Interventional procedure overview of laparoscopic insertion of a magnetic ring for gastro-oesophageal reflux disease
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.
Article | Number of patients/follow up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
|---|---|---|---|
Alicuben ET, Bell RCW, Jobe BA et al. (2018) Worldwide experience with erosion of the magnetic sphincter augmentation device. Journal of gastrointestinal surgery: official journal of the Society for Surgery of the Alimentary Tract 22(8): 1442-7 | Review of the MAUDE database n=9,453 (erosion, n=29) | Erosion of the LINX device is an important but rare complication to recognise that has been safely managed via minimally invasive approaches without long-term consequences. | Recent review (DeMarchi 2021) is included in the key evidence. |
Alicuben ET, Tatum JM, Bildzukewicz N et al. (2019) Regression of intestinal metaplasia following magnetic sphincter augmentation device placement. Surgical endoscopy 33(2): 576-9 | Case series n=86 | MSA is effective in achieving regression of intestinal metaplasia. Longer-term follow up is needed to assess durability of effect and make meaningful comparisons to fundoplication. | This study examined the possible progression and the anticipated regression rate of intestinal metaplasia after MSA for GORD and patients with intestinal metaplasia were not initially considered candidates for this procedure. |
Antiporda M, Jackson C, Smith CD et al. (2019) Short-term outcomes predict long-term satisfaction in patients undergoing laparoscopic magnetic sphincter augmentation. Journal of laparoendoscopic & advanced surgical techniques. Part A 29(2): 198-202 | Case series n=98 | Laparoscopic MSA is associated with excellent outcomes with decrease in GORD-HRQL scores in short term that are durable to longer term follow up, and with low rates of new-onset dysphagia. | Studies with larger samples or better designs are included in the key evidence. |
Asti E, Bonitta G, Lovece A et al. (2016) Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis. Medicine (Baltimore): 95(30): e4366. | Non-randomised comparative study n=238 (MSA, n=103; LTF, n=135) | The results show that LTF and LINX provide similar disease-specific quality of life over time in patients with early stage GORD. | This study was included in Guidozzi (2019). |
Asti E, Siboni S, Lazzari V et al. (2017) Removal of the magnetic sphincter augmentation device: surgical technique and results of a single-center cohort study. Annals of surgery 265(5): 941-5 | Case series n=164 | Laparoscopic removal of the LINX device can be safely done as a 1-stage procedure and in conjunction with fundoplication even in patients presenting with device erosion. | Studies with larger samples or better designs are included in the key evidence. |
Asti E, Aiolfi A, Lazzari V et al. (2018) Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies. Updates in surgery 70(3): 323-30 | Review | The procedure has proven to be highly effective in improving typical reflux symptoms, reducing the use of proton-pump inhibitors, and decreasing oesophageal acid exposure. The device can be easily removed if necessary. Most removals have occurred within 2 years after implant and have been managed non-emergently, with no complications or long-term consequences. | Review article |
Ayazi S, Schwameis K, Zheng P et al. (2021) The impact of magnetic sphincter augmentation (MSA) on esophagogastric junction (EGJ) and esophageal body physiology and manometric characteristics. Annals of surgery | Case series n=100 | MSA results in improvement in the LOS manometric characteristics. Although the device results in an increased outflow resistance at the EGJ, the compensatory increase in the force of oesophageal contraction will result in unaltered oesophageal peristaltic progression and bolus clearance. | Studies with larger samples or better designs are included in the key evidence. |
Ayazi S, Zaidi AH, Zheng P. et al. (2020) Comparison of surgical payer costs and implication on the healthcare expenses between laparoscopic magnetic sphincter augmentation (MSA) and laparoscopic Nissen fundoplication (LNF) in a large healthcare system. Surgical Endoscopy 34(5): 2279-86 | Non-randomised comparative study n=1,226 (MSA, n=195; LNF, n=1,131) | When compared with LNF, MSA results in a reduction of disease-related expenses for the payer in the year after surgery. While MSA is associated with a higher procedural payer cost compared with LNF, payer costs may offset due to reduction in the expenses after surgery. | Limited efficacy and safety data were reported. |
Ayazi S, Schwameis K, Zheng P et al. (2021) The impact of magnetic sphincter augmentation (MSA) on esophagogastric junction (EGJ) and esophageal body physiology and manometric characteristics. Annals of surgery | Case series n=100 | MSA results in improvement in the LOS manometric characteristics. Although the device results in an increased outflow resistance at the EGJ, the compensatory increase in the force of oesophageal contraction will result in unaltered oesophageal peristaltic progression and bolus clearance. | Studies with larger samples or better designs are included in the key evidence. |
Ayazi S, Zheng P, Zaidi A H et al. (2020) Magnetic sphincter augmentation and postoperative dysphagia: characterization, clinical risk factors, and management. Journal of gastrointestinal surgery: official journal of the Society for Surgery of the Alimentary Tract 24(1): 39-49 | Case series n=380 | In a large cohort of patients who had MSA, authors report 15.5% rate of persistent postoperative dysphagia. The overall response rate to dilation therapy is 67%, and the efficacy of dilation with each subsequent procedure reduces. Patients with normal hiatal anatomy, significant preoperative dysphagia, and less than 80% peristaltic contractions of the smooth muscle portion of the oesophagus should be counselled that they have an increased risk for persistent postoperative dysphagia. | Studies with larger samples or better designs are included in the key evidence. |
Baison GN, Jackson AS, Wilshire CL et al. (2022) The impact of ineffective esophageal motility on patients undergoing magnetic sphincter augmentation. Annals of surgery | Non-randomised comparative study n=210 (105 patient with ineffective oesophageal motility and 105 matched controls) | Patients with ineffective oesophageal motility having MSA show improved quality of life and reduction in acid exposure. Key differences in ineffective oesophageal motility patients include lower rates of objective GORD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GORD patients with ineffective oesophageal motility should be counselled about these possibilities. | Studies with larger samples or better designs are included in the key evidence. |
