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Memon A, Dugan N, Muniraj T, Hinchcliff ME, Masoud A. Gastroesophageal Intussusception Treated With Combined Transoral Incisionless Fundoplication in a Patient With Systemic Sclerosis. ACG Case Rep J 2025; 12:e01632. [PMID: 40196291 PMCID: PMC11975402 DOI: 10.14309/crj.0000000000001632] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/06/2024] [Accepted: 02/04/2025] [Indexed: 04/09/2025] Open
Abstract
We present a case of a 49-year-old woman with diffuse cutaneous systemic sclerosis with refractory gastroesophageal reflux disease and dysphagia for pills and solid foods. Esophagogastroduodenoscopy revealed gastroesophageal intussusception. Despite several interventions including esophageal stent placement, dysphagia persisted. Owing to refractory severe symptoms, the patient underwent a laparoscopic hiatal hernia repair combined with endoscopic transoral incisionless fundoplication. The patient tolerated the intervention well and dysphagia resolved. Although an obscure persistent dysphagia in SSc patients, gastroesophageal intussusception should be considered. This case underscores the need for persistence in the diagnostic evaluation of gastrointestinal symptoms in patients with SSc and highlights the need for a multidisciplinary team care approach.
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Affiliation(s)
- Areeka Memon
- Section of Rheumatology, Allergy, & Immunology, Yale School of Medicine, New Haven, CT
| | - Nicholas Dugan
- Department of General Surgery, Hartford Healthcare, Hartford, CT
| | | | - Monique E. Hinchcliff
- Section of Rheumatology, Allergy, & Immunology, Yale School of Medicine, New Haven, CT
| | - Amir Masoud
- Neurogastroenterology and Motility Center, Hartford Healthcare, Hartford, CT
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Bortolotti M. Problems with repairing gut sphincters malfunctions. World J Gastrointest Surg 2024; 16:2396-2408. [PMID: 39220086 PMCID: PMC11362937 DOI: 10.4240/wjgs.v16.i8.2396] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2024] [Revised: 06/24/2024] [Accepted: 07/15/2024] [Indexed: 08/16/2024] Open
Abstract
Correcting a gut sphincter malfunction is a difficult problem. Because each sphincter has two opposite functions, that of closure and opening, repairing one there is a risk of damaging the other. Indeed, widening a narrow sphincter, such as lower esophageal sphincter (LES) and anal sphincter, may cause gastroesophageal reflux and fecal incontinence, respectively, whereas narrowing a wide sphincter, may cause a difficult transit. All the corrective treatments for difficult or retrograde transit concerning LES and anal sphincter with their unwanted consequences have been analyzed and discussed. To overcome the drawbacks of sphincter surgical repairs, researchers have devised devices capable of closing and opening the gut lumen, named artificial sphincters (ASs). Their function is based on various mechanisms, e.g., hydraulic, magnetic, mechanical etc, operating through many complicated components, such as plastic cuffs, balloons, micropumps, micromotors, connecting tubes and wires, electromechanical clamps, rechargeable batteries, magnetic devices, elastic bands, etc. Unfortunately, these structures may facilitate the onset of infections and induce a local fibrotic reaction, which may cause device malfunctioning, whereas the compression of the gut wall to occlude the lumen may give rise to ischemia with erosions and other lesions. Some ASs are already being used in clinical practice, despite their considerable limits, while others are still at the research stage. In view of the adverse events of the ASs mentioned above, we considered applying bioengineering methods to analyze and resolve biomechanical and biological interaction problems with the aim to conceive and build efficient and safe biomimetic ASs.
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Affiliation(s)
- Mauro Bortolotti
- Department of Internal Medicine and Gastroenterology, S Orsola-Malpighi Polyclinic, University of Bologna, Bologna 40138, Italy
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Randhawa N, Khalyfa A, Khan M, Roebuck C, Inam M, Ayub K. Utilization of Antireflux Mucosectomy and Resection and Plication: A Novel Approach for the Management of Recurrent Gastroesophageal Reflux Disease after Prior Nissen Fundoplication or Transoral Incisionless Fundoplication. J Clin Med 2022; 11:jcm11237141. [PMID: 36498714 PMCID: PMC9735652 DOI: 10.3390/jcm11237141] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2022] [Revised: 11/24/2022] [Accepted: 11/28/2022] [Indexed: 12/02/2022] Open
Abstract
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.
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Affiliation(s)
- Navkiran Randhawa
- Franciscan Health Olympia Fields, 20201 South, Crawford Ave, Olympia Fields, Chicago, IL 60461, USA
- Correspondence: (N.R.); (K.A.)
| | - Ahamed Khalyfa
- Franciscan Health Olympia Fields, 20201 South, Crawford Ave, Olympia Fields, Chicago, IL 60461, USA
| | - Mahnoor Khan
- Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY 10029, USA
| | | | - Mahnoor Inam
- Southwest Gastroenterology, 9921 SW Hwy, Oak Lawn, IL 60453, USA
| | - Kamran Ayub
- Silver Cross Hospital, 1900 Silver Cross Blvd, New Lenox, IL 60451, USA
- Correspondence: (N.R.); (K.A.)
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McCarty TR, Jirapinyo P, James LP, Gupta S, Chan WW, Thompson CC. Transoral incisionless fundoplication is cost-effective for treatment of gastroesophageal reflux disease. Endosc Int Open 2022; 10:E923-E932. [PMID: 35845021 PMCID: PMC9286770 DOI: 10.1055/a-1783-9378] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/14/2021] [Accepted: 10/19/2021] [Indexed: 11/17/2022] Open
Abstract
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.
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Affiliation(s)
- Thomas R. McCarty
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States,Harvard Medical School, Boston, Massachusetts, United States
| | - Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States,Harvard Medical School, Boston, Massachusetts, United States
| | - Lyndon P. James
- Center for Health Decision Science, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States,PhD Program in Health Policy, Harvard University, Cambridge, Massachusetts, United States
| | - Sanchit Gupta
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States,Harvard Medical School, Boston, Massachusetts, United States
| | - Walter W. Chan
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States,Harvard Medical School, Boston, Massachusetts, United States
| | - Christopher C. Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States,Harvard Medical School, Boston, Massachusetts, United States
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Ramai D, Shapiro A, Barakat M, Facciorusso A, Dull A, Chandan S, Adler DG. Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis. Surg Endosc 2022; 36:4956-4959. [PMID: 34750704 DOI: 10.1007/s00464-021-08851-x] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2021] [Accepted: 10/21/2021] [Indexed: 02/07/2023]
Abstract
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%), and 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 Adverse events from TIF range from mild to severe. Further research is needed to develop approaches aimed at reducing patient risks.
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Affiliation(s)
- Daryl Ramai
- Division of Gastroenterology & Hepatology, University of Utah Health, Salt Lake City, UT, USA
- Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA
| | - Alexandra Shapiro
- Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA
| | - Mohamed Barakat
- Division of Gastroenterology, The Brooklyn Hospital Center, Brooklyn, NY, USA
| | - Antonio Facciorusso
- Section of Gastroenterology, Department of Medical Sciences, University of Foggia, 71122, Foggia, Italy
| | - Adriane Dull
- Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA
| | - Saurabh Chandan
- Division of Gastroenterology & Hepatology, CHI Health Creighton University Medical Center, Omaha, NE, USA
| | - Douglas G Adler
- Center for Advanced Therapeutic Endoscopy (CATE), Porter Adventist Hospital/PEAK Gastroenterology, Denver, CO, USA.
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Evaluation of Antireflux Mucosectomy for Severe Gastroesophageal Reflux Disease: Medium-Term Results of a Pilot Study. Gastroenterol Res Pract 2022; 2022:1606944. [PMID: 35237316 PMCID: PMC8885295 DOI: 10.1155/2022/1606944] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2021] [Accepted: 01/31/2022] [Indexed: 11/24/2022] Open
Abstract
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.
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Darwish MB, Logarajah SI, Nagatomo K, Jackson T, Benzie AL, McLaren PJ, Cho E, Osman H, Jeyarajah DR. To Wrap or Not to Wrap After Heller Myotomy. JSLS 2021; 25:JSLS.2021.00054. [PMID: 34803368 PMCID: PMC8580166 DOI: 10.4293/jsls.2021.00054] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
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.
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Affiliation(s)
- Muhammad B Darwish
- Department of Surgery, Methodist Richardson Medical Center, Richardson, TX
| | | | - Kei Nagatomo
- Department of Surgery, Methodist Richardson Medical Center, Richardson, TX
| | - Terence Jackson
- Department of Surgery, Methodist Richardson Medical Center, Richardson, TX
| | | | | | - Edward Cho
- Department of Surgery, Methodist Richardson Medical Center, Richardson, TX
| | - Houssam Osman
- Department of Surgery, Methodist Richardson Medical Center, Richardson, TX
| | - D Rohan Jeyarajah
- Department of Surgery, Methodist Richardson Medical Center, Richardson, TX
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The learning curve for transoral incisionless fundoplication. Endosc Int Open 2021; 9:E1785-E1791. [PMID: 34790546 PMCID: PMC8589558 DOI: 10.1055/a-1547-6599] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2021] [Accepted: 06/22/2021] [Indexed: 11/02/2022] Open
Abstract
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.
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Lechien JR, Debie G, Mahillon V, Thill MP, Rodriguez A, Horoi M, Kampouridis S, Muls V, Saussez S. A 10-Year Follow-Up of a Randomized Prospective Study of 2 Treatments for Chronic Rhinosinusitis Without Nasal Polyps and Investigation of the Impact of Gastroeosophageal Reflux Disease in the Resistance to Treatment. EAR, NOSE & THROAT JOURNAL 2021; 100:569S-577S. [PMID: 31838920 DOI: 10.1177/0145561319892460] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022] Open
Abstract
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.
