Removal of the magnetic sphincter augmentation device: an assessment of etiology, clinical presentation, and management

Abstract

Background: Magnetic sphincter augmentation (MSA) erosion, disruption or displacement clearly requires device removal. However, up to 5.5% of patients without anatomical failure require removal for dysphagia or recurrent GERD symptoms. Studies characterizing these patients or their management are limited. We aimed to characterize these patients, compare their outcomes, and determine the necessity for further reflux surgery.

Methods: This is a retrospective review of 777 patients who underwent MSA at our institution between 2013 and 2021. Patients who underwent device removal for persistent dysphagia or recurrent GERD symptoms were included. Demographic, clinical, objective testing, and quality of life data obtained preoperatively, after implantation and following removal were compared between removal for dysphagia and GERD groups. Sub-analyses were performed comparing outcomes with and without an anti-reflux surgery (ARS) at the time of removal.

Results: A total of 40 (5.1%) patients underwent device removal, 31 (77.5%) for dysphagia and 9 (22.5%) for GERD. After implantation, dysphagia patients had less heartburn (12.9-vs-77.7%, p = 0.0005) less regurgitation (16.1-vs-55.5%, p = 0.0286), and more pH-normalization (91.7-vs-33.3%, p = 0.0158). Removal without ARS was performed in 5 (55.6%) GERD and 22 (71.0%) dysphagia patients. Removal for dysphagia patients had more complete symptom resolution (63.6-vs-0.0%, p = 0.0159), freedom from PPIs (81.8-vs-0.0%, p = 0.0016) and pH-normalization (77.8-vs-0.0%, p = 0.0455). Patients who underwent removal for dysphagia had comparable symptom resolution (p = 0.6770, freedom from PPI (p = 0.3841) and pH-normalization (p = 0.2534) with or without ARS. Those who refused ARS with removal for GERD had more heartburn (100.0%-vs-25.0%, p = 0.0476), regurgitation (80.0%-vs-0.0%, p = 0.0476) and PPI use (75.0%-vs-0.0%, p = 0.0476).

Conclusions: MSA removal outcomes are dependent on the indication for removal. Removal for dysphagia yields excellent outcomes regardless of anti-reflux surgery. Patients with persistent GERD had worse outcomes on all measures without ARS. We propose a tailored approach to MSA removal-based indication for removal.

Keywords: Device removal; Dysphagia; Gastroesophageal reflux disease; Magnetic sphincter augmentation; Symptom recurrence.

Fig. 1

Median and interquartile range (error bars) of the integrated relaxation pressures at baseline, post-implantation, and post-removal among 7 patients with persistent dysphagia after device removal. There was a significant increase from baseline to post-implant (p = 0.0015) and baseline to post-removal (p = 0.0025)

Fig. 2

HRM topographic plot before (A) and after MSA implantation (B), but before removal in a patient who subsequently underwent device removal for dysphagia. At baseline (A) the patient has adequate distal contractile integral (DCI) with complete bolus clearance (not shown). There is complete LES relaxation and evidence of some degree of crural-LES separation, indicating a hiatal hernia. Following device implantation (B) the topographic plot shows an elevated intrabolus pressure (iBP) and integrated relaxation pressure (IRP) and a compensatory increase in esophageal body contractility

Fig. 3

Dense fibrotic capsule surrounding the MSA. (A) Fibrosis completely encapsulated the titanium beads. (B) The capsule can be thick and can hold substantial tension even after partial opening

Fig. 4

Proposed management paradigm for patients complaining of dysphagia or inadequate relief of their reflux symptoms after MSA