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1.
Surg Endosc ; 37(8): 6220-6227, 2023 08.
Article in English | MEDLINE | ID: mdl-37171643

ABSTRACT

BACKGROUND: According to several short-term studies, single-anastomosis sleeve ileal (SASI) bypass offers similar weight loss to Roux-en-Y Gastric Bypass (RYGB) with fewer complication and better comorbidity reduction/resolution. Long-term data on this operation is lacking in the literature. The purpose of this study was to analyze the outcomes of SASI bypass up to 4 years. METHODS: This study is a retrospective cohort analysis of 366 patients with morbid obesity who underwent primary SASI bypass from January 2018 to February 2022. RESULTS: The mean age and preoperative body mass index (BMI) were 41 years (range 22-71 years) and 43.9 ± 6.5 kg/m2, respectively. Follow-up was available for 229 patients at 1-year (89%), 112 patients at 2-year (75%), 61 patients at 3-year (75%), and 35 patients at 4-year (71%). The intraoperative, short-term, and long-term complication rates were 0%, 2.5%, 4.6%, respectively. After 4 years, mean percentage excess weight loss (%EWL) was 93.3% and total weight loss (%TWL) was 41.2%. Remission of comorbidities was 93% for type 2 diabetes mellitus, 73% for hypertension, 83% for hyperlipidemia, 79% for sleep apnea, and 25% for gastroesophageal reflux disease (GERD). Biliary gastritis and ulcers are seldom. Eight patients developed de novo GERD symptoms requiring proton pump inhibitor treatment. None of the patients in our study had hypoalbuminemia or malabsorption that did not respond to increased protein intake and vitamin or mineral supplementation. CONCLUSION: SASI bypass appears to be safe, and one of the most effective bariatric procedures regarding weight loss and obesity related comorbidities. The double-outlet created in this procedure seemingly minimizes nutritional complications.


Subject(s)
Diabetes Mellitus, Type 2 , Gastric Bypass , Gastroesophageal Reflux , Laparoscopy , Obesity, Morbid , Humans , Young Adult , Adult , Middle Aged , Aged , Obesity, Morbid/surgery , Obesity, Morbid/complications , Diabetes Mellitus, Type 2/complications , Retrospective Studies , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/surgery , Gastric Bypass/methods , Gastroesophageal Reflux/surgery , Weight Loss , Gastrectomy/methods , Treatment Outcome , Laparoscopy/methods
2.
Dis Esophagus ; 36(11)2023 Oct 27.
Article in English | MEDLINE | ID: mdl-37224461

ABSTRACT

Magnetic sphincter augmentation (MSA) is an alternative surgical treatment for gastroesophageal reflux disease; however, >1.5 T magnetic resonance imaging (MRI) is contraindicated for patients who have undergone MSA with the LINX Reflux Management System (Torax Medical, Inc. Shoreview, Minnesota, USA). This drawback can impose a barrier to access of MRI, and cases of surgical removal of the device to enable patients to undergo MRI have been reported. To evaluate access to MRI for patients with an MSA device, we conducted a structured telephone interview with all diagnostic imaging providers in Arizona in 2022. In 2022, only 54 of 110 (49.1%) locations that provide MRI services had at least one 1.5 T or lower MRI scanner. The rapid replacement of 1.5 T MRI scanners by more advanced technology may limit healthcare options and create an access barrier for patients with an MSA device.


Subject(s)
Gastroesophageal Reflux , Laparoscopy , Humans , Esophageal Sphincter, Lower/surgery , Gastroesophageal Reflux/diagnostic imaging , Gastroesophageal Reflux/surgery , Fundoplication/methods , Magnets , Magnetic Resonance Imaging , Laparoscopy/methods , Treatment Outcome , Quality of Life
3.
Dis Esophagus ; 36(10)2023 Sep 30.
Article in English | MEDLINE | ID: mdl-36942526

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.


Subject(s)
Gastroesophageal Reflux , Laparoscopy , Humans , Quality of Life , Cohort Studies , Esophageal Sphincter, Lower/surgery , Antacids/therapeutic use , Retrospective Studies , Treatment Outcome , Gastroesophageal Reflux/etiology , Gastroesophageal Reflux/surgery , Gastroesophageal Reflux/drug therapy , Fundoplication , Laparoscopy/adverse effects , Magnetic Phenomena
4.
Dis Esophagus ; 36(Supplement_1)2023 Jun 15.
Article in English | MEDLINE | ID: mdl-36776100

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.


