation | 1 (0.2) | 1 | 0 | 0 | 0 |
| Atrial fibrillation related to sedation | 1 (0.2) | 1 | 0 | 0 | 0 |
| Stent malposition | 1 (0.2) | 1 | 0 | 0 | 0 |
| Abdominal pain | 1 (0.2) | 0 | 0 | 0 | 1 |
| Nausea | 1 (0.2) | 0 | 0 | 0 | 1 |
| Globus sensation | 1 (0.2) | 1 | 0 | 0 | 0 |
| Hiccups | 1 (0.2) | 0 | 0 | 0 | 1 |
1
Including 30 patients in whom the number of SEPS used was not reported;
2
Including 40 patients in whom the number of stents used was not reported;
3
Patients can have more than one complication;
4
Including one stent-related death. FC SEMS: Fully covered self-expandable metal stent; PC SEMS: Partially covered self-expandable metal stent; SEPS: Self-expandable plastic stent.