Management of Patients After Failed Gastric Peroral Endoscopic Myotomy: A Multi-Center Study

Introduction: The heterogeneous and unpredictable clinical outcomes of gastric peroral endoscopic myotomy (G-POEM) in patients with refractory gastroparesis is a fundamental shortcoming of the procedure. The optimal management of patients who fail G-POEM is not known. We aimed to compare the outcomes of different management strategies in patients who had failed G-POEM. Methods: This was a multicenter retrospective study at 7 tertiary centers between 02/2020 and 10/2022. All patients who underwent G-POEM and experienced persistent (primary) or recurrent (secondary) symptoms were labeled as clinical failure and were included. Primary outcome was clinical success post re-treatment, defined as a 1-score decrease in average Gastroparesis Cardinal Symptom Index (GCSI) with a ≥ 25% decrease in at least 2 sub-scales post-G-POEM. Results: A total of 233 patients [mean age 47.8 ± 15.6, F 170 (73%)] underwent G-POEM for the management of refractory gastroparesis at 7 U.S. tertiary care centers, and 92 (39%) patients experienced clinical failure with a median GCSI score of 2.4 (IQR 2.1-3.3). The majority, 86 (93%), were primary clinical failures. Post-G-POEM GES was performed in 35 (38%) [abnormal in 14 (40%)], and diagnostic upper endoscopy in 57 (62%) [endoscopic findings suggestive of gastroparesis 35 (83%)]. During the duration of the study, a total of 25 (27%) underwent re-treatment, while 67 (73%) underwent pharmacologic and/or palliative symptomatic treatment (Table 1). Among the patients who underwent re-treatment, clinical success was achieved in 12 (46%) of the patients during a median duration follow-up of 9.4 (IQR 6-13) months, with a decrease in the median GCSI score from 2.8 ± 1.6 to 1.5 ± 1.8, (P = 0.024). A total of 9 patients in the re-treatment group underwent both pre- and post-retreatment GES with an improvement in gastric retention at 4 hrs. from 38 ± 20.83 % to 23 ± 19.7 %, (P = 0.124). The highest clinical success was achieved among patients with GNS, 5 (83%), followed by repeat G-POEM, 4 (67%) (Figure 1). Having abnormal GES post-G-POEM was found to be the only independent predicting factor (OR 1.6, P = 0.031) for clinical success post-re-treatment. Concomitant gastrointestinal pathologies were noted in 6 (6.5%) (esophageal dysmotility treatment 2, sphincter of Oddi dysfunction 1, candida esophagitis 3). Conclusion: In our cohort, 46% of patients with clinical failure post-G-POEM had clinical success after re-treatment, with abnormal GES post-failed G-POEM being a predictor of clinical response.Figure 1.: The management and the outcomes of post-G-POEM clinical failure management. Table 1. - Comparison of demographics and procedure characteristics between Re-treatment group and pharmacologic and/or palliative symptomatic treatment groups Total (N = 92) Re-treatment group (n = 25) Pharmacologic and/or palliative symptomatic treatment (n = 67) P value Age, mean ± SD 47.8 ± 14.7 46.2 ± 12.1 47.8 ± 14.2 0.241 Female, n (%) 67 (73%) 18 (72%) 49 (73%) 0.351 Body mass index, mean ± SD 26.8 ± 6.5 25.4 ± 8.1 27 ± 6.4 ASA Class, mean ± SD 2.55 ± 0.1 2.56 ± 0.4 2.6 ± 0.6 0.410 Duration of disease median (IQR) (years) 6.3 ± 6.2 6.4 ± 5.1 5.3 ± 5.3 0.248 Etiology, n (%) 0.221 Diabetes 54 (59%) 15 (60%) 39 (58%) Post-surgical 5 (5%) 1 (4%) 4 (6%) Idiopathic 33 (36%) 9 (36%) 24 (36%) Baseline gastric emptying scintigraphy Retention at 4 hrs. mean ± SD 42.3 ± 17.8% 41.3 ± 12.3% 43.7 ± 14% 0.23 Baseline GCSI, mean ± SD 0.123 Nausea/Vomiting 2.7 ± 2.1 2.3 ± 1.3 2.1 ± 2.1 Postprandial fullness or early satiety 2.3 ± 1.45 2.2 ± 1.8 2.9 ± 2.2 Bloating 2.1 ± 1.2 1.8 ± 1.9 2.6 ± . 1.32 Total 2.45 ± 2.1 2.7 ± 2.1 2.5 ± 2.2 Initial G-POEM Procedure characteristics 0.47 Length of mucosal incision, mean ± SD 2.6 ± 1.2 2.8 ± 0.5 2.7 ± 1.23 Length of submucosal tunnel, mean ± SD 7.6 ± 2.3 7.3 ± 1.2 7.6 ± 2.3 Length of myotomy, mean ± SD 1.9 ± 0.9 2 ± 1 1.9 ± 1 Mucosal closure Clips, n (%) 72 (78%) 18 (72%) 54 (81%) Mucosal closure Suturing, n (%) 20 (22%) 7 (28%) 13 (19%) Total time of the procedure, mean ± SD 61.4 ± 25.1 49 ± 22.1 50.2 ± 23.5 0.31 Post-G-POEM (at the time of clinical failure) GCSI, mean ± SD 0.147 Nausea/Vomiting 2.6 ± 2.5 2.3 ± 1.3 2.1 ± 2.1 Postprandial fullness or early satiety 2.4 ± 1.15 2.4 ± 1.8 2 ± 2.2 Bloating 2.4 ± 1.4 1.7 ± 1.9 2.4 ± . 1.14 Total 2.34 ± 3.2 2.8 ± 1.6 2.2 ± 1.4 Post-G-POEM prokinetics use, n (%) 86 (93%) 23 (92%) 63 (94%) 0.21 Post-G-POEM gastric emptying scintigraphy test 0.031 N 35 33 2 Retention at 4 hrs. mean ± SD 33.1 ± 23.7 % 38 ± 20.83 % 31 ± 16.5 % Abnormal test, n (%) 14 (40%) 13 (39%) 1 (50%) Endoscopic findings suggestive of gastroparesis (food residue in stomach, difficulty traversing the scope through the pylorus), n (%) 35/57 (83%) 31/39 (79%) 4/18 (22%) 0.023 Post-G-POEM failure management GCSI, mean ± SD 0.036 Nausea/Vomiting 2.1 ± 0.34 1.4 ± 1.23 1.9 ± 1.2 Postprandial fullness or early satiety 1.94 ± 1.78 1.6 ± 1.4 2.2 ± 1.7 Bloating 1.8 ± 1.56 1.3 ± 1.22 1.6 ± 1.5 Total 1.78 ± 1.69 1.5 ± 1.8 2.1 ± 3 Clinical success, n (%) 31 (34%) 12 (46%) 19 (28%) 0.231 Gastric emptying scintigraphy test (after re-treatment) N 9 Retention at 4 hrs. mean ± SD 23 ± 19.7 % Abnormal test, n (%) 4 (44%)