Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication

Abstract

Background Magnetic sphincter augmentation (MSA) is a surgical intervention for gastroesophageal reflux disease (GERD) which has been evaluated in numerous studies and has shown beneficial effects. Long-term effectiveness data for MSA as well as laparoscopic fundoplication (LF) in patients with GERD are needed. Objective The objective of this study was to evaluate the 3-year outcomes for MSA and LF in patients with GERD. Methods This prospective, multi-center, observational registry study evaluated MSA and LF in clinical practice over 3 years (ClinicalTrials.gov identifier: NCT01624506). Data collection included baseline characteristics, reflux symptoms, medication use, satisfaction and complications. Post-surgical evaluations were collected at yearly intervals. Results Between December 2009 and December 2014, 631 patients (465 MSA and 166 LF) were enrolled in the registry. Both MSA and LF resulted in improvements in total GERD-HRQL score (mean reduction in GERD-HRQL from baseline to 3 years post-surgery: MSA 22.0 to 4.6 and LF 23.6 to 4.9) and in satisfaction (GERD-HRQL satisfaction increase from baseline to 3 years: MSA 4.6% to 78.2% and LF 3.7% to 76.5%). Most patients were able to belch as needed with both therapies (MSA 97.6% and LF 91.7% at 3 years). MSA allowed a higher percentage of patients the ability to vomit as needed (MSA 91.2% and LF 68.0% at 3 years). PPI usage declined from baseline to 3 years for both groups after surgery (MSA 97.8% to 24.2% and LF 95.8% to 19.5%). The mean procedure time was shorter for MSA than for LF. Intraoperative and procedurerelated complication rates (≤ 2%) were low for both therapies. Conclusions This 3-year prospective observational registry study contributes to the mounting evidence for the effectiveness of MSA and LF. Despite the more severe nature of GERD in the LF group, the clinical outcomes for MSA and LF were favorable from an effectiveness and safety standpoint.

Expanded Indication for Magnetic Sphincter Augmentation: Outcomes in Weakly Acidic Reflux Compared to Standard GERD Patients

“…Most recently, Bonavina et al reported a significant difference in excessive gas bloating and the ability to vomit between MSA and LF patients, specifically excessive gas bloating was reported in 10% of MSA patients, compared to 31% of LF patients, while 91% of MSA patients retained their ability to vomit if needed, compared to only 44.4% of LF patients. 42 Persistent dysphagia, the most feared complication after anti-reflux surgery did not occur in our cohort, neither in patients with acidic nor weakly acidic reflux, at time of follow-up. However, rarely difficulties swallowing with solids was reported by 16 out of 67 (24%) patients, while 8 out of 67 (12%) patients had occasional difficulties swallowing with solids.…”

“…41 Concerning postoperative pharmacotherapy, here we show that 88% (p = 0.0001) of the patients did not need to use PPIs anymore, which is also in concordance with previously published articles. 17,41,42 When comparing the improvement of the three most common symptoms (heartburn 93% vs. 95%, p = 0.615; regurgitations 94% vs. 95%, p = 0.723; and respiratory complaints 91% vs. 96%, p = 0.373), we found no difference between patients with preoperative weakly acidic and acidic reflux. Also, no significant difference was observed in the postoperative use of PPIs between patients with the two types of reflux (weakly acidic 7 vs. acid 18, p = 0.808).…”

“…These findings are in line with publications so far, all indicating that not only does the GERD-related quality of life improve after MSA, but overall patient satisfaction is high. 41,42,47,48 Our study shows that patients with weakly acidic reflux, measured with a 24-h impedance-pH-metry, would profit from MSA, as this surgical technique is associated with a significant reduction in daily bothersome heartburn, regurgitations, and respiratory complaints, with favorably low morbidity and side effect rate as well as improvement in quality of life in patients. It also underlines the importance of a preoperative 24-h impedance-pH-metry where not only the total pH percentage time can be measured, as with the BRAVO capsule, but also a total number of reflux episodes as well as symptom correlation.…”

“…Rarely, in 1.5-5.6% of patients, this bothersome symptom persists, and endoscopic dilatation is needed. 32,42,45 None of our patients with weakly acidic reflux underwent endoscopic dilatation, device removal, or revisional surgery; however, the small sample size has to be taken into consideration. A safety profile analysis of the first thousand conducted MSAs showed a re-operation rate of 3.4%, all patients undergoing device removal due to dysphagia and reoccurrence of reflux symptoms.…”

Magnetic Sphincter Augmentation In Patients With Paraesophageal Hernia Vs. Large Sliding Hiatal Hernia: Comparison of Clinical Outcome And Complexity Of The Surgery

“…1− 3 Multiple studies have shown that these two anti-re ux procedures result in comparable postoperative GERD symptom control, rates of freedom from PPI and pH normalization. 1,4,5 MSA is a less invasive and more physiologic surgical option, it preserves the ability of patient to belch and has a lower rate of gas bloating. 6 Recent studies have encouraged use of MSA in patients with large sliding hiatal hernias.…”