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BACKGROUND: Transoral incisionless fundoplication (TIF) is safe and effective in select patients with hiatal hernias ≤ 2 cm with refractory gastroesophageal reflux disease (GERD). For patients with hiatal hernias > 2 cm, concomitant hiatal hernia (HH) repair with TIF (cTIF) is offered as an alternative to conventional anti-reflux surgery (ARS). Yet, data on this approach is limited. Through a comprehensive systematic review, we aim to evaluate the efficacy and safety of cTIF for managing refractory GERD in patients with hernias > 2 cm. STUDY DESIGN: We conducted a systematic review of studies evaluating cTIF outcomes from PubMed, EMBASE, SCOPUS, and Cochrane databases up to February 14, 2024. Primary outcomes included complete cessation of proton pump inhibitors (PPIs). Secondary outcomes included objective GERD assessment, adverse events, and treatment-related side effects. Pooled analysis was employed wherever feasible. RESULTS: Seven observational studies (306 patients) met the inclusion criteria. Five were retrospective cohort studies and two were prospective observational studies. The median rate of discontinuation of PPIs was 73.8% (range 56.4-94.4%). Significant improvements were observed in disease-specific, validated GERD questionnaires. The median rate for complications was 4.4% (range 0-7.9%), and the 30-day readmission rate had a median of 3.3% (range 0-5.3%). The incidence of dysphagia was 11 out of 164 patients, with a median of 5.3% (range 0-8.3%), while the incidence of gas bloating was 15 out of 127 patients, with a median of 6.9% (range 0-13.8%). CONCLUSION: Current data on cTIF suggests a promising alternative to ARS with comparable short-term efficacy and safety profile for managing refractory GERD with a low side effect profile. However, longer-term data and comparative efficacy studies are needed.

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BACKGROUND AND AIMS: Transoral incisionless fundoplication (TIF) is an established safe endoscopic technique for the management of GERD but with variable efficacy. In the last decade, the TIF technology and technique have been optimized and more widely accepted but data on outcomes outside clinical trials are limited. We tracked patient-reported and clinical outcomes of GERD patients after TIF 2.0. METHODS: Patients with BMI < 35, hiatal hernia < 2cm, and confirmed GERD with typical and/or atypical symptoms from 9 academic and community medical centers were enrolled in a prospective registry and underwent after TIF 2.0 performed by gastroenterologists and surgeons. The primary outcomes were safety and clinical success (response in >2 of 4 endpoints). Secondary endpoints were symptom improvement, acid exposure time (AET), esophagitis healing, proton pump inhibitor (PPI) use, and satisfaction. Outcomes were assessed at last follow-up within 12 months. RESULTS: 85 patients underwent TIF 2.0, 81 were included in the outcomes analysis. Clinical success was achieved in 94%, GERD-HRQL scores improved in 89%, and elevated RSI score normalized in 85% of patients with elevated baseline. Patient satisfaction improved from 8% to 79% (p <0.0001). At baseline, 81% were taking at least daily PPI, while 80% were on no or occasional PPI after TIF 2.0 (p<0.0001). Esophageal AET was normal in 72%, greater with an optimized TIF 2.0 valve >300 degree circumference, >3cm length (94% vs 57%, p=0.007). There were no TIF 2.0-related serious adverse events. CONCLUSION: TIF 2.0 is a safe and effective endoscopic outpatient treatment option for select patients with GERD.

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Gastroesophageal reflux disease (GERD) is one of the most common diseases that occurs secondary to failure of the antireflux barrier system, resulting in the frequent and abnormal reflux of gastric contents to the esophagus. GERD is diagnosed in routine clinical practice based on the classic symptoms of heartburn and regurgitation. However, a subset of patients with atypical symptoms can pose challenges in diagnosing GERD. An esophagogastroduodenoscopy (EGD) is the most common initial diagnostic test used in the assessment for GERD, although half of these patients will not have any positive endoscopic findings suggestive of GERD. The advanced endoscopic techniques have improved the diagnostic yield of GERD diagnosis and its complications, such as Barrett's esophagus and early esophageal adenocarcinoma. These newer endoscopic tools can better detect subtle irregularities in the mucosa and vascular structures. The management options for GERD include lifestyle modifications, pharmacological therapy, and endoscopic and surgical interventions. The latest addition to the armamentarium is the minimally invasive endoscopic interventions in carefully selected patients, including the electrical stimulation of the LES, Antireflux mucosectomy, Radiofrequency therapy, Transoral Incisionless Fundoplication, Endoscopic Full-Thickness plication (GERDx™), and suturing devices. With the emergence of these advanced endoscopic techniques, it is crucial to understand their selection criteria, advantages, and disadvantages.

