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Andreae T, Elshafei M, Gossage JA, Kersting T, Bell R. Current Clinical Evidence for Magnetic Sphincter Augmentation: A Scoping Review. FOREGUT: THE JOURNAL OF THE AMERICAN FOREGUT SOCIETY 2024; 4:442-453. [DOI: 10.1177/26345161241263051] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/05/2025]
Abstract
Background: Magnetic sphincter augmentation (MSA) is an alternative treatment option to laparoscopic fundoplication (LF) for patients with gastroesophageal reflux disease. To date, over 40,000 devices have been implanted worldwide since first approval in Europe in 2010 and the USA in 2012. Despite this clinical reality, the long-term safety and effectiveness of the procedure continues to be questioned. This study aims to systematically summarize and appraise the currently available evidence for MSA relative to effectiveness, safety, and healthcare resource use. Methods: A systematic literature search was carried out to identify all clinical studies published in English, as of February 15, 2023. Required endpoints were safety, effectiveness, and cost effectiveness. Results: The systematic search identified 212 publications and 14 entries in study registries. After screening and full text analysis, 82 publications were included in qualitative synthesis. One RCT established superiority of MSA compared to twice daily proton-pump inhibitors with respect to the elimination of moderate to severe regurgitation (89% vs 10%, RR 0.11, 95% CI 0.06-0.20, P < 0.001). Eleven cohort studies comparing MSA to LF showed no statistical difference in safety profile and effectiveness measured by post-operative GERD-HRQL score. In addition, patients undergoing MSA significantly retained the ability to belch and vomit when compared to LF. These results were consistent in follow-up out to 7 years. Conclusions: LINX has been shown to provide long lasting relief to patients suffering from persistent GERD while maintaining an acceptable safety profile. As an outpatient day-procedure, MSA is cost effective with short recovery.
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Affiliation(s)
| | | | - James A. Gossage
- Guy’s and St Thomas’ Hospitals NHS Trust, London, UK
- King’s College, London, UK
| | | | - Reginald Bell
- Institute of Esophageal and Reflux Surgery, Lone Tree, Englewood, CO, USA
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Fadel MG, Tarazi M, Dave M, Reddy M, Khan O, Fakih-Gomez N, Ashrafian H, Fehervari M. Magnetic sphincter augmentation in the management of gastro-esophageal reflux disease: a systematic review and meta-analysis. Int J Surg 2024; 110:6355-6366. [PMID: 38729117 PMCID: PMC11487049 DOI: 10.1097/js9.0000000000001558] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/04/2023] [Accepted: 04/23/2024] [Indexed: 05/12/2024]
Abstract
BACKGROUND Magnetic sphincter augmentation (MSA) through placement of the LINX device is an alternative to fundoplication in the management of gastro-esophageal reflux disease (GERD). This systematic review and meta-analysis aimed to assess efficacy, quality of life, and safety in patients that underwent MSA, with a comparison to fundoplication. METHODS A literature search of MEDLINE, Embase, Emcare, Scopus, Web of Science, and Cochrane library databases was performed for studies that reported data on outcomes of MSA, with or without a comparison group undergoing fundoplication, for GERD from January 2000 to January 2023. Meta-analysis was performed using random-effect models and between-study heterogeneity was assessed. RESULTS Thirty-nine studies with 8075 patients were included: 6983 patients underwent MSA and 1092 patients had laparoscopic fundoplication procedure. Ten of these studies (seven retrospective and three prospective) directly compared MSA with fundoplication. A higher proportion of individuals successfully discontinued proton-pump inhibitors ( P <0.001; WMD 0.83; 95% CI: 0.72-0.93; I2 =96.8%) and had higher patient satisfaction ( P <0.001; WMD 0.85; 95% CI: 0.78-0.93; I2 =85.2%) following MSA when compared to fundoplication. Functional outcomes were better after MSA than after fundoplication including ability to belch ( P <0.001; WMD 0.96; 95% CI: 0.93-0.98; I2 =67.8) and emesis ( P <0.001; WMD 0.92; 95% CI: 0.89-0.95; I2 =42.8%), and bloating ( P =0.003; WMD 0.20; 95% CI: 0.07-0.33; I2 =97.0%). MSA had higher rates of dysphagia ( P =0.001; WMD 0.41; 95% CI: 0.17-0.65; I2 =97.3%) when compared to fundoplication. The overall erosion and removal rate following MSA was 0.24% and 3.9%, respectively, with no difference in surgical reintervention rates between MSA and fundoplication ( P =0.446; WMD 0.001; 95% CI: -0.001-0.002; I2 =78.5%). CONCLUSIONS MSA is a safe and effective procedure at reducing symptom burden of GERD and can potentially improve patient satisfaction and functional outcomes. However, randomized controlled trials directly comparing MSA with fundoplication are necessary to determine where MSA precisely fits in the management pathway of GERD.
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Affiliation(s)
- Michael G. Fadel
- Department of Surgery and Cancer, Imperial College London
- Department of Bariatric and Metabolic Surgery, Chelsea and Westminster Hospital, London
| | - Munir Tarazi
- Department of Surgery and Cancer, Imperial College London
| | - Madhav Dave
- Department of Gastrointestinal Surgery, Maidstone and Tunbridge Wells NHS Trust, United Kingdom
| | | | - Omar Khan
- Department of Bariatric Surgery
- Population Sciences Department, St George’s University of London
| | - Naim Fakih-Gomez
- Department of Bariatric and Metabolic Surgery, Chelsea and Westminster Hospital, London
| | | | - Matyas Fehervari
- Department of Surgery and Cancer, Imperial College London
- Department of Upper Gastrointestinal Surgery, Liverpool University Hospitals, Liverpool
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Aiolfi A, Sozzi A, Bonitta G, Bona D, Bonavina L. Foregut Erosion Related to Biomedical Implants: A Scoping Review. J Laparoendosc Adv Surg Tech A 2024; 34:691-709. [PMID: 39102627 DOI: 10.1089/lap.2024.0167] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/07/2024] Open
Abstract
Introduction: Biomedical devices implanted transabdominally have gained popularity over the past 50 years in the treatment of gastroesophageal reflux disease, paraesophageal hiatal hernia, and morbid obesity. Device-related foregut erosions (FEs) represent a challenging event that demands special attention owing to the potential of severe postoperative complications and death. Purpose: The aim was to provide an overview of full-thickness foregut injury leading to erosion associated with four types of biomedical devices. Methods: The study was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). PubMed, EMBASE, and Web of Science databases were queried until December 31, 2023. Eligible studies included all articles reporting data, management, and outcomes on device-related FE. Results: Overall, 132 articless were included for a total of 1292 patients suffering from device-related FE. Four different devices were included: the Angelchik antireflux prosthesis (AAP) (n = 25), nonabsorbable mesh for crural repair (n = 60), adjustable gastric banding (n = 1156), and magnetic sphincter augmentation device (n = 51). The elapsed time from device implant to erosion ranged from 1 to 480 months. Most commonly reported symptoms were dysphagia and epigastric pain, while acute presentation was reported rarely and mainly for gastric banding. The technique for device removal evolved from more invasive open approaches toward minimally invasive and endoscopic techniques. Esophagectomy and gastrectomy were mostly reported for nonabsorbable mesh FE. Overall mortality was .17%. Conclusions: Device-related FE is rare but may occur many years after AAP, nonabsorbable mesh, adjustable gastric banding, and magnetic sphincter augmentation implant. FE-related mortality is infrequent, however, increased postoperative morbidity and the need for esophagogastric resection were observed for nonabsorbable mesh-reinforced cruroplasty.
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Affiliation(s)
- Alberto Aiolfi
- Division of General Surgery, Department of Biomedical Science for Health, I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio, University of Milan, Milano, Italy
| | - Andrea Sozzi
- Division of General Surgery, Department of Biomedical Science for Health, I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio, University of Milan, Milano, Italy
| | - Gianluca Bonitta
- Division of General Surgery, Department of Biomedical Science for Health, I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio, University of Milan, Milano, Italy
| | - Davide Bona
- Division of General Surgery, Department of Biomedical Science for Health, I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio, University of Milan, Milano, Italy
| | - Luigi Bonavina
- Department of Biomedical Sciences for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milan, Milan, Italy
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Wisniowski P, Putnam LR, Gallagher S, Rawal R, Houghton C, Lipham JC. Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis. Surg Endosc 2024; 38:1944-1949. [PMID: 38334778 PMCID: PMC10978616 DOI: 10.1007/s00464-024-10672-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2023] [Accepted: 12/30/2023] [Indexed: 02/10/2024]
Abstract
PURPOSE Magnetic Sphincter Augmentation (MSA) is an FDA-approved anti-reflux procedure with comparable outcomes to fundoplication. However, most data regarding its use are limited to single or small multicenter studies which may limit the generalizability of its efficacy. The purpose of this study is to evaluate the outcomes of patients undergoing MSA vs fundoplication in a national database. MATERIALS AND METHODS The 2017-2020 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Registry was utilized to evaluate patients undergoing MSA or fundoplication. Patients requiring Collis gastroplasty, paraesophageal hernia repair, and emergency cases, were excluded. Patient outcomes included overall complication rates, readmissions, reoperations, and mortality. RESULTS A total of 7,882 patients underwent MSA (n = 597) or fundoplication (n = 7285). MSA patients were younger (51 vs 57, p < 0.001), and more often male (49.6 vs 34.3%, p < 0.001). While patients undergoing MSA experienced similar rates of reoperation (1.0 vs 2.0%, p = 0.095), they experienced fewer readmissions (2.2 vs 4.7%, p = 0.005), complications (0.6 vs 4.0%, p < 0.001), shorter mean (SD) hospital length of stay(days) (0.4 ± 4.3 vs 1.8 ± 4.6, p < 0.001) and operative time(min) (80.8 ± 36.1 vs 118.7 ± 63.7, p < 0.001). Mortality was similar between groups (0 vs 0.3%, p = 0.175). On multivariable analysis, MSA was independently associated with reduced postoperative complications (OR 0.23, CI 0.08 to 0.61, p = 0.002), readmissions (OR 0.53, CI 0.30 to 0.94, p = 0.02), operative time (RC - 36.56, CI - 41.62 to - 31.49. p < 0.001) and length of stay (RC - 1.22, CI - 1.61 to - 0.84 p < 0.001). CONCLUSION In this national database study, compared to fundoplication MSA was associated with reduced postoperative complications, fewer readmissions, and shorter operative time and hospital length of stay. While randomized trials are lacking between MSA and fundoplication, both institutional and national database studies continue to support the use of MSA as a safe anti-reflux operation.
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Affiliation(s)
- Paul Wisniowski
- Division of Upper GI and General Surgery, Department of Surgery, Keck Medical Center of University of Southern California, 1510 San Pablo Street, HCC I, Suite 514, Los Angeles, CA, 90033, USA
| | - Luke R Putnam
- Division of Upper GI and General Surgery, Department of Surgery, Keck Medical Center of University of Southern California, 1510 San Pablo Street, HCC I, Suite 514, Los Angeles, CA, 90033, USA
| | - Shea Gallagher
- Division of Upper GI and General Surgery, Department of Surgery, Keck Medical Center of University of Southern California, 1510 San Pablo Street, HCC I, Suite 514, Los Angeles, CA, 90033, USA
| | - Rushil Rawal
- California University of Science and Medicine, Colton, CA, USA
| | - Caitlin Houghton
- Division of Upper GI and General Surgery, Department of Surgery, Keck Medical Center of University of Southern California, 1510 San Pablo Street, HCC I, Suite 514, Los Angeles, CA, 90033, USA
| | - John C Lipham
- Division of Upper GI and General Surgery, Department of Surgery, Keck Medical Center of University of Southern California, 1510 San Pablo Street, HCC I, Suite 514, Los Angeles, CA, 90033, USA.