Bell RCW (2020) Management of regurgitation in patients with gastroesophageal reflux disease. Current opinion in gastroenterology 36(4): 336-43 | Review | Precision care of regurgitation should recognise the low-therapeutic impact of acid control, while antireflux procedures are very successful. | Review article |
Bona D, Saino G, Mini E et al. (2021) Magnetic sphincter augmentation device removal: surgical technique and results at medium-term follow-up. Langenbeck's archives of surgery 406(7): 2545-51 | Case series n=5 | 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. | Small sample |
Bonavina L, Fisichella PM, Gavini S et al. (2020) Clinical course of gastroesophageal reflux disease and impact of treatment in symptomatic young patients. Annals of the New York Academy of Sciences | Review | In patients with early-stage disease, when the LOS function is still preserved and before endoscopically visible Barrett's oesophagus develops, novel laparoscopic procedures, such as magnetic and electric sphincter augmentation, may have a greater role than conventional surgical therapy. | Review article |
Bonavina L, Boyle N and Schoppmann SF (2021) The role of magnetic sphincter augmentation in the treatment of gastroesophageal reflux disease. Current opinion in gastroenterology 37(4): 384-9 | Review | MSA has a favourable side-effect profile and is highly effective in reducing typical reflux symptoms, medication dependency, and oesophageal acid exposure. Excellent outcomes have been confirmed over a 12-year follow up, showing that the operation has the potential to prevent GORD progression. Further studies are needed to confirm the cost-effectiveness of this procedure in patients with more advanced disease-stage and prior gastric surgery. A randomised control trial comparing MSA with fundoplication could raise the level of evidence and the strength of recommendation. | Review article |
Bonavina L, Saino G, Bona D et al. (2013) One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center. J Am Coll Surg 217(4): 577-85 | Case series n=100 | MSA for GORD in clinical practice provides safe and long-term reduction of oesophageal acid exposure, substantial symptom improvement, and elimination of daily PPI use. | This study was included in Zhuang (2021). |
Bortolotti M (2021) Magnetic challenge against gastroesophageal reflux. World Journal of Gastroenterology 27(48): 8227-41 | Review | considering the available studies, it can be said that the MSA system achieves a GER control roughly similar to that of fundoplication with the advantage of less gas bloating and a greater ability to vomit and belch. On the other hand, it has the disadvantage of more prolonged and severe dysphagia, needing endoscopic dilatation more frequently and, in some cases, device removal. The latter may also be necessary for some other severe complications, which are infrequent, such as mucosal erosions and device penetration through the oesophageal wall. | Review article |
Broderick RC, Smith CD, Cheverie JN et al. (2020) Magnetic sphincter augmentation: a viable rescue therapy for symptomatic reflux following bariatric surgery. Surgical Endoscopy 34(7): 3211-5 | Case series n=13 | LINX placement is a safe, effective treatment option for surgical management of refractory GORD after bariatric surgery. It can relieve symptoms and obviate the requirement of high-dose medical management. Magnetic LOS augmentation should be another tool in the surgeon's toolbox for managing reflux after bariatric surgery in select patients. | Small sample |
Buckley FP, Bell RCW, Freeman K et al. (2018) Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation. Surg Endosc. 32(4):1762-8 | Case series n=200 | This prospective study of 200 patients with >3 cm hernias having MSA with hiatoplasty resulted in favourable outcomes with a median of 9 months of follow up. Comparing this to published reports of MSA in patients with <3 cm hernias, the safety and clinical efficacy of MSA are independent of initial hernia size. | This study was included in Guidozzi (2019) |
Chen MY, Huang DY, Wu A et al. (2017) Efficacy of magnetic sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease in short term: a meta-analysis. Canadian journal of gastroenterology & hepatology 2017: 9596342 | Meta-analysis n=5 studies | MSA can be recommended as an alternative treatment for GORD according to their short-term studies, especially in main-features of gas-bloating, due to shorter operative time and less complication of gas or bloating. | All studies in this meta-analysis were included in Aiolfi (2018) and Zhuang (2021) |
Clapp B, Dodoo C, Harper B et al. (2021) Magnetic sphincter augmentation at the time of bariatric surgery: an analysis of the MBSAQIP. Surgery for obesity and related diseases: official journal of the American Society for Bariatric Surgery 17(3): 555-61 | Non-randomised comparative study n=319,580 (MSA, n=24; non-MSA, 319,556) | MSA is safe in the short term in metabolic and bariatric surgery. There is no difference in major morbidity or mortality and operative times are similar in MSA patients. The long-term efficacy of this practice is unknown. | Sample for MSA was small. This study examined the short-term outcomes of patients that had metabolic and bariatric surgery concomitantly with MSA |
Czosnyka NM, Buckley FP, Doggett SL et al. (2017) Outcomes of magnetic sphincter augmentation - A community hospital perspective. American journal of surgery 213(6): 1019-23 | Case series n=102 | MSA is a safe and effective treatment for GORD, with significant improvement in quality of life. GORD-HRQL, medication reduction, operative times, and dysphagia rates were similar to other reports, showing the reproducibility of MSA. Lower dilation rates may be due to refinements in technique and postoperative dietary management. | Studies with larger samples or better designs are included in the key evidence. |
Dunn C, Bildzukewicz N and Lipham J (2020) Magnetic sphincter augmentation for gastroesophageal reflux disease. Gastrointestinal Endoscopy Clinics of North America 30(2): 325-42 | Review | MSA with LINX is an effective surgical treatment of reflux disease. Intermediate-term outcomes have shown safety and efficacy of the LINX device compared with both laparoscopic fundoplication and medical therapy. New research has expanded on indications for MSA, including after failure of single PPI therapy rather than twice-daily therapy, in patients with Barrett's oesophagus, and in patients with large hiatal hernias. | Review article |
