Transoral Incisionless Fundoplication Procedure Research Articles

Transoral incisionless fundoplication and open hiatal hernia repair: A case report

IntroductionTransoral incisionless fundoplication is a new procedure that has recently emerged as a potential alternative to traditional anti-reflux surgeries. It is a less invasive option with fewer complications and reduced recovery time. Hiatal hernia repair is also commonly performed in conjunction with transoral incisionless fundoplication to improve outcomes. In this case, it details a successful transoral incisionless fundoplication and hiatal hernia repair procedure in a patient with long standing gastroesophageal reflux disease (GERD). The case is unique as it involved a patient with an uncharacteristically large hiatal hernia measuring above 5cm, which is a size that is generally not considered suitable for transoral incisionless fundoplication. The hiatal hernia was repaired with a gastrectomy instead of laparoscopically due to the size and adhesions present.Case detailsThis case report presents an 86 year old female patient with a history of long-standing GERD symptoms from the past 10 years who had failed to respond to medical therapy. Endoscopic imaging revealed a hernia of more than 5cm in size, which was confirmed by a bravo study. A DeMeester score of 446 was reported. The patient was referred for surgery and underwent transoral incisionless fundoplication with hiatal hernia repair. Despite the large size of the hiatal hernia, it was decided to proceed with a transoral incisionless fundoplication (TIF) procedure combined with hiatal hernia repair. The gastrectomy was chosen due to significant adhesions and anatomical distortion, making it difficult to continue laparoscopically. The esophagus was fibrosed to the pericardium, and the stomach was stuck in a retrocardiac position. Laparoscopic removal of the adhesions proved difficult since the patient had friable tissues, and there was a high risk of injury to surrounding organs. The surgery was therefore converted to an open approach, and the hernia was repaired with a gastrectomy. The TIF procedure was performed successfully, and the patient had no complications postoperatively.ConclusionThis case details a successful transoral incisionless fundoplication procedure for GERD in a patient with an uncharacteristically large hiatal hernia. Despite the challenges posed by the hernia’s size and anatomical distortion, the TIF procedure combined with hiatal hernia repair was successful in providing relief from GERD symptoms, with no postoperative complications. The case highlights the potential suitability of TIF as an alternative to laparoscopic fundoplication in patients with large hiatal hernias, although gastrectomy may be necessary in cases with significant adhesions or anatomical distortion.

S1132 Real World Outcomes of Transoral Incisionless Fundoplication at a Tertiary Academic Center

Introduction: Transoral incisionless fundoplication (TIF) is a minimally invasive procedure for treatment of gastroesophageal reflux disease (GERD). Although studies have reported long-term durability and resolution of symptoms, the procedure carries a wide range of adverse events from mild to life-threatening. This study aims to evaluate the short-term outcomes of consecutive TIF procedures in a tertiary academic center. Methods: This is a retrospective study of patients who underwent TIF procedure by a single experienced gastroenterologist at a tertiary center in the United States from January 2018 to December 2021. Clinical success was defined as the ability to create a >=270° partial wrap with estimated longitudinal length of >=2cm. Short-term outcomes including patient symptoms or procedure related adverse events immediately to two months post-op were collected retrospectively. Results: Overall, 68 patients underwent 77 consecutive TIF procedures. The average age of patients was 52.35 ± 15.74 years (67.6% female). Technical success was achieved in 100% of the patients. 10.3% of the patients had a history of prior anti-reflux surgery. Chronic GERD was the main indication for TIF procedure. The majority of patients underwent TIF for Hill grade II and III flap valves, present in 62.5% and 25%, respectively. 50.6% of patients had post-procedure symptoms up to 2 months post-procedure including abdominal pain (28%), nausea/vomiting (14.3%), chest pain (10.4%), dysphagia/odynophagia (6.5%). There was a positive correlation between number of fasteners used and immediate abdominal pain (p=0.003), sore throat (p=0.024), and nausea/vomiting (p=0.046). Two patients developed major adverse events: one developed pneumoperitoneum and the second aspiration pneumonia complicated by flash pulmonary edema. Of the 29 patients with follow-up EGDs, 62.1% had an intact wrap (Hill I). There was no significant difference in the average number of fasteners in those with intact or loose wrap on follow up EGD (21.67 ± 5.1 vs. 22.8 ± 5.2, p=0.57). 9 patients (13.2%) underwent redo TIF and 2 (2.9%) proceeded with surgical fundoplication for persistent symptoms. (Table) Conclusion: Outcomes of TIF performed on a heterogeneous population in a tertiary academic center are comparable to outcomes reported from original randomized trials of TIF. Immediate adverse effects are common after TIF, but typically improve on long-term follow-up. Table 1. - Baseline patient characteristics and short-term post-TIF outcomes Patient summary characteristics: Gender (Female) 67.6% (n=46) Age [mean ± SD 52.35 ± 15.74 Race White 79.41% (n=54) Non-Hispanic 67.65% (n=46) BMI [mean ± SD] 27.7 ± 5.1 ASA Score II 69.1% (n=47) III 29.4% (n=20) IV 1.5% (n=1) Prior history of Barrett’s ablation 4.4% (n=3) Prior esophageal surgical intervention Nissen Fundoplication 8.8% (n=6) POEM- Nissen Fundoplication 1.5% (n=1) POEM 2.9% (n=2) Indication for TIF GERD 83.82% (n=57) Chronic cough +/- GERD 16.17% (n=11) Hernia HILL grade (if available): 1 25% (n=14) 2 62.5% (n=35) 3 8.9% (n=5) 4 3.6% (n=1) PH impedance or Bravo test (uninterpreTable (n=1); not performed due to presence of BE/esophagitis (n=5)) Acid 82.26% (n=51) Non-acid 17.74% (n=11) Procedure characteristics: Number of fasteners [mean ± SD] 23.1 ± 6.2 Median Hospital LOS (days) [min, max] 1 [0,10] Immediate outcomes post procedure-2 months(%): Immediate adverse events 50.6% (n=39) Immediate abdominal pain 28.6% (n=22) Immediate chest pain 10.4% (n=8) Immediate dysphagia/odynophagia 6.5% (n=5) Immediate sore throat 7.8% (n=6) Immediate Nausea/vomiting 14.3% (n=11) Follow-up Procedural outcomes (%): Post-TIF EGD performed 42.6% (n=29) Time interval between TIF and Follow up EGD 269.8 ± 205.1 Days Esophagitis on post-TIF EGD 10.3% (n=3) Intact wrap on post-TIF EGD 62.1% (n=18) >95% SAP on follow up PH testing (out of 18) 50% (n=9) Post-TIF surgical fundoplication (n) 2.9% (n=2) Repeat TIF patient characteristics: Repeat TIF required (n) 13.2% (n=9) Female Gender (%) 66.7% (n=6) BMI at initial TIF [mean ± SD] 29.4 ± 3.7 Age at initial TIF (median) [min,max] 53 [25,65] ASA score at initial TIF (median) [min,max] 2 [2,3] Number of fasteners (median) [min, max] Initial TIF 20 [14,34] Re-Do TIF 22 [8,28] Procedure length (median) [min, max] Initial TIF 47 [36,89] Re-Do TIF 45 [29,56]

