Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease

Warren, Heather; Brown, Lisa M.; Mihura, Matías; Farivar, Alexander S.; Aye, Ralph W.; Louie, Brian E.

doi:10.1007/s00464-017-5696-5

Cited by 39 publications

(12 citation statements)

References 23 publications

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“…The results of the feasibility, pivotal, and FDA post-approval studies have shown that magnetic sphincter augmentation is highly effective in reducing typical GERD symptoms, reducing daily PPI dependence, improving patients' quality of life, and decreasing esophageal acid exposure. 12,20 The results of the present study demonstrate a similarly high degree of symptom control, improvement in quality of life, and liberation from antisecretory medication use. MSA is comparable with LNF in the control of GERD symptoms while limiting procedure-related side effects, 12 and therefore may provide a solution to the deficits experienced with the established medical and surgical GERD therapies.…”

Section: Discussionsupporting

confidence: 64%

Magnetic Sphincter Augmentation and Postoperative Dysphagia: Characterization, Clinical Risk Factors, and Management

Ayazi

Zheng

Zaidi

et al. 2020

Journal of Gastrointestinal Surgery

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Introduction Magnetic sphincter augmentation (MSA) results in less severe side effects compared with Nissen fundoplication, but dysphagia remains the most common side effect reported by patients after MSA. This study aimed to characterize and review the management of postoperative dysphagia and identify the preoperative factors that predict persistent dysphagia after MSA. Material and Methods This is a retrospective review of prospectively collected data of patients who underwent MSA between 2013 and 2018. Preoperative objective evaluation included upper endoscopy, esophagram, high-resolution impedance manometry (HRIM), and esophageal pH testing. Postoperative persistent dysphagia was defined as a postoperative score of > 3 for the dysphagia-specific item within the GERD-HRQL at a minimum of 3 months following MSA. A timeline of dysphagia and dilation rates was constructed and correlated with the evolution of our patient management practices and modifications in surgical technique. Results A total of 380 patients underwent MSA, at a mean (SD) follow up of 11.5 (8.7) months, 59 (15.5%) patients were experiencing persistent dysphagia. Thirty-one percent of patients required at least one dilation for dysphagia or chest pain and the overall response rate to this procedure was 67%, 7 (1.8%) patients required device removal specifically for dysphagia. Independent predictors of persistent dysphagia based on logistic regression model included (1) absence of a large hernia (OR 2.86 (95% CI 1.08-7.57, p = 0.035)); (2) the presence of preoperative dysphagia (OR 2.19 (95% CI 1.05-4.58, p = 0.037)); and (3) having less than 80% peristaltic contractions on HRIM (OR 2.50 (95% CI 1.09-5.73, p = 0.031)). Graded cutoffs of distal contractile integral (DCI), mean wave amplitude, DeMeester score, sex, and body mass index were evaluated within the model and did not predict postoperative dysphagia. Frequent eating after surgery, avoidance of early dilation, and increase in the size of the LINX device selected decreased the need for dilation. Conclusion In a large cohort of patients who underwent MSA, we report 15.5% rate of persistent postoperative dysphagia. The overall response rate to dilation therapy is 67%, and the efficacy of dilation with each subsequent procedure reduces. Patients with normal hiatal anatomy, significant preoperative dysphagia, and less than 80% peristaltic contractions of the smooth muscle portion of the esophagus should be counseled that they have an increased risk for persistent postoperative dysphagia.

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Section: Discussionsupporting

confidence: 64%

Magnetic Sphincter Augmentation and Postoperative Dysphagia: Characterization, Clinical Risk Factors, and Management

Ayazi

Zheng

Zaidi

et al. 2020

Journal of Gastrointestinal Surgery

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“…9,10 Currently, there is a large body of literature outlining the clinical outcomes of the Nissen procedure and the patient population where it is most likely to be successful. 11,12 However, to date, there has been no large single-institution data set outlining the clinical outcomes of patients who underwent MSA when used in a "real-world" application across the spectrum of disease severity. In addition, there is a paucity of data on identifying preoperative factors that predict successful outcomes after MSA.…”

Section: Resultsmentioning

confidence: 99%

Clinical Outcomes and Predictors of Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with More than 500 Patients

Ayazi

Zheng

Zaidi

et al. 2020

Journal of the American College of Surgeons

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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%

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. 2019

British Journal of 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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Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease

Abstract: Magnetic sphincter augmentation results in excellent/good outcomes in most patients but a higher BMI, structurally defective sphincter, and elevated LES residual pressure may prevent this goal.

Cited by 39 publications

References 23 publications

Magnetic Sphincter Augmentation and Postoperative Dysphagia: Characterization, Clinical Risk Factors, and Management

Magnetic Sphincter Augmentation and Postoperative Dysphagia: Characterization, Clinical Risk Factors, and Management

Clinical Outcomes and Predictors of Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with More than 500 Patients

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

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