Ganz RA (2017) A modern magnetic implant for gastroesophageal reflux disease. Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association 15(9): 1326-37 | Review | MSA is proven to be effective and safe in treating GORD and should be considered a surgical option for patients dissatisfied with medical management and considering surgical therapy, particularly for those seeking a fundic-sparing operation, and with reflux parameters consistent with study cohorts. | Review article |
Ganz RA, Edmundowicz SA, Taiganides PA et al. (2016) Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol: 14(5): 671-7 | Case series n=100 | Augmentation of the LOS with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the MSA device for patients with GORD. | This study was included in Zhuang (2021). |
Ganz RA, Peters JH, Horgan S et al. (2013) Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 368(8): 719-27 | Case series n=100 | The results showed that exposure to oesophageal acid decreased, reflux symptoms improved, and use of PPIs decreased. Follow-up studies are needed to assess long-term safety. | This study was included in Zhuang (2021). |
Gyawali CP and Fass R (2018) Management of gastroesophageal reflux disease. Gastroenterology 154(2): 302-18 | Review | MSA may be a viable alternative to ARS for patients with well-documented reflux disease, particularly patients with regurgitation, in the absence of significant structural disruption at the EGJ, or oesophageal body motor dysfunction. However, the long-term consequences of having an implanted titanium bracelet need to be better understood. | Review article |
Halpern SH, Gupta A, Jawitz OK et al. (2021) Safety and efficacy of an implantable device for management of gastroesophageal reflux in lung transplant recipients. Journal of Thoracic Disease 13(4): 2116-27 | Case series n=17 | Use of the LINX MSA device in a cohort of lung transplant recipients was associated with similar short-term safety compared with traditional fundoplication, however assessment of efficacy was limited. Further investigation is needed to characterise the long-term efficacy of LINX implantation after LTx. | Small sample |
Hawasli A, Sadoun M, Meguid A et al. (2019) Laparoscopic placement of the LINX system in management of severe reflux after sleeve gastrectomy. American Journal of Surgery 217(3): 496-9 | Case series n=13 | The LINX® system may be used as an alternative to RYGB conversion in managing refractory post-SG reflux. | Small sample |
Hawasli A, Tarakji M and Tarboush M (2017) Laparoscopic management of severe reflux after sleeve gastrectomy using the LINX R system: Technique and one year follow up case report. International journal of surgery case reports 30: 148-51 | Case report n=1 | Laparoscopic placement of the LINX® system to correct severe reflux after sleeve gastrectomy is a safe alternative procedure to conversion to a Roux-en-y gastric bypass. | Single case report |
Hillman L, Yadlapati R, Whitsett M et al. (2017) Review of antireflux procedures for proton pump inhibitor nonresponsive gastroesophageal reflux disease. Diseases of the esophagus: official journal of the International Society for Diseases of the Esophagus 30(9): 1-14 | Review | Laparoscopic fundoplication remains the most proven therapeutic approach. Newer antireflux procedures such as MSA and transoral incisionless fundoplication offer alternatives with varying degrees of success, durability, and side effect profiles that may better suit individual patients. Larger head-to-head comparison trials are needed to better characterise the difference in symptom response and side effect profiles. | Review article |
Huynh P, Konda V, Sanguansataya S et al. (2020) mind the gap: current treatment alternatives for GERD patients failing medical treatment and not ready for a fundoplication. Surgical laparoscopy, endoscopy & percutaneous techniques 31(2): 264-76 | Review | This literature review compares 3 rival procedures to treat "gap" patients for GORD with 4 common endpoints. MSA appears to have the most reproducible and linear outcomes but is the most invasive of the 3 procedures. MSA outcomes most closely mirrors that of fundoplication. | Review article |
Irribarra MM, Blitz S, Wilshire CL et al. (2019) Does treatment of the hiatus influence the outcomes of magnetic sphincter augmentation for chronic GERD? Journal of gastrointestinal surgery: official journal of the Society for Surgery of the Alimentary Tract 23(6): 1104-12 | Non-randomised comparative study n=197 (minimal dissection, n=81; crural closure, n=40; formal crural repair, n=42; extensive dissection without closure, n=34) | Hiatal dissection with restoration of oesophageal length and crural closure during MSA increases the likelihood of normalising acid exposure. | Studies with larger samples or better designs are included in the key evidence. |
Ji H, Chandrasekhara V, Leggett CL (2020) Magnetic sphincter augmentation device malfunction. Gastrointestinal endoscopy | Case report n=1 | It is unclear what led to device failure in this particular patient. Potential contributing factors include a hiatal hernia size >3 cm requiring intraoperative repair, and obesity. MSA device failure should be considered for patients with recurrent GORD symptoms and can be identified with x-ray or fluoroscopic imaging. | Single case report |
Kirkham EN, Main BG, Jones KJB et al. (2020) Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease. The British journal of surgery 107(1): 44-55 | Systematic review n=39 studies | Most studies on MSA lacked information about patient selection, governance, expertise, techniques and outcomes, or varied between studies. Currently, MSA is being used despite a lack of robust evidence for its effectiveness. | Meta-analysis was not conducted, and most studies were included in Aiolfi (2018), Zhuang (2021) or Guidozzi (2019). |
Kuckelman JP, Barron MR and Martin MJ (2017) "The missing LINX" for gastroesophageal reflux disease: Operative techniques video for the LINX magnetic sphincter augmentation procedure. American journal of surgery 213(5): 984-7 | Case series n=2 | LINX placement offers a technically unique option that effectively provides a less invasive alternative for symptomatic reflux disease. This procedure is effective and safe in patients with significantly altered anatomy or previous foregut surgery when there is strict adherence to sound surgical technique and when crucial operative steps are accomplished. | Small sample and limited efficacy and safety data reported. |
