Minimal versus obligatory dissection of the diaphragmatic hiatus during magnetic sphincter augmentation surgery

Tatum, James M.; Alicuben, Evan T.; Bildzukewicz, Nikolai A.; Samakar, Kamran; Houghton, Caitlin C.; Lipham, John C.

doi:10.1007/s00464-018-6343-5

Cited by 32 publications

(26 citation statements)

References 20 publications

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“…). A total of 39 full‐text papers, published between 2008 and 2019, were finally included. The 39 articles consisted of one RCT, five comparative cohort studies (2 prospective and 3 retrospective), three comparative case–control studies, 25 case series (14 prospective, 11 retrospective) and five case reports ( Fig .…”

Section: Resultsmentioning

confidence: 99%

“…Nine studies (1 RCT, 5 cohort and 3 case–control studies) included a comparator group ( Tables and ), although only one was randomized. Of these, seven compared MSA with antireflux surgery, one compared different types of dissection technique for MSA, and the RCT compared MSA with PPIs. Five, including the RCT, reported differences in patient baseline demographics, including hernia size, obesity, age, DeMeester score and disease severity, which were not accounted for in analyses.…”

Section: Resultsmentioning

confidence: 99%

“…With regard to the dissection technique, the need to identify the vagal trunk, access the retro‐oesophageal window and perform ‘minimal hiatal dissection’ was reported in seven, five and seven studies respectively, although the latter was not defined. One study aimed to undertake a comparison of ‘minimal hiatal dissection’ with ‘planned obligatory dissection’. During the study, however, this comparison was abandoned and all subsequent patients underwent obligatory hiatal dissection, with no explanation of why this occurred.…”

Section: Resultsmentioning

confidence: 99%

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Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease

Kirkham

Main

Blazeby

et al. 2020

Journal of British Surgery

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Background: Magnetic sphincter augmentation (MSA) is reported to be an innovative alternative to antireflux surgery for patients with gastro-oesophageal reflux disease. Although used in practice, little is known about how it has been evaluated. This study aimed to systematically summarize and appraise the reporting of MSA and its introduction into clinical practice, in the context of guidelines (such as IDEAL) for evaluating innovative surgical devices.Methods: Systematic searches were used to identify all published studies reporting MSA insertion. Data collected included patient selection, governance arrangements, surgeon expertise, technique description and outcome reporting.Results: Searches identified 587 abstracts; 39 full-text papers were included (1 RCT 5 cohort, 3 case-control, 25 case series, 5 case reports). Twenty-one followed US Food and Drug Administration eligibility criteria for MSA insertion. Twenty-six documented that ethical approval was obtained. Two reported that participating surgeons received training in MSA; 18 provided information about how MSA insertion was performed, although techniques varied between studies. Follow-up ranged from 4 weeks to 5 years; in 14 studies, it was less than 1 year. Conclusion:Most studies on MSA lacked information about patient selection, governance, expertise, techniques and outcomes, or varied between studies. Currently, MSA is being used despite a lack of robust evidence for its effectiveness.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease

Kirkham

Main

Blazeby

et al. 2020

Journal of British Surgery

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“…In recent years, it has become evident that the effectiveness of MSA can be enhanced by adding a formal crural repair 28,29 . The rationale behind this concept is that the extent of hiatus hernia can be underestimated both pre-and intraoperatively.…”

Section: Discussionmentioning

confidence: 99%

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

Ferrari

Asti

Lazzari

et al. 2020

Sci Rep

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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 < 0.001), and PPI were discontinued by 79% of patients. The mean total percent time with pH < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving pH normalization. Independent predictors of a favorable outcome were age at intervention < 40 years (OR 4.17) and GERD-HRQL score > 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. The global burden of gastroesophageal reflux disease (GERD) is enormous, with a pooled prevalence of 13.3% in community-based studies 1. Symptoms and complications of GERD persist in up to 40% of patients treated with proton-pump inhibitors (PPI) 2,3 , and fundoplication is largely underused because of the steep learning curve and reported variability in outcomes 4. The aim of fundoplication is to restore lower esophageal sphincter (LES) function by remodeling the esophagogastric junction 5. Both total (Nissen) and partial (Toupet) fundoplication procedures require mobilization of the gastric fundus to be wrapped around the distal esophagus 6. To further enhance the antireflux barrier, a crural diaphragmatic repair is routinely added 7. Currently, the fact that fundoplication is offered to less than 1% of the GERD population may have an impact on the progression of symptoms and the development of Barrett's esophagus 8. The magnetic sphincter augmentation (MSA) procedure (Linx Reflux Management System, Ethicon, Johnson & Johnson, Shoreview, Mn, USA) was developed as a less disruptive and more standardized and reproducible laparoscopic surgical option for the treatment of GERD. The MSA device is composed by a variable number of interlinked titanium beads with a magnetic core inside. This ring-like system produces a magnetic force that augments the LES. The first feasibility trial and a large prospective nonrandomized study were published in 2008 9 and 2013 10 , respectively. The MSA procedure has been granted approval for clinical use by the Food and Drug Administration in 2012. Previous reports from our group have shown feasibility, safety, and efficacy of the MSA procedure...

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“…At 1-year follow-up, recurrent GERD symptoms and hiatal hernia were less frequent after complete hiatal dissection compared with minimal dissection without cruroplasty. 103 In another study of 259 patients, 104 a formal crural repair was also most likely to achieve normalization of postoperative DeMeester scores, confirming that hiatal closure clearly contributes to the manometric high-pressure zone and that competence of the antireflux barrier is explained by the "two-sphincter hypothesis." 105,106 In patients with uncomplicated GERD, the LINX procedure results in equivalent symptom control and improved quality of life with less side effects compared with the Nissen fundoplication.…”

Section: Prevention Of Progressive Gerd By Laparoscopic Fundoplicatiomentioning

confidence: 90%

Clinical course of gastroesophageal reflux disease and impact of treatment in symptomatic young patients

Bonavina

Fisichella

Gavini

et al. 2020

Annals of the New York Academy of Sciences

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In symptomatic young patients with gastroesophageal reflux symptoms, early identification of progressive gastroesophageal reflux disease (GERD) is critical to prevent long‐term complications associated with hiatal hernia, increased esophageal acid and nonacid exposure, release of proinflammatory cytokines, and development of intestinal metaplasia, endoscopically visible Barrett's esophagus, and dysplasia leading to esophageal adenocarcinoma. Progression of GERD may occur in asymptomatic patients and in those under continuous acid‐suppressive medication. The long‐term side effects of proton‐pump inhibitors, chemopreventive agents, and radiofrequency ablation are contentious. In patients with early‐stage disease, when the lower esophageal sphincter function is still preserved and before endoscopically visible Barrett's esophagus develops, novel laparoscopic procedures, such as magnetic and electric sphincter augmentation, may have a greater role than conventional surgical therapy. A multidisciplinary approach to GERD by a dedicated team of gastroenterologists and surgeons might impact the patients’ lifestyle, the therapeutic choices, and the course of the disease. Biological markers are needed to precisely assess the risk of disease progression and to tailor surveillance, ablation, and management.

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Minimal versus obligatory dissection of the diaphragmatic hiatus during magnetic sphincter augmentation surgery

Abstract: OD of the hiatus with crural closure resulted in less recurrence of reflux symptoms and hiatal hernia, despite an increased proportion of patients with larger hiatal hernia and more complex anatomic disease at the time of operation.

Cited by 32 publications

References 20 publications

Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease

Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease

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

Clinical course of gastroesophageal reflux disease and impact of treatment in symptomatic young patients

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