The EsophyX® device . (a) The first-generation device; (b) the second-generation device. (Courtesy of EndoGastric Solutions, Inc., Redmond, WA, USA) (a) ©2015 EndoGastric Solutions, Inc. (b) ©2015 EndoGastric Solutions, Inc
The procedure is performed by two operators: one controls the device and the other one operates the endoscope. The device is inserted transorally with the patient in the left lateral or supine position, under general anesthesia. Hypopharyngeal perforation has been reported in this phase of the procedure if the device is introduced without an adequate caution; in difficult cases, the device can be gently rotated to pass the upper esophageal sphincter. The risk of this complication is reduced with the second-generation device, because of its smaller diameter.
Once into the stomach, air or CO2 is insufflated to distend the gastric cavity and permits an adequate vision of the gastric fundus and EGJ; CO2 is preferable, because it leads to a faster and more sustained gastric insufflation and induces less discomfort to patients. With the endoscope placed in retroflexion position, the lesser curve is located at the 12 o’ clock position and the greater curve at the 6 o’ clock in the patient placed in left decubitus. Once the tissue mold is retroflexed, it is closed against the EsophyX® device, rotated to 11 or 1 o’ clock position (lesser curve), and pulled back to place its tip just inside the esophageal lumen. At this point, the helical screw is advanced to engage tissue under direct vision just below the Z-line, the shaft of the device is advanced caudally, the tissue mold is opened, and the helical screw cable is freed from the tissue mold. Then, a tension is applied to helical retractor while a slight opening and closing of the tissue mold allows the fundus to slide through the tissue mold; in this phase the stomach is being desufflated. Failure to desufflate the stomach during this phase of the procedure limits the size of the fundoplication.
After completing this maneuver, both helical retractor and tissue mold are locked in place, suction is applied to the tissue invaginator for approximately half a minute, and the device is then advanced caudally into the stomach, which has been re-insufflated. The latter maneuver ensures that esophago-gastric plication is performed in an intra-abdominal position and reduces hiatal hernia, when present.
Plication is carried out by deploying multiple polypropylene, H-shaped fasteners advanced over two stylets, one anterior and the other posterior. The fastener deployment process initiates on the far posterior and anterior sides of the esophago-gastric valve adjacent to the lesser curvature and then is extended to the greater curvature by rotating the tissue mold axially to slide the stomach over the esophagus, resulting in circumferential tightening and a new valve circumference of >240°. The stylet is advanced under direct endoscopical vision through the tissue mold until its tip is seen by the operator. The fastener is then advanced over the stylet and deployed to create a serosa-to-serosa plication. Once the tip of the fastener becomes visible at the tissue mold, the stylet is pulled back while the fastener is maintained in place; by this way, the leading leg of the fastener is derailed and the fastener is deployed. Fourteen fasteners allowing 7 plications are needed to construct a satisfactory circumferential gastroesophageal valve; however, the higher the number of fasteners deployed, the more continent the newly created valve is [6].
Schematic representation of the EsophyX® procedure (a) The EsophyX® device enters the esophagus through the mouth and is positioned at the gastroesophageal junction. (b) The device wraps the fundus around the distal esophagus and fastens a tissue fold; this step is then repeated multiple times to reconstruct a robust tight valve (c). (Courtesy of EndoGastric Solutions, Inc., Redmond, WA, USA)
Endoscopic findings of the gastroesophageal valve before and after the TIF procedure by EsophyX® device (a) The gastroesophageal valve before the procedure by EsophyX® device . (b) The “Bell Roll” maneuver to create the new gastroesophageal valve. (c) The gastroesophageal valve immediately after the EsophyX® procedure. (d) The gastroesophageal valve 6 months after the EsophyX® procedure. (Authors’ cases)
Besides the standard procedure, two modified techniques have been reported over time to create the fundoplication. The technique we used in the last years engages tissue by advancing the helical screw just below the Z-line on the far posterior and anterior sides of the esophago-gastric valve adjacent to the lesser curvature (11 and 1 o’ clock position). Before inserting the stylet, a torque is applied by rotation (clockwise and counter-clockwise at 11 and 1 o’ clock, respectively) of the tissue mold locked; such a maneuver allows part of the fundus to rotate around the esophageal wall and more tissue to be engaged by the stylet. Four fasteners for each site are deployed, at 1 and 11 o’ clock position, and two fasteners for each site in the middle part of the valve, at 4, 6, and 8 o’ clock position, to reinforce and prolong caudally the plication. This technique increased by 30% the success rate of the procedure. With the standard TIF technique, 11/27 patients (40.7%) did not take PPI therapy at 12 months; with the application of the rotational TIF technique, 14/22 patients (63.6%) were full responders [7].
