Discussion
dysphagia, bleeding, abdominal pain, postoperative dysphagia, GERD, cardia, shoulder pain, achalasia cardia, cough, esophagitis, Hoarseness, hematoma, trauma
DYSPHAGIA, BLEEDING, ADVERSE EVENTS, GERD, ACHALASIA CARDIA, ESOPHAGITIS, HEMATOMA
In this study, at 3 months, patients randomized to EFTP had achieved the primary end point with a significant reduction in esophageal AET < 6 %. They also showed improvement in GERDQ score and reduction in PPI usage up to the 6-month follow-up, with no major adverse events. These prospective data suggest that symptom improvement and healing of esophagitis are not attributed to a sham effect. A partial, rather than complete, fundoplication is achieved during EFTP, which compares favorably with total fundoplication for controlling GERD but causes less postoperative dysphagia. The stapling enhances the angle of His and preserves the mucosal flap valve mechanism.
Endoluminal therapies for GERD have been utilized for more than two decades. EFTP creates an effective antireflux barrier by introducing an implant/suture material into the area of the lower esophageal sphincter, thereby altering the compliance of the sphincter
The published studies with plicator showed that the majority of adverse events were mild and resolved spontaneously . Hoarseness, cough, shoulder pain, and abdominal pain were reported. The latter is caused by trauma to the gastric cardia and the esophagus due to the placement of a second or third plicator implant. If the staple is placed too close to the distal esophagus, it can cause luminal narrowing and patients can present with dysphagia. In patients who have loose cardia diameter, 2–3 plications placed along a slightly diagonal vector recreates the normal antireflux valve by re-establishing the angle of His. The suture material and its length can impair the gastric/esophageal tissue. Tissue structure, deeper tissue penetration of the suture, and the way these implants are deployed can lead to bleeding and hematoma formation. As only 30 patients in this study received the EFTP procedure, conclusions regarding adverse events and safety of EFTP should be considered as exploratory, and long-term data are still required. Unlike surgical fundoplication, extra gastric mobilization of the fundus to release the tension of the fundoplication cannot be achieved with EFTP, and the continuous force on the repair eventually causes the anatomy of the GEJ to return to its original shape, causing the flap valve to unravel. This could be why eight patients (27.6 %) in the EFTP group continued to consume PPI.
The rate of post-POEM GERD depends on the type of measurement, and there is a significant difference between symptoms, endoscopic evidence, and pH measurement
The study has some strengths. This was the first randomized sham-controlled trial that demonstrated an improvement in GERD symptoms, improvement in AET, and a decreased requirement for PPI usage among post-POEM patients in whom the majority of the antireflux endoluminal therapies have shown only modest effects. This improvement in AET looks clinically relevant.
The study also has some limitations. First, the study is from a single center, the results of which may not be generalizable. Although achalasia cardia can occur at any age, patients usually receive a diagnosis between the ages of 25 and 60 years but more commonly between 40 and 60 years. The patients in this study had a median age of about 40 years, a median body mass index of 26 kg/m
In conclusion, this prospective, randomized sham-controlled trial showed that EFTP using a new plication device was safe and effective in managing post-POEM GERD. Endoscopic therapy led to a significant reduction in PPI use, and improvement in GERD symptoms and 24-hour pH impedance findings. The validity of the study findings needs greater consideration in future multicenter randomized controlled studies with a larger patient cohort, and if the results are reproducible, EFTP could become a suitable endoscopic modality for treatment of post-POEM GERD.