Summary of evidence for TIF: June 2020
- Chang CG, Thackeray L. Laparoscopic Hiatal Hernia Repair in 221 Patients: Outcomes and Experience. JSLS. 2016;20(1):1-7. The article addresses the common condition of Hiatal hernia, which is often associated with symptomatic gastroesophageal reflux disease (GERD). The article supported the studies outcomes of the efficacy and safety of laparoscopic hiatal hernia repair (LHHR) with biologic mesh to reduce and/or alleviate GERD symptoms and associated hiatal hernia recurrence. The greatest GERD-HRQL score decrease (20.5 ± 13.4) was observed in patients who underwent LHHR with a fundoplication procedure (Nissen/TIF).
- Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011; 202(6):740-747. The study supports the safety of TIF and the procedure’s ability to significantly reduce the symptoms. The technology represents a suitable alternative treatment option to patients with chronic GERD not satisfied with their current management of the disease. The use of laparoscopic HHR can augment the use of transoral fundoplication without introducing the side effects of laparoscopic Nissen fundoplication (LNF).
- Ihde, GM, Rena,C, et al. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. JSLS. 2019:23: 1-8. This article supports that hiatal hernia repair combined with transoral incisionless fundoplication significantly improved outcomes in patients with gastroesophageal reflux disease in both subjective Gastroesophageal Reflux Disease Health Related Quality of Life and Reflux Symptom Index measurements as well as in objective pH scores.
- JJanu, P, Shughoury, AB, Venkat, K. Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals. Surgical Innovation. 2109. 26(6) 675-686. This study was to assess the safety and efficacy of a HH + TIF procedure among a cohort of GERD patients with hiatal hernias. Based on the findings, the procedures can be safely performed one after the other, either with a single surgeon doing both components, or performed by a team of surgeon and gastroenterologist.
Summary of Evidence for TIF: September 2017
As noted above, transoral incisionless fundoplication surgery is a method for treating gastroesophageal reflux disease. This procedure reconstructs the valve at the top of the stomach that helps prevent acid reflux.
1. Technology Coverage Statement on Minimally Invasive Surgical Options for Gastroesophageal Reflux Disease April 2016. This is a position paper from the American Gastrological Association based on its reviews of TIF publications. It is strongly supportive.
2. Bell RCW, Barnes WE, Carter BJ, et al. Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study. AM Surg. 2014 Nov;80(11);1093-1105. This 24-month follow-up has been reported from a prospective multicenter registry of patients with chronic GERD who received transoral fundoplication using the ESOPHYX2 system with SerosaFuse fasteners. For the 100 consecutive patients who were treated in this community-based study, the median GERD symptom duration was nine years (range, one to 35 years), the median duration of PPI use was seven years (range, one to 20 years), and 92 percent of patients had incomplete symptom control despite maximal medical therapy. This three-year study provides evidence to demonstrate sustainable improvement in health outcomes, symptom relief, decrease in PPI utilization and improvement in esophageal pH with transoral fundoplication. This is supportive.
3. Hakansson B., Montgomery M., Cadiere G, et al. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Alimentary Pharmacology and Therapeutics. 2015 John Wiley & Sons Ltd. This publication is indexed in the U.S. National Library of Medicine of the National Institutes. The study was blinded and divided equally into TIF and sham procedures. The follow up period was only 6 months, the time (average days) in remission offered by the TIF procedure (197) was significantly longer compared to those submitted to the sham intervention (107), P < 0.001. After 6 months 13/22 (59%) of the chronic GERD patients remained in clinical remission after the active intervention. The secondary outcome measures were all in of the TIF2 procedure. No safety issues were raised. This is supportive.
4. Hunter JG, Kahrilas PJ, Bell RCW, et al. Gastroenterology. 2015 Feb;148(2):324-333. The largest RCT with the lowest risk of bias is an industry-sponsored double-blind sham controlled multicenter study (RESPECT) that evaluated transoral fundoplication in patients whose symptoms were not well-controlled on proton pump inhibitors (PPIs). Out of 696 patients screened, 129 met inclusion and exclusion criteria and were randomized in a 2:1 ratio; 87 patients received transoral fundoplication combined with six months of placebo and 42 patients received sham surgery with six months of daily PPI therapy (sham/PPI). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). This is supportive.
5. Clinical Spotlight Review: Endoluminal Treatments for Gastroesophageal Reflux Disease (GERD)sages.org/publications/guidelines/endoluminal-treatments-for-gastroesophageal-reflux-disease-gerd. This is a statement from the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Mar 2017. The recommendation is: Based on existing evidence, TIF can be performed with an acceptable safety risk in appropriately selected patients. The procedure leads to better control of GERD symptoms compared with PPI treatment in the short term (6 months), but appears to lose effectiveness during longer term follow-up and is associated with moderate patient satisfaction scores. Objective GERD measures improve similarly after TIF 2.0 compared with PPI. No comparative, controlled trials exist between TIF and surgical fundoplication, but preliminary evidence suggests that the latter can be used safely after TIF failure. (Per SAGES, this is level of evidence +++, strong recommendation).
6. Stefanidis G, Viazis N, Kotsikoros N, Long-term benefit of transoral incisionless fundoplication using the ESOPHYX device for the management of gastroesophageal reflux disease responsive to medical therapy. Dis Esophagus (2017) 30, 1–8. This publication is indexed in the U.S. National Library of Medicine of the National Institutes of Health. The study initially had 45 patients who had the TIF procedure and were followed for a mean of 59 months (range 36–75). One patient had a complication during surgery and thus was excluded. The 44 patients had follow-up upper endoscopy at 6 months, 1 year, and 3–5 years postoperatively (72.7%) that completed the study follow up, reported elimination of their main symptom without the need for PPI administration (none PPI usage). Six patients (13.6%), 5 with heartburn, and 1 with regurgitation reported half PPI dose taken for <50% of the preceding follow up period (occasional PPI usage), 6 more patients (4 with heartburn, 1 with regurgitation, and 1 with chest pain) reported full or half PPI dose taken for more than 50% of the preceding follow up period (daily PPI usage). This is supportive.
7. Trad, K., & et al. (2017). Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm. Surg Endosc. 2017 Jun;31(6):2498-2508. doi: 10.1007/s00464-016-5252-8. The TF EsophyX vs. Medical PPI Open Label Trial was conducted in 7 sites. Patients were enrolled with < 2 cm or absent hiatal hernia who suffered from GERD symptoms while on PPI treatment for at least 6 months and had abnormal esophageal acid exposure (EAE). Patients were randomized to TIF group or PPI group. At 6 months, all remaining PPI Patients elected to undergo crossover to TIF. 52 patients were assessed at 3 years for GERD symptom resolution, healing of esophagitis using endoscopy, EAE using 48-hour Bravo testing and discontinuation of PPI use. At 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p\0.0001. The mean total % time pH \4 improved from 10.5 (3.5) to 7.8 (5.7), p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1, 2, and 3 year follow-ups post-TF, p\0.0001. This study demonstrated TIF can be used to achieve long term control of chronic GERD symptoms, healing esophagitis and improvement of EAE. This is supportive.