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Affiliation(s)
- Jerome R Lechien
- Department of Otolaryngology, Head and Neck Surgery, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
- Department of Anatomy and Experimental Oncology, Mons School of Medicine, 54521University of Mons, Mons, Belgium, Europe
| | - Gersende Debie
- Department of Otolaryngology, Head and Neck Surgery, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
- Department of Otolaryngology, Head and Neck Surgery, 81880CHU Saint-Luc, School of Medicine, Université Catholique de Louvain, Bruxelles, Belgium, Europe
| | - Virginie Mahillon
- Department of Otolaryngology, Head and Neck Surgery, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
| | - Marie-Paule Thill
- Department of Otolaryngology, Head and Neck Surgery, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
| | - Alexandra Rodriguez
- Department of Otolaryngology, Head and Neck Surgery, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
| | - Mihaela Horoi
- Department of Otolaryngology, Head and Neck Surgery, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
| | - Stelianos Kampouridis
- Department of Radiology, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
| | - Vinciane Muls
- Department of Gastroenterology, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
| | - Sven Saussez
- Department of Otolaryngology, Head and Neck Surgery, 81880CHU Saint-Pierre, School of Medicine, Université Libre de Bruxelles, Bruxelles, Belgium, Europe
- Department of Anatomy and Experimental Oncology, Mons School of Medicine, 54521University of Mons, Mons, Belgium, Europe
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Bell RCW, Freeman K, Heidrick R, Ayazi S. Transoral incisionless fundoplication demonstrates durability at up to 9 years. Therap Adv Gastroenterol 2021; 14:17562848211004827. [PMID: 33948113 PMCID: PMC8053838 DOI: 10.1177/17562848211004827] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/13/2021] [Accepted: 02/02/2021] [Indexed: 02/04/2023] Open
Abstract
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.
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Affiliation(s)
| | | | - Rachel Heidrick
- Institute of Esophageal and Reflux Surgery, Englewood, CO, USA
| | - Shahin Ayazi
- Allegheny Health Network Ringgold Standard Institution – Surgery, Pittsburgh, PA, USA
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Choi AY, Roccato MK, Samarasena JB, Kolb JM, Lee DP, Lee RH, Daly S, Hinojosa MW, Smith BR, Nguyen NT, Chang KJ. Novel Interdisciplinary Approach to GERD: Concomitant Laparoscopic Hiatal Hernia Repair with Transoral Incisionless Fundoplication. J Am Coll Surg 2021; 232:309-318. [PMID: 33346082 DOI: 10.1016/j.jamcollsurg.2020.11.021] [Citation(s) in RCA: 28] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2020] [Revised: 11/21/2020] [Accepted: 11/23/2020] [Indexed: 12/26/2022]
Abstract
BACKGROUND Transoral incisionless fundoplication (TIF) is an endoscopic alternative for the treatment of GERD. However, TIF does not address the hiatal hernia (HH). We present a novel approach with a laparoscopic HH repair followed by same-session TIF, coined concomitant transoral incisionless fundoplication (cTIF). The aim of this study was to assess the efficacy, safety, and feasibility of cTIF in a collaborative approach between Gastroenterology and surgery. STUDY DESIGN Patients with confirmed GERD and >2 cm HH who underwent cTIF between 2018 and 2020 were included. Symptoms were assessed using the Reflux Disease Questionnaire, GERD Health-Related Quality of Life Index, and the Reflux Symptom Index pre and post cTIF. One-way ANOVA and paired samples t-test were used for statistical analysis. RESULTS Sixty patients underwent cTIF (53% were men, mean age was 59.3 years) with 100% technical success. Mean ± SD HH measurement on endoscopy was 2.9 ± 1.5 cm. Scores on Reflux Disease Questionnaire for symptom frequency and symptom severity improved significantly from before to 6 months after cTIF (17.4 to 4.72; p < 0.01 and 16.7 to 4.56; p < 0.05, respectively). According to the GERD Health-Related Quality of Life Index, significant decreases were seen post cTIF in heartburn (23.26 to 7.37; p < 0.01) and regurgitation (14.26 to 0; p = 0.05). Reflux Symptom Index similarly decreased after cTIF (17.7 to 8.1 post cTIF; p < 0.01). Mean DeMeester score decreased from 43.7 to 4.9 and acid exposure time decreased from 12.7% to 1.28% post cTIF (p = 0.06). CONCLUSIONS We present a novel multidisciplinary approach to GERD using a combined endoscopic and surgical approach with close collaboration between Gastroenterology and surgery. Our results suggest that cTIF is safe and effective in reducing reflux symptoms in a large spectrum of GERD patients.
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Affiliation(s)
- Alyssa Y Choi
- HH Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA; Departments of Medicine, University of California, Irvine Medical Center, Orange, CA.
| | - Mary Kathryn Roccato
- HH Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA; Departments of Medicine, University of California, Irvine Medical Center, Orange, CA
| | - Jason B Samarasena
- HH Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA; Departments of Medicine, University of California, Irvine Medical Center, Orange, CA
| | - Jennifer M Kolb
- HH Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA; Departments of Medicine, University of California, Irvine Medical Center, Orange, CA
| | - David P Lee
- HH Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA; Departments of Medicine, University of California, Irvine Medical Center, Orange, CA
| | - Robert H Lee
- HH Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA; Departments of Medicine, University of California, Irvine Medical Center, Orange, CA
| | - Shaun Daly
- Departments of Surgery, University of California, Irvine Medical Center, Orange, CA
| | - Marcelo W Hinojosa
- Departments of Surgery, University of California, Irvine Medical Center, Orange, CA
| | - Brian R Smith
- Departments of Surgery, University of California, Irvine Medical Center, Orange, CA
| | - Ninh T Nguyen
- Departments of Surgery, University of California, Irvine Medical Center, Orange, CA
| | - Kenneth J Chang
- HH Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA; Departments of Medicine, University of California, Irvine Medical Center, Orange, CA
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12
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Huynh P, Konda V, Sanguansataya S, Ward MA, Leeds SG. Mind the Gap: Current Treatment Alternatives for GERD Patients Failing Medical Treatment and Not Ready for a Fundoplication. Surg Laparosc Endosc Percutan Tech 2020; 31:264-276. [PMID: 33347088 PMCID: PMC8154178 DOI: 10.1097/sle.0000000000000888] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2020] [Accepted: 10/05/2020] [Indexed: 01/08/2023]
Abstract
BACKGROUND Gastroesophageal reflux disease is associated with Barrett esophagus, esophageal adenocarcinoma, and significantly impacts quality of life. Medical management is the first line therapy with surgical fundoplication as an alternative therapy. However, a small portion of patients who fail medical therapy are referred for surgical consultation. This creates a "gap" in therapy for those patients dissatisfied with medical therapy but are not getting referred for surgical consultation. Three procedures have been designed to address these patients. These include radiofrequency ablation (RFA) of the lower esophageal sphincter, transoral incisionless fundoplication (TIF), and magnetic sphincter augmentation. MATERIALS AND METHODS A Pubmed literature review was conducted of all publications for RFA, TIF, and MSA. Four most common endpoints for the 3 procedures were compared at different intervals of follow-up. These include percent of patients off proton pump inhibitors (PPIs), GERD-HRQL score, DeMeester score, and percent of time with pH <4. A second query was performed for patients treated with PPI and fundoplications to match the same 4 endpoints as a control. RESULTS Variable freedom from PPI was reported at 1 year for RFA with a weighted mean of 62%, TIF with a weighted mean of 61%, MSA with a weighted mean of 85%, and fundoplications with a weighted mean of 84%. All procedures including PPIs improved quality-of-life scores but were not equal. Fundoplication had the best improvement followed by MSA, TIF, RFA, and PPI, respectively. DeMeester scores are variable after all procedures and PPIs. All MSA studies showed normalization of pH, whereas only 4 of 17 RFA studies and 3 of 11 TIF studies reported normalization of pH. CONCLUSIONS Our literature review compares 3 rival procedures to treat "gap" patients for gastroesophageal reflux disease with 4 common endpoints. Magnetic sphincter augmentation appears to have the most reproducible and linear outcomes but is the most invasive of the 3 procedures. MSA outcomes most closely mirrors that of fundoplication.
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Affiliation(s)
- Phuong Huynh
- Division of Minimally Invasive Surgery, Baylor University Medical Center
- Center for Advanced Surgery, Baylor Scott & White Health
| | - Vani Konda
- Center for Esophageal Diseases, Baylor University Medical Center, Dallas
| | | | - Marc A. Ward
- Division of Minimally Invasive Surgery, Baylor University Medical Center
- Center for Advanced Surgery, Baylor Scott & White Health
- Texas A&M College of Medicine, Bryan, TX
| | - Steven G. Leeds
- Division of Minimally Invasive Surgery, Baylor University Medical Center
- Center for Advanced Surgery, Baylor Scott & White Health
- Texas A&M College of Medicine, Bryan, TX
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13
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Sharma P, Yadlapati R. Pathophysiology and treatment options for gastroesophageal reflux disease: looking beyond acid. Ann N Y Acad Sci 2020; 1486:3-14. [PMID: 33015827 DOI: 10.1111/nyas.14501] [Citation(s) in RCA: 59] [Impact Index Per Article: 11.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/19/2020] [Revised: 08/24/2020] [Accepted: 09/01/2020] [Indexed: 12/14/2022]
Abstract
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.
