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Controlled Clinical Trial
, 25 (10), 787-92

Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement

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Controlled Clinical Trial

Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement

Greta Saino et al. J Laparoendosc Adv Surg Tech A.

Abstract

Background: As previously reported, the magnetic sphincter augmentation device (MSAD) preserves gastric anatomy and results in less severe side effects than traditional antireflux surgery. The final 5-year results of a pilot study are reported here.

Patients and methods: A prospective, multicenter study evaluated safety and efficacy of the MSAD for 5 years. Prior to MSAD placement, patients had abnormal esophageal acid and symptoms poorly controlled by proton pump inhibitors (PPIs). Patients served as their own control, which allowed comparison between baseline and postoperative measurements to determine individual treatment effect. At 5 years, gastroesophageal reflux disease (GERD)-Health Related Quality of Life (HRQL) questionnaire score, esophageal pH, PPI use, and complications were evaluated.

Results: Between February 2007 and October 2008, 44 patients (26 males) had an MSAD implanted by laparoscopy, and 33 patients were followed up at 5 years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the long term, including no device erosions or migrations at any point.

Conclusions: Based on long-term reduction in esophageal acid, symptom improvement, and no late complications, this study shows the relative safety and efficacy of magnetic sphincter augmentation for GERD.

Figures

<b>FIG. 1.</b>
FIG. 1.
Percentage reduction in total Gastroesophageal Reflux Disease-Health Related Quality of Life questionnaire score at Year 5. Each bar represents 1 of 33 patients who completed the questionnaire at 5 years. The data shown by each bar are the percentage reduction in total Gastroesophageal Reflux Disease-Health Related Quality of Life score at Year 5 compared with the total questionnaire score at baseline for each patient. A reduction of at least 50% was considered a success. The success criterion of Gastroesophageal Reflux Disease-Health Related Quality of Life score reduction was met by 93.9% (31/33) of the patients.

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