Brewer Gutierrez, Olaya I., et al.
Transoral Incisionless Fundoplication (TIF) is a minimally invasive endoscopic technique proven to be safe and effective for treating Gastroesophageal Reflux Disease (GERD) inselected patients. The learning curve of this technique has not been studied.
Aims: (1) To report the learning curve for TIF, by identifying a breakpoint or threshold number ofprocedures at which there is a significant decrease in procedure time, time taken per 2-set fastener placement and an increase in the valve circumference.
Methods: Prospectivelycollected data on patients who had a TIF procedure at an academic medical center between September 2017 and November 2019 were analyzed. Routine pre-TIF work-up includedupper endoscopy (EGD) with biopsies, cine-esophagram, high resolution esophageal manometry (HREM) and pH-monitoring. Patients who had prior per-oral endoscopic myotomy(POEM) were excluded. Learning curve analysis was done using STATA software v 15.1 and Power BI to calculate the threshold for learning assessed by time to reach specificendpoints of the TIF procedure.
Results: 51 patients (71% male, mean age 56.5±13.2 yr.) had TIF after testing confirmed appropriate criteria (ph-positive test, < 2cm hiatal hernia,Hill grade <=2, BMI< 35). Indications for TIF were refractory GERD (51%), laryngopharyngeal reflux disease (9%), failed Nissen fundoplication (9%) and GERD in PPI-aversepatients (31%) (Table 1). Six (12%) patients had prior surgical fundoplication. All TIF procedures were performed by a single endoscopist after hands-on and supervised training. TIFwas successfully completed in 50/51 (1 aborted due to technical failure) with no serious adverse events. Overall, mean procedure time was 56±15 minutes. Break point analysisrevealed that the threshold procedure time was reached at 23 procedures, where time declined from 67±11 to 47±13 minutes (p<0.0001). The mean time to deploy set of 2 fastenerswas 4.3±1.9 minutes and mean valve circumference was 285±24 degrees. The breakpoint analysis revealed that a threshold was reached at 18 procedures for both fastenerdeployment and valve wrap, with a decrease in the mean procedure time to deploy a set of 2 fasteners from 6.5±1.4 to 3.1± 0.8 minutes (p<0.0001) and an improvement in the meanvalve circumference from 261±20 to 297±14 degrees (p<0.0001). There was a significant decrease in total procedure time and time to deploy 2-set fasteners as well as animprovement of the valve circumference with increased number of procedures (Figure 1).
Conclusions: Our single-center analysis showed that the number of procedures neededfor an endoscopist to achieve procedure times under 1-hour is 23 procedures. Furthermore, the number of procedures needed to achieve times under 4 minutes to deploy 2-set offasteners and to achieve tighter valves is 18 procedures. Future larger studies are needed to validate these results.