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Gastroesophageal reflux disease (GERD) is a prevalent condition that affects a significant portion of the Western population. Despite its benign pathophysiology, it has the potential to cause serious complications over time, ranging from conditions that are benign, premalignant, and/or malignant. Traditional treatment options include lifestyle measures, anti-secretory medications (e.g., proton pump inhibitor (PPI)), and surgical options (e.g., Nissen and Toupet fundoplication). However, recent studies have revealed long-term side effects of anti-secretory medications. Moreover, surgical options, though effective, are considered invasive and associated with potential complications. In the current age of ongoing research in minimally invasive options, endoscopic treatment of GERD has become popular. As a result, procedures such as radiofrequency treatment and transoral incisionless fundoplication (TIF) have gained FDA approval and are currently being covered by most insurance. In this review article, we will discuss pre-procedural workup, appropriate patient selection, advantages, disadvantages, procedure techniques, and follow-up of patients who undergo various endoscopic treatments for GERD. In addition, we will review the short and long-term success of these techniques in improving quality of life, use of PPI, and improvement in symptoms considering published data in high-quality peer-reviewed journals.

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In this editorial, we respond to a review article by Nabi et al, in which the authors discussed gastroesophageal reflux (GER) following peroral endoscopic myotomy (POEM). POEM is presently the primary therapeutic option for achalasia, which is both safe and effective. A few adverse effects were documented after POEM, including GER. The diagnostic criteria were not clear enough because approximately 60% of patients have a long acid exposure time, while only 10% experience reflux symptoms. Multiple predictors of high disease incidence have been identified, including old age, female sex, obesity, and a baseline lower esophageal sphincter pressure of less than 45 mmHg. Some technical steps during the procedure, such as a lengthy or full-thickness myotomy, may further enhance the risk. Proton pump inhibitors are currently the first line of treatment. Emerging voices are increasingly advocating for the routine combining of POEM with an endoscopic fundoplication method, such as peroral endoscopic fundoplication or transoral incisionless fundoplication. However, more research is necessary to determine the safety and effectiveness of these procedures in the long term for patients who have undergone them.

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Gastroesophageal reflux disease has a high incidence and prevalence in the general population. Clinical manifestations are heterogenous, and so is the response to medical treatment. Proton pump inhibitors are still the most common agents used to control reflux symptoms and for healing esophagitis, but they are not a one-size-fits-all solution for the disease. Patients with persistent troublesome symptoms despite medical therapy, those experiencing some adverse drug reaction, or those unwilling to take lifelong medications deserve valid alternatives. Anti-reflux Nissen fundoplication is an effective option, but the risk of adverse events has limited its spread. In recent years, advancements in therapeutic endoscopy have been made, and three major endoluminal alternatives are now available, including (1) the delivery of radiofrequency energy to the esophago-gastric junction, (2) transoral incisionless fundoplication (TIF), and (3) anti-reflux mucosal interventions (ARMI) based on mucosal resection (ARMS) and mucosal ablation (ARMA) techniques to remodel the cardia. Endoscopic techniques have shown interesting results, but their diffusion is still limited to expert endoscopists in tertiary centers. This review discusses the state of the art in the endoscopic approach to gastroesophageal reflux disease.

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Gastroesophageal reflux disease (GERD) is among the most prevalent diseases in the United States. Mainstay therapy is lifestyle modification and medical therapy. If patients have GERD despite medical therapy, appropriate testing should be performed to determine if surgical or endoscopic therapy will provide improvement in their symptoms. Gold standard therapy is a minimally invasive fundoplication. Patients with body mass index <35, small or no hiatal hernia, normal motility, and pathologic GERD should consider magnetic sphincter augmentation. If a patient is not interested in either fundoplication or MSA, they should consider endoscopic treatment with either STRETTA or Transoral Incisionless fundoplication 2.0. A meta-analysis by Gong and colleagues showed that endoscopic treatments are better compared with medical therapy but are worse than surgical therapy.

