796
GASTROESOPHAGEAL REFLUX AND ITS SEQUELAE AFTER PER-ORAL ENDOSCOPIC MYOTOMY (POEM)
Date
May 8, 2023
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Society: ASGE
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.
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.
Figure 1. Peroral Endoscopic Myotomy Assessment Tool (POEMAT)
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.
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.
Table 1. Baseline, procedural and post-procedural characteristics.
Figure 1A. Proportion of patients on total daily opioid use ≥ 40 MME among POEM non-responders vs responders
Figure 1B. Proportion of patients with adequate myotomy post-POEM based on EGJ-DI >2.8 mm on FLIP
BACKGROUND: Gastro-esophageal reflux (GER) is the Achilles’ heel of Per Oral Endoscopic Myotomy (POEM) in achalasia with potential impact on post-procedural quality of life. Addition of concomitant endoscopic fundoplication to POEM (POEM+F) has shown promising results in improving short & medium-term GER outcomes. Our objective was to assess whether performing concomitant fundoplication provides additional benefit for prevention of GER by comparing long-term GER outcomes in a matched cohort of achalasia patients undergoing POEM vs POEM+F.
METHODS: Single center, matched cohort study. Achalasia patients undergoing POEM+F - primary study cohort. Comparator group - isolated POEM patients, selected after matching for age, sex, BMI, achalasia type, prior interventions & ASA status. Baseline characteristics, pre/post procedure Eckardt score, technical aspects & AE recorded for all patients. Both groups followed-up annually for 3y & assessed for subjective/objective GER outcomes using validated symptom scores (GERD-Q, RSI, GERD-HQRL), EGD (erosive esophagitis, wrap integrity in POEM+F) & pH studies (esophageal acid exposure time [EAET], DeMeester score). GERD definition – Lyon consensus.
RESULTS: 41 patients underwent POEM+F (Mar 2019-Oct 2021). 7 excluded (2-technical failure, 5-Achalasia type III-lack of appropriate match). Remaining 34 patients (Age 43.68±12.66, BMI 22.76±3.81, Achalasia Type I-4, Type II-30) matched with equal number of patients undergoing POEM alone (Age 45.21±12.74, BMI 23.07±4.33, Type I-4, Type II-30, [p=NS]). No significant difference in baseline characteristics & technical aspects except longer procedure time in POEM+F (44.5±6.6 vs 103.2±13.7, p<0.001). Minor AE (mucosal injury)-11.8% vs 8.8% in POEM vs POEM+F, respectively (p=0.69). Table 1 – GER outcomes of POEM vs POEM+F at 1, 2 & 3y F/U. One POEM+F patient had recurrent achalasia at 9 months, excluded from further analyses. No statistically significant difference in symptom scores between POEM vs POEM+F at 1, 2 & 3y F/U. Mild erosive esophagitis was significantly higher in POEM group at 3y F/U (p=0.002), although no instances of severe GER were noted in both groups. Notably, fundoplication wrap remained adequate at 3y in 13/16 (87.9%) POEM+F patients. pH studies – EAET>6% significantly higher for POEM vs POEM+F at 2 & 3y (p=0.048, p<0.001, respectively), higher DeMeester scores at 1y for POEM (p=0.044). Composite GER outcomes (Table 2) – significant reduction in incidence of objective GER in POEM+F (6.67% vs 54.54%, OR 0.06, RR 0.12 [0.028-0.517], p<0.05).
CONCLUSION: Although POEM & POEM+F were comparable in terms of subjective GER, addition of concomitant fundoplication resulted in durable & significant attenuation in incidence of objective GER during long-term F/U. Randomized controlled trials with more robust sample size may provide further validation to our results.
METHODS: Single center, matched cohort study. Achalasia patients undergoing POEM+F - primary study cohort. Comparator group - isolated POEM patients, selected after matching for age, sex, BMI, achalasia type, prior interventions & ASA status. Baseline characteristics, pre/post procedure Eckardt score, technical aspects & AE recorded for all patients. Both groups followed-up annually for 3y & assessed for subjective/objective GER outcomes using validated symptom scores (GERD-Q, RSI, GERD-HQRL), EGD (erosive esophagitis, wrap integrity in POEM+F) & pH studies (esophageal acid exposure time [EAET], DeMeester score). GERD definition – Lyon consensus.
RESULTS: 41 patients underwent POEM+F (Mar 2019-Oct 2021). 7 excluded (2-technical failure, 5-Achalasia type III-lack of appropriate match). Remaining 34 patients (Age 43.68±12.66, BMI 22.76±3.81, Achalasia Type I-4, Type II-30) matched with equal number of patients undergoing POEM alone (Age 45.21±12.74, BMI 23.07±4.33, Type I-4, Type II-30, [p=NS]). No significant difference in baseline characteristics & technical aspects except longer procedure time in POEM+F (44.5±6.6 vs 103.2±13.7, p<0.001). Minor AE (mucosal injury)-11.8% vs 8.8% in POEM vs POEM+F, respectively (p=0.69). Table 1 – GER outcomes of POEM vs POEM+F at 1, 2 & 3y F/U. One POEM+F patient had recurrent achalasia at 9 months, excluded from further analyses. No statistically significant difference in symptom scores between POEM vs POEM+F at 1, 2 & 3y F/U. Mild erosive esophagitis was significantly higher in POEM group at 3y F/U (p=0.002), although no instances of severe GER were noted in both groups. Notably, fundoplication wrap remained adequate at 3y in 13/16 (87.9%) POEM+F patients. pH studies – EAET>6% significantly higher for POEM vs POEM+F at 2 & 3y (p=0.048, p<0.001, respectively), higher DeMeester scores at 1y for POEM (p=0.044). Composite GER outcomes (Table 2) – significant reduction in incidence of objective GER in POEM+F (6.67% vs 54.54%, OR 0.06, RR 0.12 [0.028-0.517], p<0.05).
