Periprocedural safety profile of peroral endoscopic myotomy (POEM)-a retrospective analysis of adverse events according to two different classifications.

BACKGROUND: Peroral endoscopic myotomy (POEM) is nowadays a standard method for treatment of achalasia; nevertheless, it remains an invasive intervention with corresponding risk of adverse events (AEs). The classification and grading of AEs are still a matter of discussion. The aim of our retrospective study was to assess the occurrence of all "undesirable" events and "true" adverse events in patients undergoing POEM and to compare the outcomes when either Clavien-Dindo classification (CDC) or American Society of Gastrointestinal Endoscopy (ASGE) lexicon classification applied. METHODS: This was a retrospective analysis of prospectively managed database of all patients who had undergone POEM between December 2012 and August 2018. We assessed the pre-, peri-, and early-postoperative (up to patient's discharge) undesirable events (including those not fulfilling criteria for AEs) and "true" AEs according the definition in either of the classifications. RESULTS: A total of 231 patients have successfully undergone 244 POEM procedures (13 × re-POEM). Twenty-nine procedures (11.9%) passed uneventfully, while in 215 procedures (88.1%), a total of 440 undesirable events occurred. The CDC identified 27 AEs (17 minor, 10 major) occurring in 23/244 (9.4%) procedures. The ASGE lexicon identified identical 27 AEs (21 mild or moderate, 6 severe or fatal) resulting in the severity distribution of AEs being the only difference between the two classifications. Only the absence of previous treatment was found to be a risk factor [p = 0.047, OR with 95% CI: 4.55 (1.02; 20.25)] in the combined logistic regression model. CONCLUSION: Undesirable events are common in patients undergoing POEM but the incidence of true AEs is low according to both classifications. Severe adverse events are infrequent irrespective of the classification applied. CDC may be more appropriate than ASGE lexicon for classifying POEM-related AEs given a surgical nature of this procedure.

Esophageal Motility Patterns After Peroral Endoscopic Myotomy in Patients With Achalasia.

BACKGROUND/AIMS: Several studies have reported partial recovery of peristalsis in patients with achalasia after myotomy. The aim of our study is to analyze esophageal motility patterns after peroral endoscopic myotomy (POEM) and to assess the potential predictors and clinical impact of peristaltic recovery. METHODS: We performed a retrospective analysis of prospectively collected data of consecutive patients with achalasia undergoing POEM at a tertiary center. High-resolution manometry (HRM) studies prior to and after POEM were reviewed and the Chicago classification was applied. RESULTS: A total of 237 patients were analyzed. The initial HRM diagnoses were achalasia type I, 42 (17.7%); type II, 173 (73.0%); and type III, 22 (9.3%). Before POEM, peristaltic fragments were present in 23 (9.7%) patients. After POEM the Chicago classification diagnoses were: 112 absent contractility, 42 type I achalasia, 15 type II, 11 type III, 26 ineffective esophageal motility, 18 esophagogastric junction outflow obstruction, 10 fragmented peristalsis, and 3 distal esophageal spasm. Altogether 68 patients (28.7%) had signs of contractile activity, but the contractions newly appeared in 47 patients (47/214, 22.0%). Type II achalasia showed a trend for appearance of contractions (P = 0.097). Logistic regression analysis did not identify any predictors of peristaltic recovery. The post-POEM Eckardt score did not differ between patients with and without contractions nor did the parameters of timed barium esophagogram. CONCLUSIONS: More than 20% of achalasia patients have signs of partial recovery of esophageal peristalsis after POEM. It occurs predominantly in type II achalasia but the clinical relevance seems to be negligible.

Gentamicin submucosal lavage during peroral endoscopic myotomy (POEM): a retrospective analysis.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) is an evolving therapeutic modality for achalasia. According to the original Inoue's technique, a submucosal lavage with gentamicin has been practiced due to the fear of infection. This single-tertiary center study was intended to assess the clinical significance of the topical antibiotic lavage during POEM. METHODS: A retrospective analysis of prospectively collected data was conducted. The outcomes of patients who received the gentamicin lavage (group A) during POEM were compared to those who did not (group B). The main outcome variables were infectious adverse events, post-POEM fever, and markers of systemic inflammatory response. One day before and after POEM, all patients received systemic antibiotic prophylaxis with ceftriaxone. RESULTS: Of 124 consecutive patients having undergone POEM, 60 patients received a lavage with 80 mg of gentamicin into the submucosal tunnel before starting the myotomy, while 64 patients did not. The overall treatment success at 3 months did not differ between the two groups (group A 94.7 vs. 97.5% group B). We did not experience any significant infectious adverse events in either group. CRP and WBC levels were lower in patients with lavage versus those without [CRP: median 52.7 (IQR 34.9) vs. 69.5 (54.1); p = 0.01; WBCs: median 10.9 (IQR 3.3) vs. 12.6 (3.9); p < 0.01]. Post-procedural fever was present in 10% of patients in either group. CONCLUSIONS: During POEM, the submucosal lavage with gentamicin prior to the myotomy does not play a role in the prevention of clinically significant infectious adverse events, although the systemic inflammatory response may be decreased.

