Clinical efficacy and safety of magnetic sphincter augmentation (MSA) and transoral incisionless fundoplication (TIF2) in refractory gastroesophageal reflux disease (GERD): a systematic review and meta-analysis.
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ABSTRACT:
SUBMITTER: Chandan S
PROVIDER: S-EPMC8043814 | biostudies-literature | 2021 Apr
REPOSITORIES: biostudies-literature
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Clinical efficacy and safety of magnetic sphincter augmentation (MSA) and transoral incisionless fundoplication (TIF2) in refractory gastroesophageal reflux disease (GERD): a systematic review and meta-analysis.
Chandan Saurabh S Mohan Babu P BP Khan Shahab R SR Jha Lokesh K LK Dhaliwal Amaninder J AJ Bilal Mohammad M Aziz Muhammad M Canakis Andrew A Arora Sumant S Malik Sarah S Kassab Lena L LL Ponnada Suresh S Bhat Ishfaq I Hewlett Alexander T AT Sharma Neil N McDonough Stephanie S Adler Douglas G DG
Endoscopy international open 20210413 4
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Project description:Background and study aims
| S-EPMC9286770 | biostudies-literature
Project description:Background and study aims Gastroesophageal reflux disease (GERD) following peroral endoscopic myotomy (POEM) occurs in 40% to 60% of patients. There are limited data evaluating antireflux surgery or transoral incisionless fundoplication (TIF) for refractory post-POEM GERD. Patients and methods In a single-center prospective cohort study, consecutive patients with medically refractory post-POEM regurgitation and/or GERD treated with TIF or combined laparoscopic hernia repair and TIF (cTIF) were evaluated. Baseline evaluation: GERD-Health Related Quality of Life (GERD-HQRL) and Reflux Symptom Questionnaire 7-day recall (RESQ-7) questionnaires, EGD, high-resolution manometry (HRM), 48-hour pH test off proton pump inhibitors (PPIs) and impedance planimetry of the esophagogastric junction (EGJ) to calculate the diameter distensibility index (EGJ-DI). A PPI was taken twice daily for 2 weeks after TIF and restarted later if required. Patients returned 9 to 12 months after treatment when all preoperative studies were repeated. Quality of life, pH studies and EGJ metrics before and after antireflux surgery were compared. Results Seventeen patients underwent TIF (n=2, 12%) or cTIF (n=15, 88%) a mean 25±15 months after POEM. At follow-up a mean of 9±1 months after TIF/cTIF, patients required less frequent daily PPIs (n=0.001), were more satisfied (P=0.008), had improved GERD-HQRL (P=0.001), less intensity and frequency of GERD (P=0.001) and fewer reflux episodes (P=0.04) by pH testing. There was no change in EGJ-DI, EGJ diameter, integrated relaxation pressure, % total time pH <4, or DeMeester score. Conclusions TIF and cTIF for difficult-to-control post-POEM GERD appear safe, decrease PPI use and reflux episodes, and improve QOL without significant change in IRP, EGJ compliance, diameter or esophageal acid exposure time.
| S-EPMC10769579 | biostudies-literature
Project description:Background and study aims Transoral incisionless fundoplication (TIF) is a safe and effective minimally invasive endoscopic technique for treating gastroesophageal reflux disease (GERD). The learning curve for this technique has not been reported. We studied the learning curve for TIF when performed by a gastroenterologist by identifying the threshold number of procedures needed to achieve consistent technical success or proficiency (consistent creation of TIF valve ≥ 270 degrees in circumference, ≥ 2 cm long) and efficiency after didactic, hands-on and case observation experience. Patients and methods We analyzed prospectively collected data from patients who had TIF performed by a single therapeutic endoscopist within 17 months after basic training. We determined thresholds for procedural learning using cumulative sum of means (CUSUM) analysis to detect changes in achievement rates over time. We used breakpoint analysis to calculate procedure metrics related to proficiency and efficiency. Results A total of 69 patients had 72 TIFs. The most common indications were refractory GERD (44.7 %) and proton pump inhbitor intolerance (23.6 %). Proficiency was achieved at the 18 th to 20 th procedure. The maximum efficiency for performing a plication was achieved after the 26 th procedure, when mean time per plication decreased to 2.7 from 5.1 minutes (P < 0.0001). TIF procedures time varied until the 44 th procedure, after which it decreased significantly from 53.7 minutes to 39.4 minutes (P < 0.0001). Conclusions TIF can be safely, successfully, and efficiently performed in the endoscopy suite by a therapeutic endoscopist. The TIF learning curve is steep but proficiency can be achieved after a basic training experience and 18 to 20 independently performed procedures.
