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. 2021 Nov 12;9(11):E1785-E1791.
doi: 10.1055/a-1547-6599. eCollection 2021 Nov.

The learning curve for transoral incisionless fundoplication

Mohamad Dbouk  1   2 , Olaya I Brewer Gutierrez  1 , Bijun Sai Kannadath  3 , Jose Valentin Camilion  4 , Saowanee Ngamruengphong  1 , Vivek Kumbhari  1 , Mouen Khashab  1 , Michael Murray  5 , Peter Janu  6 , Glenn Ihde  7 , Kenneth Chang  8 , Nirav Thosani  9 , Marcia Irene Canto  1
Affiliations

The learning curve for transoral incisionless fundoplication

Mohamad Dbouk et al. Endosc Int Open. .

Abstract

Background and study aims Transoral incisionless fundoplication (TIF) is a safe and effective minimally invasive endoscopic technique for treating gastroesophageal reflux disease (GERD). The learning curve for this technique has not been reported. We studied the learning curve for TIF when performed by a gastroenterologist by identifying the threshold number of procedures needed to achieve consistent technical success or proficiency (consistent creation of TIF valve ≥ 270 degrees in circumference, ≥ 2 cm long) and efficiency after didactic, hands-on and case observation experience. Patients and methods We analyzed prospectively collected data from patients who had TIF performed by a single therapeutic endoscopist within 17 months after basic training. We determined thresholds for procedural learning using cumulative sum of means (CUSUM) analysis to detect changes in achievement rates over time. We used breakpoint analysis to calculate procedure metrics related to proficiency and efficiency. Results A total of 69 patients had 72 TIFs. The most common indications were refractory GERD (44.7 %) and proton pump inhbitor intolerance (23.6 %). Proficiency was achieved at the 18 th to 20 th procedure. The maximum efficiency for performing a plication was achieved after the 26 th procedure, when mean time per plication decreased to 2.7 from 5.1 minutes (P < 0.0001). TIF procedures time varied until the 44 th procedure, after which it decreased significantly from 53.7 minutes to 39.4 minutes (P < 0.0001). Conclusions TIF can be safely, successfully, and efficiently performed in the endoscopy suite by a therapeutic endoscopist. The TIF learning curve is steep but proficiency can be achieved after a basic training experience and 18 to 20 independently performed procedures.

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Conflict of interest statement

Competing interests Dr. Ngamruengphong is a consultant for Boston Scientific. Dr. Kumbhari is a consultant for Medtronic, Pentax Medical (USA), Boston Scientific, FujiFilm, Apollo Endosurgery, and received research support from Erbe USA, and Apollo Endosurgery. Dr. Khashab is a consultant for Boston Scientific, Medtronic, Olympus, GI Supply, and Triton. Dr. Murray is a consultant for Endogastric Solutions. PJ is a consultant for Endogastric solutions, Ethicon/J&J, and Olympus. Dr. Ihde is a consultant for Endogastric solutions, and Microline Medical. Dr. Chang is a consultant for Apollo Endosurgery, Cook, Erbe USA, Endogastric solutions, Mauna Kea, Mederi, Medtronic, Olympus, Ovesco and Pentax Medical (USA). Dr. Thosani is a consultant for Boston Scientific, Medtronic, Pentax Medical (USA), received research support from Pentax Medical (USA), royalties from UpToDate, and is on the advisory board of ColubrisMX. Dr. Canto received research grants from Endogastric solutions and Pentax Medical (USA), and royalties from UpToDate.

Figures

Fig. 1
Fig. 1
Endoscopic images of transoral incisionless fundoplication using TIF 2.0 technique. a Endoscopic image of the Esophyx-Z + device seen in retroflex view during the initial step of transoral incisionless fundoplication. The helix (arrow) is inserted into the gastric cardia side of the squamocolumnar junction, and with concomitant suctioning, the distal esophagus is withdrawn in caudad direction under the diaphragm to create a flap valve 2 to 3 cm in length. The distal esophagus and gastric cardia are shown enclosed within the tissue mold prior to placement of plastic H fasteners to create a full thickness esophago-gastric plication. In TIF 2.0 technique, at least 20 fasteners are placed at different locations to create a flap valve that is at least 270 degrees in length. b The endoscopic image on the right is of the TIF valve 6 months later and shows the gastric cardia snug around the endoscope (normal appearance, Hill grade 1), with a 310-degree circumference.
Fig. 2
Fig. 2
Cumulative sum (CUSUM) analysis to assess procedure proficiency. (consistent creation of a ≥ 270-degree and > 2-cm-long TIF valve).
Fig. 3
Fig. 3
Breakpoint analysis of TIF valve circumference. (Proficiency: consistent creation of a minimum 270-degree TIF wrap).
Fig. 4
Fig. 4
Breakpoint analysis of average plication time.
Fig. 5
Fig. 5
Breakpoint analysis of mean TIF time.
See this image and copyright information in PMC

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