Transoral incisionless fundoplication (TIF) was introduced in 2006 as a concerted effort to produce a natural orifice procedure for reflux. Since that time, the device, as well as the procedure technique, has evolved. Significant research has been published during each stage of the evolution, and this has led to considerable confusion and a co-mingling of outcomes, which obscures the results of the current device and procedure. This report is intended to review the identified stages and literature associated with each stage to date and to review the current state of treatment outcomes.

Laparoscopic Nissen fundoplication (LNF) is the standard for surgical treatment of gastroesophageal reflux disease (GERD), but postoperative complications and pain are common in patients with severe neurological impairment (NI) and those undergoing reoperative procedures. Transoral incisionless fundoplication (TIF) is an endoscopic alternative to treat GERD. Long-term results in pediatric populations are unknown.

Eleven patients who underwent TIF between January 2008 and September 2010 were included. A retrospective chart review was performed to evaluate long-term patient outcomes. Median follow-up was 5.6 years (range = 0.42-8.76 years).

Average patient age was 16.5 ± 5.1 years. Severe NI was present in 81.8% (9/11) of patients, and 63.6% (7/11) had undergone one or more prior fundoplication attempts. Overall, symptomatic reflux recurred or persisted in 54.5% (6/11) of patients. Recurrent symptoms were more common among those who had previous fundoplications than those who did not (71.4% [5/7] vs. 25% [1/4]). Four patients went on to require reoperation, including one laparoscopic Nissen and three disconnects. At last follow-up, 81.8% (9/11) of patients were still on antireflux medications.

This is the first report of long-term outcomes for treatment of GERD using TIF in a pediatric population. The recurrence rate was high, likely related to the fact that the population treated was extremely high risk. Recurrence was higher in patients with a prior fundoplication, perhaps identifying prior antireflux operations as a relative contraindication to TIF. Nevertheless, complications were low, and a subset of patients did receive a durable benefit from the procedure.

Gastro-esophageal reflux disease (GERD) is a very common disorder that results primarily from the loss of an effective antireflux barrier, which forms a mechanical obstacle to the retrograde movement of gastric content. GERD can be currently treated by medical therapy, surgical or endoscopic transoral intervention. Medical therapy is the most common approach, though concerns have been increasingly raised in recent years about the potential side effects of continuous long-term medication, drug intolerance or unresponsiveness, and the need for high dosages for long periods to treat symptoms or prevent recurrences. Surgery too may in some cases have consequences such as long-lasting dysphagia, flatulence, inability to belch or vomit, diarrhea, or functional dyspepsia related to delayed gastric emptying. In the last few years, transoral incisionless fundoplication (TIF) has proved an effective and promising therapeutic option as an alternative to medical and surgical therapy. This review describes the steps of the TIF technique, using the EsophyX(®) device and the MUSE(TM) system. Complications and their management are described in detail, and the recent literature regarding the outcomes is reviewed. TIF reconfigures the tissue to obtain a full-thickness gastro-esophageal valve from inside the stomach, by serosa-to-serosa plications which include the muscle layers. To date the procedure has achieved lasting improvement of GERD symptoms (up to six years), cessation or reduction of proton pump inhibitor medication in about 75% of patients, and improvement of functional findings, measured by either pH or impedance monitoring.

Gastro-oesphageal reflux disease results primarily from the loss of an effective antireflux barrier, which forms a mechanical barrier against the retrograde movement of gastric content. This review describes the technique of performing a transoral incisionless fundoplication with the EsophyX® device. Transoral incisionless fundoplication reconfigures the tissue so as to establish serosa-to-serosa plications which include the muscular layers, and construct 3-5 cm long valves 200-300° in circumference. The steps of the technique, as well as complications and their management are described in detail, and a recent literature review is also provided. At present, available prospective cohort studies indicate that transoral incisionless fundoplication using the EsophyX® device may be effective in approximately half PPI-responsive gastro-oesphageal reflux disease for up to 3 years' follow-up, without troublesome procedure-related persistent side effects.

Sphincter augmentation with the LINX® Reflux Management System is a surgical option for patients with chronic gastroesophageal disease (GERD) and an inadequate response to proton pump inhibitors (PPIs). Clinical experience with sphincter augmentation is now available out to 4 years.

In a multicenter, prospective, single-arm study, 44 patients underwent a laparoscopic surgical procedure for placement of the LINX System around the gastroesophageal junction (GEJ). Each patient's baseline GERD status served as the control for evaluations post implant. Long-term efficacy measures included esophageal acid exposure, GERD quality-of-life measures, and use of PPIs. Adverse events and long-term complications were closely monitored.

For esophageal acid exposure, the mean total % time pH < 4 was reduced from 11.9 % at baseline to 3.8 % at 3 years (p < 0.001), with 80 % (18/20) of patients achieving pH normalization (≤ 5.3 %). At ≥ 4 years, 100 % (23/23) of the patients had improved quality-of-life measures for GERD, and 80 % (20/25) had complete cessation of the use of PPIs. There have been no reports of death or long-term device-related complications such as migration or erosion.

Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues, as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation.

Millions of Americans are affected by gastroesophageal reflux disease (GERD) in many different ways. The magnitude of the problem of GERD was brought to light by the ambulatory pH test, the introduction of minimally invasive surgery, and the advent of the many medications that are effective in acid suppression. Patients with GERD suffer from various consequences associated with the disease. However, interventions beyond medical therapy, such as laparoscopic fundoplication, provide satisfactory outcomes and definitive relief of acid reflux.

There are limited studies that evaluate the efficacy of endoscopic fundoplication (EF) for gastroesophageal reflux disease (GERD) with the EsophyX™ device, especially with the most recent procedural iteration (TIF-2). This study was a prospective evaluation of our early experience with this device and procedure.

Data were collected prospectively on 23 consecutive patients undergoing EF (March 2009 to August 2010). All patients completed a symptom questionnaire assessing frequency and severity of gastrointestinal and respiratory symptoms, 24-h pH, and manometry studies preoperatively and were encouraged to repeat these at 6 months.

All patients had abnormal pH studies and were on proton-pump inhibitor (PPI) therapy prior to EF. Median age was 47 years (19-62 years), and six (23%) were male. Nine (41%) patients had Body Mass Index (BMI) ≥ 30 kg/m(2), and three (14%) had a small hiatal hernia (≤ 2 cm). The procedure was aborted in two patients for retained food. Three patients underwent subsequent laparoscopic Nissen fundoplication for persistent or recurrent symptoms. Median hospitalization was 1 day, and there were no major perioperative complications. At 6 month follow-up, 19 (86%) patients completed a symptom questionnaire, and 14 (64%) and 11 (50%) patients underwent pH and manometry studies, respectively. There was a significant reduction in heartburn (P = 0.02), total percentage acid contact time (P = 0.002), DeMeester score (P = 0.002), and PPI use (P = 0.003). Overall, 8 out of 14 (57%) patients had abnormal pH studies and 11 out of 19 (58%) remained on PPI therapy at 6 months.

EF with EsophyX™ is associated with significant reduction in heartburn and abnormal acid exposure at 6 months, although the majority of patients did not experience normalization of their pH studies and remained on PPI therapy. The procedure has an acceptable safety profile, but the question remains as to whether it is effective enough to warrant a place in the armamentarium for the treatment of GERD.