Subject(s)
Gastroenterology , Gastroesophageal Reflux , Laparoscopy , Magnetic Field Therapy , Humans , Esophageal Sphincter, Lower/surgery , Treatment Outcome , Quality of Life , Gastroesophageal Reflux/surgery , Gastroesophageal Reflux/drug therapy , Magnetic Phenomena
5.
Surg Endosc ; 37(5): 3701-3709, 2023 05.
Article in English | MEDLINE | ID: mdl-36650353

ABSTRACT

BACKGROUND: Revision of a failed laparoscopic fundoplication carries higher risk of complication and lower chance of success compared to the original surgery. Transoral incisionless fundoplication (TIF) may be an endoscopic alternative for select GERD patients without need of a moderate/large hiatal hernia repair. The aim of this study was to assess feasibility, efficacy, and safety of TIF 2.0 after failed laparoscopic Nissen or Toupet fundoplication (TIFFF). METHODS: This is a multicenter retrospective cohort study of patients who underwent TIFFF between September 2017 and December 2020 using TIF 2.0 technique (EsophyX Z/Z+) performed by gastroenterologists and surgeons. Patients were included if they had (1) recurrent GERD symptoms, (2) pathologic reflux based upon pH testing or Grade C/D esophagitis or Barrett's esophagus, and (3) hiatal hernia ≤ 2 cm. The primary outcome was improvement in GERD Health-Related Quality of Life (GERD-HRQL) post-TIFFF. The TIFFF cohort was also compared to a similar surgical re-operative cohort using propensity score matching. RESULTS: Twenty patients underwent TIFFF (median 4.1 years after prior fundoplication) and mean GERD-HRQL score improved from 24.3 ± 22.9 to 14.75 ± 21.6 (p = 0.014); mean Reflux Severity Index (RSI) score improved from 14.1 ± 14.6 to 9.1 ± 8.0 (p = 0.046) with 8/10 (80%) of patients with normal RSI (< 13) post-TIF. Esophagitis healed in 78% of patients. PPI use decreased from 85 to 55% with 8/20 (45%) patients off of PPI. Importantly, mean acid exposure time decreased from 12% ± 17.8 to 0.8% ± 1.1 (p = 0.028) with 9/9 (100%) of patients with normalized pH post-TIF. There were no statistically significant differences in clinical efficacy outcomes between TIFFF and surgical revision, but TIFFF had significantly fewer late adverse events. CONCLUSION: Endoscopic rescue with TIF is a safe and efficacious alternative to redo laparoscopic surgery in symptomatic patients with appropriate anatomy and objective evidence of persistent or recurrent reflux.


Subject(s)
Esophagitis , Gastroesophageal Reflux , Laparoscopy , Humans , Fundoplication/adverse effects , Fundoplication/methods , Retrospective Studies , Quality of Life , Gastroesophageal Reflux/etiology , Gastroesophageal Reflux/surgery , Gastroesophageal Reflux/diagnosis , Treatment Outcome , Esophagitis/etiology , Esophagitis/surgery , Laparoscopy/methods
6.
London; NICE; Jan. 11, 2023. 5 p.
Non-conventional in English | BIGG | ID: biblio-1418202

ABSTRACT

Evidence-based recommendations on laparoscopic insertion of a magnetic ring for gastro-oesophageal reflux disease. This involves placing a ring of beads outside of the food pipe, just above the stomach. Magnets inside the beads hold them together to keep the food pipe closed but are weak enough to move apart to allow food or liquid to be swallowed. The aim is to prevent acid reflux. Is this guidance up to date? Next review: this guidance will be reviewed if there is new evidence or safety concerns.


Subject(s)
Humans , Adult , Gastroesophageal Reflux/surgery , Laparoscopy/standards , Magnetic Field Therapy
7.
Dis Esophagus ; 36(Supplement_1)2023 Jun 15.
Article in English | MEDLINE | ID: mdl-36585776

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.


