Magnetic sphincter augmentation for gastroesophageal reflux after sleeve gastrectomy: a prospective study.

Background: De-novo reflux or worsening of pre-existing gastroesophageal reflux disease (GERD) presents a major challenge after laparoscopic sleeve gastrectomy (LSG). Roux-en-Y gastric bypass is a viable treatment option, however, the procedure is complex and carries risks such as anastomotic leak and metabolic complications. Magnetic sphincter augmentation (MSA) has been introduced for the treatment of GERD in patients with normal anatomy, but clinical experience is still limited.

Aim: Assess the efficacy of MSA device as GERD remedial treatment after LSG.

Methods: Prospective, single-arm, multi-center study from January 2020 to January 2024. Primary outcome was post-MSA patient-reported quality of life assessed with the GERD-HRQL questionnaire. Esophageal acid exposure, endoscopic, high-resolution manometric findings, and PPI use were secondary outcomes.

Results: Twelve subjects (75% females) underwent MSA for pathologic GERD after LSG. Mean baseline BMI was 28.6 ± 4.3. All procedures included hiatoplasty and were completed laparoscopically. Mean operative time was 78.5 min. No intraoperative or perioperative short-term complications occurred. Overall, 11 patients completed the 12-month follow-up with clinical and instrumental assessment. GERD-HRQL scores (38.6 vs. 10.1; p = 0.003) and daily PPI use (100% vs. 27.3%; p = 0.003) significantly improved compared to baseline. Notably, %Acid Exposure Time (AET) (14.1 vs. 7.1; p = 0.06), DeMeester score (60.7 vs. 20.5; p = 0.017), total number of reflux episodes (110 vs. 40; p = 0.012), number of re-reflux (142 vs. 63; p = 0.016), distal contractile integral (DCI) (mmHg-s-cm) (728 vs. 2040; p = 0.043), and LES basal pressure (mmHg) (7.3 vs. 26.1; p = 0.028) were improved compared to baseline. No device adverse events nor explants occurred during follow-up.

Conclusions: This study shows that MSA seems to improve GERD-related symptoms and patient quality of life in patients with pathological GERD after LSG. At a mean follow-up of 22 months, PPI use, AET%, DeMeester score, total number of reflux episodes, DCI, and LES basal pressure seem to be improved compared to baseline.