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INTRODUCTION AND IMPORTANCE: Gastro-esophageal reflux disease (GERD) is frequently associated with obesity. Excess body weight, particularly central adiposity, with a concomitantly raised intra-abdominal pressure, leads to a reduced lower esophageal sphincter (LES) pressure and GERD. The lax LES essentially causes acid reflux in the lower esophagus. CASE PRESENTATION: We report a 44-year-old woman who presented to our surgical clinic with heartburn and acid reflux, associated with difficulty in weight management. The patient had a BMI of 35 kg/m2. The upper GI endoscopy showed a small hiatal hernia, with lax LES and grade A esophagitis. She was initially started on daily proton pump inhibitors (PPIs). All available management plans were discussed with the patient, and she did not prefer to continue with life-long PPIs. At the same time, the patient was also concerned about her weight and requested for a plausible weight management solution. CLINICAL DISCUSSION: The patient was planned for a single-stage Transoral Incisionless Fundoplication (TIF) and laparoscopic sleeve gastrectomy for her GERD and obesity, respectively. TIF was performed by two experienced endoscopists, one controlling the EsophyX device and the other ensuring continuous direct visualization of the field of work with the endoscope. Following the procedure, laparoscopic sleeve gastrectomy was performed during the same session. The patient had an uneventful recovery. CONCLUSION: Eight months after surgery, the patient reported resolution of her GERD symptoms and a weight loss of 20 kg.

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BACKGROUND: To evaluate the long-term efficacy of transoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) for gastroesophageal reflux disease (GERD). METHODS: A total of 16 patients with proton pump inhibitor-dependent gastroesophageal reflux disease had undergone TIF by MUSE in Shanghai General Hospital （Shanghai, China）from March 2017 to December 2018. Patients were followed up at 6 months, and the GERD-health-related quality of life (GERD-HRQL) questionnaire score, the GERD questionnaire (GERD-Q) score, high-resolution esophageal manometry (HREM) and 24 h esophageal pH parameters, the Hill grade of the gastroesophageal flap valve (GEFV) and daily Proton pump inhibitor (PPI) consumption before and after procedure were compared. Patients also were followed up at 3 years and 5 years using a structured questionnaire via phone which evaluated symptoms of reflux, dose of PPI medication and side effects. RESULTS: Follow-up data were collected from 13 patients, ranging from 38 to 63 months, 53 months on average. 10/13 patients reported symptomatic improvement and daily PPI consumption was stopped or halved in 11/13. After procedure, the mean scores of GERD-HRQL and GERD-Q were significantly increased. The mean DeMeester score, the mean acid exposure time percentage and the mean number of acid reflux episodes were significantly lower. The mean rest pressure at lower esophageal sphincter (LES) had no significant difference. CONCLUSION: TIF by MUSE has significant efficacy in the treatment of PPI-dependent GERD, which can improve symptoms and life quality of patients, and reduce the acid exposure time for long-term. Chictr.org.cn. TRIAL REGISTRATION: ChiCTR2000034350.

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Patients with gastroesophageal reflux disease and a large hiatal hernia can have life-disrupting symptoms, such as heartburn, regurgitation, cough, and hoarseness. Gastroesophageal reflux disease symptoms are often treated with proton pump inhibitors and occasionally treated with surgery. The last decade has seen the development of a new procedure-laparoscopic hiatal hernia repair with concomitant transoral incisionless fundoplication. When transoral incisionless fundoplication is performed immediately after a laparoscopic hiatal hernia repair, it may enable the discontinuation of proton pump inhibitors and improve a patient's quality of life. This article explores the development of the transoral incisionless fundoplication procedure as well as its concomitant use after hiatal hernia repair at all stages of perioperative care. Also included is a hypothetical case study that illustrates the perioperative nursing care of a patient undergoing this procedure.

