Table 2. POEM-TIF first-in-human procedural characteristics and clinical outcomes.
| Patient characteristics | 1 | 2 | 3 | 4 | 5 |
| Gender | F | F | M | F | F |
| BMI | 22.3 | 27.2 | 35.5 | 17.2 | 27.3 |
| Achalasia subtype | II | II | II | I | II |
| Duration of disease | 18 | 8 | 12 | 9 | 14 |
| Procedural characteristics | |||||
| Orientation of POEM | Posterior | Posterior | Anterior | Anterior | Anterior |
| POEM total time (min) | 38 | 24 | 40 | 37 | 30 |
| TIF total time (min) | 33 | 25 | 50 | 40 | 42 |
| Length of myotomy (esophagus/gastric) (cm) | 7/2 | 5/2 | 10/3 | 10/3 | 12/3 |
| Type of myotomy | Full thickness | Full thickness | Full thickness | Full thickness | Full thickness |
| Length of final valve (cm) | 3 | 4 | 3 | 3 | 2 |
| Number of fasteners | 24 | 24 | 24 | 20 | 29 |
| Method of closure | TTS clips | TTS clips | Suture | Suture | TTS clips |
| Technical outcomes | |||||
| Technical success | Yes | Yes | Yes | Yes | Yes |
| Adverse events | None | None | None | None | None |
| Injury to mucosal entry | None | None | None | None | None |
| Injury to POEM tunnel mucosa | None | None | None | None | None |
| Presence of bleeding | None | None | None | None | None |
| Clinical outcomes | |||||
| Eckardt baseline | 7 | 6 | 9 | 8 | 6 |
| Eckardt 1 month | 1 | 2 | 2 | 0 | 3 |
| Eckardt 3 months | 1 | 1 | 1 | 2 | 3 |
| Eckardt 6 months | 0 | 1 | 3 | 2 | 3 |
| GERD-HRQL 1 month | 6 | 6 | 15 | 3 | 18 |
| GERD-HRQL 3 months | 7 | 6 | 13 | 7 | 22 |
| Gerd HRQL 6 months | 4 | 7 | 16 | 16 | 24 |
| 48-hr pH testing 6 months | 2.8 | 8.4 | 3.3 | 21.6 | 1.5 1 |
| Esophagitis | None | None | None | LA Grade A | LA Grade C |
POEM, per oral endoscopic myotomy; TIF, trans oral incisionless fundoplication; GERD-HRQL, gastroesophageal reflux disorder health-related quality of life; PPI, proton pump inhibitor.
1
Performed while on twice-daily PPI due to severe symptoms.