Long-term (>5 Years) Outcomes after Magnetic Sphincter Augmentation.

OBJECTIVE

To report the long-term (5 years) patient-reported outcomes and objective pH measurements of patients undergoing magnetic sphincter augmentation (MSA).

BACKGROUND

MSA controls gastroesophageal reflux disease (GERD) as demonstrated in multiple studies. Consistent patient-reported outcomes and objective data support its use in short-term follow-up. Long-term data are required.

METHODS

This FDA post-approval study enrolled patients from 2013 to 2015, with confirmed GERD despite acid suppression therapy, undergoing laparoscopic implantation of a magnetic sphincter with a minimum of 5 years of follow-up were included. Clinical success was defined as a ≥50% improvement in the total GERD-health-related quality of life score compared with the baseline off proton pump inhibitors (PPIs). Secondary outcomes were objective evidence of GERD control on pH testing and the use of PPIs.

RESULTS

A total of 136/200 patients were available for follow-up. A ≥50% improvement in the GERD-health-related quality of life score was achieved in 81.6% with the median score improving from 26 to 4. Freedom from daily PPI use was 90.4%. Objectively, the % time pH <4 went from 9.1 to 3.2, and the DeMeester score from 29 to 11 in 81 patients. The ability to belch and vomit was retained if needed. Dysphagia occurred in 5%. There were 27 (13%) devices explanted with only 4 (2%) erosions. Of these, 25 (92.6%) patients had resolution of their symptoms with removal, conversion to fundoplication, or replacement of the device.

CONCLUSIONS

MSA controls symptoms of GERD without the need for PPIs but may need explantation in 13% of patients.