Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study (original) (raw)
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Journal of the American College of Surgeons, 2012
BACKGROUND: 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. STUDY DESIGN: 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. RESULTS: 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 Ͻ 0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p Ͻ 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 Յ 30, p ϭ 0.02) and the presence of esophagitis (p Ͻ 0.02). CONCLUSIONS: 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.
Diseases of the Esophagus, 2016
Transoral incisionless fundoplication (TIF) using the EsophyX device has been shown to be effective and safe in patients with Gastroesophageal reflux disease (GERD); however, the subset of patients that would mostly benefit from this technique remains unknown. The aim of this study was to evaluate the long-term efficacy and safety of the TIF procedure in patients with a history of esophagitis or proven chronic GERD who have achieved symptom control with the administration of proton pump inhibitors (PPIs) but did not wish to continue receiving medications for life. Forty-five patients with typical GERD symptoms (heartburn, regurgitation, chest pain) and a history of esophagitis grade A and B or proven GERD by esophageal pH monitoring underwent TIF using Esophyx. Patients with eosphagitis C and D or those with large hiatal hernias (>2 cm in length) were excluded. The primary clinical effectiveness measure was GERD symptom elimination at follow up based on normalization of the GERD health related quality of life (GERD-HRQL) questionnaire. After a median follow up period of 59 months (36-75) the median GERD-HRQL scores improved significantly from 27 (2-45) at baseline to 4 (0-26) (P < 0.001) in the 44 patients completing the study. Heartburn was eliminated in 12 out of the 21 patients included (57.1%), regurgitation was eliminated in 15 out of the 17 patients included (88.2%) and finally chest pain was eliminated in 5 patients out of the six patients included (83.3%). Overall, 32 patients out of the 44 patients (72.7%) that completed the study follow up reported elimination of their main symptom, without the need for PPI administration (none PPI usage). Furthermore, six more patients (13.6%), five with heartburn, and one with regurgitation reported half PPI dose taken for <50% of the preceding follow up period (occasional PPI usage), while six more patients (four with heartburn, one with regurgitation, and one with chest pain) reported full or half PPI dose taken for more than 50% of the preceding follow up period (daily PPI usage). Creation of an esophagogastric fundoplication using the EsophyX device abolished reflux symptoms in 72.7% of PPI-responsive GERD patients at a median 59 month follow-up.
Journal of Gastrointestinal Surgery, 2010
Background Transoral incisionless fundoplication (TIF) using the EsophyX™ system has been introduced as a possible alternative for the treatment of gastroesophageal reflux disease (GERD). The efficacy of this procedure in our centers was evaluated. Methods Patients were selected for treatment if they had typical GERD symptoms, failed management with proton pump inhibitors (PPIs), a positive esophageal pH test with symptom correlation, and no hiatus hernia larger than 2 cm. Results Nineteen patients (11 men, 8 women) underwent the TIF procedure between April 2008 and July 2009. Mean age was 48.2 years and body mass index was 24.6. The major complication rate was 3/19, including esophageal perforation, hemorrhage requiring transfusion, and permanent numbness of tongue. At mean 10.8 months follow-up, 5/19 had completely discontinued PPIs, and 3/19 had decreased their PPI dose. However, 10/19 had been converted to laparoscopic fundoplication for recurrent reflux symptoms and an endoscopically confirmed failed valve. Nine of 17 were dissatisfied with the outcome, and eight were satisfied. Thirteen of 19 (68%) were considered to have been unsuccessful. Conclusion At short-term follow-up, the TIF procedure is associated with an excessive early symptomatic failure rate, and a high surgical re-intervention rate. This procedure should not be performed outside of a clinical trial.
Surgical Endoscopy, 2012
Background Transoral incisionless fundoplication is a recently introduced endoluminal technique for the treatment of gastroesophageal reflux disease (GERD). The objective of this study was to determine outcomes in chronic GERD patients who were referred for surgical management. Methods A cohort of 38 patients underwent transoral incisionless fundoplication (TIF) in a tertiary care setting. Pre-and post-procedure assessment included GERD-related quality of life questionnaires, proton pump inhibitor (PPI) usage, 24-h pH measurements, upper gastrointestinal endoscopy, esophageal manometry, and registration of adverse events. Duration of follow-up was 36 months. Results Gastroesophageal valves were constructed of 4 cm (range, 4-6) in length and 220°(range, 180-240) in circumference. One serious adverse event occurred, consisting of intraluminal bleeding at a fastener site. Hiatal hernia was completely reduced in 56 % and esophagitis was cured in 47 % of patients. Postprocedure esophageal acid exposure did not significantly improve (p [ 0.05). At 36 (range, 29-41) months follow-up 14 patients (36 %) had undergone revisional laparoscopic fundoplication. Quality of life scores of the remaining cohort showed significant improvement (p \ 0.0001) and daily use of antisecretory medication was discontinued by 74 %. Conclusions Endoluminal fundoplication improved quality of life and reduced the need for PPIs in only a subgroup of patients at 3 years follow-up. The amount of patients requiring additional medication and revisional surgery was high.
