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Too early to aʼMUSE!
Recently, transoral endoscopic techniques have been offered to patients with gastroesophageal reflux disease (GERD) after medical therapy ahead of surgery. These techniques aim to achieve efficacy similar to surgery and are less invasive; however, they are challenging and their long-term safety data are sparse. Testoni et al. recently described 37 patients with GERD undergoing transoral incisionless fundoplication (TIF) using the Medigus ultrasonic surgical endostapler (MUSE) . There was significant benefit in terms of improvement in their subjective scores (65 % – 75 %). Similar improvement was seen in a study by Kim et al. .
However, of the patients enrolled in the study of Testoni et al., 11 had grade A esophagitis (low grade), and 23 had non-erosive esophagitis, which makes erosive esophagitis a softer indication for MUSE. There were 31 patients with Hill grade II of the gastroesophageal flap valve (GEFV), and only five had grade III. Recently, Quach et al. described a correlation between abnormal GEFV (III and IV) and the severity of GERD . Over the years, studies have shown that GEFV grades I and II are normal variants across populations  .
Another aspect that needs to be highlighted here is that pH-impedance recording done at the end of study showed non-significant improvement. Moreover, only 13 patients underwent 24-hour pH-impedance recording at the end of 12 months. This is in contrast to the sample size at the end of study, where 20 patients were considered in the per-protocol analysis (as shown in the authors’ Table 1c).
This brings us to the core issue of the selection of the ideal patients for TIF. Given the complexity, availability, and cost of MUSE, it would be better focused in patients with erosive esophagitis (Los Angeles grade C & D), GEFV grade III or IV, and needs to show objective improvement of pH-impedance parameters to have a strong recommendation. Future double-blind studies will be helpful to see the actual technical success and clinical outcomes.
26 May 2021 (online)
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- 1 Testoni PA, Testoni S, Mazzoleni G. et al. Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes. Endoscopy 2020; 52: 460-473
- 2 Kim HJ, Kwon CI, Kessler WR. et al. Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device. Surg Endosc 2016; 30: 3402-3408
- 3 Quach DT, Nguyen TT, Hiyama T. Abnormal gastroesophageal flap valve is associated with high gastresophageal reflux disease questionnaire score and the severity of gastroesophageal reflux disease in Vietnamese patients with upper gastrointestinal symptoms. J Neurogastroenterol Motility 2018; 24: 226
- 4 Contractor QQ, Akhtar SS, Contractor TQ. Endoscopic esophagitis and gastroesophageal flap valve. J Clin Gastroenterol 1999; 28: 233-237
- 5 Osman A, Albashir MM, Nandipati K. et al. Esophagogastric junction morphology on Hill’s classification predicts gastroesophageal reflux with good accuracy and consistency. Dig Dis Sci 2020; DOI: 10.1007/s10620-020-06146-0.