667 Gastric Peroral Endoscopic Myotomy (G-Poem) for the Treatment of Refractory Gastroparesis: Final Results From the First International Prospective Trial

Abstract

Background: Heller myotomy (HM) is highly effective for achalasia treatment. Nonetheless, recurrent/persistent symptoms occur in 10-20% of patients. Management options include POEM, redo-HM, or pneumatic dilatation (PD). It is currently unknown which of these options is more effective. Aims: To compare the efficacy and safety of POEM, redo-HM, or PD in patients with previous failed HM. Methods: This was an international experience at 14 centers between 10/2010 and 11/2019. Adults with failed HM who underwent POEM, redo-HM, or PD were included. Technical success was defined as successful completion of the procedure. Clinical success was defined as a decrease in Eckardt score (ES) to 3 without the need for reinterventions. Adverse events (AEs) were graded according to the ASGE Lexicon/Clavien-Dindo classification. Results: A total of 162 patients (51% F, mean age 54yr) with failed HM were included, of whom 108 underwent POEM, 23 redo-HM, and 31 PD. The baseline mean ES was 6.1, 6.6 and 6.2 (pZ0.6), and baseline mean integrated relaxation pressure was 18.7, 16.1 and 22.0 (pZ0.5). Technical success was achieved in all patients. After a mean follow up of 16.9 months (14.4 POEM, 26.0 redo-HM, 18.4 PD), the POEM group had the lowest mean post treatment ES (1.8 vs 4.4 vs 5.0, p<0.001) and rate of clinical relapse (11.7% vs 68.1% vs 48.2%, pZ0.02). At 6-12 months follow up, clinical success was achieved in 90% of POEM patients, 60% redo-HM, and 50% PD (pZ0.01), and higher in the POEM group vs redo-HM (OR 6.01, pZ0.03). At 12-24 months follow up, 83.3% of POEM patients, 40% redo-HM, and 28.5% PD remained in clinical success (0.004), which was higher in the POEM group vs redo-HM (OR 4.5, pZ0.001) and lower in the PD group vs POEM (OR 0.17, pZ0.01). In patients with >24 months follow up (nZ41, mean 38.6 mo), 72.7% of POEM patients, 40% redo-HM and 22% PD remained in clinical success (pZ0.03), which was higher in the POEM group vs redo-HM (pZ0.07), and lower in the PD group vs POEM (OR 0.11, pZ0.02). Patients who underwent redo-HM experienced more AEs (26% vs 8% POEM vs 13% PD, pZ0.05). Based on Clavien-Dindo/ASGE Lexicon, redo-HM group experienced more grade 3 and 4 AEs (13% vs 1% POEM vs 0% PD, pZ0.02) and more severe AEs (9% vs 0% PEOM vs 0% PD; pZ0.007). The PD group had the shortest mean procedure time (31.1 min, p<001) and LOS (p<0.001). The redo-HM group had longer procedure duration (167 vs 84 min, p<0.001) and LOS (5 vs 2 d, p<00.1), compared with the POEM group (Table 1). Univariable logistic regression analysis demonstrated that patients who underwent retreatment with POEM have a higher likelihood of achieving clinical success compared with redo-HM (OR 7.6, p<0.001) (Table 2). Conclusion: POEM results in higher short/mid-term clinical success and lower rate of clinical relapse compared with alternative treatments in patients with failed HM.

Gastric peroral endoscopic pyloromyotomy for decompensated gastroparesis: comprehensive motility analysis in relation to treatment outcomes

“…However, the odds ratio (OR) value for pylorus CSA at 40-mL volume was only 1.02, raising the question about the clinical relevance of this outcome. Preliminary data from a prospective trial with 80 patients showed that the increase in pylorus DI following G-POEM was associated with clinical success with an OR of 1.23 26 . Therefore, it appears that clinical response is primarily related to the extent to which the pylorus distensibility increases following pyloromyotomy but that this is not necessarily related to the distensibility prior to the intervention.…”