Surgical Endoscopy, 2012
Background A retrospective study evaluated safety, symptom resolution, patient satisfaction, and medication use 1-2 years after transoral incisionless fundoplication (TIF) in patients with gastroesophageal reflux disease (GERD) and/or laryngopharyngeal reflux (LPR) symptoms. Methods Thirty-four patients with a confirmed diagnosis of GERD symptoms that were inadequately controlled by antisecretory medications, and who where either dissatisfied with their current therapy or not willing to continue taking medication, underwent TIF using EsophyX at our community-based hospital. Follow-up assessments were completed in 28 patients. Results Median age of the study group was 57 (range = 23-77) years, BMI was 25.7 (18.3-36.4) kg/m 2 , and 50% were female. All patients had documented chronic GERD for a median 5 (1-20) years and refractory symptoms to proton pump inhibitors (PPIs). Hiatal hernia was present in 75% (21/28) of patients, and 21% (6/28) had erosive esophagitis (LA grade A or B). TIF was performed following a standardized TIF-2 protocol and resulted in reducing hiatal hernia and restoring the natural anatomy of the gastroesophageal (GE) junction (Hill grade I). There were no postoperative complications. At a median 14-months follow-up, 82% (23/28) of patients were off daily PPIs (64% completely off PPIs), and 68% (19/28) were satisfied with their current health condition compared to 4% before TIF. Median GERD Health-Related Quality of Life scores were significantly reduced to 4 (0-25) from 26 (0-45) before TIF (P \ 0.001). Heartburn was eliminated in 65% (17/26) and improved by [50% in 86% (24/28) of patients. Regurgitation was eliminated in 80% (16/20) of patients. Atypical LPR symptoms such as hoarseness, coughing, and throat clearing were eliminated in 63% (17/27) of patients as measured by Reflux Symptom Index scores. Conclusion Our results in 28 patients confirm the safety and effectiveness of TIF, documenting symptomatic improvement of GERD and LPR symptoms and clinically significant discontinuation of daily PPIs in 82% of patients.
World Chinese Journal of Digestology, 2010
Background & Aims: The effects of transoral incisionless fundoplication (TIF) and laparoscopic Nissen fundoplication (LNF) have been compared with those of proton pump inhibitors (PPIs) or a sham procedure in patients with gastroesophageal reflux disease (GERD), but there has been no direct comparison of TIF vs LNF. We performed a systematic review and network meta-analysis of randomized controlled trials to compare the relative efficacies of TIF vs LNF in patients with GERD. Methods: We searched publication databases and conference abstracts through May 10, 2017 for randomized controlled trials that compared the efficacy of TIF or LNF with that of a sham procedure or PPIs in patients with GERD. We performed a network meta-analysis using Bayesian methods under random-effects multiple treatment comparisons. We assessed ranking probability by surface under the cumulative ranking curve. Results: Our search identified 7 trials comprising 1128 patients. Surface under the cumulative ranking curve ranking indicated TIF had highest probability of increasing patients' health-related quality of life (HRQOL; 0.96), followed by LNF (0.66), a sham procedure (0.35), and PPIs (0.042). LNF had the highest probability of increasing percent time at pH<4 (0.99), followed by PPIs (0.64), TIF (0.32), and the sham procedure (0.05). LNF also had the highest probability of increasing LES pressure (0.78), followed by TIF (0.72) and PPIs (0.01). Patients who underwent the sham procedure had the had the highest probability for persistent esophagitis (0.74), followed by those receiving TIF (0.69), LNF (0.38), and PPIs (0.19). Meta-regression showed a shorter follow-up time as a significant confounder for the outcome of HRQOL in studies of TIF.
Gastroenterology, 2018
Background & Aims: The effects of transoral incisionless fundoplication (TIF) and laparoscopic Nissen fundoplication (LNF) have been compared with those of proton pump inhibitors (PPIs) or a sham procedure in patients with gastroesophageal reflux disease (GERD), but there has been no direct comparison of TIF vs LNF. We performed a systematic review and network meta-analysis of randomized controlled trials to compare the relative efficacies of TIF vs LNF in patients with GERD. Methods: We searched publication databases and conference abstracts through May 10, 2017 for randomized controlled trials that compared the efficacy of TIF or LNF with that of a sham procedure or PPIs in patients with GERD. We performed a network meta-analysis using Bayesian methods under random-effects multiple treatment comparisons. We assessed ranking probability by surface under the cumulative ranking curve. Results: Our search identified 7 trials comprising 1128 patients. Surface under the cumulative ranking curve ranking indicated TIF had highest probability of increasing patients' health-related quality of life (HRQOL; 0.96), followed by LNF (0.66), a sham procedure (0.35), and PPIs (0.042). LNF had the highest probability of increasing percent time at pH<4 (0.99), followed by PPIs (0.64), TIF (0.32), and the sham procedure (0.05). LNF also had the highest probability of increasing LES pressure (0.78), followed by TIF (0.72) and PPIs (0.01). Patients who underwent the sham procedure had the had the highest probability for persistent esophagitis (0.74), followed by those receiving TIF (0.69), LNF (0.38), and PPIs (0.19). Meta-regression showed a shorter follow-up time as a significant confounder for the outcome of HRQOL in studies of TIF.