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Nehra D, Clements CDM, Bezzaa SL, Tabbakh Y, Walsh CM. Patient-reported outcomes of laparoscopic magnetic sphincter augmentation for gastro-oesophageal reflux disease. Ann R Coll Surg Engl 2024; 106:344-352. [PMID: 37609688 PMCID: PMC10981991 DOI: 10.1308/rcsann.2023.0051] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/19/2023] [Indexed: 08/24/2023] Open
Abstract
INTRODUCTION Gastro-oesophageal reflux disease (GORD) is a chronic progressive disease, associated with substantial clinical and economic burden. Proton pump inhibitors (PPIs) are considered first-line treatment; however, there are concerns around the long-term impact of their usage. Surgical treatment with Nissen fundoplication can be considered but, because of the potential side effects, few patients undergo surgery and there remains a substantial therapeutic gap within the current treatment pathway. Laparoscopic magnetic sphincter augmentation (MSA) using the LINX® device is an alternative surgical approach. METHODS The objective of this study was to investigate patient-reported outcomes following laparoscopic MSA surgery using the LINX® device in a UK setting. A retrospective questionnaire obtained data regarding postoperative symptoms, medication use and patient satisfaction. RESULTS Out of 131 patients surveyed, 97 responses were received, with a minimum follow-up time of 1 year. In those who reported heartburn and regurgitation preoperatively, improvement was reported in 93% (84/90) and 90% (86/96) of patients, respectively. Eighty-eight per cent (73/83) of patients were able to completely stop or reduce their medication by at least 75%. Seventy-seven per cent (73/95) of patients were "very satisfied" or "satisfied". CONCLUSIONS This study is the first to present patient-reported outcomes of MSA using the LINX® device for patients with GORD in the UK. It demonstrates that the device has favourable outcomes and could effectively bridge the current therapeutic gap that exists between PPI medication and Nissen fundoplication.
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Affiliation(s)
- D Nehra
- Epsom and St Helier University Hospitals NHS Trust, UK
| | - CDM Clements
- Epsom and St Helier University Hospitals NHS Trust, UK
| | - SL Bezzaa
- Epsom and St Helier University Hospitals NHS Trust, UK
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Valinoti AC, Angeramo CA, Dreifuss N, Herbella FAM, Schlottmann F. MAGNETIC SPHINCTER AUGMENTATION DEVICE FOR GASTROESOPHAGEAL REFLUX DISEASE: EFFECTIVE, BUT POSTOPERATIVE DYSPHAGIA AND RISK OF EROSION SHOULD NOT BE UNDERESTIMATED. A SYSTEMATIC REVIEW AND META-ANALYSIS. ARQUIVOS BRASILEIROS DE CIRURGIA DIGESTIVA : ABCD = BRAZILIAN ARCHIVES OF DIGESTIVE SURGERY 2024; 36:e1781. [PMID: 38451590 PMCID: PMC10911679 DOI: 10.1590/0102-672020230063e1781] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/28/2022] [Accepted: 09/10/2023] [Indexed: 03/08/2024]
Abstract
BACKGROUND Magnetic ring (MSA) implantation in the esophagus is an alternative surgical procedure to fundoplication for the treatment of gastroesophageal reflux disease. AIMS The aim of this study was to analyse the effectiveness and safety of magnetic sphincter augmentation (MSA) in patients with gastroesophageal reflux disease (GERD). METHODS A systematic literature review of articles on MSA was performed using the Medical Literature Analysis and Retrieval System Online (Medline) database between 2008 and 2021, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A random-effect model was used to generate a pooled proportion with 95% confidence interval (CI) across all studies. RESULTS A total of 22 studies comprising 4,663 patients with MSA were analysed. Mean follow-up was 27.3 (7-108) months. The weighted pooled proportion of symptom improvement and patient satisfaction were 93% (95%CI 83-98%) and 85% (95%CI 78-90%), respectively. The mean DeMeester score (pre-MSA: 34.6 vs. post-MSA: 8.9, p=0.03) and GERD-HRQL score (pre-MSA: 25.8 vs. post-MSA: 4.4, p<0.0001) improved significantly after MSA. The proportion of patients taking proton pump inhibitor (PPIs) decreased from 92.8 to 12.4% (p<0.0001). The weighted pooled proportions of dysphagia, endoscopic dilatation and gas-related symptoms were 18, 13, and 3%, respectively. Esophageal erosion occurred in 1% of patients, but its risk significantly increased for every year of MSA use (odds ratio - OR 1.40, 95%CI 1.11-1.77, p=0.004). Device removal was needed in 4% of patients. CONCLUSIONS Although MSA is a very effective treatment modality for GERD, postoperative dysphagia is common and the risk of esophageal erosion increases over time. Further studies are needed to determine the long-term safety of MSA placement in patients with GERD.
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Affiliation(s)
- Agustin Cesar Valinoti
- Hospital Aleman de Buenos Aires, Esophagus and Stomach Surgical Unit – Buenos Aires, Argentina
| | | | - Nicolas Dreifuss
- Hospital Aleman de Buenos Aires, Esophagus and Stomach Surgical Unit – Buenos Aires, Argentina
| | | | - Francisco Schlottmann
- Hospital Aleman de Buenos Aires, Esophagus and Stomach Surgical Unit – Buenos Aires, Argentina
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Valdovinos-Diaz M, Amieva-Balmori M, Carmona-Sánchez R, Coss-Adame E, Gómez-Escudero O, González-Martínez M, Huerta-Iga F, Morel-Cerda E, Remes-Troche J, Tamayo-de la Cuesta J, Torres-Villalobos G, Valdovinos-García L, Vázquez-Elizondo G, Villar-Chávez A, Arenas-Martínez J. Recomendaciones de buena práctica clínica en el diagnóstico y tratamiento de la enfermedad por reflujo gastroesofágico. Revisión por expertos de la Asociación Mexicana de Gastroenterología. REVISTA DE GASTROENTEROLOGÍA DE MÉXICO 2024; 89:121-143. [DOI: 10.1016/j.rgmx.2023.12.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
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Valdovinos Díaz MA, Amieva-Balmori M, Carmona-Sánchez R, Coss-Adame E, Gómez-Escudero O, González-Martínez M, Huerta-Iga F, Morel-Cerda E, Remes-Troche JM, Tamayo-de la Cuesta JL, Torres-Villalobos G, Valdovinos-García LR, Vázquez-Elizondo G, Villar-Chávez AS, Arenas-Martínez JA. Good clinical practice recommendations for the diagnosis and treatment of gastroesophageal reflux disease. An expert review from the Asociación Mexicana de Gastroenterología. REVISTA DE GASTROENTEROLOGIA DE MEXICO (ENGLISH) 2024; 89:121-143. [PMID: 38580493 DOI: 10.1016/j.rgmxen.2023.12.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/13/2023] [Accepted: 12/06/2023] [Indexed: 04/07/2024]
Abstract
INTRODUCTION Gastroesophageal reflux disease (GERD) is very prevalent in the general population, with a broad spectrum of clinical manifestations, requiring accurate diagnosis and treatment. AIM The aim of this expert review is to establish good clinical practice recommendations for the diagnosis and personalized treatment of GERD. METHODS The good clinical practice recommendations were produced by a group of experts in GERD, members of the Asociación Mexicana de Gastroenterología (AMG), after carrying out an extensive review of the published literature and discussing each recommendation at a face-to-face meeting. This document does not aim to be a clinical practice guideline with the methodology such a document requires. RESULTS Fifteen experts on GERD formulated 27 good clinical practice recommendations for recognizing the symptoms and complications of GERD, the rational use of diagnostic tests and medical treatment, the identification and management of refractory GERD, the overlap with functional disorders, endoscopic and surgical treatment, and GERD in the pregnant woman, older adult, and the obese patient. CONCLUSIONS An accurate diagnosis of GERD is currently possible, enabling the prescription of a personalized treatment in patients with this condition. The goal of the good clinical practice recommendations by the group of experts from the AMG presented in this document is to aid both the general practitioner and specialist in the process of accurate diagnosis and treatment, in the patient with GERD.
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Affiliation(s)
| | - M Amieva-Balmori
- Laboratorio de Fisiología Digestiva y Motilidad Intestinal, Instituto de Investigaciones Médico-Biológicas de la Universidad Veracruzana, Veracruz, Mexico
| | - R Carmona-Sánchez
- Servicio de Gastroenterología, Práctica privada, San Luis Potosí, Mexico
| | - E Coss-Adame
- Departamento de Gastroenterología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
| | - O Gómez-Escudero
- Clínica de Gastroenterología, Endoscopia y Motilidad Gastrointestinal, Endoneurogastro, Hospital Ángeles Puebla, Puebla, Mexico
| | - M González-Martínez
- Departamento de Endoscopia, Hospital de Especialidades del CMN Siglo XXI IMSS, Mexico City, Mexico
| | - F Huerta-Iga
- Servicio de Gastroenterología, Hospital Ángeles Torreón, Torreón, Mexico
| | - E Morel-Cerda
- Departamento de Gastroenterología, Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Mexico
| | - J M Remes-Troche
- Laboratorio de Fisiología Digestiva y Motilidad Intestinal, Instituto de Investigaciones Médico-Biológicas de la Universidad Veracruzana, Veracruz, Mexico
| | - J L Tamayo-de la Cuesta
- Servicio de Gastroenterología y Endoscopia Gastrointestinal, Centro de Investigación y Docencia en Ciencias de la Salud, Universidad Autónoma de Sinaloa, Culiacán, Sinaloa, Mexico
| | - G Torres-Villalobos
- Cirugía Experimental, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
| | | | - G Vázquez-Elizondo
- Servicio de Gastroenterología, Centro de Enfermedades Digestivas ONCARE, Monterrey, Mexico
| | - A S Villar-Chávez
- Servicio de Gastroenterología, Hospital Ángeles Acoxpa, Mexico City, Mexico
| | - J A Arenas-Martínez
- Departamento de Gastroenterología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
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Froiio C, Aiolfi A, Bona D, Bonavina L. Safety profile of magnetic sphincter augmentation for gastroesophageal reflux disease. Front Surg 2023; 10:1293270. [PMID: 38026489 PMCID: PMC10661944 DOI: 10.3389/fsurg.2023.1293270] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/12/2023] [Accepted: 10/23/2023] [Indexed: 12/01/2023] Open
Abstract
Background The magnetic sphincter augmentation (MSA) procedure is an effective treatment for gastroesophageal reflux disease (GERD). Adverse events requiring MSA device removal are rare, but the true prevalence and incidence may be underestimated. Methods Retrospective study on a prospectively collected database. Patients who underwent MSA procedure between March 2007 and September 2021 in two tertiary-care referral centers for esophageal surgery were included. The trend of MSA explant, the changes in the sizing technique and crura repair over the years, the technique of explant, and the clinical outcomes of the revisional procedure were reviewed. Results Out of 397 consecutive patients, 50 (12.4%) underwent MSA removal, with a median time to explant of 39.5 [IQR = 53.7] months. Main symptoms leading to removal were dysphagia (43.2%), heartburn (25%), and epigastric pain (13.6%). Erosion occurred in 2.5% of patients. Smaller (12- and 13-bead) devices were the ones most frequently explanted. The majority of the explants were performed laparoscopically with endoscopic assistance. There was no perioperative morbidity, and the median length of stay was 2.8 ± 1.4 days. After 2014, changes in sizing technique and crura repair resulted in a decreased incidence of explants from 23% to 5% (p < 0.0001). Multivariate analysis confirmed the protective role of added bead units [HR 0.06 (95% CI = 0.001-0.220); p < 0.000]. Conclusion Oversizing and full mediastinal dissection with posterior hiatoplasty may improve the outcomes of the MSA procedure and possibly reduce removal rates.
