TIF Stretta and Endocinch all seem technically safe in well-selected patients including those with prior esophageal and gastric surgeries. Long-term effectiveness is being evaluated. Given the current enthusiasm for increasingly less invasive surgical techniques, the inertia for endolumenal therapies continues to grow. Other endolumenal therapies for Gastroesophageal reflux disease (GERD) have initiated trials. These pursue similar fundoplication or lower esophageal sphincter reconstruction using simpler techniques with fewer steps. Because all endolumenal approaches to GERD evolve, objective evaluation for symptom resolution and reduced esophageal acid exposure with improved esophagogastric physiology will remain a constant.
Key Points
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Patients suffering from gastroesophageal reflux disease that may benefit from endolumenal anti-reflux procedures, which are less invasive than standard surgical approaches.
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The workup for a patient considering an endolumenal anti-reflux procedure is the same as for a patient considering anti-reflux surgery.
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Endolumenal anti-reflux procedures have a similar complication spectrum compared with surgical procedures and are addressed in similar fashion including additional endoscopy or surgical treatment.
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Results from endolumenal anti-reflux procedures are promising however the current therapies are relatively new and require long term data to determine durability.
The medical treatment of GERD is through antisecretory pharmaceuticals such as proton pump inhibitors, histamine 2 blockers, and antacids. Unfortunately, many patients do not respond to standard dosage regimens, and for those who do, are required to adhere to life-long treatment to avoid recurrent symptoms and progression of disease. Patients who receive little to no symptomatic relief, or who do not wish to use long-term antisecretory medications, can opt for a surgical fundoplication to potentially improve their quality of life. The laparoscopic Nissen fundoplication is the standard surgical treatment for severe GERD with 90% to 94% overall patient satisfaction and overall outcomes during long-term follow-up. The main objective of the fundoplication is to restore the anti-reflux barrier by the reconstruction of the lower esophageal sphincter. However, owing to surgical morbidity and common side effects of dysphagia, bloating, flatulence, and difficulty belching and vomiting, patients may be dissuaded from the surgical approach.
In search for an alternative and less-invasive approach, attempts to create endolumenal treatments for GERD have been developed and tried over the last couple of decades. Unfortunately, inadequate initial results, failure to objectively treat GERD during long-term follow-up, and overall poor reimbursement, all have contributed to the inability for a single endolumenal treatment to be used for long term. The current endolumenal approaches that are clinically available and will be described are:
- 1.
Transoral incisionless fundoplication (TIF) performed with the EsophyX device (Endogastric Solution Inc, Redmond WA, USA) results in the creation of a 270° to 320° omega-shaped fundoplication.
- 2.
The Stretta procedure (Mederi Therapeutics Inc, Greenwich CT, USA) uses radiofrequency ablation through extended probes into the esophageal musculature to decrease compliance of the lower esophageal sphincter and creates a physiologic anti-reflux barrier.
- 3.
The Endocinch (CR BARD Endoscopic technologies, MA, USA) is used for endolumenal gastroplication. This technology is based on Bard’s endoscopic suturing system allowing plication of the gastric fundus from within the lumen to recreate the lower esophageal sphincter, or repair a patulous anti-reflux barrier.
Indications for endolumenal treatment for GERD
A standard work-up of the GERD patient should be followed whether the patient seeks medical, surgical, or endolumenal treatment. Ideally, patients with objective evidence of moderate to severe GERD without significant hiatal hernia who wish to avoid long-term medical treatment as well as formal laparoscopic or open surgical treatment are candidates for endolumenal treatment. The workup should include the following.
- 1.
Contrast esophagram : This evaluates the overall anatomy of the foregut, serves as a preoperative “road map” and identifies hiatal hernias (>2 cm hiatal hernia is a contraindication to current endolumenal treatments).
- 2.
Upper endoscopy : This evaluates the esophagogastric mucosa, allows for identification of hiatal hernias and allows for tissue diagnosis of suspect lesions, such as Barrett’s esophagus. The histologic results of tissue biopsies can then guide additional treatments.
- 3.
pH/impedance testing : The current “gold standard” for the diagnosis of GERD is pH testing. This is necessary to objectively characterize the severity of disease. Impedance testing provides additional value for patients unable to tolerate pH testing while off of antisecretory medication and in those who present with atypical symptoms not adequately characterized with standard pH testing.
- 4.
High-resolution esophageal manometry : In any patient with a complaint of dysphagia, manometry is important in characterizing relative esophageal motility and allowing for customization of treatment to avoid overtreating a patient with severe esophageal dysmotility.
Appropriate candidates for endolumenal treatment include those patients with fairly normal anatomy on esophagram, 24-hour pH study results with a Demeester score of at least 14.8 (normal, ≤14.7), no evidence of malignancy on histologic analysis and fairly normal esophageal motility.
Relative contraindications to endolumenal treatment include a body mass index of less than 35 kg/m 2 , Barrett’s esophagus, immediate prior esophageal myotomy, esophageal varices, and major connective tissue disorders.
Indications for endolumenal treatment for GERD
A standard work-up of the GERD patient should be followed whether the patient seeks medical, surgical, or endolumenal treatment. Ideally, patients with objective evidence of moderate to severe GERD without significant hiatal hernia who wish to avoid long-term medical treatment as well as formal laparoscopic or open surgical treatment are candidates for endolumenal treatment. The workup should include the following.
- 1.
Contrast esophagram : This evaluates the overall anatomy of the foregut, serves as a preoperative “road map” and identifies hiatal hernias (>2 cm hiatal hernia is a contraindication to current endolumenal treatments).
- 2.
Upper endoscopy : This evaluates the esophagogastric mucosa, allows for identification of hiatal hernias and allows for tissue diagnosis of suspect lesions, such as Barrett’s esophagus. The histologic results of tissue biopsies can then guide additional treatments.
