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Resting pressure of lower esophageal sphincter (LES) determined by manometry before and after the EsophyX-TIF procedure
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A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux dis...
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Laparoscopic Nissen fundoplication (LNF) is a commonly performed procedure for the treatment of gastro esophageal reflux disease (GERD) worldwide. However, unfavourable postoperative sequel, including gas bloat and dysphagia, has encouraged surgeons to perform alternative procedures such as laparoscopic Toupet fundoplication (LTF). This prospective...
Antireflux surgery (ARS) for gastroesophageal reflux disease (GERD) is one of the most frequently performed major operations in children. Many studies have described the results of ARS in children, however, with a wide difference in outcome. This study aims to systematically review the efficacy of pediatric ARS and its effects on gastroesophageal f...
Achalasia is an esophageal motility disorder of unknown cause, characterised by aperistalsis of the esophageal body and impaired lower esophageal sphincter relaxation. Patients present at all ages, primarily with dysphagia for solids/liquids and bland regurgitation. The diagnosis is suggested by barium esophagram or endoscopy and confirmed by esoph...
Recent studies have suggested that both laparoscopic and open anti-reflux surgery may produce regression of Barrett's mucosa. MATERIAL AND METHODS;: We reviewed 21 patients (13M: 8F, mean age 46.7±3.18 years) with documented Gastroesophageal Reflux Disease (GERD) and Non-dysplastic Barrett's esophagus (15 patients ?3 cm segment, 6 patients < 3 cm s...
Incontinence or hypercontinence of the fundic wrap depends primarily on the length of the valve or the type of procedure. Much less attention has been paid to the fundic wrap length. This study aimed to compare the effectiveness of two different wrap lengths among the patients undergoing partial or total fundoplication.
For this study, 153 patients...
Citations
... Long-term PPI use can lead to adverse effects including, but not limited to, osteoporosis, pneumonia, hypomagnesemia, acute kidney injury, dementia, and infections [4,5]. Several anatomical correction techniques have been developed to treat GERD symptoms through the reshaping of the lower esophageal sphincter (LES) [6][7][8][9][10]. Four such techniques are Nissen fundoplication (NF), transoral incisionless fundoplication (TIF), anti-reflux mucosectomy (ARMS), and Resection and Plication (RAP). ...
... acute kidney injury, dementia, and infections [4,5]. Several anatomical correction techniques have been developed to treat GERD symptoms through the reshaping of the lower esophageal sphincter (LES) [6][7][8][9][10]. Four such techniques are Nissen fundoplication (NF), transoral incisionless fundoplication (TIF), anti-reflux mucosectomy (ARMS), and Resection and Plication (RAP). ...
... The TIF procedure is a minimally invasive, FDA-approved, endoscopic procedure also utilized to treat chronic GERD. The procedure entails creating a 270-degree esophagogastric wrap to anchor around the esophagus [8,9]. Over a period of a few years, the wrap created during the NF and TIF procedures can become loose, resulting in a recurrence of GERD symptoms [12,13]. ...
Background: Nissen Fundoplication (NF) and Transoral Incisionless Fundoplication (TIF) are established procedures for the treatment of gastroesophageal reflux disease (GERD). However, the surgically induced plication can loosen over time. This multicenter study aims to evaluate the safety and efficacy of Antireflux Mucosectomy (ARMS) and Resection and Plication (RAP) in symptomatic patients with prior NF or TIF that has become loose. Patients and methods: Eighteen patients were enrolled in the study. Ten had prior TIF, while eight had prior NF. Half of these patients had a Hill Grade 3 Valve while the other half had a Hill Grade 2 valve. Endoscopic submucosal dissection (ESD) was performed in six patients, while endoscopic mucosal resection (EMR) was performed in twelve patients. A follow-up endoscopy was performed at 4–12 weeks. Results: At follow-up, 11 patients had a Hill Grade 1 valve, and seven patients had a Hill Grade 2 valve. All patients had improvement in symptoms for up to 32 months. Conclusions: In this pilot study, ARMS/RAP appears to be an effective option in patients who had prior NF or TIF with recurrent GERD symptoms.
... This dosage was chosen as previous literature has demonstrated the magnitude of difference in efficacy between low-and maximal-dose omeprazole is insufficient to warrant routine twice-daily 40-mg use for GERDassociated symptoms [28,29]. The TIF 2.0 procedure was approved by the US Food and Drug Administration for the treatment of GERD in 2007, and aims to create a full-thickness esophageal valve from inside the gastric body using serosa-to-serosa plications that include the muscle layers [30][31][32]. This endoscopic treatment strategy restores the dynamics of the angle of His and involves a 270-degree wrap, different compared to a LNF, which involves the creation of a complete 360-degree wrap with an anti-reflux valve created at the fundus of the stomach. ...
