The Impact of Ineffective Esophageal Motility on Patients Undergoing Magnetic Sphincter Augmentation.

OBJECTIVE: To evaluate and characterize outcomes of MSA in patients with IEM. SUMMARY BACKGROUND DATA: MSA improves patients with gastroesophageal reflux and normal motility. However, many patients have IEM, which could impact the outcomes of MSA and discourage use. METHODS: An international, multi-institutional case control study of IEM patients undergoing MSA matched to normal patients was performed. Primary outcomes were new onset dysphagia and need for postoperative interventions. RESULTS: A total of 105 IEM patients underwent MSA with matching controls. At 1 year after MSA: GERD-Health Related Quality of Life was similar; DeMeester scores in IEM patients improved to 15.7 and 8.5 in controls ( P = 0.021); and normalization of the DeMeester score for IEM = 61.7% and controls = 73.1% ( P = 0.079).In IEM patients, 10/12 (83%) with preop dysphagia had resolution; 11/66 (17%) had new onset dysphagia and 55/66 (83%) never had dysphagia. Comparatively, in non-IEM patients, 22/24 (92%) had dysphagia resolve; 2/24 (8%) had persistent dysphagia; 7/69 (10%) had new onset dysphagia, and 62/69 (90%) never had dysphagia.Overall, 19 (18%) IEM patients were dilated after MSA, whereas 12 (11%) non-IEM patients underwent dilation ( P = 0.151). Nine (9%) patients in both groups had their device explanted. CONCLUSIONS: Patients with IEM undergoing MSA demonstrate improved quality of life and reduction in acid exposure. Key differences in IEM patients include lower rates of objective GERD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GERD patients with IEM should be counselled about these possibilities.

Esophageal Lipoma and Liposarcoma: A Systematic Review.

BACKGROUND: Esophageal lipomatous tumors, also reported as fibrovascular polyp, fibrolipoma, angiolipoma, and liposarcoma, account for less than 1% of all benign mesenchymal submucosal tumors of the esophagus. Clinical presentation and therapy may differ based on location, size, and morphology. A comprehensive and updated systematic review of the literature is lacking. METHODS: A systematic review of the literature was performed according to PRISMA guidelines. Pubmed, Embase, Cochrane, and Medline databases were consulted using MESH keywords. Non-English written articles and abstracts were excluded. Sex, age, symptoms at presentation, diagnosis, tumor location and size, surgical approach and technique of excision, pathology, and morphology were extracted and recorded in an electronic database. RESULTS: Sixty-seven studies for a total of 239 patients with esophageal lipoma or liposarcoma were included in the qualitative analysis. Among 176 patients with benign lipoma, the median age was 55. The main symptoms were dysphagia (64.2%), transoral polyp regurgitation (32.4%), and globus sensation (22.7%). The majority of lipomas (85.7%) were intraluminal polyps, with a stalk originating from the upper esophagus. Overall, 165 patients underwent excision of the mass through open surgery (65.5%), endoscopy (27.9%), or laparoscopy/thoracoscopy (3.6%). Only 5 (3%) of patients required esophagectomy. Of the 11 untreated patients with an intraluminal polyp, 7 died from asphyxia. Overall, liposarcoma was diagnosed in 63 patients, and 12 (19%) underwent esophagectomy. CONCLUSION: Esophageal lipomatous tumors are rare but potentially lethal when are intraluminal and originate from the cervical esophagus. Modern radiological imaging has improved diagnostic accuracy. Minimally invasive transoral and laparoscopic/thoracoscopic techniques represent the therapeutic approach of choice.

Removal of the Magnetic Sphincter Augmentation Device: Surgical Technique and Results of a Single-center Cohort Study.

