IMPLEMENTATION OF A PERORAL ENDOSCOPIC MYOTOMY PROGRAM.

Introduction The aim of our study was to develop a POEM program in our Unit following a two steps sequence: training on animal models and supervision by an experienced endoscopist during our first human cases. Methods A single endoscopist experienced in advanced endoscopy was trained in POEM. After observing POEM in referral centers, training was implemented on swine models (preclinical phase). Technical aspects and adverse events were prospectively recorded. We compared a first subset of cases (group A) to a second one (group B) to assess our progression. Finally, POEM was implemented in humans under the supervision of an experienced endoscopist (clinical phase). The outcomes and adverse events were prospectively recorded. Results Preclinical phase. Fifteen POEM procedures were performed on live pigs. In group B severe AE were less frequent than in group A (12% vs. 57%, p = 0.07). After nine cases, a plateau regarding adverse events was observed. Clinical phase. Eleven POEM procedures were performed in patients under expert supervision. Technical and clinical (Eckardt score ≤ 3) success were 100% and 91%, respectively (follow-up 3-21 months). In 2 cases, the experienced endoscopist intervention was required (cases 2 and 3) because of difficult orientation at the esophagogastric junction. One mild pneumoperitoneum occurred, with no severe adverse events reported. Conclusions Training in animal models and supervision by experienced endoscopist during first cases could provide the necessary skills to perform POEM safely and effectively.