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Affiliation(s)
- Caterina Froiio
- Department of Biomedical Science for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milan, Milan, Italy
| | - Alberto Aiolfi
- Department of Biomedical Science for Health, Division of General Surgery, IRCCS Galeazzi-Sant’Ambrogio, University of Milan, Milan, Italy
| | - Davide Bona
- Department of Biomedical Science for Health, Division of General Surgery, IRCCS Galeazzi-Sant’Ambrogio, University of Milan, Milan, Italy
| | - Luigi Bonavina
- Department of Biomedical Science for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milan, Milan, Italy
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Puri A, Steven S, Markar SR, Boyle N. Longer-term outcomes of gastroesophageal reflux disease treated with magnetic sphincter augmentation. Dis Esophagus 2023; 36:doad014. [PMID: 36942526 PMCID: PMC10789235 DOI: 10.1093/dote/doad014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/18/2022] [Revised: 02/14/2023] [Accepted: 02/28/2023] [Indexed: 03/23/2023]
Abstract
Surgical intervention for gastroesophageal reflux disease (GERD) has historically been limited to fundoplication. Magnetic sphincter augmentation (MSA) is a less invasive alternative that was introduced 15 years ago, and it may have a superior side-effect profile. To date, however, there has been just a single published study reporting outcomes in a UK population. This study reports quality-of-life (QOL) outcomes and antacid use in patients undergoing MSA, with a particular focus on postoperative symptoms and those with severe reflux. A single-center cohort study was carried out to assess the QOL outcomes and report long-term safety outcomes in patients undergoing MSA. GERD-health-related quality of life (GERD-HRQL) and Reflux Symptom Index (RSI) scores were collected preoperatively, and immediately postoperatively, at 1-, 2-, 3-, and 5-year follow-up time points. All patients underwent preoperative esophagogastroduodenoscopy, impedance, and manometry. Two hundred and two patients underwent laparoscopic MSA over 9 years. The median preoperative GERD-HRQL score was 31, and the median RSI score was 17. There was a reduction in all scores from preoperative values to each time point, which was sustained at 5-year follow-up; 13% of patients had a preoperative DeMeester score of >50, and their median preoperative GERD-HRQL and RSI scores were 32 and 15.5, respectively. These were reduced to 0 at the most recent follow-up. There was a significant reduction in antacid use at all postoperative time points. Postoperative dilatation was necessary in 7.4% of patients, and the device was removed in 1.4%. Erosion occurred in no patients. MSA is safe and effective at reducing symptom burden and improving QOL scores in patients with both esophageal and laryngopharyngeal symptoms, including those with severe reflux.
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Affiliation(s)
- Aiysha Puri
- Department of Surgery and Cancer, Imperial College London, London, UK
| | - Sue Steven
- Department of Surgery, Reflux UK, London, UK
| | - Sheraz R Markar
- Department of Surgery and Cancer, Imperial College London, London, UK
- Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
- Nuffield Department of Surgery, University of Oxford, Oxford, UK
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Eriksson SE, Zheng P, Sarici IS, Shen X, Jobe BA, Ayazi S. The impact of delayed gastric emptying as measured by gastric emptying scintigraphy on the outcome of magnetic sphincter augmentation. Surg Endosc 2023; 37:7144-7152. [PMID: 37328595 PMCID: PMC10462528 DOI: 10.1007/s00464-023-10190-y] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/01/2023] [Accepted: 05/30/2023] [Indexed: 06/18/2023]
Abstract
INTRODUCTION The impact of delayed gastric emptying (DGE) on the outcome of anti-reflux surgery (ARS) is controversial. There is concern that poor gastric emptying diminishes outcomes. Magnetic sphincter augmentation (MSA) may have a comparatively mild impact on gastric physiology, but the relationship between DGE and MSA outcomes is unknown. This study aims to evaluate the relationship between objective DGE and MSA outcomes over time. METHODS Patients who completed gastric emptying scintigraphy (GES) prior to MSA between 2013 and 2021 were included. DGE was defined as a 4 h retention > 10% or half emptying time > 90 min on GES. Outcomes were compared between DGE and normal gastric emptying (NGE) groups at 6 months, 1 and 2 years. Sub-analysis of patients with severe (> 35%) DGE and correlation analysis between 4-h retention and symptom and acid-normalization were performed. RESULTS The study population consisted of 26 (19.8%) patients with DGE and 105 with NGE. DGE was associated with more 90-days readmissions (18.5 vs 2.9%, p = 0.009). At 6 months patients with DGE had higher median (IQR) GERD-HRQL total [17.0(10-29) vs 5.5(3-16), p = 0.0013], heartburn [1(1-3) vs 0(0-1), p = 0.0010) and gas-bloat [4(2-5) vs 2(1-3), p = 0.033] scores. Outcomes at 1 and 2 years follow-up were comparable (p > 0.05). From 6 months to 1-year the gas-bloat score decreased from 4(2-5) to 3(1-3), p = 0.041. Total and heartburn scores decreased, but not significantly. Severe DGE (n = 4) patients had lower antiacid medication freedom at 6 months (75 vs 87%, p = 0.014) and 1-year (50 vs 92%, p = 0.046). There were non-significant trends for higher GERD-HRQL scores, dissatisfaction, and removal rates in severe DGE at 6 months and 1-year. There was a weak correlation between 4-h retention and 6-month GERD-HRQL total score [R = 0.253, 95%CI (0.09-0.41), p = 0.039], but not acid-normalization (p > 0.05). CONCLUSION Outcomes after MSA are diminished early on in patients with mild-to-moderate DGE, but comparable by 1 year and durable at 2 years. Severe DGE outcomes may be suboptimal.
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Affiliation(s)
- Sven E Eriksson
- Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA
| | - Ping Zheng
- Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA
| | - Inanc S Sarici
- Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA
| | - Xinxin Shen
- Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA
| | - Blair A Jobe
- Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA
- Department of Surgery, Drexel University, Philadelphia, PA, USA
| | - Shahin Ayazi
- Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA.
- Department of Surgery, Drexel University, Philadelphia, PA, USA.
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12
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Poola AS, Gatta P. Reoperative surgery after magnetic sphincter augmentation. Dis Esophagus 2023; 36:doad024. [PMID: 37317932 DOI: 10.1093/dote/doad024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2022] [Revised: 03/24/2023] [Accepted: 04/03/2023] [Indexed: 06/16/2023]
Abstract
Reoperative surgery following magnetic sphincter augmentation (MSA) is rare. The clinical indications include the removal of MSA for dysphagia, the recurrence of reflux, or the issues of erosion. Diagnostic evaluation follows that of patients with recurrent reflux and dysphagia following surgical fundoplication. Procedures following the complications of MSA can be performed in a minimally invasive fashion, either endoscopically or robotic/laparoscopically, with good clinical outcomes.
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Affiliation(s)
- Ashwini S Poola
- Department of Surgery, Mayo Clinic Health Systems, Mankato, MN, USA
| | - Prakash Gatta
- Department of Surgery, Overlake Medical Center, Bellevue, WA, USA
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13
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Wisniowski P, Putnam LR, Lipham J. Use of magnetic sphincter augmentation as an adjunct procedure in paraesophageal hernia repair. Dis Esophagus 2023; 36:doad022. [PMID: 37317931 DOI: 10.1093/dote/doad022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/27/2022] [Revised: 03/22/2023] [Indexed: 06/16/2023]
Abstract
Magnetic sphincter augmentation (MSA) is an anti-reflux procedure with comparable outcomes to fundoplication, yet its use in patients with larger hiatal or paraesophageal hernias has not been widely reported. This review discusses the history of MSA and how its utilization has evolved from initial Food and Drug Administration (FDA) approval in 2012 for patients with small hernias to its contemporary use in patients with paraesophageal hernias and beyond.
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Affiliation(s)
- Paul Wisniowski
- Department of Surgery, Division of Upper GI and General Surgery, Keck Medical Center of University of Southern California, Los Angeles, CA, USA
- Department of Surgery, Division of Upper GI, General, and Bariatric Surgery, Hoag Memorial Hospital Presbyterian, Newport Beach, CA, USA
| | - Luke R Putnam
- Department of Surgery, Division of Upper GI and General Surgery, Keck Medical Center of University of Southern California, Los Angeles, CA, USA
- Department of Surgery, Division of Upper GI, General, and Bariatric Surgery, Hoag Memorial Hospital Presbyterian, Newport Beach, CA, USA
| | - John Lipham
- Department of Surgery, Division of Upper GI and General Surgery, Keck Medical Center of University of Southern California, Los Angeles, CA, USA
- Department of Surgery, Division of Upper GI, General, and Bariatric Surgery, Hoag Memorial Hospital Presbyterian, Newport Beach, CA, USA
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14
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DeMeester TR. Magnetic sphincter augmentation: paradigm change or just another device in the surgeon's toolbox? Dis Esophagus 2023; 36:doad026. [PMID: 37317933 DOI: 10.1093/dote/doad026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2022] [Revised: 03/29/2023] [Indexed: 06/16/2023]
Abstract
The common denominator for virtually all episodes of gastroesophageal reflux in health and disease is the loss of the barrier that confines the distal esophagus to the stomach. Factors important in maintaining the function of the barrier are its pressure, length and position. In early reflux disease, overeating, gastric distention and delayed gastric emptying led to a transient loss of the barrier. A permanent loss of the barrier occurs from inflammatory injury to the muscle allowing free flow of gastric juice into the esophageal body. Corrective therapy requires augmentation or restoration of the barrier referred to more commonly as the lower esophageal sphincter.
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Affiliation(s)
- Tom R DeMeester
- Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA
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15
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Patel A, Gyawali CP. The role of magnetic sphincter augmentation (MSA) in the gastroesophageal reflux disease (GERD) treatment pathway: the gastroenterology perspective. Dis Esophagus 2023:7034219. [PMID: 36776100 DOI: 10.1093/dote/doad005] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/29/2022] [Revised: 01/18/2023] [Indexed: 02/14/2023]
Abstract
Magnetic sphincter augmentation (MSA) is a surgical intervention for well-characterized gastroesophageal reflux disease (GERD), where the esophagogastric junction barrier is augmented using a bracelet of magnetized titanium beads. MSA could be an attractive option for patients with documented GERD who wish to avoid long-term pharmacologic therapy or whose symptoms are not adequately managed with lifestyle modifications and pharmacologic therapy. The 'ideal' MSA patient is one with prominent regurgitation, without dysphagia or esophageal motor dysfunction, with objective evidence of GERD on upper endoscopy and/or ambulatory reflux monitoring. Appropriate candidates with significant hiatus hernia may pursue MSA with concomitant hiatus hernia repair. The increasing adoption of MSA in the GERD treatment pathway reflects research that shows benefits in long-term outcomes and healthcare costs compared with other established therapies in appropriate clinical settings.
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Affiliation(s)
- Amit Patel
- Division of Gastroenterology, Duke University School of Medicine and the Durham VA Medical Center, Durham, NC, USA
| | - C Prakash Gyawali
- Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO, USA
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16
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Rausa E, Ferrari D, Kelly ME, Aiolfi A, Vitellaro M, Rottoli M, Bonitta G, Bona D. Efficacy of laparoscopic Toupet fundoplication compared to endoscopic and surgical procedures for GERD treatment: a randomized trials network meta-analysis. Langenbecks Arch Surg 2023; 408:52. [PMID: 36680602 DOI: 10.1007/s00423-023-02774-y] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/10/2022] [Accepted: 12/27/2022] [Indexed: 01/22/2023]
Abstract
PURPOSE We aim to review and quantitatively compare laparoscopic Toupet fundoplication (LTF), Nissen fundoplication (LNF), anterior partial fundoplication (APF), magnetic augmentation sphincter (MSA), radiofrequency ablation (RFA), transoral incisionless fundoplication (TIF), proton pump inhibitor (PPI), and placebo for the treatment of GERD. A number of meta-analyses compared the efficacy of surgical and endoscopic procedures for recalcitrant GERD, but considerable debate on the effectiveness of operative strategies remains. METHODS A systematic review of MEDLINE databases, EMBASE, and Web of Science for randomized controlled trials (RCTs) comparing the aforementioned surgical and endoscopic GERD treatments was performed. Risk ratio and weighted mean difference were used as pooled effect size measures, whereas 95% credible intervals (CrI) were used to assess relative inference. RESULTS Thirty-three RCTs were included. Surgical and endoscopic treatments have similar RR for heartburn, regurgitation, bloating. LTF has a lower RR of post-operative dysphagia when compared to APF (RR 3.3; Crl 1.4-7.1) and LNF (RR 2.5; Crl 1.3-4.4). The pooled network meta-analysis did not observe any significant improvement regarding LES pressure and pH < from baseline. LTF, APF, LNF, MSA, RFA, and TIF had have a similar post-operative PPI discontinuation rate. CONCLUSION LTF has a lower rate of post-operative dysphagia when compared to APF and LNF. The pre-post effects, such as GERD-HQRL, LES pressure, and pH <4, should be avoided in meta-analyses because results may be biased. Last, a consensus about the evaluation of GERD treatments' efficacy and their outcomes is needed.