S1098 Learning Curve of Transoral Incisionless Fundoplication: A Proficiency Study

Introduction: Transoral incisionless fundoplication (TIF) is a minimally invasive endoscopic procedure for treatment of gastroesophageal reflux disease. Performing TIF requires unique training to achieve proficiency. This study aims to evaluate the learning curve of performing TIF in relation to patient and procedure-specific characteristics. Methods: This is a retrospective study of consecutive TIF procedures performed by a single experienced gastroenterologist to assess the procedure learning curve. Historical and procedural characteristics were recorded, and the learning curve was estimated by cumulative sum of means (CUSUM) analysis. Proficiency was defined as reliably achieving a procedure length less than 45 minutes. Results: 77 consecutive TIF procedures (68 patients) were included. The average age of patients was 52.35 ± 15.74 years (32.4% male). The estimated learning plateaus for procedure time and number of fasteners were 41 minutes and 24 fasteners, respectively. Twelve procedures were required to reliably achieve a procedure length of 45 minutes or less. There was no significant correlation between the length of the TIF procedure and number of fasteners (p=0.091) or Hill classification (I vs II/III) (p=0.483). There was no relationship between the Hill classification (I vs. II/III) and number of fasteners (p=0.475). We observed a significant increase in average number of fasteners used over time from 18.5 ± 2.28 during the first quartile of procedures to 29.82 ± 4.61 in the last quartile (p=0.01). There was no relationship between procedure length, ASA score, number of fasteners, and hospital length of stay. Conclusion: Proficiency in performing TIF in less than 45 minutes can be achieved after independently performing 12 procedures.Figure 1.: Non-linear regression curves for proficiency of procedure duration and number of fasteners Table 1. - Baseline patient characteristics and procedural outcomes Patient summary characteristics: Gender (Female) 67.6% (n=46) Age [mean ± SD] 52.35 ± 15.74 Race White 79.41% (n=54) Non-Hispanic 67.65% (n=46) BMI [mean ± SD] 27.7 ± 5.1 ASA Score II 69.1% (n=47) III 29.4% (n=20) IV 1.5% (n=1) Prior history of Barrett’s ablation 4.4% (n=3) Prior esophageal surgical intervention Nissen Fundoplication 8.8% (n=6) POEM- Nissen Fundoplication 1.5% (n=1) POEM 2.9% (n=2) Indication for TIF GERD 83.82% (n=57) Chronic cough +/- GERD 16.17% (n=11) Hernia HILL grade (if available): 1 25% (n=14) 2 62.5% (n=35) 3 8.9% (n=5) 4 3.6% (n=1) Longitudinal length of hernia ≥ 2cm (available value; n=56) 26.78% (n=15) PH impedance or Bravo test (uninterpreTable; n=1, not performed due to presence of BE/esophagitis=5) Acid 82.26% (n=51) Non-acid 17.74% (n=11) Procedure characteristics: Total TIF procedures (n=77) Median procedure length(minutes) [min, max] 41 [26,91] Number of fasteners [mean ± SD] 23.1 ± 6.2 Number of fasteners original TIF per Quartiles [mean ± SD] First 18.5 ± 2.28 Second 21.53 ± 3.12 Third 24.71 ± 3.53 Forth 29.82 ± 4.61 Median Hospital LOS (days) [min, max] 1 [0,10]

The learning curve for transoral incisionless fundoplication.