| S-EPMC8589558 | biostudies-literature
Project description:Background and aimsTransoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions, Inc, Redmond, Wash, USA) is a minimally invasive endoscopic fundoplication technique. Our study aimed to assess the efficacy of TIF for atypical GERD symptoms in patients with chronic or refractory GERD.MethodsA systematic search of 4 major databases was performed. All original studies assessing atypical GERD using a validated symptom questionnaire (the reflux symptom index [RSI]) were included. The RSI score was assessed before and after TIF at a 6- and 12-month follow-up. Data on technical success rate, adverse events, proton pump inhibitor (PPI) use, and patient satisfaction were also collected. Only TIF procedures currently in practice using the EsophyX device (ie, TIF 2.0) and TIF with concomitant hiatal hernia repair were included in the review.ResultsTen studies (564 patients) were included. At the 6- and 12- month follow-up, there was a mean reduction of 15.72 (95% confidence interval, 12.15-19.29) and 14.73 (95% confidence interval, 11.74-17.72) points, respectively, in the RSI score post-TIF, with a technical success rate of 99.5% and a pooled adverse event rate of 1%. At both time intervals, more than two-thirds of the patients were satisfied with their health condition and roughly three-fourths of the patients were off daily PPIs.ConclusionsOur study shows that TIF using the EsophyX device is safe and effective in reducing atypical GERD symptoms at 6 and 12 months of follow-up. It improves patient-centered outcomes and can be a minimally invasive therapeutic option for patients suffering from atypical GERD symptoms on chronic medical therapy.
| S-EPMC10201409 | biostudies-literature
Project description:PurposeThe development of gastroesophageal reflux disease (GERD) has been shown to be not infrequent after laparoscopic sleeve gastrectomy (LSG). Management may vary from medical therapy to Roux-en-Y gastric bypass (RYGB) conversion. Magnetic sphincter augmentation (MSA) device has been shown to be a promising option with excellent results. The purpose of this video was to demonstrate the laparoscopic management of post-LSG GERD with MSA device implant.Materials and methodsAn intraoperative video has been edited to demonstrate the MSA device placement after LSG for the treatment of pathologic GERD.ResultsThe procedure started with the lysis of the perigastric adhesions to free the distal esophagus circumferentially. The posterior vagus nerve was identified, and a small window was created between the posterior esophageal wall anteriorly and the vagus nerve posteriorly. A hiatoplasty was performed using two non-resorbable interrupted 2.0 Prolene® sutures. The system's sizer was placed to measure the junctional circumference. A 15-mm MSA device was implanted.ConclusionMSA device placement seems technically feasible and safe with promising results in term of improved LES resting pressure and esophageal acid exposure. While future studies are necessary to corroborate these preliminary indications, MSA device may possibly become a valid option in surgeon armamentarium.
| S-EPMC8986733 | biostudies-literature
Project description:Background and study aims Few reports exist about long-term outcomes of transoral incisionless fundoplication (TIF) for treating refractory gastro-esophageal reflux disease (GERD). Methods A literature search of four major scientific databases was performed up to May 2020 for studies reporting on more than 3-year outcomes of TIF. Data on atient satisfaction, proton pump inhibitor (PPI) daily consumption, PPI use reduction, GERD health-related quality-of-life (GERD-HRQL) score, and normalization of heartburn and regurgitation scores were pooled and summarized with forest plots. Publication bias and heterogeneity were explored. Results Overall, eight studies (418 patients, 232 men; 55.5 %) with a mean follow-up of 5.3 years (range: 3-10 years) were included. The pooled proportion of patient-reported satisfaction before and after TIF was 12.3 % (95 % CI:12.3-35.1 %, I 2 = 87.4 %) and 70.6 % (95 % CI:51.2-84.6, I 2 = 80 %), respectively, corresponding to an odds ratio of 21.4 (95 % CI:3.27-140.5). Pooled rates of patients completely off PPIs and on occasional PPIs were 53.8 % (95 %CI: 42.0 %-65.1 %) and 75.8 % (95 %CI: 67.6-82.6), respectively. The pooled estimated mean GERD-HRQL scores off PPI before and after TIF werey 26.1 (95 %CI: 21.5-30.7; range: 20.0-35.5) and 5.9, respectively (95 %CI:0.35.1-11.4; range: 5.3-9.8; P < 0.001). The overall pooled rates of heartburn and regurgitation scores normalization were 73.0 % (95 %CI: 0.62-0.82) and 86 %, respectively (95 %CI: 75.0-91.0 %). Conclusion Our study shows that TIF appears to offer a long-term safe therapeutic option for selected patients with GERD who refuse life-long medical therapy or surgery, are intolerant to PPIs, or are at increased surgical risk.
