Abstract
Transoral Incisionless Fundoplication (TIF) is a minimally invasive endoscopic technique proven to be safe and effective for treating Gastroesophageal Reflux Disease (GERD) in selected patients. The learning curve of this technique has not been studied. (1) To report the learning curve for TIF, by identifying a breakpoint or threshold number of procedures at which there is a significant decrease in procedure time, time taken per 2-set fastener placement and an increase in the valve circumference. Prospectively collected 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 included upper 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 specific endpoints of the TIF procedure. 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-averse patients (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. TIF was 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 analysis revealed 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 fasteners was 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 fastener deployment 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 mean valve 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 an improvement of the valve circumference with increased number of procedures (Figure 1). Our single-center analysis showed that the number of procedures needed for 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 of fasteners and to achieve tighter valves is 18 procedures. Future larger studies are needed to validate these results.TIF learning curve breakpoint analysisView Large Image Figure ViewerDownload Hi-res image Download (PPT)
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