Background and study aims Transoral incisionless fundoplication (TIF) is a safe and effective minimally invasive endoscopic technique for treating gastroesophageal reflux disease (GERD). The learning curve for this technique has not been reported. We studied the learning curve for TIF when performed by a gastroenterologist by identifying the threshold number of procedures needed to achieve consistent technical success or proficiency (consistent creation of TIF valve ≥ 270 degrees in circumference, ≥ 2 cm long) and efficiency after didactic, hands-on and case observation experience. Patients and methods We analyzed prospectively collected data from patients who had TIF performed by a single therapeutic endoscopist within 17 months after basic training. We determined thresholds for procedural learning using cumulative sum of means (CUSUM) analysis to detect changes in achievement rates over time. We used breakpoint analysis to calculate procedure metrics related to proficiency and efficiency. Results A total of 69 patients had 72 TIFs. The most common indications were refractory GERD (44.7 %) and proton pump inhbitor intolerance (23.6 %). Proficiency was achieved at the 18 th to 20 th procedure. The maximum efficiency for performing a plication was achieved after the 26 th procedure, when mean time per plication decreased to 2.7 from 5.1 minutes (P < 0.0001). TIF procedures time varied until the 44 th procedure, after which it decreased significantly from 53.7 minutes to 39.4 minutes (P < 0.0001). Conclusions TIF can be safely, successfully, and efficiently performed in the endoscopy suite by a therapeutic endoscopist. The TIF learning curve is steep but proficiency can be achieved after a basic training experience and 18 to 20 independently performed procedures.

The Benefits of Nonablative Radiofrequency Treatment of the Lower Esophageal Sphincter After Transoral Incisionless Fundoplication

Non-ablative radiofrequency treatment to the lower esophageal sphincter (Stretta) has been shown to be beneficial after failed Nissen fundoplication. To our knowledge, this is the first report of Stretta after transoral incisionless fundoplication (TIF). This patient is a 17-year-old female who had gastroesophageal reflux disease (GERD) symptoms for 9 years. She presented with heartburn, regurgitation, and epigastric discomfort. She used omeprazole for 9 years. Esophagogastroduodenoscopy (EGD) showed a 2 cm sliding hiatal hernia and DeMeester score of 25. The GERD Health-Related Quality of Life (GERD-HRQL) score on omeprazole was 14. Patient underwent a TIF procedure, which was uneventful. Her symptoms resolved, and she discontinued omeprazole. Six months later, she had episodes of repeated violent vomiting followed by recurrence of regurgitation, nausea, bloating, and dysphagia. She resumed omeprazole. Diagnostic workup included gastric emptying scan, which was normal. EGD showed no hiatal hernia and partial disruption of the TIF valve. DeMeester score was 36.3. Esophageal manometry with impedance showed intact peristalsis and normal relaxation of the lower esophageal sphincter. The patient underwent Stretta, which was uneventful. The previous TIF did not increase the complexity of the procedure. There were no immediate or postoperative complications. The patient reported gradual improvement of her symptoms with complete resolution 2 months postoperatively. She discontinued omeprazole. The GERD-HRQL score 17 months post-Stretta was 0. This case highlights the feasibility, safety, and efficacy of performing Stretta following TIF. It provides an endoluminal alternative to complex revisional antireflux surgery. Prospective studies with longer follow-up are required to validate this concept.

