A systematic review has concluded that magnetic sphincter augmentation may represent a feasible, safe, and less invasive option compared to RYGB for selected patients with post-sleeve gastroesophageal reflux disease (GERD), especially those with a normalised or < 35 kg/m2 BMI and no evidence of associated oesophageal motility disorders. The findings were reported by researchers from IRCCS Ospedale Galeazzi–Sant’Ambrogio, Milan, Italy, in the paper, ‘Magnetic Sphincter Augmentation for Gastroesophageal Reflux After Sleeve Gastrectomy: A Systematic Review’, published in Obesity Surgery.
The authors noted that GERD still represents a significant clinical challenge post-LSG. In addition, anatomical and physiological changes associated with the procedure could result in a regurgitation-dominant GERD phenotype unresponsive to conventional medical treatment. Conversion to RYGB is an option but patients are wary of the major anatomical changes and the perceived side-effects.
They stated that magnetic sphincter augmentation device has become a “promising alternative” to traditional fundoplication for the treatment of primary GERD. However, there is limited knowledge regarding the safety, feasibility and efficacy of the MSA (LINX procedure, Ethicon) for the treatment of post-LSG GERD.
Subsequently, they conducted a literature search on the use of MSA in GERD patients after LSG. The primary aim was to evaluate the effectiveness and safety of MSA placement. Secondary outcomes included the reduction in GERD symptoms, reduction in the use of PPIs, reduction of oesophageal acid exposure, and occurrence and type of adverse events (AEs).
In total, 14 studies (109 patients) met the inclusion criteria, spanning from 2015 to 2024, including seven case reports, five retrospective observational studies and two prospective observational studies.
Outcomes
The age of patients ranged from 25 to 73 years and the majority were female (82.5%), the mean BMI of patients at presentation was 29.8±4.8 and the vast majority of patients (97.4%) were treated with Proton Pump Inhibitors (PPIs). Eleven studies reported the time from LSG to MSA implant (range 7 to 124 months). The GERD-HRQL score was reported in ten studies and the baseline weighted mean score was 38.2 ± 13.6.
The presence of hiatal hernia was reported in ten studies, but only a few provided data on the hernia size. Sleeve herniation through the hiatus was estimated to be present in 89.6% of the patients, with a mean size of 2.1±0.7cm. Esophagitis was reported in ten studies and was present in 56.3% of the patients.
Thirteen studies reported a successful laparoscopic LINX™ procedure without conversions in all patients. In seven studies, the mean duration of surgery was 70.3±23.7min. A crural repair was performed in 95% of the patients however, none of the studies specified the extent of mediastinal dissection and the length of intra-abdominal oesophagus.
The size of the LINX device was reported in six studies, ranging from 13 to 17 beads (median 15). However, there was little data on sizing technique and postoperative radiologic position. The overall post-operative 30-day morbidity and mortality were 21.97% and 0, and the mean duration of hospitalisation was 0.98±0.5 days. There were 91 device-related adverse events. It should be noted that although the total number of AEs exceeds the number of patients experiencing them, each patient can have multiple AEs. Unfortunately, the researchers were not able to identify which patients had multiple AEs. Seven patients (6.4%) has the device reomoved due to dysphagia (n=3), broken device without dislocation (n=2), erosion (n=1) or intrathoracic migration (n=1).
Nine studies reported complete cessation of PPI use in 60.4% of the patients, daily use in 25.3% of the patients and intermittent use in 14.3% of the patients. There was a statistically significant reduction of daily PPI use compared vs. preoperative baseline (97.4% vs. 25.3%; p<0.0001).
Both pre- and post-operative GERD-HRQL scores were reported in eight studies (82 patients). The weighted average postoperative GERD-HRQL score was significantly lower (38.2±13.6 vs. 10.2±11.1; p=0.0078) vs. the baseline preoperative values. For patients with a BMI <35 (n=26), the mean pre-MSA GERD-HRQL score was 37.6±13.26, decreasing to 11.42±9.24 post-MSA. This was a mean reduction of 26.19±14.37.
However, patients with a BMI>35 (n=11) had a mean pre-MSA GERD-HRQL score of 35.54±18.88, which decreased to 17.27±16.7 post-implantation, resulting in a mean reduction of 18.27±15.08.
Based on the outcomes from this review, the authors suggest a management algorithm for post-sleeve gastrectomy GERD, shown in Figure 1.
“While recognising that definitive conclusions cannot be drawn at present, we believe that well-designed, prospective, and long-term follow-up studies will clarify the role of the LINX procedure in this patient population,” the authors concluded.
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