Subject(s)
Deglutition Disorders , Gastroesophageal Reflux , Laparoscopy , Humans , Esophageal Sphincter, Lower/surgery , Deglutition Disorders/etiology , Deglutition Disorders/surgery , Treatment Outcome , Laparoscopy/methods , Quality of Life , Gastroesophageal Reflux/etiology , Gastroesophageal Reflux/surgery , Gastroesophageal Reflux/diagnosis , Fundoplication/methods , Magnetic Phenomena
8.
Surg Endosc ; 36(11): 8255-8260, 2022 11.
Article in English | MEDLINE | ID: mdl-35474390

ABSTRACT

BACKGROUND: The use of the magnetic sphincter augmentation (MSA) in patients with de novo or persistent gastroesophageal reflux disease (GERD) after sleeve gastrectomy has not been thoroughly investigated. OBJECTIVE: The aim of this study is to evaluate the efficacy of MSA device placement in improving GERD symptoms and reducing anti-reflux medication usage in patients with persistent or de novo GERD after sleeve gastrectomy. METHODS: This is a retrospective analysis of patients who underwent laparoscopic MSA device placement between January 2018 and July 2020 after sleeve gastrectomy. RESULTS: A total of twenty-two patients met inclusion criteria. Twenty patients were female (91%) and two patients were male (9%). All patients were taking anti-reflux medications daily to control GERD symptoms prior to MSA device placement. There was a significant improvement in the mean GERD-HRQL survey scores when comparing scores prior to (43.8) and after (16.7) MSA device placement (p < 0.0001). Majority of the patients did well without any post-operative complications (77%). Nearly 82% of patients were no longer taking any anti-acid medications after MSA device placement (p < 0.0485). There were no patients that required MSA device removals. There were no adverse events such as MSA device erosions or device-related mortalities. CONCLUSIONS: MSA device placement in patients with medically refractory GERD after sleeve gastrectomy is a safe and viable alternative to Roux-en-Y gastric bypass without conferring additional risks. We show an improvement in reflux symptoms after MSA device placement as evidenced by decreased post-operative GERD-HRQL scores, decreased anti-acid medication usage, and overall patient satisfaction with the procedure. Further prospective and comparative studies with longer term follow-up are needed to validate the use of MSA in patients who have undergone sleeve gastrectomy.


Subject(s)
Gastroesophageal Reflux , Laparoscopy , Obesity, Morbid , Male , Female , Humans , Retrospective Studies , Quality of Life , Gastroesophageal Reflux/etiology , Gastroesophageal Reflux/surgery , Gastrectomy/adverse effects , Gastrectomy/methods , Laparoscopy/adverse effects , Magnetic Phenomena , Treatment Outcome , Obesity, Morbid/surgery
9.
Surg Endosc ; 36(9): 6851-6858, 2022 09.
Article in English | MEDLINE | ID: mdl-35041056

ABSTRACT

BACKGROUND: Laparoscopic magnetic sphincter augmentation (MSA) has emerged as an alternative to laparoscopic Nissen fundoplication (LNF) for the management of symptomatic gastroesophageal reflux disease (GERD). While short-term outcomes of MSA compare favorably to those of LNF, direct comparisons of long-term outcomes are lacking. We hypothesized that the long-term patient-reported outcomes of MSA would be similar to those achieved with LNF. METHODS: We tested this hypothesis in a retrospective cohort undergoing primary LNF or MSA between March 2013 and July 2015. The primary outcome was GERD-Health Related Quality of Life (GERD-HRQL) score at long-term follow-up relative to baseline. Secondary outcomes included dysphagia and bloating scores, proton-pump inhibitor (PPI) cessation, reoperations, and overall satisfaction with surgery. RESULTS: 70 patients (25 MSA, 45 LNF) met criteria for study inclusion. MSA patients had lower baseline BMI (median: 27.1 [IQR: 22.7-29.9] versus 30.4 [26.4-32.8], p = 0.02), lower total GERD-HRQL (26 [19-32] versus 34 [25-40], p = 0.02), and dysphagia (2 [0-3] versus 3 [1-4], p = 0.02) scores. Median follow-up interval exceeded 5 years (MSA: 68 [65-74]; LNF: 65 months [62-69]). Total GERD-HRQL improved from 26 to 9 after MSA (p < 0.001) and from 34 to 7.5 after LNF (p < 0.01); these scores did not differ between groups (p = 0.68). Dysphagia (MSA: 1 [0-2]; LNF: 0 [0-2], p = 0.96) and bloating (MSA: 1.5 [0.5-3.0]; LNF: 3.0 [1.0-4.0], p = 0.08) scores did not show any statistically significant differences. Device removal was performed in 4 (16%) MSA patients and reoperation in 3 (7%) LNF patients. Eighty-nine percent of LNF patients reported satisfaction with the procedure, compared to 70% of MSA patients (p = 0.09). CONCLUSIONS: 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 to LNF, but need for reoperation and device removal may be associated with patient dissatisfaction.