OBJECTIVE: The aim of this study was to identify patients' characteristics that may predict failure and removal of the Linx sphincter augmentation device, and to report the results of 1-stage laparoscopic removal and fundoplication. BACKGROUND: The Linx device is a long-term magnetic implant that was developed as a less disruptive and more reproducible surgical option for patients with early-stage gastroesophageal reflux disease (GERD). Removal of the device has been shown to be feasible, but no long-term results of this procedure have been reported yet. METHODS: A review of the prospectively collected research database of antireflux surgery was performed to identify all patients who underwent a Linx implant between 2007 and 2015 in our Institution. Demographics, duration of symptoms and proton pump inhibitor (PPI) therapy, GERD-Health Related Quality of Life scores, esophageal acid exposure, lower esophageal sphincter pressure, number of beads (size) of the implanted device, concurrent crura repair, angle of inclination of the device at postoperative chest film, operative time, postoperative complications, and length of stay were recorded. Data of the explanted patients were compared with those with the device in situ in an attempt to identify factors associated with Linx removal. RESULTS: Over the study period, 164 patients underwent a laparoscopic Linx implant and had a median follow-up of 48 months [interquartile range (IQR) 36]. Eleven (6.7%) of these patients were explanted at a later date. The estimated removal-free probability at 80 months was 0.91 [confidence interval (CI) 0.86-0.96]. Supine esophageal acid exposure before the index operation was associated with Linx removal (odds ratio 1.05, CI 1.01-1.11, P = 0.037). The main presenting symptom requiring device removal was recurrence of heartburn or regurgitation in 5 patients (46%), followed by dysphagia (n = 4, 37%) and chest pain (n = 2, 18%). In 2 patients, full-thickness erosion of the esophageal wall with partial endoluminal penetration of the device occurred. The median implant duration was 20 months, with 82% of the patients being explanted between 12 and 24 months after the implant. Device removal was most commonly combined with partial fundoplication. There were no conversions to laparotomy and the postoperative course was uneventful in all patients. At the latest follow-up, ranging from 12 to 58 months, the GERD-HRQL score was within normal limits in all patients. CONCLUSIONS: Laparoscopic removal of the Linx device can be safely performed as a 1-stage procedure and in conjunction with fundoplication even in patients presenting with device erosion.

Reference high-resolution manometry values after magnetic sphincter augmentation.

BACKGROUND: Magnetic sphincter augmentation (MSA) is an innovative antireflux procedure that can improve lower esophageal sphincter (LES) competency and reduce symptoms of gastroesophageal reflux disease (GERD). Some patients report postoperative dysphagia. To date, no studies have described reference high-resolution manometry (HRM) values after MSA implantation. METHODS: High-resolution manometry was performed in patients free of dysphagia after MSA with or without concurrent crura repair. Reference values for all parameters of the Chicago Classification were defined as those between the 5th and 95th percentiles. The contribution of concurrent crura repair to LES competency and to reference values was also analyzed. KEY RESULTS: Eighty-four patients met the study inclusion criteria. The upper limit of normality for integrated relaxation pressure (IRP) and intrabolus pressure (IBP) was 20.2 mmHg and 30.3 mmHg, respectively. Both variables were higher after MSA compared to normative Chicago Classification v3.0 values. The Distal Contractile Integral upper limit was in the range of normality. Patients undergoing crura repair had a significantly higher IRP (p = 0.0378) and lower GERDQ-A scores (p = 0.0374) and Reflux Symptom Index (p = 0.0030) compared to those who underwent MSA device implantation alone. CONCLUSION & INFERENCES: This study provides HRM reference values for patients undergoing successful MSA implantation. Crural repair appears to be a key component of LES augmentation and is associated with improved clinical outcomes.

High-resolution manometry findings after Linx procedure for gastro-esophageal reflux disease.