Kuckelman JP, Phillips CJ, Derickson MJ et al. (2018) Esophageal magnetic sphincter augmentation as a novel approach to post-bariatric surgery gastroesophageal reflux disease. Obesity surgery 28(10): 3080-3086 | Non-randomised comparative study n=28 | MSA is a technically simple operation that offers a safe and highly effective new option for all patients with GORD. This procedure appears to exhibit a similar profile for patients who have previously had bariatric surgery, particularly sleeve gastrectomy. Prospective randomised studies will be necessary, but there is exciting potential for the role of MSA in providing surgeons a new and much needed tool in their armamentarium against refractory or de novo GORD after bariatric procedures. | Studies with larger samples or better designs are included in the key evidence. |
Kuckelman JP, Phillips CJ, Hardin MO et al. (2017) Standard vs expanded indications for esophageal magnetic sphincter augmentation for reflux disease. JAMA surgery 152(9): 890-891 | Non-randomised comparative study n=31 | Evidence found MSA to be safe and effective for GORD, with relatively low complication rates and acceptable degrees of improvement in subjective GORD symptoms and in G-QOL survey scores for all patients. Of greatest importance, results were equivalent even when using MSA for expanded indications, such as larger hiatal hernias, higher BMI, or prior foregut surgery. | Studies with larger samples or better designs are included in the key evidence. |
Laird J (2020) Magnetic sphincter augmentation device placement for treatment of gastroesophageal reflux. JAAPA: official journal of the American Academy of Physician Assistants 33(12): 30-2 | Review | The MSA procedure showed the results in treating reflux and regurgitation, with reduction in PPI use comparable with that seen with fundoplication, but without the loss of ability to belch and vomit. The improvement in quality of life and the less-invasive nature of the procedure offer patients with GORD an alternative between medical management and more invasive surgeries. The MSA procedure should be considered a viable option for any antireflux surgical candidate. | Review article |
Louie BE, Smith CD, Smith CC et al. (2019) Objective evidence of reflux control after magnetic sphincter augmentation: one year results from a post approval study. Annals of surgery 270(2): 302-308 | Case series n=200 | Safety and effectiveness of MSA has been shown outside of an investigational setting to further confirm MSA as treatment for GORD. | This study was included in Zhuang (2021) |
Louie BE, Farivar AS, Shultz D et al. (2014) Short-term outcomes using magnetic sphincter augmentation versus Nissen fundoplication for medically resistant gastroesophageal reflux disease. Annals of Thoracic Surgery 98: 498–505 | Non-randomised comparative study n=66 | MSA results in similar objective control of GORD, symptom resolution, and improved quality of life compared with LNF. MSA seems to restore a more physiologic sphincter that allows physiologic reflux, facilitates belching, and creates less bloating and flatulence. This device has the potential to allow individualised treatment of GORD and increase the surgical treatment of GORD. | Studies with larger samples or better designs are included in the key evidence. |
Melloni M, Lazzari V, Asti E et al. (2018) Magnetic sphincter augmentation is an effective option for refractory duodeno-gastro-oesophageal reflux following Billroth II gastrectomy. BMJ case reports 2018 | Case report n=1 | MSA is a new and highly standardised surgical option for treating refractory GORD after partial gastrectomy and Billroth 2 reconstruction. Compared with the classic Roux-en-Y anastomosis, MSA can be done laparoscopically and can simultaneously correct acid and biliary reflux. | Single case report |
Mermelstein J, Mermelstein AC and Chait MM (2018) Proton pump inhibitor-refractory gastroesophageal reflux disease: Challenges and solutions. Clinical and Experimental Gastroenterology 11: 119-34 | Review | Data is limited to short-term case series, but multiple prospective studies have shown the safety and efficacy of LINX in treating refractory GORD symptoms. | Review article |
Min MX and Ganz RA (2014) Update in procedural therapy for GERD - Magnetic sphincter augmentation, endoscopic transoral incisionless fundoplication vs laparoscopic Nissen fundoplication. Current Gastroenterology Reports 16(2): 374 | Review | Collective data gathered from 4 studies published within the past year suggest that MSA, TIF and Nissen fundoplication share comparable effectiveness in pH monitoring and patient satisfaction, TIF may have a lower PPI cessation rate, and Nissen fundoplication needed longer recovery time and had a more serious adverse effects profile. Large, prospective, RCTs are needed to reliably compare the 3 procedures. | Review article |
Ndubizu GU, Petrick AT and Horsley R (2020) Concurrent magnetic sphincter augmentation and hiatal hernia repair for refractory GERD after laparoscopic sleeve gastrectomy. Surgery for Obesity and Related Diseases 16(1): 168-70 | Case report n=1 | MSA can be considered in the management of refractory GORD after laparoscopic sleeve gastrectomy (LSG) in patients with normal oesophageal motility. The procedure is relatively uncomplicated and appears to be safe with little variation in technique between post SG patients and those having MSA for primary GORD symptoms. While more studies are required to determine the efficacy of MSA after SG, it appears to be a promising alternative to conversion to RYGB in select patients with recalcitrant GORD after SG. | Single case report |
Nicolau AE, Lobontiu A and Constantinoiu S (2018) New minimally invasive endoscopic and surgical therapies for gastroesophageal reflux disease (GERD). Chirurgia (Bucharest, Romania: 1990) 113(1): 70-82 | Review | Laparoscopic procedures can address HH larger than 2 cm. They are technically easy less invasive and with reduced adverse events and post fundoplication syndromes in comparing with fundoplication. In case of recurrence, fundoplication can be done, so there are no bridges burnt. | Review article |