Subject(s)
Deglutition Disorders , Gastroesophageal Reflux , Laparoscopy , Deglutition Disorders/etiology , Deglutition Disorders/surgery , Esophageal Sphincter, Lower/surgery , Follow-Up Studies , Fundoplication/methods , Gastroesophageal Reflux/surgery , Humans , Laparoscopy/methods , Magnetic Phenomena , Patient Reported Outcome Measures , Quality of Life , Retrospective Studies , Treatment Outcome
10.
Acta Chir Belg ; 122(5): 321-327, 2022 Oct.
Article in English | MEDLINE | ID: mdl-33534655

ABSTRACT

Background: Although medical treatment is the best approach for treating gastroesophageal reflux disease (GERD), surgery has a significant role to play not only in cases of failure of medical treatment but also as in a long-term approach, specifically in young patient. On the other hand, alarming reports have been published concerning the outcomes and usefulness of antireflux surgery (ARS). The aim of this study was to evaluate medium and long-term functional outcomes following ARS performed in our institution over a 10 year period.Methods: This was a retrospective review of patients in our department who underwent primary or redo laparoscopic fundoplication between 2005 and 2015. Evaluation of the outcomes was made using a validated questionnaire specifically dedicated to GERD (the Gastroesophageal Reflux Disease - Health-Related Quality of Life (GERD-HRQL) questionnaire) and by investigation about the continued use of proton-pump inhibitors (PPIs). Exclusion criteria were patients treated for GERD with Roux-en-Y gastric bypass, emergency reduction of hiatal hernia, patients missing from follow-up and patients deceased from unrelated causes.Results: 296 patients out of 309 met the inclusion criteria. Primary procedures included 214 Nissen, 35 Toupet, and 23 Collis gastroplasty; there were additionally 62 redo operations. Neither postoperative mortality nor conversion was observed. The mean follow-up was 8 years post-surgery, and contact was made with 96% of the original group. 85% of the patients had stopped PPI use since their operation (86% after Nissen, 73% after Toupet, 94% after Collis and 82% after redos). 90% of the patients had good to excellent functional results as reported by their GERD-HRQL score, and independent of the type of previous procedure. 31 patients were dissatisfied due to dysphagia in 7 and GERD recurrence in 24. Again 75% were extremely satisfied and 15% satisfied. Our own incidence of redo procedures was 11% but the functional result and satisfaction index were comparable between redo and primary procedures. The addition of Collis gastroplasty in cases of real short oesophagus did not alter the final result.Conclusions: Laparoscopic ARS presents a superior alternative to lifetime medication use and can provide long-term control of GERD symptoms in the majority of patients if it is performed skillfully and in carefully evaluated patients. Based on the present study, we believed that significant improvement in GERD health-related quality of life can be attained following both primary and reoperative ARS.


Subject(s)
Gastroesophageal Reflux , Laparoscopy , Fundoplication/methods , Gastric Acid , Gastroesophageal Reflux/drug therapy , Gastroesophageal Reflux/etiology , Gastroesophageal Reflux/surgery , Humans , Laparoscopy/methods , Proton Pump Inhibitors , Quality of Life , Retrospective Studies , Treatment Outcome
11.
Am Surg ; 88(1): 20-27, 2022 Jan.
Article in English | MEDLINE | ID: mdl-33560890

ABSTRACT

OBJECTIVE: Our goal was to compile the most recent and accurate data on the side effects of proton pump inhibitors (PPI). We also compared the efficacy of PPI to the efficacy of different surgical options for acid reflux control. BACKGROUND: Proton pump inhibitors are the primary therapy for chronic control of gastroesophageal reflux disease (GERD), but newer studies demonstrate deleterious side effects. Collating this information and contrasting it with surgical therapy for GERD provides evidence for possible practice changes in treatment. METHODS: A literature search utilizing PubMed was performed evaluating for PPI and anti-reflux surgery (ARS), focusing on articles that reflected information regarding the usage and efficacy of symptom control of both PPI and ARS. Search terms included "ARS, fundoplication, MSA, acute interstitial nephritis, acute kidney injury, chronic kidney disease, meta-analysis, PPI, H2 blocker, cardiovascular risk, and gut dysbiosis." We evaluated 271 articles by title, abstract, and data for relevance and included 70. RESULTS: Long-term control of GERD with PPI may have a greater than expected side effect profile than initially thought. Surgical options may provide greater symptom control than PPI without the side effects of long-term medical therapy. CONCLUSIONS: Anti-reflux control can be safely achieved with either PPI or surgical options; however, the long-term side effects noted in the review such as increased risk of cardiovascular events, renal disease, and gut dysbiosis may suggest surgical anti-reflux control as a better long-term option.


