Exploring the feasibility and safety of laparoscopic anti-reflux surgery with the new RefluxStop™ device: a retrospective cohort study of 40 patients.

AIMS OF THE STUDY: Anti-reflux surgery aims to restore the anti-reflux barrier and reduce the retrograde flow of stomach contents. However, traditional surgical techniques generally involve some degree of encircling of the oesophagus, which can result in adverse effects such as dysphagia and the inability to belch or vomit. Based on the first published results, a novel surgical technique - with the RefluxStop™ device - appears promising for treating gastroesophageal reflux disease (GERD) with minimal postoperative dysphagia. This study describes the initial clinical experience with this procedure in a cohort of patients with chronic gastroesophageal reflux disease to evaluate its feasibility and safety in clinical practice. METHODS: This retrospective cohort study examined the first 40 patients who underwent laparoscopic anti-reflux surgery with the RefluxStop™ device at a private hospital in Switzerland. The procedure involves implanting a nonactive device on the outside of the gastric fundus to stabilise a narrow oesophagogastric plication. Feasibility was assessed based on the proportion of patients in whom the device could be successfully implanted, with a discussion of the operative details. Intraoperative and postoperative complications, adverse effects, and changes in gastroesophageal reflux disease-related quality of life (GERD-HRQL questionnaire) are also reported. RESULTS: Between May 2020 and April 2022, 40 patients underwent elective surgery for laparoscopic hiatal hernia repair and RefluxStop™ device implantation. All patients had typical symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation; 20 (50%) had preoperative dysphagia. Laparoscopic surgery was feasible in all patients except one who required laparotomy due to adhesions and associated bleeding when accessing the abdomen. The median operating time was 57.5 minutes (interquartile range = 51.75-64.25 minutes) with no device-related intraoperative or postoperative complications. All patients were imaged one day and three months postoperative, confirming the correct placement of the device. Reflux symptoms (heartburn and acid regurgitation) were significantly improved in all patients at three months (p <0.0001). CONCLUSION: These preliminary results support the feasibility and safety of introducing this novel laparoscopic anti-reflux surgical treatment option in clinical practice.

Robotic Magnetic Sphincter Augmentation Device Removal.

Although most patients with reflux can be managed with medical therapy, some require surgical intervention to manage their disease. Newer technologies, such as magnetic sphincter augmentation (MSA), have been promoted as the replacement of fundoplication. However, as time has elapsed, our institution noticed the need for the removal of MSA devices. Although a few reports have described MSA device removals, we provide a deeper explanation of how to perform a robotic device removal. Our article describes the technical steps and includes a video to demonstrate how to complete the surgery robotically.

Robotic LINX Placement: Is it Worth It?

Background: Laparoscopic Nissen fundoplication is considered the current gold standard of surgical treatment of gastroesophageal reflux disease. Magnetic sphincter augmentation with the LINX® device was developed as a less technically challenging alternative that has proven to be a safe and effective surgical antireflux procedure. Despite rapid adoption of the robotic platform in many areas of general surgery, no studies have compared laparoscopic and robotic approaches to placement of the LINX device. This retrospective study is the first to compare the robotic platform with the laparoscopic approach for minimally invasive LINX placement. Methods: We conducted a retrospective review of a total cohort of 20 patients who underwent LINX placement with hiatal hernia repair at our institution. Half of the patients underwent surgery using laparoscopy and the other half with robotic technology. Patient characteristics, surgical outcomes, and charge differences were analyzed. Results: We found that there were no significant differences in hospital length of stay, surgical outcomes, use of proton pump inhibitors (PPIs) postoperatively, or postoperative dysphagia. Patients undergoing robotic surgery had longer operative time (139 ± 25 minutes versus 81 ± 14 minutes, P < .01), higher intraoperative charges ($8980 ± 275 versus $7239 ± 355, P < .01), and higher charges associated with their hospital stay ($45,037 ± 4112.41 versus $39,565 ± 3731.64, P < .01). Conclusions: In comparison with laparoscopic LINX procedures, robotic LINX does not offer superior surgical outcomes in terms of postoperative PPI use, dysphagia, or hospital length of stay. Robotic LINX procedures are associated with increased operative time and overall charges.

Tension-free mesh versus suture-alone cruroplasty in antireflux surgery: a randomized, double-blind clinical trial.