Erratum to: Per-oral endoscopic myotomy (POEM): mid-term efficacy and safety.

The Given Names and Family Names were all inadvertently inverted. The correct order is: Jan Martinek, Hana Svecova, Zuzana Vackova, Radek Dolezel, Ondrej Ngo, Jana Krajciova, Eva Kieslichova, Radim Janousek, Alexander Pazdro, Tomas Harustiak, Lucie Zdrhova, Pavla Loudova, Petr Stirand, Julius Spicak. The original article was corrected.

Per-oral endoscopic myotomy (POEM): mid-term efficacy and safety.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) is becoming a standard treatment for achalasia. Long-term efficacy and the rate of post-POEM reflux should be further investigated. The main aim of this study was to analyze safety and mid-term (12 and 24 months) clinical outcomes of POEM. METHODS: Data on single tertiary center procedures were collected prospectively. The primary outcome was treatment success defined as an Eckardt score < 3 at 12 and 24 months. A total of 155 consecutive patients with achalasia underwent POEM; 133 patients were included into the analysis (22 patients will be analyzed separately as part of a multicenter randomized clinical trial). RESULTS: POEM was successfully completed in 132 (99.2%) patients, and the mean length of the procedure was 69.8 min (range 31-136). One patient underwent a drainage for pleural effusion; no other serious adverse events occurred. Treatment success at 3, 12, and 24 months was observed in 95.5% (CI 89.6-98.1), 93.4% (86.5-96.8), and 84.0% (71.4-91.4) of patients, respectively. A total of 11 patients (8.3%) reported initial treatment failure (n = 5) or later recurrence (n = 6). The majority of relapses occurred in patients with achalasia type I (16.7 vs. 1.1% achalasia type II vs. 0% achalasia type III; p<0.05). At 12 months, post-POEM reflux symptoms were present in 29.7% of patients. At 3 months, mild reflux esophagitis was diagnosed in 37.6% of patients, and pathological gastroesophageal reflux was detected in 41.5% of patients. A total of 37.8% of patients had been treated with a proton pump inhibitor. CONCLUSION: POEM resulted in greater than 90% treatment success at 12 months which tends to decrease to 84% after 2 years. More than one-third of the patients had mild reflux symptoms and/or mild esophagitis.

Non-erosive and erosive gastroesophageal reflux diseases: No difference with regard to reflux pattern and motility abnormalities.

OBJECTIVE: To investigate whether gastroesophageal reflux disease (GERD) with mild to moderate erosive esophagitis (ERD) is a more severe disease regarding the amount of acid reflux, motor abnormalities, and the presence/absence of hiatus hernia than non-erosive reflux disease (NERD). MATERIAL AND METHODS: The study comprised a retrospective analysis of prospectively collected data on 313 consecutive subjects referred for endoscopy, pH-metry, and esophageal manometry. The patients were divided into four groups: Group I (n=92), subjects without GERD with normal pH-metry, without esophagitis and without reflux symptoms; Group II (n=111), patients with NERD (no esophagitis, abnormal pH-metry); Group III (n=77), patients with mild to moderate ERD (LA A, B; abnormal pH-metry); Group IV (n=33), patients with severe or complicated esophagitis (LA C, D; Barrett's esophagus). All data are expressed as medians with 5th-95th percentiles. RESULTS: No difference was found in the amount of acid reflux between patients with mild to moderate ERD and those with NERD. The DeMeester score was 34.5 (17-105) in NERD patients and 31.6 (15-102) in ERD patients. No significant differences were found between NERD and ERD patients regarding lower esophageal sphincter (LES) basal pressure (11.6 mmHg; 3-25 in NERD versus 10.7 mmHg; 3-22 in ERD). Similar proportions of patients with NERD and ERD had low LES basal pressure (20.7% in NERD versus 24.7% in ERD; NS) and hiatus hernia (44% and 56%; NS). A relatively high proportion of patients without GERD (Group I) had ineffective esophageal motility (39%) and hiatus hernia (30%). CONCLUSIONS: No difference was found between NERD and mild to moderate ERD in terms of acid exposure time and esophageal motor abnormalities. To a certain extent, ERD is a "more complicated" form of the disease. Host factors related to a particular patient (e.g. mucosal defense, genetics, acid clearance) might be responsible for the development of esophagitis.