Background and study aims Given the sizable number of patients with symptomatic gastroesophageal reflux disease (GERD) despite proton pump inhibitor (PPI) therapy, non-pharmacologic treatment has become increasingly utilized. The aim of this study was to analyze the cost-effectiveness of medical, endoscopic, and surgical treatment of GERD.
Patients and methods A deterministic Markov cohort model was constructed from the US healthcare payer’s perspective to evaluate the cost-effectiveness of three competing strategies: 1) omeprazole 20 mg twice daily; 2) transoral incisionless fundoplication (TIF 2.0); and 3) laparoscopic Nissen fundoplication [LNF]. Cost was reported in US dollars with health outcomes recorded in quality-adjusted life years (QALYs). Ten-year and lifetime time horizons were utilized with 3 % discount rate and half-cycle corrections applied. The main outcome was incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $ 100,000 per QALY. Probabilistic sensitivity analyses were also performed.
Results In our base-case analysis, the average cost of TIF 2.0 was $ 13,978.63 versus $ 17,658.47 for LNF and $ 10,931.49 for PPI. Compared to the PPI strategy, TIF 2.0 was cost-effective with an incremental cost of $ 3,047 and incremental effectiveness of 0.29 QALYs, resulting in an ICER of $ 10,423.17 /QALY gained. LNF was strongly dominated by TIF 2.0. Over a lifetime horizon, TIF 2.0 remained the cost-effective strategy for patients with symptoms despite twice-daily 20-mg omeprazole. TIF 2.0 remained cost-effective after varying parameter inputs in deterministic and probabilistic sensitivity analyses and for scenario analyses in multiple age groups.
Conclusions Based upon this study, TIF 2.0 was cost-effective for patients with symptomatic GERD despite low-dose, twice-daily PPI.
... The TIF procedure is an alternative method of reconstructing the gastroesophageal valve. The goal of TIF is to endoscopically restore valve function as a reflux barrier in patients with severe refractory GERD [6]. The TIF procedure is accomplished utilizing the EsophyX (EndoGastric Solutions, Inc., USA) specialized device. ...
Background: Transoral incisionless fundoplication (TIF) has been used for treating chronic gastroesophageal reflux disease (GERD) refractory to medical therapy. We aim to investigate the complications associated with TIF using a national database.
Methods: We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2011 through Jan 2021.
Results: During the study period, approximately 95 event cases reported to the FDA. Approximately 131 patient complications were identified. The number of adverse events declined from 2011 to 2016 (R2 = 0.96) but increased from 2016 to 2020 (R2 = 0.99). The most common adverse event was perforation (19.8%), followed by laceration 17.6%, bleeding (9.2%), pleural effusion (9.2%). The most common patient complications were treated using endoscopic clips (12.3%), chest tube or drain insertion (12.3%), use of endoscopic retriever device (11.1%), esophageal stent (8.6%), and emergent or open surgery (11.1%).
Conclusions: Findings from the MAUDE database suggest that TIF is associated with major adverse events. Further research is needed to develop approaches aimed at reducing patient risks
... These endoscopic techniques are aimed at approximating tissues at the esophagogastric junction (EGJ) for staple or suture. However, a low response rate has been demonstrated, and no endoscopic procedure has been widely accepted due to insufficient symptom control and cost of devices [13][14][15][16][17][18]. Inoue et al. showed that healing of EGJ mucosectomy may reduce GERD symptoms [19]. ...
Background:
Antireflux mucosectomy, a new endoscopic treatment for gastroesophageal reflux disease, consists of endoscopic mucosal resection at the esophagogastric junction. This study aim was to evaluate the medium-term efficacy of the antireflux mucosectomy technique for patients with severe gastroesophageal reflux disease symptoms (proton pump inhibitor treatment-dependent or proton pump inhibitor treatment-resistant gastroesophageal reflux disease).
Methods:
Between January 2017 and June 2018, 13 patients with severe gastroesophageal reflux disease without hiatal hernia, with positive pH reflux, were included in this monocentric prospective pilot study. The primary outcome was clinical success, defined by improvement evaluated by the Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire at 24 months. Secondary outcomes were technical success, decreased use of proton pump inhibitors, patient satisfaction, and adverse events.