Nikolic M, Matic A, Feka J et al. (2021) Expanded indication for magnetic sphincter augmentation: outcomes in weakly acidic reflux compared to standard GERD patients. Journal of gastrointestinal surgery: official journal of the Society for Surgery of the Alimentary Tract | Non-randomised comparative study n=268 (weakly acidic reflux, n=67; acidic reflux, n=201) | MSA statistically significantly improves GORD-related symptoms and quality of life in patients with weakly acidic reflux with very low postoperative morbidity. | Studies with larger samples or better designs are included in the key evidence. |
Nikolic M, Schwameis K, Paireder M et al. (2019) Tailored modern GERD therapy - steps towards the development of an aid to guide personalized anti-reflux surgery. Scientific reports 9(1): 19174 | Non-randomised comparative study n=267 (MSA, n=73; electrical stimulation, n=25; Nissen fundoplication, n=169 | The main differences and the deciding factors in the aid for choice of GORD therapy were found to be the preoperative DCI and subsequently the presence of ineffective oesophageal motility, hiatal hernia size and the patient's preference. The overall low postoperative dysphagia-rate and no statistically significant differences in symptom control and patient satisfaction rates between the 3 surgical treatments show that such a treatment decision aid is feasible in the short-term postoperative time and could be considered in surgical antireflux evaluation. | Studies with larger samples or better designs are included in the key evidence. |
O'Neill SM, Jalilvand AD, Colvin JS et al. (2022) S148: Long-term patient-reported outcomes of laparoscopic magnetic sphincter augmentation versus Nissen fundoplication: a 5-year follow-up study. Surgical Endoscopy | Non-randomised comparative study n=70 (MSA, n=25; LNF, n=45) | MSA appears to offer similar long-term improvement in disease-specific quality of life as LNF. For MSA, there was a trend toward reduced long-term bloating compared with LNF but need for reoperation and device removal may be associated with patient dissatisfaction. | Studies with larger samples or better designs are included in the key evidence. |
Parmar AD, Tessler RA, Chang HY et al. (2017) Two-stage explantation of a magnetic lower esophageal sphincter augmentation device due to esophageal erosion. Journal of laparoendoscopic & advanced surgical techniques. Part A 27(8): 829-33 | Case report n=1 | This paper presented the first account of LINX explantation for oesophageal erosion in the US. It showed that a staged laparoendoscopic approach to LINX removal is feasible with minimal morbidity. | Single case report |
Prakash D, Campbell B and Wajed S (2018) Introduction into the NHS of magnetic sphincter augmentation: an innovative surgical therapy for reflux - results and challenges. Annals of the Royal College of Surgeons of England 100(4): 251-6 | Case series n=47 | MSA is highly effective in treating uncomplicated GORD, with durable results and an excellent safety profile. This laparoscopic, minimally invasive procedure provides a good alternative for patients where surgical anatomy is unaltered. | Small sample |
Rabach L, Saad AR, Velanovich V (2019) How to choose among fundoplication, magnetic sphincter augmentation or transoral incisionless fundoplication. Current Opinion in Gastroenterology 35(4): 371-8 | Review | Fundoplication remains the standard of care for patients with GORD complicated by hiatal hernias more than 2 cm, Barrett's oesophagus or grade C and D erosive esophagitis. For the patient with uncomplicated GORD, MSA appears to be a viable alternative that has greater technical standardisation and fewer postoperative side-effects than fundoplication. TIF remains an option for patients with refractory GORD who refuse surgical intervention. | Review article |
Rausa E, Manfredi R, Kelly ME et al. (2021) Magnetic sphincter augmentation placement for recalcitrant gastroesophageal reflux disease following bariatric procedures: a systematic review and Bayesian meta-analysis. Journal of laparoendoscopic & advanced surgical techniques. Part A 31(9): 1034-9 | Systematic review and Bayesian meta-analysis n=3 studies (33 patients) | MSA for refractory GORD after bariatric surgery appears feasible. Prospective randomised controlled with standardised surgical technique and objective follow-up evaluation is needed to better assess short- and long-term efficacy. | Small sample, with limited efficacy outcomes reported. |
Rebecchi F, Allaix ME, Cinti L et al. (2018) Comparison of the outcome of laparoscopic procedures for GERD. Updates in surgery 70(3): 315-21 | Review | laparoscopic fundoplication is the standard of care for treating GORD. During the last 10 years, many efforts have been done to develop a minimally invasive alternative to laparoscopic fundoplication with reduced less side effects. Both MSA and LOS Electrical Stimulation have been proven to be safe. However, there are no long-term and robust studies comparing these two novel techniques to the laparoscopic fundoplication. | Review article |
Reynolds JL, Zehetner J, Nieh A et al. (2016) Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD. Surg Endosc 30(8): 3225-30 | Non-randomised comparative study n=119 (MSA, n=52; LNF, n=67) | The side effect profile of MSA is better than LNF as evidenced by less gas bloat and increase ability to belch and vomit. LNF and MSA are comparable in symptom control, safety, and overall hospital charges. The charge for the MSA device is offset by less charges in other categories as a result of the shorter operative time and LOS. | This study was included in Guidozzi (2019). |
Reynolds JL, Zehetner J, Wu P et al. (2015) Laparoscopic magnetic sphincter augmentation vs laparoscopic Nissen fundoplication: a matched-pair analysis of 100 patients. Journal of the American College of Surgeons 221: 123-8 | Non-randomised comparative study n=100 | Analogous GORD patients had similar control of reflux symptoms after both MSA and LNF. The inabilities to belch and vomit were significantly fewer with MSA, along with a significantly lower incidence of severe gas-bloat symptoms. These results support the use of MSA as first-line therapy in patients with mild to moderate GORD. | Studies with larger samples or better designs are included in the key evidence. |
