Landscape of Adverse Events Related to Peroral Endoscopic Myotomy in 3,135 Patients and A Risk-Scoring System to Predict Major Adverse Events.

Abstract

BACKGROUND AND AIMS\nWe aimed to 1) systemically describe the landscape of Peroral Endoscopic Myotomy (POEM) related adverse events (AE) and compare the different grading systems; 2) establish and validate a combined risk factor model and a simplified risk-scoring system to predict POEM related major AEs (mAEs).\n\n\nMETHODS\n3,135 achalasia patients treated with POEM were included and the AEs were systemically described and graded. A predictive model and risk-scoring system was developed using logistic regression and then internally validated using bootstrapping approaches.\n\n\nRESULTS\n258 out of 3,135 patients, accounting for 8.23% of the total patients, presented with 292 adverse events. According to Clavien-Dindo grading, 175 (67.83%), 23 (8.91%), 56 (21.71%), 4 (1.55%) and 0 (0.00%) patients were graded as grade I-V, respectively. By ASGE lexicon, 175 (67.83%) patients were classified with mild AE, 66 (25.58%) were classified with moderate AE, and 17 (6.59%) were classified with severe AE, respectively. 68 (2.17%) patients were classified with mAE. Air insufflation, selective myotomy, mucosal injury, and long operation time were selected into the predictive model with an area under the operator curve (AUC) of 0.795. They were assigned with scores of 18, 5, 3, and 5 in the risk-scoring system, respectively. By applying the risk scoring system, patients with higher scores had higher rates of mAE. The model showed little evidence for overfitting and was well-calibrated CONCLUSIONS: Based on a systematic landscape analysis, POEM is a safe procedure with low rates of severe AEs. Our prediction model and risk-scoring system demonstrated good performance in predicting mAEs.