Mo1283 LEARNING CURVE OF TRANSORAL INCISIONLESS FUNDOPLICATION: A SINGLE ENDOSCOPIST EXPERIENCE

Transoral Incisionless Fundoplication (TIF) is a minimally invasive endoscopic technique proven to be safe and effective for treating Gastroesophageal Reflux Disease (GERD) in selected patients. The learning curve of this technique has not been studied. (1) To report the learning curve for TIF, by identifying a breakpoint or threshold number of procedures at which there is a significant decrease in procedure time, time taken per 2-set fastener placement and an increase in the valve circumference. Prospectively collected data on patients who had a TIF procedure at an academic medical center between September 2017 and November 2019 were analyzed. Routine pre-TIF work-up included upper endoscopy (EGD) with biopsies, cine-esophagram, high resolution esophageal manometry (HREM) and pH-monitoring. Patients who had prior per-oral endoscopic myotomy (POEM) were excluded. Learning curve analysis was done using STATA software v 15.1 and Power BI to calculate the threshold for learning assessed by time to reach specific endpoints of the TIF procedure. 51 patients (71% male, mean age 56.5±13.2 yr.) had TIF after testing confirmed appropriate criteria (ph-positive test, < 2cm hiatal hernia, Hill grade <=2, BMI< 35). Indications for TIF were refractory GERD (51%), laryngopharyngeal reflux disease (9%), failed Nissen fundoplication (9%) and GERD in PPI-averse patients (31%) (Table 1). Six (12%) patients had prior surgical fundoplication. All TIF procedures were performed by a single endoscopist after hands-on and supervised training. TIF was successfully completed in 50/51 (1 aborted due to technical failure) with no serious adverse events. Overall, mean procedure time was 56±15 minutes. Break point analysis revealed that the threshold procedure time was reached at 23 procedures, where time declined from 67±11 to 47±13 minutes (p<0.0001). The mean time to deploy set of 2 fasteners was 4.3±1.9 minutes and mean valve circumference was 285±24 degrees. The breakpoint analysis revealed that a threshold was reached at 18 procedures for both fastener deployment and valve wrap, with a decrease in the mean procedure time to deploy a set of 2 fasteners from 6.5±1.4 to 3.1± 0.8 minutes (p<0.0001) and an improvement in the mean valve circumference from 261±20 to 297±14 degrees (p<0.0001). There was a significant decrease in total procedure time and time to deploy 2-set fasteners as well as an improvement of the valve circumference with increased number of procedures (Figure 1). Our single-center analysis showed that the number of procedures needed for an endoscopist to achieve procedure times under 1-hour is 23 procedures. Furthermore, the number of procedures needed to achieve times under 4 minutes to deploy 2-set of fasteners and to achieve tighter valves is 18 procedures. Future larger studies are needed to validate these results.TIF learning curve breakpoint analysisView Large Image Figure ViewerDownload Hi-res image Download (PPT)

Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes.

Transoral incisionless fundoplication (TIF) with the Medigus ultrasonic surgical endostapler (MUSE) is a new intervention for the treatment of the gastroesophageal reflux disease (GERD). The aim of this study was to assess the 12-month clinical, functional, and endoscopic effects of TIF by MUSE. Patients undergoing MUSE completed the GERD-Health Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI) questionnaires, and underwent endoscopy, esophageal 24-hour pH-impedance recording, and high resolution manometry (HRM) before the TIF procedure and 12 months later, or after 6 months for HRM. Among the 37 patients treated, esophageal intubation was not possible in one and esophageal perforation occurred in another. Clinical and endoscopic follow-up at 12 months was completed in 20 patients, with significant improvements in GERD-HRQL, RSI, heartburn, regurgitation scores, and proton pump inhibitor (PPI) consumption observed. One patient required surgery for persisting symptoms. Functional follow-up was possible in 13 patients and showed no significant improvements in the analyzed parameters. TIF with MUSE significantly improved symptoms at 1-year follow-up, allowing the consumption of PPIs to be stopped or halved in 90 % of patients.

Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals.

The TIF (transoral incisionless fundoplication) 2.0 procedure is indicated for patients with a hiatal hernia less than 2 cm. Many patients with gastroesophageal reflux disease (GERD) require hiatal hernia repair. This study examined the safety and efficacy when repairing defects in 2 anatomical structures (hiatus and lower esophageal sphincter) in a concomitant set of procedures in patients with hiatal hernias between 2 and 5 cm. Methods. Prospective data were collected from 99 patients who underwent hiatal hernia repair followed immediately by the TIF procedure (HH + -TIF). GERD-HRQL (Health-Related Quality of Life), RSI (Reflux Symptom Index), and GERSS (Gastroesophageal Reflux Symptom Score) questionnaires were administered before the procedure and mailed at 6 and 12 months. Results. Ninety-nine patients were enrolled, and all were symptomatic on PPI medications with hiatal hernias between 2 and 5 cm. Overall baseline GERD-HRQL scores indicated daily bothersome symptoms. At 12-month follow-up, median GERD-HRQL scores improved by 17 points, indicating that subjects had no bothersome symptoms. The median GERSS scores decreased from 25.0 at baseline to 1.0 and 90% of subjects reported having effective symptom control (score <18) at 12 months. Seventy-seven percent of subjects reported effective control of laryngopharyngeal reflux (LPR) symptoms at 12 months with an RSI score of 13 or less. At 12 months, 74% of subjects reported that they were not using proton pump inhibitors. All measures were statistically improved at P < .05. There were no adverse effects reported. Conclusion. HH + TIF provides significant symptom control for heartburn and regurgitation with no long-term dysphagia or gas bloat normally associated with traditional antireflux procedures. Most patients reported durable symptom control and satisfaction with health condition at 12 months.