Reynolds JL, Zehetner J, Bildzukewicz N et al. (2014) Magnetic sphincter augmentation with the LINX device for gastroesophageal reflux disease after U.S. Food and Drug Administration approval. Am Surg. 80(10): 1034-8 | Case series n=67 | MSA with LINX is a safe and effective alternative to fundoplication for treating GORD. The most common postoperative complaint is mild to moderate dysphagia, which usually resolves within 12 weeks. | Studies with larger samples or better designs are included in the key evidence. |
Rettura F, Bronzini F, Campigotto M et al. (2021) Refractory gastroesophageal reflux disease: a management update. Frontiers in Medicine 8: 765061 | Review | The most widely done invasive antireflux option remains laparoscopic antireflux surgery (LARS), even if other, less invasive, interventions have been suggested in the last few decades, including endoscopic transoral incisionless fundoplication (TIF), MSA (LINX) or radiofrequency therapy (Stretta). Due to the different mechanisms underlying refractory GORD, the most effective strategy can vary, and it should be tailored to each patient. | Review article |
Richards WO and McRae C (2018) Comparative analysis of laparoscopic fundoplication and magnetic sphincter augmentation for the treatment of medically refractory GERD. The American surgeon 84(11): 1762-7 | Non-randomised comparative study n=38 (MSA, n=32; fundoplication, n=6) | MSA and laparoscopic fundoplication both lead to a comparable decrease in HRQL score and an increase in patient satisfaction when compared with patient's preoperative symptoms with maximum PPI use. In addition, our study shows that MSA is a safe minimally invasive antireflux procedure without the negative side-effects, such as gas bloat, inability to belch, and inability to vomit, commonly associated with NF. | This study was included in Zhuang (2021) |
Richter JE (2020) Laparoscopic magnetic sphincter augmentation: potential applications and safety are becoming more clear-but the story is not over. Clinical Gastroenterology and Hepatology 18(8): 1685-7 | Editorial | To an admitted sceptic about new antireflux treatments, the available data about the symptomatic and physiological effectiveness, durability, and safety of MSA are very impressive. This procedure now deserves to be routinely done as an alternative surgical procedure to traditional fundoplication for patients with mild-moderate GORD. | Editorial |
Riegler M, Schoppman SF, Bonavina L et al. (2015) Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surgical Endoscopy 29: 1123–9 | Non-randomised comparative study n=249 (MSA, n=202; fundoplication, n=47) | Both MSA device and fundoplication showed significant improvements in reflux control, with similar safety and reoperation rates. In the treatment continuum of antireflux surgery, MSA device should be considered as a first-line surgical option in appropriately selected patients without Barrett's oesophagus or a large hiatal hernia in order to avoid unnecessary dissection and preserve the patient's native gastric anatomy. | This study was included in Guidozzi (2019). |
Riva CG, Siboni S, Sozzi M et al. (2020) High-resolution manometry findings after LINX procedure for gastro-esophageal reflux disease. Neurogastroenterology and Motility 32(3): e13750 | Case series n=45 | The Linx procedure had a remarkable effect on oesophageal motility in the short‐term follow‐up. It appears that the overall postoperative increase of IRP and IBP may justify the higher DCI values. Preoperative dysphagia was the only factor associated with postoperative dysphagia. | Small sample |
Riva CG, Asti E, Lazzari V et al. (2019) Magnetic sphincter augmentation after gastric surgery. JSLS: Journal of the Society of Laparoendoscopic Surgeons 23(4) | Systematic review n=7 studies (35 patients) | MSA is a safe, simple, and standardized antireflux procedure. It is also feasible in patients with refractory GORD after gastric or bariatric surgery. Further prospective and comparative studies are needed to validate the preliminary clinical experience in this subset of patients. | This study investigated the effect of MSA for GORD after gastric/bariatric surgery, and systematic reviews with larger samples are included in the key evidence |
Rogers BD, Valdovinos LR, Crowell MD et al. (2020) Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation. Gut | Post hoc analysis of an RCT (NCT02505945) n=152 | Reduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GORD. | Patients in this study were included in Bell (2020). |
Rona KA, Reynolds J, Schwameis K et al. (2017) Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surgical endoscopy 31(5): 2096-102 | Non-randomised comparative study n=192 (hiatal hernia<3 cm, n=140; large hiatal hernia, n=52) | MSA in patients with large hiatal hernias shows decreased postoperative PPI requirement and mean GORD-HRQL scores compared with patients with smaller hernias. The incidence of symptom resolution or improvement and the percentage of patients needing intervention for dysphagia are similar. Short-term outcomes of MSA are encouraging in patients with GORD and large hiatal hernias. | Studies with larger sample or better designs are included in the key evidence. |
Rona KA, Tatum JM, Zehetner J et al. (2018) Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes. Surgical endoscopy 32(7): 3374-9 | Case series n=47 | Concomitant MSA and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia shows durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow up. | Studies with larger sample or better designs are included in the key evidence. |
Salvador R, Costantin, M, Capovilla G et al. (2017) Esophageal penetration of the magnetic sphincter augmentation device: history repeats itself. Journal of laparoendoscopic & advanced surgical techniques. Part A 27(8): 834-838 | Case series n=2 | Judging from the literature, MSAD implantation may be an effective way to control GORD, but the method can carry major complications, such as migration of the device into the oesophagus (as in the 2 cases reported here). Endoscopic removal of a device possibly penetrating inside the oesophagus is feasible and safe, and may later be followed up with a laparoscopic antireflux procedure without any particular difficulty. | Small sample |
Saino G, Bonavina L, Lipham JC et al. (2015) Magnetic sphincter augmentation for gastroesophageal reflux at 5 years: final results of a pilot study show long-term acid reduction and symptom improvement. J Laparoendosc Adv Surg Tech A 25(10): 787-92 | Case series n=44 | Based on long-term reduction in oesophageal acid, symptom improvement, and no late complications, this study shows the relative safety and efficacy of MSA for GORD. | This study was included in Zhuang (2021). |
