Challenges for endoscopic antireflux procedures

The 1-year outcome of improvement in reflux symptoms after ultrasound-guided transoral incisional fundoplication (TIF) with the Medigus ultrasonic surgical endostapler (MUSE) reported in this issue by Testoni et al. [1] is an important contribution to the literature in the developing field of alternative methods of anatomical and functional repair for the lower esophageal sphincter (LES) in gastroesophageal reflux disease (GERD). In order to be a valid improvement on current therapeutic options, TIF with MUSE needs to compare favorably with laparoscopic Nissen fundoplication, and with other new technologies, such as magnetic sphincter augmentation (LINX) or endoscopic microwave therapy (Stretta).

TIF with the MUSE device is a technological development of the Esophyx TIF procedure as it utilizes ultrasound technology to help in accurately placing staples during the anterior fundoplication.

Case selection for this procedure was based on the persistence of symptoms while on a proton pump inhibitor and the lack of significant (> 2.5 cm) hiatus hernia, but not on the grounds of medical fitness or on any potential qualification for a standard surgical approach. It is important that case selection is carefully considered as per the Icarus guidelines [2].

The TIF with MUSE technique avoids a surgical incision but still requires the patient to undergo a general anesthetic and takes > 1 hour to complete, with a hospital stay of 2 days. As such, the hospital process is little better than having a traditional laparoscopic Nissen fundoplication. Indeed, no overnight stay is needed after laparoscopic Nissen fundoplication [3]. It was reasonable here to keep patients in hospital for 2 days as this study and others looking at endoscopic plication have shown that such procedures are susceptible to esophageal perforation. The cases selected avoided patients with large hiatal hernias; it is interesting to note that the length of the LES was significantly longer at functional testing 6 months later and that no recurrent hiatal hernia were seen in what is a relatively short follow-up period. The partial fundoplication appears to remain in place for at least 6 months.

“...the current state of the TIF with MUSE technology is one of apparent symptom improvement in an uncontrolled study but with no evidence of physical reflux control.”

The safety data reported one perforation, but it is not clear if this was due to an upper esophageal tear during insertion of the device or a tear at the gastroesophageal junction during the creation of the fundoplication. Data from other studies on TIF show a similar complication rate for perforations [4]. No data are given on dysphagia in the early follow-up period. This is an area where current methods (both Nissen and magnetic sphincter augmentation) suffer significant side effects, although in both the problems have usually resolved by 3 months [5] [6].

This study suffers from the lack of any control or comparative data. It is possible that a significant placebo effect may contribute to the symptom improvement. No sham or control procedure was offered for comparison in this study, unlike in the TIF study of Hunter et al. [7], which showed a placebo response of 64 %. Therefore, caution should be exercised when describing the real benefit of this therapy to patients who are considering it as an option.

The interpretation of the functional tests, particularly the pH monitoring at 12 months, is complicated by the fact that this was performed in only 13 of the 36 patients (65 % of those with full follow-up to 12 months). The patients who did not attend for follow-up tests were described as asymptomatic and it is possible that their lack of inclusion skews the pH measures towards patients who might have had some residual symptoms. The actual data shows that acid exposure overall, as measured by the DeMeester score, did not improve (19.5 before vs. 21 after 12 months), nor did the proximal or total reflux events, as measured by impedance studies, improve significantly.

Notwithstanding the effect of the follow-up patients potentially having improved less than the average in this study, it is a disappointing finding to see the lack of documentable improvement in gastroesophageal reflux. This calls into question the mechanism of symptom improvement that was seen; however, it is similar to the results reported for other forms of TIF [7].

Compared with the results for both the laparoscopic Nissen procedure (24-hour pH study: acid exposure time 8.6 % before treatment vs. 0.7 % after) and Linx (10.9 % before treatment vs. 3.3 % after) [6] [7], the lack of demonstrable improvement in the reflux parameters seen by Testoni et al. is concerning. The improvement in GERD HRQL score in the study of Testoni et al. (24 before vs. 7 after) is similar in scale to the symptom improvement seen in those surgical patients studied where proof of reflux control is clear. It is somewhat perplexing to explain how such symptom improvement could have occurred without a change in the amount or frequency of gastroesophageal reflux.

In conclusion, the current state of the TIF with MUSE technology is one of apparent symptom improvement in an uncontrolled study but with no evidence of physical reflux control. If the symptoms remain controlled, it would have a place in the armamentarium of gastroenterologists, but long-term data are needed to see if the improved symptoms are sustained at 5 years and beyond. Data from the Lotus study shows sustained symptom control at 5 – 7 years after surgical fundoplication.

In the view of this author, the gold standard of care for patients with persistent GERD despite optimal medical control is laparoscopic fundoplication and hiatal hernia repair with crural approximation. The fundamental difficulty that the endoscopic approaches suffer is the lack of ability to control the open diaphragmatic hiatus and, until such hiatal repair can be created endoscopically, non-surgical approaches may continue to offer a relatively poor outcome for GERD therapy. Reliance on symptom measures in the absence of improved reflux measures not only leaves patients susceptible to recurrence of their symptoms, but also to continuing damage from acid or bile, with the potential development of Barrett’s esophagus or adenocarcinoma of the esophagus [8].

Publication History

Article published online:
27 May 2020

• References

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