Subject(s)
Gastroesophageal Reflux/drug therapy , Gastroesophageal Reflux/surgery , Proton Pump Inhibitors/adverse effects , Acute Kidney Injury/chemically induced , Dysbiosis/chemically induced , Fundoplication/methods , Hepatic Encephalopathy/chemically induced , Humans , Magnets , Myocardial Infarction/chemically induced , Nephritis, Interstitial/chemically induced , Proton Pump Inhibitors/therapeutic use , Renal Insufficiency, Chronic/chemically induced , Risk Assessment , Stroke/chemically induced
12.
Gastroenterol Clin North Am ; 50(4): 809-823, 2021 12.
Article in English | MEDLINE | ID: mdl-34717872

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.


Subject(s)
Gastroesophageal Reflux , Laparoscopy , Fundoplication , Gastroesophageal Reflux/drug therapy , Gastroesophageal Reflux/surgery , Humans , Quality of Life , Treatment Outcome
13.
Zentralbl Chir ; 146(2): 210-214, 2021 Apr.
Article in German | MEDLINE | ID: mdl-33851383

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.


Subject(s)
Gastroesophageal Reflux , Laparoscopy , Esophageal Sphincter, Lower/surgery , Fundoplication , Gastroesophageal Reflux/surgery , Humans , Quality of Life , Treatment Outcome
14.
Surgery ; 169(3): 533-538, 2021 03.
Article in English | MEDLINE | ID: mdl-32919782

ABSTRACT

BACKGROUND: The functional lumen imaging probe is a balloon-based catheter that can be used as a bougie during fundoplication. Our goal was to compare the short-term, quality-of-life outcomes and esophageal-injury rate after fundoplication over a functional lumen imaging probe compared to a traditional bougie. METHODS: This is a retrospective review of a quality database at a single center. Three-week and 6-month Reflux Symptom Index, Gastroesophageal Reflux Disease-health Related Quality of Life, and dysphagia scores were compared. The need for endoscopy and dilation between the groups was also compared. RESULTS: Between 2008 and 2020, 423 fundoplications were performed over a bougie and 62 over the functional lumen imaging probe. Six months after surgery, the functional lumen imaging probe group reported significantly worse dysphagia scores (1.5 ± 1.0 vs 1.1 ± 0.3, P = .007), but rates of endoscopy (4.8% vs 5.0%, P = .966) and dilation (4.8% vs 3.8%, P = .723) were similar. There were no differences between Reflux Symptom Index and Gastroesophageal Reflux Disease-health Related Quality of Life scores. The rate of bougie-related injuries was 2.1% vs 0% for the functional lumen imaging probe group. CONCLUSION: Patients undergoing fundoplication over the functional lumen imaging probe had comparable short-term outcomes compared with those over a traditional bougie. The rate of esophageal injury while using the functional lumen imaging probe is lower than a bougie and may be preferable for fundoplication creation.


Subject(s)
Diagnostic Imaging , Fundoplication , Gastroesophageal Reflux/diagnostic imaging , Gastroesophageal Reflux/surgery , Aged , Diagnostic Imaging/methods , Disease Management , Female , Fundoplication/methods , Gastroesophageal Reflux/pathology , Humans , Male , Middle Aged , Quality of Life , Retrospective Studies , Symptom Assessment , Treatment Outcome
15.
Surg Laparosc Endosc Percutan Tech ; 31(2): 264-276, 2020 Dec 16.
Article in English | MEDLINE | ID: mdl-33347088

