CLINICAL OUTCOMES OF PERORAL ENDOSCOPIC MYOTOMY (POEM) IN PATIENTS WITH SPASTIC ESOPHAGEAL MOTILITY DISORDERS ON CHRONIC OPIOID USE: A MULTICENTER STUDY

Background: Video analysis has emerged as a potentially strategy for performance assessment of specialized techniques where local expertise and mentorship are limited. The aim of this American Society of Gastrointestinal Endoscopy (ASGE) supported study was to develop a video based skill assessment tool specific for peroral endoscopic myotomy (POEMAT).
Methods: The POEM procedure was deconstructed into basic components on video analysis by an expert panel. Subsequently, a modified Delphi panel and 2 validation exercises were conducted with the goal of iteratively refining the tool. Twelve assessors used the final POEMAT version to grade 10 POEM videos performed by 2 skilled endoscopists. Fully crossed generalizability studies (G analysis) evaluated the contributions of assessors, POEM endoscopists performance and technical elements to reliability. A G coefficient of ≥0.7 was accepted as reliable for formative assessment in training or practice. A decision (D) study was then conducted to identify the number of assessors required to achieve a reliable mean assessment score ≥.70 on core technical elements (submucosal entry, submucosal tunneling, myotomy, mucosal closure, and hemostasis).
Results: Eight technical elements were initially generated from task deconstruction and included in the tool using the Delphi methodology. Subsequent iterative refinements including the addition and/or modification of descriptive anchors for each technical element, aimed to provide specific explanations of what constituted effective and ineffective performance. Ultimately, the final POEMAT version comprised of 9 technical elements each with descriptive anchors (Figure 1). Results from G analysis for POEMAT are shown Table 1. Differences in performance between endoscopists accounted for 0.8-24.9% of the observed variance across the categories. The G analysis attributed most variance to the interaction between endoscopist performance and the assessor (range from 63.2% to 90.1%), indicating lack of agreement between assessors across videos. D study results showed that ≤16 assessors would be needed for a reliability threshold of ≥.70 for 4 out of the 5 core technical elements.
Conclusions: We developed and validated the first instrument to assess skills of performing POEM. Development and refinement of this video-based tool followed a rigorous protocol. The initial validation showed a low variance between endoscopists, considered experts in this procedure. The next step is to apply the instrument among endoscopists with varying levels of expertise and practice settings to establish and further improve the discriminative validity of this tool.

Background: Chronic opioid use continues to rise in the United States and imposes substantial morbidity. Opioid induced esophageal disorder (OIED) is increasingly recognized and is manifested mostly as spastic esophageal motility disorders (SEMD). The aim of the study was to evaluate clinical outcomes of POEM in patients with SEMD on chronic opioid use.
Methods: Multicenter retrospective analysis of prospective databases on consecutive patients with chronic opioid use who underwent POEM for SEMD between January 2012 to September 2022. SEMD included: diffuse esophageal spasm (DES), hypercontractile esophagus (HE), esophagogastric outflow obstruction (EGJOO) and type III achalasia. Total daily opioid use was expressed in morphine mg equivalents (MME), with high daily use defined as ≥ 40 MME. Data on Eckardt scores (ES), endoscopy, high-resolution esophageal manometry (HRM), and endoscopic impedance planimetry (FLIP) were obtained through chart review. Primary outcome was to evaluate the impact of opioid use on clinical success, defined as Eckardt score ≤ 3, and its effect on post-POEM esophagogastric junction distensibility index (EGJ-DI) measured on FLIP. An adequate myotomy was defined as post-POEM EGJ-DI >2.8 mm²/mmHg.
Results: One-hundred and three patients (mean age 62.6±13.8; 61.2% women) with DES (n=6), HE (n=15), EGJOO (n=20), type III achalasia (n=62), with mean baseline Eckardt score of 7.5 ± 2.7, underwent POEM during the study period. Mean baseline integrated relaxation pressure (IRP) and EGJ-DI were 27.4 ± 14.6 mmHg and 1.0 ± 1.1 mm²/mmHg, respectively. Median MME was 60 (IQR: 20-120). Out of the 103 patients, 82 had a median follow-up of 13 months (IQR:5-23). Clinical success was achieved in 65/82 (79.3%) and not significantly different based on type of SEMD. The median total daily opioid use trended higher among POEM non-responders (120 MME; IQR: 67.5-260.5) vs POEM responders (45 MME; IQR: 20-120) (p=0.2). The proportion of patients with total daily opioid use ≥ 40 MME was higher among POEM non-responders (88.2%) vs responders (52.3%) (p=0.01). There was no differences in the proportion of patients with post-POEM EGJ-DI > 2.8 mm²/mm Hg between the POEM non-responders (87.5%) and responders (77.8%) (p=1.0). There were 6 (5.8%) adverse events of mild (n=4) and moderate (n=2) severity managed medically or endoscopically.
Conclusion: The overall clinical success of POEM in patients with SEMD on chronic opioid use was relatively low. Our study demonstrates that patients who did not respond to POEM were more likely to be on high daily doses of opioids (>40 MME), even though the proportion of patients with adequate post-POEM myotomy based on FLIP EGJ-DI was similar between POEM responders and non-responders. Additional data is needed to provide guidance in the management of patients with OIED.