PERORAL ENDOSCOPIC MYOTOMY FOR ACHALASIA: SAFETY PROFILE, COMPLICATIONS AND RESULTS OF 94 PATIENTS.

BACKGROUND: Achalasia is an esophageal motility disorder, with clinical presentation of dysphagia and regurgitation. This is a chronic condition with no cure. Current treatment options aim to reduce lower esophageal sphincter tone by pharmacological, endoscopic or surgical means, with the aim of improving patients' symptoms. Peroral endoscopic myotomy (POEM) is an alternative endoscopic surgery to Heller cardiomyotomy, in which the procedure is performed orally, by endoscopy, offering efficacy comparable to surgical myotomy, with relative ease and minimal invasion, without external incisions. AIMS: To study the safety of POEM by analyzing its results, adverse events and perioperative complications and the main ways to overcome them, in addition to evaluating the effectiveness of the procedure and the short-term postoperative quality of life. METHODS: A qualitative and quantitative, observational and cross-sectional study that analyzed patients who underwent the POEM in a reference center, from December 2016 to December 2022, maintaining the technical standard of pre-, peri- and postoperative protocol. RESULTS: A total of 94 patients were included in the study, and only three had postoperative complications. The average early postoperative Eckardt score was 0.93 and the late 1.40, with a mean improvement of 7.1 in early results and 6.63 in late results (p<0.05). CONCLUSIONS: POEM can be reproduced with an excellent safety profile, significant relief of symptoms and improvement in esophageal emptying, and in quality of life.

Magnetic sphincter augmentation may limit access to magnetic resonance imaging.

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.

Longer-term outcomes of gastroesophageal reflux disease treated with magnetic sphincter augmentation.

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.

The role of magnetic sphincter augmentation in the gastroesophageal reflux disease treatment pathway: the gastroenterology perspective.

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.

Successful Design and Implementation of a POEM Program for Achalasia in an Integrated Healthcare System.

BACKGROUND: Per Oral Endoscopic Myotomy (POEM) is a minimally invasive treatment for achalasia with results comparable to laparoscopic Heller myotomy (LHM). Studies have described the development of proficiency for endoscopists learning to perform POEM, and societies have defined educational and technical objectives for advanced endoscopy fellows in training. However, there is limited guidance on the organizational strategy and educational plan necessary to develop an achalasia service with POEM expertise. AIMS: We aim to outline the steps for design and implementation of a successful POEM program. METHODS: We reported our experience developing a multi-disciplinary clinical program for POEM and the steps taken to achieve procedural proficiency. We also reported our technical success (successful tunneling into the gastric cardia and myotomy of LES muscle fibers) and clinical success (post-procedure Eckardt score ≤ 3) at 3-6 months and 12 months post-procedure. Adverse events were classified per the ASGE lexicon for endoscopic adverse events. RESULTS: After creating a multi-disciplinary clinical program for achalasia and completing procedural proficiency for POEM, our technical success rate was 100% and clinical success rate 90% for the first 41 patients. One adverse event (2.4%) occurred, moderate in severity per the American Society of Gastrointestinal Endoscopy (ASGE) lexicon for adverse endoscopic events. CONCLUSION: In this study, we outlined the steps involved to establish a POEM service in a large integrated healthcare system. Prior competency in interventional endoscopy, procedural training models, POEM observation and education, proctorship, and interdisciplinary patient care are recommended.

Long-term clinical and functional results of magnetic sphincter augmentation.

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.

S148: Long-term patient-reported outcomes of laparoscopic magnetic sphincter augmentation versus Nissen fundoplication: a 5-year follow-up study.

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.

[Alternative Surgical Anti-Reflux Procedures]. / Alternative operative Verfahren zur Behandlung der gastroösophagealen Refluxerkrankung.

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.

Effect of electrical stimulation therapy of the lower esophageal sphincter in GERD patients with ineffective esophageal motility.