CONCLUSION: Although POEM & POEM+F were comparable in terms of subjective GER, addition of concomitant fundoplication resulted in durable & significant attenuation in incidence of objective GER during long-term F/U. Randomized controlled trials with more robust sample size may provide further validation to our results.
Table 1: Difference in gastro-esophageal reflux (GER) outcomes in patients undergoing POEM vs POEM+F at different points of follow-up. *p<0.05; statistically significant. NA: Not available.
Table 2: Comparison of long-term composite GER related clinical outcomes between POEM+F and POEM patients.
Subjective success: One or more positive symptom score.
Objective success: Presence of erosive esophagitis LA grade C/D or/and EAET>6% ( as per Lyon consensus)
Introduction: Peroral endoscopic myotomy (POEM) is nowadays considered a standard method for achalasia treatment with excellent long term treatment success. However, the benefits of POEM are tempered by the risk of post-POEM reflux complications.
Aims and Methods: The aim of our study was to evaluate the long-term post-POEM reflux in patients undergoing POEM at a single tertiary center. We performed a retrospective analysis of prospectively collected data of all consecutive patients who underwent POEM between December 2012 and November 2022. The follow-up visits took place 3 and 12 months after the procedure and every year thereafter. The patients underwent upper GI endoscopy, high-resolution manometry (HRM) and 24-hour pH monitoring 3 months after the procedure; endoscopy was then repeated at 2-3 years and at 6 years after POEM. Reflux esophagitis, reflux complications, reflux parameters measured by 24h pH monitoring, GERD symptoms and the use of proton pump inhibitors (PPIs) were principal outcomes.
Results: A total of 522 POEM procedures (20x re-POEM) were performed in 502 patients. 361 patients underwent 24h pH monitoring, abnormal acid exposure was detected in 170 of them (47.1% [95% CI: 42, 52.2]). Reflux esophagitis was observed in 172/415 patients (41.4% [95% CI: 36.8, 46.2]; grades LA C/D in 19 patients, 4.6%) at 3 months, in 83/240 patients (34.5% [95% CI: 28.8, 40.8]; LA C/D in 5 patients, 2.1%) at 24-36 months and in 15/73 patients (20.5% [95% CI: 12.9, 31.1]; (LA C/D in 0 patients) 6 years after the procedure. Follow- up questionnaires were completed in 172, 145 and 88 patients 48, 60, 72 months after the procedure with 32.6%, 34.5% and 36.5% of patients having occasional heartburn. PPIs were taken by 52.1%, 47.2% and 56.4% of patients at 48, 60 and 72 months after POEM with more than 80% of them taking PPIs on daily basis. Regarding reflux complications, there were no cases of Barrett's esophagus and esophageal cancer. One patient developed a peptic stricture 2 years after POEM which was treated with 4 sessions of balloon dilation. Comparison of patients who underwent anterior (60%) and posterior myotomy (40%) did not show any significant differences in pH-monitoring results, occurrence of esophagitis, subjective GERD symptoms or PPIs intake between the patient groups.
Conclusion: The rate of post-POEM reflux esophagitis decreases over time, however approximately 50% of patients require long-term antisecretory treatment. Due to the risk of severe post-reflux complications, patients after POEM should remain under long-term surveillance.
Aims and Methods: The aim of our study was to evaluate the long-term post-POEM reflux in patients undergoing POEM at a single tertiary center. We performed a retrospective analysis of prospectively collected data of all consecutive patients who underwent POEM between December 2012 and November 2022. The follow-up visits took place 3 and 12 months after the procedure and every year thereafter. The patients underwent upper GI endoscopy, high-resolution manometry (HRM) and 24-hour pH monitoring 3 months after the procedure; endoscopy was then repeated at 2-3 years and at 6 years after POEM. Reflux esophagitis, reflux complications, reflux parameters measured by 24h pH monitoring, GERD symptoms and the use of proton pump inhibitors (PPIs) were principal outcomes.
Results: A total of 522 POEM procedures (20x re-POEM) were performed in 502 patients. 361 patients underwent 24h pH monitoring, abnormal acid exposure was detected in 170 of them (47.1% [95% CI: 42, 52.2]). Reflux esophagitis was observed in 172/415 patients (41.4% [95% CI: 36.8, 46.2]; grades LA C/D in 19 patients, 4.6%) at 3 months, in 83/240 patients (34.5% [95% CI: 28.8, 40.8]; LA C/D in 5 patients, 2.1%) at 24-36 months and in 15/73 patients (20.5% [95% CI: 12.9, 31.1]; (LA C/D in 0 patients) 6 years after the procedure. Follow- up questionnaires were completed in 172, 145 and 88 patients 48, 60, 72 months after the procedure with 32.6%, 34.5% and 36.5% of patients having occasional heartburn. PPIs were taken by 52.1%, 47.2% and 56.4% of patients at 48, 60 and 72 months after POEM with more than 80% of them taking PPIs on daily basis. Regarding reflux complications, there were no cases of Barrett's esophagus and esophageal cancer. One patient developed a peptic stricture 2 years after POEM which was treated with 4 sessions of balloon dilation. Comparison of patients who underwent anterior (60%) and posterior myotomy (40%) did not show any significant differences in pH-monitoring results, occurrence of esophagitis, subjective GERD symptoms or PPIs intake between the patient groups.
Conclusion: The rate of post-POEM reflux esophagitis decreases over time, however approximately 50% of patients require long-term antisecretory treatment. Due to the risk of severe post-reflux complications, patients after POEM should remain under long-term surveillance.
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