Schizas, D., Mastoraki, A., Papoutsi, E. et al. (2020) LINX reflux management system to bridge the "treatment gap" in gastroesophageal reflux disease: A systematic review of 35 studies. World Journal of Clinical Cases 8(2): 294-305 | Systematic review n=20 | The findings of our review suggest that MSA has the potential to bridge the treatment gap between maxed-out medical treatment and fundoplication. However, further studies with longer follow up are needed for a better elucidation of these results. | Meta-analysis was not carried out, and all studies were included in Aiolfi (2018), Zhuang (2021) or Guidozzi (2019) |
Schwameis K, Ayazi S, Zaidi AH et al. (2020) Development of pseudoachalasia following magnetic sphincter augmentation (MSA) with restoration of peristalsis after endoscopic dilation. Clinical Journal of Gastroenterology | Case report n=1 | This case report presents a patient with long-standing GORD symptoms that had MSA with complete resolution of his reflux symptoms. He did not have dysphagia before surgery and his preoperative manometry showed normal peristaltic progression of oesophageal contractions. He developed pseudoachalasia 14 months after surgery. Repeated endoscopic dilation resulted in resolution of dysphagia and complete restoration of peristaltic contractions. | Single case report |
Schwameis K, Ayazi S, Zheng P et al. (2021) Efficacy of magnetic sphincter augmentation across the spectrum of GERD disease severity. Journal of the American College of Surgeons 232(3): 288-97 | Non-randomised comparative study n=334 (mild-to-severe GORD, n=274; severe GORD, n=60) | MSA is an effective treatment in patients with severe GORD and leads to significant clinical improvement across the spectrum of disease severity, with few objective outcomes being superior in patients with mild-to-moderate reflux disease. | Studies with larger samples or better designs are included in the key evidence. |
Schwameis K, Nikolic M, Morales Castellano DG et al. (2018) Crural closure improves outcomes of magnetic sphincter augmentation in GERD patients with hiatal hernia. Scientific reports 8(1): 7319 | Case series n=68 | MSA leads to significant symptom relief, increased quality of life and alimentary satisfaction with low perioperative morbidity. Cruroplasty tends to result in better reflux control and symptom relief than exclusive MSA without increasing dysphagia rates. | Studies with larger samples or better designs are included in the key evidence. |
Schwameis K, Nikolic M, Morales Castellano DG et al. (2018) Results of magnetic sphincter augmentation for gastroesophageal reflux disease. World journal of surgery 42(10): 3263-3269 | Case series n=68 | Sphincter augmentation results in significantly reduced reflux symptoms, increased GORD-specific quality of life and excellent alimentary satisfaction with low perioperative morbidity. This procedure should be considered an excellent alternative to fundoplication in treating GORD. | This study was included in Zhuang (2021) |
Siboni S, Ferrari D, Riva CG et al. (2021) Reference high-resolution manometry values after magnetic sphincter augmentation. Neurogastroenterology and Motility 33(10): e14139 | Non-randomised comparative study n=84 (MSA without crural repair, n=31; MSA with crural repair, n=53) | This study provides HRM reference values for patients having successful MSA implantation. Crural repair appears to be a key component of LOS augmentation and is associated with improved clinical outcomes. | Studies with larger samples or better designs are included in the key evidence. |
Sheu EG, Nau P, Nath B et al. (2015) A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surg Endosc: 29(3): 505-9 | Non-randomised comparative study n=24 (MSA, n=12; LNF, n=12) | MSA and LNF are both effective and safe treatments for GORD; however, severe dysphagia requiring endoscopic intervention is more common with MSA. Other adverse GI side effects may be less frequent after MSA. Consideration should be paid to these distinct postoperative symptom profiles when selecting a surgical therapy for reflux disease. | This study was included in Guidozzi (2019). |
Skubleny D, Switzer NJ, Dang J et al. (2017) LINX® magnetic esophageal sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease: a systematic review and meta-analysis. Surgical endoscopy 31(8): 3078-84 | Systematic review n=3 studies | MSA appears to be an effective treatment for GORD with short-term outcomes comparable with the more technically challenging and time consuming Nissen fundoplication. Long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of MSA. | All studies in this systematic review were included in Aiolfi (2018) |
Smith CD, Ganz RA, Lipham JC et al. (2017) Lower esophageal sphincter augmentation for gastroesophageal reflux disease: the safety of a modern implant. Journal of laparoendoscopic & advanced surgical techniques. Part A 27(6): 586-91 | Review of MAUDE n=3,283 | During a 4-year period in more than 3000 patients, no unanticipated MSAD complications have emerged, and there is no data to suggest a trend of increased events over time. The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GORD. MSAD is considered safe for the widespread treatment of GORD. | Recent review (DeMarchi 2021) is included in the key evidence. |
Smith CD, DeVault KR and Buchanan M (2014) Introduction of mechanical sphincter augmentation for gastroesophageal reflux disease into practice: early clinical outcomes and keys to successful adoption. J Am Coll Surg. 218(4): 776-81 | Case series n=66 | 92% of patients are satisfied or neutral with their condition, and 83% are PPI free. The GORD-HRQL scores are similar to those of patients without GORD. There were no device ulcers or erosions and no devices explanted. Thirteen patients had additional testing for dysphagia or persistent symptoms. | This study was included in Zhuang (2021). |
Stadlhuber RJ, Dubecz A, Meining A et al. (2015) Adenocarcinoma of the distal esophagus in a patient with a magnetic sphincter augmentation device: first of many to come? Annals of Thoracic Surgery 99: e147-8 | Case report n=1 | This case report shows the development of oesophageal cancer after laparoscopic implantation of a magnetic sphincter device and highlights the need for further endoscopic surveillance of patients even after a successful antireflux procedure. | Single case report included in the previous review. |