ABSTRACT

BACKGROUND: Gastroesophageal reflux disease is associated with Barrett esophagus, esophageal adenocarcinoma, and significantly impacts quality of life. Medical management is the first line therapy with surgical fundoplication as an alternative therapy. However, a small portion of patients who fail medical therapy are referred for surgical consultation. This creates a "gap" in therapy for those patients dissatisfied with medical therapy but are not getting referred for surgical consultation. Three procedures have been designed to address these patients. These include radiofrequency ablation (RFA) of the lower esophageal sphincter, transoral incisionless fundoplication (TIF), and magnetic sphincter augmentation. MATERIALS AND METHODS: A Pubmed literature review was conducted of all publications for RFA, TIF, and MSA. Four most common endpoints for the 3 procedures were compared at different intervals of follow-up. These include percent of patients off proton pump inhibitors (PPIs), GERD-HRQL score, DeMeester score, and percent of time with pH <4. A second query was performed for patients treated with PPI and fundoplications to match the same 4 endpoints as a control. RESULTS: Variable freedom from PPI was reported at 1 year for RFA with a weighted mean of 62%, TIF with a weighted mean of 61%, MSA with a weighted mean of 85%, and fundoplications with a weighted mean of 84%. All procedures including PPIs improved quality-of-life scores but were not equal. Fundoplication had the best improvement followed by MSA, TIF, RFA, and PPI, respectively. DeMeester scores are variable after all procedures and PPIs. All MSA studies showed normalization of pH, whereas only 4 of 17 RFA studies and 3 of 11 TIF studies reported normalization of pH. CONCLUSIONS: Our literature review compares 3 rival procedures to treat "gap" patients for gastroesophageal reflux disease with 4 common endpoints. Magnetic sphincter augmentation 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.


Subject(s)
Fundoplication , Gastroesophageal Reflux , Gastroesophageal Reflux/drug therapy , Gastroesophageal Reflux/surgery , Humans , Proton Pump Inhibitors/therapeutic use , Quality of Life , Treatment Outcome
16.
Zhonghua Wai Ke Za Zhi ; 58(9): 672-676, 2020 Sep 01.
Article in Chinese | MEDLINE | ID: mdl-32878412

ABSTRACT

Gastroesophageal reflux disease (GERD) is a common digestive disease with characteristics of a multitude of pathogenesis, a variety of clinical manifestations and a strong negative impact on physical and mental health of the patients. GERD is classified into non-erosive reflux disease and reflux esophagitis in terms of absence or presence of mucosal damage at endoscopic findings. Proton pump inhibitors (PPI) are widely used in the treatment of GERD, especially for patients with non-erosive reflux disease or mild reflux esophagitis. However, PPI do not affect pathophysiologic mechanisms of GERD or reduce the number of reflux events. When PPI fails to adequately control the symptoms of GERD as a result of gastroesophagel junction structural defects, the antireflux surgical procedures are indicated to create a mechanical barrier to reflux. The laparoscopic fundoplication remains the most commonly performed and is the current "gold-standard" anti-reflux procedure. The outcomes of the antireflux surgical procedures are superior to medical therapy for GERD in light of subjective symptoms, objective examinations, quality of life and patient satisfaction. As of now, enough attention has not been paid to the traditional surgical procedures of GERD in China. It is controversial about which is optimal among the three major types of procedures, selection should be tailored to classification, mechanism, age, mental status and esophageal motility. GERD is a chronic disease and either medical or surgical therapy may put the patient at different risk, therefore the patient's preferences should be considered adequately before choosing the treatment protocols.


Subject(s)
Gastroesophageal Reflux/surgery , China , Esophagitis, Peptic/drug therapy , Esophagitis, Peptic/etiology , Esophagitis, Peptic/surgery , Fundoplication , Gastroesophageal Reflux/complications , Gastroesophageal Reflux/drug therapy , Humans , Laparoscopy , Proton Pump Inhibitors/therapeutic use , Quality of Life , Treatment Outcome
17.
Zhonghua Wai Ke Za Zhi ; 58(9): 683-686, 2020 Sep 01.
Article in Chinese | MEDLINE | ID: mdl-32878414

ABSTRACT

The lower esophageal sphincter incompetent is fundamental pathological abnormality of gastroesophageal reflux disease (GERD). Magnetic sphincter augmentation (MSA) is a magnetic bracelet, which designed to be placed surgically around the exterior surface of the distal esophagus. In the closed position, the highest attractive force between the magnetic beads would reinforce the lower esophageal sphincter to strengthen the antireflux barrier. Animal experiments and clinical trials have verified the safety and efficacy of MSA in GERD patients. For refractory GERD and GERD with huge hernia, MSA can also achieve acceptable clinical effect. Comparative researches appeared that there is no significantly difference in clinical effect between Nissen fundoplication and MSA. MSA could preserve the function of belching and vomiting postoperatively, and it can be implanted with the use of standard laparoscopic techniques. The long-term effect of MSA is satisfactory with less complications, which has been carried out in China since 2018. It can be predicted that MSA will play an important role in the treatment of GERD in the future.