Bell R et al. have developed a rotational fundoplication, the so-called “Bell Roll” maneuver [8]. The helical retractor is engaged at 12 o’ clock and the tissue mold is placed at 6 o’ clock. The device, with the tissue mold partially closed against the fundus of the stomach, is pulled cranially by 1–3 cm into the esophagus, depending on the depth of the plication intended; tension is then applied to the helical retractor to advance caudally the EGJ while the stomach is desufflated; at this time, the tissue mold locked is rotated toward the lesser curve by a radial motion of the handle of the device to the 12 o’ clock position. This maneuver rolls the fundus over and around the distal esophagus to the 1 o’ clock position.
At the end of the plication, an immediate endoscopy is performed to evaluate the pharynx, the esophageal lumen, and the gastric fundus and the fundoplication.
Transoral Fundoplication by MUSE™
The MUSE™ device includes the endostapler and a console connected with the endostapler, containing a controller for the camera, ultrasonic range finder and various sensors, a pump for insufflation and irrigation, a suction system, power, and controls for the LED.
The endostapler has (a) a handle, wherein controls are located; (b) an insertion tube 15.5 mm in diameter, 66 cm long, containing the suction, insufflation/irrigation channels, and electrical and mechanical cables which operate the device; (c) a rigid section 66 mm in length that contains the cartridge (each cartridge contains five standard 4.8-mm titanium staples, the ultrasound mirror, one alignment pin funnel, and two anvil screw funnels); and (d) the distal tip, similar to that of an endoscope, with suction, irrigation, illumination (via LED), and visualization (via miniature camera) capabilities. The anvil, alignment pin, anvil screw, and ultrasound are all designed to ensure proper alignment and positioning of the device during stapling. The distal tip may be articulated in one direction to align with the rigid section and cartridge, with a bending radius of 26 and 40 mm.
The Medigus surgical ultrasonic endostapler device (MUSE™) . (Courtesy of Medigus, Omer, Israel) (a) The MUSE™ device. (b) The console connected with the endostapler, containing a controller for the camera, ultrasonic range finder, and various sensors (banding angle, banding force, alignment pin, anvil screws, gap)
The procedure can be performed by one operator in experienced hands. The patient is placed in the supine position, under general anesthesia with endotracheal intubation. Positive end expiratory pressure (PEEP) of at least 5 mm Hg (7.5 cm H2O) is administered. After a preliminary endoscopic assessment of the esophagus and stomach and once no contraindications are found, an overtube is placed. Then, the endostapler is inserted transorally through the overtube and gently advanced into the stomach under direct vision; passing the rigid section across the pharyngo-esophageal junction may encounter some resistance. To avoid applying excessive force and risk of injury to the esophagus, the overtube may be withdrawn approximately 5 cm and then advanced with the endostapler as a unit. This maneuver can be repeated until the system reaches the esophageal midbody. Flexing the neck may make passage easier.
Once into the stomach, distended by insufflation of air or CO2, the stapler is advanced until the tip is approximately 5 cm past the EGJ and then retroflexed by 180° to obtain an adequate vision of the gastric fundus and EGJ to select stapling location.
The most important stapling location is the leftmost location, which is typically performed first. This is the anchoring point for the fundus and should be placed as far to the left of the esophagus as possible. At times, depending on anatomy, it may be easier to perform the first stapling in a more central location. The additional stapling locations should be within 60°–180° as long as the rightmost stapling should not be done on the lesser curve, because stapling in the lesser curve may attach the antrum to the esophagus and open the esophago-gastric junction rather than close it. Additional staplings may be placed between the leftmost and rightmost. Once the correct location for stapling has been identified, all the procedures are performed under ultrasound guidance. Subsequent phases of the procedure include clamping tissue, deploying alignment pin, advancing anvil screw, stapling, and retrieving anvil screws [9].
Schematic representation of the Medigus ultrasonic surgical endostapler (MUSE™) procedure (a) The endostapler is inserted transorally through the overtube and gently advanced into the stomach under direct vision. (b) Once into the stomach, distended by insufflation of air or CO2, the stapler is advanced until the tip is approximately 5 cm past the EGJ and then retroflexed by 180° to obtain an adequate vision of the gastric fundus and EGJ to select stapling location. Tissue clamping and stapling are performed under ultrasonic guidance. (c) This step is then repeated at least twice to reconstruct a robust tight valve. The additional stapling locations should be within 60°–180° of the valve circumference. (Courtesy of Medigus, Omer, Israel)
Endoscopic findings of gastroesophageal valve before and after the TIF procedure by Medigus ultrasonic surgical endostapler (MUSE™) (a) The gastroesophageal valve before the TIF procedure by Medigus ultrasonic surgical endostapler (MUSE™). (b) The gastroesophageal valve immediately after the TIF procedure by Medigus ultrasonic surgical endostapler (MUSE™).(c) The gastroesophageal valve 6 months after the TIF procedure by Medigus ultrasonic surgical endostapler (MUSE™). (Authors’ cases)
Post-operative Care
Antiemetic prophylaxis with at least two drugs (according to the ASA recommendations for interventions with high risk of post-procedure nausea and vomiting) and full muscle relaxation throughout the procedure are mandatory for TIF. Antiemetic prophylaxis is maintained i.v. for 24 h, while broad-spectrum antibiotic therapy is maintained i.v. for 48 h and then by oral route over a 5-day period.