Stanak M, Erdos J, Hawlik K et al. (2018) Novel surgical treatments for gastroesophageal reflux disease: systematic review of magnetic sphincter augmentation and electric stimulation therapy. Gastroenterology research 11(3): 161-73 | Systematic review n=6 studies for MSAD | Clinical effectiveness and safety of both MSAD and EST are not sufficiently proven and are yet to be supported by high quality evidence from RCTs. | Most studies included in this systematic review were included in Aiolfi (2018) and Zhuang (2021) |
Sterris JA, Dunn CP, Bildzukewicz NA et al. (2020) Magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: pros and cons. Current opinion in gastroenterology 36(4): 323-8 | Review | 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 have MSA, whereas further research will be required before MSA is widely used for patients after bariatric surgery or for patients needing a transthoracic surgical approach. MSA is equivalent or superior to laparoscopic fundoplication in all surgical outcomes measured thus far. | Review article |
Strollo DC, Chan EG, Jaimes Vanegas N et al. (2019) Innovative and Contemporary Interventional Therapies for Esophageal Diseases. Journal of thoracic imaging 34(4): 217-35 | Review | Patients with benign disorders of GORD and achalasia or with premalignant or early-stage oesophageal cancer may now be treated with minimally invasive or endoscopic techniques such LINX device, POEM, and EMR or RFA, respectively. | Review article |
Tatum JM, Alicuben E, Bildzukewicz N et al. (2019) Minimal versus obligatory dissection of the diaphragmatic hiatus during magnetic sphincter augmentation surgery. Surgical endoscopy 33(3): 782-8 | Non-randomised comparative study n=182 (minimal hiatal dissection, n=96; obligatory hiatal dissection, n=86) | Obligatory dissection of the hiatus with crural closure resulted in less recurrence of reflux symptoms and hiatal hernia, despite an increased proportion of patients with larger hiatal hernia and more complex anatomic disease at the time of operation. | This study was included in Guidozzi (2019). |
Tatum JM, Alicuben E, Bildzukewicz N et al. (2019) Removing the magnetic sphincter augmentation device: operative management and outcomes. Surgical endoscopy 33(8): 2663-9 | Case series n=435 (device removal, n=24) | MSA removal when necessary can be accomplished through minimally invasive means. Repeat LINX or fundoplication can be done after removal, however, may not be necessary in patients with removal for dysphagia. | This study focused on removing the MSA device, and studies with larger samples or better designs are included in the key evidence. |
Tsai C, Steffen R, Kessler U et al. (2020) Postoperative dysphagia following magnetic sphincter augmentation for gastroesophageal reflux disease. Surgical Laparoscopy, Endoscopy and Percutaneous Techniques | Case series n=118 | Postoperative dysphagia after MSA with routine posterior cruroplasty is a common transient condition, with some patients requiring dilation procedures. Patients who have atypical GORD symptoms preoperatively are more likely to require a dilation procedure for postoperative dysphagia. Most persistent dysphagia can be safely treated with 1 to 2 dilation procedures, which do not negatively affect patient quality of life. | Studies with larger samples or better designs are included in the key evidence. |
Wahi JE, Le C, Yousef M et al. (2021) Robotic LINX placement: is it worth it? Journal of laparoendoscopic & advanced surgical techniques. Part A 31(5): 526-9 | Non-randomised comparative study n=20 (laparoscopic LINX placement, n=10; robotic LINX place, n=10) | In comparison with laparoscopic LINX procedures, robotic LINX does not offer superior surgical outcomes in terms of postoperative PPI use, dysphagia, or hospital length of stay. Robotic LINX procedures are associated with increased operative time and overall charges. | Small sample |
Warren HF, Brown LM, Mihura M et al. (2018) Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease. Surgical endoscopy 32(1): 405-12 | Case series n=170 | MSA results in excellent/good outcomes in most patients but a higher BMI, structurally defective sphincter, and elevated LOS residual pressure may prevent this goal. | Studies with larger samples or better designs are included in the key evidence. |
Warren HF, Louie BE, Farivar AS et al. (2017) Manometric changes to the lower oesophageal sphincter after magnetic sphincter augmentation in patients with chronic gastroesophageal reflux disease. Annals of surgery 266(1): 99-104 | Case series n=121 | MSA results in significant manometric improvement of the LOS without apparent deleterious effects on the oesophageal body. A manometrically defective LOS can be restored to normal sphincter, whereas a normal LOS remains stable. | Studies with larger samples or better designs are included in the key evidence. |
Warren HF, Reynolds JL, Lipham JC et al. (2016) Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease. Surgical Endoscopy and Other Interventional Techniques 30: 3289–96 | Non-randomised comparative study n=415 (MSA, n=201; Nissen fundoplication, n=214) | MSA for uncomplicated GORD achieves similar improvements in quality of life and symptomatic relief, with fewer side effects, but lower PPI elimination rates when compared with propensity-matched NF cases. In appropriate candidates, MSA is a valid alternative surgical treatment for GORD management. | This study was included in Zhuang (2021). |
Yeung BPM and Fullarton G (2017) Endoscopic removal of an eroded magnetic sphincter augmentation device. Endoscopy 49(7): 718-9 | Case report n=1 | This study presented a single case of LINX erosion and its endoscopic removal. The patient was discharged with PPIs on postoperative day 1 after a normal oral contrast swallow study. | Single case report |
Zadeh J, Andreoni A, Treitl D et al. (2018) Spotlight on the LINXTM reflux management system for the treatment of gastroesophageal reflux disease: Evidence and research. Medical Devices: Evidence and Research 11: 291-300 | Review | The LINX device has been shown to not only be effective for managing GORD but also be as effective as fundoplication. The most common complication of MSA is dysphagia. Erosion of the device into the oesophagus appears to be the most significant complication of the device after extended follow up. While very rare, the potentially severe consequences of this phenomenon suggest that the device should be used with some restraint and that patients should be made aware of this potential morbidity. | Review article |
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