Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. Risk factors for developing GERD include being overweight or obese, pregnancy, use of certain medicines, tobacco use or regular exposure to second-hand smoke. It results from the reflux of stomach fluids into the esophagus, which exposes the esophagus to gastric acid. While some GERD patients experience mild or moderate symptoms of their disease, others have more severe manifestations that can include daily heartburn, asthma, chronic cough, hoarse voice or chest pain. Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but more than 10 million Americans are refractory to PPI therapy and may opt for surgery.
Hiatal hernia means that the stomach partially or completely herniated (moved) to the chest through a natural defect in the diaphragm. Hiatal hernia repair to correct anatomical defects and fundoplication to restore effective esophageal valve function are the main pillars of anti-reflux surgery. Some GERD patients require both anatomical issues be addressed. For these patients, some physicians may opt to perform both procedures laparoscopically. However, there is a growing body of evidence demonstrating advantages in laparoscopic hiatal hernia repair (LHHR) and then shifting to an endoscopic approach for fundoplication. LHHR with concomitant transoral incisionless fundoplication (TIF) has previously been shown to provide several benefits compared with LHHR in combination with open or laparoscopic fundoplication procedures. One advantage to this concomitant procedure set is to accomplish the LHHR with minimal dissection. Beside minimizing internal scarring and leaving connective tissues in place, another advantage is for patients with anatomical aberrations—e.g. individuals with an aberrant left hepatic artery (ALHA). The presence of ALHA creates a significant challenge for foregut surgery by creating a limited surgical field. A recent study demonstrates the success of LHHR with concomitant TIF procedure in patients with ALHA. This approach minimized the intraoperative and postoperative bleeding risk associated with other surgical approaches used to work around the ALHA.
Overview of GERD
GERD can result from loss of esophageal valve function and/or hiatal hernia (which lowers the pressure in the esophageal valve). Each of these anatomical defects contributes to refluxing of stomach contents into the esophagus. This reflux contributes to other conditions that can have long-term health consequences. First, uncontrolled GERD leads to esophagitis, esophageal stricture, significant sleep disturbances and respiratory problems due to backwash and/or inhalation of stomach contents. Second, untreated GERD is a significant risk factor for developing Barrett’s esophagus, a precancerous condition that occurs when gastric acid erodes the esophageal lining to a point where biopsy reveals changes at the cellular level. The acid-resistant cells that replace the normal lining of the esophagus can become cancerous, leading to adenocarcinoma (esophageal cancer).
Periodic or persistent GERD may sometimes be controlled through diet and lifestyle modifications. This approach encourages healthy habits such as cessation of smoking and weight loss. However, some other aspects can impact quality of life such as poor sleep due to elevation of the head of bed or even worse sleeping in a chair. Rigorous sleeping time, not less than 2 hours after meals and avoiding trigger food can lead to struggle to control GERD and socializing or travelling.
For patients with persistent GERD symptoms, PPI therapy is more effective than H2 blockers.3 However, PPIs do not cure reflux because this chronic condition fundamentally is an anatomical issue that needs to be addressed. In addition, patients may be refractory to PPI therapy initially (e.g. regurgitation is notoriously not responsive to PPI). Over time, many patients require escalating doses both higher and/or more frequent doses (e.g. two pills, two times per day) to control their symptoms. Additionally, there are increasing concerns about the safety of long-term PPI dependency for GERD symptom control. Since 2010, the U.S. Food and Drug Administration has issued multiple safety warnings related to the potential effects of long-term PPI therapy, including increased risk of fractures, hypomagnesemia, Clostridium difficile-associated diarrhea, vitamin B12 deficiency, acute interstitial nephritis and lupus erythematosus events. Several observational studies also suggest that long-term PPI use is associated with an increased risk of pneumonia, dementia and hypergastrinemia. It should also be noted that some patient are intolerant to PPI or have no access to it due to cost.
Surgical approaches to treating GERD include LHHR in patients with hiatal hernia and fundoplication in patients with esophageal valve dysfunction. Fundoplication (developed by Dr. Rudolf Nissen surgery) entails wrapping the top portion of the stomach around the lower section of the esophagus, which provides additional support for the esophageal valve and helps to prevent reflux. Initially, fundoplication was performed as an open surgical procedure that utilizes a single large incision; today, however, it’s performed laparoscopically. In both procedures, the stomach tissue is dissected and then a portion of it is used to create a 360-degree wrap of the esophagus. In some patients, this results in an inability to belch or vomit and is also associated with difficulty swallowing and increased bloating and flatulence. Additionally, traditional fundoplication subjects patients to the typical risks associated with surgical incisions, including blood loss, infection and scarring.
Nissen fundoplication significantly alters the configuration of the stomach and transform it into a straight organ. This change in shape abolishes the angle of His which normally directs the stomach content toward the upper left side of the abdomen when the diaphragm descends with breathing and compresses the stomach. When the fundus is wrapped around the stomach and it becomes straight tube, the stomach content will have a straight upward trajectory when the diaphragm descends. The surgeons are always cautious not to make the wrap too tight and cause dysphagia or make it too loose and impair its anti-reflux barrier. More recently, the TIF 2.0 procedure using the EsophyX technology has enabled an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. The esophagus is lengthened and then upper portion of the stomach is partially wrapped (270-300 degrees) around the lower esophagus without the need for dissection. The partial wrapping allows for normal belching and vomiting. TIF procedure recreates the angle of His and spares the fundus.