BACKGROUND: Magnetic sphincter augmentation with the Linx® system is a novel laparoscopic procedure for the treatment of gastro-esophageal reflux disease (GERD). Only few data are available regarding the impact of Linx on high-resolution manometry (HRM) variables. METHODS: The prospectively collected database of patients who underwent Linx procedure at a single institution was queried. All patients who completed pre- and postoperative HRM, GERD health-related quality of life (GERD-HRQL) questionnaire, and functional outcome swallowing scale (FOSS) questionnaire were included in the study. KEY RESULTS: Forty-five out of 304 patients were included. At a median follow-up of 12 months (IQR 10) after surgery, a statistically significant increase of lower esophageal sphincter (LES) total length (P = .002), intra-abdominal length (P = .001), integrated relaxation pressure (IRP), intrabolus pressure (IBP), and esophagogastric contractile integral (EGJ-CI) was noted (P < .001). Distal esophageal amplitude (P = .004), mean distal contractile integral (DCI) (P < .001), post multiple repeated swallows DCI (P = .001), and the percent of normal peristalsis increased (P = .040). All patients were relieved of reflux symptoms. Ineffective esophageal motility reversed to normal in 36% of patients after surgery. The only factor significantly associated with postoperative dysphagia was preoperative dysphagia (P = .006). Postoperatively, a significant correlation between IRP and DCI (r = 0.361 and P = .019) and between IBP and DCI (r = 0.443 and P = .003) was found. CONCLUSIONS AND INFERENCES: The Linx procedure had a remarkable effect on esophageal 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.

Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease.

The magnetic sphincter augmentation (MSA) device has been proven safe and effective in controlling typical reflux symptoms and esophageal acid exposure for up to 6-year follow-up. Longer term outcomes have not been reported yet. A prospectively maintained database was reviewed to assess long-term safety and efficacy of the laparoscopic MSA procedure at a single referral center. Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), use of proton-pump inhibitors (PPI), and esophageal acid exposure were compared to baseline. Favorable outcomes were defined as ≥ 50% improvement of GERD-HRQL total score and PPI discontinuation. Between March 2007 and March 2020, 335 patients met the study inclusion criteria, and 124 of them were followed from 6 to 12 years after surgery (median 9 years, IQR 2). Mean total GERD-HRQL score significantly improved from 19.9 to 4.01 (p < 0.001), and PPI were discontinued by 79% of patients. The mean total percent time with pH < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving pH normalization. Independent predictors of a favorable outcome were age at intervention < 40 years (OR 4.17) and GERD-HRQL score > 15 (OR 4.09). We confirm long-term safety and efficacy of MSA in terms of symptom improvement, decreased drug dependency, and reduced esophageal acid exposure.

The Malnutrition Universal Screening Tool can predict malnutrition in patients with esophageal achalasia.

BACKGROUND: At present, little research has been done to clarify why some achalasia patients do not lose weight or are even obese and to investigate their nutritional status. The aim of this study was to identify predictive factors of malnutrition in these patients and to assess their response to treatment. METHODS: We conducted a retrospective cohort study on consecutive patients referred to a tertiary-care center for laparoscopic or endoscopic treatment of achalasia. Demographics, anthropometric variables, presenting symptoms, and results of the objective investigation were recorded on a prospectively collected database. The severity of symptoms and the nutritional risk were assessed by the Eckardt score and the Malnutrition Universal Screening Tool (MUST), respectively, before and after treatment. RESULTS: Between 2013 and 2019, 171 patients met the study inclusion criteria. There were 87 (50.9%) male and the median age was 53.0 (39-66) years. The median Eckardt score was 6 (interquartile range 3). Based on the MUST score, 121 (70.8%) patients were classified at moderate/high risk of malnutrition. Of these, 93 (76.9%) were overweight or obese. Compared to low-risk group, predictive factors of moderate/high risk of malnutrition were higher Eckardt score [odds ratio (OR) 1.63; 95% CI, 1.35-1.99], more severe dysphagia (OR 2.68, 95% CI, 1.66-4.30), and greater absolute weight loss (OR 2.37; 95% CI, 1.77-3.17). The latter was the only independent predictive factor of malnutrition (OR 2.54; 95% CI, 1.69-3.82). After treatment, the measured MUST score was 0 in 96% of patients. CONCLUSIONS: Over 70% of achalasia patients were at moderate/high risk of malnutrition. These individuals may benefit from a perioperative multidisciplinary approach including dietary intervention to stabilize weight and improve their nutritional status.