BACKGROUND: Electrical stimulation therapy (EST) of the lower esophageal sphincter (LES) is a novel technique in antireflux surgery. Due to the minimal alteration at the LES during surgery, LES-EST is meant to be ideal for patients with gastroesophageal reflux disease (GERD) and ineffective esophageal motility (IEM). The aim of this prospective trial (NCT03476265) is to evaluate health-related quality of life and esophageal acid exposure after LES-EST in patients with GERD and IEM. METHODS: This is a prospective non-randomized open-label study. Patients with GERD and IEM undergoing LES-EST were included. Follow-up (FUP) at 12 months after surgery included health-related quality of life (HRQL) assessment with standardized questionnaires (GERD-HRQL) and esophageal functional testing. RESULTS: According to the study protocol, 17 patients fulfilled eligibility criteria. HRQL score for heartburn and regurgitation improved from 21 (interquartile range (IQR) 15-27) to 7.5 (1.25-19), p = 0.001 and from 17 (11-23.5) to 4 (0-12), p = 0.003, respectively. There was neither significant improvement of esophageal acid exposure nor reduction of number of reflux events in pH impedance measurement. Distal contractile integral improved from 64 (11.5-301) to 115 (IQR 10-363) mmHg s cm, p = 0.249. None of the patients showed any sign of dysphagia after LES-EST. One patient needed re-do surgery and re-implantation of the LES-EST due to breaking of the lead after one year. CONCLUSION: Although patient satisfaction improved significantly after surgery, this study fails to demonstrate normalization or significant improvement of acid exposure in the distal esophagus after LES-EST.

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.

OBJECTIVE: Number of reflux episodes, an adjunctive metric on pH-impedance monitoring, is incompletely studied. We aimed to determine if number of reflux episodes associates with therapeutic outcome in regurgitation predominant gastro-oesophageal reflux disease (GERD). DESIGN: We performed post hoc analysis of postintervention pH-impedance data from adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI), randomised to either two times a day PPI or magnetic sphincter augmentation (MSA) in 2:1 allocation. After 6 and 12 months, symptom response was defined by improvement in Foregut Symptom Questionnaire (FSQ) regurgitation score to none or minimal, ≥50% reduction in GERD health-related quality of life (HRQL) score and satisfaction with therapy. Univariate and multivariate analyses were performed to determine predictors of symptom improvement. RESULTS: Of 152 randomised patients, 123 (age 46.9±1.2 year, 43% female) had complete data. Symptom and satisfaction scores significantly improved after MSA compared with two times a day PPI. Both acid exposure time (13.4%±0.7% to 1.3±0.2%, p<0.001) and reflux episodes (86±4 to 48±4, p<0.001) declined with therapy. Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis. On multivariate analysis, improvement in regurgitation score remained independently predictive of satisfaction with therapy (p<0.001 for each). In patients crossing over to MSA, >80 episodes pretreatment predicted improvement. CONCLUSIONS: Reduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GERD. TRAIL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02505945.

[Application of magnetic sphincter augmentation for treating gastroesophageal reflux disease].

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.

[Preliminary results of Chinese magnetic sphincter augmentation in treating gastroesophageal reflux disease].

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.

Achalasia: what to do in the face of failures of Heller myotomy.

Achalasia is a primary motility disorder of the esophagus, and while there are several treatment options, there is no consensus regarding them. When therapeutic intervention for achalasia fails, a careful evaluation of the cause of the persistent or recurrent symptoms using upper endoscopy, esophageal manometry, and contrast radiologic studies is required to understand the cause of therapy failure and guide plans for subsequent treatment. Options for reintervention are the same as for primary intervention and include pneumatic dilation, botulinum toxin injection, peroral endoscopic myotomy, or redo esophageal myotomy. When reintervention fails or if the esophagus is not amenable to intervention and the disease is considered end-stage, esophagectomy is the last option to manage recurrent achalasia.

The role of preoperative workup in predicting dysphagia, dilation, or explantation after magnetic sphincter augmentation.

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.

Postoperative Dysphagia Following Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease.

The addition of posterior cruroplasty to magnetic sphincter augmentation (MSA-PC) has been shown to be effective in treating gastroesophageal reflux disease (GERD). This study evaluates the predictors of persistent postoperative dysphagia, one of the major complaints after MSA-PC. From August 2015 to February 2018 the medical records of 118 patients (male=59, female=59) receiving MSA-PC for GERD were reviewed. Postoperative dysphagia was present in 80 patients (67.8%), with 20 (16.9%) requiring dilation for persistent dysphagia. Three patients (2.5%) had the magnetic sphincter augmentation device removed for persistent dysphagia, one was converted to a Nissen fundoplication. The median number of dilations was 1, mean time from surgery to dilation was 5.6 months, and 15/20 (75%) had symptom resolution after 1 to 2 dilations. Dilated patients were more likely than nondilated patients to have atypical GERD symptoms preoperatively (70% vs. 44.7%, P=0.042). After dilation, 93.3% of patients reported a good quality of life.

Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease.

Magnetic sphincter augmentation is an effective and safe surgical method for the treatment of gastroesophageal reflux disease (GERD). The device has been compared with twice-daily proton pump inhibitor therapy and laparoscopic fundoplication (in randomized trials and prospective cohort studies, respectively). Magnetic sphincter augmentation was superior to medical therapy and equivalent to surgery for the relief of GERD symptoms. Recent research focuses on implanting the device into more complex patients, such as those with larger hiatal hernias or those with Barrett's esophagus. Additional novel research topics include cost analysis and predicting and minimizing postoperative dysphagia.

Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease.

BACKGROUND: Magnetic sphincter augmentation (MSA) is reported to be an innovative alternative to antireflux surgery for patients with gastro-oesophageal reflux disease. Although used in practice, little is known about how it has been evaluated. This study aimed to systematically summarize and appraise the reporting of MSA and its introduction into clinical practice, in the context of guidelines (such as IDEAL) for evaluating innovative surgical devices. METHODS: Systematic searches were used to identify all published studies reporting MSA insertion. Data collected included patient selection, governance arrangements, surgeon expertise, technique description and outcome reporting. RESULTS: Searches identified 587 abstracts; 39 full-text papers were included (1 RCT 5 cohort, 3 case-control, 25 case series, 5 case reports). Twenty-one followed US Food and Drug Administration eligibility criteria for MSA insertion. Twenty-six documented that ethical approval was obtained. Two reported that participating surgeons received training in MSA; 18 provided information about how MSA insertion was performed, although techniques varied between studies. Follow-up ranged from 4 weeks to 5 years; in 14 studies, it was less than 1 year. CONCLUSION: 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.

ANTECEDENTES: El aumento de esfínter con un dispositivo magnético (magnetic sphincter augmentation, MSA) se ha descrito como una alternativa innovadora a la cirugía antirreflujo para pacientes con enfermedad por reflujo gastroesofágico. Aunque este procedimiento se utiliza en la práctica, se sabe poco acerca de cómo ha sido evaluado. Este estudio se propuso resumir sistemáticamente y evaluar los trabajos sobre MSA y su introducción en la práctica clínica, en el contexto de las guías (como IDEAL) para la evaluación de dispositivos quirúrgicos innovadores. MÉTODOS: Se identificaron todos los estudios publicados que describían la colocación de MSA efectuando búsquedas sistemáticas. Los datos recogidos incluían la selección de los pacientes, disposiciones de gobernanza, experiencia del cirujano, descripción técnica, y descripción de resultados. RESULTADOS: Las búsquedas identificaron 587 resúmenes, incluyéndose 39 artículos completos (5 estudios de cohortes, 3 estudios de casos y controles, 26 series de casos, 5 casos clínicos). En 21 estudios se siguieron los criterios de elegibilidad de la FDA para la colocación de MSA. En 26 estudios se confirmaba que se había obtenido la aprobación ética. Dos estudios describieron que los cirujanos participantes habían recibido formación en MSA; 18 proporcionaron información sobre cómo se realizó la colocación de MSA, aunque las técnicas variaron entre los estudios. El seguimiento oscilaba entre 4 semanas y 5 años; en 14 estudios fue inferior a un año. CONCLUSIÓN: La mayoría de los estudios sobre MSA fueron casos aislados y series de casos, sin un incremento apreciable en la calidad de la evidencia sobre MSA. La información sobre la selección de los pacientes, gobernanza, experiencia, técnicas, y resultados estaba ausente o variaba entre los estudios, haciendo difíciles las comparaciones. En la actualidad, MSA se utiliza a pesar de la falta de evidencia robusta sobre su efectividad.

Electrical Stimulation as an Alternative Treatment in Gastroesophageal Reflux Disease - Clinical Study.

