SSAT - LAPAROSCOPIC ANTIREFLUX SURGERY OUTCOMES AT 12 MONTHS IN THE FIRST 100 PATIENTS TO UNDERGO REFLUXSTOP PROCEDURE IN A SINGLE INSTITUTION IN SWITZERLAND

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LAPAROSCOPIC ANTIREFLUX SURGERY OUTCOMES AT 12 MONTHS IN THE FIRST 100 PATIENTS TO UNDERGO REFLUXSTOP PROCEDURE IN A SINGLE INSTITUTION IN SWITZERLAND
Joerg Zehetner^*, Ioannis Linas, Ulf Kessler, Yannick Fringeli
Surgery, Clinic Beau-Site Berne, Bern, Switzerland

Background
Laparoscopic antireflux surgery (LARS) with the RefluxStop device has been shown effective to treat gastroesophageal reflux disease (GERD) in clinical trials. The RefluxStop procedure (RSP) employs a new rationale that corrects key components of the defective antireflux barrier that does not encircle the food passageway and avoids postoperative side effects related to traditional LARS. The RSP consists of hiatal hernia repair, esophageal/fundus dissection, esophagogastric plication (80-110�), and device invagination on the fundus. Following CE-mark approval (not yet FDA-approved), the RSP has been offered at our clinic in Switzerland since 2020. The aim of the study is to present the 12-month clinical outcomes of the first 100 patients.

Methods
The RSP is performed since June 2020 at our institution in Switzerland. The retrospective chart analysis included the first 100 patients (until December 2023) that underwent RefluxStop surgery with 12-month follow-up data. The primary outcome was effectiveness in clinical practice, quantified with the GERD Health-Related Quality of Life (GERD-HRQL) score. Additional outcomes were patient satisfaction, proton pump inhibitor (PPI) use, and postoperative complications (e.g., early penetration and return to the operating room).

Results
Patient characteristics are presented in Table 1. The median (IQR) GERD-HRQL score (0-75 points) was 41 (IQR 28.75-50) before surgery and 1 (IQR 0-5) at 12 months (p<0.001).
Excellent patient satisfaction was reported in 92% postoperatively. No use of PPI increased from 5% at baseline to 92% at follow-up. Postoperative complications are listed in Table 2. One case of early penetration occurred, which is likely attributable to surgical technique with too tight closure of the invagination pouch; no further action required. One case of dislocation occurred from insufficient closure of the deployment tool channel. Three cases of re-do hiatal repair occurred in subjects with very large hernia (>7 cm) at baseline. One case of incisional trocar hernia repair (i.e., unrelated to device) occurred.

Conclusion
This study shows excellent results at 12 months following RefluxStop surgery for GERD despite inclusion of difficult-to-treat patients with esophageal motility disorder (66%) and large hiatal hernia (55%) greater than 3 cm in size. This is reflected by the substantial improvement in total GERD-HRQL score with minimal adverse outcomes. It is of interest to follow the evolution of outcomes as surgeons gain experience with the procedure in different patient groups.

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