Because there are no incisions or dissection, the TIF technique reduces the risk of adhesions and surgical complications. The safety in TIF was recently highlighted in reports of Medicare beneficiaries and Jehovah’s Witness patients. There was no adverse events in this older group with significant improvement of their GERD questionnaires. TIF procedure was reported to be safe enough to be considered for Jehovah’s Witness patients who refuse blood transfusion. Additionally, the incisionless nature of the procedure reduces recovery time to just a few days for most patients and results in less discomfort.
Long-term outcomes from a prospective study in which 50 consecutive patients with symptomatic, PPI-responsive GERD underwent TIF procedure support the clinical utility of the procedure in controlling GERD symptoms. Over the 10-year follow-up period in this study, mean scores on a GERD-health related quality of life (HRQL) questionnaire were significantly reduced compared with pre-TIF scores (46±19), with most of the improvement achieved within two years following the procedure. Additionally, 84.4%, 73.5%, 83.3%, and 91.7% of patients were able to eliminate or halve their PPI use at 3, 5, 7 and 10 years after TIF procedure, respectively. The majority of patients were able to eliminate daily dependence on PPIs. Here again, a significant benefit was seen within two years following the procedure (87.8% at 2-year post-procedure) and was maintained for 10 years. These results indicate that TIF procedure is a reproducible and durable solution to addressing GERD symptoms in patients who are refractory to PPI therapy.
In a separate randomized controlled trial, all 63 patients with PPI-refractory GERD who were initially randomized to the PPI arm of a clinical trial comparing optimized PPI dose with procedure intervention received a TIF procedure—in this case 100% of the control group crossed over at the 6-month evaluation point. In this study, troublesome regurgitation and atypical symptoms were eliminated in 86% and 80% of patients, respectively, five years following TIF procedure. While all patients entered the study using PPIs daily, 66% were no longer daily dependent on PPIs at the five-year follow up.
A recent review of the literature related to the current TIF 2.0 technique found that it can be effective in treating regurgitation, heartburn and laryngopharyngeal reflux that is refractory to optimal PPI doses. Importantly, this analysis confirmed that TIF procedure is associated with a low rate of serious complications. Similarly, the occurrence of dysphagia, bloating and flatulence, which are known complications of traditional fundoplication, is virtually absent in the TIF literature. In fact, TIF procedures have been shown to reduce the occurrence of these symptoms in at least 81% of patients at six months post-procedure. The analysis also found that the TIF intervention provides durable improvements in GERD symptoms in studies that have assessed outcomes at 1, 3 and 6 years post-procedure.
Laparoendoscopic Reflux Surgery in Patients With ALHA
TIF procedure is indicated for a hiatal hernia of 2 cm or less. Patients with larger hiatal hernias required laparoscopic repair of the hiatal hernia with concomitant TIF procedure. This combination, commonly referred to as “hybrid” TIF procedure or laparoendoscopic approach have numerous advantages. It causes minimal alteration of the shape of the stomach and requires minimal dissection thus avoid required division of blood vessels supplying the stomach known as short gastrics. It results in partial fundoplication and spares the fundus. One main advantage for this approach is when there are anatomical obstacles in the operative fields such as the aberrant left hepatic artery (ALHA). Various assessments estimate that 3-34% of adults have ALHA. The presence of ALHA in patients who require both LHHR and fundoplication to fully address the anatomic causes of their GERD symptoms can create a challenge to achieving optimal outcomes. This is because ALHA results in a reduced operating field and can lead to inadequate hiatal dissection and suboptimal fundoplication. In fact, the presence of ALHA is associated with a 6% failure rate in patients undergoing Nissen fundoplication.
One way to address ALHA in these patients is to operate in a way that avoids the hepatic artery, although this approach is associated operative bleeding in 4.1% of patients.9 Another approach is to dissect around the ALHA in order to increase the operative space, but this is associated with operative bleeding in 5.3% of patients. An approach of last resort is to divide the ALHA, but this associated with a risk of necrosis in the left lobe of the liver.
A recent study evaluated a novel approach in which the ALHA is preserved using an alternative surgical strategy that employs the ESAK (extracorporeal sliding arthroscopic knots) suturing technique. The advantage to ESAK is that they allow for navigation around anatomic obstacles and have been shown to provide in benefit in both LHHR and other confined operative fields. Patients in the study underwent concomitant TIF 2.0 procedure once the LHHR procedure was complete.
There was no conversion from laparoscopic to open procedure. TIF procedure enabled the surgeon to perform fundoplication in a limited surgical field. There were no intraoperative or postoperative bleeding and no incidents of 90-day mortality or morbidity. Recurrence of hiatal hernia was not observed at three months post-procedure in all patients and at 12 months in three of four patients who had the procedure more than one year ago. The same applied to the fourth patient who had his procedure 2 years ago (in press)
These results demonstrate that concomitant LHHR and TIF procedure are safe and effective even in patients with ALHA. The absence of intraoperative bleeding in this study suggests a clinical benefit compared with other approaches to addressing ALHA during LHHR without introducing the risk of left liver lobe necrosis. Significant improvements GERD-HRQL scores, heartburn scores, regurgitation scores, Reflux Symptom Index and GERD Symptom Score were also reported, highlighting patient satisfaction with this laparoendoscopic approach.