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PURPOSE: We aim to review and quantitatively compare laparoscopic Toupet fundoplication (LTF), Nissen fundoplication (LNF), anterior partial fundoplication (APF), magnetic augmentation sphincter (MSA), radiofrequency ablation (RFA), transoral incisionless fundoplication (TIF), proton pump inhibitor (PPI), and placebo for the treatment of GERD. A number of meta-analyses compared the efficacy of surgical and endoscopic procedures for recalcitrant GERD, but considerable debate on the effectiveness of operative strategies remains. METHODS: A systematic review of MEDLINE databases, EMBASE, and Web of Science for randomized controlled trials (RCTs) comparing the aforementioned surgical and endoscopic GERD treatments was performed. Risk ratio and weighted mean difference were used as pooled effect size measures, whereas 95% credible intervals (CrI) were used to assess relative inference. RESULTS: Thirty-three RCTs were included. Surgical and endoscopic treatments have similar RR for heartburn, regurgitation, bloating. LTF has a lower RR of post-operative dysphagia when compared to APF (RR 3.3; Crl 1.4-7.1) and LNF (RR 2.5; Crl 1.3-4.4). The pooled network meta-analysis did not observe any significant improvement regarding LES pressure and pH < from baseline. LTF, APF, LNF, MSA, RFA, and TIF had have a similar post-operative PPI discontinuation rate. CONCLUSION: LTF has a lower rate of post-operative dysphagia when compared to APF and LNF. The pre-post effects, such as GERD-HQRL, LES pressure, and pH <4, should be avoided in meta-analyses because results may be biased. Last, a consensus about the evaluation of GERD treatments' efficacy and their outcomes is needed.

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

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Gastroesophageal reflux disease (GERD) results in a total healthcare cost of 12.3 billion dollars to the United States annually. GERD is often seen with hiatal hernias. Our study aims to compare short-term functional outcomes and postoperative symptom relief afforded by hiatal hernia repair with transoral incisionless fundoplication (TIF), together known as hybrid repair, to those of hiatal hernia repair with surgical fundoplication (conventional repair). We performed a retrospective chart review on 112 consecutive patients who underwent robot assisted laparoscopic hiatal hernia repair at a community hospital by a single surgeon. We found that the short-term functional results and symptom relief with hybrid repair were no superior to those with conventional repair. We did not find a significant difference between hybrid and conventional repair in terms of in 30 day complications, ER visits or inpatients admissions. The number of patients who were symptomatic at delayed follow-up was not significantly different between both the groups. As such, short-term functional outcomes and symptom relief with hybrid hiatal hernia repair are no superior to those with conventional repair. Therefore, surgical repair of hiatal hernia with surgical fundoplication remains the standard of care until further data is available on long-term outcomes of the hybrid approach.

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Per-oral endoscopic myotomy (POEM) is a minimally invasive procedure that is very effective in the treatment of achalasia, a rare esophageal motility disorder. POEM has become the first-line treatment for achalasia, with high success rates reported in the literature. However, a known complication of POEM is gastroesophageal reflux disease (GERD). The exact cause and risk factors of post-POEM GERD are not fully understood; however, a number of factors have played a role in its development. The management of post-POEM GERD is mainly by conservative measures, such as lifestyle changes and medications, like proton pump inhibitors (PPI), which are often the first-line method of treatment. However, surgical procedures, such as fundoplication, may be necessary in some patients. This literature review will discuss the effectiveness of the use of PPIs as a management strategy for post-POEM GERD, the factors that lead to PPI-resistant GERD, and other management strategies utilized in these cases.

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Background: Nissen Fundoplication (NF) and Transoral Incisionless Fundoplication (TIF) are established procedures for the treatment of gastroesophageal reflux disease (GERD). However, the surgically induced plication can loosen over time. This multicenter study aims to evaluate the safety and efficacy of Antireflux Mucosectomy (ARMS) and Resection and Plication (RAP) in symptomatic patients with prior NF or TIF that has become loose. Patients and methods: Eighteen patients were enrolled in the study. Ten had prior TIF, while eight had prior NF. Half of these patients had a Hill Grade 3 Valve while the other half had a Hill Grade 2 valve. Endoscopic submucosal dissection (ESD) was performed in six patients, while endoscopic mucosal resection (EMR) was performed in twelve patients. A follow-up endoscopy was performed at 4-12 weeks. Results: At follow-up, 11 patients had a Hill Grade 1 valve, and seven patients had a Hill Grade 2 valve. All patients had improvement in symptoms for up to 32 months. Conclusions: In this pilot study, ARMS/RAP appears to be an effective option in patients who had prior NF or TIF with recurrent GERD symptoms.

