Table 7.
Summary of the Evidence Supporting Peroral Endoscopic Myotomy After Prior Treatment Failure in Patients With Achalasia
| Study | Design | Population | Intervention | Comparator | Follow-up duration | Outcome |
|---|---|---|---|---|---|---|
| 2015, Inoue et al115 | Prospective cohort study | Patients with achalasia with/without prior treatment | POEM after prior treatment, n = 195 | None | 3 yr | Technical success rate: 100.0% |
| Adverse event rate: 3.2% | ||||||
| Two-month outcome, pre- vs post-op: Eckardt score, 6.0 ± 3.0 vs 1.0 ± 2.0, P < 0.0001, LES pressure (persisting at 3 yr post-POEM), 25.4 ± 17.1 vs 13.4 ± 5.9 mmHg , P < 0.0001 Gastroesophageal reflux rate: 16.8% at 2 mo and 21.3% at the 3-yr follow-up | ||||||
| 2018, Liu et al116 | Prospective cohort study | Patients with achalasia with/without prior treatment | POEM after prior treatment, n = 262 | POEM without prior treatment, n = 604 | 23.0 mo | Clinical success rate: 88.9% |
| Reflux rate: 23.9%, symptomatic reflux rate: 15.9%, GERD rate: 19.0% | ||||||
| POEM-related major adverse event rate: 4.0% | ||||||
| POEM after prior treatment was associated with a longer operation time (P = 0.001), longer hospital stay (P = 0.001), and increased rate of clinical failure during follow-up (hazard ratio, 1.90; P = 0.002 [Cox regression]). | ||||||
| 2014, Ling et al117 | Prospective case–control study | Patients with achalasia with/without prior PBD | POEM after prior PBD, n = 21 | POEM without prior PBD, n = 30 | 14.0 mo | Operation time: prior PBD vs no prior PBD, 42.4 ± 8.3 vs 34.3 ± 7.4, P = 0.01 |
| Subcutaneous emphysema: prior PBD vs no prior PBD, 13.3% vs 14.3% | ||||||
| Pneumothorax: prior PBD vs no prior PBD, 4.8% vs 6.7% | ||||||
| Post-POEM Eckardt score: prior PBD vs no prior PBD, 0.7 ± 0.6 vs 0.5 ± 0.8, P = 0.11 | ||||||
| Post-POEM Eckardt score: prior PBD vs no prior PBD, 7.1 ± 6.8 vs 6.7 ± 5.4, P = 0.23 | ||||||
| 2017, Tang et al118 | Prospective cohort study | Patients with achalasia with/without prior treatment | POEM after prior treatment, n = 22 | POEM without prior treatment, n = 39 | 1 yr | Operation time, min: prior treatment vs no prior treatment, 60.8 ± 30.9 vs 62.0 ± 21.0, P = 0.863 |
| Treatment success (Eckardt score ≤ 3), n (%): prior treatment vs no prior treatment, 21 (95.5%) vs 36 (92.3%), P = 0.624 | ||||||
| Pre-POEM Eckardt score: prior treatment vs no prior treatment, 7.4 ± 2.4 vs 7.3 ± 1.8 | ||||||
| Post-POEM Eckardt score: prior treatment vs no prior treatment, 1.2 ± 1.1 vs 1.2 ± 1.1 | ||||||
| Pre-/post-POEM D-value: prior treatment vs no prior treatment, 6.2 ± 2.2 vs 6.4 ± 1.8, P = 0.840 | ||||||
| Pre-LES pressure: prior treatment vs no prior treatment, 41.1 ± 15.7 vs 39.9 ± 14.4 | ||||||
| Post-LES pressure: prior treatment vs no prior treatment, 13.4 ± 5.3 vs 14.5 ± 5.6 | ||||||
| Pre-/post-LES pressure D-value: prior treatment vs no prior treatment, 27.9 ± 17.6 vs 24.9 ± 15.2, P = 0.569 | ||||||
| Cases with adverse events: prior treatment vs no prior treatment, 5 (22.7%) vs 8 (20.5%), P = 0.958 | ||||||
| Cases of gastroesophageal reflux: prior treatment vs no prior treatment, 4 (23.5%) vs 7 (20.0%), P = 0.771 based on symptoms and endoscopy | ||||||
| 2017, Nabi et al119 | Prospective cohort study | Patients with achalasia with/without prior treatment | POEM after prior treatment, n = 189 | POEM without prior treatment, n = 216 | Median 17.0 mo | Technical success rate: prior treatment vs no prior treatment, 96.8% vs 97.3%, P = 0.795 |