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Affiliation(s)
- Priya Sharma
- Department of Medicine, University of California San Diego School of Medicine, La Jolla, California
| | - Rena Yadlapati
- Division of Gastroenterology, University of California San Diego School of Medicine, Center for Esophageal Diseases, La Jolla, California
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14
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Patil G, Dalal A, Maydeo A. Feasibility and outcomes of anti-reflux mucosectomy for proton pump inhibitor dependent gastroesophageal reflux disease: First Indian study (with video). Dig Endosc 2020; 32:745-752. [PMID: 31834663 DOI: 10.1111/den.13606] [Citation(s) in RCA: 28] [Impact Index Per Article: 5.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2019] [Accepted: 12/10/2019] [Indexed: 02/08/2023]
Abstract
BACKGROUND Anti-reflux mucosectomy (ARMS) is a newfangled minimally invasive technique, with successful outcomes for the management of gastroesophageal reflux (GER). We present our initial experience (success rate) and safety profile for this procedure. METHODS Consecutive patients with daily dependence on proton pump inhibitor (PPI) for GER were prospectively enrolled from September 2016 to August 2019 and underwent ARMS using a cap assisted endoscopic mucosal resection. Severity was assessed by gastroesophageal reflux disease questionnaire. Gastroscopy and 24-h pH-metry was done pre and post procedure. Patient characteristics, PPI requirement, adverse events and follow-up were documented. RESULTS Sixty-two patients [44 (71%) male] underwent successful ARMS with a mean age (SD) of 36 (9.9) years. Technical success was achieved in 100 % of patients. Intraoperative bleeding was noted in 62 (100%) patients, endoscopic hemostasis was successfully achieved. At follow-up dysphagia was seen in 5 (8%) patients which needed a single session of endoscopic dilation. At 2 months, mean (SD) DeMeester score normalized in 45 (72.5%) patients from 76.8 (18.3) to 14.3 (6.1) (P < 0.001). PPI could be stopped in 43 (69.4%) patients. The mean (SD) GERD-Q score reduced from 10.6 (1.9) to 3.4 (1.5) (P < 0.001). However, in 12 (19.3%) patients low dose of PPIs was continued, while 7 (11.3%) patients continued full dose. Thirty-eight (61.3%) patients telephonically reported symptomatic improvement and were off PPIs at 12 months. CONCLUSIONS Anti-reflux mucosectomy is safe and effective for treatment of GER. The long term outcomes are favorable, response is durable and promising at our center. Appropriate patient selection still remains primal to the overall success of ARMS.
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Affiliation(s)
- Gaurav Patil
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, India
| | - Ankit Dalal
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, India
| | - Amit Maydeo
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, India
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15
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Ihde GM. The evolution of TIF: transoral incisionless fundoplication. Therap Adv Gastroenterol 2020; 13:1756284820924206. [PMID: 32499834 PMCID: PMC7243382 DOI: 10.1177/1756284820924206] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/26/2019] [Accepted: 04/15/2020] [Indexed: 02/04/2023] Open
Abstract
Transoral incisionless fundoplication (TIF) was introduced in 2006 as a concerted effort to produce a natural orifice procedure for reflux. Since that time, the device, as well as the procedure technique, has evolved. Significant research has been published during each stage of the evolution, and this has led to considerable confusion and a co-mingling of outcomes, which obscures the results of the current device and procedure. This report is intended to review the identified stages and literature associated with each stage to date and to review the current state of treatment outcomes.
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16
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Endoscopic GERD therapy: a primer for the transoral incisionless fundoplication procedure. Gastrointest Endosc 2019; 90:370-383. [PMID: 31108091 DOI: 10.1016/j.gie.2019.05.028] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2019] [Accepted: 05/11/2019] [Indexed: 02/06/2023]
Abstract
Patients with medically refractory GERD have the option of surgery but may opt for effective minimally invasive interventions, when available. However, the primary GERD pharmacologic therapy, proton pump inhibitors, does not satisfactorily address the pathophysiology of the disease. Moreover, a therapeutic gap exists in those severely symptomatic patients who fail medical management and who are poor candidates for surgical fundoplication. Recently, a revival of minimally invasive endoscopic interventions aiming to correct the antireflux barrier has followed existing device modifications, enhancing their safety and efficacy profile. Of these technologies, the trans-oral incisionless fundoplication (TIF) technique, in its current 2.0 iteration, has been studied in several randomized controlled trials with favorable outcomes and a low rate of adverse events. In this review, we discuss the landscape of endoscopic GERD therapy, focusing on recent updates in the TIF 2.0 procedure with the EsophyX-Z device (EndoGastricSolutions, Redmond, Wash, USA). We discuss the evolution, differences, and improvements in this technique across different generations of the EsophyX device. We also present a framework for candidate selection, based on medical and anatomic considerations. When streamlined within a milieu of comprehensive multidisciplinary programs, these improved endoscopic interventions can provide viable avenues for a carefully selected patients population, bridging therapy gaps, and selectively targeting the primary pathophysiology of the disease.
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17
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Ihde GM, Pena C, Scitern C, Brewer S. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. JSLS 2019; 23:JSLS.2018.00087. [PMID: 30675094 PMCID: PMC6333564 DOI: 10.4293/jsls.2018.00087] [Citation(s) in RCA: 27] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
Background and Objectives Transoral incisionless fundoplication is an alternative to traditional laparoscopic fundoplications. Recently, hiatal hernia repair combined with transoral incisionless fundoplication has become an accepted modification of the original procedure; however, outcomes information, particularly objective pH monitoring, has been sparse. We retrospectively review the subjective and objective outcomes of transoral incisionless fundoplication combined with hiatal hernia repair. Methods Ninety-seven consecutive patients presenting for reflux evaluation were reviewed for outcomes after evaluation and treatment. Fifty-five patients proceeded to hiatal hernia repair with transoral incisionless fundoplication. Twenty-nine patients (53%) were found to have matched preoperative and postoperative validated surveys and pH evaluations. Results There were no serious complications. The mean followup was 296 days (SD, 117 days). The mean Gastroesophageal Reflux Disease Health Related Quality of Life score improved from 33.7 (SD, 22.0) to 9.07 (SD, 13.95), P < .001. The mean Reflux Symptom Index score improved from 20.32 (SD, 13) to 8.07 (SD, 9.77), P < .001. The mean pH score improved from 35.3 (SD, 2.27) to 10.9 (SD, 11.5), P < .001. Twenty-two of the 29 patients were judged to have an intact hiatal repair with transoral incisionless fundoplication (76%). Of the 22 patients with an intact hiatal repair and intact fundoplication, 21 (95%) had normalized their pH exposure. Conclusions In this retrospective review, hiatal hernia repair combined with transoral incisionless fundoplication significantly improved outcomes in patients with gastroesophageal reflux disease in both subjective Gastroesophageal Reflux Disease Health Related Quality of Life and Reflux Symptom Index measurements as well as in objective pH scores.
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Affiliation(s)
- Glenn Michael Ihde
- Department of Surgery, San Angelo Community Medical Center, San Angelo, TX 76904, USA
| | - Catalina Pena
- Department of Surgery, San Angelo Community Medical Center, San Angelo, TX 76904, USA
| | - Christy Scitern
- Department of Surgery, San Angelo Community Medical Center, San Angelo, TX 76904, USA
| | - Steve Brewer
- Department of Surgery, San Angelo Community Medical Center, San Angelo, TX 76904, USA
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18
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Bell R, Lipham J, Louie B, Williams V, Luketich J, Hill M, Richards W, Dunst C, Lister D, McDowell-Jacobs L, Reardon P, Woods K, Gould J, Buckley FP, Kothari S, Khaitan L, Smith CD, Park A, Smith C, Jacobsen G, Abbas G, Katz P. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointest Endosc 2019; 89:14-22.e1. [PMID: 30031018 DOI: 10.1016/j.gie.2018.07.007] [Citation(s) in RCA: 70] [Impact Index Per Article: 11.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/18/2018] [Accepted: 07/11/2018] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. METHODS One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. RESULTS Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P < .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD-health-related quality of life scores (P < .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (P < .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia. CONCLUSION Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.).
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Affiliation(s)
- Reginald Bell
- Institute of Esophageal and Reflux Surgery, Englewood, Colorado, USA
| | - John Lipham
- Department of Surgery, University of Southern California, Los Angeles, California, USA
| | - Brian Louie
- Swedish Cancer Institute and Medical Center, Seattle, Washington, USA
| | | | - James Luketich
- University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA
| | - Michael Hill
- Adirondack Surgical Group, Saranac Lake, New York, USA
| | | | | | - Dan Lister
- Arkansas Heartburn Treatment Center, Heber Springs, Arkansas, USA
| | | | | | | | - Jon Gould
- Medical College of Wisconsin, Milwaukee, Wisconsin, USA
| | | | | | - Leena Khaitan
- University Hospitals, Cleveland, Cleveland, Ohio, USA
| | | | - Adrian Park
- Anne Arundel Health System, Annapolis, Maryland, USA
| | | | - Garth Jacobsen
- University of California, San Diego, San Diego, California, USA
| | - Ghulam Abbas
- West Virginia University School of Medicine, Morgantown, West Virginia, USA
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Lall C, Cruz AA, Bura V, Rudd AA, Bosemani T, Chang KJ. What the radiologist needs to know about gastrointestinal endoscopic surgical procedures. Abdom Radiol (NY) 2018; 43:1482-1493. [PMID: 28983652 DOI: 10.1007/s00261-017-1318-x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
Natural orifice transluminal endoscopic surgery (NOTES) is a novel surgical approach, currently performed for an array of conditions. Endoscopic procedures offer significant benefits, including lower cost, no surgical incisions, and shorter hospital stays. These advantages align with the current trends in health care, namely a push for "cost-effective care." There are a multitude of health issues which are now being addressed by the endoscopic surgical approach, including peroral endoscopic myotomy (POEM), which is a relatively new technique used in the treatment of achalasia. Endoscopic treatment utilized for GERD includes transoral incisionless fundoplication. Endoscopic bariatric surgical procedures include intragastric balloon placement, endoscopic sleeve gastroplasty, and revision of prior bariatric procedures including Roux-en-Y gastric bypass and conventional gastric sleeve procedures. Endoscopic clips are routinely utilized for achieving hemostasis, treating iatrogenic gastric and bowel ulcerations and perforations and for the closure of enteric fistulization. Novel endoscopic procedures are now replacing conventional surgery due to their non-invasive nature, faster recovery and lower healthcare costs. Radiologists need to understand how these procedures are performed, as well as expected post-procedural imaging appearance and potential complications.