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Affiliation(s)
- E Rausa
- Colorectal Surgery Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
| | - D Ferrari
- General Surgery I, Papa Giovanni XXIII Hospital, Bergamo, Italy
| | - M E Kelly
- Department of Surgery, St. James Hospital, School of Medicine-Trinity College Dublin, Dublin, Ireland
| | - A Aiolfi
- General Surgery, Istituto Clinico Sant'Ambrogio, Milano, Italy
| | - Marco Vitellaro
- Colorectal Surgery Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy
| | - M Rottoli
- Surgery of the Alimentary Tract, IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy
| | - G Bonitta
- General Surgery, Istituto Clinico Sant'Ambrogio, Milano, Italy
| | - D Bona
- General Surgery, Istituto Clinico Sant'Ambrogio, Milano, Italy
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17
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Froiio C, Tareq A, Riggio V, Siboni S, Bonavina L. Real-world evidence with magnetic sphincter augmentation for gastroesophageal reflux disease: a scoping review. Eur Surg 2023. [DOI: 10.1007/s10353-022-00789-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
Abstract
Summary
Background
The burden of gastroesophageal reflux disease (GERD) is high, with up to 30% of the Western population reporting reflux-related symptoms with or without hiatal hernia. Magnetic sphincter augmentation (MSA) is a standardized laparoscopic procedure for patients who are dissatisfied with medical therapy and for those with early-stage disease who would not usually be considered ideal candidates for fundoplication. The MSA device is manufactured in different sizes and is designed to augment the physiologic barrier to reflux by magnetic force.
Methods
An extensive scoping review was performed to provide a map of current evidence with respect to MSA, to identify gaps in knowledge, and to make recommendations for future research. All the authors contributed to the literature search in PubMed and Web of Science and contributed to summarizing the evidence.
Results
Magnetic sphincter augmentation, especially in combination with crural repair, is effective in reducing GERD symptoms, proton pump inhibitor use, and esophageal acid exposure, and in improving patients’ quality of life. Safety issues such as device erosion or migration have been rare and not associated with mortality. The MSA device can be removed laparoscopically if necessary, thereby preserving the option of fundoplication or other therapies in the future. Contraindication to scanning in high-power Tesla magnetic resonance systems remains a potential limitation of the MSA procedure. High-resolution manometry and functional lumen imaging probes appear to be promising tools to predict procedural outcomes by improving reflux control and reducing the incidence of dysphagia.
Conclusion
A consensus on acquisition and interpretation of high-resolution manometry and impedance planimetry data is needed to gain better understanding of physiology, to improve patient selection, and to pave the way for a personalized surgical approach in antireflux surgery.
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18
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Sarici IS, Dunn CP, Eriksson SE, Jobe BA, Ayazi S. Long-term clinical and functional results of magnetic sphincter augmentation. Dis Esophagus 2022:6965898. [PMID: 36585776 DOI: 10.1093/dote/doac109] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/20/2022] [Indexed: 01/01/2023]
Abstract
Magnetic sphincter augmentation (MSA) was introduced in 2007 as an alternative surgical procedure for patients with gastroesophageal reflux disease (GERD). The majority of data since MSA's introduction has focused on short and intermediate-term results, demonstrating safety and high efficacy in terms of reflux symptom control, freedom from proton pump inhibitor use and normalization of distal esophageal acid exposure. However, GERD is a chronic condition that demands a long-term solution. Limited available data from studies reporting outcomes at 5 years or later following MSA demonstrate that the promising short- and mid-term efficacy and safety profile of MSA remains relatively constant in the long term. Compared with Nissen fundoplication, MSA has a much lower rate of gas-bloat and inability to belch at a short-term follow-up, a difference that persists in the long-term. The most common complaint after MSA at a short-term follow-up is dysphagia. However, limited data suggest dysphagia rates largely decrease by 5 years. Dysphagia is the most common indication for dilation and device removal in both early- and long-term studies. However, the overall rates of dilation and removal are similar in short- and long-term reports, suggesting the majority of these procedures are performed in the short-term period after device implantation. The indications and standard practices of MSA have evolved over time. Long-term outcome data currently available are all from patient cohorts who were selected for MSA under early restricted indications and outdated regimens. Therefore, further long-term studies are needed to corroborate the preliminary, yet encouraging long-term results.
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Affiliation(s)
- Inanc S Sarici
- Esophageal Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, USA
| | - Colin P Dunn
- Esophageal Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, USA
| | - Sven E Eriksson
- Esophageal Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, USA
| | - Blair A Jobe
- Esophageal Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, USA.,Department of Surgery, Drexel University, Philadelphia, PA, USA
| | - Shahin Ayazi
- Esophageal Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, USA.,Department of Surgery, Drexel University, Philadelphia, PA, USA
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19
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Bridges LC, Shillinglaw JP, Smith BE, Vazquez de Santos MG, Parker JC, Vaughn DM. Augmentation of the Esophageal Sphincter Using LINX. Am Surg 2022; 88:2170-2175. [PMID: 35593894 DOI: 10.1177/00031348221093800] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
Gastroesophageal reflux disease (GERD) is the retrograde flow of gastric contents into the distal esophagus and may be treated medically or surgically. Magnetic sphincter augmentation surgery using LINX has recently demonstrated comparable results to Nissen fundoplication. We aimed to evaluate preoperative patient risk factors that were associated with LINX removal rates or postoperative EGD with dilation rates (POEGDD). This is a single institution retrospective review of patients undergoing LINX between 2015 and 2021. One hundred and twelve patients were reviewed, 106 included within the study; those excluded had prior foregut surgery or device fracture. Variables including age, sex, BMI, size of device, DeMeester score, manometry, GERD Health-Related Quality of Life (GERD HRQL) questionnaires, POEGDD, and removal rates were recorded. Comparing removal and dilation status, the chi-square or Fisher's exact test and the Mann-Whitney U test were used to analyze categorical and continuous variables, respectively. A P < .05 was considered to be statistically significant. Eleven LINX devices were removed (10%); of these, 9 (81%) underwent POEGDD (P = .0023). There was no difference in DeMeester scores, size of device, or BMI in patients requiring LINX removal compared to those not removed or POEGDD rates. Patients who required LINX removal had higher GERD HRQL scores both preoperatively (median 34 vs 28) and postoperatively at all visits compared to those patients who did not undergo removal (P = .032). Manometry and DeMeester scores were not associated with LINX removal suggesting a less invasive GERD HRQL questionnaire may be a better predictor of patients who will succeed with LINX surgery.
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Affiliation(s)
| | | | - Betsy E Smith
- Internal Medicine and Community Medicine, 5225Mercer University School of Medicine, Macon GA, USA
| | - Maria G Vazquez de Santos
- Department of Surgery, Atrium Health Navicent, Macon Georgia, 12241Mercer University School of Medicine, Macon GA, USA
| | - James C Parker
- Department of Surgery, 14414Saint Luke's Hospital of Kansas City, Kansas City, MO, USA
| | - Danny M Vaughn
- Department of Surgery, Atrium Health Navicent, Macon Georgia, 12241Mercer University School of Medicine, Macon GA, USA.,Department of Minimally Invasive Surgery, 417871Atrium Health Navicent, Macon GA, USA
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20
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Abstract
BACKGROUND Dysphagia remains the most significant concern after anti-reflux surgery, including magnetic sphincter augmentation (MSA). The aim of this study was to evaluate postoperative dysphagia rates, its risk factors, and management after MSA. METHODS From a prospectively collected database of all 357 patients that underwent MSA at our institution, a total of 268 patients were included in our retrospective study. Postoperative dysphagia score, gastrointestinal symptoms, proton pump inhibitor intake, GERD-HRQL, Alimentary Satisfaction, and serial contrast swallow imaging were evaluated within standardized follow-up appointments. To determine patients' characteristics and surgical factors associated with postoperative dysphagia, a multivariable logistic regression analysis was performed. RESULTS At a median follow-up of 23 months, none of the patients presented with severe dysphagia, defined as the inability to swallow solids or/and liquids. 1% of the patients underwent endoscopic dilatation, and 1% had been treated conservatively for dysphagia. 2% of the patients needed re-operation, most commonly due to recurrent hiatal hernia. Two patients underwent device removal due to unspecific discomfort and pain. No migration of the device or erosion by the device was seen. The LINX® device size ≤ 13 was found to be the only factor associated with postoperative dysphagia (OR 5.90 (95% CI 1.4-24.8)). The postoperative total GERD-HRQL score was significantly lower than preoperative total score (2 vs. 19; p = 0.001), and daily heartburn, regurgitations, and respiratory complains improved in 228/241 (95%), 131/138 (95%) and 92/97 (95%) of patients, respectively. CONCLUSIONS Dysphagia requiring endoscopic or surgical intervention was rare after MSA in a large case series. LINX® devices with a size < 13 were shown to be an independent risk factor for developing postoperative dysphagia.
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21
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Wu H, Attaar M, Wong HJ, Campbell M, Kuchta K, Denham W, Linn J, Ujiki MB. Impedance planimetry (EndoFLIP™) after magnetic sphincter augmentation (LINX®) compared to fundoplication. Surg Endosc 2022; 36:7709-7716. [PMID: 35169878 DOI: 10.1007/s00464-022-09128-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/03/2021] [Accepted: 02/07/2022] [Indexed: 10/19/2022]
Abstract
INTRODUCTION Functional luminal imaging probe (FLIP) use during laparoscopic fundoplication (LF) for gastroesophageal reflux disease is well described. However, there is a lack of data on FLIP measurements during magnetic sphincter augmentation (MSA). This study aims to report our institutional experience in performing FLIP during MSA and to compare these measurements to those obtained during Nissen and Toupet fundoplication. METHODS AND PROCEDURES A retrospective review of a prospectively maintained quality database was performed. Patients who underwent MSA or LF and had FLIP measurements between April 2018 and June 2021 were included. FLIP measurements at the gastroesophageal junction (GEJ) were recorded without pneumoperitoneum at 40 mL balloon fill after hernia reduction, cruroplasty, and MSA or fundoplication. Reflux symptom index (RSI), GERD-HRQL, and dysphagia score were collected up to 2 years. Group comparisons were made using two-tailed Wilcoxon rank-sum and χ2 tests, with statistical significance of p < 0.05. RESULTS Twenty-seven patients underwent MSA and 100 patients underwent LF (66% Toupet, 34% Nissen). Type III hiatal hernia was present in 3.7% of MSA patients versus over 50% for fundoplication patients. Minimum diameter, cross-sectional area, and distensibility index (DI) were lower after MSA device placement compared to Nissen or Toupet fundoplication (p < 0.05). Postoperative follow-up showed no differences in RSI, GERD-HRQL, and dysphagia score between MSA and Nissen fundoplication (p > 0.05). CONCLUSION Intraoperative impedance planimetry provided objective information regarding the geometry of the GEJ during MSA. The ring of magnetic beads restores the anti-reflux barrier and transiently opens with food bolus and belching. The magnetic force of the beads may explain why the DI after MSA is lower yet postoperative quality of life is no different than Nissen fundoplication.
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Affiliation(s)
- Hoover Wu
- Department of Surgery, NorthShore University Health System, Evanston, IL, USA. .,Department of Surgery, University of Chicago Medical Center, Chicago, IL, USA. .,Department of Surgery, NorthShore University Health System, 2650 Ridge Ave, GCSI Suite B665, Evanston, IL, 60201, USA.
| | - Mikhail Attaar
- Department of Surgery, NorthShore University Health System, Evanston, IL, USA.,Department of Surgery, University of Chicago Medical Center, Chicago, IL, USA
| | - Harry J Wong
- Department of Surgery, NorthShore University Health System, Evanston, IL, USA.,Department of Surgery, University of Chicago Medical Center, Chicago, IL, USA
| | - Michelle Campbell
- Department of Surgery, NorthShore University Health System, Evanston, IL, USA.,Department of Surgery, University of Chicago Medical Center, Chicago, IL, USA
| | | | - Woody Denham
- Department of Surgery, NorthShore University Health System, Evanston, IL, USA
| | - John Linn
- Department of Surgery, NorthShore University Health System, Evanston, IL, USA
| | - Michael B Ujiki
- Department of Surgery, NorthShore University Health System, Evanston, IL, USA
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22
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Nikolic M, Matic A, Feka J, Gensthaler L, Kristo I, Osmokrovic B, Riegler FM, Mosleh BO, Schoppmann SF. Expanded Indication for Magnetic Sphincter Augmentation: Outcomes in Weakly Acidic Reflux Compared to Standard GERD Patients. J Gastrointest Surg 2022; 26:532-541. [PMID: 34590216 PMCID: PMC8926968 DOI: 10.1007/s11605-021-05152-5] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/25/2021] [Accepted: 09/11/2021] [Indexed: 01/31/2023]
Abstract
BACKGROUND Magnetic sphincter augmentation (MSA) is a modern surgical anti-reflux technique with proven efficacy and low postoperative morbidity in patients with acidic reflux. The aim of this retrospective review study was to evaluate the symptomatic outcome of MSA in patients with weakly acidic reflux. METHODS From a prospectively collected clinical database, comprising all 327 patients that underwent MSA at our institution, a total of 67 patients with preoperative weakly acidic reflux measured in the 24-h impedance-pH-metry were identified. Postoperative gastrointestinal symptoms, proton pump inhibitor intake (PPI), GERD Health-Related Quality-of-Life (GERD-HRQL), alimentary satisfaction (AS), and patients' overall satisfaction were evaluated within highly standardized follow-up appointments. Furthermore, outcome of these patients was compared to the postoperative outcome of a comparable group of patients with a preoperative acidic reflux. RESULTS At a median follow-up of 24 months, none of the patients with weakly acidic reflux presented with persistent dysphagia, or underwent endoscopic dilatation or reoperation. The postoperative GERD-HRQL score was significantly reduced (2 vs. 20; p = 0.001) and the median AS was 9/10. Preoperative daily heartburn, regurgitations, and respiratory complaints were improved in 95%, 95%, and 96% of patients, respectively. A total of 10% of the patients continued to use PPIs postoperatively. No significant difference was observed in terms of postoperative outcome or quality of life when comparing weakly acidic reflux patients with those diagnosed with preoperative acidic reflux. CONCLUSION Magnetic sphincter augmentation significantly improves GERD-related symptoms and quality of life in patients with weakly acidic reflux with very low postoperative morbidity.