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There have been many devices and ideas to treat reflux disease endoscopically. Several devices have been tried and even FDA approved but now are no longer used. The push for these therapies is to find effective reflux control with lower risk and faster recovery. In this article we describe an endoscopic suturing device (TIF), radiofrequency device (Stretta) and a newer technique that has a lot of promise called antireflux mucosectomy. All these procedures seem to help control reflux at a minimum of morbidity given current information. As reflux is so prevalent a shift to these techniques for appropriate patients is likely to improve patient care.

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Endoscopic anti-reflux treatment is emerging as a new option for gastro-esophageal reflux disease (GERD) treatment in patients with the same indications as for laparoscopic fundoplication. There are many techniques, the first of which are transoral incisionless fundoplication (TIF) and nonablative radio-frequency (STRETTA) that have been tested with comparative studies and randomized controlled trials, whereas the other more recent ones still require a deeper evaluation. The purpose of the latter is to verify whether reflux is abolished or significantly reduced after intervention, whether there is a valid high pressure zone at the gastroesophageal junction, and whether esophagitis, when present, has disappeared. Unfortunately in a certain number of cases, and especially in the more recently introduced ones, the evaluation has been based almost exclusively on subjective criteria, such as improvement in the quality of life, remission of heartburn and regurgitation, and reduction or suspension of antacid and antisecretory drug consumption. However, with the most studied techniques such as TIF and STRETTA, an improvement in symptoms better than that of laparoscopic fundoplication can often be observed, whereas the number of acid episodes and acid exposure time are similar or higher, as if the acid refluxes are better tolerated by these patients. The suspicion of a local hyposensitivity taking place after anti-reflux endoscopic intervention seems confirmed by a Bernstein test at least for STRETTA. This examination should be done for all the other techniques, both old and new, to identify the ones that reassure rather than cure. In conclusion, the evaluation of the effectiveness of the endoscopic anti-reflux techniques should not be based exclusively on subjective criteria, but should also be confirmed by objective examinations, because there might be a gap between the improvement in symptoms declared by the patient and the underlying pathophysiologic alterations of GERD.

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BACKGROUND/AIMS: Transoral incisionless fundoplication (TIF) is an accepted anatomic treatment for gastroesophageal reflux disease in selected patients. In this report, we analyze our institution's programmatic allocation of resources during the safe implementation of TIF as a new procedure. METHODS: A retrospective analysis of all patients who underwent TIF from January 2020 to February 2021 at our institution was performed. The process of initially allocating the operating room (OR) with overnight admission and postoperative esophagram for added safety, and subsequently transitioning TIF to the endoscopy suite (ES) as an outpatient procedure was described. Patient safety and outcomes were evaluated during transition. RESULTS: Thirty patients who underwent TIF were identified. The mean age was 51.2±16.0 years. TIF was performed in an OR in nine patients (30%) and 21 (70%) in the ES. All the OR patients were admitted overnight and had routine EG. In contrast, four (19%) from the ES group required clinically-indicated admission and three (14.2%) required esophagram. The mean procedure duration was significantly lower in the ES group (65.7 min vs. 84 min, p=0.02). CONCLUSION: A stepwise, resource-efficient process was described that allowed safe initiation of TIF as a new technique and its effective transition to a fully outpatient procedure.

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Gastroesophageal reflux disease (GERD) has consistently been the most frequently diagnosed gastrointestinal malady in the USA. The mainstay of therapy has traditionally been medical management, including lifestyle and dietary modifications as well as antacid medications. In those patients found to be refractory to medical management or with a contraindication to medications, the next step up has been surgical anti-reflux procedures. Recently, though innovative advancements in therapeutic endoscopy have created numerous options for the endoscopic management of GERD, in this review, we discuss the various endoscopic therapy options, as well as suggested strategies we use to recommend the most appropriate therapy for patients.

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