Magnetic Sphincter Augmentation After Gastric Surgery.

BACKGROUND: Persistent or de novo gastroesophageal reflux disease (GERD) may be a significant clinical issue after gastric/bariatric surgical procedures. We investigated the effect of magnetic sphincter augmentation (MSA) in the treatment of GERD after previous gastric/bariatric surgery. DATABASE: We conducted a systematic review according to the Preferred Reporting Items For Systematic Reviews and Meta-analyses statement. We searched multiple databases (PubMed, Cochrane, Embase, Scopus) up to May 2019. We also queried the prospectively collected database of patients who underwent MSA at our tertiary-care hospital and compared postsurgical to naïve patients operated during the same time period. RESULTS: Seven studies (3 case series and 4 case reports), for a total of 35 patients, met the inclusion criteria in the systematic review. The most common index operation was a bariatric procedure, either sleeve gastrectomy or Roux-en-Y gastric bypass. After MSA implant, the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score significantly improved compared to baseline (P = .005). Two patients (5.7%) required laparoscopic device removal. In the local institutional cohort series of 67 patients treated by MSA, the prevalence of preoperative grade B esophagitis, operative time, size of MSA, and length of stay were greater in patients with prior gastric surgery compared to naïve patients. CONCLUSIONS: MSA is a safe, simple, and standardized antireflux procedure. It is also feasible in patients with refractory GERD following gastric/bariatric surgery. Further prospective and comparative studies are needed to validate the preliminary clinical experience in this subset of patients.

Magnetic sphincter augmentation is an effective option for refractory duodeno-gastro-oesophageal reflux following Billroth II gastrectomy.

Bile reflux into the gastric stump and then into the oesophagus is a common event after distal gastrectomy and Billroth II reconstruction. In addition to typical symptoms of nausea, epigastric pain and bile vomiting, acid reflux can also occur in patients with concomitant hiatus hernia and lower oesophageal sphincter incompetency. Diverting the bile away from the oesophagus by conversion into a Roux-en-Y anastomosis or by completion gastrectomy and Roux-en-Y esophagojejunostomy have so far represented the mainstay of treatment. We report the first case of magnetic sphincter augmentation to relieve refractory reflux symptoms after Billroth II gastrectomy. The procedure was performed through a laparoscopic approach and proved very effective at 1-year follow-up.

Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies.

Use of the magnetic sphincter augmentation (MSA) device for the laparoscopic treatment of gastroesophageal reflux disease is increasing since the first clinical implant performed a decade ago. The MSA procedure is a minimally invasive and highly standardized surgical option for patients who are partially responders to proton-pump inhibitors, which have troublesome regurgitation or develop progressive symptoms despite continuous medical therapy. The procedure has proven to be highly effective in improving typical reflux symptoms, reducing the use of proton-pump inhibitors, and decreasing esophageal acid exposure. Observational cohort studies have shown that MSA compares well with fundoplication in selected patients and has an acceptable safety profile. The device can be easily removed if necessary, thereby preserving the option of fundoplication in the future. The majority of the removals have occurred within 2 years after implant and have been managed non-emergently, with no complications or long-term consequences. "Expanded" indications to MSA (large hiatal hernia and Barrett's esophagus) need to be tested in further comparative studies with classic fundoplication procedures.

Transanal removal of a broken drinking glass self-inserted and retained in the rectum.