Background: Recently, there was described the possibility to increase the lower esophageal sphincter (LES) tone by means of implantable electrical stimulator. Although, this method has already been used in clinical practice, however, the optimal parameters of LES electrical stimulation are still unknown. Aims: The goals of this study were to get clinical data regarding the effects of different types of electrical stimulation on LES and to elaborate and test the prototype on laboratory animals. Material and Methods: In the Department of Surgery no 4, during 4 years (2015-2018), there has been achieved one clinical-experimental study of LES electrical stimulation. During the first stage, the electrical stimulation of the LES, using an external pulse generator, was assessed in 15 patients. These patients underwent an antireflux intervention, with an additional insertion of 2 temporary electrodes on the LES. During the second stage, there was created an experimental device which consisted of a re-insertable microstimulator using wireless energy transfer. During the third stage, it was tested in the experimental surgery center "Pius Branzeu", Timisoara, on laboratory animals (pigs). Results: Values of the LES resting pressure and integrated relaxation pressure (IRP) were significantly different during the prestimulation and poststimulation periods. Conclusions: There was successfully demonstrated the possibility to increase the LES tone. Modifications in the LES functionality and tone, during the electrical stimulation and in the period immediately after the stimulation, depend upon the pulse frequency and length. Also, the additional change of the Bluetooth transmitter antenna is necessary to offset the screening effect of the biological tissues.

Videoesophagography versus Endoscopy for Prediction of Intraoperative Hiatal Hernia Size.

Magnetic sphincter augmentation is a novel surgical procedure for gastroesophageal reflux disease. Limited dissection at the hiatus is one of the benefits of the procedure, but makes precise and accurate preoperative assessment of even small hiatal hernia critical. Retrospective cohort study of 136 patients having undergone both endoscopy (EGD) and videoesophagography followed by operative assessment for hiatal hernia during magnetic sphincter augmentation. The objective of the study is to determine which preoperative modality more accurately predicts operative hiatal hernia size. Videoesophagography underestimated operative measurement by 0.37 ± 1.41 cm (P = 0.003) and was less accurate in predicting intraoperative hiatal hernia size than EGD on linear regression analysis (ß -0.729, SE 0.057, P < 0.001). EGD was less accurate at predicting hiatal hernia size as patient age increased (ß -0.018, SE 0.007, P = 0.014) and with larger hernias (ß -0.615, standard error (SE) 0.067, P < 0.001); however, endoscopic measurements did not differ significantly from intraoperative measurements (0.93 ± 1.23 cm vs 1.12 ± 1.43 cm, P = 0.12). EGD better predicts the size of small hiatal hernia measured during subsequent laparoscopic surgery.

Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes.

BACKGROUND: We have previously reported short-term outcomes after hiatal hernia repair (HHR) at the time of magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease (GERD). Here we report intermediate-term outcomes and hernia recurrence rate after concomitant MSA and HHR. METHODS: This is a retrospective cohort study of patients who underwent repair of a hiatal hernia 3 cm or larger at the time of MSA implantation between May 2009 and December 2015. The primary endpoint was hiatal hernia recurrence identified by routine postoperative videoesophagography or endoscopy. Recurrence was defined by a 2 cm or greater upward displacement of the stomach through the diaphragmatic esophageal hiatus. Secondary endpoints included cessation of proton-pump inhibitor (PPI), persistent dysphagia requiring intervention, and GERD health-related quality-of-life (HRQL) scores 1 year from surgery. RESULTS: During the study period, 47 of 53 (89%) patients underwent concomitant MSA with HHR and complied with surveillance. Hiatal hernias ranged from 3 to 7 cm (mean 4 ± 1). Mean clinical follow-up time was 19 months (range 1-39). GERD-HRQL score decreased from 20.3 to 3.1 (p < .001), 89% of patients remained off PPIs, and 97% of patients reported improvement or resolution of symptoms. Two recurrent hiatal hernias were identified on surveillance imaging for a recurrence rate of 4.3% at a mean 18 (± 10) months after initial operation. Persistent dysphagia occurred in 13% (6/47) over the first year, which resolved after a single balloon dilation in 67% (4/6). Two patients elected for device removal due to dilation-refractory dysphagia and persistent reflux symptoms. CONCLUSION: Concomitant magnetic sphincter augmentation and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia demonstrates durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow-up.