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Affiliation(s)
- Milena Nikolic
- Department of Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria
| | - Aleksa Matic
- Department of Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria
| | - Joy Feka
- Department of Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria
| | - Lisa Gensthaler
- Department of Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria
| | - Ivan Kristo
- Department of Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria
| | - Bogdan Osmokrovic
- Department of Trauma Surgery, Krankenhaus Oberwart, Dornburggasse 80, 7400, Oberwart, Austria
| | - Franz M Riegler
- Reflux Ordination, Mariannengasse 10/4/9, 1090, Vienna, Austria
| | - Berta O Mosleh
- Department of Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria
| | - Sebastian F Schoppmann
- Department of Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
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23
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Bortolotti M. Magnetic challenge against gastroesophageal reflux. World J Gastroenterol 2021; 27:8227-8241. [PMID: 35068867 PMCID: PMC8717015 DOI: 10.3748/wjg.v27.i48.8227] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/27/2021] [Revised: 07/07/2021] [Accepted: 12/03/2021] [Indexed: 02/06/2023] Open
Abstract
Almost 15 years have passed since the first paper on the possibility of using magnets to prevent gastro-esophageal reflux (GER) was published and so it is time to assess the results obtained with the first magnetic device available on the market, the Linx magnetic sphincter augmentation (MSA) and to consider what other options are forthcoming. MSA demonstrated an anti-reflux activity similar to that of Nissen fundoplication, considered the "gold standard" surgical treatment for GER disease, and caused less gas-bloating and a better ability to allow vomiting and belching. However, unlike Nissen fundoplication, this magnetic device is burdened by complications, which are roughly similar to those of the non-magnetic anti-reflux Angelchik prosthesis, that, after considerable use in the eighties, was shelved due to these complications. It is interesting to note that some of these complications show the same pathophysiological mechanism in both devices. The upcoming new magnetic devices should avoid these complications, as their anti-reflux magnetic mechanism is completely different. The experiments in animals regarding these new magnetic appliances were examined, remarking their advantages and drawbacks, but the way to apply them in surgical practice is long and difficult, although worthy, as they represent the future of magnetic surgery.
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Affiliation(s)
- Mauro Bortolotti
- Department of Internal Medicine and Gastroenterology, S. Orsola-Malpighi Polyclinic, University of Bologna, Bologna 40138, Italy
- Via Massarenti 48, Bologna 40138, Italy
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Domingues G, Moraes-Filho JPPD. GASTROESOPHAGEAL REFLUX DISEASE: A PRACTICAL APPROACH. ARQUIVOS DE GASTROENTEROLOGIA 2021; 58:525-533. [PMID: 34909861 DOI: 10.1590/s0004-2803.202100000-94] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/20/2021] [Accepted: 06/26/2021] [Indexed: 01/10/2023]
Abstract
Gastroesophageal reflux disease (GERD) presents typical manifestations such as heartburn and/or regurgitation as well as atypical manifestations such as throat symptoms, laryngitis, hoarseness, chronic cough, asthma, and sleep alterations. There are two phenotypes of the disease: erosive GERD, when erosions are identified by upper digestive endoscopy, and non-erosive GERD, when the esophageal mucosa presents a normal endoscopic aspect. Relevant clinical findings are usually absent in the physical examination, but it should be highlighted that obesity is an important aggravating factor of reflux. The treatment is established based on clinical findings and, according to the clinical situation, on complementary exams such as upper digestive endoscopy. In dubious cases where a precise diagnosis is required, the indicated test is esophageal pHmetry or impedance-pHmetry. Clinical treatment is divided into behavioral/dietary measures and pharmacological measures. Most patients benefit from clinical treatment, but surgical treatment may be indicated in the presence of a larger hiatal hernia and complications of the disease.
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Affiliation(s)
- Gerson Domingues
- Faculdade de Ciências Médicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil
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25
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Wu H, Attaar M, Wong HJ, Campbell M, Kuchta K, Ungerleider S, Denham W, Linn J, Ujiki MB. Impedance planimetry (EndoFLIP) measurements persist long term after anti-reflux surgery. Surgery 2021; 171:628-634. [PMID: 34865861 DOI: 10.1016/j.surg.2021.08.065] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2021] [Revised: 08/18/2021] [Accepted: 08/19/2021] [Indexed: 11/18/2022]
Abstract
PURPOSE The functional lumen imaging probe provides objective measurements of the gastroesophageal junction during laparoscopic anti-reflux surgery. There is a lack of data on how functional lumen imaging probe measurements change at follow-up. We aim to describe our institutional experience in performing functional lumen imaging probe during postoperative endoscopy after laparoscopic anti-reflux surgery. METHODS A prospectively maintained database was queried. Patients who had postoperative endoscopic functional lumen imaging probe measurements between March 2018 and June 2021 were assessed at different time points from their index laparoscopic anti-reflux surgery using paired t test. Standardized quality of life questionnaires were collected for up to 2 years. Group comparisons were made using the Wilcoxon rank-sum test. RESULTS Fifty-eight patients who underwent laparoscopic anti-reflux surgery (magnetic sphincter augmentation or fundoplication) had postoperative functional lumen imaging probe. Thirty-two intraoperative functional lumen imaging probe values were compared with their postoperative functional lumen imaging probe. Fundoplication values did not differ. Postoperative functional lumen imaging probe distensibility index for magnetic sphincter augmentation patients was decreased (P = .04). Functional lumen imaging probe measurements for all postoperative endoscopies showed that magnetic sphincter augmentation had the lowest distensibility index (P < .01). Dysphagia as a reason for endoscopy had a decrease in distensibility index (P = .03). CONCLUSION Functional lumen imaging probe measurements after fundoplication persist at long-term follow up while patients may have a tighter gastroesophageal junction after magnetic sphincter augmentation. Functional lumen imaging probe has the potential to assess the success or failure after laparoscopic anti-reflux surgery and optimize patient outcomes.
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Affiliation(s)
- Hoover Wu
- Department of Surgery, NorthShore University Health System, Evanston, IL; Department of Surgery, University of Chicago Medical Center, Chicago, IL.
| | - Mikhail Attaar
- Department of Surgery, NorthShore University Health System, Evanston, IL; Department of Surgery, University of Chicago Medical Center, Chicago, IL
| | - Harry J Wong
- Department of Surgery, NorthShore University Health System, Evanston, IL; Department of Surgery, University of Chicago Medical Center, Chicago, IL
| | - Michelle Campbell
- Department of Surgery, NorthShore University Health System, Evanston, IL; Department of Surgery, University of Chicago Medical Center, Chicago, IL
| | | | | | - Woody Denham
- Department of Surgery, NorthShore University Health System, Evanston, IL
| | - John Linn
- Department of Surgery, NorthShore University Health System, Evanston, IL
| | - Michael B Ujiki
- Department of Surgery, NorthShore University Health System, Evanston, IL
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Zimmermann CJ, Lidor A. Endoscopic and Surgical Management of Gastroesophageal Reflux Disease. Gastroenterol Clin North Am 2021; 50:809-823. [PMID: 34717872 DOI: 10.1016/j.gtc.2021.07.005] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Approximately, 10% to 15% of patients in the United States experience gastroesophageal reflux symptoms on a weekly basis, negatively affecting the quality of life and increasing the risk of reflux-related complications. For patients with symptoms recalcitrant to proton pump inhibitor (PPI) therapy or those who cannot take PPIs, surgical fundoplication is the gold standard. The preoperative workup is complex but vital for operative planning and ensuring good postoperative outcomes. Most patients are highly satisfied after fundoplication, though transient dysphagia, gas bloating, and resumption of PPI use are common postoperatively. Multiple newer technologies offer safe alternatives to fundoplication with similar outcomes.
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Affiliation(s)
- Christopher J Zimmermann
- Department of Surgery, University of Wisconsin- Madison, Clinical Science Center, 600 Highland Avenue, Madison, WI 53792-7375, USA
| | - Anne Lidor
- Department of Surgery, University of Wisconsin- Madison, Clinical Science Center, 600 Highland Avenue, Madison, WI 53792-7375, USA.
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Zhuang QJ, Tan ND, Chen SF, Zhang MY, Xiao YL. Magnetic sphincter augmentation in treating refractory gastroesophageal reflux disease: A systematic review and meta-analysis. J Dig Dis 2021; 22:695-705. [PMID: 34693633 DOI: 10.1111/1751-2980.13063] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/07/2021] [Revised: 09/13/2021] [Accepted: 10/20/2021] [Indexed: 02/06/2023]
Abstract
OBJECTIVE In this systematic review and meta-analysis we aimed to determine the efficacy and safety of magnetic sphincter augmentation (MSA) in the management of refractory gastroesophageal reflux disease (rGERD). METHODS Literature search was conducted in PubMed, the Cochrane Library, EMBASE, Web of Science, OpenGrey and ClincalTrials.gov for single-arm studies evaluating the efficacy and safety of MSA in rGERD or comparative studies with proton pump inhibitor (PPI) or laparoscopic Nissen fundoplication (LNF) serving as the control published until April 2020. Primary outcome was the rate of postoperative PPI use, and secondary outcomes included postoperative GERD-health-related quality of life (GERD-HRQL), normalization of acid exposure time (AET) and incidence of procedure-related adverse events (AE). RESULTS Ten single-arm studies, one randomized controlled trial and three cohort studies involving 1138 participants were included. Post-MSA PPI withdrawal, significant GERD-HRQL improvement and AET normalization were achieved in 87.0%, 88.0% and 75.0% of the patients, respectively. The incidence of postoperative dysphagia was 29% and endoscopic dilation was required in 7.4% of patients undergoing MSA. MSA showed a better efficacy in symptom control than PPI (PPI cessation: 91% vs 0%; GERD-HRQL improvement: 81% vs 8%) and similar effectiveness but a lower risk of gas-bloat syndrome (risk ratio [RR] 0.69, 95% confidence interval [CI] 0.51-0.93, P = 0.01) and better reserved ability to belch (RR 1.48, 95% CI 0.76-2.86, P = 0.25) compared with LNF. CONCLUSIONS MSA was an effective and safe therapy for rGERD. Well-designed randomized trials that compare the efficacy of MSA with other therapies are needed.
