The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been ...performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM.
Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case-control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders).
A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs.
This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.
Abstract
Background and study aims
The efficacy of per oral endoscopic myotomy (POEM) in non-achalasia esophageal motility disorders such as esophagogastric junction outflow obstruction (EGJOO), ...diffuse esophageal spasm (DES), and jackhammer esophagus (JE) has not been well demonstrated. The aim of this international multicenter study was to assess clinical outcomes of POEM in patients with non-achalasia disorders, namely DES, JE, and EGJOO, in a large cohort of patients.
Patients and methods
This was a retrospective study at 11 centers. Consecutive patients who underwent POEM for EGJOO, DES, or JE between 1/2014 and 9/2016 were included. Rates of technical success (completion of myotomy), clinical response (symptom improvement/Eckardt score ≤ 3), and adverse events (AEs, severity per ASGE lexicon) were ascertained
.
Results
Fifty patients (56 % female; mean age 61.7 years) underwent POEM for EGJOO (n = 15), DES (n = 17), and JE (n = 18). The majority of patients (68 %) were treatment-naïve. Technical success was achieved in all patients with a mean procedural time of 88.4 ± 44.7 min. Mean total myotomy length was 15.1 ± 4.7 cm. Chest pain improved in 88.9 % of EGJOO and 87.0 % of DES/JE (
P
= 0.88). Clinical success was achieved in 93.3 % of EGJOO and in 84.9 % of DES/JE (
P
= 0.41) with a median follow-up of 195 and 272 days, respectively. Mean Eckardt score decreased from 6.2 to 1.0 in EGJOO (
P
< 0.001) and from 6.9 to 1.9 in DES/JE (
P
< 0.001). A total of 9 (18 %) AEs occurred and were rated as mild in 55.6 % and moderate in 44.4 %.
Conclusion
POEM is effective and safe in management of non-achalasia esophageal motility disorders, which include DES, JE, and EGJOO.
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