Tu1106 EVALUATION OF THE LEARNING CURVE FOR TRANSORAL INCISIONLESS FUNDOPLICATION: A SINGLE CENTER EXPERIENCE

Transoral incisionless fundoplication (TIF) is an emerging technology, offering a minimally invasive option of the management of symptomatic reflux. We sought to define the learning curve associated with this procedure. Retrospective chart review was performed on patients who underwent TIF by a single therapeutic endoscopist between November 2016 and November 2017. Demographic information and pre- and post-procedure HRQL scores were collected. The TIF procedure involved insertion of the Esophyx device into the esophagus followed by deployment of H shaped fasteners across the distal esophagus and fundus of the stomach to create a 270-degree wrap and lengthening of the valve. Procedure times and number of fasteners per procedure were recorded and tested for structural break using STATA version 15.1. Fastener times were also measured by dividing procedure time by the number of fasteners, since there was variability in the number of fasteners applied in each procedure. Linear regression was performed to evaluate the association between fastener times and experience. There were a total of 14 patients who underwent TIF for management of symptomatic reflux during the study period with 4 males (28.6%). The average age of patients was 56.6±10.6 years. The average number of fasteners used was 17.8. Average procedure time was 42.7±8.3 minutes. There was no break point identified with structural break analysis. There was a linear decrease in procedure time with increased experience, but this was not statistically significant (p=0.0751). No break point was identified with average fastener time, but linear regression analysis showed that average clip time was negatively associated with experience (p=0.0096). As experience grows, more fasteners can be applied in a shorter period of time, suggesting that use of the device becomes less cumbersome over time. There were no complications associated with the procedure. Patients’ HRQL score significantly decreased from 31.8±11.4 pre-procedure to 3.2±2.8 post-procedure (p=0.0026). Our analysis suggests that increased experience with the TIF procedure improves efficiency with handling the EsophyX device. More fasteners can be deployed in shorter periods of time. The procedure is safe and effective at improving quality of life in patients with symptomatic reflux.

Endoscopic Fundoplication: Effectiveness for Controlling Symptoms of Gastroesophageal Reflux Disease.

Transoral incisionless fundoplication (TIF) is a completely endoscopic approach to treat gastroesophageal reflux disease (GERD). We previously reported our initial results demonstrating safety and early effectiveness. We now present an updated experience describing outcomes with longer follow-up. For a three-year period, TIF procedures were performed on 80 patients. Preoperative workup routinely consisted of contrast esophagram and manometry. PH testing was reserved for patients with either atypical symptoms or typical symptoms unresponsive to proton-pump inhibitors (PPIs). Heartburn severity was longitudinally assessed using the GERD health-related quality of life index. Safety analysis was performed on all 80 patients, and an effectiveness analysis was performed on patients with at least 6-month follow-up. Mean procedure time was 75 minutes. There were seven (8.75%) grade 2 complications and one (1.25%) grade 3 complication (aspiration pneumonia). The median length of stay was 1 day (mean, 1.4). Forty-one patients had a minimum of 6-month of follow-up (mean, 24 months; range, 6-68 months). The mean satisfaction scores at follow-up improved significantly from baseline (P < 0.001). Sixty-three percent of patients had completely stopped or reduced their PPI dose. Results were not impacted by impaired motility; however, the presence of a small hiatal hernia or a Hill grade 2/4 valve was associated with reduced GERD health-related quality of life scores postoperatively. At a mean follow-up of 24 months, TIF is effective. Although symptoms and satisfaction improved significantly, many patients continued to take PPIs. Future studies should focus on longer-term durability and comparisons with laparoscopic techniques.

Evolution and Outcome of Eight Patients Undergoing Treatment of Gastroesophageal Disease by Esophyx

Background: Gastroesophageal reflux disease (GERD) is arguably the most common disease encountered by the gastroenterologist. It is mainly caused by defects in the lower esophageal sphincter (LES) that induces spontaneous transient LES relaxations (tLESRs). This is a chronic condition with typical and atypical, sometimes troublesome manifestations requiring long term treatment. Anti-reflux surgery is an alternative option. The TIF (transoral incisionless fundoplication) procedure by offering some advantages over surgery could be recommended for patients whose symptoms recur upon discontinuation of the medications. This study intended to assess the safety and efficacy of TIF for treating GERD. Methods: A prospective trial was conducted at Lebanese Hospital Geitaoui University Medical Center and Middle East Institute of Health in Lebanon, on 8 patients, age 28-55 years, with chronic GERD, symptoms (>5 years), undergoing EsophyX procedure and followed for 1 year after their procedure. Information concerning the patients was gathered using an international questionnaire (GERD-HRQL, Health Related Quality of Life questionnaire) filled by the treating physician. Results: When compared to scores before TIF and without medications, the GERD-HRQL scores were significantly reduced one year after the procedure. Regurgitation experienced was reduced to 62.5% compared to 75% while patients were off PPI. Symptoms free (GERD-HRQL score ≤ 12) achieving complete cessation of medications, were reported by 25% of patients. Overall 37.5% of patients were satisfied, 12.5% neutral, and 50% less satisfied with their results.