- 3.
pH/impedance testing : The current “gold standard” for the diagnosis of GERD is pH testing. This is necessary to objectively characterize the severity of disease. Impedance testing provides additional value for patients unable to tolerate pH testing while off of antisecretory medication and in those who present with atypical symptoms not adequately characterized with standard pH testing.
- 4.
High-resolution esophageal manometry : In any patient with a complaint of dysphagia, manometry is important in characterizing relative esophageal motility and allowing for customization of treatment to avoid overtreating a patient with severe esophageal dysmotility.
Appropriate candidates for endolumenal treatment include those patients with fairly normal anatomy on esophagram, 24-hour pH study results with a Demeester score of at least 14.8 (normal, ≤14.7), no evidence of malignancy on histologic analysis and fairly normal esophageal motility.
Relative contraindications to endolumenal treatment include a body mass index of less than 35 kg/m 2 , Barrett’s esophagus, immediate prior esophageal myotomy, esophageal varices, and major connective tissue disorders.
Procedural techniques
TIF
The patient should be prepared for standard upper endoscopy, placing the patient in the left lateral decubitus position. The EsophyX device ( Fig. 1 ) and endoscope should be tested on a back table for size compatibility. Next, the patient should have neck extended with bite block with the bed tilted slightly (head higher) to avoid risk of aspiration. General anesthesia with nasotracheal or orotracheal intubation are then induced. Diagnostic upper endoscopy is initially performed to reconfirm no obvious evidence of malignancy or other concerning mucosal abnormalities. Lubrication of the endoscope and EsophyX device with medical grade olive oil or similar lubricant allows for easier manipulation of the component devices. The fastener cartridge and polypropylene H-fasteners are then loaded using the stylet knobs. Next the EsophyX device is placed over the endoscope with the endoscope tip protruding. The EsophyX helical retractor and stylets are locked in retracted position for safety. The EsophyX device and endoscope are introduced as a unit transorally down through the esophagus into the stomach under direct retroflexed visualization. With the EsophyX device facing the greater curvature, the endoscope is withdrawn back to the level of the hinge. The EsophyX device is partially flexed and the endoscope is advanced behind the EsophyX hinge and retroflexed as the EsophyX device is fully flexed into closed position. (Orientation is now as follows: 12 o’clock describes the lesser curvature of the esophagogastric junction; 6 o’clock describes the greater curvature direction located at the Angle of His; 3 o’clock describes the anterior aspect; and 9 o’clock describes the posterior aspect; Fig. 2 ). The helical retractor is advanced into the 12 o’clock position and tissue is secured. The tissue mold is partially opened at the 6 o’clock position and closed over 2 to 3 cm of tissue. The invaginator is then engaged. The tissue mold is swung toward 1 o’clock and gastric disinflation is simultaneously performed. Gastric insufflation is followed by advancement of anterior and posterior stylets and fasteners (via the fastener pushers) in sequential fashion ( Fig. 3 ). The tissue mold is unlocked, repositioned, and relocked. Two more fasteners are deployed. The tissue invaginator is released. The tissue mold is swung around the 12 o’clock position and similar maneuvers are used to place a total of 4 fasteners at the 11 o’clock position. The helical retractor is released and re-engaged at the 6 o’clock position. The tissue invaginator is re-engaged. Two fasteners are deployed after grasping 3 cm of tissue in the tissue mold at the 8 o’clock position and then at the 4 o’clock position. There is no need for tissue swinging or disinflation during these fastener deployments. A total of 12 fasteners are deployed approximately 1 to 2 cm above the esophageal Z-line. Additional fasteners can be deployed as necessary to develop a 2 to 3 cm 270° to 320° omega shaped esophagogastric wrap.
The endoscope and EsophyX device (with stylets and helical retractor locked in retracted position) are then removed. Before concluding the procedure, a final upper endoscopy is performed to confirm that an adequate fundoplication has been created and that no perforation or bleeding is present. The patient is extubated and taken to the recovery room, before going to the ward or home for postoperative care.
Stretta
Begin by preparing the patient for standard upper endoscopy, placing the patient in the left lateral decubitus position. The patient should have neck extended with a bite block in place then tilt the bed slightly (head higher) to avoid risk of aspiration. Prepare the patient using standard technique for monopolar electrosurgery by initially applying the return electrode pad to a cleaned and hairless area on the patient’s right mid scapular area off the mid line. The recommended treatments for Stretta are 4 antegrade treatment levels in and around the lower esophageal sphincter, 5 mm apart from each other (two 1-minute treatment sites per level at home position and the 45° to right for treatment levels 1 to 4) and 2 pull-back treatment levels in the gastric cardia (three 1-minute treatment sites per level, home position, 30° to the left and 30° to the right of home for levels 5 and 6). Endoscopic inspection of the esophagus, measurement of distance from Z-line to bite block confirms the location and depth of the patients Z-line (squamocolumnar tissue) versus the fixed oral bite block. The Z-line serves as the reference landmark for the first 4 (antegrade) of 6 total treatment levels. A guide wire is then passed through the scope and into the stomach of the patient to run the Stretta Catheter over. From Standby mode, push the Power On/Mode button to advance to Ready mode, the catheter is lubricated ( Fig. 4 ) and inserted into the esophagus down to the Z-line measurement and then retracted to a position 1 cm above the Z-line for treatment level 1. Placement is confirmed versus the bite block. Next suction is attached to the catheter. The pressure release valve is attached to the air syringe. Thirty milliliters of air are drawn into the syringe and inserted into the insufflation port on the Stretta Catheter until the pressure release valve releases excess air. Once the balloon is inflated, extend the needles that go into the tissue of the esophagus.
