Assessment of the learning curve for peroral endoscopic myotomy with fundoplication for a single operator

Abstract

Background and Aims

Peroral endoscopic myotomy with fundoplication (POEM-F) is a novel procedure that provides a preventative interventional option to reduce rates of post-POEM gastroesophageal reflux disease (GERD) via anterior myotomy followed by a partial anterior wrap. Defining the learning curve (LC) is necessary to create adequate subspecialty training programs and quality assurance.

Methods

This study is a retrospective analysis of a prospectively maintained data set of patients who underwent POEM-F at a single tertiary referral center. The primary outcome was the LC for POEM-F, defined by the number of cases needed to achieve proficiency and mastery, assessed using cumulative sum analysis. Sequential time-block analysis also was performed.

Results

Thirty-one consecutive patients underwent POEM-F. The same endoscopist performed all procedures using the same technique. Technical success was achieved in 96.8% and clinical success (Eckardt score <3) in 100% of patients. The mean (standard deviation) total procedural and fundoplication alone times were 93.8 (19.6) minutes and 55.5 (18.2) minutes, respectively. Over a median follow-up of 14 weeks, the mean Eckardt score decreased from 7.3 to 0.3. At follow-up, Los Angeles reflux esophagitis of grades B, C, and D was observed in 2 patients (10.5%), 1 (5.3%), and none, respectively. There was only 1 postprocedural adverse event, graded as mild and successfully treated conservatively. Evaluation of the cumulative sum curve using the fundoplication time revealed that 17 cases were needed to achieve proficiency and 19 cases to achieve mastery. These results were confirmed with sequential time-block analysis.

Conclusions

We report data on the LC for POEM-F. Approximately 17 procedures may be the threshold to achieve proficiency, and approximately 19 cases to master the technique, although larger studies with more endoscopists, both experts and novices, are required.