Results:
Thirteen patients [females = 8 (62%)], mean age 59 (range, 54-68), were included. The antireflux mucosectomy procedure had technical success in all patients. At 24 months, for 11 patients, gastroesophageal reflux disease symptoms were significantly improved, and mean gastroesophageal reflux disease score decreased from 33 (range, 26-42) to 3 (range, 0-7) (p = 0.001). Ninety-one percent (n = 10) of patients had a lower proton pump inhibitor intake at 24 months. One patient had 3 endoscopic balloon dilatations for EGJ stenosis, two patients had melena ten days after procedure, and seven patients had thoracic or abdominal pain. Patient's satisfaction at 24 months was 81%.
Conclusions:
In patients with severe gastroesophageal reflux disease, despite occurrence of several short-term adverse events, antireflux mucosectomy seemed effective in improving gastroesophageal reflux disease symptoms at 24 months. This trial is registered with ClinicalTrials: NCT03357809.
... However, alternative treatments for gastroesophageal reflux disease (GERD) have emerged over the last 15 years, including transoral incisionless fundoplication (TIF). It is a safe and effective minimally invasive endoscopic technique for the management of GERD in selected patients with small hiatal hernias ≤ 2 cm and small diaphragmatic defects (Hill grade 1-2) [4][5][6][7]. Introduced in 2005, TIF is an endoscopic procedure that creates a flap valve with full-thickness serosa-serosa plications of the esophagus and gastric cardia, with the aim of restoring the angle of His, similar to a surgical partial fundoplication [6,8]. Multiple randomized controlled clinical trials report resolution of troublesome regurgitation not responding to proton pump inhibitor (PPI) therapy in the majority of patients treated with TIF [4,5,[9][10][11][12]. ...
... It is a safe and effective minimally invasive endoscopic technique for the management of GERD in selected patients with small hiatal hernias ≤ 2 cm and small diaphragmatic defects (Hill grade 1-2) [4][5][6][7]. Introduced in 2005, TIF is an endoscopic procedure that creates a flap valve with full-thickness serosa-serosa plications of the esophagus and gastric cardia, with the aim of restoring the angle of His, similar to a surgical partial fundoplication [6,8]. Multiple randomized controlled clinical trials report resolution of troublesome regurgitation not responding to proton pump inhibitor (PPI) therapy in the majority of patients treated with TIF [4,5,[9][10][11][12]. ...
... It would be interesting to study the learning curve of different specialties and experience levels, such as trainees, general surgeons, specialized foregut surgeons, and therapeutic endoscopists. Second, our study included TIF data on a limited number of patients, but our sample size of 72 TIF procedures approaches or exceeds that in some multicenter randomized controlled trials where TIF was performed by more than one operator [5,6,12,28]. Finally, we report the learning curve for TIF only considering proficiency and efficiency. ...
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 18th to 20th procedure. The maximum efficiency for performing a plication was achieved after the 26th procedure, when mean time per plication decreased to 2.7 from 5.1 minutes (P < 0.0001). TIF procedures time varied until the 44th 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.
... 22 TIF has been shown to significantly decrease the rate of symptoms and PPI use in patients complaining of GER. 23,24 Although there have been no studies showing this technique used after a Heller myotomy, it has been performed successfully after peroral endoscopic myotomy procedures 25 . Some studies suggest that TIF is equivalent to a Dor fundoplication but remains inferior to a Nissen fundoplication. ...
Background and objectives:
The primary aim of this study is to assess the necessity of fundoplication for reflux in patients undergoing Heller myotomy for achalasia. The secondary aim is to assess the safety of the robotic approach to Heller myotomy.
Methods:
This is a single institution, retrospective analysis of 61 patients who underwent robotic Heller myotomy with or without fundoplication over a 4-year period (January 1, 2015 - December 31, 2019). Symptoms were evaluated using pre-operative and postoperative Eckardt scores at < 2 weeks (short-term) and 4 - 55 months (long-term) postoperatively. Incidence of gastroesophageal reflux and use of antacids postoperatively were assessed. Long-term patient satisfaction and quality of life (QOL) were assessed with a phone survey. Finally, the perioperative safety profile of robotic Heller myotomy was evaluated.