| Clinical success rate: prior treatment vs no prior treatment, 92.6% vs 95.7%, P = 0.275 | ||||||
| Mean Eckardt score: pre- vs 1-year post-op, 7.07 ± 1.6 vs 1.27 ± 1.06, P = 0.001 | ||||||
| Mean LES pressure: pre- vs post-op, 45 ± 16.5 mmHg vs 15.6 ± 6.1 mmHg, P = 0.001 | ||||||
| Significant improvement in esophageal emptying on TBE (> 50%): 1-year post-op, 93.8% | ||||||
| Abnormal acid reflux on pH monitoring: 28.3% | ||||||
| Erosive esophagitis: 18.5% | ||||||
| 2018, Nabi et al120 | Prospective cohort study | Patients with achalasia with/without prior treatment | POEM after prior treatment, n = 242 | POEM without prior treatment, n = 260 | Median 20.0 mo | Mean operation time, min: prior treatment vs no prior treatment, 74.9 ± 30.6 vs 67.0 ± 27.1, P = 0.002 |
| Technical success rate: prior treatment vs no prior treatment: 97.1% vs 98.1%, P = 0.56 | ||||||
| Adverse events rate: prior treatment vs no prior treatment: 33.1% vs 35.8%, P = 0.57 | ||||||
| Clinical success rate at 6 months: prior treatment vs no prior treatment: 92.5% vs 92.4%, P = 0.95 | ||||||
| Rate of elevation of DeMeester score: prior treatment vs no prior treatment: 32.1% vs 25.0%, P = 0.50 | ||||||
| Rate of esophagitis diagnosed by EGD (247/342): prior treatment vs no prior treatment: 20.7% vs 22.1%, P = 0.88 | ||||||
| 24-hour pH study (n = 97), DeMeester score > 14.7: prior treatment vs no prior treatment: 32.0% vs 25.0%, P = 0.50 | ||||||
| 2017, Haito-Chavez et al96 | Retrospective matched case-control study | Patients with achalasia with/without prior treatment | POEM after prior treatment, n = 112 | None | 2-4 wk | Adverse event rate: 7.5% (mild, 6.4%; moderate, 1.7%; severe, 0.5%) |
| Mucosoctomy: 2.8% | ||||||
| Factors associated with adverse events: sigmoid-type esophagus (OR = 2.28, P = 0.05), less surgeon experience (< 20 cases) (OR = 1.98, P = 0.04), use of a triangular tip knife (OR = 3.22, P = 0.05), use of an electrosurgical technique other than spray coagulation (OR = 3.09, P = 0.02) | ||||||
| 2016, Li et al121 | Prospective cohort study | Prior POEM failure | Redo POEM, n = 15 | None | 11.3 mo | Technical success rate: 100.0% |
| Mean operation time, min: 41.5 (range: 28-62) | ||||||
| Mean symptom score: pre- vs post-op, 5.6 (range: 4-8) vs 1.2 (range: 0-3), P < 0.001 | ||||||
| Mean LES pressure, mmHg: pre- vs post-op. 25.0 vs 9.5, P < 0.001 | ||||||
| Clinical reflux rate: 33.3% | ||||||
| 2017, Tyberg et al122 | Prospective cohort study | Prior POEM failure | Redo POEM, n = 46 | None | At least 6.0 mo | Technical success rate: 100.0% |
| Clinical success rate: 85.0% | ||||||
| Mean Eckardt score: pre- vs post-op, 4.3 ± 2.48 vs 1.64 ± 1.67, P < 0.00001 | ||||||
| Procedural bleeding rate: 17.0% (managed successfully by endoscopy) | ||||||
| 2018, van Hoeij et al110 | Prospective cohort study | Prior POEM failure | Redo POEM, n = 8 | PBD after prior POEM failure, n = 15 | Median 39.0 mo (range, 6-59) | Clinical success rate: POEM, 63.0%; PBD, 20.0%; HM 45.0% |
| HM after prior POEM failure, n = 11 |
POEM, peroral endoscopic myotomy; op, operation; LES, lower esophageal sphincter; GERD, gastroesophageal reflux disease; PBD, pneumatic balloon dilatation; TBE, timed barium esophagogram; EGD, esophagogastroduodenoscopy; OR, odds ratio; HM, Heller myotomy.