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Long-term (>5 Years) Outcomes after Magnetic Sphincter Augmentation

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TL;DR

This study reports that magnetic sphincter augmentation provides sustained long-term control of GERD, with 81.6% achieving at least 50% improvement in quality of life and 90.4% remaining PPI-free after five years; objective pH measures also improved significantly, though 13% of devices were explanted.

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Objective:To report the long-term (5 years) patient-reported outcomes and objective pH measurements of patients undergoing magnetic sphincter augmentation (MSA).Background:MSA controls gastroesophageal reflux disease (GERD) as demonstrated in multiple studies. Consistent patient-reported outcomes and objective data support its use in short-term follow-up. Long-term data are required.Methods:This FDA post-approval study enrolled patients from 2013 to 2015, with confirmed GERD despite acid suppression therapy, undergoing laparoscopic implantation of a magnetic sphincter with a minimum of 5 years of follow-up were included. Clinical success was defined as a ≥50% improvement in the total GERD-health-related quality of life score compared with the baseline off proton pump inhibitors (PPIs). Secondary outcomes were objective evidence of GERD control on pH testing and the use of PPIs.Results:A total of 136/200 patients were available for follow-up. A ≥50% improvement in the GERD–health-related quality of life score was achieved in 81.6% with the median score improving from 26 to 4. Freedom from daily PPI use was 90.4%. Objectively, the % time pH <4 went from 9.1 to 3.2, and the DeMeester score from 29 to 11 in 81 patients. The ability to belch and vomit was retained if needed. Dysphagia occurred in 5%. There were 27 (13%) devices explanted with only 4 (2%) erosions. Of these, 25 (92.6%) patients had resolution of their symptoms with removal, conversion to fundoplication, or replacement of the device.Conclusions:MSA controls symptoms of GERD without the need for PPIs but may need explantation in 13% of patients.

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Background Gastroesophageal reflux disease (GERD) represents a common burden after bariatric procedures, particularly after laparoscopic sleeve gastrectomy (LSG). While GERD after LSG is usually treated with conversion to Roux-en-Y gastric bypass (RYGB), there are limited surgical options to manage medically refractory GERD after RYGB due to the altered anatomy. The use of magnetic sphincter augmentation (MSA) is one option, but the literature on this topic remains scarce. Aims To present mid- to long-term outcome of patients treated with MSA for GERD after RYGB. Methods We performed a retrospective single-centre analysis of data from patients who underwent laparoscopic MSA for GERD between August 2015 and December 2023, and who had previously RYGB. Outcomes were persistence/recurrence of GERD symptoms, use of proton pump inhibitors (PPIs) and need for redo surgery related to MSA complications or recurrent GERD. Results Of the 312 MSA procedures performed for GERD, we identified 13 patients who underwent laparoscopic MSA after RYGB. There were 10 female patients (77%), with mean age of 42.6 ± 13.7 years and mean BMI of 27.2 ± 2.7 kg/m2. Seven patients (54%) had de novo GERD. All MSA procedures included hiatoplasty. Median follow-up was 40 months (range 7-72) and median time between RYGB and MSA placement was 42 months (range 8-242). One patient (8%) required endoscopic dilatation due to persistent postoperative dysphagia. Two patients (15%) needed redo surgery: 1 redo hiatoplasty with adhaesiolysis and 1 conversion to esophagojejunostomy with implant removal. There was no erosion or migration of the MSA implant. Overall satisfactory control of reflux with discontinuation or reduction of PPIs was achieved in 9 patients (69%). Conclusion The use of MSA to manage refractory GERD after RYGB is a safe option and was effective in 69% of patients but is limited to patients with intact oesophageal motility.

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