Two-Year Outcomes Post-Transoral Incisionless Fundoplication for Gastroesophageal Reflux Disease

Introduction: GERD is one of the most prevalent gastrointestinal disorders in the United States. Transoral incisionless fundoplication (TIF) has emerged as an endoscopic treatment for a subset of patients with chronic gastroesophageal reflux disease (GERD) who do not obtain adequate symptom relief with PPI's. Long-term comparison to Nissen fundoplication and proton pump inhibitor therapy deserves further evaluation. Methods: We used the Optum healthcare database to determine overall resource utilization including costs for hospitalizations, outpatient visits and PPI therapy. Standardized costs were used for inpatient and outpatient visits and pharmacologic therapy. We used the Charlson co-morbidity index (CCI) to estimate patient co-morbidities. Standard CPT codes were used for Nissen. Since there was no CPT code for TIF, we verified cases by review of hospital records. Combined Nissen+hiatal hernia repair (HHR) were excluded, but cases involving TIF+HHR were included. We collected outcomes over a 2-year period post-therapy. 3-way ANOVA testing was performed. Results: The cohort consisted of a total of 13,293 patients of whom 10,486 were on high-dose PPI therapy, 2,734 underwent Nissen, and 73 patients had the TIF procedure. The mean CCI scores scores were higher for the PPI cohort (1.4±0.02 for PPI, 0.95±1.4 for Nissen and 0.86±0.13 for TIF, p=0.00). Table 1 demonstrates utilization of medication and outpatient visits pre- and post-therapy. At two years post-TIF, healthcare utilization and total health care costs were decreased for the TIF cohort. There were no differences comparing TIF and Nissen cohorts. As shown in Table 2 and Figure 1, median costs increased during the 1st year post-index when the endoscopic or surgical therapy was performed (median cost $9,031 for the PPI cohort per patient compared to $29,151 for the Nissen cohort and $26,196 for the TIF patients). These healthcare costs were normalized based on U.S. geographic region and procedure/treatment type. During the 2nd year, these costs were significantly decreased for the TIF cohort. Limitations of the analysis include the short time period post-TIF and small number of patients with available follow-up information.Figure 1Table 1: Record of Median Utilization Pre and Post-ProcedureTable 2: Median Costs at 24 Months Per CohortConclusion: At two years post-therapy, total costs decreased overall for the TIF cohort and healthcare utilization was reduced. The outcomes post-TIF appear to be comparable to those post-Nissen.Figure 2

Symptomatic Outcomes and Safety of Combined Transoral Incisionless Fundoplication and Laparoscopic Hiatal Hernia Repair

Introduction: Transoral incisionless fundoplication (TIF) has been shown to improve symptomatic outcomes in chronic refractory GERD. However, patients with large hiatal hernias have typically been excluded due to difficulty in endoscopic reduction. Data is limited on the use of combined TIF with laparoscopic hiatal hernia repair. We aimed to evaluate the symptomatic outcomes and safety of hybrid TIF. Methods: TIFs performed using EsophyX device from February 1, 2011 to December 31, 2014 were evaluated for patient demographics, prior studies (EGD, pH study, and manometry), size of hiatal hernia, and post-procedure complications. Typical and atypical reflux symptoms before and after TIF were retrospectively assessed using 3 validated questionnaires: Gastroesophageal Reflux Disease-Health related Quality of Life (GERD-HQRL), Reflux Symptom Index (RSI), and Gastroesophageal Reflux Symptom Score (GERSS). Results: 19 TIF procedures were reviewed, with 10 standard and 9 hybrid procedures performed. The average age was 49 years with 58% males. The average body mass index was 28. The average size of the hiatal hernia longitudinally in the standard and hybrid groups was 0.5 cm and 3.2 cm, respectively (p < 0.01). The mean GERD-HQRL score improved significantly in both the standard (27.4 to 10.9, p < 0.01) and hybrid group (22.4 to 5.2, p < 0.01). The mean RSI score improved significantly in both the standard (15.3 to 7.2, p < 0.02) and hybrid group (12.1 to 3.4, p < 0.04). The mean GERSS score improved significantly in both the standard (32.4 to 6.7, p < 0.01) and hybrid group (24.7 to 4.9, p < 0.01). There were no major complications in either group. Conclusion: Transoral incisionless fundoplication with concurrent laparoscopic hiatal hernia repair is safe and effective in improving symptoms of refractory GERD. Hybrid TIF may be a less invasive option compared to Nissen fundoplication for patients with large hiatal hernias.

Measurement of Esophagogastric Junction Distensibility May Assist in Selecting Patients for Endoluminal Gastroesophageal Reflux Disease Surgery: Author's Reply.