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Affiliation(s)
- Chandana Lall
- Department of Radiological Sciences, University of California, Irvine, 101 The City Dr South, Bldg 1, Suite 0115, Orange, CA, 92868, USA
| | - Anastasia A Cruz
- Department of Radiological Sciences, University of California, Irvine, 101 The City Dr South, Bldg 1, Suite 0115, Orange, CA, 92868, USA
| | - Vlad Bura
- Department of Radiology, Clinical Emergency Hospital, Cluj County, 3-5 Clinicilor, Cluj-Napoca, 400006, Cluj County, Romania.
| | - Adam A Rudd
- Department of Radiological Sciences, University of California, Irvine, 101 The City Dr South, Bldg 1, Suite 0115, Orange, CA, 92868, USA
| | - Thangavijayan Bosemani
- Department of Radiological Sciences, University of California, Irvine, 101 The City Dr South, Bldg 1, Suite 0115, Orange, CA, 92868, USA
| | - Kenneth J Chang
- Division of Gastroenterology & Hepatology, Department of Medicine, University of California, Irvine, 3rd Floor, 101 The City Dr South, Bldg 23, Orange, CA, 92868, USA
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Anti-reflux procedures: complications, radiologic findings, and surgical and gastroenterologic perspectives. Abdom Radiol (NY) 2018; 43:1308-1318. [PMID: 29302737 DOI: 10.1007/s00261-017-1446-3] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
This article provides an overview of the current surgical anti-reflux procedures and their imaging findings, as well as the surgical complications. Accurate and timely clinical assessment requires an engaged radiologist fluoroscopist who understands the perspectives of their interdisciplinary colleagues, including the surgeon and gastroenterologist. The complex pathophysiology calls for an interdisciplinary approach, and the radiologist needs to tailor their evaluation to answer the specific questions posed by their clinical colleagues and by the presenting symptomatology.
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21
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Puri R, Smith CD, Bowers SP. The Spectrum of Surgical Remediation of Transoral Incisionless Fundoplication-Related Failures. J Laparoendosc Adv Surg Tech A 2018; 28:1089-1093. [PMID: 29768079 DOI: 10.1089/lap.2018.0063] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
AIM To evaluate outcomes of surgical remediation for symptomatic or anatomic failure after a transoral incisionless fundoplication (TIF). METHODS This retrospective study was performed on 11 patients who underwent a remedial operation following TIF failure between June 2011 and September 2016 at the Mayo Clinic in Florida for persistent foregut symptoms. Upper gastrointestinal workup characterized 1 patient as having normal post-TIF anatomy and 10 as having anatomic failure. Ambulatory pH testing was performed in 7 patients and was abnormal in all. All patients underwent a laparoscopic takedown of the prior endoscopic fundoplication and removal of all accessible polypropylene T-fasteners. RESULTS All patients had esophageal salvage and have not required a reoperation. Anatomical findings included hiatal hernia (7), esophageal diverticulum (2), hiatal mesh erosion of esophagus (1), long-segment esophageal stricture (1), and normal anatomy (1). Remedial operations included laparoscopic explant of fasteners in all patients with conversion to fundoplication (7), resection/imbrication of esophageal diverticulum (2), Heller myotomy (1), and mesh explant and complex esophageal repair (1). Mean operative time was 177 minutes and median length of stay 3 days (range 2-13 days). At mean follow-up of 10.7 months (range 1-42 months), 7 patients had persistent complaints. Esophagogastroduodenoscopy was repeated in these 7 patients and was normal (n = 3), mild stenosis requiring dilation (n = 2), Los Angeles grade B esophagitis (n = 1), and Barrett's esophagus (n = 1). CONCLUSION Anatomic distortion of the distal esophagus after TIF can be significant, making subsequent operations complex. After remedial surgery, few patients will continue to have troublesome symptoms such as dysphagia.
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Affiliation(s)
- Ruchir Puri
- 1 Department of Surgery, University of Florida , Jacksonville, Florida
| | | | - Steven P Bowers
- 3 Department of Surgery, Mayo Clinic , Jacksonville, Florida
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22
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Weitzendorfer M, Spaun GO, Antoniou SA, Witzel K, Emmanuel K, Koch OO. Clinical feasibility of a new full-thickness endoscopic plication device (GERDx™) for patients with GERD: results of a prospective trial. Surg Endosc 2018; 32:2541-2549. [PMID: 29602998 PMCID: PMC5897467 DOI: 10.1007/s00464-018-6153-9] [Citation(s) in RCA: 30] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2017] [Accepted: 03/21/2018] [Indexed: 01/08/2023]
Abstract
Background Previous studies suggest clinical effectiveness of endoscopic full-thickness plication in selected patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the clinical safety and efficiency of the GERDx™ device by evaluating clinical parameters, reflux symptom scores, and quality of life (QoL). Methods Prospective one-arm trial evaluating the outcome of forty patients with GERD subjected to endoscopic plication with the GERDx™ device. We included patients with at least one typical reflux symptom despite treatment with a PPI for > 6 months, pathologic esophageal acid exposure, hiatal hernia of size < 2 cm, and endoscopic Hill grade II–III. Evaluation of Gastrointestinal Quality of Life Index (GIQLI), symptom scores, esophageal manometry, and impedance-pH-monitoring were performed at baseline and at 3 months after surgery. (Trial Registration: ClinicalTrials.gov NCT 01798212.) Results There were no intraoperative complications. Four out of forty patients experienced postoperative complications requiring intervention. Seven of forty patients were subjected to laparoscopic fundoplication 3 months after endoscopic plication due to persistent symptoms and were lost to further follow-up. Thirty out of forty patients were available at 3-month follow-up. There was an improvement of the GIQLI score, from a mean of 92.45 ± 18.47 to 112.03 ± 13.11 (p < 0.001). The general reflux-specific score increased from a mean of 49.84 ± 24.83 to 23.93 ± 15.63 (p < 0.001), and the DeMeester score from a mean of 46.48 ± 30.83 to 20.03 ± 23.62 (p < 0.001). There was no significant change in manometric data after intervention. Three of thirty patients continued daily antireflux medication. Conclusions Endoscopic plication with the GERDx™ device reduced distal acid exposure of the esophagus, reflux-related symptoms, and improved GIQLI scores with minimal side effects in a selected cohort of patients and may be a safe alternative in the treatment of GERD.
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Affiliation(s)
| | - Georg O Spaun
- Department of Surgery, Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria
| | | | - Kai Witzel
- Department of Surgery, Paracelsus Medical University, 5020, Salzburg, Austria.,Minimal Invasiv Center, Hersfelder Strasse 1, 36088, Huenfeld, Germany
| | - Klaus Emmanuel
- Department of Surgery, Paracelsus Medical University, 5020, Salzburg, Austria
| | - Oliver O Koch
- Department of Surgery, Paracelsus Medical University, 5020, Salzburg, Austria
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Endoscopic Fundoplication: Effectiveness for Controlling Symptoms of Gastroesophageal Reflux Disease. INNOVATIONS-TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY 2018; 12:180-185. [PMID: 28296655 DOI: 10.1097/imi.0000000000000351] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
Abstract
OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.
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Trad KS, Barnes WE, Prevou ER, Simoni G, Steffen JA, Shughoury AB, Raza M, Heise JA, Fox MA, Mavrelis PG. The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective. Surg Innov 2018; 25:149-157. [PMID: 29405886 PMCID: PMC5946656 DOI: 10.1177/1553350618755214] [Citation(s) in RCA: 92] [Impact Index Per Article: 13.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0. METHODS A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated. RESULTS Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P < .001). CONCLUSION In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.
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Affiliation(s)
- Karim S Trad
- 1 The George Washington University School of Medicine and Health Science, Washington, DC, USA.,2 The George Washington University Medical Faculty Associates, Washington, DC, USA
| | - William E Barnes
- 3 Livingston Hospital and Healthcare Services, Inc, CAH, Salem, KY, USA
| | - Elizabeth R Prevou
- 2 The George Washington University Medical Faculty Associates, Washington, DC, USA
| | - Gilbert Simoni
- 4 Advanced Gastroenterology, Inc, Thousand Oaks, CA, USA
| | - Jennifer A Steffen
- 2 The George Washington University Medical Faculty Associates, Washington, DC, USA
| | - Ahmad B Shughoury
- 5 Saint Mary Medical Center, Hobart, IN, USA.,6 Internal Medicine Associates, Merrillville, IN, USA
| | - Mamoon Raza
- 7 Indiana Medical Research, Elkhart, IN, USA.,8 Unity Surgical Hospital, Mishawaka, IN, USA
| | | | - Mark A Fox
- 10 Crossville Medical Group, Crossville, TN, USA.,11 Cumberland Medical Center, Crossville, TN, USA
| | - Peter G Mavrelis
- 5 Saint Mary Medical Center, Hobart, IN, USA.,6 Internal Medicine Associates, Merrillville, IN, USA
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Interim Report of a Prospective Trial on the Clinical Efficiency of a New Full-thickness Endoscopic Plication Device for Patients With GERD: Impact of Changed Suture Material. Surg Laparosc Endosc Percutan Tech 2017; 27:163-169. [DOI: 10.1097/sle.0000000000000396] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
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Ebright MI, Sridhar P, Litle VR, Narsule CK, Daly BD, Fernando HC. Endoscopic Fundoplication. INNOVATIONS-TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY 2017. [DOI: 10.1177/155698451701200303] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Affiliation(s)
- Michael I. Ebright
- Section of Thoracic Surgery, Columbia University Medical Center, New York, NY USA
| | - Praveen Sridhar
- Division of Thoracic Surgery, Boston University School of Medicine, Boston Medical Center, Boston, MA USA
| | - Virginia R. Litle
- Division of Thoracic Surgery, Boston University School of Medicine, Boston Medical Center, Boston, MA USA
| | - Chaitan K. Narsule
- Division of Thoracic Surgery, Boston University School of Medicine, Boston Medical Center, Boston, MA USA
| | - Benedict D. Daly
- Division of Thoracic Surgery, Boston University School of Medicine, Boston Medical Center, Boston, MA USA
| | - Hiran C. Fernando
- Section of Thoracic Surgery, Inova Fairfax Hospital, Fairfax, VA USA
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Huang X, Chen S, Zhao H, Zeng X, Lian J, Tseng Y, Chen J. Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis. Surg Endosc 2017; 31:1032-1044. [PMID: 27495332 DOI: 10.1007/s00464-016-5111-7] [Citation(s) in RCA: 87] [Impact Index Per Article: 10.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2016] [Accepted: 07/11/2016] [Indexed: 12/31/2022]
Abstract
BACKGROUND The efficacy of transoral incisionless fundoplication (TIF) performed with the EsophyX device (Redmond, Washington, USA) and its long-term outcomes in gastresophageal reflux disease (GERD) are debated. We, therefore, performed a systematic review with meta-analysis of studies evaluating the role of TIF in GERD. METHODS A systematic search of EMBASE, SCOPUS, PubMed, and the Cochrane Library Central was performed. All original studies reporting outcomes in GERD patients who underwent TIF were identified. Only randomized controlled trials (RCTs) evaluating the efficacy of TIF, and prospective observational studies reporting outcomes after TIF were included. RESULTS A total of 18 studies (963 patients) published between 2007 and 2015 were identified, including five RCTs and 13 prospective observational studies. The pooled relative risk of response rate to TIF versus PPIs/sham was 2.44 (95 % CI 1.25-4.79, p = 0.0009) in RCTs in the intention-to-treat analysis. The total number of refluxes was reduced after TIF compared with the PPIs/sham group. The esophageal acid exposure time and acid reflux episodes after TIF were not significantly improved. Proton-pump inhibitors (PPIs) usage increased with time and most of the patients resumed PPIs treatment at reduced dosage during the long-term follow-up. The total satisfaction rate after TIF was about 69.15 % in 6 months. The incidence of severe adverse events consisting of gastrointestinal perforation and bleeding was 2.4 %. CONCLUSIONS TIF is an alternative intervention in controlling GERD-related symptoms with comparable short-term patient satisfaction. Long-term results showed decreased efficacy with time. Patients often resume PPIs at reduced doses in the near future.
