Evaluation of the safety profile of endoscopic pyloromyotomy by G-POEM: a French multicenter study

Abstract

Background: Gastric per oral endoscopic esophageal myotomy (G-POEM) is a promising procedure to treat refractory gastroparesis. The safety profile of G-POEM is an important topic because gastroparesis is a functional pathology, with a procedure whose effectiveness is between 50 and 65% depending on the studies. Objectives: We present this retrospective multicenter study, with the aim of establishing a safety profile, focusing on serious adverse events (AEs). Design: This was a multicenter observational cohort study conducted in five French expert centers. Methods: All patients who underwent G-POEM for refractory gastroparesis between 2015 and 2021 were included for analysis. AEs were classified into per endoscopic, early postoperative, and late postoperative, up to 1 month. Their severity was assessed using Dindo–Clavien and American Society for Gastrointestinal Endoscopy classification. The primary objective was to evaluate the rate of G-POEM severe AEs. Secondary objectives were to document other postoperative AEs, and to identify predictive factors. Results: In all, 217 patients were included: 81 men and 136 women, mean age 52 ± 17 years. The average procedural time was 44 ± 14 min (12–78). The average hospital stay was 3.7 ± 2.3 days. The AEs rate classified as Clavien–Dindo ⩾3 was 0.4% (one delayed bleeding requiring blood transfusion and endoscopic management). There were no deaths or patients admitted to intensive care unit. The rates of mucosotomy and capnoperitoneum were 3.7 and 1.8%, respectively, without clinical consequences. Most patients (81.5%) did not experience any AE. Three cases of dumping syndrome occurred, quickly managed by dietary measures. Conclusion: Our study confirms the safety of G-POEM with less than 0.5% of serious AEs, medically managed. This outcome makes this a procedure to have a good benefit–risk ratio.

The Impact of Pyloric Directed Therapy for Gastroparesis

“…17,18,28 In the cohort carefully followed after G-POEM, dumping syndrome was a rare complication (1.4%). 26 A recent systematic review and meta-analysis of studies describing G-POEM for refractory gastroparesis with 3 years of follow-up identified 5 investigations with 560 patients, although the proportions of patients who were followed the full 3 years varied between studies. 29 Technical success, defined as achieving pyloromyotomy, was 98.6%.…”

How to implement adverse events as a quality indicator in gastrointestinal endoscopy

“…In this classification, AEs are graded from I to V. Grade I corresponds with incidents, grade II corresponds with AEs needing pharmacological treatment or blood transfusion, grade IIIa requires surgical, radiological, or endoscopic intervention not under general anesthesia, whereas in grade IIIb therapeutic intervention is performed under general anesthesia, grade IVa requires hospitalization in the intensive care unit because of single organ dysfunction, grade IVb because of multiple organ dysfunction, and grade V corresponds to death related to the surgery 25 . This clinically useful classification of surgery‐related AEs is widely accepted and even adopted in endoscopic clinical trials 24,26 . It was therefore recently adapted and improved for endoscopy under the name of the adverse events in gastrointestinal endoscopy (AGREE) classification of endoscopy‐related AEs (Table 2).…”

“…25 This clinically useful classification of surgeryrelated AEs is widely accepted and even adopted in endoscopic clinical trials. 24,26 It was therefore recently adapted and improved for endoscopy under the name of the adverse events in gastrointestinal endoscopy (AGREE) classification of endoscopy-related AEs (Table 2). 27 The use of a surgical classification for endoscopy-related AEs should not be surprising because therapeutic endoscopy is progressively evolving onto the surgical terrain.…”

Dumping Syndrome: Pragmatic Treatment Options and Experimental Approaches for Improving Clinical Outcomes

“…three patients were reported to have developed dumping symptoms after G-POEM however, this is without confirmation by provocative testing 36. …”