BACKGROUND: Antireflux surgery is effective for the treatment of gastro-oesophageal reflux disease (GORD) but recurrence of hiatal hernia remains a challenge. In other types of hernia repair, use of mesh is associated with reduced recurrence rates. The aim of this study was to compare the use of mesh versus sutures alone for the repair of hiatal hernia in laparoscopic antireflux surgery. METHODS: Patients undergoing laparoscopic Nissen fundoplication for GORD between January 2006 and December 2010 were allocated randomly to closure of the diaphragmatic hiatus with crural sutures or non-absorbable polytetrafluoroethylene mesh (CruraSoft®). The primary outcome was recurrence of hiatal hernia, as determined by barium swallow study 12 months after surgery. Secondary outcomes were: intraoperative and postoperative complications, use of antireflux medication, postoperative oesophageal acid exposure, quality of life, dysphagia and duration of hospital stay. RESULTS: Some 77 patients were randomized to the suture technique and 82 patients underwent mesh repair. At 1 year, the hiatal hernia had recurred in six of 64 patients (9 per cent) in the mesh group and two of 64 (3 per cent) in the suture group (P = 0·144). Reflux symptoms, use of proton pump inhibitors and oesophageal acid exposure did not differ between the groups. At 3 years, recurrence rates were 13 and 10 per cent in the mesh and suture groups respectively (P = 0·692). Dysphagia scores decreased in both groups, but more patients had dysphagia for solid food after mesh closure (P = 0·013). Quality-of-life scores were comparable between the groups. CONCLUSION: Tension-free crural repair with non-absorbable mesh does not reduce the incidence of recurrent hiatal hernia compared with use of sutures alone in patients undergoing laparoscopic fundoplication. NCT03730233 ( http://www.clinicaltrials.gov).

ANTECEDENTES: La cirugía antirreflujo es efectiva para el tratamiento de la enfermedad por reflujo gastroesofágico (gastro-oesophageal reflux disease, GORD), pero la recidiva de la hernia de hiato sigue siendo un desafío. En otros tipos de reparación herniaria, la utilización de mallas se asocia con tasas reducidas de recidiva. El objetivo de este estudio fue comparar la utilización de una malla con suturas solo para la reparación de la hernia de hiato en cirugía antirreflujo laparoscópica. MÉTODOS: Pacientes sometidos a funduplicatura de Nissen por GORD entre enero 2006 y diciembre 2010 fueron asignados de forma aleatoria a cierre del hiato diafragmático con suturas de la crura o malla PTFE no absorbible (CruraSoft®). El resultado primario fue la recidiva de la hernia hiatal determinada mediante estudio radiológico con papilla de bario a los 12 meses de la cirugía. Los resultados secundarios fueron las complicaciones intra- y postoperatorias, utilización de medicación antirreflujo, exposición postoperatoria del esófago al reflujo ácido, calidad de vida, disfagia y duración de la estancia postoperatoria. RESULTADOS: Un total de 77 pacientes fueron aleatorizados a la técnica con suturas y 82 pacientes fueron sometidos a reparación con malla. Al año, se observó recidiva de la hernia de hiato en 6 de 64 pacientes en el grupo con malla (9%) y 2 de 64 pacientes (3%) en el grupo con suturas (P = 0,144). Los síntomas de reflujo, utilización de inhibidores de la bomba de protones (IBPs) y exposición del esófago al ácido no difirieron entre los grupos. A los 3 años, las tasas de recidiva fueron 13% y 10% para el grupo con malla y para el grupo con sutura, respectivamente (P = 0,692). Las puntuaciones de disfagia se redujeron en ambos grupos, pero más pacientes presentaron disfagia para sólidos tras el cierre con malla (P = 0,013). Las puntuaciones de calidad de vida posteriores fueron similares en ambos grupos. CONCLUSIÓN: En pacientes sometidos a funduplicatura laparoscópica, la reparación de la crura sin tensión con malla no absorbible no reduce la incidencia de recidiva de la hernia de hiato en comparación con el uso de suturas solo.

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.

Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals.

The TIF (transoral incisionless fundoplication) 2.0 procedure is indicated for patients with a hiatal hernia less than 2 cm. Many patients with gastroesophageal reflux disease (GERD) require hiatal hernia repair. This study examined the safety and efficacy when repairing defects in 2 anatomical structures (hiatus and lower esophageal sphincter) in a concomitant set of procedures in patients with hiatal hernias between 2 and 5 cm. Methods. Prospective data were collected from 99 patients who underwent hiatal hernia repair followed immediately by the TIF procedure (HH + -TIF). GERD-HRQL (Health-Related Quality of Life), RSI (Reflux Symptom Index), and GERSS (Gastroesophageal Reflux Symptom Score) questionnaires were administered before the procedure and mailed at 6 and 12 months. Results. Ninety-nine patients were enrolled, and all were symptomatic on PPI medications with hiatal hernias between 2 and 5 cm. Overall baseline GERD-HRQL scores indicated daily bothersome symptoms. At 12-month follow-up, median GERD-HRQL scores improved by 17 points, indicating that subjects had no bothersome symptoms. The median GERSS scores decreased from 25.0 at baseline to 1.0 and 90% of subjects reported having effective symptom control (score <18) at 12 months. Seventy-seven percent of subjects reported effective control of laryngopharyngeal reflux (LPR) symptoms at 12 months with an RSI score of 13 or less. At 12 months, 74% of subjects reported that they were not using proton pump inhibitors. All measures were statistically improved at P < .05. There were no adverse effects reported. Conclusion. HH + TIF provides significant symptom control for heartburn and regurgitation with no long-term dysphagia or gas bloat normally associated with traditional antireflux procedures. Most patients reported durable symptom control and satisfaction with health condition at 12 months.