| S-EPMC7857958 | biostudies-literature
Project description:IntroductionMagnetic sphincter augmentation (MSA) is a novel surgical technique investigated at many clinical institutes worldwide. In 2012, it received approval for treating Gastroesophageal reflux disease (GERD) because of its superior benefits compared to drug therapies. This study aimed to explore the safety and efficacy of MSA compared with Laparoscopic Nissen fundoplication (LNF) for GERD treatment.MethodsA retrospective analysis was conducted on 40 patients who received preoperative matching features of MSA and LNF. The surgical details and one-year postoperative outcomes were analyzed and reported.ResultsSignificant improvement in GERD symptoms was observed in both MSA and LNF patients over the one-year surgical follow-up. Dysphagia was a common postoperative complication observed in both procedures, but no cases required endoscopic dilation. MSA had a significantly shorter operative time compared to LNF (112 vs.175 min, P < 0.001), with faster postoperative dietary recovery [1(0.5,1.5) vs. 3(1.63,5.38) month(s), P < 0.001] and more preservation of hiccup ability (87.5% vs. 45.83%, P = 0.01). No significant disparities were observed between the two groups regarding hospital duration, recovery of physical strength, and upper gastrointestinal complaints.ConclusionIn conclusion, both LNF and MSA are safe and successful surgical therapies for GERD. The benefits of MSA include reduced surgical time, quicker nutritional recovery following surgery, and preservation of hiccup capacity. However, with both surgeries, postoperative dysphagia is a prevalent problem that emphasizes the significance of improving preoperative communication. When selecting between two surgical techniques, it is crucial to consider the postoperative symptoms associated with each procedure.
| S-EPMC11530483 | biostudies-literature
Project description: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.
| S-EPMC10789235 | biostudies-literature
Project description:This systematic review aims to evaluate the current evidence regarding safety and efficacy of magnetic sphincter augmentation (MSA) for the treatment of gastroesophageal reflux disease (GERD) after laparoscopic sleeve gastrectomy (LSG). Conversion to Roux-en-Y gastric bypass (RYGB) carries the risk of surgical and metabolic complications and may be contraindicated in patients with normalized or near-normalized body mass index. The LINX™ procedure aims to restore LES competency and to repair the crura. We included 109 patients (14 studies) undergoing LINX™ implant after LSG. Median follow-up was 18.9 months (range 0.3-63). Both the GERD-HRQL (38 ± 13 vs. 10 ± 11; p = 0.0078) and daily PPI use (97.4% vs. 25.3%; p < 0.0001) were significantly improved. Overall, 31.8% of the patients experienced device-related adverse events, mainly self-limiting. LINX™ explant for esophageal erosion occurred in 0.9% of the patients.
| S-EPMC11541252 | biostudies-literature
Project description:Magnetic sphincter augmentation using the LINX® device is a minimally invasive surgical option for patients with gastroesophageal reflux disease. An estimated 30,000 devices have been implanted worldwide. Device removals and erosion are identified risks. The objective of this analysis is to explore the procedure evolution with an emphasis on the removals and associated characteristics that may guide future clinical practice. The Manufacturer and User Facility Device Experience and Ethicon's complaint databases were queried for all surgical device explants since January 2013. Device unit sales were used to determine the rates. The endpoint was based upon the time from implant to explant. Explant and erosion rates were calculated at yearly intervals and the Kaplan-Meier estimator was used to measure the time to explant. Chi-square analyses were used to investigate the risk of explant associated with the size, geography and implant year. Overall, 7-year cumulative risk of removal was 4.81% (95% Confidence Interval (CI) CI: 4.31-5.36%). The likelihood of removal was significantly related to the device size (P < 0.0001), with smaller sizes being more likely to be explanted. The primary reasons for device removal and relative percentages were dysphagia/odynophagia (47.9%), persistent gastroesophageal reflux disease (20.5%) and unknown/other (11.2%). Overall, the 7-year cumulative risk of erosion was 0.28% (95% CI: 0.17-0.46%). The average device size increased from 14.2 beads ± 1.0 in 2013 to 15.3 beads ± 1.2 in 2019 (P < 0.001). Surgical technique and perioperative management play an important role in the outcomes. Clinical practice changes since magnetic sphincter augmentation has been incorporated into clinical use are associated with improved outcomes and should be further characterized. Smaller device size is associated with increased removal and erosion rates.
| S-EPMC8597906 | biostudies-literature