TO THE EDITOR: We thank the author for his interest in our manuscript.1,2 During the transoral incisionless fundoplication (TIF) procedure, a retractor is anchored at the esophagogastric junction (EGJ) after which tension is applied to advance the EGJ caudally.3,4 Therefore, we agree that lengthening of the EGJ is a substantial mode of action of the TIF procedure. In addition, transmural placement of polypropylene fasteners creates an endoluminal fundoplication through permanent serosa-to-serosa or serosa-to-muscularis fusion with tightening of the distal esophagus, which decreases EGJ diameter and distensibility. 5,6 Therefore, we believe that EGJ distensibility can be an important parameter for evaluation of endoluminal gastroesophageal reflux disease (GERD) surgery like the TIF procedure, although we agree that the immediate decrease in EGJ distensibility after the TIF procedure might be the consequence of postoperative edema.7 It is important to note that consensus is lacking with regard to analysis of parameters obtained from EndoFLIP measurements. According to the most widely accepted approach, EGJ distensibility is assessed based on the narrowest cross sectional area and corresponding intra-bag pressure. Standardized methods to evaluate the change in EGJ length with the EndoFLIP technique are still to be defined. Therefore, we anticipate that development of more extensive biomechanical measures will result in more accurate interpretation of EndoFLIP data. In the present study, we used the EndoFLIP technique in the preoperative diagnostic work-up to predict postoperative outcome. Recent studies highlight that the EndoFLIP technique could be used as an intra-operative quality tool during either anti-reflux or achalasia surgery.8,9 Teitelbaum et al10 described that the EndoFLIP technique is able to guide laparoscopic Heller myotomy and peroral esophageal myotomy to obtain an ideal postoperative EGJ distensibility with regard to both postoperative achalasia and reflux symptoms. In addition, Perretta et al8 provided observational data about the change in EGJ distensibility and diameter during different stages of laparoscopic Nissen fundoplication. In the future, the EndoFLIP method could potentially be used during laparoscopic fundoplication to prevent creation of a hypercompetent valve with associated postoperative symptoms (eg, dysphagia or gas bloating).8 It therefore appears that the EndoFLIP technique has considerable potential as an intra-operative tool. On the other hand, currently available methodologies limit its role with regards to the assessment of EGJ distensibility in the preoperative diagnostic work-up or in post-procedure evaluation of patients undergoing endoluminal GERD surgery like TIF. Additional research is necessary to define the role of the EndoFLIP technique for both the preoperative work-up and tool for intraoperative calibration.

Measurement of Esophagogastric Junction Distensibility May Assist in Selecting Patients for Endoluminal Gastroesophageal Reflux Disease Surgery.

TO THE EDITOR: I read with interest the study by Smeets et al,1 who evaluated the association between pre-operative distensibility measurements and objective and clinical outcomes after transoral incisionless fundoplication (TIF) surgery. The study concluded that distensibility measurements have no added value in the pre-operative diagnostic work-up or in the post-procedure evaluation of endoluminal anti-reflux therapy. This study adds to a growing body of literature,2–9 which in general suggests that there is little benefit in the use of any of the standard gastrodiagnostic methods to predict post-surgical outcomes in gastroesophageal reflux disease (GERD) surgery. The outcomes of such functional surgery are operator and technique dependent, producing highly variable gastroesophageal junction (GEJ) constructs.10 It is therefore questionable whether the geometry of the GEJ pre-surgery alone could be reasonably expected to predict how the GEJ will perform post-surgically. However the authors, in my view, have made an important contribution in addressing a question of significant clinical importance, namely as to whether a pre-operative measurement can help stratify patients who might reasonably benefit from a lower risk transoral GERD procedure versus, for example, a laparoscopic fundoplication. Using criteria of a distensibility cut-off value of 2.3 mm2/mmHg (measured at 30 mL distension volume) combined with acid exposure time < 11%, they noted that 94% of the patients meeting these combined pre-operative criteria had normalized acid exposure time at 6 months after TIF surgery. On a technical note, I would question whether distensibility is a measurement best suited for the evaluation of TIF procedure itself. Distensibility is calculated by dividing the minimum cross sectional area of the GEJ by balloon distending pressure. Observational experience of the TIF procedure would suggest that the mode of action of the EsophyX device serves to lengthen the high pressure zone as distinct from tightening it. This mode of action is somewhat different from the clear barrier to distension of the GEJ created during cruroplasty, or with an external wrap. I would alternatively hypothesize that the immediate post-operative tightening presented in Table 4 may be due to intra-procedural edema which has resolved by the time the 6-month measurement was taken. In conclusion, I would disagree that distensibility measurements have no added value in the pre-operative diagnostic work-up, but believe that they may offer an important adjunctive measurement to assist a surgeon decide whether a more minimally invasive approach to GERD surgery should be offered to a patient.

Real-time measurement of luminal compliance during transoral incisionless fundoplication

A 71-year-old woman who had a family history of esophageal cancer presented with symptoms of chronic heartburn. The patient expressed interest in definitive treatment, declining long-term medical therapy and opting to undergo transoral incisionless fundoplication (TIF) ([Fig. 1]). This was accomplished by using the EsophyX Device (EndoGastric Solutions, San Mateo, California, USA). Before and after the TIF procedure, an EndoFLIP Endolumenal Functional Lumen Imaging Probe (Crospon, Carlsbad, California, USA) was used to measure the luminal compliance and high pressure zone of the gastroesophageal junction. EndoFLIP utilizes impedance planimetry technology to measure the geometry and physical properties of hollow lumina. The patient was observed for 24 hours after the procedure and was discharged in a stable condition.

Revisional laparoscopic antireflux surgery after unsuccessful endoscopic fundoplication

Transoral incisionless fundoplication (TIF), a novel endoscopic procedure for treating gastroesophageal reflux disease (GERD), currently is under evaluation. In case of treatment failure, subsequent revisional laparoscopic antireflux surgery (rLARS) may be required. This study aimed to evaluate the feasibility, safety, and outcomes of revisional antireflux surgery after previous endoscopic fundoplication. Chronic GERD patients who underwent rLARS after a previous TIF procedure were included in the study. Pre- and postoperative assessment included GERD-related quality-of-life scores, proton pump inhibitor (PPI) usage, 24-h pH-metry, upper gastrointestinal endoscopy, and registration of adverse events. Revisional laparoscopic Nissen fundoplication was feasible for all 15 patients included in the study without conversions to open surgery. Acid exposure of the distal esophagus improved significantly after rLARS, and esophagitis, PPI usage, and hiatal hernia decreased. Quality of life did not improve significantly after rLARS, and 33 % of the patients experienced dysphagia. Revisional laparoscopic Nissen fundoplication was feasible and safe after unsuccessful endoscopic fundoplication, resulting in objective reflux control at the cost of a relatively high rate of dysphagia.

Three-Year Results of a Multicenter Prospective Study of Transoral Incisionless Fundoplication

To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry. Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years. The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.

A Prospective Multicenter Registry of Patients with Chronic Gastroesophageal Reflux Disease Receiving Transoral Incisionless Fundoplication

This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings. Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures at 10 centers were enrolled in this prospective, open-label, multicenter, single-arm study. Symptom improvement and objective outcomes of TIF were analyzed at 6-month follow-up. One hundred TIF procedures were performed. No complications were reported. Median GERD symptom duration was 9 years (range 1 to 35 years) and median duration of proton pump inhibitor (PPI) use was 7 years (1 to 20 years). Maximal medical therapy resulted in incomplete symptom control for 92% of patients; GERD Health-Related Quality of Life (GERD-HRQL) total score was normalized in 73%. Median heartburn and regurgitation scores improved significantly, from 18 (range 0 to 30) and 15 (range 0 to 30) on PPIs before TIF to 3 (range 0 to 25) and 0 (range 0 to 25), respectively; p < 0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p < 0.001. Eighty percent of patients were completely off PPIs after TIF vs 92% of patients on PPIs before TIF. Preoperative factors associated with clinical outcomes were less severe heartburn (total GERD-HRQL ≤ 30, p = 0.02) and the presence of esophagitis (p < 0.02). Transoral incisionless fundoplication is safe and effective in multiple community-based settings in the treatment of medically refractory GERD, as demonstrated by an absence of complications, excellent symptom relief, and complete cessation of PPIs at 6-month follow-up.

Effectiveness of a transluminal endoscopic fundoplication for the treatment of pediatric gastroesophageal reflux disease

Although laparoscopic Nissen fundoplication is the standard surgical treatment for gastroesophageal reflux disease (GERD), surgical complications and post-operative pain are not uncommon, especially for those patients who are neurologically impaired (NI) or undergoing re-operative procedures. To address this challenge, we utilized the transoral incisionless fundoplication (TIF) procedure to treat GERD via an endoscopic approach. Eleven TIF patients were included with an average age of 16.5 ± 5.1 years and weight of 45.7 ± 13.3 kg. NI was present in nine patients (82%), including a predominant number of patients with a history of seizures and gastrostomy tube feeding. Five patients had a history of a previous failed fundoplication requiring a re-operative procedure (45%). A retrospective chart review evaluated patient outcomes and post-operative complications. The length of the TIF procedure was 113.3 ± 31.3 min with minimal blood loss. The length of stay was 1.2 ± 0.4 days, although one TIF patient was re-admitted for endoscopic clipping for gastric bleeding. At a follow-up of 8.2 ± 4.2 months, TIF effectively resolved GERD in 10 out of 11 children. A few of the patient's families reported complaints of gagging or dysphagia (30%, 3/11); however it was difficult to determine if complaints were due the procedures itself or baseline NI. All patients who had a follow-up upper GI or pH probe study showed no evidence of reflux. One TIF patient had no recurrent reflux but required an esophago-gastric disconnection for retching. The TIF procedure can complement the current surgically and medically available options for children with GERD, especially in complicated patients such as those with NI. However, complications including hemorrhage emphasize the potential risk of the procedure. Further studies with more patients and a longer follow-up course must be conducted to better assess efficacy.