Laparoscopic antireflux surgery: how I do it?

Gastroesophageal reflux disease (GERD) affects an estimated 20% of the population in the US, and its prevalence is increasing worldwide. Lifestyle modifications and proton pump inhibitors (PPI) are effective in the majority of patients. However, some patients will become candidates for surgical intervention, because they have partial control of symptoms, do not want to be on long-term medical treatment, or suffer complications related to PPI. In these patients, a properly executed laparoscopic antireflux surgery controls esophageal and extra-esophageal symptoms and avoids life-long medical therapy. Important technical elements should be taken into account during the operation to avoid troublesome side effects and obtain optimal postoperative outcomes.

Whose patient is it? The path to multidisciplinary management of achalasia.

In the past decade, the introduction of high-resolution manometry and the classification of achalasia into subtypes has made possible to accurately diagnose the disease and predict the response to treatment for its different subtypes. However, even to date, in an era of exponential medical progress and increased insight in disease mechanisms, treatment of patients with achalasia is still rather simplistic and mostly confined to mechanical disruption of the lower esophageal sphincter by different means. In addition, there is partial consensus on what is the best form of available treatments for patients with achalasia. Herein, we provide a comprehensive outlook to a general approach to the patient with suspected achalasia by: 1) defining the modern evaluation process; 2) describing the diagnostic value of high-resolution manometry and the Chicago Classification in predicting treatment outcomes and 3) discussing the available treatment options, considering the patient conditions, alternatives available to both the surgeon and the gastroenterologist, and the burden to the health care system. It is our hope that such discussion will contribute to value-based management of achalasia through promoting a leaner clinical flow of patients at all points of care.

Transoral Incisionless Fundoplication TIF 2.0 with "EsophyX Z®" Device for GERD: Seven Years after Endo Lumenal Fundoplication. World's First Case Report.

Transoral Incisionless Fundoplication (TIF) with EsophyX device for a well selected GERD patient population has proven its efficacy, safety and durability. We present a case report of a male, 63 y old, with typical and atypical GERD symptoms started 15 years ago. The esophagogastroduodenoscopy (EGD) showed a Hiatal Hernia (HH) of 3 cm and an erosive esophagitis Los Angeles Grade B. The first surgery was performed 7 years ago, in March 2009: a TIF with the EsophyX 2® device (EndoGastric Solution, Inc., Redmond, WA, United States). Post-surgery the symptoms were controlled, completely eliminated, the EGD showing the healing of the esophagitis. Six years after the surgery the sore throat re-appears, while the EGD shows a 2 cm hiatal hernia and erosive esophagitis Los Angeles Grade A. The Impedance pH-metry confirms GERD with a DeMeester score of 44.5. In 2016 (7 years after first procedure) a second and new TIF 2.0 procedure, this time with EsophyX Z device is performed. The EsophyX Z device is an automatic stapler-like fastener delivery system, easier of use, faster, safer and more reproducible (standardized fastener delivery). The time of the procedure was significantly reduced, compared to first procedure. The patient is now symptom free, EGD is normal, the impendance ph metry at 13 months post-surgery showed a normal DeMeester score at 8. This is a World's first case report of a TIF 2.0 procedure with EsophyX Z device 7 years after a first TIF procedure with EsophyX 2 device, with excellent results and a significant reduction of the time for the procedure.

[Creative surgery for hiatal hernia]. / Kreativnaia khirurgiia gryzhi pishchevodnogo otverstiia diafragmy.

