Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorders causing substantial morbidity in the United States.1 GERD symptoms occur when stomach contents are refluxed into the esophagus, which results in discomfort and eventually leads to mucosal erosion. The symptoms of GERD are present in about 28% of the United States population.2 However, the cardinal symptoms of GERD may not always be present in some patients with endoscopic esophagitis or Barrett’s esophagus.3,4

Depending on the severity of symptoms, general management of GERD involves lifestyle and dietary modifications, antacids, surface agents, histamine 2 receptor antagonists, and proton pump inhibitors (PPIs).5 Despite multiple medical treatment options, GERD symptoms that are refractory to PPIs occur anywhere between 17% and 45% of the patients.6 Long-term PPI use has been implicated in increased risk of osteopenia, acute kidney injury, microscopic colitis, and Clostridium difficile infections.7,8 GERD is an anatomic problem, and other interventions may be considered in patients refractory to medical therapy or those who opt to discontinue PPIs. These include surgical fundoplication, magnetic sphincter augmentation, lower esophageal sphincter radiofrequency application, and transoral incisionless fundoplication (TIF).5 Historically, surgical methods have been the definitive management for GERD.

TIF was introduced in 2009 as an alternative to surgical intervention and has shown promise as an anatomical treatment option in the symptom management of GERD.9 However, certain challenges in maintaining patient safety and training personnel are met when introducing a new and effective procedure. The correct balance involves maintaining patient safety and effective outcomes while navigating procedural learning curves, complications, and institutional costs. In this report, we share our institution’s TIF implementation experience, where a programmatic allocation of resources to implement a new technique was performed. The TIF procedure was initially performed in the operating room (OR) to ensure extra safety with a planned overnight admission. With clinical experience, we systematically transitioned the procedure to be performed at the endoscopy suite (ES) as an outpatient procedure. Herein, we report our data to aid in the dissemination of this implementation technique.

A retrospective qualitative study involving all patients who underwent TIF from January 2020 to February 2021 was performed. This study aimed to describe the implementation of TIF procedure at our center.

Over a period of 14 months (January 2020 to February 2021), 30 patients underwent TIF. The mean age was 51.17±16.01 years, the mean body mass index was 28.01±6.94 kg/m² and 18 of patients (60%) were female (Table 1).

The mean duration of GERD in patients undergoing TIF was 12±10.5 years. All patients were on acid suppressive therapy with PPI and/or H2 receptor blockers prior to the procedure. Evidence of esophagitis was seen in 50% of patients, while 63.3% of patients had evidence of a small hiatal hernia. The mean DeMeester score was 57.12±46.4. The initial nine patients (30%) underwent the procedure in the OR, and 21 subsequent patients (70%) underwent TIF at the ES. All initial patients had planned admission to the hospital with a median length of stay of 1 day (range, 1−7 days), while only four patients (19%) in the latter group required admission based on their symptoms with a median length of stay of 1 day. Two of these patients were admitted for nausea and vomiting, one had significant pain, and one patient necessitated overnight admission due to lack of transportation (patient resided out of town). As the procedure transitioned towards ES, 81% of patients were successfully discharged on the same day of procedure. All patients in the OR group had routine EG, while only three patients (14.2%) in the ES required EG based on suspicious symptoms such as nausea, vomiting, and pain. Two patients required readmission within 30 days, one from the OR and ES groups respectively. One patient from the OR group had a peripherally inserted central catheter (PICC) line dysfunction and a PICC-associated deep vein thrombosis which required admission for anticoagulation and eventual replacement of PICC line (non-TIF-related issue). In contrast, the other patient from the ES group had an emergency room visit for post-procedural pain requiring intravenous pain medications.

The TIF procedure was technically successful in 29/30 patients (96.6%) except in one who had undergone sleeve gastrectomy. Three patients (10%) who had successful TIF had minor intraoperative complications. One patient experienced bleeding at a fastener site in the distal esophagus, which was treated with epinephrine and coaptive coagulation. Another patient had mild mucosal and submucosal tears at the cricopharyngeus from the device passage, but no full-thickness perforation was noted. The third patient had difficult esophageal passage requiring dilation, causing mucosal stretching and tearing without perforation. A total of three patients (10%) had minor postoperative adverse events. Two had intractable pain requiring an ER visit and/or hospital admission after being discharged, and one had persistent nausea and vomiting requiring overnight admission. All these adverse events were observed in patients from the ES group. No major adverse events were noted. Esophageal leak or perforation did not occur in any patient. The mean duration of the procedure was significantly lower in procedures performed at the ES (65.71±10.15 min vs. 84±18.42 min; p=0.002) (Fig. 2). Among the successful TIF patients who had 3 months follow-up (25/29 patients), 17/25 patients (68%) had stopped or reduced acid suppressive therapy while pre-procedural doses of acid suppressive therapy was continued in 8/25 (32%). Similarly, 20/25 (80%) had no reflux on follow-up EG, 2/25 (8%) had reflux only with provocative maneuvers, 2/25 (8%) had reduced reflux compared to pre-procedural EG, and 1/25 (4%) continued to have spontaneous reflux. No symptom improvement was noted in 2/25 (8%), with subsequent arrangement of further studies and additional follow-up. Table 2 shows procedural characteristics and post-procedural outcomes.

