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Page 6 of 9                                                                                   Kitamura et al. Mini-invasive Surg 2022;6:44   https://dx.doi.org/10.20517/2574-1225.2022.27



                          Table 2. Summary of systemic reviews and meta-analyses comparing MSA vs. LF

                                               Included               Follow-up       GERD-      PPI                      Endoscopic                                                           MSA         MSA
                          References     Year               MSA/LF                                            Dysphagia                    Belching     Vomiting     Gas bloat Reoperation
                                               studies                (months)        HRQL       cessation                dilation                                                             erosion     removal
                                   [26]
                          Chen et al.    2017 4             299/325 6-12              -          ND           ND          ND               ND           ND           RR: 0.71     ND           -           -
                                                                                                                                                                     95%CI:
                                                                                                                                                                     0.54-0.94
                                                                                                                                                                     P = 0.02

                          Skubleny       2017 3             415/273   7-16            -          ND           ND          ND               95.2 MSA     93.5% vs.    ND           -            -           -
                              [29]
                          et al.                                                                                                           65.9% LF     49.5%
                                                                                                                                           P < 0.00001  P < 0.0001
                                    [2]
                          Aiolfi et al.  2018 7             686/525 6-12              ND         ND           -           ND               OR: 5.53     OR: 10.10    OR: 0.39     ND           -           -
                                                                                                                                           95%CI: 3.73- 95%CI: 5.33- 95%CI:
                                                                                                                                           8.19         19.15        0.25-0.61
                                                                                                                                           P < 0.001    P < 0.001    P < 0.001

                          Guidozzi       2019 19*           632/467 6-44              ND         ND           ND          -                OR: 12.34    -            OR: 0.34     ND           0.30%       3.30%
                              [19]
                          et al.                                                                                                           95%CI: 6.43-              95CI: 0.16-
                                                                                                                                           23.7                      0.71

                          *This study pooled data from 6 comparative studies and 13 single-cohort studies. P-values are listed when reported for significant differences in reported symptoms. LF: Laparoscopic fundoplication; GERD-HRQL:
                          gastroesophageal reflux disease-health-related quality of life; PPI: proton-pump inhibitor; MSA: magnetic sphincter augmentation; ND: no difference; OR: odd’s ratio; RR: relative risk.



                          Dysphagia, device explantation, and erosion
                          There is data to support the safety and efficacy of MSA with acceptable risk. Intraoperative complications are 0.1%, explantation of 1.1 to 6.7%, and erosion of

                          0.1 to 1.2%. There are no reported deaths .
                                                                          [18]


                          The most common adverse effect is dysphagia in the immediate postoperative period, which is 43% to 83%. Persistent dysphagia may occur in up to 19% of
                          patients, but the majority will resolve within three months, while few will require endoscopic dilation                [28,29] .



                          Endoscopic dilation is effective in 67% to 76.9% of patients with persistent dysphagia . This may be due to non-standardization of whether the crural repair is
                                                                                                                              [18]
                          performed, which may vary between reported studies. One would expect, with newer studies incorporating larger hiatal hernias and complicated reflux cases,
                          rates of postoperative dysphagia may rise        [20,30] . When reoperation was necessary, a crural closure was noted to be the culprit in one case and symptoms resolved
                          when the crural repair was redone . Richards and McRae laparoscopically explored two patients and found the MSA device was encapsulated in scar tissue,
                                                                   [23]
                          preventing expansion . Capsulotomy was performed and the dysphagia subsequently resolved.
                                                   [13]


                          Device explantation has been reported rarely in patients with persistent GERD or dysphagia. In those instances, device removal has been uncomplicated and
                          completed in a single stage. Conversion to fundoplication is done successfully and authors feel relatively easy given the limited dissection needed for MSA                           [13,23] .
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