AIM: To present an experience of surgical treatment of hiatal hernia. MATERIAL AND METHODS: An experience of more than thousand laparoscopic fundoplications in various modifications has been accumulated in the Clinic of Bashkir State Medical University for the period 2001-2016. RESULTS: An original device for intraoperative measurement of hiatal orifice is described. Hiatal orifice repair was indicated in case of its dimension over 3.5 cm. 310 patients underwent hiatal orifice repair including diaphragmocrurorrhaphy in 189 cases, hiatal orifice replacement by using of mesh implant in 121 cases. Simultaneous interventions were performed in 211 cases due to hiatal hernia combined with other abdominal diseases. CONCLUSION: Thus, selection of hiatal hernia patients for antireflux surgery should be clearly indicated according to clinical and instrumental data in the context of health care system reforming and widespread use of minimally invasive technologies. Laparoscopic operations for hiatal hernia are preferable and contribute to decrease of morbidity and improvement of outcomes.

Peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic heller myotomy.

BACKGROUND/AIM: Several uncontrolled studies comparing peroral endoscopic myotomy (POEM) and Heller myotomy have demonstrated equivalent short-term efficacy and safety. However, no data exists rergarding the cost of POEM and how it compares to that of robotic Heller myotomy (RHM). The primary aim of this study was to compare the inpatient charges incurred in patients who underwent POEM or RHM for the treatment of achalasia. PATIENTS AND METHODS: A retrospective single center review was conducted among 52 consecutive POEM patients (2012-2014) and 52 consecutive RHM patients (2009-2014). All RHM procedures included a Toupet fundoplication and were performed via a transabdominal approach. All POEM procedures were performed by a gastroenterologist in the endoscopy unit. Clinical response was defined by improvement of symptoms and decrease in Eckardt stage to ≤I. All procedural and facility charges were obtained from review of the hospital finance records. RESULTS: There was no difference between POEM and RHM with regards to age, gender, symptom duration, achalasia subtype, manometry findings, or Eckardt symptom stage. There was no significant difference in the rate of adverse events (19.2% vs 9.6%, P = 0.26) or the length of stay (1.9 vs. 2.3, P = 0.18) between both groups. Clinical response rate of patients in the POEM groups was similar to that in the RHM group (94.3% vs. 88.5%, P = 0.48). POEM incurred significantly less total charges compared to LHM ($14481 vs. $17782, P = 0.02). CONCLUSIONS: POEM when performed in an endoscopy unit was similar in efficacy and safety to RHM. However, POEM was associated with significant cost savings ($3301/procedure).

Interim Report of a Prospective Trial on the Clinical Efficiency of a New Full-thickness Endoscopic Plication Device for Patients With GERD: Impact of Changed Suture Material.

BACKGROUND: The aim of the present trial is to investigate the clinical efficiency of the GERDx device for patients with gastroesophageal reflux disease (GERD). MATERIALS AND METHODS: Prospective study evaluating Gastrointestinal Quality of Life Index, symptoms scores, as well as esophageal manometry and impedance-pH-monitoring data at baseline and 3 months after endoscopic full-thickness plication with the GERDx device. RESULTS: In total, 28 patients underwent the procedure so far. Mean Gastrointestinal Quality of Life Index scores, DeMeester scores, and general and reflux-specific scores improved (P<0.01). Three of 6 patients, who were treated with converted sutures, experienced postoperative complications. CONCLUSIONS: Endoscopic plication using the GERDx device may be effective in improving quality of life and GERD symptoms. Suture length between pledgets and suture material may have an impact on procedure outcomes.

[Surgical and interventional procedures for reflux therapy : Endoscopic or laparoscopic?] / Operative/interventionelle Verfahren zur Refluxtherapie : Endoskopisch oder laparoskopisch?

An optimal functioning of the gastroesophageal antireflux barrier depends on an anatomical overlapping of the lower esophageal sphincter and the crural diaphragm. Restoration of this situation is currently only possible by antireflux interventions combined with hiatoplasty and necessitates a laparoscopic approach. Newer alternative techniques to the generally accepted fundoplication are laparoscopic implantation of the LINX® device or the EndoStim® system and various endoscopic antireflux procedures, such as radiofrequency energy treatment, plication and implantation techniques aimed at augmentation of the gastroesophageal valve. Endoscopic techniques are becoming established more and more between pharmaceutical and surgical therapy instead of replacing them.

Improved control of hypertension following laparoscopic fundoplication for gastroesophageal reflux disease.