Results:
The long-term average Eckardt score in patients undergoing Heller myotomy without fundoplication was notably lower than in patients with a fundoplication (0.72 vs 2.44). Gastroesophageal reflux rates were lower in patient without a fundoplication (16.0% vs 33.3%). Additionally, dysphagia rates were lower in patients without a fundoplication (32.0% vs 44.4%). Only 34.8% (8/25) of patients without fundoplication continued use of antacids in the long-term. There were no mortalities and a 4.2% complication rate with two delayed leaks.
Conclusion:
Robotic Heller myotomy without fundoplication is safe and effective for achalasia. The rate of reflux symptoms and overall Eckardt scores were low postoperatively. Great patient satisfaction and QOL were observed in the long term. Our results suggest that fundoplication is unnecessary when performing Heller myotomy.
... A total score !8 is suggestive of GERD. 21 In the present study and according to recommendations, 21 patients with GERD HRQL score !8 received additional examinations including esogastroscopy and gastric biopsies to detect H pylori. With regard to this procedure, we studied the relationship between GERD (symptoms and esogastroscopy), H pylori infection, and some CRSnNP findings including SNOT-20 (t0, t1, t2), Lund and Mackay score (t0, t1), immediate or late recurrence, and FESS. ...
... A total score !8 is suggestive of GERD. 21 In the present study and according to recommendations, 21 patients with GERD HRQL score !8 received additional examinations including esogastroscopy and gastric biopsies to detect H pylori. With regard to this procedure, we studied the relationship between GERD (symptoms and esogastroscopy), H pylori infection, and some CRSnNP findings including SNOT-20 (t0, t1, t2), Lund and Mackay score (t0, t1), immediate or late recurrence, and FESS. ...
Objectives:
To compare the 2 long-term medical strategies in chronic rhinosinusitis without nasal polyps (CRSnNP) and to identify the role of gastroesophageal reflux disease (GERD) and Helicobacter pylori as factors of treatment failure.
Material and methods:
Fifty-seven patients with CRSnNP were randomized into 2 therapeutic groups. The first group was treated with 4 weeks of amoxicillin/clavulanate and a short course of oral steroids. The second group received 8 weeks of clarithromycin. Sinonasal Outcome Test-20 (SNOT-20) and Lund and Mackay scores were assessed at baseline and after treatment, and GERD Health-Related Quality of Life (GERD-HRQL) questionnaire was evaluated in all patients. Patients with a GERD-HRQL score >8 received esogastroscopy and H pylori detection. Patients were followed during a 10-year period for clinical course and GERD evolution. The 10-year evolution of patients was described in terms of recurrence, medical, and surgical treatments.
Results:
Thirty-seven patients completed the study; SNOT-20 and Lund and Mackay scores similarly improved in both groups. Amoxicillin/clavulanate group had significantly more adverse reactions than the clarithromycin group (P = .03). After the therapeutic course, 35% (amoxicillin/clavulanate) and 41% (clarithromycin) of patients needed functional endoscopic sinus surgery (FESS). During the long-term follow-up, 54% (amoxicillin/clavulanate) and 40% (clarithromycin) of patients had late CRSnNP recurrence; FESS was performed in less than 15% of cases of recurrence. Gastroesophageal reflux disease complaint's severity was associated with late recurrence of CRSnNP.
Conclusion:
Amoxicillin/clavulanate and clarithromycin would be competitive treatments for CRSnNP. Gastroesophageal reflux disease seems to be a negative factor for treatment response and recurrence.
... undergone TIF 1.0, and over 22,000 patients have undergone TIF 2.0. Initial studies by Cadière et al. [44][45][46] using the first generation of the EsophyX device performed the ELF procedure. The authors demonstrated considerable safety and efficacy that remained unchanged at 6 and 12-month follow-up. ...
Purpose of review
Endoscopic intervention is one of the therapeutic modalities that are currently available for GERD. Endoscopic treatment for GERD has been recently positioned as an alternative for chronic medical therapy or anti-reflux surgery. Patients who are candidates for these procedures include those with typical symptoms of GERD, low-grade erosive esophagitis (Los Angeles A and B), abnormal esophageal acid exposure if normal endoscopy, small hiatal hernia (< 3 cm), and partial or complete response to PPI treatment. This review will highlight the present and emerging data available about current and new endoscopic therapeutic modalities for GERD.