Subject(s)
Esophageal Sphincter, Lower/surgery , Gastroesophageal Reflux/surgery , Animals , Clinical Trials as Topic , Disease Models, Animal , Fundoplication , Humans , Laparoscopy , Magnetic Field Therapy , Treatment Outcome
18.
Zhonghua Wai Ke Za Zhi ; 58(9): 691-696, 2020 Sep 01.
Article in Chinese | MEDLINE | ID: mdl-32878416

ABSTRACT

Objective: To examine the preliminary clinical efficacy of Chinese magnetic sphincter augmentation (MSA) in the treatment of gastroesophageal reflux disease (GERD). Methods: According to the enrollment criteria for the MSA developed by ShengJieKang Co. and Shanghai Chest Hospital (SS-MSA) clinical trial, a total of 19 GERD patients were treated with SS-MSA from August 2018 to January 2020 at Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University. The majority of registered cases were male patients with age of (32.2±7.3) years (range: 22 to 50 years), height of (170.7±6.2) cm (range: 160 to 179 cm) and weight of (65.2±10.3) kg (range: 47.5 to 90.0 kg). SS-MSA was implanted via laparoscopy. The major evaluation indexs of postoperative efficacy were the total time of acid exposure within 24 hours and the total number of reflux. Secondary efficacy indicators included: (1) evaluation of the average daily dose of proton pump inhibitor medications; (2) the score of GERD health related quality of life questionnaire (GERD-Q) before and after MSA implantation. Paired design t-test was used to evaluate the efficacy of the SS-MSA. Results: A total of 19 patients underwent SS-MSA surgery successfully. The history of the GERD were 19 (54) months (M(Q(R))). The operation time was 63 (22) minutes and the in-hospital stay was 3 (2) days. No obvious surgical complications occurred. Postoperative adverse events included 14 cases with mild to moderate dysphagia exited after surgery, gradually eased within 1 to 3 months, 1 case with the removal of the device after 1 month of severe swallowing difficulties, 1 case of diarrhea. No corrosion, perforation, displacement occurred. The GERD-Q score (11.0(4.5) vs. 6(1.0), t=4.274, P=0.013), 24-hour acid exposure time (6.2(4.8)% vs. 0.1(0.9)%, t=5.814, P=0.004), and Demeester score (23.72(16.20) vs. 0.96(3.10), t=6.678, P=0.003) were significantly decreased 1 year after surgery(n=5). Proton pump inhibitor reuse rates were 6/18, 5/15, 3/10, and 1/5 in 1, 3, 6 and 12 months after the operation, respectively. Conclusions: SS-MSA implantation is feasible and safe with short hospital stay and rare perioperative complications. The preliminary results is good after 1 year follow-up. It could be expected to be an ideal substitutive for future GERD treatment.


Subject(s)
Gastroesophageal Reflux/therapy , Magnetic Field Therapy , Adult , China , Clinical Trials as Topic , Esophageal Sphincter, Lower/surgery , Female , Gastroesophageal Reflux/drug therapy , Gastroesophageal Reflux/surgery , Humans , Laparoscopy , Male , Middle Aged , Proton Pump Inhibitors/therapeutic use , Quality of Life , Treatment Outcome , Young Adult
19.
Gastroenterology ; 159(4): 1504-1525, 2020 10.
Article in English | MEDLINE | ID: mdl-32621903

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.


Subject(s)
Gastroesophageal Reflux/surgery , Minimally Invasive Surgical Procedures , Electric Stimulation Therapy , Fundoplication , Humans , Radiofrequency Ablation , Surgical Stapling
20.
Surg Endosc ; 34(8): 3663-3668, 2020 08.
Article in English | MEDLINE | ID: mdl-32462333

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.


Subject(s)
Esophageal Sphincter, Lower/surgery , Gastroesophageal Reflux/surgery , Magnetic Field Therapy/instrumentation , Postoperative Complications/prevention & control , Preoperative Care , Dilatation , Female , Humans , Male , Middle Aged , Retrospective Studies
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