This study aims to determine whether successful laparoscopic fundoplication for gastroesophageal reflux disease (GERD) can improve the control of hypertension. We conducted an observational study of GERD patients with hypertension. The esophageal and gastroesophageal symptoms of these patients were successfully treated with laparoscopic fundoplication, as measured by the reduced GERD symptoms and proton pump inhibitor consumption. A hypertension control scale was used to classify the use of antihypertensive medications and the quality of blood pressure control before and after anti-reflux surgery.Wilcoxon signed-ranks test was used for the statistical analyses. Seventy GERD patients were included in the analysis and followed up for a mean period of 3.5 ± 1.4 years. Prior to surgery, all participating patients were taking at least one class of antihypertensive medication, and 56 patients (80%) had intermittently high blood pressure. After surgery, the mean number of antihypertensive medication classes per patient was significantly reduced from 1.61 ± 0.77 pre-procedure to 1.27 ± 0.88 post-procedure (P < 0.001). The blood pressure of 48 of the 56 cases (86%) with preoperative intermittent high blood pressure returned to normal post procedure. A total of 50 patients (71%) recorded improvements on the hypertension control scale, with the overall mean score decreasing from 3.1 ± 1.0 preprocedure to 1.4 ± 1.0 post-procedure (P < 0.001). Therefore, successful laparoscopic fundoplication may result in better blood pressure control in some hypertensive GERD patients. This result suggests a possible connection between gastroesophageal reflux and hypertension.

Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy.

Transoral incisionless fundoplication (TIF) using the EsophyX device has been shown to be effective and safe in patients with Gastroesophageal reflux disease (GERD); however, the subset of patients that would mostly benefit from this technique remains unknown. The aim of this study was to evaluate the long-term efficacy and safety of the TIF procedure in patients with a history of esophagitis or proven chronic GERD who have achieved symptom control with the administration of proton pump inhibitors (PPIs) but did not wish to continue receiving medications for life. Forty-five patients with typical GERD symptoms (heartburn, regurgitation, chest pain) and a history of esophagitis grade A and B or proven GERD by esophageal pH monitoring underwent TIF using Esophyx. Patients with eosphagitis C and D or those with large hiatal hernias (>2 cm in length) were excluded. The primary clinical effectiveness measure was GERD symptom elimination at follow up based on normalization of the GERD health related quality of life (GERD-HRQL) questionnaire. After a median follow up period of 59 months (36-75) the median GERD-HRQL scores improved significantly from 27 (2-45) at baseline to 4 (0-26) (P < 0.001) in the 44 patients completing the study. Heartburn was eliminated in 12 out of the 21 patients included (57.1%), regurgitation was eliminated in 15 out of the 17 patients included (88.2%) and finally chest pain was eliminated in 5 patients out of the six patients included (83.3%). Overall, 32 patients out of the 44 patients (72.7%) that completed the study follow up reported elimination of their main symptom, without the need for PPI administration (none PPI usage). Furthermore, six more patients (13.6%), five with heartburn, and one with regurgitation reported half PPI dose taken for <50% of the preceding follow up period (occasional PPI usage), while six more patients (four with heartburn, one with regurgitation, and one with chest pain) reported full or half PPI dose taken for more than 50% of the preceding follow up period (daily PPI usage). Creation of an esophagogastric fundoplication using the EsophyX device abolished reflux symptoms in 72.7% of PPI-responsive GERD patients at a median 59 month follow-up.

Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis.

BACKGROUND: The efficacy of transoral incisionless fundoplication (TIF) performed with the EsophyX device (Redmond, Washington, USA) and its long-term outcomes in gastresophageal reflux disease (GERD) are debated. We, therefore, performed a systematic review with meta-analysis of studies evaluating the role of TIF in GERD. METHODS: A systematic search of EMBASE, SCOPUS, PubMed, and the Cochrane Library Central was performed. All original studies reporting outcomes in GERD patients who underwent TIF were identified. Only randomized controlled trials (RCTs) evaluating the efficacy of TIF, and prospective observational studies reporting outcomes after TIF were included. RESULTS: A total of 18 studies (963 patients) published between 2007 and 2015 were identified, including five RCTs and 13 prospective observational studies. The pooled relative risk of response rate to TIF versus PPIs/sham was 2.44 (95 % CI 1.25-4.79, p = 0.0009) in RCTs in the intention-to-treat analysis. The total number of refluxes was reduced after TIF compared with the PPIs/sham group. The esophageal acid exposure time and acid reflux episodes after TIF were not significantly improved. Proton-pump inhibitors (PPIs) usage increased with time and most of the patients resumed PPIs treatment at reduced dosage during the long-term follow-up. The total satisfaction rate after TIF was about 69.15 % in 6 months. The incidence of severe adverse events consisting of gastrointestinal perforation and bleeding was 2.4 %. CONCLUSIONS: TIF is an alternative intervention in controlling GERD-related symptoms with comparable short-term patient satisfaction. Long-term results showed decreased efficacy with time. Patients often resume PPIs at reduced doses in the near future.