Recent findings
Presently, there are three endoscopic techniques that are approved for GERD, including the Stretta procedure, transoral incisionless fundoplication (TIF), and Medigus ultrasonic surgical endostapler (MUSE). Overall, all endoscopic techniques for GERD have reported excellent control of GERD-related symptoms, improvement of health-related quality of life, durability, and safety. However, the quality of evidence to support these claims varies greatly from one procedure to the other. Furthermore, there is an important discrepancy between improvement of subjective clinical parameters versus objective clinical parameters. There is a growing interest in positioning the endoscopic techniques in patient’s post-bariatric surgery, after peroral endoscopic myotomy (POEM), and in those who also require hiatal hernia repair. There are several new endoscopic interventions for GERD that are currently under investigation.
Summary
Endoscopic techniques are currently part of our therapeutic armamentarium for GERD. Criticism about their limited effect on objective clinical endpoints has tempered the enthusiasm of patients and physicians alike about their therapeutic value. However, endoscopic therapy for GERD is here to stay as more patients are looking for alternatives to medical and surgical therapy.
... 3 Treatment TIF was performed under general anesthesia with complete muscle relaxation in the main operating room (95%) or endoscopy suite (5%). We have previously described the technique, 12 complete upper endoscopy re-evaluated for appropriateness for TIF procedure. No patients in this report underwent concomitant hiatal hernia repair. ...
Goals
To assess the long-term results of transoral incisionless fundoplication (TIF 2).
Background
TIF with the EsophyX2 is an accepted procedure to treat gastroesophageal reflux disease (GERD). Long-term data have been limited. We report clinical outcomes of 151 patients followed up to 9 years.
Study
A single institution prospective registry of patients undergoing TIF 2 between 11/2008 and 7/2015. Outcomes were assessed by complications, re-interventions, and a mixed effect model of clinical response over time.
Results
A total of 151 patients (87 women), mean age 62 years (30–91), mean body mass index (BMI) 26.6 (20–36.1), 93% on daily proton pump inhibitor (PPI), underwent TIF 2 without hiatal hernia repair; 131 of the 151 patients (86%) were available for follow-up at a median of 4.92 years (0.7–9.7 years). Of 120 patients ⩾5 years post-TIF, 62 (51%) were followed for a median 6.8 years. Median GERD-health-related quality of life (HRQL) scores decreased from 21 (interquartile range (IQR) 9.5–30) off PPI and 14 (4–24) on PPI at baseline to 4 (2–8) at 4.92 years and remained at 5 (2–9) in the 62 patients 5–9 years post-TIF. Sixty-four per cent had successful (>50%) reductions in GERD-HRQL scores at 4.92 years and 68% of patients followed ⩾5 years. Median regurgitation decreased from 15 (8–20) off PPI and 11 (5–20) on PPI at baseline to 0 (0–4) at 4.92 years, remaining at 1 (0–3) in 62 patients 5–9 years post-TIF. Mixed model analyses confirmed significant and stable improvements in GERD-HRQL and regurgitation scores at all annual follow-up time points after TIF. Daily PPI use decreased from 93% to 32% at 4.92, and 22% at ⩾5 years post-TIF. Revision to laparoscopic fundoplication in 33(22%) showed comparable outcomes. Two patients recovered uneventfully after laparoscopic surgery for localized perforation.
Conclusions
TIF 2 provides durable relief of GERD symptoms at up to 9 years with 69–80% of patients having a successful outcome by symptom response and PPI use.
... 97 Transoral incisionless fundoplication (TIF) is an endoluminal antireflux intervention option for GERD, particularly in cases without significant disruption of the antireflux barrier. 98,99 Bariatric surgery is the mainstay surgical option for patients with GERD and obesity. By the nature of the procedure, bypass surgery leads to a decreased size of the stomach cavity, which limits acid production by reducing the area of acid-producing parietal cells and intraabdominal pressure by promoting weight loss. ...
Gastroesophageal reflux disease (GERD) is a disorder due to the retrograde flow of refluxate into the esophagus. Although GERD is a common clinical diagnosis, its pathogenesis is quite complex. As a result of its multifactorial development, many patients continue to experience adverse symptoms due to GERD despite prolonged acid suppression with proton pump inhibitor therapy. The pathogenesis of GERD involves an interplay of chemical, mechanical, psychologic, and neurologic mechanisms, which contribute to symptom presentation, diagnosis, and treatment. As such, GERD should be approached as a disorder beyond acid. This review will investigate the major factors that contribute to the development of GERD, including factors related to the refluxate, esophageal defenses, and factors that promote pathologic reflux into the esophagus. In reviewing GERD pathogenesis, this paper will highlight therapeutic advances, with mention of future opportunities of study when approaching GERD.
