ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease.

https://www.cghjournal.org/article/S1542-3565(15)00763-6/pdf

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux.

Antireflux surgery with a magnetic sphincter augmentation device (MSAD) restores the competency of the lower esophageal sphincter with a device rather than a tissue fundoplication. As a regulated device, safety information from the published clinical literature can be supplemented by tracking under the Safe Medical Devices Act. The aim of this study was to examine the safety profile of the MSAD in the first 1000 implanted patients. We compiled safety data from all available sources as of July 1, 2013. The analysis included intra/perioperative complications, hospital readmissions, procedure-related interventions, reoperations, and device malfunctions leading to injury or inability to complete the procedure. Over 1000 patients worldwide have been implanted with the MSAD at 82 institutions with median implant duration of 274 days. Event rates were 0.1% intra/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations. All reoperations were performed non-emergently for device removal, with no complications or conversion to laparotomy. The primary reason for device removal was dysphagia. No device migrations or malfunctions were reported. Erosion of the device occurred in one patient (0.1%). The safety analysis of the first 1000 patients treated with MSAD for gastroesophageal reflux disease confirms the safety of this device and the implantation technique. The overall event rates were low based on data from 82 institutions. The MSAD is a safe therapeutic option for patients with chronic, uncomplicated gastroesophageal reflux disease.

/pdf/safety-analysis-of-first-1000-patients-treated-with-magnetic-53b2v42jpe.pdf

Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease.

The LINX® magnetic sphincter augmentation system (MSA) is a surgical technique with short-term evidence demonstrating efficacy in the treatment of medically refractory or chronic gastroesophageal reflux disease (GERD). Currently, the Nissen fundoplication is the gold-standard surgical treatment for GERD. We are the first to systematically review the literature and perform a meta-analysis comparing MSA to the Nissen fundoplication. A comprehensive search of electronic databases (e.g., MEDLINE, EMBASE, SCOPUS, Web of Science and the Cochrane Library) using search terms “Gastroesophageal reflux or heartburn” and “LINX or endoluminal or magnetic” and “fundoplication or Nissen” was completed. All randomized controlled trials, non-randomized comparison study and case series with greater than 5 patients were included. Five hundred and forty-seven titles were identified through primary search, and 197 titles or abstracts were screened after removing duplicates. Meta-analysis was performed on postoperative quality of life outcomes, procedural efficacy and patient procedural satisfaction. Three primary studies identified a total of 688 patients, of whom 273 and 415 underwent Nissen fundoplication and MSA, respectively. MSA was statistically superior to LNF in preserving patient’s ability to belch (95.2 vs 65.9%, p < 0.00001) and ability to emesis (93.5 vs 49.5%, p < 0.0001). There was no statistically significant difference between MSA and LNF in gas/bloating (26.7 vs 53.4%, p = 0.06), postoperative dysphagia (33.9 vs 47.1%, p = 0.43) and proton pump inhibitor (PPI) elimination (81.4 vs 81.5%, p = 0.68). Magnetic sphincter augmentation appears to be an effective treatment for GERD with short-term outcomes comparable to the more technically challenging and time-consuming Nissen fundoplication. Long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation.

LINX® magnetic esophageal sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease: a systematic review and meta-analysis

Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial

Background This study was undertaken to evaluate our clinical experience during a 6-year period with an implantable device that augments the lower esophageal sphincter for gastroesophageal reflux disease (GERD). The device uses magnetic sphincter augmentation (MSA) to strengthen the antireflux barrier. Study Design In a single-center, prospective case series, 100 consecutive patients underwent laparoscopic MSA for GERD between March 2007 and February 2012. Clinical outcomes for each patient were tracked post implantation and compared with presurgical data for esophageal pH measurements, symptom scores, and proton pump inhibitor (PPI) use. Results Median implant duration was 3 years (range 378 days to 6 years). Median total acid exposure time was reduced from 8.0% before implant to 3.2% post implant (p Conclusions Magnetic sphincter augmentation for GERD in clinical practice provides safe and long-term reduction of esophageal acid exposure, substantial symptom improvement, and elimination of daily PPI use. For candidates of antireflux surgery who have been carefully evaluated before surgery to confirm indication for MSA, MSA has become a standard treatment at our institution because control of reflux symptoms and pH normalization can be achieved with minimal side effects and preservation of gastric anatomy.

https://www.journalacs.org/article/S1072-7515(13)00356-6/pdf

One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center.

Objective:The aim of this study was to identify patients’ characteristics that may predict failure and removal of the Linx sphincter augmentation device, and to report the results of 1-stage laparoscopic removal and fundoplication.Background:The Linx device is a long-term magnetic implant that was d

Removal of the Magnetic Sphincter Augmentation Device: Surgical Technique and Results of a Single-center Cohort Study.

Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis.

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   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.

/pdf/six-to-12-year-outcomes-of-magnetic-sphincter-augmentation-4n7bjocxly.pdf

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

Use of the magnetic sphincter augmentation (MSA) device for the laparoscopic treatment of gastroesophageal reflux disease is increasing since the first clinical implant performed a decade ago. The MSA procedure is a minimally invasive and highly standardized surgical option for patients who are partially responders to proton-pump inhibitors, which have troublesome regurgitation or develop progressive symptoms despite continuous medical therapy. The procedure has proven to be highly effective in improving typical reflux symptoms, reducing the use of proton-pump inhibitors, and decreasing esophageal acid exposure. Observational cohort studies have shown that MSA compares well with fundoplication in selected patients and has an acceptable safety profile. The device can be easily removed if necessary, thereby preserving the option of fundoplication in the future. The majority of the removals have occurred within 2 years after implant and have been managed non-emergently, with no complications or long-term consequences. “Expanded” indications to MSA (large hiatal hernia and Barrett’s esophagus) need to be tested in further comparative studies with classic fundoplication procedures.

Veronica Lazzari

Papers

One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center.

Removal of the Magnetic Sphincter Augmentation Device: Surgical Technique and Results of a Single-center Cohort Study.

Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis.

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

Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies.