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. 2020 Aug 13;10(1):13753.
doi: 10.1038/s41598-020-70742-3.

Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease

Davide Ferrari  1 , Emanuele Asti  2 , Veronica Lazzari  2 , Stefano Siboni  2 , Daniele Bernardi  2 , Luigi Bonavina  3   4
Affiliations

Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease

Davide Ferrari et al. Sci Rep. .

Abstract

The magnetic sphincter augmentation (MSA) device has been proven safe and effective in controlling typical reflux symptoms and esophageal acid exposure for up to 6-year follow-up. Longer term outcomes have not been reported yet. A prospectively maintained database was reviewed to assess long-term safety and efficacy of the laparoscopic MSA procedure at a single referral center. Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), use of proton-pump inhibitors (PPI), and esophageal acid exposure were compared to baseline. Favorable outcomes were defined as ≥ 50% improvement of GERD-HRQL total score and PPI discontinuation. Between March 2007 and March 2020, 335 patients met the study inclusion criteria, and 124 of them were followed from 6 to 12 years after surgery (median 9 years, IQR 2). Mean total GERD-HRQL score significantly improved from 19.9 to 4.01 (p < 0.001), and PPI were discontinued by 79% of patients. The mean total percent time with pH < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving pH normalization. Independent predictors of a favorable outcome were age at intervention < 40 years (OR 4.17) and GERD-HRQL score > 15 (OR 4.09). We confirm long-term safety and efficacy of MSA in terms of symptom improvement, decreased drug dependency, and reduced esophageal acid exposure.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Average percent reduction (± SD) of total GERD-HRQL score per year over the follow-up.
Figure 2
Figure 2
Changes of Hill grade classification in 45 patients after magnetic sphincter augmentation.
Figure 3
Figure 3
Median % time at pH < 4 (A) and median DeMeester score (B) in sequential pH studies compared to baseline.
Figure 4
Figure 4
Kaplan–Meier estimate of explant-free probability over 6- to 12-year follow-up after magnetic sphincter augmentation (95% confidence interval indicated pointwise). [Graph created using SPSS software 23.0, URL = https://www.ibm.com/software/analytics/spss/register/].
Figure 5
Figure 5
Kaplan–Meier estimate of clinical success (GERD-HRQL < 50% reduction or PPI discontinuation) over 6- to 12-year follow-up after magnetic sphincter augmentation (95% confidence interval indicated pointwise).[Graph created using SPSS software 23.0, URL = https://www.ibm.com/software/analytics/spss/register/].
See this image and copyright information in PMC

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