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Affiliation(s)
- Xiaoquan Huang
- Center of Evidence-Based Medicine, Zhongshan Hospital, Fudan University, Shanghai, 200032, China
- Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, China
| | - Shiyao Chen
- Center of Evidence-Based Medicine, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
- Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
- Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
| | - Hetong Zhao
- Department of Traditional Chinese Medicine, Changhai Hospital, Shanghai, 200433, China
| | - Xiaoqing Zeng
- Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China
| | - Jingjing Lian
- Center of Evidence-Based Medicine, Zhongshan Hospital, Fudan University, Shanghai, 200032, China
- Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, China
| | - Yujen Tseng
- Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China
| | - Jie Chen
- Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China
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Stefanidis G, Viazis N, Kotsikoros N, Tsoukalas N, Lala E, Theocharis L, Fassaris A, Manolakopoulos S. Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy. Dis Esophagus 2017; 30:1-8. [PMID: 27868281 DOI: 10.1111/dote.12525] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
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.
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Affiliation(s)
| | - Nikos Viazis
- Gastroenterology Department, Evangelismos Hospital, Athens, Greece
| | | | | | - Eythymia Lala
- Gastroenterology Department, Athens Naval Hospital, Athens, Greece
| | | | - Andreas Fassaris
- Anesthesiology Department, Athens Naval Hospital, Athens, Greece
| | - Spilios Manolakopoulos
- 2nd Academic Department of Internal Medicine, Hippokration Hospital of Athens, Athens, Greece
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Abstract
For patients with gastroesophageal reflux disease (GERD) who suffer from severe symptoms despite adequate medical therapy, interventional procedures are the only option for improving symptoms and thus the quality of life. In the clinical practice it is decisive if a hiatal hernia (HH) is present or not and whether it is larger or smaller than 2-3 cm. Patients who have a HH > 2-3 cm should undergo laparoscopic fundoplication with hiatal hernia repair. Patients with a larger HH are no longer eligible for endoscopic therapy as closure of the HH is not endoscopically possible. With the new laparoscopic methods (e.g. LINX and electrical stimulation) HH closure is theoretically possible but sufficient data is lacking. Furthermore, if a hiatal closure is additionally carried out the actual advantages of these methods are partly lost. Currently, outside of clinical trials only laparoscopic fundoplication can be recommended for patients with GERD and HH, because convincing long-term data are only available for this method. It seems that in clinical practice it is not so important what type of fundoplication is performed, more important seems to be the experience of the surgeon with the technique.
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Abstract
PURPOSE OF REVIEW Transoral incisionless fundoplication (TIF) performed with the EsophyX device (Redmond, Washington, USA) is a totally endoscopic procedure with the objectives to mechanically repair a defective gastroesophageal valve and to reduce small hiatal hernias. The recent publication of randomized controlled trials and long-term follow-up data offers the opportunity to reevaluate this treatment modality and its role in the management of patients with chronic gastroesophageal reflux disease (GERD). RECENT FINDINGS Randomized controlled trials have confirmed the ability of TIF to eliminate troublesome GERD symptoms, heal esophagitis, and improve distal esophageal acid exposure in appropriately selected patient populations. These studies establish TIF's superiority to conventional medical therapy, especially in clinical scenarios where proton-pump inhibitors fail to provide complete symptom relief across the spectrum of classic and atypical GERD manifestations, including regurgitation and laryngopharyngeal reflux. Long-term data indicate sustained positive outcomes and durability up to 6 years after procedure. These results were achieved with a low rate of serious adverse events and usually without introducing troublesome dysphagia, gas bloat, or flatulence. SUMMARY Based on the most recent data, TIF appears to be a valuable treatment alternative for the management of appropriately selected patients with moderate to severe chronic GERD symptoms.
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31
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Testoni PA, Mazzoleni G, Testoni SGG. Transoral incisionless fundoplication for gastro-esophageal reflux disease: Techniques and outcomes. World J Gastrointest Pharmacol Ther 2016; 7:179-89. [PMID: 27158533 PMCID: PMC4848240 DOI: 10.4292/wjgpt.v7.i2.179] [Citation(s) in RCA: 28] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/17/2015] [Revised: 12/24/2015] [Accepted: 02/23/2016] [Indexed: 02/06/2023] Open
Abstract
Gastro-esophageal reflux disease (GERD) is a very common disorder that results primarily from the loss of an effective antireflux barrier, which forms a mechanical obstacle to the retrograde movement of gastric content. GERD can be currently treated by medical therapy, surgical or endoscopic transoral intervention. Medical therapy is the most common approach, though concerns have been increasingly raised in recent years about the potential side effects of continuous long-term medication, drug intolerance or unresponsiveness, and the need for high dosages for long periods to treat symptoms or prevent recurrences. Surgery too may in some cases have consequences such as long-lasting dysphagia, flatulence, inability to belch or vomit, diarrhea, or functional dyspepsia related to delayed gastric emptying. In the last few years, transoral incisionless fundoplication (TIF) has proved an effective and promising therapeutic option as an alternative to medical and surgical therapy. This review describes the steps of the TIF technique, using the EsophyX(®) device and the MUSE(TM) system. Complications and their management are described in detail, and the recent literature regarding the outcomes is reviewed. TIF reconfigures the tissue to obtain a full-thickness gastro-esophageal valve from inside the stomach, by serosa-to-serosa plications which include the muscle layers. To date the procedure has achieved lasting improvement of GERD symptoms (up to six years), cessation or reduction of proton pump inhibitor medication in about 75% of patients, and improvement of functional findings, measured by either pH or impedance monitoring.
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32
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Jain D, Singhal S. Transoral Incisionless Fundoplication for Refractory Gastroesophageal Reflux Disease: Where Do We Stand? Clin Endosc 2016; 49:147-56. [PMID: 26878326 PMCID: PMC4821522 DOI: 10.5946/ce.2015.044] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/10/2015] [Revised: 05/19/2015] [Accepted: 05/25/2015] [Indexed: 12/13/2022] Open
Abstract
Gastroesophageal reflux disease (GERD) is a chronic, progressive, and costly medical condition affecting a substantial proportion of the world population, predominantly the Western population. The available treatment options for patients with refractory GERD symptoms are limited to either laparoscopic surgery with significant sequelae or potentially lifelong, high-dose proton pump inhibitor therapy. The restoration of the antireflux competence of the gastroesophageal junction at the anatomic and physiologic levels is critical for the effective long-term treatment of GERD. Transoral incisionless fundoplication (TIF) surgery is a safe, well-tolerated, and effective treatment that has yielded significant symptomatic improvement in patients with medically refractory GERD symptoms. In this review article, we have summarized case series and reports describing the role of TIF for patients with gastroesophageal reflux symptoms. The reported indications, techniques, complications, and success rates are also discussed.
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Affiliation(s)
- Deepanshu Jain
- Department of Internal Medicine, Albert Einstein Medical Center, Philadelphia, PA, USA
| | - Shashideep Singhal
- Division of Gastroenterology, Hepatology and Nutrition, University of Texas Health Science Center at Houston, Houston, TX, USA
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33
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Maradey-Romero C, Fass R. Novel Upcoming Therapies. DIAGNOSIS AND TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE 2016:93-115. [DOI: 10.1007/978-3-319-19524-7_6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
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Håkansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther 2015; 42:1261-70. [PMID: 26463242 DOI: 10.1111/apt.13427] [Citation(s) in RCA: 78] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2015] [Revised: 08/08/2015] [Accepted: 09/21/2015] [Indexed: 12/13/2022]
Abstract
BACKGROUND Until recently only two therapeutic options have been available to control symptoms and the esophagitis in chronic gastro-oesophageal reflux disease (GERD), i.e. lifelong proton pump inhibitor (PPI) therapy or anti-reflux surgery. Lately, transoral incisionless fundoplication (TIF) has been developed and found to offer a therapeutic alternative for these patients. AIM To perform a double-blind sham-controlled study in GERD patients who were chronic PPI users. METHODS We studied patients with objectively confirmed GERD and persistent moderate to severe GERD symptoms without PPI therapy. Of 121 patients screened, we finally randomised 44 patients with 22 patients in each group. Those allocated to TIF had the TIF2 procedure completed during general anaesthesia by the EsophyX device with SerosaFuse fasteners. The sham procedure consisted of upper GI endoscopy under general anaesthesia. Neither the patient nor the assessor was aware of the patients' group affiliation. The primary effectiveness endpoint was the proportion of patients in clinical remission after 6-month follow-up. Secondary outcomes were: PPI consumption, oesophageal acid exposure, reduction in Quality of Life in Reflux and Dyspepsia and Gastrointestinal Symptom Rating Scale scores and healing of reflux esophagitis. RESULTS The time (average days) in remission offered by the TIF2 procedure (197) was significantly longer compared to those submitted to the sham intervention (107), P < 0.001. After 6 months 13/22 (59%) of the chronic GERD patients remained in clinical remission after the active intervention. Likewise, the secondary outcome measures were all in favour of the TIF2 procedure. No safety issues were raised. CONCLUSION Transoral incisionless fundoplication (TIF2) is effective in chronic PPI-dependent GERD patients when followed up for 6 months. Clinicaltrials.gov: CT01110811.