Historically, surgery has been the mainstay for the definitive anatomic management of refractory GERD. Randomized controlled trials comparing TIF and PPI therapy have demonstrated the superiority of TIF in eliminating troublesome refractory reflux symptoms with durable results.10 Studies have shown TIF to be comparable to Nissen fundoplication (NF) for symptom relief in a subset of patients without a large hiatal hernia.11 A systematic review and network meta-analysis by Richter et al.12 reported TIF to be superior to laparoscopic NF in improving health-related quality of life. However, the same study showed laparoscopic NF was better than TIF in achieving improved % time pH <4. Compared to other anti-reflux surgeries, the main advantages of TIF include its minimally invasive nature, short and reliable postoperative recovery, and its ability to be performed as an outpatient procedure. The data on short-term effectiveness of TIF is robust and although some studies have reported sustained results, further studies are required to demonstrate long-term efficacy.10 The need to create a protocol for safely introducing this minimally invasive approach for definitive treatment of GERD at our VMFH was identified. Utilizing the resources available at VMFH, we have described the development of a protocol to implement the TIF procedure. Moreover, the challenges and accomplishments of protocolizing this minimally invasive approach to treating refractory GERD was discussed.

There are no protocols or guidelines in place to guide the safe introduction and implementation of a novel procedure such as TIF. A multidisciplinary approach was used to introduce the procedure at our center. A decision was made to introduce this procedure using two attending physicians (gastroenterologist and thoracic surgeon) based on the clinical expertise associated with the two operators. All operators underwent training according to the manufacturer’s guidelines and all procedures were supervised by the manufacturer representatives with extensive experience in the technique. Both OR and ES staffs underwent the necessary mandatory training. The procedure was initially implemented in the OR, with all patients requiring overnight admission. While the length of hospital stay among all OR patients was 1 day, one patient who had multiple chronic medical and psychosocial conditions and a history of multiple prior hospitalizations was admitted for 7 days due to issues related to her comorbidities. A prolonged admission like the one mentioned is unusual in TIF patients, and this admission was due to a non-gastroenterology-related issue. The OR was adequately equipped with the necessary instruments and staff on standby for the possibility of an emergent thoracic surgery in case any complications arose. As the providers gained experience, resource utilization was systematically reduced. The procedure was then transitioned to the ES, with overnight admission and postoperative EG was no longer considered a routine procedure unless a clinical indication was present. The initial demonstration of safety with routine postoperative EG led to the omission of this study in the cohort. Currently, more than 80% of patients who undergo TIF are discharged on the same day.

With the introduction of TIF at our institution, a technical success rate of nearly 97% in our experience with the first 30 patients was observed. One technical failure occurred at the ES in a patient with prior gastric sleeve surgery, which is a technically difficult procedure given the altered anatomy. Four other patients had successful TIF despite altered anatomy. Two of these patients had previously undergone DaVinci robotic-assisted hiatal and paraesophageal hernia repair with partial fundoplication. One patient had prior open paraesophageal hernia repair, while the other had hiatal hernia repair with partial fundoplication. No major complications were associated with TIF. Furthermore, the tapering or discontinuation of PPI medications in patients was generally initiated at their 3-month appointments. However, earlier discontinuation of PPIs was possible in 40% of patients.

Anatomic endoscopic treatments for GERD have been available for more than 20 years,5,13 with radiofrequency application and TIF being the two main endoscopic treatment options currently available.5 Endoscopic fundoplication was first introduced in 2005 and involved gastro-gastric plication below the Z line. The next iterations were TIF 1.0 and the currently performed TIF 2.0, which were introduced in 2007 and 2009 respectively.13 TIF 2.0 involves esophagogastric plication 1–3 cm above the Z line using around 12–23 fasteners to form a 270°–300° plication.13,14 As of 2019, it has been reported that more than 22,000 patients have undergone TIF.13 An abstract by Brewer Gutierrez et al.15 reported their experience with the learning curve of TIF, which showed a progressive decrease in the total procedure time with experience. They also reported that endoscopists required at least 23 procedures to achieve procedure times <1 hour. This is in line with the findings of our study, which shows consistently lower procedure times after 20 procedures with an average time of 65 minutes (Fig. 2).

The strength of this study lies in the fact that this is the first to report the experience of systematically implementing the TIF procedure at a tertiary referral center with extensive previous experience in surgical repair of reflux. The process of planned resource allocation with subsequent transition to a resource-optimal, cost-effective process for outpatient TIF has been implemented. The limitations of this study are the retrospective nature and the small sample size with inherent limitations and risks of bias. Moreover, qualitative scales such as the GERD Health-Related Quality of Life Questionnaire were not used to assess the impact of TIF on symptom improvement and quality of life. Finally, four patients (13.8%) were unable to comply with the 3-month postoperative ES follow-up.

We share our TIF introduction experience to aid in the dissemination of our implementation technique. A stepwise process of planned reduction in-hospital resource allocation over time for the safe implementation of TIF was described. With this process, we were able to introduce a new technique without major complications while successfully transitioning to a fully outpatient procedure. The introduction of a new procedure in a hospital or healthcare system requires the understanding that despite initial extended safety protocols and additional costs in the form of training time and resource utilization, the new procedure will be more cost-effective and efficient once implementation is complete.