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Affiliation(s)
- Qian Jun Zhuang
- Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Nian Di Tan
- Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Song Feng Chen
- Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Meng Yu Zhang
- Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Ying Lian Xiao
- Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
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Magnetic sphincter augmentation device removal: surgical technique and results at medium-term follow-up. Langenbecks Arch Surg 2021; 406:2545-2551. [PMID: 34462810 PMCID: PMC8578182 DOI: 10.1007/s00423-021-02294-7] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/01/2021] [Accepted: 08/03/2021] [Indexed: 02/07/2023]
Abstract
Background The magnetic sphincter augmentation (MSA) device has become a common option for the treatment of gastroesophageal reflux disease (GERD). Knowledge of MSA-related complications, indications for removal, and techniques are puzzled. With this study, we aimed to evaluate indications, techniques for removal, surgical approach, and outcomes with MSA removal. Methods This is an observational singe-center study. Patients were followed up regularly with endoscopy, pH monitoring, and assessed for specific gastroesophageal reflux disease health-related quality of life (GERD-HRQL) and generic short-form 36 (SF-36) quality of life. Results Five patients underwent MSA explant. Four patients were males and the median age was 47 years (range 44–55). Heartburn, epigastric/chest pain, and dysphagia were commonly reported. The median implant duration was 46 months (range 31–72). A laparoscopic approach was adopted in all patients. Intraoperative findings included normal anatomy (40%), herniation in the mediastinum (40%), and erosion (20%). The most common anti-reflux procedures were Dor (n = 2), Toupet (n = 2), and anterior partial fundoplication (n = 1). The median operative time was 145 min (range 60–185), and the median hospital length of stay was 4 days (range 3–6). The median postoperative follow-up was 41 months (range 12–51). At the last follow-up, 80% of patients were off PPI; the GERD-HRQL and SF-36 questionnaire were improved with DeMeester score and esophageal acid exposure normalization. Conclusion The MSA device can be safely explanted through a single-stage laparoscopic procedure. Tailoring a fundoplication, according to preoperative patient symptoms and intraoperative findings, seems feasible and safe with a promising trend toward improved symptoms and quality of life. Supplementary Information The online version contains supplementary material available at 10.1007/s00423-021-02294-7.
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Zhang L, Sun B, Zhou X, Wei Q, Liang S, Luo G, Li T, Lü M. Barrett's Esophagus and Intestinal Metaplasia. Front Oncol 2021; 11:630837. [PMID: 34221959 PMCID: PMC8252963 DOI: 10.3389/fonc.2021.630837] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/18/2020] [Accepted: 05/31/2021] [Indexed: 02/05/2023] Open
Abstract
Intestinal metaplasia refers to the replacement of the differentiated and mature normal mucosal epithelium outside the intestinal tract by the intestinal epithelium. This paper briefly describes the etiology and clinical significance of intestinal metaplasia in Barrett’s esophagus. This article summarizes the impact of intestinal metaplasia on the diagnosis, monitoring, and treatment of Barrett’s esophagus according to different guidelines. We also briefly explore the basis for the endoscopic diagnosis of intestinal metaplasia in Barrett’s esophagus. The identification techniques of goblet cells in Barrett’s esophagus are also elucidated by some scholars. Additionally, we further elaborate on the current treatment methods related to Barrett’s esophagus.
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Affiliation(s)
- Lu Zhang
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou City, China
| | - Binyu Sun
- Department of Endoscope, Public Health Clinical Medical Center of Chengdu, Chengdu City, China
| | - Xi Zhou
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou City, China
| | - QiongQiong Wei
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou City, China
| | - Sicheng Liang
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou City, China
| | - Gang Luo
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou City, China
| | - Tao Li
- Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu City, China
| | - Muhan Lü
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou City, China
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DeMarchi J, Schwiers M, Soberman M, Tokarski A. Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation. Dis Esophagus 2021; 34:6295819. [PMID: 34117494 PMCID: PMC8597906 DOI: 10.1093/dote/doab036] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/25/2020] [Revised: 03/18/2021] [Accepted: 05/09/2021] [Indexed: 12/11/2022]
Abstract
Magnetic sphincter augmentation using the LINX® device is a minimally invasive surgical option for patients with gastroesophageal reflux disease. An estimated 30,000 devices have been implanted worldwide. Device removals and erosion are identified risks. The objective of this analysis is to explore the procedure evolution with an emphasis on the removals and associated characteristics that may guide future clinical practice. The Manufacturer and User Facility Device Experience and Ethicon's complaint databases were queried for all surgical device explants since January 2013. Device unit sales were used to determine the rates. The endpoint was based upon the time from implant to explant. Explant and erosion rates were calculated at yearly intervals and the Kaplan-Meier estimator was used to measure the time to explant. Chi-square analyses were used to investigate the risk of explant associated with the size, geography and implant year. Overall, 7-year cumulative risk of removal was 4.81% (95% Confidence Interval (CI) CI: 4.31-5.36%). The likelihood of removal was significantly related to the device size (P < 0.0001), with smaller sizes being more likely to be explanted. The primary reasons for device removal and relative percentages were dysphagia/odynophagia (47.9%), persistent gastroesophageal reflux disease (20.5%) and unknown/other (11.2%). Overall, the 7-year cumulative risk of erosion was 0.28% (95% CI: 0.17-0.46%). The average device size increased from 14.2 beads ± 1.0 in 2013 to 15.3 beads ± 1.2 in 2019 (P < 0.001). Surgical technique and perioperative management play an important role in the outcomes. Clinical practice changes since magnetic sphincter augmentation has been incorporated into clinical use are associated with improved outcomes and should be further characterized. Smaller device size is associated with increased removal and erosion rates.
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Affiliation(s)
| | | | - Mark Soberman
- Medical Safety, Ethicon Incorporated, Cincinnati, OH, USA
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31
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Schoppmann SF. [Alternative Surgical Anti-Reflux Procedures]. Zentralbl Chir 2021; 146:210-214. [PMID: 33851383 DOI: 10.1055/a-1369-9732] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
Patient satisfaction when treated with acid-suppressing medication for chronic GERD disease is less than 70%. Surgical standardisation, centralisation, improved awareness of patient selection and new surgical methods have stimulated interest in surgical reflux therapy in recent years. Magnetic sphincter augmentation (MSA) seems to be a safe alternative to laparoscopic fundoplication, with reported complication rates of 0.1% and reoperation rates of 3.4% and is also effective (GERD-HRQL improvement from 19.9 to 4.1, p = 0.001 as well PPI cessation and pH normalisation in 79 and 89% of patients, respectively). Electric sphincter augmentation shows promising short-term results in small patient cohorts (92% symptomatic improvement). However, randomised controlled studies comparing these new techniques to the "gold standard" of laparoscopic fundoplication are still missing.
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Zerbib F, Bredenoord AJ, Fass R, Kahrilas PJ, Roman S, Savarino E, Sifrim D, Vaezi M, Yadlapati R, Gyawali CP. ESNM/ANMS consensus paper: Diagnosis and management of refractory gastro-esophageal reflux disease. Neurogastroenterol Motil 2021; 33:e14075. [PMID: 33368919 DOI: 10.1111/nmo.14075] [Citation(s) in RCA: 67] [Impact Index Per Article: 16.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/27/2020] [Revised: 11/11/2020] [Accepted: 12/13/2020] [Indexed: 02/08/2023]
Abstract
Up to 40% of patients with symptoms suspicious of gastroesophageal reflux disease (GERD) do not respond completely to proton pump inhibitor (PPI) therapy. The term "refractory GERD" has been used loosely in the literature. A distinction should be made between refractory symptoms (ie, symptoms may or may not be GERD-related), refractory GERD symptoms (ie, persisting symptoms in patients with proven GERD, regardless of relationship to ongoing reflux), and refractory GERD (ie, objective evidence of GERD despite adequate medical management). The present ESNM/ANMS consensus paper proposes use the term "refractory GERD symptoms" only in patients with persisting symptoms and previously proven GERD by either endoscopy or esophageal pH monitoring. Even in this context, symptoms may or may not be reflux related. Objective evaluation, including endoscopy and esophageal physiologic testing, is requisite to provide insights into mechanisms of symptom generation and evidence of true refractory GERD. Some patients may have true ongoing refractory acid or weakly acidic reflux despite PPIs, while others have no evidence of ongoing reflux, and yet others have functional esophageal disorders (overlapping with proven GERD confirmed off therapy). In this context, attention should also be paid to supragastric belching and rumination syndrome, which may be important contributors to refractory symptoms.
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Affiliation(s)
- Frank Zerbib
- CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Gastroenterology Department, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France
| | | | - Ronnie Fass
- Digestive Health Center, MetroHealth System, Cleveland, OH, USA
| | - Peter J Kahrilas
- Division of Gastroenterology and Hepatology, Northwestern University, Chicago, IL, USA
| | - Sabine Roman
- Hospices Civils de Lyon, Hôpital E Herriot, Digestive Physiology, Université de Lyon, Inserm U1032, LabTAU, Lyon, France
| | - Edoardo Savarino
- Division of Gastroenterology, Department of Surgical, Oncological and Gastroenterological Sciences, University Hospital of Padua, Padua, Italy
| | - Daniel Sifrim
- Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
| | - Michael Vaezi
- Division of Gastroenterology, Vanderbilt University, Nashville, TN, USA
| | - Rena Yadlapati
- Division of Gastroenterology, University of California San Diego School of Medicine, La Jolla, CA, USA
| | - C Prakash Gyawali
- Division of Gastroenterology, Washington University School of Medicine, St. Louis, MO, USA
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Abstract
IMPORTANCE Gastroesophageal reflux disease (GERD) is defined by recurrent and troublesome heartburn and regurgitation or GERD-specific complications and affects approximately 20% of the adult population in high-income countries. OBSERVATIONS GERD can influence patients' health-related quality of life and is associated with an increased risk of esophagitis, esophageal strictures, Barrett esophagus, and esophageal adenocarcinoma. Obesity, tobacco smoking, and genetic predisposition increase the risk of developing GERD. Typical GERD symptoms are often sufficient to determine the diagnosis, but less common symptoms and signs, such as dysphagia and chronic cough, may occur. Patients with typical GERD symptoms can be medicated empirically with a proton pump inhibitor (PPI). Among patients who do not respond to such treatment or if the diagnosis is unclear, endoscopy, esophageal manometry, and esophageal pH monitoring are recommended. Patients with GERD symptoms combined with warning symptoms of malignancy (eg, dysphagia, weight loss, bleeding) and those with other main risk factors for esophageal adenocarcinoma, such as older age, male sex, and obesity, should undergo endoscopy. Lifestyle changes, medication, and surgery are the main treatment options for GERD. Weight loss and smoking cessation are often useful. Medication with a PPI is the most common treatment, and after initial full-dose therapy, which usually is omeprazole 20 mg once daily, the aim is to use the lowest effective dose. Observational studies have suggested several adverse effects after long-term PPI, but these findings need to be confirmed before influencing clinical decision making. Surgery with laparoscopic fundoplication is an invasive treatment alternative in select patients after thorough and objective assessments, particularly if they are young and healthy. Endoscopic and less invasive surgical techniques are emerging, which may reduce the use of long-term PPI and fundoplication, but the long-term safety and efficacy remain to be scientifically established. CONCLUSIONS AND RELEVANCE The clinical management of GERD influences the lives of many individuals and is responsible for substantial consumption of health care and societal resources. Treatments include lifestyle modification, PPI medication, and laparoscopic fundoplication. New endoscopic and less invasive surgical procedures are evolving. PPI use remains the dominant treatment, but long-term therapy requires follow-up and reevaluation for potential adverse effects.
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Affiliation(s)
- John Maret-Ouda
- Upper Gastrointestinal Surgery, Department of Molecular Medicine and Surgery, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden
- Centre for Clinical Research Sormland, Uppsala University, Eskilstuna, Sweden
| | - Sheraz R Markar
- Upper Gastrointestinal Surgery, Department of Molecular Medicine and Surgery, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden
- Department of Surgery and Cancer, Imperial College London, London, United Kingdom
| | - Jesper Lagergren
- Upper Gastrointestinal Surgery, Department of Molecular Medicine and Surgery, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden
- School of Cancer and Pharmaceutical Sciences, King's College London, London, United Kingdom
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Magnetic sphincter augmentation device placement for treatment of gastroesophageal reflux. JAAPA 2020; 33:30-32. [PMID: 33234893 DOI: 10.1097/01.jaa.0000721664.47053.0e] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
Gastroesophageal reflux disease typically is treated with lifestyle modifications and proton pump inhibitors (PPIs). Surgery is effective in treating the symptoms associated with gastroesophageal reflux, but common procedures involve invasive techniques that can leave the patient unable to belch or vomit. Research has raised concerns regarding the long-term use of PPIs, leaving few treatment options for patients with refractory reflux symptoms. The magnetic sphincter augmentation device demonstrates similar efficacy to existing antireflux procedures, avoids complex surgery techniques, and preserves normal physiologic functions at the lower esophageal sphincter. This device is a safe and effective alternative to more invasive procedures for patients whose GERD does not respond to medical management.