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Affiliation(s)
- B Håkansson
- Department of Surgery, Ersta Hospital, Karolinska Institutet, Danderyds Hospital, Stockholm, Sweden
| | - M Montgomery
- Department of Surgery, Ersta Hospital, Karolinska Institutet, Danderyds Hospital, Stockholm, Sweden
| | - G B Cadiere
- Department of Surgery and Gastroenterology, Park Leopold Clinic, CHIREC, Brussels, Belgium
| | - A Rajan
- Department of Surgery and Gastroenterology, Park Leopold Clinic, CHIREC, Brussels, Belgium
| | | | - M Lerhun
- CHU Hotel Dieu Institut des Maladies de l' Appareil Digestif, Nantes, France
| | - E Coron
- CHU Hotel Dieu Institut des Maladies de l' Appareil Digestif, Nantes, France
| | - J Tack
- Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium
| | - R Bischops
- Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium
| | - A Thorell
- Department of Surgery, Ersta Hospital, Karolinska Institutet, Danderyds Hospital, Stockholm, Sweden
| | - U Arnelo
- Department of Surgery, Centre for Digestive Diseases, Karolinska University Huddinge Hospital, Karolinska Institutet, Stockholm, Sweden
| | - L Lundell
- Department of Surgery, Centre for Digestive Diseases, Karolinska University Huddinge Hospital, Karolinska Institutet, Stockholm, Sweden
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Smeets FGM, Keszthelyi D, Bouvy ND, Masclee AAM, Conchillo JM. Does Measurement of Esophagogastric Junction Distensibility by EndoFLIP Predict Therapy- responsiveness to Endoluminal Fundoplication in Patients With Gastroesophageal Reflux Disease? J Neurogastroenterol Motil 2015; 21:255-64. [PMID: 25742904 PMCID: PMC4398245 DOI: 10.5056/jnm14111] [Citation(s) in RCA: 27] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/24/2014] [Revised: 11/11/2014] [Accepted: 11/12/2014] [Indexed: 12/13/2022] Open
Abstract
Background/Aims In patients with gastroesophageal reflux disease (GERD), an increased esophagogastric junction (EGJ) distensibility has been described. Assessment of EGJ distensibility with the endoscopic functional luminal imaging probe (EndoFLIP) technique might identify patients responsive to transoral incisionless fundoplication (TIF), whereas postoperative measurement of EGJ distensibility might provide insight into the antireflux mechanism of TIF. Therefore, we investigated the value of the EndoFLIP technique in GERD patients treated by TIF. Methods Forty-two GERD patients underwent EGJ distensibility measurement before TIF using the EndoFLIP technique. In a subgroup of 25 patients, EndoFLIP measurement was repeated both postoperative and at 6 months follow-up. Treatment outcome was assessed according to esophageal acid exposure time (AET; objective outcome) and symptom scores (clinical outcome) 6 months after TIF. Results Multiple logistic regression analysis showed that preoperative EGJ distensibility (OR, 0.16; 95% CI, 0.03–0.78; P = 0.023) and preoperative AET (OR, 0.62; 95% CI, 0.42–0.90; P = 0.013) were independent predictors for objective treatment outcome but not for clinical outcome after TIF. The best cut-off value for objective outcome was 2.3 mm2/mmHg for preoperative EGJ distensibility and 11% for preoperative AET. EGJ distensibility decreased direct postoperative from 2.0 (1.2–3.3) to 1.4 (1.0–2.2) mm2/mmHg (P = 0.014), but increased to 2.2 (1.5–3.0) at 6 months follow-up (P = 0.925, compared to preoperative). Conclusions Preoperative EGJ distensibility and preoperative AET were independent predictors for objective treatment outcome but not for clinical outcome after TIF. According to our data, the EndoFLIP technique has no added value either in the preoperative diagnostic work-up or in the post-procedure evaluation of endoluminal antireflux therapy.
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Affiliation(s)
- Fabienne G M Smeets
- Departments of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, the Netherlands.,NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University , Maastricht, the Netherlands
| | - Daniel Keszthelyi
- Departments of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, the Netherlands.,NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University , Maastricht, the Netherlands
| | - Nicole D Bouvy
- Departments of General Surgery, Maastricht University Medical Center, Maastricht, the Netherlands
| | - Ad A M Masclee
- Departments of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, the Netherlands.,NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University , Maastricht, the Netherlands
| | - Jose M Conchillo
- Departments of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, the Netherlands.,NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University , Maastricht, the Netherlands
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Witteman BPL, Conchillo JM, Rinsma NF, Betzel B, Peeters A, Koek GH, Stassen LPS, Bouvy ND. Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. Am J Gastroenterol 2015; 110:531-42. [PMID: 25823768 DOI: 10.1038/ajg.2015.28] [Citation(s) in RCA: 78] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/02/2014] [Accepted: 12/02/2014] [Indexed: 02/07/2023]
Abstract
OBJECTIVES Transoral incisionless fundoplication (TIF) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery. The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease (GERD) patients controlled with proton pump inhibitors (PPIs) who opted for an endoscopic intervention over lifelong drug dependence. METHODS Patients with chronic GERD were randomized (2:1) for TIF or continuation of PPI therapy. American Society of Anesthesiologists >2, body mass index >35 kg/m(2), hiatal hernia >2 cm, and esophageal motility disorders were exclusion criteria. Primary outcome measure was GERD-related quality of life. Secondary outcome measures were esophageal acid exposure, number of reflux episodes, PPI usage, appearance of the gastroesophageal valve, and healing of reflux esophagitis. Crossover for the PPI group was allowed after 6 months. RESULTS A total of 60 patients (TIF n=40, PPI n=20, mean body mass index 26 kg/m(2), 37 male) were included. At 6 months, GERD symptoms were more improved in the TIF group compared with the PPI group (P<0.001), with a similar improvement of distal esophageal acid exposure (P=0.228) compared with baseline. The pH normalization for TIF group and PPI group was 50% and 63%, respectively. All patients allocated for PPI treatment opted for crossover. At 12 months, quality of life remained improved after TIF compared with baseline (P<0.05), but no improvement in esophageal acid exposure compared with baseline was found (P=0.171) and normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61%. CONCLUSION Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved.
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Affiliation(s)
- Bart P L Witteman
- 1] Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands [2] Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands
| | - Jose M Conchillo
- Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands
| | - Nicolaas F Rinsma
- Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands
| | - Bark Betzel
- Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands
| | - Andrea Peeters
- Department of Clinical Epidemiolgy and Medical Technology Assessment, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands
| | - Ger H Koek
- Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands
| | - Laurents P S Stassen
- Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands
| | - Nicole D Bouvy
- Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands
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Hunter JG, Kahrilas PJ, Bell RCW, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis KM, Turgeon DG, Hungness ES, Diggs BS. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology 2015; 148:324-333.e5. [PMID: 25448925 DOI: 10.1053/j.gastro.2014.10.009] [Citation(s) in RCA: 131] [Impact Index Per Article: 13.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/16/2014] [Revised: 10/06/2014] [Accepted: 10/07/2014] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.
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Affiliation(s)
- John G Hunter
- Department of Surgery, Oregon Health & Science University, Portland, Oregon.
| | - Peter J Kahrilas
- Department of Surgery and Department of Gastroenterology, Northwestern University, Chicago, Illinois
| | | | - Erik B Wilson
- Department of Surgery, University of Texas Health Science Center, Houston, Texas
| | - Karim S Trad
- Department of Surgery, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia; Reston Surgical Associates, Reston, Virginia
| | - James P Dolan
- Department of Surgery, Oregon Health & Science University, Portland, Oregon
| | - Kyle A Perry
- Department of Surgery, The Ohio State University, Columbus, Ohio
| | | | - Nathaniel J Soper
- Department of Surgery and Department of Gastroenterology, Northwestern University, Chicago, Illinois
| | - Brad E Snyder
- Department of Surgery, University of Texas Health Science Center, Houston, Texas
| | - Miguel A Burch
- Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California
| | | | - Kevin M Reavis
- Department of Surgery, Oregon Health & Science University, Portland, Oregon; Department of Surgery, Oregon Clinic, Portland, Oregon
| | - Daniel G Turgeon
- Department of Surgery, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia; Reston Surgical Associates, Reston, Virginia
| | - Eric S Hungness
- Department of Surgery and Department of Gastroenterology, Northwestern University, Chicago, Illinois
| | - Brian S Diggs
- Department of Surgery, Oregon Health & Science University, Portland, Oregon
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Does the cost of robotic cholecystectomy translate to a financial burden? Surg Endosc 2014; 29:2115-20. [PMID: 25492447 DOI: 10.1007/s00464-014-3933-8] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/09/2014] [Accepted: 10/01/2014] [Indexed: 01/05/2023]
Abstract
INTRODUCTION Robotic application to cholecystectomy has dramatically increased, though its impact on cost of care and reimbursement has not been elucidated. We undertook this study to evaluate and compare cost of care and reimbursement with robotic versus laparoscopic cholecystectomy. METHODS AND PROCEDURES The charges and reimbursement of all robotic and laparoscopic cholecystectomies at one hospital undertaken from June 2012 to June 2013 were determined. Operative duration is defined as time into and time out of the operating room. Data are presented as median data. Comparisons were undertaken using the Mann-Whitney U-test with significance accepted at p ≤ 0.05. RESULTS Robotic cholecystectomy took longer (47 min longer) and had greater charges ($8,182.57 greater) than laparoscopic cholecystectomy (p < 0.05 for each). However, revenue, earnings before depreciation, interest, and taxes (EBDIT), and Net Income were not impacted by approach. CONCLUSIONS Relative to laparoscopic cholecystectomy, robotic cholecystectomy takes longer and has greater charges. Revenue, EBDIT, and Net Income are similar after either approach; this indicates that costs with either approach are similar. Notably, this is possible because much of hospital-based costs are determined by cost allocation and not cost accounting. Thus, the cost of longer operations and costs inherent to the robotic approach for cholecystectomy do not translate to a perceived financial burden.
