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.

• Klíčová slova
• Achalasia, Adverse events, Peroral endoscopic myotomy,
• MeSH
• achalázie jícnu * chirurgie   MeSH
• chirurgie trávicího traktu * MeSH
• dolní jícnový svěrač chirurgie   MeSH
• endoskopické operace přirozenými otvory * metody   MeSH
• lidé MeSH
• myotomie * metody   MeSH
• retrospektivní studie MeSH
• rizikové faktory MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

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.

• Klíčová slova
• Achalasia, Gastroesophageal reflux, Per-oral endoscopic myotomy,
• MeSH
• achalázie jícnu chirurgie   MeSH
• dospělí MeSH
• endoskopické operace přirozenými otvory metody   MeSH
• Hellerova myotomie metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• následné studie MeSH
• retrospektivní studie MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

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.

• Klíčová slova
• Achalasia, Gentamicin submucosal lavage, Infectious adverse events, Per-oral endoscopic myotomy,
• MeSH
• achalázie jícnu chirurgie   MeSH
• antibakteriální látky aplikace a dávkování   MeSH
• antibiotická profylaxe * MeSH
• ceftriaxon aplikace a dávkování   MeSH
• dospělí MeSH
• endoskopické operace přirozenými otvory metody   MeSH
• gastrointestinální endoskopie metody   MeSH
• gentamiciny aplikace a dávkování   MeSH
• léčebná irigace metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• myotomie metody   MeSH
• retrospektivní studie MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• antibakteriální látky MeSH
• ceftriaxon MeSH
• gentamiciny MeSH