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35
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Regression of Barrett’s esophagus after magnetic sphincter augmentation: intermediate-term results. Surg Endosc 2020; 35:5804-5809. [DOI: 10.1007/s00464-020-08074-6] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/04/2020] [Accepted: 10/01/2020] [Indexed: 02/07/2023]
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36
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Magnetic sphincter augmentation with hiatal hernia repair: long term outcomes. Surg Endosc 2020; 35:5607-5612. [DOI: 10.1007/s00464-020-08063-9] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2020] [Accepted: 09/29/2020] [Indexed: 12/22/2022]
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Vaezi MF, Shaheen NJ, Muthusamy VR. State of Evidence in Minimally Invasive Management of Gastroesophageal Reflux: Findings of a Scoping Review. Gastroenterology 2020; 159:1504-1525. [PMID: 32621903 DOI: 10.1053/j.gastro.2020.05.097] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2020] [Revised: 04/30/2020] [Accepted: 05/11/2020] [Indexed: 12/13/2022]
Abstract
BACKGROUNDS & AIMS Endoscopic management of gastroesophageal reflux disease (GERD) is being employed increasingly. The aim of this scoping review was to assess the volume of available evidence on the benefits of endoscopic and minimally invasive surgical therapies for GERD. METHODS criteria were used to perform an extensive literature search of data regarding the reported benefit of endoscopic therapies in GERD. Randomized controlled studies were utilized when available; however, data from observational studies were also reviewed. RESULTS A formal review of evidence was performed in 22 studies. Inclusion and exclusion criteria and study duration were noted and tabulated. Assessment of outcomes was based on symptoms and objective criteria reported by investigators. Reported outcomes for the interventions were tabulated under the heading of subjective (symptom scores, quality of life metrics, and change in proton pump inhibitor use) and objective metrics (pH parameters, endoscopic signs, and lower esophageal sphincter pressure changes). Adverse events were noted and tabulated. The majority of studies showed symptomatic and objective improvement of GERD with the device therapies. Adverse events were minimal. However, normalization of acid exposure occurred in about 50% of patients and, for some modalities, long-term durability is uncertain. CONCLUSIONS This scoping review revealed that the endoluminal and minimally invasive surgical devices for GERD therapy are a promising alternative to proton pump inhibitor therapy. Their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially durability of effect, are better understood.
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Affiliation(s)
- Michael F Vaezi
- Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.
| | - Nicholas J Shaheen
- Division of Gastroenterology, Hepatology, and Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - V Raman Muthusamy
- Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California
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Ferrari D, Asti E, Lazzari V, Siboni S, Bernardi D, Bonavina L. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep 2020; 10:13753. [PMID: 32792508 PMCID: PMC7426413 DOI: 10.1038/s41598-020-70742-3] [Citation(s) in RCA: 27] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2020] [Accepted: 07/27/2020] [Indexed: 12/23/2022] Open
Abstract
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.
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Affiliation(s)
- Davide Ferrari
- Department of Biomedical Sciences for Health, University of Milan, Milan, Italy
| | - Emanuele Asti
- Division of General and Foregut Surgery, IRCCS Policlinico San Donato, Piazza E. Malan, 1, 20097, San Donato Milanese, MI, Italy
| | - Veronica Lazzari
- Division of General and Foregut Surgery, IRCCS Policlinico San Donato, Piazza E. Malan, 1, 20097, San Donato Milanese, MI, Italy
| | - Stefano Siboni
- Division of General and Foregut Surgery, IRCCS Policlinico San Donato, Piazza E. Malan, 1, 20097, San Donato Milanese, MI, Italy
| | - Daniele Bernardi
- Division of General and Foregut Surgery, IRCCS Policlinico San Donato, Piazza E. Malan, 1, 20097, San Donato Milanese, MI, Italy
| | - Luigi Bonavina
- Department of Biomedical Sciences for Health, University of Milan, Milan, Italy. .,Division of General and Foregut Surgery, IRCCS Policlinico San Donato, Piazza E. Malan, 1, 20097, San Donato Milanese, MI, Italy.
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Safety and efficacy of magnetic sphincter augmentation dilation. Surg Endosc 2020; 35:3861-3864. [DOI: 10.1007/s00464-020-07799-8] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/04/2020] [Accepted: 07/07/2020] [Indexed: 12/17/2022]
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Bell R, Lipham J, Louie BE, Williams V, Luketich J, Hill M, Richards W, Dunst C, Lister D, McDowell-Jacobs L, Reardon P, Woods K, Gould J, Buckley FP, Kothari S, Khaitan L, Smith CD, Park A, Smith C, Jacobsen G, Abbas G, Katz P. Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. Clin Gastroenterol Hepatol 2020; 18:1736-1743.e2. [PMID: 31518717 DOI: 10.1016/j.cgh.2019.08.056] [Citation(s) in RCA: 40] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/24/2019] [Revised: 08/19/2019] [Accepted: 08/30/2019] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. METHODS Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. RESULTS Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. CONCLUSIONS In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.
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Affiliation(s)
- Reginald Bell
- Institute of Esophageal and Reflux Surgery, Englewood, Colorado.
| | - John Lipham
- Department of Surgery, University of Southern California, Los Angeles, California
| | - Brian E Louie
- Division of Thoracic Surgery, Swedish Medical Center, Seattle, Washington
| | - Valerie Williams
- Thoracic Surgery Department, St. Elizabeth's Healthcare, Edgewood, Kentucky
| | - James Luketich
- Division of Thoracic Surgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania
| | - Michael Hill
- Department of Surgery, Adirondack Medical Center and Adirondack Surgical Group, Saranac Lake, New York
| | - William Richards
- Department of Surgery, University of South Alabama, Mobile, Alabama
| | - Christy Dunst
- Department of Surgery, Oregon Clinic, Portland, Oregon
| | - Dan Lister
- Arkansas Heartburn Treatment Center, Baptist Health Medical Center, Heber Springs, Arkansas
| | | | - Patrick Reardon
- Department of Surgery, Houston Methodist Hospital, Houston, Texas
| | - Karen Woods
- Department of Medicine, Houston Methodist Hospital, Houston, Texas
| | - Jon Gould
- Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin
| | - F Paul Buckley
- Department of Surgery and Perioperative Care, University of Texas at Austin, Austin, Texas
| | - Shanu Kothari
- Department of Surgery, Prisma Health, Greenville, South Carolina
| | - Leena Khaitan
- Department of Surgery, Digestive Health Institute, University Hospitals, Cleveland Medical Center, Cleveland, Cleveland, Ohio
| | | | - Adrian Park
- Department of Surgery, Anne Arundel Health System and Johns Hopkins Medicine, Annapolis, Maryland
| | | | - Garth Jacobsen
- Department of Surgery, University of California, San Diego, San Diego, California
| | - Ghulam Abbas
- Division of Thoracic Surgery, West Virginia University School of Medicine, Morgantown, West Virginia
| | - Philip Katz
- Department of Gastroenterology, Weill Cornell Medicine, New York, New York
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Richter JE. Laparoscopic Magnetic Sphincter Augmentation: Potential Applications and Safety Are Becoming More Clear-But the Story Is Not Over. Clin Gastroenterol Hepatol 2020; 18:1685-1687. [PMID: 31678603 DOI: 10.1016/j.cgh.2019.10.038] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/10/2019] [Revised: 10/22/2019] [Accepted: 10/23/2019] [Indexed: 02/07/2023]
Affiliation(s)
- Joel E Richter
- Division of Digestive Diseases and Nutrition, Joy McCann Culverhouse Center for Swallowing Disorders, Morsani College of Medicine, University of South Florida, Tampa, Florida
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Magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: pros and cons. Curr Opin Gastroenterol 2020; 36:323-328. [PMID: 32398565 DOI: 10.1097/mog.0000000000000643] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
PURPOSE OF REVIEW The purpose of this magnetic sphincter augmentation (MSA) year in review article is to provide a clear understanding for the current state of MSA literature in 2019, and contrast MSA outcomes with traditional fundoplication. RECENT FINDINGS Continued work was performed in 2019 to expand patient populations eligible for MSA including those with hiatal hernia, post-bariatric patients, patients necessitating a thoracic approach, and patients with esophageal intestinal metaplasia. Additionally, a large systematic review reinforced earlier findings comparing laparoscopic fundoplication to MSA. This study demonstrated equivalency over many different operative outcomes, with MSA patients having less bloating while also retaining the ability to belch and vomit. Furthermore, independent research teams found a modest cost savings for MSA over laparoscopic fundoplication with budget analysis. SUMMARY MSA is a safe and efficacious procedure originally approved for patients with medically refractory, uncomplicated gastroesophageal reflux disease. The accumulating body of evidence suggests patients with intestinal metaplasia or hiatal hernias can safely and effectively undergo MSA, whereas further research will be required before MSA is widely used for post-bariatric patients or for patients requiring a transthoracic surgical approach. MSA is equivalent or superior to laparoscopic fundoplication in all surgical outcomes measured thus far.
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Bellorin O, Dolan P, Vigiola-Cruz M, Al Hussein Alawamlh O, Pomp A, Dakin G, Afaneh C. Robotic-assisted approaches to GERD following sleeve gastrectomy. Surg Endosc 2020; 35:3033-3039. [PMID: 32572629 DOI: 10.1007/s00464-020-07753-8] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2020] [Accepted: 06/16/2020] [Indexed: 11/28/2022]
Abstract
BACKGROUND Sleeve gastrectomy (SG) is the most common bariatric operation in the United States but increases the incidence of gastroesophageal reflux disease (GERD). The aim of our study was to describe our experience with robotic-assisted management of intractable GERD after SG. METHODS A systematic review of a prospectively maintained database was performed of consecutive patients undergoing robotic-assisted magnetic sphincter augmentation placement after sleeve gastrectomy (MSA-S group) or conversion to Roux-en-Y gastric bypass (RYGB group) for GERD from 2015 to 2019 at our tertiary- care bariatric center. These were compared to a consecutive group of patients undergoing robotic-assisted magnetic sphincter augmentation placement (MSA group) for GERD without a history of bariatric surgery from 2016 to 2019. The primary outcome was perioperative morbidity. Secondary outcomes were operative time (OT), 90-day re-intervention rate, length of stay, symptom resolution and weight change. RESULTS There were 51 patients included in this study; 18 patients in the MSA group, 13 patients in the MSA-S group, and 20 patients in the RYGB group. There was no significant difference in age, gender, ASA score, preoperative endoscopic findings, or DeMeester scores (P > 0.05). BMI was significantly higher in patients undergoing RYGB compared to MSA or MSA-S (P < 0.0001). There were significant differences in OT between the MSA and RYGB groups (P < 0.0001) and MSA-S and RYGB groups (P = 0.009), but not MSA group to MSA-S group (P = 0.51). There was no significant difference in intraoperative and postoperative morbidity (P = 1.0 and P = 0.60, respectively). 30-day morbidity: 5.6% (MSA), 15.4% (MSA-S) and 15% (RYGB). There was no difference on PPI discontinuation among groups, with more than 80% success rate in all. CONCLUSIONS The use of the robotic platform in the different approaches available for treatment of GERD after SG appears to be a feasible option with low morbidity and high success rate. Further data is needed to support our findings.
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Affiliation(s)
- Omar Bellorin
- Department of Surgery, New York Presbyterian Hospital - Weill Cornell Medicine, 525 East 68th St., Box 294, New York, NY, 10065, USA
| | - Patrick Dolan
- Department of Surgery, New York Presbyterian Hospital - Weill Cornell Medicine, 525 East 68th St., Box 294, New York, NY, 10065, USA
| | - Mariana Vigiola-Cruz
- Department of Surgery, New York Presbyterian Hospital - Weill Cornell Medicine, 525 East 68th St., Box 294, New York, NY, 10065, USA
| | | | - Alfons Pomp
- Department of Surgery, New York Presbyterian Hospital - Weill Cornell Medicine, 525 East 68th St., Box 294, New York, NY, 10065, USA
| | - Gregory Dakin
- Department of Surgery, New York Presbyterian Hospital - Weill Cornell Medicine, 525 East 68th St., Box 294, New York, NY, 10065, USA
| | - Cheguevara Afaneh
- Department of Surgery, New York Presbyterian Hospital - Weill Cornell Medicine, 525 East 68th St., Box 294, New York, NY, 10065, USA.