Almost all patients complain of transient pharyngeal irritation, as a result of insertion and manipulation of the device, and some have mild to moderate epigastric pain in the 6 h after the procedure. Pain persisting for 2–4 days may require analgesics and should be considered for esophageal or gastric leak; CT scan and hydrosoluble contrast x-ray investigation should be carried out in these cases. Dysphagia or gas bloating is generally not reported by patients. White blood cell count may be slightly increased after the procedure. At discharge, patients were instructed to follow a liquid diet for the first 2 weeks and a soft diet for the next 4 weeks. PPI were discontinued 7 days after the procedure.
Patients were also asked to refrain from vigorous exercise for 4 weeks.
Complications
The overall complication rate reported in studies so far available for TIF by EsophyX® ranges from 3% to 10%. Sixteen studies (4 RCTs and 12 prospective observational trials) reported the occurrence of severe adverse events [10]. As a whole, 19 severe adverse events occurred in a total of 781 patients who underwent TIF, with a mean incidence rate of 2.4%. Severe adverse events included seven cases of perforation, five cases of bleeding requiring blood transfusions, four cases of pneumothorax, and one involving severe epigastric pain. Mediastinal abscess as a consequence of esophageal perforation has been reported in less than 2% of cases. Bleeding occurred at the site of the helical retractor insertion. No procedure-related deaths occurred.
The finding of free air in the abdomen immediately after the procedure is not always a sign of clinically relevant complications.
In the three studies so far published on TIF by MUSE™ device, minor side effects such as chest pain, sore throat, transient atelectasis, shoulder pain, and belching were reported in 5.5–22% of patients. Major complications were reported in 6.2% of cases (4 out of 64 patients) and were pneumothorax (one case), pneumothorax and esophageal leak (one case), and bleeding (one case). Patients with pneumothorax and esophageal leak and with bleeding required intervention [11–14].
No late complications or long-lasting side effects were reported for both TIF techniques.
Outcomes
To date, 14 observational non- randomized prospective studies and 5 randomized controlled trials have been published on TIF performed by EsophyX® [10]. Three observational prospective studies and two abstracts have been published on TIF performed by MUSE™.
Among the observational studies on EsophyX® procedure, two provided results in 3 months (32 pts) [4, 15], nine in 6 months (439 pts) [7, 16–23], seven in 12 months (329 pts) [6, 7, 14, 16, 17, 22–24], and three in 24 months (81 pts) [7, 23–25] and 36 months (105 pts) [20, 23, 24], and only one showed results after 4, 5, and 6 years of follow-up [23]. In all studies but three, TIF was proven to discontinue anti-reflux medications or markedly decrease their dose; three studies raised concerns about the effectiveness of the procedure [15, 17, 26]. Results at 3 years have been published recently in the TEMPO randomized trial with a crossover arm: regurgitation and atypical GERD symptoms were eliminated in 90% and 88% of patients, respectively [27].
Sixteen studies assessed symptoms by means of the GERD health-related quality of life (HRQL); 11 evaluated pre- and post-procedure pH +/− impedance recordings.
Six- and 12-month outcomes after TIF showed that 75% to 84% and 53% to 85% of patients had either discontinued PPI use or halved the dose of PPI therapy, respectively. Normalization of esophageal acid exposure, in terms of total acidic refluxes, number of refluxates, and DeMeester score, was reported in 37–89% of patients.
Two years after TIF, daily high-dosage PPI dependence was eliminated in 75–93% of patients.
In the three observational series reporting 3-year outcomes, discontinuation of daily PPI ranged from 74% to 84% of cases.
Only one study assessed outcomes 6 years after TIF in 14/50 patients who undergone the procedure. High-dosage PPI dependence was eliminated in 86% of patients, and approximately half of them completely stopped PPI use [23], providing evidence of the lasting effect of TIF on symptoms and PPI usage. The long-term efficacy of TIF was maintained in the 12 patients of the same prospective series followed up to 10 years: 91.7% patients had either stopped or halved their PPI therapy. Intention-to-treat analysis of the effect of TIF on PPI use at 10 years showed that 78.6% of patients had stopped or halved PPI therapy, while 35.7% had completely discontinued it.
Related posts:
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