The American Journal of Surgery, 2011
BACKGROUND: A retrospective community-based study evaluated the safety and symptomatic outcomes of the transoral incisionless fundoplication (TIF) procedure with or without hiatal hernia repair (HHR) in patients with chronic gastroesophageal reflux disease (GERD). MATERIALS AND METHODS: Forty-eight patients underwent TIF using EsophyX (EndoGastric Solutions, Redmond, WA) in 3 community hospitals. Patients who presented with a hiatal hernia 3 cm or more in the greatest transverse diameter underwent laparoscopic HHR before TIF. RESULTS: Forty-two patients completed follow-up assessment at a median of 6 (range 1-11) months. Laparoscopic HHR was performed in 18 (43%) patients before TIF. There were no long-term postoperative complications. GERD-health related quality of life scores indicated heartburn elimination in 63% of patients. The need for daily proton pump inhibitor (PPI) therapy was eliminated in 76% of patients. Atypical symptom relief measured by the median reflux symptom index score reduction was significant (5 [0-47] vs 22 [2-42] on PPIs, P Ͻ .001). CONCLUSIONS: Our results support the safety and symptomatic improvement of TIF with or without laparoscopic HHR. The patients' symptoms were significantly improved, and PPI use was significantly reduced.
JAMA Surgery, 2019
ImportanceRestoration of the esophagogastric junction competence is critical for effective long-term treatment of gastroesophageal reflux disease. Surgical repair results in such restoration, but mechanical adverse effects seem unavoidable. Minimizing these adverse effects without jeopardizing reflux control is warranted.ObjectiveTo determine whether partial fundoplication (PF) or total fundoplication (TF) is superior in laparoscopic antireflux surgery.Design, Setting, and ParticipantsIn this double-blind, randomized clinical trial of 1171 patients scheduled for laparoscopic antireflux surgery at a single university-affiliated center between November 19, 2001, and January 24, 2006, 456 patients were randomized and followed up for 5 years. Data were collected from November 2001 to April 2012, and data were analyzed from April 2012 to September 2018.InterventionsA 270° posterior PF or a 360° Nissen TF.Main Outcomes and MeasuresEsophageal acid exposure at 3 years after surgery.ResultOf the 456 randomized patients, 268 (58.8%) were male, and the mean (SD) age was 49.0 (11.7) years. A total of 229 patients were randomized to PF, and 227 patients were randomized to TF. At 3 years postoperatively, the median (interquartile range) esophageal acid exposure was reduced from 14.6% (9.8-21.9) to 1.8% (0.7-4.4) after PF and from 16.0% (10.4-22.7) to 2.5% (0.8-6.8) after TF (P = .31). Likewise, reflux symptoms were equally and effectively controlled. Early postoperative dysphagia (6 weeks) was common in both groups but then decreased toward normality. A small but statistically significant difference in favor of PF was noted in the mean (SD) scoring of dysphagia for liquids at 6 weeks (PF, 1.6 [0.9]; TF, 1.9 [1.3]; P = .01) and for solid food at 12 months (PF, 1.3 [1.0]; TF, 1.9 [1.4]; P < .001) and 24 months (PF, 1.3 [0.9]; TF, 1.7 [1.2]; P = .001). Quality of life was reduced before surgery but increased to normal values after surgery and remained so over 5-year follow-up, with no difference between the groups.Conclusions and RelevanceThe results from this randomized clinical trial suggest that although PF and TF could be recommended for treatment of gastroesophageal reflux disease, PF might be superior by inducing less dysphagia.Trial RegistrationClinicalTrials.gov identifier: {"type":"clinical-trial","attrs":{"text":"NCT03659487","term_id":"NCT03659487"}}NCT03659487
Gastroenterology, 2014
Background: The aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF. Methods: In seven United States centers, patients with hiatal hernia ≤2 cm and abnormal esophageal acid exposure (EAE) were randomized to TF (n = 40) or HD PPIs (n = 23) group. At 6-month follow-up, PPI patients underwent crossover. We assessed clinical outcomes 6-month post TF in crossover patients (COP), as compared to 6-month of HD PPI therapy, and 12-month outcomes in patients initially randomized to TF. The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index. Secondary outcomes included healing of esophagitis, normalization of EAE and PPI use after TF. We analyzed 21 COP and 39 TF patients. McNemar's test or Fisher exact test was used to compare proportions.