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Ashfaq A, Rhee HK, Harold KL. Revision of failed transoral incisionless fundoplication by subsequent laparoscopic Nissen fundoplication. World J Gastroenterol 2014; 20:17115-17119. [PMID: 25493024 PMCID: PMC4258580 DOI: 10.3748/wjg.v20.i45.17115] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/29/2013] [Revised: 03/18/2014] [Accepted: 05/29/2014] [Indexed: 02/06/2023] Open
Abstract
AIM: To evaluate the feasibility and outcomes of laparoscopic Nissen fundoplication after failed transoral incisionless fundoplication (TIF).
METHODS: TIF is a new endoscopic approach for treating gastroesophageal reflux disease (GERD). In cases of TIF failure, subsequent laparoscopic fundoplication may be required. All patients from 2010 to 2013 who had persistence and objective evidence of recurrent GERD after TIF underwent laparoscopic Nissen fundoplication. Primary outcome measures included operative time, blood loss, length of hospital stay and complications encountered.
RESULTS: A total of 5 patients underwent revisional laparoscopic Nissen fundoplication (LNF) or gastrojejunostomy for recurrent GERD at a median interval of 24 mo (range: 16-34 mo) after TIF. Patients had recurrent reflux symptoms at an average of 1 mo following TIF (range: 1-9 mo). Average operative time for revisional surgical intervention was 127 min (range: 65-240 min) and all surgeries were performed with a minimal blood loss (< 50 mL). There were no cases of gastric or esophageal perforation. Three patients had additional finding of a significant hiatal hernia that was fixed simultaneously. Median length of hospitalization was 2 d (range: 1-3 d). All patients had resolution of symptoms at the last follow up.
CONCLUSION: LNF is a feasible and safe option in a patient who has persistent GERD after a TIF. Previous TIF did not result in additional operative morbidity.
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Testoni PA, Testoni S, Mazzoleni G, Vailati C, Passaretti S. Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Surg Endosc 2014; 29:2770-80. [PMID: 25480624 DOI: 10.1007/s00464-014-4008-6] [Citation(s) in RCA: 65] [Impact Index Per Article: 5.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/21/2014] [Accepted: 11/11/2014] [Indexed: 12/11/2022]
Abstract
BACKGROUND Transoral incisionless fundoplication (TIF) with the EsophyX™ device creates an antireflux valve with good functional results in patients with gastro-esophageal reflux disease (GERD). The aim of this study was to assess the long-term effect of TIF 2.0 on pathological reflux and symptoms in GERD patients with daily dependence on proton pump inhibitors (PPI). METHODS Fifty patients underwent TIF. All underwent GERD-HRQL and GERD-QUAL questionnaires, upper GI endoscopy, esophageal manometry, and 24-h pH-impedance before and 6, 12, and 24 months after TIF, and subsequent yearly clinical re-evaluation. RESULTS Patients were followed for up to six years (mean 52.7 ± 19.7 months). In all, 83.7, 79.6, 87.8, and 84.4% of patients stopped or halved the PPI therapy 6, 12, 24, and 36 months after TIF. Three-year figure remained stable up to 6 years. Symptom scores off PPI were significantly lower at 6, 12, 24, and 36 months. At 6 months, Hill's grade I of the newly created valve persisted in all pre-procedure Hill's grade I patients, in 66.7% of grade II and 58.3% of grade III. This figure remained substantially unchanged at 12 and 24 months, too. Impedance monitoring indicated significantly fewer total and acid refluxes after treatment (p = 0.01). Factors predicting good outcomes were pre-procedure Hill's grade I-II, no hiatal hernia or hernia ≤2 cm (p = 0.03), absence of ineffective esophageal motility (p < 0.0001), and number of fasteners deployed (p = 0.01). CONCLUSIONS TIF by the EsophyX achieved lasting elimination of daily dependence on PPI in 75-80% of patients for up to 6 years. TIF seems an effective therapy for selected symptomatic GERD patients.
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Affiliation(s)
- Pier Alberto Testoni
- Unit of Gastroenterology and Gastrointestinal Endoscopy, Division of Experimental Oncology, IRCCS San Raffaele Scientific Institute - Vita-Salute San Raffaele University, Milan, Italy,
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Edriss H, El-Bakush A, Nugent K. Esophgeal Perforation and Bilateral Empyema Following Endoscopic EsophyX Transoral Incisionless Fundoplication. Clin Endosc 2014; 47:560-3. [PMID: 25505723 PMCID: PMC4260105 DOI: 10.5946/ce.2014.47.6.560] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2013] [Revised: 10/17/2013] [Accepted: 10/19/2013] [Indexed: 01/10/2023] Open
Abstract
Transoral incisionless fundoplication (TIF) has been used for endoscopic treatment of gastroesophageal reflux disease (GERD). TIF using the EsophyX device system (EndoGastric Solutions) was designed to create a full-thickness valve at the gastroesophageal junction through the insertion of multiple fasteners; it improves GERD, reduces proton pump inhibitor use, and improves quality of life. Although TIF is effective in select patients, a significant subset of patients undergoing TIF develop persistent or recurrent GERD symptoms and may need antireflux surgery to control the GERD symptoms. We now report a 48-year-old man with chronic GERD unresponsive to medical management. He underwent TIF complicated by esophageal perforation and developed mediastinitis, left pneumothorax, bilateral pleural effusions, and acute respiratory failure. He required chest tube placement and bilateral decortication for treatment of nonresolving empyemas. Additional postmarketing studies are required to assess the safety, efficacy, and clinical outcomes of this novel procedure, and patients undergoing this procedure need close postprocedural follow-up.
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Affiliation(s)
- Hawa Edriss
- Department of Internal Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA
| | - Amal El-Bakush
- Department of Internal Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA
| | - Kenneth Nugent
- Department of Internal Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA
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Trad KS, Simoni G, Barnes WE, Shughoury AB, Raza M, Heise JA, Turgeon DG, Fox MA, Mavrelis PG. Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study. BMC Gastroenterol 2014; 14:174. [PMID: 25284142 PMCID: PMC4287131 DOI: 10.1186/1471-230x-14-174] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/07/2014] [Accepted: 10/03/2014] [Indexed: 12/15/2022] Open
Abstract
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. Results Of 63 randomized patients, 3 were lost to follow-up, leaving 39 TF and 21 COP for analyses. In the COP, TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs. Of 20 patients with GERD symptoms after six months of high-dose PPI therapy, 65% (13/20) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs; 67% (6/9) reported no troublesome regurgitation. Esophagitis further healed in 75% (6/8) of patients. Seventy-one percent of COP patients were off PPIs six months following TF. Normalization of EAE decreased from 52% after HD PPIs (on PPIs) to 33% after TF (off PPIs), p =0.388. In the original TF group, 12-month post TF, 77% of patients achieved complete symptom control, 82% ceased PPI therapy, 100% healed esophagitis and 45% normalized EAE. Conclusions The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing. In the original TF group, the clinical outcomes of TF remained stable between 6- and 12-month follow-up. Trail registration Clinicaltrials.gov: NCT01647958. Electronic supplementary material The online version of this article (doi:10.1186/1471-230X-14-174) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Karim Sami Trad
- Department of Surgery, The George Washington University School of Medicine and Health Sciences, Washington DC, USA.
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Toomey P, Teta A, Patel K, Ross S, Sukharamwala P, Rosemurgy AS. Transoral Incisionless Fundoplication: Is it as Safe and Efficacious as a Nissen or Toupet Fundoplication? Am Surg 2014. [DOI: 10.1177/000313481408000918] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
Transoral incisionless fundoplication (TIF) was U.S. Food and Drug Administration-approved in 2007 to treat gastroesophageal reflux disease (GERD), but comparative data are lacking. This study was undertaken to compare outcomes for patients with GERD undergoing TIF versus laparoscopic Nissen or Toupet fundoplications. We undertook a case-controlled study of three cohorts of 20 patients undergoing TIF or laparoscopic Nissen or Toupet fundoplications from 2010 to 2013 controlling for age, body mass index, and preoperative DeMeester scores. All patients were pro-spectively followed. Median data are reported. Patients undergoing TIF had significantly shorter operative times (in minutes: 71 vs 119 and 85, respectively, P < 0.001) and length of stay (in days: 1, 2, and 1, respectively, P < 0.001). No matter the approach, patients reported dramatic and similar reduction in symptom frequency and severity (e.g., heartburn 8 to 0, P < 0.05). At follow-up, 83 per cent of patients after TIF, 80 per cent after Nissen, or 92 per cent after Toupet fundoplications had symptoms less than once per month ( P = 0.12). TIF leads to dramatic symptom resolution, similar when compared with Nissen or Toupet fundoplications. TIF promotes shorter operative times and lengths of stay. Patient satisfaction and effective palliation of symptoms show that TIF is safe and efficacious in comparison to Nissen and Toupet fundoplications and support its continued application and evaluation.
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Zacherl J, Roy-Shapira A, Bonavina L, Bapaye A, Kiesslich R, Schoppmann SF, Kessler WR, Selzer DJ, Broderick RC, Lehman GA, Horgan S. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial. Surg Endosc 2014; 29:220-9. [PMID: 25135443 PMCID: PMC4293474 DOI: 10.1007/s00464-014-3731-3] [Citation(s) in RCA: 60] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2014] [Accepted: 06/22/2014] [Indexed: 12/20/2022]
Abstract
BACKGROUND Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler. METHODS Patients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥ 50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months. RESULTS 66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60-83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥ 50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects. CONCLUSIONS The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group.