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The role of preoperative workup in predicting dysphagia, dilation, or explantation after magnetic sphincter augmentation. Surg Endosc 2020; 34:3663-3668. [PMID: 32462333 DOI: 10.1007/s00464-020-07664-8] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2020] [Accepted: 05/20/2020] [Indexed: 02/06/2023]
Abstract
BACKGROUND Magnetic sphincter augmentation (MSA) is a surgical treatment for gastroesophageal reflux disease using a ring of titanium beads to improve the function of the lower esophageal sphincter. Prior to implantation, a comprehensive preoperative esophageal workup is required to determine patient candidacy in an effort to reduce the dysphagia, dilation, and explantation rate of the device. This study was designed to assess the best predictors for these endpoints. METHODS A prospectively maintained IRB-approved database was retrospectively reviewed for patients undergoing MSA implantation. Patients were divided into 3 groups, those that needed no intervention, those that needed medical intervention with oral steroids for reported dysphagia, and surgical intervention, which included endoscopic dilation and/or surgical explantation. Primary endpoints included preoperative objective and subjective testing from a comprehensive esophageal workup including intraoperative notation of number of beads on the device. RESULTS There were 99 patients eligible for the study with a mean age of 52 and mean follow-up of 10.2 months. Mean BMI was 27 and 59% were female. The no-intervention group had 59 patients, medical intervention group had 25 patients, and surgical intervention group had 15 patients. Preoperative esophageal manometry findings, pH testing off medications, endoscopic and radiologic evaluation showed no difference between the 3 groups. No differences were seen in preoperative subjective evaluations based on GERD-HRQL or RSI scores. There was no difference in average number of beads on the device between the 3 groups. CONCLUSION A comprehensive esophageal workup is important to confirm the presence of gastroesophageal reflux disease and rule out other esophageal pathology. However, this study shows that a preoperative comprehensive esophageal workup does not predict which patients will develop dysphagia or require either medical or surgical interventions following MSA implantation.
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Klimara MJ, Randall DR, Allen J, Figueredo E, Johnston N. Proximal reflux: biochemical mediators, markers, therapeutic targets, and clinical correlations. Ann N Y Acad Sci 2020; 1481:127-138. [PMID: 32401362 DOI: 10.1111/nyas.14366] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2020] [Revised: 04/14/2020] [Accepted: 04/21/2020] [Indexed: 12/12/2022]
Abstract
Airway reflux is implicated in the pathophysiology of a wide range of adult and pediatric upper and lower airway diseases. However, the diagnosis of proximal reflux-associated disease remains challenging due to evolving clinical criteria and institutional and regional variances in diagnostic practices. Evidence suggests that nonacidic contents of reflux may serve as both pathologic mediators of and biomarkers for reflux in the upper airway. Furthermore, they offer potential pharmaceutical and surgical intervention targets and are the focus of novel clinical diagnostic tools currently under investigation.
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Affiliation(s)
- Miles J Klimara
- Department of Otolaryngology-Head & Neck Surgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa
| | - Derrick R Randall
- Department of Surgery, Section of Otolaryngology-Head & Neck Surgery, University of Calgary, Calgary, Alberta, Canada
| | - Jacqueline Allen
- Department of Otolaryngology-Head & Neck Surgery, University of Auckland, Auckland, New Zealand
| | - Edgar Figueredo
- Minimally Invasive Surgery, Surgical Critical Care, Department of Surgery, Seattle VA Medical Center, University of Washington, Seattle, Washington
| | - Nikki Johnston
- Department of Otolaryngology & Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin.,Department of Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, Wisconsin
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Bonavina L, Boyle N, Dunn C, Horbach T, Knowles TB, Lipham JC, Louie BE, Markar S, Schppmann SF, Zehetner J. Comment on: Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease. Br J Surg 2020; 107:e209. [PMID: 32320049 DOI: 10.1002/bjs.11567] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2020] [Accepted: 02/03/2020] [Indexed: 01/08/2023]
Affiliation(s)
- L Bonavina
- Deaprtment of Surgery, University of Milan Medical School, Milan, Italy
| | - N Boyle
- London Reflux Centre, Lister Hospital, London, UK
| | - C Dunn
- Division of Upper GI and General Surgery, Department of Surgery, Keck Medical Center of USC, University of Southern California, Los Angeles, California, USA
| | - T Horbach
- General and Abdominal Surgery, Schoen Clinic, Nürnberg Fürth, Germany
| | - T B Knowles
- Swedish Digestive Health Institute, Division of Thoracic Surgery, Swedish Medical Center, Seattle, Washington, USA
| | - J C Lipham
- Division of Upper GI and General Surgery, Department of Surgery, Keck Medical Center of USC, University of Southern California, Los Angeles, California, USA
| | - B E Louie
- London Reflux Centre, Lister Hospital, London, UK
| | - S Markar
- Department of Surgery and Cancer, Imperial College, London, UK
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Tsai C, Steffen R, Kessler U, Merki H, Lipham J, Zehetner J. Postoperative Dysphagia Following Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease. Surg Laparosc Endosc Percutan Tech 2020; 30:322-326. [DOI: 10.1097/sle.0000000000000785] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
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Dunn C, Bildzukewicz N, Lipham J. Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease. Gastrointest Endosc Clin N Am 2020; 30:325-342. [PMID: 32146949 DOI: 10.1016/j.giec.2019.12.010] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
Magnetic sphincter augmentation is an effective and safe surgical method for the treatment of gastroesophageal reflux disease (GERD). The device has been compared with twice-daily proton pump inhibitor therapy and laparoscopic fundoplication (in randomized trials and prospective cohort studies, respectively). Magnetic sphincter augmentation was superior to medical therapy and equivalent to surgery for the relief of GERD symptoms. Recent research focuses on implanting the device into more complex patients, such as those with larger hiatal hernias or those with Barrett's esophagus. Additional novel research topics include cost analysis and predicting and minimizing postoperative dysphagia.
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Affiliation(s)
- Colin Dunn
- General Surgery Rutgers NJMS, 185 South Orange Avenue, Medical Science Building, Room G 594, Newark, NJ 07101, USA
| | - Nikolai Bildzukewicz
- The Advanced GI/MIS Fellowship, Keck Medical Center of USC, 1510 San Pablo Street, HCC I, Suite 514, Los Angeles, CA 90033-4612, USA
| | - John Lipham
- Upper GI Cancer, Keck Medical Center of USC, 1510 San Pablo Street, HCC I, Suite 514, Los Angeles, CA 90033-4612, USA.
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Dragomiretska NV, Babov KD, Gushcha SG, Zabolotna IB, Plakida AL, Izha AN, Babova IK, Nasibullin BA, Trubka IA. Application of mineral waters in the complex treatment of patients with gastroesophageal reflux disease. MINERVA GASTROENTERO 2020; 66:225-237. [PMID: 32218417 DOI: 10.23736/s1121-421x.20.02601-x] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
BACKGROUND Gastroesophageal reflux disease (GERD) is one of the most common gastric pathologies. Recently, there has been a growing interest in the healing effects of mineral waters (MW). METHODS Ninety patients with GERD were under observation. The study used the following methods: anamnestic, clinical, studies of biochemical blood parameters, ultrasonographic studies of the digestive system, fibroesophagogastroduodenoscopy with intragastric pH-metric. After preliminary research, all patients were randomly divided into three groups of 30 people. The control group (group 1) who were prescribed a basic treatment complex-dietary and proton pump inhibitor group drugs. Patients of group 2 in addition to the standard course of treatment received boric highly mineralized bicarbonate sodium water. Patients of group 3 in addition to the basic therapy were prescribed an internal course treatment of highly mineralized sulfate-bicarbonate sodium-magnesium water. RESULTS The use of the basic complex of treatment for a month in control group did not lead to a significant leveling of signs of dyspeptic and asthenic syndromes. The use of boron highly mineralized sodium bicarbonate water led to a significant leveling of signs of abdominal pain and dyspeptic syndromes, improvement of acid-forming function of the stomach, but no reliable dynamics were observed in eliminating signs of cytolytic, mesenchymal inflammatory and cholestatic syndromes. Application of highly mineralized sulfate-hydrocarbonate sodium magnesium water improves the elimination of dyspepsia and pain syndromes, normalization of the functional state of the liver. CONCLUSIONS The obtained data confirm the prospects of using highly mineralized mineral waters in the complex treatment of GERD patients.
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Affiliation(s)
- Nataliya V Dragomiretska
- Department of Medical Rehabilitation, State Institution "Ukrainian Research Institute of Medical Rehabilitation and Resorts of the Ministry of Health of Ukraine, " Odessa, Ukraine
| | - Konstantin D Babov
- Department of Medical Rehabilitation, State Institution "Ukrainian Research Institute of Medical Rehabilitation and Resorts of the Ministry of Health of Ukraine, " Odessa, Ukraine
| | - Sergey G Gushcha
- Department of Basic Research, State Institution "Ukrainian Research Institute of Medical Rehabilitation and Resorts of the Ministry of Health of Ukraine, " Odessa, Ukraine
| | - Irina B Zabolotna
- Department of Medical Rehabilitation, State Institution "Ukrainian Research Institute of Medical Rehabilitation and Resorts of the Ministry of Health of Ukraine, " Odessa, Ukraine
| | - Alexander L Plakida
- Department of Physical Rehabilitation, Sports Medicine, Physical Education and Valeology, Odessa National Medical University, Odessa, Ukraine -
| | - Anna N Izha
- Department of Medical Rehabilitation, State Institution "Ukrainian Research Institute of Medical Rehabilitation and Resorts of the Ministry of Health of Ukraine, " Odessa, Ukraine
| | - Irina K Babova
- Odessa Regional Institute of Public Administration of the National Academy of Public Administration under the President of Ukraine, Odessa, Ukraine
| | - Boris A Nasibullin
- Department of Basic Research, State Institution "Ukrainian Research Institute of Medical Rehabilitation and Resorts of the Ministry of Health of Ukraine, " Odessa, Ukraine
| | - Irina A Trubka
- Shupik' National Medical Academy of Postgraduate Education, Kyiv, Ukraine
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50
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Riva CG, Asti E, Lazzari V, Aquilino K, Siboni S, Bonavina L. Magnetic Sphincter Augmentation After Gastric Surgery. JSLS 2020; 23:JSLS.2019.00035. [PMID: 31624454 PMCID: PMC6785249 DOI: 10.4293/jsls.2019.00035] [Citation(s) in RCA: 20] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022] Open
Abstract
Background Persistent or de novo gastroesophageal reflux disease (GERD) may be a significant clinical issue after gastric/bariatric surgical procedures. We investigated the effect of magnetic sphincter augmentation (MSA) in the treatment of GERD after previous gastric/bariatric surgery. Database We conducted a systematic review according to the Preferred Reporting Items For Systematic Reviews and Meta-analyses statement. We searched multiple databases (PubMed, Cochrane, Embase, Scopus) up to May 2019. We also queried the prospectively collected database of patients who underwent MSA at our tertiary-care hospital and compared postsurgical to naïve patients operated during the same time period. Results Seven studies (3 case series and 4 case reports), for a total of 35 patients, met the inclusion criteria in the systematic review. The most common index operation was a bariatric procedure, either sleeve gastrectomy or Roux-en-Y gastric bypass. After MSA implant, the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score significantly improved compared to baseline (P = .005). Two patients (5.7%) required laparoscopic device removal. In the local institutional cohort series of 67 patients treated by MSA, the prevalence of preoperative grade B esophagitis, operative time, size of MSA, and length of stay were greater in patients with prior gastric surgery compared to naïve patients. Conclusions MSA is a safe, simple, and standardized antireflux procedure. It is also feasible in patients with refractory GERD following gastric/bariatric surgery. Further prospective and comparative studies are needed to validate the preliminary clinical experience in this subset of patients.
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Affiliation(s)
- Carlo Galdino Riva
- Department of Biomedical Sciences for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milano, Milano, Italy
| | - Emanuele Asti
- Department of Biomedical Sciences for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milano, Milano, Italy
| | - Veronica Lazzari
- Department of Biomedical Sciences for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milano, Milano, Italy
| | - Krizia Aquilino
- Department of Biomedical Sciences for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milano, Milano, Italy
| | - Stefano Siboni
- Department of Biomedical Sciences for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milano, Milano, Italy
| | - Luigi Bonavina
- Department of Biomedical Sciences for Health, Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milano, Milano, Italy
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