Original article
General thoracic
Short-Term Outcomes Using Magnetic Sphincter Augmentation Versus Nissen Fundoplication for Medically Resistant Gastroesophageal Reflux Disease

Presented at the Fiftieth Annual Meeting of The Society of Thoracic Surgeons, Orlando, FL, Jan 25–29, 2014.
https://doi.org/10.1016/j.athoracsur.2014.04.074Get rights and content

Background

In 2012 the United States Food and Drug Administration approved implantation of a magnetic sphincter to augment the native reflux barrier based on single-series data. We sought to compare our initial experience with magnetic sphincter augmentation (MSA) with laparoscopic Nissen fundoplication (LNF).

Methods

A retrospective case-control study was performed of consecutive patients undergoing either procedure who had chronic gastrointestinal esophageal disease (GERD) and a hiatal hernia of less than 3 cm.

Results

Sixty-six patients underwent operations (34 MSA and 32 LNF). The groups were similar in reflux characteristics and hernia size. Operative time was longer for LNF (118 vs 73 min) and resulted in 1 return to the operating room and 1 readmission. Preoperative symptoms were abolished in both groups. At 6 months or longer postoperatively, scores on the Gastroesophageal Reflux Disease Health Related Quality of Life scale improved from 20.6 to 5.0 for MSA vs 22.8 to 5.1 for LNF. Postoperative DeMeester scores (14.2 vs 5.1, p = 0.0001) and the percentage of time pH was less than 4 (4.6 vs 1.1; p = 0.0001) were normalized in both groups but statistically different. MSA resulted in improved gassy and bloated feelings (1.32 vs 2.36; p = 0.59) and enabled belching in 67% compared with none of the LNFs.

Conclusions

MSA results in similar objective control of GERD, symptom resolution, and improved quality of life compared with LNF. MSA seems to restore a more physiologic sphincter that allows physiologic reflux, facilitates belching, and creates less bloating and flatulence. This device has the potential to allow individualized treatment of patients with GERD and increase the surgical treatment of GERD.

Section snippets

Material and Methods

We retrospectively reviewed prospectively collected data on consecutive patients who underwent laparoscopic implantation of a magnetic sphincter at Swedish Medical Center from September 2012 to December 2013. The Institutional Review Board of Swedish Medical Center approved this study and waived the need to implant the devices under a research protocol. Magnetic sphincters were placed as part of clinical care, and patient consent was provided for implantation; however, individual patient

Results

Of the 34 patients who underwent MSA, 24 completed the 6-month follow-up. For comparison, 32 patients underwent LNF. The baseline demographic and GERD characteristics of both groups were similar, except MSA patients were older, and LNF patients had a higher body mass index (Table 1).

The operative time for MSA was 73 minutes compared with 118 minutes for LNF (p = 0.001). There were no operative deaths. In the MSA group, there were no major morbidities. Minor morbidities included symptomatic

Comment

The main finding in this study is that patients with GERD, with or without a hiatal hernia smaller than 3 cm, undergoing MSA with the LINX device (Torax Medical Inc, Shoreview, MN) have equivalent outcomes compared with patients with similar characteristics undergoing LNF. MSA alleviates typical and atypical symptoms of GERD, improves quality of life, and normalizes distal esophageal acid exposure. Our MSA results are similar compared with previous published studies and add to the growing

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