A comparative trial of LINX versus Lap Nissen: caveats for patient selection

Eric G Sheu, MD, DPhil, Peter Nau, MD, Barbara Nath, MD, Braden Kuo, MD, David W Rattner, MD. Massachusetts General Hospital.

Background: The LINX procedure, magnetic sphincter augmentation (MSA), is a promising new therapy for the treatment of gastroesophageal reflux disease (GERD). While initial clinical trials have shown MSA to be safe and effective, MSA has not been directly compared to laparoscopic Nissen fundoplication (LNF).

Methods: A single institution, case matched-control study was conducted of MSA (n=12) performed from 2012-2013 and a cohort of LNF (n=12) matched for age, gender, symptoms, and hiatal hernia size. Exclusion criteria for MSA included prior anti-reflux surgery and hiatal hernia > 2 cm. Intra-operatively, the LINX device was sized according to manufacturer’s instructions with a manufacturer representative present. The median size of the implanted MSA devices was 13 mm. No crural repair sutures were placed in MSA patients. LNF were performed with a floppy wrap constructed over a 56 Fr dilator. A procedure specific post op pathway was used in all patients. The indication for esophageal dilation was inability to tolerate a soft diet >6 weeks post op with ongoing weight loss.

Results: Significant post-operative dysphagia occurred in the majority of MSA patients with the usual onset of symptoms 5-10 days post op. 50% of MSA patients required endoscopic dilation (mean time to dilation, 130 days) for ongoing dysphagia with weight loss, while no LNF patients required dilation (50% vs. 0%, p=0.01). Need for dilation did not correlate with the size of LINX device, presence of hiatal hernia, sex, BMI, or pre-operative manometry. 33% of LNF patients developed mild abdominal bloating or hyperflatulence; no MSA patients reported these symptoms. Both operations effectively treated reflux symptoms, with 75% of MSA and 83% of LNF patients reporting resolution of symptoms at a mean follow-up of 7 months. Compared to LNF, MSA patients had a shorter operative time (64 vs. 90 min, p < 0.001), were more likely to be self-referred (58% vs. 0%, p < 0.01), and had a non-significant trend towards decreased post-op narcotic usage. Hospital length of stay was equivalent in both groups (1 vs. 1.1 days). There were no 30-day re-admissions, re-operations, or any other serious complications in either group.

Conclusions: Laparoscopic magnetic sphincter augmentation is a safe and effective therapy for GERD. While MSA is easier and faster to perform than LNF, in our initial experience, more post operative care was required for MSA patients. Dysphagia occurs frequently and requires intervention more often with MSA; however, fewer MSA patients develop "the windy symptoms" post op than with LNF. Consideration should be paid to these distinct post-operative symptom profiles when selecting MSA vs. LNF as a treatment for GERD.


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