Retained rectal foreign bodies are increasingly reported in current clinical practice, and there is no clear consensus in the literature as to whether transanal extraction should be performed in the emergency or in the operating room. A 47-year-old presented to the hospital for a retained drinking glass in the rectum that was broken after an attempt at self-extraction. Physical examination showed no evidence of abdominal guarding nor bleeding from the rectum; abdominal and pelvic X-rays confirmed the presence of a broken glass, 8×6 cm in size and no signs of perforation. Initial anoscopy performed in the emergency room confirmed the partial fracture of the glass. The patient was transferred to the operating room and transanal extraction was carried out under general anaesthesia without complications.

Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis.

Only a minority of patients with gastro-esophageal reflux disease (GERD) are offered a surgical option. This is mostly due to the fear of potential side effects, the variable success rate, and the extreme alteration of gastric anatomy with the current gold standard, the laparoscopic Nissen fundoplication. It has been reported that laparoscopic Toupet fundoplication (LTF) and laparoscopic sphincter augmentation using a magnetic device (LINX) can treat reflux more physiologically and with a lower incidence of side-effects and reoperation rate. We present the first comparing quality of life in patients undergoing LTF versus LINX.Observational cohort study. Consecutive patients undergoing LTF or LINX over the same time period were compared by using the propensity score full matching method and generalized estimating equation. Criteria of exclusion were >3 cm hiatal hernia, grade C-D esophagitis, ineffective esophageal motility, body mass index >35, and previous upper abdominal surgery. The primary study outcome was quality of life measured with the Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire. Secondary outcomes were proton pump inhibitors (PPI) use, presence of gas-related symptoms or dysphagia, and reoperation-free probability.Between March 2007 and July 2014, 238 patients with GERD met the criteria of inclusion in the study. Of these, 103 underwent an LTF and 135 a LINX procedure. All patients had a minimum 1-year follow-up. Over time, patients in both groups had similar GERD-HRQL scores (odds ratio [OR] 1.04, confidence interval [CI] 0.89-1.27; P = 0.578), PPI use (OR 1.18, CI 0.81-1.70; P = 0.388), gas-related symptoms (OR 0.69, CI 0.21-2.28; P = 0.542), dysphagia (OR 0.62, CI 0.26-1.30; P = 0.241), and reoperation-free probability (stratified log-rank test = 0.556).In 2 concurrent cohorts of patients with early stage GERD undergoing LTF or LINX and matched by propensity score analysis, health-related quality of life significantly improved and GERD-HRQL scores had a similar decreasing trend over time up to 7 years of follow-up. We conclude that LTF and LINX provide similar disease-specific quality of life over time in patients with early stage GERD.

One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center.

BACKGROUND: This study was undertaken to evaluate our clinical experience during a 6-year period with an implantable device that augments the lower esophageal sphincter for gastroesophageal reflux disease (GERD). The device uses magnetic sphincter augmentation (MSA) to strengthen the antireflux barrier. STUDY DESIGN: In a single-center, prospective case series, 100 consecutive patients underwent laparoscopic MSA for GERD between March 2007 and February 2012. Clinical outcomes for each patient were tracked post implantation and compared with presurgical data for esophageal pH measurements, symptom scores, and proton pump inhibitor (PPI) use. RESULTS: Median implant duration was 3 years (range 378 days to 6 years). Median total acid exposure time was reduced from 8.0% before implant to 3.2% post implant (p < 0.001). The median GERD Health Related Quality of Life score at baseline was 16 on PPIs and 24 off PPIs and improved to a score of 2 (p < 0.001). Freedom from daily dependence on PPIs was achieved in 85% of patients. There have been no long-term complications, such as device migrations or erosions. Three patients had the device laparoscopically removed for persistent GERD, odynophagia, or dysphagia, with subsequent resolution of symptoms. CONCLUSIONS: Magnetic sphincter augmentation for GERD in clinical practice provides safe and long-term reduction of esophageal acid exposure, substantial symptom improvement, and elimination of daily PPI use. For candidates of antireflux surgery who have been carefully evaluated before surgery to confirm indication for MSA, MSA has become a standard treatment at our institution because control of reflux symptoms and pH normalization can be achieved with minimal side effects and preservation of gastric anatomy.