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Affiliation(s)
- Johannes Zacherl
- Department of General Surgery, Herz Jesu Krankenhaus, Vienna, Austria
| | - Aviel Roy-Shapira
- Department of Surgery A, Soroka University Hospital, Beer Sheva, Israel
| | - Luigi Bonavina
- Department of Surgery IRCCS Policlinico San Donato, University of Milan School of Medicine Director, Milan, Italy
| | - Amol Bapaye
- Department of Digestive Diseases & Endoscopy, Deenanath Mangeshkar Hospital & Research Center, Pune, India
| | - Ralf Kiesslich
- Department of Internal Medicine and Gastroenterology, St. Marienkrankenhaus Frankfurt, Frankfurt, Germany
| | - Sebastian F. Schoppmann
- Department of Surgery Comprehensive Cancer Center Vienna GET-Unit, Medical University of Vienna, Vienna, Austria
| | - William R. Kessler
- Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN USA
| | - Don J. Selzer
- Division of General Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN USA
| | - Ryan C. Broderick
- Department of Surgery, Division of Minimally Invasive Surgery, Center for the Future of Surgery, University of California San Diego, San Diego, CA USA
| | - Glen A. Lehman
- Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN USA
| | - Santiago Horgan
- Department of Surgery, Division of Minimally Invasive Surgery, Center for the Future of Surgery, University of California San Diego, San Diego, CA USA
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Abstract
There has been a marked decline over the last several years in drug development for gastroesophageal reflux disease and specifically for nonerosive reflux disease (NERD), despite there being many areas of unmet need. In contrast, we have seen a proliferation, during the same period of time, in development of novel, nonmedical therapeutic strategies for NERD using cutting-edge technology. Presently, compliance and lifestyle modifications are readily available noninvasive therapeutic interventions for NERD. Other nonmedical therapies include, the Stretta procedure, transoral incisionless fundoplication, and the magnetic sphincter augmentation device (LINX). Antireflux surgery, in experienced hands, has been repeatedly shown to be efficacious in resolving NERD-related symptoms. Psychological therapeutic interventions and alternative medicine techniques, such as acupuncture, continue to show promise, especially in NERD patients who failed antireflux treatment.
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Galmiche JP, Zerbib F, des Varannes SB. Treatment of GORD: Three decades of progress and disappointments. United European Gastroenterol J 2014; 1:140-50. [PMID: 24917952 DOI: 10.1177/2050640613484021] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/30/2013] [Accepted: 03/01/2013] [Indexed: 12/16/2022] Open
Abstract
The treatment of GORD has been revolutionized by the introduction, in the 1980s, of proton-pump inhibitors as the mainstay of medical therapy and by the development of laparoscopic antireflux surgery which has definitively replaced open surgery. However, despite these major advances, many unmet therapeutic needs still persist and justify novel therapeutic approaches. The aim of this historical review is to recall the main discoveries in the treatment of GORD that have occurred during the last three decades and to discuss why some initially promising drugs or techniques have not translated into clinical applications. A careful analysis of these previous disappointing experiences should help to identify high priorities and better research programmes on the management of GORD.
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Affiliation(s)
| | - Frank Zerbib
- CHU Bordeaux, Bordeaux, France ; Bordeaux Segalen University, Bordeaux, France
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Bell RCW, Fox MA, Barnes WE, Mavrelis PG, Sewell RW, Carter BJ, Ihde GM, Trad KS, Dargis D, Hoddinott KM, Freeman KD, Gunsberger T, Hausmann MG, Gill BD, Wilson E. Univariate and multivariate analyses of preoperative factors influencing symptomatic outcomes of transoral fundoplication. Surg Endosc 2014; 28:2949-58. [PMID: 24879134 PMCID: PMC4186971 DOI: 10.1007/s00464-014-3557-z] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/10/2014] [Accepted: 04/12/2014] [Indexed: 12/11/2022]
Abstract
Background
Preoperative factors predicting symptomatic improvement after transoral fundoplication (TF) in chronic gastroesophageal reflux disease (GERD) patients with persistent symptoms on proton-pump inhibitors (PPIs) therapy have not been elucidated fully. Methods Univariate and multivariate logistic regression analyses were performed on data from 158 consecutive patients who underwent TF with the EsophyX device between January 2010 and June 2012 in 14 community centers. Variables included age, gender, body mass index, GERD duration, PPIs therapy duration, presence of hiatal hernia, esophagitis, Hill grade, quality of life scores (QOL) on PPIs, % total time pH < 4, and DeMeester score on reflux testing off PPIs. Results All patients suffered from typical GERD symptoms. Additionally, 78 % (124/158) of patients suffered from atypical symptoms. Six percent (10/158) with recurrent GERD symptoms refractory to PPI therapy underwent revisional procedure (9 laparoscopic Nissen, 1 TF). Median follow-up was 22 (range 10–43) months. For patients with typical symptoms, univariate analyses revealed 4 preoperative factors predictive of successful outcomes: age ≥ 50 [odds ratio (OR) = 2.4, 95 % confidence interval (CI) = 1.2–4.8, p = 0.014], GERD Health-related Quality of Life score (GERD-HRQL) ≥ 15 on PPIs (OR = 6.0, CI = 1.2–29.4, p = 0.026, Reflux Symptom Index score > 13 on PPIs (OR = 2.4, CI = 1.1–5.2, p = 0.027), and Gastroesophageal Reflux Symptom Score ≥ 18 on PPIs (OR = 2.6, CI = 1.2–5.8, p = 0.018). Age and GERD-HRQL score remained significant predictors by multivariate analysis. For patients with atypical symptoms, only GERD-HRQL score ≥ 15 on PPIs (OR = 9.9, CI = 0.9–4.6, p = 0.036) was associated with successful outcomes. Conclusions Elevated preoperative QOL scores on PPIs and age ≥ 50 were most closely associated with successful outcome of TF in patients with persistent symptoms despite medical therapy.
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Affiliation(s)
- Reginald C W Bell
- SurgOne Foregut Institute, 401 West Hampden Place, Suite 230, Englewood, CO, 80110, USA,
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Univariate and multivariate analyses of preoperative factors influencing symptomatic outcomes of transoral fundoplication. Surg Endosc 2014. [PMID: 24879134 DOI: 10.1007/s00464-014-3557-z.] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/29/2022]
Abstract
BACKGROUND Preoperative factors predicting symptomatic improvement after transoral fundoplication (TF) in chronic gastroesophageal reflux disease (GERD) patients with persistent symptoms on proton-pump inhibitors (PPIs) therapy have not been elucidated fully. METHODS Univariate and multivariate logistic regression analyses were performed on data from 158 consecutive patients who underwent TF with the EsophyX device between January 2010 and June 2012 in 14 community centers. Variables included age, gender, body mass index, GERD duration, PPIs therapy duration, presence of hiatal hernia, esophagitis, Hill grade, quality of life scores (QOL) on PPIs, % total time pH < 4, and DeMeester score on reflux testing off PPIs. RESULTS All patients suffered from typical GERD symptoms. Additionally, 78% (124/158) of patients suffered from atypical symptoms. Six percent (10/158) with recurrent GERD symptoms refractory to PPI therapy underwent revisional procedure (9 laparoscopic Nissen, 1 TF). Median follow-up was 22 (range 10-43) months. For patients with typical symptoms, univariate analyses revealed 4 preoperative factors predictive of successful outcomes: age ≥ 50 [odds ratio (OR) = 2.4, 95% confidence interval (CI) = 1.2-4.8, p = 0.014], GERD Health-related Quality of Life score (GERD-HRQL) ≥ 15 on PPIs (OR = 6.0, CI = 1.2-29.4, p = 0.026, Reflux Symptom Index score > 13 on PPIs (OR = 2.4, CI = 1.1-5.2, p = 0.027), and Gastroesophageal Reflux Symptom Score ≥ 18 on PPIs (OR = 2.6, CI = 1.2-5.8, p = 0.018). Age and GERD-HRQL score remained significant predictors by multivariate analysis. For patients with atypical symptoms, only GERD-HRQL score ≥ 15 on PPIs (OR = 9.9, CI = 0.9-4.6, p = 0.036) was associated with successful outcomes. CONCLUSIONS Elevated preoperative QOL scores on PPIs and age ≥ 50 were most closely associated with successful outcome of TF in patients with persistent symptoms despite medical therapy.
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Pandolfino JE, Krishnan K. Do endoscopic antireflux procedures fit in the current treatment paradigm of gastroesophageal reflux disease? Clin Gastroenterol Hepatol 2014; 12:544-54. [PMID: 23811248 PMCID: PMC3880639 DOI: 10.1016/j.cgh.2013.06.012] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2013] [Revised: 06/06/2013] [Accepted: 06/08/2013] [Indexed: 12/12/2022]
Abstract
Gastroesophageal reflux disease (GERD) is a common condition requiring considerable medical resources. The mainstay of therapy is proton pump inhibitors (PPIs), which are effective at reducing acid reflux. In patients who have refractory acid reflux and esophagitis despite high-dose PPI, or are intolerant of the side effects of PPI therapy, surgical fundoplication is the primary therapy. The risk and cost gap between medical therapy and surgery has resulted in substantial interest in less-invasive endoscopic therapies. In this review, we discuss the underlying physiology of GERD along with the anatomic hurdles that must be overcome to develop an effective antireflux procedure. We also review the current published literature and assess the clinical efficacy of the devices that have been studied or currently are being investigated. Despite promising early studies, many of the devices fall short in high-quality randomized controlled trials. Furthermore, the physiologic aberration resulting in GERD oftentimes is addressed inadequately. Although there is certainly a need for less-invasive, safe, and effective therapy for reflux, therapy will need to withstand the established clinical efficacy of both PPI and surgical fundoplication. At present, we have the luxury of time to wait for such a device to become available.
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Affiliation(s)
- John E Pandolfino
- Department of Medicine, Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
| | - Kumar Krishnan
- Department of Medicine, Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois
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